[Congressional Record Volume 166, Number 117 (Thursday, June 25, 2020)]
[Senate]
[Pages S3502-S3503]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2036. Mr. CASEY (for himself and Mr. Cassidy) submitted an
amendment intended to be proposed by him to the bill S. 4049, to
authorize appropriations for fiscal year 2021 for military activities
of the Department of Defense, for military construction, and for
defense activities of the Department of Energy, to prescribe military
personnel strengths for such fiscal year, and for other purposes; which
was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. ENCOURAGING THE DEVELOPMENT AND USE OF DISARM
ANTIMICROBIAL DRUGS.
(a) Additional Payment for DISARM Antimicrobial Drugs Under
Medicare.--
(1) In general.--Section 1886(d)(5) of the Social Security
Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end
the following new subparagraph:
``(N)(i)(I) In the case of discharges occurring on or after
October 1, 2021, and before October 1, 2026, subject to
subclause (II), the Secretary shall, after notice and
opportunity for public comment (in the publications required
by subsection (e)(5) for a fiscal year or otherwise), provide
for an additional payment under a mechanism (separate from
the mechanism established under subparagraph (K)), with
respect to such discharges involving any DISARM antimicrobial
drug, in an amount equal to--
``(aa) the amount payable under section 1847A for such drug
during the calendar quarter in which the discharge occurred;
or
``(bb) if no amount for such drug is determined under
section 1847A, an amount to be determined by the Secretary in
a manner similar to the manner in which payment amounts are
determined under section 1847A based on information submitted
by the manufacturer or sponsor of such drug (as required
under clause (v)).
``(II) In determining the amount payable under section
1847A for purposes of items (aa) and (bb) of subclause (I),
subparagraphs (A) and (B) of subsection (b)(1) of such
section shall be applied by substituting `100 percent' for
`106 percent' each place it appears and paragraph (8)(B) of
such section shall be applied by substituting `0 percent' for
`6 percent'.
``(ii) For purposes of this subparagraph, a DISARM
antimicrobial drug is--
``(I) a drug--
``(aa) that--
``(AA) is approved by the Food and Drug Administration;
``(BB) is designated by the Food and Drug Administration as
a qualified infectious disease product under subsection (d)
of section 505E of the Federal Food, Drug, and Cosmetic Act;
and
``(CC) has received an extension of its exclusivity period
pursuant to subsection (a) of such section; and
``(bb) that has been designated by the Secretary pursuant
to the process established under clause (iv)(I)(bb); or
``(II) an antibacterial or antifungal biological product--
``(aa) that is licensed for use, or an antibacterial or
antifungal biological product for which an indication is
first licensed for use, by the Food and Drug Administration
on or after June 5, 2014, under section 351(a) of the Public
Health Service Act for human use to treat serious or life-
threatening infections, as determined by the Food and Drug
Administration, including those caused by, or likely to be
caused by--
``(AA) an antibacterial or antifungal resistant pathogen,
including novel or emerging infectious pathogens; or
``(BB) a qualifying pathogen (as defined under section
505E(f) of the Federal Food, Drug, and Cosmetic Act); and
``(bb) has been designated by the Secretary pursuant to the
process established under clause (iv)(I)(bb).
``(iii) The mechanism established pursuant to clause (i)
shall provide that the additional payment under clause (i)
shall--
``(I) with respect to a discharge, only be made to a
subsection (d) hospital that, as determined by the
Secretary--
``(aa) is participating in the National Healthcare Safety
Network Antimicrobial Use and Resistance Module of the
Centers for Disease Control and Prevention or a similar
reporting program, as specified by the Secretary, relating to
antimicrobial drugs; and
``(bb) has an antimicrobial stewardship program that aligns
with the Core Elements of Hospital Antibiotic Stewardship
Programs of the Centers for Disease Control and Prevention or
the Antimicrobial Stewardship Standard set by the Joint
Commission; and
``(II) apply to discharges occurring on or after October 1
of the year in which the drug or biological product is
designated by the Secretary as a DISARM antimicrobial drug.
