Every health insurance policy issued under Insurance Article, Title 15, Annotated Code of Maryland, as amended to date, shall comply with this chapter (except that Regulation .03D and J of this chapter are not applicable to policies issued under Insurance Article, Title 13, Subtitle 3), as well as with any other regulations promulgated under Insurance Article, §12-203, concerning the submission of forms. As used in these regulations, the word “forms” includes applications, policies, certificates, contracts, riders, and endorsements except when the context indicates otherwise. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means a person that is: An insurer; or A nonprofit health service plan. “Health benefit plan” has the meaning stated in Insurance Article, §15-1301, Annotated Code of Maryland. “Individual health benefit plan” means a health benefit plan issued by a carrier to a policyholder to cover: The policyholder; The policyholder's dependents; or The policyholder and the policyholder's dependents. “Mail” means first class mail or compliance with the Uniform Electronics Transactions Act, Commercial Law Article, Title 21, Annotated Code of Maryland. “Policyholder” means the person to whom the carrier’s contract is issued. The filing of a form shall be accompanied by the filing of premium rates for it. Subsequent changes in premium rates shall be filed with supporting data at least 90 days before the date any change in the rate is proposed to become effective. A carrier submitting forms for approval, or premiums for forms pending approval or previously approved, shall print or type in a conspicuous manner immediately below the name of the carrier on the letter of transmittal the carrier’s National Association of Insurance Commissioners (NAIC) company code number. Any name or title of a policy should be printed in a size of type smaller than that used for the name of the carrier. Reference to a standard of time shall specify time at the place the insured resides, or at the place the accident or illness occurs, or at the place the policy is delivered. A form will not be approved for issuance at any age which does not provide a reasonable period of full coverage before the age at which benefits terminate or are substantially reduced. If a rider or endorsement reduces or eliminates coverage of a policy, signed acceptance by the policyowner at the time of or before delivery of the policy is required. Any form which by its terms provides that only one of several benefits will be payable as a result of any one accident or sickness shall state that the largest of the benefits will be payable. If the claimant has the right to elect alternative benefits, the time allowed for the election shall be not less than 90 days from the date of the accident or commencement of the loss. If payment of benefits is related to the first visit of a physician or the date of the first medical attendance, this stipulation shall appear in the benefit provision to which it applies. Payment of benefits may be limited in duration to the time the insured is under the care of a physician, but may not be conditioned upon any specified frequency of visits or attendance by the physician. Except in the case of group health insurance, if any policy provision terminates upon entry of the insured into military service, or if the policy excludes any coverage while the insured is in military service, the policy shall provide for a refund upon request of the policyowner of pro rata unearned premium for any period during which the insured is not covered. However, if coverage is excluded only for loss resulting from military service while in military service, a refund is not required. In policies of noncancellable or guaranteed renewable health insurance, when the coverage is automatically reinstated upon discharge from military service or within a stated period not exceeding 6 months after discharge, a refund is not required. In lieu of the definitions contained in §§L, M, and N of this regulation, the policy may contain a definition which, in the opinion of the Commissioner, is not less favorable to the policyholder. During at least the first 12 months, or the first 52 weeks, of disability, total disability for which benefits may become due and payable shall be defined as “inability by reason of injury or sickness to perform each and every duty pertaining to the insured's occupation”. After the first 12 months, or the first 52 weeks, of disability, total disability may be defined as “inability to perform each and every duty of any business or occupation for which the insured is reasonably fitted by education, training and experience”. Partial disability shall be defined as “inability to perform one or more, but not all, of the important daily duties of the insured's occupation”. If a form provides coverage due to the wrecking or disablement of, or material damage to, an automobile, elevator, or other conveyance in which the insured is a passenger at the time of the accident, the wrecking, disablement, or material damage shall be defined substantially as damage which necessitates repair in order to place the conveyance in as good a condition as it was before the accident. An exception excluding liability for chronic or organic disease will not be permitted. Any disease to be excluded from coverage shall be stated with sufficient clarity so as to be readily identifiable. A provision may not contain the words “reimburse” or “reimbursement” or the phrase “amount actually expended”. A benefit may not be conditioned on the payment by the claimant of expenses for which the policy provides a benefit. A form may not contain the phrase “strict compliance” or words of similar import. Except in the case of a health benefit plan, in any policy form in which the carrier has the right to change premium rates, the policy shall provide that notice of any increase in rates shall be given to the policyholder by mail at least 40 days before the expiration of the grace period applicable to the first increased premium. In any individual health benefit plan in which the carrier has the right to change premium rates, the health benefit plan shall provide that notice of any increase in premium rates shall be given to the policyholder by mail at least 45 days before the change in premium rates is proposed to become effective. A noncancellable or guaranteed renewable family health insurance policy which covers the spouse of the insured shall provide that, in the event of the death of the insured applicant, the spouse will become the successor insured. Insurance Article, §§2-109, 12-203, 12-205, 13-110(a), 13-111(b), 14-109(3)(iv), 14-126(a)(1), 14-405(b)(9),14-410(c), 15-903, 15-904, 15-906 — 15-908, and 15-911,; Annotated Code of Maryland Effective date: June 1, 1965 Amended effective May 1, 1968 Regulation .02A-1 adopted effective July 19, 1993 (20:13 Md. R. 1169) Chapter recodified from COMAR 09.30.44 to COMAR 31.10.01 effective September 7, 1998 (25:18 Md. R. 1439) Chapter revised effective September 17, 2012 (39:18 Md. R. 1198) Regulation .02B amended effective May 9, 2016 (43:9 Md. R. 532) Regulation .03S amended effective May 9, 2016 (43:9 Md. R. 532) This chapter does not apply to: Group health insurance policies initially issued to employer/employee groups of more than 1,000 employees; Group health insurance policies issued pursuant to a collective bargaining labor-management agreement; or Reinsurance contracts. Except as provided in §A of this regulation, this chapter applies to all health insurance policies, including riders, endorsements, and certificates, issued or delivered in this State by any insurer or nonprofit health service plan. The Insurance Commissioner may except other policies from the requirements of this chapter if the Commissioner determines that an exception is warranted by the nature of the particular policy form or if the policy language is drafted to conform to requirements of any other applicable law or regulation. In addition to any other requirements or law, a policy form to which this chapter is applicable may not be issued or delivered in this State unless: The text achieves a minimum score of 40 on the Flesch Reading Ease Test; The policy contains a table of contents or an index of the principal sections of the policy if it has more than 3,000 words or more than three pages regardless of the number of words; The style, arrangement, and overall appearance of the policy do not give undue prominence to any portion of the text or to any endorsements or riders; and Except for specification pages, schedules, tables, and tables of contents, if any, the policy is plainly printed in a style in general use and the size is uniform and not less than 10-point type, 1-point leaded, with a lower case alphabet length not less than 120 point. If any provision of Insurance Article, Annotated Code of Maryland, requires that any particular section of a policy or any particular type of policy be printed in larger type style or with greater prominence, then the provisions of the Insurance Article prevail over the requirements of these regulations. The Flesch Reading Ease Test scores shall be calculated according to the requirements of §§B—F of this regulation. For policy forms containing 10,000 words or less of text, the entire form shall be analyzed. For policy forms containing more than 10,000 words, the readability of two 200-word samples per page may be analyzed instead of the entire form. The samples shall be separated by at least 20 printed lines. The number of words and sentences in the text shall be counted and the total number of words divided by the total number of sentences. The figure obtained shall be multiplied by a factor of 1.015. The total number of syllables shall be counted and divided by the total number of words. The figure obtained shall be multiplied by a factor of 84.6. The sum of the figures computed in §§C and D of this regulation, subtracted from 206.835, equals the Flesch Reading Ease Test Score for the policy form. For purposes of §§C—E of this regulation, the following procedures shall be used: A contraction, hyphenated word, or number or letter separated by spaces is counted as one word; A unit of words ending with a period, semicolon, or colon, but excluding headings and captions, is counted as one sentence; and A syllable means a unit of spoken language consisting of one or more letters of a word as divided by a commonly accepted dictionary, although when the dictionary shows two or more equally acceptable pronunciations of a word, the pronunciation containing fewer syllables may be used. The Flesch Reading Ease Test shall be applied to all printed matter in the policy, except for: The name and address of the insurer, policy number, name or title of policy, table of contents or index, specification pages, schedules, tables, captions, and subcaptions; and Medical terminology, language which is drafted to conform to the requirements of any applicable law or regulation, language required by a collective bargaining labor-management agreement, or terms defined in the policy. At the option of the insurer, riders, endorsements, and other forms which are attached to and made a part of the policy may be scored separately or as part of the policy with which they are to be used. A policy form to which these regulations apply, and which is required to be submitted for approval in accordance with Insurance Article, §§12-203 and 12-205, Annotated Code of Maryland, shall be accompanied by a certificate signed by an officer of the insurer stating that the language of the form has been measured by the Flesch Reading Ease Test, and giving the resulting score achieved on that test. If any language has been omitted from the test in accordance with Regulation .03G(2) of this chapter, the certificate shall so specify. These regulations apply to all health insurance policies, certificates, riders, and endorsements submitted for approval on or after January 1, 1992. If any policy form, certificate, rider, or endorsement which does not comply with the minimum standards of Regulation .02 of this chapter has been submitted for approval before January 1, 1992, and approved by the Commissioner, it may be issued or delivered in this State until January 1, 1997, but not after that unless it has been submitted or resubmitted in accordance with the requirements of these regulations. A policy form, certificate, rider, or endorsement submitted before January 1, 1992, which complies with the minimum standards of Regulation .02 of this chapter need not be resubmitted. Insurance Article, §§2-109, 12-102—12-104, 12-107, 12-203—12-205, 12-209, 15-103, 15-201, 15-202, 15-402, 15-502, 15-916, 15-919, and 15-924, Annotated Code of Maryland Effective date: March 30, 1992 (19:6 Md. R. 672) Chapter recodified from COMAR 09.30.36 to COMAR 31.10.02 effective September 7, 1998 (25:18 Md. R. 1439) Effective date: September 25, 1995 (22:19 Md. R. 1473) Regulation .02B, .03B, and .05 amended as an emergency provision effective December 23, 1995 (23:2 Md. R. 92); emergency status expired April 1, 1996 Chapter recodified from COMAR 09.31.02 to COMAR 31.10.03 effective September 7, 1998 (25:18 Md. R. 1439) Chapter repealed effective January 16, 2006 (33:1 Md. R. 40) This chapter applies to all insurers writing health insurance in this State. This chapter does not apply to health benefit plans issued under Insurance Article, Title 15, Subtitles 12, 13, or 14, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Health benefit plan” has the meaning stated in Insurance Article, §31-101, Annotated Code of Maryland. “Health insurance product” means any: Group or individual health insurance policy or contract which covers a Maryland resident; Individual health insurance contract issued to a Maryland resident; or Rider to any group or individual health insurance contract issued to a Maryland resident. “Single case basis” means a contract which was approved by the Maryland Insurance Administration for issuance to only one contract holder in Maryland. When an insurer intends to cancel or not renew a health insurance product for all of the insurer's covered insureds in the State, the insurer shall file a plan of withdrawal with the Commissioner at least 90 days from the date of the proposed cancellation or nonrenewal. When an insurer intends to cancel or not renew all of the insurer's health insurance products for all of its covered insureds in the State, the insurer shall file a plan of withdrawal with the Commissioner at least 180 days before the date of the proposed withdrawal. A plan of withdrawal may not be required for nonrenewal of a contract which was approved for issuance on a single case basis. Insurance Article, §§2-109 and 27-606, Annotated Code of Maryland Effective date: October 9, 1995 (22:20 Md. R. 1543) Chapter recodified from COMAR 09.31.10 to COMAR 31.10.04 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .01B amended effective May 9, 2016 (43:9 Md. R. 532) Regulation .02B amended effective May 9, 2016 (43:9 Md. R. 532) The purpose of this chapter is to provide for the reasonable standardization of coverage and simplification of terms and benefits of Medicare supplement policies, to facilitate public understanding and comparison of these policies, to eliminate policy provisions which may be misleading or confusing in connection with the purchase of the policies or with the settlement of claims, and to provide for full disclosures in the sale of health insurance coverages to persons eligible for Medicare by reason of age. This chapter is issued pursuant to the authority given the Insurance Commissioner under Insurance Article, §2-109 and TItle 15, Subtitle 9, and Health-General Article, §§19-705 and 19-706, Annotated Code of Maryland. Except as otherwise specifically provided, this chapter applies to all: Medicare supplement policies and subscriber contracts delivered or issued for delivery in this State before July 1, 1992; and Certificates issued under group Medicare supplement policies or subscriber contracts if the certificates were delivered or issued for delivery in this State before July 1, 1992. Whenever used in this chapter or in a Medicare supplement policy subject to these regulations, or in any advertisement soliciting a Medicare supplement policy, the following terms shall have the meanings indicated. Terms Defined. “Applicant” means, in the case of: An individual Medicare supplement policy or subscriber contract, the person who seeks to contract for insurance benefits; and A group Medicare supplement policy or subscriber contract, the proposed certificate holder. “Certificate” means any certificate issued under a group Medicare supplement policy or contract which has been delivered or issued for delivery in this State, including any individual certificate issued by a nonprofit health service plan or by a health maintenance organization. “Direct response solicitation” means solicitation of individuals or groups through the mail or by mass media advertising, including both print and broadcast advertising. “Health care expenses” means expenses of health maintenance organizations associated with the delivery of health care services which are analogous to incurred losses of insurers. These expenses do not include: Home office and overhead costs; Advertising costs; Commissions and other acquisition costs; Taxes; Capital costs; Administrative costs; or Claims processing costs. “Health insurance” means insurance coverage as defined in Insurance Article, §1-101(q), Annotated Code of Maryland. “Individual policy” means: Individually issued policies and certificates; and Certificates issued under group policies as a result of the direct response solicitation. “Low-dose mammography” means X-ray examination of the breast using dedicated equipment including an X-ray tube, filter, compression device, screens, films, and cassettes specifically for mammography with average radiation exposure to deliver less than 1 rad mid-breast, two views per breast. “Medicaid” means the Maryland Medical Assistance Program or any similar program provided by the State in which the insured person resides. “Medicare” means the Health Insurance for the Aged Act, Title XVIII of the Social Security Amendments of 1965 as then constituted or later amended. “Medicare eligible expenses” means health care expenses of the kinds covered by Medicare to the extent these services are considered reasonable under Medicare rules and regulations. Medicare Supplement Policy. “Medicare supplement policy” means an individual or group policy, subscriber contract, or certificate of health insurance primarily designed, advertised, marketed, or otherwise purported to be a supplement to reimbursements under Medicare for the hospital, medical, surgical, nursing, or related expenses of persons eligible for Medicare by reason of age. “Medicare supplement policy” does not include benefits offered by a health maintenance organization or other direct service organization in connection with a contract with the United States Health Care Financing Administration. “Medigap policy” means a Medicare supplement policy. “Policy and subscriber contracts”, whenever they appear in these regulations, include “certificate” unless the context indicates otherwise. An insurance policy, subscriber contract, or certificate may not be advertised, marketed, solicited, or issued for delivery in this State as a Medicare supplement policy unless it contains definitions or terms which conform to the requirements of this regulation, or definitions which are more favorable to the insured person or certificate holder. Terms To Be Defined in the Policy. Accident. “Accident”, “accidental injury”, or “accidental means” shall be defined to employ “result” language and may not include words which establish an accidental means test or use words such as “external, violent, and accidental means”, “visible contusion or wound”, or words of similar import, description, or characterization. The definition may not be more restrictive than the following: “Injury or injuries for which benefits are provided means accidental bodily injury sustained by the insured person which is the direct result of an accident, independent of disease or bodily infirmity or any other cause, and occurs while insurance coverage is in force.” The definition may additionally provide that injuries do not include injuries for which benefits are provided or available to the insured under any workers' compensation, occupational disease, employer's liability, or similar law, or to the extent permitted by law, to benefits provided or available under any motor vehicle no-fault plan. “Benefit period” or “Medicare benefit period” may not be defined in a manner more restrictive than as defined in the Medicare program. “Convalescent nursing home”, “extended care facility”, or “skilled nursing facility” shall be defined in relation to its status, facilities, and available services. The following apply: The definition may not be more restrictive than one requiring that the home or facility: Be operated pursuant to law; Be approved for payment of Medicare benefits or be qualified to receive that approval; Be primarily engaged in providing, in addition to room and board accommodations, skilled nursing care under the supervision of a duly licensed physician; Provide continuous 24-hour-a-day nursing service by or under the supervision of a registered graduate professional nurse (R.N.); and Maintain a daily medical record of each patient. The definition of the home or facility may provide that the term does not include: A home, facility, or part of a home or facility used primarily for rest; A home or facility for the aged or for the care of drug addicts or alcoholics; or A home or facility primarily used for the care and treatment of mental diseases or disorders, or for custodial or educational care. “Hospital” shall be defined in relation to its status, facilities, and available services, or to reflect its accreditation by the Joint Commission on Accreditation of Hospitals. The definition of the term “hospital”: May not be more restrictive than one requiring that the hospital: Be an institution operated pursuant to law, Be primarily and continuously engaged in providing or operating, either on its premises or in facilities available to the hospital on a prearranged basis and under the supervision of a staff of duly licensed physicians, medical, diagnostic, and major surgical facilities for the medical care and treatment of sick or injured persons on an inpatient basis, for which a charge is made, and Provide 24-hour nursing service by or under the supervision of registered graduate professional nurses (R.N.'s); May provide that the term does not include: Convalescent homes, convalescent rest or nursing facilities, Facilities primarily affording custodial, educational, or rehabilitative care, Facilities for the aged, drug addicts or alcoholics, military, veterans' or soldiers' home, or any hospital contracted for or operated by any national government or national governmental agency for the treatment of members or ex-members of the armed forces, except for services rendered on an emergency basis when legal liability exists for charges made to the individual for these services. “Medicare” shall be defined in the policy substantially either as: “The Health Insurance for the Aged Act, Title XVIII of the Social Security Amendments of 1965 as then constituted or later amended”; or “Title I, Part 1 of Public Law 89-97, as enacted by the 89th Congress of the United States of America and popularly known as the Health Insurance for the Aged Act, as then constituted and any later amendments or substitutes of that Act.” “Medicare eligible expenses” shall be defined in the policy as health care expenses of the kind covered by Medicare, to the extent recognized as reasonable by Medicare. The insurer may modify the definition to provide that payments under the policy will be conditioned on less restrictive payment conditions, including determinations of medical necessity, than the conditions applicable to medical claims. “Mental or nervous disorders” may be defined in a manner which includes neurosis, psychoneurosis, psychopathy, psychosis, and mental and emotional disease or disorder of any kind. “Nurse” may be defined to include a registered graduate professional nurse (R.N.), a licensed practical nurse (L.P.N.), a licensed nurse anesthetist, or a licensed vocational nurse (L.V.N.). The use of the words “nurse” or “trained nurse” without further qualification will require the insurer to recognize the services of any individual qualified under applicable statutes or regulations provided the nurse is acting within the lawful scope of practice of the nurse's license. “Physician” shall be defined to include a licensed physician or any duly licensed provider of medical care and treatment when the services to be performed are within the lawful scope of practice of the provider. “Sickness” shall be defined so as to be not more restrictive than a sickness or disease of an insured person which first manifests itself after the effective date of the insurance and while the insurance is in force. The insurer may modify the definition to exclude sickness or disease for which benefits are provided under any workers' compensation, occupational disease, employer's liability, or similar law. Waivers may not be included in or attached to a Medicare supplement policy if the effect of the waivers is to exclude, limit, or reduce coverage or benefits for specifically named or described diseases or physical conditions. A Medicare supplement policy or subscriber contract may not be advertised, solicited, or issued for delivery in this State as a Medicare supplement policy or subscriber contract if the policy or contract limits or excludes coverage by type of illness, accident, treatment, or medical condition, except for the following, provided however, that if any of the following limitations or exclusions are contained in a Medicare supplement policy, the limitation or exclusion may not be more restrictive than that applicable to the Medicare program: Foot care in connection with corns, calluses, flat feet, fallen arches, weak feet, chronic foot strain, or symptomatic complaints of the feet; Mental or emotional disorders, alcoholism, and drug addiction; Illness, treatment, or medical condition arising out of: War or act of war (whether declared or undeclared), participation in a felony, riot or insurrection, service in the armed forces or auxiliary units, Suicide while sane or insane, attempted suicide, or intentionally self-inflicted injury, or Aviation or air travel other than as a fare-paying passenger on a regularly scheduled airline or on a group-chartered plane; Cosmetic surgery, but this exclusion may not apply to reconstructive surgery when the surgery is incidental to or follows surgery resulting from trauma, infection, or diseases of the involved part; Care in connection with the detection and correction by manual or mechanical means of structural imbalance, distortion, or subluxation in the human body for purposes of removing nerve interference and their effects, if the interference is the result of or related to distortion, misalignment or subluxation of, or in, the vertebral column; Treatment provided in a federal government hospital, benefits provided under Medicare or other governmental program (except Medicaid), any workers' compensation, employer's liability or occupational disease or similar law, or any motor vehicle no-fault or similar law; Services rendered by, and separately billed by, the employees of hospitals, laboratories, or other institutions; Services performed by a member of the covered person's immediate family, and services for which no charge is normally made in the absence of insurance; Dental care or treatment; Eyeglasses, hearing aids, and examination for their prescription or fitting; Rest cures, custodial care, transportation, and routine physical examinations; Territorial limitations outside the United States; and Coverage of any expense to the extent of any benefit available to the insured under Medicare. The terms “Medicare supplement”, “Medigap”, and words of similar import may not be used in connection with the advertisement, solicitation, or policy description or title unless the policy is issued in compliance with these regulations. A Medicare supplement policy, contract, or certificate in force in this State may not include benefits which duplicate benefits provided by Medicare. An insurer may not deny, reduce, or condition coverage or apply an increased premium rating to an applicant for a Medicare supplement policy by reason of the applicant's health status, claims experience, medical condition, or use of medical care if the applicant applies for the Medicare supplement policy within the first 6 months after becoming eligible for Medicare by reason of age. However, the insurer may include a provision with regard to preexisting conditions which complies with Regulation .07B(1) of this chapter. A health insurance policy, contract, or certificate may not be advertised, marketed, solicited, or issued for delivery in this State as a Medicare supplement policy or as a Medigap policy unless it meets the following general and minimum standards and unless the insurer and its agents adhere to the requirements of the Maryland statutes and regulations regarding the sale of Medicare supplement policies. The minimum standards do not preclude the provision of additional benefits which are not inconsistent with these requirements and the use of other provisions which are more favorable to the insured or the policyholder. Whenever a policy is referred to in these regulations, it shall include a certificate. General Standards. A Medicare supplement policy may not deny a claim for losses incurred more than 6 months after the effective date of coverage for a preexisting condition. The policy may not define a preexisting condition more restrictively than a condition for which medical advice was given or treatment was recommended by or received from a physician within 6 months before the effective date of coverage. A Medicare supplement policy may not provide benefits for losses resulting from sickness on a different basis than benefits provided for losses resulting from accidents. Automatic Changes to Correspond to Changes in Medicare. A Medicare supplement policy shall provide that benefits designed to cover deductibles or coinsurance amounts under Medicare will be changed automatically to coincide with any corresponding changes in the applicable Medicare deductible and copayment amounts. The insurer shall reserve the right to adjust premiums under the policy for the changes described in §B(3)(a) of this regulation. Proposed premium adjustments shall be submitted for approval by the Commissioner in accordance with the requirements of COMAR 31.10.01 and with other applicable regulations and statutes. Guaranteed Renewability. A Medicare supplement policy which provides coverage for an insured and spouse shall provide, except in the event of nonpayment of premium, continuation of coverage on the: Insured if coverage for the spouse is terminated; and Spouse if coverage for the insured is terminated. Except in the event of nonpayment of premium, or as authorized by the Commissioner, an insurer may not cancel or nonrenew a Medicare supplement policy or certificate. Extension of Benefits. Termination of a Medicare supplement policy shall be without prejudice to any continuous loss which began while the policy was in force, but the extension of benefits beyond the period during which the policy was in force may be predicated upon the continuous total disability of the insured limited to the duration of the policy benefit period, if any, or payment of the maximum benefits. Receipt of Medicare Part D benefits may not be considered in determining a continuous loss. If a Medicare supplement policy eliminates an outpatient prescription drug benefit as a result of requirements imposed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the modified policy shall be deemed to satisfy the guaranteed renewal requirements of this regulation. Termination by a Group Policyholder. If a group Medicare supplement policy is terminated by the group policyholder and not replaced as provided in §B(9) of this regulation, the insurer shall offer certificate holders an individual Medicare supplement policy. The insurer shall offer the certificate holders described in §B(7)(a) of this regulation at least the following choices: An individual Medicare supplement policy which provides for continuation of the benefits contained in the group policy; and An individual Medicare supplement policy which provides only those benefits which are required to meet the minimum standards of these regulations. If membership in a group is terminated, the insurer shall: Offer the certificate holder the conversion rights described in §B(7) of this regulation; or At the option of the group policyholder, offer the certificate holder continuation of coverage under the group policy. If a group Medicare supplement policy is replaced by another group Medicare supplement policy purchased by the same policyholder, the succeeding insurer shall offer coverage to all persons covered under the old group policy on its date of termination. Coverage under the new group policy may not result in any exclusion for preexisting conditions that would have been covered under the group policy being replaced. Minimum Required Benefits. A Medicare supplement policy shall provide at least the following minimum benefits: Coverage of Medicare Part A eligible expenses for the initial Medicare deductible for hospitalization in any Medicare benefit period; Coverage of Medicare Part A eligible expenses for hospitalization to the extent not covered by Medicare for the 61st day through the 90th day in any Medicare benefit period; Coverage of Medicare Part A eligible expenses incurred as daily hospital charges to the extent not covered by Medicare during use of Medicare's lifetime hospital inpatient reserve days; Upon exhaustion of all Medicare inpatient hospital coverage, including the lifetime reserve days, coverage of 90 percent of all Medicare Part A eligible expenses for hospitalization not covered by Medicare subject to a lifetime maximum benefit of an additional 365 days; Coverage for the coinsurance amount of Medicare eligible expenses under Medicare Part B regardless of hospital confinement; Coverage under Medicare Part A for the reasonable cost of the first three pints of blood, or equivalent quantities of packed red blood cells as defined under federal regulations, in any calendar year unless replaced in accordance with federal regulations or already paid for under Medicare Part B; Coverage under Medicare Part B for the reasonable cost of the first three pints of blood, or equivalent quantities of packed red blood cells, as defined under federal regulations, in any calendar year unless replaced in accordance with federal regulations or already paid for under Part A, subject to the Medicare Part B deductible amount; and Coverage for up to $100 in each calendar year for an annual screening by low-dose mammography for the presence of occult breast cancer. Each insurer issuing a Medicare supplement policy shall include in the policy, or offer as an option, coverage of the initial annual deductible for Medicare eligible expenses under Medicare Part B. Payment of benefits by insurers for Medicare eligible expenses may be conditioned upon the same or less restrictive payment conditions, including determinations of medical necessity, as are applicable to medical claims. An insurer shall restore any benefits which were eliminated from a Medicare supplement policy by operation of the Medicare Catastrophic Coverage Act of 1988. A Medicare supplement policy shall provide for suspension of policy benefits and premiums for up to 24 months if the covered person is receiving benefits under Medicaid. Each insurer providing Medicare supplement policies or contracts shall comply with all provisions of §4081 of the Omnibus Budget Reconciliation Act of 1987 (P.L. 100-203), and with applicable rules and regulations issued under the Act by the Secretary of the federal Department of Health and Human Services. Some of the provisions of the Act require each insurer issuing Medicare supplement policies to: Agree to accept claims notices as claims for benefits under the policies; Agree to make payment determination based on the information provided in the notices; Provide notices to participating providers and suppliers and to the beneficiaries concerning the payment determinations; Provide payment directly to participating providers and suppliers; Provide Medicare beneficiaries with the name and address of Medicare contracting carriers to which notices should be sent; and Agree to pay usual fees. Each insurer shall certify on its Medicare supplement insurance experience reporting forms compliance with the requirements set forth in §A of this regulation. As soon as practicable, but before the effective date of Medicare benefit changes, each insurer issuing or delivering Medicare supplement policies or subscriber contracts in this State shall file with the Commissioner, in accordance with applicable filing procedures: Appropriate premium adjustments necessary to produce loss ratios as originally anticipated for the applicable policies or certificates. Supporting documents necessary to justify the proposed adjustments shall be included with the filing. The following apply: Each insurer subject to the Medicare Supplement Act of Insurance Article, Annotated Code of Maryland, issuing or delivering Medicare supplement policies or contracts to residents of this State, shall make those premium adjustments which are necessary to produce an expected loss ratio under the policies or contracts which will conform with the minimum loss ratio standards for Medicare supplement policies and which are expected to result in a loss ratio at least as great as that originally anticipated in the rates used to produce current premiums for the Medicare supplement policies or contracts. Premium adjustments shall be calculated for the period beginning with Medicare benefit changes. Premium adjustments which would modify the loss ratio under the policies and contracts other than the adjustments described in this section may be made only on the renewal date or anniversary date of the policy or contract. Appropriate riders, endorsements, or policy forms, which shall be drafted to: Accomplish Medicare supplement insurance modifications necessary to: Eliminate benefit duplications with Medicare, and Provide any additional benefits necessary to comply with State or federal statutes, rules, and regulations modifying minimum benefit requirements under Medicare supplement policies and contracts; Provide a clear description of the Medicare supplement benefits to be provided by the policies or contracts. Each insurer providing group Medicare supplement insurance benefits to a resident of this State under a group policy issued elsewhere shall file a copy of the master policy and any certificate used in this State in accordance with the filing requirements and procedures applicable to group Medicare supplement policies issued in this State. If the out-of-State group policy is issued to an employer having a home office in the state in which the policy is issued, the filing required by §A of this regulation shall be made not later than 30 days after the effective date of the certificate issued to any employee resident in this State. General. Medicare supplement policies shall contain a clearly worded provision regarding the right of the policyholder to renew or continue the policy. This provision shall be appropriately captioned and shall be printed on the first page of the policy. Except for riders or endorsements by which the insurer effectuates a request made in writing by the insured or exercises a specifically reserved right under a Medicare supplement policy, or is required to reduce or eliminate benefits to avoid duplication of Medicare benefits, all riders or endorsements added to a Medicare supplement policy after date of issue or at reinstatement or renewal which reduce or eliminate benefits or coverage in the policy shall require a signed acceptance by the insured unless otherwise authorized by the Commissioner. After the date of policy issue, any rider or endorsement which increases benefits or coverage with a concomitant increase in premium during the policy term must be agreed to in writing, signed by the insured unless the benefits or coverage are required by the minimum standards for Medicare supplement insurance policies or are required by law. When a separate additional premium is charged for benefits provided in connection with riders or endorsements, the additional premium charge shall be stated in the policy. A Medicare supplement policy which provides for the payment of benefits based on standards described as “usual and customary”, “reasonable and customary”, or words of similar import shall include a definition of these terms and an explanation of the terms in its accompanying outline of coverage. If a Medicare supplement policy contains any limitations with respect to preexisting conditions, the limitations shall appear as a separate paragraph of the policy and may be labeled as “preexisting condition limitations” or a title of similar import. Medicare supplement policies or certificates shall have a notice prominently printed on the first page of the policy or certificate stating that the policyholder or certificate holder shall have the right to return the policy or certificate within 30 days of its delivery and to have the premium refunded. Notice Requirements. As soon as practicable, but not later than 30 days before the annual effective date of any Medicare benefit changes, each insurer, including any health service plan, which provides Medicare supplement insurance or benefits to a resident of this State, shall notify its policyholders, contract holders, and certificate holders of modifications to be made to Medicare insurance policies or contracts in a manner approved by the Commissioner. In addition, the notice shall: Include a description of revisions to the Medicare program and a description of each modification made to the coverage provided under the Medicare supplement insurance policy or contract; and Inform each covered person as to when any premium adjustment is to be made by reason of changes in Medicare benefits. The notices of benefit modifications and of any premium adjustments shall be in outline form and in clear and simple terms in order to facilitate comprehension. The notices may not contain or be accompanied by any solicitation materials. Insurance Article, §2-109 and Title 15, Subtitle 9; Health-General Article, §§19-705 and 19-706; Annotated Code of Maryland Effective date: Regulations .01—.09, Appendixes A—C adopted as an emergency provision effective July 1, 1982 (9:13 Md. R. 1340); adopted permanently effective October 1, 1982 (9:17 Md. R. 1707) Regulation .01 amended, Regulations .02—.09 and Appendices A—C repealed, and new Regulations .02—.14 and Appendices A—C adopted as an emergency provision effective July 25, 1989 (16:16 Md. R. 1738); emergency status extended at 16:26 Md. R. 2782 and 17:5 Md. R. 633; emergency status expired July 20, 1990 Regulation .01 amended, Regulations .02—.09 and Appendices A—C repealed, and new Regulations .02—.21 adopted effective July 23, 1990 (17:14 Md. R. 1757) Regulation .06E adopted effective November 11, 1991 (18:22 Md. R. 2396) Regulation .07E adopted effective November 11, 1991 (18:22 Md. R. 2396) Regulation .16 amended effective November 11, 1991 (18:22 Md. R. 2396) Chapter recodified from COMAR 09.30.59 to COMAR 31.10.05 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .03 amended effective January 1, 2006 (32:18 Md. R. 1522) Regulation .07 amended effective January 1, 2006 (32:18 Md. R. 1522) Regulation .09 amended effective January 1, 2006 (32:18 Md. R. 1522) Regulation .11 amended effective January 1, 2006 (32:18 Md. R. 1522) Regulations .12—.21 repealed effective January 1, 2006 (32:18 Md. R. 1522) Except as otherwise provided in Regulations .10, .11, and .17 of this chapter, this chapter applies to all: Medicare supplement policies delivered or issued for delivery in this State; and Certificates issued under group Medicare supplement policies if the certificates are delivered or issued for delivery in this State. This chapter is applicable to all Medicare supplement policies and certificates under group Medicare supplement policies held by residents of this State and in force on the day preceding the effective date of House Bill 305 (Chapter 526, Acts of 1992), except as to the benefits and other policy provisions of those policies and certificates. While those policies and certificates remain in effect, their benefits and policy provisions shall continue to be governed by the applicable provisions of the Annotated Code of Maryland in effect immediately preceding the effective date of House Bill 305 (Chapter 526, Acts of 1992) and of the applicable regulations of COMAR 31.10.05 where the latter regulations are inconsistent with this chapter. This chapter does not apply to a policy or a certificate under a group policy issued to one or more employers or labor organizations, or to the trustees of a fund established by one or more employers or labor organizations for employees or former employees of the employers, or for members or former members of the labor organizations. In this chapter, the following terms have the meanings indicated. Terms Defined. “Adverse decision” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. “Applicant” means: In the case of an individual Medicare supplement policy, the person who seeks to contract for insurance benefits; and In the case of a group Medicare supplement policy, the proposed certificate holder. “Bankruptcy” means when a Medicare Advantage organization that is not an issuer has filed, or has had filed against it, a petition for declaration of bankruptcy and has ceased doing business in the State. “Certificate” means any certificate delivered or issued for delivery in this State under a group Medicare supplement policy. “Certificate form” means the form on which the certificate is delivered or issued for delivery by the issuer. “Complaint” means any dissatisfaction expressed by an individual concerning a Medicare Select issuer or its network providers. “Continuous period of creditable coverage” means the period during which an individual was covered by creditable coverage, if during the period of the coverage the individual had no breaks in coverage greater than 63 days. “Coverage decision” has the meaning stated in Insurance Article, §15-10D-01, Annotated Code of Maryland. Creditable coverage. “Creditable coverage” means, with respect to an individual, coverage of the individual provided under any of the following: A group health plan; Health insurance coverage; Part A or Part B of Title XVIII of the Social Security Act (Medicare); Title XIX of the Social Security Act (Medicaid), other than coverage consisting solely of benefits under §1928; Chapter 55 of Title 10 United States Code (CHAMPUS); A medical care program of the Indian Health Service or of a tribal organization; A State health benefits risk pool; A health plan offered under Chapter 89 of Title 5 United States Code (Federal Employees Health Benefits Program); A public health plan as defined in federal regulation; and A health benefit plan under §5(e) of the Peace Corps Act (22 U.S.C. §2504(e)). “Creditable coverage” does not include one or more, or any combination of, the following: Coverage only for accident or disability income insurance, or any combination of them; Coverage issued as a supplement to liability insurance; Liability insurance, including general liability insurance and automobile liability insurance; Workers' compensation or similar insurance; Automobile medical payment insurance; Credit-only insurance; Coverage for on-site medical clinics; and Other similar insurance coverage, specified in federal regulations, under which benefits for medical care are secondary or incidental to other insurance benefits. “Creditable coverage” does not include coverage for the following benefits if they are provided under a separate policy, certificate, or contract of insurance, or are otherwise not an integral part of a plan of coverage described in §B(9)(a) of this regulation: Limited scope dental or vision benefits; Benefits for long-term care, nursing home care, home health care, community-based care, or any combination of these coverages; and Other similar, limited benefits as are specified in federal regulations. “Creditable coverage” does not include coverage for the following benefits if offered as independent, noncoordinated benefits: Coverage only for a specified disease or illness; and Hospital indemnity or other fixed indemnity insurance. “Creditable coverage” does not include the following coverage if it is offered as a separate policy, certificate, or contract of insurance: Medicare supplemental health insurance as defined under §1882(g)(1) of the Social Security Act; Coverage supplemental to the coverage provided under Chapter 55 of Title 10, United States Code; and Similar supplemental coverage provided to coverage under a group health plan. “Employee welfare benefit plan” means a plan, fund, or program of employee benefits as defined in 29 U.S.C. §1002 (Employee Retirement Income Security Act). “Grievance” means dissatisfaction expressed in writing by an individual insured under a Medicare Select policy or certificate with the administration, claims practices, or provision of services concerning a Medicare Select issuer or its network providers. “Insolvency” means when an issuer, licensed to transact the business of insurance in this State, has had a final order of liquidation entered against it with a finding of insolvency by a court of competent jurisdiction in the issuer's state of domicile. “Issuer” means insurance companies, fraternal benefit societies, nonprofit health service plans, health maintenance organizations, and any other entity delivering or issuing for delivery in this State Medicare supplement policies or certificates. “Medicare” means the Health Insurance for the Aged Act, Title XVIII of the Social Security Amendments of 1965, as then constituted or later amended. Medicare Advantage Plan. “Medicare Advantage plan” means a plan of coverage for health benefits under Medicare Part C as defined in 42 U.S.C. §1395w-28(b)(1). “Medicare Advantage plan” includes: Coordinated care plans that provide health care services, including health maintenance organization plans (with or without a point-of-service option), plans offered by provider-sponsored organizations, and preferred provider organization plans; Medical savings account plans coupled with a contribution into a Medicare Advantage Plan medical savings account; and Medicare Advantage private fee-for-service plans. “Medicare Select certificate” means a Medicare supplement certificate that contains restricted network provisions. “Medicare Select issuer” means an issuer offering, or seeking to offer, a Medicare Select policy or certificate. “Medicare Select policy” means a Medicare supplement policy that contains restricted network provisions. Medicare Supplement Policy. “Medicare supplement policy” means a group or individual policy of health insurance, or a certificate of a fraternal benefit society, or a subscriber contract of a nonprofit health service plan or of a health maintenance organization, other than a policy issued pursuant to a contract under the federal Social Security Act, §1876, or an issued policy under a demonstration project specified in 42 U.S.C. §1395ss(g)(1), which is advertised, marketed, or designed primarily as a supplement to reimbursements under Medicare for the hospital, medical, or surgical expenses of persons eligible for Medicare. “Medicare supplement policy” does not include Medicare Advantage plans established under Medicare Part C, Outpatient Prescription Drug plans established under Medicare Part D, or any Health Care Prepayment Plan (HCPP) that provides benefits pursuant to an agreement under §1833(a)(1)(A) of the Social Security Act. “Network provider” means a provider, or group of providers, of health care which has entered into a written agreement with the issuer to provide benefits insured under a Medicare Select policy. “Newly eligible for Medicare” means the individual: Attained age 65; or Became entitled to benefits under part A pursuant to §226(b) or 226A of the Social Security Act, or is deemed to be eligible for benefits under §226(a) of the Social Security Act. 1990 standardized Medicare Supplement Benefit Plan. “1990 standardized Medicare supplement benefit plan”, “1990 standardized benefit plan”, or “1990 plan” means a group or individual policy of Medicare supplement insurance issued on or after July 14, 1992, and with an effective date for coverage before June 1, 2010. “1990 standardized Medicare supplement benefit plan”, “1990 standardized benefit plan”, or “1990 plan” includes Medicare supplement insurance policies and certificates described in §B(21)(a) of this regulation that are renewed on or after June 1, 2010, which are not replaced by the issuer at the request of the insured. “Policy form” means the form on which the policy or certificate is delivered or issued for delivery by the issuer. “Restricted network provision” means any provision which conditions the payment of benefits, in whole or in part, on the use of network providers. “Secretary” means the Secretary of the United States Department of Health and Human Services. “Service area” means the geographic area approved by the Secretary of the Maryland Department of Health within which an issuer is authorized to offer a Medicare Select policy. “2010 standardized Medicare supplement benefit plan”, “2010 standardized benefit plan”, or “2010 plan” means a group or individual policy of Medicare supplement insurance issued with an effective date for coverage on or after June 1, 2010. A policy or certificate may not be advertised, solicited, or issued for delivery in this State as a Medicare supplement policy or certificate unless the policy or certificate contains definitions or terms which conform to the requirements of these regulations. Policy Terms Defined. Accident. “Accident”, “accidental injury”, or “accidental means” shall be defined to employ “result” language. “Accident”, “accidental injury”, or “accidental means” does not include words which establish an accidental means test or use words such as “external, violent, visible wounds” or similar words of description or characterization. The definition may not be more restrictive than the following: “Injury or injuries for which benefits are provided means accidental bodily injury sustained by the insured person which is the direct result of an accident, independent of disease or bodily infirmity or any other cause, and occurs while insurance coverage is in force.” The definition may provide that injuries not include injuries for which benefits are provided or available under any workers' compensation, employer's liability or similar law, or motor vehicle no-fault plan, unless prohibited by law. “Benefit period” or “Medicare benefit period” may not be defined more restrictively than as defined in the Medicare program. “Convalescent nursing home”, “extended care facility”, or “skilled nursing facility” may not be defined more restrictively than as defined in the Medicare program. “Health care expenses” means, for the purposes of Regulation .11 of this chapter, expenses of health maintenance organizations associated with the delivery of health care services, which expenses are analogous to incurred losses of insurers. “Hospital” may be defined in relation to its status, facilities, and available services or to reflect its accreditation by the Joint Commission on Accreditation of Hospitals, but not more restrictively than as defined in the Medicare program. “Medicare” shall be defined in the policy and certificate. Medicare may be substantially defined as “The Health Insurance for the Aged Act, Title XVIII of the Social Security Amendments of 1965 as then constituted or later amended”, or “Title I, Part I of Public Law 89-97, as Enacted by the Eighty-Ninth Congress of the United States and popularly known as the Health Insurance for the Aged Act, as then constituted and any later amendments or substitutes of it” or words of similar import. “Medicare eligible expenses” means expenses of the kinds covered by Medicare Parts A and B, to the extent recognized as reasonable and medically necessary by Medicare. Restrictions on Policy Definitions. “Physician” may not be defined more restrictively than as defined in the Medicare program. Sickness. “Sickness” may not be defined to be more restrictive than the following: Sickness means illness or disease of an insured person which first manifests itself after the effective date of insurance and while the insurance is in force. This definition may be further modified to exclude sicknesses or diseases for which benefits are provided under any workers' compensation, occupational disease, employer's liability, or similar law. An issuer may not deliver or issue for delivery a Medicare supplement policy or certificate to a resident of this State unless the policy form or certificate form has been filed with and approved by the Commissioner in accordance with filing requirements and procedures prescribed by applicable provisions of Insurance Article, §§12-203, 12-205, and 14-126, Annotated Code of Maryland, and other applicable provisions of Insurance Article and Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland, and applicable regulations and procedures for filing for approval of forms. An issuer shall file any riders or amendments to policy or certificate forms to delete outpatient prescription drug benefits as required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 only with the commissioner in the state in which the policy or certificate was issued. Premium Rates. An insurer may not use or change premium rates for a Medicare supplement policy or certificate unless the rates, rating schedule, methodology, and supporting documentations have been filed with and approved by the Commissioner in accordance with the filing requirements and procedures prescribed by the Commissioner. An issuer may not increase the premium rates for a Medicare Supplement policy for an insured person until: For an individual policy, at least 1 year after the date on which the individual policy became effective; and For a group policy, at least 1 year after the date on which the certificate became effective. Starting 1 year after the date on which an individual policy or certificate became effective, an issuer may not increase the premium rates for a Medicare Supplement policy for an insured person more than once each year. Filing for Approval. Except as provided in §D(2) of this regulation, an issuer may not file for approval more than one form of a policy or certificate of each type for each standard Medicare supplement benefit plan. An issuer may offer, with the approval of the Commissioner, up to four additional policy forms or certificate forms of the same type for the same standard Medicare supplement benefit plan, one for each of the following cases: The inclusion of new or innovative benefits; The addition of either direct response or agent marketing methods; The addition of either guaranteed issue or underwritten coverage; The offering of coverage to individuals eligible for Medicare by reason of disability. For the purposes of this section, a “type” means an individual policy, a group policy, an individual Medicare Select policy, or a group Medicare Select policy. Availability. Except as provided in §E(2) of this regulation, an issuer shall continue to make available for purchase any policy form or certificate form issued after the effective date of this regulation that has been approved by the Commissioner. A policy form or certificate form may not be considered to be available for purchase unless the issuer has actively offered it for sale in the previous 12 months. An issuer may discontinue the availability of a policy form or certificate form if the issuer provides to the Commissioner in writing its decision at least 30 days before discontinuing the availability of the form of the policy or certificate. After the effective date of the notice, the issuer may no longer offer for sale the policy form or certificate form in this State. An issuer that discontinues the availability of a policy form or certificate form in accordance with §E(2) of this regulation may not file for approval a new policy form or certificate form of the same type for the same standard Medicare supplement benefit plan as the discontinued form for a period of 5 years after the issuer provides notice to the Commissioner of the discontinuance. The period of discontinuance may be reduced if the Commissioner determines that a shorter period is appropriate. The sale or other transfer of Medicare supplement business to another issuer shall be considered a discontinuance for the purposes of this section. A change in the rating structure or methodology shall be considered a discontinuance under this section unless the issuer complies with the following requirements: The issuer provides an actuarial memorandum, in a form and manner prescribed by the Commissioner, describing the manner in which the revised rating methodology and resultant rates differ from the existing rating methodology and existing rates. The issuer does not subsequently put into effect a change of rates or rating factors that would cause the percentage differential between the discontinued and subsequent rates as described in the actuarial memorandum to change. The Commissioner may approve a change to the differential which is in the public interest. Basis of Experience Calculation. Except as provided in §F(2) of this regulation, the experience of all policy forms or certificate forms of the same type in a standard Medicare supplement benefit plan shall be combined for purposes of the refund or credit calculation prescribed in Regulation .11 of this chapter. Forms assumed under an assumption reinsurance agreement may not be combined with the experience of other forms for purposes of the refund or credit calculation. An issuer shall provide a copy of any Medicare supplement advertisement intended for use in this State whether through written, radio, or television medium or otherwise, to the Commissioner for review by the Commissioner at least 5 business days before using the advertisement. Period of Open Enrollment. An issuer may not deny or condition the issuance or effectiveness of any Medicare supplement policy or certificate available for sale in this State, nor discriminate in the pricing of the policy or certificate because of the health status, claims experience, receipt of health care, or medical condition of an applicant when: An application for the policy or certificate is submitted during the 6-month period beginning with the first day of the first month in which an individual is both 65 years old or older and is enrolled for benefits under Medicare Part B; or An application for the policy or certificate is submitted on or up to 30 days after the birthday of an individual enrolled in a Medicare supplement policy or certificate. Each Medicare supplement policy and certificate currently available from an issuer shall be made available to all applicants who qualify under §A(1)(a) of this regulation without regard to age. Subject to Regulation .31A of this chapter, an insurer shall make available to applicants who qualify under §A(1)(b) of this regulation Medicare supplement policies or certificates with benefits that are equal to or less than the benefits of the applicant’s existing Medicare supplement policy or certificate. For the purpose of this regulation, “benefits that are equal to or less than the benefits of the applicant’s existing Medicare supplement policy or certificate” means a policy or certificate of the same or lower benefit level as indicated in the below chart. Application of Creditable Coverage. If an applicant qualifies under §A of this regulation and submits an application during the time period referenced in §A of this regulation and, as of the date of application, has had a continuous period of creditable coverage of at least 6 months, the issuer may not exclude benefits based on a preexisting condition. If the applicant qualifies under §A of this regulation and submits an application during the time period referenced in §A of this regulation and, as of the date of application, has had a continuous period of creditable coverage that is less than 6 months, the issuer shall reduce the period of any preexisting condition exclusion by the aggregate of the period of creditable coverage applicable to the applicant as of the enrollment date. The Secretary shall specify the manner of the reduction under §B(2) of this regulation. Except as provided in §B of this regulation and in Regulations .09-1 and .18 of this chapter, §A of this regulation is not to be construed as preventing the exclusion of benefits under a policy during the first 6 months based on a preexisting condition for which the policyholder or certificate holder received treatment or was otherwise diagnosed during the 6 months before the policy became effective. Individuals Younger than 65 Years Old and Enrolled in Medicare Part B. An issuer shall comply with the open enrollment requirements that are described in Insurance Article, §15-909, Annotated Code of Maryland, as applying to individuals who are both younger than 65 years old and enrolled in Part B of Medicare. Except for permitted preexisting condition clauses as described in Regulations .08B and .27B(2) of this chapter, a policy or certificate may not be advertised, solicited, or issued for delivery in this State as a Medicare supplement policy if the policy or certificate contains limitations or exclusions on coverage that are more restrictive than those of Medicare. A Medicare supplement policy or certificate may not use waivers to exclude, limit, or reduce coverage or benefits for specifically named or described preexisting diseases or physical conditions. A Medicare supplement policy or certificate in force in this State may not contain benefits which duplicate benefits provided by Medicare. Polices With Benefits for Outpatient Prescription Drugs. Subject to COMAR 31.10.05.07B(4) and (6)—(9), and Regulation .08B(5)—(10) of this chapter, a Medicare supplement policy with benefits for outpatient prescription drugs in existence before January 1, 2006, shall be renewed for current policyholders who do not enroll in Part D at the option of the policyholder. A Medicare supplement policy with benefits for outpatient prescription drugs may not be issued after December 31, 2005. After December 31, 2005, a Medicare supplement policy with benefits for outpatient prescription drugs may not be renewed after the policyholder enrolls in Medicare Part D unless: The policy is modified to eliminate outpatient prescription coverage for expenses of outpatient prescription drugs incurred after the effective date of the individual's coverage under a Part D plan; and Premiums are adjusted to reflect the elimination of outpatient prescription drug coverage at the time of Medicare Part D enrollment, accounting for any claims paid, if applicable. General Standards. The following standards are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this State on or after July 14, 1992, and with an effective date for coverage before June 1, 2010. A policy or certificate may not be advertised, solicited, delivered, or issued for delivery in this State as a Medicare supplement policy or certificate unless it complies with these benefit standards. Required Standards. The standards in this section apply to Medicare supplement policies and certificates and are in addition to all other requirements of these regulations. A Medicare supplement policy or certificate may not exclude or limit benefits for losses incurred more than 6 months from the effective date of coverage because it involved a preexisting condition. The policy or certificate may not define a preexisting condition more restrictively than a condition for which medical advice was given or treatment was recommended by or received from a physician within 6 months before the effective date of coverage. A Medicare supplement policy or certificate may not indemnify against losses resulting from sickness on a different basis than losses resulting from accidents. A Medicare supplement policy or certificate shall provide that benefits designed to cover cost sharing amounts under Medicare will be changed automatically to coincide with any changes in the applicable Medicare deductible, copayment, or coinsurance amounts. Premiums may be modified to correspond with these changes. A Medicare supplement policy or certificate may not provide for termination of coverage of a spouse solely because of the occurrence of an event specified for termination of coverage of the insured, other than the nonpayment of premium. Each Medicare supplement policy shall be guaranteed renewable. The issuer may not: Cancel or nonrenew the policy solely on the ground of health status of the individual; or Cancel or nonrenew the policy for any reason other than nonpayment of premium or material misrepresentation. If the Medicare supplement policy is terminated by the group policyholder and is not replaced as provided under §B(9) of this regulation, the issuer shall offer certificate holders an individual Medicare supplement policy which at the option of the certificate holder provides for: Continuation of the benefits contained in the group policy; or Benefits which meet the requirements of these regulations. If an individual is a certificate holder in a group Medicare supplement policy and the individual terminates membership in the group, the issuer shall: Offer the certificate holder the conversion option described in §B(7) of this regulation; or At the option of the group policyholder, offer the certificate holder continuation of coverage under the group policy. If a group Medicare supplement policy is replaced by another group Medicare supplement policy purchased by the same policyholder, the succeeding issuer shall offer coverage to all persons covered under the old group policy on the group policy's date of termination. Coverage under the new policy may not result in any exclusion for preexisting conditions that would have been covered under the group policy being replaced. If a Medicare supplement policy eliminates an outpatient prescription drug benefit as a result of requirements imposed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the modified policy shall be deemed to satisfy the guaranteed renewal requirements of §B(6) of this regulation. Extension of Benefits. Termination of a Medicare supplement policy or certificate shall be without prejudice to any continuous loss that commenced while the policy was in force, but the extension of benefits beyond the period during which the policy was in force may be conditioned upon the continuous total disability of the insured, limited to the duration of the policy benefit period, if any, or payment of the maximum benefits. Receipt of Medicare Part D benefits may not be considered in determining a continuous loss under §B(11)(a) of this regulation. Suspension of Benefits. A Medicare supplement policy or certificate shall provide that benefits and premiums under the policy or certificate shall be suspended at the request of the policyholder or certificate holder for a period not to exceed 24 months in which the policyholder or certificate holder has applied for and is determined to be entitled to medical assistance under Title XIX of the Social Security Act (Medicaid), but only if the policyholder or certificate holder notifies the issuer of the policy or certificate within 90 days after the date the individual becomes entitled to medical assistance. If the suspension described in §B(12)(a) of this regulation occurs and if the policyholder or certificate holder loses entitlement to Medicaid, the policy or certificate shall be automatically reinstituted, effective as of the date of termination of entitlement, if the policyholder or certificate holder provides notice of loss of entitlement within 90 days after the date of loss of entitlement and pays the premium attributable to the period, effective as of the date of termination of entitlement. A Medicare supplement policy shall provide that benefits and premiums under the policy shall be suspended, for any period that may be provided by federal regulation, at the request of the policyholder, if the policyholder is: Entitled to benefits under §226(b) of the Social Security Act; and Covered under a group health plan as defined in §1862(b)(1)(A)(v) of the Social Security Act. If the suspension described in §B(12)(c) of this regulation occurs and if the policyholder or the certificate holder loses coverage under the group health plan, the Medicare supplement policy shall be reinstituted automatically, effective as of the date of the loss of coverage under the group health plan, if the policyholder described in §B(12)(c): Provides notice of loss of coverage within 90 days after the date of the loss of group coverage; and Pays the premium attributable to the period, effective as of the date of termination of enrollment in the group health plan. Reinstitution of coverage under §B(12)(b) or (d) of this regulation: May not provide for any waiting period with respect to treatment of preexisting conditions; Shall provide for resumption of coverage that is substantially equivalent to coverage in effect before the date of suspension; If the suspended Medicare supplement policy provided coverage for outpatient prescription drugs, shall provide for the reinstitution of the policy for Medicare Part D enrollees without coverage for outpatient prescription drugs and shall otherwise provide substantially equivalent coverage