SECTION 1. Chapter 32A of the General laws, as appearing in the 2022 Official Edition, is hereby amended by inserting after Section 33, the following new section:-
Section 34
(a) DEFINITIONS. For purposes of this section:
(1) “340B-covered entity”, has the same meaning as that set forth in section 256b(a)(4) of Title 42 of the United States Code.
(2) “Contract pharmacy” means a pharmacy operating under contract with a 340B-covered entity to provide dispensing services to the 340B-covered entity as described in 75 Fed. Reg. 10,272 (Mar. 5, 2010).
(3) “Drug coverage” means:
(i) An insurance company organized under this Chapter providing reimbursement for covered outpatient drugs, accepting any Medicaid insurance plan of the Commonwealth as defined in G. L. c. 118E or other applicable laws governing Medicaid in the Commonwealth;
(ii) Notwithstanding the foregoing, the term “drug coverage” does not include any amounts paid by an individual on his or her own behalf or on behalf of another individual.
(b) TERMS OF AGREEMENTS. No drug coverage that reimburses a-340B-covered entity or its contract pharmacy for drugs that are subject to an agreement under section 256b(a)(1) of Title 42 of the United States Code:
(i) Shall reimburse a covered entity or contract pharmacy for a quantity of a 340B drug in an amount less than such plan, issuer, or manager would pay to any other similarly situated entity or pharmacy that is not a covered entity or a contract pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs.
(ii) Shall discriminate against a 340B-covered entity (as defined in subsection (a)(1)) or a contract pharmacy (as defined in subsection (a)(2)) by imposing requirements, exclusions, reimbursement terms, or other conditions on such entity or pharmacy that differ from those applied to entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).
(iii) Shall impose any terms or conditions on 340B-covered entities or contract pharmacies with respect to any of the following that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a 340B-covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs:
(A) Fees, chargebacks, clawbacks, adjustments, or other assessments.
(B) Professional dispensing fees.
(C) Restrictions or requirements regarding participation in standard or preferred pharmacy networks.
(D) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles.
(iv) Shall require a claim for a drug to include a modifier to indicate that the drug is a 340B drug, or any other method of identifying the claim as 340B, unless the claim is for payment, directly or indirectly, by Medicaid as defined in Section 8 of Chapter 118E.
(c) Patient’s Choice. With respect to a patient eligible to receive drugs that are subject to an agreement under section 256b of Title 42 of the United States Code from a 340B-covered entity or its contract pharmacy, no entity that makes payment for such drugs shall discriminate against the 340B-covered entity or its contract pharmacy in a manner that prevents, steers, or otherwise interferes with the patient’s choice to receive such drugs from the 340B-covered entity or its contract pharmacy.
SECTION 2. Chapter 175 of the General laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after Section 47UU, the following new section:-
Section 47VV
(a)DEFINITIONS. For purposes of this section:
(1) “340B drug”, a drug that has been subject to any offer for reduced prices by a manufacturer pursuant to section 256b of Title 42 of the United States Code and is purchased by a 340B grantee as defined in this section.
(2) “340B grantee”, has the same meaning as “covered entity” set forth in section 256b(a)(4) of Title 42 of the United States Code
(3) “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.
(4) “Federally qualified health center”, an entity receiving a grant under section 254(b) of Title 42 of the United State Code.
(5) “Manufacturer” means a “manufacturer” of covered outpatient drugs as set forth in section 1396r-8(k)(5) of Title 42 of the United States Code that has signed a pharmaceutical pricing agreement pursuant to section 256b(a)(1) of Title 42 of the United States Code.
(6) “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.
(7) “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, agent, or affiliate of such manufacturer or distributor shall not:
(i) either directly or indirectly, deny, restrict, prohibit, discriminate against, or otherwise interfere with 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) interfere with a contract between a pharmacy and a 340B grantee.
(c) A manufacturer or distributor, agent, or affiliate of such manufacturer or distributor shall not, either directly or indirectly, 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, utilization, purchasing, or other 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.
(d) 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.
(e) 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.
(f) 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.
(g) 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.
(h) Limited distribution of a drug required under section 355-1 of Title 21 of the United States Code shall not be a violation of this section.
(i) If any provision or provisions of this Section 47VV is or are declared unconstitutional or inoperative by a final judgement, 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.
SECTION 3. Chapter 175 of the General laws, as appearing in the 2024 Official Edition, is hereby further amended by inserting after Section 47VV, inserted by Section 2, the following new section:-
Section 47WW
(a) DEFINITIONS. For purposes of this section:
(1) “340B-covered entity”, has the same meaning as that set forth in section 256b(a)(4) of Title 42 of the United States Code.
