EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. [Brackets] indicate matter deleted from existing law. *sb0974* SENATE BILL 974 J5, J1, J4 5lr2824 CF HB 1013 By: Senator Lam Introduced and read first time: January 28, 2025 Assigned to: Finance A BILL ENTITLED AN ACT concerning 1 Maryland Medical Assistance Program and Health Insurance – Nonopioid Drugs 2 for the Treatment of Pain 3 FOR the purpose of prohibiting the Maryland Medical Assistance Program and certain 4 insurers, nonprofit health service plans, health maintenance organizations, and 5 managed care organizations from applying a prior authorization requirement, step 6 therapy protocol, or fail–first protocol for a nonopioid drug used for the treatment of 7 pain that is more restrictive than a prior authorization requirement, step therapy 8 protocol, or fail–first protocol applied to an opioid or narcotic drug used for the 9 treatment of pain; requiring the Maryland Medical Assistance Program and certain 10 insurers, nonprofit health service plans, health maintenance organizations, and 11 managed care organizations to provide coverage for nonopioid drugs used for the 12 treatment of pain to the same extent as an opioid or narcotic drug used for the 13 treatment of pain; and generally relating to coverage of nonopioid drugs used for the 14 treatment of pain. 15 BY adding to 16 Article – Health – General 17 Section 15–102.3(m), 15–103(a)(2)(xxv), and 15–157 18 Annotated Code of Maryland 19 (2023 Replacement Volume and 2024 Supplement) 20 BY repealing and reenacting, without amendments, 21 Article – Health – General 22 Section 15–103(a)(1) 23 Annotated Code of Maryland 24 (2023 Replacement Volume and 2024 Supplement) 25 BY repealing and reenacting, with amendments, 26 Article – Health – General 27 Section 15–103(a)(2)(xxiii) and (xxiv) 28 2 SENATE BILL 974 Annotated Code of Maryland 1 (2023 Replacement Volume and 2024 Supplement) 2 BY repealing and reenacting, without amendments, 3 Article – Insurance 4 Section 15–142(a)(1) and (4) and (b) 5 Annotated Code of Maryland 6 (2017 Replacement Volume and 2024 Supplement) 7 BY repealing and reenacting, with amendments, 8 Article – Insurance 9 Section 15–142(e) 10 Annotated Code of Maryland 11 (2017 Replacement Volume and 2024 Supplement) 12 BY adding to 13 Article – Insurance 14 Section 15–861 15 Annotated Code of Maryland 16 (2017 Replacement Volume and 2024 Supplement) 17 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 18 That the Laws of Maryland read as follows: 19 Article – Health – General 20 15–102.3. 21 (M) BEGINNING JULY 1, 2026, THE PROVISIONS OF §§ 15–142(E)(2) AND 22 15–861 OF THE INSURANCE ARTICLE APPLY TO MANAGED CARE ORGANIZATIONS I N 23 THE SAME MANNER THEY APPLY TO CARRIERS . 24 15–103. 25 (a) (1) The Secretary shall administer the Maryland Medical Assistance 26 Program. 27 (2) The Program: 28 (xxiii) Beginning on July 1, 2025, shall provide, subject to the 29 limitations of the State budget, and as permitted by federal law, coverage for biomarker 30 testing in accordance with § 15–859 of the Insurance Article; [and] 31 (xxiv) Beginning on January 1, 2025, shall provide coverage for 32 prostheses in accordance with § 15–844 of the Insurance Article; AND 33 SENATE BILL 974 3 (XXV) BEGINNING ON JULY 1, 2026, SHALL PROVIDE COVERA GE 1 FOR ANY NONOPIOID DR UG APPROVED BY THE U.S. FOOD AND DRUG 2 ADMINISTRATION FOR TH E TREATMENT OF PAIN TO THE SAME EXTENT A S A 3 COVERED OPIOID OR NA RCOTIC DRUG USED FOR THE TREA TMENT OF PAIN . 4 15–157. 5 BEGINNING ON JULY 1, 2026, THE PROGRAM MAY NOT APPLY A PRIOR 6 AUTHORIZATION REQUIR EMENT, FAIL–FIRST PROTOCOL , OR STEP THERAPY 7 PROTOCOL FOR A NONOP IOID DRUG APPROVED B Y THE U.S. FOOD AND DRUG 8 ADMINISTRATION FOR TH E TREATMENT OF PAIN THAT IS MORE RESTRIC TIVE THAN 9 A PRIOR AUTHORIZATIO N REQUIREMENT , FAIL–FIRST PROTOCOL , OR STEP 10 THERAPY PROTOCOL APP LIED TO AN OPIOID OR NARCOTIC DRUG USED F OR THE 11 TREATMENT OF PAIN . 12 SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 13 as follows: 14 Article – Insurance 15 15–142. 16 (a) (1) In this section the following words have the meanings indicated. 17 (4) (i) “Step therapy or fail–first protocol” means a protocol established 18 by an insurer, a nonprofit health service plan, or a health maintenance organization that 19 requires a prescription drug or sequence of prescription drugs to be used by an insured or 20 an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 21 is covered. 