to the coverage in effect before the date of suspension; and Shall provide for classification of premiums on terms at least as favorable to the policyholder or certificate holder as the premium classification terms that would have applied to the policyholder or certificate holder had the coverage not been suspended. Exchange Offer. If an issuer makes a written offer to each Medicare supplement policyholder or certificate holder of one or more of its plans, to exchange during a specified period the individual's 1990 standardized benefit plan, as described in Regulation .09 of this chapter, for a 2010 standardized benefit plan, as described in Regulation .28 of this chapter, the offer and subsequent exchange shall comply with the requirements of this subsection. An issuer need not provide justification to the Commissioner if the insured replaces a 1990 standardized benefit plan policy or certificate with an issue age rated 2010 standardized plan policy or certificate at the insured's original issue age and duration. If an insured's policy or certificate to be replaced is priced on an issue age rate schedule at the time of the offer, the rate charged to the insured for the new exchanged policy shall recognize the policy reserve buildup, due to the prefunding inherent in the use of an issue age rate basis, for the benefit of the insured. The rate method proposed to be used by an issuer shall be filed with the Commissioner in accordance with COMAR 31.10.01.02. The rating class of the new policy or certificate shall be the class closest to the insured's class of the replaced coverage. An issuer may not apply a new preexisting condition limitation or a new incontestability period to the new policy for those benefits contained in the exchanged 1990 standardized benefit plan policy or certificate of the insured, but may apply a preexisting condition limitation of not more than 6 months to any added benefits contained in the new 2010 standardized benefit plan policy or certificate not contained in the exchanged policy. The new policy or certificate shall be offered to each policyholder or certificate holder within a given plan, except where the offer or issue would be in violation of State or federal law. Standards for Basic (Core) Benefits Common to Benefit Plans A—J. Every issuer shall make available a policy or certificate including only the following basic core package of benefits to each prospective insured: Coverage of Part A Medicare eligible expenses for hospitalization to the extent not covered by Medicare from the 61st day through the 90th day in any Medicare benefit period; Coverage of Part A Medicare eligible expenses incurred for hospitalization to the extent not covered by Medicare for each Medicare lifetime inpatient reserve day used; Upon exhaustion of the Medicare hospital inpatient coverage including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable prospective payment system (PPS) rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days; Coverage under Medicare Parts A and B for the reasonable cost of the first three pints of blood, or equivalent quantities of packed red blood cells, as defined under federal regulations, unless replaced in accordance with federal regulations; Coverage for the coinsurance amount, or in the case of hospital outpatient department services paid under a prospective payment system, the copayment amount, of Medicare eligible expenses under Part B regardless of hospital confinement, subject to the Medicare Part B deductible. The provider shall accept the issuer's payment of the Medicare Part A eligible expenses for hospitalization under §C(1)(c) of this regulation as payment in full and may not bill the insured for any balance. An issuer may make available to prospective insureds any of the other Medicare supplement insurance benefit plans in addition to the basic core package, but not instead of the core package. Standards for Additional Benefits. The following additional benefits shall be included in Medicare supplement benefit plans B through J only as provided by Regulation .09 of this chapter: Medicare Part A Deductible. Coverage for all of the Medicare Part A inpatient hospital deductible amount per benefit period. Skilled Nursing Facility Care. Coverage for the actual billed charges up to the coinsurance amount from the 21st day through the 100th day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A. Medicare Part B Deductible. Coverage for all of the Medicare Part B deductible amount per calendar year regardless of hospital confinement. Eighty percent of the Medicare Part B Excess Charges. Coverage for 80 percent of the difference between the actual Medicare Part B charge as billed, not to exceed any charge limitation established by the Medicare program or state law, and the Medicare-approved Part B charge. One hundred percent of the Medicare Part B Excess Charges. Coverage for all of the difference between the actual Medicare Part B charge as billed, not to exceed any charge limitation established by the Medicare program or state law, and the Medicare-approved Part B charge. Basic Outpatient Prescription Drug Benefit. Coverage for 50 percent of outpatient prescription drug charges after a $250 calendar year deductible, to a maximum of $1,250 in benefits received by the insured per calendar year, to the extent not covered by Medicare. The outpatient prescription drug benefit may be included for sale or issuance in a Medicare supplement policy until January 1, 2006. Extended Outpatient Prescription Drug Benefit. Coverage for 50 percent of outpatient prescription drug charges, after a $250 calendar year deductible to a maximum of $3,000 in benefits received by the insured per calendar year, to the extent not covered by Medicare. The outpatient prescription drug benefit may be included for sale or issuance in a Medicare supplement policy until January 1, 2006. Medically Necessary Emergency Care in a Foreign Country. Coverage to the extent not covered by Medicare for 80 percent of the billed charges for Medicare-eligible expenses for medically necessary emergency hospital, physician, and medical care received in a foreign country, which care would have been covered by Medicare if provided in the United States and which care began during the first 60 consecutive days of each trip outside the United States, subject to a calendar year deductible of $250, and a lifetime maximum benefit of $50,000. For purposes of this benefit “emergency care” means care needed immediately because of an injury or an illness of sudden and unexpected onset. Preventive Medical Care Benefit. Coverage for the following preventive health services not covered by Medicare: An annual clinical preventive medical history and physical examination that may include tests and services from §D(9)(a)(ii) of this regulation and patient education to address preventive health care measures; and Preventive screening tests or preventive services, the selection and frequency of which is determined to be medically appropriate by the attending physician. Reimbursement shall be for the actual charges up to 100 percent of the Medicare-approved amount for each service, as if Medicare were to cover the service as identified in American Medical Association Current Procedural Terminology (AMA CPT) Codes, to a maximum of $120 annually under this benefit, and this benefit may not include payment for any procedure covered by Medicare. At-Home Recovery Benefit. Coverage for services to provide short-term, at-home assistance with activities of daily living for those recovering from an illness, injury, or surgery. For purposes of the at-home recovery benefit, the following definitions shall apply: “Activities of daily living” include, but are not limited to, bathing, dressing, personal hygiene, transferring, eating, ambulating, assistance with drugs that are normally self-administered, and changing bandages or other dressings. “Care provider” means a duly qualified or licensed home health aide/homemaker, personal care aide, or nurse provided through a licensed home health care agency or referred by a licensed referral agency or licensed nurses registry. “Home” means any place used by the insured as a place of residence, provided that this place qualifies as a residence for home health care services covered by Medicare. A hospital or skilled nursing facility may not be considered the insured's place of residence. “At-home recovery visit” means the period of a visit required to provide at-home recovery care, without limit on the duration of the visit, except each consecutive 4 hours in a 24-hour period of services provided by a care provider is one visit. Coverage Requirements and Limitations. At-home recovery services provided shall be primarily services which assist in activities of daily living. The insured's attending physician shall certify that the specific type and frequency of at-home recovery services are necessary because of a condition for which a home care plan of treatment was approved by Medicare. Limitation of Coverage. Coverage is limited to: The number and type of at-home recovery visits certified as necessary by the insured's attending physician. The total number of at-home recovery visits may not exceed the number of Medicare-approved home health care visits under a Medicare-approved home care plan of treatment. The actual charges for each visit up to a maximum reimbursement of $40 per visit. $1,600 per calendar year. Seven visits in any 1 week. Care furnished on a visiting basis in the insured's home. Services provided by a care provider as defined in §D(10)(b)(ii) of this regulation. At-home recovery visits while the insured is covered under the policy or certificate and not otherwise excluded. At-home recovery visits received during the period the insured is receiving Medicare-approved home care services or not more than 8 weeks after the service date of the last Medicare-approved home health care visit. Coverage is excluded for: Home care visits paid for by Medicare or other government programs; Care provided by family members, unpaid volunteers, or providers who are not care providers. Standards for Plans K and L. Standardized Medicare supplement benefit plan K shall consist of the following: Coverage of 100 percent of the Part A hospital coinsurance amount for each day used from the 61st through the 90th day in any Medicare benefit period; Coverage of 100 percent of the Part A hospital coinsurance amount for each Medicare lifetime inpatient reserve day used from the 91st through the 150th day in any Medicare benefit period; Upon exhaustion of the Medicare hospital inpatient coverage, including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable prospective payment system (PPS) rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days; Medicare Part A deductible: Coverage for 50 percent of the Medicare Part A inpatient hospital deductible amount per benefit period until the out-of-pocket limitation is met as described in §E(1)(j) of this regulation; Skilled nursing facility care: Coverage for 50 percent of the coinsurance amount for each day used from the 21st day through the 100th day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A until the out-of-pocket limitation is met as described in §E(1)(j) of this regulation; Hospice care: Coverage for 50 percent of cost sharing for all Part A Medicare eligible expenses and respite care until the out-of-pocket limitation is met as described in §E(1)(j) of this regulation; Coverage for 50 percent, under Medicare Part A or B, of the reasonable cost of the first 3 pints of blood, or equivalent quantities of packed red blood cells, as defined under federal regulations, unless replaced in accordance with federal regulations until the out-of-pocket limitation is met as described in §E(1)(j) of this regulation; Except for coverage provided in §E(1)(i) of this regulation, coverage for 50 percent of the cost sharing otherwise applicable under Medicare Part B after the policyholder pays the Part B deductible until the out-of-pocket limitation is met as described in §E(1)(j) of this regulation; Coverage of 100 percent of the cost sharing for Medicare Part B preventive services after the policyholder pays the Part B deductible; and Coverage of 100 percent of all cost sharing under Medicare Parts A and B for the balance of the calendar year after the individual has reached the out-of-pocket limitation on annual expenditures under Medicare Parts A and B of $4,000 in 2006, indexed each year by the appropriate inflation adjustment specified by the Secretary of the U.S. Department of Health and Human Services. The provider shall accept the issuer's payment of the Medicare Part A eligible expenses for hospitalization under §E(1)(c) of this regulation as payment in full and may not bill the insured for any balance. Standardized Medicare supplement benefit plan L shall consist of the following: The benefits described in §E(1)(a)—(c) and(i) of this regulation; The benefits described in §E(1)(d)—(h) of this regulation, but substituting 75 percent for 50 percent; and The benefit described in §E(1)(j) of this regulation, but substituting $2,000 for $4,000. Definitions. In this regulation, the following term has the meaning indicated. Term Defined. “Structure, language, and format” means style, arrangement, and overall content of a benefit. General Standards. The standards found in §§C—I of this regulation are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this State on or after July 14, 1992, and with an effective date for coverage before June 1, 2010. A policy or certificate may not be advertised, solicited, delivered, or issued for delivery in this State as a Medicare supplement policy or certificate during the time period described in §B(1) of this regulation unless it complies with the benefit plan standards described in this regulation. An issuer shall make available to each prospective policyholder and certificate holder a policy form or certificate form containing only the core benefits, as defined in Regulation .08C of this chapter. Groups, packages, or combinations of Medicare supplement benefits other than those listed in this regulation may not be offered for sale in this State, except as may be permitted in §I of this regulation and Regulation .24 of this chapter. Structure of Benefits. Benefit plans shall be uniform in structure, language, designation, and format to the standard benefit plans A through L listed in this regulation and conform to the definitions in Regulations .02 and .03 of this chapter. Each benefit shall be structured in accordance with the format provided in Regulation .08C—E of this chapter and list the benefits in the order shown in this regulation. An issuer may use, in addition to the benefit plan designations required in §E of this regulation, other designations to the extent permitted by law. Make-up of 1990 Standardized Benefit Plans. Standardized Medicare supplement benefit plan A shall be limited to the basic (core) benefits common to all benefit plans, as defined in Regulation .08C of this chapter. Standardized Medicare supplement benefit plan B shall include only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible as defined in Regulation .08D(1) of this chapter. Standardized Medicare supplement benefit plan C shall include only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, Medicare Part B Deductible, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .08D(1), (2), (3), and (8) of this chapter. Standardized Medicare supplement benefit plan D shall include only the following: The core benefit, as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, Medically Necessary Emergency Care in a Foreign Country, and the At-Home Recovery Benefit as defined in Regulation .08D(1), (2), (8), and (10) of this chapter. Standardized Medicare supplement benefit plan E shall include only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, Medically Necessary Emergency Care in a Foreign Country, and Preventive Medical Care as defined in Regulation .08D(1), (2), (8), and (9) of this chapter. Standardized Medicare supplement benefit plan F shall include only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, the Skilled Nursing Facility Care, the Part B Deductible, 100 Percent of the Medicare Part B Excess Charges, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .08D(1), (2), (3), (5), and (8) of this chapter. High Deductible Plan F. Standardized Medicare supplement benefit high deductible plan F shall include only 100 percent of covered expenses following the payment of the annual high deductible plan F deductible. The covered expenses include the core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, the Medicare Part B Deductible, 100 Percent of the Medicare Part B Excess Charges, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .08D(1)—(3), (5), and (8) of this chapter. The annual high deductible plan F deductible shall consist of out-of-pocket expenses, other than premiums, for services covered by the Medicare supplement plan F policy, and is in addition to any other specific benefit deductibles. The annual high deductible plan F deductible is $1,500 for 1999, and is based on the calendar year. The deductible shall be adjusted annually after 1999 by the Secretary to reflect the change in the Consumer Price Index for all urban consumers for the 12-month period ending with August of the preceding year, and rounded to the nearest multiple of $10. Standardized Medicare supplement benefit plan G shall include only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, 80 Percent of the Medicare Part B Excess Charges, Medically Necessary Emergency Care in a Foreign Country, and the At-Home Recovery Benefit as defined in Regulation .08D(1), (2), (4), (8), and (10) of this chapter. Standardized Medicare Supplement Benefit Plan H. Standardized Medicare supplement benefit plan H shall consist of only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, Basic Prescription Drug Benefit, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .08D(1), (2), (6), and (8) of this chapter. The outpatient prescription drug benefit may not be included in a Medicare supplement policy sold after December 31, 2005. Standardized Medicare Supplement Benefit Plan I. Standardized Medicare supplement benefit plan I shall consist of only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, 100 Percent of the Medicare Part B Excess Charges, Basic Prescription Drug Benefit, Medically Necessary Emergency Care in a Foreign Country, and At-Home Recovery Benefit as defined in Regulation .08D(1), (2), (5), (6), (8), and (10) of this chapter. The outpatient prescription drug benefit may not be included in a Medicare supplement policy sold after December 31, 2005. Standardized Medicare Supplement Benefit Plan J. Standardized Medicare supplement benefit plan J shall consist of only the following: The core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A Deductible, Skilled Nursing Facility Care, Medicare Part B Deductible, 100 Percent of the Medicare Part B Excess Charges, Extended Prescription Drug Benefit, Medically Necessary Emergency Care in a Foreign Country, Preventive Medical Care, and At-Home Recovery Benefit as defined in Regulation .08D(1)—(3) and (5)—(10) of this chapter. The outpatient prescription drug benefit may not be included in a Medicare supplement policy sold after December 31, 2005. High Deductible Plan J. Standardized Medicare supplement benefit high deductible plan J shall consist of only 100 percent of covered expenses following the payment of the annual high deductible plan J deductible. The covered expenses include the core benefit as defined in Regulation .08C of this chapter, plus the Medicare Part A deductible, skilled nursing facility care, Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, extended outpatient prescription drug benefit, medically necessary emergency care in a foreign country, preventive medical care benefit, and at-home recovery benefit as defined in Regulation .08D(1)—(3), (5), and (7)—(10) of this chapter. The annual high deductible plan J deductible shall consist of out-of-pocket expenses, other than premiums, for services covered by the Medicare supplement plan J policy, and is in addition to any other specific benefit deductibles. The annual deductible is $1,500 for 1999 and is based on a calendar year. The deductible shall be adjusted annually after 1999 by the Secretary to reflect the change in the Consumer Price Index for all urban consumers for the 12-month period ending with August of the preceding year, and rounded to the nearest multiple of $10. The outpatient prescription drug benefit may not be included in a Medicare supplement policy sold after December 31, 2005. Plans Mandated by the Medicare Prescription Drug, Improvement and Modernization Act of 2003. Standardized Medicare supplement benefit plan K shall consist of only those benefits described in Regulation .08E(1) of this chapter. Standardized Medicare supplement benefit plan L shall consist of only those benefits described in Regulation .08E(3) of this chapter. New or Innovative Benefits. An issuer may, with the prior approval of the Commissioner, offer policies or certificates with new or innovative benefits in addition to the benefits provided in a policy or certificate that otherwise complies with the applicable standards. The new or innovative benefits described in §I(1) of this regulation may include benefits that are appropriate to Medicare supplement insurance, new or innovative, not otherwise available, cost-effective, and offered in a manner that is consistent with the goal of simplification of Medicare supplement policies. After December 31, 2005, the innovative benefit may not include an outpatient prescription drug benefit. Guaranteed Issue. Eligible individuals are those individuals described in §B of this regulation who: Seek to enroll under the policy during the period specified in §C of this regulation; and Submit evidence of the date of termination, disenrollment, or Medicare Part D enrollment with the application for a Medicare supplement policy. With respect to eligible individuals, an issuer may not: Deny or condition the issuance or effectiveness of a Medicare supplement policy described in §E of this regulation that is offered and is available for issuance to new enrollees by the issuer; Discriminate in the pricing of a Medicare supplement policy described in §E of this regulation because of health status, claims experience, receipt of health care, or medical condition; and Impose an exclusion of benefits based on a preexisting condition under a Medicare supplement policy described in §E of this regulation. An eligible individual is an individual described in any of the following: The individual is enrolled under an employee welfare benefit plan that provides health benefits that supplement the benefits under Medicare, and the plan terminates or the plan ceases to provide all supplemental health benefits to the individual; The individual is enrolled with a Medicare Advantage organization under a Medicare Advantage plan under Part C of Medicare, and any of the following circumstances apply: The certification of the organization or plan under the federal Social Security Act has been terminated; The organization has terminated or otherwise discontinued providing the plan in the area in which the individual resides; The individual is no longer eligible to elect the plan because: Of a change in the individual's place of residence, Of another change in circumstances specified by the Secretary, but not including termination of the individual's enrollment on the basis described in §1851(g)(3)(B) of the federal Social Security Act (when the individual has not paid premiums on a timely basis or has engaged in disruptive behavior as specified in standards under §1856 of the federal Social Security Act), or The plan is terminated for all individuals within a residence area; The individual demonstrates, in accordance with guidelines established by the Secretary, that: The organization offering the plan substantially violated a material provision of the organization's contract under Part C of Medicare in relation to the individual, including the failure to provide an enrollee on a timely basis medically necessary care for which benefits are available under the plan or the failure to provide medically necessary covered care in accordance with applicable quality standards, or The organization, or agent or other entity acting on the organization's behalf, materially misrepresented the plan's provisions in marketing the plan to the individual; or The individual meets any other exceptional conditions as the Secretary may provide; The individual is 65 years old or older and is enrolled with a Program of All-Inclusive Care for the Elderly (PACE) provider under §1894 of the Social Security Act, and there are circumstances similar to those described in §B(2) of this regulation that would permit discontinuance of the individual's enrollment with the PACE provider if the individual were enrolled in a Medicare Advantage plan; The individual: Is enrolled with: An eligible organization under a contract under §1876 of the federal Social Security Act (Medicare cost), A similar organization to the organization described in §B(4)(a)(i) of this regulation operating under demonstration project authority, effective for periods before April 1, 1999, An organization under an agreement under §1833(a)(1)(A) of the federal Social Security Act (health care prepayment plan), or An organization under a Medicare Select policy; and Ceases to be enrolled under the same circumstances that would permit discontinuance of an individual's election of coverage under §B(2) of this regulation; The individual is enrolled under a Medicare supplement policy and the enrollment ceases because of: The insolvency of the issuer or bankruptcy of the nonissuer organization or other involuntary termination of coverage or enrollment under the policy; The issuer of the policy substantially violated a material provision of the policy; or The issuer, or an agent or other entity acting on the issuer's behalf, materially misrepresented the policy's provisions in marketing the policy to the individual; The individual: Was enrolled under a Medicare supplement policy and terminates enrollment and subsequently enrolls, for the first time with: Any Medicare Advantage organization under a Medicare Advantage plan under Part C of Medicare, Any eligible organization under a contract under §1876 of the federal Social Security Act (Medicare cost), Any similar organization operating under demonstration project authority, A Medicare Select policy, or Any Program of All-Inclusive Care for the Elderly (PACE) provider under §1894 of the Social Security Act; and Terminates the subsequent enrollment under §B(6)(a) of this regulation during any period within the first 12 months of the subsequent enrollment (during which the enrollee is permitted to terminate the subsequent enrollment under §1851(e) of the federal Social Security Act); The individual, upon first becoming enrolled in Part B of Medicare at 65 years old or older, enrolls in a Medicare Advantage plan under Part C of Medicare, or with a PACE provider under §1894 of the Social Security Act, and disenrolls from the plan or program by not later than 12 months after the effective date of enrollment; or The individual: Enrolls in a Medicare Part D plan during the initial enrollment period; At the time of enrollment in Part D: Was enrolled under a Medicare supplement policy that covers outpatient prescription drugs; and Terminates enrollment in the Medicare supplement policy described in §B(8)(b)(i) of this regulation; and Submits evidence of enrollment in Medicare Part D with the application for a policy described in §E(5) of this regulation. Guaranteed Issue Time Periods. The guaranteed issue period for an individual described in §B(1) of this regulation: Begins on the later of the date: The individual receives a notice of termination or cessation of all supplemental health benefits, or, if the individual does not receive the notice, the date the individual receives notice that a claim has been denied because of a termination or cessation of all supplemental health benefits; or The applicable coverage terminates or ceases; and Ends 63 days after the beginning of the period described in §C(1)(a) of this regulation. The guaranteed issue period for an individual described in §B(2)—(4), (6), or (7) of this regulation whose enrollment is terminated involuntarily: Begins on the date that the individual receives a notice of termination; and Ends 63 days after the date the applicable coverage is terminated. The guaranteed issue period for an individual described in §B(5)(a) of this regulation: Begins on the earlier of: The date that the individual receives a notice of termination, a notice of the issuer's bankruptcy or insolvency, or other similar notice, if any; or The date that the applicable coverage is terminated; and Ends on the date that is 63 days after the date the coverage is terminated. The guaranteed issue period for an individual described in §B(2), (3), (5)(b), (5)(c), (6), or (7) of this regulation, who disenrolls voluntarily: Begins on the date that is 60 days before the effective date of the disenrollment; and Ends on the date that is 63 days after the effective date. The guaranteed issue period for an individual described in §B(8) of this regulation: Begins on the date the individual receives notice pursuant to §1882(v)(2)(B) of the Social Security Act from the Medicare supplement issuer during the 60-day period immediately preceding the initial Part D enrollment period; and Ends on the date that is 63 days after the effective date of the individual's coverage under Medicare Part D. The guaranteed issue period for an individual described in §B of this regulation but not described in §C(1)—(5) of this regulation: Begins on the effective date of disenrollment; and Ends on the date that is 63 days after the effective date of disenrollment. Extended Medigap Access for Interrupted Trial Periods. A subsequent enrollment of an individual described in §B(6) of this regulation shall be deemed to be a first time enrollment described in §B(6) of this regulation if both of the following are satisfied: The individual's enrollment with an organization or provider described in §B(6)(a) of this regulation is involuntarily terminated within the first 12 months of enrollment; and The individual enrolls with another organization or provider described in §B(6)(a) of this regulation without an intervening enrollment. A subsequent enrollment of an individual described in §B(7) of this regulation shall be deemed to be a first time enrollment described in §B(7) of this regulation if both of the following are satisfied: The individual's enrollment with a plan or in a program described in §B(7) of this regulation is involuntarily terminated within the first 12 months of enrollment; and The individual enrolls in another plan or program described in §B(7) of this regulation, without an intervening enrollment. For purposes of §B(6) and (7) of this regulation, an enrollment of an individual with an organization or provider described in §B(6)(a) of this regulation, or with a plan or in a program described in §B(7) of this regulation, may not be deemed to be a first time enrollment under this section after the 2-year period beginning on the date on which the individual first enrolled with the organization, provider, plan, or program. Products to Which Eligible Individuals Are Entitled. The Medicare supplement policy to which eligible individuals are entitled under: §B(1)—(5) of this regulation is a Medicare supplement policy which has a benefit package classified as plan A, B, C, F, including F with a high deductible, K, or L offered by any issuer; Subject to §E(3) of this regulation, §B(6) of this regulation is the same Medicare supplement policy in which the individual was most recently previously enrolled, if available from the same issuer, or, if not so available, a policy described in §E(1) of this regulation; §B(6) of this regulation after December 31, 2005, if the individual was most recently enrolled in a Medicare supplement policy with an outpatient prescription drug benefit, a Medicare supplement policy described in this subsection is: The policy available from the same issuer but modified to remove outpatient prescription drug coverage; or At the election of the policyholder, an A, B, C, F, including F with a high deductible, K, or L policy that is offered by any issuer; §B(7) of this regulation shall include any Medicare supplement policy offered by any issuer; and §B(8) of this regulation is a Medicare supplement policy that has a benefit package classified as Plan A, B, C, F, including F with a high deductible, K, or L, and that is offered and is available for issuance to new enrollees by the same issuer that issued the individual's Medicare supplement policy with outpatient prescription drug coverage. Notification Provisions. At the time of an event described in §B of this regulation because of which an individual loses coverage or benefits due to the termination of a contract or agreement, policy, or plan, the organization that terminates the contract or agreement, the issuer terminating the policy, or the administrator of the plan being terminated, respectively, shall notify the individual of the individual's rights under this section, and of the obligations of issuers of Medicare supplement policies under §A of this regulation. The notice required by §F(1) of this regulation shall be communicated contemporaneously with the notification of termination. At the time of an event described in §B of this regulation because of which an individual ceases enrollment under a contract or agreement, policy, or plan, the organization that offers the contract or agreement, regardless of the basis for the cessation of enrollment, the issuer offering the policy, or the administrator of the plan, respectively, shall notify the individual of the individual's rights under this section, and of the obligations of issuers of Medicare supplement policies under §A of this regulation. The notice required by §F(3) of this regulation shall be communicated within 10 working days of the issuer receiving notification of disenrollment. An issuer shall comply with §1882(c)(3) of the Social Security Act, as enacted by §4081(b)(2)(C) of the Omnibus Budget Reconciliation Act of 1987 (OBRA) 1987, Public Law No. 100-203, by: Accepting a notice from a Medicare carrier on dually assigned claims submitted by participating physicians and suppliers as a claim for benefits in place of any other claim form otherwise required and making a payment determination on the basis of the information contained in that notice; Notifying the participating physician or supplier and the beneficiary of the payment determination; Paying the participating physician or supplier directly; Furnishing, at the time of enrollment, each enrollee with a card listing the policy name, number, and a central mailing address to which notices from a Medicare carrier may be sent; Paying user fees for claim notices that are transmitted electronically or otherwise; and Providing to the federal Secretary of Health and Human Services, at least annually, a central mailing address to which all claims may be sent by Medicare carriers. The issuer shall certify to compliance with requirements set forth in §A of this regulation on the Medicare supplement insurance experience reporting form. Loss Ratio Standards. An issuer may not deliver or issue for delivery a Medicare supplement policy form or certificate in this State unless the policy form or certificate can be expected, as estimated for the entire period for which rates are computed to provide coverage, to return to policyholders and certificate holders in the form of aggregate benefits, not including anticipated refunds or credits, provided under the policy form or certificate form: At least 75 percent of the aggregate amount of premiums earned in the case of group policies; or At least 65 percent of the aggregate amount of premiums earned in the case of individual policies. The aggregate benefits as determined in accordance with §A(1)(a) and (b) of this regulation shall be calculated on the basis of incurred claims experience, or incurred health care expenses when coverage is provided by a health maintenance organization on a service rather than reimbursement basis. Earned premiums for the period for which rates are computed shall be calculated in accordance with accepted actuarial principles and practices. Incurred health care expenses where coverage is provided by a health maintenance organization may not include: Home office and overhead costs; Advertising costs; Commissions and other acquisition costs; Taxes; Capital costs; Administrative costs; or Claims processing costs. All filings of rates and rating schedules shall demonstrate that expected claims in relation to premiums comply with the requirements of this regulation when combined with actual experience to date. Filings of rate revisions shall also demonstrate that the anticipated loss ratio over the entire future period for which the revised rates are computed to provide coverage can be expected to meet the appropriate loss ratio standards. For purposes of applying §A(1) of this regulation and Regulation .04C(3) of this chapter only, policies issued as a result of solicitations of individuals through the mails or by mass media advertising, including both print and broadcast advertising, shall be considered to be individual policies. For policies issued before July 1, 1992, expected claims in relation to premiums shall meet the: Originally filed anticipated loss ratio when combined with the actual experience since inception; Appropriate loss ratio requirement from §A(1)(a) and (b) of this regulation when combined with actual experience beginning with April 1, 1996, Appropriate loss ratio requirement from §A(1)(a) and (b) of this regulation over the entire future period for which the rates are computed to provide coverage. Refund or Credit Calculation. An issuer shall collect and file with the Commissioner by May 31 of each year the data contained in the reporting form in Regulation .19 of this chapter for each type of standard Medicare supplement benefit plan. If, on the basis of the experience as reported, the benchmark ratio since inception (ratio 1) exceeds the adjusted experience ratio since inception (ratio 3), then a refund or credit calculation is required. The refund calculation shall be done on a Statewide basis for each type in a standard Medicare supplement benefit plan. For purposes of the refund or credit calculation, experience on policies issued within the reporting year shall be excluded. For purposes of this section, for policies or certificates issued before July 1, 1992, the issuer shall make the refund or credit calculation separately for all individual policies, including all group policies subject to an individual loss ratio standard when issued, combined and all other group policies combined for experience after April 1, 1996. The first report shall be due by May 31, 1998. A refund or credit shall be made only when the benchmark loss ratio exceeds the adjusted experience loss ratio and the amount to be refunded or credited exceeds a de minimis level. The refund shall include interest from the end of the calendar year to the date of the refund or credit at a rate specified by the federal Secretary of Health and Human Services, but may not be less than the average rate of interest for 13-week Treasury notes. A refund or credit against premiums due shall be made by September 30 following the experience year upon which the refund or credit is based. Annual Filing of Premium Rates. An issuer of Medicare supplement policies and certificates issued before or after the effective date of these regulations in this State shall file annually its rates, rating schedule, and supporting documentation including ratios of incurred losses to earned premiums by policy duration for approval by the Commissioner in accordance with the filing requirements and procedures required by the Commissioner. The supporting documentation shall also demonstrate in accordance with actuarial standards of practice, using reasonable assumptions, that the appropriate loss ratio standards can be expected to be met over the entire period for which rates are computed. The demonstration shall exclude active life reserves. An expected third year loss ratio which is greater than or equal to the applicable percentage shall be demonstrated for policies or certificates in force less than 3 years. As soon as practicable, but before the effective date of enhancements in Medicare benefits, every issuer of Medicare supplement policies or certificates in this State shall file with the Commissioner in accordance with the applicable filing procedures of this State: Appropriate premium adjustments necessary to produce loss ratios as anticipated for the current premium for the applicable policies or certificates; and Supporting documents as necessary to justify the adjustment which shall accompany the filing. An issuer shall make the premium adjustments which are necessary to produce an expected loss ratio under the policy or certificate to conform with minimum loss ratio standards for Medicare supplement policies in compliance with §A(1)(a) and (b) of this regulation and which are expected to result in a loss ratio at least as great as that originally anticipated in the rates used to produce current premiums by the issuer for the Medicare supplement policies or certificates. A premium adjustment which would modify the loss ratio experience under the policy other than the adjustments described in §C(3) of this regulation may not be made with respect to a policy at any time other than upon its renewal date or anniversary date. If an issuer fails to make premium adjustments acceptable to the Commissioner, the Commissioner may order premium adjustments, refunds, or premium credits considered necessary to achieve the loss ratio required by this regulation. Before the effective date of changes in Medicare benefits, every issuer of Medicare supplement policies or certificates in this State shall file with the Commissioner for approval appropriate riders, endorsements, or policy forms needed to accomplish the Medicare supplement policy or certificate modifications necessary to eliminate benefit duplications with Medicare. The riders, endorsements, or policy forms shall provide a clear description of the Medicare supplement benefits provided by the policy or certificate. Public Hearings. The Commissioner may conduct a public hearing to gather information concerning a request by an issuer for an increase in a rate for a policy form or certificate form issued before or after the effective date of these regulations if the experience of the form for the previous reporting period is not in compliance with the applicable loss ratio standard. The determination of compliance is made without consideration of any refund or credit for the reporting period. Public notice of the hearing shall be furnished in a manner considered appropriate by the Commissioner. An issuer or other entity may provide commission or other compensation to an agent or other representative for the sale of a Medicare supplement policy or certificate only if the first year commission or other first year compensation is not more than 200 percent of the commission or other compensation paid for selling or servicing the policy or certificate in the second year or period. The commission or other compensation provided in subsequent renewal years shall be the same as that provided in the second year or period and shall be provided for not fewer than 5 renewal years. If an existing Medicare supplement policy or certificate is replaced, an issuer or other entity may not provide compensation to its agents or other producers and an agent or producer may not receive compensation greater than the renewal compensation payable by the replacing issuer on renewal policies or certificates. For purposes of this regulation, “compensation” includes pecuniary or nonpecuniary remuneration of any kind relating to the sale or renewal of the policy or certificate including bonuses, gifts, prizes, awards, and finders fees. Definitions. In this regulation, the following terms have the meanings indicated. Terms Defined. “Form” means the language, format, type size, type proportional spacing, bold character, and line spacing. “Guide” means the Guide to Health Insurance for People with Medicare. General Rules. Medicare supplement policies and certificates shall include a renewal or continuation provision. The language or specifications of this provision shall be consistent with the type of contract issued. The provision shall be appropriately captioned and shall appear on the first page of the policy, and shall include any reservation by the issuer of the right to change premiums and any automatic renewal premium increases based on the policyholder's age. Except for riders or endorsements by which the issuer effectuates a request made in writing by the insured, exercises a specifically reserved right under a Medicare supplement policy, or is required to reduce or eliminate benefits to avoid duplication of Medicare benefits, all riders or endorsements added to a Medicare supplement policy after the date of issue or at reinstatement or renewal which reduce or eliminate benefits or coverage in the policy shall require a signed acceptance by the insured. After the date of the policy or certificate issue, any rider or endorsement which increases benefits or coverage with a concomitant increase in premium during the policy term shall be agreed to in writing signed by the insured, unless the benefits are required by the minimum standards for Medicare supplement policies, or if the increased benefits or coverage are required by law. When a separate additional premium is charged for benefits provided in connection with riders or endorsements, the premium charge shall be set forth in the policy. Medicare supplement policies or certificates may not provide for the payment of benefits based on standards described as “usual and customary”, “reasonable and customary”, or words of similar import. If a Medicare supplement policy or certificate contains any limitations with respect to preexisting conditions, these limitations shall appear as a separate paragraph of the policy and be labeled “preexisting condition limitations”. Medicare supplement policies and certificates shall have a notice prominently printed on the first page of the policy or certificate or attached to it stating in substance that the policyholder or certificate holder shall have the right to return the policy or certificate within 30 days of its delivery and to have the premium refunded if, after examination of the policy or certificate, the insured person is not satisfied for any reason. Guide to Health Insurance for People With Medicare. Issuers of health policies or certificates that provide hospital or medical expense coverage on an expense-incurred or indemnity basis to persons eligible for Medicare shall provide to those applicants a Guide to Health Insurance for People with Medicare in the form developed jointly by the National Association of Insurance Commissioners and the Centers for Medicare and Medicaid Services. The Guide shall be printed in a type size not smaller than 12-point type. Delivery of the Guide shall be made whether or not the policies or certificates are advertised, solicited, or issued as Medicare supplement policies or certificates as defined in this chapter. Except in the case of direct response issuers, issuers shall: Deliver the Guide to the applicant at the time of application; and Obtain acknowledgement of receipt of the Guide. Direct response issuers shall deliver the Guide to the applicant upon request, but not later than at the time the policy is delivered. Notice Requirements. As soon as practicable, but not later than 30 days before the annual effective date of any Medicare benefit changes, an issuer shall notify its Medicare supplement policyholders and certificate holders of modifications the insurer has made to Medicare supplement insurance policies or certificates in a format acceptable to the Commissioner. The notice shall: Include a description of revisions to the Medicare program and a description of each modification made to the coverage provided under the Medicare supplement policy or certificate; and Inform each policyholder or certificate holder as to when any premium adjustment is to be made due to changes in Medicare. The notice of benefit modifications and any premium adjustments shall be in outline form and in clear and simple terms so as to facilitate comprehension. The notice may not contain or be accompanied by a solicitation. MMA Notice Requirements. Issuers shall comply with any notice requirements of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Outline of Coverage Requirements for Medicare Supplement Policies. Issuers shall provide an outline of coverage to all applicants at the time the application is presented to the prospective applicant and, except for direct response policies, shall obtain an acknowledgement of receipt of the outline from the applicant. If an outline of coverage is provided at the time of application and the Medicare supplement policy or certificate is issued on a basis which would require revision of the outline, the issuer shall provide the applicant with a substitute outline of coverage properly describing the policy or certificate which is delivered. The substitute outline of coverage shall contain the following statement in not less than 12-point type, immediately above the company name: Outline of Coverage. The outline of coverage provided to applicants in accordance with this regulation consists of four parts: A cover page; Premium information; Disclosure pages; and Charts displaying the features of each benefit plan offered by the issuer. The outline of coverage for 2010 standardized Medicare supplement benefit plan policies or certificates shall be in the language and format described in Regulation .30 of this chapter in not less than 12-point type. All plans shall be shown on the cover page, and the plans that are offered by the issuer shall be prominently identified. Premium information for plans that are offered shall be shown on the cover page or immediately following the cover page and shall be prominently displayed. The premium and mode shall be stated for all plans that are offered to the prospective applicant. All possible premiums for the prospective applicant shall be illustrated. “NOTICE: Read this outline of coverage carefully. It is not identical to the outline of coverage provided upon application and the coverage originally applied for has not been issued.” Notice Regarding Policies or Certificates Which Are Not Medicare Supplement Policies. Any health insurance policy or certificate, other than a Medicare supplement policy, or a policy issued pursuant to a contract under §1876 of the federal Social Security Act (42 U.S.C. §1395 et seq.), disability income policy, or other policy identified in Regulation .01C of this chapter, issued for delivery in this State to persons eligible for Medicare shall contain a notice to insureds under the policy that the policy is not a Medicare supplement policy or certificate. The notice shall either be printed or attached to the first page of the outline of coverage delivered to insureds under the policy, or if no outline of coverage is delivered, to the first page of the policy or certificate delivered to the insureds. The notice shall be in not less than 12-point type and contain the following language. Disclosure Statements. Applications provided to persons eligible for Medicare for the health insurance policies or certificates described in §F(1) of this regulation shall disclose, using the applicable statement in Regulation .22 of this chapter, the extent to which the policy duplicates Medicare. The disclosure statement required by §F(2)(a) of this regulation shall be provided as a part of, or together with, the application for the policy or certificate. Required Questions in Medicare Supplement Applications. Application forms shall include the following questions designed to elicit information as to whether, as of the date of the application, the applicant currently has Medicare supplement, Medicare Advantage, Medicaid coverage, or another health insurance policy or certificate in force or whether a Medicare supplement policy or certificate is intended to replace any other accident and sickness policy or certificate presently in force. A supplementary application or other form to be signed by the applicant and insurance producer containing these questions and statements may be used. You do not need more than one Medicare supplement policy. If you purchase this policy, you may want to evaluate your existing health coverage and decide if you need multiple coverages. You may be eligible for benefits under Medicaid and may not need a Medicare supplement policy. If, after purchasing this policy, you become eligible for Medicaid, the benefits and premiums under your Medicare supplement policy can be suspended, if requested, during your entitlement to benefits under Medicaid for 24 months. You must request this suspension within 90 days of becoming eligible for Medicaid. If you are no longer entitled to Medicaid, your suspended Medicare supplement policy (or, if that is no longer available, a substantially equivalent policy) will be reinstituted if requested within 90 days of losing Medicaid eligibility. If the Medicare supplement policy provided coverage for outpatient prescription drugs and you enrolled in Medicare Part D while your policy was suspended, the reinstituted policy will not have outpatient prescription drug coverage, but will otherwise be substantially equivalent to your coverage before the date of the suspension. If you are eligible for, and have enrolled in a Medicare supplement policy by reason of disability and you later become covered by an employer or union-based group health plan, the benefits and premiums under your Medicare supplement policy can be suspended, if requested, while you are covered under the employer or union-based group health plan. If you suspend your Medicare supplement policy under these circumstances, and later lose your employer or union-based group health plan, your suspended Medicare supplement policy (or, if that is no longer available, a substantially equivalent policy) will be reinstituted if requested within 90 days of losing your employer or union-based group health plan. If the Medicare supplement policy provided coverage for outpatient prescription drugs and you enrolled in Medicare Part D while your policy was suspended, the reinstituted policy will not have outpatient prescription drug coverage, but will otherwise be substantially equivalent to your coverage before the date of the suspension. Counseling services may be available in your state to provide advice concerning your purchase of Medicare supplement insurance and concerning medical assistance through the State Medicaid program, including benefits as a Qualified Medicare Beneficiary (QMB) and a Specified Low-Income Medicare Beneficiary (SLMB). Did you turn age 65 in the last 6 months? Did you enroll in Medicare Part B in the last 6 months? If yes, what is the effective date?_____________ Are you covered for medical assistance through the State Medicaid program? Will Medicaid pay your premiums for this Medicare supplement policy? Do you receive any benefits from Medicaid OTHER THAN payments toward your Medicare Part B premium? If you had coverage from any Medicare plan other than original Medicare within the past 63 days (for example, a Medicare Advantage plan, or a Medicare HMO or PPO), fill in your start and end dates below. If you are still covered under this plan, leave “END” blank. If you are still covered under the Medicare plan, do you intend to replace your current coverage with this new Medicare supplement policy? Was this your first time in this type of Medicare plan? Did you drop a Medicare supplement policy to enroll in the Medicare plan? Do you have another Medicare supplement policy in force? If so, with what company, and what plan do you have {optional for Direct Mailers}? If so, do you intend to replace your current Medicare supplement policy with this policy? Have you had coverage under any other health insurance within the past 63 days? (For example, an employer, union, or individual plan) If so, with what company and what kind of policy? What are your dates of coverage under the other policy? If you lost or are losing other health insurance coverage and received a notice from your prior insurer saying you were eligible for guaranteed issue of a Medicare supplement insurance policy, or that you had certain rights to buy such a policy, you may be guaranteed acceptance in one or more of our Medicare supplement plans. Please include a copy of the notice from your prior insurer with your application. PLEASE ANSWER ALL QUESTIONS. Agents shall list any other health insurance policies they have sold to the applicant. List policies sold which are still in force. List policies sold in the past five (5) years which are no longer in force. In the case of a direct response issuer, a copy of the application or supplemental form, signed by the applicant, and acknowledged by the insurer, shall be returned to the applicant by the insurer upon delivery of the policy. Upon determining that a sale will involve replacement of Medicare supplement coverage, any issuer, other than a direct response issuer, or its agent, shall furnish the applicant, prior to issuance or delivery of the Medicare supplement policy or certificate, a notice regarding replacement of Medicare supplement coverage. One copy of the notice signed by the applicant and the agent, except where the coverage is sold without an agent, shall be provided to the applicant and an additional signed copy shall be retained by the issuer. A direct response issuer shall deliver to the applicant at the time of the issuance of the policy the notice regarding replacement of Medicare supplement coverage. The notice required by §D of this regulation for an issuer shall be provided in substantially the following form in not less than 12-point type: Note: If the issuer of the Medicare supplement policy being applied for does not, or is otherwise prohibited from imposing preexisting condition limitations, please skip to statement 2 below. Health conditions which you may presently have (preexisting conditions) may not be immediately or fully covered under the new policy. This could result in denial or delay of a claim for benefits under the new policy, whereas a similar claim might have been payable under your present policy. State law provides your replacement policy or certificate may not contain new preexisting conditions, waiting periods, elimination periods, or probationary periods. The insurer will waive any time periods applicable to preexisting conditions, waiting periods, elimination periods, or probationary periods in the new policy (or coverage) for similar benefits to the extent such time was spent (depleted) under the original policy. If you still wish to terminate your present policy and replace it with new coverage, be certain to truthfully and completely answer all questions on the application concerning your medical and health history. Failure to include all material medical information on an application may provide a basis for the company to deny any future claims and to refund your premium as though your policy had never been in force. After the application has been completed and before you sign it, review it carefully to be certain that all information has been properly recorded. (If the policy or certificate is guaranteed issue, this paragraph need not appear.) Paragraphs 1 and 2 of the replacement notice (applicable to preexisting conditions) may be deleted by an issuer if the replacement does not involve application of a new preexisting condition limitation. An issuer, directly or through its producers, shall: Establish marketing procedures to assure that any comparison of policies by its agents or other producers will be fair and accurate; Establish marketing procedures to assure that excessive insurance is not sold or issued; Display prominently by type, stamp, or other appropriate means on the first page of the policy the following: “Notice to buyer: This policy may not cover all of your medical expenses.”; Inquire and otherwise make every reasonable effort to identify whether a prospective applicant or enrollee for Medicare supplement insurance already has health insurance and the types and amounts of any insurance; Establish auditable procedures for verifying compliance with this section. In addition to the practices prohibited in Insurance Article, Title 27, Annotated Code of Maryland, the following acts and practices are prohibited: Twisting: Knowingly making any misleading representation or incomplete or fraudulent comparison of any insurance policies or insurers for the purpose of inducing, or tending to induce, any person to lapse, forfeit, surrender, terminate, retain, pledge, assign, borrow on, or convert any insurance policy or to take out a policy of insurance with another insurer; High pressure tactics: Employing any method of marketing having the effect of or tending to induce the purchase of insurance through force, fright, threat, whether explicit or implied, or undue pressure to purchase or recommend the purchase of insurance; Cold lead advertising: Making use directly or indirectly of any method of marketing which fails to disclose in a conspicuous manner that a purpose of the method of marketing is solicitation of insurance and that contact will be made by an insurance agent or insurance company. The terms “Medicare Supplement”, “Medigap”, “Medicare Wrap-Around”, and words of similar import may not be used unless the policy is issued in compliance with these regulations. In recommending the purchase or replacement of any Medicare supplement policy or certificate an agent shall make reasonable efforts to determine the appropriateness of a recommended purchase or replacement. Any sale of a Medicare supplement policy or certificate that will provide an individual more than one Medicare supplement policy or certificate is prohibited. An issuer may not issue a Medicare supplement policy or certificate to an individual enrolled in Medicare Part C unless the effective date of the coverage is after the termination date of the individual's Part C coverage. On or before March 1 of each year, an issuer shall report the following information for every individual resident of this State for which the issuer has in force more than one Medicare supplement policy or certificate: Policy or certificate number; and Date of issuance. The items set forth in §A of this regulation shall be grouped by individual policyholder. If a Medicare supplement policy or certificate replaces another Medicare supplement policy or certificate, the replacing issuer shall waive any time periods applicable to preexisting conditions, waiting periods, elimination periods, and probationary periods in the new Medicare supplement policy or certificate to the extent time was spent under the original policy. If a Medicare supplement policy or certificate replaces another Medicare supplement policy or certificate which has been in effect for at least 6 months, the replacing policy may not provide any time period applicable to preexisting conditions, waiting periods, elimination periods, and probationary periods. The following forms are to be used for reporting loss ratios and calculating refunds for credits required under Regulation .11B of this chapter: Medicare Supplement Refund Calculation Form. Signature ________________________________ Name-Please Type ________________________________ Title-Please Type ________________________________ Date Reporting Form for Benchmark Ratio for Group Policies. Reporting Form for Benchmark Ratio for Individual Policies. The following form is to be used in making reports of multiple policies in accordance with the requirements of Regulation .17 of this chapter: (a)3 (b)4 (c) (d) (e) (f) (g) (h) (i) (j) (o)5 Year Earned Premium Factor (b) × (c) CumulativeLoss Ratio (d) × (e) Factor (b) × (g) CumulativeLoss Ratio (h) × (i) Policy YearLoss Ratio 1 2.770 0.442 0.000 0.000 0.4 2 4.175 0.493 0.000 0.000 0.55 3 4.175 0.493 1.194 0.659 0.65 4 4.175 0.493 2.245 0.669 0.67 5 4.175 0.493 3.170 0.678 0.69 6 4.175 0.493 3.998 0.686 0.71 7 4.175 0.493 4.754 0.695 0.73 8 4.175 0.493 5.445 0.702 0.75 9 4.175 0.493 6.075 0.708 0.76 10 4.175 0.493 6.650 0.713 0.76 11 4.175 0.493 7.176 0.717 0.76 12 4.175 0.493 7.655 0.720 0.77 13 4.175 0.493 8.093 0.723 0.77 14 4.175 0.493 8.493 0.725 0.77 15+6 4.175 0.493 8.684 0.725 0.77 ________ ________ ________ ________ Total: (k): (l): (m): (n): The purpose of this form is to report the following information on each resident of this state who has in force more than one Medicare supplement policy or certificate. The information is to be grouped by individual policyholder. FORM FOR REPORTINGMEDICARE SUPPLEMENT POLICIES Company name: ________________________________________ Address: ________________________________________ ________________________________________ Phone Number: ________________________________________ Due: March 1, annually Policy andCertificate # Date ofIssuance If any regulations of this chapter or the application of these regulations to any person or circumstance is for any reason held to be invalid, the remainder of the chapter and the application of the regulations to other persons or circumstances may not be affected. Instructions. Section 1882(d) of the federal Social Security Act (42 U.S.C. 1395ss) prohibits the sale of a health insurance policy (the term policy includes certificate) to Medicare beneficiaries that duplicates Medicare benefits unless it will pay benefits without regard to a beneficiary's other health coverage and it includes the prescribed disclosure statement on or together with the application for the policy. All types of health insurance policies that duplicate Medicare shall include one of the attached disclosure statements, according to the particular policy type involved, on the application or together with the application. The disclosure statement may not vary from the attached statements in terms of language or format (type size, type proportional spacing, bold character, line spacing, and usage of boxes around text). State and federal law prohibits insurers from selling a Medicare supplement policy to a person that already has a Medicare supplement policy except as a replacement. Property/casualty and life insurance policies are not considered health insurance. Disability income policies are not considered to provide benefits that duplicate Medicare. Long-term care insurance policies that coordinate with Medicare and other health insurance are not considered to provide benefits that duplicate Medicare. The federal law does not preempt state laws that are more stringent than the federal requirements. The federal law does not preempt existing state form filing requirements. Section 1882 of the federal Social Security Act was amended in subsection (d)(3)(A) to allow for alternative disclosure statements. The disclosure statements already in §B of this regulation remain. Carriers may use either disclosure statement with the requisite insurance product. However, carriers shall use either the original disclosure statements or the alternative disclosure statements and not use both simultaneously. Insurers shall use the disclosure statements found in §§B and C of this regulation if the disclosure statement was printed before January 1, 2006. Original Disclosure Statements. Accidental Injury Only Policies. The following is an original disclosure statement for policies that provide benefits for expenses incurred for an accidental injury only: Specified Limited Services Policies. The following is an original disclosure statement for policies that provide benefits for specified limited services: Expense Incurred Specified Disease Policies. The following is an original disclosure statement for policies that reimburse expenses incurred for specified disease(s) or other specified impairment(s). This includes expense incurred cancer, specified disease and other types of health insurance policies that limit reimbursement to named medical conditions. Fixed Dollar Specified Disease Policies. The following is an original disclosure statement for policies that pay fixed dollar amounts for specified diseases or other specified impairments. This includes cancer, specified disease, and other health insurance policies that pay a scheduled benefit or specific payment based on diagnosis of the conditions named in the policy. Policies Providing Both Expense Incurred and Fixed Indemnity Benefits. The following is an Original disclosure statement for policies that provide benefits for both expenses incurred and fixed indemnity basis: Policies Providing Fixed Dollar Benefits. The following is an original disclosure statement for indemnity policies and other policies that pay a fixed dollar amount per day, excluding long-term care policies: Other Health Insurance Policies. The following is an original disclosure statement for other health insurance policies not specifically identified in the previous statements: Alternative Disclosure Statements. Accidental Injury Only Policies. The following is an alternative disclosure statement for policies that provide benefits for expenses incurred for an accidental injury only: Specified Limited Services Policies. The following is an alternative disclosure statement for policies that provide benefits for specified limited services: Expense Incurred Specified Disease Policies. The following is an alternative disclosure statement for policies that reimburse expenses incurred for specified diseases or other specified impairments. This includes expense-incurred cancer, specified disease, and other types of health insurance policies that limit reimbursement to named medical conditions. Fixed Dollar Specified Disease Policies. The following is an alternative disclosure statement for policies that pay fixed dollar amounts for specified diseases or other specified impairments. This includes cancer, specified disease, and other health insurance policies that pay a scheduled benefit or specific payment based on diagnosis of the conditions named in the policy. Policies Providing Both Expense Incurred and Fixed Indemnity Benefits. The following is an alternative disclosure statement for policies that provide benefits upon both an expense-incurred and fixed indemnity basis: Policies Providing Only Fixed Dollar Benefits. The following is an alternative disclosure statement for indemnity policies and other policies that pay a fixed dollar amount per day, excluding long-term care policies: Other Health Insurance Policies. The following is an alternative disclosure statement for other health insurance policies not specifically identified in the preceding statements: Instructions. The instructions found in Regulation .22A(1)—(8) of this chapter also apply to the disclosure statements printed after December 31, 2005. Use of Original or Alternative Disclosure Statements. Section 1882 of the federal Social Security Act was amended in Subsection (d)(3)(A) to allow for alternative disclosure statements. Carriers may use either disclosure statement with the requisite insurance product. Carriers shall use either the original disclosure statements or the alternative disclosure statement, but not both simultaneously. Insurers shall use the disclosure statements found in §§C and D of this regulation if the disclosure statements were printed after December 31, 2005. Original Disclosure Statements. Accidental Injury Only Policies. The following is an original disclosure statement for policies that provide benefits for expenses incurred for an accidental injury only: Specified Limited Services Policies. The following is an original disclosure statement for policies that provide benefits for specified limited services: Expense Incurred Specified Disease Policies. The following is an original disclosure statement for policies that reimburse expenses incurred for specified diseases or other specified impairments. This includes expense-incurred cancer, specified disease, and other types of health insurance policies that limit reimbursement to named medical conditions. Fixed Dollar Specified Disease Policies. The following is an original disclosure statement for policies that pay fixed dollar amounts for specified diseases or other specified impairments. This includes cancer, specified disease, and other health insurance policies that pay a scheduled benefit or specific payment based on diagnosis of the conditions named in the policy. Policies Providing Fixed Dollar Benefits. The following is an original disclosure statement for indemnity policies and other policies that pay a fixed dollar amount per day, excluding long-term care policies: Policies Providing Both Expense Incurred and Fixed Indemnity Benefits. The following is an original disclosure statement for policies that provide benefits upon both an expense-incurred and fixed indemnity basis: Other Health Insurance Policies. The following is an original disclosure statement for other health insurance policies not specifically identified in the statements set forth in §C(1)-6) of this regulation: Alternative Disclosure Statements. Accidental Injury Only Policies. The following is an alternative disclosure statement for policies that provide benefits for expenses incurred for an accidental injury only: Specified Limited Services Policies. The following is an alternative disclosure statement for policies that provide benefits for specified limited services: Expense-Incurred Specified Disease Policies. The following is an alternative disclosure statement for policies that reimburse expenses incurred for specified diseases, or other specified