[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4261 Introduced in House (IH)]

<DOC>






118th CONGRESS
  1st Session
                                H. R. 4261

To amend titles XVIII and XIX of the Social Security Act to provide for 
 coverage of peripheral artery disease screening tests furnished to at-
risk beneficiaries under the Medicare and Medicaid programs without the 
    imposition of cost-sharing requirements, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 21, 2023

    Mr. Payne (for himself, Mr. Grijalva, Ms. Sewell, Mr. Carter of 
 Louisiana, Mrs. Watson Coleman, Mr. Veasey, Mr. Stanton, Ms. Porter, 
 Mr. Smith of New Jersey, Mr. Van Drew, Ms. Norton, Mr. Gallego, Mrs. 
 Beatty, Mr. Sessions, Mr. Davis of North Carolina, Mr. Cardenas, Mr. 
 Doggett, Mr. Neguse, Mr. Johnson of Georgia, Mr. Vargas, Mrs. Sykes, 
Mr. Takano, Ms. McCollum, Ms. Blunt Rochester, Ms. Kuster, Mr. Thompson 
of Mississippi, Ms. Matsui, Mr. Allred, Mr. Bishop of Georgia, and Mr. 
   Carson) introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, 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 titles XVIII and XIX of the Social Security Act to provide for 
 coverage of peripheral artery disease screening tests furnished to at-
risk beneficiaries under the Medicare and Medicaid programs without the 
    imposition of cost-sharing requirements, 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; FINDINGS.

    (a) Short Title.--This Act may be cited as the ``Amputation 
Reduction and Compassion Act of 2023'' or the ``ARC Act of 2023''.
    (b) Findings.--Congress makes the following findings:
            (1) Atherosclerosis occurs when blood flow is reduced 
        because arteries become narrowed or blocked with fatty 
        deposits.
            (2) Atherosclerosis is responsible for more deaths in the 
        United States than any other condition, and heart attacks, 
        resulting from clogged coronary arteries, are the leading cause 
        of death in America.
            (3) Atherosclerosis also occurs in the legs and is known as 
        peripheral artery disease (in this subsection referred to as 
        ``PAD'') and having PAD significantly increases the risk for 
        heart attack, stroke, amputation, and death.
            (4) While most Americans are aware of atherosclerosis in 
        the heart, many Americans have never heard of PAD and Americans 
        with PAD are often unaware of the serious risks of the disease.
            (5) An estimated 21 million Americans have PAD, and about 
        200,000 of them--disproportionately minorities--suffer 
        avoidable amputations every year as a result of such disease.
            (6) According to the Dartmouth Atlas, amputation risks for 
        African Americans living with diabetes are as much as four 
        times higher than the national average.
            (7) Data analyses have similarly found that Native 
        Americans are more than twice as likely to be subjected to 
        amputation and Hispanics are up to 75 percent more likely to 
        have an amputation.
            (8) Fifty-two percent of patients with an above-the-knee 
        amputation and 33 percent of patients with a below-the-knee 
        amputation will die within two years of their amputation.
            (9) Screening and arterial testing for PAD is cost-
        effective and should be part of routine medical care.
            (10) Once PAD is detected, amputations and deaths can be 
        reduced through the use of national, evidence-based PAD care 
        guidelines.
            (11) Americans with a PAD diagnosis are associated with a 
        67-percent increase in the risk of cardiac death compared to 
        people without a PAD diagnosis. Consequently, screening for PAD 
        enables health care professionals to identify cardiac risk 
        factors earlier and take proactive measures to reduce the risk 
        of cardiac death.

SEC. 2. PERIPHERAL ARTERY DISEASE EDUCATION PROGRAM.

     Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following new 
section:

``SEC. 399V-7. PERIPHERAL ARTERY DISEASE EDUCATION PROGRAM.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, in collaboration with 
the Administrator of the Centers for Medicare & Medicaid Services, the 
Administrator of the Health Resources and Services Administration, 
leading clinical and patient advocacy organizations, and other 
interested stakeholders shall establish and coordinate a peripheral 
artery disease education program to support, develop, and implement 
educational initiatives and outreach strategies that inform health care 
professionals and the public about the existence of peripheral artery 
disease and methods to reduce amputations related to such disease, 
particularly with respect to at-risk populations.
    ``(b) Best Practices.--The Secretary shall, as appropriate, 
identify and disseminate to health care professionals best practices 
with respect to peripheral artery disease.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $6,000,000 for each of fiscal 
years 2024 through 2028.''.

