This section applies to: insurers that propose to issue or deliver in the State group or blanket health insurance policies that are written on an expense-incurred basis; and nonprofit health service plans that propose to issue or deliver in the State group medical or major medical contracts that are written on an expense-incurred basis. An entity subject to this section shall offer the policyholder the option of providing benefits for expenses arising from the care, including nursing home care and intermediate or custodial nursing care, of individuals who have Alzheimer’s disease. An entity subject to this section shall offer the policyholder the option of providing benefits for expenses arising from the care of elderly individuals, including nursing home care and intermediate or custodial nursing care of elderly individuals who have any disease, other than Alzheimer’s disease, that is designated in regulations adopted by the Commissioner. An entity subject to this section may establish reasonable limits on the benefits offered under this section, including copayment and deductible provisions and maximum annual and lifetime dollar limits.

In this section the following words have the meanings indicated. “Alcohol misuse” has the meaning stated in § 8–101 of the Health – General Article. “ASAM criteria” means the most recent edition of the American Society of Addiction Medicine treatment criteria for addictive, substance–related, and co–occurring conditions that establishes guidelines for placement, continued stay and transfer or discharge of patients with addiction and co–occurring conditions. “Drug misuse” has the meaning stated in § 8–101 of the Health – General Article. “Grandfathered health plan coverage” has the meaning stated in 45 C.F.R. § 147.140. “Health benefit plan” means: for a group or blanket plan, a health benefit plan as defined in § 15–1401 of this title; for an individual plan, a health benefit plan as defined in § 15–1301(l) of this title; or short–term limited duration insurance as defined in § 15–1301(s) of this title. “Managed care system” means a system of cost containment methods that a carrier uses to review and preauthorize a treatment plan developed by a health care provider for a covered individual in order to control utilization, quality, and claims. “Partial hospitalization” means the provision of medically directed intensive or intermediate short–term treatment: to an insured, subscriber, or member; in a licensed or certified facility or program; for mental illness, emotional disorders, drug misuse, or alcohol misuse; and for a period of less than 24 hours but more than 4 hours in a day. “Small employer” has the meaning stated in § 31–101 of this article. With the exception of small employer grandfathered health plan coverage, this section applies to each individual, group, and blanket health benefit plan that is delivered or issued for delivery in the State by an insurer, a nonprofit health service plan, or a health maintenance organization. A health benefit plan subject to this section shall provide at least the following benefits for the diagnosis and treatment of a mental illness, emotional disorder, drug use disorder, or alcohol use disorder: inpatient benefits for services provided in a licensed or certified facility, including hospital inpatient and residential treatment center benefits; partial hospitalization benefits; and outpatient and intensive outpatient benefits, including all office visits, diagnostic evaluation, opioid treatment services, medication evaluation and management, and psychological and neuropsychological testing for diagnostic purposes. The benefits under this section are required only for expenses arising from the treatment of mental illnesses, emotional disorders, drug misuse, or alcohol misuse if, in the professional judgment of health care providers: the mental illness, emotional disorder, drug misuse, or alcohol misuse is treatable; and the treatment is medically necessary. The benefits required under this section: shall be provided as one set of benefits covering mental illnesses, emotional disorders, drug misuse, and alcohol misuse; shall comply with 45 C.F.R. § 146.136(a) through (d) and 29 C.F.R. § 2590.712(a) through (d); subject to paragraph (3) of this subsection, may be delivered under a managed care system; and for partial hospitalization under subsection (c)(2) of this section, may not be less than 60 days. The benefits required under this section may be delivered under a managed care system only if the benefits for physical illnesses covered under the health benefit plan are delivered under a managed care system. The processes, strategies, evidentiary standards, or other factors used to manage the benefits required under this section must be comparable as written and in operation to, and applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used to manage the benefits for physical illnesses covered under the health benefit plan. An insurer, nonprofit health service plan, or health maintenance organization shall use the ASAM criteria for all medical necessity and utilization management determinations for substance use disorder benefits. An entity that issues or delivers a health benefit plan subject to this section shall provide on its website and annually in print to its insureds or members: notice about the benefits required under this section and the federal Mental Health Parity and Addiction Equity Act; and notice that the insured or member may contact the Administration for further information about the benefits. An entity that issues or delivers a health benefit plan subject to this section shall: post a release of information authorization form on its website; and provide a release of information authorization form by standard mail within 10 business days after a request for the form is received.

An insurer or nonprofit health service plan that issues or delivers an individual, group, or blanket health insurance policy or contract in the State, or a health maintenance organization that issues or delivers an individual or group contract in the State, may not exclude payments for blood products, both derivatives and components, that otherwise would be covered under the health insurance contract. This section does not apply to whole blood or concentrated red blood cells.

In this section the following words have the meanings indicated. “Medical literature” means scientific studies published in a peer–reviewed national professional medical journal. “Off–label use” means the prescription of a drug for a treatment other than those treatments stated in the labeling approved by the federal Food and Drug Administration. “Standard reference compendia” means any authoritative compendia as recognized periodically by the federal Secretary of Health and Human Services or the Commissioner. This section does not: alter any law that limits the coverage of drugs that have not been approved by the federal Food and Drug Administration; require coverage of a drug if the federal Food and Drug Administration has determined use of the drug to be contraindicated; or require coverage of experimental drugs not approved for any indication by the federal Food and Drug Administration. This subsection applies to each health insurance policy or contract that is delivered or issued for delivery in the State to an employer or individual on a group or individual basis, including a contract issued by a health maintenance organization. A policy or contract subject to this subsection that provides coverage for drugs may not exclude coverage of a drug for an off–label use of the drug if the drug is recognized for treatment in any of the standard reference compendia or in the medical literature. Coverage of a drug required by this subsection also includes medically necessary services associated with the administration of the drug. The Commissioner may direct a person, including a health maintenance organization, that issues a health insurance policy or contract to make payments required by this section.

In this section the following words have the meanings indicated. “Authorized prescriber” means a licensed dentist, licensed physician, or licensed podiatrist who is authorized under the Health Occupations Article to prescribe a pharmaceutical product. “Pharmaceutical product” means a drug or medicine that may be prescribed by an authorized prescriber. This section does not apply to a policy or contract that is issued to an employer under a collective bargaining agreement. This subsection applies to each policy or contract that is issued or delivered in the State to an employer or individual by an insurer or nonprofit health service plan and that provides group or individual hospital, medical, or surgical benefits. A policy or contract subject to this subsection that provides reimbursement for a pharmaceutical product prescribed by an authorized prescriber may not establish the amount of reimbursement to the insured or the insured’s beneficiary, including copayments and deductibles, based on the identity, practicing specialty, or occupation of the authorized prescriber. This subsection applies to each individual or group policy or contract that is issued or delivered in the State to an employer or individual by an insurer or nonprofit health service plan and that provides benefits for pharmaceutical products. A policy or contract subject to this subsection may not impose a copayment, deductible, or other condition on an insured or certificate holder who uses the services of a community pharmacy that is not imposed when the insured or certificate holder uses the services of a mail order pharmacy, if the benefits are provided under the same program, policy, or contract.

A nonprofit health service plan that provides pharmaceutical services shall allow a subscriber, member, or beneficiary to fill prescriptions at the pharmacy of the subscriber’s, member’s, or beneficiary’s choice.

In this section the following words have the meanings indicated. “Inherited metabolic disease” means a disease caused by an inherited abnormality of body chemistry. “Inherited metabolic disease” includes a disease for which the State screens newborn babies. “Low protein modified food product” means a food product that is: specially formulated to have less than 1 gram of protein per serving; and intended to be used under the direction of a physician for the dietary treatment of an inherited metabolic disease. “Low protein modified food product” does not include a natural food that is naturally low in protein. “Medical food” means a food that is: intended for the dietary treatment of a disease or condition for which nutritional requirements are established by medical evaluation; and formulated to be consumed or administered enterally under the direction of a physician. This section applies to each individual hospital or major medical insurance policy, group or blanket health insurance policy, and nonprofit health service plan that: is delivered or issued for delivery in the State; is written on an expense-incurred basis; and provides coverage for a family member of the insured. A policy or plan subject to this section shall include under the family member coverage, coverage for medical foods and low protein modified food products for the treatment of inherited metabolic diseases if the medical foods or low protein modified food products are: prescribed as medically necessary for the therapeutic treatment of inherited metabolic diseases; and administered under the direction of a physician.

In this section, “home health care” means the continued care and treatment of a covered individual if: institutionalization of the individual would have been required if home health care was not provided; and the individual’s physician establishes and approves in writing the plan of treatment covering the home health care service. This section applies to each individual, group, or blanket health insurance policy that is issued or delivered in the State by an insurer or nonprofit health service plan. A policy subject to this section that provides coverage for inpatient hospital care on an expense-incurred basis shall provide benefits for the expenses of home health care that is provided by a person licensed under the Health Occupations Article. Home health care shall be provided by: a hospital that has a valid operating certificate and is certified to provide home health care services; or a public or private health service or agency that is licensed as a home health agency under Title 19, Subtitle 4 of the Health - General Article to provide coordinated home health care. A contract may limit the number of home health care visits, but not to fewer than 40 visits in a calendar year or in a continuous 12-month period for each individual covered under the contract. In determining the benefits for home health care available to a covered individual: each visit by a member of a home health care team is considered one home health care visit; and up to 4 hours of home health care service is considered one home health care visit.