impairments. This includes expense-incurred cancer, specified disease, and other types of health insurance policies that limit reimbursement to named medical conditions. Fixed Dollar Specified Disease Policies. The following is an alternative disclosure statement for policies that pay fixed dollar amounts for specified diseases or other specified impairments. This includes cancer, specified disease, and other health insurance policies that pay a scheduled benefit or specific payment based on diagnosis of the conditions named in the policy. Policies Providing Only Fixed Dollar Benefits. The following is an alternative disclosure statement for indemnity policies and other policies that pay a fixed dollar amount per day, excluding long-term care policies: Policies Providing Both Expense-Incurred and Fixed Indemnity Benefits. The following is an alternative disclosure statement for policies that provide benefits upon both an expense-incurred and fixed indemnity basis: Other Health Insurance Policies. The following is an alternative disclosure statement for other health insurance policies not specifically identified in the statements set forth in §D(1)-(6) of this regulation: Applicability. This regulation applies to Medicare Select policies and certificates, as defined in Regulation .02 of this chapter. A policy or certificate may not be advertised as a Medicare Select policy or certificate unless it meets the requirements of this regulation. The Commissioner may authorize an issuer to offer a Medicare Select policy or certificate pursuant to this regulation and §4358 of the Omnibus Budget Reconciliation Act (OBRA) of 1990 if the Commissioner finds that the issuer has satisfied all of the requirements of this regulation. A Medicare Select issuer may not issue a Medicare Select policy or certificate in Maryland until its plan of operation has been approved by the Commissioner. Required Filing of Plan of Operation. A Medicare Select issuer shall file a proposed plan of operation with the Commissioner and with the Secretary of the Maryland Department of Health in a format prescribed by the Commissioner. The plan of operation filed with the Commissioner shall contain at least the following information: A statement or map providing a clear description of the service area; A description of the grievance procedure to be utilized; Copies of the written information proposed to be used by the issuer to comply with Regulation .25B of this chapter; and Any other information requested by the Commissioner. The plan of operation filed with the the Secretary of the Maryland Department of Health shall contain, at a minimum, the following information: Evidence that all covered services subject to restricted network provisions are available and accessible through network providers, including a demonstration that: Services can be provided by network providers with reasonable promptness with respect to geographic location, hours of operation, and after-hours care; The number of network providers in the service area is sufficient, with respect to current and expected policyholders, either to deliver adequately all services that are subject to a restricted network provision or to make appropriate referrals; There are written agreements with network providers describing specific responsibilities; Emergency care is available 24 hours per day and 7 days per week; and In the case of covered services that are subject to a restricted network provision and are provided on a prepaid basis, there are written agreements with network providers prohibiting the providers from billing or otherwise seeking reimbursement from or recourse against any individual insured under a Medicare Select policy or certificate; A statement or map providing a clear description of the service area; A description of the quality assurance program, including: The formal organizational structure; The written criteria for selection, retention and removal of network providers; and The procedures for evaluating quality of care provided by network providers, and the process to initiate corrective action if warranted; and A list and description, by specialty, of the network providers. In determining the reasonable promptness of services provided with respect to geographic location in §D(3)(a)(i) of this regulation, the geographic availability shall reflect the usual travel times within the community. In determining the reasonable promptness of services provided with respect to hours of operation and after-hours care in §D(3)(a)(i) of this regulation, the hours of operation and availability of after-hours care shall reflect usual practice in the local area. With respect to the requirements in §D(3)(a)(v) of this regulation that prohibit providers from billing or otherwise seeking reimbursement from or recourse against any individual insured under a Medicare Select policy or certificate, the prohibition is not required to be applied to supplemental charges or coinsurance amounts stated in the Medicare Select policy or certificate. The Secretary of the Maryland Department of Health shall notify the Commissioner in writing after the determining that the plan of operation filed by the issuer is acceptable. Required Filing of Changes to Plan of Operation. In General. A Medicare Select issuer shall file with the Commissioner any proposed changes to the plan of operation, except for changes to the list of network providers, prior to implementing the changes. Changes shall be deemed approved by the Commissioner after 30 days unless specifically disapproved. A Medicare Select issuer shall file an updated list of network providers with the Secretary of the Maryland Department of Health at least quarterly. The Secretary of the Maryland Department of Health shall notify the Commissioner in writing if the updated list of providers submitted in accordance with §E(2) of this regulation ceases to meet the criteria set forth in §D(3)(a) of this regulation. A Medicare Select policy or certificate may not restrict payment for covered services provided by nonnetwork providers if: The services are for symptoms requiring emergency care or are immediately required for an unforeseen illness, injury, or condition; and It is not reasonable to obtain services through a network provider. A Medicare Select policy or certificate shall provide payment for full coverage under the policy for covered services that are not available through network providers. A Medicare Select issuer shall comply with reasonable requests for data made by state or federal agencies, including the United States Department of Health and Human Services, for the purpose of evaluating the Medicare Select Program. Applicability. This regulation shall apply to Medicare Select policies and certificates, as defined in Regulation .02 of this chapter. A policy or certificate may not be advertised as a Medicare Select policy or certificate unless it meets the requirements of this regulation. Required Disclosure. A Medicare Select issuer shall make full and fair disclosure in writing of the provisions, restrictions, and limitations of the Medicare Select policy or certificate to each applicant. The disclosure required by §B(1) of this regulation shall include at least the following: An outline of coverage sufficient to permit the applicant to compare the coverage and premiums of the Medicare Select policy or certificate with: Other Medicare supplement policies or certificates offered by the issuer; and Other Medicare Select policies or certificates; A description, including address, phone number, and hours of operation, of the network providers, including primary care physicians, specialty physicians, hospitals, and other providers; A description of the restricted network provisions, including payments for coinsurance and deductibles if providers other than network providers are utilized; A description of coverage for emergency and urgently needed care and other out-of-service-area coverage; A description of limitations on referrals to restricted network providers and to other providers; A description of the policyholder's rights to purchase any other Medicare supplement policy or certificate otherwise offered by the issuer; and A description of the Medicare Select issuer's quality assurance program and grievance procedure. With regard to the description of restricted network provisions required by §B(2)(c) of this regulation, expenses incurred when using out-of-network providers may not count toward the out-of-pocket annual limit contained in plans K and L, except to the extent specified in the policy or certificate. Before the sale of a Medicare Select policy or certificate, a Medicare Select issuer shall obtain from the applicant a signed and dated form stating that the applicant has received the information provided under §B of this regulation and that the applicant understands the restrictions of the Medicare Select policy or certificate. Complaints and Grievances. Procedures Required. A Medicare Select issuer shall have and use procedures for hearing complaints and resolving written grievances from the subscribers. The procedures for hearing complaints and resolving written grievances from subscribers shall be aimed at mutual agreement for settlement. The grievance procedure shall be described in the policy and certificates and in the outline of coverage. Any grievance procedure involving coverage decisions shall comply with the requirements found in Insurance Article, Title 15, Subtitle 10D, Annotated Code of Maryland. Any grievance procedure involving adverse decisions shall comply with the requirements found in Insurance Article, Title 15, Subtitle 10A, Annotated Code of Maryland. At the time the policy or certificate is issued, the issuer shall provide detailed information to the policyholder describing how a grievance may be registered with the issuer. An issuer shall consider grievances in a timely manner and shall transmit the grievances to appropriate decision-makers who have authority to fully investigate the issue and take corrective action. If a grievance is found to be valid, an issuer shall take corrective action promptly. An issuer shall notify all concerned parties about the results of a grievance. Annual Report. The issuer shall report not later than March 31 of each year to the Commissioner regarding its grievance procedure. The report required by §D(9)(a) of this regulation shall be in a format prescribed by the Commissioner and shall contain the number of grievances filed in the past year and a summary of the subject, nature, and resolution of the grievances. At the time of initial purchase, a Medicare Select issuer shall make available to each applicant for a Medicare Select policy or certificate the opportunity to purchase any Medicare supplement policy or certificate otherwise offered by the issuer. Right to Purchase Medicare Supplement Policy or Certificate. At the request of an individual insured under a Medicare Select policy or certificate, a Medicare Select issuer shall make available to the individual insured the opportunity to purchase a Medicare supplement policy or certificate offered by the issuer which has comparable or lesser benefits and which does not contain a restricted network provision. The issuer shall make available the policies or certificates described in §F(1) of this regulation without requiring evidence of insurability after the Medicare Select policy or certificate has been in force for 6 months. For the purposes of §F(1) of this regulation, a Medicare supplement policy or certificate shall be considered to have comparable or lesser benefits unless the Medicare supplement policy or certificate contains one or more significant benefits not included in the Medicare Select policy or certificate being replaced. A benefit shall be considered a significant benefit under §F(3) of this regulation if the benefit includes coverage for the Medicare Part A deductible, coverage for at-home recovery services, or coverage for Part B excess charges. Options if the Medicare Select Program is Discontinued. Medicare Select policies and certificates shall provide for continuation of coverage in the event the Secretary determines that Medicare Select policies and certificates issued under this regulation shall be discontinued due to either the: Failure of the Medicare Select Program to be reauthorized under law; or Substantial amendment of the Medicare Select Program. If the Secretary determines that Medicare Select policies and certificates should be discontinued as described in §G(1) of this regulation, each Medicare Select issuer shall make available to each individual insured under a Medicare Select policy or certificate the opportunity to purchase any Medicare supplement policy or certificate offered by the issuer which has comparable or lesser benefits and which does not contain a restricted network provision. The issuer referenced in §G(2) of this regulation shall make available the policies and certificates without requiring evidence of insurability. For the purposes of §G(2) of this regulation, a Medicare supplement policy or certificate shall be considered to have comparable or lesser benefits unless it contains one or more significant benefits not included in the Medicare Select policy or certificate being replaced. A benefit shall be considered a significant benefit under §G(4) of this regulation if the benefit includes coverage for the Medicare Part A deductible, coverage for at-home recovery services or coverage for Part B excess charges. This regulation applies to all policies with policy years beginning on or after July 1, 2009. Definitions. In this regulation, the following terms have the meanings indicated. Terms Defined. “Family member” means, with respect to an individual, any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of the individual. Genetic Information. “Genetic information” means, with respect to an individual, information about the individual's genetic tests, the genetic tests of a family member of the individual, and the manifestation of a disease or disorder in a family member of the individual. “Genetic information” includes, with respect to an individual, a request for, or receipt of, genetic services, or participation in clinical research that includes genetic services, by the individual or a family member of the individual. “Genetic information” includes, with respect to a pregnant woman, genetic information of a fetus carried by the pregnant woman, “Genetic information” includes, with respect to an individual or family member utilizing reproductive technology, genetic information of an embryo legally held by the individual or family member. “Genetic information” does not include information about the sex or age of an individual. “Genetic services” means: A genetic test; Genetic counseling, including obtaining, interpreting, or assessing genetic information; or Genetic education. Genetic Test. “Genetic test” means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. “Genetic test” does not mean an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes. “Genetic test” does not mean an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved. Issuer of a Medicare Supplement Policy or Certificate. “Issuer of a Medicare supplement policy or certificate” means an insurance company, fraternal benefit society, nonprofit health service plan, health maintenance organization, or any other entity delivering or issuing for delivery in this State Medicare supplement policies or certificates. “Issuer of a Medicare supplement policy or certificate” includes a third-party administrator or other person acting for or on behalf of an entity described in §B(2)(e)(i) of this regulation. “Underwriting purposes” means: Rules for, or determination of, eligibility, including enrollment and continued eligibility, for benefits under the policy; The computation of premium or contribution amounts under the policy; The application of a preexisting condition exclusion under the policy; and Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits. An issuer of a Medicare supplement policy or certificate may not: Deny or condition the issuance or effectiveness of the policy or certificate, including the imposition of an exclusion of benefits under the policy or certificate because of a preexisting condition, based on the genetic information with respect to an individual; Discriminate in the pricing of the policy or certificate, including the adjustment of premium rates, of an individual based on the genetic information with respect to the individual; Request or require an individual or a family member of the individual to undergo a genetic test; Request, require, or purchase genetic information for underwriting purposes; or Request, require, or purchase, in connection with an enrollment, genetic information with respect to an individual before the individual's enrollment under the policy. The prohibitions described in §C(1) and (2) of this regulation do not limit the ability of an issuer of a Medicare supplement policy or certificate, to the extent otherwise permitted by law, from: Denying or conditioning the issuance or effectiveness of the policy or certificate or increasing the premium for a group based on the manifestation of a disease or disorder of an insured or applicant; or Increasing the premium for a policy issued to an individual based on the manifestation of a disease or disorder of an individual who is covered under the policy, but the manifestation of a disease or disorder in one individual may not also be used as genetic information about other group members and to further increase the premium for the group. The prohibition described in §C(3) of this regulation does not preclude an issuer of a Medicare supplement policy or certificate from obtaining and using the results of a genetic test in making a determination regarding payment, as defined for the purposes of applying the regulations promulgated under Part C of Title XI and Section 264 of the Health Insurance Portability and Accountability Act of 1996, and consistent with §C(1) and (2) of this regulation. For purposes of carrying out §E of this regulation, an issuer of a Medicare supplement policy or certificate may request only the minimum amount of information necessary to accomplish the intended purpose. Notwithstanding §C(3) of this regulation, an issuer of a Medicare supplement policy or certificate may request, but not require, that an individual or a family member of the individual undergo a genetic test if all of the following conditions are met: The request is made pursuant to research that complies with Part 46 of Title 45, Code of Federal Regulations, or equivalent federal regulations, and any applicable State or local law or regulations for the protection of human subjects in research; The issuer clearly indicates to the individual, or in the case of a minor child, to the legal guardian of the child, to whom the request is made that: Compliance with the request is voluntary, and Noncompliance with the request will have no effect on enrollment status or premium or contribution amounts; The issuer does not use genetic information collected or acquired under §G of this regulation to underwrite, determine eligibility to enroll or maintain enrollment status, set premium rates, or determine whether to issue, renew, or replace a policy or certificate; The issuer notifies the Secretary in writing that the issuer is conducting activities under the exception provided by §G of this regulation, and includes a description of the activities conducted; and The issuer complies with all other conditions for activities conducted under §G of this regulation, as the Secretary may require by regulation. If an issuer of a Medicare supplement policy or certificate obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning an individual, the request, requirement, or purchase will not be considered a violation of §C(5) of this regulation if the request, requirement, or purchase does not violate §C(4) of this regulation. General Standards. The standards found in §§B—D of this regulation are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this State with an effective date for coverage on or after June 1, 2010. A policy or certificate may not be advertised, solicited, delivered, or issued for delivery in this State as a Medicare supplement policy or certificate on or after June 1, 2010, unless it complies with the benefit standards found in this regulation. An issuer may not offer a 1990 standardized Medicare supplement benefit plan for sale on or after June 1, 2010. Benefit standards applicable to Medicare supplement policies and certificates issued with an effective date for coverage before June 1, 2010, remain subject to the requirements of Regulation .08 of this chapter. Required Standards. The standards in this section apply to Medicare supplement policies and certificates and are in addition to all other requirements of this chapter. A Medicare supplement policy or certificate may not exclude or limit benefits for a loss incurred more than 6 months after the effective date of coverage because the loss involved a preexisting condition. The policy or certificate may not define a preexisting condition more restrictively than a condition for which medical advice was given or treatment was recommended by or received from a physician within 6 months before the effective date of coverage. A Medicare supplement policy or certificate may not indemnify against losses resulting from sickness on a different basis than losses resulting from accidents. A Medicare supplement policy or certificate shall provide that benefits designed to cover cost sharing amounts under Medicare will be changed automatically to coincide with any changes in the applicable Medicare deductible, copayment, or coinsurance amounts. Premiums may be modified to correspond with the changes to the cost-sharing amounts. A Medicare supplement policy or certificate may not provide for termination of coverage of a spouse solely because of the occurrence of an event specified for termination of coverage of the insured, other than the nonpayment of premium. Each Medicare supplement policy shall be guaranteed renewable. The issuer may not: Cancel or nonrenew the policy solely on the ground of the health status of the individual; or Cancel or nonrenew the policy for any reason other than nonpayment of premium or material misrepresentation. If the Medicare supplement policy is terminated by the group policyholder and is not replaced as provided under §B(9) of this regulation, the issuer shall offer each certificate holder an individual Medicare supplement policy, which at the option of the certificate holder provides for: Continuation of the benefits contained in the group policy; or Benefits that meet the requirements of these regulations. If an individual is a certificate holder in a group Medicare supplement policy and the individual terminates membership in the group, the issuer shall: Offer the certificate holder the conversion option described in §B(7) of this regulation; or At the option of the group policyholder, offer the certificate holder continuation of coverage under the group policy. If a group Medicare supplement policy is replaced by another group Medicare supplement policy purchased by the same policyholder, the issuer of the replacement policy shall offer coverage to each individual covered under the old group policy on the group policy's date of termination. Coverage under the new policy may not result in an exclusion for a preexisting condition that would have been covered under the group policy being replaced. Extension of Benefits. Termination of a Medicare supplement policy or certificate shall be without prejudice to a continuous loss that commenced while the policy was in force, but the extension of benefits beyond the period during which the policy was in force may be conditioned on the continuous total disability of the insured, limited to the duration of the policy benefit period, if any, or payment of the maximum benefits. Receipt of Medicare Part D benefits may not be considered in determining a continuous loss under §B(10)(a) of this regulation. Suspension of Benefits. A Medicare supplement policy or certificate shall provide that benefits and premiums under the policy or certificate shall be suspended at the request of the policyholder or certificate holder for a period not to exceed 24 months in which the policyholder or certificate holder has applied for and is determined to be entitled to medical assistance under Title XIX of the Social Security Act, but only if the policyholder or certificate holder notifies the issuer of the policy or certificate within 90 days after the date the individual becomes entitled to medical assistance. If the suspension described in §B(11)(a) of this regulation occurs and if the policyholder or certificate holder loses entitlement to medical assistance under Title XIX of the Social Security Act, the policy or certificate shall be reinstituted automatically, effective as of the date of termination of entitlement, if the policyholder or certificate holder provides notice of loss of entitlement within 90 days after the date of loss of entitlement and pays the premium attributable to the period, effective as of the date of termination of entitlement. A Medicare supplement policy shall provide that benefits and premiums under the policy shall be suspended, for any period that may be provided by federal regulation, at the request of the policyholder, if the policyholder is: Entitled to benefits under §226 (b) of the Social Security Act; and Covered under a group health plan as defined in §1862(b)(1)(A)(v) of the Social Security Act. If the suspension described in §B(11)(c) of this regulation occurs and if the policyholder or certificate holder loses coverage under the group health plan, the policy shall be reinstituted automatically, effective as of the date of loss of coverage under the group health plan, if the policyholder described in §B(11)(c): Provides notice of loss of coverage within 90 days after the date of the loss of group coverage; and Pays the premium attributable to the period, effective as of the date of termination of enrollment in the group health plan. Reinstitution of coverage under §B(11)(b) or (d) of this regulation: May not provide for any waiting period with respect to treatment of preexisting conditions; Shall provide for resumption of coverage that is substantially equivalent to coverage in effect before the date of suspension; and Shall provide for classification of premiums on terms at least as favorable to the policyholder or certificate holder as the premium classification terms that would have applied to the policyholder or certificate holder had the coverage not been suspended. Standards for Basic (Core) Benefits Common to Benefit Plans A, B, C, D, F, F with High Deductible, G, M, and N. Every issuer of Medicare supplement insurance benefit plans shall make available a policy or certificate including only the following basic core package of benefits to each prospective insured: Coverage of Part A Medicare eligible expenses for hospitalization to the extent not covered by Medicare from the 61st day through the 90th day in any Medicare benefit period; Coverage of Part A Medicare eligible expenses incurred for hospitalization to the extent not covered by Medicare for each Medicare lifetime inpatient reserve day used; Upon exhaustion of the Medicare hospital inpatient coverage, including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable prospective payment system (PPS) rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days; Coverage under Medicare Parts A and B for the reasonable cost of the first 3 pints of blood, or equivalent quantities of packed red blood cells, as defined under federal regulations, unless replaced in accordance with federal regulations; Coverage for the coinsurance amount, or, in the case of hospital outpatient department services paid under a prospective payment system, the copayment amount, of Medicare eligible expenses under Part B regardless of hospital confinement, subject to the Medicare Part B deductible; and Coverage of cost sharing for all Part A Medicare eligible hospice care and respite care expenses. The provider shall accept the issuer's payment of the Medicare Part A eligible expenses for hospitalization under §C(1)(c) of this regulation as payment in full and may not bill the insured for any balance. An issuer may make available to prospective insureds any of the other Medicare supplement insurance benefit plans in addition to the basic core package, but not instead of it. Standards for Additional Benefits. The following additional benefits shall be included in Medicare supplement benefit Plans B, C, D, F, F with High Deductible, G, M, and N as provided by Regulation .28 of this chapter: Medicare Part A Deductible—Coverage for 100 percent of the Medicare Part A inpatient hospital deductible amount per benefit period; Medicare Part A Deductible—Coverage for 50 percent of the Medicare Part A inpatient hospital deductible amount per benefit period; Skilled Nursing Facility Care—Coverage for the actual billed charges up to the coinsurance amount from the 21st day through the 100th day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A; Medicare Part B Deductible—Coverage for 100 percent of the Medicare Part B deductible amount per calendar year regardless of hospital confinement; 100 Percent of the Medicare Part B Excess Charges—Coverage for all of the difference between the actual Medicare Part B charges as billed, not to exceed any charge limitation established by the Medicare program or state law, and the Medicare-approved Part B charge; and Medically Necessary Emergency Care in a Foreign Country—Coverage to the extent not covered by Medicare for 80 percent of the billed charges for Medicare-eligible expenses for medically necessary emergency hospital, physician, and medical care received in a foreign country, which care would have been covered by Medicare if provided in the United States and which care began during the first 60 consecutive days of each trip outside the United States, subject to a calendar year deductible of $250, and a lifetime maximum benefit of $50,000; for purposes of this benefit, “emergency care” means care needed immediately because of an injury or an illness of sudden and unexpected onset. Definitions. In this regulation, the following term has the meaning indicated. Term Defined. “Structure, language, and format” means style, arrangement, and overall content of a benefit. General Standards. The standards found in §§C—I of this regulation are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this State with an effective date for coverage on or after June 1, 2010. A policy or certificate may not be advertised, solicited, delivered, or issued for delivery in this State as a Medicare supplement policy or certificate unless it complies with the benefit plan standards set forth in this regulation. Benefit plan standards applicable to Medicare supplement policies and certificates issued with an effective date for coverage before June 1, 2010, remain subject to the requirements of Regulation .09 of this chapter. An issuer shall make available to each prospective policyholder and certificate holder a policy form or certificate form containing only the basic core benefits, as defined in Regulation .27C of this chapter. If an issuer makes available any of the additional benefits described in Regulation .27D of this chapter, or offers standardized benefit Plans K or L, as described in §H(8) and (9) of this regulation, then the issuer shall make available to each prospective policyholder and certificate holder: A policy form or certificate form with only the core benefits as described in §C of this regulation; and A policy form or certificate form containing either standardized benefit Plan C, as described in §H(3) of this regulation, or standardized benefit Plan F, as described in §H(5) of this regulation. Groups, packages, or combinations of Medicare supplement benefits other than those listed in this regulation may not be offered for sale in this State, except as may be permitted in §I of this regulation and Regulation .24 of this chapter. Structure of Benefits. Benefit plans shall be uniform in structure, language, designation, and format to the standard benefit plans listed in this regulation and conform to the definitions in Regulation .02 of this chapter. Each benefit shall be structured in accordance with the format provided in Regulation .27C and D of this chapter, or in the case of plans K or L in §H(8) and (9) of this regulation, and shall list the benefits in the order shown in this regulation. An issuer may use, in addition to the benefit plan designations required in §F of this regulation, other designations to the extent permitted by law. Make-up of 2010 Standardized Benefit Plans. Standardized Medicare supplement benefit Plan A shall include only the following: The core benefits as defined in Regulation .27C of this chapter. Standardized Medicare supplement benefit Plan B shall include only the following: The core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible as defined in Regulation .27D(1) of this chapter. Standardized Medicare supplement benefit Plan C shall include only the following: The core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, 100 percent of the Medicare Part B Deductible, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .27D(1), (3), (4), and (6) of this chapter. Standardized Medicare supplement benefit Plan D shall include only the following: The core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, and Medically Necessary Emergency Care in an Foreign Country as defined in Regulation .27D(1), (3), and (6) of this chapter. Standardized Medicare supplement benefit Plan F shall include only the following: The basic core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, 100 percent of the Medicare Part B Deductible, 100 percent of the Medicare Part B Excess Charges, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .27D(1) and (3)—(6) of this chapter. Standardized Medicare Supplement Benefit Plan F With High Deductible. Plan F with High Deductible shall include only 100 percent of covered expenses following the payment of the annual deductible set forth in §H(6)(c) of this regulation. The covered expenses include the core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, 100 percent of the Medicare Part B Deductible, 100 percent of the Medicare Part B Excess Charges, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .27D(1) and (3)—(6) of this chapter. Annual Deductible. The annual deductible in Plan F with High Deductible shall consist of out-of-pocket expenses, other than premiums, for services covered by Plan F, and is in addition to any other specific benefit deductibles. The basis for the deductible is $1,500. The Secretary shall adjust the deductible annually after 1999 to reflect the change in the Consumer Price Index for all urban consumers for the 12-month period ending with August of the preceding year, and rounded to the nearest multiple of $10. Standardized Medicare Supplement Benefit Plan G. Standardized Medicare supplement benefit Plan G shall include only the following: The core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, 100 percent of the Medicare Part B Excess Charges, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .27D(1), (3), (5), and (6) of this chapter. Effective January 1, 2020, the standardized benefit plan described in Regulation .31B(3) of this chapter (Re-designated Plan G High Deductible) may be offered to any individual who was eligible for Medicare prior to January 1, 2020. Standardized Medicare Supplement Benefit Plan K. Plan K is mandated by the Medicare Prescription Drug, Improvement and Modernization Act of 2003. Plan K shall include only the following: Part A Hospital Coinsurance 61st Through 90th Days — Coverage of 100 percent of the Part A hospital coinsurance amount for each day used from the 61st through the 90th day in any Medicare benefit period; Part A Hospital Coinsurance 91st Through 150th Days — Coverage of 100 percent of the Part A hospital coinsurance amount for each Medicare lifetime inpatient reserve day used from the 91st through the 150th day in any Medicare benefit period; Part A Hospitalization After Lifetime Reserve Days are Exhausted — Upon exhaustion of the Medicare hospital inpatient coverage, including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable prospective payment system (PPS) rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days; Medicare Part A Deductible — Coverage for 50 percent of the Medicare Part A inpatient hospital deductible amount per benefit period until the out-of-pocket limitation is met as described in §H(8)(b)(x) of this regulation; Skilled Nursing Facility Care — Coverage for 50 percent of the coinsurance amount for each day used from the 21st day through the 100th day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A until the out-of-pocket limitation is met as described in §H(8)(b)(x) of this regulation; Hospice Care — Coverage for 50 percent of cost sharing for all Part A Medicare eligible expenses and respite care until the out-of-pocket limitation is met as described in §H(8)(b)(x) of this regulation; Blood — Coverage for 50 percent, under Medicare Part A or B, of the reasonable cost of the first 3 pints of blood, or equivalent quantities of packed red blood cells, as defined under federal regulations, unless replaced in accordance with federal regulations until the out-of-pocket limitation is met as described in §H(8)(b)(x) of this regulation; Part B Cost Sharing — Except for coverage provided in §H(8)(b)(ix) of this regulation, coverage for 50 percent of the cost sharing otherwise applicable under Medicare Part B after the policyholder pays the Part B deductible until the out-of-pocket limitation is met as described in §H(8)(b)(x) of this regulation; Part B Preventive Services — Coverage of 100 percent of the cost sharing for Medicare Part B preventive services after the policyholder pays the Part B deductible; and Cost Sharing After Out-of-Pocket Limit — Coverage of 100 percent of all cost sharing under Medicare Parts A and B for the balance of the calendar year after the individual has reached the out-of-pocket limitation on annual expenditures under Medicare Parts A and B of $4,000 in 2006, indexed each year by the appropriate inflation adjustment specified by the Secretary. The provider shall accept the issuer's payment of the Medicare Part A eligible expenses for hospitalization under §H(8)(b)(iii) of this regulation as payment in full and may not bill the insured for any balance. Standardized Medicare Supplement Benefit Plan L. Plan L is mandated by The Medicare Prescription Drug, Improvement and Modernization Act of 2003. Plan L shall include only the following: The benefits described in §H(8)(b)(i)—(iii) and (ix) of this regulation; The benefit described in §H(8)(b)(iv)—(viii) of this regulation, but substituting 75 percent for 50 percent; and The benefit described in §H(8)(b)(x) of this regulation, but substituting $2,000 for $4,000. Standardized Medicare supplement benefit Plan M shall include only the following: The core benefits as defined in Regulation .27C of this chapter, plus 50 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .27D(2), (3), and (6) of this chapter. Standardized Medicare Supplement Benefit Plan N. Plan N shall include only the following: The core benefits as defined in Regulation .27C of this chapter, plus 100 percent of the Medicare Part A Deductible, Skilled Nursing Facility Care, and Medically Necessary Emergency Care in a Foreign Country as defined in Regulation .27D(1), (3), and (6) of this chapter, with copayments in the following amounts: The lesser of $20 or the Medicare Part B coinsurance or copayment for each covered health care provider office visit, including visits to medical specialists; and The lesser of $50 or the Medicare Part B coinsurance or copayment for each covered emergency room visit. The copayment described in §H(11)(a)(ii) of this regulation shall be waived if the insured is admitted to a hospital and the emergency visit is subsequently covered as a Medicare Part A expense. New or Innovative Benefits. An issuer may, with the prior approval of the Commissioner, offer policies or certificates with new or innovative benefits, in addition to the standardized benefits provided in a policy or certificate that otherwise complies with the applicable standards. The new or innovative benefits described in §I(1) of this regulation shall include only benefits that are appropriate to Medicare supplement insurance, are new or innovative, are not otherwise available, and are cost-effective. Approval of new or innovative benefits may not adversely impact the goal of Medicare supplement simplification. New or innovative benefits may not include an outpatient prescription drug benefit. New or innovative benefits may not be used to change or reduce benefits, including a change of any cost-sharing provision, in any standardized plan. Forms. General Standards. A policy or certificate that provides coverage of the Medicare Part B deductible may not be advertised, solicited, delivered, or issued for delivery in this State as a Medicare supplement policy or certificate to individuals newly eligible for Medicare on or after January 1, 2020. Medicare supplement policies and certificates delivered or issued for delivery to individuals eligible for Medicare before January 1, 2020 remain subject to the requirements of Regulation .28 of the chapter. Medicare supplement policies or certificates delivered or issued for delivery to individuals newly eligible for Medicare on or after January 1, 2020 are subject to the requirements of Regulation .28 of this chapter, except as stated in §§B and C of this regulation. Standardized Medicare supplement benefit Plans C, F, and F with High Deductible may not be offered to individuals newly eligible for Medicare on or after January 1, 2020. Make-up of 2020 Standardized Benefit Plans Standardized Medicare supplement benefit Plan C is re-designated as Plan D and shall include the benefits contained in Regulation .28H(3) of this chapter except for coverage for 100 percent or any portion of the Medicare Part B deductible. Standardized Medicare supplement benefit Plan F is re-designated as Plan G and shall include the benefits contained in Regulation .28H(5) of this chapter except for coverage for 100 percent or any portion of the Medicare Part B deductible. Standardized Medicare Supplement Benefit Plan G With High Deductible. Standardized Medicare supplement benefit Plan F with High Deductible is re-designated as Plan G with High Deductible. Standardized Medicare supplement benefit Plan G with High Deductible shall include the benefits contained in Regulation .28H(6) of this chapter except for coverage for 100 percent or any portion of the Medicare Part B deductible. The Medicare Part B deductible paid by the beneficiary shall be considered an out-of-pocket expense in meeting the annual Plan G high deductible. In the case of an individual newly eligible for Medicare on or after January 1, 2020, the reference to Plans C or F in Regulation .28D(2) of this chapter is deemed a reference to Plans D or G, respectively. On or after January 1, 2020, the standardized benefit plan described in §B(3) of this regulation may be offered to an individual who was eligible for Medicare prior to January 1, 2020 in addition to the standardized plans described in Regulation .28H of this chapter. For purposes of Regulation .09-1E of this chapter, in the case of an individual newly eligible for Medicare on or after January 1, 2020, any reference to Plans C or F (including F With High Deductible) shall be deemed to be a reference to Plans D or G (including G With High Deductible) respectively. Health-General Article, §§19-705 and 19-706; Insurance Article, §§2-109 and 8-403(b), Title 15, Subtitle 9, and Title 27; Annotated Code of Maryland Effective date: Regulations .01—.21 adopted as an emergency provision effective July 14, 1992 (19:16 Md. R. 1466); adopted permanently effective August 3, 1992 (19:15 Md. R. 1389) Chapter revised effective April 1, 1996 (23:6 Md. R. 475) Regulation .14A amended, and Regulation .21 repealed, and Regulations .22 and .23 recodified to Regulations .21 and .22, respectively, as an emergency provision effective April 25, 1996 (23:10 Md. R. 728); amended permanently effective September 10, 1996 (23:18 Md. R. 1317) Chapter recodified from COMAR 09.30.90 to COMAR 31.10.06 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .02 amended as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); amended permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .02 amended as an emergency provision effective July 25, 2000 (27:16 Md. R. 1520); amended permanently effective November 13, 2000 (27:22 Md. R. 2061) Regulation .02 amended as an emergency provision effective October 1, 2001 (28:23 Md. R. 2053); emergency status expired March 29, 2002; amended permanently effective April 1, 2002 (29:6 Md. R. 570) Regulation .03 amended as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); amended permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .04B amended as an emergency provision effective January 1, 2000 (27:4 Md. R. 452); emergency status expired June 28, 2000 Regulation .04B amended effective August 21, 2000 (27:16 Md. R. 1526) Regulation .06 amended as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); amended permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .08 amended as an emergency provision effective July 25, 2000 (27:16 Md. R. 1520); amended permanently effective November 13, 2000 (27:22 Md. R. 2061) Regulation .08 amended as an emergency provision effective October 1, 2001 (28:23 Md. R. 2053); emergency status expired March 29, 2002; amended permanently effective April 1, 2002 (29:6 Md. R. 570) Regulation .09 amended as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); amended permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .09-1 adopted as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); adopted permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .09-1 amended as an emergency provision effective July 25, 2000 (27:16 Md. R. 1520); amended permanently effective November 13, 2000 (27:22 Md. R. 2061) Regulation .09-1 amended as an emergency provision effective October 1, 2001 (28:23 Md. R. 2053); emergency status expired March 29, 2002; amended permanently effective April 1, 2002 (29:6 Md. R. 570) Regulation .13 amended as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); amended permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .13 amended as an emergency provision effective July 25, 2000 (27:16 Md. R. 1520); amended permanently effective November 13, 2000 (27:22 Md. R. 2061) Regulation .22 amended as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); amended permanently effective March 22, 1999 (26:6 Md. R. 489) Regulation .23 adopted as an emergency provision effective October 1, 2001 (28:23 Md. R. 2053); emergency status expired March 29, 2002; adopted permanently effective April 1, 2002 (29:6 Md. R. 570) Regulation .24 adopted as an emergency provision effective October 1, 2001 (28:23 Md. R. 2053); emergency status expired March 29, 2002; adopted permanently effective April 1, 2002 (29:6 Md. R. 570) Chapter revised effective January 1, 2006 (32:18 Md. R. 1522) Regulation .02B amended effective September 21, 2009 (36:19 Md. R. 1439); January 14, 2019 (46:1 Md. R. 13) Regulation .06A amended effective August 21, 2023 (50:16 Md. R. 729) Regulation .07A amended effective September 21, 2009 (36:19 Md. R. 1439) Regulation .08 amended effective September 21, 2009 (36:19 Md. R. 1439) Regulation .09 amended effective September 21, 2009 (36:19 Md. R. 1439) Regulation .13 amended effective September 21, 2009 (36:19 Md. R. 1439) Regulation .13E amended effective November 29, 2010 (37:24 Md. R. 1660) Regulation .26 adopted effective June 29, 2009 (36:13 Md. R. 901) Regulations .27—.30 adopted effective September 21, 2009 (36:19 Md. R. 1439) Regulation .28H amended effective November 29, 2010 (37:24 Md. R. 1660); January 14, 2019 (46:1 Md. R. 13) Regulation .29 repealed effective November 29, 2010 (37:24 Md. R. 1660) Regulation .30 amended effective January 14, 2019 (46:1 Md. R. 13) Regulation .30I, J amended effective November 29, 2010 (37:24 Md. R. 1660) Regulation .31 adopted effective January 14, 2019 (46:1 Md. R. 13) Effective date: December 21, 1992 (19:25 Md. R. 2205) Chapter recodified from COMAR 09.30.92 to COMAR 31.10.07 effective September 7, 1998 (25:18 Md. R. 1439) Chapter repealed effective October 5, 1998 (25:20 Md. R. 1534) Effective date: December 21, 1992 (19:25 Md. R. 2205) Chapter recodified from COMAR 09.30.93 to COMAR 31.10.08 effective September 7, 1998 (25:18 Md. R. 1439) Chapter repealed effective October 5, 1998 (25:20 Md. R. 1534) This chapter is applicable to each: Group, blanket, or individual health insurance contract written on an expense-incurred basis which is issued or renewed in the State on or after April 1, 1997; Individual or group nonprofit health service plan contract which is issued or renewed on or after April 1, 1997; and Individual or group contract issued or renewed by a health maintenance organization on or after April 1, 1997. This chapter does not apply to a comprehensive health benefit plan issued to a small employer in accordance with Insurance Article, Title 15, Subtitle 12, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Bereavement counseling” means counseling provided to the immediate family or family caregiver of the insured after the insured's death to help the immediate family or family caregiver cope with the death of the insured. “Carrier” means an insurer, a nonprofit health service plan, or a health maintenance organization. Expense Incurred. “Expense incurred” means the benefits payable under the contract are based on the medical expenses the insured incurs. For the purpose of this chapter, a contract which includes both expense-incurred benefits and indemnity benefits shall be considered to be written on an “expense-incurred” basis. “Family caregiver” means a relative by blood, marriage, or adoption who lives with or is the primary caregiver of the terminally ill insured. “Family counseling” means counseling given to the immediate family or family caregiver of the terminally ill insured for the purpose of learning to care for the insured and to adjust to the death of the insured. “Hospice care program” means a coordinated, interdisciplinary program of hospice care services for meeting the special physical, psychological, spiritual, and social needs of terminally ill individuals and their families, by providing palliative and supportive medical, nursing, and other health services through home or inpatient care during the illness and bereavement to: Individuals who have no reasonable prospect of cure as estimated by a physician; and The immediate families or family caregivers of those individuals described in §B(6)(a) of this regulation. “Immediate family” means the spouse, parents, siblings, grandparents, and children of the terminally ill insured. “Indemnity” means the benefits payable under the contract are flat amounts which are not related to the expenses the insured incurs, such as a hospital indemnity contract which pays a flat fee for each day the insured is confined in a hospital regardless of the actual expenses the insured incurs during the hospital confinement. “Insured” means a person who is covered under a: Group, blanket, or individual health insurance policy written on an expense-incurred basis; Nonprofit health service plan contract; or Health maintenance organization contract. “Respite care” means temporary care provided to the terminally ill insured to relieve the family caregiver from the daily care of the insured. “Terminally ill” means a medical prognosis given by a physician that the insured's life expectancy is 6 months or less. A carrier shall offer the policyholder the option of purchasing the minimum hospice care benefits required by this chapter when the policyholder applies for coverage. Contracts Issued Before April 1, 1997. Except as provided in §B(2) of this regulation, if a policyholder purchases a contract with hospice care benefits before April 1, 1997, the carrier shall revise the contract to include at least the minimum benefits required by this chapter on the renewal date occurring on or after April 1, 1997. Section B(1) of this regulation does not apply to guaranteed renewable or noncancellable contracts. Except as provided in §B of this regulation, the hospice care benefit offered shall include the following minimum benefits provided through a hospice care program: 30 days of inpatient care per insured; Part-time nursing care by or supervised by a registered graduate nurse; Counseling, including dietary counseling, for the terminally ill insured; Family counseling for the immediate family and the family caregiver before the death of the terminally ill insured; Bereavement counseling for the immediate family or family caregiver of the insured for at least the 6-month period following the insured's death or 15 visits, whichever occurs first; Respite care subject to the following: The annual benefit shall be at least 14 days, and The carrier may limit any one inpatient stay for respite care to 5 consecutive days; and Medical supplies, equipment, and medication required to maintain the comfort and manage the pain of the terminally ill insured. If a contract does not include inpatient benefits, the carrier shall offer the benefits described in §A(2)—(7) of this regulation. If a contract contains hospital indemnity benefits but is defined as an expense incurred policy according to Regulation .02B(3) of this chapter, the hospice care benefit may limit the hospice daily inpatient benefit to the amount payable for hospital confinement under the contract. The hospice care benefit may not be subject to a lifetime maximum which is separate from the lifetime maximum applicable to other benefits in the contract. The hospice care benefit may not be subject to an annual maximum benefit which is separate from the annual maximum applicable to other benefits in the contract. A carrier may not exclude immediate family members or family caregivers of the insured from the family counseling benefit or the bereavement counseling benefit because the immediate family member or family caregiver is not otherwise covered under the contract which provides coverage to the insured. A carrier may not exclude the siblings of a terminally ill child from the family counseling benefit or the bereavement counseling benefit, even if the siblings are not otherwise covered under the same contract as the terminally ill child. A hospice care benefit may not exclude inpatient benefits if the hospice care benefit appears in a contract which includes other inpatient benefits. The benefits provided as part of the hospice care benefit may not be subject to separate dollar maximum limits, except as provided in this chapter. The carrier may not condition the inpatient hospice care benefits on a prior hospital confinement. Insurance Article, §§2-109, 12-204, 12-205, and 15-809; Health-General Article, §§19-703(c) and 19-901; Annotated Code of Maryland Effective date: April 7, 1997 (24:7 Md. R. 553) Chapter recodified from COMAR 09.31.15 to COMAR 31.10.09 effective September 7, 1998 (25:18 Md. R. 1439) This chapter applies to all health insurers, including nonprofit health service plans, authorized to do business in Maryland, which provide benefits for inpatient hospitalization or outpatient surgical care on an expense-incurred basis in group or individual contracts, both for insured business and business for which the insurer is an administrator. In this chapter, the following terms have the meanings indicated. Terms Defined. “Claimant” means an insured individual resident in Maryland making a claim against the insurer for benefits, who is a: Policyholder covered by an individual policy; or Certificate holder covered under a group policy or under an administration contract. “Service” means any service for which a charge is made which is covered under the policy or contract, including charges for, but not limited to: Fees of surgeons, anesthetists, and other physicians; Room and board charges; Operating room charges; Recovery room charges; and Nursing care charges. An insurer which provides benefits for inpatient hospitalization or outpatient surgical care on an expense-incurred basis shall provide claimants annually a consolidated summary explanation regarding benefits claimed for those services during each calendar year. The summary shall identify the provider by name and shall state the: Date of the service; Amount claimed; Amount which was paid or is payable by the insurer on claims processed during the year; and Balance to be paid by the covered individual, if the balance is determinable from the claim forms submitted. The summary referred to in §B of this regulation shall be provided by insurers to claimants between January 1 and February 15 for claims made during the preceding calendar year. At the insurer's option, the summary may include information pertaining to benefits other than those specified in §A of this regulation. Instead of the procedure outlined in Regulation .03 of this chapter, an insurer may make the annual summary to claimants who are covered under group policies, or who are covered under employer-employee groups administered by the insurer, within 36 days after the annual anniversary of the group policy, or of the administration contract, for the 12-month period ending with that anniversary. An insurer desiring to use the alternate procedure specified in Regulation .04 of this chapter may elect the procedure for: All groups; or Groups in excess of a certain size. An insurer shall notify the Insurance Commissioner of its election under this regulation and Regulation .04 of this chapter within 90 days of the effective date of this chapter. An insurer that follows the procedures set forth in Regulation .03 of this chapter, or that elects to comply with the procedures set forth in this regulation and Regulation .04 of this chapter, may change its procedures only after approval by the Commissioner. Insurance Article, §§2-109 and 15-1007, Annotated Code of Maryland Effective date: December 1, 1993 (20:20 Md. R. 1570) Chapter recodified from COMAR 09.30.95 to COMAR 31.10.10 effective September 7, 1998 (25:18 Md. R. 1439) This chapter is applicable to all: Claims submitted to third-party payors as defined in Regulation .02B(22) of this chapter; Claims submitted by health care practitioners as defined in Regulation .02B(12) of this chapter; Claims submitted by hospitals as defined in Health-General Article, §19-301(g), Annotated Code of Maryland; and Claims submitted by other persons entitled to reimbursement from a third-party payor who submit claims to third-party payors on the HCFA Form 1500 or HCFA Form UB-92. This chapter is not applicable to claims submitted by members. In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicable standard code set” means the most recent versions, as of the date of service, of the following: For services rendered by health care practitioners, the Current Procedural Terminology (CPT) maintained and distributed by the American Medical Association, including its codes and modifiers, and codes for anesthesia services; For dental services, the Current Dental Terminology (CDT) maintained and distributed by the American Dental Association; For all professional and hospital services, the International Classification of Diseases, Clinical Modification (ICD-9 CM); For other health-related services, including prescribed drugs covered under a medical benefit of a contract issued by a third-party payor, the Centers for Medicare and Medicaid Services Common Procedure Coding System (HCPCS) levels I and II and modifiers maintained and distributed by the U.S. Department of Health and Human Services; For prescribed drugs covered under a pharmacy benefit of a contract issued by a third-party payor, the National Drug Codes (NDC) maintained and distributed by the U.S. Department of Health and Human Services; For anesthesia services, the codes maintained and distributed by the American Society of Anesthesiologists; For psychiatric services, the DSM-IV codes distributed by the American Psychiatric Association; For hospital and other applicable health-care services, including home health services, the State UB-92, Uniform Billing Data Elements Specification Manual; For hospital services pursuant to a Maryland contract or insurance policy, a revenue code: Approved by the Health Services Cost Review Commission for a hospital located in the State, or Of the National or State Uniform Billing Data Elements Specifications for a hospital not located in the State; and For services rendered pursuant to Health-General Article, §15-103(b)(2), Annotated Code of Maryland, a code established by the Medicaid Program. “Auto code” means an ICD-9 code designed by a third-party payor as a diagnosis that is an emergency service. “CDT-1 Codes” means the current dental terminology, and its successors, required by the American Dental Association. “Clean claim” means a claim for reimbursement submitted to a third-party payor by a health care practitioner, pharmacy or pharmacist, hospital, or person entitled to reimbursement, that contains: In the case of a health care practitioner or person entitled to reimbursement: The data elements required by Regulation .08 of this chapter, and Any attachments requested by the third-party payor pursuant to Regulation .10 of this chapter; In the case of a hospital or person entitled to reimbursement; The data elements required by Regulation .09 of this chapter, and Any attachments requested by the third-party payor pursuant to Regulation .10 of this chapter; or In the case of a pharmacy or pharmacist, the data elements set forth on the Universal Prescription Drug Claim Form or its electronic equivalent. “CMS” means the federal Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services. “CPT-4 Codes” means the Current Procedural Terminology published by the American Medical Association. “Emergency services” has the meaning stated in Health-General Article, §19-701(d), Annotated Code of Maryland. “Global contract” means an agreement between a third-party payor, and a health care practitioner, hospital, or person entitled to reimbursement in which: For billing and payment purposes: The services of one or more health care practitioners, hospitals, or persons entitled to reimbursement are bundled together; and The third-party payor agrees to pay, and the health care practitioner, hospital, or person entitled to reimbursement, agrees to accept a single rate for the applicable technical, facility, ancillary, and professional components of the services specified in the agreement; or The third-party payor agrees to pay, and the health care practitioner, hospital, or person entitled to reimbursement, agrees to accept a daily or per diem rate for the services related to home infusion therapy. HCFA Form 1500. “HCFA Form 1500” means the health insurance claims form and its electronic successor or equivalent published by CMS for use by health care practitioners or persons entitled to reimbursement. “HCFA Form 1500” includes any successor to HCFA Form 1500 published by CMS. HCFA Form UB-92. “HCFA Form UB-92” means the Revenue Code Summary UB-92 health insurance claim form and its electronic successor or equivalent published by CMS for use by hospitals, or person entitled to reimbursement. “HCFA Form UB-92” includes any successor to HCFA Form UB-92 published by the CMS. “HCPCS” means CMS's current Healthcare Common Procedural Coding System. Health Care Practitioner. “Health care practitioner” means a physician or any other person licensed or certified under Health Occupations Article, Annotated Code of Maryland. “Health care practitioner” does not include a physician or other person licensed or certified under Health Occupations Article, Annotated Code of Maryland, who: Is compensated by a health maintenance organization on a salaried or capitated basis; or Is rendering care to a member or subscriber of the health maintenance organization on a salaried or capitated system basis. “Hospital” means a hospital as defined in Health-General Article, §19-301(g), Annotated Code of Maryland. ICD 9-CM Codes. “ICD-9-CM Codes” means the current disease and procedure codes in the international classification of diseases published by the U.S. Department of Health and Human Services. “ICD-9-CM Codes” includes any successor to ICD-9-CM Codes published by the U.S. Department of Health and Human Services. “J512 Form” means the uniform dental claim form approved by the American Dental Association for use by dentists and its electronic successor or equivalent. Member. “Member” means an individual entitled to health care benefits under a policy, plan, or certificate issued or delivered in the State by a carrier. “Member” includes a subscriber or an insured. “Modifier” means a code that is appended to a CPT or HCPCS code to provide more specific information about a medical procedure. “Person entitled to reimbursement” means: A health care practitioner as defined in §B(12) of this regulation; or Any other person who furnishes health care services or supplies. “Primary care” has the meaning stated in COMAR 31.11.06.02B(49). “Primary payor” means a third-party payor that, pursuant to the terms of an insurance policy or contract, is required to provide coverage for benefits to the insured or member: Before any other third-party payor provides benefits; and Regardless of whether benefits are available under any other insurance policy or contract. “Secondary payor” means a third-party payor that, pursuant to the terms of an insurance policy or contract, is required to pay all or some portion of the difference between the total amount of a claim and the amount paid by the primary payor, subject to the limitations of the insurance policy or contract. “Third-party payor” means a person that administers or provides reimbursement for health care benefits on an expense-incurred basis including: A health maintenance organization issued a certificate of authority in accordance with Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland; A health insurer or nonprofit health service plan authorized to offer health insurance policies or contracts in this State in accordance with the Insurance Article, Annotated Code of Maryland; or A third-party administrator registered under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland. “Universal Prescription Drug Claim Form” means the uniform prescription drug claim form developed by the National Council for Prescription Drug Programs, Inc. and its electronic successor or equivalent. Except as provided in Regulation .10 of this chapter, third-party payors shall accept the HCFA Form 1500 and instructions provided by CMS for use of the HCFA 1500 as the sole instrument for filing claims with third-party payors for professional services. The requirement set forth in §A of this regulation does not apply to: Dental services which are billed by dentists using the J512 Form, or its equivalent, and CDT-1 Codes; or Pharmacists or pharmacies which are filing claims for prescription drugs. Except for parties to a global contract, a third-party payor may not require a health care practitioner or other person entitled to reimbursement to use any code or modifier for the filing of claims for health care services that is different from, or in addition to, what is required under the applicable standard code set for the professional services provided. Except as provided in Regulation .10 of this chapter, a third-party payor may not use, and may not require a health care practitioner or other person entitled to reimbursement to use, any other descriptor with a code or to furnish additional information with the initial submission of a HCFA Form 1500 that is different from, or in addition to, the applicable standard code set for the professional services provided. A health care practitioner or other person entitled to reimbursement whose billing is based on the amount of time involved shall indicate the start and stop time or number of minutes in field 24G, currently titled Days or Units, of the HCFA Form 1500 if it is not used to specify the number of days of treatment. Third-party payors shall accept the J512 Form, or its equivalent, and most recent version of the instructions provided by the American Dental Association CDT-1 for use of the J512 Form, or its equivalent, as the sole instrument for filing claims with third-party payors for dental services. A third-party payor may not require a dentist to use any code other than the CDT-1 codes for the initial filing of claims for dental care services. Third-party payors shall accept HCFA Form UB-92, and its successors, and the instructions provided by CMS for use of the HCFA Form UB-92, as the sole instrument for filing claims with third-party payors for hospital and other health-care services. Except for parties to a global contract, a third-party payor may not use, and may not require a hospital, or person entitled to reimbursement, to use any code or modifier for the filing of claims for hospital or other health-care services that is different from or in addition to, what is required under the applicable standard code set for the hospital or other health-care services provided. Except as provided in Regulation .10 of this chapter, a third-party payor may not use and may not require a hospital or person entitled to reimbursement to furnish additional information with the initial submission of the UB-92 that is different from, or in addition to, the applicable standard code set or for the hospital or other health-care services provided. Third-party payors shall accept the Universal Prescription Drug Claim Form, or its electronic equivalent, as the sole instrument for filing claims with third-party payors for prescription drugs. A third-party payor shall accept a clean claim which is submitted in compliance with these regulations for the processing of the third-party payor's claims. A third-party payor is subject to the provisions of Insurance Article, §15-1005, Annotated Code of Maryland. If a third party payor delegates its claims processing to another entity, the third-party payor is responsible for a violation by the entity of any regulation under this chapter. A third-party payor shall accept current coding changes by the effective date of the changes set forth by the developers of the codes. If a referral is required under Regulation .10 of this chapter, a third party payor may not deny a claim on the basis that a referral was not received unless the third party payor could not identify the member using the member's name and the following information specified on the referral form: Date of birth; Subscriber's plan identification number; or Other personally identifying information. In General. To qualify as a clean claim, a claim submitted to a third-party payor by a health care practitioner as provided in Regulation .03 of this chapter, or by a person entitled to reimbursement, shall conform to the applicable standard code set and include the following data elements: Subscriber's plan ID number (HCFA Form 1500, field 1a); Patient's name (HCFA Form 1500, field 2); Patient's date of birth and gender (HCFA Form 1500, field 3); Subscriber's name (HCFA Form 1500, field 4); Patient's address (street or P.O. box, city, and zip code) (HCFA Form 1500, field 5); Patient's relationship to the subscriber (HCFA Form 1500, field 6); Subscriber's address (street or P.O. box, city, and zip code) (HCFA Form 1500, field 7); Except in the case of a laboratory issued a license pursuant to Health-General Article, §17-205, Annotated Code of Maryland, patient status (HCFA Form 1500, field 8); Whether the patient's condition is related to employment (HCFA Form 1500, field 10(a)); Whether the patient's condition is related to an auto accident (HCFA Form 1500, field 10(b)); Whether the patient's condition is related to an accident other than an auto accident (HCFA Form 1500, field 10(c)); Subscriber's policy number (HCFA Form 1500, field 11); Except in the case of a laboratory issued a license pursuant to Health-General Article, §17-205, Annotated Code of Maryland, subscriber's birth date and gender (HCFA Form 1500, field 11a); Except in the case of a laboratory issued a license pursuant to Health-General Article, §17-205, Annotated Code of Maryland, name of the third-party payor (HCFA Form 1500, field 11c); Disclosure of any other health benefit plans (HCFA Form 1500, field 11d); Patient's or authorized person's signature or notation that the signature is on file with the health care practitioner (HCFA Form 1500, field 12); Subscriber's or authorized person's signature or notation that the signature is on file with the health care practitioner or person entitled to reimbursement, if applicable (HCFA Form 1500, field 13); Except in the case of a laboratory issued a license pursuant to Health-General Article, §17-205, Annotated Code of Maryland, date of current illness, injury, or pregnancy (HCFA Form 1500, field 14); Except in the case of a health care practitioner for emergency services, or a laboratory issued a license pursuant to Health-General Article, §17-205, Annotated Code of Maryland, whether the patient has had the same or a similar illness (HCFA Form 1500, field 15); Except in the case of a health care practitioner for emergency services, the name of the referring physician or health maintenance organization (HCFA Form 1500, field 17); Hospitalization dates related to current services, if applicable (HCFA Form 1500, field 18); Diagnosis codes or nature of the illness or injury (HCFA Form 1500, field 21); Date of service (HCFA Form 1500, field 24A); Place of service codes for all claims, as designated by HFCA for Medicare (HCFA Form 1500, field 24B); Procedure code (HCFA Form 1500, field 24D); Diagnosis code by specific service (HCFA