,i #aaith ,,congress #ast ,session ,h4 ,r4 #cjg ,,in ,,the ,,house ,,of ,,representatives ,january #i1 #bjbe,mrs4 ,mc,iver 7for herself1 ,mr4 ,jackson of ,illinois1 and ,ms4 ,kelly of ,illinois7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 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 requirements1 and for other purposes4 #a4 ,short title2 findings 7a7 ,short title ,this ,act may be cited as the ,amputation ,reduction and ,compassion ,act of #bjbe or the ,,arc ,act of #bjbe4 7b7 ,findings ,congress makes the following findings3 7#a7 ,atherosclerosis occurs when blood flow is reduced because arteries become narrowed or blocked with fatty deposits4 7#b7 ,atherosclerosis is responsible for more deaths in the ,united ,states than any other condition1 and heart attacks1 resulting from clogged coronary arteries1 are the leading cause of death in ,america4 7#c7 ,atherosclerosis also occurs in the legs and is known as peripheral artery disease 7in this subsection referred to as ,,pad7 and having ,,pad significantly increases the risk for heart attack1 stroke1 amputation1 and death4 7#d7 ,while most ,americans are aware of atherosclerosis in the heart1 many ,americans have never heard of ,,pad and ,americans with ,,pad are often unaware of the serious risks of the disease4 7#e7 ,an estimated #ba million ,americans have ,,pad1 and about #bjj1jjj of them--disproportionately minorities--suffer avoidable amputations every year as a result of such disease4 7#f7 ,according to the ,dartmouth ,atlas1 amputation risks for ,african ,americans living with diabetes are as much as four times higher than the national average4 7#g7 ,data analyses have similarly found that ,native ,americans are more than twice as likely to be subjected to amputation and ,hispanics are up to #ge percent more likely to have an amputation4 7#h7 ,fifty-two percent of patients with an above-the-knee amputation and #cc percent of patients with a below-the-knee amputation will die within two years of their amputation4 7#i7 ,screening and arterial testing for ,,pad is cost-effective and should be part of routine medical care4 7#aj7 ,once ,,pad is detected1 amputations and deaths can be reduced through the use of national1 evidence-based ,,pad care guidelines4 7#aa7 ,americans with a ,,pad diagnosis are associated with a #fg-percent increase in the risk of cardiac death compared to people without a ,,pad diagnosis4 ,consequently1 screening for ,,pad enables health care professionals to identify cardiac risk factors earlier and take proactive measures to reduce the risk of cardiac death4 #b4 ,peripheral artery disease education program ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following new section3 #cii,v-#h4 ,peripheral artery disease education program 7a7 ,establishment ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 in collaboration with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,administrator of the ,health ,resources and ,services ,administration1 leading clinical and patient advocacy organizations1 and other interested stakeholders shall establish and coordinate a peripheral artery disease education program to support1 develop1 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 disease1 particularly with respect to at-risk populations4 7b7 ,best practices ,the ,secretary shall1 as appropriate1 identify and disseminate to health care professionals best practices with respect to peripheral artery disease4 7c7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #f1jjj1jjj for each of fiscal years #bjbf through #bjcj4 4 #c4 ,medicare coverage of peripheral artery disease screening tests furnished to at-risk beneficiaries without imposition of cost-sharing requirements 7a7 ,in general ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7#a7 in subsection 7s77#b7-- 7,a7 in subparagraph 7,,jj71 by striking the semicolon at the end and inserting 2 and2 and 7,b7 by adding at the end the following new subparagraph3 7,,kk7 peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in subsection 7nnn774 2 and 7#b7 by adding at the end the following new subsection3 7nnn7 ,peripheral artery disease screening test2 ,at-,risk beneficiary 7#a7 ,the term peripheral artery disease screening test means-- 7,a7 noninvasive physiologic studies of extremity arteries 7commonly referred to as ankle-brachial index testing72 7,b7 arterial duplex scans of lower extremity arteries vascular2 and 7,c7 such other items and services as the ,secretary determines1 in consultation with relevant stakeholders1 to be appropriate for screening for peripheral artery disease for at-risk beneficiaries4 7#b7 ,the term at-risk beneficiary means an individual entitled to1 or enrolled for1 benefits under part ,a and enrolled for benefits under part ,b-- 7,a7 who is #fe years of age or older2 7,b7 who is at least #ej years of age but not older than #fd years of age with risk factors for atherosclerosis 7such as diabetes mellitus1 a history of smoking1 hyperlipidemia1 and hypertension7 or a family history of peripheral artery disease2 7,c7 who is younger than #ej years of age with diabetes mellitus and one additional risk factor for atherosclerosis2 or 