Each insurer that issues or delivers individual health insurance policies in the State that are written on an expense-incurred basis shall offer benefits for hospice care services to its insureds. Each insurer that issues or delivers group or blanket health insurance policies or contracts in the State that are written on an expense-incurred basis shall offer benefits for hospice care services to its policyholders or beneficiaries. Each nonprofit health service plan shall offer benefits for hospice care services to its subscribers.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section that provides coverage for infertility benefits other than in vitro fertilization may not require as a condition of that coverage, for a patient who is married to an individual of the same sex: that the patient’s spouse’s sperm be used in the covered treatments or procedures; or that the patient demonstrate infertility exclusively by means of a history of unsuccessful heterosexual intercourse. This subsection does not apply to insurers, nonprofit health service plans, and health maintenance organizations that provide hospital, medical, or surgical benefits under health insurance policies or contracts: that are issued or delivered to a small employer in the State; and for which the Administration has determined that in vitro fertilization procedures are not essential health benefits, as determined under § 31–116 of this article. An entity subject to this section that provides pregnancy–related benefits may not exclude benefits for all outpatient expenses arising from in vitro fertilization procedures performed on a policyholder or subscriber or on the dependent spouse of a policyholder or subscriber. The benefits under this subsection shall be provided: for insurers and nonprofit health service plans, to the same extent as the benefits provided for other pregnancy–related procedures; and for health maintenance organizations, to the same extent as the benefits provided for other infertility services. Subsection (c) of this section applies if: the patient is the policyholder or subscriber or a covered dependent of the policyholder or subscriber; for a married patient whose spouse is of the opposite sex, the patient’s oocytes are fertilized with the patient’s spouse’s sperm, unless: the patient’s spouse is unable to produce and deliver functional sperm; and the inability to produce and deliver functional sperm does not result from: a vasectomy; or another method of voluntary sterilization; for a married patient, the patient and the patient’s spouse have a history of involuntary infertility, which may be demonstrated by a history of: if the patient and the patient’s spouse are of opposite sexes, intercourse of at least 1 year’s duration failing to result in pregnancy; or if the patient and the patient’s spouse are of the same sex, three attempts of artificial insemination over the course of 1 year failing to result in pregnancy; or the infertility of the patient or the patient’s spouse is associated with any of the following medical conditions: endometriosis; exposure in utero to diethylstilbestrol, commonly known as DES; blockage of, or surgical removal of, one or both fallopian tubes (lateral or bilateral salpingectomy); or abnormal male factors, including oligospermia, contributing to the infertility; for an unmarried patient: the patient has had three attempts of artificial insemination over the course of 1 year failing to result in pregnancy; or the infertility is associated with any of the following medical conditions of the patient: endometriosis; exposure in utero to diethylstilbestrol, commonly known as DES; blockage of, or surgical removal of, one or both fallopian tubes (lateral or bilateral salpingectomy); or abnormal male factors, including oligospermia, contributing to the infertility; the patient has been unable to attain a successful pregnancy through a less costly infertility treatment for which coverage is available under the policy or contract; and the in vitro fertilization procedures are performed at medical facilities that conform to applicable guidelines or minimum standards issued by the American College of Obstetricians and Gynecologists or the American Society for Reproductive Medicine. An entity subject to this section may limit coverage of the benefits for in vitro fertilization required under this section to three in vitro fertilization attempts per live birth, not to exceed a maximum lifetime benefit of $100,000. An entity subject to this section is not responsible for any costs incurred by a policyholder or subscriber or a dependent of a policyholder or subscriber in obtaining donor sperm. A denial of coverage for in vitro fertilization benefits required under this section by an entity subject to this section constitutes an adverse decision under Subtitle 10A of this title. This section may not be construed to require an entity subject to this section to provide coverage for a treatment or a procedure that would not treat a diagnosed medical condition of a patient. Notwithstanding any other provision of this section, if the coverage required under this section conflicts with the bona fide religious beliefs and practices of a religious organization, on request of the religious organization, an entity subject to this section shall exclude the coverage otherwise required under this section in a policy or contract with the religious organization.

In this section the following words have the meanings indicated. “Iatrogenic infertility” means an impairment of fertility caused directly or indirectly by surgery, chemotherapy, radiation, or other medical treatment affecting the reproductive organs or processes. “Medical treatment that may directly or indirectly cause iatrogenic infertility” means medical treatment with a likely side effect of infertility as established by the American Society for Reproductive Medicine, the American College of Obstetricians and Gynecologists, or the American Society of Clinical Oncology. “Standard fertility preservation procedures” means procedures to preserve fertility that are consistent with established medical practices and professional guidelines published by the American Society for Reproductive Medicine, the American College of Obstetricians and Gynecologists, or the American Society of Clinical Oncology. “Standard fertility preservation procedures” includes sperm and oocyte cryopreservation and evaluations, laboratory assessments, medications, and treatments associated with sperm and oocyte cryopreservation. “Standard fertility preservation procedures” does not include the storage of sperm or oocytes. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. Except as provided in subsection (d) of this section, an entity subject to this section shall provide coverage for standard fertility preservation procedures: performed on a policyholder or subscriber or on the covered dependent of a policyholder or subscriber; and that are medically necessary to preserve fertility for a policyholder or subscriber or for the covered dependent of a policyholder or subscriber due to a need for medical treatment that may directly or indirectly cause iatrogenic infertility. An entity subject to this section may not be required to provide coverage under subsection (c) of this section to a religious organization that requests and receives an exclusion from in vitro fertilization coverage under § 15–810(i) of this subtitle.

Each insurer and nonprofit health service plan that issues or delivers an individual, group, or blanket health insurance policy in the State that provides hospitalization benefits for normal pregnancy shall provide hospitalization benefits for childbirth to the same extent as the hospitalization benefits provided in the policy for any covered illness. In addition to the provisions of subsection (a) of this section and § 15-812 of this subtitle, whenever a mother is required to remain hospitalized after childbirth for medical reasons and the mother requests that the newborn remain in the hospital, the insurer or nonprofit health service plan shall pay the cost of additional hospitalization for the newborn for up to 4 days. The attending physician or certified nurse midwife of the mother, or designee of the attending physician or certified nurse midwife, shall provide notice to the mother of the provisions of paragraph (1) of this subsection.

In this section the following words have the meanings indicated. “Attending provider” means an obstetrician, pediatrician, other physician, certified nurse midwife, or pediatric nurse practitioner attending a mother or newborn child. “High-deductible health plan” means a health benefit plan that meets the federal requirements established by § 1201 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This section applies to: insurers and nonprofit health service plans that provide inpatient hospitalization coverage to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide inpatient hospitalization coverage to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for the cost of inpatient hospitalization services for a mother and newborn child for a minimum of: 48 hours of inpatient hospitalization care after an uncomplicated vaginal delivery; and 96 hours of inpatient hospitalization care after an uncomplicated cesarean section. A mother may request a shorter length of stay than that provided in subsection (c) of this section if the mother decides, in consultation with the mother’s attending provider, that less time is needed for recovery. For a mother and newborn child who have a shorter hospital stay than that provided under subsection (c) of this section, an entity subject to this section shall provide coverage for: one home visit scheduled to occur within 24 hours after hospital discharge; and an additional home visit if prescribed by the attending provider. For a mother and newborn child who remain in the hospital for at least the length of time provided under subsection (c) of this section, an entity subject to this section shall provide coverage for a home visit if prescribed by the attending provider. A home visit under paragraph (1) or (2) of this subsection shall: be provided in accordance with generally accepted standards of nursing practice for home care of a mother and newborn child; be provided by a registered nurse with at least 1 year of experience in maternal and child health nursing or community health nursing with an emphasis on maternal and child health; and include any services required by the attending provider. An entity subject to this section may not deny, limit, or otherwise impair the participation of an attending provider under contract with the entity in providing health care services to enrollees or insureds for: advocating the interest of a mother and newborn child through the entity’s utilization review or appeals system; advocating more than 48 hours of inpatient hospital care after a complicated vaginal delivery or more than 96 hours of inpatient hospital care after a complicated cesarean section; or prescribing a home visit under subsection (e)(1)(ii) or (2) of this section. Except as provided in paragraph (2) of this subsection, an entity subject to this section may not impose a copayment or coinsurance requirement or deductible for coverage required under subsection (e)(1) or (2) of this section or refuse reimbursement under subsection (e)(1) of this section if the services do not occur within the time specified. If an insured or enrollee is covered under a high-deductible health plan, an entity subject to this section may require that the coverage required under subsection (e)(1) and (2) of this section be subject to the deductible of the high-deductible health plan. An entity subject to this section shall provide notice annually to insureds and enrollees about the coverage provided by this section.

This section applies to each group or blanket health insurance policy that: is issued or delivered in the State; is issued or delivered to an entity that is incorporated or has a main office in the State; or covers individuals who reside or work in the State. Each insurer that proposes to issue a policy subject to this section that provides benefits for temporary disability shall offer the policyholder the option of providing benefits for temporary disability caused or contributed to by pregnancy or childbirth. The benefits under this section shall be provided to the same extent and on the same terms as the benefits provided for any other covered disability.

In this section, “digital tomosynthesis” means a radiologic procedure that involves the acquisition of projection images over the stationary breast to produce cross–sectional digital three–dimensional images of the breast. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. Subject to paragraph (2) of this subsection, an entity subject to this section shall provide coverage for breast cancer screening in accordance with the latest screening guidelines issued by the American Cancer Society. The coverage required under this section shall include coverage for digital tomosynthesis that, under accepted standards in the practice of medicine, the treating physician determines is medically appropriate and necessary for an enrollee or insured. An entity subject to this section is not required to cover breast cancer screenings used to identify breast cancer in asymptomatic women that are provided by a facility that is not accredited by the American College of Radiology or certified or licensed under a program established by the State. An entity subject to this section may not impose a deductible on the coverage required under this section. Each health insurance policy and certificate issued by an entity subject to this section shall contain a notice of the prohibition established by paragraph (1) of this subsection in a form approved by the Commissioner. An entity subject to this section may not impose a copayment or coinsurance requirement for digital tomosynthesis that is greater than a copayment or coinsurance requirement for other breast cancer screenings for which coverage is required under this section.

In this section the following words have the meanings indicated. “Diagnostic breast examination” means a medically necessary and appropriate examination of the breast that is used to evaluate an abnormality that is: seen or suspected from a prior screening examination for breast cancer; or detected by another means of prior examination. “Diagnostic breast examination” includes an examination using diagnostic mammography, breast magnetic resonance imaging, or breast ultrasound. “Supplemental breast examination” means a medically necessary examination of the breast that is used to screen for breast cancer when: there is no abnormality seen or suspected from a prior examination; and there is a personal or family medical history or additional factors that may increase an individual’s risk of breast cancer. “Supplemental breast examination” includes an examination using breast magnetic resonance imaging, breast ultrasound, or image–guided breast biopsy. This section applies to: insurers and nonprofit health service plans that provide coverage for diagnostic breast examinations or supplemental breast examinations under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for diagnostic breast examinations or supplemental breast examinations under individual or group contracts that are issued or delivered in the State. Except as provided in paragraph (2) of this subsection, an entity subject to this section may not impose a copayment, coinsurance, or deductible requirement on coverage for diagnostic breast examinations or supplemental breast examinations. If an insured or enrollee is covered under a high–deductible health plan, as defined in 26 U.S.C. § 223, an entity subject to this section may subject diagnostic breast examinations or supplemental breast examinations to the deductible requirement of the high–deductible health plan.

In this section the following words have the meanings indicated. “Mastectomy” means the surgical removal of all or part of a breast. “Reconstructive breast surgery” means surgery performed as a result of a mastectomy to reestablish symmetry between the two breasts. “Reconstructive breast surgery” includes augmentation mammoplasty, reduction mammoplasty, and mastopexy. This section applies to contracts issued by: insurers and nonprofit health service plans that provide medical and surgical benefits to individuals or groups on an expense–incurred basis under health insurance contracts that are issued or delivered in the State; and health maintenance organizations that provide medical and surgical benefits to individuals or groups under contracts that are issued or delivered in the State. A contract subject to this section shall provide coverage for: reconstructive breast surgery, including coverage for all stages of reconstructive breast surgery performed on a nondiseased breast to establish symmetry with the diseased breast when reconstructive breast surgery is performed on the diseased breast; and physical complications of all stages of mastectomy, including lymphedemas, in a manner determined in consultation with the attending physician and the patient.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section: shall classify an obstetrician/gynecologist as a primary care provider; or if the obstetrician/gynecologist chooses not to be a primary care provider, shall allow a woman to receive routine gynecological care from an in-network obstetrician/gynecologist without requiring the woman to visit a primary care provider first, if: the care is medically necessary, including care that is routine; after each visit for gynecological care, the obstetrician/gynecologist communicates with the woman’s primary care provider about any diagnosis or treatment rendered; and the obstetrician/gynecologist confers with the primary care provider before performing any diagnostic procedure that is not routine gynecological care rendered during an annual visit. If an entity subject to this section classifies an obstetrician/gynecologist as a primary care provider as provided in subsection (b) of this section, and a woman does not choose an obstetrician/gynecologist as the woman’s primary care provider, the entity shall allow the woman an annual visit to an in-network obstetrician/gynecologist for routine gynecological care without requiring the woman to visit the woman’s primary care provider first, whether or not the primary care provider is qualified to and regularly does provide routine gynecological care. An entity subject to this section shall allow a woman to receive medically necessary, routine obstetric and gynecological care from an in-network, certified nurse midwife or any other in-network provider authorized under the Health Occupations Article to provide obstetric and gynecological services without first requiring the woman to visit a primary care provider. A certified nurse midwife or other nonphysician provider authorized under the Health Occupations Article to provide obstetric and gynecological services shall consult with an obstetrician/gynecologist with whom the certified nurse midwife or other provider has a collaborative agreement, in accordance with the collaborative agreement, regarding any care rendered under this subsection.

