Sec. 107. Requiring manufacturers of certain single-dose container or single-use package drugs payable under part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs

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Section 1847A of the Social Security Act ( 42 U.S.C. 1395–3a ), as amended by section 106, is amended by adding at the end the following new subsection: For each calendar quarter beginning on or after July 1, 2021, the Secretary shall, with respect to a refundable single-dose container or single-use package drug (as defined in paragraph (8)), report to each manufacturer (as defined in subsection (c)(6)(A)) of such refundable single-dose container or single-use package drug the following for the calendar quarter:

Subject to subparagraph (C), information on the total number of units of the billing and payment code of such drug, if any, that were discarded during such quarter, as determined using a mechanism such as the JW modifier used as of the date of enactment of this subsection (or any such successor modifier that includes such data as determined appropriate by the Secretary). The refund amount that the manufacturer is liable for pursuant to paragraph (3). For purposes of subparagraph (A)(i), with respect to a refundable single-dose container or single-use package drug furnished during a quarter, the amount of such drug that was discarded shall be determined based on the amount of such drug that was unused and discarded for each drug on the date of service.

The total number of units of the billing and payment code of a refundable single-dose container or single-use package drug of a manufacturer furnished during a calendar quarter for purposes of subparagraph (A)(i), and the determination of the estimated total allowed charges for the drug in the quarter for purposes of paragraph (3)(A)(ii), shall not include such units that are packaged into the payment amount for an item or service and are not separately payable. For each calendar quarter beginning on or after July 1, 2021, the manufacturer of a refundable single-dose container or single-use package drug shall, for such drug, provide to the Secretary a refund that is equal to the amount specified in paragraph

(3)for such drug for such quarter. The amount of the refund specified in this paragraph is, with respect to a refundable single-dose container or single-use package drug of a manufacturer assigned to a billing and payment code for a calendar quarter beginning on or after July 1, 2021, an amount equal to the estimated amount (if any) by which— the product of— the total number of units of the billing and payment code for such drug that were discarded during such quarter (as determined under paragraph (1)); and in the case of a refundable single-dose container or single-use package drug that is a single source drug or biological, the amount determined for such drug under subsection (b)(4); or in the case of a refundable single-dose container or single-use package drug that is a biosimilar biological product, the average sales price determined under subsection (b)(8)(A); exceeds an amount equal to the applicable percentage (as defined in subparagraph (B)) of the estimated total allowed charges for such drug during the quarter. For purposes of subparagraph (A)(ii), the term applicable percentage means— subject to subclause (II), 10 percent; and in the case of a refundable single-dose container or single-use package drug described in subclause

(I)of clause

(iii)and, if applicable, a refundable single-dose container or single-use package drug described in subclause

(II)of such clause, a percentage specified by the Secretary pursuant to clause (ii). The Secretary, through notice and comment rulemaking— in the case of a refundable single-dose container or single-use package drug described in subclause

(I)of clause (iii), shall increase the applicable percentage otherwise applicable under clause (i)(I) as determined appropriate by the Secretary; and in the case of a refundable single-dose container or single-use package drug described in subclause

(II)of clause (iii), may increase the applicable percentage otherwise applicable under clause (i)(I) as determined appropriate by the Secretary. For purposes of clause (ii), a refundable single-dose container or single-use package drug described in this clause is either of the following: A refundable single-dose container or single-use package drug for which preparation instructions required and approved by the Commissioner of the Food and Drug Administration include filtration during the drug preparation process, prior to dilution and administration, and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process. Any other refundable single-dose container or single-use package drug that has unique circumstances involving similar loss of product. Amounts required to be refunded pursuant to paragraph

(2)shall be paid in regular intervals (as determined appropriate by the Secretary). Amounts paid as refunds pursuant to paragraph

(2)shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under section 1841. Each manufacturer of a refundable single-dose container or single-use package drug that is required to provide a refund under this subsection shall be subject to periodic audit with respect to such drug and such refunds by the Secretary. The Secretary shall conduct periodic audits of claims submitted under this part with respect to refundable single-dose container or single-use package drugs in accordance with the authority under section 1833(e) to ensure compliance with the requirements applicable under this subsection. The Secretary shall impose a civil money penalty on a manufacturer of a refundable single-dose container or single-use package drug who has failed to comply with the requirement under paragraph

(2)for such drug for a calendar quarter in an amount equal to the sum of— the amount that the manufacturer would have paid under such paragraph with respect to such drug for such quarter; and 25 percent of such amount. The provisions of section 1128A (other than subsections

(a)and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). The Secretary shall implement this subsection through notice and comment rulemaking. Except as provided in subparagraph (B), in this subsection, the term refundable single-dose container or single-use package drug means a single source drug or biological (as defined in section 1847A(c)(6)(D)) or a biosimilar biological product (as defined in section 1847A(c)(6)(H)) for which payment is established under this part and that is furnished from a single-dose container or single-use package. The term refundable single-dose container or single-use package drug does not include a drug or biological that is either a radiopharmaceutical or an imaging agent. .

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42 USC 1395–3a

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Sec. 107

Requiring manufacturers of certain single-dose container or single-use package drugs payable under part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs

Cite42 USC 1395–3a

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