,i #aac? ,,congress #a/ ,session ,h4 ,r4 #caab ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #ag1 #bjac,mr4 ,?ompson ( ,p5nsylvania 7= himself & ,mr4 ,?ompson ( ,cali=nia7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,xviii ( ! ,social ,security ,act to modify ! designation ( accr$itation organizations = or?otics & pro/hetics1 to apply accr$itation & lic5sure requirem5ts to suppli]s ( su* devices & items = purposes ( paym5t "u ! ,m$ic>e program1 & to modify ! paym5t rules = su* devices & items "u su* program to acc\nt = practition] qualifications & complexity ( c>e1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ic>e ,or?otics & ,pro/hetics ,improvem5t ,act ( #bjac4 #b4 ,modification ( requirem5ts applicable "u m$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 organizations4-- 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 an indep5d5t accr$itation organization "u clause 7i7 only if su* organization is a ,bo>d or program describ$ 9 subsection 7h77#a77;,f77iv74 ,n lat] ?an ,janu>y #a1 #bjad1 ! ,secret>y %all ensure t at lea/ "o indep5d5t accr$itation organization is designat$ & 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 ,an organization mu/ satisfy ! requirem5t ( section #ahcd7;a77#bj77;,b77ii71 z add$ by subsection 7a77#b71 n lat] ?an ,janu>y #a1 #bjad1 reg>dless ( :e!r su* 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$2 7#b7 9 clause 7i71 by /rik+ an item ( cu/om-fabricat$ 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 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 #bjad1 t is includ$ 9 a competitive acquisition program 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 #bjad4 #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 a category ( or?otics & pro/hetics c>e describ$ 9 clause 7i71 7ii71 7iii71 7iv71 or 7v7 ( p>agraph 7#e77;,c7 furni%$ on or aft] ,janu>y #a1 #bjad1 & subject to p>agraph 7#e77;,a71 satisfies all applicable crit]ia ( ! suppli] qualification designation = su* category describ$ 9 ! respective clause1 & :o2 7#b7 9 p>agraph 7#a77;,f77iv71 by ins]t+ be=e ! p]iod ! foll[+3 &1 ) respect to a category ( or?otics & pro/hetics c>e describ$ 9 clause 7i71 7ii71 7iii71 7iv71 or 7v7 ( p>agraph 7#e77;,c7 furni%$ on or aft] ,janu>y #a1 #bjad1 & subject to p>agraph 7#e77;,a71 satisfies all applicable crit]ia ( ! provid] qualification designation = su* category describ$ 9 ! respective clause2 & 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 #bjad1 ! ,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 ,individual & entities exempt$ f suppli] qualification designation crit]ia ,) respect to an item ( or?otics or pro/hetics describ$ 9 clause 7ii71 7iii71 7iv7 or 7v7 ( subp>agraph 7,c71 any crit]ia = ! suppli] qualification designations "u su* respective clause1 includ+ application ( subp>agraph 7,d71 %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$ic>e-eligible prior to ,janu>y #a1 #bjad1 exempt$ ,9 ! case ( a qualifi$ suppli] :o is eligible to receive paym5t "u ?is title be=e ,janu>y #a1 #bjad-- 7,i7 ) respect to an item ( or?otics or pro/hetics describ$ 9 clause 7i7 ( subp>agraph 7,c71 any crit]ia = ! provid] qualification designations "u su* clause1 includ+ application ( subp>agraph 7,d71 %all n apply to su* suppli]1 respectively1 = ! furni%+ or fabrication ( su* an item s describ$2 & 7,,ii7 ) respect to an item ( or?otics or pro/hetics describ$ 9 clause 7ii71 7iii71 or 7iv7 ( subp>agraph 7,c71 any crit]ia = ! suppli] qualification designations "u ! respective clause 7or a subsequ5t clause ( su* subp>agraph71 includ+ application ( subp>agraph 7,d71 %all n apply to su* suppli]1 respectively1 = ! furni%+ or fabrication ( su* an item describ$ 9 su* respective 7or su* subsequ5t7 clause4 7iv7 ,delay$ application ( c]ta9 suppli] qualification designation crit]ia ,! suppli] qualification designations "u clauses 7i71 7ii71 & 7iii7 ( subp>agraph 7,c71 includ+ ! application ( subp>agraph 7,d7 to su* clauses1 %all n be tak5 into acc\nt ) respect to paym5t made "u ?is subsection = or?otics & pro/hetics furni%$ be=e ,janu>y #a1 #bjae4 7v7 ,modifications ,! ,secret>y %all1 9 consultation ) ! ,bo>ds & programs describ$ 9 p>agraph 7#a77;,f77iv71 p]iodically review ! crit]ia = ! suppli] qualification designation "u subp>agraph 7,c77i77,,iii7 & may implem5t by regulation any modifications to su* crit]ia1 z det]m9$ appropriate 9 accordance ) su* consultation4 ,any su* modification %all take effect no e>li] ?an ,janu>y #a1 #bjaf4 7,b7 ,assignm5t ( bill+ codes ,= purposes ( subp>agraph 7,a71 ! ,secret>y1 9 consultation ) repres5tatives ( ! fields ( occupational !rapy1 physical !rapy1 or?otics1 & pro/hetics %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>e describ$ 9 ea* ( clauses 7i7 ?r\gh 7v7 ( subp>agraph 7,c7 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 ! previ\s s5t5ce %all be appli$ ) respect to ! mo/ rec5t update1 reissuance1 or replacem5t ( su* docum5t4 7,c7 ,categories ( or?otic & pro/hetic c>e describ$ 7i7 ,cu/om-fabricat$ limb pro/hetics category ,! category ( or?otic & pro/hetic c>e describ$ 9 ?is clause is a category = artificial legs & arms1 includ+ replacem5ts 7z describ$ 9 section #ahfa7s77#i77 t are made f detail$ measurem5ts1 images1 or models 9 accordance ) a prescription & t c only be utiliz$ by a specific int5d$ pati5t & = :i* paym5t is made "u ?is "p4 ,! suppli] qualification designation = ! category %all reflect ea* ( ! foll[+1 9 accordance ) subp>agraph 7,d73 7,i7 ,! category ( c>e involves ! highe/ level ( complexity ) sub/antial cl9ical risk4 7,,ii7 ,! category ( c>e requires a suppli] :o satisfies any ( ! education requirem5ts describ$ 9 subclause 7,,iii71 has complet$ a pro/hetic resid5cy accr$it$ by ! ,national ,commission on ,or?otic & ,pro/hetic ,education 7,,ncope71 & is c]tifi$ or lic5s$ 9 pro/hetics to ensure ! compreh5sive provision ( pro/hetic c>e4 7,,iii7 ,! category ( c>e requires a suppli] :o has complet$ any ( ! foll[+ education requirem5ts3 7aa7 ,a ba*elor's degree or ma/]'s degree 9 pro/hetics z (f]$ by educational in/itutions accr$it$ by ! ,commission on ,accr$itation ( ,alli$ ,heal? ,education ,programs4 7bb7 ,a ba*elor's degree1 plus a c]tificate 9 pro/hetics z (f]$ by educational in/itutions accr$it$ by ! ,commission on ,accr$itation ( ,alli$ ,heal? ,education ,programs4 7cc7 ,a =eign degree det]m9$ by ! ,_w ,education ,s]vice to be equival5t to an educational program 9 pro/hetics accr$it$ by ! ,commission on ,accr$itation ( ,alli$ ,heal? ,education ,programs4 7ii7 ,cu/om-fabricat$ or?otics categry ,! category ( or?otics & pro/hetics c>e describ$ 9 ?is clause is a category = cu/om-fabricat$ or?otics t are made f detail$ measurem5ts1 images1 or models 9 accordance ) a prescription & t c only be utiliz$ by a specific int5d$ pati5t4 ,! suppli] qualification designation = ! category %all reflect ! foll[+1 9 