The Insurance Commissioner promulgates this chapter pursuant to Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland, for the purpose of governing and regulating various phases of the operations of health maintenance organizations. In this chapter, the following terms have the meanings indicated. Terms Defined. “Advertising” means: Printed and published material; Descriptive literature and sales aids; Sales talks; Sales materials, booklets, forms, pamphlets, brochures, illustrations, depictions, and form letters; Newspaper, radio, television, or direct mail advertising; and Any other material used for the promotion of enrollment. “Carrier” means: An HMO; An insurer; A nonprofit health service plan; A dental plan organization; or A fraternal benefit society. Contract on an Insert Page Basis. “Contract on an insert page basis” means a contract that is composed of insert pages, with each insert page being identified with a unique form number. “Contract on an insert page basis” does not include a contract that contains an insert that is identified with a unique form number and is longer than one page. Contract on a Sectional Basis. “Contract on a sectional basis” means a contract that is composed of sections, with each section being identified with a unique form number. “Contract on a sectional basis” includes a contract that contains sections that are only one page long. Form. “Form” means: A policy; A contract; A certificate; A rider; An endorsement; or An application. “Form” does not include a provider contract. “Group certificate” means the description of benefits and rights which pertain to the members covered under a group policy. “Group contract” or “group policy” means a contractual agreement entered into between an HMO and an employer, union, trustee, association, or organization for the provision of health care services on a prepaid basis to: Subscribers; or Subscribers and the subscriber's dependents, family members, or both. “HMO” means a health maintenance organization. “Individual contract” means a contractual agreement for the provision of health care services on a prepaid basis entered into between an HMO and a subscriber, provided the contract covers only the following persons: The subscriber; The subscriber and the subscriber's dependents, family members, or both; or The subscriber's dependents, family members, or both. “Member” means the subscriber and any of the subscriber's dependents or family members who are entitled to receive health care benefits from the HMO. “Subscriber” means for: Group contracts, the person who is eligible to be covered under the contract, other than as a dependent or a family member by reason of satisfying the eligibility requirements of the group contract; and Individual contracts, the person who completes the application for coverage with the HMO and who is covered under the contract. Submittals of Forms to Commissioner. An HMO shall submit to the Commissioner for approval every form that it intends to use in Maryland. The Commissioner shall either approve or disapprove the form for use within 60 days of the receipt of the form in the Commissioner's office. An HMO may not use a form before the Commissioner's approval unless the Commissioner has not acted at the end of the 60-day period described in §A(2) of this regulation. The Commissioner may withdraw the Commissioner's prior approval or may disapprove a form previously permitted to be used if the Commissioner gives the HMO at least 30 days' notice before the effective date of the Commissioner's action disapproving the form. Duplicate Forms Required For Nonelectronic Form Submissions. An HMO shall submit duplicate copies of each nonelectronic form the HMO intends to use in Maryland to the Commissioner for approval. If the Commissioner approves the nonelectronic form submitted by or on behalf of the HMO, the Commissioner shall: Retain one copy; and Return to the HMO one copy, with an appropriate notation indicating approval. Each form submitted for approval shall be accompanied by: A current transmittal form developed by: The Maryland Insurance Administration; or The National Association of Insurance Commissioners (NAIC); A filing fee in accordance with Insurance Article, §2-112, Annotated Code of Maryland; Except for electronic form filings, a self-addressed, stamped envelope; and A cover letter listing the forms submitted for approval by form number, with a brief description of each form filed for approval. The HMO may not use a form disapproved by the Commissioner. If a printed form has been disapproved, the HMO may resubmit the form with modifications made by imprinting, multigraph, mimeograph, multilith, electronic printer, or rubber stamp. The HMO may not resubmit a form with handwritten or typewritten changes, interlineations, or deletions. Submission of Forms. Except as provided in §F(2) of this regulation, an HMO shall submit forms for approval with the Commissioner. A third party may submit a form for approval on behalf of an HMO, if the third party includes a written authorization from the HMO to make the form filing. Representative Specimen Data. Except for applications filed for approval, an HMO shall complete each form filed for approval with representative specimen data. Contracts with Insert Pages. An HMO may file for approval of a contract on an insert page basis, only if: Each insert page is identified by a unique form number appearing in the lower left corner of the insert page; and The HMO includes the following information in the filing submission: A description of how the various insert pages will be combined; A listing of the insert pages that can be substituted for other specific insert pages; and The filing fee required under Insurance Article, §2-112, Annotated Code of Maryland, for each insert page with a unique form number. An HMO may not file for approval of insert pages for use with a previously approved contract, if the previously approved contract was not approved on an insert page basis. If an HMO files for approval of insert pages for a previously approved contract, the submission shall: Identify by form number and date of approval any insert pages that the new insert pages will replace; and