Sec. 3. Ensuring the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program

1,297 words·~6 min read·/bill/117/hr/4390/ih/section-3

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Subpart II of part A of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–11 et seq. ) is amended by adding at the end the following new section: A group health plan, a health insurance issuer offering group or individual health insurance coverage, or a pharmacy benefit manager may not discriminate against a covered entity (as defined in subsection (d)(1)) or a specified pharmacy (as defined in subsection (d)(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 covered entities or specified pharmacies on the basis that the entity or pharmacy is a covered entity or specified pharmacy or that the entity or pharmacy dispenses 340B drugs, including by taking any action prohibited under subsection (b).

A group health plan, a health insurance issuer offering group or individual health insurance coverage, or a pharmacy benefit manager may not discriminate against a covered entity or a specified pharmacy by doing any of the following: Reimbursing a covered entity or specified pharmacy for a quantity of a 340B drug (as defined in subsection (d)) in an amount less than such plan, issuer, or manager (as applicable) would pay to any other similarly situated (as specified by the Secretary) entity or pharmacy that is not a covered entity or a specified pharmacy for such quantity of such drug on the basis that the entity or pharmacy is a covered entity or specified pharmacy or that the entity or pharmacy dispenses 340B drugs.

Imposing any terms or conditions on covered entities or specified 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 covered entities or specified pharmacies on the basis that the entity or pharmacy is a covered entity or specified pharmacy or that the entity or pharmacy dispenses 340B drugs: Fees, chargebacks, clawbacks, adjustments, or other assessments. Professional dispensing fees.

Restrictions or requirements regarding participation in standard or preferred pharmacy networks. Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles. Any other restrictions, conditions, practices, or policies that, as specified by the Administrator of the Health Resources and Services Administration, interfere with the ability of a covered entity to maximize the value of discounts provided under section 340B.

Interfering with an individual’s choice to receive a 340B drug from a covered entity or specified pharmacy, whether in person or via direct delivery, mail, or other form of shipment. Requiring a covered entity or specified pharmacy to identify, either directly or through a third party, 340B drugs. Refusing to contract with a covered entity or specified pharmacy for reasons other than those that apply equally to entities or pharmacies that are not covered entities or specified pharmacies, or on the basis that— the entity or pharmacy is a covered entity or a specified pharmacy; or the entity or pharmacy is described in any of subparagraphs

(A)through

(O)of section 340B(a)(4). The Secretary shall impose a civil monetary penalty on any pharmacy benefit manager that violates the requirements of this section. Such penalty shall not exceed $5,000 per violation per day. The Secretary shall issue proposed regulations to implement this subsection not later than 60 days after the date of the enactment of this subsection and shall finalize such regulations not later than 180 days after such date of enactment. For purposes of this section: The term covered entity has the meaning given such term in section 340B(a)(4). The term specified pharmacy means a pharmacy with which a covered entity has contracted to dispense 340B drugs on behalf of the covered entity whether distributed in person or via mail. The term 340B drug means a drug that is— a covered outpatient drug (as defined for purposes of section 340B); and purchased under an agreement in effect under such section. . Section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended by adding at the end the following new paragraph: Each contract entered into under this subsection with a PDP sponsor shall provide that the requirements of section 2730 of the Public Health Service Act apply to such sponsor, and to any pharmacy benefit manager that contracts with such sponsor, in the same manner as such requirements apply with respect to a group health plan, a health insurance issuer, or a pharmacy benefit manager described in such section. . Section 1857(f)(3) of the Social Security Act ( 42 U.S.C. 1395w–27(f)(3) ) is amended by adding at the end the following new subparagraph: Section 1860D–12(b)(8). . Section 1927 of the Social Security Act ( 42 U.S.C. 1396r–8 ) is amended by adding at the end the following new subsection: Not later than 1 year after the date of the enactment of this subsection, the Secretary shall enter into a contract with a third-party entity (who shall be free of conflicts of interest, as specified by the Secretary) for purposes of— identifying claims for 340B drugs (as defined in section 2730(d) of the Public Health Service Act) for which reimbursement was made under a State plan (or waiver of such plan); and ensuring such claims are not included in any State rebate request under this section in violation of section 340B(a)(5)(A) of the Public Health Service Act or section 1903(m)(2)(A)(xiii) or 1927(j)(1). The entity with a contract in effect under paragraph

(1)shall— request and review, in the most efficient and least burdensome manner practicable— claims level data from covered entities (as defined in section 340B of the Public Health Service Act) itemizing 340B drugs dispensed to individuals enrolled under a State plan (or waiver of such plan); and claims level rebate file data from State agencies administering such plan (or such waiver); request, receive, and maintain data described in either of subclauses

(I)and

(II)of clause

(i)in a confidential manner; and notify the State and the Secretary of any violation described in paragraph (1)(B) to ensure that such violation is remedied. In requesting and reviewing claims level data described in subparagraph (A)(i)(I) from a covered entity, the entity with a contract in effect under paragraph

(1)shall allow such covered entity the option of submitting such data on a retrospective basis. . Section 340B(a)(5) of the Public Health Service Act ( 42 U.S.C. 256b(a)(5) ) is amended by adding at the end the following new subparagraph: A covered entity shall furnish to the entity with a contract in effect under section 1927(l) of the Social Security Act, upon request of such entity, the data described in paragraph (2)(A)(i) of such section. . Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ) is amended— in paragraph (86), by striking and at the end; in paragraph (87)(D), by striking the period and inserting ; and ; and by inserting after paragraph

(87)the following new paragraph: provide for a mechanism to furnish to the entity with a contract in effect under section 1927(l), upon request of such entity, the data described in paragraph (2)(A)(ii) of such section and remove from any rebate request described in paragraph (1)(B) of such section any claim that is the subject of a notice submitted by such entity under paragraph (2)(C) of such section. . No funds appropriated under any Act may be used to implement Executive Order 13937 published on July 29, 2020, or to otherwise specify or limit the amount that a covered entity (as defined in section 340B(a)(4) of the Public Health Service Act ( 42 U.S.C. 256b(a)(4) )) charges patients for 340B drugs (as defined in section 2730(d) of the Public Health Service Act, as added by subsection (a)).

Connectionstraces to 3

Traces to 3 documents

U.S. Code