Except for non-covered services set forth in Regulation .27 of this chapter and the non-capitated services described in COMAR 10.67.08, an MCO shall provide its enrollees with a benefits package that includes the covered services specified in this chapter when these services are deemed to be medically necessary including services covered under the Maryland Medicaid State Plan in the amount, duration, and scope set forth in the State Plan and in accordance with 42 CFR §440.230. An MCO shall ensure that the services provided are sufficient in amount, duration, or scope to reasonably achieve the purpose for which the services are furnished. An MCO is not required to provide non-covered services even when the service is medically necessary. Any limitations set forth in this chapter on covered services are not applicable to services required by enrollees who are younger than 21 years old when it is shown that the services are medically necessary to correct or lessen health problems detected or suspected by EPSDT screening services, as described in Regulation .20 of this chapter. An MCO may place appropriate limits on a service on the basis of criteria applied under the State plan, such as medical necessity. Cost Sharing and Prohibitions. Except for the following, an MCO may not charge its enrollees any copayments, premiums, or cost sharing: Up to a $3 copayment for brand-name drugs; Up to a $1 copayment for generic drugs; Any other charge up to fee-for-service limits as approved by the Department. An MCO may not: Deny services to an individual who is eligible for services because of the individual's inability to pay the cost sharing; Impose copayments for the following: Family planning services and supplies; Individuals younger than 21 years old; Pregnant women; Institutionalized individuals who are inpatients in long-term care facilities or other institutions; and Emergency services. Arbitrarily deny or reduce the amount, duration, or scope of a required service solely because of diagnosis, type of illness, or condition of the enrollee. An MCO shall ensure that all health care services provided under this chapter are performed, to the extent required by law, by an appropriate health care provider who is licensed, certified, or otherwise legally authorized to practice or deliver the services in the state in which the service is provided. An MCO shall provide for a second opinion from a qualified health care professional within the network, or, if necessary, arrange for the enrollee to obtain one outside the MCO network. An MCO shall provide to its enrollees medically necessary primary care services that are provided: By the enrollee's PCP; At the direction of the enrollee's PCP; or With respect to a primary care service that is self-referred pursuant to Regulation .28 of this chapter: By an appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience; or By a clinic that furnishes health care services by or under the direction of a physician. An MCO shall provide to its enrollees medically necessary specialty care services that are outside of the enrollee's PCP's scope of practice, or, in the judgment of the enrollee's PCP, are not services that the PCP customarily provides, is specifically trained for, or is experienced in and are provided by: A physician or an advanced practice nurse, acting within the scope of the individual's license or certification, training, and experience; A practitioner other than a physician or an advanced practice nurse when the practitioner is in a physician's employ, is under the physician's direct supervision, and performs the service within the scope of the practitioner's license, certification, or other legal authorization, for the purpose of assisting in the provision of the specialty care service; A clinic that furnishes health care services by or under the direction of a physician; or For enrollees who are younger than 21 years old, a doctor of dental medicine or dental surgery, if the services are surgical services that are also typically performed by physicians. Notwithstanding §A(2) of this regulation, specialty care services provided under Regulations .04—.25 of this chapter may include medically necessary diagnostic and treatment services provided by a physician or other appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience. An MCO shall provide outpatient drugs as defined in §1927(k)(2) of the Social Security Act. An MCO shall provide to its enrollees all medically necessary pharmaceutical services and pharmaceutical counseling, including but not limited to: Legend drugs; Insulin; All FDA approved contraceptives; Hypodermic needles and syringes; Enteral nutritional and supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home; Enteric coated aspirin prescribed for the treatment of arthritic conditions; Nonlegend ferrous sulfate oral preparations; Nonlegend chewable tablets of any ferrous salt when combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation when the enrollee is younger than 12 years old; Medical supplies used in the preparation of compounded prescriptions for home intravenous therapy; Medical supplies or equipment used in the administration or monitoring of medication prescribed or ordered for an enrollee by a qualifying provider as specified in §B of this regulation; Latex condoms; Nonlegend ergocalciferol liquid (Vitamin D); and Emergency contraceptives for female recipients. Except as provided in §B of this regulation, an MCO is required to provide only those