I 117th CONGRESS 1st Session H. R. 2631 IN THE HOUSE OF REPRESENTATIVES April 16, 2021 Mr. Payne (for himself, Mr. Gallego , Mr. Rush , Mr. Takano , Mr. Grijalva , Ms. Porter , Mr. Soto , Mr. Butterfield , Mr. Van Drew , Ms. Pressley , and Mr. Sires ) 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, 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.

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. 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: 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. . 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. 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) . 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. 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). . 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.