In this section, “child wellness services” means preventive activities designed to protect children from morbidity and mortality and promote child development. This section applies to each individual hospital or major medical insurance policy, group or blanket health insurance policy, and nonprofit health service plan that: is delivered or issued for delivery in the State; is written on an expense–incurred basis; and provides coverage for a family member of the insured. A policy or plan subject to this section shall include under the family member coverage a minimum package of child wellness services that are consistent with: public health policy; professional standards; and scientific evidence of effectiveness. The minimum package of child wellness services shall cover at least: all visits for and costs of childhood and adolescent immunizations recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention as of December 31, 2024, as updated by recommendations issued by the Secretary of Health in accordance with § 18–112 of the Health – General Article; visits for the collection of adequate samples, the first of which is to be collected before 2 weeks of age, for hereditary and metabolic newborn screening and follow–up between birth and 4 weeks of age; universal hearing screening of newborns provided by a hospital before discharge; all visits for and costs of age–appropriate screening tests for tuberculosis, anemia, lead toxicity, hearing, and vision as determined by the American Academy of Pediatrics; all visits for obesity evaluation and management; all visits for and costs of developmental screening as recommended by the American Academy of Pediatrics; a physical examination, developmental assessment, and parental anticipatory guidance services at each of the visits required under items (i), (ii), (iv), (v), and (vi) of this paragraph; and any laboratory tests considered necessary by the physician as indicated by the services provided under items (i), (ii), (iv), (v), (vi), or (vii) of this paragraph. Except as provided in subsection (e) of this section, an insurer or nonprofit health service plan that issues a policy or plan subject to this section, on notification of the pregnancy of the insured and before the delivery date, shall: encourage and help the insured to choose and contact a primary care provider for the expected newborn before delivery; and provide the insured with information on postpartum home visits for the mother and the expected newborn, including the names of health care providers that are available for postpartum home visits. An insurer or nonprofit health service plan that does not require or encourage the insured to use a particular health care provider or group of health care providers that has contracted with the insurer or nonprofit health service plan to provide services to the insurer’s or nonprofit health service plan’s insureds need not comply with subsection (d) of this section. A policy or plan subject to this section may not impose a deductible on the coverage required under this section. Each health insurance policy and certificate shall contain a notice of the prohibition established by paragraph (1) of this subsection in a form approved by the Commissioner. The Commissioner may adopt regulations necessary to carry out subsection (c)(2)(i) of this section consistent with federal statutes, rules, and guidance in effect on December 31, 2024, as updated by recommendations issued by the Secretary of Health in accordance with § 18–112 of the Health – General Article.

This section applies to: each individual or group hospital or major medical insurance policy or certificate that is delivered or issued for delivery in the State by an insurer and is written on an expense–incurred basis; each individual or group medical or major medical contract, policy, or certificate that is delivered or issued for delivery in the State by a nonprofit health service plan; and each contract that provides hospital, medical, or surgical benefits to individuals or groups and is issued or delivered in the State by a health maintenance organization. A policy, contract, or certificate subject to this section shall include benefits for inpatient or outpatient expenses arising from orthodontics, oral surgery, and otologic, audiological, and speech/language treatment involved in the management of the birth defect known as cleft lip or cleft palate or both.

This section applies to: each individual, group, or blanket health insurance policy that is issued or delivered in the State by an insurer; and each contract or certificate that is issued or delivered in the State by a nonprofit health service plan. A policy, contract, or certificate subject to this section that provides coverage for an inpatient service in an acute general hospital shall provide coverage for: a corresponding outpatient service that is provided to the insured instead of the inpatient service because of the denial, after review under a utilization review program, of a request by the attending physician for an inpatient admission; and an objective second opinion given to the insured when required by a utilization review program under § 19-319 of the Health - General Article.

In this section, “orthopedic brace” means a rigid or semi–rigid device that is used to: support a weak or deformed body member; or restrict or eliminate motion in a diseased or injured part of the body. Each health insurance contract that is delivered or issued for delivery in the State by a nonprofit health service plan and that provides hospital benefits shall provide benefits for orthopedic braces.

This section applies to each policy or contract that is issued or delivered in the State to an employer or individual by an insurer or nonprofit health service plan. A policy or contract subject to this section that provides coverage on a group or individual basis for a diagnostic or surgical procedure involving a bone or joint of the skeletal structure may not exclude or deny coverage for the same diagnostic or surgical procedure involving a bone or joint of the face, neck, or head if, under the accepted standards of the profession of the health care provider rendering the service, the procedure is medically necessary to treat a condition caused by a congenital deformity, disease, or injury. This subsection does not apply to intraoral prosthetic devices. This section does not affect any other coverage required under this article or restrict the scope of coverage under a policy or contract subject to this section. This section is not intended to encourage surgical procedures over appropriate nonsurgical procedures, or to prohibit the continued coverage of nonsurgical procedures in the treatment of a bone or joint of the face, neck, or head.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for all medically appropriate and necessary diabetes equipment, diabetes supplies, and diabetes outpatient self–management training and educational services, including medical nutrition therapy, that the insured’s or enrollee’s treating physician or other appropriately licensed health care provider, or a physician who specializes in the treatment of diabetes, certifies are necessary for the treatment of: insulin–using diabetes; noninsulin–using diabetes; elevated or impaired blood glucose levels induced by pregnancy; or consistent with the American Diabetes Association’s standards, elevated or impaired blood glucose levels induced by prediabetes. If certified as necessary under subsection (b) of this section, the diabetes outpatient self–management training and educational services, including medical nutrition therapy, to be provided to the insured or enrollee shall be provided through a program supervised by an appropriately licensed, registered, or certified health care provider whose scope of practice includes diabetes education or management. Subject to paragraph (2) of this subsection, and except as provided in paragraph (3) of this subsection, the coverage required under this section may be subject to the annual deductibles or coinsurance requirements imposed by an entity subject to this section for similar coverages under the same health insurance policy or contract. Except as provided in paragraph (3) of this subsection, the annual deductibles or coinsurance requirements imposed under paragraph (1) of this subsection for the coverage required under this section may not be greater than the annual deductibles or coinsurance requirements imposed by the entity for similar coverages. Except as provided in subparagraph (ii) of this paragraph, an entity subject to this section may not impose a deductible, copayment, or coinsurance requirement on diabetes test strips. If an insured or enrollee is covered under a high–deductible health plan, as defined in 26 U.S.C. § 223, an entity subject to this section may subject diabetes test strips to the deductible requirement of the high–deductible health plan. An entity subject to this section may not reduce or eliminate coverages in its health insurance policies or contracts due to the requirements of this section.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs and devices to individuals or groups under health insurance policies or contracts that are delivered in the State; and health maintenance organizations that provide coverage for prescription drugs and devices to individuals or groups under contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs and devices through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section shall limit the amount a covered individual is required to pay in copayments or coinsurance for a covered prescription insulin drug to not more than $30 for a 30–day supply, regardless of the amount or type of insulin needed to fill the covered individual’s prescription. An entity subject to this section may set the amount a covered individual is required to pay to an amount that is less than the payment amount limit under subsection (b) of this section. A contract between an entity subject to this section, or a pharmacy benefits manager through which the entity provides coverage for prescription drugs and devices, and a pharmacy or the pharmacy’s contracting agent, may not: authorize a party to the contract to charge a covered individual an amount that is more than the payment amount limit under subsection (b) of this section; require a pharmacy to collect from a covered individual an amount that is more than the payment amount limit under subsection (b) of this section; or require a covered individual to pay an amount that is more than the payment amount limit under subsection (b) of this section.

In this section the following words have the meanings indicated. “Bone mass measurement” means a radiologic or radioisotopic procedure or other scientifically proven technology performed on a qualified individual for the purpose of identifying bone mass or detecting bone loss. “Qualified individual” means: an estrogen deficient individual at clinical risk for osteoporosis; an individual with a specific sign suggestive of spinal osteoporosis, including roentgenographic osteopenia or roentgenographic evidence suggestive of collapse, wedging, or ballooning of one or more thoracic or lumbar vertebral bodies, who is a candidate for therapeutic intervention or for an extensive diagnostic evaluation for metabolic bone disease; an individual receiving long–term glucocorticoid (steroid) therapy; an individual with primary hyperparathyroidism; or an individual being monitored to assess the response to or efficacy of an approved osteoporosis drug therapy. This section applies to: each individual hospital or major medical insurance policy of an insurer that is delivered or issued for delivery in the State and is written on an expense–incurred basis; each group or blanket health insurance policy of an insurer that is issued or delivered in the State and is written on an expense–incurred basis; each individual or group medical or major medical contract or certificate of a nonprofit health service plan that is issued or delivered in the State and is written on an expense–incurred basis; and each individual or group contract of a health maintenance organization that is issued or delivered in the State. A policy, contract, or certificate subject to this section shall include coverage for qualified individuals for reimbursement for bone mass measurement for the prevention, diagnosis, and treatment of osteoporosis when the bone mass measurement is requested by a health care provider for the qualified individual.

In this section the following words have the meanings indicated. “Authorized prescriber” has the meaning stated in § 12-101 of the Health Occupations Article. “Maintenance drug” means a drug anticipated to be required for 6 months or more to treat a chronic condition. This section applies to: insurers and nonprofit health service plans that provide coverage for drugs under health insurance policies or contracts that are delivered or issued for delivery in the State to employers or individuals on a group or individual basis; and health maintenance organizations that provide coverage for drugs under contracts that are delivered or issued for delivery in the State to employers or individuals on a group or individual basis. This section does not apply to an insured or enrollee who is a resident of a nursing home. An entity subject to this section shall allow an insured or enrollee, if authorized by an authorized prescriber, to receive up to a 90-day supply of a maintenance drug in a single dispensing of the prescription. The provisions of paragraph (1) of this subsection do not apply to the first prescription or change in a prescription for a maintenance drug that the authorized prescriber prescribes for the insured or enrollee. Whenever an entity subject to this section increases the co-payment for a single dispensing of a prescription in a supply in excess of 30 days, the entity shall also proportionately increase the dispensing fee to the pharmacist for the prescription.