SEC. 3. MEDICARE COVERAGE OF PERIPHERAL ARTERY DISEASE SCREENING TESTS 
              FURNISHED TO AT-RISK BENEFICIARIES WITHOUT IMPOSITION OF 
              COST-SHARING REQUIREMENTS.

    (a) In General.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) in subparagraph (JJ), by striking the semicolon 
                at the end and inserting ``; and''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(KK) peripheral artery disease screening tests 
                furnished to at-risk beneficiaries (as such terms are 
                defined in subsection (nnn)).''; and
            (2) by adding at the end the following new subsection:
    ``(nnn) Peripheral Artery Disease Screening Test; At-Risk 
Beneficiary.--(1) The term `peripheral artery disease screening test' 
means--
            ``(A) noninvasive physiologic studies of extremity arteries 
        (commonly referred to as ankle-brachial index testing);
            ``(B) arterial duplex scans of lower extremity arteries 
        vascular; and
            ``(C) such other items and services as the Secretary 
        determines, in consultation with relevant stakeholders, to be 
        appropriate for screening for peripheral artery disease for at-
        risk beneficiaries.
    ``(2) The term `at-risk beneficiary' means an individual entitled 
to, or enrolled for, benefits under part A and enrolled for benefits 
under part B--
            ``(A) who is 65 years of age or older;
            ``(B) who is at least 50 years of age but not older than 64 
        years of age with risk factors for atherosclerosis (such as 
        diabetes mellitus, a history of smoking, hyperlipidemia, and 
        hypertension) or a family history of peripheral artery disease;
            ``(C) who is younger than 50 years of age with diabetes 
        mellitus and one additional risk factor for atherosclerosis; or
            ``(D) with a known atherosclerotic disease in another 
        vascular bed such as coronary, carotid, subclavian, renal, or 
        mesenteric artery stenosis, or abdominal aortic aneurysm.
    ``(3) The Secretary shall, in consultation with appropriate 
organizations, establish standards regarding the frequency for 
peripheral artery disease screening tests described in subsection 
(s)(2)(KK) for purposes of coverage under this title.''.
    (b) Inclusion of Peripheral Artery Disease Screening Tests in 
Initial Preventive Physical Examination.--Section 1861(ww)(2) of the 
Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended--
            (1) in subparagraph (N), by moving the margins of such 
        subparagraph 2 ems to the left;
            (2) by redesignating subparagraph (O) as subparagraph (P); 
        and
            (3) by inserting after subparagraph (N) the following new 
        subparagraph:
                    ``(O) Peripheral artery disease screening tests 
                furnished to at risk-beneficiaries (as such terms are 
                defined in subsection (nnn)).''.
    (c) Payment.--
            (1) In general.--Section 1833(a) of the Social Security Act 
        (42 U.S.C. 1395l(a)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (N), by inserting ``and 
                        other than peripheral artery disease screening 
                        tests furnished to at-risk beneficiaries (as 
                        such terms are defined in section 1861(nnn))'' 
                        after ``other than personalized prevention plan 
                        services (as defined in section 
                        1861(hhh)(1))'';
                            (ii) by striking ``and'' before ``(HH)''; 
                        and
                            (iii) by adding at the end the following: 
                        ``and (II) with respect to peripheral artery 
                        disease screening tests furnished to at-risk 
                        beneficiaries (as such terms are defined in 
                        section 1861(nnn)), the amount paid shall be 
                        100 percent of the lesser of the actual charge 
                        for the services or the amount determined under 
                        the payment basis determined under section 
