I 117TH CONGRESS 1ST SESSION H. R. 2631 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 pur- poses. IN THE HOUSE OF REPRESENTATIVES APRIL 16, 2021 Mr. PAYNE (for himself, Mr. GALLEGO, Mr. RUSH, Mr. TAKANO, Mr. GRI- JALVA, Ms. PORTER, Mr. SOTO, Mr. BUTTERFIELD, Mr. VAN DREW, Ms. PRESSLEY, and Mr. SIRES) introduced the following bill; which was re- ferred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently de- termined 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 imposi- tion 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 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 2631 IH 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; FINDINGS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Amputation Reduction and Compassion Act of 2021’’ or 5 the ‘‘ARC Act of 2021’’. 6 (b) FINDINGS.—Congress makes the following find- 7 ings: 8 (1) Atherosclerosis occurs when blood flow is 9 reduced because arteries become narrowed or 10 blocked with fatty deposits. 11 (2) Atherosclerosis is responsible for more 12 deaths in the United States than any other condi- 13 tion, and heart attacks, resulting from clogged coro- 14 nary arteries, are the leading cause of death in 15 America. 16 (3) Atherosclerosis also occurs in the legs and 17 is known as peripheral artery disease (in this sub- 18 section referred to as ‘‘PAD’’) and having PAD sig- 19 nificantly increases the risk for heart attack, stroke, 20 amputation, and death. 21 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 2631 IH (4) While most Americans are aware of athero- 1 sclerosis in the heart, many Americans have never 2 heard of PAD and Americans with PAD are often 3 unaware of the serious risks of the disease. 4 (5) An estimated 21 million Americans have 5 PAD, and about 200,000 of them—disproportion- 6 ately minorities—suffer avoidable amputations every 7 year as a result of such disease. 8 (6) According to the Dartmouth Atlas, amputa- 9 tion risks for African Americans living with diabetes 10 are as much as four times higher than the national 11 average. 12 (7) Data analyses have similarly found that Na- 13 tive Americans are more than twice as likely to be 14 subjected to amputation and Hispanics are up to 75 15 percent more likely to have an amputation. 16 (8) Fifty-two percent of patients with an above- 17 the-knee amputation and 33 percent of patients with 18 a below-the-knee amputation will die within two 19 years of their amputation. 20 (9) Screening and arterial testing for PAD is 21 cost-effective and should be part of routine medical 22 care. 23 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 2631 IH (10) Once PAD is detected, amputations and 1 deaths can be reduced through the use of national, 2 evidence-based PAD care guidelines. 3 (11) Americans with a PAD diagnosis are asso- 4 ciated with a 67 percent increase in the risk of car- 5 diac death compared to people without a PAD diag- 6 nosis. Consequently, screening for PAD enables 7 health care professionals to identify cardiac risk fac- 8 tors earlier and take proactive measures to reduce 9 the risk of cardiac death. 10 SEC. 2. PERIPHERAL ARTERY DISEASE EDUCATION PRO- 11 GRAM. 12 Part P of title III of the Public Health Service Act 13 (42 U.S.C. 280g et seq.) is amended by adding at the end 14 the following new section: 15 ‘‘SEC. 399V–7. PERIPHERAL ARTERY DISEASE EDUCATION 16 PROGRAM. 17 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 18 through the Director of the Centers for Disease Control 19 and Prevention, in collaboration with the Administrator 20 of the Centers for Medicare & Medicaid Services and the 21 Administrator of the Health Resources and Services Ad- 22 ministration, shall establish and coordinate a peripheral 23 artery disease education program to support, develop, and 24 implement educational initiatives and outreach strategies 25 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 2631 IH that inform health care professionals and the public about 1 the existence of peripheral artery disease and methods to 2 reduce amputations related to such disease, particularly 3 with respect to at-risk populations. 