This section applies to: insurers and nonprofit health service plans that provide inpatient hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide inpatient hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for the expenses incurred in conducting a medically recognized diagnostic examination which shall include a digital rectal exam and a blood test called the prostate–specific antigen (PSA) test: for men who are between 40 and 75 years of age; when used for the purpose of guiding patient management in monitoring the response to prostate cancer treatment; when used for staging in determining the need for a bone scan in patients with prostate cancer; or when used for male patients who are at high risk for prostate cancer. Subject to federal guidance on the preventive care safe harbor for the absence of a preventive care deductible provided for under 26 U.S.C. § 223(c)(2)(C), an entity subject to this section may not apply a deductible, a copayment, or coinsurance to coverage for preventive care screening services for prostate cancer, which shall include a digital rectal exam and a blood test called the prostate–specific antigen (PSA) test in accordance with subsection (b) of this section.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under contracts that are issued or delivered in the State. An entity subject to this section: shall provide coverage for any contraceptive drug or device that is approved by the United States Food and Drug Administration for use as a contraceptive and that is obtained under a prescription written by an authorized prescriber as defined in § 12-101 of the Health Occupations Article; shall provide coverage for the insertion or removal, and any medically necessary examination associated with the use, of such contraceptive drug or device; and may not impose a different copayment or coinsurance for a contraceptive drug or device than is imposed for any other prescription. A religious organization may request and an entity subject to this section shall grant the request for an exclusion from coverage under the policy, plan, or contract for the coverage required under subsection (b) of this section if the required coverage conflicts with the religious organization’s bona fide religious beliefs and practices. A religious organization that obtains an exclusion under paragraph (1) of this subsection shall provide its employees reasonable and timely notice of the exclusion.

In this section, “authorized prescriber” has the meaning stated in § 12–101 of the Health Occupations Article. This section applies to: insurers and nonprofit health service plans that provide coverage for contraceptive drugs and devices under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for contraceptive drugs and devices under individual or group contracts that are issued or delivered in the State. This subsection does not apply to a health benefit plan that is a grandfathered health plan, as defined in § 1251 of the Affordable Care Act. An entity subject to this section: except for a drug or device for which the U.S. Food and Drug Administration has issued a black box warning, may not apply a prior authorization requirement for a contraceptive drug or device that is: an intrauterine device; or an implantable rod; approved by the U.S. Food and Drug Administration; and obtained under a prescription written by an authorized prescriber; and except as provided in paragraph (3) of this subsection, may not apply a copayment or coinsurance requirement for a contraceptive drug or device that is: approved by the U.S. Food and Drug Administration; and obtained under a prescription written by an authorized prescriber. An entity subject to this section may apply a copayment or coinsurance requirement for a contraceptive drug or device that, according to the U.S. Food and Drug Administration, is therapeutically equivalent to another contraceptive drug or device that is available under the same policy or contract without a copayment or coinsurance requirement. An entity subject to this section shall provide coverage for a single dispensing to an insured or an enrollee of a supply of prescription contraceptives for up to a 12–month period. Whenever an entity subject to this section increases the copayment for a single dispensing of a supply of prescription contraceptives for up to a 12–month period, the entity shall also increase proportionately the dispensing fee paid to the pharmacist. This subsection may not be construed to require a provider to prescribe, furnish, or dispense 12 months of contraceptives at one time. Subject to paragraph (2) of this subsection, an entity subject to this section: shall provide coverage without a prescription for all contraceptive drugs approved by the U.S. Food and Drug Administration and available by prescription and over the counter; and may not apply a copayment or coinsurance requirement for a contraceptive drug dispensed without a prescription under item (i) of this paragraph that exceeds the copayment or coinsurance requirement for the contraceptive drug dispensed under a prescription. An entity subject to this section: may only be required to provide point–of–sale coverage under paragraph (1)(i) of this subsection at in–network pharmacies; and may limit the frequency with which the coverage required under paragraph (1)(i) of this subsection is provided.

In this subsection, “group” means a group that is not a group covered under a health insurance policy or contract or under a health maintenance organization contract issued or delivered to a small employer, as defined in § 31–101 of this article. This subsection applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to groups under contracts that are issued or delivered in the State. This subsection does not apply to an organization that requests and receives an exclusion from coverage under § 15–826(c) of this subtitle. An entity subject to this subsection shall provide coverage for male sterilization. This subsection applies to: insurers and nonprofit health service plans that provide coverage for male sterilization under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for male sterilization under individual or group contracts that are issued or delivered in the State. Except as provided in paragraph (3) of this subsection and except with respect to a health benefit plan that is a grandfathered health plan, as defined in § 1251 of the Affordable Care Act, an entity subject to this subsection may not apply a copayment, coinsurance requirement, or deductible to coverage for male sterilization. If an insured or enrollee is covered under a high–deductible health plan, as defined in 26 U.S.C. § 223, an entity subject to this subsection may subject male sterilization to the deductible requirement of the high–deductible health plan.

In this section, “fertility awareness–based methods” means methods of identifying times of fertility and infertility by an individual to avoid pregnancy, including: cervical mucus methods; sympto–thermal or sympto–hormonal methods; the standard days method; and the lactational amenorrhea method. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for instruction by a licensed health care provider on fertility awareness–based methods. Except with respect to a health benefit plan that is a grandfathered health plan, as defined in § 1251 of the Affordable Care Act, an entity subject to this section may not apply a copayment, coinsurance requirement, or deductible to the coverage required under this section.

In this section the following words have the meanings indicated. “Cooperative group” means a formal network of facilities that collaborate on research projects and have an established NIH-approved Peer Review Program operating within the group. “Cooperative group” includes: the National Cancer Institute Clinical Cooperative Group; the National Cancer Institute Community Clinical Oncology Program; the AIDS Clinical Trials Group; and the Community Programs for Clinical Research in AIDS. “FDA” means the federal Food and Drug Administration. “Member” means a policyholder, subscriber, insured, or certificate holder or a covered dependent of a policyholder, subscriber, insured, or certificate holder. “Multiple project assurance contract” means a contract between an institution and the federal Department of Health and Human Services that defines the relationship of the institution to the federal Department of Health and Human Services and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects. “NIH” means the National Institutes of Health. “Patient cost” means the cost of a medically necessary health care service that is incurred as a result of the treatment being provided to the member for purposes of the clinical trial. “Patient cost” does not include: the cost of an investigational drug or device; the cost of nonhealth care services that a patient may be required to receive as a result of the treatment being provided for purposes of the clinical trial; costs associated with managing the research associated with the clinical trial; or costs that would not be covered under the patient’s policy, plan, or contract for noninvestigational treatments. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, surgical, or pharmaceutical benefits to individuals or groups on an expense-incurred basis under a health insurance policy or contract issued or delivered in the State; and health maintenance organizations that provide hospital, medical, surgical, or pharmaceutical benefits to individuals or groups under contracts that are issued or delivered in the State. This section does not apply to a policy, plan, or contract paid for under Title XVIII or Title XIX of the Social Security Act. A policy, plan, or contract subject to this section shall provide coverage for patient cost to a member in a clinical trial, as a result of: treatment provided for a life-threatening condition; or prevention, early detection, and treatment studies on cancer. The coverage under subsection (d) of this section shall be required if: the treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer; or the treatment is being provided in a 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: one of the National Institutes of Health; an NIH cooperative group or an NIH center; the FDA in the form of an investigational new drug application; the federal Department of Veterans Affairs; or an institutional review board of an institution in the State which has a multiple project assurance contract approved by the Office of Protection from Research Risks of the National Institutes of Health; the facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise; there is no clearly superior, noninvestigational treatment alternative; and the available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative. In conjunction with the provisions of subsection (d) of this section, a policy, plan, or contract shall provide coverage for patient cost incurred for drugs and devices that have been approved for sale by the FDA whether or not the FDA has approved the drug or device for use in treating the patient’s particular condition, to the extent that the drugs or devices are not paid for by the manufacturer, distributor, or provider of that drug or device. An entity seeking coverage for treatment in a clinical trial approved by an institutional review board under subsection (e)(2)(v) of this section shall post electronically and keep up-to-date a list of the clinical trials meeting the requirements of subsections (d) and (e) of this section. The list shall include, for each clinical trial: the phase for which the trial is approved; the entity approving the trial; whether the trial is for treatment of cancer or another life-threatening disease and, if not cancer, the particular disease; and the estimated number of participants in the trial. This section may not be construed to affect compliance with § 15-804 of this subtitle regarding coverage for off-label use of drugs.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for general anesthesia and associated hospital or ambulatory facility charges in conjunction with dental care provided to an enrollee or insured if the enrollee or insured: is 7 years of age or younger or is developmentally disabled; is an individual for whom a successful result cannot be expected from dental care provided under local anesthesia because of a physical, intellectual, or other medically compromising condition of the enrollee or insured; and is an individual for whom a superior result can be expected from dental care provided under general anesthesia; or is an extremely uncooperative, fearful, or uncommunicative child who is 17 years of age or younger with dental needs of such magnitude that treatment should not be delayed or deferred; and is an individual for whom lack of treatment can be expected to result in oral pain, infection, loss of teeth, or other increased oral or dental morbidity. An entity subject to this section may require prior authorization for general anesthesia and associated hospital or ambulatory facility charges for dental care in the same manner that prior authorization is required for these benefits in connection with other covered medical care. An entity subject to this section may restrict coverage for general anesthesia and associated hospital or ambulatory facility charges to dental care that is provided by: a fully accredited specialist in pediatric dentistry; a fully accredited specialist in oral and maxillofacial surgery; and a dentist to whom hospital privileges have been granted. The provisions of this section may not be construed to require coverage for the dental care for which the general anesthesia is provided. The provisions of this section do not apply to dental care rendered for temporal mandibular joint disorders.

In this section the following words have the meanings indicated. “Chlamydia screening test” means any laboratory test that: specifically detects for infection by one or more agents of chlamydia trachomatis; and is approved for this purpose by the federal Food and Drug Administration. “Human papillomavirus screening test” means any laboratory test that: specifically detects for infection by one or more agents of the human papillomavirus; and is approved for this purpose by the federal Food and Drug Administration. “Multiple risk factors” means having a prior history of a sexually transmitted disease, new or multiple sex partners, inconsistent use of barrier contraceptives, or cervical ectopy. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall: provide coverage for an annual routine chlamydia screening test for: women who are: under the age of 20 years if they are sexually active; and at least 20 years old if they have multiple risk factors; and men who have multiple risk factors; and provide coverage for a human papillomavirus screening at the testing intervals outlined in the recommendations for cervical cytology screening developed by the American College of Obstetricians and Gynecologists. Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to a copayment or coinsurance requirement or deductible that an entity subject to this section imposes for similar coverages under the same policy or contract. The copayment or coinsurance requirement or deductible imposed under paragraph (1) of this subsection may not be greater than the copayment or coinsurance requirement or deductible imposed by the entity for similar coverages. Nothing in this section may be construed to prohibit an entity subject to this section from providing coverages that are greater than or more favorable to an insured or enrollee than the coverage required under this section.

