DISARM Act of 2021
Bill: H.R.4127 | Sponsor: Rep. Davis, Danny K. (D-IL)
Policy area: Health

Summary:
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2021 or the DISARM Act of 2021
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.

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 2021'' and as the 
``DISARM Act of 2021''.

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:
    ``(N)(i)(I) Effective for discharges beginning on or after October 
1, 2021, or such sooner date as specified by the Secretary, 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; 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.
For purposes of this clause, in the case of a similar reporting program 
described in item (aa), a subsection (d) hospital shall be treated as 
participating in such a program if the entity maintaining such program 
identifies to the Secretary such hospital as so participating.
    ``(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 (and removal of such 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, 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 subclause (I)(bb). The Secretary shall annually update such list.
    ``(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) 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 (N)(vii), provide''.
    (b) Authorization of Appropriations for the Centers for Disease 
Control and Prevention.--There is authorized to be appropriated to the 
Centers for Disease Control and Prevention $500,000,000, to remain 
available until expended, to support establishment and implementation 
of antimicrobial stewardship programs and data reporting capabilities 
to the Antimicrobial Use and Resistance option of the CDC National 
Healthcare Safety Network, especially in critical access hospitals, 
rural hospitals, and community hospitals, to support detection, 
surveillance, containment, and prevention of resistant pathogens in the 
United States and overseas.
    (c) 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 over a 5-year period of 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)), including--
                    (A) patient outcomes in conjunction with the use of 
                DISARM drugs, including--
                            (i) duration of stay in the intensive care 
                        unit;
                            (ii) recidivism within 30 days; and
                            (iii) measures of additional follow up 
                        care;
                    (B) the effectiveness of antimicrobial stewardship 
                and surveillance programs, including--
                            (i) changes in the percentage of hospitals 
                        in the United States with an antimicrobial 
                        stewardship program in place that aligns with 
                        the Core Elements of Hospital Antibiotic 
                        Stewardship Programs, as outlined by the 
                        Centers for Disease Control and Prevention;
                            (ii) changes in inpatient care of 
                        clostridioides difficile infection; and
                            (iii) changes in inpatient rates of 
                        resistance to key pathogens; and
                    (C) considerations relating to Medicare payment 
                reform, including--
                            (i) changes in the number of qualified 
                        antimicrobial products approved;
                            (ii) changes in wholesale acquisition cost 
                        of individual qualified antimicrobial products 
                        over time;
                            (iii) changes in year-over-year volume of 
                        individual qualified antimicrobial products 
                        sold; and
                            (iv) the overall cost of qualified 
                        antimicrobial products to the Medicare program 
                        as a proportion of total Medicare part A 
                        spending.
            (2) 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.
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