4 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 5 is authorized to be appropriated to carry out this section 6 such sums as may be necessary for each of fiscal years 7 2022 through 2026.’’. 8 SEC. 3. MEDICARE COVERAGE OF PERIPHERAL ARTERY 9 DISEASE SCREENING TESTS FURNISHED TO 10 AT-RISK BENEFICIARIES WITHOUT IMPOSI- 11 TION OF COST SHARING REQUIREMENTS. 12 (a) IN GENERAL.—Section 1861 of the Social Secu- 13 rity Act (42 U.S.C. 1395x) is amended— 14 (1) in subsection (s)(2)— 15 (A) in subparagraph (GG), by striking 16 ‘‘and’’ at the end; 17 (B) in subparagraph (HH), by striking the 18 period at the end and inserting ‘‘; and’’; and 19 (C) by adding at the end the following new 20 subparagraph: 21 ‘‘(II) peripheral artery disease screening 22 tests furnished to at-risk beneficiaries (as such 23 terms are defined in subsection (lll)).’’; and 24 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 2631 IH (2) by adding at the end the following new sub- 1 section: 2 ‘‘(lll) PERIPHERAL ARTERY DISEASE SCREENING 3 TEST; AT-RISK BENEFICIARY.—(1) The term ‘peripheral 4 artery disease screening test’ means— 5 ‘‘(A) noninvasive physiologic studies of extrem- 6 ity arteries (commonly referred to as ankle-brachial 7 index testing); 8 ‘‘(B) arterial duplex scans of lower extremity 9 arteries vascular; and 10 ‘‘(C) such other items and services as the Sec- 11 retary determines, in consultation with relevant 12 stakeholders, to be appropriate for screening for pe- 13 ripheral artery disease for at-risk beneficiaries. 14 ‘‘(2) The term ‘at-risk beneficiary’ means an indi- 15 vidual entitled to, or enrolled for, benefits under part A 16 and enrolled for benefits under part B— 17 ‘‘(A) who is 65 years of age or older; 18 ‘‘(B) who is at least 50 years of age but not 19 older than 64 years of age with risk factors for ath- 20 erosclerosis (such as diabetes mellitus, a history of 21 smoking, hyperlipidemia, and hypertension) or a 22 family history of peripheral artery disease; 23 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 2631 IH ‘‘(C) who is younger than 50 years of age with 1 diabetes mellitus and one additional risk factor for 2 atherosclerosis; or 3 ‘‘(D) with a known atherosclerotic disease in 4 another vascular bed such as coronary, carotid, sub- 5 clavian, renal, or mesenteric artery stenosis, or ab- 6 dominal aortic aneurysm. 7 ‘‘(3) The Secretary shall, in consultation with appro- 8 priate organizations, establish standards regarding the 9 frequency for peripheral artery disease screening tests de- 10 scribed in subsection (s)(2)(II) for purposes of coverage 11 under this title.’’. 12 (b) INCLUSION OF PERIPHERAL ARTERY DISEASE 13 SCREENING TESTS IN INITIAL PREVENTIVE PHYSICAL 14 EXAMINATION.—Section 1861(ww)(2) of the Social Secu- 15 rity Act (42 U.S.C. 1395x(ww)(2)) is amended— 16 (1) in subparagraph (N), by moving the mar- 17 gins of such subparagraph 2 ems to the left; 18 (2) by redesignating subparagraph (O) as sub- 19 paragraph (P); and 20 (3) by inserting after subparagraph (N) the fol- 21 lowing new subparagraph: 22 ‘‘(O) Peripheral artery disease screening 23 tests furnished to at risk-beneficiaries (as such 24 terms are defined in subsection (lll)).’’. 25 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 2631 IH (c) PAYMENT.— 1 (1) IN GENERAL.—Section 1833(a) of the So- 2 cial Security Act (42 U.S.C. 1395l(a)) is amended— 3 (A) in paragraph (1)— 4 (i) in subparagraph (N), by inserting 5 ‘‘and other than peripheral artery disease 6 screening tests furnished to at-risk bene- 7 ficiaries (as such terms are defined in sec- 8 tion 1861(lll))’’ after ‘‘other than personal- 9 ized prevention plan services (as defined in 10 section 1861(hhh)(1))’’; 11 (ii) by striking ‘‘and’’ before ‘‘(DD)’’; 12 and 13 (iii) by striking ‘‘such service,;’’ at the 14 end and inserting the following: ‘‘, and 15 (EE) with respect to peripheral artery dis- 16 ease screening tests furnished to at-risk 17 beneficiaries (as such terms are defined in 18 section 1861(lll)), the amount paid shall be 19 100 percent of the lesser of the actual 20 charge for the services or the amount