[Congressional Record Volume 165, Number 34 (Monday, February 25, 2019)]
[Senate]
[Page S1439]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Portman):
  S. 551. A bill to amend title XVIII of the Social Security Act to 
require manufacturers of certain single-dose vial drugs payable under 
part B of the Medicare program to provide rebates with respect to 
amounts of such drugs discarded, and for other purposes; to the 
Committee on Finance.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 551

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Recovering Excessive Funds 
     for Unused and Needless Drugs Act of 2019'' or the ``REFUND 
     Act of 2019''.

     SEC. 2. REQUIRING MANUFACTURERS OF CERTAIN SINGLE-DOSE VIAL 
                   DRUGS PAYABLE UNDER PART B OF THE MEDICARE 
                   PROGRAM TO PROVIDE REBATES WITH RESPECT TO 
                   DISCARDED AMOUNTS OF SUCH DRUGS.

       (a) In General.--Section 1834 of the Social Security Act 
     (42 U.S.C. 1395m) is amended by adding at the end the 
     following new subsection:
       ``(w) Rebate for Certain Discarded Single-dose Vial 
     Drugs.--
       ``(1) In general.--The manufacturer (as defined in section 
     1847A(c)(6)(A)) of a rebatable single-dose vial drug 
     furnished in a calendar quarter shall, not later than 30 days 
     after the date of receipt of information described in 
     paragraph (2)(A)(iii) with respect to such quarter, provide 
     to the Secretary a rebate that is equal to the amount 
     specified in paragraph (3) for such drug for such quarter.
       ``(2) Secretarial duties.--
       ``(A) In general.--For each calendar quarter, the Secretary 
     shall, with respect to a rebatable single-dose vial drug of a 
     manufacturer furnished during such quarter--
       ``(i) require, through use of a modifier such as the JW 
     modifier used as of the date of enactment of this subsection 
     (or any such successor code that includes such data as 
     determined appropriate by the Secretary), an indication on a 
     claim for such drug of the amount of such drug that was 
     discarded after such drug was furnished, if any;
       ``(ii) determine the rebatable amount (as defined in 
     subparagraph (B)) with respect to such drug; and
       ``(iii) not later than 60 days after the end of such 
     quarter, provide to such manufacturer notice of--

       ``(I) the total number of units of such drug discarded 
     during such quarter (as determined by the Secretary based on 
     the aggregate rebatable amount (as so defined) with respect 
     to such drug for such quarter), if any; and
       ``(II) the rebate amount specified in paragraph (3) for 
     such drug and such quarter.

       ``(B) Rebatable amount.--The term `rebatable amount' means, 
     with respect to a rebatable single-dose vial drug of a 
     manufacturer furnished during a quarter, 90 percent of the 
     amount (if any) of such drug that was discarded as indicated 
     pursuant to subparagraph (A)(i).
       ``(3) Rebate amount.--The amount of the rebate specified in 
     this paragraph is, with respect to a rebatable single-dose 
     vial drug of a manufacturer furnished in a calendar quarter, 
     an amount equal to the product of--
       ``(A) the total number of units of such drug discarded 
     during such quarter as determined under paragraph 
     (2)(A)(iii)(I); and
       ``(B) the lesser of--
       ``(i) the average sales price (as defined in section 
     1847A(c)(1)) for a unit of such drug for such quarter (or, in 
     the case of a drug subject to an agreement with such 
     manufacturer under section 340B of the Public Health Service 
     Act, the price for a unit of such drug for such quarter under 
     such agreement); or
       ``(ii) the wholesale acquisition cost (as defined in 
     section 1847A(c)(6)(B)) for a unit of such drug.
       ``(4) Rebate deposits.--Amounts paid as rebates pursuant to 
     paragraph (1) shall be deposited into the Federal 
     Supplementary Medical Insurance Trust Fund established under 
     section 1841.
       ``(5) Enforcement.--
       ``(A) Audits.--Each manufacturer of a rebatable single 
     dose-vial drug that is required to provide a rebate under 
     this subsection shall be subject to periodic audit with 
     respect to such drug and such rebates by the Secretary.
       ``(B) Civil money penalty.--
       ``(i) In general.--The Secretary shall impose a civil money 
     penalty on a manufacturer of a rebatable single dose-vial 
     drug who has failed to comply with the requirement under 
     paragraph (1) for such drug for a calendar quarter in an 
     amount the Secretary determines is commensurate with the sum 
     of--

       ``(I) the amount that the manufacturer would have paid 
     under such paragraph with respect to such drug for such 
     quarter; and
       ``(II) 25 percent of such amount.

       ``(ii) Application.--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).
       ``(6) Definitions.--In this subsection:
       ``(A) Rebatable single-dose vial drug.--The term `rebatable 
     single-dose vial drug' means a single source drug or 
     biological (as defined in section 1847A(c)(6)(D)) paid for 
     under this part and furnished on or after January 1, 2020, 
     from a single-dose vial.
       ``(B) Unit.--The term `unit' has the meaning given such 
     term in section 1847A(b)(2)(B).''.
       (b) Collection of Coinsurance Only for Portion of Rebatable 
     Single-dose Vial Drug Administered.--Section 1833(a) of the 
     Social Security Act (42 U.S.C. 1395l) is amended--
       (1) in subsection (a)(1)(S), by inserting subject to 
     subsection (cc), before with respect to; and
       (2) by adding at the end the following new subsection:
       ``(cc) Collection of Coinsurance Only for Portion of 
     Rebatable Single-dose Vial Drug Administered.--When 
     processing a claim for a rebatable single-dose vial drug (as 
     defined in section 1834(w)(6)), the Secretary, acting through 
     the relevant medicare administrative contractor with respect 
     to such claim, shall only collect coinsurance from a 
     beneficiary, taking into account any coverage under a 
     Medicare supplemental policy certified under section 1882 or 
     any other supplemental insurance coverage of the beneficiary, 
     with respect to the portion of the drug administered (as 
     indicated by the J-portion of the claim for the drug used as 
     of the date of enactment of this subsection, or any successor 
     code that includes such data as determined appropriate by the 
     Secretary), in an amount equal to 20 percent of the amount of 
     payment that would be made if payment for the claim was based 
     only on the portion of the drug administered (as so 
     indicated). Nothing in the preceding sentence shall affect 
     the amount paid to the provider of services or supplier with 
     respect to the drug under this part (as determined based on 
     the total amount of the drug for which the claim was 
     submitted, including the portion of the drug administered and 
     the portion discarded, as indicated by the J-portion of the 
     claim and the JW modifier, respectively, used as of such date 
     of enactment or any successor codes that include such data as 
     determined appropriate by the Secretary).''

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