                        1848;''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (G), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (H), by striking the 
                        semicolon at the end and inserting ``; and''; 
                        and
                            (iii) by inserting after subparagraph (H) 
                        the following new subparagraph:
            ``(I) with respect to peripheral artery disease screening 
        tests (as defined in paragraph (1) of section 1861(nnn)) 
        furnished by an outpatient department of a hospital to at-risk 
        beneficiaries (as defined in paragraph (2) of such section), 
        the amount determined under paragraph (1)(II);''.
            (2) No deductible.--Section 1833(b) of the Social Security 
        Act (42 U.S.C. 1395l(b)) is amended, in the first sentence--
                    (A) by striking ``, and'' before ``(13)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (14) such deductible shall not apply 
                with respect to peripheral artery disease screening 
                tests furnished to at-risk beneficiaries (as such terms 
                are defined in section 1861(nnn))''.
            (3) Exclusion from prospective payment system for hospital 
        outpatient department services.--Section 1833(t)(1)(B)(iv) of 
        the Social Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is 
        amended--
                    (A) by striking ``, or personalized'' and inserting 
                ``, personalized''; and
                    (B) by inserting ``, or peripheral artery disease 
                screening tests furnished to at-risk beneficiaries (as 
                such terms are defined in section 1861(nnn))'' after 
                ``personalized prevention plan services (as defined in 
                section 1861(hhh)(1))''.
            (4) Conforming amendment.--Section 1848(j)(3) of the Social 
        Security Act (42 U.S.C. 1395w-4(j)(3)) is amended by striking 
        ``(2)(FF) (including administration of the health risk 
        assessment) ,'' and inserting ``(2)(FF) (including 
        administration of the health risk assessment), (2)(KK),''.
    (d) Exclusion From Coverage and Medicare as Secondary Payer for 
Tests Performed More Frequently Than Allowed.--Section 1862(a)(1) of 
the Social Security Act (42 U.S.C. 1395y(a)(1)) is amended--
            (1) in subparagraph (O), by striking ``and'' at the end;
            (2) in subparagraph (P), by striking the semicolon at the 
        end and inserting ``, and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(Q) in the case of peripheral artery disease 
                screening tests furnished to at-risk beneficiaries (as 
                such terms are defined in section 1861(nnn)), which are 
                performed more frequently than is covered under such 
                section;''.
    (e) Authority To Modify or Eliminate Coverage of Certain Preventive 
Services.--Section 1834(n) of the Social Security Act (42 U.S.C. 
1395m(n)) is amended--
            (1) by redesignating subparagraphs (A) and (B) of paragraph 
        (1) as clauses (i) and (ii), respectively, and moving the 
        margins of such clauses, as so redesignated, 2 ems to the 
        right;
            (2) by redesignating paragraphs (1) and (2) as 
        subparagraphs (A) and (B), respectively, and moving the margins 
        of such subparagraphs, as so redesignated, 2 ems to the right;
            (3) by striking ``Certain Preventive Services'' and all 
        that follows through ``any other provision of this title'' and 
        inserting: ``Certain Preventive Services.--
            ``(1) In general.--Notwithstanding any other provision of 
        this title''; and
            (4) by adding at the end the following new paragraph:
            ``(2) Inapplicability.--The Secretarial authority described 
        in paragraph (1) shall not apply with respect to preventive 
        services described in section 1861(ww)(2)(O).''.
    (f) Effective Date.--The amendments made by this section shall 
apply with respect to items and services furnished on or after January 
1, 2024.

