Amendment #11 to H4891

340B PACT Act

Ms. Montaño of Boston moves to amend the amendment by adding the following sections:

"SECTION XX. Said chapter 175 of the General Laws is hereby further amended by inserting after section 47UU, inserted by section 45, 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.

“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”, an entity receiving a grant under 42 U.S.C. 254(b).

“Manufacturer”, means a “manufacturer” of covered outpatient drugs as stated in 42 U.S.C. §1396r-8(k)(5) that has signed a pharmaceutical pricing agreement pursuant to 42 U.S.C. §256b(a)(1).

“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.

“Package,” the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product.

(b) A manufacturer or distributor shall not:

(i) deny, restrict, prohibit, discriminate against, 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, or is otherwise authorized by, a 340B grantee to receive  340B drugs on behalf of the 340B grantee unless such receipt is prohibited by the United States Department of Health and Human Services; or

(ii) require a 340B grantee, or a pharmacy that is under contract with a 340B grantee or is otherwise authorized by a 340B grantee to receive and dispense 340B drugs on behalf of the 340B grantee, to submit any claims or utilization data as a condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B grantee or a pharmacy that is under contract with a 340B grantee, unless the claims or utilization data sharing is required by the United States Department of Health and Human Services.

(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 package of 340B drugs subject to a prohibited act under Subsection (b) 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 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.

(h) If any provision or provisions of this Section 47VV is or are declared unconstitutional or inoperative by a final judgment, order or decree of the supreme court of the United States or of the supreme judicial court of the commonwealth, the remaining parts of said Section shall not be affected thereby."

Additional co-sponsor(s) added to Amendment #11 to H4891

340B PACT Act