Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 or the DISARM Act of 2019
This bill requires additional payment under Medicare's inpatient prospective payment system for services that involve certain antimicrobial drugs, in accordance with specified limitations. Additionally, the Government Accountability Office must report on the barriers to developing such antimicrobial drugs and must recommend ways to address such barriers.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1712 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 1712
To amend title XVIII of the Social Security Act to encourage the
development and use of DISARM antimicrobial drugs, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 4, 2019
Mr. Isakson (for himself and Mr. Casey) 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 encourage the
development and use of DISARM antimicrobial drugs, 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 ``Developing an Innovative Strategy
for Antimicrobial Resistant Microorganisms Act of 2019'' and as the
``DISARM Act of 2019''.
SEC. 2. 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:
``(M)(i)(I) Effective for discharges beginning on or after October
1, 2020, 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 `102 percent' for `106 percent' each place it appears and
paragraph (8)(B) of such section shall be applied by substituting `2
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, 2020, and annually thereafter,
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) under 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)(I) The mechanism established pursuant to clause (i) shall
provide that--
``(aa) except as provided in item (bb), 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);
``(bb) 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
``(cc) 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 (M)(vii), 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)(M)(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) Reports.--
(A) Interim report.--Not later than 3 years after
the date of the enactment of this Act, the Comptroller
General shall submit to Congress an interim report
containing the preliminary results of the study
conducted under paragraph (1), together with
recommendations for such legislation and administrative
action as the Comptroller General determines
appropriate.
(B) Final report.--Not later than 5 years after the
date of the enactment of this Act, the Comptroller
General shall submit to Congress a report containing
the results of the study conducted under paragraph (1),
together with recommendations for such legislation and
administrative action as the Comptroller General
determines appropriate.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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