,,ii #aae? ,,congress #a/ ,session ,s4 #aaia ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bb1 #bjag,mr4 ,grassley introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to ref9e h[ ,m$ic>e pays = or?otics & pro/hetics & to improve b5efici>y exp]i5ce & outcomes ) or?otic & pro/hetic c>e1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,m$ic>e ,or?otics & ,pro/hetics ,improvem5t ,act ( #bjag4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,sec4 #b4 ,modification ( requirem5ts applicable "u ,m$ic>e to ! designation ( accr$itation organizations = suppli]s ( or?otics & pro/hetics4,sec4 #c4 ,application ( exi/+ accr$itation & lic5sure requirem5ts to c]ta9 pro/hetics & cu/om-fabricat$ or cu/om-fitt$ or?otics4,sec4 #d4 ,eligibility = ,m$ic>e paym5t = or?otics & pro/hetics bas$ on suppli] qualifications & complexity ( c>e4,sec4 #e4 ,or?oti/'s & pro/heti/'s cl9ical notes z "p ( ! pati5t's m$ical record4,sec4 #f4 ,di/+ui%+ or?oti/s & pro/heti/s f suppli]s ( durable m$ical equipm5t & supplies4,sec4 #g4 ,cl>ification ab\t m9imal self-adju/m5t = (f-!-%elf or?otics4,sec4 #h4 ,regulations4 #b4 ,modification ( requirem5ts applicable "u ,m$ic>e to ! designation ( accr$itation organizations = suppli]s ( or?otics & pro/hetics 7a7 ,9 g5]al ,section #ahcd7;a77#bj77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77#bj77;,b77 is am5d$-- 7#a7 by /rik+ organizations4--,n lat] ?an & ins]t+3 8organizations4-- 7i7 ,9 g5]al ,subject to clause 7ii71 n lat] ?an 2 & 7#b7 by add+ aft] clause 7i71 z add$ by p>agraph 7#a71 ! foll[+ new clauses3 7ii7 ,special requirem5ts = accr$itation ( suppli]s ( or?otics & pro/hetics ,= purposes ( apply+ quality /&>ds "u subp>agraph 7,a7 = suppli]s 7o!r ?an suppli]s describ$ 9 clause 7iii77 ( items & s]vices describ$ 9 subp>agraph 7,d77ii71 ! ,secret>y %all designate & approve indep5d5t accr$itation organizations "u clause 7i7 only if su* organizations are ,bo>ds or programs describ$ 9 subsection 7h77#a77;,f77iv74 ,n lat] ?an ,janu>y #a1 #bjah1 ! ,secret>y %all ensure t at lea/ "o1 & ideally multiple1 indep5d5t accr$itation organizations are designat$ & approv$ 9 accordance ) ?is clause4 7iii7 ,exception ,suppli]s describ$ 9 ?is clause are physicians1 occupational !rapi/s1 or physical !rapi/s :o are lic5s$ or o!rwise regulat$ by ! ,/ate 9 :i* !y are practic+ & :o receive paym5t "u ?is title1 includ+ regulations promulgat$ pursuant to ?is subsection4 4 7b7 ,effective date ,ea* organization mu/ satisfy ! requirem5t ( section #ahcd7;a77#bj77;,b77ii71 z add$ by subsection 7a77#b71 n lat] ?an ,janu>y #a1 #bjah1 reg>dless ( :e!r ! organization is designat$ or approv$ z an indep5d5t accr$itation organization be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act4 #c4 ,application ( exi/+ accr$itation & lic5sure requirem5ts to c]ta9 pro/hetics & cu/om-fabricat$ or cu/om-fitt$ or?otics 7a7 ,9 g5]al ,section #ahcd7;h77#a77;,f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,f77 is am5d$-- 7#a7 9 ! head+1 by ins]t+ or cu/om-fitt$ aft] cu/om-fabricat$2 7#b7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by /rik+ an item ( cu/om-fabricat$ or?otics describ$ 9 clause 7ii7 or = an item ( pro/hetics unless su* item is & ins]t+ an item ( or?otics or pro/hetics1 includ+ an item ( cu/om-fabricat$ or?otics describ$ 9 clause 7ii71 unless su* item is2 7#c7 9 clause 7ii77,,ii71 9 ! fir/ s5t5ce1 by /rik+ a li/ ( items to :i* ?is subp>agraph applies & ins]t+ a li/ ( items = purposes ( clause 7i72 7#d7 9 clause 7iii77,,iii71 by /rik+ to provide or manage ! provision ( pro/hetics & cu/om-design$ or -fabricat$ or?otics & ins]t+ to provide or manage ! provision ( or?otics & pro/hetics 7& cu/om-design$ or -fabricat$ or?otics1 9 ! case ( an item describ$ 9 clause 7ii772 & 7#e7 by add+ at ! end ! foll[+ new clause3 7v7 ,exemption ( (f-!