(2) “Contract pharmacy” means a pharmacy operating under contract with a 340B-covered entity to provide dispensing services to the 340B-covered entity as described in 75 Fed. Reg. 10,272 (Mar. 5, 2010).
(3) “Drug coverage” means:
(i) An insurance company organized under this Chapter providing reimbursement for covered outpatient drugs, accepting any Medicaid insurance plan of the Commonwealth as defined in G. L. c. 118E or other applicable laws governing Medicaid in the Commonwealth;
(ii) Notwithstanding the foregoing, the term “drug coverage” does not include any amounts paid by an individual on his or her own behalf or on behalf of another individual.
(b) TERMS OF AGREEMENTS. No drug coverage that reimburses a-340B-covered entity or its contract pharmacy for drugs that are subject to an agreement under section 256b(a)(1) of Title 42 of the United States Code:
(i) Shall reimburse a covered entity or contract pharmacy for a quantity of a 340B drug in an amount less than such plan, issuer, or manager would pay to any other similarly situated entity or pharmacy that is not a covered entity or a contract pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs.
(ii) Shall discriminate against a 340B-covered entity (as defined in subsection (a)(1)) or a contract pharmacy (as defined in subsection (a)(2)) by imposing requirements, exclusions, reimbursement terms, or other conditions on such entity or pharmacy that differ from those applied to entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).
(iii) Shall impose any terms or conditions on 340B-covered entities or contract pharmacies with respect to any of the following that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a 340B-covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs:
(A) Fees, chargebacks, clawbacks, adjustments, or other assessments.
(B) Professional dispensing fees.
(C) Restrictions or requirements regarding participation in standard or preferred pharmacy networks.
(D) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles.
(iv) Shall require a claim for a drug to include a modifier to indicate that the drug is a 340B drug, or any other method of identifying the claim as 340B, unless the claim is for payment, directly or indirectly, by Medicaid as defined in Section 8 of Chapter 118E.
(c) Patient’s Choice. With respect to a patient eligible to receive drugs that are subject to an agreement under section 256b of Title 42 of the United States Code from a 340B-covered entity or its contract pharmacy, no entity that makes payment for such drugs shall discriminate against the 340B-covered entity or its contract pharmacy in a manner that prevents, steers, or otherwise interferes with the patient’s choice to receive such drugs from the 340B-covered entity or its contract pharmacy.
SECTION 4. Chapter 176A of the General laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after Section 38, the following Section:
Section 39
(a) DEFINITIONS. For purposes of this section:
(1) “340B-covered entity”, has the same meaning as that set forth in section 256b(a)(4) of Title 42 of the United States Code.
(2) “Contract pharmacy” means a pharmacy operating under contract with a 340B-covered entity to provide dispensing services to the 340B-covered entity as described in 75 Fed. Reg. 10,272 (Mar. 5, 2010).
(3) “Drug coverage” means:
(i) An insurance company organized under this Chapter providing reimbursement for covered outpatient drugs, accepting any Medicaid insurance plan of the Commonwealth as defined in G. L. c. 118E or other applicable laws governing Medicaid in the Commonwealth;
(ii) Notwithstanding the foregoing, the term “drug coverage” does not include any amounts paid by an individual on his or her own behalf or on behalf of another individual.
(b) TERMS OF AGREEMENTS. No drug coverage that reimburses a-340B-covered entity or its contract pharmacy for drugs that are subject to an agreement under section 256b(a)(1) of Title 42 of the United States Code:
(i) Shall reimburse a covered entity or contract pharmacy for a quantity of a 340B drug in an amount less than such plan, issuer, or manager would pay to any other similarly situated entity or pharmacy that is not a covered entity or a contract pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs.
(ii) Shall discriminate against a 340B-covered entity (as defined in subsection (a)(1)) or a contract pharmacy (as defined in subsection (a)(2)) by imposing requirements, exclusions, reimbursement terms, or other conditions on such entity or pharmacy that differ from those applied to entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).
(iii) Shall impose any terms or conditions on 340B-covered entities or contract pharmacies with respect to any of the following that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a 340B-covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs:
(A) Fees, chargebacks, clawbacks, adjustments, or other assessments.
(B) Professional dispensing fees.
(C) Restrictions or requirements regarding participation in standard or preferred pharmacy networks.
(D) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles.
