Title: REFUND Act of 2019
Policy area: Health

Summary:
Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 or the REFUND Act of 2019
This bill requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services (CMS) in relation to discarded amounts (i.e., amounts remaining after administration) of single-dose vial drugs that are covered under Medicare. Manufacturers that fail to comply are subject to civil penalties.
The CMS must determine rebate amounts based on payment claims from providers. (Currently, providers may receive payment under Medicare for discarded amounts of single-dose vial drugs through the use of a specific claims modifier.)

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4178 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 4178

      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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 9, 2019

  Mr. Engel introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 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.

    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:
    ``(x) 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 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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