[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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