Form 1500, field 24E); Charge for each listed service (HCFA Form 1500, field 24F); Number of days, time (minutes), start and stop time, or units (HCFA Form 1500, field 24G); The carrier-assigned rendering provider number until the National Provider Identifier is developed and assigned, if applicable (HCFA Form 1500, field 24K); Health care practitioner's or person entitled to reimbursement's federal tax ID number (HCFA Form 1500, field 25); Patient's account number (HCFA Form 1500, field 26); Total charge (HCFA Form 1500, field 28); For claims: Submitted electronically, a computer-printed name as the signature of the health care practitioner or person entitled to reimbursement (HCFA Form 1500, field 31), or Not submitted electronically, the signature of the health care practitioner who provided the service, or person entitled to reimbursement who provided the service, or notation that the signature is on file with the HMO or preferred provider carrier (HCFA Form 1500, field 31); Name and address of the facility where services were rendered (if other than home or office) (HCFA Form 1500, field 32); Health care practitioner's or person entitled to reimbursement's billing name, address, zip code, phone number, and, if applicable, carrier-assigned provider number until the National Provider Identifier (NPI) is developed and assigned, including a provider number pursuant to Health-General Article, §19-710.1(b)(3), Annotated Code of Maryland, (HCFA Form 1500, field 33); and Any other field or essential data element necessary to comply with the applicable standard code set. Specific Circumstances. In addition to the data elements required by §A of this regulation, to qualify as a clean claim, a claim submitted to a third-party payor by a health care practitioner or person entitled to reimbursement shall include the following data elements if circumstances exist that render the data elements applicable to the specific claim being filed: The other insured's or enrollee's name (HCFA Form 1500, field 9) is applicable if the patient is covered by more than one health benefit plan; The other insured's or enrollee's policy/group number (HCFA Form 1500, field 9a) is applicable if the patient is covered by more than one health benefit plan; The other insured's or enrollee's date of birth (HCFA Form 1500, field 9b) is applicable if the patient is covered by more than one health benefit plan; The other insured's or enrollee's plan name (employer, school, etc.) (HCFA Form 1500, field 9c) is applicable if the patient is covered by more than one health benefit plan; The other insured's or enrollee's HMO or insurer name (HCFA Form 1500, field 9d) is applicable if the patient is covered by more than one health benefit plan; Except in the case of a laboratory issued a license pursuant to Health-General Article, §17-205, Annotated Code of Maryland, the subscriber's plan name (employer, school, etc.) (HCFA Form 1500, field 11(b)) is applicable if the health benefit plan is a group plan; The prior authorization number (HCFA Form 1500, field 23) is applicable when prior authorization is required; A code pursuant to a global contract (HCFA Form 1500, field 24D) is applicable if the claim is between parties to a global contract; A code established by the Medicaid Program (HCFA Form 1500, field 24D) is applicable if the claim is for services rendered pursuant to Health-General Article, §15-103(b)(2), Annotated Code of Maryland; The modifier code (HCFA Form 1500, field 24(D)) is applicable when a modifier code is used to explain unusual circumstances; Whether an assignment was accepted (HCFA Form 1500, field 27) is applicable when an assignment has been accepted; The amount paid (HCFA Form 1500, field 29) is applicable if an amount has been paid to the health care practitioner or person entitled to reimbursement submitting the claim, by the patient or subscriber, or on behalf of the patient or subscriber; and The balance due (HCFA Form 1500, field 30) is applicable if an amount has been paid to the health care practitioner or person entitled to reimbursement submitting the claim, by the patient or subscriber, or on behalf of the patient or subscriber. A third-party payor may not use or require a health care practitioner or person entitled to reimbursement to use any field for purposes that are inconsistent with these essential data elements or in addition to the applicable standard code set. A third-party payor may accept a HCFA Form 1500 that includes data elements in addition to those set forth in §§A and B of this regulation. In General. To qualify as a clean claim, a claim submitted to a third-party payor by a hospital, or person entitled to reimbursement, shall conform to the applicable standard code set and include the following data elements: Hospital's, or person entitled to reimbursement's, name, address, and telephone number (HCFA Form UB-92, field 1); Patient's control number (HCFA Form UB-92, field 3); Type of bill code (HCFA Form UB-92, field 4); Hospital's, or person entitled to reimbursement's, federal tax ID number (HCFA Form UB-92, field 5); Beginning and ending date of claim period (HCFA Form UB-92, field 6); Patient's name (HCFA Form UB-92, field 12); Patient's address (HCFA Form UB-92, field 13); Patient's date of birth (HCFA Form UB-92, field 14); Patient's gender (HCFA Form UB-92, field 15); Patient's marital status (HCFA Form UB-92, field 16); Date of admission (HCFA Form UB-92, field 17); Admission hour (HCFA Form UB-92, field 18); Type of admission (for example, emergency, urgent, elective, newborn) (HCFA Form UB-92, field 19); Source of admission code (HCFA Form UB-92, field 20); Patient-status-at-discharge code (HCFA Form UB-92, field 22); Medical record number (HCFA Form UB-92, field 23); Responsible party name and address (HCFA Form UB-92, field 38); Value code and amounts (HCFA Form UB-92, fields 39—41); Applicable revenue code (HCFA Form UB-92, field 42) of: The Health Services Cost Review Commission, for hospitals located in the State, or The National or State Uniform Billing Data Elements Specifications, for hospitals not located in the State; Revenue description (HCFA Form UB-92, field 43); Service date (HCFA Form UB-92, field 45); Units of service (HCFA Form UB-92, field 46); Total charge (HCFA Form UB-92, field 47); Noncovered charges (HCFA Form UB-92, field 48); Name of the third-party payor (HCFA Form UB-92, field 50); Provider number (HCFA Form UB-92, field 51); Release of information (HCFA Form UB-92, field 52); Assignment of benefits (HCFA Form UB-92, field 53); Estimated amount due (HCFA Form UB-92, field 55); Subscriber's name (HCFA Form UB-92, field 58); Patient's relationship to the subscriber (HCFA Form UB-92, field 59); Patient's/subscriber's certificate number, health claim number, and ID number (HCFA Form UB-92, field 60); Treatment authorization code (HCFA Form UB-92, field 63); Principal diagnosis code (HCFA Form UB-92, field 67); Admitting diagnosis (HCFA Form UB-92, field 76); Attending physician ID (HCFA Form UB-92, field 82); Other physician ID (HCFA Form UB-92, field 83); Signature of the provider representative or notation that the signature is on file with the third-party payor (HCFA Form UB-92, field 85); Date the bill was submitted (HCFA Form UB-92, field 86); and Any other field or essential data element necessary to comply with the applicable standard code set. Specific Circumstances. In addition to the data elements required by §A of this regulation, to qualify as a clean claim, a claim submitted to a third-party payor by a hospital, or person entitled to reimbursement, shall include the following data elements if circumstances exist that render the data elements applicable to the specific claim being filed: Covered days (HCFA Form UB-92, field 7) is applicable if Medicare is a primary or secondary payor; Noncovered days (HFCA Form UB-92, field 8) is applicable if Medicare is a primary or secondary payor; Coinsurance days (HFCA Form UB-92, field 9) is applicable if Medicare is a primary or secondary payor; Lifetime reserve days (HCFA Form UB-92, field 10) is applicable if Medicare is a primary or secondary payor and the patient was an inpatient; The discharge hour (HCFA Form UB-92, field 21) is applicable if the patient was an inpatient or was admitted for outpatient observation; The condition codes (HCFA Form UB-92, fields 24—30) are applicable if the HCFA Form UB-92 manual contains a condition code appropriate to the patient's condition; The occurrence codes and dates (HCFA Form UB-92, fields 32—35) are applicable if the HCFA Form UB-92 manual contains an occurrence code appropriate to the patient's condition; The occurrence span code and from and through dates (HCFA Form UB-92 field 36) are applicable if the HCFA Form UB-92 manual contains an occurrence span code appropriate to the patient's condition; HCPCS/Rates (HCFA Form UB-92, field 44) are applicable if there is a primary or secondary payor; A code pursuant to a global contract (HCFA Form UB-92, field 44) is applicable if the claim is between parties to a global contract; Prior payments (HCFA Form UB-92, field 54) are applicable if payments have been made to the hospital by the patient or another payor; The employment status code (HCFA Form UB-92, field 64) is applicable if there are payors of higher priority than the third-party payor, including workers' compensation; The employer name (HCFA Form UB-92, field 65) is applicable if there are payors of higher priority than the third-party payor, including workers' compensation; The employer location (HCFA Form UB-92, field 66) is applicable if there is workers' compensation involvement; Diagnoses codes other than the principal diagnosis code (HCFA Form UB-92, field 68—75) are applicable if there are diagnoses other than the principal diagnosis; Diagnoses codes describing the patient's signs, or presenting symptoms, or both (HCFA Form UB 92, field 76) are applicable for services provided in a hospital emergency department; The procedure coding methods used (HCFA Form UB-92, field 79) are applicable if the HCFA Form UB-92 manual indicates a procedural coding method appropriate to the patient's condition; The principal procedure code (HCFA Form UB-92, field 80) is applicable if the patient has undergone an inpatient or outpatient surgical procedure; and Other procedure codes (HCFA Form UB-92, field 81) are applicable as an extension of §B(17) of this regulation if additional surgical procedures were performed. A third-party payor may not use or require a hospital to use any field for purposes that are inconsistent with these data elements or in addition to the applicable standard code set. A third-party payor may accept the HCFA Form UB-92 that includes data elements in addition to those set forth in §§A and B of this regulation. A third-party payor may require a health care practitioner, hospital, or person entitled to reimbursement to include any of the following attachments to a HCFA Form UB-92 or HCFA Form 1500, respectively, for a claim to qualify as a clean claim: A referral or consultant treatment plan submitted by the specialist, if the claim is for specialty services under an HMO plan or in-network point-of-service plan, unless the third-party payor requires the provider of primary care services to submit directly to it the referral or consultant treatment plan for specialty services; An explanation of benefits statement from the primary payor to the secondary payor, unless an electronic remittance notice has been sent by the primary payor to the secondary payor; A Medicare remittance notice, if the claim involves Medicare as a primary payor and the third-party payor provides evidence that it does not have a crossover agreement to accept an electronic remittance notice; A description of the procedure or service, which may include the medical record, if a procedure or service rendered has no corresponding Current Procedural Terminology (CPT) or HCPCS code, or additional description information relating to a CDT code;; Operative notes, if the claim is for multiple surgeries, or includes modifier 22, 58, 62, 66, 78, 80, 81, or 82; Anesthesia records documenting the time spent on the service, if the claim for anesthesia services rendered includes modifiers P4 or P5; Documents referenced as contractual requirements in the global contract, if there is a global contract between a third-party payor and a health care practitioner, hospital, or person entitled to reimbursement; An ambulance trip report, if the claim is for ambulance services submitted by an ambulance company licensed by the Maryland Institute for Emergency Medical Services Systems; Office visit notes, if the claim includes modifier 21 or 22; Information related to the audit as specified in writing by the third-party payor, if the third-party payor's audit of the health care practitioner, hospital, or person entitled to reimbursement demonstrated a pattern of fraud, improper billing, or improper coding; Admitting notes, except in the case of services rendered in accordance with Health-General Article, §§19-701(d) and 19-712.5, Annotated Code of Maryland, if the claim is for inpatient services provided outside of the time or scope of the authorization; Physician notes, except in the case of services rendered in accordance with Health-General Article, §§19-701(d) and 19-712.5, Annotated Code of Maryland, if the claim for services provided is outside of the time or scope of the authorization, or when there is an authorization in dispute; Itemized bills, except in the case of services rendered in accordance with Health-General Article, §§19-701(d) and 19-712.5, Annotated Code of Maryland, if the claim is for services: Rendered in a hospital and the hospital claim has no prior authorization for admission, or Inconsistent with a third-party payor's concurrent review determination rendered before the delivery of services, regarding the medical necessity of the service; Adjunct claims documentation pursuant to Health-General Article, §19-710.1(b)(3), Annotated Code of Maryland; A treatment plan from a child’s health care practitioner that includes one or more specific treatment goals, if the claim is for habilitative services for a child diagnosed with autism or autism spectrum disorder. In its manual, or other document that sets forth the claim filing procedures pursuant to Insurance Article, §15-1004(d), Annotated Code of Maryland, a third-party payor shall: List the attachments to an HCFA Form UB-92 or HCFA Form 1500 that it may require under §A of this regulation for a claim to qualify as a clean claim; and Describe the circumstances under which each attachment may be required. A third-party payor may accept any additional attachments with the HCFA Form 1500 or HCFA Form UB-92. The following are permissible categories of disputed claims for which third-party payors may request additional information pursuant to Insurance Article, §§15-1004(c) and 15-1005(c), Annotated Code of Maryland: Except in cases of services rendered in accordance with Health-General Article, §§19-701(d) and 19-712.5, Annotated Code of Maryland, the legitimacy, medical necessity, or appropriateness of the health care service, if: There is no authorization; or There was preauthorization and the third-party payor disputes the claim: Consistent with the bases for a carrier's denial as set forth in Insurance Article, §15-1009(b), Annotated Code of Maryland, or Because the claim is for services provided outside of the time or scope of the authorization and the applicable attachment required in Regulation .10 of this chapter was not submitted with the claim; Eligibility for benefits or coverage in accordance with Insurance Article, §15-1004(e)(1), Annotated Code of Maryland; The appropriateness of a service, procedure, or durable medical equipment rendered or provided by a specialist not requested by the primary care provider of an enrollee of a health maintenance organization on a referral form or consultant treatment plan; In the case of a claim made pursuant to a global contract, the information necessary to adjudicate the claim consistent with the global contract; A reasonable belief of incorrect billing in accordance with Insurance Article, §15-1005(c)(2)(ii), Annotated Code of Maryland; The insured's or enrollee's liability for the service under the insurance policy or contract, subject to the third-party payor obtaining the additional information from its insured or enrollee within 30 days from receipt of the claim; Legibility of the claim in a material matter; A reasonable belief of fraudulent or improper coding consistent with the bases for a carrier's retroactive denial as set forth in Insurance Article, §15-1008(e), Annotated Code of Maryland; A reasonable belief that a claim for emergency services may not meet the standards for an emergency service pursuant to Health-General Article, §19-701(d), Annotated Code of Maryland; The essential information required for a third-party payor to adjudicate a claim for dental services; and A category approved by the Commissioner by regulation. A third-party payor may not request additional information if an attachment containing the same type of information was submitted with the claim pursuant to Regulation .10 of this chapter. Except as provided for in §A(1) and (2) of this regulation, a third-party payor may not request medical records if: The claim is for services as set forth in Regulation .10A(12) of this chapter; and An itemized bill was submitted with the claim. The following are impermissible categories of disputed claims for which third-party payors may not request additional information pursuant to Insurance Article, §§15-1004(c) and 15-1005(c), Annotated Code of Maryland: Except for global contracts, a description of the procedure or service that is inconsistent with the applicable standard code set; Reimbursement for hospital services, in accordance with the rates approved by the Health Services Cost Review Commission pursuant to Insurance Article, §15-1214, Annotated Code of Maryland; and Except for the bases for a carrier's denial of reimbursement for preauthorized or approved services as set forth in Insurance Article, §15-1009(b), Annotated Code of Maryland, services that were preauthorized by the third-party payor or a private review agent. Each third-party payor shall: Date-stamp the claim with the date received, for a written claim; or Assign to the document a batch number that includes the date received for an electronic claim. Each third-party payor shall maintain a written or electronic record of the date of receipt of a claim. Except as provided in §E of this regulation, a claim is presumed to have been received by a third-party payor according to the date of receipt of the claim stated in the written or electronic record required under §B of this regulation. Pursuant to a request for claim receipt verification by a health care practitioner, hospital, or person entitled to reimbursement, a third-party payor shall provide within 5 working days verification of the date of claim receipt as stated in the written or electronic record, either in: Electronic form, if the request was for electronic verification; or Written form, including microfilm, if the request was for written verification. A claim is presumed to have been received by a third-party payor: 3 working days from the date the submitting health care practitioner, hospital, or person entitled to reimbursement placed the claim in the U.S. mail, if the health care practitioner, hospital, or person entitled to reimbursement maintains the stamped certificate of mailing for the claim; or On the date recorded by the courier, if the claim was delivered by courier. Third-party payors shall follow the disclosure requirements set forth in Insurance Article, §15-1004(d), Annotated Code of Maryland. If a third-party payor uses auto codes to determine whether health care services provided in a hospital emergency facility are “emergency services” as defined in Health-General Article, §19-701(e), Annotated Code of Maryland, the third-party payor shall provide to all contracting health care practitioners or hospitals rendering emergency services, or to all health care practitioners or hospitals rendering emergency services that request them: Auto codes used by the third-party payor to determine emergency services; and Updated auto codes for emergency services at least 30 days before an update of the auto codes will be used, stating the date on which the updated auto codes for emergency services will be used. Required. Except as provided in §B(2) of this regulation, twice each calendar year a third-party payor shall submit to the Commissioner a claims data filing that documents the payment and denial practices for claims from health care practitioners, hospitals, and other persons entitled to reimbursement of: The third-party payor; and Each entity to which the third-party payor has delegated claims processing. Each claims data filing required pursuant to this regulation shall include, at a minimum, data documenting: The number of claims received; The number of claims received that were clean claims pursuant to Regulations .08, .09, and .10 of this chapter; Claims for which additional information was requested by the third-party payor, or the entity to which the third-party payor has delegated claims processing, pursuant to Regulation .11 of this chapter; and As to all claims received, compliance or noncompliance with the requirements of Insurance Article, §15-1005, Annotated Code of Maryland, including timeliness of processing claims and paying interest. Filing Deadlines. The claim data filing shall be in the form approved by the Commissioner and shall be submitted to the Commissioner not later than: September 1 of each year, beginning on September 1, 2002, for all claims received for the period of January 1—June 30 of the same calendar year; and March 1 of each year, beginning on March 1, 2003, for all claims received for the period of July 1—December 31 of the preceding calendar year. If the Commissioner has evidence that a third-party payor, or an entity to which a third-party payor has delegated claims processing, is not in compliance with Insurance Article, §15-1003, 15-1004, or 15-1005, Annotated Code of Maryland, the Commissioner may require a third-party payor to submit a claims data filing more frequently than twice a year. Use of Data by Commissioner. The Commissioner shall use the claims data filings to determine the general business practices of third-party payors and entities to which third-party payors have delegated claims processing pursuant to Insurance Article, §15-1005, Annotated Code of Maryland. Confidentiality of Information. A claims data filing submitted to the Commissioner pursuant to this regulation is confidential commercial information pursuant to State Government Article, §10-617, Annotated Code of Maryland. Except as provided in §D(3) of this regulation, the Commissioner shall deny inspection of a claims data filing. If information from a claims data filing is used as the basis for imposing interest or penalties on a third-party payor, the information shall be available for public inspection only as to the portions pertinent to the imposition of interest or penalties. The Commissioner may impose penalties if a third-party payor submits inaccurate information required by §A of this regulation, in an amount not to exceed the penalty amount set forth in Insurance Article, §4-113(d)(1), Annotated Code of Maryland. The Commissioner may act in accordance with Insurance Article, §4-113(b) or (d), Annotated Code of Maryland, if a third-party payor willfully submits inaccurate information required by §A of this regulation. Health Occupations Article, §1-208; Insurance Article, §§2-108, 2-109, and 15-1003—15-1005; Annotated Code of Maryland Regulations .01—.07 adopted as an emergency provision effective July 22, 1993 (20:16 Md. R. 1274); adopted permanently effective October 25, 1993 (20:21 Md. R. 1653) Chapter recodified from COMAR 09.30.56 to COMAR 31.10.11 effective September 7, 1998 (25:18 Md. R. 1439) Chapter revised effective September 7, 2001 (28:12 Md. R. 1113); December 11, 2003 (30:24 Md. R. 1747) Regulation .02B amended effective October 1, 2015 (42:15 Md. R. 1019) Regulation .07E adopted effective January 26, 2009 (36:2 Md. R. 102) Regulation .10A amended effective March 17, 2014 (41:5 Md. R. 348) Regulation .14C amended effective February 27, 2017 (44:4 Md. R. 256) This chapter is applicable to all: Carriers as defined in Regulation .02B(1) of this chapter; Consultant/facility providers as defined in Regulation .02B(2) of this chapter; and Primary or requesting providers as defined in Regulation .02B(4) of this chapter. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means: An insurer; A nonprofit health service plan; A health maintenance organization; or A dental plan organization. “Consultant/facility provider” means: A person licensed or certified under Health Occupations Article, Annotated Code of Maryland, who receives a referral from a primary or requesting provider; or Hospitals and related institutions that receive a referral from a primary or requesting provider. “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. “Primary or requesting provider” means a person licensed or certified under the Health Occupations Article, Annotated Code of Maryland, who refers patients for consultation to a consultant/facility provider. “Related institution” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. “Uniform consultation referral form” means: For dentists referring patients for dental care procedures or services, the Maryland Uniform Dental Consultation Referral Form or its electronic equivalent shown in Regulation .08 of this chapter; or For all other health care professionals referring patients for health, medical, or dental care procedures or services, the Maryland Uniform Consultation Referral Form or its electronic equivalent shown in Regulation.06 of this chapter. If a carrier requires a covered person to have a written referral in order to receive services, the carrier shall use the uniform consultation referral form as defined in Regulation .02B(6) of this chapter. The carrier may not impose as a condition of coverage a requirement to: Modify the uniform consultation referral form, except as provided in §E of this regulation; or Submit additional consultation referral forms. The carrier may provide a separate set of instructions for properly completing the Uniform Consultation Referral Form. For the uniform consultation referral form, the carrier’s specific instructions: If applicable, may be preprinted on the back of the uniform consultation referral form, if the instructions do not result in any modifications in the format of, or information categories directed to be supplied on the front of, the uniform consultation referral form; and Shall be made available to primary or requesting providers on the carrier’s website. Notwithstanding the provisions of §B of this regulation, the carrier may provide stamps or preprinted stickers to include additional information to the carrier information block on the uniform consultation referral form. The carrier may preprint the designated carrier information in the carrier information field on the Maryland uniform consultation referral form. The primary or requesting provider shall use the uniform consultation referral form as defined in Regulation .02B(6) of this chapter and instructions as provided in Regulation .03C of this chapter. The uniform consultation referral form shall be properly completed by the primary or requesting provider. The consultant/facility provider shall accept a properly completed uniform consultation referral form. The requirements under these regulations do not apply to an entity that would be using a consultation form solely for internal purposes. The Maryland Uniform Consultation Referral Form shall read as follows: The electronic equivalent of the uniform consultation referral form is as follows: A transmission by facsimile is not considered an electronic transfer for the purposes of this chapter. A carrier shall accept the electronic transfer of the uniform consultation referral form. The Maryland Uniform Dental Consultation Referral Form shall read as follows: The electronic equivalent of the uniform consultation referral form is as follows: Insurance Article, §§2-109 and 15-120, Annotated Code of Maryland Effective date: October 21, 1996 (23:21 Md. R. 1467) Regulation .03 amended as an emergency provision effective January 28, 1997 (24:4 Md. R. 289); adopted permanently effective May 19, 1997 (24:10 Md. R. 710) Regulation .07 adopted as an emergency provision effective January 28, 1997 (24:4 Md. R. 289); adopted permanently effective May 19, 1997 (24:10 Md. R. 710) Chapter recodified from COMAR 09.31.23 to COMAR 31.10.12 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .02B amended effective January 1, 2005 (31:23 Md. R. 1655); January 13, 2011 (38:1 Md. R. 12) Regulation .03 amended effective January 13, 2011 (38:1 Md. R. 12) Regulation .03A amended effective January 1, 2005 (31:23 Md. R. 1655) Regulation .04A amended effective January 1, 2005 (31:23 Md. R. 1655) Regulation .05 amended effective January 13, 2011 (38:1 Md. R. 12) Regulation .06 amended effective January 13, 2011 (38:1 Md. R. 12) Regulation .06D amended effective January 1, 2005 (31:23 Md. R. 1655) Regulation .07 amended effective January 13, 2011 (38:1 Md. R. 12) Regulation .08 adopted effective January 1, 2005 (31:23 Md. R. 1655); January 13, 2011 (38:1 Md. R. 12) The issuance or delivery of health insurance policies in Maryland in any manner not in compliance with this chapter shall be deemed to constitute the transaction of insurance business hazardous to policyholders and the public and contrary to the public interest and otherwise contrary to requirements of the Insurance Article. Insurance Article, §2-109, Annotated Code of Maryland, authorizes the Commissioner to make reasonable regulations necessary for or as an aid to implementing any provision of the Insurance Article. Insurance Article, §12-203, Annotated Code of Maryland, provides, in part, that no health insurance policy form shall be delivered or issued for delivery in this State unless the form has been filed with and approved by the Commissioner. Insurance Article, §12-205, Annotated Code of Maryland, authorizes the Commissioner to disapprove any policy form if it contains an inequitable provision or a provision without substantial benefit to the policyholder or if the policy benefits are unreasonable in relation to the premium charged or if the policy benefits are not of real economic value to the insured. This chapter applies to individual policies of health insurance and its application varies with the types of benefit provided by a policy. For this purpose, the benefits which have been found to appear in individual policies of health insurance are classified as follows: Type 1: A benefit payable if an event involving a morbidity risk occurs or commences during the premium paying period of the policy. Most accident and health insurance benefits fall into this category. Type 2: A deferred benefit in the form of a payment at the expiration date of the policy or at a date specified instead of an expiration date. This payment may be defined as an amount equal to all or a stated portion of the accumulated premiums for the policy, with or without interest, or the amount may be defined without regard to the premiums. Type 3: A deferred periodic benefit providing for specified amounts payable at one or more specified times or intervals during the premium paying period. The specified amounts may be defined as equal to all or a stated portion of the premiums paid during a specified period, with or without interest, or the amounts of the payments may be defined without regard to the premiums. The purpose of this chapter is to serve the interests of continuing policyholders and to afford reasonable protection to the interests of those policyholders who are forced to discontinue their policies prematurely by regulating the design of the policies in a manner which is equitable to the policyholder and which provides benefits reasonable in relation to the premium charged and which provides benefits of economic value to the insured. The classification in Regulation .02 of this chapter applies to the benefit rather than to the policy. A policy may contain benefits of more than one type. Benefits of Type 2 and Type 3 are deemed supplementary to Type 1 benefits. Premiums for Type 2 benefits and Type 3 benefits are normally payable at the same time as premiums for other benefits of the policy, but payments of Type 2 and Type 3 benefits will normally be made only after the passage of a considerable period of time. In this chapter, the following terms have the meanings indicated. Terms Defined. “Guaranteed renewable” when used in connection with an individual health insurance policy means that the insured has the right to continue the policy in force by the timely payment of premiums: Until at least age 50; or In the case of a policy issued after age 44, for at least 5 years from its date of issue, during which period the insurer has no right to make unilaterally any change in any policy provision except the right to change premiums in accordance with the terms of the policy. “Withdrawal benefit” means: Any paid-up nonforfeiture benefit, for example, extended insurance for a limited period of time or insurance continued for the original term of the policy but for a reduced amount of benefit, providing coverage for morbidity risks; or Any cash surrender nonforfeiture benefit or any endowment or annuity payment which is payable without reference to any morbidity risk. “Morbidity risk” means any loss resulting from injury, sickness, childbirth, or health care. Provision for a withdrawal benefit in connection with a nondeferred benefit, Type 1, is not required. However, provision for a withdrawal benefit in connection with a Type 1 benefit may be used at the insurer's option, if any payment under it is not greater than an amount corresponding to a reserve which might properly be held at the time of withdrawal with respect to the Type 1 benefit to which it is related. No deferred benefit of Type 2 or Type 3, or any provision for a withdrawal benefit, may be used in any individual policy of health insurance unless the policy is guaranteed renewable. An individual policy containing a provision for a Type 2 or Type 3 benefit shall make further provision for a withdrawal benefit. In the event of discontinuance by the policyholder on or after the fifth anniversary of the effective date of the policy, or any earlier date which the policy may specify, the withdrawal benefit shall be payable. The value of the withdrawal benefit before any reduction because of provision for claim payments offset (see §F of this regulation), shall be not less than an amount computed (without provision for claim payments offset for the purpose of this section) in the same manner as the minimum reserve required with respect to the Type 2 or Type 3 benefit to which it is related but on a 5-year preliminary term basis with an interest rate of 5 percent per annum, using mortality and morbidity tables which are approved by the Commissioner as acceptable for reserve purposes. If the policy gives the policy owner the option of electing one of two or more withdrawal benefits, the right of election shall extend for at least 60 days after the date the policy ceases to be in force, and one of the withdrawal benefits shall be designated as the automatic benefit in event the policy owner does not make a timely election. If the policy gives the policy owner the option of electing one of two or more withdrawal benefits, and one of these benefits provides for extended insurance, the extended insurance benefit shall be in effect from the date the policy lapses until the earlier of the date the policyholder exercises his option to elect an alternate benefit or until the date an alternate benefit becomes effective as an automatic withdrawal benefit. The insurer may deduct the cost of the extended insurance benefit from the value of an alternate withdrawal benefit which later becomes effective. If the policy provides a cash surrender nonforfeiture benefit upon lapse before the expiry date stated in the policy, the insurer may provide the policyholder the option of electing an arrangement for automatic premium loans. The insurer may charge the amount advanced as automatic premium loans, together with interest thereon at an effective rate not to exceed 8 percent per annum, against the cash surrender value or against the value of any other withdrawal benefit which may later become effective under the policy. Claim Payments Offset. An individual health insurance policy may provide that a Type 2 benefit or a Type 3 benefit, or any withdrawal benefit associated with a Type 2 or Type 3 benefit, shall be reduced because of prior claim payments under the policy. No provision may be used which could cause the amount of a Type 2 or Type 3 benefit, or any associated withdrawal benefit, to be reduced by more than the amount of any currently incurred and prior claims. If a policy provides for withdrawal benefits in connection with more than one benefit or more than one type of benefit, provision for these withdrawal benefits may be combined in a single part of the policy. Any cash withdrawal benefit provided by a policy shall be payable on death of an insured. If a policy covers more than one life, any provision of the regulation defining a minimum withdrawal benefit shall be construed, when appropriate, to be applicable separately to each covered life. The benefit provision shall be specific in regard to the determination of the amount of benefits under these cases. For purposes of this chapter, dividends to policyholders may not be regarded as claims paid, but may be regarded as reductions of premiums paid. For purposes of this chapter, a waived premium shall be regarded both as a premium paid and a claim paid. The insurer shall send the policyholder timely advance notice of each premium as it comes due, unless the premium installments are payable on a payroll savings or salary deduction plan, or by a series of preauthorized checks or bank drafts, or a similar plan. A sales presentation or advertising concerning any Type 2 or Type 3 benefit may not state, or in any manner indicate or imply, or tend to cause the policyholder to believe, that any withdrawal benefit is provided free or without additional cost or charge to the policyholder. Insurance Article, §§2-109 and 12-203—12-205, Annotated Code of Maryland Effective date: August 10, 1979 (6:16 Md. R. 1330) Chapter recodified from COMAR 09.30.46 to COMAR 31.10.13 effective September 7, 1998 (25:18 Md. R. 1439) The purpose of this chapter is to establish minimum loss ratios with respect to specified disease policies in order to assure that the benefits provided in those policies are reasonable in relation to the premium charged and may be approved under the requirements of Insurance Article, §§12-203—12-205, and 15-109, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Claim reserve” means the sum of the present value of amounts not yet due on claims plus the reserve for future contingent benefits included in Exhibit 9, Part B of the Annual Statement. All numerical references to the Annual Statement in this regulation are to the National Association of Insurance Commissioners form for Life and Accident and Health insurers, current edition. “Claims liability” means the amount included in Line 4a of Exhibit 11, Part 1 of the Annual Statement. “Loss ratio” means the ratio of losses incurred to premiums earned on specified disease policies. “Policy reserves” means the sum of the additional reserves plus the reserve for future contingent benefits included in Lines 2 and 3 of Exhibit 9, Part A of the Annual Statement. “Premium reserve” means unearned premiums plus advance premiums plus reserve for dividends, refunds, and retrospective rate credits. “Premiums written” means premiums due during the current year and is equal to premiums collected during the current year plus premiums uncollected at the end of the current year less premiums uncollected at the end of the previous year. Specified Disease Policy. “Specified disease policy” means a health insurance policy that provides: Benefits only for a disease or diseases specified in the policy or for treatment unique to a specified disease or diseases; or Additional benefits for a disease or diseases specified in the policy or for treatment unique to a specified disease or diseases, provided the actuarial net premium for the additional benefits exceeds 33 percent of the actuarial net premium for all of the health insurance benefits provided in the policy. If an insurer issues a health insurance policy to which a rider providing coverage for a specified disease or diseases may be added at the option of the policy owner and if the actuarial net premium for the benefits provided by the rider exceeds 33 percent of the actuarial net premium for all of the health insurance benefits provided by the policy including the rider, then either the policy to which the rider is attached, or the rider separately, shall be considered to be a “specified disease policy”, whichever the insurer elects. In order to assure that benefits under specified disease policies are reasonable in relation to the premium charged, the insurer shall establish premiums for specified disease policies in accordance with generally accepted actuarial principles and practices so as to return to policyholders in the form of aggregate benefits provided under the policy during the period for which rates are computed at least 75 percent of the aggregate premiums earned in the case of group and blanket policies, and at least 60 percent of the aggregate premiums earned in the case of individual policies. Policies issued as a result of solicitation of individuals through the mail or mass media advertising, including both print and broadcast advertising, shall be considered individual policies for purposes of this regulation. The benefits provided in a specified disease policy shall be considered unreasonable in relation to the premium charged if the actual or anticipated loss ratio is less than 75 percent in the case of group and blanket policies, or less than 60 percent in the case of individual policies. In filing a specified disease policy for approval, the insurer shall also file the premium rates proposed to be charged for the policy and shall include an actuarial memorandum based on credible data to show that the anticipated loss ratio under the policy will be not less than the ratios required by Regulation .03 of this chapter. The actuarial memorandum shall describe how the rates were determined and how the anticipated loss ratio was calculated and shall include a general description and the source of each assumption used in the memorandum. This filing as well as those required under Regulations .05 and .06 of this chapter shall assume a reasonable rate of interest to be earned on claim and policy reserves. On or before June 30 of each calendar year, each insurer issuing specified disease policies in Maryland shall file with the Commissioner a report regarding the loss ratio being experienced under each specified disease policy form being issued by the insurer in this State. Experience with regard to substantially similar policy forms may be combined as if they were the same form. The report as to each policy form or combination of similar policy forms shall show for each of the 5 preceding calendar years, or for the preceding years since the policy form was first issued, the following information regarding experience on direct business (before reinsurance ceded or assumed) issued, delivered, or renewed in Maryland: Premiums written; Dividends, refunds, and retrospective rate credits paid or allowed; Premiums written net of §B(2) of this regulation; Premium reserve at end of previous year; Premium reserve at end of current year; Premiums earned (§B(3) + (4) - (5)); Claims paid; Claims liability at end of current year; Claim reserve at end of current year; Policy reserves at end of current year; Claims liability at end of previous year; Claim reserve at end of previous year; Policy reserves at end of previous year; Losses incurred (§B(7) + (8) + (9) + (10) - (11) - (12) - (13)); Loss ratio (§B(14) divided by (6)). If the amount of the insurer's specified disease business in Maryland is not sufficient to make the report credible from a statistical standpoint, upon application to and with the approval of the Commissioner, the insurer may make the report based on its entire national experience. If the report referred to in Regulation .05 of this chapter with respect to a policy form or combination of similar policy forms indicates that the form or forms are not meeting the loss ratio requirements of Regulation .03 of this chapter, the insurer, within 30 days after the due date of the report, shall file for an appropriate reduction in premium to be effective not later than 90 days after the due date of the report. The filing shall include an actuarial memorandum as described in Regulation .04 of this chapter. If the insurer does not propose a reduced premium which in the opinion of the Commissioner meets the requirements of these regulations, the Commissioner shall afford the insurer a hearing upon due notice. If, as a result of the hearing, the Commissioner finds that the premium proposed to be charged by the insurer would not be likely to result in a loss ratio meeting the requirements of these regulations, he may withdraw approval of the affected policy form or forms in accordance with Insurance Article, §12-203(c)(5), Annotated Code of Maryland. If a reduced premium is required, the insurer may offer the policy owner the option of obtaining increased benefits instead of the reduction in premium. The proposed benefit increase should be filed in accordance with Regulation .04 of this chapter. These regulations apply to all insurers to whom Insurance Article, §15-109, Annotated Code of Maryland, is applicable. Insurance Article, §§2-109, 12-203—12-205, and 15-109, Annotated Code of Maryland Effective date: March 15, 1982 (9:5 Md. R. 527) Regulation .02B amended effective November 6, 1995 (22:22 Md. R. 1657) Chapter recodified from COMAR 09.30.57 to COMAR 31.10.14 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .07 amended effective September 21, 2009 (36:19 Md. R. 1439) Effective date: October 11, 1993 (20:20 Md. R. 1570) Chapter recodified from COMAR 09.30.96 to COMAR 31.10.15 effective September 7, 1998 (25:18 Md. R. 1439) Chapter, Reporting of Benefits for Child Wellness Services and Mammograms, repealed effective October 5, 1998 (25:20 Md. R. 1534) Regulations .01—.10, Substantial, Available, and Affordable Coverage Plan, adopted effective November 16, 1998 (25:23 Md. R. 1697) Regulation .01 amended as an emergency provision effective June 28, 1999 (26:15 Md. R. 1146); emergency status expired December 15, 1999 Regulation .01E amended as an emergency provision effective November 10, 1999 (26:25 Md. R1896); emergency status expired April 5, 2000 Regulation .01E amended as an emergency provision effective April 5, 2000 (27:8 Md. R. 795); amended permanently effective July 24, 2000 (27:14 Md. R. 1344) Chapter revised as an emergency provision effective August 7, 2000 (27:19 Md. R. 1724); revised permanently effective November 27, 2000 (27:23 Md. R. 2150) Regulation .01E amended effective April 16, 2001 (28:7 Md. R. 692) Regulation .02B amended effective March 18, 2002 (29:5 Md. R. 506) Regulation .03A amended effective April 16, 2001 (28:7 Md. R. 692); March 18, 2002 (29:5 Md. R. 506) Regulation .04E amended effective April 16, 2001 (28:7 Md. R. 692) Regulation .05H amended effective April 16, 2001 (28:7 Md. R. 692) Regulation .06B amended effective April 16, 2001 (28:7 Md. R. 692) Regulation .08A amended effective March 18, 2002 (29:5 Md. R. 506) Regulation .08C amended effective April 16, 2001 (28:7 Md. R. 692) Regulation .10 amended effective April 16, 2001 (28:7 Md. R. 692) Chapter repealed effective June 17, 2008 (35:12 Md. R. 1121) This chapter applies to all insurers, nonprofit health service plans, health maintenance organizations, dental plans, and to any other person or organization which utilizes a provider panel and which provides health benefit plans subject to regulation in this State. In this chapter, the following terms have the meanings indicated. Terms Defined. Carrier. “Carrier” means: An insurer; A nonprofit health service plan; A health maintenance organization; A dental plan organization; and Any other person or organization that provides health benefit plans subject to State regulation. “Carrier” includes an entity that arranges a provider panel for a carrier. “Provider” means a health care practitioner or a group of health care practitioners licensed or otherwise authorized by law to provide health care services. Provider Panel. “Provider panel” means those providers with which a carrier contracts to provide health care services to the carrier's enrollees under the carrier's health benefit plan. “Provider panel” does not include an arrangement between a carrier and providers in which a provider may participate solely on the basis of the provider's contracting with the carrier to provide services at a discounted fee-for-service rate. A carrier that utilizes a provider panel shall establish written procedures for reviewing applications for participation in the provider panel. A carrier that utilizes a provider panel shall, upon request, make its applications publicly available. The form of application: Shall include instructions for completion of the application; Shall provide a specifically designated space for dating the receipt of the application by the carrier; and Shall comply with federal and State laws concerning the Americans with Disability Act. A carrier shall maintain an application log which, at a minimum, provides the following information: Name of the provider requesting or submitting the application; Date the provider requested an application, if applicable; Date the application is sent or delivered to the provider, if applicable; Date the application is received from the provider; Date the application is returned to the provider with a request for additional information to complete the application, if applicable; Date of receipt by the carrier of an application previously returned for additional information, if applicable; Date that the provider is notified of: Rejection, or Carrier's intent to continue the credentialing process; and Date after completion of credentialing that the provider is notified of acceptance or rejection in the provider panel. The log shall be available for inspection by the Commissioner. Notice. A carrier shall: If the carrier maintains a web site: Post on the web site a notice of how to apply to the carrier's provider panel; and Provide, on request, a paper copy of the notice of how to apply to the carrier's provider panel; or If the carrier does not maintain a web site, provide on request a paper copy of the notice of how to apply to the carrier's provider panel. The notice required pursuant to §F(1) of this regulation shall include relevant addresses and telephone numbers for contact purposes. A carrier may charge a reasonable fee for any application that a provider submits to the carrier. The fee shall be nonrefundable and uniform for all applicants within a practice specialty. The fee may not exceed $75 for each provider application. A carrier may not charge additional fees for processing an application which was returned because of insufficient information. A carrier shall maintain its provider application log for a minimum of 3 years or until its next market conduct examination, whichever occurs last. A carrier shall: Date stamp each application received from a provider upon initial receipt; and Maintain a legible copy of each application, and any correspondence regarding that application, for a minimum of 3 years or until its next market conduct examination, whichever occurs last. Insurance Article, §§2-109 and 15-112, Annotated Code of Maryland Effective date: June 17, 1996 (23:12 Md. R. 870) Chapter recodified from COMAR 09.31.13 to COMAR 31.10.16 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .03C amended effective April 21, 2008 (35:8 Md. R. 812) Regulation .03D amended effective May 9, 2016 (43:9 Md. R. 532) Regulation .03F amended effective December 23, 2002 (29:25 Md. R. 1984) Regulation .05B amended effective December 6, 2018 (45:24 Md. R. 1164) This chapter applies to all carriers that provide health care services to enrollees or otherwise make health care services available to enrollees through contracts with providers. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means: An insurer; A nonprofit health service plan; A health maintenance organization; A dental plan organization; Any person or entity acting as a third-party administrator; or Except for a managed care organization as defined in Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, any other person that provides health benefit plans subject to regulation by the State. “Enrollment sales materials” means any materials provided by a carrier to: An employer at the time of plan selection; or Enrollees at the time of enrollment. Each carrier that provides health care services to enrollees, or otherwise makes health care services available to enrollees through contracts with providers, shall disclose in its enrollment sales material the: Methodology or methodologies that the carrier uses to compensate the physicians for health care services rendered to enrollees; and Distribution of each $100 it receives in premium dollars from enrollees for the preceding calendar year. The information required to be disclosed under §A of this regulation shall be based on Maryland-specific information. Each carrier shall include the following in its enrollment sales materials: The following disclosure statement typeset in bold italic type: The table, specified in §C of this regulation, defining methods of paying physicians and giving an example of each method; and A statement of: The payment method or methods used to compensate physicians during the preceding year, and An estimated percentage of physicians under contract with the carrier compensated by each payment method. Requests Pursuant to Disclosure. Each carrier shall provide information in response to requests made pursuant to the disclosure requirement set forth in §A(1) of this regulation with respect to provider compensation by disclosing the method by which a specific physician is compensated. A carrier is not required to state the dollar amount of compensation or otherwise provide more specific information about the compensation arrangement it has with a specific physician. Methods of Paying Physicians. The disclosure required under this regulation shall: Be in the form of a pie chart or bar graph; and Identify, in layman's terms, the proportion of every $100 in premium dollars that the carrier uses to pay: Providers for the provision of health care services to enrollees, including what proportion is for direct medical care expenses, and For plan administration. The computation used in the pie chart or bar graph shall be in accordance with the National Association of Insurance Commissioners' instructions and formulas used in deriving the 5-year historical data page of the carrier's annual statement. The pie chart or bar graph to be included in enrollment sales material shall be based on the annual statement of the: Immediate prior year for enrollment sales material used on or after July 1 of each year; and Year before the immediate prior year for enrollment sales material used before July 1 of each year. The computation used under §B of this regulation shall be limited to benefits under policies which make health care services available through contracts with providers. The disclosures required by this chapter may be on a separate form, which shall be provided to employers at the time of plan selection and to enrollees at the time of enrollment. A carrier may disclose on the pie chart or bar graph that the administrative expenses do not include taxes. A carrier may disclose on the pie chart or bar graph whether the carrier includes dental benefits as part of the underlying benefit plan. Insurance Article, §§2-109 and 15-121; Health-General Article, §19-706; Annotated Code of Maryland Effective date: July 12, 1998 (25:14 Md. R. 1132) Chapter recodified from COMAR 09.31.26 to COMAR 31.10.17 effective September 7, 1998 (25:18 Md. R. 1439) This chapter applies to carriers and to private review agents to whom the internal grievance process has been delegated by a carrier. In this chapter, the following terms have the meanings indicated. Terms Defined. Adverse Decision. “Adverse decision” means a utilization review determination by a private review agent, a carrier, or a health care provider acting on behalf of a carrier that: A proposed or delivered health care service which would otherwise be covered under the member's contract is not or was not medically necessary, appropriate, or efficient; and May result in noncoverage of the health care service. “Adverse decision” does not include a decision concerning a person's status as a member. “Carrier” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. “Complaint” means a protest filed with the Commissioner involving an adverse decision or grievance decision concerning a member. “Emergency case” means a case involving an adverse decision for which an expedited review is required under Regulation .05 of this chapter. “Filing date” means the earlier of: 5 days after the date of mailing; or The date of receipt. “Grievance” means a protest filed by a member, a member’s representative, or a health care provider on behalf of a member with a carrier through the carrier's internal grievance process regarding an adverse decision concerning the member. “Grievance decision” means a final determination by a carrier that arises from a grievance filed with the carrier under its internal grievance process regarding an adverse decision concerning a member. “Health Advocacy Unit” means the Health Education and Advocacy Unit in the Division of Consumer Protection of the Office of the Attorney General established under Commercial Law Article, Title 13, Subtitle 4A, Annotated Code of Maryland. “Health care provider” means: An individual who is: Licensed or otherwise authorized in this State to provide health care services in the ordinary course of business or practice of a profession, and A treating provider of a member; or A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland. “Health care service” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. Member. “Member” means a person entitled to health care benefits under a policy, plan, or certificate issued or delivered in the State by a carrier. “Member” includes: A subscriber; and Unless preempted by federal law, a Medicare recipient. “Member” does not include a Medicaid recipient. “Member’s representative” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. “Private review agent” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland. A carrier shall include in each notice of adverse decision the following disclosure in at least 12-point typeface, with the first sentence in bold capital typeface: "THERE IS HELP AVAILABLE TO YOU IF YOU WISH TO DISPUTE THE DECISION OF THE PLAN ABOUT PAYMENT FOR HEALTH CARE SERVICES. You may contact the Health Advocacy Unit of Maryland's Consumer Protection Division at (phone number, address, fax, e-mail). The Health Advocacy Unit can help you, your representative, and your health care provider prepare a grievance to file under the carrier's internal grievance procedure. That unit can also attempt to mediate a resolution to your dispute. The Health Advocacy Unit is not available to represent or accompany you during any proceeding of the internal grievance process. Additionally, you, your representative, or your health care provider may file a complaint with the Maryland Insurance Administration, without having to first file a grievance with the plan, if: The plan has denied authorization for a health care service not yet provided to you; and You, your representative, or your provider can show a compelling reason to file a complaint, including that a delay in receiving the health care service could result in loss of life, serious impairment to a bodily function, or serious dysfunction of a bodily organ or part, or the member remaining seriously mentally ill with symptoms that cause the member to be in danger to self or others. INFORMATION DESCRIBED IN THIS NOTICE MAY ALSO BE FOUND IN (cite policy, plan, certificate, enrollment materials, or other evidence of coverage)." An expedited review of an adverse decision in accordance with this regulation is required if the: Adverse decision is rendered for health care services that are proposed but have not been delivered; and Services are necessary to treat a condition or illness that, without immediate medical attention, would: Seriously jeopardize the life or health of the member of the member’s ability to regain maximum functions; Cause the member to be in danger to self or others; or Cause the member to continue using intoxicating substances in an imminently dangerous manner. The content of any written notice by a carrier of an adverse decision or grievance decision under this regulation shall comply with Regulation .04 of this chapter and Insurance Article, §15-10A-02(f) and(i), Annotated Code of Maryland. Each carrier shall establish an internal grievance process. Each carrier shall: File with the Commissioner its internal grievance process not more than 30 days after the effective date of this chapter; File with the Commissioner each amendment to its internal process at least 30 days before its intended use; Include with the filing the circumstances, if any, under which the internal grievance process will be delegated to a private review agent; Include with the filing a copy of the applicable part of the policy, plan, certificate, enrollment materials, or other evidence of coverage that shows the information required under Insurance Article, §15-10A-02(k), Annotated Code of Maryland; and Submit to the Health Advocacy Unit the document describing the details of its internal grievance process and procedures that the carrier will send to a member, member’s representative, or health care provider when the member, member’s representative, or provider contacts the carrier about an adverse decision. Each carrier shall submit its internal grievance process and any amendments to the Health Advocacy Unit not later than the date on which the carrier begins to use the process or amendment. An internal grievance process shall: Meet the requirements established under this chapter; and Include an expedited procedure for use in an emergency case for purposes of rendering a grievance decision within 24 hours after filing the grievance pursuant to the carrier's internal grievance process, that includes an explanation about: Who will make the determination whether an emergency case exists when a grievance asserts an emergency case, How the determination will be made about the existence of an emergency case, How the disclosure to the member, the member’s representative, or health care provider required by Insurance Article, §15-10A-02(g), Annotated Code of Maryland, will be provided when the grievance asserts that an emergency case exists; and How the notice to the member and, if applicable, the member’s representative and health care provider required by Insurance Article, §15-10A-02(i), Annotated Code of Maryland, will be provided when the grievance asserts that an emergency case exists. Except as otherwise provided in this regulation, a carrier shall render a final decision on a grievance that involves a: Prospective denial in a nonemergency case within 30 working days after the filing date; and Retrospective denial within 45 working days after the filing date. With the written consent of the member, member’s representative, or health care provider who filed a grievance on behalf of the member, a carrier may extend the period for making a final decision for an additional period of not longer than 30 working days. A member, a member’s representative, or a health care provider on behalf of a member may file a complaint without first exhausting the internal grievance process of a carrier if the complaint demonstrates to the satisfaction of the Commissioner a compelling reason to do so. A compelling reason includes showing that the potential delay in receipt of a health care service until after the member or health care provider exhausts the internal grievance process and obtains a final decision under the grievance process could result in: Loss of life; Serious impairment to a bodily function; Serious dysfunction of a bodily organ; The member remaining seriously mentally ill or using intoxicating substances with symptoms that cause the member to be in danger to self or others; or The member continuing to experience severe withdrawal symptoms. A member is considered to be in danger to self or others if the member is unable to function in activities of daily living or care for self without imminent dangerous consequences. In a case involving a retrospective denial, there is no compelling reason to allow a member, a member’s representative, or a health care provider on behalf of a member to file a complaint without first exhausting the internal grievance process of a carrier. Consent Form. For services rendered on or after January 1, 1999, the Commissioner shall request the signed consent of the member that filed the complaint, or a legally authorized designee of the member, authorizing the release of the member's medical records to the Commissioner or the Commissioner's designee that are needed in order for the Commissioner to make a final decision on the complaint. The Commissioner may refuse to investigate a complaint if the member or legally authorized designee of the member fails to sign a consent form. In the case of alcohol and drug abuse, the member shall deliver the member's medical records to the Health Advocacy Unit or to the Commissioner, or to both, pursuant to federal law and regulations. The Commissioner may refer complaints not within the Commissioner's jurisdiction to the Health Advocacy Unit or any other appropriate federal or state government agency or unit for disposition or resolution. Insurance Article, §2-109 and Title 15, Subtitle 10A, Annotated Code of Maryland Effective date: Regulations .01—.15 adopted as an emergency provision effective January 1, 1999 (26:2 Md. R. 104); adopted permanently effective March 22, 1999 (26:6 Md. R. 490) Chapter revised effective April 11, 2005 (32:7 Md. R. 686) Chapter revised effective April 16, 2012 (39:7 Md. R. 496) Regulation .05A amended effective July 30, 2018 (45:15 Md. R. 728) Regulation .11 amended effective July 30, 2018 (45:15 Md. R. 728) In this chapter, the following terms have the meanings indicated. Terms Defined. Adverse Decision. “Adverse decision” means a utilization review determination by a private review agent, a carrier, or a health care provider acting on behalf of a carrier that: A proposed or delivered health care service that is otherwise covered under the member's contract is not or was not medically necessary, appropriate, or efficient; and May result in noncoverage of the health care service. “Adverse decision” does not include a decision concerning a subscriber's status as a member. “Affiliate” means a person who directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with another person. “Carrier” means: An insurer that offers health insurance other than long-term care insurance or disability insurance; A nonprofit health service plan; A health maintenance organization; A dental plan organization; or Any other person that provides health benefit plans subject to regulation by the State. “Complaint” means a protest filed with the Commissioner involving an adverse decision or grievance decision concerning a member. “Emergency case” means a case involving an adverse decision for which an expedited review is required under COMAR 31.10.18.05. “Expert reviewer” means a physician or other appropriate health care provider who contracts with or is retained by an independent review organization to conduct external review of a carrier's adverse decision pursuant to Insurance Article, §15-10A-05, Annotated Code of Maryland. “Health care provider” means: An individual who is: Licensed under the Health Occupations Article, Annotated Code of Maryland, or holds a nonrestricted license in a state of the United States to provide health care services in the ordinary course of business or practice of a profession, and A treating provider of the member; or A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland. “Health care service” means a health or medical care procedure or service rendered by a health care provider including: Testing, diagnosis, or treatment of a human disease or dysfunction; Dispensing of drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction; and Any other care, service, or treatment of disease or injury, the correction of defects, or the maintenance of the physical and mental well-being of human beings. “Independent review organization” means an entity that contracts with the Commissioner to conduct independent review of a carrier's adverse decision pursuant to Insurance Article, §15-10A-05, Annotated Code of Maryland. “Medical expert” means a physician or other appropriate health care provider who contracts with the Commissioner to conduct external review of a carrier's adverse decision pursuant to Insurance Article, §15-10A-05, Annotated Code of Maryland. “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland. Member. “Member” means a person entitled to health care benefits under a policy, plan, or certificate issued or delivered in the State by a carrier. “Member” includes: A subscriber; and Unless preempted by federal law, a Medicare recipient. “Member” does not include a Medicaid recipient. “Member’s representative” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. “Private review agent” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland. In cases considered appropriate by the Commissioner, the Commissioner shall seek advice concerning adverse decisions from an independent review organization or medical expert, as provided in Insurance Article, §15-10A-05, Annotated Code of Maryland. For any independent review organization or medical expert that contracts with the Commissioner, the independent review organization or medical expert shall have a quality assurance mechanism in place that assures the: Timeliness and quality of the reviews; Qualifications and independence of the expert reviewers and the independent review organization, or the medical expert; and Confidentiality of medical records and review materials, consistent with federal and State laws. An independent review organization seeking to contract with the Commissioner shall submit to the Commissioner a copy of the accreditation certificate issued by a nationally recognized private accrediting organization. An independent review organization designated by the Commissioner to review an adverse decision shall have the authority and powers as delegated by the Commissioner for the following functions related to conducting an independent review: Obtaining all information relative to the complaint from the carrier, the provider, the member, and the member’s representative; Assigning the expert reviewer for review of an adverse decision; and Performing conflicts checks relative to the independent review organization and the expert reviewer assigned to review the adverse decision. A medical expert designated by the Commissioner to review an adverse decision shall have the authority and powers, as delegated by the Commissioner, for obtaining all information relative to the complaint from the: Carrier; Provider; Member; and Member’s representative. An independent review organization or medical expert may not be an affiliate of a trade association of: Health benefit plans; or Health care providers. The independent review organization shall provide to the Commissioner the following: The name and biographical information for each director, officer, and management employee of the independent review organization, and a description of any relationship, either direct or indirect, the named individual has that represents ownership of or income from any of the following entities: A health maintenance organization; An insurer; A private review agent; A nonprofit health corporation; A carrier dental plan organization; A health care provider or health care provider group; or Any group acting on behalf of any of the entities described by §B(1)(a)—(f) of this regulation; If the independent review organization is a publicly held organization, the names of all stockholders and owners of more than 5 percent of any stock or options of the independent review organization; The names of all holders of bonds or notes in excess of $100,000; A list of any currently outstanding loans or contracts to provide services between the independent review organization and any entity listed in §B(1) of this regulation; The names of all affiliates of the independent review organization and the nature and extent of any ownership or control, including: The affiliate's type of business; and A chart or list clearly identifying the relationships between the independent review organization and any affiliates; and A list of any currently outstanding loans or contracts to provide services between the independent review organization and any affiliates. The medical expert, or independent review organization on behalf of the expert reviewer, shall provide to the Commissioner the following: The name and biographical information for the medical expert or expert reviewer, and a description of any relationship, either direct or indirect, the medical expert or expert reviewer has which represents ownership of or income from any of the following entities: A health