7,d7 with a known atherosclerotic disease in another vascular bed such as coronary1 carotid1 subclavian1 renal1 or mesenteric artery stenosis1 or abdominal aortic aneurysm4 7#c7 ,the ,secretary shall1 in consultation with appropriate organizations1 establish standards regarding the frequency for peripheral artery disease screening tests described in subsection 7s77#b77,,kk7 for purposes of coverage under this title4 4 7b7 ,inclusion of peripheral artery disease screening tests in initial preventive physical examination ,section #ahfa7ww77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77#b77 is amended-- 7#a7 in subparagraph 7,n71 by moving the margins of such subparagraph #b ems to the left2 7#b7 by redesignating subparagraph 7,o7 as subparagraph 7,p72 and 7#c7 by inserting after subparagraph 7,n7 the following new subparagraph3 7,o7 ,peripheral artery disease screening tests furnished to at risk-beneficiaries 7as such terms are defined in subsection 7nnn774 4 7c7 ,payment 7#a7 ,in general ,section #ahcc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is amended-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,n71 by inserting and other than peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #ahfa7nnn77 after other than personalized prevention plan services 7as defined in section #ahfa7;hhh77#a772 7ii7 by striking and before 7,,hh72 and 7iii7 by adding at the end the following3 and 7,,ii7 with respect to peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #ahfa7nnn771 the amount paid shall be #ajj percent of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section #ahdh22 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,g71 by striking and at the end2 7ii7 in subparagraph 7,h71 by striking the semicolon at the end and inserting 2 and2 and 7iii7 by inserting after subparagraph 7,h7 the following new subparagraph3 7,i7 with respect to peripheral artery disease screening tests 7as defined in paragraph 7#a7 of section #ahfa7nnn77 furnished by an outpatient department of a hospital to at-risk beneficiaries 7as defined in paragraph 7#b7 of such section71 the amount determined under paragraph 7#a77;,,ii72 4 7#b7 ,no deductible ,section #ahcc7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7b77 is amended1 in the first sentence-- 7,a7 by striking 1 and before 7#ac72 and 7,b7 by inserting before the period at the end the following3 1 and 7#ad7 such deductible shall not apply with respect to peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #ahfa7nnn774 7#c7 ,exclusion from prospective payment system for hospital outpatient department services ,section #ahcc7t77#a77;,b77iv7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#a77;,b77iv77 is amended-- 7,a7 by striking 1 or personalized and inserting 1 personalized2 and 7,b7 by inserting 1 or peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #ahfa7nnn77 after personalized prevention plan services 7as defined in section #ahfa7;hhh77#a774 7#d7 ,conforming amendment ,section #ahdh7;j77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;j77#c77 is amended by striking 7#b77;,,ff7 7including administration of the health risk assessment71 and inserting 7#b77;,,ff7 7including administration of the health risk assessment71 7#b77,,kk714 7d7 ,exclusion from coverage and ,medicare as secondary payer for tests performed more frequently than allowed ,section #ahfb7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a77 is amended-- 7#a7 in subparagraph 7,o71 by striking and at the end2 7#b7 in subparagraph 7,p71 by striking the semicolon at the end and inserting 1 and2 and 7#c7 by adding at the end the following new subparagraph3 7,q7 in the case of peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #ahfa7nnn771 which are performed more frequently than is covered under such section2 4 7e7 ,authority ,to modify or eliminate coverage of certain preventive services ,section #ahcd7n7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7n77 is amended-- 7#a7 by redesignating subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 as clauses 7i7 and 7ii71 respectively1 and moving the margins of such clauses1 as so redesignated1 #b ems to the right2 7#b7 by redesignating paragraphs 7#a7 and 7#b7 as subparagraphs 7,a7 and 7,b71 respectively1 and moving the margins of such subparagraphs1 as so redesignated1 #b ems to the right2 7#c7 by striking ,certain ,preventive ,services and all that follows through any other provision of this title and inserting3 ,certain ,preventive ,services4-- 7#a7 ,in general ,notwithstanding any other provision of this title 2 and 7#d7 by adding at the end the following new paragraph3 7#b7 ,inapplicability ,the ,secretarial authority described in paragraph 7#a7 shall not apply with respect to preventive services described in section #ahfa7ww77#b77,o74 4 7f7 ,effective date ,the amendments made by this section shall apply with respect to items and services furnished on or after ,january #a1 #bjbf4 #d4 ,medicaid coverage of peripheral artery disease screening tests furnished to at-risk beneficiaries without imposition of cost-sharing requirements 7a7 ,in general ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#ca71 