LAWRENCE J. HOGAN, JR., Governor Ch. 365
– 1 –
Chapter 365
(House Bill 1274)
AN ACT concerning
Prescription Drugs – Pharmacy Benefits Managers and Purchasers – Federal
340B Program
FOR the purpose of establishing requirements and prohibitions on pharmacy benefits
managers and purchasers related to the federal 340B Program, including
requirements related to coverage and reimbursement for drugs purchased under the
Program; and generally relating to prescription drugs, purchasers, and pharmacy
benefits managers.
BY adding to
Article – Insurance
Section 15–1611.2
Annotated Code of Maryland
(2017 Replacement Volume and 2021 Supplement)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Insurance
15–1611.2.
(A) (1) IN THIS SECTION, THE FOLLOWING WORDS HAVE THE MEANINGS
INDICATED.
(2) “COVERED ENTITY ” HAS THE MEANING STAT ED IN § 602 OF THE
FEDERAL VETERANS HEALTH CARE ACT OF 1992.
(3) “PHARMACIES OR PHARMAC ISTS THAT PARTICIPAT E IN THE 340B
PROGRAM” MEANS:
(I) A PHARMACY OWNED OR OPERATED BY A COVERE D ENTITY
THAT IS ELIGIBLE TO OR IS ACTIVELY PAR TICIPATING IN THE 340B PROGRAM; OR
(II) A PHARMACY OR PHARMA CIST UNDER CONTRACT WITH A
COVERED ENTITY TO DI SPENSE DRUGS PURCHAS ED UNDER THE 340B PROGRAM TO
PATIENTS OF THE COVE RED ENTITY.
Ch. 365 2022 LAWS OF MARYLAND
– 2 –
(4) “340B PROGRAM” MEANS THE DRUG PRICI NG PROGRAM
ESTABLISHED UNDER § 602 OF THE FEDERAL VETERANS HEALTH CARE ACT OF
1992.
(B) BEFORE ALLOWING A BEN EFICIARY TO USE A MA IL–ORDER PHARMACY
THAT PARTICIPATES IN THE 340B PROGRAM, A PHARMACY BENEFITS MANAGER OR
A PURCHASER SHALL OB TAIN A SIGNED WAIVER FROM THE BENEFICIA RY STATING
THAT THE BENEFICIARY IS NOT REQUIRED TO U SE THE MAIL–ORDER PHARMACY .
(C) (B) A PHARMACY BENEFITS MA NAGER OR A PURCHASER SHALL:
(1) MAKE FORMULARY AND C OVERAGE DECISIONS FO R A PHARMACY
OR PHARMACIST THAT P ARTICIPATES IN THE 340B PROGRAM BASED ON THE
NORMAL COURSE OF BUS INESS OF THE PHARMAC Y BENEFITS MANAGER OR
PURCHASER ; AND
(2) ALLOW A BENEFICIARY TO USE ANY IN–NETWORK PHARMACY OR
PHARMACIST THAT THE BENEFICIARY CHOOSES , WITHOUT REGARD TO WH ETHER
THE PHARMACY OR PHAR MACIST PARTICIPATES IN 340B PROGRAM.