maintenance organization; An insurer; A private review agent; A nonprofit health organization; A carrier dental plan organization; A health care provider or health care provider group; or Any group activity on behalf of any of the entities described by §C(1)(a)—(f) of this regulation; A list of any currently outstanding loans or contracts to provide services between the medical expert or expert reviewer and any entity listed in §B(1) of this regulation; The names of all affiliates of the medical expert or expert reviewer and the nature and extent of any ownership or control, including: The affiliate's type of business; and A chart or list clearly identifying the relationships between the medical expert or expert reviewer and any of the affiliates; and A list of any currently outstanding loans or contracts to provide services between the medical expert or expert reviewer and any affiliates. An expert reviewer assigned by an independent review organization or a medical expert selected by the Commissioner may not have a material professional, familial, or financial conflict of interest with any of the following: The carrier that is the subject of the complaint; Any officer, director, or management employee of the carrier that is the subject of the complaint; The member that is subject to the adverse decision; The health care provider, the health care provider's medical group, or the independent practice association that rendered or is proposing to render the health care service that is under review; The health care facility at which the health care service was provided or will be provided; or The developer or manufacturer of the principal drug, device, procedure, or other therapy that is being proposed for the member. The independent review organization or medical expert shall report any material changes in the information submitted to the Commissioner not later than the 30th day before the date on which the change takes effect. Concurrently with the assignment of a complaint to an independent review organization or a medical expert, the Commissioner shall notify the member, member’s representative, or health care provider acting on behalf of the member, and the carrier of the assignment. If the complaint is assigned to an independent review organization, the independent review organization shall screen its expert reviewer for potential material conflicts of interest. The Commissioner shall have the discretion to determine whether a material conflict of interest exists for the expert reviewer of an independent review organization or the medical experts subject to this regulation and as provided by Insurance Article, §15-10A-05, Annotated Code of Maryland. An expert reviewer or medical expert shall: Be an expert in the treatment of the member's specific medical condition; Be knowledgeable about the recommended health care service or treatment through actual clinical experience as determined by the Commissioner based on the period of time: Actually treating patients with the same or similar specific medical condition, and That has elapsed between the clinical experience and the present; Hold: A nonrestricted license as a physician or other appropriate health care provider in a state of the United States; and For physicians, a current certification by a recognized American Medical Specialty Board in the area appropriate to the subject of review; Be licensed in the same health care occupation as the health care provider who considers the health care service that is the subject of the carrier's adverse decision to be medically necessary, appropriate, or efficient; and Have no history of disciplinary investigations, actions, or sanctions, including loss of staff privileges or participation restrictions that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body, that raises a substantial question as to the expert reviewer's or medical expert's physical, mental or professional competence or moral character as determined by the Commissioner. To allow the Commissioner to determine whether an expert reviewer assigned by the independent review organization or a medical expert has a history of disciplinary investigations, actions, or sanctions that raises a substantial question as to the expert reviewer's or medical expert's physical, mental, or professional competence or moral character, the independent review organization or medical expert shall disclose to the Commissioner any: Pending investigation or action against the expert reviewer or medical expert relating to health care of which the expert reviewer or medical expert has notice, and the nature of the action; Civil or criminal investigation or action against the expert reviewer or medical expert relating to health care, and the nature of the action; and Investigation, conviction, or plea of guilty or nolo contendere with respect to a crime of moral turpitude against the expert reviewer or medical expert, regardless of whether any appeal or other proceeding is pending to have the conviction or plea set aside. The information relevant to the consideration by the Commissioner of whether the expert reviewer or medical expert meets the requirements of this regulation will be handled in accordance with State Government Article, §10-618, Annotated Code of Maryland. In conducting a review of an adverse decision, each independent review organization or medical expert shall, after reviewing all relevant medical and contractual information, advise the Commissioner in writing on whether the service was medically necessary. The advice to the Commissioner shall state in writing the specific factual bases for the decision of the expert reviewer or the medical expert and reference the specific criteria and standards, including interpretive guidelines, on which the expert reviewer's or the medical expert's decision was based. The Commissioner shall preserve the confidentiality of commercial information and a member's medical records and personal records in accordance with: State Government Article, §10-611 et seq., Annotated Code of Maryland; Health-General Article, §4-301, Annotated Code of Maryland; and Any pertinent federal laws. The carrier that is the subject of the complaint is responsible for paying the reasonable expenses for the complaint under review by the independent review organization or medical expert selected by the Commissioner. The independent review organization or medical expert for each complaint under review shall: Present to the carrier: An invoice detailing the expenses incurred by the independent review organization or medical expert related to the complaint under review, and Any other information required in the event that the contract between the independent review organization or the medical expert and the Commissioner requires a flat fee; and Provide a copy of the invoice for each complaint under review to the Commissioner. Payment by Carrier. A carrier shall pay the reasonable expenses of an independent review organization or medical expert related to the complaint under review directly within 30 days of receipt of an invoice. Failure by a carrier to pay an invoice from an independent review organization or medical expert for the complaint under review within 30 days of receipt shall result in the issuance of an order for payment by the Commissioner. Failure by a carrier to pay in accordance with the order for payment issued by the Commissioner shall constitute a violation of the Insurance Article and the Health-General Article, Annotated Code of Maryland, subject to penalty pursuant to Health-General Article, §19-730, Annotated Code of Maryland, and Insurance Article, §27-305, Annotated Code of Maryland. The carrier that is the subject of the complaint may not pay and an independent review organization or medical expert may not accept any compensation for the complaint under review in addition to the payment for reasonable expenses under §A of this regulation. Except for an emergency case as provided in COMAR 31.10.18.05 or as provided in §B of this regulation, the Commissioner shall make a final written decision on a complaint within 45 days after a complaint is filed. The Commissioner may extend the period within which a final written decision is to be made under §A of this regulation for up to an additional 30 working days if the: Commissioner has not yet received the information requested by the Commissioner; and Information requested is necessary for the Commissioner to render a final written decision on the complaint. Insurance Article, §§2-109, 15-10A-05, and 15-10A-09, Annotated Code of Maryland; Effective date: Regulations .01—.07 adopted as an emergency provision effective January 1, 1999 (25:26 Md. R. 1917); adopted permanently effective February 22, 1999 (26:4 Md. R. 274) Regulation .01B amended effective April 16, 2012 (39:7 Md. R. 496) Regulation .02 amended effective April 16, 2012 (39:7 Md. R. 496) Regulation .04A, D amended effective April 16, 2012 (39:7 Md. R. 496) Regulation .06C amended effective April 16, 2012 (39:7 Md. R. 496) Regulation .07 amended effective April 16, 2012 (39:7 Md. R. 496) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administration” means the Maryland Insurance Administration. “Board” means the State Board of Physician Quality Assurance established under Health Occupations Article, Title 14, Annotated Code of Maryland. “Certificate” means a certificate, issued by the Commissioner under this chapter, to act as a medical director. “Commissioner” means the State Insurance Commissioner. “Contact information” means an individual’s name, job title and department, address, telephone number, facsimile number, and email address. “Department” means the Maryland Department of Health. “Governing authority” means the person or persons designated in the bylaws with the responsibility for operating the health maintenance organization. “Health maintenance organization” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland. Medical Director. “Medical director” means a physician employed by or under contract with a health maintenance organization who is responsible for: The establishment or maintenance of the policies and procedures at the health maintenance organization for quality assurance and utilization management; Compliance with the quality assurance and utilization management policies and procedures of the health maintenance organization; and Oversight of utilization review decisions of private review agents employed by or under contract with the health maintenance organization. “Medical director” includes an associate medical director or an assistant medical director who has been delegated any of the functions of a medical director. “Quality assurance” means a formal set of activities to review the quality of medical services provided to those persons covered by the health maintenance organization including implementation of corrective actions to address any deficiencies identified in the care and services provided to those persons covered by the health maintenance organization. “Utilization management” means the process of evaluating and determining the appropriateness of the utilization of covered medical services, including prior authorization, concurrent review, retrospective review, discharge planning, and case management. Not later than the date of hire, a medical director seeking temporary certification shall submit to the Commissioner an application for certification on a form specified by the Commissioner. The medical director shall attach the following additional information to the application: A description of the applicant's professional qualifications, including medical education, medical training and experience, clinical experience, history of malpractice claims; and licensures; Evidence of one of the following: An advanced health-related degree; Current board certification from either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA); or A minimum of 5 years clinical experience; Evidence of licensure status; Disclosure of any disciplinary action or sanction taken by any hospital, professional board, or regulating entity; The name, address, phone number, and facsimile number of the health maintenance organization, and the name of the governing authority of the health maintenance organization that the applicant is employed by or contracted with as a medical director; and The date of hire or expected date of hire. A certificate issued under this regulation is effective for 90 days from the date of the applicant's employment as a medical director with the health maintenance organization. Extension of Temporary Certificate. Unless the Commissioner extends for good cause under §D(2) of this regulation, a certificate issued under this regulation may not be renewed. At the Commissioner's discretion, the Commissioner may extend for good cause for a 30-day period a temporary certificate issued under this regulation. A medical director shall hold a certificate from the Commissioner that authorizes the applicant to act as the medical director of a health maintenance organization. To qualify for a certificate to act as a medical director of a health maintenance organization, the applicant: Shall be a physician licensed to practice medicine in Maryland; Shall have one of the following: An advanced health-related degree; Current board certification from either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA); or A minimum of 5 years clinical experience; May not receive any direct or indirect financial compensation that: Violates Health-General Article, §19-705.1, Annotated Code of Maryland; or Deters the delivery of medically appropriate care to an enrollee; and Shall be of good character and trustworthy. An applicant for a certificate to act as a medical director of a health maintenance organization does not qualify if there is a history of disciplinary action or sanction taken by any hospital, professional board, or regulating entity that raises a substantial question as to the applicant's physical, mental, or professional competence. An applicant seeking certification as a medical director shall submit to the Commissioner an application for certification on a form specified by the Commissioner. A medical director shall submit to the Commissioner the contact information of one person who will be available to respond to inquiries from the Maryland Insurance Administration. If the contact information for the designated person changes, the medical director shall: Notify the Commissioner in writing within 30 days; and Provide new contact information. The medical director shall attach the following additional information to the application: A description of the applicant's professional qualifications, including medical education, medical training and experience, history of malpractice claims, and licensures; Evidence of education; Evidence of internship or residency training; Evidence of board certification from either ABMS or AOA, as appropriate; Evidence of licensure status; Disclosure of any disciplinary action or sanction taken by any hospital, professional board, or regulating entity; Verification of status through the federal national practitioner data bank; Disclosure of all methods of compensation to the applicant by the health maintenance organization; Unless already on file with the Commissioner, the utilization management procedures and policies to be used by the health maintenance organization; Certification by the medical director that the utilization management procedures and policies are: Objective; Clinically valid; Compatible with established principles of health care; and Flexible enough to allow deviations from the norms when justified on a case by case basis; A list of all staff who conduct utilization management; and Payment to the Commissioner of the nonrefundable application fee of $100. The delegation by a medical director of any of the medical director's responsibilities under this chapter to an associate medical director or an assistant medical director does not prevent the medical director, regardless of the delegation, from being held responsible for any violation of this chapter. The Commissioner shall deny a certificate to an applicant if the Commissioner finds that the initial application does not meet the requirements of this chapter. The Commissioner may revoke the certification of a medical director: Who violates any provision of this chapter; Who fails to meet the requirements for certification under Regulation .04B of this chapter; Who obtains certification based on inaccurate information; Who fraudulently or deceptively obtains, attempts to obtain, or uses a certificate; or If the Commissioner finds a pattern that the utilization management procedures and policies used by the medical director in making utilization review decisions or used by a private review agent employed by or under contract with the health maintenance organization over whose utilization review decisions the medical director has responsibility are not: Objective; Clinically valid; Compatible with established principles of health care; or Flexible enough to allow deviations from the norms when justified on a case by case basis. Before denying an initial application for certification or revoking an issued certificate, the Commissioner shall provide the applicant or certificate holder with: Reasonable time to supply additional information which demonstrates compliance with the requirements of this chapter and the opportunity to request a hearing; Written notice of the reasons for the denial or revocation; and 30 days in which to request a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. A certificate: Is not transferable; and Expires on the second anniversary of its effective date unless certification has been renewed for another 2-year term. Before certification expires, a medical director may renew certification if the certified medical director: Otherwise is entitled to be certified; Pays to the Commissioner the nonrefundable renewal fee of $100; and Submits to the Commissioner: A renewal application on a form that the Commissioner requires; and An update of the information required under Regulation .04B of this chapter. The Commissioner shall annually provide to the Board a list of certified individuals authorized by the Commissioner to act as a medical director. The Commissioner shall notify the Board of the revocation of a certificate issued under this chapter. Insurance Article, §§2-109 and 15-10C-02, Annotated Code of Maryland Effective date: Regulations .01—.07 adopted as an emergency provision effective January 1, 1999 (26:1 Md. R. 18); adopted permanently effective March 22, 1999 (26:6 Md. R. 490) Chapter revised effective May 9, 2016 (43:9 Md. R. 532) Regulation .01B amended effective August 27, 2018 (45:17 Md. R. 804) Regulation .03 amended effective August 27, 2018 (45:17 Md. R. 804) In this chapter, the following terms have the meanings indicated. Terms Defined. “Accrediting organization” means an entity that accredits or certifies the utilization management activities of a private review agent. “Administration” means the Maryland Insurance Administration. Adverse Decision. “Adverse decision” means a utilization review determination made by a private review agent that a proposed or delivered health care service that is otherwise covered under the patient's contract: Is or was not medically necessary, appropriate, or efficient; and May result in noncoverage of the health care service. “Adverse decision” does not include a decision concerning a subscriber's status as a member. “Approved accrediting organization” means an accrediting organization that has been approved by the Commissioner as having accreditation standards that meet or exceed standards in this chapter. “Carrier” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. “Certificate” means a certificate of registration granted by the Commissioner to a private review agent. “Commissioner” means the State Insurance Commissioner. “Contact information” means an individual’s name, job title and department, address, telephone number, facsimile number, and email address. “Emergency case” means a case involving an adverse decision for which an expedited review is required under COMAR 31.10.18.05. Employee Assistance Program. “Employee assistance program” means a health care service plan that, in accordance with a contract with an employer or labor union: Consults with employees or members of an employee's family or both to identify the employee's or the employee's family member's mental health, alcohol, or substance abuse problems, and refers the employee or the employee's family member to health care providers or other community resources for counseling, therapy, or treatment; and Performs utilization review for the purpose of making claims or payment decisions on behalf of the employer's or labor union's health insurance or health benefit plan. “Employee assistance program” does not include a health care service plan operated by a hospital solely for employees, or members of an employee's family, of that hospital. Grievance. “Grievance” means a protest filed by a patient or health care provider on behalf of a patient with a private review agent through the private review agent's internal grievance process regarding an adverse decision concerning a patient. “Grievance” does not include a verbal request for reconsideration of a utilization review determination. “Grievance decision” means a final determination by a private review agent that arises from a grievance filed with the private review agent under its internal grievance process regarding an adverse decision concerning a patient. “Health care facility” means: A hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland; A related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland; An ambulatory surgical facility or center which is any entity or part of an entity that operates primarily for the purpose of providing surgical services to patients not requiring hospitalization and seeks reimbursement from third-party payors as an ambulatory surgical facility or center; A facility that is organized primarily to help in the rehabilitation of disabled individuals; A home health agency as defined in Health-General Article, §19-401, Annotated Code of Maryland; A hospice as defined in Health-General Article, §19-901, Annotated Code of Maryland; A facility that provides radiological or other diagnostic imagery services; A medical laboratory as defined in Health-General Article, §17-201, Annotated Code of Maryland; or An alcohol abuse and drug abuse treatment program as defined in Health-General Article, §8-403, Annotated Code of Maryland. “Health care provider” means: An individual who is: Licensed or otherwise authorized to provide health care services in the ordinary course of business or practice of a profession, and A treating provider of the patient; or A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland. “Health care service” means a health or medical care procedure or service rendered by a health care provider licensed or authorized to provide health care services that: Provides testing, diagnosis, or treatment of a human disease or dysfunction; Dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction; or Provides any other care, service, or treatment of disease or injury, the correction of defects, or the maintenance of the physical and mental well-being of human beings. “Private review agent” means: A non-hospital-affiliated person or entity performing utilization review that is either affiliated with, under contract with, or acting on behalf of a Maryland business entity, or a third party that pays for, provides, or administers health care services to citizens of this State; or A person or entity including a hospital-affiliated person performing utilization review for the purpose of making claims or payment decisions for health care services on behalf of the employer's or labor union's health insurance plan under an employee assistance program for employees other than the employees: Employed by the hospital; or Employed by a business wholly owned by the hospital. “Reconsideration” means a verbal request or verbal inquiry by a patient, the patient's representative, or a provider regarding an adverse decision. “Significant beneficial interest” means the ownership of any financial interest that is greater than the lesser of: 5 percent of the whole; or $5,000. “Specific criteria and standards” means professionally developed objective measures used during utilization review to make determinations to authorize or certify the appropriate use and efficient allocation of health care resources. “Uniform treatment plan form” means a form specified by the Commissioner to be used for utilization review of services for the treatment of a mental illness, emotional disorder, or a substance abuse disorder. “Utilization review” means a system for reviewing the appropriate and efficient allocation of health care resources and services given or proposed to be given to a patient or group of patients. “Utilization review plan” means a description of the standards governing utilization review activities performed by a private review agent. A private review agent shall hold a certificate from the Commissioner to conduct utilization review in this State. A private review agent shall submit to the Commissioner the contact information of one person who will be available to respond to inquiries from the Maryland Insurance Administration. If the contact information for the designated person changes, the private review agent shall: Notify the Commissioner in writing within 30 days; and Provide new contact information. A private review agent seeking certification shall submit to the Commissioner an application for certification on a form specified by the Commissioner so that the Commissioner can determine whether the private review agent meets the requirements of this regulation. The private review agent shall attach the following additional information to the application: A utilization review plan which includes the following: Types of reviews performed and a written protocol describing each type of review, including: Preauthorization; Preadmission; Admission; Emergency admission; Second surgical opinion; Discharge planning; Concurrent; or Retrospective; Copies of specific criteria and standards to be used in conducting utilization reviews of proposed or delivered health care services, including: A list of the interpretive guidelines used by the private review agent that identifies the title, author, publisher, and edition of the guidelines; and Copies of interpretive guidelines for which there are no applicable copyright laws; Forms that are completed during the review; Specified time frames in which the private review agent makes determinations to authorize or certify services; A written protocol describing the following: The grievance procedure by which a patient, a patient's representative, or a patient's health care provider may file a grievance with a private review agent; The grievance procedure for receipt of an emergency case, including the initial acceptance of a verbal grievance by a patient, a patient's representative, or a patient's health care provider; and Any procedures for handling a verbal request for reconsideration of a utilization review determination; Forms to be completed by a private review agent, a patient, or a patient's representative, including a health care provider, during the grievance procedure; Specified time frames in which a private review agent shall make a final grievance decision in writing; Qualifications of the personnel making the final grievance determinations; and The circumstances, if any, under which utilization review may be delegated to a hospital utilization review program and, if applicable, a list of the carriers for whom the private review agent: Is performing utilization review; and Has been delegated the internal grievance process pursuant to Insurance Article, Title 15, Subtitle 10A, Annotated Code of Maryland; Type and qualifications of the personnel either employed or under contract to perform utilization review which includes: Registered nurses; Medical records technicians or similar personnel supported and supervised by physicians as may be required; Physicians; or Other appropriate health care providers; Policies and procedures to ensure that a representative of a private review agent is reasonably accessible to patients and providers 7 days a week, 24 hours a day in this State; Policies and procedures to ensure that all applicable State and federal laws protecting the confidentiality of individual medical records are followed; A copy of materials designed to inform patients and providers of requirements of the utilization review plan; A list of third-party payors for which a private review agent is performing utilization review in this State; Policies and procedures to ensure that a private review agent has a formal program for the effective orientation and training of the personnel either employed or under contract to perform utilization review; An outline of the training program which includes content and schedule of presentation; Qualifications of health care providers involved in establishing the specific criteria and standards to be used in conducting utilization review if nationally recognized criteria are not used; Certification by a private review agent that the criteria and standards to be used in conducting utilization review are: Objective; Clinically valid; Compatible with established principles of health care; and Flexible enough to allow deviations from norms when justified on a case-by-case basis; and A nonrefundable application fee of $1,500. Scope. This regulation does not apply to a person that uses a treatment plan form solely for internal purposes, unless the private review agent requires the information to authorize treatment. Form Required. If a private review agent requires a health care provider to submit a treatment plan or telephonically provide the information requested on the uniform treatment plan, to enable the private review agent to conduct utilization review of services for the treatment of a mental illness, emotional disorder, or a substance abuse disorder, the private review agent shall use the uniform treatment plan form set forth in §H of this regulation. Acceptance of Form by Private Review Agent. A private review agent shall accept the uniform treatment plan form as a properly submitted treatment plan form and may not require a health care provider to: Modify the uniform treatment plan form or its content except as provided in this regulation; or Submit additional treatment plan forms. Instructions. A private review agent may provide a set of instructions for use by the health care provider regarding the private review agent's specific managed care requirements. Modification of Form Prohibited. A private review agent may not modify the uniform treatment plan form in any manner. Use of Form by Health Care Provider. A health care provider shall use and properly complete the uniform treatment plan form as provided in this regulation. Submission of Form by Electronic Transfer. The uniform treatment plan form may be submitted by electronic transfer. The uniform treatment plan form required by this regulation shall read as follows: Telephonic Review. If a private review agent conducts utilization review of services for the treatment of a mental illness, emotional disorder, or a substance abuse disorder telephonically, the private review agent may not require the health care provider to provide any information that is not requested on the uniform treatment plan form. Required Copies. Upon the written request of a person or health care facility, a private review agent shall provide one copy of the specific criteria and standards to be used in conducting utilization review of proposed or delivered services and any subsequent revisions or modifications to the specific criteria and standards. Fee for Copy. A private review agent shall: Make available a copy of specific criteria and standards used in conducting utilization review of proposed or delivered services for inspection on the premises during normal business hours; Provide a copy of the specific criteria and standards to a person or health care facility upon request at a reasonable fee determined by the private review agent; and Provide a copy of the specific criteria and standards upon request to a State agency at no charge to the agency. Nonemergency Treatment. A private review agent shall make all initial determinations on whether to authorize or certify a nonemergency course of treatment for a patient within the time period specified in Insurance Article, §15-10B-06, Annotated Code of Maryland. Extended Stays or Additional Health Care Services. A private review agent shall make all determinations on whether to authorize or certify an extended stay in a health care facility or additional health care services within the time period specified in Insurance Article, §15-10B-06, Annotated Code of Maryland. Except as provided in §B of this regulation, this regulation does not apply to: A private review agent referring an individual to a health care provider or facility that participates in a health maintenance organization; A preferred provider organization network of participating health care providers or facilities to which the individual would otherwise be referred as part of the individual's membership or insurance contract; or An employee assistance program referring an individual to a network of participating health care providers or facilities in accordance with a contract with the individual's employer or labor union to provide comprehensive mental health and substance abuse services. A private review agent or other individual who is affiliated with, under contract with, or acting on behalf of a private review agent, may not approve or fail to approve treatment based on whether the treatment is delivered by a provider who is a participating or nonparticipating provider in the preferred provider organization or an employee assistance program network. Prohibited Referrals. A private review agent or individual who is affiliated with, under contract with, or acting on behalf of a private review agent may not: Refer a patient who has undergone utilization review by that private review agent to: A health care facility in which the private review agent owns a significant beneficial interest; or A health care practice owned by the private review agent; Pay, agree to pay, accept, or agree to accept a sum for bringing or referring a patient to a private review agent; or Provide for different insurance coverage or benefits based on the patient receiving service from a health care facility or provider in which a private review agent owns a significant beneficial interest. Authorized Referrals. A private review agent, or individual who is affiliated with, under contract with, or acting on behalf of a private review agent, may refer a patient to another health care provider if: The patient or health care provider requests the private review agent to provide the patient with the name of a health care provider appropriate to meet the health care needs of the patient; or The patient has no attending physician. If §D(1) of this regulation is satisfied the private review agent shall provide the patient with names of at least two health care providers appropriate to meet the health care needs of the patient. The Commissioner shall deny a certificate to an applicant if the Administration finds that the initial application does not include all requirements of Regulation .02 of this chapter. The Commissioner may revoke the certification of a private review agent: That violates any provision of this chapter; That fraudulently or deceptively obtains, attempts to obtain, or uses a certificate; That fails to meet the requirements for certification under Regulation .02B of this chapter; That obtains certification based on inaccurate information; or If the Commissioner finds a pattern that the utilization management procedures and policies used by a private review agent are not: Objective, Clinically valid, Compatible with established principles of health care, or Flexible enough to allow deviations from the norms when justified on a case by case basis. Before denying an initial application for certification or revoking an issued certificate, the Commissioner shall provide the applicant or certificate holder with: Reasonable time to supply additional information which demonstrates compliance with the requirements of this chapter and the opportunity to request a hearing; Written notice of the reasons for the denial or revocation; and 30 days in which to request a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. A certificate of registration: Is not transferable; and Expires on the second anniversary of its effective date unless certification has been renewed for another 2-year term. Before certification expires, a private review agent may renew its certification if the certified private review agent: Otherwise is entitled to be certified; Pays to the Commissioner the nonrefundable renewal fee of $1,500; and Submits to the Commissioner: A renewal application on a form that the Commissioner requires, and An update of the information required under Regulation .02B of this chapter. The Commissioner shall renew the certification of each certified private review agent if the requirements of this chapter are met. Criminal Penalty. A person who violates a provision of this chapter shall be guilty of a misdemeanor, and on conviction is subject to a penalty not exceeding $1,000. Each day a violation is continued after the first conviction is a separate offense. Administrative Penalty. In addition to, or instead of, the criminal penalty described in §A of this regulation, the Commissioner may impose an administrative penalty not to exceed $5,000 for violation of any regulation of this chapter. When considering whether conditions warrant the imposition of an administrative penalty, the Commissioner shall consider the following factors: The nature and seriousness of each condition of noncompliance; The number of conditions of noncompliance; The extent to which a condition of noncompliance is part of an ongoing pattern; The efforts made by, and the ability of the private review agent to correct, the condition of noncompliance in a timely manner; and Other factors as justice may require. The Commissioner may impose an administrative penalty for any one of the factors in §C of this regulation. A private review agent subject to an administrative penalty, or to denial or revocation of certification, has the right to a hearing and the right to appeal from an action of the Commissioner in accordance with Insurance Article, §§2-210—2-215, Annotated Code of Maryland. The Commissioner may waive the requirements of this chapter for a private review agent that operates solely under contract with the federal government for utilization review of patients eligible for hospital services under Title XVIII of the Social Security Act. Determination of Approved Accrediting Organization. An accrediting organization is not an approved accrediting organization until the Commissioner issues a letter of approval to the accrediting organization. For the purpose of determining which entities are approved accrediting organizations, the Commissioner shall consider whether: Some or all of the accreditation standards required to be met for accreditation by the accrediting organization meet or exceed the requirements of Insurance Article, Title 15, Subtitles 10A and 10B, Annotated Code of Maryland; The accrediting organization measures an applicant's ability to meet each standard; and The accrediting organization agrees to notify the Commissioner at least 30 days in advance if it revises its accreditation standards or changes the method in which it reviews private review agents. The approved accrediting organization continues to be approved by the Commissioner until notified in writing by the Commissioner that its approval has been withdrawn. Demonstration by Applicant of Meeting Filing Requirement through Accreditation. An applicant for a private review agent certification may request an exemption from a particular filing requirement of this chapter if the applicant: Is accredited by an approved accrediting organization; and Submits the following information to the Commissioner for approval: A list of the filing items for which the private review agent applicant is requesting exemption; The letter of accreditation from an approved accrediting organization; The standards by which the private review agent applicant was measured by the approved accrediting organization; and Evidence that the private review agent applicant met or exceeded each accreditation standard for which the private review agent applicant is requesting a filing exemption. In addition to the information specified in §B(1) of this regulation, the Commissioner may request additional information before granting the filing exemption provided by this regulation. Insurance Article, §§2-109(a)(1), 15-10B-03(h), and 15-802(d)(5), Annotated Code of Maryland Effective date: June 6, 1994 (21:11 Md. R. 951) Chapter revised and recodified from COMAR 10.07.19 to COMAR 31.10.21 as an emergency provision effective January 1, 1999 (26:2 Md. R. 104); amended and recodified permanently effective March 22, 1999 (26:6 Md. R. 491) Regulation .02-1 adopted effective August 21, 2000 (27:16 Md. R. 1526) Chapter revised effective April 12, 2004 (31:7 Md. R. 587) Regulation .01B amended effective August 27, 2018 (45:17 Md. R. 804) Regulation .02 amended effective August 27, 2018 (45:17 Md. R. 804) Regulation .02-1 repealed and new Regulation .02-1 adopted effective January 30, 2006 (33:2 Md. R. 83) Regulation .02-1 amended effective May 17, 2010 (37:10 Md. R. 724) Regulation .02-1H amended as an emergency provision effective January 1, 2013 (40:6 Md. R. 470); amended permanently effective April 15, 2013 (40:7 Md. R. 613) Regulation .02-1H amended effective May 11, 2015 (42:9 Md. R. 648); February 24, 2020 (47:4 Md. R. 264) Regulation .03 amended effective August 15, 2016 (43:16 Md. R. 902) The scope of this chapter is the scope of Health-General Article, Title 19, Subtitle 7A, Annotated Code of Maryland, as it relates to the Insurance Commissioner. In this chapter, the following terms have the meanings indicated. Terms Defined. “Commissioner” means the Maryland Insurance Commissioner. “Contract” means the contractual agreement for the provision of health care services on a prepaid, capitated basis entered into between a provider-sponsored organization and the Health Care Finance Administration to provide health care benefits to medicare program beneficiaries. “Enrollee” means an individual who is enrolled in a provider-sponsored organization. Health Care Delivery Assets. “Health care delivery assets” means any tangible asset that is part of a provider-sponsored organization operation. “Health care delivery assets” includes: Hospitals, medical facilities, and their ancillary equipment; and Property as may reasonably be required for a provider-sponsored organization's principal office or for such purposes as may be necessary in the transaction of the business of a provider-sponsored organization. “Health Care Finance Administration” means the Health Care Finance Administration of the federal Department of Health and Human Services. “Health care services” means a health or medical procedure or service rendered by a health care provider that: Provides testing, diagnosis, or treatment of a human disease or dysfunction; or Dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction. “Insolvent” means the condition of having been: Declared as not meeting the fiscal requirements for continued licensing; or Placed under an order of liquidation by a court of competent jurisdiction. “Leasehold estate improvements” means improvements made to property that is leased by a provider-sponsored organization and used by it to provide health care services directly. “Net worth” means the excess of total admitted assets over liabilities, but the liabilities may not include fully subordinated debt. “Provider” means a physician, hospital, or other person licensed or otherwise authorized to provide health care services. “Provider-sponsored organization” has the meaning stated in Health-General Article, §19-7A-01(f), Annotated Code of Maryland. “Subordinated debt” means a surplus account item derived from the subordination of provider-sponsored organization debts to owners, medical providers, or other creditors. Before a person may operate as a provider-sponsored organization under the federal Medicare+Choice Program, the person shall obtain a certificate of authority from the Commissioner. Submission of Application. An applicant shall submit an application for a certificate of authority to the Commissioner at least 90 days before the date that the applicant proposes to engage in business in the State. Provision of Application Form. The Commissioner shall provide an application form to an applicant on request. Filing of Information. Each applicant seeking a certificate of authority to transact business in the State shall file the following items with the Commissioner: If incorporated, a copy of the articles of incorporation of the applicant and any amendments to the articles of incorporation, certified by the Department of Assessments and Taxation; A copy of the applicant's current bylaws, certified by the appropriate officer of the applicant; A list of the names, addresses, and official capacity with the applicant of the individuals who are to be responsible for conducting the applicant's affairs, including all members of the governing body, the officers and directors in the case of a corporation, and the partners or associates in the case of a partnership or association; A resume of the qualifications of the administrator, the medical director, each officer, and each other individual associated with the applicant or as requested by the Commissioner; A statement generally describing the: Applicant and its structure, Applicant's operations, The location of the facilities at which health care services will be regularly available to members, and The type, specialty, and number of physicians and health care personnel engaged or contracted with to provide health care services; A statement describing with reasonable certainty the geographic area to be served by the applicant; A certified statement of the financial condition of the applicant, including: Sources of financial support, Assets and liabilities and minimum net worth, and Other financial information the Commissioner requires for adequate financial evaluation; Copies of proposed techniques and methods of marketing the services of the applicant; A power of attorney duly executed by the applicant appointing the Commissioner and the Commissioner's duly authorized deputies as the true and lawful attorney of the applicant in and for the State on whom may be served all lawful process in any action, proceeding, or cause of action arising in the State against the applicant; A certificate of compliance evidencing employee coverage under the Maryland Workers' Compensation Act (Labor and Employment Article, Title 9, Annotated Code of Maryland); and A prospective budget and expected cash flow analysis for the first 12 months of the applicant's anticipated operation, demonstrating its financial viability based on reasonable assumptions. Disclosure. Each individual who is responsible for the conduct of the affairs of an applicant shall disclose to the Commissioner and the governing body of the applicant the extent and nature of any contracts or arrangements between the individual and the applicant, including any possible conflicts of interest. Insurance—General Liability and Medical Malpractice. An applicant may not obtain a certificate of authority until the applicant: Submits to the Commissioner evidence of general liability and medical malpractice insurance or a plan of self-insurance to cover general liability and medical malpractice; and Obtains approval of its insurance or plan of self-insurance from the Commissioner with respect to the amount of coverage and type of coverage. With each annual report, a provider-sponsored organization shall submit to the Commissioner evidence of renewal of insurance or continuation of self-insurance. Advertising. Before using any advertising that has been approved by the Health Care Financing Administration, a provider-sponsored organization shall file a copy of the advertising with the Commissioner. Initial Net Worth. An applicant may not obtain a certificate of authority unless the applicant has an initial net worth of at least: $1,500,000; or $1,000,000, based on evidence from the applicant's financial plan, as required by 42 CFR §422.384, demonstrating to the Commissioner's satisfaction that the applicant has available to it an administrative infrastructure that the Commissioner considers appropriate to reduce, control, or eliminate start-up administrative costs. Minimum Net Worth. After issuance of a certificate of authority, a provider-sponsored organization shall maintain at least the minimum net worth required under this section. Except as provided in §C of this regulation, each provider-sponsored organization shall maintain a minimum net worth equal to the greater of: $1,000,000; 2 percent of annual premium revenues as reported on the most recent annual financial statement filed with the Commissioner on the first $150,000,000 of premium and 1 percent of annual premium revenues on the premium in excess of $150,000,000; An amount equal to the sum of 3 months uncovered health care expenditures as reported on the most recent financial statement filed with the Commissioner; or Using the most recent annual financial statement filed with the Commissioner, an amount equal to the sum of: 8 percent of annual health care expenditures paid on a non-capitated basis to non-affiliated providers, 4 percent of annual health care expenditures paid on a capitated basis to non-affiliated providers plus annual health care expenditures paid on a non-capitated basis to affiliated providers, and Annual health care expenditures that are paid on a capitated basis to affiliated providers that are not included in the calculation of the net worth requirement under §§A and B(2)(d)(i) and (ii) of this regulation. Determining Net Worth. In determining net worth: A debt may not be considered fully subordinated unless the subordination clause is in a form acceptable to the Commissioner; Any interest obligation relating to the repayment of a subordinated debt shall be similarly subordinated; The interest expense relating to the repayment of any fully subordinated debt shall be considered covered expenses; and Any debt incurred by a note meeting the requirements of this section, and otherwise acceptable to the Commissioner, is not considered a liability and shall be recorded as equity. Composition of Assets. To meet the minimum net worth requirements, a provider-sponsored organization shall have the following composition of assets: At the time of application, at least $750,000 of the minimum net worth shall be in cash or cash equivalents; After the effective date of the Medicare+Choice contract, the greater of $750,000 or 40 percent of the minimum net worth amount shall be in cash or cash equivalents; During the licensing process, up to 10 percent of the minimum net worth amount may be comprised of intangible assets except that, if a provider-sponsored organization keeps $1,000,000 in cash or cash equivalents and does not use the administrative reduction, then up to 20 percent of that provider-sponsored organization's minimum net worth may be comprised of intangible assets; After the licensing process, a provider-sponsored organization shall keep the greater of $1,000,000 or 67 percent of the ongoing minimum net worth in cash or cash equivalents to qualify for the 20 percent level on intangibles; Subject to §D(1)—(4) of this regulation, health care delivery assets may be admitted at 100 percent of their value according to generally accepted accounting principles (GAAP); and Subject to §D(1)—(5) of this regulation, other assets may be admitted according to their value under statutory accounting practices (SAP). Additional Assets. In any determination of the financial condition of an applicant or provider-sponsored organization, in addition to the assets under Regulation .05 of this chapter, the following assets are allowed: Cash in the possession of the applicant or provider-sponsored organization or in transit under its control, and the balance of any deposit of the applicant or provider-sponsored organization in a solvent bank or trust company; Investments and securities owned and held by the applicant or provider-sponsored organization, free and clear of any liens, encumbrances, pledges, or judgements, and the income due or accrued on the investments and securities; Member premium charges in the course of collection, not more than 90 days past due (the foregoing limitation does not apply to amounts payable directly by the federal government under the Medicare+Choice contract); Health care delivery assets in accordance with Regulation .05C of this chapter; Prepaid charges on contracts with other organizations or hospitals, or other persons as approved by the Commissioner; Pharmaceutical and medical supply inventories; Cost of land and depreciated cost of buildings owned and occupied by the applicant or provider-sponsored organization and used to directly provide health care, in excess of any encumbrances on it; Leasehold estate improvements, if the initial cost is amortized over the useful life of the improvements but not beyond the termination of the lease; Electronic, mechanical, and computer hardware including the operating system software used for data processing and accounting purposes, the cost of which shall be amortized in full over a period not to exceed 5 calendar years; and Other assets, not inconsistent with the foregoing provisions, deemed by the Commissioner available for the provision of health care, at values to be determined by the Commissioner. Non-Admitted Assets. The following may not be allowed as assets in determining the financial condition of an applicant or provider-sponsored organization: Deferred acquisition costs; Subject to the provisions of Regulation .05 of this chapter, good will, trade names, and other similar intangible assets; Advances to officers, whether secured or not, and advances to employees, agents, and other persons on personal security only; Stock of the applicant or provider-sponsored organization, owned by it, or any equity in it or loans secured by it, or any proportionate interest in the stock through the ownership by the applicant or provider-sponsored organization or an interest in another firm, corporation, or business unit; The amount, if any, by which the aggregate book value of investments as carried in the ledger assets of the applicant or provider-sponsored organization exceeds the aggregate value of the investments as determined by the values approved annually by the Securities Valuation Office of the National Association of Insurance Commissioners; and Furniture and fixtures, leasehold improvements other than leasehold estate improvements which qualify under §A(8) of this regulation, vehicles, and maintenance equipment. Liabilities Chargeable Against Assets. In any determination of the financial condition of an applicant or provider-sponsored organization, liabilities to be charged against its assets shall include: The amount of its capital stock outstanding, if any; The estimated amount necessary to pay for all accrued benefits to enrollees and all claims, both reported or unreported, incurred on or before the date of the statement, together with estimated costs of adjusting or settling disputed claims; The pro rata amount of premium charges paid by or on behalf of enrollees for any period of coverage beyond the date of the statement; and Its other liabilities, including but not limited to taxes, expenses, and other obligations due or accrued at the date of the statement. Earned Charges. Charge Defined. In this section, “charge” means consideration for health services regardless of the name given to the consideration. In this section, “charge” includes an assessment, membership fee, policy fee, survey fee, inspection fee, service fee, or similar fee or charge in consideration for the provider-sponsored organization contract. Earned charges shall include Medicare+Choice contract charges and premium charges, including all determined excess and additional charges, less: Return charges; Charges on canceled contracts; and Unearned charges on contracts in force as shown by the provider-sponsored organization's annual statement. Every provider-sponsored organization shall maintain an unearned charge reserve on all health care contracts in force. This reserve shall be set up as a liability. All prepaid charges shall be considered unearned. Standards for Investments. An applicant or provider-sponsored organization may not make or engage in an investment unless the investment has been authorized or ratified by: The board of directors; or A committee of the board of directors charged with the duty of supervising investments. All investments of the applicant or provider-sponsored organization may be held in a custodial account pursuant to COMAR 31.09.04. Deposit Required. The Commissioner may not issue or renew a certificate of authority for a provider-sponsored organization unless it has deposited and maintains in trust with the State Treasurer, for the protection of its members or its members and creditors, cash or government securities of the type described in Health-General Article, §19-710, Annotated Code of Maryland, in the market value amount of $100,000. Assets. For purposes of determining net worth, the deposit is an admitted asset of the provider-sponsored organization. All income from deposits is an asset of the provider-sponsored organization. Withdrawal of Deposit. A provider-sponsored organization that has made a securities deposit may withdraw that deposit, or any part of the deposit, after making a substitute deposit of cash, securities, or any combination of these, or other measures of equal amount and value. Approval of Commissioner. Securities shall be approved by the Commissioner before being deposited or substituted. Use of Deposit. The deposit shall be used to: Protect the interests of the provider-sponsored organization's enrollees; and Assure continuation of health care services to enrollees of a provider-sponsored organization that is in rehabilitation, conservation, or liquidation. Expiration. Unless previously suspended or revoked, each original and renewal certificate of authority issued to a provider-sponsored organization expires at midnight on the November 30 after its effective date in accordance with Health-General Article, §19-721(a), Annotated Code of Maryland. Renewal. On payment of an annual renewal fee of $25 by the provider-sponsored organization before the expiration date of its certificate of authority, its certificate of authority remains in effect until a new certificate of authority is issued or specifically refused in accordance with Health-General Article, §19-721, Annotated Code of Maryland. Refusal to Renew. The Commissioner may refuse to renew a certificate of authority in accordance with Health-General Article, §19-722, Annotated Code of Maryland. If a provider-sponsored organization violates any provision of Health-General Article, §19-729, Annotated Code of Maryland, the Commissioner may take any action against the provider-sponsored organization that is authorized pursuant to Health-General Article, §19-730, Annotated Code of Maryland. A provider-sponsored organization may not: Use a name that has not been approved by the Commissioner; or Change its name without the prior approval of the Commissioner. Notice of Intent to Terminate. When a provider-sponsored organization desires to cease offering a service under the contract, the provider-sponsored organization shall provide written notice of the intent to terminate to the Commissioner at least 30 days before ceasing to offer the service. Permissible Reasons for Cancellation or Nonrenewal of Enrollment. A provider-sponsored organization may cancel or nonrenew enrollment in the provider-sponsored organization only for the following reasons: Change of the place of residence of the member from the geographical area served by the provider-sponsored organization; Failure of the member to pay any deductible or co-payment charges permitted under a contract; Fraudulent use of the provider-sponsored organization's identification card on the part of the member or the alteration or sale of prescriptions by the member; Failure of the enrollee to pay a premium charge when due; Termination of the contract. Termination of the plan with respect to all individuals in the area in which the enrollee resides; or The enrollee has: Engaged in disruptive behavior as specified in standards under 42 U.S.C. §1395w-21, Lost entitlement to Part A or Part B of Title 42, Chapter 7, Subchapter XVIII of the U.S. Code, or Died. Required. Each licensed provider-sponsored organization shall file with the Commissioner a report, certified by at least two principal officers, showing its financial condition on the last day of the preceding calendar year. Form. The report shall be on the form adopted by the Commissioner. Filing Deadline. Unless the time is extended for good cause, a provider-sponsored organization shall file its annual report with the Commissioner on or before the first day of March of each year. Supplemental Information. The report shall be supplemented with a description of any changes in the information submitted with the last previous annual report or with the provider-sponsored organization's original application for a certificate of authority. Audited Financial Statement. A provider-sponsored organization shall file a certified audited financial statement on or before June 1 of each year. Additional Reports. The Commissioner may require additional reports as are deemed necessary and appropriate to enable the Commissioner to carry out the duties of the Commissioner under the law. Frequency of Examination. The Commissioner may examine the operation of a provider-sponsored organization as often as the Commissioner deems necessary for the protection of the interest of the people of Maryland, but the examinations may not be less frequent than once every 5 years. Cost of Examination. The Commissioner shall assess the provider-sponsored organization being examined for the cost of the examination. The provider-sponsored organization shall remit the cost of the examination to the Commissioner. Effective Date of Contract. A provider-sponsored organization shall inform the Commissioner of the effective date of its contract. Review of Agreements by Commissioner. All signed written agreements, including those defining physicians' services, shall be on file and available for review by the Commissioner at all times in the provider-sponsored organization's central office. Duration of Agreements. All agreements shall have a duration of 12 months. Insurance Coverage Required. Unless the Commissioner grants an exemption from the requirements of this section, a provider-sponsored organization shall secure insurance coverage to provide: Payments or services required to be made or furnished under the health care contract to those enrollees who are injured or become ill outside the geographic limits served by the provider-sponsored organization; and Reinsurance protection to the provider-sponsored organization in the event of catastrophic or unusual losses that would be in excess of the levels of loss that the provider-sponsored organization assumes in the basis of its calculation of premium charges. Term and Renewal of Exemptions. Any exemption to the requirements of §A shall be for a period of 1 year, and may be renewed from year to year after that. The provider-sponsored organization shall make any request for renewal of an exemption at least 90 days before the expiration date of the then-current exemption. Reinsurance. With the approval of the Commissioner, a provider-sponsored organization may reinsure any portion or aspect of its operation. Health-General Article, Title 19, Subtitle 7A, Annotated Code of Maryland Effective date: Regulations .01—.15 adopted as an emergency provision effective June 29, 1999 (26:15 Md. R. 1146); emergency status extended at 27:3 Md. R. 326; emergency status expired April 17, 2000; adopted permanently effective May 15, 2000 (27:9 Md. R. 860) Violations. In addition to the requirement that an insurer, nonprofit health service plan, or health maintenance organization pay interest as required under Insurance Article, §15-1005(f), Annotated Code of Maryland, an insurer, nonprofit health service plan, or health maintenance organization is subject to the penalties set forth in §B of this regulation if the insurer, nonprofit health service plan, or health maintenance organization: Fails to: Pay a claim within 30 days after receipt of a claim for reimbursement from a: Person entitled to reimbursement under Insurance Article, §15-701(a), Annotated Code of Maryland, or Hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland; or Send a notice of receipt and status of the claim in accordance with Insurance Article, §15-1005(c)(2), Annotated Code of Maryland; Requests additional information that is not reasonably necessary to determine if all or part of the claim will be reimbursed, in accordance with Insurance Article, §15-1005(c)(2)(ii), Annotated Code of Maryland; Fails to pay a claim within 30 days after receipt of all reasonable and necessary documentation in accordance with Insurance Article, §15-1005(e)(1), Annotated Code of Maryland; or Fails to pay interest in accordance with Insurance Article, §15-1005(e)(2) or (f), Annotated Code of Maryland. Penalties. The penalties for insurers, nonprofit health service plans, and health maintenance organizations for the commission of an act listed in §A of this regulation are as follows: Up to $500 for a single commission of an act listed in §A of this regulation that is arbitrary or capricious based on all available information; and As provided in Insurance Article, §4-113(d), Annotated Code of Maryland, for commission of an act listed in §A of this regulation with the frequency to indicate a general business practice as defined by regulation by the Commissioner. Health-General Article, §§19-729, and 19-730; Insurance Article, §§4-113 and 15-1005; Annotated Code of Maryland Effective date: Regulation .01 adopted as an emergency provision effective April 12, 1999 (26:10 Md. R. 796); emergency status expired October 1, 1999 Regulation .01 adopted as an emergency provision effective October 1, 1999 (26:23 Md. R. 1776); emergency status expired November 15, 1999; adopted permanently effective December 13, 1999 (26:25 Md. R. 1900) This chapter applies to discount medical plans and discount drug plans sold, marketed, or solicited in Maryland in accordance with the requirements of Insurance Article, Title 14, Subtitle 6, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Discount drug plan” has the meaning stated in Insurance Article, §14-601(b), Annotated Code of Maryland. “Discount drug plan organization” has the meaning stated in Insurance Article, §14-601(c), Annotated Code of Maryland. “Discount medical plan” has the meaning stated in Insurance Article, §14-601(d), Annotated Code of Maryland. “Discount medical plan organization” has the meaning stated in Insurance Article, §14-601(e), Annotated Code of Maryland. “Medical services” has the meaning stated in Insurance Article, §14-601(g), Annotated Code of Maryland. “Nominal fee” means the fee that may be retained by a discount drug plan organization or a discount medical plan organization if a plan member's membership in a discount drug plan or discount medical plan is canceled within the first 30 calendar days after the effective date of enrollment. “Plan member” has the meaning stated in Insurance Article, §14-601(i), Annotated Code of Maryland. A discount drug plan organization or discount medical plan organization shall reimburse all monies collected from a plan member if the plan member cancels membership in the discount drug plan or the discount medical plan within the first 30 calendar days after the effective date of enrollment. If electronic fund transfer is employed as a method of payment for discount drug plan or discount medical plan membership and membership is canceled within the first 30 calendar days after the effective date of enrollment, the discount drug plan organization or discount medical plan organization has 30 days from the date of cancellation in which to reverse the electronic fund transfer less the applicable nominal fee for this period. Notwithstanding the provisions of Regulation .03 of this chapter, a discount drug plan organization or a discount medical plan organization may retain a nominal fee if a plan member cancels membership in the discount drug plan or discount medical plan within the first 30 calendar days after the effective date of enrollment, if: The discount drug plan organization or the discount medical plan organization has filed the applicable nominal fee with the Insurance Commissioner prior to use; and The nominal fee does not exceed the lesser of $5, or the actual expenses incurred for issuing a plan member's discount drug plan card or discount medical plan card. A discount drug plan or discount medical plan shall disclose the amount of the nominal fee and the circumstances when the discount drug plan organization or discount medical plan organization may retain the nominal fee in writing in 12 point type and in all marketing materials relating to an application or contract soliciting prospective members, including all: Printed materials; Brochures; and Websites. Insurance Article, §2-109 and Title 14, Subtitle 6; Annotated Code of Maryland Effective date: Regulations .01—.04 adopted as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); adopted permanently effective January 26, 2009 (36:2 Md. R. 103) This chapter applies to each individual nonprofit health service plan contract issued or delivered in Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means a nonprofit health service plan. “Covered individual” means an individual covered under an individual contract. “Coverage period” means the interval of time the individual contract provides protection to the insured, in exchange for the payment of a particular premium. “Health benefit plan” has the meaning stated in Insurance Article, §15-1301, Annotated Code of Maryland. “Individual contract” means a contract issued by a nonprofit health service plan to a subscriber covering: The subscriber; The subscriber's dependents; or The subscriber and the subscriber's dependents. “Preferred provider” means a provider that has entered into a provider service contract. “Preferred provider benefit” means a benefit that appears in an individual contract under which health care services are to be provided to the covered individual by a preferred provider. “Provider service contract” means a contract between a provider and a carrier or other entity, under which the provider agrees to provide health care services on a preferential basis under contracts containing preferred provider benefits. “Subscriber” means the individual to whom the nonprofit health service plan contract is issued. An individual contract may not be delivered in Maryland unless it contains in substance the provisions listed in Regulation .04 of this chapter, or provisions which in the opinion of the Commissioner are not less favorable in any respect to the subscriber and covered individuals. Inapplicable and Inconsistent Provisions. If a provision required by Regulation .04 of this chapter is wholly or partly inapplicable to or inconsistent with the coverage provided by a particular contract, the carrier shall: Omit from the contract the inapplicable provision or part of the provision; or Modify the inconsistent provision or part of the provision to make it consistent with the coverage provided by the contract. Entire Contract; Changes. Each individual contract shall contain in substance the following provision: “Entire contract; changes: This certificate, including the endorsements and the attached papers, if any, constitutes the entire contract of insurance. No change in this certificate shall be valid until approved by an executive officer of the carrier and unless such approval is endorsed on the certificate or attached to the certificate. No agent has authority to change this certificate or to waive any of its provisions.” Time Limit on Certain Defenses. Except as provided in §B(2) of this regulation, each individual contract shall contain in substance the following provision: “Time limit on certain defenses:(1) After two years from the date of issue of this contract no misstatements, except fraudulent misstatements, made by the applicant in the application for the contract shall be used to void the contract or to deny a claim for loss incurred after two years from the date of issue of the contract. (2) No claim for loss incurred after two years from the date of issue of this contract shall be reduced or denied on the ground that a disease or physical condition not excluded from coverage by name or specific description effective on the date of loss had existed prior to the effective date of coverage of this contract.” The first provision set forth in §B(1) of this regulation does not: Affect a legal requirement for avoidance of a policy or denial of a claim during the initial 2-year period after the issuance of the contract; or Limit the application of the provision found in Regulation .06E of this chapter if there is a misstatement with respect to age. Contract Incontestable After 2 Years. This subsection applies only to a contract that the subscriber may continue in effect subject to its terms by the timely payment of premiums: Until the subscriber is at least 50 years old; or If the contract is issued after the subscriber is 44 years old, for at least 5 years after its date of issue. A contract subject to this subsection may omit the first provision set forth in §B(1) of this regulation and substitute in substance the following provision under the caption “Incontestable”: “After this contract has been in force for a period of two years during the lifetime of the subscriber, it shall become incontestable as to the statements contained in the application.” Grace Period. If the individual contract is guaranteed renewable for the life of the contract, the contract shall contain in substance the following provision: “Grace period: A grace period of 31 days will be granted for the payment of each premium falling due after the first premium, during which grace period this contract shall continue in force.” If the contract gives the carrier the right to refuse renewal, the contract shall contain in substance the following provision: “Grace period: Unless at least 30 days prior to the premium due date the carrier has delivered to the subscriber, or has mailed to the subscriber's last address as shown by the records of the carrier, written notice of its intention not to renew this contract beyond the period for which the premium has been accepted, a grace period of 31 days will be granted for the payment of each premium falling due after the first premium, during which grace period this policy shall continue in force.” The grace period provisions described in §C(1) and (2) of this regulation shall not apply to an individual contract that is a health benefit plan under which the subscriber is receiving advance payment of federal premium tax credits. If the individual contract is a health benefit plan under which the subscriber is receiving advance payment of federal premium tax credits, the individual contract shall contain the grace period provision required by Insurance Article, §15-1315, Annotated Code of Maryland. If an individual contract lapses due to nonpayment of premium, a carrier may not charge a premium for the time coverage continues in force under the grace period, except as permitted in the unpaid premiums provision in Regulation .06F of this chapter. A carrier may not apply the unpaid premiums provision to recover a premium due for the grace period as described in §C(3) of this regulation, unless the carrier includes the unpaid premiums provision in the individual's contract. An individual contract may not require the subscriber to notify the carrier in advance of the subscriber's intention to terminate the individual contract. Reinstatement. Each individual contract shall contain in substance the following provision: “Reinstatement: If any renewal premium is not paid in full within the time granted the subscriber for payment, a later acceptance of premium in full by the carrier or by any agent authorized by the carrier to accept the premium, without requiring a reinstatement application in connection with the acceptance of the premium in full, shall reinstate the contract. However, if the carrier or the agent requires an application for reinstatement and issues a conditional receipt for the premium tendered, the contract will be reinstated upon approval of the application by the carrier or, lacking approval, upon the forty-fifth day following the date of the conditional receipt unless the carrier has previously notified the subscriber in writing of its disapproval of the reinstatement application. The subscriber and carrier shall have the same rights under the reinstated contract as they had under the contract immediately before the due date of the defaulted premium, subject to any provisions endorsed on the contract or attached to the contract in connection with the reinstatement. Any premium accepted in connection with a reinstatement shall be applied to a period for which premium has not been previously paid, but not to any period more than 60 days prior to the date of reinstatement.” The last sentence of the provision set forth in §D(1) of this regulation may be omitted from a contract that the subscriber may continue in effect subject to its terms by the timely payment of premiums: Until the subscriber is at least 50 years old; or If the contract is issued after the subscriber is 44 years old, for at least 5 years after its date of issue. The reinstatement provision of an individual contract that is not a health benefit plan may also include the following sentence: “The reinstated contract shall cover only loss resulting from accidental injury sustained after the date of reinstatement and loss due to sickness that first manifests itself more than ten days after the date of reinstatement.” Notice of Claim. Each individual contract shall contain a provision describing how and when a claim form can be requested from a carrier. If the carrier requires written notice of claim for the carrier to send a claim form to the claimant, the provision shall indicate that: The written notice of claim may not be required before 20 days after the occurrence or commencement of the loss covered by the policy; The carrier may not invalidate or reduce a claim if it is shown that: It was not reasonably possible to give notice within 20 days, and Notice was given as soon as was reasonably possible. Claims Forms. Each individual contract shall contain in substance the following provision: “Claim forms: The carrier, upon receipt of a notice of claim, will furnish to the claimant such forms as are usually furnished by it for filing proofs of loss. If claim forms are not furnished within 15 days after the giving of notice the claimant shall be deemed to have complied with the requirements of this contract as to proof of loss upon submitting, within the time fixed in the contract for filing proof of loss, written proof covering the occurrence, the character and the extent of the loss for which claim is made.” Proofs of Loss. Each individual contract shall contain in substance the following provision: “Proofs of loss: Written proof of loss must be furnished to the carrier within 90 days after the date of the loss. Failure to furnish proof within the time required shall not invalidate or reduce any claim if it was not reasonably possible to give proof within the required time, provided proof is furnished as soon as reasonably possible and in no event, except in the absence of legal capacity, later than one year from the time proof is otherwise required.” Time of Payment of Claims. Each individual contract shall contain in substance the following provision: “Time of payment of claims: Benefits under this contract will be paid within 30 days after receipt of written proof of loss.” Payment of Claims. Each individual contract shall contain a provision that: All benefits, other than those described in §I(1)(b) of this regulation, will be payable to the subscriber; and Any accrued benefits unpaid at the subscriber's death shall be paid to the subscriber's estate. If an individual contract contains a preferred provider benefit, the contract may indicate that the preferred provider benefits will be paid directly to the preferred provider. At the option of the carrier, the substance of the following paragraph may be added to the provision described in §I(1) of this regulation: “If any benefit of this contract shall be payable to the estate of the subscriber, or to a subscriber who is under 18 years of age or otherwise not competent to give a valid release, the carrier may pay the benefit, up to an amount not exceeding $5,000, to any relative by blood or connection by marriage of the subscriber who is deemed by the carrier to be equitably entitled to the benefit. Any payment made by the carrier in good faith pursuant to this provision shall fully discharge the carrier to the extent of the payment.” Legal Actions. Each individual contract shall contain in substance the following provision: “Legal actions: No action at law or in equity shall be brought to recover on this contract prior to the expiration of 60 days after written proof of loss has been furnished in accordance with the requirements of this contract. No such action shall be brought after the expiration of three years after the written proof of loss is required to be furnished.” 