drugs and related pharmaceutical products that are prescribed or ordered by: An MCO provider; An out-of-plan provider, when the pharmacy services are ordered or prescribed in connection with medical care furnished by the provider to the MCO's enrollee: In response to the enrollee's emergency medical condition; or Pursuant to the enrollee's self-referral to the provider, when the care delivered qualifies as a permissible self-referred service under Regulation .28 of this chapter; or A behavioral health provider for drugs not in the behavioral health formulary. An MCO shall provide over-the-counter emergency contraceptives and latex condoms to enrollees without requiring an order from an authorized prescriber. An MCO shall provide coverage for the following when performed by a pharmacist: Contraceptive services, as follows: A patient assessment performed at the pharmacist’s practice location in order to determine: Whether to prescribe contraceptives; and Which contraceptive options to prescribe; and If contraceptives are prescribed, a referral: To the participant’s primary care practitioner or reproductive health care practitioner; or If the participant does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services. Administration of: Injectable medications for the treatment of sexually transmitted infection; and Maintenance injectables medications. Drug Formulary. An MCO shall establish and maintain a drug formulary that is at least equivalent to the standard therapies of the Maryland Medical Assistance Program, and include at a minimum: Covered generic and name brand medications; and The tier each medication is on. An MCO shall include in its formulary drugs that are appropriate for medical management, safe, and effective. An MCO shall expand its formulary, as needed, to include drugs that are equivalent to new drugs approved by the federal Food and Drug Administration, and which are deemed to be appropriate, safe, and efficacious in the medical management of the MCO's enrollees. An MCO shall include in its formulary the following drugs: Leuprolide acetate; Clonidine; Guanfacine; Medroxyprogesterone; and Liothyronine. To ensure that its formulary drugs are medically necessary, safe, and efficacious, an MCO shall: Subject its formulary to a review process that is: Established and conducted by the MCOs Pharmacy and Therapeutics Committee; Approved by the Department; and Coordinated with the formulary review process of the Specialty Mental Health Services delivery system; and Submit its formulary for the review and approval of the Department, based upon the standards set forth in this regulation. Unless approved by the Department, an MCO may not require or utilize prior authorization or step therapy criteria for coverage of formulary drugs if such prior authorization or step therapy requires a recipient to use a drug that is included in the behavioral health formulary. Any option for accessing pharmacy services by mail order may be implemented only at the request of the enrollee except for when the drug is a specialty drug as defined in §H of this regulation. In this regulation, the term specialty drug means: A prescription drug that: Is prescribed for an individual with a complex, chronic or rare medical condition; Costs $600 or more for up to a 30-day supply; Is not typically stocked at retail pharmacies; and Requires a difficult or unusual process of delivery to the patient in the preparation, handling storage, inventory or distribution of the drug; or Requires enhanced patient education, management, or support, beyond those required for traditional dispensing, before or after administration of the drug. . If an enrollee subsequently requests to use a retail pharmacy for specialty drugs the MCO may not limit the enrollee to the use of a mail order pharmacy. An MCO shall: Establish and maintain a drug utilization review program; Adhere to the minimum performance standards established by the Department for these programs, whenever used, including but not limited to standards for the following drug use management components: Formulary management; Generic substitution; Therapeutic substitution; Prior authorization that complies with the requirements of §1927(d)(5) of the Social Security Act; Drug use evaluation (DUE); Disease management; and Pharmacy and Therapeutic Committee; Establish procedures to distinguish drug utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program; and Provide to the Department a detailed description of its drug utilization review program activities on an annual basis. The Department shall: Review each MCO’s drug utilization review program annually; and Notify an MCO annually if any of the standards established in §J(2) of this regulation have not been met. For any performance standard identified in §K(2) of this regulation, MCOs shall acknowledge any deficiencies within 30 days and correct any deficiencies within 90 days or be subject to sanctions listed in COMAR 10.67.10.01A and B. Subject to the conditions specified in §B of this regulation, an MCO shall provide to its enrollees medically necessary home health services, including: Skilled nursing services, including the supervisory visits required by §A(2) of this regulation; Home health aide services, including biweekly supervisory visits by a registered nurse in the recipient's home, every second visit of which includes observations of the delivery of services by the aide to the enrollee; Physical therapy services; Occupational therapy services; Speech