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 atrisk 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. 

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 


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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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; FINDINGS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Amputation Reduction and Compassion Act of 2021’’ or 

6 the ‘‘ARC Act of 2021’’. 

7 (b) FINDINGS.—Congress makes the following find8 ings: 

9 (1) Atherosclerosis occurs when blood flow is 

10 reduced because arteries become narrowed or 

11 blocked with fatty deposits. 

12 (2) Atherosclerosis is responsible for more 

13 deaths in the United States than any other condi14 tion, and heart attacks, resulting from clogged coro15 nary arteries, are the leading cause of death in 

16 America. 

17 (3) Atherosclerosis also occurs in the legs and 

18 is known as peripheral artery disease (in this sub19 section referred to as ‘‘PAD’’) and having PAD sig20 nificantly increases the risk for heart attack, stroke, 

21 amputation, and death. 


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1 (4) While most Americans are aware of athero2 sclerosis in the heart, many Americans have never 

3 heard of PAD and Americans with PAD are often 

4 unaware of the serious risks of the disease. 

5 (5) An estimated 21 million Americans have 

6 PAD, and about 200,000 of them—disproportion7 ately minorities—suffer avoidable amputations every 

8 year as a result of such disease. 

9 (6) According to the Dartmouth Atlas, amputa10 tion risks for African Americans living with diabetes 

11 are as much as four times higher than the national 

12 average. 

13 (7) Data analyses have similarly found that Na14 tive Americans are more than twice as likely to be 

15 subjected to amputation and Hispanics are up to 75 

16 percent more likely to have an amputation. 

17 (8) Fifty-two percent of patients with an above18 the-knee amputation and 33 percent of patients with 

19 a below-the-knee amputation will die within two 

20 years of their amputation. 

21 (9) Screening and arterial testing for PAD is 

22 cost-effective and should be part of routine medical 

23 care. 


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1 (10) Once PAD is detected, amputations and 

2 deaths can be reduced through the use of national, 

3 evidence-based PAD care guidelines. 

4 (11) Americans with a PAD diagnosis are asso5 ciated with a 67 percent increase in the risk of car6 diac death compared to people without a PAD diag7 nosis. Consequently, screening for PAD enables 

8 health care professionals to identify cardiac risk fac9 tors earlier and take proactive measures to reduce 

10 the risk of cardiac death. 

11 SEC. 2. PERIPHERAL ARTERY DISEASE EDUCATION PRO12 GRAM. 

13 Part P of title III of the Public Health Service Act 

14 (42 U.S.C. 280g et seq.) is amended by adding at the end 

15 the following new section: 

16 ‘‘SEC. 399V–7. PERIPHERAL ARTERY DISEASE EDUCATION 

17 PROGRAM. 

18 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

19 through the Director of the Centers for Disease Control 

20 and Prevention, in collaboration with the Administrator 

21 of the Centers for Medicare & Medicaid Services and the 

22 Administrator of the Health Resources and Services Ad23 ministration, shall establish and coordinate a peripheral 

24 artery disease education program to support, develop, and 

25 implement educational initiatives and outreach strategies 


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1 that inform health care professionals and the public about 

2 the existence of peripheral artery disease and methods to 

3 reduce amputations related to such disease, particularly 

4 with respect to at-risk populations. 

5 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

6 is authorized to be appropriated to carry out this section 

7 such sums as may be necessary for each of fiscal years 

8 2022 through 2026.’’. 

9 SEC. 3. MEDICARE COVERAGE OF PERIPHERAL ARTERY 

10 DISEASE SCREENING TESTS FURNISHED TO 

11 AT-RISK BENEFICIARIES WITHOUT IMPOSI12 TION OF COST SHARING REQUIREMENTS. 

13 (a) IN GENERAL.—Section 1861 of the Social Secu14 rity Act (42 U.S.C. 1395x) is amended— 

15 (1) in subsection (s)(2)— 

16 (A) in subparagraph (GG), by striking 

17 ‘‘and’’ at the end; 

18 (B) in subparagraph (HH), by striking the 

19 period at the end and inserting ‘‘; and’’; and 

20 (C) by adding at the end the following new 

21 subparagraph: 

22 ‘‘(II) peripheral artery disease screening 

23 tests furnished to at-risk beneficiaries (as such 

24 terms are defined in subsection (lll)).’’; and 


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1 (2) by adding at the end the following new sub2 section: 