10-Day Right to Examine Contract. Subject to §K(2) of this regulation, a notice shall be prominently printed on or attached to the face of the contract that states that: The contract may be surrendered to the carrier for cancellation within 10 days after the date the contract is delivered to the subscriber; and If the contract is canceled during the 10-day period, a pro rata premium for the unexpired term of the contract shall be returned to the subscriber. The subscriber shall notify the carrier of the cancellation in writing. The carrier may print or attach the notice required under §K(1) of this regulation or a notice of equal prominence that, in the opinion of the Commissioner, is not less favorable to the subscriber. Age Limit; Misstatement of Age. The individual contract shall state that the contract will continue in effect until the end of the period for which the carrier has accepted the premium if an individual contract establishes, as an age limit or otherwise, a date after which the coverage provided by the contract will not be effective and: The date falls within a period for which the carrier accepts a premium for the contract; or The carrier accepts a premium for the contract after the date specified in this section. The individual contract shall state that the liability of the carrier is limited to the refund, on request, of the premiums paid for the period not covered by the contract if the age of the covered individual is misstated and according to the correct age of the covered individual, the coverage provided by the contract would: Not have become effective; or Have ceased before the acceptance of the premium for the contract. Premium Due Date. Each individual contract shall specify the premium due date. The premium due date shall be no earlier than the date the coverage period begins. A carrier may offer each subscriber the option to pay the premium through an electronic payment. If the subscriber elects an electronic payment, the carrier may not debit or charge the amount of the premium due prior to the premium due date, except as authorized by the subscriber. Crime. An individual contract may not include a limitation or exclusion for loss to which a contributing cause was the covered individual's commission of or attempt to commit a crime. An individual contract may not include a limitation or exclusion for loss for which a contributing cause was the commission of or the attempt to commit a crime by an individual other than the covered individual. Illegal Occupation. An individual contract may not include a limitation or exclusion for loss to which a contributing cause was the covered individual's being engaged in an illegal occupation. Intoxicants or Narcotics or Use of Intoxicants or Narcotics. An individual contract may not include a limitation or exclusion for loss sustained or contracted in consequence of the covered individual's being intoxicated or under the influence of any drug. An individual contract may not include a limitation or exclusion for loss due to: The use of alcohol; The use of drugs or narcotics; or Alcoholism or drug addiction. Preexisting Condition. If an individual contract contains a preexisting condition limitation or exclusion, the limitation or exclusion may not apply to a condition which the applicant revealed in the application for the contract, unless the condition is excluded by means of a signed waiver rider attached to the contract. A carrier may include any of the optional provisions described in §§C—G of this regulation. A carrier may not include an optional provision dealing with the same subjects set forth in §§C—G of this regulation if the provision is drafted in a manner that is less favorable to the subscriber or any covered individual than the corresponding optional provision set forth in §§C—G of this regulation. Physical Examination. A carrier may include a provision in an individual contract giving the carrier the right to examine the covered individual when and as often as it may reasonably require during the pendency of a claim under the contract. If the carrier includes the provision described in §C(1) of this regulation, the provision shall indicate that any physical examination required by the carrier will be performed at the expense of the carrier. Autopsy. A carrier may include a provision in an individual contract giving the carrier the right to make an autopsy in case of death when an autopsy is not forbidden by law. If the carrier includes the provision described in §D(1) of this regulation, the provision shall indicate that any autopsy required by the carrier will be performed at the expense of the carrier. Misstatement of Age. An individual contract may contain the following provision: “Misstatement of age: If the age of the covered individual has been misstated, all amounts payable under this contract shall be such as the premium would have purchased at the correct age.” Unpaid Premiums. An individual contract may contain in substance the following provision: “Unpaid premiums: Upon the payment of a claim under this contract, any premium then due and unpaid or covered by any note or written order may be deducted from the claim payment.” Arbitration. A carrier may include a provision in an individual contract giving the covered individual the option of entering binding arbitration to settle a dispute with the carrier. If the carrier includes the provision described in §G(1) of this regulation, the provision may not require the covered individual to enter binding arbitration. Insurance Article, §12-203(g), Annotated Code of Maryland Effective date: October 30, 2000 (27:21 Md. R. 1978) Regulation .02B amended effective October 18, 2010 (37:21 Md. R. 1438); May 9, 2016 (43:9 Md. R. 532) Regulation .04C amended effective November 7, 2005 (32:22 Md. R. 1760) Regulation .04C, D amended effective May 9, 2016 (43:9 Md. R. 532) Regulation .04M adopted effective October 18, 2010 (37:21 Md. R. 1438) Regulation .04M amended effective April 22, 2019 (46:8 Md. R. 402) Regulation .05A amended as an emergency provision effective May 9, 2003 (30:11 Md. R. 732); amended permanently effective October 27, 2003 (30:21 Md. R. 1531) This chapter applies to all: Carriers as defined in Regulation .02B(1) of this chapter; and Credentialing intermediaries as defined in Regulation .02B(2) of this chapter. In this chapter, the following terms have the meanings indicated. Terms Defined. Carrier. “Carrier” means: An insurer; A nonprofit health service plan; A health maintenance organization; A dental plan organization; or Any other person that provides health benefit plans subject to regulation by the State. “Carrier” includes an entity that arranges a provider panel for a carrier. “Credentialing intermediary” means a person to whom a carrier has delegated credentialing or recredentialing authority and responsibility. “Health benefit plan” means: A hospital or medical policy, contract, or certificate, including those issued under multiple employer trusts or associations; A hospital or medical policy, contract, or certificate issued by a nonprofit health service plan; A health maintenance organization contract; or A dental plan organization contract. “Health care provider” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services. “Provider panel” means the health care providers that contract with a carrier to provide health care services to the enrollees under a health benefit plan of the carrier. “Uniform credentialing form” means the form designated by the Insurance Commissioner for use by a carrier or its credentialing intermediary for credentialing and recredentialing a health care provider for participation on a provider panel. A carrier or its credentialing intermediary shall: Accept the uniform credentialing form as the sole application for a health care provider to become credentialed or recredentialed for a provider panel of the carrier; and Make the uniform credentialing form available to any health care provider that is to be credentialed or recredentialed by the carrier or credentialing intermediary. A carrier may not, for purposes of credentialing or recredentialing, require a health care provider to: Modify the uniform credentialing form; Submit additional credentialing forms; Use any other credentialing form not designated by the Commissioner; or Submit any additional information not specified by the uniform credentialing form, except as stated in §F of this regulation. A carrier may preprint the designated carrier information on the uniform credentialing form. A carrier may not deny a uniform credentialing form because the form does not include the designated carrier information of the carrier. A carrier may require a health care provider to submit a new Authorization to Release Information and Affirmation page, with an original signature and date, for the purpose of credentialing or recredentialing. A carrier that is a managed care organization may require a provider to make the disclosure required by 42 CFR §1002.3. The uniform credentialing form may be obtained in an electronic format. The uniform credentialing form may be transmitted by facsimile. A transmission by facsimile is not considered an electronic transfer for the purposes of this chapter. Capability of Electronic Filing. The uniform credentialing form developed under this chapter shall be capable of electronic filing. The uniform credentialing form may be filed electronically in any format that contains the data required to be contained in the uniform credentialing form. The regulations in this chapter are applicable for all credentialing and recredentialing forms used on or after January 1, 2008. Insurance Article, §§2-109 and 15-112.1, Annotated Code of Maryland Effective date: December 25, 2000 (27:25 Md. R. 2285) Chapter revised effective December 6, 2007 (34:24 Md. R. 2159) Regulation .03B amended effective January 20, 2014 (41:1 Md. R. 13) Regulation .03F adopted effective January 20, 2014 (41:1 Md. R. 13) Effective date: Regulations .01—.06 adopted as an emergency provision effective October 1, 2001 (28:22 Md. R. 1932); emergency status expired effective March 29, 2002; adopted permanently effective April 1, 2002 (29:6 Md. R. 570) Chapter revised as an emergency provision effective January 1, 2003 (30:5 Md. R. 365); revised permanently effective January 6, 2003 (29:26 Md. R. 2028) Regulation .03B amended effective January 1, 2005 (31:22 Md. R. 1599) Regulations .01—.03 repealed effective February 15, 2016 (43:3 Md. R. 274) This chapter is applicable to each individual health insurance contract issued or delivered in Maryland on or after the effective date of this chapter. In this chapter, the following terms have the meanings indicated. Terms Defined. “Coverage period” means the interval of time the individual health insurance contract provides protection to the insured, in exchange for the payment of a particular premium. “Individual health insurance contract” means a health insurance contract issued by an insurer to a policyholder that provides health insurance coverage for permissible individuals as described in Insurance Article, §15-201(c), Annotated Code of Maryland. “Insured” means a person covered under an individual health insurance contract. Crime. Except as provided in §A(3) of this regulation, an individual health insurance contract may not include a limitation or exclusion for loss to which a contributing cause was the insured's commission of or attempt to commit a crime. An individual health insurance contract may not include a limitation or exclusion for loss for which a contributing cause was the commission of or the attempt to commit a crime by an individual other than the insured. A disability benefit or an accidental death and dismemberment benefit in an individual health insurance contract: May be subject to exclusion or limitation for loss to which a contributing cause was the insured's commission of or attempt to commit a felony; and May not be subject to an exclusion or limitation regarding the commission of or attempt to commit a crime that is more restrictive to the insured than the exclusion or limitation set forth in §A(3)(a) of this regulation. Illegal Occupation. Except as provided in §B(2) of this regulation, an individual health insurance contract may not include a limitation or exclusion for loss to which a contributing cause was the insured's being engaged in an illegal occupation. A disability benefit or an accidental death and dismemberment benefit in an individual health insurance contract: May be subject to an exclusion or limitation for loss to which a contributing cause was the insured's being engaged in an illegal occupation; and May not be subject to an exclusion or limitation regarding an illegal occupation that is more restrictive to the insured than the exclusion or limitation set forth in §B(2)(a) of this regulation. Intoxicants and Narcotics. Except as provided in §C(2) of this regulation, an individual health insurance contract may not include a limitation or exclusion for loss: Sustained or contracted in consequence of the insured's being intoxicated or under the influence of any drug; Due to the use of alcohol; Due to the use of drugs or narcotics; or Due to alcoholism or drug addiction. A disability benefit or an accidental death and dismemberment benefit in an individual health insurance contract: May be subject to an exclusion or limitation for loss sustained or contracted in consequence of the insured's being intoxicated or under the influence of any narcotic unless administered on the advice of a physician; and May not be subject to an exclusion or limitation regarding the use of alcohol or drugs that is more restrictive to the insured than the exclusion or limitation set forth in §C(2)(a) of this regulation. Preexisting Condition Limitation. If an individual health insurance contract contains a preexisting condition limitation or exclusion, the limitation or exclusion may not apply to a condition that the applicant revealed in the application for the contract, unless the condition is excluded by means of a signed waiver rider attached to the contract. If an insurer includes an arbitration provision in an individual health insurance contract, the arbitration provision may not require the insured to use arbitration to settle disputes with the insurer. Each individual health insurance contract shall specify the premium due date. The premium due date shall be no earlier than the date the coverage period begins. An insurer may offer each individual policyholder the option to pay the premium through an electronic payment. If the individual policyholder elects an electronic payment, the insurer may not debit or charge the amount of the premium due prior to the premium due date, except as authorized by the individual policyholder. Insurance Article, §§2-109, 12-203(g), and 12-205(b)(4), Annotated Code of Maryland Effective date: Regulations .01—.04 adopted as an emergency provision effective January 1, 2002 (28:26 Md. R. 2270); adopted permanently effective June 10, 2002 (29:11 Md. R. 891) Regulation .02B amended effective October 18, 2010 (37:21 Md. R. 1438) Regulation .03A amended as an emergency provision effective May 9, 2003 (30:11 Md. R. 733); amended permanently effective October 27, 2003 (30:21 Md. R. 1531) Regulation .05 adopted effective October 18, 2010 (37:21 Md. R. 1438) Regulation .05B amended effective April 22, 2019 (46:8 Md. R. 402) This chapter applies to carriers and representatives of carriers making coverage decisions. In this chapter, the following terms have the meaning indicated. Terms Defined. “Appeal” means a protest filed by a member, a member’s representative, or a health care provider with a carrier under its internal appeal process regarding a coverage decision concerning a member. “Appeal decision” means a final determination by a carrier that arises from an appeal filed with the carrier under its appeal process regarding a coverage decision concerning a member. “Carrier” means a person that offers a health benefit plan and is: An authorized insurer that provides health insurance in the State; A nonprofit health service plan; A health maintenance organization; A dental plan organization; or Except for a managed care organization, as defined in Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, any other person that offers a health benefit plan subject to regulation by the State. “Complaint” means a protest filed with the Commissioner involving a coverage decision other than that which is covered by Insurance Article, Title 15, Subtitle 10A, Annotated Code of Maryland. “Coverage decision” has the meaning stated in Insurance Article, §15-10D-01, Annotated Code of Maryland. Health Benefit Plan. “Health benefit plan” means: A hospital or medical policy or contract, including a policy or contract issued under a multiple employer trust or association; A hospital or medical policy or contract issued by a nonprofit health service plan; A health maintenance organization contract; or A dental plan organization contract. “Health benefit plan” does not include one or more, or any combination, of the following: Long-term care insurance; Disability insurance; Accidental travel and accident death and dismemberment insurance; Credit health insurance; A health benefit plan issued by a managed care organization, as defined in Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland; Disease-specific insurance; or Fixed indemnity insurance. “Health care provider” means: An individual who is licensed under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession and is a treating provider of the member; or A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland. “Health care service” means a health or medical care procedure or service rendered by a health care provider that: Provides testing, diagnosis, or treatment of a human disease or dysfunction; or Dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction. “Internal appeal process” means the appeal process required by Insurance Article, Title 15, Subtitle 10D, Annotated Code of Maryland, to be adopted by the carrier for use by its members and health care providers to dispute coverage decisions made by the carrier or a representative of the carrier. Member. “Member” means a person entitled to health care services under a policy, plan, or contract issued or delivered in the State by a carrier. “Member” includes: A subscriber; and Unless preempted by federal law, a Medicare recipient. “Member” does not include a Medicaid recipient. “Member’s representative” has the meaning stated in Insurance Article, §15-10D-01, Annotated Code of Maryland. “Urgent medical condition” means a condition that satisfies either of the following: A medical condition, including a physical condition, a mental condition, or a dental condition, where the absence of medical attention within 72 hours could reasonably be expected by an individual, acting on behalf of a carrier, applying the judgment of a prudent layperson who possesses an average knowledge of health and medicine, to result in: Placing the member's life or health in serious jeopardy; The inability of the member to regain maximum function; Serious impairment to bodily function; Serious dysfunction of any bodily organ or part; or The member remaining seriously mentally ill with symptoms that cause the member to be a danger to self or others; or A medical condition, including a physical condition, a mental health condition, or a dental condition, where the absence of medical attention within 72 hours in the opinion of a health care provider with knowledge of the member's medical condition, would subject the member to severe pain that cannot be adequately managed without the care or treatment that is the subject of the coverage decision. “Retrospective denial” means a coverage decision which is made by the carrier after the health care service has been rendered to the member. Except as provided in §B of this regulation, the carrier's internal appeal process shall be exhausted before filing a complaint with the Commissioner under this chapter. In a case involving a prospective denial, a member, a member’s representative, or a health care provider filing a complaint on behalf of a member may file a complaint with the Commissioner without first filing an appeal with a carrier and receiving a final decision on the appeal if the member, the member’s representative, or the health care provider gives sufficient information and supporting documentation in the complaint that demonstrates an urgent medical condition exists as defined under this chapter. In a case involving a retrospective denial, an urgent medical condition is not deemed to exist to allow a member, a member’s representative, or a health care provider on behalf of a member to file to a complaint without first exhausting the internal appeal process of a carrier. Insurance Article, §§15-10D-02(d) and 15-10D-04, Annotated Code of Maryland Effective date: June 10, 2002 (29:11 Md. R. 891) Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 497) Regulation .03B, C amended effective April 16, 2012 (39:7 Md. R. 497) This chapter applies to insurers that issue or deliver individual or group health insurance policies in Maryland that include a disability benefit. In this chapter, the following terms have the meanings indicated. Terms Defined. “Adverse appeal determination” means a decision made by an insurer on an appeal of an adverse benefit determination to uphold: A denial, reduction, or termination of a disability benefit; A failure to provide or make payment, in whole or in part, for a disability benefit; or Any denial, reduction, termination, or failure to provide or make payment that is based on a determination of a covered individual's eligibility for coverage of a disability benefit. “Adverse benefit determination” means a determination arising from a claim for disability benefits which results in: A denial, reduction, or termination of a disability benefit; A failure to provide or make payment, in whole or in part, for a disability benefit; or Any denial, reduction, termination, or failure to provide or make payment that is based on a determination of a covered individual's eligibility for coverage of a disability benefit. “Authorized representative” means a person, including a health care provider, authorized by the covered individual to act on behalf of the covered individual. “Covered individual” means an individual covered under an insurance policy that provides a disability benefit. Disability benefit. “Disability benefit” means a benefit that is payable based on the disability of a covered individual. “Disability benefit” does not include: Benefits under a long-term care insurance policy; A benefit that is payable based solely on a dismemberment of a covered individual; Benefits in a life insurance policy that operate to safeguard the contract from lapse or to provide a special surrender value, special benefit, or annuity in the event of total and permanent disability; or Benefits in a health insurance policy that operate to safeguard the contract from lapse due to disability. Each insurer subject to this chapter shall establish procedures for processing disability benefits claims and appeals of adverse benefit determinations in accordance with this chapter. The procedures established by an insurer shall: Be in writing; Contain administrative processes and safeguards designed to ensure and to verify that benefit claim determinations are made in accordance with the insurance policy provisions and that, where appropriate, the insurance policy provisions have been applied consistently with respect to similarly situated covered individuals; Allow covered individuals at least 180 days following receipt of a notice of an adverse benefit determination to request an appeal of the adverse benefit determination; Provide covered individuals an opportunity to submit written comments, documents, records, and other information relating to the claim for disability benefits; Provide a covered individual who is appealing or has appealed an adverse benefit determination, upon request and free of charge, reasonable access to, and copies of all documents, records, and other information relevant to the covered individual's claim for disability benefits; Provide for a review that takes into account all comments, documents, records, and other information submitted by the covered individual appealing an adverse benefit determination, without regard to whether the information was submitted or considered in the initial adverse benefit determination; Require that the review on appeal of an adverse benefit determination be conducted by an individual who is neither the individual who made the adverse benefit determination nor a subordinate of the individual who made the adverse benefit determination; Provide that the review on appeal of an adverse benefit determination may not afford deference to the initial adverse benefit determination; Provide for the identification of medical or vocational experts whose advice was obtained on behalf of the insurer in connection with a covered individual's adverse benefit determination, without regard to whether the advice was relied upon in making the adverse benefit determination; Require the individual deciding an appeal of an adverse benefit determination, based in whole or in part on a medical judgment, to consult with a health care professional who: Has appropriate training and experience in the field of medicine involved in the medical judgment; and Is not: The health care professional consulted in connection with the initial adverse benefit determination; or The subordinate of the health care professional; Ensure that all claims and appeals are adjudicated in a manner designed to ensure the independence and impartiality of the persons involved in making the decision, and, accordingly, decisions regarding hiring, compensation, termination, promotion, or other similar matters with respect to any individual, such as a claims adjudicator or medical or vocational expert, may not be made based upon the likelihood that the individual will support the denial of benefits; Provide that, before the insurer issues an adverse appeal determination, the insurer shall provide the claimant, free of charge, with any new or additional evidence considered, relied upon, or generated by the insurer or other person making the benefit determination in connection with the claim, which shall be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse appeal determination is required to be provided to give the covered individual a reasonable opportunity to respond prior to that date; and Provide that, before the insurer can issue an adverse appeal determination based on a new or additional rationale, the insurer shall provide the claimant, free of charge, with the rationale, which shall be provided as soon as possible and sufficiently in advance. The claims procedures established by the insurer: May not: Preclude an authorized representative of a covered individual from acting on behalf of the covered individual in filing a benefit claim or an appeal of an adverse benefit determination; Require the payment of a fee or costs as a condition to filing a claim or appealing an adverse benefit determination; Require a covered individual to complete more than two appeals of an adverse benefit determination before filing a complaint with the Commissioner; or Require a covered individual to submit a dispute regarding a claim for disability benefits to binding arbitration; but May include reasonable procedures for determining whether a person has been authorized to act on behalf of a covered individual. For purposes of §B(5) of this regulation and Regulation .05F(3) of this chapter, a document, record, or other information shall be considered relevant to a covered individual's claim if the document, record, or other information: Was relied on in making the adverse benefit determination; Was submitted, considered, or generated in the course of making the adverse benefit determination, without regard to whether the document, record, or other information was relied upon in making the adverse benefit determination; Demonstrates compliance with the procedures required by §B(2) of this regulation; or Constitutes a statement of policy or guidance of the insurer concerning the denied disability benefit without regard to whether the statement was relied upon in making the adverse benefit determination. An insurer shall give written or electronic notice that complies with the standards imposed by 29 CFR §2520.104b-1(c)(1)(i), (iii), and (iv), of an adverse benefit determination to a covered individual within a reasonable period of time, but not later than 45 days after receipt of a claim for disability benefits, unless the 45-day period is extended in accordance with this regulation. Subject to §F(2) of this regulation, the period of time within which a benefit determination shall be made begins at the time a claim is received, without regard to whether all the information necessary to make a benefit claim determination accompanies the filing. The 45-day time period under §A of this regulation may be extended for up to 30 days if the insurer: Determines that the extension is necessary due to matters beyond the control of the insurer; and Provides the notice required under §E of this regulation to the covered individual before the expiration of the initial 45-day period. The first 30-day extension may be extended for an additional 30 days if the insurer: Determines that, due to matters beyond the control of the insurer, a decision cannot be rendered within the first 30-day extension period; and Provides the notice required under §E of this regulation to the covered individual before the expiration of the first 30-day extension period. The notice of an extension under §§C and D of this regulation shall be in writing and include: A description of the circumstances requiring the extension of time; The date by which the insurer plans to render a decision; A specific explanation of: The standards on which entitlement to a disability benefit is based; The unresolved issues that prevent a decision on the claim; and The additional information needed to resolve the issues; and A statement that the covered individual shall be given at least 45 days within which to provide the specified information. If the period of time within which a benefit determination is required to be made is extended under §C or D of this regulation due to a covered individual's failure to submit information necessary to decide a claim: The covered individual shall be given at least 45 days within which to provide the information; and The period for making the benefit determination is tolled (temporarily suspended) from the date on which the notice of the extension is sent to the covered individual until the date on which the covered individual responds to the request for additional information. The notice of an adverse benefit determination shall include: The specific reason or reasons for the adverse benefit determination; A reference to the specific policy provisions on which the adverse benefit determination is based; A description of any additional material or information necessary for the covered individual to perfect the claim and an explanation of why the material or information is necessary; A description of the insurer's appeal procedures and the time limits applicable to the procedures; If an internal rule, guideline, protocol, or similar criterion was relied on in making the adverse benefit determination, either: The specific rule, guideline, protocol, or other similar criterion; or A statement that: An internal rule, guideline, protocol, or other similar criterion was relied on in making the adverse benefit determination; and A copy of the rule, guideline, protocol, or other similar criterion will be provided on request free of charge to the covered individual; and A discussion of the decision, including an explanation of the basis for disagreeing with or not following: The views presented by the claimant to the plan of health care professionals treating the claimant and vocational professionals who evaluated the claimant; The views of medical or vocational experts whose advice was obtained on behalf of the plan in connection with a claimant’s adverse benefit determination, without regard to whether the advice was relied upon in making the benefit determination; and A disability determination regarding the claimant presented by the claimant to the plan made by the Social Security Administration. The notification shall be provided in a culturally and linguistically appropriate manner. An insurer is considered to provide relevant notices in a culturally and linguistically appropriate manner if: The insurer provides oral language services, such as a telephone customer assistance hotline, that include answering questions in any applicable non-English language and providing assistance with filing claims and appeals in any applicable non-English language; The insurer provides, upon request, a notice in any applicable non-English language; and The insurer includes in the English version of all notices a statement prominently displayed in any applicable non-English language, clearly indicating how to access the language services provided by the insurer. With respect to an address in any United States county to which a notice is sent, a non-English language is an applicable non-English language if 10 percent or more of the population residing in the county is literate only in the same non-English language, as determined in guidance published by the U.S. Secretary of Labor An insurer shall give written or electronic notice that complies with the standards imposed by 29 CFR §2520.104b-1(c)(1)(i), (iii), and (iv), of an appeal determination to a covered individual within a reasonable period of time, but not later than 45 days after receipt of an appeal of an adverse benefit determination, unless the 45-day period is extended in accordance with this regulation. Subject to §E of this regulation, the period of time within which an appeal determination shall be made begins at the time an appeal is received, without regard to whether all the information necessary to make an appeal determination accompanies the filing. The initial 45-day time period under §A of this regulation may be extended for a period not to exceed 45 days if the insurer: Determines that the extension is necessary due to special circumstances; and Provides the notice required under §D of this regulation to the covered individual prior to the expiration of the initial 45-day period. The notice of an extension under §C of this regulation shall be in writing and include: A description of the special circumstances requiring the extension of time; and The date by which the insurer plans to render a decision. If the period of time within which an appeal determination is required to be made is extended under §C of this regulation due to a covered individual's failure to submit information necessary to decide the appeal, the period for making the appeal determination shall be tolled (temporarily suspended) from the date on which the notice of the extension is sent to the covered individual until the date on which the covered individual responds to the request for additional information. The notice of an adverse appeal determination shall include: The specific reason or reasons for the adverse appeal determination; A reference to the specific policy provisions on which the adverse appeal determination is based; A statement that the covered individual is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relevant to the covered individual's claim for benefits; and If an internal rule, guideline, protocol, or other similar criterion was relied upon in making the adverse appeal determination, either: The specific rule, guideline, protocol, or other similar criterion; or A statement that: An internal rule, guideline, protocol, or other similar criterion was relied on in making the adverse appeal determination; and A copy of the rule, guideline, protocol, or other similar criterion will be provided on request free of charge to the covered individual; and The address, telephone number, and facsimile number of the Commissioner. An insurer shall provide access to, and copies of, documents, records, and other information described in §F(3) and (4) of this regulation. Insurance Article, §§2-109(a)(1) and 15-1010, Annotated Code of Maryland Effective date: August 2, 2004 (31:15 Md. R. 1186) Regulation .03B amended effective April 15, 2024 (51:7 Md. R. 334) Regulation .04 amended effective April 15, 2024 (51:7 Md. R. 334) Regulation .05 amended effective April 15, 2024 (51:7 Md. R. 334) This chapter applies to each carrier that provides behavioral health care services through: A company owned wholly or partly by the carrier; or A contract with a managed behavioral health care organization. This chapter does not apply to a person that, for an administrator fee only, solely arranges a provider panel for a carrier for the provision of behavioral health care services on a discounted fee-for-service basis. In this chapter, the following terms have the meanings indicated. Terms Defined. Behavioral Health Care Administrative Expenses. “Behavioral health care administrative expenses” means any expenses that are for administrative functions including: Billing and collection expenses; Accounting and financial reporting expenses; Quality assurance and utilization management program or activity expenses; Promotion and marketing expenses; Taxes, fees, and assessments; Legal expenses; Salary expenses for employees that are not related to the delivery of behavioral health care services to patients; Computer expenses; Provider credentialing; Collection and administrative review of treatment plans; Auditing the financial report submitted to the Commissioner under Insurance Article, §15-127, Annotated Code of Maryland; Debt payment and debt service; and Other general and administrative expenses. “Behavioral health care administrative expenses” does not include expenses incurred for behavioral health care services. Behavioral Health Care Services. “Behavioral health care services” means procedures or services rendered by a health care provider for the treatment of mental illness, emotional disorders, drug abuse, or alcohol abuse. “Behavioral health care services” includes any quality assurance or utilization management activities or treatment plan reviews that are clinical in nature. “Behavioral health care services” does not include administrative functions. “Carrier” means: A health insurer; A nonprofit health service plan; A health maintenance organization; A preferred provider organization; A third party administrator; or Except for a managed care organization as defined in Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, any other person that provides health benefit plans subject to regulation by the State. “Direct behavioral health care expenses” means any payment to a health care provider by a managed behavioral health care organization for the provision of behavioral health care services to a member. “Direct payments” means the money that a carrier disburses to a managed behavioral health care organization for the provision of behavioral health care services to a member. “Managed behavioral health care organization” means a company, organization, private review agent, or subsidiary that: Contracts with a carrier to provide, undertake to arrange, or administer behavioral health care services to members; or Otherwise makes behavioral health care services available to members through contracts with health care providers. Member. “Member” means an individual entitled to behavioral health care services from a carrier or a managed behavioral health care organization under a policy or plan issued or delivered in the State. “Member” includes a subscriber. “Provider” means a person licensed, certified, or otherwise authorized under Health Occupations Article, or Health-General Article, Annotated Code of Maryland, to provide health care services. Within 90 days after the end of each calendar year, each carrier shall complete the form developed by the Commissioner by obtaining, as necessary, and entering on the form the following information: The name of each managed behavioral health care organization with which the carrier has a contract; The calendar year for which the data is reported; Total direct payments made by the carrier to each managed behavioral health care organization during the calendar year; Direct behavioral health care expenses during the calendar year; Amounts included in direct behavioral health care expenses for quality assurance or utilization management activities or treatment plan reviews; Behavioral health care administrative expenses during the calendar year; and The name, title, telephone number, and signature of the individual completing the form and the date that the form was completed. A carrier shall maintain each form that the carrier is required to complete under Regulation .03 of this chapter for at least 5 years after the date that the form is required to be completed. A carrier may maintain a form in paper, photographic, microprocessed, magnetic, mechanical, electronic, digital, or any other media provided that the form is maintained in a manner that: Is clear and legible; Reproduces accurately the original form in its entirety, including any attachments to the form; Is capable of producing a clear and legible hard copy of the original form; and Preserves evidence of the signature contained on the original form. A carrier shall make copies of each form that the carrier is required to complete and maintain publicly available to an individual, enrollee, or member, on request, and may charge: A reasonable preparation fee not to exceed $15 for each form requested; and The actual cost for any postage and handling required to provide copies of the requested forms. Insurance Article, §15-127(f), Annotated Code of Maryland Effective date: February 16, 2004 (31:3 Md. R. 209) This chapter applies to each nonprofit health service plan that is subject to Insurance Article, §14-115(d), Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Baltimore metro region” means Anne Arundel County, Baltimore City, Baltimore County, Carroll County, Harford County, and Howard County. “Cost-sharing arrangement” includes: A deductible; A co-insurance amount; A co-payment amount; An annual limit; A lifetime limit; and An out-of-pocket maximum. “DC metro region” means Montgomery County and Prince George's County. “Eastern Shore region” means Caroline County, Cecil County, Dorchester County, Kent County, Queen Anne's County, Somerset County, Talbot County, Wicomico County, and Worcester County. Health Benefit Plan. “Health benefit plan” means a hospital or medical policy, contract, or certificate issued by a nonprofit health service plan. “Health benefit plan” includes: A Medicare supplement policy, contract, or certificate; A long-term care policy, contract, or certificate; or A stop loss contract. “Health care provider” has the meaning stated in Insurance Article, §14-101(b), Annotated Code of Maryland. “Key specialty” means: Cardiology; Dermatology; Family practice; Gastroenterology; Geriatrics; Internal medicine; Obstetrics/Gynecology (Ob/Gyn); Ophthalmology; Orthopedic surgery; or Pediatrics. “Market” means: The individual Medigap market; The individual non-Medigap market; The small-employer market governed by Insurance Article, Title 15, Subtitle 12, Annotated Code of Maryland; or The group market other than the small-employer market governed by Insurance Article, Title 15, Subtitle 12, Annotated Code of Maryland. “Nonprofit health service plan” means a corporation that: Holds a certificate of authority from the Commissioner to act as a nonprofit health service plan; and Has been assigned a National Association of Insurance Commissioners (NAIC) company code number. “Option” means a benefit or cost-sharing arrangement that: Is available in a health benefit plan; and If chosen, would alter the cost of the health benefit plan. “Product” means a category of one or more health benefits plans sold by a nonprofit health service plan in a particular market. “Southern Maryland region” means Calvert County, Charles County, and St. Mary's County. “Western Maryland region” means Allegany County, Frederick County, Garrett County, and Washington County. For purposes of Insurance Article, §14-115(d)(11)(i), Annotated Code of Maryland, a modification is material if it modifies: The options available in a health benefit plan marketed in the State in a manner that results in a change of 20 percent or more in the actuarial benefit value of the health benefit plan; A provider network in a manner that results in a change of: 10 percent or more in the number of health care providers in the provider network: For the entire State: or In the Baltimore metro region or DC metro region; 7 percent or more in the number of health care providers in the provider network in the Southern Maryland region; 5 percent or more in the number of health care providers in the provider network in the Eastern Shore region or Western Maryland region; 10 percent or more in the number of health care providers in a key specialty in the provider network: For the entire State; or In the Baltimore metro region, DC metro region, Eastern Shore region, Southern Maryland region, or Western Maryland region; 10 percent or more in the amount of reimbursement paid to health care providers in the provider network: For the entire State; or In the Baltimore metro region or DC metro region; 7 percent or more in the amount of reimbursement paid to health care providers in the provider network in the Southern Maryland region; or 5 percent or more in the amount of reimbursement paid to health care providers in the provider network in the Eastern Shore region or the Western Maryland region; Underwriting guidelines for a product of a nonprofit health insurance plan in a manner that results in: A refusal to provide the least expensive rate for the product of a nonprofit health service plan to 20 percent or more of applicants for the product; or A relative increase of 50 percent or more in the current level of refusals to provide the least expensive rate for the product of a nonprofit health service plan to applicants; or Rates or rating plans that are required to be approved by the Commissioner in a manner that results in: A rate increase of 15 percent or more in 1 year for any product sold by a nonprofit health service plan in a particular market; or A rate increase of 25 percent or more in 1 year for coverage variations within a product sold by a nonprofit health service plan in a particular market. Development and Submission of Marketing Plan. Each year, a nonprofit health service plan shall: Develop a marketing plan; and Submit the marketing plan and any changes to the marketing plan to the board of directors of the nonprofit health service plan for approval. Contents of Marketing Plan. A nonprofit health service plan shall include in the marketing plan all of the nonprofit health service plan's marketing goals and objectives in the State, including any plan to: Reenter a market; Retain or expand enrollment in a market or market segment; Change the product portfolio of the nonprofit health service plan; Establish or change distribution methods or sales systems of the nonprofit health service plan; Establish or change a pricing strategy; Form a partnership with another entity for marketing purposes; Establish or change a communication and image strategy; Engage in community outreach and education; Market membership through one company in a holding company system rather than another company in the holding company system; or Move subscribers from one company in a holding company system to another company in the holding company system. Approval Required. A nonprofit health service plan may not wholly or partially implement a marketing plan or any change to the marketing plan unless the board of the nonprofit health service plan has approved the marketing plan or the change to the marketing plan. One year after the effective date of this chapter, the board of directors of a nonprofit health service plan shall submit to the Commissioner an evaluation report that contains: The number of items that were required to be submitted to the board during the preceding year under each category contained in Regulation .03 of this chapter; and An evaluation of whether Regulation .03 of this chapter is effective in ensuring that the board of a nonprofit health service plan reviews items that are appropriate for review by the board without being unduly burdened by review of items that are not appropriate for review by the board. Compliance with Insurance Article, §14-115(d)(11)(i), Annotated Code of Maryland, and this chapter does not relieve the board of directors of a nonprofit health service plan or the individual members of the board from taking or refraining from taking any action otherwise required to comply with their fiduciary duties. Insurance Article, §§2-109(a)(1) and 14-115(d)(11)(ii), Annotated Code of Maryland Effective date: September 26, 2005 (32:19 Md. R. 1588) This chapter establishes the manner in which carriers and private review agents acting on behalf of carriers may apply utilization review criteria and impose documentation requirements to the surgical treatment of the morbid obesity benefit mandated by Insurance Article, §15-839, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Body mass index” has the meaning stated in Insurance Article, §15-839, Annotated Code of Maryland. “Carrier” means an insurer, a nonprofit health service plan, or a health maintenance organization. “Commissioner” means the Maryland Insurance Commissioner. “Health maintenance organization” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland. “Insurer” has the meaning stated in Insurance Article, §1-101, Annotated Code of Maryland. “Member” means an individual who is covered by a contract that: Is issued or delivered by a carrier in the State; and Includes a benefit for the surgical treatment of morbid obesity. “Morbid obesity” has the meaning stated in Insurance Article, §15-839, Annotated Code of Maryland. “Nonprofit health service plan” means a person who has received a certificate of authority from the Commissioner to act as a nonprofit health service plan in the State. “Private review agent” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland. “Utilization review” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland. When establishing utilization review criteria for the surgical treatment of morbid obesity as a covered benefit under Insurance Article, §15-839, Annotated Code of Maryland, a carrier or a private review agent acting on behalf of a carrier: Shall limit the criteria to the permissible criteria listed in §B of this regulation; and May not use any criteria that is more restrictive to the member than the criteria listed in §B of this regulation. Permissible Criteria for Utilization Review Decisions. Body Mass Index. Except as permitted under §B(1)(b) of this regulation, a carrier or a private review agent acting on behalf of a carrier shall consider a member to meet the body mass index criterion if the member has a body mass index greater than 40 kilograms per meter squared. If the member has a comorbid medical condition, the carrier or private review agent acting on behalf of the carrier may not impose the criterion described in §B(1)(a) of this regulation, but shall consider the member to meet the body mass index criterion if the member has a body mass index equal to or greater than 35 kilograms per meter squared. In determining whether the member has a comorbid medical condition under §B(1)(b) of this regulation, the carrier or the private review agent acting on behalf of the carrier shall consider the member to have a comorbid condition if the member has one of the following conditions: Hypertension; A cardiopulmonary condition; Sleep apnea; Diabetes; or Any life threatening or serious medical condition that is weight induced. The carrier or private review agent acting on behalf of the carrier may establish a utilization review criterion that limits the benefit for surgical treatment of morbid obesity to adults who are 18 years old or older. The carrier or private review agent acting on behalf of the carrier may establish a utilization review criterion that requires the member to complete a psychological examination of the member's readiness and fitness for surgery and the necessary postoperative lifestyle changes before undergoing surgical treatment of morbid obesity. Completion of a Structured Diet Program. If a carrier or a private review agent acting on behalf of a carrier establishes a criterion that requires a member to complete a structured diet program, the carrier or private review agent acting on behalf of the carrier may not establish a criterion that is more restrictive than described in §B(4)(b) of this regulation. The carrier or the private review agent acting on behalf of the carrier shall consider the member to have completed a structured diet program, if the member completes either of the following in the 2-year period that immediately precedes the request for the surgical treatment of morbid obesity: One structured diet program for 6 consecutive months; or Two structured diet programs for 3 consecutive months. A carrier or a private review agent acting on behalf of a carrier shall use flexibility with regard to defining a structured diet program. A carrier or a private review agent acting on behalf of a carrier shall consider commonly available diet programs, such as Weight Watchers or Jenny Craig, to be structured diet programs. The carrier or private review agent acting on behalf of the carrier shall accept any one of the items listed in §B of this regulation as acceptable documentation that the member has completed the structured diet program required by Regulation .03B(4) of this chapter. Acceptable documentation of completion of a structured diet program includes: Physician notes; Notes of health care providers, other than physicians; Receipts of payment for a structured diet program; or Diet or weight loss logs from a structured diet program. Insurance Article, §§2-109(a)(1) and 15-893, Annotated Code of Maryland; Ch. 301, Acts of 2005 Effective date: April 10, 2006 (33:7 Md. R. 676) The purpose of this chapter is to: Establish standards for the creation and maintenance of provider panels by insurers, nonprofit health service plans, and dental plan organizations; and Assure the availability of health care providers to meet the health care needs of enrollees. This chapter applies to insurers, nonprofit health service plans, and dental plan organizations that use provider panels. In this chapter, the following terms have the meanings indicated. Terms Defined. “Accredited hospital” means a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations. “Carrier” means an insurer, a nonprofit health service plan, or a dental plan organization. “Enrollee” means an individual entitled to health care benefits from a carrier. “Hospital-based physician” means an anesthesiologist, pathologist, radiologist, neonatologist, hospitalist, intensivist, or emergency medicine physician that practices exclusively within an accredited hospital and provides care to enrollees only as a result of the enrollees being directed to the hospital. “Prominent carrier” means a carrier reporting at least $90,000,000 in written premium for medical benefits in Maryland in the most recent annual statement. “Provider” means a health care practitioner or group of health care practitioners licensed, certified, or otherwise authorized by law to provide health care services. “Provider panel” means the providers that contract either directly or through a subcontracting entity with a carrier to provide health care services to the carrier's enrollees under the carrier's health benefit plan. A carrier shall maintain a provider panel that is sufficient in numbers and types of available providers to meet the health care needs of enrollees. Standards to meet the health care needs of enrollees shall be determined in accordance with the requirements of this chapter, and may be established by reference to any reasonable criteria used by the carrier, including but not limited to: Provider-enrollee ratios by specialty; Primary care provider-enrollee ratios; Geographic accessibility; Waiting times for appointments with providers; Hours of operation; and The volume of technological and specialty services available to serve the needs of enrollees requiring technologically advanced or specialty care. A carrier shall implement an availability plan describing: If the carrier is an insurer or nonprofit health service plan, the quantifiable and measurable standards for the number and geographic distribution of: General and internal medicine providers; Family practitioners; Pediatricians; Obstetricians and gynecologists; High-volume specialty behavioral health care providers, including psychiatrists, psychologists, clinical social workers, and any other behavioral health care providers identified by the carrier; and High-volume specialty health care providers, identified by the carrier; or If the carrier is a dental plan organization, or an insurer or nonprofit health service plan that provides coverage only for dental services, the quantifiable and measurable standards for the number and geographic distribution of: Dentists; and Any other dental service provider identified by the carrier. The availability plan required by §A of this regulation shall also include: The method used to annually assess the carrier's performance against the standards specified in the availability plan; The method used to ensure timely access to health care services, as identified by the carrier; and The carrier's process for monitoring and assuring on an ongoing basis the sufficiency of the provider panel to meet the health care needs of enrollees. Availability Plan and Annual Performance Assessment. A carrier shall: On an annual basis, review and update the availability plan required by §A of this regulation; On an annual basis, conduct a performance assessment regarding its compliance with its availability plan using the method provided in §B(1) of this regulation; and Submit its availability plan and its annual performance assessment to the Commissioner upon request. In addition to the requirements of §C(1) of this regulation, a prominent carrier shall submit to the Commissioner the prominent carrier's: Availability plan not later than: 90 days after the effective date of this chapter, if the carrier is a prominent carrier on the effective date of this chapter; or 90 days after the carrier becomes a prominent carrier, if the carrier becomes a prominent carrier after the effective date of this chapter; and Annual performance assessment: Not later than November 1, 2008, for the period beginning on the effective date of this regulation; and Within 30 days of completing the annual performance assessment, for calendar year 2009 and thereafter. In addition to the requirements of §C(2) of this regulation, a prominent carrier shall: File with the Commissioner the availability plan described in §C(2)(a) of this regulation not later than 30 days after the carrier makes any change to the availability plan; Provide annually to the Commissioner a list of the hospital-based physician specialties available on the prominent carrier's provider panel; and Submit the report required in §A of this regulation with the submission of the prominent carrier's performance assessment required by §C(2)(b) of this regulation. The Commissioner may request additional information from the carrier in order to evaluate the carrier's performance with the availability plan. In addition to any other enforcement powers available to the Commissioner, if a carrier violates this chapter, the Commissioner may order a carrier to take reasonably appropriate corrective action. The reasonably appropriate corrective action required by the Commissioner in §A of this regulation may include, but not be limited to, ordering the carrier to: Meet the standards specified in the carrier's availability plan by increasing the number of providers by specialty or geographic area in the carrier's provider panel; and Make restitution to an enrollee who received services during the time the carrier failed to meet the standards specified in the carrier's availability plan, from a provider that was not on the carrier's provider panel, if the carrier fails to take a corrective action ordered by the Commissioner. Insurance Article, §§2-108(2) and 15-112(b)(1)(i)1, Annotated Code of Maryland; Effective date: July 17, 2008 (35:14 Md. R. 1247) The purpose of this chapter is to establish: The use of the term domestic partner in a contract; and The proof that a carrier may use to determine if an individual is a domestic partner of another individual. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means an insurer, a nonprofit health service plan, or a health maintenance organization. “Commissioner” means the Maryland Insurance Commissioner. “Contract” means either of the following: A health insurance contract that is issued or delivered in Maryland by an insurer or a nonprofit health service plan that provides inpatient hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis; or A contract issued or delivered in Maryland by a health maintenance organization to individuals or groups. “Health maintenance organization” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland. “Insurer” has the meaning defined in Insurance Article, §1-101, Annotated Code of Maryland. “Nonprofit health service plan” means a person who has received a certificate of authority from the Commissioner to act as a nonprofit health service plan in the State. The term “domestic partner” in a contract or rider to a contract shall include individuals of the same and the opposite sex. If an individual makes an application to include a domestic partner or a child dependent of a domestic partner as a dependent under a contract, the carrier may require the individual to submit not more than the following as proof of the domestic partner relationship: The affidavit described in §C of this regulation; Proof that the individual meets one criteria from §D of this regulation; and Proof that the individual meets one criteria from §E of this regulation. Affidavit Attesting to Domestic Partnership. An affidavit signed by both the insured and the domestic partner shall include only the following attestations: Both individuals are 18 years old or older; Neither individual is related to the other by blood or marriage within four degrees of consanguinity under civil law rule; Neither individual is married or in a civil union or domestic partnership with another individual; Both individuals have been financially interdependent for at least 6 consecutive months prior to application in which each individual contributes to some extent to the other individual's maintenance and support with the intention of remaining in the relationship indefinitely; and Both individuals share a common primary residence. Carriers may develop their own affidavits or may use the affidavit set forth in §C(3) of this regulation. The following is a sample affidavit that complies with the requirements of §B(1) of this regulation:AFFIDAVIT OF DOMESTIC PARTNERSHIP Instructions: In order to enroll your Domestic Partner for medical benefits, you and your Domestic Partner must sign this Affidavit of Domestic Partnership. Please carefully read this Affidavit and the information below. Both you and your Domestic Partner must certify that you are Domestic Partners by completing and signing below. I, {Name of Subscriber} and {Name of Partner} certify that we are Domestic Partners and that we: Are at least 18 years old; Are not related to the other by blood or marriage within four degrees of consanguinity under civil law rule; Are not married or in a civil union or domestic partnership with another individual; Have been financially interdependent for at least 6 consecutive months prior to application in which each individual contributes to some extent to the other individual's maintenance and support with the intention of remaining in the relationship indefinitely; and Share a common primary residence. We understand that a civil action may be brought against us for losses, including reasonable attorney fees and court costs, because of willful falsification of information in this Affidavit of Domestic Partnership. We understand that willful falsification of information contained in this Affidavit may result in our termination of enrollment. We certify under penalty of perjury under applicable state laws, that the foregoing is true and accurate to the best of our knowledge. _________________________________________________________________________ Signature of Subscriber Date _________________________________________________________________________ Signature of Domestic Partner Date The carrier shall accept any one of the following documents as proof of a common primary residence between domestic partners: Common ownership of the primary residence via joint deed or mortgage agreement; Common leasehold interest in the primary residence; Driver's license or State-issued identification listing a common address; or Utility or other household bill with both the name of the insured and the name of the domestic partner appearing. The carrier shall accept any one of the following documents as proof of financial interdependence between domestic partners: Joint bank account or credit account; Designation as the primary beneficiary for life insurance or retirement benefits of the domestic partner; Designation as primary beneficiary under the domestic partner's will; Mutual assignments of valid durable powers of attorney under Estates and Trusts Article, §13-601, Annotated Code of Maryland; Mutual valid written advanced directives under Health-General Article, §5-601 et seq., Annotated Code of Maryland, approving the other domestic partner as health care agent; Joint ownership or holding of investments; or Joint ownership or lease of a motor vehicle. A carrier may require a group policyholder to obtain the documents specified under this chapter prior to enrolling a domestic partner or a child dependent of a domestic partner. Insurance Article, §§2-109(a)(1) and 15-403.2, Annotated Code of Maryland Effective date: Regulations .01—.04 adopted as an emergency provision effective January 10, 2008 (35:3 Md. R. 287); emergency status expired July 8, 2008 Regulations .01—.03 adopted effective July 8, 2008 (35:12 Md. R. 1122) The purpose of this chapter is to establish the factors the Commissioner shall consider when approving an accrediting organization for the purposes of Insurance Article, §15-1618, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Accrediting organization” means an entity that accredits a pharmacy benefits manager. “Applicant” means a pharmacy benefits manager that is applying for a registration from the Commissioner to act as a pharmacy benefits manager in Maryland. “Commissioner” means the Maryland Insurance Commissioner. “Pharmacy and therapeutics committee” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy benefits manager” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. An accrediting organization is not an approved accrediting organization for the purposes of Insurance Article, §15-601, Annotated Code of Maryland, until the Commissioner issues a letter of approval to the accrediting organization. For the purpose of determining which entities are approved accrediting organizations, the Commissioner shall consider whether: The accreditation standards required to be met for accreditation by the accrediting organization meet or exceed the requirements of Insurance Article, §§15-1614 and 15-1617, Annotated Code of Maryland; The accrediting organization measures an applicant's pharmacy and therapeutics committee's ability to meet each standard; and The accrediting organization agrees to notify the Commissioner at least 30 days in advance if it revises its accreditation standards that pertain to a pharmacy and therapeutics committee or changes the method in which it reviews a pharmacy and therapeutics committee of an applicant. An accrediting organization continues to be approved by the Commissioner until notified in writing by the Commissioner that its approval has been withdrawn. Insurance Article, §§2-109, 15-1618, and 15-1619, Annotated Code of Maryland Effective date: May 4, 2009 (36:9 Md. R. 654) The purpose of this chapter is to establish time frames in which carriers are required to provide: Health insurance contracts, nonprofit health service plan contracts, health maintenance organization contracts, and dental plan organization contracts to individual contract holders and group contract holders; and Health insurance certificates, nonprofit health service plan certificates, health maintenance organization certificates, and dental plan organization certificates to certificate holders. In this chapter, the following terms have the meanings indicated. Terms Defined. “Blanket insurance” has the meaning stated in Insurance Article, §15-305, Annotated Code of Maryland. “Carrier” means any of the following: An insurer; A nonprofit health service plan; A health maintenance organization; and A dental plan organization. “Certificate” or “summary plan description” means the benefit summary that sets forth the essential elements of a group contract and that is required to be provided by a carrier to individuals covered under a group contract. “Certificate holder” means an individual who is eligible to be covered under a group contract by reason of satisfying the eligibility requirements of the group contract, other than an individual who is covered under a group contract as the spouse, domestic partner, or dependent of the certificate holder. “Contract holder” means the entity to whom a contract is issued. “Group contract” means a health insurance contract, a nonprofit health service plan contract, a health maintenance organization contract, or a dental plan organization contract issued by a carrier to a group for the purpose of covering: Employees or members of the group; The dependents of employees or members of the group; or The employees, or members of the group, and the employee's, or member's dependents. “Health insurance” has the meaning stated in Insurance Article, §1-101, Annotated Code of Maryland. “Individual contract” means a health insurance contract, a nonprofit health service plan contract, a health maintenance organization contract, or a dental plan organization contract issued by a carrier to a contract holder covering: The contract holder; The contract holder's dependents; or The contract holder, and the contract holder's dependents. “Insurance producer” has the meaning stated in Insurance Article, §1-101, Annotated Code of Maryland. Except as described in §B of this regulation, a carrier shall deliver an individual health insurance contract, an individual nonprofit health service plan contract, an individual health maintenance organization contract, or an individual dental plan organization contract to the contract holder within 60 days of the effective date of the contract. If a carrier back dates an individual health insurance contract so that the individual health insurance contract is written at a younger age, the carrier shall deliver the individual health insurance contract to the contract holder within 60 days of the later of the: Effective date of the individual health insurance contract; or Date the carrier approves the application for the individual health insurance contract. A carrier shall deliver a group or blanket health insurance contract, a group nonprofit health service plan, a group health maintenance organization contract, or a group dental plan organization contract to the contract holder within 60 days of the later of the: Effective date of the contract; or Date the contract holder provides all the information needed to finalize the benefits offered under the contract. A carrier shall deliver a certificate under a group health insurance contract, a group nonprofit health service plan contract, a group health maintenance organization contract, or a group dental plan organization contract to the: Certificate holder within 60 days of the effective date of the certificate holder's coverage; or Group contract holder within 60 days of the effective date of the certificate holder's effective date of coverage, for delivery to each certificate holder. A carrier may satisfy the requirement of §A of this regulation by making the certificate available to the certificate holder on the Internet, if: Written notice of the availability of the certificate on the Internet is provided to the: Certificate holder in writing within 60 days of the date of the certificate holder's effective date of coverage; or Group contract holder or insurance producer of record within 60 days of the effective date of the certificate holder's effective date of coverage, for the group contract holder or insurance producer of record to provide delivery to the certificate holder; and The written notice described in §B(1) of this regulation includes an option for the certificate holder to request the certificate be delivered to the certificate holder by mail. The certificate requested under §B of this regulation shall be made available in paper form within 60 days of the receipt by the carrier of the request for the paper certificate from the certificate holder. If a carrier cannot comply with the requirements of §A of this regulation because the group contract holder delays providing the necessary information to the carrier to issue the certificate, the carrier's time limit to provide the certificate is extended to the shorter of: 30 days from the date the employer group provides the information to the carrier; or 120 days from the effective date of the employer group contract. Failure of a carrier to deliver a contract or certificate as provided in Regulations .03 and .04 of this chapter shall constitute: A violation of Insurance Article, §4-113, Annotated Code of Maryland, for a carrier, other than a health maintenance organization; or A violation of Health-General Article, §19-729, Annotated Code of Maryland, for a health maintenance organization. Health-General Article, §§19-705(a)(2), and 19-729; Insurance Article, §§2-109(a)(1), 4-113, and 12-20; Annotated Code of Maryland Effective date: January 14, 2010 (37:1 Md. R. 16) The purpose of this chapter is to establish a limit on the value of incentives offered by carriers in wellness programs. This chapter applies only to the wellness programs as defined in Regulation .03 of this chapter, and Insurance Article, §27-210(h)(1), Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means: An insurer; A nonprofit health service plan; A health maintenance organization; or A dental plan organization. “Wellness program” has the meaning stated in Insurance Article, §27-210(h)(1), Annotated Code of Maryland. A carrier may offer an incentive for participation in a wellness program if the incentive: Is reasonably related to the wellness program; and Does not have a value that exceeds any limit established by Regulation .05 of this chapter. An incentive offered for participation in a wellness program by a carrier may not have a value that exceeds $500 per year, per individual who is an insured, a subscriber, or a member. Insurance Article, §§2-109(a)(1) and 27-210(h)(4), Annotated Code of Maryland Effective date: June 29, 2009 (36:13 Md. R. 907) Regulation .01 amended effective June 6, 2016 (43:11 Md. R. 635) Regulation .02 amended effective March 8, 2010 (37:5 Md. R. 433); June 6, 2016 (43:11 Md. R. 635) Regulation .03B amended effective March 8, 2010 (37:5 Md. R. 433); June 6, 2016 (43:11 Md. R. 635) Regulation .04 amended effective June 6, 2016 (43:11 Md. R. 635) Regulation .05 amended effective June 6, 2016 (43:11 Md. R. 635) This chapter establishes the manner in which carriers and private review agents acting on behalf of carriers may apply utilization review criteria and impose documentation requirements regarding the treatment of children diagnosed with autism or autism spectrum disorders, when covered under a habilitative services benefit under a health benefit plan. In this chapter, the following terms have the meanings indicated. Terms Defined. “Applied behavior analysis” means the design, implementation, and evaluation of environmental modifications, using behavioral stimuli and consequences, to produce socially significant improvement in human behavior, including the use of direct observation, measurement, and functional analysis of the relationship between environment and behavior. “Behavioral health treatment” means professional counseling and treatment programs, including applied behavior analysis, that are necessary to develop, maintain, or restore, to the maximum extent practicable, the functioning of an individual. “Carrier” means an insurer, a nonprofit health service plan, or a health maintenance organization. “Child” means an individual who is: Younger than 19 years of age; and Diagnosed with autism or autism spectrum disorder. “Commissioner” means the Maryland Insurance Commissioner. “Habilitative services” has the meaning stated in Insurance Article, §15-835, Annotated Code of Maryland. “Health benefit plan” has the meaning stated in Insurance Article, §15-1301, Annotated Code of Maryland. “Health maintenance organization” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland. “Insurer” has the meaning stated in Insurance Article, §1-101, Annotated Code of Maryland. “Nonprofit health service plan” means a person who has received a certificate of authority from the Commissioner to act as a nonprofit health service plan in the State. “Private review agent” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland. Psychological Care. “Psychological care” means direct or consultative services provided by a psychologist licensed in the state in which the services are provided or by a social worker licensed in the state in which in which the services are provided. “Psychological care” includes psychotherapy. “Therapeutic care” means services provided by a speech-language pathologist, occupational therapist, or physical therapist licensed in the state in which the services are provided. “Utilization review” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland. The utilization review criteria of a carrier or private review agent acting on behalf of a carrier to determine medical necessity or appropriateness may not be more restrictive for habilitative services for the treatment of autism and autism spectrum disorders than the criteria listed in this regulation. The carrier’s criteria for habilitative services shall include criteria for behavioral health treatment, psychological care, and therapeutic care. Utilization review criteria of a carrier or private review agent acting on behalf of a carrier may require: A comprehensive evaluation of a child by the child’s primary care provider or specialty physician identifying the need for habilitative services for the treatment of autism or autism spectrum disorder; A prescription from a child’s primary care provider or specialty physician that includes specific treatment goals; and An annual review by the prescribing primary care provider or specialty physician, in consultation with the habilitative services provider, that includes: Documentation of benefit to the child; Identification of new or continuing treatment goals; and Development of a new or continuing treatment plan. A carrier or private review agent acting on behalf of a carrier may not deny coverage based solely on the number of hours of habilitative services prescribed, for: Less than or equal to 25 hours per week in the case of a child who is at least 18 months of age and who has not reached the child’s sixth birthday, or Less than or equal to 10 hours per week in the case of a child who has reached the child’s sixth birthday and who has not reached the child’s nineteenth birthday. Notwithstanding §D(1) and (2) of this regulation, a carrier may authorize additional hours of habilitative services that are medically necessary and appropriate for the treatment of autism or autism spectrum disorders. A carrier may limit payment for habilitative services to payment for services provided by individuals who are licensed, certified, or otherwise authorized under the Health Occupations Article or similar licensing, certification, or authorization requirements of another state or U.S. territory where the habilitative services are provided. Location of services. A carrier may not deny payment for habilitative services if a treatment goal identifies the location of the habilitative services as the child’s educational setting. Nothing in §F(1) of this regulation shall be construed to require a carrier to provide services to a child under an individualized education program or any obligation imposed on a public school by the Individuals With Disabilities Education Act, 20 U.S.C. 1400 et seq., as amended from time to time. A carrier or a private review agent acting on behalf of a carrier may not deny payment for applied behavior analysis on the basis that it is experimental or investigational. Coverage required under this chapter may be subject to limitations in a health benefit plan relating to coordination of benefits, participating provider requirements, restrictions on services provided by family or household members, case management provisions, and co-payments, co-insurance, and deductible amounts. Insurance Article, §§2-109(a)(1) and 15-835, Annotated Code of MarylandCh. 294, §2, Acts of 2012 Effective date: March 17, 2014 (41:5 Md. R. 348) Effective date: Regulations .01—.08 adopted as an emergency provision effective December 14, 2010 (38:2 Md. R. 81); adopted permanently effective March 7, 2011 (38:5 Md. R. 320) Regulations .01—.08 repealed effective June 23, 2014 (41:12 Md. R. 669) This chapter applies to preferred provider insurance policies that are issued, renewed, or delivered by a carrier in the State on or after July 1, 2011. In this chapter, the following terms have the meanings indicated. Terms Defined. “Allowed amount” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Assignment of benefits” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Carrier” means an insurer or nonprofit health service plan. “Covered service” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Explanation of benefits” means the document that is provided by a carrier to an insured that explains the claims paid, reduced, or denied by the carrier. “Hospital-based physician” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland and does not include an on-call physician. “Insured” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Insurer” has the meaning stated in Insurance Article, §1-101, Annotated Code of Maryland. “Nonpreferred provider” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Nonprofit health service plan” means a person who has a certificate of authority to operate as a nonprofit health service plan in Maryland. “On-call physician” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Preferential basis” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Preferred provider insurance policy” means a policy or insurance contract issued or delivered in the State by a carrier under which health care services furnished by a preferred provider are paid on a preferential basis. A nonpreferred provider who is an on-call physician may accept an assignment of benefits under a preferred provider insurance policy. A nonpreferred provider who is an on-call physician and accepts an assignment of benefits under a preferred provider insurance policy shall: Accept the carrier’s allowed amount as payment in full for the covered services provided; Collect or attempt to collect from the insured only the monies for the items identified in Insurance Article, §14-205.2(b)(3), Annotated Code of Maryland; Submit to the carrier the uniform claims form required by COMAR 31.10.11.03 and indicate acceptance of the assignment of benefits in box 27 of the uniform claims form to satisfy the notice requirements under Insurance Article, §14-205.2(a)(3), Annotated Code of Maryland; and Designate CPT code 99026, or its successor, on the uniform claims form. A carrier shall reimburse a nonpreferred provider who is an on-call physician and who has provided the information specified in §B(3) and (4) of this regulation in accordance with the provisions of Insurance Article, §14-205.2(c), Annotated Code of Maryland. A nonpreferred provider who is a hospital-based physician may accept an assignment of benefits under a preferred provider insurance policy. A nonpreferred provider who is a hospital-based physician and accepts an assignment of benefits under a preferred provider insurance policy shall: Accept the carrier’s allowed amount as payment in full for the covered services provided; Collect or attempt to collect from the insured only the monies for the items identified in Insurance Article, §14-205.2(b)(3), Annotated Code of Maryland; and Submit to the carrier the uniform claims form required by COMAR 31.10.11.03 and indicate acceptance of the assignment of benefits in box 27 of the uniform claims form to satisfy the notice requirements of Insurance Article, §14-205.2(a)(3), Annotated Code of Maryland. A carrier shall reimburse a nonpreferred provider who is a hospital-based physician and who has provided the information specified in §B(3) of this regulation in accordance with the provisions of Insurance Article, §14-205.2(d), Annotated Code of Maryland. This regulation applies to carriers who receive claims for services provided by physicians who are nonpreferred providers but are not on-call physicians or hospital-based physicians. A carrier shall permit a nonpreferred provider described in §A of this regulation to accept an assignment of benefits under a preferred provider insurance policy offered by the carrier. Except as provided in Insurance Article, §14-205.3(g), Annotated Code of Maryland, a carrier that receives a claim for services provided by a nonpreferred provider described in §A of this regulation who accepts an assignment of benefits under a preferred provider insurance policy shall pay the nonpreferred provider directly if the nonpreferred provider: Provides a copy of the disclosure set forth in Regulation .06 of this chapter to an insured before performing a health care service for the insured; and Submits a copy of the signed disclosure set forth in Regulation .06 of this chapter to the carrier. Except for a nonpreferred provider who is an on-call physician or a hospital-based physician, a nonpreferred provider who is a physician shall provide a copy of the disclosure set forth in §B of this regulation to each insured before performing a health care service for the insured in order to qualify for an assignment of benefits under a preferred provider insurance policy. The disclosure text required by §A of this regulation shall be printed in at least 12 point type and shall read as follows: A carrier shall provide the information listed in §B of this regulation with the payment to the insured for health care services if: The carrier receives a claim for health care services provided by a physician who is a nonpreferred provider and who is not an on-call physician or a hospital-based physician; and The insured did not provide an assignment of benefits to the physician who provided the health care services. The information required by §A of this regulation shall include: The specific claim covered by the payment; The amount paid for the claim; The amount that is the insured’s responsibility; and A statement instructing the insured to use the payment to pay the nonpreferred provider in the event the insured has not paid the nonpreferred provider in full for the health care services rendered by the nonpreferred provider. If the payment for a claim is sent to the insured by the carrier with an explanation of benefits, the carrier shall include the information required to be provided under §§A and B of this regulation on the explanation of benefits or on a separate page included with the explanation of benefits. If the payment for a claim is sent to the insured by the carrier separately from the explanation of benefits, the carrier shall include the information required under §§A and B of this regulation with the payment of claim. Insurance Article, §§2-109(a)(1), 14-205.2, and 14-205.3, Annotated Code of Maryland Effective date: September 19, 2011 (38:19 Md. R. 1148) This chapter applies to each: Receiving carrier that issues or delivers individual or group health benefit plans in Maryland; and Receiving managed care organization that enrolls Program recipients in Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means: An insurer authorized to sell health insurance; A nonprofit health service plan; A health maintenance organization; A dental plan organization; or Any other entity providing a plan of health insurance, health benefits, or health services authorized under the Insurance Article of the Annotated Code of Maryland or the Affordable Care Act. “Enrollee” means a: Person entitled to health care benefits from a carrier; or Program recipient who is enrolled in a managed care organization. “Health benefit plan” has the meaning stated in Insurance Article, §15-140, Annotated Code of Maryland. “Managed care organization” means: A certified health maintenance organization that is authorized to receive medical assistance prepaid capitation payments; A corporation that: Is a managed care system that is authorized to receive medical assistance prepaid capitation payments; Enrolls only Program recipients or individuals or families served under the Maryland Children’s Health Program; and Is subject to the requirements of Health-General Article, §15-102.4, Annotated Code of Maryland.; or A prepaid dental plan that receives fees to manage dental services. “Program recipient” means an individual who receives benefits under the Maryland Medical Assistance Program. “Receiving carrier” means the carrier that issues the new health benefit plan when an enrollee transitions from another carrier or a managed care organization. “Receiving managed care organization” means the managed care organization that accepts the enrollee when the enrollee transitions from another managed care organization or a carrier. “Relinquishing carrier” means a carrier that issued the prior health benefit plan when an enrollee transitions to a new carrier or a managed care organization. “Relinquishing managed care organization” means a managed care organization in which an enrollee had been enrolled prior to the enrollee’s transition to a new managed care organization or a carrier. “Transitioning enrollee” means an enrollee: Who has an effective date of coverage with a receiving carrier or a receiving managed care organization on or after January 1, 2015, under a contract that is issued or renewed on or after January 1, 2015; and Whose coverage under the receiving carrier or receiving managed care organization began within 1 month of the date coverage terminated under the: Health benefit plan with a relinquishing carrier; or Relinquishing managed care organization. A receiving carrier shall send a transitioning enrollee the Continuity of Health Care Notice set forth in Regulation .04A of this chapter: Except as provided in §A(2) of this regulation, within 30 days of the enrollee’s effective date of coverage; and If the enrollee’s coverage is made effective retroactively, within 30 days of the date the receiving carrier is notified of the enrollment. A receiving managed care organization shall send a transitioning enrollee the Continuity of Health Care Notice set forth in Regulation .04B of this chapter: Except as provided in §B(2) of this regulation, within 30 days of the enrollee’s effective date of coverage; and If the enrollee’s coverage is made effective retroactively, within 30 days of the date the receiving managed care organization is notified of the enrollment. The Continuity of Health Care Notices shall be in the language and format described in Regulation .04 of this chapter in not less than 12-point type. The following form is to be used by receiving carriers as the Continuity of Health Care Notice required by Regulation .03A of this chapter. The following form is to be used by receiving managed care organizations as the Continuity of Health Care Notice required by Regulation .03B of this chapter. Insurance Article, §§2-109(a)(1), 15-140, and 15-10D-01, Annotated Code of Maryland and Ch. 159, §3, Acts of 2013 Effective date: Regulations .01—.04 adopted as an emergency provision effective January 1, 2015 (42:1 Md. R. 16); adopted permanently effective April 27, 2015 (42:8 Md. R. 608) This chapter applies to carriers that sell medical stop-loss insurance to small employers in Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means an insurer or nonprofit health service plan that sells medical stop loss insurance in Maryland. “Medical stop-loss insurance” has the meaning stated in Insurance Article, §15-129, Annotated Code of Maryland. “Medical stop-loss insurance disclosure form” means the form shown in Regulation .04 of this chapter. “Small employer” has the meaning stated in Insurance Article, §31-101, Annotated Code of Maryland. Before entering into a policy or contract of medical stop-loss insurance with a small employer, a carrier shall provide the small employer a completed medical stop-loss insurance disclosure form. When determining whether an employer satisfies the definition of a small employer, the carrier shall base the determination on the definition that applies on the proposed effective date of the medical stop-loss insurance policy or contract. The medical stop-loss insurance disclosure form shall be printed in at least 12-point type. The portion of the medical stop-loss insurance disclosure form that requires a listing of any limitations in the medical stop-loss insurance policy or contract is required to include any: Dollar limitations in the medical stop-loss insurance policy or contract, such as annual limitations; Day or visit limits on the services covered under the medical stop-loss insurance policy or contract; Limitations or exclusions that apply to benefits covered under the medical stop-loss insurance policy or contract, such as: Pre-existing condition exclusions; Exclusions or limitations for particular services, such as an exclusion or limitation for prescription drugs or mental health services; Exclusions or limitations for particular medical conditions, such as AIDS; Limitations or exclusions for non-medically necessary services; and Limitations or exclusions for experimental or investigational services; and Different attachment points for any particular service, such as organ transplants. The medical stop-loss insurance disclosure form shall read as follows: FORM AT END OF CHAPTER Insurance Article, §§2-109(a)(1) and 15-129(f)(3), Annotated Code of Maryland Effective date: Regulations .01—.04 adopted effective January 1, 2016 (42:23 Md. R. 1436) This chapter applies to carriers that issue or renew health benefit plans in Maryland and use a provider panel for a health benefit plan offered in Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Access plan” means the materials that each carrier is required to file annually with the Commissioner to demonstrate that each of the carrier’s provider panels is adequate to meet the needs of its enrollees. “Ambulatory infusion therapy center” means any location authorized to administer chemotherapy or infusion services on an outpatient basis. “Behavioral health care” means care for mental health or a substance use disorder. “Carrier” means: An insurer authorized to sell health insurance; A nonprofit health service plan; or A health maintenance organization. “Certified registered nurse practitioner” means an individual who is licensed as a certified nurse practitioner under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland. “Continuing care patient” means an individual who, with respect to a provider or facility: Is undergoing a course of treatment for a serious and complex condition from the provider or facility; Is undergoing a course of institutional or inpatient care from the provider or facility; Is scheduled to undergo nonelective surgery from the provider or facility, including receipt of postoperative care from such provider or facility with respect to such a surgery; Is pregnant and undergoing a course of treatment for the pregnancy from the provider or facility; or Is or was determined to be terminally ill, as determined under Section 1861(dd)(3)(A) of the Social Security Act, and is receiving treatment for such illness from such provider or facility “Enrollee” means a person entitled to health care benefits from a carrier under a policy or contract subject to Maryland law. “Essential community provider” means a provider that serves predominantly low-income or medically underserved individuals. “Essential community provider” includes: Local health departments; Outpatient mental health and community based substance use disorder programs; Any entity listed in 45 CFR §156.235(c);and School-based health centers. “Group model HMO” means a type of health maintenance organization that: Contracts with one multispecialty group of physicians who are employed by and shareholders of the multispecialty group; and Provides or arranges for the provision of physician and other health care services to patients at medical facilities operated by the HMO or employs its own physicians and other providers on a salaried basis in health maintenance organization buildings to provide care to enrollees of the health maintenance organization. “Health benefit plan” has the meaning stated in Insurance Article, §15-112, Annotated Code of Maryland. “Health care facility” has the meaning stated in Insurance Article, §15-112, Annotated Code of Maryland. “Health professional shortage area” means those geographic areas in Maryland which have been designated by the Health Resources and Services Administration as such, as a result of having a shortage of primary medical care or behavioral health providers. “HEDIS” means the Healthcare Effectiveness Data and Information Set of standardized performance measures, developed and used by the National Committee for Quality Assurance, to evaluate managed care health plan performance for care and services provided. “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. “Hospital-based physician” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Material change to an access plan” means a change to an access plan that affects a carrier’s ability to comply with the requirements of this chapter. “Network” means: A carrier’s participating providers and the health care facilities with which a carrier contracts to provide health care services to the carrier’s enrollees under the carrier’s health benefit plan. If a carrier uses a provider panel developed by a subcontracting entity, “network” includes providers and health care facilities that contract with the subcontracting entity to provide health care services to the carrier’s enrollees under the carrier’s health benefit plan. “Network adequacy waiver” means the Commissioner’s decision to relieve a carrier of the obligation to comply with certain network adequacy standards in this chapter for 1 year. “On-call physician” has the meaning stated in Insurance Article, §14-201, Annotated Code of Maryland. “Opioid treatment services provider” means a program with a valid and current accreditation-based license under COMAR 10.63 to provide community-based behavioral health services, and authorized to provide opioid treatment services. “Participating provider” means a provider on a carrier’s provider panel. “Preventive care” means health care provided for the prevention and early detection of disease, illness, injury or other health condition, and includes all of the services required by 42 U.S.C. §300gg-13. “Primary care provider” means: A provider who is responsible for: Providing initial and primary care to patients; Maintaining the continuity of patient care; or Initiating referrals for specialist care. “Primary care provider” includes: A physician whose practice of medicine is limited to general practice; and A board-certified or board-eligible internist, pediatrician, obstetrician-gynecologist or family practitioner. “Provider” means a person or group of persons licensed, certified, or otherwise authorized by law to provide health care services. “Provider panel” means the providers that contract either directly or through a subcontracting entity with a carrier to provide health care services to the carrier’s enrollees under the carrier’s health benefit plan. “Provider panel” does not include an arrangement in which any provider may participate solely by contracting with the carrier to provide health care services at a discounted fee-for-service rate. “Residential crisis services” has the meaning stated in Insurance Article, §15-840, Annotated Code of Maryland. “Road travel distance” means: Actual driving distance measured between two geographic locations based on turn-by-turn directions along public roads; or Subject to approval by the Commissioner, driving distance between two geographic locations estimated using a methodology that, in the discretion of the Commissioner, sufficiently accounts for significant geographic barriers that are impassable by automobile, such as the Chesapeake Bay. “Rural area” means a zip code that, according to the Maryland Department of Planning, has a human population of less than 1,000 per square mile. “School-based health center” means a community health resource described in Health-General Article, §19-2101, Annotated Code of Maryland that is located within an elementary, middle, or high school and approved by the Maryland Department of Health. “Specialty provider” means a provider who: Focuses on a specific area of physical care or behavioral health care for a group of patients; Has successfully completed required professional training; and For a physician, has obtained Board certification or is Board eligible through the American Board of Medical Specialties. “Suburban area” means a zip code that, according to the Maryland Department of Planning, has a human population equal to or more than 1,000 per square mile, but less than 3,000 per square mile. “Telehealth” has the meaning stated in Insurance Article, §15-139, Annotated Code of Maryland., “Urban area” means a zip code that, according to the Maryland Department of Planning, has a human population equal to or greater than 3,000 per square mile. “Urgent care” means the treatment for a condition of an enrollee that satisfies either of the following: A medical condition, including a physical condition or a behavioral health condition, that, in the absence of medical care or treatment within 72 hours, could reasonably be expected by an individual, acting on behalf of a carrier and applying the judgment of a prudent layperson who possesses an average knowledge of health and medicine, would result in: Placing the enrollee’s life or health in serious jeopardy; The inability of the enrollee to regain maximum function; Serious impairment to the enrollee’s bodily function; Serious dysfunction of any bodily organ or part of the enrollee; or The enrollee remaining seriously ill with behavioral health symptoms that cause the enrollee to be a danger to self or others; or A medical condition of an enrollee, including a physical condition or a behavioral health condition, that, in the absence of medical care or treatment within 72 hours, would, in the opinion of a provider with knowledge of the enrollee’s medical condition, subject the enrollee to severe pain that cannot be adequately managed without the care or treatment. “Waiting time” means the time from the initial request for health care services by an enrollee or by the enrollee’s treating provider to the earliest date offered for the appointment for services with a provider possessing the appropriate skill and expertise to treat the condition. Sufficiency Standards. A carrier shall develop and maintain a network of providers in sufficient numbers, geographic locations, and practicing specialties to ensure enrollees have access to participating providers for the full scope of benefits and services covered under the carrier’s health benefit plan. A carrier shall establish written policies and procedures to implement a process for addressing network deficiencies that result in an enrollee lacking access to any providers with the professional training and expertise necessary to deliver a covered service without unreasonable travel or delay. A carrier shall clearly define and specify referral requirements, if any, to specialty and other providers. A carrier shall take reasonable steps to ensure that participating providers provide physical access, reasonable accommodations, and accessible equipment for enrollees with physical or mental disabilities. A carrier’s written policies and procedures to monitor availability of services shall include how the carrier will monitor the availability of services for: Continuing care patients; Individuals with physical or mental disabilities, including individuals who have disabilities that limit their physical ability to access services; and Individuals with limited English proficiency, including diverse cultural and ethnic backgrounds. A carrier shall take reasonable steps to ensure services are delivered in a culturally competent manner to all enrollees, including enrollees: With limited English proficiency; With diverse cultural, racial, and ethnic backgrounds; and Of all genders, sexual orientations, and gender identities. A carrier must have the ability to identify, by county and for the City of Baltimore, the number of participating providers for each facility type listed in the charts in Regulation .05A(5) and B(5) of this chapter and each provider type code and specialty code listed on the uniform credentialing form described in Insurance Article, §15-112.1, Annotated Code of Maryland. The identification of the number of participating providers described in §A(7) of this regulation: Shall include either: All participating providers who were credentialed for a specific provider type or specialty code listed in the uniform credentialing form described in Insurance Article, §15-112.1, Annotated Code of Maryland; or All participating providers who reported a specific provider type or specialty code when completing the uniform credentialing form described in Insurance Article, §15-112.1, Annotated Code of Maryland; and May include additional participating providers identified by the carrier through other documented means. A carrier shall retain copies of its policies and procedures required by this chapter for a period of 3 years following the date the policies and procedures were last effective. At the request of the Commissioner, a carrier shall file with the Commissioner a copy of its current and retained past policies and procedures required by this chapter. A carrier may request a finding by the Commissioner that its policies and procedures are considered confidential commercial information. Monitoring Sufficiency Standards. A carrier shall continuously monitor its provider network for compliance with this chapter and shall conduct internal compliance audits for the standards listed in Regulations .05, .06, and .07 of this chapter on at least a quarterly basis; and A carrier shall continuously verify and update its network directory consistent with Insurance Article, §15-112, Annotated Code of Maryland and §2799A-5of the Public Health Service Act, enacted by 116 of the federal No Surprises Act. Using the instructions on the Maryland Insurance Administration's website for submission method and to determine rural, suburban, and urban zip code areas, each carrier subject to this chapter shall file an annual access plan with the Commissioner on or before July 1 of each year for each provider panel used by the carrier, with the first access plan filing due on or before July 1, 2018. If a carrier makes a material change to an access plan, the carrier shall: Notify the Commissioner of the change in writing within 15 business days after the material change to the access plan occurs; and Include in the notice required under §B(1) of this regulation a reasonable timeframe within which the carrier will file with the Commissioner an update to the existing access plan for review by the Commissioner. Each annual access plan filed with the Commissioner shall include the following information in the standardized format described on the Maryland Insurance Administration’s website: An executive summary in the form set forth in Regulation .11 of this chapter; The information and process required by Insurance Article, §15-112(c)(4), Annotated Code of Maryland, and the methods used by the carrier to comply with the monitoring requirement under §15-112(c)(5); A description of out-of-network claims received by the carrier in the prior calendar year, which shall include: The percentage of total claims received that are out-of-network claims; The percentage of out-of-network claims received that are paid; The percentage of claims described in §C(3)(a) and (b) of this regulation that the carrier identifies as claims for emergency services, on-call physicians, or hospital-based physicians; The percentage of total claims received that are out-of-network claims for: Subject to §G of this regulation, all enrollees with a residence in a zip code where less than 100 percent of enrollees have access to a provider within the applicable travel distance standard in Regulation .05 of this chapter for the provider type in the claim, listed by provider type for each of the rural, suburban, and urban areas; Subject to §G of this regulation, the ten provider types with the highest number of out-of-network claims for enrollees with a residence in each of the rural, suburban, and urban areas, listed by provider type and geographic area; and Subject to §G of this regulation, the ten provider types with the highest percentage of total claims that are out-of-network claims for enrollees with a residence in each of the rural, suburban, and urban areas, listed by provider type and geographic area; For each provider type and geographic area described in §C(3)(d) of this regulation, the following information regarding requests to obtain a referral to an out-of-network provider in accordance with Insurance Article, §15-830, Annotated Code of Maryland: The number of referral requests received; The number of referral requests granted; The percentage of out-of-network claims received for which a referral was requested; The percentage of out-of-network claims received for which a referral was granted; The number of single case agreements requested between the carrier and an out-of-network provider; The number of single case agreements entered between the carrier and an out-of-network provider; The percentage of out-of-network claims received for which a single case agreement was requested between the carrier and an out-of-network provider; and The percentage of out-of-network claims received for which a single case agreement was entered between the carrier and an out-of-network provider; and Any additional information deemed necessary by the carrier to provide context for the information described in §C(3)(a)—(e) of this regulation; A description of complaints received by the carrier in the prior calendar year relating to access to or availability of providers, which shall include: The total number of complaints made by enrollees relating to the waiting time or distance of participating providers; The total number of complaints made by providers, whether or not under contract, relating to the waiting time or distance of participating providers; The total number of complaints relating to the accuracy of the network directory; The total number of complaints relating to the dollar amount of reimbursement for out-of-network claims, including balance billing; and The percentage of complaints described in §C(4)(d) of this regulation that are for claims subject to the federal No Surprises Act; A description of the carrier’s procedures, including training of customer service representatives, detailing how claims will be handled when participating providers are not available and an enrollee obtains health care services pursuant to Insurance Article, §15-830, Annotated Code of Maryland; A description of the procedures that the carrier will utilize to assist enrollees in obtaining medically necessary services when no participating provider is available without unreasonable travel or delay, including procedures to coordinate care and to limit the likelihood of costs to the enrollee that exceed the amount that would have been incurred had the health care services been provided by a participating provider; A description of whether the carrier’s provider contracts require health care providers to engage in appointment management, including procedures related to: No show policies; Patient appointment confirmation; Same day appointment slotting; Patient portals; Access to a provider performance dashboard to monitor appointment lag time, no show rate, bump rate (health care provider initiated cancelation of a scheduled appointment), and new patient appointments; and Weekly polling programs of providers to check for appointment availability; An indication of whether the network directory is searchable by covered benefit, for example, hearing aid, knee surgery, or physical therapist; An indication of whether the carrier has a patient portal for enrollees to make health care appointments; A description of whether the carrier has a formal process for assisting enrollees who have been unsuccessful in using the network directory to locate an appropriate provider with the necessary skill and expertise to treat the enrollee’s condition; A description of whether and how the carrier considered the role of public transportation in addressing the needs of enrollees who do not own a personal automobile when evaluating enrollees’ access to care under the travel distance standards described in Regulation .05 of this chapter; A description of telehealth utilization as described in Regulation .08 of this chapter; Documentation justifying to the Commissioner how the access plan meets each network sufficiency standard set forth in Regulations .05 — .07 of this chapter; and A list of all changes made to the access plan filed the previous year. The Commissioner may require a carrier to include in the annual access plan a report of the number of participating providers described in Regulation .03A(7) of this chapter for designated facility types, provider type codes, and specialty codes, if the Commissioner notifies the carrier in writing and identifies the particular facility types, provider type codes, and specialty codes that must be reported. The description required by Insurance Article, §15-112(c)(4)(iii), Annotated Code of Maryland shall identify whether the carrier has: Engaged in outreach to minority health care providers; and Offered financial incentives, such as payment towards loans previously incurred for health care provider education, to encourage health care providers to contract with the carrier. The description required by Insurance Article, §15-112(c)(4)(iv), Annotated Code of Maryland shall include: The number of primary care providers who report to the carrier that they use any of the following languages in their practices: American Sign Language; Spanish; Korean; Chinese (Mandarin or Cantonese); Tagalog; or French; A description of outreach efforts to recruit and retain providers from diverse cultural, racial, or ethnic backgrounds; A copy of the most recent enrollees’ language needs assessment made by or on behalf of the carrier, if one was made; A copy of the most recent demographic profile of the enrollee population made by or on behalf of the carrier, if one was made; A copy of any analysis or assessment made of provider network requirements based on an assessment of language needs or demographic profile of the enrollee population; A copy of any provider manual provisions that describe requirements for access to individuals with physical or mental disabilities; and Copies of policies and procedures designed to ensure that the provider network is sufficient to address the needs of both adult and child enrollees, including adults and children with: Limited English proficiency or illiteracy; Diverse cultural, racial, or ethnic backgrounds; Physical or mental disabilities; and Serious, chronic, or complex health conditions. For a group model HMO plan, when an enrollee’s place of employment is used instead of residence to calculate travel distance under Regulation .05B of this chapter, the data described in §C(3) of this regulation that is based on enrollee residence shall be reported based on the enrollee’s place of employment. The requirements found in §§C(3)—(12) and D— G of this regulation shall apply to annual access plans submitted on or after July 1, 2024. A carrier may file the information described in §C(3), (4), and (12) of this regulation separately from the other access plan materials described in §C of this regulation, provided the information described in §C(3), (4), and (12) of this regulation is submitted by a calendar day that shall be designated in a bulletin issued by the Commissioner at least 60 days prior to such filing date. The date by which the information described in §C(3), (4), and (12) of this regulation must be filed shall be set later in time than July 1 of the reporting year. Sufficiency Standards. Standard and Methodology. Except as stated in §B of this regulation, each provider panel of a carrier shall have within the geographic area served by the carrier’s network or networks, sufficient primary care providers, specialty providers, mental health and substance use disorder providers, hospitals, and health care facilities to meet the maximum travel distance standards listed in the chart in §A(5) of this regulation for each type of geographic area. The distances listed in §A(5) of this regulation shall be: Measured from the enrollee’s place of residence to the practicing location of the provider or facility; and Calculated based on road travel distance. Except for those provider types excluded under §A(3) of this regulation, for each provider type and facility type included on the carrier’s provider panel, the carrier shall: Map the residences of all Maryland enrollees covered under health benefit plans that use the provider panel; Calculate the road travel distance for each enrollee to the provider or facility with the closest practicing location; For each zip code, identify the total number of enrollees residing in the zip code and the number of enrollees residing within an area where the applicable distance standard is not met; For each zip code, calculate the percentage of enrollees residing within an area where the applicable distance standard is met; For each zip code that includes enrollees for whom the applicable travel distance standard is not met, calculate the average distance to the closest provider or facility for all enrollees residing in the zip code; For each of the urban, rural, and suburban areas identify the total number of enrollees residing in the geographic area; For each of the urban, rural, and suburban areas identify the total number of enrollees residing within an area where the applicable distance standard is not met; and For each of the urban, rural, and suburban areas identify the percentage of enrollees residing within an area where the applicable distance standard is met. Instead of independently calculating the road travel distance for each enrollee as described in §A(1)(c)(i) and (ii) of this regulation, a carrier may use a methodology that: Maps the practicing locations of every participating provider within the geographic area served by the carrier’s network or networks; Identifies any geographic areas within each Maryland zip code that fall outside of the applicable distance standard based on road travel distance from the provider locations; and Enables the carrier to accurately identify the information and perform the calculations described in §A(1)(c)(iii)-(viii) of this regulation. A carrier shall submit, as part of its documentation justifying to the Commissioner how the access plan meets the network sufficiency standards in this regulation: Geo-access maps for each provider type and facility type except for those excluded under §A(3) of this regulation showing the practicing locations of participating providers, and identifying either the geographic areas within each zip code where the applicable distance standard is not met, or the locations of enrollees with a residence outside the applicable distance standard; For any facility types listed in §A(5) of this regulation that provide services for substance use disorders, the percentage of facilities on the carrier’s provider panel that provide adolescent services; and For any facility types listed in §A(5) of this regulation that provide services for substance use disorders, the percentage of facilities on the carrier’s provider panel that provide services for alcohol treatment only, drug abuse treatment only, and alcohol and drug abuse treatment. A carrier shall report each number and percentage described in §A(1)(c)(iii)—(viii) of this regulation as part of the annual access plan filing. When an enrollee elects to utilize a gynecologist, pediatrician, or certified registered nurse practitioner for primary care, a carrier may consider that utilization as a part of its meeting the primary care provider standards listed in §A(5) of this regulation. The travel distance standards listed in §A(5) of this regulation do not apply to the following: Home health care; Durable medical equipment; Heart transplant programs; Heart or lung transplant programs; Kidney transplant programs; Liver transplant programs; Lung transplant programs; or Pancreas transplant programs. All other providers and facility types included on the carrier’s provider panel but not listed in the chart in §A(5) of this regulation, including physical therapists and licensed dietitian-nutritionist, shall individually be required to meet maximum distances standards of 15 miles for Urban Areas, 40 miles for Suburban Areas, and 90 miles for Rural Areas. Chart of Travel Distance Standards. Group Model HMO Plans Sufficiency Standards. Standard and Methodology. Each group model HMO’s health benefit plan’s provider panel shall have within the geographic area served by the group model HMO’s network or networks, sufficient primary care providers, specialty providers, mental health and substance use disorder providers, hospitals, and health care facilities to meet the maximum travel distance standards listed in the chart in §B(5) of this regulation for each type geographic area. The distances listed in §B(5) of this regulation shall be: Measured from the enrollee’s place of residence or, at the option of the carrier, place of employment from which the enrollee gains eligibility for participation in the group model HMO’s health benefit plan to the practicing location of the provider or facility; and Calculated based on road travel distance. Except for those provider types excluded §B(3) of this regulation, for each provider type and facility type included on the group model HMO’s provider panel, the carrier shall: Map the residences or places of employment of all Maryland enrollees covered under health benefit plans that use the provider panel; Calculate the road travel distance for each enrollee to the provider or facility with the closest practicing location; For each zip code identify the total number of enrollees with a residence or place of employment in the zip code and the number of enrollees with a residence or a place of employment within an area where the applicable distance standard is not met; For each zip code calculate the percentage of enrollees with a residence or place of employment within an area where the applicable distance standard is met; For each zip code that includes enrollees for whom the applicable travel distance standard is not met, calculate the average distance to the closest provider or facility for all enrollees with a residence or place of employment within the zip code; For each of the urban, rural, and suburban areas identify the total number of enrollees with a residence or place of employment in the geographic area; For each of the urban, rural, and suburban areas identify the number of enrollees with a residence or place of employment within an area where the applicable distance standard is not met; and For each of the urban, rural, and suburban areas identify the percentage of enrollees with a residence or place of employment within an area where the applicable distance standard is met. Instead of independently calculating the road travel distance for each enrollee as described in §B(1)(c)(i) and (ii) of this regulation, a carrier may use a methodology that: Maps the practicing locations of every participating provider within the geographic area served by the group model HMO’s network or networks; Identifies any geographic areas within each Maryland zip code that fall outside of the applicable distance standard based on road travel distance from the provider locations; and Enables the carrier to accurately identify the information and perform the calculations described in §B(1)(c)(iii)—(viii) of this regulation. When calculating the number or percentage of enrollees with a place of employment within an area or zip code under §B(1)(c)(iii)—(viii) of this regulation, the carrier shall include only those enrollees who gain eligibility for participation in the group model HMO’s health benefit plan from their place of employment. A carrier shall submit, as part of its documentation justifying to the Commissioner how the access plan meets the network sufficiency standards in this regulation: Geo-access maps for each provider type and facility type except for those excluded under §B(3) of this regulation showing the practicing locations of participating providers, and identifying either the geographic areas within each zip code where the applicable distance standard is not met, or the locations of enrollees with a residence or place of employment outside the applicable distance standard; For any facility types listed in §B(5) of this regulation that provide services for substance use disorders, the percentage of facilities on the carrier’s provider panel that provide adolescent services; and For any facility types listed in §B(5) of this regulation that provide services for substance use disorders, the percentage of facilities on the carrier’s provider panel that provide services for alcohol treatment only, drug abuse treatment only, and alcohol and drug abuse treatment. A carrier shall report each number and percentage described in §B(1)(c)(iii)—(viii) of this regulation as part of the annual access plan filing. When an enrollee elects to utilize a gynecologist, pediatrician, or certified registered nurse practitioner for primary care, a carrier may consider that utilization as a part of its meeting the primary care provider standards listed in §B(5) of this regulation. The travel distance standards listed in §B(5) of this regulation do not apply to the following: Home health care; Durable medical equipment; Heart transplant programs; Heart or lung transplant programs; Kidney transplant programs; Liver transplant programs; Lung transplant programs; or Pancreas transplant programs. All other provider and facility types included on the carrier’s provider panel, but not listed in the chart at §B(5) of this regulation, including physical therapists and licensed dietitian-nutritionist, shall individually be required to meet maximum distances standards of 20 miles for Urban Areas, 40 miles for Suburban Areas, and 90 miles for Rural Areas. Chart of Travel Distance Standards. Essential Community Providers. Each provider panel of a carrier, that is not a group model HMO provider panel, shall include: At least 30 percent of the available essential community providers providing medical services in each of the urban, rural, and suburban areas; At least 30 percent of the available essential community providers providing mental health services in each of the urban, rural, and suburban areas; and At least 30 percent of the available essential community providers providing substance use disorder services in each of the urban, rural, and suburban areas. Methodology for calculating essential community provider inclusion standard. Except as provided in §§C(2)(b) and (c) of this regulation, a carrier shall use the MHBE ECP Network Inclusion Calculation Methodology that is described in the Instructions on Meeting the Essential Community Provider Plan Certification Standard guidance provided by the Maryland Health Benefit Exchange, which is current as of the date 3 months prior to the due date of the annual access plan. The calculation described in §C(2)(a) of this regulation shall be performed separately for essential community providers providing medical services, mental health services, and substance use disorder services in each of the urban, rural, and suburban areas. If the Maryland Health Benefit Exchange changes the MHBE ECP Network Inclusion Calculation Methodology after the effective date of this regulation, a carrier may not use the revised methodology to calculate the essential community provider inclusion standard in §C(1) of this regulation unless the Commissioner has approved the revised methodology for this purpose. Each group model HMO plan shall demonstrate that its own providers located in Health Professional Shortage Areas or low-income zip codes within its service area perform at or above the 50th percentile on the following two HEDIS measures: Initiation and Engagement of Alcohol and Other Drug Abuse or Dependence Treatment; and Utilization of the PHQ-9 to Monitor Depression Symptoms for Adolescents and Adults. Each group model HMO plan shall demonstrate that it has alternative standards for addressing the needs of low income, medically underserved individuals. One manner in which a group model HMO may demonstrate this is by providing the Maryland Insurance Administration with its narrative or alternate standard justification to the essential community provider requirement, which was submitted to and accepted by the Maryland Health Benefit Exchange for certification as a qualified health planstandards of practice as determined by the treating provider acting within the scope of the provider’s license, certification, or other authorization. Network Capacity. Each carrier shall create and utilize written policies and procedures to monitor the availability of services. On a semiannual basis, each carrier shall make available to its enrollees the median waiting times to obtain the following in-person appointments with a participating provider as measured from the date of the initial request to the date of the earliest available in-person appointment: Urgent care for medical services; Inpatient urgent care for mental health services; Inpatient urgent care for substance use disorder services; Outpatient urgent care for mental health services; Outpatient urgent care for substance use disorder services; Routine primary care; Preventive care/well visits; Non-urgent specialty care; Non-urgent mental health care; and Non-urgent substance use disorder care. To calculate the median waiting times for the appointments described in §A(2) of this regulation, a carrier shall: Make direct contact with a random selection of provider offices qualified to provide the services for each of the appointment types listed in §A(2) of this regulation to ask for next available in-person appointments; and Retain documentation of the efforts described in §A(3)(a) of this regulation. The minimum sample size for the random selection of provider offices described in §A(3)(a) of this regulation shall be equivalent to the lesser of: Fifty percent of the participating providers qualified to provide the services for each of the appointment types listed in §A(2) of this regulation; or One hundred provider offices. The Commissioner may conduct a centralized survey to measure waiting time, by carrier, for each appointment type listed in §A(2) of this regulation. The survey described in §A(5) of this regulation shall utilize a statistically reliable and valid methodology that includes making direct contact with a random selection of participating providers for each carrier who are qualified to provide the services for each of the appointment types listed in §A(2) of this regulation to ask for next available appointments. The Commissioner may: Contract with a vendor to conduct the survey; and Charge a carrier a reasonable fee to cover the costs of the survey. The Commissioner shall publish the methodology used to conduct the survey on the Maryland Insurance Administration’s website. For any semiannual period in which the Commissioner conducts the survey described in §A(5) of this regulation: The Commissioner shall provide notice to each carrier subject to this chapter of the intent to conduct the survey at least 3 months in advance; The Commissioner may require each carrier to submit a current roster of network providers for each provider panel used by the carrier, and any additional information the Commissioner determines is necessary for the survey to be conducted; and A carrier is exempt from the requirement to make direct contact with a random selection of provider offices to calculate the median waiting times as described in §A(3) of this regulation. Sufficiency Standards. On a semiannual basis, a carrier shall determine whether the provider panel meets the waiting time standards listed in §E of this regulation based on the direct contacts with provider offices described in §A(3)(a) of this regulation or the survey described in §A(5) of this regulation. Subject to the exceptions in §§C and D of this regulation, if a carrier’s provider panel fails to meet the waiting time standards listed in §E of this regulation for at least 90 percent of appointments in each category, the carrier shall notify the Administration within 10 business days identifying the deficiency in the provider network and the efforts that have been taken or will be taken to correct the deficiency. Preventive care services and periodic follow-up care, including but not limited to, standing referrals to specialty providers for chronic conditions, periodic office visits to monitor and treat pregnancy, cardiac or mental health or substance use disorder conditions, and laboratory and radiological monitoring for recurrence of disease, may be scheduled in advance consistent with professionally recognized standards of practice as determined by the treating provider acting within the scope of the provider’s license, certification, or other authorization. A visit scheduled in advance in accordance with §C of this regulation may be disregarded when determining compliance with the waiting time standards listed in §E of this regulation. Chart of Waiting Time Standards. Except for a Group Model HMOs health benefit plan, the provider panel for each carrier shall meet the provider-to-enrollee ratio standards listed in §B of this regulation. The provider-to-enrollee ratios shall be equivalent to at least 1 full-time physician, or as appropriate, another full-time provider for: 1,200 enrollees for primary care; 2,000 enrollees for pediatric care; 2,000 enrollees for obstetrical/gynecological care; 2,000 enrollees for mental health care or services; and 2,000 enrollees for substance use disorder care or services. The ratios described in §B of this regulation shall be calculated based on: The number of enrollees covered under all health benefit plans issued by the carrier in Maryland that use that provider panel; and The number of providers in that provider panel with practicing locations: In Maryland; or Within the applicable maximum travel distance standard specified in Regulation .05 of this chapter outside the geographic boundaries of Maryland. Telehealth Utilization Data Reporting. For annual access plans submitted on or after July 1, 2024, a carrier shall report the following data on telehealth utilization for the calendar year prior to submission of the annual access plan: The total number of in-network telehealth claims for each provider type and facility type listed in Regulation .05 of this chapter in each of the urban, rural, and suburban areas and in each Maryland county and Baltimore City; and The percentage of total in-network claims for each provider type and facility type listed in Regulation .05 of this chapter in each of the urban, rural, and suburban areas and in each Maryland county and Baltimore City that are in-network telehealth claims. The geographic area for claims data described in §A(1) of this regulation shall be based on: The enrollee’s place of residence; or When an enrollee’s place of employment is used instead of residence to calculate travel distance under Regulation .05B of this chapter for a group model HMO, place of employment from which the enrollee gains eligibility for participation in the health benefit plan. Travel Distance Credit. Subject to approval by the Commissioner as described in §B(5) of this regulation, when calculating the enrollee travel distance for each provider type under Regulation .05A and B of this chapter, a carrier may apply a per-enrollee telehealth mileage credit in a geographic area where the applicable maximum travel distance standard is not met as measured between the practicing location of the nearest provider and the enrollee’s place of residence or, at the option of a group model HMO, place of employment from which the enrollee gains eligibility for participation in the health benefit plan. The telehealth mileage credit described in §B(1) of this regulation shall be: Five miles for an enrollee with a residence or, for a group model HMO, place of employment from which the enrollee gains eligibility for participation in the health benefit plan, in an urban geographic area; Ten miles for an enrollee with a residence or, for a group model HMO, place of employment from which the enrollee gains eligibility for participation in the health benefit plan, in a suburban geographic area; and Fifteen miles for an enrollee with a residence or, for a group model HMO, place of employment from which the enrollee gains eligibility for participation in the health benefit plan, in a rural geographic area. The telehealth mileage credit described in §B(1) of this regulation may be applied to a maximum of 10 percent of enrollees for each provider type in each of the urban, rural, or suburban geographic areas. A carrier seeking to apply the telehealth mileage credit described in §B(1) of this regulation shall identify: Each provider type and geographic area to which the credit is being applied; The percentage of enrollees for which the carrier met the travel distance standard for the provider type and geographic area before the credit was applied; and The percentage of enrollees for which the carrier met the travel distance standard for the provider type and geographic area after the credit was applied. The Commissioner may approve the telehealth mileage credit described in §B(1) of this regulation if the carrier sufficiently demonstrates that it provides coverage for and access to clinically appropriate telehealth services from participating providers for the provider type and geographic area to which the credit is being applied, in accordance with the documentation requirements of §D of this regulation. Appointment Waiting Time Credit. Subject to approval by the Commissioner as described in §C(3) of this regulation, when determining whether the carrier’s provider panel meets the waiting time standards under Regulation .06E of this chapter for at least 90 percent of appointments in each category, a carrier may apply a telehealth credit of up to 10 percentage points for each appointment category where the