pathology services; and Medical supplies that are used during a home health visit. An MCO shall provide the home health services specified in §A of this regulation that are: Certified by the enrollee's PCP or by the enrollee's attending physician to be required on a part-time, intermittent basis; and Rendered in the enrollee's home. An MCO shall provide the following medically necessary habilitation services to enrollees eligible for Medical Assistance under §1902(a)(10)(A)(i)(VIII) of the Social Security Act: Physical therapy; Occupation therapy; and Speech therapy. At a minimum, an MCO shall provide the services in hospital inpatient and outpatient departments and physical therapy in an outpatient community setting. An MCO shall provide to its enrollees medically necessary inpatient hospital services as specified in this regulation. Admission to Long-Term Care Facility. An MCO shall provide to its enrollees medically necessary long-term care facility services for: The first 90 continuous days following the enrollee's admission; and Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department's determination that the admission is medically necessary as specified in §B(2) of this regulation. For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary. The Department’s determination as described in §B(2) of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day. Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility. The Department shall render a determination with respect to the medical necessity of a stay in a long-term care facility as specified in §B of this regulation within 3 business days of receipt of a complete application from the MCO. Childbirth — Length of Stay and Home Visits. Except as provided in §D(2) and (3) of this regulation, the criteria and standards used by an MCO in performing utilization review of hospital services related to maternity and newborn care, including length of stay, shall be in accordance with the medical criteria outlined in the Guidelines for Perinatal Care, which is incorporated by reference in COMAR 10.67.04.01. Unless the enrollee decides, in consultation with her attending provider, that less time is needed for recovery, an MCO shall provide or reimburse the cost of hospitalization including at least the following length of stay for an enrollee recovering from childbirth: 48 hours of inpatient hospitalization care following an uncomplicated vaginal delivery; or 96 hours of inpatient hospitalization care following an uncomplicated cesarean section. If the enrollee elects to be discharged earlier than the length of stay specified in §D(2) of this regulation, the MCO is required to provide a home visit or visits pursuant to Regulation .21B—D of this chapter. In addition to the mother's length of stay required to be afforded by §D(2) of this regulation, whenever a mother is required to remain hospitalized after childbirth for medical reasons and she requests that her newborn remain in the hospital while she is hospitalized, the MCO shall afford the newborn additional hospitalization while the mother remains hospitalized, for up to 4 days. If an enrollee is in the hospital at the time of disenrollment from the MCO, and remains eligible for Medical Assistance, the MCO is responsible for covering the remainder of that hospital admission following disenrollment. An MCO shall provide for a private hospital room when: The enrollee's condition requires a need for isolation; or The enrollee requires admission and only private rooms are available. Payment For Ancillary Services. Effective January 1, 2009, an MCO shall pay for all medically necessary ancillary services provided on inpatient hospital days including those days for which the inpatient hospitalization is otherwise appropriately denied. A denial of an inpatient ancillary service shall be based on the medical necessity of the specific ancillary service. An MCO is not required to pay for ancillary services if the entire hospitalization in §H(1) of this regulation is appropriately denied. Transports between hospitals are covered by the MCO when: A medically necessary covered service is not available at the hospital where an enrollee is being treated; and The enrollee is not being discharged from the sending hospital. An MCO's benefits package shall include medically necessary outpatient hospital services. An MCO shall provide to its enrollees medically necessary transplants. An MCO shall provide to its enrollees medically necessary: Diagnostic services; and Laboratory services, performed by a provider who: Is Clinical Laboratory Improvement Amendments (CLIA) certified; or Has a waiver of a certificate registration along with a CLIA identification number. An MCO shall provide to its enrollees medically necessary services in a chronic hospital, a chronic rehabilitation hospital, or a nursing facility for: The first 90 continuous days following the enrollee's admission; and Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department’s determination that the admission is medically necessary as specified in §C of this regulation. Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility. For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary. The Department’s determination as described in §C of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day. The Department shall render a determination with respect to the medical necessity of a stay in a nursing facility as specified in §C of this regulation within 3 business days of receipt of a complete application from the MCO. A determination by the Department that the admission is medically necessary does not relieve the MCO of the obligation to pay for the admission through the day on which the determination is made. An MCO shall use the Department’s criteria for determining medical necessity for the days described in §A(1) of this regulation. An MCO shall provide to its enrollees medically necessary disposable medical supplies and durable medical equipment, including but not limited to: All supplies and equipment used in the administration or monitoring of prescriptions by the enrollees; Incontinency pants and disposable underpads for medical conditions associated with prolonged urinary or bowel incontinence if necessary to prevent institutionalization or infection; Orthotic devices when medically necessary for use in the MCO enrollee’s home, school, or place of employment; Prosthetic devices once annually when medically necessary: For use in the enrollee’s home, school, or place of employment; or For the purpose of performing physical activities, including running, biking, swimming, strength training, and other activities to maximize the whole-body health and lower or upper limb function of the enrollee; Annual repairs to prosthetic devices covered under §A(4) of this regulation when: Medically necessary; and When the repair’s necessity is not due to misuse; Replacement of prosthetic devices covered under §A(4)of this regulation when medically necessary as follows: Once annually for devices less than 3 years old if the replacement is necessary for the following reasons: Because of a change in the physiological condition of the patient; Unless necessitated by misuse, because of an irreparable change in the condition of the prosthesis or the component of the prosthetic device; or Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device. For devices more than 3 years old subject to §A(4) and (5) of this regulation. Except as required in §C(1), an MCO shall provide preauthorization within 72 hours for DMS/DME services and supplies that require preauthorization by the MCO. An MCO shall provide its enrollees the disposable medical supplies and durable medical equipment in a timely manner so as to not adversely affect the health of the enrollees, in accordance with the following: For medical equipment or supplies, or both, when there is an urgent medical need such as to facilitate hospital discharge or when a potential exists for worsening of enrollee's condition, the MCO shall provide needed items within 24 hours of request; and For all other requests for DMS/DME, the MCO shall provide these items within 7 days from the date of request unless the MCO can document to the Department that justification for additional time is necessary. An MCO is responsible for paying for any durable medical equipment authorized and ordered while the member is active with the MCO if: The delivery of the item occurs within 90 days after the member's termination date from the MCO; and The member remains a Medicaid recipient. An MCO shall provide to its enrollees medically necessary vision care services as specified in this regulation. For enrollees who are 21 years old or older, the MCO is responsible for providing at least one eye examination every 2 years. For its enrollees who are younger than 21 years old, the MCO is responsible for providing medically necessary vision services, including but not limited to: At least one eye examination every year in addition to any vision screen performed as part of an EPSDT screen; Eyeglasses, limited to one pair per year unless lost, stolen, broken, or no longer vision appropriate; and Contact lenses, if medically necessary and if eyeglasses are not efficacious for the condition. An MCO shall provide for its enrollees medically necessary podiatry services. In addition to the services described in §A of this regulation, an MCO shall provide: Diabetes care services specified in COMAR 10.67.06.24; and Routine foot care for enrollees, 21 years old or older with vascular disease affecting the lower extremities. An MCO shall provide to its enrollees medically necessary outpatient rehabilitative services, including but not limited to physical therapy for adult enrollees. An MCO shall provide to its enrollees medically necessary oxygen and related respiratory equipment services. An MCO shall provide to its enrollees medically necessary dialysis services. An MCO shall provide to its enrollees comprehensive family planning services, including but not limited to medically necessary office visits and laboratory tests, all FDA-approved contraceptive devices, methods, and supplies, and voluntary sterilizations. An MCO may place appropriate limits on family planning services for the purpose of utilization control, provided that the services are provided in a manner that protects and enables the enrollee’s freedom to choose the method of family planning to be used consistent with 42 CFR §441.20. An MCO may not apply a copayment or coinsurance requirement for contraceptive drugs or devices. An MCO shall provide coverage for a single dispensing of a supply of prescription contraceptives for a 12-month period. An MCO shall provide, to enrollees younger than 21 years old, medically necessary Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) services, including: EPSDT comprehensive well-child services provided in accordance with the EPSDT periodicity schedule and performed by an EPSDT-certified provider, including: A comprehensive health and developmental history, including an evaluation of both physical and mental health development; A comprehensive unclothed physical exam; Immunizations appropriate to age and health history; Laboratory tests, including blood lead level assessment, as appropriate to age and risk; Health education, including anticipatory guidance; and Vision, hearing, and dental screening; EPSDT partial or interperiodic well-child services; and Health care services that are: Necessary to prevent, treat, or ameliorate physical, mental, or developmental problems or conditions identified by an EPSDT-certified provider or other health professional; Sufficient in amount, duration, and scope to treat the identified condition; and Subject to limitation only on the basis of medical necessity. The health care services described in §A(3) of this regulation shall include, at a minimum, all services described in this chapter, and the following: Chiropractic services; Nutrition counseling services; Private duty nursing services including: An initial assessment and development of a plan of care by a registered nurse; and On-going private duty nursing services delivered by a licensed practical nurse or a registered nurse; and Durable medical equipment. An MCO shall provide referrals for services not covered by Medicaid, but which are furnished at little or no cost to recipients, including appropriate referrals to: The Head Start Program; The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); School Health-Related Special Education Services; Vocational Rehabilitation; and Maternal and Child Health Services located at local health departments. An MCO shall provide to its pregnant and postpartum enrollees medically necessary pregnancy-related services, including: Comprehensive prenatal, perinatal, and postpartum care, including high-risk specialty care when appropriate; Prenatal risk assessment and development of an individualized plan of care that specifies the actions required to address each identified need and is appropriately modified during the course of care; Enriched maternity services, including: Prenatal and postpartum counseling and education; Basic nutritional education; Substance abuse treatment, as provided in Regulation .10 of this chapter; Appropriate referrals to services that may improve the pregnancy outcome, including: Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and Healthy Start services; High-risk nutrition counseling services for nutritionally high-risk pregnant women; Appropriate levels of inpatient care, including emergency transfer of pregnant women and newborns to tertiary care centers; Smoking cessation education and treatment; Doula services; and Home visiting services. When an enrollee recovering from childbirth elects to be discharged before 48 hours following a normal vaginal delivery or 96 hours following an uncomplicated cesarean section, the MCO is responsible for providing: One home visit scheduled to occur within 24 hours after discharge; and An additional home visit as may be prescribed by the attending provider. When an enrollee recovering from childbirth and her newborn enrollee remain in the hospital for at least as long as the period of time provided under §B of this regulation, the MCO shall provide a home visit as prescribed by the attending provider. An MCO shall provide for home visits required by §§B and C of this regulation to be performed by a registered nurse and in accordance with generally accepted standards of nursing practice for home care of a mother and newborn child, including: An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant; An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse symptoms of the mother; Collection of a blood specimen for newborn screening if not previously completed; Referrals for any medically necessary continuing health care services; and Any other nursing services ordered by the referring provider. An MCO shall provide medically necessary case management services to its qualifying enrollees, as specified in COMAR 10.67.04.10C. An MCO shall include in its benefits package medically necessary hospice care services to enrollees who are terminally ill. The Department shall allow an enrollee to disenroll from an MCO and choose a new MCO if: The enrollee was auto-assigned to the MCO; and The enrollee's hospice provider does not contract with the enrollee's assigned MCO. If an enrollee who is in a hospice that does not contract with the enrollee's MCO and the enrollee will not voluntarily choose a new MCO, the enrollee's current MCO: Shall authorize and pay the out-of-network hospice provider at the established Medicaid rate, to ensure continuity of care; and May not require the hospice care enrollee to change their out-of-network hospice provider to an in-network hospice provider. An MCO shall provide to its qualifying enrollees medically necessary diabetes prevention and care services as specified in this regulation. National Diabetes Prevention Program. In addition to the services included in its usual benefits package, an MCO shall make available to its enrollees who meet the Centers for Disease Control and Prevention (CDC) eligibility criteria defined in §B(2) of this regulation the National Diabetes Prevention Program through a CDC-recognized lifestyle change organization. To be eligible for participation in the National Diabetes Prevention Program, a HealthChoice enrollee: Shall be 18 through 64 years old; Shall be overweight or obese; Shall