ARC Act of 2021
Bill: H.R.2631 | Sponsor: Rep. Payne, Donald M., Jr. (D-NJ)
Policy area: Health

Summary:
Amputation Reduction and Compassion Act of 2021 or the ARC Act of 2021
This bill provides for coverage of peripheral artery disease screening tests without cost-sharing under Medicare, Medicaid, and private health insurance for certain at-risk individuals, and requires the development of certain educational programs and Medicare quality measures to reduce amputations relating to such disease.

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, to amend title XXVII of the 
  Public Health Service Act to require group health plans and health 
    insurance issuers offering group or individual health insurance 
 coverage to provide coverage for such screening tests furnished to at-
  risk enrollees of group health plans and group or individual health 
insurance coverage 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 2021'' or the ``ARC Act of 2021''.
    (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 and 
the Administrator of the Health Resources and Services Administration, 
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) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of fiscal years 2022 through 2026.''.

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 (GG), by striking ``and'' at 
                the end;
                    (B) in subparagraph (HH), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(II) peripheral artery disease screening tests 
                furnished to at-risk beneficiaries (as such terms are 
                defined in subsection (lll)).''; and
            (2) by adding at the end the following new subsection:
    ``(lll) 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)(II) 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 (lll)).''.
    (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(lll))'' 
                        after ``other than personalized prevention plan 
                        services (as defined in section 
                        1861(hhh)(1))'';
                            (ii) by striking ``and'' before ``(DD)''; 
                        and
                            (iii) by striking ``such service,;'' at the 
                        end and inserting the following: ``, and (EE) 
                        with respect to peripheral artery disease 
                        screening tests furnished to at-risk 
                        beneficiaries (as such terms are defined in 
                        section 1861(lll)), 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 
                        comma 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(lll)) 
        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)(EE),''.
            (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 ``(12)''; and
                    (B) by inserting ``, and (13) 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(lll))'' before 
                the period at the end.
            (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(lll))'' 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)(II)''.
    (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(lll)), 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, 2022.

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 (hh)); and''; and
            (2) by adding at the end the following new subsection:
    ``(hh) 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 (F), by striking ``or'' at the 
                end;
                    (B) in subparagraph (G), by striking ``; and'' and 
                inserting ``, or''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(H) peripheral artery disease screening tests 
                furnished to at-risk beneficiaries (as such terms are 
                defined in section 1905(hh)); 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:
                            ``(xii) Peripheral artery disease screening 
                        tests furnished to at-risk beneficiaries (as 
                        such terms are defined in section 1905(hh)).''.
    (c) Mandatory Coverage.--Section 1902(a)(10)(A) of the Social 
Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended by striking ``and 
(30)'' and inserting ``(30), and (31)''.
    (d) 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 (30)'' 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 (30)'' 
        and inserting ``following paragraph (32)''.

SEC. 5. REQUIREMENT FOR GROUP HEALTH PLANS AND HEALTH INSURANCE ISSUERS 
              OFFERING GROUP OR INDIVIDUAL HEALTH INSURANCE COVERAGE TO 
              PROVIDE COVERAGE FOR PERIPHERAL ARTERY DISEASE SCREENING 
              TESTS FURNISHED TO AT-RISK ENROLLEES WITHOUT IMPOSITION 
              OF COST SHARING REQUIREMENTS.

