I 116TH CONGRESS 2D SESSION H. R. 8615 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 OCTOBER 16, 2020 Mr. PAYNE (for himself, Mr. RUSH, Mr. GALLEGO, Mr. THOMPSON of Mis- sissippi, Ms. JOHNSON of Texas, and Ms. BLUNT ROCHESTER) intro- duced 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 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 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 8615 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 2020’’ or 5 the ‘‘ARC Act of 2020’’. 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 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 8615 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 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 8615 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 SEC. 2. PERIPHERAL ARTERY DISEASE EDUCATION PRO- 4 GRAM. 5 Part P of title III of the Public Health Service Act 6 (42 U.S.C. 280g et seq.) is amended by adding at the end 7 the following new section: 8 ‘‘SEC. 399V–7. PERIPHERAL ARTERY DISEASE EDUCATION 9 PROGRAM. 10 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 11 through the Director of the Centers for Disease Control 12 and Prevention, in collaboration with the Administrator 13 of the Centers for Medicare & Medicaid Services and the 14 Administrator of the Health Resources and Services Ad- 15 ministration, shall establish and coordinate a peripheral 16 artery disease education program to support, develop, and 17 implement educational initiatives and outreach strategies 18 that inform health care professionals and the public about 19 the existence of peripheral artery disease and methods to 20 reduce amputations related to such disease, particularly 21 with respect to at-risk populations. 22 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 23 is authorized to be appropriated to carry out this section 24 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 8615 IH such sums as may be necessary for each of fiscal years 1 2022 through 2026.’’. 2 SEC. 3. MEDICARE COVERAGE OF PERIPHERAL ARTERY 3 DISEASE SCREENING TESTS FURNISHED TO 4 AT-RISK BENEFICIARIES WITHOUT IMPOSI- 5 TION OF COST SHARING REQUIREMENTS. 6 (a) IN GENERAL.—Section 1861 of the Social Secu- 7 rity Act (42 U.S.C. 1395x) is amended— 8 (1) in subsection (s)(2)— 9 (A) in subparagraph (GG), by striking 10 ‘‘and’’ at the end; 11 (B) in subparagraph (HH), by striking the 12 period at the end and inserting ‘‘; and’’; and 13 (C) by adding at the end the following new 14 subparagraph: 15 ‘‘(II) peripheral artery disease screening 16 tests furnished to at-risk beneficiaries (as such 17 terms are defined in subsection (kkk)).’’; and 18 (2) by adding at the end the following new sub- 19 section: 20 ‘‘(kkk) PERIPHERAL ARTERY DISEASE SCREENING 21 TEST; AT-RISK BENEFICIARY.—(1) The term ‘peripheral 22 artery disease screening test’ means— 23 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 8615 IH ‘‘(A) noninvasive physiologic studies of extrem- 1 ity arteries (commonly referred to as ankle-brachial 2 index testing); 3 ‘‘(B) arterial duplex scans of lower extremity 4 arteries vascular; and 5 ‘‘(C) such other items and services as the Sec- 6 retary determines, in consultation with relevant 7 stakeholders, to be appropriate for screening for pe- 8 ripheral artery disease for at-risk beneficiaries. 9 ‘‘(2) The term ‘at-risk beneficiary’ means an indi- 10 vidual entitled to, or enrolled for, benefits under part A 11 and enrolled for benefits under part B— 12 ‘‘(A) who is 65 years of age or older; 13 ‘‘(B) who is at least 50 years of age but not 14 older than 64 years of age with risk factors for ath- 15 erosclerosis (such as diabetes mellitus, a history of 16 smoking, hyperlipidemia, and hypertension) or a 17 family history of peripheral artery disease; 18 ‘‘(C) who is younger than 50 years of age with 19 diabetes mellitus and one additional risk factor for 20 atherosclerosis; or 21 ‘‘(D) with a known atherosclerotic disease in 22 another vascular bed such as coronary, carotid, sub- 23 clavian, renal, or mesenteric artery stenosis, or ab- 24 dominal aortic aneurysm. 25 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 8615 IH ‘‘(3) The Secretary shall, in consultation with appro- 1 priate organizations, establish standards regarding the 2 frequency for peripheral artery disease screening tests de- 3 scribed in subsection (s)(2)(II) for purposes of coverage 4 under this title.’’. 5 (b) INCLUSION OF PERIPHERAL ARTERY DISEASE 6 SCREENING TESTS IN INITIAL PREVENTIVE PHYSICAL 7 EXAMINATION.—Section 1861(ww)(2) of the Social Secu- 8 rity Act (42 U.S.C. 1395x(ww)(2)) is amended— 9 (1) in subparagraph (N), by moving the mar- 10 gins of such subparagraph 2 ems to the left; 11 (2) by redesignating subparagraph (O) as sub- 12 paragraph (P); and 13 (3) by inserting after subparagraph (N) the fol- 14 lowing new subparagraph: 15 ‘‘(O) Peripheral artery disease screening 16 tests furnished to at-risk beneficiaries (as such 17 terms are defined in subsection (kkk)).’’. 18 (c) PAYMENT.— 19 (1) IN GENERAL.