have an elevated blood glucose level or a history of gestational diabetes mellitus; May not have a previous diagnosis of type 1 or type 2 diabetes prior to enrollment; and May not be currently pregnant. In addition to the services included in its usual benefits package, an MCO shall provide enrollees with a diabetes diagnosis the following medically necessary special diabetes-related services: Diabetes nutrition counseling, consisting of one initial one-on-one session and up to 4 subsequent sessions annually; Diabetes outpatient education; Diabetes-related durable medical equipment, disposable medical supplies, and therapeutic footwear and related services, when ordered as medically necessary, including: Therapeutic footwear, orthopedic shoes, arch supports, orthotic devices, in-shoe supports, elastic support, or examinations for prescription or fitting and related services to prevent or delay a foot amputation that would be highly probable in the absence of the specialized footwear; Blood glucose monitoring supplies; Diagnostic reagent strips and tablets used in testing for ketones and glucose in urine and glucose in blood; Finger-sticking devices used in obtaining blood samples for blood glucose testing; and Blood glucose reflectance meters for home use; Routine foot care; and Vision care consisting of: One ophthalmologic examination per year; and One pair of eyeglasses per year. An MCO shall provide to its enrollees medically necessary blood, blood products, derivatives, components, biologics, and serums to include autologous services, whole blood, red blood cells, platelets, plasma, immunoglobulin, and albumin. An MCO shall provide to its enrollees medically necessary primary mental health services, including appropriate referrals for service to the Department’s behavioral health ASO as described in COMAR 10.09.59. Effective October 1, 2023, MCOs shall provide their enrollees medically necessary primary mental health services, including the Collaborative Care Model, pursuant to COMAR 10.09.64. Subject to the conditions specified in §§B—F of this regulation, an MCO shall provide coverage for cost to an enrollee in an approved clinical trial for: Treatment provided for life-threatening conditions; or Prevention, early detection, and treatment studies on cancer. Clinical trials are deemed to be automatically approved if: The treatment is: Being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trials for cancer; or Being provided in Phase I, Phase II, Phase III, or Phase IV clinical trial for any other life-threatening condition; The treatment is being provided in a clinical trial: Approved by: The National Institutes of Health (NIH); An NIH cooperative group or an NIH center; The Centers for Disease Control and Prevention; The Agency for Healthcare Research and Quality; The Centers for Medicare and Medicaid Services (CMS); The Department of Defense; The Department of Veterans Affairs; or An institutional review board of an institution in the State that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the NIH; or Conducted: At National Cancer Institute Centers; Under Investigational New Drug application (IND) reviewed by the Food and Drug Administration (FDA); or As a clinical trial with deemed status through an exemption from having an IND under 21 CFR §312.2(b)(1); The facility and the personnel providing the treatment are capable of doing so by virtue of the facility and the personnel's experience, training, and volume of patients treated to maintain expertise; There is no clearly superior, non-investigational treatment alternative; and The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative. Enrollee cost includes the following: The cost of all medically necessary items and services that are otherwise available to Medicaid beneficiaries such as hospital services, physician services, or diagnostic tests; and The cost of medically necessary items or services required solely for the provision of the following: Investigational item or service such as administration of a noncovered chemotherapeutic agent; The clinically appropriate monitoring of the effects of the item or service; or The prevention, diagnosis, and treatment of complications. Enrollee cost does not include the following: The cost of the investigational item or service itself; The cost of items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the enrollee; The cost of items and services customarily provided by the research sponsors free of charge for any enrollee in the trial; and The cost of non-health care services that an enrollee may be required to receive as a result of the treatment being provided for purposes of the clinical trial. If the enrollee has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the enrollee for, services covered by this regulation, the provider shall seek payment from that source first. The MCO shall authorize the request for participation in an approved clinical trial within 72 hours of the request. An MCO shall provide to an enrollee medically necessary surgery to correct a deformity from disease, trauma, congenital or developmental anomalies, or to restore body functions. An MCO shall provide medically necessary gender-affirming treatment services which include but are not limited to the following: Hormone therapy, hormone blockers, and puberty blockers; Hair alteration for the purposes of altering secondary sex characteristics and surgical site preparation; Alterations to voice, voice therapy, and voice lessons; Alterations