In this section the following words have the meanings indicated. “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 except for a managed care organization as defined in Title 15, Subtitle 1 of the Health – General Article, any other person that provides health benefit plans subject to State regulation. “Member” means an individual entitled to health care benefits under a policy or plan issued or delivered in the State by a carrier. “Member” includes a subscriber. “Nonphysician specialist” means a health care provider: who is not a physician; who is licensed or certified under the Health Occupations Article; and who is certified or trained to treat or provide health care services for a specified condition or disease in a manner that is within the scope of the license or certification of the health care provider; or that is licensed as a behavioral health program under § 7.5–401 of the Health – General Article. “Provider panel” means the providers that contract with a carrier either directly or through a subcontracting entity to provide health care services to enrollees of the carrier. “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. “Specialist” means a physician who is certified or trained to practice in a specified field of medicine and who is not designated as a primary care provider by the carrier. Each carrier that does not allow direct access to specialists shall establish and implement a procedure by which a member may receive a standing referral to a specialist in accordance with this subsection. The procedure shall provide for a standing referral to a specialist if: the primary care physician of the member determines, in consultation with the specialist, that the member needs continuing care from the specialist; the member has a condition or disease that: is life threatening, degenerative, chronic, or disabling; and requires specialized medical care; and the specialist: has expertise in treating the life–threatening, degenerative, chronic, or disabling disease or condition; and is part of the carrier’s provider panel. Except as provided in subsection (c) of this section, a standing referral shall be made in accordance with a written treatment plan for a covered service developed by: the primary care physician; the specialist; and the member. A treatment plan may: limit the number of visits to the specialist; limit the period of time in which visits to the specialist are authorized; and require the specialist to communicate regularly with the primary care physician regarding the treatment and health status of the member. The procedure by which a member may receive a standing referral to a specialist may not include a requirement that a member see a provider in addition to the primary care physician before the standing referral is granted. Notwithstanding any other provision of this section, a member who is pregnant shall receive a standing referral to an obstetrician in accordance with this subsection. After the member who is pregnant receives a standing referral to an obstetrician, the obstetrician is responsible for the primary management of the member’s pregnancy, including the issuance of referrals in accordance with the carrier’s policies and procedures, through the postpartum period. A written treatment plan may not be required when a standing referral is to an obstetrician under this subsection. Each carrier shall establish and implement a procedure by which a member may request a referral to a specialist or nonphysician specialist who is not part of the carrier’s provider panel in accordance with this subsection. The procedure shall provide for a referral to a specialist or nonphysician specialist who is not part of the carrier’s provider panel if: the member is diagnosed with a condition or disease that requires specialized health care services or medical care; and the carrier does not have in its provider panel a specialist or nonphysician specialist with the professional training and expertise to treat or provide health care services for the condition or disease; or the carrier cannot provide reasonable access to a specialist or nonphysician specialist with the professional training and expertise to treat or provide health care services for the condition or disease without unreasonable delay or travel, including within the reasonable appointment waiting time and travel distance standards established in regulation for mental health and substance use disorder services; or the member is seeking mental health or substance use disorder care; and the carrier cannot provide reasonable access to a specialist or nonphysician specialist within the reasonable appointment waiting time and travel distance standards established in regulation for mental health and substance use disorder services. The procedure shall ensure that a request to obtain a referral to a specialist or nonphysician specialist who is not part of the carrier’s provider panel is addressed in a timely manner that is: appropriate for the member’s condition; and in accordance with the timeliness requirements for determinations made by private review agents under § 15–10B–06 of this title. If a member cannot access mental health or substance use disorder services through the referral requirements under paragraphs (2) and (3) of this subsection, the procedure shall require the carrier to provide additional assistance to the member in identifying and arranging coverage of mental health or substance use disorder services by a specialist or nonphysician specialist who is not part of the carrier’s provider panel. If a carrier approves a member’s request for a referral made in accordance with this subsection, the carrier may not require utilization review other than what would be required if the covered benefit were provided by a provider on the carrier’s provider panel. The procedure may not be used by a carrier as a substitute for establishing and maintaining a sufficient provider network in accordance with § 15–112 of this title. Each carrier shall: have a system in place that documents all requests to obtain a referral to receive a covered service from a specialist or nonphysician specialist who is not part of the carrier’s provider panel; inform members of the procedure to request a referral under paragraph (1) of this subsection; and provide the information documented under item (i) of this paragraph to the Commissioner on request. Except as provided in paragraph (2) of this subsection, for purposes of calculating any deductible, copayment amount, or coinsurance payable by the member, a carrier shall treat services received in accordance with subsection (d) of this section as if the service was provided by a provider on the carrier’s provider panel. A carrier shall ensure that services received in accordance with subsection (d) of this section for mental health or substance use disorders are provided for the duration of the treatment plan at no greater cost to the covered individual than if the covered benefit were provided by a provider on the carrier’s provider panel. A decision by a carrier not to provide access to or coverage of treatment or health care services by a specialist or nonphysician specialist in accordance with this section constitutes an adverse decision as defined under Subtitle 10A of this title if the decision is based on a finding that the proposed service is not medically necessary, appropriate, or efficient. Each carrier shall file with the Commissioner a copy of each of the procedures required under this section, including: steps the carrier requires of a member to request a referral; the carrier’s timeline for decisions; and the carrier’s grievance procedures for denials. Each carrier shall make a copy of each of the procedures filed under paragraph (1) of this subsection available to its members: in the carrier’s online provider directory required under § 15–112(n)(1) of this title; and on request. The Consumer Education and Advocacy Program, established under Title 2, Subtitle 3 of this article, in collaboration with the Health Education and Advocacy Unit of the Office of the Attorney General, shall provide public education to inform consumers of their procedures to request a referral to a specialist or nonphysician specialist as provided for in this section. This section may not be construed to limit the provisions in § 19–710(p) of the Health – General Article.

In this section the following words have the meanings indicated. “Authorized prescriber” has the meaning stated in § 12–101 of the Health Occupations Article. “Formulary” means a list of prescription drugs or devices that are covered by an entity subject to this section. “Member” means an individual entitled to health care benefits for prescription drugs or devices under a policy issued or delivered in the State by an entity subject to this section. “Member” includes a subscriber. This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs and devices under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs and devices under individual or group contracts that are issued or delivered in the State. An insurer, nonprofit health service plan, or health maintenance organization that provides coverage for prescription drugs and devices through a pharmacy benefits manager is subject to the requirements of this section. This section does not apply to a managed care organization as defined in § 15–101 of the Health – General Article. Each entity subject to this section that limits its coverage of prescription drugs or devices to those in a formulary shall establish and implement a procedure by which a member may: receive a prescription drug or device that is not in the entity’s formulary or has been removed from the entity’s formulary in accordance with this section; or continue the same cost sharing requirements if the entity has moved the prescription drug or device to a higher deductible, copayment, or coinsurance tier. The procedure shall provide for coverage for a prescription drug or device in accordance with subsection (c) of this section if, in the judgment of the authorized prescriber: there is no equivalent prescription drug or device in the entity’s formulary in a lower tier; an equivalent prescription drug or device in the entity’s formulary in a lower tier: has been ineffective in treating the disease or condition of the member; or has caused or is likely to cause an adverse reaction or other harm to the member; or for a contraceptive prescription drug or device, the prescription drug or device that is not on the formulary is medically necessary for the member to adhere to the appropriate use of the prescription drug or device. A decision by an entity subject to this section not to provide access to or coverage of a prescription drug or device in accordance with this section constitutes an adverse decision as defined under Subtitle 10A of this title if the decision is based on a finding that the proposed drug or device is not medically necessary, appropriate, or efficient. An entity subject to this section that removes a drug from its formulary or moves a prescription drug or device to a benefit tier that requires a member to pay a higher deductible, copayment, or coinsurance amount for the prescription drug or device shall provide a member who is currently on the prescription drug or device and the member’s health care provider with: notice of the change at least 30 days before the change is implemented; and in the notice required under item (1) of this subsection, the process for requesting an exemption through the procedure adopted in accordance with this section.

This section applies to: insurers and nonprofit health service plans that provide inpatient hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide inpatient hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. For a patient who receives less than 48 hours of inpatient hospitalization following the surgical removal of a testicle, or who undergoes the surgical removal of a testicle on an outpatient basis, an entity subject to this section shall provide coverage for: one home visit scheduled to occur within 24 hours after discharge from the hospital or outpatient health care facility; and an additional home visit if prescribed by the patient’s attending physician. Each entity subject to this section shall provide notice annually to its enrollees and insureds about the coverage required under this section.

In this section, “mastectomy” means the surgical removal of all or part of a breast as a result of breast cancer. This section applies to: insurers and nonprofit health service plans that provide inpatient hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide inpatient hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for the cost of inpatient hospitalization services for a patient for a minimum of 48 hours following a mastectomy. A patient may request a shorter length of stay than that provided in subsection (c) of this section if the patient decides, in consultation with the patient’s attending physician, that less time is needed for recovery. For a patient who receives less than 48 hours of inpatient hospitalization following a mastectomy or who undergoes a mastectomy on an outpatient basis, an entity subject to this section shall provide coverage for: one home visit scheduled to occur within 24 hours after discharge from the hospital or outpatient health care facility; and an additional home visit if prescribed by the patient’s attending physician. For a patient who remains in the hospital for at least the length of time provided under subsection (c) of this section, an entity subject to this section shall provide coverage for a home visit if prescribed by the attending physician. An entity subject to this section may not deny, limit, or otherwise impair the participation of an attending physician under contract with the entity in providing health care services to enrollees or insureds for: advocating the interest of a mastectomy patient through the entity’s utilization review or appeals system; advocating more than 48 hours of inpatient hospital care for a patient with complications related to a mastectomy; or prescribing a home visit under subsection (e)(1)(ii) or (2) of this section. An entity subject to this section may not refuse reimbursement under subsection (e)(1) of this section if the services do not occur within the time specified. An entity subject to this section shall provide notice annually to insureds and enrollees about the coverage provided by this section.

A policy will be considered to provide benefits on an expense-incurred basis if benefits payable under the policy are based on both medical expenses incurred and flat fees regardless of actual expenses incurred. This section applies to health benefit plans issued under Subtitle 12 of this title. This section does not apply if: coverage is terminated because an individual fails to pay a required premium; coverage is terminated for fraud or material misrepresentation by the individual; or any coverage provided by a succeeding health benefit plan: is provided at a cost to the individual that is less than or equal to the cost to the individual of the extended benefit required under this section; and does not result in an interruption of benefits. During an extension period required under this section a premium may not be charged. This subsection applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits on an expense-incurred basis under group or blanket health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits under contracts that are issued or delivered in the State. If an individual is totally disabled when the individual’s coverage terminates, an entity subject to this subsection shall continue to pay covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, for expenses incurred by the individual for the condition causing the disability until the earlier of: the date the individual ceases to be totally disabled; or 12 months after the date coverage terminates. An entity subject to this subsection may at any time require the individual to provide proof of total disability. This subsection applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits on an expense-incurred basis under individual health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits under individual contracts that are issued or delivered in the State. If an individual has a claim in progress when the individual’s coverage terminates, an entity subject to this subsection shall continue to pay covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, related to the claim until the earlier of: the date the individual is released from the care of a physician for the condition that is the basis of the claim; or 12 months after the date coverage terminates. This subsection applies to: group, blanket, and individual policies that limit coverage to hospital or surgical benefits on an expense-incurred basis; and group, blanket, and individual hospital indemnity policies. If an individual is confined in a hospital on the date coverage terminates, a policy subject to this subsection shall continue to pay covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, for the confinement until the earlier of: the date the individual is discharged from the hospital; or 12 months after the date coverage terminates. This subsection applies to insurers, nonprofit health service plans, and health maintenance organizations that provide group, blanket, or individual vision benefits. If an individual has ordered glasses or contact lenses before the date coverage terminates, an entity subject to this subsection that provides coverage for glasses or contact lenses shall continue to provide covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, for the glasses or contact lenses if the individual receives the glasses or contact lenses within 30 days after the date of the order. This subsection applies to insurers that provide group, blanket, or individual accidental death or dismemberment benefits. An insurer subject to this subsection shall provide covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, for a covered loss that occurs after the date coverage terminates if: an accident occurs while the individual is covered; and the loss occurs within 90 days after the accident. This subsection applies to insurers, nonprofit health service plans, health maintenance organizations, and dental plan organizations that provide group, blanket, or individual dental benefits. Except as provided in paragraph (3) of this subsection, an entity subject to this subsection shall provide covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, for a course of treatment for at least 90 days after the date coverage terminates if the treatment: begins before the date coverage terminates; and requires two or more visits on separate days to a dentist’s office. An entity subject to this subsection that provides coverage for orthodontics shall provide covered benefits, in accordance with the policy in effect at the time the individual’s coverage terminates, for orthodontics: for 60 days after the date coverage terminates if the orthodontist has agreed to or is receiving monthly payments; or until the later of 60 days after the date coverage terminates or the end of the quarter in progress, if the orthodontist has agreed to accept or is receiving payments on a quarterly basis.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for a prosthesis that has been prescribed by a physician for an enrollee or insured who has undergone a mastectomy and has not had breast reconstruction.