standard is not met. A carrier seeking to apply the telehealth credit described in §C(1) of this regulation shall identify: Each appointment type to which the credit is being applied; The percentage of appointments for which the carrier met the waiting time standard before the credit was applied; and The percentage of appointments for which the carrier met the waiting time standard after the credit was applied. The Commissioner may approve the telehealth credit described in §C(1) of this regulation if a carrier sufficiently demonstrates, in accordance with the documentation requirements of §D of this regulation, that: The carrier provides coverage for and access to clinically appropriate telehealth services from participating providers for the appointment type to which the credit is being applied; The carrier provides coverage for a corresponding in-person service if the enrollee chooses not to elect utilization of a telehealth service; and The carrier establishes, maintains, and adheres to written policies and procedures to assist enrollees for whom a telehealth service is not clinically appropriate, not available, or not accessible with obtaining timely access to an in-person appointment within a reasonable travel distance with: A participating provider; or A nonparticipating provider at no greater cost to the enrollee than if the service was obtained from a participating provider. Required Documentation. A carrier seeking to apply the telehealth credit described in §B(1) or C(1) of the regulation shall submit the following documentation to demonstrate that it provides coverage for and access to clinically appropriate telehealth services as described in §§B(5) and C(3)(a) of this regulation: A description of any requirements imposed or incentives provided for participating providers to offer telehealth services; A detailed description of all telehealth services offered under the health benefit plans issued by the carrier in Maryland that use the provider panel including: Telehealth modalities covered; Types of platforms through which participating providers may deliver telehealth; Whether the carrier offers or provides services through a telehealth-only vendor or platform, and which types of services are provided on this basis; Whether the carrier arranges for telehealth services to be available on a 24/7 basis, and which types of services are provided on this basis; Whether the carrier arranges for telehealth kiosks to be installed and maintained in convenient locations throughout Maryland; and The specific services available through telehealth for each provider type and appointment type to which the telehealth credit is being applied; Evidence that telehealth is clinically appropriate and available for the services performed by each provider type and for each appointment type to which the telehealth credit is being applied, which may include: Actual telehealth utilization data comparing telehealth claims for the specific provider type or appointment type to telehealth claims for all provider types or appointment types; Actual telehealth utilization data comparing telehealth claims for the specific provider type or appointment type to all claims for the same provider type or appointment type; Survey results or attestations from participating providers indicating that telehealth is offered for the services performed by the specific provider type or for the specific appointment type; Enrollee survey results indicating that enrollees have the willingness and ability to use telehealth services for the specific provider type or appointment type; and Other documentation that, in the discretion of the Commissioner, demonstrates the clinical appropriateness and availability of telehealth services for the provider type or appointment type to which the credit is being applied; and For the telehealth mileage credit described in §B(1) of this regulation, evidence that telehealth services in general are available and accessible in the zip codes where the telehealth mileage credit is being applied to enrollee’s residence or place of employment, which may include: Actual telehealth utilization data comparing the ratio of telehealth claims to in-person claims for all types of services on the aggregate in the geographic area of the zip codes where the credit is being applied to the ratio of telehealth claims to in-person claims for all types of services on the aggregate statewide; Enrollee survey results indicating that enrollees have the willingness and ability to use telehealth services in general in the geographic area where the credit is being applied; and Other documentation that, in the discretion of the Commissioner, demonstrates the availability and accessibility of telehealth services in the zip codes where the credit is being applied. A carrier seeking to apply the telehealth credit described in §C(1) of the regulation shall submit the following documentation to demonstrate that it provides coverage for a corresponding in-person service and that it establishes, maintains, and adheres to written policies and procedures to assist enrollees with obtaining timely access to an in-person appointment as described in §C(3)(b)—(c) of this regulation: Excerpts from actual plan materials describing benefits for telehealth and in-person services; Copies of the actual written policies and procedures; A description of any information, outreach, and educational materials the carrier provides to enrollees informing them of the assistance available from the carrier to assist with obtaining a timely appointment; A description of whether the carrier provides assistance on a 24/7 basis to guide enrollees needing urgent care after normal business hours to an appropriate provider, including assistance provided through a customer service telephone option or a contracted telehealth triage service; and Evidence that the carrier ensures, in practice, that enrollees are able to obtain timely access to an in-person appointment as described in §C(3)(c) of this regulation, which may include: Documentation of the number of enrollees the carrier assisted with getting appointments within the applicable waiting time standard under Regulation .06E of this chapter; Documentation of the number of appointments with a nonparticipating provider for the appointment type to which the credit is being applied where the enrollee received services at no greater cost than if the service was obtained from a participating provider; Enrollee survey results indicating satisfaction with the carrier’s efforts to provide assistance with obtaining a timely in-person appointment; and Other documentation that, in the discretion of the Commissioner, demonstrates that the carrier regularly assists enrollees in obtaining timely in-person appointments. If a carrier’s provider panel fails to meet one or more of the standards specified in Regulations .05—.07 of this chapter, the carrier shall provide the following information to the Commissioner as part of the annual access plan: A description of any network adequacy waiver previously granted by the Commissioner; An explanation of how many providers in each specialty or health care facility type that the carrier reasonably estimates it would need to contract with or otherwise include in its network to satisfy each unmet standard; A description of the methodology used to calculate the estimated number of providers in §A(2) of this regulation; A list of physicians, other providers, or health care facilities related to each unmet standard and within the relevant service area that the carrier attempted to contract with, identified by name and specialty, if any, or health care facility type; A description of how and when the carrier last contacted the physicians, other providers, or health care facilities; A description of any reason each physician, other provider, or health care facility gave for refusing to contract with the carrier; An analysis of any trends in the reasons given by physicians, providers, or health care facilities for refusing to contract with the carrier, and a description of the carrier’s proposals or attempts to address those reasons and improve future contracting efforts; Identification of all incentives the carrier offers to providers to join the network; If applicable, a substantiated statement that there are insufficient numbers of physicians, other providers, or health care facilities available within the relevant service area for a covered service or services for which the carrier failed to meet a standard; A description of other efforts and initiatives undertaken by the carrier in the past year to enhance its network and address the deficiencies that contributed to each unmet standard; A description of steps the carrier will take to attempt to improve its network to avoid a future failure to meet a standard; An explanation of any other mitigating factors that the carrier requests the Commissioner to consider; and An attestation to the accuracy of the information provided in relation to each unmet standard. The Commissioner may find good cause to grant a network adequacy waiver of one or more of the standards specified in Regulations .05—.07 of this chapter, if the information provided by the carrier under §A of this regulation demonstrates that: The physicians, other providers, or health care facilities necessary for an adequate network: Are not available to contract with the carrier; Are not available in sufficient numbers; Have refused to contract with the carrier; or Are unable to reach agreement with the carrier. The reported failure to meet a standard is a result of limitations or constraints with the measurement methodology rather than an actual deficiency in the network. The Commissioner shall post a list of all network adequacy waivers that are granted for each annual access plan on the Maryland Insurance Administration’s website. Subject to Insurance Article, §15-802, Annotated Code of Maryland, the following information that is included in a carrier’s access plan shall be considered confidential by the Commissioner: Proprietary methodology used to annually assess the carrier’s performance in meeting the standards established under this chapter; Proprietary methodology used to annually measure timely access to health care services; and Factors used by the carrier to build its network. A carrier submitting an access plan or supplemental information required for the network adequacy waiver standards may submit a written request to the Commissioner that specific information included in the plan not be disclosed under the Public Information Act and shall: Identify the particular information that the carrier requests not be disclosed; and Cite the statutory authority that permits denial of access to the information. The Commissioner may review a request made under §B of this regulation upon receipt of a request for access pursuant to the Public Information Act. The Commissioner may notify the carrier that made a request under §B of this regulation before granting access to information that was the subject of the request. For each provider panel used by a carrier for a health benefit plan, the carrier shall provide the following network sufficiency results for the health benefit plan service area in the standardized format described on the Maryland Insurance Administration’s website: Travel Distance Standards. For each provider type and facility type listed in Regulation .05 of this chapter, list the percentage of enrollees for which the carrier met the travel distance standards, in the following format, with provider types listed first in alphabetical order, followed by facility types in alphabetical order: All provider and facility types described in §§A(4) and B(4) of Regulation .05 of this chapter and included on the carrier’s provider panel shall be listed individually in the chart described in §A(1)(a) of this regulation with the corresponding data for that specific type of provider or facility. If the telehealth mileage credit described Regulation .08B of this chapter was applied when calculating the percentage of enrollees for which the carrier met the travel distance standards, the carrier shall: Note the particular provider types and geographic areas to which the credit was applied by including an asterisk in the chart; and Include a corresponding footnote stating “As permitted by Maryland regulations, a telehealth mileage credit was applied to up to 10 percent of enrollees for each provider type noted with an asterisk in each of the urban, rural, or suburban geographic areas. The mileage credit is 5 miles for urban areas, 10 miles for suburban areas, and 15 miles for rural areas.” List the total number of certified registered nurse practitioners counted as a primary care provider. List the total percentage of primary care providers who are certified registered nurse practitioners. List the total number of essential community providers in the carrier’s network in each of the urban, rural, and suburban areas providing: Medical services; Mental health services; and Substance use disorder services. List the total percentage of essential community providers available in the health benefit plan’s service area that are participating providers for each of the nine categories described in §A(1)(f) of this regulation. List the total number and percentage of local health departments in the carrier’s network providing: Medical services; Mental health services; and Substance use disorder services. Appointment Waiting Time Standards. For each appointment type listed in Regulation .06 of this chapter, list the calculated median waiting time to obtain an in-person appointment with a participating provider, in the following format: If the telehealth credit described Regulation .08C of this chapter was applied when determining whether the carrier’s provider panel met the waiting time standards under Regulation .06E of this chapter for at least 90 percent of appointments in any category, the carrier may include a statement on the executive summary disclosing the availability of telehealth appointments to supplement the in-person appointments for that category. If the carrier arranges for telehealth services to be provided from participating providers beyond traditional office hours for an appointment type listed in Regulation .06 of this chapter, the carrier may include a statement on the executive summary disclosing the availability of those services. Provider-to-Enrollee Ratio Standards. This subsection does not apply to Group Model HMO health benefit plans. For all other carriers, summarize the network performance for each provider-to-enrollee ratio standard listed in Regulation .07 of this chapter by listing the calculated number of providers in the provider panel, rounded to the nearest whole number, for each of the following categories of enrollees: 1,200 enrollees for primary care; 2,000 enrollees for pediatric care; 2,000 enrollees for obstetrical/gynecological care; 2,000 enrollees for mental health care or service; and 2,000 enrollees for substance use disorder care and services. The network adequacy access plan executive summary form filed by a carrier pursuant to §A of this regulation is not confidential information. Insurance Article, §§2-109(a)(1) and 15-112(a)—(d), Annotated Code of Maryland Effective date: December 31, 2017 (44:25 Md. R. 1180) Chapter revised effective May 15, 2023 (50:9 Md. R. 379) This chapter applies to carriers that issue or renew dental plans in Maryland and use a provider panel for a dental plan offered in Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Carrier” means: An insurer authorized to sell dental insurance; A nonprofit health service plan that provides coverage for dental services; or A dental plan organization as defined in Insurance Article, §14-401, Annotated Code of Maryland. “Dental plan” means a contractual arrangement for dental services. “Dental network adequacy waiver request” means a written request from a carrier to the Commissioner in which the carrier seeks the Commissioner’s approval to be relieved of certain dental network adequacy standards in this chapter for 1 year. “Dental service” has the meaning stated in Insurance Article, §14-401, Annotated Code of Maryland. “Dentist” has the meaning stated in Health Occupations Article §4-101, Annotated Code of Maryland. “Enrollee” means a person entitled to dental benefits from a carrier. Essential Community Provider. “Essential community provider” means a provider that serves predominantly low-income or dentally underserved individuals. “Essential community provider” includes local health departments. Network. “Network” means a carrier’s participating providers with which a carrier contracts to provide dental services to the carrier’s enrollees under the carrier’s dental plan. “Network” includes, if a carrier uses a provider panel developed by a subcontracting entity, providers that contract with the subcontracting entity to provide dental services to the carrier’s enrollees under the carrier’s dental plan. “Participating provider” means a provider on a carrier’s provider panel. “Provider” means: A dentist; A group of dentists; or A facility where dentists provide dental services. Provider Panel. “Provider panel” means the providers who participate in a carrier’s network. “Provider panel” does not include an arrangement in which any provider may participate solely by contracting with the carrier to provide dental services at a discounted fee-for-service rate. “Rural area” means a list of zip codes provided on the Maryland Insurance Administration’s website, with a human population of less than 1,000 per square mile according to the Maryland Department of Planning. “Specialty provider” means a dentist who focuses on a specific area of dental care for a group of patients and is identified as a specialist by the Maryland State Board of Dental Examiners. “Suburban area” means a list of zip codes provided on the Maryland Insurance Administration’s website, with a human population equal to or more than 1,000 per square mile, but less than 3,000 per square mile according to the Maryland Department of Planning. Telehealth. “Telehealth” means, as it relates to the delivery of dental services, the use of interactive audio, video, or other telecommunications or electronic technology by a provider to deliver a dental service within the scope of practice of the provider at a location other than the location of the patient. “Telehealth” does not include: An audio-only telephone conversation between a provider and a patient; An electronic mail message between a provider and a patient; or A facsimile transmission between a provider and a patient. “Urban area” means a list of zip codes provided on the Maryland Insurance Administration’s website, with a human population equal to or greater than 3,000 per square mile according to the Maryland Department of Planning. “Urgent care” means the treatment for a condition of an enrollee that satisfies either of the following: A dental condition that, in the absence of dental services within 72 hours, could reasonably be expected by an individual, acting on behalf of a carrier and applying the judgment of a prudent layperson who possesses an average knowledge of health and medicine, would result in: Placing the enrollee’s life or dental health in serious jeopardy; The inability of the enrollee to regain maximum dental function; Serious impairment to the enrollee’s dental function; or Serious dysfunction of any bodily organ or part of the enrollee; or A dental condition of an enrollee that, in the absence of dental services or treatment within 72 hours, would, in the opinion of a provider with knowledge of the enrollee’s condition, subject the enrollee to severe pain that cannot be adequately managed without the care or treatment. “Waiting time” means the time from the initial request for dental services by an enrollee or by the enrollee’s treating provider to the earliest date offered for the appointment for services. Sufficiency Standards. Using the zip code list on the Maryland Insurance Administration’s website, each provider panel of a carrier shall have within the geographic area served by the carrier’s network or networks, sufficient dentists, including specialty providers, and facilities to meet the maximum travel distance standards listed in the chart under §A(2) of this regulation for each type of geographic area measured from the enrollee’s place of residence. Chart of Travel Distance Standards. Each provider panel of a carrier shall include at least 20 percent of the available essential community providers who provide dental services in each of the urban, rural, and suburban areas. Sufficiency Standards. Subject to §B of this regulation, each carrier’s provider panel shall meet the waiting time standards listed in §C of this regulation for at least 95 percent of the enrollees covered under dental plans that use that provider panel. When it is clinically appropriate and an enrollee elects to utilize a telehealth appointment, a carrier may consider that utilization as a part of its meeting the standards listed in §C of this regulation. Preventive care services and periodic follow-up care may be scheduled in advance consistent with professionally recognized dental standards of practice as determined by the treating provider acting within the scope of the provider’s license. Chart of Waiting Time Standards. A carrier may apply for a dental network adequacy waiver, for up to 1 year, of a dental network adequacy requirement listed in this chapter. The Commissioner may find good cause to grant the dental network adequacy waiver request only if the carrier demonstrates that the providers necessary for an adequate network: Are not available to contract with the carrier; Are not available in sufficient numbers; Have refused to contract with the carrier; or Are unable to reach agreement with the carrier. A carrier seeking a dental network adequacy waiver shall submit a written request to the Commissioner that includes the following information: A description of any waiver previously granted by the Commissioner; A list of providers within the relevant service area that the carrier attempted to contract with, identified by name and specialty, if any, or facility type; A description of how and when the carrier last contacted the providers; A description of any reason each provider gave for refusing to contract with the carrier; Steps the carrier will take to attempt to improve its network to avoid future dental network adequacy waiver requests; If applicable, a statement that there are no providers available within the relevant service area for a covered service or services for which the carrier requests the waiver; and An attestation to the accuracy of the information contained in the dental network adequacy waiver request. A carrier submitting a dental network adequacy waiver request may submit a written request to the Commissioner that specific information included in the plan or request not be disclosed under the Public Information Act and shall: Identify the particular information that the carrier requests not be disclosed; and Cite the statutory authority that permits denial of access to the information. The Commissioner may review a request made under §D of this regulation upon receipt of a request for access pursuant to the Public Information Act. The Commissioner may notify the carrier that made a request under §D of this regulation before granting access to information that was the subject of the request. For each provider panel used by a carrier for a dental plan, the carrier shall provide the network sufficiency results for the dental plan service area as follows: Travel Distance Standards. For each provider type listed in Regulation .03 of this chapter, list the percentage of enrollees for which the carrier met the travel distance standards, in the following format: List the total number of essential community providers in the carrier’s network. List the total percentage of essential community providers available in the dental benefit plan’s service area that are participating providers. Appointment Waiting Time Standards. For each appointment type listed in Regulation .04 of this chapter, list the percentage of enrollees in which the carrier met the appointment waiting time standards, in the following format: List the total percentage of telehealth appointments counted as part of the appointment waiting time standard results. Each carrier shall provide a description of how it will monitor, on an ongoing basis, the ability of participating providers to provide covered services to the carrier’s enrollees. The dental network adequacy access plan executive summary form filed by a carrier pursuant to §A of this regulation is not confidential information. Insurance Article, §§2-109(a)(1) and 15-112(e), Annotated Code of Maryland Effective date: Effective December 31, 2017 (44:25 Md. R. 1184) This chapter applies to all maximum allowable cost pricing claims made to a pharmacy benefits manager for a multisource generic prescription drug, medical product, or device, provided to a beneficiary of a purchaser. In this chapter, the following terms have the meanings indicated. Terms Defined. “Appeal decision” means a written or electronic notice issued by a PBM in response to an appeal filed by a contracted pharmacy of the maximum allowable cost used to adjudicate a claim. “Beneficiary” means an individual who receives prescription drug coverage or benefits from a purchaser. “Carrier” has the meaning stated in Insurance Article §15-1601, Annotated Code of Maryland. “Compensation program” has the meaning stated in Insurance Article §15-1601, Annotated Code of Maryland. “Contracted pharmacy” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “MAC complaint” means a communication by a contracted pharmacy that disputes the appeal decision, and is submitted on a MAC complaint form to the Commissioner, after the pharmacy benefits manager’s internal appeal process has been exhausted as required by Insurance Article, §15-1628.1(f), Annotated Code of Maryland. “MAC complaint form” means the form adopted by the Commissioner under Regulation .05 of this chapter. “MAC list” means a list of multisource generic drugs, medical products, and devices for which a MAC has been established by a pharmacy benefits manager or a purchaser. “Maximum allowable cost” or “MAC” has the meaning stated in Insurance Article, §15-1628.1, Annotated Code of Maryland. “Multisource generic drug” means a generic drug as defined in Health-General Article, §21-2C-01(f), Annotated Code of Maryland, for which there is at least one other drug and does not include a brand name drug as that term is defined in Health Occupations, §12-504, Annotated Code of Maryland. “Participating pharmacy contract” means a contract filed with the Commissioner that is: Between a pharmacy and a: Pharmacy benefits manager; Pharmacy services administrative organization; or Group purchasing organization; Filed as required by the Commissioner; Not disapproved by the Commissioner; and In compliance with the requirements stated in this chapter. “Pharmacist” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland. “Pharmacy” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland. “Pharmacy benefits management services” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy benefits manager” or “PBM” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy services administration organization” or “PSAO” means an entity that provides a contracted pharmacy with contracting administrative services relating to prescription drug benefits. “Pricing information” means anything used in the mathematical calculation to determine the payment to a contracted pharmacy. “Purchaser” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Source” means the publisher or publishers stated in the participating pharmacy contract, used by the PBM, in any manner, to establish the basis of the PBM’s MAC reimbursement amount to a contracted pharmacy, under a participating pharmacy contract compensation program. “Working day” means any day that the Maryland Insurance Administration is open for business. A PBM, whether its contract is directly with a pharmacy or indirectly with a pharmacy through a PSAO or group purchasing organization, shall disclose to a contracted pharmacy at the time of entering into a contract with a pharmacy and at least 30 working days before any contract change for a contracted pharmacy: The applicable terms, conditions, and reimbursement rates, including: The sources; and The terms of the compensation program; The process and procedures for verifying pharmacy benefits and beneficiary eligibility; The dispute resolution, internal appeal process under Regulation .04 of this chapter, and audit appeals process; and The process and procedures for verifying the prescription drugs included on the formularies used by the PBM. A PBM, whether its contract is directly with a pharmacy or indirectly with a pharmacy through a PSAO or group purchasing organization, shall: Update its pricing information at least every 7 days; Establish a reasonable process by which a contracted pharmacy has access to the current and applicable MAC lists and price list in an electronic format as updated in accordance with the requirements of this section; and Immediately after a pricing information update occurs pursuant to this regulation, use the updated pricing information in calculating the payments made to all contracted pharmacies. A claim paid on behalf of a carrier to a contracted pharmacy under a participating pharmacy contract is subject to the requirements of Insurance Article, §§15-1005, 15-1008, 15-1009, and 15-1631, Annotated Code of Maryland. Each PBM subject to this chapter shall establish written procedures to investigate and resolve disputes filed by a contracted pharmacy. The internal appeal procedures established by the PBM shall: Be in writing; and Contain administrative processes and safeguards designed to ensure and verify that the MAC pricing was determined in accordance with the participating pharmacy contract and Maryland law, and that the contract provisions have not been applied in an arbitrary or capricious manner. The procedures established by the PBM may not require: More than one appeal before filing a complaint with the Commissioner; or The payment of a fee to file an appeal. The internal appeal procedures established by the PBM shall be provided to the Commissioner on request. Prior to filing a MAC complaint with the Commissioner, a contracted pharmacy or its designee shall exhaust the internal appeal process established in the participating pharmacy contract and used by the PBM to appeal, investigate, and resolve a dispute regarding the MAC claim amount. A contracted pharmacy or its designee may file a MAC complaint with the Commissioner to dispute a PBM’s appeal decision for the following reasons: The PBM’s MAC pricing did not meet the requirements of Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland, related to MAC pricing; or The PBM’s MAC pricing did not meet the applicable terms of the applicable participating pharmacy contract. A MAC complaint is properly completed and may be filed if a contracted pharmacy or designee: Completes all applicable portions of the Commissioner’s MAC complaint form; Provides a copy of the relevant contract or the provisions that are related to the MAC appeal, including but not limited to: MAC; MAC pricing; Sources; Pricing information; and The compensation program of the applicable participating pharmacy contract; and Provides a copy of the appeal decision. A MAC complaint may not include more than ten appeal decisions using a single MAC complaint form. Notification of the MAC Complaint to the PBM. Upon receipt of a completed MAC complaint form, the Commissioner shall provide a copy of the submitted MAC complaint form to the PBM. Within 5 working days of receiving the Commissioner’s notice, the PBM shall provide the Commissioner: A complete, unredacted copy of the applicable portion of the participating pharmacy contract relating to the compensation program and the complaint filed with the Commissioner, including any other contract under which the pricing information is determined; A copy of the applicable source and pricing information used to calculate the MAC; The MAC calculated on a per unit basis based on the same generic product identifier or national drug code number; A mathematical calculation that demonstrates how the reimbursement amount was determined; All information required to complete the response portion of the MAC complaint form; and Any other information the Commissioner may require for the purposes of determining a PBM’s compliance with: Insurance Article, Annotated Code of Maryland; This chapter; The compensation program; or The applicable terms of the applicable participating pharmacy contract. Insurance Article, §§15-1601, 15-1604, 15-1605, 15-1607, 15-1609, 15-1628, 15-1628.1, and 15-1642, Annotated Code of Maryland Effective date: Effective March 23, 2020 (47:6 Md. R. 343) Regulation .02B amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .03 amended effective February 7, 2022 (49:3 Md. R. 141) This chapter applies to all cost pricing and reimbursement disputes or a request to review the failure to pay the contractual reimbursement amount of a submitted claim made to a pharmacy benefits manager by a pharmacist or pharmacy for a prescription drug, medical product, or device, provided to a beneficiary of a purchaser. In this chapter, the following terms have the meanings indicated. Terms Defined. “Appeal decision” means a written or electronic notice in response to an appeal under this chapter provided to a contracted pharmacy that includes a reason for the appeal denial. “Beneficiary” means an individual who receives prescription drug coverage or benefits from a purchaser. “Carrier” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Compensation program” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Complaint” means a communication by a contracted pharmacy that disputes the appeal decision, and is submitted on a complaint form to the Commissioner, after the pharmacy benefits manager’s internal appeal process has been exhausted as required by Insurance Article, §15-1628.2, Annotated Code of Maryland. “Complaint form” means the form developed by the Commissioner under Regulation .05 of this chapter. “Contracted pharmacy” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Direct or indirect remuneration fee” means an adjustment in total compensation received directly or indirectly by a contracted pharmacy from a PBM that is determined after the sale of the product or service, including an adjustment of an adjudicated claim based on the use of a generic effective rate or fee or performance-based reimbursement. “Participating pharmacy contract” means a contract filed with the Commissioner that is: Between a pharmacy and a: Pharmacy benefits manager; Pharmacy services administrative organization; or Group purchasing organization; Filed as required by the Commissioner; Not disapproved by the Commissioner; and In compliance with the requirements stated in this chapter. “Pharmacist” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland. “Pharmacy” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland. “Pharmacy benefits management services” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy benefits manager” or “PBM” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy services administration organization” or “PSAO” means an entity that provides a contracted pharmacy with contracting administrative services relating to prescription drug benefits. “Pricing information” means anything used in the mathematical calculation to determine the payment to a contracted pharmacy. “Purchaser” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. Review Decision. “Review decision” means a written or electronic notice in response to a request from a contracted pharmacy for a review of a failure to pay the contractual reimbursement amount of a submitted claim. “Review decision” does not include an appeal decision. “Source” means the publisher or publishers stated in the participating pharmacy contract, used by the PBM, in any manner, to establish the basis of the PBM’s pricing or the reimbursement amount to a contracted pharmacy, under a participating pharmacy contract’s stated compensation program. “Working day” means any day that the Maryland Insurance Administration is open for business. A PBM, whether its contract is directly with a pharmacy or indirectly with a pharmacy through a PSAO or group purchasing organization, shall disclose to a contracted pharmacy at the time of entering into a contract with a pharmacy and at least 30 working days before any contract change for a contracted pharmacy: The applicable terms, conditions, and reimbursement rates, including: The sources; and The terms of the compensation program; The process and procedures for verifying pharmacy benefits and beneficiary eligibility; The dispute resolution, internal appeal process under Regulation .04 of this chapter, and audit appeals process; and The process and procedures for verifying the prescription drugs included on the formularies used by the PBM. A claim paid on behalf of a carrier to a contracted pharmacy under a participating pharmacy contract is subject to the requirements of Insurance Article, §§15-1005, 15-1008, 15-1009, and 15-1631, Annotated Code of Maryland. Each PBM subject to this chapter shall establish written procedures to investigate and resolve disputes filed by a contracted pharmacy. The internal appeal procedures established by the PBM shall: Be in writing; and Contain administrative processes and safeguards designed to ensure and verify that the pricing was determined in accordance with the participating pharmacy contract and Maryland law, and that the contract provisions have not been applied in an arbitrary or capricious manner. The procedures established by the PBM may not require: More than one appeal before filing a complaint with the Commissioner; or The payment of a fee to file an appeal. The internal appeal procedures established by the PBM shall be provided to the Commissioner on request. The internal procedures established by the PBM shall: Provide written notice of the PBM’s decision no later than 90 days after receipt of the appeal or review; Pay any money due within 30 days after the internal review is complete; and Provide a contracted pharmacy: 21 days to file an appeal after the contracted pharmacy is charged a direct or indirect remuneration fee; or A minimum of 180 days to request review of the reimbursement amount of a submitted claim. Prior to filing a complaint with the Commissioner, a contracted pharmacy or its designee shall exhaust the internal appeal process established in the participating pharmacy contract. A contracted pharmacy or its designee may file a complaint with the Commissioner to dispute a PBM’s appeal decision for the following reasons: The PBM’s cost pricing did not comply with Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland; or The PBM’s cost pricing or reimbursement amount determination did not meet the terms of the applicable participating pharmacy contract. A complaint is properly completed and may be filed if a contracted pharmacy or its designee: Completes all applicable portions of the Commissioner’s complaint form; Provides a copy of the relevant contract or the provisions that are related to the appeal, including but not limited to establishing a drug pricing or pharmacy reimbursement amount, sources, pricing information, and the compensation program of the applicable participating pharmacy contract; and Provides a copy of the appeal decision. A complaint may not include more than ten appeal decisions using a single complaint form. Notification of the Complaint to the PBM. Upon receipt of a completed complaint form, the Commissioner shall provide a copy of the submitted complaint form to the PBM. Within 5 working days of receiving the Commissioner’s notice, the PBM shall provide the Commissioner: A complete, unredacted copy of the applicable portion of the participating pharmacy contract relating to the compensation program and the complaint filed with the Commissioner, including any other contract under which the pricing or reimbursement amount is determined; A copy of the applicable source and pricing information used to calculate the pharmacy reimbursement amount; A mathematical calculation that demonstrates how the reimbursement amount was determined; All information required to complete the response portion of the complaint form; and Any other information the Commissioner may require for the purposes of determining a PBM’s compliance with: Insurance Article, Annotated Code of Maryland; This chapter; The compensation program; or The applicable terms of the participating pharmacy contract. Insurance Article, §§15-1601, 15-1604, 15-1605, 15-1607, 15-1609, 15-1628, 15-1628.2, 15-1630, and 15-1642, Annotated Code of Maryland Effective date: Effective March 23, 2020 (47:6 Md. R. 343) Regulation .02B amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .03 amended effective February 7, 2022 (49:3 Md. R. 141) This chapter applies to the submission of any participating pharmacy contract or amendment required to be filed under Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Administration” means the Maryland Insurance Administration. “Commissioner” means the Maryland Insurance Commissioner. “Noncompliant” means a contract or amendment that is not in compliance with Maryland statutes and regulations. “Participating pharmacy contract” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Working day” means any day that the Maryland Insurance Administration is open for business. Pursuant to the requirements of Insurance Article, §15-1628(b), Annotated Code of Maryland, a PBM shall submit to the Commissioner as an informational filing each participating pharmacy contract form and each amendment to a contract form at least 30 days before the contract form or amendment to the contract form is to become effective. The Commissioner is not required to review the informational filing to evaluate whether a contract form or amendment to a contract form is in violation of Maryland law at the time the informational filing is made. Unless it is disapproved by the Commissioner, a PBM may use a contract form or amendment to a contract form after it has been filed with the Commissioner and 30 days have passed since the filing was acknowledged by the Commissioner in writing as having been received. A PBM may not file a contract form or amendment form that has been previously disapproved by the Commissioner. Nothing in this regulation shortens the time period for notice under Insurance Article, §15-1628(a), Annotated Code of Maryland, which requires a PBM to provide at least 30 working days’ notice before any contract change. The filing shall include a cover letter which includes the following: A list of the contract forms and amendment forms included in the submission; and A brief description of the purpose of each contract form and amendment form included in the submission. Each page of a contract or amendment shall be identified by a form number which is unique to that form. This number shall be printed in the lower left-hand corner of the first page, and no other number shall appear in close proximity to the form number. A filing made under this chapter shall include a signed certification from a responsible officer of the PBM that, to the best of the officer’s knowledge and belief, the contract forms and amendment forms comply with applicable statutes and regulations. A PBM may not file a contract form or amendment form before the PBM has successfully registered as a PBM with the Commissioner. A PBM may have a contract form or amendment to a contract form disapproved at any time after the contract form or amendment to a contract form has been submitted as part of an informational filing if the contract form or amendment form contains or uses any language that: Violates Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland, or any applicable statutory provisions, including but not limited to Insurance Article, §§15-112, 15-112.2(a)—(e), 15-123(d), 15-1004, 15-1005, 15-1008(c), 15-1009, 15-1628—15-1628.3, 15-1629, 15-1631, and 15-1633—15-1639, and Health-General Article, §§19-710(s) and (t) and 19-712.2, Annotated Code of Maryland; Does not disclose the components of the compensation program through which a reimbursement rate is set; Includes a definition of “multisource generic drug” that is inconsistent with COMAR 31.10.46, or “generic” or “brand name drug” that is inconsistent with Health Occupations Article, §12-504, Annotated Code of Maryland; Allows the PBM to reimburse a covered drug in an amount that differs, including zero, based on the identity of the wholesale distributor used by a contracting pharmacy for acquisition of the covered drug; Except for instances of error or fraud, allows the PBM to reclassify, recategorize, or recharacterize an adjudicated claim; In any way prohibits or restricts a pharmacist or pharmacy from filing a complaint with the Commissioner; or Fails to include the internal appeal provisions in the contract. No provisions in Insurance Article, Annotated Code of Maryland, or this chapter may be waived or modified by contract. If a PBM uses a contract form or amendment form which becomes effective and the contract form or amendment form is subsequently found by the Commissioner to be noncompliant, the Commissioner may: Issue an order that: Gives notice of the disapproval; States a reason for the disapproval; and States the effective date of the disapproval in the notice; and Impose a penalty as provided under Insurance Article, §15-1642, Annotated Code of Maryland. An order under this regulation is subject to a hearing under Insurance Article, §2-210, Annotated Code of Maryland. A request for a hearing under this regulation does not stay that portion of the order that requires a PBM to cease and desist from the conduct identified in the order. Insurance Article, §§2-109, 12-203(d)(2), 15-1628, and 15-1642, Annotated Code of Maryland Effective date: Effective March 23, 2020 (47:6 Md. R. 343) Regulation .02B amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .03 amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .04A amended effective February 7, 2022 (49:3 Md. R. 141) Regulation .05A amended effective February 7, 2022 (49:3 Md. R. 141) This chapter applies to all contractual agreements between a pharmacy services administrative organization and an independent pharmacy in which a pharmacy services administrative organization negotiates on behalf of an independent pharmacy with purchasers or pharmacy benefit managers for prescription drug coverage or benefits, medical devices, or biologics provided to a beneficiary of a purchaser. In this chapter, the following terms have the meanings indicated. Terms Defined. “Appeal decision” means a written or electronic notice in response to an appeal under this chapter provided to a contracted pharmacy that includes a reason for the appeal denial. “Contracted pharmacy” means an independent pharmacy in a pharmacy services administrative contract. “Delivered by electronic means” includes: Delivery to an electronic mail address at which an independent pharmacy or contracted pharmacy has consented to receive notice; and Posting on an electronic network, together with separate notice to an independent pharmacy or contracted pharmacy directed to the electronic mail address at which the independent pharmacy or contracted pharmacy has consented to receive notice of the posting. “Independent pharmacy” has the meaning stated in Insurance Article, §15-2001(b), Annotated Code of Maryland. “Material change” means a change in control or business operations of a pharmacy services administrative organization after a purchase, merger, or acquisition of a parent company, subsidiary, or other organization. Medical Device. “Medical device” means a device used in the diagnosis, treatment, or prevention of disease. “Medical device” does not include: Any surgical or dental instrument; Physical therapy equipment; Any x-ray apparatus; or Any component or accessory of any of these items. “Pharmacy benefits manager (PBM)” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy services administrative contract” has the meaning stated in Insurance Article, §15-2001(d), Annotated Code of Maryland. “Pharmacy services administrative organization” or “PSAO” has the meaning stated in Insurance Article, §15-2001(e), Annotated Code of Maryland. “Purchaser” has the meaning stated in Insurance Article, §15-2001(f), Annotated Code of Maryland. “Working days” means any day that the Maryland Insurance Administration is open for business. A PSAO shall provide to a contracted pharmacy an electronic or paper copy of any contracts, amendments, payment schedules, or reimbursement rates within 5 working days after the execution of a contract, or an amendment to a contract, signed on behalf of the contracted pharmacy by the PSAO. A PSAO shall provide written notice to an independent pharmacy of any ownership interest or control by a parent company, subsidiary, or other organization before entering into a pharmacy services administrative contract with the independent pharmacy. A PSAO shall disclose to a contracted pharmacy in writing within 5 working days of any material change of ownership or control or a parent company, subsidiary, or other organization. The written disclosures required in §§B and C of this regulation shall identify the extent of any ownership interest or control, to include the percent of shares owned, by a parent company, subsidiary, or other organization that: Provides pharmacy services, prescription drug, or device services; or Manufactures, sells, or distributes prescription drugs, biologics, or medical devices. The written disclosures required in §§B and C of this regulation may be delivered by electronic means provided: The independent pharmacy or contracted pharmacy has affirmatively consented to that method of delivery and has not withdrawn the consent; The independent pharmacy or contracted pharmacy, before giving consent, is provided with a clear and conspicuous statement informing the pharmacy of: Any right or option of the pharmacy to have the notice provided or made available in paper or another nonelectronic form; The right of the pharmacy to withdraw consent to have notice delivered by electronic means and any fees, conditions, or consequences imposed in the event consent is withdrawn; Whether the consent applies: Only to notices or communications related to a particular transaction; or To identified categories of notices that may be delivered by electronic means during the course of the parties’ relationship; and The procedures the pharmacy must use to withdraw consent to have notice delivered by electronic means and to update information needed to contact the party electronically; The independent pharmacy or contracted pharmacy, before giving consent, is provided with a statement of the hardware and software requirements for access to and retention of a notice delivered by electronic means; and The process used to obtain consent of the independent pharmacy or contracted pharmacy to have notice delivered by electronic means meets the requirements of Commercial Law Article, Title 21, Subtitle 1, Annotated Code of Maryland. Each PSAO subject to this chapter shall establish written procedures to investigate and resolve disputes filed against the PSAO by a contracted pharmacy. The internal appeal procedures shall: Be in writing; and Contain administrative processes and safeguards designed to ensure and verify that a PSAO remits payment to a contracted pharmacy in accordance with the pharmacy services administrative contract and Maryland law, and that the contract provisions have not been applied in an arbitrary or capricious manner. The procedures established by the PSAO may not require: More than one appeal before filing a complaint with the Commissioner; or The payment of a fee to file an appeal. The internal appeal procedures established by the PSAO shall be provided to the Commissioner on request. Prior to filing a complaint with the Commissioner, a contracted pharmacy or its designee shall exhaust the internal appeal process established by the PSAO. A complaint is properly completed and may be filed if a contracted pharmacy or designee for the pharmacy: Completes all applicable portions of the Commissioner’s complaint form; and Provides a copy of the relevant contract or the provisions that are related to the internal dispute, including but not limited to any applicable remittance and copy of any appeal decision. Notification of the complaint to the PSAO. Upon receipt of a completed complaint form, the Commissioner shall provide a copy to the PSAO. Within 15 working days of receiving the Commissioner’s notice, the PSAO shall provide the Commissioner with: A complete, unredacted copy of the applicable portion of the pharmacy services administrative contract relating to the complaint filed with the Commissioner, including any other contract applicable to the complaint; and Any other information the Commissioner may require for the purposes of determining a PSAO’s compliance with: The Insurance Article, Annotated Code of Maryland; This chapter; or The applicable terms of the applicable pharmacy services administrative contract, PBM contract, or applicable purchaser’s contract. Insurance Article, §§15-2001—15-2019, Annotated Code of Maryland Effective date: December 26, 2022 (49:26 Md. R. 1081) This chapter applies to the submission of a pharmacy services administrative contract or an amendment to a pharmacy services administrative contract required to be filed under Insurance Article, Title 15, Subtitle 20, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Commissioner” means the Maryland Insurance Commissioner. “Contracted pharmacy” means an independent pharmacy in a contract with a pharmacy services administrative organization. “Independent pharmacy” has the meaning stated in Insurance Article, §15-2001(b), Annotated Code of Maryland. “Noncompliant” means a contract or amendment that is not in compliance with Maryland statutes and regulations. “Pharmacy benefits manager (PBM)” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Pharmacy services administrative contract” has the meaning stated in Insurance Article, §15-2001(d), Annotated Code of Maryland. “Pharmacy services administrative organization” or “PSAO” has the meaning stated in Insurance Article, §15-2001(e), Annotated Code of Maryland. Pursuant to the requirements of Insurance Article, §15-2010, Annotated Code of Maryland, and except as provided in §E of this regulation, a PSAO shall submit to the Commissioner all pharmacy services administrative contract forms and amendments to pharmacy services administrative contract forms. Unless it is disapproved by the Commissioner, and except as provided in §E of this regulation, a PSAO may not use a contract form or amendment to a contract form unless it has been filed with the Commissioner and: 60 days have passed since the filing was acknowledged by the Commissioner in writing as having been received; or Subject to the filing corrections under §C of this regulation, a PSAO receives written notice from the Commissioner that the contract form or amendment to a contract form may be used in Maryland. A PSAO that receives written notice from the Commissioner that its contract form or amendment to a contract form contains defects and is disapproved, may re-submit the disapproved forms indicating the corrections made. Except for the circumstances in §C of this regulation, a PSAO may not file a contract form or amendment form that has been previously disapproved by the Commissioner. Amendments to Contracts. A PSAO that amends any of the following provisions of a previously filed contract shall file the amendment form with the Commissioner: Any provision dealing with prohibitions on certain communications between a pharmacy or pharmacist and a beneficiary, as described in Insurance Article, §15-1611, Annotated Code of Maryland; Any provision dealing with the responsibility of a PBM to disclose specified information to a pharmacy, as described in Insurance Article, §15-1628, Annotated Code of Maryland; Any provision dealing with fees for credentialing a pharmacy or pharmacist to participate in the network of a PBM or purchaser or the frequency of credentialing renewals, as described in Insurance Article, §15-1628, Annotated Code of Maryland; Any provision describing the sources used to determine maximum allowable cost pricing, the process for updating pricing information, or the process to appeal, investigate, and resolve disputes regarding maximum allowable cost pricing, as described in Insurance Article, §15-1628.1, Annotated Code of Maryland; Any provision describing the process to appeal, investigate, and resolve disputes regarding cost pricing and reimbursement, as described in Insurance Article, §15-1628.2, Annotated Code of Maryland; Any provision dealing with a pharmacy being charged or held responsible for a fee or performance-based reimbursement related to the adjudication of a claim or an incentive program or being subject to a reduction in payment due to a reconciliation process, as described in Insurance Article, §15-1628.3, Annotated Code of Maryland; Any provision describing the process to audit pharmacies, as described in Insurance Article, §15-1629, Annotated Code of Maryland; Any provision dealing with retroactive denials or modifications of reimbursement to a pharmacy or pharmacist, as described in Insurance Article, §15-1631, Annotated Code of Maryland; Any provision dealing with therapeutic interchanges, as described in Insurance Article, §§15-1633, 15-1634, 15-1635, 15-1636, and 15-1637, Annotated Code of Maryland; Any provision dealing with the PSAO providing copies of contracts, amendments, payment schedules, or reimbursement rates to a pharmacy, as described in Insurance Article, §15-2011, Annotated Code of Maryland; Any provision dealing with notification to a pharmacy of a material change in ownership or control of certain organizations affiliated with the PSAO, as described in Insurance Article, §15-2013, Annotated Code of Maryland; Any provision dealing with the PSAO passing claims remittances from a PBM or purchaser to a pharmacy, as described in Insurance Article, §15-2015, Annotated Code of Maryland; Any provision describing an arrangement for a pharmacy to purchase drugs, biologics, or medical devices from an entity under common ownership with the PSAO, as described in Insurance Article, §15-2016, Annotated Code of Maryland; Any provision dealing with the applicability of Maryland law; or Any provision of the contract that is revised to comply with Maryland law. An amendment to a previously filed contract form that does not amend a provision described in §E(1) of this regulation is not required to be filed with the Commissioner. A filing made under this chapter shall include a cover letter which includes the following: A list of the contract forms and amendment forms included in the submission; and A brief description of the purpose of each contract form and amendment form included in the submission. Each page of a contract or amendment shall be identified by a form number which is unique to that form. This number shall be printed in the lower left-hand corner of each page, and no other number shall appear in close proximity to the form number. A filing made under this chapter shall include a signed certification from a responsible officer of the PSAO that, to the best of the officer’s knowledge and belief, the contract forms and amendment forms comply with applicable statutes and regulations. A PSAO may not file a contract form or amendment form before the PSAO has successfully registered as a PSAO with the Commissioner. A PSAO may have a contract form or amendment to a contract form disapproved if the contract or amendment contains or uses any language that: Violates Title 15, Subtitle 16 or Subtitle 20 of the Insurance Article, Annotated Code of Maryland or any applicable statutory provisions, including but not limited to Insurance Article, §§15-1611, 15-1628, 15-1628.1, 15-1628.2, 15-1628.3, 15-1629, 15-1631, 15-1633, 15-1634—15-1639, 15-2011, 15-2013(c), 15-2015, and 15-2016, Annotated Code of Maryland; Includes a definition of “multisource generic drug” that is inconsistent with COMAR 31.46, or “generic” or “brand name drug” that is inconsistent with Health Occupations Article, §12-504, Annotated Code of Maryland; Allows the PBM to reimburse a covered drug in an amount that differs, including zero, based on the identity of the wholesale distributor used by a contracting pharmacy for acquisition of the covered drug; Except for instances of error or fraud, allows a PBM or PSAO to re-classify, re-categorize, or re-characterize an adjudicated claim; In any way prohibits or restricts a pharmacist or pharmacy from filing a complaint with the Commissioner; and Fails to include the internal appeal provisions in the contract. No provisions If a PSAO uses a contract or amendment that becomes effective and the contract or amendment is subsequently found by the Commissioner to be noncompliant, the Commissioner may: Issue an order that: Gives notice of the disapproval; States a reason for the disapproval; and States the effective date of the disapproval in the notice; and Impose a civil penalty as provided under Insurance Article, §15-2019, Annotated Code of Maryland. An order under this regulation is subject to a hearing under Insurance Article, §2-210, Annotated Code of Maryland. A request for a hearing under this regulation does not stay that portion of the order that requires a PSAO to cease and desist from the conduct identified in the order Insurance Article, §§2-109, 15-2010, 15-2011, 15-2013, 15-2015, and 15-2016, Annotated Code of Maryland Effective date: December 26, 2022 (49:26 Md. R. 1081) The purpose of this chapter is to adopt regulations to implement Insurance Article, §15-144, Annotated Code of Maryland, to ensure uniform definitions and methodology for the reporting requirements established under this chapter. This chapter applies to carriers that deliver or issue for delivery a health benefit plan in Maryland. In this chapter, the following terms have the meaning indicated. Terms Defined. “Analysis report” means the report required by Insurance Article, §15-144(c)(2), Annotated Code of Maryland. “As written” means the written policies, procedures, and related documents, including medical necessity criteria or guidelines, used in the development and description of a NQTL and the decision whether to apply a NQTL to a particular benefit by the carrier or any entity delegated by the carrier to manage mental health, substance use disorder, or medical/surgical benefits on behalf of the carrier. “Evidentiary standards” has the meaning stated in 45 C.F.R. §146.136(a). “Factor” has the meaning stated in 45 C.F.R. §146.136(a). “In operation” means as used in the implementation and application of NQTLs, including the administration of benefits. “Medical/surgical benefits” has the meaning stated in Insurance Article, §15-144(a)(4), Annotated Code of Maryland, and may be abbreviated as “med/surg benefits” or “M/S benefits”. “Medical Necessity” means medical necessity as determined by the definition, criteria, or guidelines used by the carrier or its private review agent to determine what is necessary, efficient, or appropriate for purposes of coverage of a service or benefit. Insurance Article, §15-802, Annotated Code of Maryland, requires use of the criteria published by the American Society of Addiction Medicine for the evaluation of the medical necessity, efficiency, or appropriateness of services to treat a substance use disorder. “Mental health benefits” has the meaning stated in Insurance Article, §15-144(a)(5), Annotated Code of Maryland. “MH/SUD” means mental health benefits and substance use disorder benefits as a combined category. “NQTL” means a nonquantitative treatment limitation as defined in Insurance Article, §15-144(a)(6), Annotated Code of Maryland. “Parity Act” has the meaning stated in Insurance Article, §15-144(a)(7), Annotated Code of Maryland. “Parity Act classification” has the meaning stated in Insurance Article, §15-144(a)(8), Annotated Code of Maryland. “Process” has the meaning stated in 45 C.F.R. §146.136(a). “Product” has the meaning stated in Insurance Article, §15-1309(a)(3), Annotated Code of Maryland. “Provider” means: A physician; Hospital; Facility; Practitioner; or Other person who is licensed or otherwise authorized to provide healthcare services. “Source” means the data, analyses, recommendation, requirement, meeting, or other information upon which a factor is based or from which a factor is derived or arises. “Strategy” has the meaning stated in 45 C.F.R. §146.136(a). “Substance use disorder benefits” has the meaning stated in Insurance Article, §15-144(a)(9), Annotated Code of Maryland. “Summary form” means the form required by Insurance Article, §15-144(g)(5), Annotated Code of Maryland. For each product offered by the carrier in the individual, small, and large group markets, a carrier that delivers or issues for delivery a health benefit plan in the State shall file a comparative analysis for each nonquantitative treatment limitation selected by the Commissioner in accordance with Insurance Article, §15-144 (c)(5), Annotated Code of Maryland, in the form required by the Commissioner, to demonstrate the carrier’s compliance with the Parity Act, in accordance with Insurance Article, §15-144(c)—(e), and (g), Annotated Code of Maryland. An analysis report shall be filed with the Commissioner using only the form developed by the Commissioner and posted on the Administration’s website. If, for any plan within a product described in §A of this regulation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the selected NQTLs to MH/SUD benefits and M/S benefits are different, as written or in operation, from the other plans within the product, the carrier shall submit a separate comparative analysis for the selected NQTLs for the plan, and the statement required by Insurance Article, §15-144(c)(3)(iii) shall note the exception and identify the plan. A carrier shall submit the data templates described in Insurance Article, §15-144(f), Annotated Code of Maryland, in the form required by the Commissioner. The analysis reports described in §§A—C of this regulation shall be submitted on or before July 1, 2024, and every 2 years thereafter. Carriers shall prepare the analysis report in coordination with any entity the carrier contracts with to provide, manage, or administer MH/SUD benefits. Carriers shall follow the instructions posted on the Administration's website to complete the analysis report. A complete analysis report shall include responses to each section of the standardized form, as described in the instructions posted on the Administration's website. Each analysis report shall contain the statements required by Insurance Article, §15-144(c)(3)(iii) and (g)(4), Annotated Code of Maryland. Failure to file a complete analysis report shall constitute noncompliance with the Parity Act and the Commissioner will have authority to act in accordance with the provisions of Insurance Article, §15-144 (j), Annotated Code of Maryland. Complete Analysis Report. The analysis required by Insurance Article, §15-144(d), Annotated Code of Maryland, shall have been performed for NQTLs in place during the calendar year preceding the analysis report. A carrier shall analyze each NQTL separately for each classification and sub-classification, as applicable, of benefits. If the carrier delegates administration or management of mental health, substance use disorder, or medical/surgical benefits to another entity (for example, a private review agent specializing in mental health and substance use disorder benefits or a pharmacy benefits manager), the analyses shall be conducted with close and coordinated involvement of both the carrier and the entity delegated by the carrier to manage mental health, substance use disorder, or medical/surgical benefits on behalf of the carrier. The carrier is responsible for providing all required information for the analyses, regardless of any delegation arrangement with a subcontracted entity. The analysis reports shall include the following information to be considered complete: All of the information identified in Insurance Article, §15-144(d)-(f), Annotated Code of Maryland, in the manner and format specified in the standard reporting form and associated instructions provided on the Administration’s website; A response to each step listed in the reporting form, for each NQTL selected in accordance with Insurance Article, §15-144 (c)(5), Annotated Code of Maryland in each classification and sub-classification, as applicable. If a particular item in a step is not applicable (for example, if none of the factors used to determine that the NQTL will apply to a benefit was given more weight than another), an explanation shall be provided as to why the item is not applicable; A statement as to whether there is any variation in the design or application of a guideline or standard used by the carrier between MH/SUD and medical/surgical benefits, and, if so, a description of the factors and process used for establishing that variation. Specific definitions of factors, processes, or criteria used to establish or support any variation is required. Any practice guidelines that may be associated with the NQTL shall also be provided; If the design or application of the NQTL turns on specific decisions in the administration of the benefits, identification of the basis of the decisions, the decision maker or makers, the timing of the decisions, and the qualifications of the decision maker or makers, including expertise and specialty; If the analyses rely upon any experts, an assessment of each expert's qualifications, expertise and specialty, and a description of the extent to which the carrier relied upon each expert's evaluations in setting recommendations regarding both MH/SUD and medical/surgical benefits. Any variation in the use of experts (for example, specialty matching, licensure levels, etc.) for MH/SUD compared to M/S shall be defined and justified; A description of all exception processes available for each NQTL and when the exception may be applied; An explanation of how much discretion is allowed in applying the NQTL and whether such discretion is afforded comparably for processing MH/SUD benefit claims and medical/surgical benefits claims; Documentation of audits, reviews, and analyses to check sample claims or other administrative data to assess how each NQTL operates in practice, and whether written processes are correctly carried out, including the results of the audits and reviews performed on the NQTLs selected in accordance with Insurance Article, §15-144(c)(5), Annotated Code of Maryland, to conduct the comparative analysis required under Insurance Article, §15-144 (d)(2), Annotated Code of Maryland, as written, and in operation; Citations to any documents, studies, testing, claims data, or reports that include factors, sources, evidentiary standards, or other evidence relied upon in developing or applying the NQTL (for example, meeting minutes or reports showing how those considerations were applied), with copies of those items available on request; and A description of the consequences or penalties that apply when the NQTL requirement is not met. A carrier subject to Insurance Article, §15-144, Annotated Code of Maryland, shall prepare a summary form using only the template form posted on the Administration’s website. The summary form shall be made available to plan members and accessible to the public on the carrier’s website no later than 30 days following the due date of each analysis report. In addition to the requirement under Insurance Article, § 15-144(c)(1)(iv), Annotated Code of Maryland that a carrier must provide the full comparative analysis to a member within 30 days of a written request, the carrier shall make the summary form available to plan members in response to a written request within 30 days of the request. Carriers shall follow the instructions for completing the summary form using the instructions posted on the Administration’s website. A complete summary form shall include responses to each applicable section of the standardized form, as described in the instructions posted on the Administration’s website. If, as a result of the review of the reports described in Regulation .04 of this chapter, the Commissioner finds that a carrier subject to Insurance Article, §15-144, Annotated Code of Maryland, failed to comply with provisions of the Parity Act, the Commissioner shall notify the carrier and require the carrier to submit a compliance plan pursuant to Insurance Article, §15-144(i), Annotated Code of Maryland, to correct the noncompliance. The notice shall be in writing, but may be transmitted electronically. The carrier shall have 90 days to file a compliance plan following the date a notice of noncompliance is issued by the Commissioner. The compliance plan shall include: An acknowledgement of the Commissioner’s finding of noncompliance; A summary of action or actions taken by the carrier to correct the noncompliance prior to the notice from the Commissioner; A summary of future action or actions to correct the noncompliance and the time frame when the actions will be taken; and A summary of amounts owed to members or providers due to violations of the Parity Act, including: Any amounts owed to members and the payment date or dates; Draft correspondence to members; Any amounts owed to providers and the payment date or dates; Draft correspondence to providers; and Confirmation of amounts paid to members and providers. This chapter is applicable to all reports filed after January 1, 2022. Insurance Article, §§2-109(a)(1) and 15-144, Annotated Code of Maryland Effective date: Effective December 27, 2021 (48:26 Md. R. 1113) Chapter revised effective October 13, 2025 (52:20 Md. R. 1003)