Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 or DISARM Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to: (1) recognize the costs of new antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the new antimicrobial drugs, and (4) further reduce each of the average standardized payment amounts in a specified manner to maintain budget neutrality in a fiscal year beginning with FY2015.
(Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.)
Directs the Comptroller General (GAO) to study the barriers that prevent the development of new antimicrobial drugs and develop recommendations for actions to be taken in order to overcome such barriers.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4187 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 4187
To amend title XVIII of the Social Security Act to encourage the
development and use of new antimicrobial drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 11, 2014
Mr. Roskam (for himself and Mr. Danny K. Davis of Illinois) introduced
the following bill; which was referred to the Committee on Ways and
Means, and in addition to the Committee on Energy and Commerce, 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 encourage the
development and use of new 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 2014'' and as the
``DISARM Act of 2014''.
SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF NEW ANTIMICROBIAL DRUGS.
(a) Additional Payment for New 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) Effective for discharges beginning on or after October 1,
2014, the Secretary shall, after notice and opportunity for public
comment (in the publications required by subsection (e)(5) for a fiscal
year or otherwise), recognize the costs of new antimicrobial drugs
under the payment system established under this subsection.
``(ii) Pursuant to clause (i), the Secretary shall provide for
additional payment to be made under this subsection with respect to
discharges involving new antimicrobial drugs in the amount provided for
under section 1847A for drugs and biologicals that are described in
section 1842(o)(1)(C).
``(iii) For purposes of this subparagraph, the term `new
antimicrobial drug' means a product that is approved for use, or a
product for which an indication is first approved for use, by the
Federal Food and Drug Administration on or after January 1, 2014, and
that--
``(I) is indicated to treat an infection caused by, or
likely to be caused by, a qualifying pathogen (as defined under
section 505E(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355f(f))) for which there is an unmet medical need and
which is associated with high rates of mortality or significant
patient morbidity (as determined by the Secretary, in
consultation with the Director of the Centers for Disease
Control and Prevention and the infectious disease professional
community); and
``(II) is used in facilities that participate in the
Antimicrobial Use and Resistance Module of the National
Healthcare Safety Network of the Centers for Disease Control
and Prevention (or, in the case that such Module is not
available, is used in facilities that participate in such
successor or similar reporting module or program relating to
antimicrobials as the Secretary shall specify to the extent
available to such facilities, as determined by the Secretary).
``(iv) Not later than July 1, 2014, the Secretary shall first
publish in the Federal Register a list of the new antimicrobial
drugs.''.
(2) Budget neutrality.--Section 1886(d)(3)(C) of the Social
Security Act (42 U.S.C. 1395ww(d)(3)(C)) is amended by adding
at the end the following new clause:
``(iii) Maintaining budget neutrality for certain
antimicrobial drugs.--For discharges occurring in a fiscal year
beginning with fiscal year 2015, the Secretary shall further
reduce each of the average standardized amounts in an amount
equal to the amount of the net additional expenditures, if any,
in such fiscal year resulting from the application of paragraph
(5)(M).''.
(b) Study and Report on Removing Barriers to Development of New
Antimicrobial Drugs.--
(1) Study.--The Comptroller General of the United States
shall, in consultation with the Director of the United States
Patent and Trademark Office, the Director of the National
Institutes of Health, the Commissioner of Food and Drugs, 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 new antimicrobial drugs, as defined
in section 1886(d)(5)(M)(iii) of the Social Security
Act (42 U.S.C. 1395ww(d)(5)(M)(iii)); and
(B) develop recommendations for actions to be taken
in order to overcome any barriers identified under
subparagraph (A).
(2) Report.--Not later than one year after the date of the
enactment of this Act, the Comptroller General shall submit to
Congress a report on the study conducted under paragraph (1).
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Introduced in House
Introduced in House
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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.
Referred to the Subcommittee on Health.
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