Amendment ID: S2499-9-R2
2nd Redraft Amendment 9
Protecting the Dispensing and Distribution of 340B Drugs in the Commonwealth
Messrs. Payano and Collins, Ms. Miranda, Ms. Rausch, Ms. Edwards and Mr. Gomez move that the proposed new draft be amended by inserting after section 45 the following section:-
“SECTION 45A. Said chapter 175 of the General Laws is hereby further amended by inserting after section 47UU the following section:-
Section 47VV. (a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:
“340B drug”, a drug that has been subject to any offer for reduced prices by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a 340B grantee as defined in this section.
“340B grantee”, a federally qualified health center, a non-state, government public safety net hospital system established pursuant to chapter 147 of the acts of 1996 or a non-profit acute care hospital in the commonwealth that received not less than 60 per cent of its gross patient service revenue in fiscal year 2021 from government payers, including Medicare, MassHealth and the Health Safety Net Trust Fund based on the hospital’s fiscal year 2021 cost report and that is also authorized to participate in the federal drug discount program under 42 U.S.C 256b, including its pharmacies or any contracted pharmacy.
“Distributor”, a person engaged in the sale, distribution or delivery, at wholesale, of drugs or medicines within the commonwealth, including entities operating outside of the commonwealth that cause deliveries of drugs or medicines to be made within the commonwealth.
“Federally qualified health center”, shall have the same meaning as defined in 42 U.S.C. 254(b).
“Manufacturer”, an entity engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs or medical devices, either directly or indirectly, by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs.
“Pharmacy”, an entity engaged in the drug business, as defined in section 37 of chapter 112, or engaged in the practice of compounding to fulfill a practitioner prescription.
(b) A manufacturer or distributor shall not:
(i) deny, restrict, prohibit, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract with a 340B grantee and is authorized under such contract to receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited by the United States Department of Health and Human Services; or
(ii) interfere with a contract between a pharmacy and a 340B grantee.
(c) The commission of any act prohibited under subsection (b) of this section shall constitute an unfair or deceptive practice within the meaning of section 2 of chapter 93A. Each commission of a prohibited act shall constitute a separate violation.
(d) The attorney general shall have jurisdiction, consistent with the provisions of chapter 93A, to enforce the provisions of this section. The attorney general shall issue regulations to implement this chapter.
(e) The board of registration in pharmacy shall promulgate regulations to implement and enforce of this section and may investigate any complaint of a violation of this section by an individual or entity licensed by the board and may impose discipline, suspension or revocation of any such license.
(f) Nothing in this section shall be construed or applied to be less restrictive than any federal law as to any person or entity regulated by this section or to conflict with: (i) any applicable federal law and related regulations; or (ii) any other general law that is compatible with applicable federal law.
(g) Limited distribution of a drug required under 21 U.S.C. 355-1 shall not be a violation of this section.”; and
by inserting after section 65 the following section:-
“SECTION 65A. The regulations required by subsections (e) and (f) of section 47VV of chapter 175 of the General Laws shall be promulgated not later than 3 months after the effective date of this act.”