to abdomen, chest, trunk, and buttocks; Alterations to the face and neck; Alterations to the genitals and gonads; Laser treatment for scars from gender-affirming treatment; Standard fertility preservation procedures as set forth in Insurance Article, §15-810.1, Annotated Code of Maryland; Revisions to previous treatments and reversal of treatments; Combinations of gender-affirming procedures; and Other treatments as prescribed to suppress the development of endogenous secondary sex characteristics, align the individual’s appearance of physical body with gender identity, and alleviate symptoms of clinically significant distress resulting from gender dysphoria. An MCO may not issue an adverse benefit determination denying or limiting access to gender-affirming treatment unless a health care provider with experience prescribing or delivering gender-affirming treatment has reviewed and confirmed the appropriateness of the adverse benefit determination. An MCO shall provide enrollees medically necessary audiology services as described in COMAR 10.09.51, including: Hearing aids; Cochlear implants; Auditory osseointegrated devices; and Related services. An MCO shall provide its enrollees medically necessary remote patient monitoring services as described in COMAR 10.09.96. An MCO shall provide its enrollees medically necessary mobile integrated health services as described in COMAR 10.09.31. Subject to COMAR 10.09.63, an MCO shall provide coverage for community violence prevention. The benefits or services not required to be provided by an MCO are as follows: Experimental or investigational services, including organ transplants determined by Medicare to be experimental, except when an enrollee is participating in an authorized clinical trial as specified in Regulation .26-1 of this chapter; Any service or treatment that is not medically necessary; Services performed or prescribed under the direction of a person who is not a health care practitioner; Services that are beyond the scope of practice of the health care practitioner performing the service; Transportation services provided through grants to local governments pursuant to COMAR 10.09.19, other than assisting enrollees to access nonemergency transportation services through their local transportation grantee agency; Health-related services and targeted case management services provided to children when the services are: Specified in the enrollee's individualized family service plan (IFSP), or an individualized education program (IEP); and Delivered in the schools or through Children's Medical Services community-based providers; Autopsies; Immunizations required for travel outside the continental United States; Services received while the enrollee is outside the United States; Abortions; Diet and exercise programs for the loss of weight; Prescriptions or injections for central nervous system stimulants and anorectic agents when used for controlling weight; In vitro fertilization, ovum transplants and gamete intrafallopian tube transfer, zygote intrafallopian transfer, or other techniques used in these or similar procedures; Services to reverse a voluntary sterilization procedure; Lifestyle improvements, including smoking cessation, nutrition counseling, or physical fitness programs, unless specifically included as a covered service; Nonmedical ancillary services such as vocational rehabilitation, employment counseling, or educational therapy; Private duty nursing for adults 21 years old and older; Services incurred before the effective date of coverage for an enrollee; Dental or orthodontic care; Piped-in oxygen or oxygen prescribed for standby purposes or on an as-needed basis; and Cosmetic surgery when performed solely to maintain normal physical appearance or enhance beyond average level toward an aesthetic ideal. Enteral nutritional and supplemental vitamins and mineral products when administered orally. An MCO is not required to provide any of the benefits or services which are reimbursed directly by the Department as described in COMAR 10.67.08. An MCO shall be financially responsible for reimbursing, in accordance with COMAR 10.67.04.20, an out-of-plan provider chosen by the participant for the following services: Family planning services specified in COMAR 10.67.04.20A(2), (6), and (7); Services performed by school-based health centers (SBHCs), as provided in COMAR 10.09.76; Pregnancy-related services for women who are pregnant and, at the time of initial enrollment, have received prenatal care during their current pregnancy from an out-of-plan provider, and this pre-enrollment care consists of at least the following: A full prenatal examination; A risk assessment; and Appropriate laboratory services; Initial medical examination for children in State custody when performed by an EPSDT certified provider; One annual diagnostic and evaluation service (DES) visit for any enrollee diagnosed with HIV/AIDS, which the MCO is responsible for facilitating on the enrollee's behalf; Renal dialysis services performed in a Medicare-certified facility; Initial medical examination of a newborn when the: Examination is performed in a hospital by an on-call physician; and MCO failed to provide for the service before the newborn's discharge from the hospital; Emergency services as described in COMAR 10.67.05.08B; Prenatal, intrapartum, and postpartum services performed at a free-standing birth center located in Maryland or a contiguous state; and Doula services, through December 31, 