by striking and at the end2 7,b7 by redesignating paragraph 7#cb7 as paragraph 7#cc72 and 7,c7 by inserting after paragraph 7#ca7 the following new paragraph3 7#cb7 peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in subsection 7kk772 and 2 and 7#b7 by adding at the end the following new subsection3 7kk7 ,peripheral artery disease screening test2 ,at-,risk beneficiary 7#a7 ,peripheral artery disease screening test ,the term peripheral artery disease screening test means-- 7,a7 noninvasive physiologic studies of extremity arteries 7commonly referred to as ankle-brachial index testing72 7,b7 arterial duplex scans of lower extremity arteries vascular2 and 7,c7 such other items and services as the ,secretary determines1 in consultation with relevant stakeholders1 to be appropriate for screening for peripheral artery disease for at-risk beneficiaries4 7#b7 ,at-risk beneficiary ,the term at-risk beneficiary means an individual enrolled under a ,state plan 7or a waiver of such plan7-- 7,a7 who is #fe years of age or older2 7,b7 who is at least #ej years of age but not older than #fd years of age with risk factors for atherosclerosis 7such as diabetes mellitus1 a history of smoking1 hyperlipidemia1 and hypertension7 or a family history of peripheral artery disease2 7,c7 who is younger than #ej years of age with diabetes mellitus and one additional risk factor for atherosclerosis2 or 7,d7 with a known atherosclerotic disease in another vascular bed such as coronary1 carotid1 subclavian1 renal1 or mesenteric artery stenosis1 or abdominal aortic aneurysm4 7#c7 ,frequency ,the ,secretary shall1 in consultation with appropriate organizations1 establish standards regarding the frequency for peripheral artery disease screening tests described in subsection 7a77#ca7 for purposes of coverage under a ,state plan under this title4 4 7b7 ,no cost sharing 7#a7 ,in general ,subsections 7a77#b7 and 7b77#b7 of section #aiaf of the ,social ,security ,act 7#db ,u4,s4,c4 #acifo7 are each amended-- 7,a7 in subparagraph 7,i71 by striking or at the end2 7,b7 in subparagraph 7,j71 by striking 2 and and inserting 1 or2 and 7,c7 by adding at the end the following new subparagraph3 7,k7 peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #aije7kk772 and 4 7#b7 ,application to alternative cost sharing ,section #aiaf;,a7b77#c77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifo-#a7;b77#c77;,b77 is amended by adding at the end the following new clause3 7xv7 ,peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #aije7kk774 4 7c7 ,conforming amendments 7#a7 ,section #aijb7nn77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7nn77#c77 is amended by striking following paragraph 7#ca7 and inserting following paragraph 7#cb74 7#b7 ,section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is amended by striking following paragraph 7#ca7 and inserting following paragraph 7#cb74 #e4 ,development and implementation of quality measures 7a7 ,development ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 in consultation with relevant stakeholders1 develop quality measures for nontraumatic1 lower-limb1 major amputation that utilize appropriate diagnostic screening 7including peripheral artery disease screening7 in order to encourage alternative treatments 7including revascularization7 in lieu of such an amputation4 7b7 ,implementation ,not later than #ah months after the date of enactment of this ,act1 the ,secretary shall complete appropriate testing and validation of the measures developed under subsection 7a7 and 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 7#db ,u4,s4,c4 #acie et seq471 including for purposes of-- 7#a7 the merit-based incentive payment system under section #ahdh7q7 of such ,act 7#db ,u4,s4,c4 #aciew-#d7q772 7#b7 incentive payments for participation in eligible alternative payment models under section #ahcc7z7 of such ,act 7#db ,u4,s4,c4 #aciel7z772 7#c7 the shared savings program under section #ahii of such ,act 7#db ,u4,s4,c4 #acie;jjj72 7#d7 models under section #aaae;,a of such ,act 7#db ,u4,s4,c4 #acae;a72 and 7#e7 such other payment systems or models as the ,secretary may specify4 #f4 ,amputation prevention pilot program 7a7 ,in general ,section #aaae;,a7b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b77 is amended by adding at the end the following new clause3 7xxviii7 ,promoting voluntary1 nontraumatic lower-limb major amputation prevention programs at hospitals1 ambulatory surgical centers1 and office-based centers that will increase access to amputation prevention services1 reduce amputation rates1 and reduce costs to such hospitals1 surgical centers1 and office-based centers1 through-- 7,i7 patient risk modification and management2 7,,ii7 early screening and detection and surveillance2 7,,iii7 testing and treatment for peripheral artery disease2 and 7,,iv7 improved care coordination for individuals at high risk for amputation4 4 7b7 ,testing of model ,not later than #ah months after the date of the enactment of this ,act1 the ,deputy ,administrator and ,director of the ,center for ,medicare and ,medicaid ,innovation shall test the model described under subsection 7a74