Include a copy of the currently approved contract, unless the Commissioner waives the requirement or determines that a copy is not necessary to review the submission. Contracts Comprised of Sections. An HMO may file for approval of a contract on a sectional basis, only if: Each section is identified by a unique form number appearing in the lower left corner of the first page of the section; and The HMO includes the following information in the filing submission: A description of how the various sections will be combined; A listing of the sections that can be substituted for other specific sections; and The filing fee required under Insurance Article, §2-112, Annotated Code of Maryland, for each section with a unique form number. An HMO may not file for approval of sections for use with a previously approved contract, if the previously approved contract was not approved on a sectional basis. If an HMO files for approval of sections for a previously approved contract, the submission shall: Identify by form number and date of approval any sections that the new sections will replace; and Include a copy of the currently approved contract, unless the Commissioner waives the requirement or determines that a copy is not necessary to review the submission. Individual Contracts. Except as specified in §A(2) of this regulation, an HMO may not include variable material in an individual contract, or in a form to be used with an individual contract. An HMO may include variable material, in an individual contract or in a form to be used with an individual contract in the following portions of the form: The specifications, data, or schedule page; The product marketing name; The address of the HMO; Signatures of officers of the HMO; Descriptions of copayment amounts, deductibles, coinsurance amounts, out-of-pocket limits, annual maximums, or lifetime maximums; Specific dates, such as effective dates and termination dates; and Descriptions of benefit amounts or benefit limits. If an individual contract or a form to be used with an individual contract contains variable material as permitted under §A(2) of this regulation, the HMO shall: Bracket the variable material or otherwise mark the variable material to denote variability; and Include a statement of variability, in duplicate, that discusses how each variable item may change. If an individual contract or a form to be used with an individual contract is approved with variable material, an HMO may not submit a new statement of variability to be used with the previously approved contract or form, except for the following: Copayment amounts; Coinsurance amounts; Deductible amounts; Out-of-pocket limits; Annual maximums; Lifetime maximums; Benefit amounts; or Benefit limits. An HMO shall include the following with a new statement of variability filing for a previously approved form: A cover letter identifying the HMO and the HMO's National Association of Insurance Commissioners company code number; and The form number and date of approval of the form for which new variable material is being submitted. Group Contracts. An HMO may include variable material in a group contract or in a form to be used with a group contract, if the HMO: Brackets the variable material or otherwise marks the variable material to denote variability; and Includes a statement of variability, in duplicate, that discusses how each variable item may change, including all textual variations that are intended. If a group contract or a form to be used with a group contract is approved with variable material, an HMO may not submit a new statement of variability to be used with the previously approved group contract or form, except for the following: Copayment amounts; Coinsurance amounts; Deductible amounts; Out-of-pocket limits; Annual maximums; Lifetime maximums; Benefit amounts; or Benefit limits. An HMO shall include the following with a new statement of variability filing for a previously approved form: A cover letter identifying the HMO and the HMO's National Association of Insurance Commissioners company code number; and The form number and date of approval of the form for which new variable material is being submitted. The Commissioner shall deem a filing withdrawn by the HMO if the HMO fails to respond to correspondence from the Commissioner regarding the filing within 90 days of the date of the correspondence from the Commissioner. If an HMO resubmits a form for approval after 90 days of the date of the Commissioner's correspondence regarding the filing in which the form was included, the HMO shall: Include a new filing fee for the form and associated premium rates included in the filing; and Include in the filing all the information required in Regulation .03 of this chapter. Form Numbers. Each form shall be identified by a form number that is unique to that form. The form number shall be printed in the lower left corner of the first page, and no other number may appear near the form number. The text of each form shall be printed in a style of type which is easily legible, the size of which shall be uniform and not less than 10 point with a lower case unspaced alphabet length not less than 120 point. The text shall include all printed matter except the name and address of the HMO, name or title of the policy, the brief description, if any, and captions and subcaptions. Each form shall be clearly worded with all limitations, exclusions, and exceptions printed in the same size of type used to describe the benefits and grouped together under appropriate captions in boldfaced type. Name of HMO. Each complete form, except riders or endorsements, shall bear on the face the corporate name and either: The address (city and state) of the HMO; or The address of the company office that will administer the form. The name of the HMO shall appear more prominently on a form than the name of: An affiliate; A producer; An underwriter; A holding company; or A third party administrator. The name of the HMO shall be printed in a size of type larger than the title of the policy. Time shall be determined by any of the following which the HMO specifies in the contract: Time at the place the enrollee resides; Time at the place the contract is