3 ‘‘(lll) PERIPHERAL ARTERY DISEASE SCREENING

4 TEST; AT-RISK BENEFICIARY.—(1) The term ‘peripheral 

5 artery disease screening test’ means— 

6 ‘‘(A) noninvasive physiologic studies of extrem7 ity arteries (commonly referred to as ankle-brachial 

8 index testing); 

9 ‘‘(B) arterial duplex scans of lower extremity 

10 arteries vascular; and 

11 ‘‘(C) such other items and services as the Sec12 retary determines, in consultation with relevant 

13 stakeholders, to be appropriate for screening for pe14 ripheral artery disease for at-risk beneficiaries. 

15 ‘‘(2) The term ‘at-risk beneficiary’ means an indi16 vidual entitled to, or enrolled for, benefits under part A 

17 and enrolled for benefits under part B— 

18 ‘‘(A) who is 65 years of age or older; 

19 ‘‘(B) who is at least 50 years of age but not 

20 older than 64 years of age with risk factors for ath21 erosclerosis (such as diabetes mellitus, a history of 

22 smoking, hyperlipidemia, and hypertension) or a 

23 family history of peripheral artery disease; 


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1 ‘‘(C) who is younger than 50 years of age with 

2 diabetes mellitus and one additional risk factor for 

3 atherosclerosis; or 

4 ‘‘(D) with a known atherosclerotic disease in 

5 another vascular bed such as coronary, carotid, sub6 clavian, renal, or mesenteric artery stenosis, or ab7 dominal aortic aneurysm. 

8 ‘‘(3) The Secretary shall, in consultation with appro9 priate organizations, establish standards regarding the 

10 frequency for peripheral artery disease screening tests de11 scribed in subsection (s)(2)(II) for purposes of coverage 

12 under this title.’’. 

13 (b) INCLUSION OF PERIPHERAL ARTERY DISEASE

14 SCREENING TESTS IN INITIAL PREVENTIVE PHYSICAL

15 EXAMINATION.—Section 1861(ww)(2) of the Social Secu16 rity Act (42 U.S.C. 1395x(ww)(2)) is amended— 

17 (1) in subparagraph (N), by moving the mar18 gins of such subparagraph 2 ems to the left; 

19 (2) by redesignating subparagraph (O) as sub20 paragraph (P); and 

21 (3) by inserting after subparagraph (N) the fol22 lowing new subparagraph: 

23 ‘‘(O) Peripheral artery disease screening 

24 tests furnished to at risk-beneficiaries (as such 

25 terms are defined in subsection (lll)).’’. 


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1 (c) PAYMENT.— 

2 (1) IN GENERAL.—Section 1833(a) of the So3 cial Security Act (42 U.S.C. 1395l(a)) is amended— 

4 (A) in paragraph (1)— 

5 (i) in subparagraph (N), by inserting 

6 ‘‘and other than peripheral artery disease 

7 screening tests furnished to at-risk bene8 ficiaries (as such terms are defined in sec9 tion 1861(lll))’’ after ‘‘other than personal10 ized prevention plan services (as defined in 

11 section 1861(hhh)(1))’’; 

12 (ii) by striking ‘‘and’’ before ‘‘(DD)’’; 

13 and 

14 (iii) by striking ‘‘such service,;’’ at the 

15 end and inserting the following: ‘‘, and 

16 (EE) with respect to peripheral artery dis17 ease screening tests furnished to at-risk 

18 beneficiaries (as such terms are defined in 

19 section 1861(lll)), the amount paid shall be 

20 100 percent of the lesser of the actual 

21 charge for the services or the amount de22 termined under the payment basis deter23 mined under section 1848’’; and 

24 (B) in paragraph (2)— 


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1 (i) in subparagraph (G), by striking 

2 ‘‘and’’ at the end; 

3 (ii) in subparagraph (H), by striking 

4 the comma at the end and inserting ‘‘; 

5 and’’; and 

6 (iii) by inserting after subparagraph 

7 (H) the following new subparagraph: 

8 ‘‘(I) with respect to peripheral artery disease 

9 screening tests (as defined in paragraph (1) of sec10 tion 1861(lll)) furnished by an outpatient depart11 ment of a hospital to at-risk beneficiaries (as defined 

12 in paragraph (2) of such section), the amount deter13 mined under paragraph (1)(EE),’’. 