In this section the following words have the meanings indicated. “Habilitative services” means services and devices, including occupational therapy, physical therapy, and speech therapy, that help a child keep, learn, or improve skills and functioning for daily living. “Managed care system” means a method that an insurer, a nonprofit health service plan, or a health maintenance organization uses to review and preauthorize a treatment plan that a health care practitioner develops for a covered person using a variety of cost containment methods to control utilization, quality, and claims. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section: shall provide coverage of habilitative services for insureds and enrollees who are children until at least the end of the month in which the insured or enrollee turns 19 years old; and may do so through a managed care system. An entity subject to this section is not required to provide reimbursement for habilitative services delivered through early intervention or school services. An entity subject to this section shall provide notice annually to its insureds and enrollees about the coverage required under this section: in print; and on its Web site. Beginning November 1, 2013, a determination by an entity subject to this section of whether habilitative services covered under this section are medically necessary and appropriate to treat autism and autism spectrum disorders shall be made in accordance with regulations adopted by the Commissioner.

This section applies to: insurers and nonprofit health service plans that provide inpatient hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide inpatient hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. Subject to paragraph (2) of this subsection, an entity subject to this section shall provide, for an enrollee or insured whose hair loss results from chemotherapy or radiation treatment for cancer, coverage for one hair prosthesis. The cost of a hair prosthesis required under paragraph (1) of this subsection may not exceed $350. To be covered under this section, a hair prosthesis must be prescribed by the oncologist in attendance.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for colorectal cancer screening in accordance with the latest screening guidelines issued by the American Cancer Society. Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to a copayment or coinsurance requirement or deductible that an entity subject to this section imposes for similar coverages under the same policy or contract. The copayment or coinsurance requirement or deductible imposed under paragraph (1) of this subsection may not be greater than the copayment or coinsurance requirement or deductible imposed by the entity for similar coverages. Nothing in this section may be construed to prohibit an entity subject to this section from providing coverages that are greater than or more favorable to an insured or enrollee than the coverage required under this section.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. In this subsection, “hearing aid” means a device that: is of a design and circuitry to optimize audibility and listening skills in the environment commonly experienced by children; and is nondisposable. An entity subject to this section shall provide coverage for hearing aids for a minor child who is covered under a policy or contract if the hearing aids are prescribed, fitted, and dispensed by a licensed audiologist. An entity subject to this section may limit the benefit payable under paragraph (2) of this subsection to $1,400 per hearing aid for each hearing–impaired ear every 36 months. An insured or enrolled individual may choose a hearing aid that is priced higher than the benefit payable under this subsection and may pay the difference between the price of the hearing aid and the benefit payable under this subsection, without financial or contractual penalty to the provider of the hearing aid. This section does not prohibit an entity subject to this section from providing coverage that is greater or more favorable to an insured or enrolled individual than the coverage required under this section.

In this section, “hearing aid” means a device that: is of a design and circuitry to optimize audibility and listening skills in the environment commonly experienced by adults; and is nondisposable. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for all medically appropriate and necessary hearing aids for an adult who is covered under a policy or contract if the hearing aids are: prescribed, fitted, and dispensed by a licensed audiologist; or ordered, fitted, and dispensed by a licensed hearing aid dispenser. An entity subject to this section may limit the benefit payable under subsection (c) of this section to $1,400 per hearing aid for each hearing–impaired ear every 36 months. An insured or enrollee may choose a hearing aid that is priced higher than the benefit payable under this subsection and may pay the difference between the price of the hearing aid and the benefit payable under this subsection, without financial or contractual penalty to the provider of the hearing aid. This section does not prohibit an entity subject to this section from providing coverage that is greater or more favorable to an insured or enrollee than the coverage required under this section.

In this section the following words have the meanings indicated. “Body mass index” means a practical marker that is used to assess the degree of obesity and is calculated by dividing the weight in kilograms by the height in meters squared. “Morbid obesity” means a body mass index that is: greater than 40 kilograms per meter squared; or equal to or greater than 35 kilograms per meter squared with a comorbid medical condition, including hypertension, a cardiopulmonary condition, sleep apnea, or diabetes. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State; and managed care organizations, as defined in § 15-101 of the Health - General Article. An entity subject to this section shall provide coverage for the surgical treatment of morbid obesity that is: recognized by the National Institutes of Health as effective for the long-term reversal of morbid obesity; and consistent with guidelines approved by the National Institutes of Health. An entity subject to this section shall provide the benefits required under this section to the same extent as for other medically necessary surgical procedures under the enrollee’s or insured’s contract or policy with the entity.

In this section, “residential crisis services” means intensive mental health and support services that are: provided to a child or an adult with a mental illness who is experiencing or is at risk of a psychiatric crisis that would impair the individual’s ability to function in the community; designed to prevent a psychiatric inpatient admission, provide an alternative to psychiatric inpatient admission, or shorten the length of inpatient stay; provided out of the individual’s residence on a short–term basis in a community–based residential setting; and provided by entities that are licensed by the Maryland Department of Health to provide residential crisis services. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for medically necessary residential crisis services. The services required under this section may be delivered under a managed care system.

In this section the following words have the meanings indicated. “Authorized prescriber” has the meaning stated in § 12-101 of the Health Occupations Article. “Nicotine replacement therapy” means a product that: is used to deliver nicotine to an individual attempting to cease the use of tobacco products; and is obtained under a prescription written by an authorized prescriber. “Nicotine replacement therapy” does not include any over-the-counter product that may be obtained without a prescription. “Tobacco product” has the meaning stated in § 10-101 of the Criminal Law Article. This subsection applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs to individuals or groups under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this subsection shall provide coverage for: except for a drug that may be obtained over-the-counter without a prescription, any drug that: is approved by the United States Food and Drug Administration as an aid for the cessation of the use of tobacco products; and is obtained under a prescription written by an authorized prescriber; and two 90-day courses of nicotine replacement therapy during each policy year. An entity subject to this subsection may not impose a different copayment or coinsurance requirement for a drug or nicotine replacement therapy provided under paragraph (2) of this subsection than is imposed for any other comparable prescription.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs and devices under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs and devices under contracts that are issued or delivered in the State. An insurer, nonprofit health service plan, or health maintenance organization that provides coverage for prescription drugs and devices through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section may not impose a copayment or coinsurance requirement for a covered prescription drug or device that exceeds the retail price of the prescription drug or device.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, and surgical benefits to individuals or groups under contracts that are issued or delivered in the State. Subject to paragraph (2) of this subsection, a policy or plan subject to this section shall include, under the family member coverage, coverage for amino acid–based elemental formula, regardless of delivery method, for the diagnosis and treatment of: Immunoglobulin E and non–Immunoglobulin E mediated allergies to multiple food proteins; severe food protein induced enterocolitis syndrome; eosinophilic disorders, as evidenced by the results of a biopsy; and impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract. Subject to paragraph (3) of this subsection, the coverage required under paragraph (1) of this subsection is required if the ordering physician has issued a written order stating that the amino acid–based elemental formula is medically necessary for the treatment of a disease or disorder listed in paragraph (1) of this subsection. In accordance with Subtitle 10A of this title, a private review agent, acting on behalf of an insurer, nonprofit health service plan, or health maintenance organization, may review the ordering physician’s determination of the medical necessity of the amino acid–based elemental formula for the treatment of a disease or disorder listed in paragraph (1) of this subsection.

In this section, “prosthesis” means an artificial device to replace, in whole or in part, a leg, an arm, or an eye. “Prosthesis” includes a custom–designed, –fabricated, –fitted, or –modified device to treat partial or total limb loss for purposes of restoring physiological function. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide once annually coverage for: prostheses; components of prostheses; repairs to prostheses; and subject to subsection (d) of this section, replacements of prostheses or prosthesis components. An entity subject to this section shall provide coverage for replacements of prostheses if an ordering health care provider determines that the provision of a replacement prosthesis or a component of the prosthesis is necessary: 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 a component of the prosthesis; or unless necessitated by misuse, because the condition of the prosthesis or the component of the prosthesis requires repairs and the cost of the repairs would be more than 60% of the cost of replacing the prosthesis or the component of the prosthesis. An entity subject to this section may require an ordering health care provider to confirm that the prosthesis or component of the prosthesis being replaced meets the requirements of paragraph (1) of this subsection if the prosthesis or component is less than 3 years old. The covered benefits under this section may not be subject to a higher copayment or coinsurance requirement than the copayment or coinsurance for other similar medical and surgical benefits covered under the policy or contract of the insured or enrollee. An entity subject to this section may not impose an annual or lifetime dollar maximum on coverage required under this section separate from any annual or lifetime dollar maximum that applies in the aggregate to all covered benefits under the policy or contract of the insured or enrollee. An entity subject to this section may not establish requirements for medical necessity or appropriateness for the coverage required under this section that are more restrictive than the indications and limitations of coverage and medical necessity established under the Medicare Coverage Database. The covered benefits under this section include prostheses determined by a treating health care provider to be medically necessary for: completing activities of daily living; essential job–related activities; or 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 insured or enrollee. An entity subject to this section that uses a provider panel for a policy or contract described in subsection (b) of this section and the provision of covered benefits under this section shall comply with § 15–112(b)(3) of this title.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription eye drops under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription eye drops under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for a refill of prescription eye drops: in accordance with guidance for early refills of topical ophthalmic products provided to Medicare Part D plan sponsors by the Centers for Medicare and Medicaid Services; and if: the prescribing health care practitioner indicates on the original prescription that additional quantities of the prescription eye drops are needed; the refill requested by the insured does not exceed the number of additional quantities indicated on the original prescription by the prescribing health care practitioner; and the prescription eye drops prescribed by the health care practitioner are a covered benefit under the policy or contract of the insured.

In this section, “cancer chemotherapy” means medication that is prescribed by a licensed physician to kill or slow the growth of cancer cells. This section applies to: insurers and nonprofit health service plans that provide coverage for both orally administered cancer chemotherapy and cancer chemotherapy that is administered intravenously or by injection under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for both orally administered cancer chemotherapy and cancer chemotherapy that is administered intravenously or by injection under contracts that are issued or delivered in the State. An entity subject to this section may not impose dollar limits, copayments, deductibles, or coinsurance requirements on coverage for orally administered cancer chemotherapy that are less favorable to an insured or enrollee than the dollar limits, copayments, deductibles, or coinsurance requirements that apply to coverage for cancer chemotherapy that is administered intravenously or by injection. An entity subject to this section may not reclassify cancer chemotherapy or increase a copayment, deductible, coinsurance requirement, or other out–of–pocket expense imposed on cancer chemotherapy to achieve compliance with this section.

