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Code · BILL · 116th Congress · H.R. 1332 (Introduced in House) — To address the high costs of health care services, prescription drugs, and health insurance coverage in the United St... · Sec. 342

Sec. 342. PBM transparency and elimination of DIR fees

1,434 words·~7 min read·/bill/116/hr/1332/ih/section-342·

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Section 1860D–12(b)(4)(A) of the Social Security Act ( 42 U.S.C. 1395w–112(b)(4)(A) ) is amended by adding at the end the following new clause: Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that after the date of receipt of a clean claim submitted by a pharmacy, the PDP sponsor (or an agent of the PDP sponsor) may not retroactively reduce payment on such claim directly or indirectly through aggregated effective rate or otherwise except in the case such claim is found to not be a clean claim (such as in the case of a claim lacking required substantiating documentation) during the course of a routine audit as permitted pursuant to written agreement between the PDP sponsor (or such an agent) and such pharmacy.
The previous sentence shall not prohibit any retroactive increase in payment to a pharmacy pursuant to a written agreement between a PDP sponsor (or an agent of such sponsor) and such pharmacy. . The amendment made by subsection
(a)shall apply with respect to contracts entered into on or after January 1, 2021. 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 with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor or with an MA organization offering an MA–PD plan under part C shall provide that the sponsor or organization, respectively, may not enter into a contract with any pharmacy benefits manager (referred to in this paragraph as a PBM ) to manage the prescription drug coverage provided under such plan, or to control the costs of the prescription drug coverage under such plan, unless the PBM adheres to the following criteria when handling personally identifiable utilization and claims data or other sensitive patient data: The PBM may not transmit any personally identifiable utilization, protected health information, or claims data, with respect to a plan enrollee, to a pharmacy owned by a PBM if the plan enrollee has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at the PBM-owned pharmacy. The PBM may not require that a plan enrollee use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM, or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM, if the incentive is applicable only to such pharmacies. . Paragraph
(6)of section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended to read as follows: If the PDP sponsor of a prescription drug plan (or MA organization offering an MA–PD plan) uses a standard for reimbursement (as described in subparagraph (B)) of pharmacies based on the cost of a drug, each contract entered into with such sponsor under this part (or organization under part C) with respect to the plan shall provide that the sponsor (or organization) shall— update such standard not less frequently than once every 7 days, beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug; disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request; if the source for such a standard for reimbursement is not publicly available, disclose to the applicable pharmacies and the respective contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims; establish a process to appeal, investigate, and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug, which must be adjudicated within 7 days of the pharmacy filing its appeal; and provide all such pricing data in an .xml spreadsheet format or a comparable easily accessible and complete spreadsheet format. For purposes of subparagraph (A), a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved, including drug pricing references and amounts that are based upon average wholesale price, wholesale average cost, average manufacturer price, average sales price, maximum allowable cost (MAC), or other costs, whether publicly available or not. . The amendments made by this section shall apply to plan years beginning on or after January 1, 2020. Section 1074g(d) of title 10, United States Code, is amended by adding at the end the following new paragraph: To the extent practicable, with respect to the TRICARE retail pharmacy program described in subsection (a)(2)(E)(ii), the Secretary shall ensure that a contract entered into with a TRICARE managed care support contractor includes requirements described in section 1860D–12(b)(6) of the Social Security Act ( 42 U.S.C. 1395w–112(b)(6) ) to ensure the provision of information regarding the pricing standard for prescription drugs. . Section 8902 of title 5, United States Code, is amended by adding at the end the following new subsections: A contract may not be made or a plan approved under this chapter under which a carrier has an agreement with a pharmacy benefits manager (in this subsection referred to as a PBM ) to manage prescription drug coverage or to control the costs of the prescription drug coverage unless the carrier and PBM adhere to the following criteria: The PBM may not transmit any personally identifiable utilization, protected health information, or claims data with respect to an individual enrolled under such contract or plan to a pharmacy owned by the PBM if the individual has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at such a pharmacy. The PBM may not require that an individual enrolled under such contract or plan use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy, mail order pharmacy, specialty pharmacy, or other pharmacy entity providing pharmacy services in which the PBM has an ownership interest or that has an ownership interest in the PBM, if the incentive is applicable only to such pharmacies. If a contract made or plan approved under this chapter provides for a standard for reimbursement (as described in paragraph (2)) with respect to a prescription drug plan, such contract or plan shall provide that the applicable carrier— update such standard not less frequently than once every 7 days, beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug; disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request; if the source for such a standard for reimbursement is not publicly available, disclose to the applicable pharmacies and contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims; establish a process to appeal, investigate, and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug, which must be adjudicated within 7 days of the pharmacy filing its appeal; and provide all such pricing data in an .xml spreadsheet format or a comparable easily accessible and complete spreadsheet format. For purposes of paragraph (1), a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved, including drug pricing references and amounts that are based upon average wholesale price, wholesale average cost, average manufacturer price, average sales price, maximum allowable cost, or other costs, whether publicly available or not. . The amendment made by subparagraph
(A)shall apply to any contract entered into under section 8902 of title 5, United States Code, on or after the date of enactment of this section.
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  • 42 USC 1395w–112(b)(4)(A)
  • 42 USC 1395w–112(b)
  • 42 USC 1395w–112(b)(6)
Citation graph
cites case law
Sec. 342
PBM transparency and elimination of DIR fees
Cite42 USC 1395w–112(b)(4)(A)
Cite42 USC 1395w–112(b)
Cite42 USC 1395w–112(b)(6)
Cites 3Cited by 0 across 0 sources
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