14 (2) NO DEDUCTIBLE.—Section 1833(b) of the 

15 Social Security Act (42 U.S.C. 1395l(b)) is amend16 ed, in the first sentence— 

17 (A) by striking ‘‘and’’ before ‘‘(12)’’; and 

18 (B) by inserting ‘‘, and (13) such deduct19 ible shall not apply with respect to peripheral 

20 artery disease screening tests furnished to at21 risk beneficiaries (as such terms are defined in 

22 section 1861(lll))’’ before the period at the end. 

23 (3) EXCLUSION FROM PROSPECTIVE PAYMENT

24 SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT

25 SERVICES.—Section 1833(t)(1)(B)(iv) of the Social 


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1 Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is 

2 amended— 

3 (A) by striking ‘‘, or personalized’’ and in4 serting ‘‘, personalized’’; and 

5 (B) by inserting ‘‘, or peripheral artery 

6 disease screening tests furnished to at-risk 

7 beneficiaries (as such terms are defined in sec8 tion 1861(lll))’’ after ‘‘personalized prevention 

9 plan services (as defined in section 

10 1861(hhh)(1))’’. 

11 (4) CONFORMING AMENDMENT.—Section 

12 1848(j)(3) of the Social Security Act (42 U.S.C. 

13 1395w–4(j)(3)) is amended by striking ‘‘(2)(FF) 

14 (including administration of the health risk assess15 ment) ,’’ and inserting ‘‘(2)(FF) (including adminis16 tration of the health risk assessment), (2)(II)’’. 

17 (d) EXCLUSION FROM COVERAGE AND MEDICARE AS

18 SECONDARY PAYER FOR TESTS PERFORMED MORE FRE19 QUENTLY THAN ALLOWED.—Section 1862(a)(1) of the 

20 Social Security Act (42 U.S.C. 1395y(a)(1)) is amended— 

21 (1) in subparagraph (O), by striking ‘‘and’’ at 

22 the end; 

23 (2) in subparagraph (P), by striking the semi24 colon at the end and inserting ‘‘, and’’; and 


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1 (3) by adding at the end the following new sub2 paragraph: 

3 ‘‘(Q) in the case of peripheral artery dis4 ease screening tests furnished to at-risk bene5 ficiaries (as such terms are defined in section 

6 1861(lll)), which are performed more frequently 

7 than is covered under such section;’’. 

8 (e) AUTHORITY TO MODIFY OR ELIMINATE COV9 ERAGE OF CERTAIN PREVENTIVE SERVICES.—Section 

10 1834(n) of the Social Security Act (42 U.S.C. 1395m(n)) 

11 is amended— 

12 (1) by redesignating subparagraphs (A) and 

13 (B) of paragraph (1) as clauses (i) and (ii), respec14 tively, and moving the margins of such clauses, as 

15 so redesignated, 2 ems to the right; 

16 (2) by redesignating paragraphs (1) and (2) as 

17 subparagraphs (A) and (B), respectively, and mov18 ing the margins of such subparagraphs, as so redes19 ignated, 2 ems to the right; 

20 (3) by striking ‘‘CERTAIN PREVENTIVE SERV21 ICES’’ and all that follows through ‘‘any other provi22 sion of this title’’ and inserting: ‘‘CERTAIN PREVEN23 TIVE SERVICES.— 

24 ‘‘(1) IN GENERAL.—Notwithstanding any other 

25 provision of this title’’; and 


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1 (4) by adding at the end the following new 

2 paragraph: 

3 ‘‘(2) INAPPLICABILITY.—The Secretarial au4 thority described in paragraph (1) shall not apply 

5 with respect to preventive services described in sec6 tion 1861(ww)(2)(O).’’. 

7 (f) EFFECTIVE DATE.—The amendments made by 

8 this section shall apply with respect to items and services 

9 furnished on or after January 1, 2022. 