In this section the following words have the meanings indicated. “Complex or chronic medical condition” means a physical, behavioral, or developmental condition that: may have no known cure; is progressive; or can be debilitating or fatal if left untreated or undertreated. “Complex or chronic medical condition” includes: multiple sclerosis; hepatitis C; and rheumatoid arthritis. “Managed care system” means a system of cost containment methods that an insurer, a nonprofit health service plan, or a health maintenance organization uses to review and preauthorize drugs prescribed by a health care provider for a covered individual to control utilization, quality, and claims. “Rare medical condition” means a disease or condition that affects fewer than: 200,000 individuals in the United States; or approximately 1 in 1,500 individuals worldwide. “Rare medical condition” includes: cystic fibrosis; hemophilia; and multiple myeloma. “Specialty drug” means a prescription drug that: is prescribed for an individual with a complex or chronic medical condition or a 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. “Specialty drug” does not include a prescription drug prescribed to treat diabetes, HIV, or AIDS. This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State. Subject to paragraph (2) of this subsection, an entity subject to this section may not impose a copayment or coinsurance requirement on a covered specialty drug that exceeds $150 for up to a 30–day supply of the specialty drug. On July 1 of each year, the limit on the copayment or coinsurance requirement on a covered specialty drug shall increase by a percentage equal to the percentage change from the preceding year in the medical care component of the March Consumer Price Index for All Urban Consumers, Washington Metropolitan Area, from the U.S. Department of Labor, Bureau of Labor Statistics. Subject to subsection (h) of this section and § 15–805 of this subtitle, notwithstanding § 15–806 of this subtitle, and except as provided in § 15–847.2 of this subtitle, this article or regulations adopted under this article do not preclude an entity subject to this section from requiring a covered specialty drug to be obtained through: a designated pharmacy or other source authorized under the Health Occupations Article to dispense or administer prescription drugs; or a pharmacy participating in the entity’s provider network, if the entity determines that the pharmacy: meets the entity’s performance standards; and accepts the entity’s network reimbursement rates. A pharmacy registered under § 340B of the federal Public Health Services Act may apply to an entity subject to this section to be a designated pharmacy under subsection (d)(1) of this section for the purpose of enabling the pharmacy’s patients with hepatitis C to receive the copayment or coinsurance maximum provided for in subsection (c) of this section if: the pharmacy is owned by a federally qualified health center, as defined in 42 U.S.C. § 254B; the federally qualified health center provides integrated and coordinated medical and pharmaceutical services to hepatitis C patients; and the prescription drugs are covered specialty drugs for the treatment of hepatitis C. An entity subject to this section may not unreasonably withhold approval of a pharmacy’s application under paragraph (1) of this subsection. An entity subject to this section may provide coverage for specialty drugs through a managed care system. A determination by an entity subject to this section that a prescription drug is not a specialty drug is considered a coverage decision under § 15–10D–01 of this title. For complaints filed with the Commissioner under this subsection, if the entity made its determination that a prescription drug is not a specialty drug on the basis that the prescription drug did not meet the criteria listed in subsection (a)(5)(i) of this section: the Commissioner may seek advice from an independent review organization or medical expert on the list compiled under § 15–10A–05(b) of this title; and the expenses for any advice provided by an independent review organization or medical expert shall be paid for as provided under § 15–10A–05(h) of this title. This section may not be construed to supersede the authority of the Health Services Cost Review Commission to set rates for specialty drugs administered to patients in a setting regulated by the Health Services Cost Review Commission.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under individual group contracts that are issued or delivered in the State. Subject to paragraph (2) of this subsection and § 15–822.1 of this subtitle, an entity subject to this section may not impose a copayment or coinsurance requirement on a prescription drug prescribed to treat diabetes, HIV, or AIDS that exceeds $150 for up to a 30–day supply of the drug. On July 1 each year, the limit on the copayment or coinsurance requirement on a prescription drug prescribed to treat diabetes, HIV, or AIDS shall increase by a percentage equal to the percentage change from the preceding year in the medical care component of the March Consumer Price Index for All Urban Consumers, Washington Metropolitan Area, from the U.S. Department of Labor, Bureau of Labor Statistics.

In this section, “specialty drug” has the meaning stated in § 15–847 of this subtitle. This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section may not exclude coverage for a covered specialty drug administered or dispensed by a provider under § 12–102 of the Health Occupations Article if the entity determines that: the provider that administers or dispenses the covered specialty drug: is an in–network provider of covered oncology services; and complies with State regulations for the administering and dispensing of specialty drugs; and the covered specialty drug is: auto–injected or an oral targeted immune modulator; or an oral medication that: requires complex dosing based on clinical presentation; or is used concomitantly with other infusion or radiation therapies. Subject to subsection (f) of this section, the reimbursement rate for specialty drugs covered under this section shall be: agreed to by the covered, in–network provider and the entity subject to this section; and billed at a nonhospital level of care or place of service. Unless otherwise agreed to by the covered, in–network provider and the entity subject to this section, the reimbursement rate for specialty drugs covered under this section may not exceed the rate applicable to a designated specialty pharmacy for dispensing the covered specialty drugs. This section does not prohibit an entity subject to this section from refusing to authorize or approve or from denying coverage for a covered specialty drug administered or dispensed by a provider if administering or dispensing the drug fails to satisfy medical necessity criteria. This section may not be construed to supersede the authority of the Health Services Cost Review Commission to set rates for specialty drugs administered to patients in a setting regulated by the Health Services Cost Review Commission.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. This section does not apply to a policy or contract issued or delivered by an entity subject to this section that provides the essential health benefits required under § 1302(a) of the Affordable Care Act. An entity subject to this section shall provide coverage for all medically appropriate and necessary equipment and supplies used for the treatment of ostomies, including flanges, collection bags, clamps, irrigation devices, sanitizing products, ostomy rings, ostomy belts, and catheters used for drainage of urostomies. Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to the annual deductibles or coinsurance requirements imposed by an entity subject to this section for similar coverages under the same health insurance policy or contract. The annual deductibles or coinsurance requirements imposed under paragraph (1) of this subsection for the coverage required under this section may not be greater than the annual deductibles or coinsurance requirements imposed by the entity for similar coverages.

In this section the following words have the meanings indicated. “Abuse–deterrent opioid analgesic drug product” means a brand name or generic opioid analgesic drug product approved by the U.S. Food and Drug Administration with abuse–deterrent labeling that indicates the drug product is expected to result in a meaningful reduction in abuse. “Opioid analgesic drug product” means a drug product that contains an opioid agonist and is indicated by the U.S. Food and Drug Administration for the treatment of pain, regardless of whether the drug product: is in immediate release or extended release form; or contains other drug substances. This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section shall provide coverage for: at least two brand name abuse–deterrent opioid analgesic drug products, each containing different analgesic ingredients, on the lowest cost tier for brand name prescription drugs on the entity’s formulary for prescription drug coverage; and if available, at least two generic abuse–deterrent opioid analgesic drug products, each containing different analgesic ingredients, on the lowest cost tier for generic drugs on the entity’s formulary for prescription drug coverage. An entity subject to this section may not require an insured or an enrollee to first use an opioid analgesic drug product without abuse–deterrent labeling before providing coverage for an abuse–deterrent opioid analgesic drug product covered on the entity’s formulary for prescription drug coverage. Notwithstanding subsection (c)(2) of this section, an entity subject to this section may undertake utilization review, including preauthorization, for an abuse–deterrent opioid analgesic drug product covered by the entity, if the same utilization review requirements are applied to non–abuse–deterrent opioid analgesic drug products covered by the entity in the same formulary tier as the abuse–deterrent opioid analgesic product.

In this section, “opioid antagonist” means: naloxone hydrochloride; or any other similarly acting and equally safe drug approved by the federal Food and Drug Administration for the treatment of a drug overdose. This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section that includes on its formulary an opioid antagonist may apply a prior authorization requirement for an opioid antagonist only if the entity provides coverage for at least one formulation of the opioid antagonist without a prior authorization requirement.

This section applies to: insurers and nonprofit health service plans that provide coverage for substance use disorder benefits or prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for substance use disorder benefits or prescription drugs under individual or group contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for substance use disorder benefits under the medical benefit or for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section may not apply a prior authorization requirement for a prescription drug: when used for treatment of an opioid use disorder; and that contains methadone, buprenorphine, or naltrexone.

In this section the following words have the meanings indicated. “In–network pharmacy” means a pharmacy that is among the participating providers with which an entity subject to this section contracts to provide health care services to members. “Member” means an individual entitled to health care benefits for prescription drugs or devices under a policy issued or delivered in the State by an entity subject to this section. This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs and devices under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs and devices under contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs and devices through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section shall allow and apply a prorated daily copayment or coinsurance amount for a partial supply of a prescription drug dispensed by an in–network pharmacy if: the prescriber or the pharmacist determines dispensing a partial supply of a prescription drug to be in the best interest of the member; the prescription drug is anticipated to be required for more than 3 months; the member requests or agrees to a partial supply for the purpose of synchronizing the dispensing of the member’s prescription drugs; the prescription drug is not a Schedule II controlled dangerous substance; and the supply and dispensing of the prescription drug meets all prior authorization and utilization management requirements specific to the prescription drug at the time of the synchronized dispensing. Subject to subsection (c) of this section, an entity subject to this section: may not deny payment of benefits to an in–network pharmacy for a covered prescription drug solely on the basis that only a partial supply of the prescription drug was dispensed; and shall allow an in–network pharmacy to override any denial codes indicating that a prescription is being refilled too soon. Subject to subsection (c) of this section, an entity subject to this section: may not use a payment structure that incorporates prorated dispensing fees for dispensing a partial supply of a prescription drug; and shall pay an in–network pharmacy a full dispensing fee for dispensing a partial supply of a prescription drug under this section, regardless of: any prorated copayment or coinsurance amount charged to a member; or any fee paid to the pharmacy for synchronizing a member’s prescriptions.

