,i #aafth ,,congress #b;d ,session ,h4 ,r4 #hfae ,,in ,,the ,,house ,,of ,,representatives ,october #af1 #bjbj ,mr4 ,payne 7for himself1 ,mr4 ,rush1 ,mr4 ,gallego1 ,mr4 ,thompson of ,mississippi1 ,ms4 ,johnson of ,texas1 and ,ms4 ,blunt ,rochester7 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 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 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 #bjbj or the ,,arc ,act of #bjbj4 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 #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-#g4 ,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 ,services and the ,administrator of the ,health ,resources and ,services ,administration1 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 ,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 #bjbb through #bjbf4 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,,gg71 by striking and at the end2 7,b7 in subparagraph 7,,hh71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new subparagraph3 7,,ii7 peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in subsection 7kkk774 2 and 7#b7 by adding at the end the following new subsection3 7kkk7 ,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;,,ii7 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 7kkk774 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 #ahfa7kkk77 after other than personalized prevention plan services 7as defined in section #ahfa7;hhh77#a772 7ii7 by striking and before 7,,dd72 and 7iii7 by striking such service12 at the end and inserting the following3 1 and 7,,ee7 with respect to peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #ahfa7kkk771 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 #ahdh2 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 comma 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 #ahfa7kkk77 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;,,ee71 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 and before 7#ab72 and 7,b7 by inserting 1 and 7#ac7 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 #ahfa7kkk77 before the period at the end4 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 #ahfa7kkk77 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 assessment7 1 and inserting 7#b77;,,ff7 7including administration of the health risk assessment71 7#b77;,,ii74 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 #ahfa7kkk771 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 #bjbb4 #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#bi71 by striking and at the end2 7,b7 by redesignating paragraph 7#cj7 as paragraph 7#ca72 and 7,c7 by inserting after paragraph 7#bi7 the following new paragraph3 7#cj7 peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in subsection 7gg772 and 2 and 7#b7 by adding at the end the following new subsection3 7gg7 ,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#cj7 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,f71 by striking or at the end2 7,b7 in subparagraph 7,g71 by striking 2 and and inserting 1 or2 and 7,c7 by adding at the end the following new subparagraph3 7,h7 peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #aije7;gg772 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 7xii7 ,peripheral artery disease screening tests furnished to at-risk beneficiaries 7as such terms are defined in section #aije7;gg774 4 7c7 ,mandatory coverage ,section #aijb7;a77#aj77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77 is amended by striking and 7#bi7 and inserting 7#bi71 and 7#cj74 7d7 ,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#cj7 and inserting following paragraph 7#ca74 7#b7 ,section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is amended by striking following paragraph 7#cj7 and inserting following paragraph 7#ca74 #e4 ,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 7a7 ,in general ,subsection 7a7 of section #bgac of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ac7 is amended to read as follows3 7a7 ,coverage of preventive health services 7#a7 ,in general ,a group health plan and a health insurance issuer offering group or individual health insurance coverage shall1 at a minimum1 provide coverage for and shall not impose any cost sharing requirements for-- 7,a7 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 ,force2 7,b7 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 involved2 7,c7 with respect to infants1 children1 and adolescents1 evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the ,health ,resources and ,services ,administration2 7,d7 with respect to women1 such additional preventive care and screenings not described in subparagraph 7,a7 as provided for in comprehensive guidelines supported by the ,health ,resources and ,services ,administration for purposes of this subparagraph2 and 7,e7 with respect to at-risk enrollees1 peripheral artery disease screening tests4 7#b7 ,peripheral artery disease screening test2 ,at-risk enrollee ,for purposes of paragraph 7#a77;,e73 7,a7 ,peripheral artery disease screening test ,the term peripheral artery disease screening test means-- 7i7 noninvasive physiologic studies of extremity arteries 7commonly referred to as ankle-brachial index testing72 7ii7 arterial duplex scans of lower extremity arteries vascular2 and 7iii7 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 enrollees4 7,b7 ,at-risk enrollee ,the term at-risk enrollee means an individual enrolled in a group health plan or group or individual health insurance coverage-- 7i7 who is #fe years of age or older2 7ii7 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 7iii7 who is younger than #ej years of age with diabetes mellitus and one additional risk factor for atherosclerosis2 or 7iv7 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 paragraph 7#a77;,e7 for purposes of coverage under this section4 7#c7 ,clarification regarding breast cancer screening1 mammography1 and prevention recommendations ,for the purposes of this ,act1 and for the purposes of any other provision of law1 the current recommendations of the ,united ,states ,preventive ,service ,task ,force regarding breast cancer screening1 mammography1 and prevention shall be considered the most current other than those issued in or around ,november #bjji4 7#d7 ,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 ,force4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to plan years beginning on or after ,january #a1 #bjbb4 #f4 ,disallowance of payment for nontraumatic amputation services furnished without anatomical testing services ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7x7 ,disallowance of payment for nontraumatic amputation services furnished without anatomical testing services 7#a7 ,in general ,in the case of nontraumatic amputation services furnished by a supplier on or after ,january #a1 #bjbb1 to an individual entitled to1 or enrolled for1 benefits under part ,a and enrolled for benefits under this part1 for which payment is made under this part1 payment may only be made under this part if such supplier furnishes anatomical testing services to such individual during the #c-month period preceding the date on which such nontraumatic amputation services is furnished4 7#b7 ,definitions ,in this subsection3 7,a7 ,anatomical testing services ,the term anatomical testing services means arterial duplex scanning1 computed tomography angiography1 and magnetic resonance angiography4 7,b7 ,nontraumatic amputation services ,the term nontraumatic amputation services means amputations as a result of atherosclerotic vascular disease or a related comorbity of such disease 7including diabetes74 4 #g4 ,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 ,after appropriate testing and validation of the measures developed under subsection 7a71 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 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