accordance ) subp>agraph 7,d73 7,i7 ,! category ( c>e involves ! highe/ level ( complexity ) sub/antial cl9ical risk4 7,,ii7 ,! category ( c>e requires a suppli] :o satisfies any ( ! education requirem5ts describ$ 9 clause 7i77,,iii7 7except t = purposes ( ?is subclause su* clause %all be appli$ by sub/itut+ ! t]m or?otics ea* place ! t]m pro/hetics is us$71 has complet$ an or?otic resid5cy accr$it$ by ! ,national ,commission on ,or?otic & ,pro/hetic ,education1 & is c]tifi$ or lic5s$ 9 or?otics to ensure ! appropriate provision ( or?otic c>e4 7iii7 ,cu/om-fitt$ high or?otics category ,! category ( or?otic c>e describ$ 9 ?is clause is a category = prefabricat$ or?otics t are manufactur$ ) no specific pati5t 9 m9d1 b t are appropriately siz$1 adapt$1 modifi$1 & configur$ 7) ! requir$ tools & equipm5t7 to a specific pati5t 9 accordance ) a prescription4 ,! suppli] qualification designation = ! category %all reflect ! foll[+1 9 accordance ) subp>agraph 7,d73 7,i7 ,! category ( c>e involves mod]ate to high complexity ) sub/antial cl9ical risk4 7,,ii7 ,! category ( c>e requires a practition] :o ei!r-- 7aa7 satisfies any ( ! education requirem5ts describ$ 9 clause 7i77,,iii71 except t = purposes ( ?is subclause su* clause %all be appli$ by sub/itut+ ! t]m or?otics ea* place ! t]m pro/hetics is us$2 or 7bb7 is c]tifi$ or lic5s$ 9 or?otics to ensure ! appropriate provision ( or?otic c>e )9 ! practition]'s normal scope ( practice4 7iv7 ,cu/om-fitt$ l[ or?otics category ,! category ( or?otics & pro/hetics c>e describ$ 9 ?is clause is a category = prefabricat$ or?otics t are manufactur$ ) no specific pati5t 9 m9d1 b t are appropriately siz$ & adju/$ to a specific pati5t 9 accordance ) a prescription4 ,! suppli] qualification designation = ! category %all reflect ! foll[+3 7,i7 ,! category ( c>e involves a l[ level ( complexity & l[ cl9ical risk4 7,,ii7 ,! category ( c>e requires a suppli] t is c]tifi$ or lic5s$ )9 a limit$ scope ( practice to ensure appropriate provision ( or?otic c>e4 ,! suppli]'s education & tra9+ %all ensure t basic cl9ical k & te*nical exp]tise is available to confirm successful fit & device compliance ) ! prescription4 7v7 ,(f-!-%elf ,! category ( or?otic c>e describ$ 9 ?is clause is describ$ 9 section #ahdg7;a77#b77;,c74 ,! suppli] qualification designation = ! category %all reflect t no =mal cr$5tial+1 cl9ical education1 or te*nical tra9+ is requir$ to disp5se su* items4 7,d7 ,c>e bas$ on s\nd cl9ical judgm5t & te*nical exp]tise ,c>e describ$ 9 clauses 7i71 7ii71 & 7iii7 ( subp>agraph 7,c7 %all be bas$ on s\nd cl9ical judgm5t & te*nical exp]tise bas$ on ! suppli]'s education & cl9ical tra9+1 9 ord] to all[ ! practition] to det]m9e-- 7i7 ) respect to c>e describ$ 9 clause 7i7 or 7ii7 ( subp>agraph 7,c71 ! device p>amet]s & design1 fabrication process1 & functional purpose specific to ! ne$s ( ! pati5t to maximize optimal cl9ical outcomes2 & 7ii7 ) respect to c>e describ$ 9 clause 7iii7 ( su* subp>agraph1 ! appropriate device relative to ! diagnosis & specific to ! ne$s ( ! pati5t to maximize optimal cl9ical outcomes4 4 #e4 ,consultation ,9 implem5t+ ! provisions (1 & am5dm5ts made by1 ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all consult ) appropriate exp]ts 9 or?otics & pro/hetics1 includ+ suppli]s t furni% items )9 ! categories ( or?otic & pro/hetic c>e describ$ 9 p>agraph 7#e77;,c7 ( section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 z add$ by section #d4 #f4 ,reports 7a7 ,report on en=c+ new lic5s+ & accr$itation requirem5ts ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! /eps tak5 by ! ,dep>tm5t ( ,heal? & ,human ,s]vices to ensure t ! ,/ate lic5sure & accr$itation requirem5ts "u section #ahcd7;h77#a77;,f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,f771 z am5d$ by section #c1 are en=c$4 ,su* report %all include a det]m9ation ( ! ext5t to :i* paym5ts = or?otics & pro/hetics "u ! ,m$ic>e program "u title ,,xviii ( su* ,act are made only to ^? suppli]s t meet ! relevant accr$itation & lic5sure requirem5ts "u su* section & a det]m9ation ( :e!r additional /eps are ne$$4 7b7 ,report on fraud & abuse ,n lat] ?an #cj mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report on ! effect ( ! requirem5ts "u subsection 7a77#bj77;,b77ii7 ( section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 z add$ by section #b1 & subsection 7h77#a77;,f7 ( su* section1 z am5d$ by section #c1 on ! occurr5ce ( fraud & abuse "u ! ,m$ic>e program "u title ,,xviii ( su* ,act1 ) respect to or?otics & pro/hetics = :i* paym5t is made "u su* program4 #g4 ,r$uction 9 m$ic>e sp5d+ 7a7 ,projection ( cumulative effect on sp5d+ ,n lat] ?an ,decemb] #ca1 #bjad1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y71 act+ ?r\gh ! ,*ief ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 79 ?is section ref]r$ to z ! ,*ief ,actu>y71 %all submit to ,congress1 & h publi%$ 9 ! ,f$]al ,regi/]1 a projection ( ! effect on cumulative ,f$]al sp5d+ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act = ! p]iod ( ye>s #bjad ?r\gh #bjah z a result ( ! implem5tation ( ! provisions (1 & am5dm5ts made by1 ?is ,act4 7b7 ,/r5g!n+ /&>ds applicable if sav+s n a*iev$ 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 if ! ,*ief ,actu>y projects "u subsection 7a7 t ! implem5tation ( ! provisions (1 & am5dm5ts made by1 ?is ,act w n result 9 a cumulative r$uction 9 sp5d+ "u su* "p ( at lea/ #bej1jjj1jjj = ! p]iod ( ye>s #bjad ?r\gh #bjah 7us+ a #bjac basel9e71 ! ,secret>y %all1 9 accordance ) ! ,*ief ,actu>y's projection1 issue an int]im f9al regulation 7to take effect = #bjae & subsequ5t ye>s7 ) a p]iod = public comm5t on su* regulation aft] ! date ( publication to /r5g!n ! lic5sure1 accr$itation1 & quality /&>ds applicable to suppli]s ( or?otics & pro/hetics "u title ,,xviii ( ! ,social ,security ,act1 includ+ su* /&>ds describ$ 9 subsections 7a77#bj7 & 7h77#a77;,f7 ( section #ahcd ( su* ,act 7#db ,u4,s4,c4 #aciem71 z am5d$ by ?is ,act1 9 ord] to produce su* cumulative r$uction by ,decemb] #ca1 #bjah4 7#b7 ,exception ,! int]im f9al regulation issu$ "u p>agraph 7#a7 %all n apply to a qualifi$ physical !rapi/ or qualifi$ occupational !rapi/ 7z describ$ 9 section #ahcd7;h77#a77;,f77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,f77iii7774 #h4 ,no effect on paym5t basis = or?otics & pro/hetics or competitive bidd+ programs ,no?+ 9 ! provisions (1 or am5dm5ts made by1 ?is ,act %all h any effect on-- 7#a7 ! det]m9ation ( ! paym5t basis = or?otics & pro/hetics "u section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h772 or 7#b7 ! implem5tation ( competitive acquisition programs "u section #ahdg ( su* ,act 7#db ,u4,s4,c4 #aciew-#c71 includ+ su* implem5tation ) respect to (f-!-%elf or?otics describ$ 9 subsection 7a77#b77;,c7 ( t section1 t are includ$ 9 a competitive acquisition program 9 a competitive acquisition area "u t section4