[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 551 Introduced in Senate (IS)]
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116th CONGRESS
1st Session
S. 551
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 SENATE OF THE UNITED STATES
February 25, 2019
Mr. Durbin (for himself and Mr. Portman) introduced the following bill;
which was read twice and referred to the Committee on Finance
_______________________________________________________________________
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:
``(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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