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”.
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014
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.
Sec. 2 Encouraging the development and use of new antimicrobial drugs
Additional payment for new antimicrobial drugs under Medicare—
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.”
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).”
Study and report on removing barriers to development of new antimicrobial drugs—
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—
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
develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A).
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).