10 SEC. 4. MEDICAID COVERAGE OF PERIPHERAL ARTERY 

11 DISEASE SCREENING TESTS FURNISHED TO 

12 AT-RISK BENEFICIARIES WITHOUT IMPOSI13 TION OF COST SHARING REQUIREMENTS. 

14 (a) IN GENERAL.—Section 1905 of the Social Secu15 rity Act (42 U.S.C. 1396d) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (30), by striking ‘‘and’’ 

18 at the end; 

19 (B) by redesignating paragraph (31) as 

20 paragraph (32); and 

21 (C) by inserting after paragraph (30) the 

22 following new paragraph: 

23 ‘‘(31) peripheral artery disease screening tests 

24 furnished to at-risk beneficiaries (as such terms are 

25 defined in subsection (hh)); and’’; and 


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1 (2) by adding at the end the following new sub2 section: 

3 ‘‘(hh) PERIPHERAL ARTERY DISEASE SCREENING

4 TEST; AT-RISK BENEFICIARY.— 

5 ‘‘(1) PERIPHERAL ARTERY DISEASE SCREENING

6 TEST.—The term ‘peripheral artery disease screen7 ing test’ means— 

8 ‘‘(A) noninvasive physiologic studies of ex9 tremity arteries (commonly referred to as ankle10 brachial index testing); 

11 ‘‘(B) arterial duplex scans of lower extrem12 ity arteries vascular; and 

13 ‘‘(C) such other items and services as the 

14 Secretary determines, in consultation with rel15 evant stakeholders, to be appropriate for 

16 screening for peripheral artery disease for at17 risk beneficiaries. 

18 ‘‘(2) AT-RISK BENEFICIARY.—The term ‘at-risk 

19 beneficiary’ means an individual enrolled under a 

20 State plan (or a waiver of such plan)— 

21 ‘‘(A) who is 65 years of age or older; 

22 ‘‘(B) who is at least 50 years of age but 

23 not older than 64 years of age with risk factors 

24 for atherosclerosis (such as diabetes mellitus, a 

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1 tension) or a family history of peripheral artery 

2 disease; 

3 ‘‘(C) who is younger than 50 years of age 

4 with diabetes mellitus and one additional risk 

5 factor for atherosclerosis; or 

6 ‘‘(D) with a known atherosclerotic disease 

7 in another vascular bed such as coronary, ca8 rotid, subclavian, renal, or mesenteric artery 

9 stenosis, or abdominal aortic aneurysm. 

10 ‘‘(3) FREQUENCY.—The Secretary shall, in con11 sultation with appropriate organizations, establish 

12 standards regarding the frequency for peripheral ar13 tery disease screening tests described in subsection 

14 (a)(31) for purposes of coverage under a State plan 

15 under this title.’’. 

16 (b) NO COST SHARING.— 

17 (1) IN GENERAL.—Subsections (a)(2) and 

18 (b)(2) of section 1916 of the Social Security Act (42 

19 U.S.C. 1396o) are each amended— 

20 (A) in subparagraph (F), by striking ‘‘or’’ 

21 at the end; 

22 (B) in subparagraph (G), by striking ‘‘; 

23 and’’ and inserting ‘‘, or’’; and 

24 (C) by adding at the end the following new 

25 subparagraph: 


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1 ‘‘(H) peripheral artery disease screening 

2 tests furnished to at-risk beneficiaries (as such 

3 terms are defined in section 1905(hh)); and’’. 

4 (2) APPLICATION TO ALTERNATIVE COST SHAR5 ING.—Section 1916A(b)(3)(B) of the Social Security 

6 Act (42 U.S.C. 1396o–1(b)(3)(B)) is amended by 

7 adding at the end the following new clause: 

8 ‘‘(xii) Peripheral artery disease 

9 screening tests furnished to at-risk bene10 ficiaries (as such terms are defined in sec11 tion 1905(hh)).’’. 

12 (c) MANDATORY COVERAGE.—Section 

13 1902(a)(10)(A) of the Social Security Act (42 U.S.C. 

14 1396a(a)(10)(A)) is amended by striking ‘‘and (30)’’ and 

15 inserting ‘‘(30), and (31)’’. 

16 (d) CONFORMING AMENDMENTS.— 

17 (1) Section 1902(nn)(3) of the Social Security 

18 Act (42 U.S.C. 1396a(nn)(3)) is amended by strik19 ing ‘‘following paragraph (30)’’ and inserting ‘‘fol20 lowing paragraph (32)’’. 

21 (2) Section 1905(a) of the Social Security Act 

22 (42 U.S.C. 1396d(a)) is amended by striking ‘‘fol23 lowing paragraph (30)’’ and inserting ‘‘following 

24 paragraph (32)’’. 