-%elf or?otics includ$ 9 a competitive acquisition program ,?is subp>agraph %all n apply to an item ( or?otics describ$ 9 p>agraph 7#b77;,c7 ( section #ahdg7;a7 furni%$ on or aft] ,janu>y #a1 #bjah1 t is includ$ 9 a competitive acquisition area "u su* section4 4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply to or?otics & pro/hetics furni%$ on or aft] ,janu>y #a1 #bjah4 #d4 ,eligibility = ,m$ic>e paym5t = or?otics & pro/hetics bas$ on suppli] qualifications & complexity ( c>e ,section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77 is am5d$-- 7#a7 9 p>agraph 7#a77;,f77iii71 9 ! matt] prec$+ subclause 7,i71 by /rik+ o!r individual :o & ins]t+ o!r individual :o1 ) respect to ! provision ( or?otics & pro/hetics furni%$ on or aft] ,janu>y #a1 #bjah1 & subject to p>agraph 7#e77;,a71 satisfies all applicable crit]ia ( ! provid] qualification designation = su* or?otic or pro/hetic1 & :o2 7#b7 9 p>agraph 7#a77;,f77iv71 by ins]t+ be=e ! p]iod ! foll[+3 &1 ) respect to ! provision ( or?otics & pro/hetics furni%$ on or aft] ,janu>y #a1 #bjah1 & subject to p>agraph 7#e77;,a71 satisfies all applicable crit]ia ( ! provid] qualification designation = su* or?otic or pro/hetic2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,eligibility = paym5t bas$ on suppli] qualifications & complexity ( c>e 7,a7 ,consid]ations = eligibility = paym5ts 7i7 ,9 g5]al ,9 apply+ clauses 7iii7 & 7iv7 ( p>agraph 7#a77;,f7 = purposes ( det]m9+ :e!r paym5t may be made "u ?is subsection = or?otics & pro/hetics furni%$ on or aft] ,janu>y #a1 #bjah1 ! ,secret>y %all take into acc\nt ! complexity ( ! respective item &1 subject to clauses 7ii71 7iii71 & 7iv71 ! qualifications ( ! individual or entity furni%+ & fabricat+ su* respective item 9 accordance ) ?is p>agraph4 7ii7 ,individuals & entities exempt$ f suppli] qualification crit]ia ,) respect to ! provision ( or?otics or pro/hetics1 any crit]ia = suppli] qualifications %all n apply to physicians1 occupational !rapi/s1 or physical !rapi/s :o are lic5s$ or o!rwise regulat$ by ! ,/ate 9 :i* !y are practic+ & :o receive paym5t "u ?is title1 includ+ regulations promulgat$ pursuant to ?is subsection1 = ! provision ( or?otics & pro/hetics4 7iii7 ,suppli]s ,m$ic>e-eligible prior to ,janu>y #a1 #bjah1 exempt$ ,9 ! case ( a qualifi$ suppli] :o is eligible to receive paym5t "u ?is title be=e ,janu>y #a1 #bjah1 ) respect to ! provision ( or?otics & pro/hetics1 any new crit]ia = provid] qualifications e/abli%$ aft] su* date %all n apply to su* suppli]1 = ! furni%+ or fabrication ( su* an item4 7iv7 ,modifications ,! ,secret>y %all1 9 consultation ) ! ,bo>ds & programs describ$ 9 p>agraph 7#a77;,f77iv71 p]iodically review ! crit]ia = suppli] qualifications & may implem5t by regulation any modifications to su* crit]ia1 z det]m9$ appropriate 9 accordance ) su* consultation4 ,any su* modifications %all take effect no e>li] ?an ,janu>y #a1 #bjah4 7,b7 ,assignm5t ( bill+ codes ,= purposes ( subp>agraph 7,a71 ! ,secret>y1 9 