In this section, “gradient compression garment” means a garment that: is used for the treatment of lymphedema; requires a prescription; and is custom fit for the individual for whom the garment is prescribed. “Gradient compression garment” does not include disposable medical supplies, including over–the–counter compression or elastic knee–high or other stocking products. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for the medically necessary diagnosis, evaluation, and treatment of lymphedema, including equipment, supplies, complex decongestive therapy, gradient compression garments, and self–management training and education. Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to the annual deductibles, copayments, or coinsurance requirements imposed by an entity subject to this section for similar coverages under the same health insurance policy or contract. The annual deductibles, copayments, or coinsurance requirements imposed under paragraph (1) of this subsection for the coverage required under this section may not be greater than the annual deductibles, copayments, or coinsurance requirements imposed by the entity for similar coverages.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs through a pharmacy benefit under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs through a pharmacy benefit under individual or group contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager or that contracts with a private review agent under Subtitle 10B of this title is subject to the requirements of this section. This section does not apply to a managed care organization as defined in § 15–101 of the Health – General Article. If an entity subject to this section requires a prior authorization for a prescription drug, the prior authorization request shall allow a health care provider to indicate whether a prescription drug is to be used to treat a chronic condition. If a health care provider indicates that the prescription drug is to treat a chronic condition, an entity subject to this section may not request a reauthorization for a repeat prescription for the prescription drug for 1 year or for the standard course of treatment for the chronic condition being treated, whichever is less. For a prior authorization that is filed electronically, the entity shall maintain a database that will prepopulate prior authorization requests with an insured’s available insurance and demographic information. On receipt of information documenting a prior authorization from the insured or from the insured’s health care provider, an entity subject to this section shall honor a prior authorization granted to an insured from a previous entity for at least the lesser of 90 days or the length of the course of treatment. During the time period described in paragraph (1) of this subsection, an entity may perform its own review to grant a prior authorization for the prescription drug. An entity subject to this section shall honor a prior authorization issued by the entity for a prescription drug and may not require a health care provider to submit a request for another prior authorization for the prescription drug: if the insured changes health benefit plans that are both covered by the same entity and the prescription drug is a covered benefit under the current health benefit plan; or except as provided in paragraph (2) of this subsection, when the dosage for the approved prescription drug changes and the change is consistent with federal Food and Drug Administration labeled dosages. Except as provided in § 15–851 of this subtitle, an entity may require a prior authorization for a change in dosage for an opioid under this subsection. If an entity under this section implements a new prior authorization requirement for a prescription drug, the entity shall provide notice of the new requirement at least 60 days before the implementation of a new prior authorization requirement: in writing to any insured who is prescribed the prescription drug; and either in writing or electronically to all contracted health care providers. The notice required under paragraph (1) of this subsection shall indicate that the insured may remain on the prescription drug at the time of reauthorization in accordance with subsection (g) of this section. Except as provided in paragraph (2) of this subsection, an entity subject to this section may not require more than one prior authorization if two or more tablets of different dosage strengths of the same prescription drug are: prescribed at the same time as part of an insured’s treatment plan; and manufactured by the same manufacturer. This subsection does not prohibit an entity from requiring more than one prior authorization if the prescription is for two or more tablets of different dosage strengths of an opioid that is not an opioid partial agonist. An entity subject to this section may not issue an adverse decision on a reauthorization for the same prescription drug or request additional documentation from the prescriber for the reauthorization request if: the prescription drug is: an immune globulin (human) as defined in 21 C.F.R. § 640.100; or used for the treatment of a mental disorder listed in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association; the entity previously approved a prior authorization for the prescription drug for the insured; the insured has been treated with the prescription drug without interruption since the initial approval of the prior authorization; and the prescriber attests that, based on the prescriber’s professional judgment, the prescription drug continues to be necessary to effectively treat the insured’s condition. If the prescription drug that is being requested has been removed from the formulary or has been moved to a higher deductible, copayment, or coinsurance tier, the entity shall provide the insured and insured’s health care provider the information required under § 15–831 of this subtitle.

In this section the following words have the meanings indicated. “Active course of treatment” means a course of treatment for which an insured is actively seeing a health care provider and following the course of treatment. “Course of treatment” means treatment that: is prescribed to treat or ordered for the treatment of an insured with a specific condition; is outlined and agreed to by the insured and the health care provider before the treatment begins; and may be part of a treatment plan. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that contracts with a private review agent under Subtitle 10B of this title is subject to the requirements of this section. An insurer, a nonprofit health service plan, or a health maintenance organization that contracts with a third party to dispense medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction is subject to the requirements of this section. Notwithstanding § 15–854 of this subtitle as it applies to coverage for prescription drugs, an entity subject to this section shall approve a request for the prior authorization of a course of treatment, including for chronic conditions, rehabilitative services, substance use disorders, and mental health conditions, that is: for a period of time that is as long as necessary to avoid disruptions in care; and determined in accordance with applicable coverage criteria, the insured’s medical history, and the health care provider’s recommendation. For new enrollees, an entity subject to this section may not disrupt or require reauthorization for an active course of treatment for covered services for at least 90 days after the date of enrollment.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for medically necessary diagnosis, evaluation, and treatment of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome, including the use of intravenous immunoglobulin therapy. Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to the annual deductibles, copayments, or coinsurance requirements imposed by an entity subject to this section for similar coverages under the same health insurance policy or contract. The annual deductibles, copayments, or coinsurance requirements imposed under paragraph (1) of this subsection for the coverage required under this section may not be greater than the annual deductibles, copayments, or coinsurance requirements imposed by the entity for similar coverages. Except as provided for in paragraph (2) of this subsection, pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome shall be coded as autoimmune encephalitis for billing and diagnosis purposes. If the American Medical Association and the Centers for Medicare and Medicaid Services create and assign a specific code for pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections or pediatric acute onset neuropsychiatric syndrome for billing and diagnosis purposes, pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome may be coded as: autoimmune encephalitis; pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections; or pediatric acute onset neuropsychiatric syndrome.

In this section the following words have the meanings indicated. “COVID–19” means, interchangeably and collectively, the coronavirus known as COVID–19 or 2019–nCoV and the SARS–CoV–2 virus. “COVID–19 test” means an in vitro diagnostic test for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, as described in § 3201 of the federal Coronavirus Aid, Relief, and Economic Security (CARES) Act. “COVID–19 test” includes a federal Food and Drug Administration–approved, cleared, or authorized rapid point–of–care test and an at–home collection test for the detection or diagnosis of COVID–19. “Health benefit plan”: for a small employer plan, has the meaning stated in § 15–1201 of this title; and for an individual plan, has the meaning stated in § 15–1301 of this title. “Member” means an individual entitled to health care benefits under a policy issued or delivered in the State by an entity subject to this section. “Member” includes a subscriber. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. This section applies to each individual and small employer health benefit plan that is issued or delivered in the State by an insurer, a nonprofit health service plan, or a health maintenance organization, irrespective of §§ 15–1207(d) and 31–116 of this article. An entity subject to this section shall provide coverage for COVID–19 tests and related items and services for the administration of COVID–19 tests, including facility fees, health care practitioner fees, and evaluation of the member for purposes of determining the need for the COVID–19 test, as required by the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and any applicable federal regulations or guidance. An entity subject to this section may not apply a copayment, coinsurance requirement, or deductible to coverage for COVID–19 tests and related items and services for the administration of COVID–19 tests.

This section applies to: insurers and nonprofit health service plans that provide labor and delivery coverage to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide labor and delivery coverage to individuals or groups under contracts that are issued or delivered in the State. This section does not apply to a multistate plan that does not provide coverage for abortions in accordance with 42 U.S.C. § 18054(a)(6). An organization that is eligible to obtain an exclusion from the coverage requirements under § 15–826 of this subtitle may obtain from an entity subject to this section an exclusion from the coverage and notice requirements of this section if the requirements conflict with the organization’s bona fide religious beliefs and practices. Except as provided in subsection (c) or (d) of this section and notwithstanding § 31–116(a) of this article, an entity subject to this section shall: cover abortion care services without: a deductible, coinsurance, copayment, or any other cost–sharing requirement; and restrictions that are inconsistent with the protected rights under Title 20, Subtitle 2 of the Health – General Article; and provide information to consumers about abortion care coverage using the terminology “abortion care” to describe coverage. If the Commissioner determines that enforcement of this section may adversely affect the allocation of federal funds to the State, the Commissioner may grant an exemption to the requirements of this section to the minimum extent necessary to ensure the continued receipt of federal funds. A high–deductible plan, as defined in 26 U.S.C. § 223(c)(2)(C) of the Internal Revenue Code, is exempt from the requirements of this section if the Commissioner determines that abortion care services are excluded from the safe harbor provisions for preventive care under § 223(c)(2)(C) of the Internal Revenue Code.

This section applies to: insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State. An insurer, a nonprofit health service plan, or a health maintenance organization that provides coverage for prescription drugs through a pharmacy benefits manager is subject to the requirements of this section. An entity subject to this section may not apply a prior authorization requirement for a prescription drug used as postexposure prophylaxis for the prevention of HIV if the prescription drug is prescribed for use in accordance with Centers for Disease Control and Prevention guidelines.

In this section the following words have the meanings indicated. “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene–drug interactions for medications being considered for use or already being administered. “Biomarker” includes gene mutations, characteristics of genes, or protein expression. “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker, the results of which: provide information that may be used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision; and include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision. “Biomarker testing” includes single–analyte tests, multi–plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for biomarker testing for the purpose of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition that is supported by medical and scientific evidence, including testing: cleared or approved by the U.S. Food and Drug Administration; required or recommended for a drug approved by the U.S. Food and Drug Administration to ensure an insured or enrollee is a good candidate for the drug treatment; required or recommended through a warning or precaution for a drug approved by the U.S. Food and Drug Administration to identify whether an insured or enrollee will have an adverse reaction to the drug treatment or dosage; covered under a Centers for Medicare and Medicaid Services National Coverage Determination or Medicare Administrative Contractor Local Coverage Determination; or supported by nationally recognized clinical practice guidelines that are: developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and that have a conflict of interest policy; and established standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care. An entity subject to this section shall ensure that the coverage required under subsection (c) of this section is provided in a manner that limits disruptions in care including the need for multiple biopsies or biospecimen samples. Subject to paragraph (2) of this subsection, the coverage required under this section may be subject to the annual deductibles, copayments, or coinsurance requirements imposed by an entity subject to this section for similar coverages under the same health insurance policy or contract. The annual deductibles, copayments, or coinsurance requirements imposed under paragraph (1) of this subsection for the coverage required under this section may not be greater than the annual deductibles, copayments, or coinsurance requirements imposed by the entity for similar coverages.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for recommended lung cancer screening or follow–up diagnostic imaging to assist in the diagnosis of lung cancer for individuals for which lung cancer screening or follow–up diagnostic imaging is recommended by the U.S. Preventative Services Task Force. The coverage required under paragraph (1) of this subsection: shall include diagnostic ultrasound, magnetic resonance imaging, computed tomography, and image–guided biopsy; and may not be subject to a prior authorization requirement. Except as provided in paragraph (2) of this subsection, an entity subject to this section may not impose a copayment, coinsurance, or deductible requirement on coverage for lung cancer screening or follow–up diagnostic imaging that is greater than the copay, coinsurance, or deductible requirement for breast cancer screening or diagnosis. If an insured or enrollee is covered under a high–deductible health plan, as defined in 26 U.S.C. § 223, an entity subject to this section may subject follow–up diagnostic lung imaging to the deductible requirement of the high–deductible health plan.

In this section, “special pediatric hospital” has the meaning stated in § 15–101 of the Health – General Article. This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section may not require prior authorization for a transfer to a special pediatric hospital.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section that covers the delivery of anesthesia for a procedure for which a licensed medical professional issues an order: shall provide coverage for: the delivery of anesthesia for the entire duration of the procedure; and medical care related to the delivery of anesthesia for the procedure that is provided immediately before and after the procedure; and may not establish, implement, or enforce a policy, practice, or procedure that places time limitations on the delivery of anesthesia.

This section applies to: insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State; and health maintenance organizations that provide hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State. An entity subject to this section shall provide coverage for calcium score testing in accordance with the most recent guidelines issued by the American College of Cardiology that expand the scope of preventive care services for the benefit of consumers.