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1 SEC. 5. REQUIREMENT FOR GROUP HEALTH PLANS AND 

2 HEALTH INSURANCE ISSUERS OFFERING 

3 GROUP OR INDIVIDUAL HEALTH INSURANCE 

4 COVERAGE TO PROVIDE COVERAGE FOR PE5 RIPHERAL ARTERY DISEASE SCREENING 

6 TESTS FURNISHED TO AT-RISK ENROLLEES 

7 WITHOUT IMPOSITION OF COST SHARING RE8 QUIREMENTS. 

9 (a) IN GENERAL.—Subsection (a) of section 2713 of 

10 the Public Health Service Act (42 U.S.C. 300gg–13) is 

11 amended to read as follows: 

12 ‘‘(a) COVERAGE OF PREVENTIVE HEALTH SERV13 ICES.— 

14 ‘‘(1) IN GENERAL.—A group health plan and a 

15 health insurance issuer offering group or individual 

16 health insurance coverage shall, at a minimum, pro17 vide coverage for and shall not impose any cost shar18 ing requirements for— 

19 ‘‘(A) evidence-based items or services that 

20 have in effect a rating of ‘A’ or ‘B’ in the cur21 rent recommendations of the United States Pre22 ventive Services Task Force; 

23 ‘‘(B) immunizations that have in effect a 

24 recommendation from the Advisory Committee 

25 on Immunization Practices of the Centers for 


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1 Disease Control and Prevention with respect to 

2 the individual involved; 

3 ‘‘(C) with respect to infants, children, and 

4 adolescents, evidence-informed preventive care 

5 and screenings provided for in the comprehen6 sive guidelines supported by the Health Re7 sources and Services Administration; 

8 ‘‘(D) with respect to women, such addi9 tional preventive care and screenings not de10 scribed in subparagraph (A) as provided for in 

11 comprehensive guidelines supported by the 

12 Health Resources and Services Administration 

13 for purposes of this subparagraph; and 

14 ‘‘(E) with respect to at-risk enrollees, pe15 ripheral artery disease screening tests. 

16 ‘‘(2) PERIPHERAL ARTERY DISEASE SCREENING

17 TEST; AT-RISK ENROLLEE.—For purposes of para18 graph (1)(E): 

19 ‘‘(A) PERIPHERAL ARTERY DISEASE

20 SCREENING TEST.—The term ‘peripheral artery 

21 disease screening test’ means— 

22 ‘‘(i) noninvasive physiologic studies of 

23 extremity arteries (commonly referred to 

24 as ankle-brachial index testing); 


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1 ‘‘(ii) arterial duplex scans of lower ex2 tremity arteries vascular; and 

3 ‘‘(iii) such other items and services as 

4 the Secretary determines, in consultation 

5 with relevant stakeholders, to be appro6 priate for screening for peripheral artery 

7 disease for at-risk enrollees. 

8 ‘‘(B) AT-RISK ENROLLEE.—The term ‘at9 risk enrollee’ means an individual enrolled in a 

10 group health plan or group or individual health 

11 insurance coverage— 

12 ‘‘(i) who is 65 years of age or older; 

13 ‘‘(ii) who is at least 50 years of age 

14 but not older than 64 years of age with 

15 risk factors for atherosclerosis (such as di16 abetes mellitus, a history of smoking, 

17 hyperlipidemia, and hypertension) or a 

18 family history of peripheral artery disease; 

19 ‘‘(iii) who is younger than 50 years of 

20 age with diabetes mellitus and one addi21 tional risk factor for atherosclerosis; or 

22 ‘‘(iv) with a known atherosclerotic dis23 ease in another vascular bed such as coro24 nary, carotid, subclavian, renal, or mesenVerDate Sep 11 2014 02:06 Jun 09, 2021 Jkt 019200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H2631.IH H2631

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1 teric artery stenosis, or abdominal aortic 

2 aneurysm. 

3 ‘‘(C) FREQUENCY.—The Secretary shall, 

4 in consultation with appropriate organizations, 

5 establish standards regarding the frequency for 

6 peripheral artery disease screening tests de7 scribed in paragraph (1)(E) for purposes of 

8 coverage under this section. 