consultation ) repres5tatives ( ! fields ( occupational !rapy1 physical !rapy1 or?otics1 & pro/hetics1 %all utilize & incorporate ! set ( ,l-codes li/$1 z ( ! date ( enactm5t ( ?is p>agraph1 9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices docum5t entitl$ ,transmittal #fef 7,,cms ,pub4 #ajj-jd1 ,*ange ,reque/ #ciei1 ,augu/ #ai1 #bjje74 ,transmittal #fef %all be ! controll+ s\rce ( category1 product1 & code assignm5ts = ! or?otics & pro/hetics c>e1 us+ ! suppli] qualification designation = ea* ,,hcpcs code z /at$ 9 su* docum5t4 ,9 ! case t ,transmittal #fef is updat$1 reissu$1 or replac$ by a subsequ5t docum5t1 ! prec$+ s5t5ce %all be appli$ ) respect to ! mo/ rec5t update1 reissuance1 or replacem5t ( su* docum5t4 4 #e4 ,or?oti/'s & pro/heti/'s cl9ical notes z "p ( ! pati5t's m$ical record ,section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 z am5d$ by section #d1 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,docum5tation creat$ by or?oti/s & pro/heti/s ,) respect to claims fil$ aft] ! date ( ! enactm5t ( ! ,m$ic>e ,or?otics & ,pro/hetics ,improvem5t ,act ( #bjag1 = purposes ( det]m9+ ! reasonabl5ess1 m$ical necessity1 & functional level 7applicable to pro/hetics7 ( or?otics & pro/hetics1 docum5tation creat$ by an or?oti/ or pro/heti/ %all be consid]$ "p ( ! pati5t's m$ical record &1 consi/5t ) ! treatm5t ( or?otic & pro/hetic pati5t c>e deliv]y /at$ 9 ! heal? c>e pr(essional exception provid$ 9 clause 7ii7 ( subsection 7a77#bj77;,f71 %all be consid]$ along ) docum5tation creat$ by o!r heal? pr(essionals1 includ+ physicians1 nurse practition]s1 occupational !rapi/s1 & physical !rapi/s4 4 #f4 ,di/+ui%+ or?oti/s & pro/heti/s f suppli]s ( durable m$ical equipm5t & supplies 7a7 ,requirem5ts = suppli]s ( m$ical equipm5t & supplies ,section #ahcd7;j77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7j77#e77 is am5d$ by /rik+ subp>agraph 7,c74 7b7 ,requirem5ts = or?oti/s & pro/heti/s 7#a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7v7 ,requirem5ts = or?oti/s & pro/heti/s 7#a7 ,issuance & r5ewal ( suppli] numb] 7,a7 ,paym5t 7i7 ,9 g5]al ,no paym5t may be made "u ?is "p to an or?otic or pro/hetic suppli] unless su* or?otic or pro/hetic suppli] obta9s 7& r5ews at su* int]vals z ! ,secret>y may require7 a suppli] numb]4 7ii7 ,cl>ification reg>d+ provid]s "u "p ,a ,no?+ 9 clause 7i7 %all prohibit a provid] o!rwise p]mitt$ to receive paym5t = or?otics & pro/hetics "u "p ,a f cont9u+ to receive paym5t "u su* "p )\t int]ruption4 7,b7 ,/&>ds = possess+ a suppli] numb] ,an or?otic or pro/hetic suppli] may only obta9 a suppli] numb] if ! suppli] meets /&>ds prescrib$ by ! ,secret>y t include requirem5ts t ! or?otic or pro/hetic suppli] 7&1 :]e applicable1 ! or?oti/ or pro/heti/7-- 7i7 lic5sure or accr$itation-- 7,i7 complies ) all applicable ,/ate & ,f$]al lic5sure & regulatory requirem5ts2 or 7,,ii7 acquires accr$itation f ! ,am]ican ,bo>d = ,c]tification 9 ,or?otics1 ,pro/hetics & ,p$or?ics1 ,inc4 7,,abc7 or ! ,bo>d ( ,c]tification_/,accr$itation1 ,int]national 7,,boc71 or o!r accr$itation entity t ! ,secret>y det]m9es has /&>ds t are ess5tially equival5t to ! /&>ds ( su* ,bo>ds2 7ii7 ma9ta9s a physical facility on an appropriate site2 7iii7 has pro( ( appropriate liability insurance2 & 7iv7 meets su* o!r requirem5ts z ! ,secret>y %all specify4 7,c7 ,prohibition aga9/ multiple suppli] numb]s ,! ,secret>y may n issue m ?an "o suppli] numb] to any or?otic or pro/hetic suppli] unless ! ,secret>y f9ds t ! issuance ( m ?an "o numb] is appropriate to id5tify o!r entities "u ! own]%ip or control ( ! or?otic or pro/hetic suppli]4 7#b7 ,ord] = or?otics or pro/hetics 7,a7 ,in=mation provid$ by or?oti/s & pro/heti/s on detail$ writt5 ord]s = or?otics & pro/hetics ,an or?oti/ or pro/heti/ may di/ribute to physicians1 or to an individual enroll$ "u ?is "p1 a detail$ writt5 ord] = or?otics or pro/hetics 7z def9$ 9 p>agraph 7#e77 = comm]cial purposes t conta9s ! foll[+ in=mation3 7i7 ,! id5tification (-- 7,i7 ! or?otic or pro/hetic suppli]2 & 7,,ii7 ! individual to :om ! or?otics or pro/hetics are furni%$4 7ii7 ,! id5tification ( ! treat+ physician1 includ+ ! "n1 address1 & telephone numb] ( ! physician4 7iii7 ,a description ( ! or?otics or pro/hetics ord]$4 7iv7 ,any bill+ code id5tify+ ! or?otics or pro/hetics4 7v7 ,diagnosis codes1 a description ( ! individual's m$ical & functional condition1 & in=mation ab\t ! ne$ = ! or?otics or pro/hetics4 7,b7 ,in=mation on cod+ & descriptors ( compon5ts provid$ ,if an or?oti/ or pro/heti/ di/ributes a detail$ writt5 ord] = or?otics or pro/hetics describ$ 9 subp>agraph 7,a71 ! or?oti/ or pro/heti/ %all also li/ on ! ord] ! ,,hcpcs codes & summ>y descriptors ( ! items & s]vices be+ recomm5d$ prior to submission ( ! ord] to ! treat+ physician = approval4 7,c7 ,signature by treat+ physician ,a detail$ writt5 ord] = or?otics or pro/hetics describ$ 9 subp>agraph 7,a7 %all be sign$ by ! treat+ physician4 7#c7 ,limitation on individual liability ,except z provid$ 9 p>agraph 7#d71 if an or?oti/ or pro/heti/-- 7,a7 furni%es an or?osis or pro/hesis to an individual = :i* no paym5t may be made "u ?is "p2 or 7,b7 subject to section #ahgi1 furni%es an or?osis or pro/hesis to an individual = :i* paym5t is d5i$ "u section #ahfb7;a77#a71 any exp5ses incurr$ = ! or?osis or pro/hesis furni%$ to an individual by ! or?oti/ or pro/heti/ n on an assign$ basis %all be ! responsibility ( su* or?oti/ or pro/heti/4 ,! individual %all h no f9ancial responsibility = su* exp5ses & ! or?oti/ or pro/heti/ %all refund on a timely basis to ! individual 7& %all be liable to ! individual =7 any am\nts collect$ f ! individual = su* items & s]vices4 ,! provisions ( subsection 7a77#ah7 %all apply to refunds requir$ "u ! previ\s s5t5ce 9 ! same mann] z su* provisions apply to refunds "u su* subsection4 7#d7 ,individual liability ,if an or?oti/ or pro/heti/ furni%es an or?osis or pro/hesis to an individual = :i* paym5t is d5i$ 9 advance "u subsection 7a77#ae71 exp5ses incurr$ = su* or?osis or pro/hesis furni%$ to ! individual by ! or?oti/ or pro/heti/ %all be ! responsibility ( ! individual4 7#e7 ,def9itions ,9 ?is subsection3 7,a7 ,detail$ writt5 ord] = or?otics or pro/hetics 7i7 ,9 g5]al ,! t]m detail$ writt5 ord] = or?otics or pro/hetics means a =m or o!r docum5t prep>$ by an or?oti/ or pro/heti/ & sign$ by ! physician 7z def9$ by section #ahfa7r77 t conta9s in=mation requir$ by ! ,secret>y to be submitt$ to %[ t an or?osis or pro/hesis is reasonable & necess>y = ! treatm5t ( an illness or injury or to improve ! function+ ( a mal=m$ body memb]4 7ii7 ,cl>ification ,! detail$ writt5 "w ord] = or?otics or pro/hetic %all n be consid]$ alone = purposes ( det]m9+ ! reasonabl5ess1 m$ical necessity1 & functional level 7applicable to pro/hetics7 ( pro/hetic devices & or?otics4 