EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. [Brackets] indicate matter deleted from existing law. *hb1274* HOUSE BILL 1274 J5 2lr2276 By: Delegate Kipke Introduced and read first time: February 11, 2022 Assigned to: Health and Government Operations A BILL ENTITLED AN ACT concerning 1 Prescription Drugs – Pharmacy Benefits Managers and Purchasers – Federal 2 340B Program 3 FOR the purpose of establishing requirements and prohibitions on pharmacy benefits 4 managers and purchasers related to the federal 340B Pr ogram, including 5 requirements related to coverage and reimbursement for drugs purchased under the 6 Program; and generally relating to prescription drugs, purchasers, and pharmacy 7 benefits managers. 8 BY adding to 9 Article – Insurance 10 Section 15–1611.2 11 Annotated Code of Maryland 12 (2017 Replacement Volume and 2021 Supplement) 13 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 14 That the Laws of Maryland read as follows: 15 Article – Insurance 16 15–1611.2. 17 (A) IN THIS SECTION , “340B PROGRAM” MEANS THE DRUG PRICING 18 PROGRAM ESTABLISHED UNDE R § 602 OF THE FEDERAL VETERANS HEALTH CARE 19 ACT OF 1992. 20 (B) BEFORE ALLOWING A BENEFICIARY TO USE A MAIL–ORDER PHARMACY 21 THAT PARTICIPATES IN THE 340B PROGRAM, A PHARMACY BENEFITS MANAGER OR 22 A PURCHASER SHALL OBTAIN A SIGNED WAIV ER FROM THE BENEFICIARY STATING 23 THAT THE BENEFICIARY IS NOT REQUIRED TO USE THE MAIL–ORDER PHARMACY . 24 2 HOUSE BILL 1274 (C) A PHARMACY BENEFITS MA NAGER OR A PURCHASER SHALL: 1 (1) MAKE FORMULARY AND COVERA GE DECISIONS FOR A PHARMACY 2 OR PHARMACIST THAT P ARTICIPATES IN THE 340B PROGRAM BASED ON THE 3 NORMAL COURSE OF BUS INESS OF THE PHARMACY BENE FITS MANAGER OR 4 PURCHASER ; AND 5 (2) ALLOW A BENEFICIARY TO USE ANY PHARMACY OR PHARMACIST 6 THAT THE BENEFICIARY CHOOSES, WITHOUT REG ARD TO WHETHER THE PHARMACY 7 OR PHARMACIST PARTICIPA TES IN 340B PROGRAM. 8 (D) A PHARMACY BENEFITS MA NAGER OR A PURCHASER MAY NOT : 9 (1) TRANSFER 340B PROGRAM SAVINGS FROM A PHARMACY OR 10 PHARMACIST THAT PART ICIPATES IN THE 340B PROGRAM TO A PHARMACY 11 BENEFITS MANAGER OR PURCHASER ; 12 (2) OFFER LOWER REIMBURSEMENT FOR A PRESCRIPTION DRUG 13 PURCHASED UNDER THE 340B PROGRAM THAN THE REIMBURSEMENT IT OFFERS 14 FOR THE SAME PRESCRIPTION DRUG IF IT IS NOT PURCHASED UNDER THE 340B 15 PROGRAM; 16 (3) REFUSE TO COVER PRESCRIPTION DRUGS PURCHASED UNDE R 17 THE 340B PROGRAM; 18 (4) REFUSE TO ALLOW PHARMACIES OR PHARMACISTS THAT 19 PARTICIPATE IN THE 340B PROGRAM TO PARTICIPATE IN THE PHARMACY BENEFITS 20 MANAGER’S PURCHASER ’S NETWORK; 21 (5) CHARGE MORE THAN FAIR MARKE T VALUE OR SEEK PROFIT 22 SHARING IN EXCHANGE FOR COVERAGE OF SERVICES FOR A PHARMACY OR 23 PHARMACIST THAT PART ICIPATES IN THE 340B PROGRAM; 24 (6) REQUIRE, AS A CONDITION OF CO VERAGE, THAT A BENEFICIARY 25 USE A SPECIFIED MAIL–ORDER PHARMACY OR PHARMACIST THAT P ARTICIPATES IN 26 THE 340B PROGRAM OR OTHERWISE COERCE A BENEFICIARY INTO USING A 27 SPECIFIC MAIL–ORDER PHARMACY OR PHARMACIST THAT P ARTICIPATES IN THE 28 340B PROGRAM; 29 (7) IMPOSE DIFFERENT CONTRACT TERMS ON PHARMACIES OR 30 PHARMACISTS THAT PAR TICIPATE IN A PHARMACY BENEFITS MA NAGER’S OR 31 HOUSE BILL 1274 3 PURCHASER ’S NETWORK BASED ON WHETHER A PHARMACY OR PHARMACIST 1 PARTICIPATES IN THE 340B PROGRAM; 2 (8) REQUIRE A PHARMACY OR PHARMACIST TO REVERSE, RESUBMIT, 3 OR CLARIFY A 340B PROGRAM CLAIM AFTER THE INIT IAL ADJUDICATION , UNLESS 4 THE ACTIONS ARE IN THE N ORMAL COURSE OF BUSI NESS OF THE PHARMACY 5 BENEFITS MANAGER OR PURCHASER AND ARE NOT RELATED TO WHETHER THE 6 PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM; 7 (9) REQUIRE A BILLING MODIFIER T O INDICATE THAT THE CLAIM FOR 8 A PRESCRIPTION DRUG IS A 340B PROGRAM CLAIM, UNLESS THE PRESCRIPTION 9 DRUG IS BEING BILLED TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM OR A 10 MANAGED CARE ORGANIZ ATION; 11 (10) MODIFY A BENEFICIARY’S COPAYMENT ON THE BAS IS OF 12 WHETHER A PHARMACY OR PHARMACI ST PARTICIPATES IN THE 340B PROGRAM; 13 (11) ESTABLISH OR SET NETWORK ADEQU ACY REQUIREMENTS BA SED 14 ON WHETHER A PHARMACY O R PHARMACIST PARTICI PATES IN THE 340B PROGRAM; 15 OR 16 (12) PROHIBIT AN ENTITY AUTHORIZED TO PARTIC IPATE IN THE 340B 17 PROGRAM OR A PHARMACY OR PHARMACIST UNDER CONTRACT WITH AN ENTITY 18 AUTHORIZED TO PARTICIPATE IN THE 340B PROGRAM FROM PARTICIPATING I N 19 THE PHARMACY BENEFITS MA NAGER’S OR PURCHASER ’S NETWORK ON THE BASIS 20 OF THE ENTITY’S PARTICIPATION IN THE 340B PROGRAM. 21 (E) A PHARMACY BENEFITS MA NAGER OR PURCHASER MAY NOT BASE A 22 FORMULARY OR PRESCRIPTION DRUG COVERAGE DECISI ONS ON: 23 (1) THE PRICE OF THE PRE SCRIPTION DRUG UNDER THE 340B 24 PROGRAM; OR 25 (2) WHETHER THE DISPENSING PHARMACY OR PHARMACIST 26 PARTICIPATES IN THE 340B PROGRAM. 27 (F) A 340B PROGRAM CLAIM PROCESSED BY A PHARMACY OR PHARMACIST 28 THAT PARTICIPATES IN THE 340B PROGRAM IS FINAL AT THE POIN T OF 29 ADJUDICATION . 30 (G) THE ADMINISTRATION SHALL ADOPT REGULATI ONS TO CARRY OUT 31 THIS SECTION. 32 4 HOUSE BILL 1274 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 1 October 1, 2022. 2