delivered; Time at the place the treatment is delivered; or Time at the location of the administrative office of the HMO. Each form shall contain the signature of a responsible officer of the HMO. A contract, certificate, rider, or endorsement may not contain any advertising material. HMO Coverage as Secondary Coverage. Each individual contract, group contract, and group certificate shall state whether or not benefits provided are to be secondary to the benefits which the member is entitled to receive under: Workers' compensation insurance; Medicare; and Any programs for which the member is not required to pay. An HMO contract may not: Provide benefits that are secondary to benefits payable under an automobile policy; or Include an exclusion for losses covered by an automobile policy. Each individual contract and group contract shall provide that notice of any increase in charges shall be given to the contract holder by the HMO at least 45 days before the change in rate is proposed to become effective. Each individual contract provided to subscribers shall describe the health services to be provided under the contract and shall contain the entire agreement between the HMO and the subscriber, including but not limited to: Date and time of inception and termination of contract; Initial rate to be charged and when the initial rate may be modified; Mode of payment, with provision for change of mode, if available; Late payment and reinstatement privileges; Cost sharing provisions, including copayments, coinsurance, and deductibles; Renewal conditions and applicable termination provisions; Provisions for adding new family members; Services to be provided under the contract; Provision for out-of-area coverage; Limits on length of stay, if any; Other limitations, exclusions, and exceptions; and The formal procedure to be followed in filing complaints or grievances. Each individual contract which covers the spouse of the subscriber shall provide that, in the event of the death of the subscriber, the spouse will become the successor subscriber. Each individual contract shall provide that the subscriber may, if the contract is not satisfactory for any reason, return it within 10 days of its receipt and receive a full refund of the charges paid. This right may not be exercised, however, if any member under the contract utilizes the services of the HMO within the 10-day period. Each group contract and each group certificate furnished to subscribers of a group shall comply with all applicable provisions required by §§A—J of this regulation, inclusive, except that the certificate may omit those items which pertain only to the group contract holder. Each individual contract, group contract, and group certificate shall include an incapacitated child provision that complies with the requirements found in Insurance Article, §15-402, Annotated Code of Maryland. Newborn Child, Adopted Child, Child Under Guardianship Provision. Each individual contract, group contract, and group certificate shall contain a provision for covering newborn children, adopted children, and children under guardianship in accordance with Insurance Article, §15-401, Annotated Code of Maryland. Each individual contract, group contract, and group certificate shall provide that, if the HMO for any reason beyond its control is unable to provide the health services promised in the contract, the HMO shall be liable for reimbursement of the expenses necessarily incurred by any member in procuring the services through other providers, to the extent prescribed by the Insurance Commissioner of Maryland. An application form shall stipulate the plan and any optional benefits being applied for. Permissible Look-Back Periods. Except as provided in §B(2) of this regulation, an application form may not ask any question relative to any previously existing injury, sickness, or condition which has not required medical care or advice during the: 7-year period immediately preceding the date of the application if the application is made for coverage under a group contract; or 5-year period immediately preceding the date of the application, if the application is made for coverage under an individual contract. An application may inquire about a dismemberment or other current impairment, the cause of which may have occurred before the time periods permitted by §B(1) of this regulation. If an application contains questions regarding past or present health conditions: The questions shall be asked to the best of the applicant's knowledge and belief; or The application shall include a statement that all of the answers provided are representations and are not warranties. If a rider or endorsement modifies the coverage applied for, signed acceptance by the applicant is required at or before delivery of the contract. A statement may not appear in the application with respect to a proxy through which one or more members of the board of directors is authorized to vote in the election of directors, or at any meeting of the board of directors. If an application inquires about the applicant's participation in “hazardous activities”, the application shall list the activities that are considered to be “hazardous”. If an application inquires about the applicant's use of “other habit-forming drugs”, the application shall list the specific drugs that are considered “habit-forming”. If an application inquires about a symptom of an applicant, the question shall be asked about a “known symptom” of a physical condition or mental condition. If an application inquires if an applicant has had any indication of a physical condition or mental condition, the question shall be asked about a “known indication” of a physical condition or mental condition. Applications for Individual HMO Contracts. If an application is to be used by more than one carrier, the application shall include check-off boxes to indicate the carrier to which application is being made. Each carrier using the application shall: File the application with the Commissioner for approval; and Receive approval of use of the application from the Commissioner before using it in Maryland. Applications for Group HMO Contracts. A group application may be used by more than