(iv) Shall require a claim for a drug to include a modifier to indicate that the drug is a 340B drug, or any other method of identifying the claim as 340B, unless the claim is for payment, directly or indirectly, by Medicaid as defined in Section 8 of Chapter 118E.
(c) Patient’s Choice. With respect to a patient eligible to receive drugs that are subject to an agreement under section 256b of Title 42 of the United States Code from a 340B-covered entity or its contract pharmacy, no entity that makes payment for such drugs shall discriminate against the 340B-covered entity or its contract pharmacy in a manner that prevents, steers, or otherwise interferes with the patient’s choice to receive such drugs from the 340B-covered entity or its contract pharmacy.
SECTION 5. Section 1 of Chapter 176B of the General laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after the definition of “Commissioner”, the following new definitions:
“340B-covered entity”, has the same meaning as that set forth in section 256b(a)(4) of Title 42 of the United States Code.
“Contract pharmacy” means a pharmacy operating under contract with a 340B-covered entity to provide dispensing services to the 340B-covered entity as described in 75 Fed. Reg. 10,272 (Mar. 5, 2010).
“Drug coverage” means:
(i) An insurance company organized under this Chapter providing reimbursement for covered outpatient drugs, accepting any Medicaid insurance plan of the Commonwealth as defined in G. L. c. 118E or other applicable laws governing Medicaid in the Commonwealth;
(ii) Notwithstanding the foregoing, the term “drug coverage” does not include any amounts paid by an individual on his or her own behalf or on behalf of another individual.
SECTION 6. Chapter 176B of the General laws, as appearing in the 2024 Official Edition, is hereby further amended by inserting after Section 25 the following new section:-
Section 26.
(a) TERMS OF AGREEMENTS. No drug coverage that reimburses a-340B-covered entity or its contract pharmacy for drugs that are subject to an agreement under section 256b(a)(1) of Title 42 of the United States Code:
(i) Shall reimburse a covered entity or contract pharmacy for a quantity of a 340B drug in an amount less than such plan, issuer, or manager would pay to any other similarly situated entity or pharmacy that is not a covered entity or a contract pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs.
(ii) Shall discriminate against a 340B-covered entity (as defined in subsection (a)(1)) or a contract pharmacy (as defined in subsection (a)(2)) by imposing requirements, exclusions, reimbursement terms, or other conditions on such entity or pharmacy that differ from those applied to entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).
(iii) Shall impose any terms or conditions on 340B-covered entities or contract pharmacies with respect to any of the following that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a 340B-covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs:
(A) Fees, chargebacks, clawbacks, adjustments, or other assessments.
(B) Professional dispensing fees.
(C) Restrictions or requirements regarding participation in standard or preferred pharmacy networks.
(D) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles.
(iv) Shall require a claim for a drug to include a modifier to indicate that the drug is a 340B drug, or any other method of identifying the claim as 340B, unless the claim is for payment, directly or indirectly, by Medicaid as defined in Section 8 of Chapter 118E.
(b) Patient’s Choice. With respect to a patient eligible to receive drugs that are subject to an agreement under section 256b of Title 42 of the United States Code from a 340B-covered entity or its contract pharmacy, no entity that makes payment for such drugs shall discriminate against the 340B-covered entity or its contract pharmacy in a manner that prevents, steers, or otherwise interferes with the patient’s choice to receive such drugs from the 340B-covered entity or its contract pharmacy.
SECTION 7. Section 1 of Chapter 176G of the General laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after the definition of “Company”, the following new definitions:
“340B-covered entity”, has the same meaning as that set forth in section 256b(a)(4) of Title 42 of the United States Code.
“Contract pharmacy” means a pharmacy operating under contract with a 340B-covered entity to provide dispensing services to the 340B-covered entity as described in 75 Fed. Reg. 10,272 (Mar. 5, 2010).
“Drug coverage” means:
(i) An insurance company organized under this Chapter providing reimbursement for covered outpatient drugs, accepting any Medicaid insurance plan of the Commonwealth as defined in G. L. c. 118E or other applicable laws governing Medicaid in the Commonwealth;
(ii) Notwithstanding the foregoing, the term “drug coverage” does not include any amounts paid by an individual on his or her own behalf or on behalf of another individual.
SECTION 8. Chapter 176G of the General laws, as appearing in the 2024 Official Edition, is hereby further amended by inserting after Section 33 the following new section:-
Section 34.