2025. An MCO shall pay undisputed claims of the SBHC for services provided to its participants within 30 days of the MCO's receipt of the invoice. An MCO shall provide SBHCs in its service area with the current information needed to facilitate communication between the SBHC, PCP, and the MCO regarding care provided to the MCO's participant, and to effect reimbursement by the MCO, including: Information concerning the MCO's policies and procedures regarding the provision of pharmacy and laboratory services; Instructions for submitting claims; and Contact information, including names and phone numbers of the following individuals: The MCO representative who serves as an SBHC's contact person for coordination of care; and The student-participant's PCP. An MCO may provide its enrollees with additional health care services that are not required by this chapter. Optional health care services that an applicant intends to include in its benefits package shall be specified, including the terms and conditions for, and limitations to the provision of these services, in the applicant's initial application to the Department, as well as for periodic Departmental review. An MCO's provision of optional services that it has represented to be available to its enrollees is subject to monitoring of complaints and consumer satisfaction surveys, and to random audits. An MCO's provision of additional services that are not required by this regulation may not be taken into account when setting the MCO's capitation rate. Effective January 1, 2015, any changes to the health care services being offered by the MCO under §A of this regulation, including reducing or waiving pharmacy co-pays, shall be effective for an entire calendar year. An MCO shall notify the Department of any changes to their optional services by September 15 for the following calendar year. The Department may waive the requirement under §E of this regulation if the Department determines that the circumstance warrant, including but not limited to a reduction in rates outside the normal rate setting process. An MCO shall provide medically necessary fertility preservation services for the following individuals: Individuals who have iatrogenic infertility; Individuals who are receiving medical treatment that may directly or indirectly cause iatrogenic infertility; or Individuals who are receiving gender-affirming treatment. Fertility preservation services include sperm and oocyte cryopreservation and evaluations, laboratory assessments, medications, and treatments associated with sperm and oocyte cryopreservation. Fertility preservation services do not include the storage of sperm or oocytes. An MCO shall provide to its enrollees medically necessary telemedicine services as described in COMAR 10.09.49. Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland Effective date: Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253) Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255) Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528) Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220) Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281) Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316) Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253) Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144) Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668) Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301) Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732) Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584) Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180) Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220) Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253) Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82) Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221) Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732) Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973) Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973) Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732) Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726) Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316) Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955) Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775) Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973) Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947) Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355) Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981) Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732) Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698) Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775) Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471) Chapter transferred from COMAR 10.09.67 effective November 1, 2019 (46:22 Md. R. 977) Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337) Regulation .21A amended effective February 21, 2022 (49:4 Md. R. 300) Regulation .26 amended effective August 5, 2024 (51:15 Md. R, 707) Regulation .26-1 amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .26-3 amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .26-6 adopted effective May 1, 2023 (50:8 Md. R. 337) Regulation .26-7 adopted effective November 13, 2023 (50:22 Md. R. 974) Regulation .27 amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .27A amended effective April 28, 2025 (52:8 Md. R. 359) Regulation .28A amended effective June 24, 2024 (51:12 Md. R. 618) Regulation .30 adopted effective June 24, 2024 (51:12 Md. R. 620)