one carrier if each carrier using the application: Files the application with the Commissioner; and Receives approval of the application from the Commissioner before using it in Maryland. If more than one carrier requests approval to use the same application with different group applicants, the application shall include check-off boxes to indicate the carrier to which application is being made. If more than one carrier requests approval to use the same application with the same group applicant, the application shall clearly identify the coverages underwritten by each carrier. If an application is to be completed by more than one individual, the signature box in the application shall clearly indicate that the signature applies only to the portion of the application completed by that individual. The submittal of a form shall be accompanied by the submittal of the rates charged for it, together with detailed supporting actuarial data. Subsequent changes in charged rates shall be submitted with detailed supporting actuarial data at least 60 days before the date that any change in the rate is proposed to become effective. The Commissioner shall approve or disapprove any rate submittal or change in the same manner as prescribed for approval or disapproval of forms. An HMO may not make or permit any differential in charged rates for any reason based on the age or sex of an enrollee unless there is actuarial justification for the differential. Charges may not be excessive, inadequate, or unfairly discriminatory. Advertising shall be truthful and may not be misleading in fact or implication. Advertising may not use words or phrases whose: Meaning is unclear or ambiguous; or Understanding depends upon familiarity with technical terminology. Advertising may not include words, phrases, or illustrations that are used in a manner which misleads or has the capacity or tendency to deceive or mislead. All advertising shall contain the name and address of the HMO as filed with the Commissioner. Termination of a Particular Service. If an HMO desires to cease offering a service under the health care contract in force, the services may not be terminated without prior approval of the Commissioner. If an HMO ceases offering a service under an in-force health care contract, arrangements equitable to the members regarding a cost adjustment or substitution of an equivalent service satisfactory to the Commissioner shall be made. A member of an HMO may have the membership cancelled or nonrenewed by the HMO only for the following reasons: Termination of the conditions, other than a change in the health of the member, under which the member became eligible to be enrolled under a group contract; Inability of the medical staff and the member to establish a reasonable physician-patient relationship; The member no longer resides, lives, or works in the service area; Failure of the member to pay any deductible or copayment charges permitted under any contracts approved by the Commissioner; Fraudulent use of the HMO's identification card by the member; The alteration or sale of prescriptions by the member; An attempt by the subscriber to enroll noneligible persons as dependents; The member has performed an act or practice that constitutes fraud; The member has made an intentional misrepresentation of material fact under the application for the HMO coverage; or Failure of the subscriber to pay any premium charge when due. Failure to Follow Prescribed Course of Treatment. An HMO may not cancel or nonrenew a member's HMO membership due to the member's refusal to follow a prescribed course of treatment. The HMO contract may provide that the HMO is not required to furnish any further benefits or services for a particular condition if the member refuses to follow a prescribed course of treatment for that condition. If the member disagrees with a prescribed course of treatment from an HMO physician, the HMO shall permit the member to receive a second opinion from another HMO physician. If the member receives a second opinion as described in §C(3) of this regulation, and if the second physician disagrees with the prescribed course of treatment, the HMO may not refuse to provide services or benefits for that particular condition, subject to the HMO's coverage documents and its utilization review protocols and policies. Required Notice of Termination. Except as provided in §D(3) of this regulation, if a member's coverage in an HMO is terminated or nonrenewed for a reason set forth in §B(2)—(9) of this regulation, the HMO shall provide notice of the termination or nonrenewal not less than 30 days before the date of cancellation or nonrenewal. The notice required by §D(1) of this regulation shall be delivered to the member in person or by first class mail addressed to the member's address last known to the HMO. An HMO is not required to provide the notice described in §D(1) of this regulation if the cause of termination is nonpayment of premium. If the member is entitled to have issued a health care contract, the notice required by §D(1) of this regulation shall be accompanied by information as to how the member may apply for a contract. If termination or nonrenewal is for nonpayment of copayments or deductibles, the notice required by §D(1) of this regulation shall state: The amount of charges due; and That if the member pays the amount of charges due, plus any administrative cost incurred in preparing and delivering the notice before the date of cancellation, membership will remain in full force and effect. The HMO shall provide, without limitations as to frequency or cost, except as established in the health care contract and provided for in these regulations, basic and supplemental health services to its members in the following manner: Reasonable deductibles and copayments may be required for the provision of specific services within the basic health services, unless the payments or the manner of payment unduly serves as a barrier to the delivery of basic health services; All services of health care providers provided for in the health care contract shall be provided through health care providers that are under contract to, or have agreements with, the HMO, except that