EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. [Brackets] indicate matter deleted from existing law. *hb1243* HOUSE BILL 1243 J5 5lr2645 CF SB 975 By: Delegate S. Johnson Introduced and read first time: February 7, 2025 Assigned to: Health and Government Operations A BILL ENTITLED AN ACT concerning 1 Health Insurance – Coverage for Specialty Drugs 2 FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 3 maintenance organizations from excluding coverage for certain specialty drugs that 4 are administered or dispensed by a provider that meets certain criteria; requiring 5 the reimbursement rate for certain specialty drugs to meet certain criteria; and 6 generally relating to health insurance coverage for specialty drugs. 7 BY repealing and reenacting, without amendments, 8 Article – Insurance 9 Section 15–847(a)(1) and (5) 10 Annotated Code of Maryland 11 (2017 Replacement Volume and 2024 Supplement) 12 BY repealing and reenacting, with amendments, 13 Article – Insurance 14 Section 15–847(d), 15–1611.1, and 15–1612 15 Annotated Code of Maryland 16 (2017 Replacement Volume and 2024 Supplement) 17 BY adding to 18 Article – Insurance 19 Section 15–847.2 20 Annotated Code of Maryland 21 (2017 Replacement Volume and 2024 Supplement) 22 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23 That the Laws of Maryland read as follows: 24 Article – Insurance 25 2 HOUSE BILL 1243 15–847. 1 (a) (1) In this section the following words have the meanings indicated. 2 (5) (i) “Specialty drug” means a prescription drug that: 3 1. is prescribed for an individual with a complex or chronic 4 medical condition or a rare medical condition; 5 2. costs $600 or more for up to a 30–day supply; 6 3. is not typically stocked at retail pharmacies; and 7 4. A. requires a difficult or unusual process of delivery to 8 the patient in the preparation, handling, storage, inventory, or distribution of the drug; or 9 B. requires enhanced patient education, management, or 10 support, beyond those required for traditional dispensing, before or after administration of 11 the drug. 12 (ii) “Specialty drug” does not include a prescription drug prescribed 13 to treat diabetes, HIV, or AIDS. 14 (d) Subject to § 15–805 of this subtitle [and], notwithstanding § 15–806 of this 15 subtitle, [nothing in] AND EXCEPT AS PROVIDED IN § 15–847.2 OF THIS SUBTITLE, this 16 article or regulations adopted under this article [precludes] DO NOT PRECLUDE an entity 17 subject to this section from requiring a covered specialty drug to be obtained through: 18 (1) a designated pharmacy or other source authorized under the Health 19 Occupations Article to dispense or administer prescription drugs; or 20 (2) a pharmacy participating in the entity’s provider network, if the entity 21 determines that the pharmacy: 22 (i) meets the entity’s performance standards; and 23 (ii) accepts the entity’s network reimbursement rates. 24 15–847.2. 25 (A) IN THIS SECTION, “SPECIALTY DRUG ” HAS THE MEANING STAT ED IN § 26 15–847 OF THIS SUBTITLE . 27 (B) (1) THIS SECTION APPLIES TO: 28 HOUSE BILL 1243 3 (I) INSURERS AND NONPROF IT HEALTH SERVICE PLANS THAT 1 PROVIDE COVERAGE FOR PRESCRIPTION DRUGS U NDER INDIVIDUAL , GROUP, OR 2 BLANKET HEALTH INSUR ANCE POLICIES OR CON TRACTS THAT ARE ISSU ED OR 3 DELIVERED IN THE STATE; AND 4 (II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 5 COVERAGE FOR PRESCRI PTION DRUGS UNDER IN DIVIDUAL OR GROUP CO NTRACTS 6 THAT ARE ISSUED OR D ELIVERED IN THE STATE. 