``(iv)(I) The mechanism established pursuant to clause (i)
shall provide for a process for--
``(aa) a manufacturer or sponsor of a drug or biological
product to request the Secretary to designate the drug or
biological product as a DISARM antimicrobial drug; and
``(bb) the designation by the Secretary of drugs and
biological products as DISARM antimicrobial drugs.
``(II) A designation of a drug or biological product as a
DISARM antimicrobial drug may be revoked by the Secretary if
the Secretary determines that--
``(aa) the drug or biological product no longer meets the
requirements for a DISARM antimicrobial drug under clause
(ii);
``(bb) the request for such designation contained an untrue
statement of material fact; or
``(cc) clinical or other information that was not available
to the Secretary at the time such designation was made shows
that--
``(AA) such drug or biological product is unsafe for use or
not shown to be safe for use for individuals who are entitled
to benefits under part A; or
``(BB) an alternative to such drug or biological product is
an advance that substantially improves the diagnosis or
treatment of such individuals.
``(III) Not later than October 1, 2021, and annually
thereafter through October 1, 2025, the Secretary shall
publish in the Federal Register a list of the DISARM
antimicrobial drugs designated under this subparagraph
pursuant to the process established under clause (iv)(I)(bb).
``(v)(I) For purposes of determining additional payment
amounts under clause (i), a manufacturer or sponsor of a drug
or biological product that submits a request described in
clause (iv)(I)(aa) shall submit to the Secretary information
described in section 1927(b)(3)(A)(iii).
``(II) The penalties for failure to provide timely
information under clause (i) of subparagraph (C) of section
1927(b)(3) and for providing false information under clause
(ii) of such subparagraph shall apply to manufacturers and
sponsors of a drug or biological product under this section
with respect to information under subclause (I) in the same
manner as such penalties apply to manufacturers under such
clauses with respect to information under subparagraph (A) of
such section.
``(vi) The mechanism established pursuant to clause (i)
shall provide that--
``(I) except as provided in subclause (II), no additional
payment shall be made under this subparagraph for discharges
involving a DISARM antimicrobial drug if any additional
payments have been made for discharges involving such drug as
a new medical service or technology under subparagraph (K);
``(II) additional payments may be made under this
subparagraph for discharges involving a DISARM antimicrobial
drug if any additional payments have been made for discharges
occurring prior to the date of enactment of this subparagraph
involving such drug as a new medical service or technology
under subparagraph (K); and
``(III) no additional payment shall be made under
subparagraph (K) for discharges involving a DISARM
antimicrobial drug as a new medical service or technology if
any additional payments for discharges involving such drug
have been made under this subparagraph.''.
(2) Conforming amendment.--Section 1886(d)(5)(K)(ii)(III)
of the Social Security Act (42 U.S.C.
1395ww(d)(5)(K)(ii)(III)) is amended by striking ``provide''
and inserting ``subject to subparagraph (N)(vi), provide''.
(b) Study and Reports on Removing Barriers to the
Development of DISARM Antimicrobial Drugs.--
(1) Study.--The Comptroller General of the United States
(in this subsection referred to as the ``Comptroller
General'') shall, in consultation with the Director of the
National Institutes of Health, the Commissioner of Food and
Drugs, the Administrator of the Centers for Medicare &
Medicaid Services, and the Director of the Centers for
Disease Control and Prevention, conduct a study to--
(A) identify and examine the barriers that prevent the
development of DISARM antimicrobial drugs (as defined in
section 1886(d)(5)(N)(ii) of the Social Security Act, as
added by subsection (a)); and
(B) develop recommendations for actions to be taken in
order to overcome any barriers identified under subparagraph
(A).
(2) Report.--October 1, 2025, the Comptroller General shall
submit to Congress a report containing the preliminary
results of
[[Page S3503]]
the study conducted under paragraph (1), together with
recommendations for such legislation and administrative
action as the Comptroller General determines appropriate.
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