22 (ii) “Step therapy or fail–first protocol” includes a protocol that 23 meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 24 or terminology used by the insurer, nonprofit health service plan, or health maintenance 25 organization to identify the protocol. 26 (b) (1) This section applies to: 27 (i) insurers and nonprofit health service plans that provide hospital, 28 medical, or surgical benefits to individuals or groups on an expense–incurred basis under 29 health insurance policies or contracts that are issued or delivered in the State; and 30 (ii) health maintenance organizations that provide hospital, 31 medical, or surgical benefits to individuals or groups under contracts that are issued or 32 delivered in the State. 33 4 SENATE BILL 974 (2) An insurer, a nonprofit health service plan, or a health maintenance 1 organization that provides coverage for prescription drugs through a pharmacy benefits 2 manager is subject to the requirements of this section. 3 (e) An entity subject to this section may not impose a step therapy or fail–first 4 protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 5 Drug Administration if: 6 (1) (I) the prescription drug is used to treat the insured’s or enrollee’s 7 stage four advanced metastatic cancer; and 8 [(2)] (II) use of the prescription drug is: 9 [(i)] 1. consistent with the U.S. Food and Drug 10 Administration–approved indication or the National Comprehensive Cancer Network 11 Drugs & Biologics Compendium indication for the treatment of stage four advanced 12 metastatic cancer; and 13 [(ii)] 2. supported by peer–reviewed medical literature; OR 14 (2) THE PRESCRIPTION DRU G IS A NONOPIOID DRU G APPROVED BY 15 THE U.S. FOOD AND DRUG ADMINISTRATION FOR TH E TREATMENT OF PAIN AND 16 THE ENTITY DOES NOT IMPOSE A STEP THERAP Y OR FAIL–FIRST PROTOCOL FOR A N 17 OPIOID OR NARCOTIC D RUG USED FOR THE TRE ATMENT OF PAIN . 18 15–861. 19 (A) (1) THIS SECTION APPLIES TO: 20 (I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 21 PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 22 BLANKET HEALTH INSUR ANCE POLIC IES OR CONTRACTS THA T ARE ISSUED OR 23 DELIVERED IN THE STATE; AND 24 (II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 25 COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CO NTRACTS 26 THAT ARE ISSUED OR D ELIVERED IN THE STATE. 27 (2) AN INSURER, A NONPROFIT HEALTH SERVICE PLAN, OR A HEALTH 28 MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 29 DRUGS THROUGH A PHAR MACY BENEFITS MANAGE R IS SUBJECT TO THE 30 REQUIREMENTS OF THIS SECTION. 31 (B) AN ENTITY SUBJECT TO THIS SECTION SHALL P ROVIDE COVERAGE FOR 32 ANY NONOPIOID DRUG A PPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION 33 SENATE BILL 974 5 FOR THE TREATMENT OF PAIN TO THE SAME EXT ENT AS A COVERED OPI OID OR 1 NARCOTIC DRUG USED F OR THE TREATMENT OF PAIN. 2 (C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT APPLY A PRIOR 3 AUTHORIZATION REQUIR EMENT FOR A NONOPIOI D PRESCRIPTION DRUG APPROVED 4 BY THE U.S. FOOD AND DRUG ADMINISTRATION FOR TH E TREATMENT OF PAIN 5 THAT IS MORE RESTRIC TIVE THAN A PRIOR AU THORIZATION REQUIREM ENT 6 APPLIED TO AN OPIOID OR NARCOTIC DRUG USE D FOR THE TREATMENT OF PAIN. 7 SECTION 3. AND BE IT FURTHER ENACTED, That: 8 (a) On or before December 1, 2026, each insurer and nonprofit health service plan 9 that provides coverage for prescription drugs under individual, group, or blanket health 10 insurance policies or contracts that are issued or delivered in the State and each health 11 maintenance organization that provides coverage for prescription drugs under individual 12 or group contracts that are issued or delivered in the State shall submit to the Maryland 13 Insurance Administration a plan to provide adequate coverage and access to a broad 14 spectrum of pain management services, including nonopioid drugs for the treatment and 15 management of pain and nonpharmologic, nonoperative pain management modalities that 16 serve as an alternative to the prescribing of opioid drugs. 17 (b) The Maryland Insurance Administration shall review each plan submitted 18 under subsection (a) of this section to determine whether the entity submitting the plan is 19 in compliance with this Act and whether any policies adopted by the entity may create 20 unduly preferential coverage of and access to opioid drugs. 21 SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 22 apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the 23 State on or after January 1, 2026. 24 SECTION 5. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 25 effect January 1, 2026. 26 SECTION 6. AND BE IT FURTHER ENACTED, That, except as provided in Section 27 5 of this Act, this Act shall take effect July 1, 2025. 28