(a) TERMS OF AGREEMENTS. No drug coverage that reimburses a-340B-covered entity or its contract pharmacy for drugs that are subject to an agreement under section 256b(a)(1) of Title 42 of the United States Code:
(i) Shall reimburse a covered entity or contract pharmacy for a quantity of a 340B drug in an amount less than such plan, issuer, or manager would pay to any other similarly situated entity or pharmacy that is not a covered entity or a contract pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs.
(ii) Shall discriminate against a 340B-covered entity (as defined in subsection (a)(1)) or a contract pharmacy (as defined in subsection (a)(2)) by imposing requirements, exclusions, reimbursement terms, or other conditions on such entity or pharmacy that differ from those applied to entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).
(iii) Shall impose any terms or conditions on 340B-covered entities or contract pharmacies with respect to any of the following that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a 340B-covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs:
(A) Fees, chargebacks, clawbacks, adjustments, or other assessments.
(B) Professional dispensing fees.
(C) Restrictions or requirements regarding participation in standard or preferred pharmacy networks.
(D) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles.
(iv) Shall require a claim for a drug to include a modifier to indicate that the drug is a 340B drug, or any other method of identifying the claim as 340B, unless the claim is for payment, directly or indirectly, by Medicaid as defined in Section 8 of Chapter 118E.
(b) Patient’s Choice. With respect to a patient eligible to receive drugs that are subject to an agreement under section 256b of Title 42 of the United States Code from a 340B-covered entity or its contract pharmacy, no entity that makes payment for such drugs shall discriminate against the 340B-covered entity or its contract pharmacy in a manner that prevents, steers, or otherwise interferes with the patient’s choice to receive such drugs from the 340B-covered entity or its contract pharmacy.
SECTION 9. Section 1 of Chapter 176I of the General laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after the definition of “Commissioner”, the following new definitions:
“340B-covered entity”, has the same meaning as that set forth in section 256b(a)(4) of Title 42 of the United States Code.
“Contract pharmacy” means a pharmacy operating under contract with a 340B-covered entity to provide dispensing services to the 340B-covered entity as described in 75 Fed. Reg. 10,272 (Mar. 5, 2010).
“Drug coverage” means:
(i) An insurance company organized under this Chapter providing reimbursement for covered outpatient drugs, accepting any Medicaid insurance plan of the Commonwealth as defined in G. L. c. 118E or other applicable laws governing Medicaid in the Commonwealth;
(ii) Notwithstanding the foregoing, the term “drug coverage” does not include any amounts paid by an individual on his or her own behalf or on behalf of another individual.
SECTION 10. Chapter 176I of the General laws, as appearing in the 2024 Official Edition, is hereby further amended by inserting after Section 13 the following new section:-
Section 14.
(a) TERMS OF AGREEMENTS. No drug coverage that reimburses a-340B-covered entity or its contract pharmacy for drugs that are subject to an agreement under section 256b(a)(1) of Title 42 of the United States Code:
(i) Shall reimburse a covered entity or contract pharmacy for a quantity of a 340B drug in an amount less than such plan, issuer, or manager would pay to any other similarly situated entity or pharmacy that is not a covered entity or a contract pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs.
(ii) Shall discriminate against a 340B-covered entity (as defined in subsection (a)(1)) or a contract pharmacy (as defined in subsection (a)(2)) by imposing requirements, exclusions, reimbursement terms, or other conditions on such entity or pharmacy that differ from those applied to entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).
(iii) Shall impose any terms or conditions on 340B-covered entities or contract pharmacies with respect to any of the following that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not 340B-covered entities or contract pharmacies on the basis that the entity or pharmacy is a 340B-covered entity or contract pharmacy or that the entity or pharmacy dispenses 340B drugs:
(A) Fees, chargebacks, clawbacks, adjustments, or other assessments.
(B) Professional dispensing fees.
(C) Restrictions or requirements regarding participation in standard or preferred pharmacy networks.
(D) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles.
(iv) Shall require a claim for a drug to include a modifier to indicate that the drug is a 340B drug, or any other method of identifying the claim as 340B, unless the claim is for payment, directly or indirectly, by Medicaid as defined in Section 8 of Chapter 118E.
(b) Patient’s Choice. With respect to a patient eligible to receive drugs that are subject to an agreement under section 256b of Title 42 of the United States Code from a 340B-covered entity or its contract pharmacy, no entity that makes payment for such drugs shall discriminate against the 340B-covered entity or its contract pharmacy in a manner that prevents, steers, or otherwise interferes with the patient’s choice to receive such drugs from the 340B-covered entity or its contract pharmacy.
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