SEC. 4. MEDICAID COVERAGE OF PERIPHERAL ARTERY DISEASE SCREENING TESTS 
              FURNISHED TO AT-RISK BENEFICIARIES WITHOUT IMPOSITION OF 
              COST-SHARING REQUIREMENTS.

    (a) In General.--Section 1905 of the Social Security Act (42 U.S.C. 
1396d) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (30), by striking ``and'' at the 
                end;
                    (B) by redesignating paragraph (31) as paragraph 
                (32); and
                    (C) by inserting after paragraph (30) the following 
                new paragraph:
            ``(31) peripheral artery disease screening tests furnished 
        to at-risk beneficiaries (as such terms are defined in 
        subsection (jj)); and''; and
            (2) by adding at the end the following new subsection:
    ``(jj) Peripheral Artery Disease Screening Test; At-Risk 
Beneficiary.--
            ``(1) Peripheral artery disease screening test.--The term 
        `peripheral artery disease screening test' means--
                    ``(A) noninvasive physiologic studies of extremity 
                arteries (commonly referred to as ankle-brachial index 
                testing);
                    ``(B) arterial duplex scans of lower extremity 
                arteries vascular; and
                    ``(C) such other items and services as the 
                Secretary determines, in consultation with relevant 
                stakeholders, to be appropriate for screening for 
                peripheral artery disease for at-risk beneficiaries.
            ``(2) At-risk beneficiary.--The term `at-risk beneficiary' 
        means an individual enrolled under a State plan (or a waiver of 
        such plan)--
                    ``(A) who is 65 years of age or older;
                    ``(B) who is at least 50 years of age but not older 
                than 64 years of age with risk factors for 
                atherosclerosis (such as diabetes mellitus, a history 
                of smoking, hyperlipidemia, and hypertension) or a 
                family history of peripheral artery disease;
                    ``(C) who is younger than 50 years of age with 
                diabetes mellitus and one additional risk factor for 
                atherosclerosis; or
                    ``(D) with a known atherosclerotic disease in 
                another vascular bed such as coronary, carotid, 
                subclavian, renal, or mesenteric artery stenosis, or 
                abdominal aortic aneurysm.
            ``(3) Frequency.--The Secretary shall, in consultation with 
        appropriate organizations, establish standards regarding the 
        frequency for peripheral artery disease screening tests 
        described in subsection (a)(31) for purposes of coverage under 
        a State plan under this title.''.
    (b) No Cost Sharing.--
            (1) In general.--Subsections (a)(2) and (b)(2) of section 
        1916 of the Social Security Act (42 U.S.C. 1396o) are each 
        amended--
                    (A) in subparagraph (I), by striking ``or'' at the 
                end;
                    (B) in subparagraph (J), by striking ``; and'' and 
                inserting ``, or''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(K) peripheral artery disease screening tests 
                furnished to at-risk beneficiaries (as such terms are 
                defined in section 1905(jj)); and''.
            (2) Application to alternative cost sharing.--Section 
        1916A(b)(3)(B) of the Social Security Act (42 U.S.C. 1396o-
        1(b)(3)(B)) is amended by adding at the end the following new 
        clause:
                            ``(xv) Peripheral artery disease screening 
                        tests furnished to at-risk beneficiaries (as 
                        such terms are defined in section 1905(jj)).''.
    (c) Conforming Amendments.--
            (1) Section 1902(nn)(3) of the Social Security Act (42 
        U.S.C. 1396a(nn)(3)) is amended by striking ``following 
        paragraph (31)'' and inserting ``following paragraph (32)''.
            (2) Section 1905(a) of the Social Security Act (42 U.S.C. 
        1396d(a)) is amended by striking ``following paragraph (31)'' 
        and inserting ``following paragraph (32)''.

SEC. 5. DEVELOPMENT AND IMPLEMENTATION OF QUALITY MEASURES.

    (a) Development.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall, in 
consultation with relevant stakeholders, develop quality measures for 
nontraumatic, lower-limb, major amputation that utilize appropriate 
diagnostic screening (including peripheral artery disease screening) in 
order to encourage alternative treatments (including revascularization) 
in lieu of such an amputation.
    (b) Implementation.--Not later than 18 months after the date of 
enactment of this Act, the Secretary shall complete appropriate testing 
and validation of the measures developed under subsection (a) and shall 
incorporate such measures in quality reporting programs for appropriate 
providers of services and suppliers under the Medicare program under 
title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), 
including for purposes of--
            (1) the merit-based incentive payment system under section 
        1848(q) of such Act (42 U.S.C. 1395w-4(q));
            (2) incentive payments for participation in eligible 
        alternative payment models under section 1833(z) of such Act 
        (42 U.S.C. 1395l(z));
            (3) the shared savings program under section 1899 of such 
        Act (42 U.S.C. 1395jjj);
            (4) models under section 1115A of such Act (42 U.S.C. 
        1315a); and
            (5) such other payment systems or models as the Secretary 
        may specify.

SEC. 6. AMPUTATION PREVENTION PILOT PROGRAM.

    (a) In General.--Section 1115A(b)(2)(B) of the Social Security Act 
(42 U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the 
following new clause:
                            ``(xxviii) Promoting voluntary, 
                        nontraumatic lower-limb major amputation 
                        prevention programs at hospitals, ambulatory 
                        surgical centers, and office-based centers that 
                        will increase access to amputation prevention 
                        services, reduce amputation rates, and reduce 
                        costs to such hospitals, surgical centers, and 
                        office-based centers, through--
                                    ``(I) patient risk modification and 
                                management;
                                    ``(II) early screening and 
                                detection and surveillance;
                                    ``(III) testing and treatment for 
                                peripheral artery disease; and
                                    ``(IV) improved care coordination 
                                for individuals at high risk for 
                                amputation.''.
    (b) Testing of Model.--Not later than 18 months after the date of 
the enactment of this Act, the Deputy Administrator and Director of the 
Center for Medicare and Medicaid Innovation shall test the model 
described under subsection (a).
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