this subsection does not apply to: Health care providers' services which the HMO and the Commissioner determine are unusual or infrequently used; Emergency services; Services performed outside of the HMO's service area for urgent care services; Services received from health care providers that do not contract with the HMO, if the member has a benefit under the HMO contract for services received from non-HMO health care providers; or Services received from a health care provider that does not contract with the HMO, if the member was referred to the health care provider by the HMO or by a provider under contract with the HMO; All services provided for in the health care contract shall, within the area serviced by the HMO, be available and accessible to each of its members: Promptly as appropriate; In a manner which assures continuity; and When medically necessary, 24 hours a day and 7 days a week; and Emergency services as follows: The HMO shall be liable for emergency expenses incurred by the member in securing any service customarily provided in the contract for emergency services incurred by the member which cannot reasonably be provided through the facilities of the HMO and which are considered medically necessary and justified; and The method used to establish the necessity of these services and the method the HMO shall use in fulfilling its financial responsibility for its health care services shall be set forth in the health care contract. Health Care Contracts. The HMO shall bind itself to provide to the members basic health services and other supplemental services as specified in the health care contract. A copy of coverages and costs shall be given to each member or member family unit. All services included in the benefits, as well as any limitations or exclusions, shall be clearly stated in written form. 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 HMO's central office. If agreements with consultants or other institutions are established by any HMO, the responsibilities, functions, objectives, and the terms of the agreements including financial arrangements and charges, of each outside resource shall be described in writing and signed by an authorized representative of the facility and the person or the agency providing the services. Filing Requirements. The HMO may not use a provider contract unless the form of the contract has been filed in duplicate with the Commissioner. The HMO shall file a provider contract at least 30 days before its intended use. Form Numbers. The provider contract shall be identified by a unique form number that appears in the lower left corner of the first page of the provider contract. Each amendment rider to a provider contract shall be identified by a unique form number that appears in the lower left corner of the first page of the amendment rider. If the HMO intends to amend any of the following provisions of a previously filed provider contract, the HMO shall file the amendment with the Commissioner at least 30 days before its intended use: The hold-harmless clause; Any provision dealing with the administration of a coordination of benefits clause; Any provision dealing with termination of the provider contract, as described in Insurance Article, §15-112, Annotated Code of Maryland; Any provision dealing with the process of filing or payment of claims, as described in Insurance Article, §§15-1004 and 15-1005, Annotated Code of Maryland; Any provision dealing with when capitation payments are due for newly assigned HMO members, as described in Insurance Article, §15-113, Annotated Code of Maryland; Any provision dealing with retroactive denials of reimbursement or denials of reimbursement for preauthorized care, as described in Insurance Article, §§15-1008 and 15-1009, Annotated Code of Maryland; Any provision dealing with the payment of bonuses or other incentive-based compensation, as described in Insurance Article, §15-113, Annotated Code of Maryland, but actual payment amounts or percentages are not required to be filed; Any provision requiring the health care provider to provide services to other than HMO members or giving the health care provider an option to provide services to other than HMO members, as described in Insurance Article, §15-112, Annotated Code of Maryland; Any provision that gives the HMO the right to assign, transfer or subcontract a health care provider's contract to an insurer that offers personal injury protection coverage, as described in Insurance Article, §15-125, Annotated Code of Maryland; Any provision dealing with a provider's responsibility for the acts or decisions of the HMO, as described in Health-General Article, §19-710, 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. The Commissioner shall consider any provider contract filed with the Commissioner to be proprietary commercial information and not a public record. All provider contracts, including agreements with hospitals, nonphysician providers, clinics, physicians' offices, and other related providers are subject to disapproval by the Commissioner for any of the following reasons: The provider contract does not meet reasonable requirements of providing quality medical care; The provider contract does not contain a hold-harmless clause in compliance with Health-General Article, §19-710(i), Annotated Code of Maryland; The provider contract does not provide for the rendition of services called for in the contracts with members in a reasonable manner; or The provider contract contains a provision that does not comply with Maryland law. Health-General Article, Title 19, Subtitle 7; Insurance Article, §§2-109 and 15-122; Annotated Code of Maryland Effective date: October 1, 1977 (4:18 Md. R. 1426) Regulation .01 amended effective April 1, 1991 (18:6 Md. R. 684) Regulation .02 amended effective April 1, 1991 (18:6 Md. R. 684) Regulation .04 amended effective April 1, 1991 (18:6 Md. R. 684) Chapter recodified from COMAR 09.30.55 to COMAR 31.12.02 effective September 7, 1998 (25:18 Md. R. 1439) Regulation .04H amended effective January 9, 2000 (26:27 Md. R. 2018) Chapter revised effective October 10, 2005 (32:10 Md. R. 1657) Regulation .07B amended effective May 17, 2010 (37:10 Md. R. 724)