(D) (C) A PHARMACY BENEFITS MA NAGER OR A PURCHASER MAY NOT:
(1) TRANSFER 340B PROGRAM SAVINGS FROM A PHARMACY OR
PHARMACIST THAT PARTI CIPATES IN THE 340B PROGRAM TO A PHARMACY
BENEFITS MANAGER OR PURCHASER ;
(2) OFFER LOWER REIMBURS EMENT FOR A PRESCRIP TION DRUG
PURCHASED UNDER THE 340B PROGRAM THAN THE REIM BURSEMENT IT OFFERS
FOR THE SAME PRESCRI PTION DRUG IF IT IS NOT PURCHASED UNDER THE 340B
PROGRAM;
(3) REFUSE TO COVER PRES CRIPTION DRUGS PURCH ASED UNDER
THE 340B PROGRAM;
(4) REFUSE TO ALLOW PHAR MACIES OR PHARMACIST S THAT
PARTICIPATE IN THE 340B PROGRAM TO PARTICIPAT E IN THE PHARMACY BE NEFITS
MANAGER’S PURCHASER’S NETWORK ON THE SOLE BASIS TH AT THE PHARMACY OR
PHARMACIST PARTICIPA TES IN THE 340B PROGRAM;
(5) CHARGE MORE THAN FAI R MARKET VALUE OR SE EK PROFIT
SHARING IN EXCHANGE FOR COVERAGE OF SERV ICES FOR A PHARMACY OR
PHARMACIST THAT PART ICIPATES IN THE 340B PROGRAM;
LAWRENCE J. HOGAN, JR., Governor Ch. 365
– 3 –
(6) REQUIRE, AS A CONDITION OF CO VERAGE, THAT A BENEFICIARY
USE A SPECIFIED MAIL –ORDER PHARMACY OR PH ARMACIST THAT PARTIC IPATES IN
THE 340B PROGRAM OR OTHERWISE COERCE A BENEFICIARY INTO USING A
SPECIFIC MAIL–ORDER PHARMACY OR PH ARMACIST THAT PARTICIPATES IN THE
340B PROGRAM;
(7) (5) IMPOSE DIFFERENT REIMBURSEMENT OR NET WORK
PARTICIPATION CONTRACT TERMS ON PH ARMACIES OR PHARMACI STS THAT
PARTICIPATE IN A PHA RMACY BENEFITS MANAG ER’S OR PURCHASER ’S NETWORK
BASED ON WHETHER A P HARMACY OR PH ARMACIST PARTICIPATE S IN THE 340B
PROGRAM;
(8) REQUIRE A PHARMACY O R PHARMACIST TO REVE RSE, RESUBMIT,
OR CLARIFY A 340B PROGRAM CLAIM AFTER T HE INITIAL ADJUDICAT ION, UNLESS
THE ACTIONS ARE IN T HE NORMAL COURSE OF BUSINESS OF THE PHAR MACY
BENEFITS MANAGER OR PURCHASER AND ARE NOT RELATED TO WHETHER THE
PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM;
(9) REQUIRE A BILLING MO DIFIER TO INDICATE T HAT THE CLAIM FOR
A PRESCRIPTION DRUG IS A 340B PROGRAM CLAIM , UNLESS THE PRESCRIPT ION
DRUG IS BEING BILLED TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM OR A
MANAGED CARE ORGANIZ ATION;
(6) IMPOSE DIFFERENT FEE S, CHARGEBACKS , OR OTHER
ADJUSTMENTS ON PHARM ACIES OR PHARMACISTS BASED ON WHETHER A
PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM;
(10) (7) MODIFY A BENEFICIARY ’S COPAYMENT ON THE B ASIS OF
WHETHER A PHARMACY O R PHARMACIST PARTICI PATES IN THE 340B PROGRAM;
(11) (8) ESTABLISH OR SET NET WORK ADEQUACY REQUIR EMENTS
BASED ON WHETHER A P HARMACY OR PHARMACIS T PARTICIPATES IN TH E 340B
PROGRAM; OR
(12) (9) PROHIBIT AN A COVERED ENTITY AUTHORIZED TO
PARTICIPATE IN THE 340B PROGRAM OR A PHARMACY OR PHARMACIST UNDER
CONTRACT WITH AN A COVERED ENTITY AUTHORIZED TO PARTICIPATE IN THE 340B
PROGRAM FROM PARTICIP ATING IN THE PHARMAC Y BENEFITS MANAGER ’S OR
PURCHASER ’S NETWORK ON THE BASIS OF THE COVERED ENTITY’S PARTICIPATION
IN THE 340B PROGRAM.
(E) (D) A PHARMACY BENEFITS MA NAGER OR PURCHASER MAY NOT BASE
A FORMULARY OR PRESCRI PTION DRUG COVERAGE DECISIONS ON:
Ch. 365 2022 LAWS OF MARYLAND
– 4 –
(1) THE PRICE OF THE PRE SCRIPTION DRUG UNDER THE 340B
PROGRAM; OR
(2) WHETHER THE DISPENSI NG PHARMACY OR PHARM ACIST
PARTICIPATES IN THE 340B PROGRAM.
(F) A 340B PROGRAM CLAIM PROCESS ED BY A PHARMACY OR PHARMACIST
THAT PARTICIPATES IN THE 340B PROGRAM IS FINAL AT T HE POINT OF
ADJUDICATION .
(G) THE ADMINISTRATION SHALL ADOPT REGULATIONS TO CARRY OUT
THIS SECTION.
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
October 1, 2022.
Approved by the Governor, May 16, 2022.