—Section 1833(a) of the So- 20 cial Security Act (42 U.S.C. 1395l(a)) is amended— 21 (A) in paragraph (1)— 22 (i) in subparagraph (N), by inserting 23 ‘‘and other than peripheral artery disease 24 screening tests furnished to at-risk bene- 25 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 8615 IH ficiaries (as such terms are defined in sec- 1 tion 1861(kkk))’’ after ‘‘other than person- 2 alized prevention plan services (as defined 3 in section 1861(hhh)(1))’’; 4 (ii) by striking ‘‘and’’ before ‘‘(DD)’’; 5 and 6 (iii) by striking ‘‘such service,;’’ at the 7 end and inserting the following: ‘‘, and 8 (EE) with respect to peripheral artery dis- 9 ease screening tests furnished to at-risk 10 beneficiaries (as such terms are defined in 11 section 1861(kkk)), the amount paid shall 12 be 100 percent of the lesser of the actual 13 charge for the services or the amount de- 14 termined under the payment basis deter- 15 mined under section 1848’’; and 16 (B) in paragraph (2)— 17 (i) in subparagraph (G), by striking 18 ‘‘and’’ at the end; 19 (ii) in subparagraph (H), by striking 20 the comma at the end and inserting ‘‘; 21 and’’; and 22 (iii) by inserting after subparagraph 23 (H) the following new subparagraph: 24 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 8615 IH ‘‘(I) with respect to peripheral artery disease 1 screening tests (as defined in paragraph (1) of sec- 2 tion 1861(kkk)) furnished by an outpatient depart- 3 ment of a hospital to at-risk beneficiaries (as defined 4 in paragraph (2) of such section), the amount deter- 5 mined under paragraph (1)(EE),’’. 6 (2) NO DEDUCTIBLE.—Section 1833(b) of the 7 Social Security Act (42 U.S.C. 1395l(b)) is amend- 8 ed, in the first sentence— 9 (A) by striking ‘‘and’’ before ‘‘(12)’’; and 10 (B) by inserting ‘‘, and (13) such deduct- 11 ible shall not apply with respect to peripheral 12 artery disease screening tests furnished to at- 13 risk beneficiaries (as such terms are defined in 14 section 1861(kkk))’’ before the period at the 15 end. 16 (3) EXCLUSION FROM PROSPECTIVE PAYMENT 17 SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT 18 SERVICES.—Section 1833(t)(1)(B)(iv) of the Social 19 Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is 20 amended— 21 (A) by striking ‘‘, or personalized’’ and in- 22 serting ‘‘, personalized’’; and 23 (B) by inserting ‘‘, or peripheral artery 24 disease screening tests furnished to at-risk 25 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 8615 IH beneficiaries (as such terms are defined in sec- 1 tion 1861(kkk))’’ after ‘‘personalized prevention 2 plan services (as defined in section 3 1861(hhh)(1))’’. 4 (4) CONFORMING AMENDMENT.—Section 5 1848(j)(3) of the Social Security Act (42 U.S.C. 6 1395w–4(j)(3)) is amended by striking ‘‘(2)(FF) 7 (including administration of the health risk assess- 8 ment) ,’’ and inserting ‘‘(2)(FF) (including adminis- 9 tration of the health risk assessment), (2)(II)’’. 10 (d) EXCLUSION FROM COVERAGE AND MEDICARE AS 11 SECONDARY PAYER FOR TESTS PERFORMED MORE FRE- 12 QUENTLY THAN ALLOWED.—Section 1862(a)(1) of the 13 Social Security Act (42 U.S.C. 1395y(a)(1)) is amended— 14 (1) in subparagraph (O), by striking ‘‘and’’ at 15 the end; 16 (2) in subparagraph (P), by striking the semi- 17 colon at the end and inserting ‘‘, and’’; and 18 (3) by adding at the end the following new sub- 19 paragraph: 20 ‘‘(Q) in the case of peripheral artery dis- 21 ease screening tests furnished to at-risk bene- 22 ficiaries (as such terms are defined in section 23 1861(kkk)), which are performed more fre- 24 quently than is covered under such section;’’. 25 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 8615 IH (e) AUTHORITY TO MODIFY OR ELIMINATE COV- 1 ERAGE OF CERTAIN PREVENTIVE SERVICES.—Section 2 1834(n) of the Social Security Act (42 U.S.C. 1395m(n)) 3 is amended— 4 (1) by redesignating subparagraphs (A) and 5 (B) of paragraph (1) as clauses (i) and (ii), respec- 6 tively, and moving the margins of such clauses, as 7 so redesignated, 2 ems to the right; 8 (2) by redesignating paragraphs (1) and (2) as 9 subparagraphs (A) and (B), respectively, and mov- 10 ing the margins of such subparagraphs, as so redes- 11 ignated, 2 ems to the right; 12 (3) by striking ‘‘CERTAIN PREVENTIVE SERV- 13 ICES’’ and all that follows through ‘‘any other provi- 14 sion of this title’’ and inserting: ‘‘CERTAIN PREVEN- 15 TIVE SERVICES.— 16 ‘‘(1) IN GENERAL.—Notwithstanding any other 17 provision of this title’’; and 18 (4) by adding at the end the following new 19 paragraph: 20 ‘‘(2) INAPPLICABILITY.—The Secretarial au- 21 thority described in paragraph (1) shall not apply 22 with respect to preventive services described in sec- 23 tion 1861(ww)(2)(O).’’. 24 VerDate Sep 11 2014 00:13 Nov 13, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H8615.IH H8615 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 8615 IH (f) EFFECTIVE DATE.—The amendments made by 1 this section shall apply with respect to items and services 2 furnished on or after January 1, 2022. 3 SEC. 4. MEDICAID COVERAGE OF PERIPHERAL ARTERY 4 DISEASE SCREENING TESTS FURNISHED TO 5 AT-RISK BENEFICIARIES WITHOUT IMPOSI- 6 TION OF COST SHARING REQUIREMENTS. 7 (a) IN GENERAL.—Section 1905 of the Social Secu- 8 rity Act (42 U.S.C. 1396d) is amended— 9 (1) in subsection ( [Text truncated for display. Full text available on Congress.gov.]