7,b7 ,or?otics & pro/hetics ,! t]m or?otics & pro/hetics has ! mean+ giv5 t t]m 9 section #ahcd7;h77#d77;,c74 7,c7 ,or?oti/ or pro/heti/ ,! t]m or?oti/ or pro/heti/ means an individual :o is specifically tra9$ & educat$ 9 ! provision (1 & pati5t c>e managem5t relat$ to1 pro/hetics & cu/om-fabricat$ or cu/om-fit or?otics1 &-- 7i7 9 ! case ( a ,/ate t provides = ! lic5s+ ( or?oti/s & pro/heti/s1 is lic5s$ by ! ,/ate 9 :i* ! or?otics or pro/hetics 7 suppli$2 or 7ii7 9 ! case ( a ,/ate t does n provide = ! lic5s+ ( or?oti/s & pro/heti/s1 is c]tifi$ by ! ,am]ican ,bo>d ( ,c]tification 9 ,or?otics1 ,pro/hetics & ,p$or?ics1 ,inc4 or by ! ,bo>d ( ,c]tification_/,accr$itation1 ,int]national1 or is c]tifi$ & approv$ by an entity t ! ,secret>y det]m9es has c]tification & approval /&>ds t are ess5tially equival5t to ! c]tification & approval /&>ds ( su* ,bo>ds4 4 7#b7 ,impact on ,,dmepos b5efit ,! am5dm5t made by p>agraph 7#a7-- 7,a7 %all n be con/ru$ to create a sep>ate b5efit category "u title ,,xviii ( ! ,social ,security ,act = or?otic & pro/hetic devices2 b 7,b7 %all be con/ru$ z diff]5tiat+ ! mann] 9 :i* or?otic & pro/hetic devices & s]vices are provid$ 9 contra/ to o!r durable m$ical equipm5t & supplies s]vices cov]$ "u su* title4 7c7 ,def9ition ( or?otics & pro/hetics synonym\s ) or?oses & pro/heses ,section #ahcd7;h77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#d77;,c77 is am5d$ by ins]t+ 7:i* may also be ref]r$ to )\t di/9ction z or?oses & pro/heses7 aft] ! t]m or?otics & pro/hetics4 7d7 ,limitation ( competitive acquisition = (f-!-,%elf or?otics ,section #ahdg7;a77#g77;,a77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g77;,a77i77 is am5d$-- 7#a7 by ins]t+ 1 or?oti/ or pro/heti/ 7z def9$ 9 section #ahcd7v77#e77;,c771 aft] by a physician2 7#b7 by ins]t+ 1 or?oti/'s or pro/heti/'s1 aft] to ! physician's2 & 7#c7 by ins]t+ 1 or?oti/'s or pro/heti/'s1 aft] ( ! physician's4 7e7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date ( enactm5t ( ?is ,act1 & apply to items & s]vices furni%$ on or aft] su* date4 #g4 ,cl>ification ab\t m9imal self-adju/m5t = (f-!-%elf or?otics 7a7 ,9 g5]al ,section #ahdg7;a77#b77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77;,c77 is am5d$-- 7#a7 by ins]t+ furni%$ to a pati5t aft] section #ahfa7s77#i72 7#b7 by ins]t+ by t pati5t 7& n by any o!r p]son7 aft] m9imal self-adju/m5t2 & 7#c7 by /rik+ to fit to ! individual & ins]t+ to fit to t pati5t4 7b7 ,inclusion 9 m$ical & o!r heal? s]vices ,section #ahfa7s77#i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#i77 is am5d$-- 7#a7 by /rik+ leg1 arm & ins]t+ 7,a7 leg1 arm2 7#b7 9 subp>agraph 7,a71 z add$ by p>agraph 7#a71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 & 7#c7 by add+ ! foll[+ new subp>agraph3 7,b7 (f-!-%elf or?otics 7z def9$ 9 section #ahdg7;a77#b77;,c774 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ,april #a1 #bjjg1 & apply to items & s]vices furni%$ on or aft] su* date4 #h4 ,regulations ,! ,secret>y %all promulgate-- 7#a7 n lat] ?an #a ye> aft] ! enactm5t ( ?is ,act1 f9al regulations to implem5t ! provisions (1 & am5dm5ts made by1 ?is ,act2 & 7#b7 n lat] ?an #abj days aft] ! enactm5t ( ?is ,act1 f9al regulations to implem5t ! provisions (1 & am5dm5ts made by1 section #dbg ( ! ,m$ic>e1 ,m$icaid1 & ,,s*ip ,b5efits ,improvem5t & ,protections ,act ( #bjjj1 z enact$ into law by section #a7;a77#f7 ( ,public ,law #ajf-eed4