7 (2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 8 MAINTENANCE ORGANIZA TION THAT PROVIDES C OVERAGE FOR PRESCRIP TION 9 DRUGS THROUGH A PHAR MACY BENEFITS MA NAGER IS SUBJECT TO THE 10 REQUIREMENTS OF THIS SECTION. 11 (C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT EXCLUDE COVERAGE 12 FOR A COVERED SPECIA LTY DRUG ADMINISTERE D OR DISPENSED BY A PROVIDER 13 UNDER § 12–102 OF THE HEALTH OCCUPATIONS ARTICLE IF THE ENTITY 14 DETERMINES THAT: 15 (1) THE PROVIDER THAT AD MINISTERS OR DISPENS ES THE COVERED 16 SPECIALTY DRUG : 17 (I) IS AN IN–NETWORK PROVIDER OF COVERED MEDICAL 18 ONCOLOGY SERVICES ; AND 19 (II) COMPLIES WITH STATE REGULATIONS FOR THE 20 ADMINISTERING AND DI SPENSING OF SPECIALT Y DRUGS; AND 21 (2) THE COVERED SPECIALT Y DRUG IS: 22 (I) INFUSED, AUTO–INJECTED, OR AN ORAL TARGETED 23 IMMUNE MODULATOR ; OR 24 (II) AN ORAL MEDICATION T HAT: 25 1. REQUIRES COMPLEX DOS ING BASED ON CLINICA L 26 PRESENTATION ; OR 27 2. IS USED CONCOMITANTL Y WITH OTHER INFUSION OR 28 RADIATION THERAPIES . 29 (D) THE REIMBURSEMENT RAT E FOR SPECIALTY DRUG S COVERED UNDER 30 THIS SECTION SHALL B E: 31 4 HOUSE BILL 1243 (1) AGREED TO BY THE COV ERED, IN–NETWORK PROVIDER AND THE 1 ENTITY SUBJECT TO TH IS SECTION; AND 2 (2) BILLED AT A NONHOSPI TAL LEVEL OF CARE OR PLA CE OF 3 SERVICE. 4 (E) THIS SECTION DOES NOT PROHIBIT AN ENTITY S UBJECT TO THIS 5 SECTION FROM REFUSIN G TO AUTHORIZE OR AP PROVE OR FROM DENYIN G 6 COVERAGE FOR A COVER ED SPECIALTY DRUG AD MINISTERED OR DISPEN SED BY A 7 PROVIDER IF ADMINIST ERING OR DISPENSING THE DRU G FAILS TO SATISFY 8 MEDICAL NECESSITY CR ITERIA. 9 15–1611.1. 10 (a) This section applies only to a pharmacy benefits manager that provides 11 pharmacy benefits management services on behalf of a carrier. 12 (b) Except as provided in subsection (c) of this section, a pharmacy benefits 13 manager may not require that a beneficiary use a specific pharmacy or entity to fill a 14 prescription if: 15 (1) the pharmacy benefits manager or a corporate affiliate of the pharmacy 16 benefits manager has an ownership interest in the pharmacy or entity; or 17 (2) the pharmacy or entity has an ownership interest in the pharmacy 18 benefits manager or a corporate affiliate of the pharmacy benefits manager. 19 (c) [A] EXCEPT AS PROVIDED IN § 15–847.2 OF THIS TITLE, A pharmacy 20 benefits manager may require a beneficiary to use a specific pharmacy or entity for a 21 specialty drug as defined in § 15–847 of this title. 22 15–1612. 23 (a) This section applies only to a pharmacy benefits manager that provides 24 pharmacy benefits management services on behalf of a carrier. 25 (b) This section does not apply to reimbursement: 26 (1) EXCEPT AS PROVIDED I N § 15–847.2 OF THIS TITLE, for specialty 27 drugs; 28 (2) for mail order drugs; or 29 (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 30 an employee of the chain pharmacy. 31 HOUSE BILL 1243 5 (c) A pharmacy benefits manager may not reimburse a pharmacy or pharmacist 1 for a pharmaceutical product or pharmacist service in an amount less than the amount that 2 the pharmacy benefits manager reimburses itself or an affiliate for providing the same 3 product or service. 4 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 5 policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 6 after January 1, 2026. 7 SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 8 January 1, 2026. 9