de- 21 termined under the payment basis deter- 22 mined under section 1848’’; and 23 (B) in paragraph (2)— 24 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 9 •HR 2631 IH (i) in subparagraph (G), by striking 1 ‘‘and’’ at the end; 2 (ii) in subparagraph (H), by striking 3 the comma at the end and inserting ‘‘; 4 and’’; and 5 (iii) by inserting after subparagraph 6 (H) the following new subparagraph: 7 ‘‘(I) with respect to peripheral artery disease 8 screening tests (as defined in paragraph (1) of sec- 9 tion 1861(lll)) furnished by an outpatient depart- 10 ment of a hospital to at-risk beneficiaries (as defined 11 in paragraph (2) of such section), the amount deter- 12 mined under paragraph (1)(EE),’’. 13 (2) NO DEDUCTIBLE.—Section 1833(b) of the 14 Social Security Act (42 U.S.C. 1395l(b)) is amend- 15 ed, in the first sentence— 16 (A) by striking ‘‘and’’ before ‘‘(12)’’; and 17 (B) by inserting ‘‘, and (13) such deduct- 18 ible shall not apply with respect to peripheral 19 artery disease screening tests furnished to at- 20 risk beneficiaries (as such terms are defined in 21 section 1861(lll))’’ before the period at the end. 22 (3) EXCLUSION FROM PROSPECTIVE PAYMENT 23 SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT 24 SERVICES.—Section 1833(t)(1)(B)(iv) of the Social 25 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 10 •HR 2631 IH Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is 1 amended— 2 (A) by striking ‘‘, or personalized’’ and in- 3 serting ‘‘, personalized’’; and 4 (B) by inserting ‘‘, or peripheral artery 5 disease screening tests furnished to at-risk 6 beneficiaries (as such terms are defined in sec- 7 tion 1861(lll))’’ after ‘‘personalized prevention 8 plan services (as defined in section 9 1861(hhh)(1))’’. 10 (4) CONFORMING AMENDMENT.—Section 11 1848(j)(3) of the Social Security Act (42 U.S.C. 12 1395w–4(j)(3)) is amended by striking ‘‘(2)(FF) 13 (including administration of the health risk assess- 14 ment) ,’’ and inserting ‘‘(2)(FF) (including adminis- 15 tration of the health risk assessment), (2)(II)’’. 16 (d) EXCLUSION FROM COVERAGE AND MEDICARE AS 17 SECONDARY PAYER FOR TESTS PERFORMED MORE FRE- 18 QUENTLY THAN ALLOWED.—Section 1862(a)(1) of the 19 Social Security Act (42 U.S.C. 1395y(a)(1)) is amended— 20 (1) in subparagraph (O), by striking ‘‘and’’ at 21 the end; 22 (2) in subparagraph (P), by striking the semi- 23 colon at the end and inserting ‘‘, and’’; and 24 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 11 •HR 2631 IH (3) by adding at the end the following new sub- 1 paragraph: 2 ‘‘(Q) in the case of peripheral artery dis- 3 ease screening tests furnished to at-risk bene- 4 ficiaries (as such terms are defined in section 5 1861(lll)), which are performed more frequently 6 than is covered under such section;’’. 7 (e) AUTHORITY TO MODIFY OR ELIMINATE COV- 8 ERAGE OF CERTAIN PREVENTIVE SERVICES.—Section 9 1834(n) of the Social Security Act (42 U.S.C. 1395m(n)) 10 is amended— 11 (1) by redesignating subparagraphs (A) and 12 (B) of paragraph (1) as clauses (i) and (ii), respec- 13 tively, and moving the margins of such clauses, as 14 so redesignated, 2 ems to the right; 15 (2) by redesignating paragraphs (1) and (2) as 16 subparagraphs (A) and (B), respectively, and mov- 17 ing the margins of such subparagraphs, as so redes- 18 ignated, 2 ems to the right; 19 (3) by striking ‘‘CERTAIN PREVENTIVE SERV- 20 ICES’’ and all that follows through ‘‘any other provi- 21 sion of this title’’ and inserting: ‘‘CERTAIN PREVEN- 22 TIVE SERVICES.— 23 ‘‘(1) IN GENERAL.—Notwithstanding any other 24 provision of this title’’; and 25 VerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631 pbinns on DSKJLVW7X2PROD with BILLS 12 •HR 2631 IH (4) by adding at the end the following new 1 paragraph: 2 ‘‘(2) INAPPLICABILITY.—The Secretarial au- 3 thority described in paragraph (1) shall not apply 4 with respect to preventive services described in sec- 5 tion 1861(ww)(2)(O).’’. 6 (f) EFFECTIVE DATE.—The amendments made by 7 this section shall apply with re [Text truncated for display. 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