9 ‘‘(3) CLARIFICATION REGARDING BREAST CAN10 CER SCREENING, MAMMOGRAPHY, AND PREVENTION

11 RECOMMENDATIONS.—For the purposes of this Act, 

12 and for the purposes of any other provision of law, 

13 the current recommendations of the United States 

14 Preventive Service Task Force regarding breast can15 cer screening, mammography, and prevention shall 

16 be considered the most current other than those 

17 issued in or around November 2009. 

18 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

19 this subsection shall be construed to prohibit a plan 

20 or issuer from providing coverage for services in ad21 dition to those recommended by the United States 

22 Preventive Services Task Force or to deny coverage 

23 for services that are not recommended by such Task 

24 Force.’’. 


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1 (b) EFFECTIVE DATE.—The amendment made by 

2 subsection (a) shall apply with respect to plan years begin3 ning on or after January 1, 2022. 

4 SEC. 6. DISALLOWANCE OF PAYMENT FOR NONTRAUMATIC 

5 AMPUTATION SERVICES FURNISHED WITH6 OUT ANATOMICAL TESTING SERVICES. 

7 Section 1834 of the Social Security Act (42 U.S.C. 

8 1395m) is amended by adding at the end the following 

9 new subsection: 

10 ‘‘(z) DISALLOWANCE OF PAYMENT FOR NONTRAU11 MATIC AMPUTATION SERVICES FURNISHED WITHOUT

12 ANATOMICAL TESTING SERVICES.— 

13 ‘‘(1) IN GENERAL.—In the case of nontrau14 matic amputation services furnished by a supplier on 

15 or after January 1, 2022, to an individual entitled 

16 to, or enrolled for, benefits under part A and en17 rolled for benefits under this part, for which pay18 ment is made under this part, payment may only be 

19 made under this part if— 

20 ‘‘(A) such supplier furnishes anatomical 

21 testing services to such individual during the 3- 

22 month period preceding the date on which such 

23 nontraumatic amputation services is furnished; 

24 or 


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1 ‘‘(B) such individual has a pre-existing 

2 dysfunctional or unsalvageable limb, life-threat3 ening sepsis, intractable infection, extensive 

4 gangrene or necrotic tissue loss beyond salvage, 

5 a poor functional status, severe dementia, or a 

6 short life expectancy after shared decision-mak7 ing with a health care team and patient, family, 

8 or caregiver. 

9 ‘‘(2) DEFINITIONS.—In this subsection: 

10 ‘‘(A) ANATOMICAL TESTING SERVICES.— 

11 The term ‘anatomical testing services’ means 

12 arterial duplex scanning, computed tomography 

13 angiography, and magnetic resonance 

14 angiography. 

15 ‘‘(B) NONTRAUMATIC AMPUTATION SERV16 ICES.—The term ‘nontraumatic amputation 

17 services’ means amputations as a result of ath18 erosclerotic vascular disease or a related comor19 bidity of such disease (including diabetes).’’. 

20 SEC. 7. DEVELOPMENT AND IMPLEMENTATION OF QUALITY 

21 MEASURES. 

22 (a) DEVELOPMENT.—The Secretary of Health and 

23 Human Services (referred to in this section as the ‘‘Sec24 retary’’) shall, in consultation with relevant stakeholders, 

25 develop quality measures for nontraumatic, lower-limb, 


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1 major amputation that utilize appropriate diagnostic 

2 screening (including peripheral artery disease screening) 

3 in order to encourage alternative treatments (including 

4 revascularization) in lieu of such an amputation. 

5 (b) IMPLEMENTATION.—After appropriate testing 

6 and validation of the measures developed under subsection 

7 (a), the Secretary shall incorporate such measures in qual8 ity reporting programs for appropriate providers of serv9 ices and suppliers under the Medicare program under title 

10 XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), 

11 including for purposes of— 

12 (1) the merit-based incentive payment system 

13 under section 1848(q) of such Act (42 U.S.C. 

14 1395w–4(q)); 

15 (2) incentive payments for participation in eligi16 ble alternative payment models under section 

17 1833(z) of such Act (42 U.S.C. 1395l(z)); 

18 (3) the shared savings program under section 

19 1899 of such Act (42 U.S.C. 1395jjj); 

20 (4) models under section 1115A of such Act 

21 (42 U.S.C. 1315a); and 

22 (5) such other payment systems or models as 

23 the Secretary may specify. 

Æ 


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