    (a) In General.--Subsection (a) of section 2713 of the Public 
Health Service Act (42 U.S.C. 300gg-13) is amended to read as follows:
    ``(a) Coverage of Preventive Health Services.--
            ``(1) In general.--A group health plan and a health 
        insurance issuer offering group or individual health insurance 
        coverage shall, at a minimum, provide coverage for and shall 
        not impose any cost sharing requirements for--
                    ``(A) evidence-based items or services that have in 
                effect a rating of `A' or `B' in the current 
                recommendations of the United States Preventive 
                Services Task Force;
                    ``(B) immunizations that have in effect a 
                recommendation from the Advisory Committee on 
                Immunization Practices of the Centers for Disease 
                Control and Prevention with respect to the individual 
                involved;
                    ``(C) with respect to infants, children, and 
                adolescents, evidence-informed preventive care and 
                screenings provided for in the comprehensive guidelines 
                supported by the Health Resources and Services 
                Administration;
                    ``(D) with respect to women, such additional 
                preventive care and screenings not described in 
                subparagraph (A) as provided for in comprehensive 
                guidelines supported by the Health Resources and 
                Services Administration for purposes of this 
                subparagraph; and
                    ``(E) with respect to at-risk enrollees, peripheral 
                artery disease screening tests.
            ``(2) Peripheral artery disease screening test; at-risk 
        enrollee.--For purposes of paragraph (1)(E):
                    ``(A) Peripheral artery disease screening test.--
                The term `peripheral artery disease screening test' 
                means--
                            ``(i) noninvasive physiologic studies of 
                        extremity arteries (commonly referred to as 
                        ankle-brachial index testing);
                            ``(ii) arterial duplex scans of lower 
                        extremity arteries vascular; and
                            ``(iii) 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 enrollees.
                    ``(B) At-risk enrollee.--The term `at-risk 
                enrollee' means an individual enrolled in a group 
                health plan or group or individual health insurance 
                coverage--
                            ``(i) who is 65 years of age or older;
                            ``(ii) 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;
                            ``(iii) who is younger than 50 years of age 
                        with diabetes mellitus and one additional risk 
                        factor for atherosclerosis; or
                            ``(iv) with a known atherosclerotic disease 
                        in another vascular bed such as coronary, 
                        carotid, subclavian, renal, or mesenteric 
                        artery stenosis, or abdominal aortic aneurysm.
                    ``(C) Frequency.--The Secretary shall, in 
                consultation with appropriate organizations, establish 
                standards regarding the frequency for peripheral artery 
                disease screening tests described in paragraph (1)(E) 
                for purposes of coverage under this section.
            ``(3) Clarification regarding breast cancer screening, 
        mammography, and prevention recommendations.--For the purposes 
        of this Act, and for the purposes of any other provision of 
        law, the current recommendations of the United States 
        Preventive Service Task Force regarding breast cancer 
        screening, mammography, and prevention shall be considered the 
        most current other than those issued in or around November 
        2009.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to prohibit a plan or issuer from providing 
        coverage for services in addition to those recommended by the 
        United States Preventive Services Task Force or to deny 
        coverage for services that are not recommended by such Task 
        Force.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to plan years beginning on or after January 1, 2022.

SEC. 6. DISALLOWANCE OF PAYMENT FOR NONTRAUMATIC AMPUTATION SERVICES 
              FURNISHED WITHOUT ANATOMICAL TESTING SERVICES.

    Section 1834 of the Social Security Act (42 U.S.C. 1395m) is 
amended by adding at the end the following new subsection:
    ``(z) Disallowance of Payment for Nontraumatic Amputation Services 
Furnished Without Anatomical Testing Services.--
            ``(1) In general.--In the case of nontraumatic amputation 
        services furnished by a supplier on or after January 1, 2022, 
        to an individual entitled to, or enrolled for, benefits under 
        part A and enrolled for benefits under this part, for which 
        payment is made under this part, payment may only be made under 
        this part if--
                    ``(A) such supplier furnishes anatomical testing 
                services to such individual during the 3-month period 
                preceding the date on which such nontraumatic 
                amputation services is furnished; or
                    ``(B) such individual has a pre-existing 
                dysfunctional or unsalvageable limb, life-threatening 
                sepsis, intractable infection, extensive gangrene or 
                necrotic tissue loss beyond salvage, a poor functional 
                status, severe dementia, or a short life expectancy 
                after shared decision-making with a health care team 
                and patient, family, or caregiver.
            ``(2) Definitions.--In this subsection:
                    ``(A) Anatomical testing services.--The term 
                `anatomical testing services' means arterial duplex 
                scanning, computed tomography angiography, and magnetic 
                resonance angiography.
                    ``(B) Nontraumatic amputation services.--The term 
                `nontraumatic amputation services' means amputations as 
                a result of atherosclerotic vascular disease or a 
                related comorbidity of such disease (including 
                diabetes).''.

SEC. 7. 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.--After appropriate testing and validation of 
the measures developed under subsection (a), the Secretary 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.
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