Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 2687 Date: April 19, 2013

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1 nul ysem ub edice lims ocessing Depmen of elh & umn evices (D) enes fo edice & edicid evices () Tnsmil 2687 De: pil 19, 2013 hnge eques 8194 UBJT: lify he definiion of cusomized duble medicl equipmen (D) iems. UY O NG: The pupose of his chnge eques () is o clify he definiion of cusomized D iems se foh 42 ecion TV DT: Jnuy 1, 1992 LNTTON DT: July 19, 2013 Disclime fo mnul chnges only: The evision de nd nsmil numbe pply only o ed ilicized meil. ny ohe meil ws peviously published nd emins unchnged. oweve, if his evision conins ble of conens, you will eceive he new/evised infomion only, nd no he enie ble of conens.. NG N NUL NTUTON: (N/ if mnul is no upded) =VD, N=NW, D=DLTD-Only One e ow. /N/D T / TON / UBTON / TTL 20/30.3/ein usomized ems. UNDNG: o iscl nemediies (s), egionl ome elh nemediies (s) nd/o ies: No ddiionl funding will be povided by ; onco s civiies e o be cied ou wihin hei opeing budges. o edice dminisive oncos (s): The edice dminisive onco is heeby dvised h his consiues echnicl diecion s defined in you conc. does no consue his s chnge o he semen of Wok. The conco is no obliged o incu coss in excess of he mouns lloed in you conc unless nd unil specificlly uhoized by he oncing Office. f he conco consides nyhing povided, s descibed bove, o be ouside he cuen scope of wok, he conco shll wihhold pefomnce on he p(s) in quesion nd immediely noify he oncing Office, in wiing o by e-mil, nd eques foml diecions egding coninued pefomnce equiemens. V. TTNT: Business equiemens nul nsucion *Unless ohewise specified, he effecive de is he de of sevice.

2 chmen - Business equiemens ub Tnsmil: 2687 De: pil 19, 2013 hnge eques: 8194 UBJT: lify he definiion of cusomized duble medicl equipmen (D) iems TV DT: Jnuy 1, 1992 LNTTON DT: July 19, GNL NOTON. Bckgound: The definiion of cusomized D se foh in egulions 42 ecion is bsed on he longsnding definiion of cusomized D used in mking decisions egding when o mke individul pymen deeminions ouside he noml pocess fo clculing cusomy nd peviling chges unde he esonble chge pymen mehodology used fo D pio o ublic Lw , Omnibus Budge econciliion c (OB), Novembe 5, 1990 ( ) mended he ciei fo emen of wheelchi s cusomized iem secion 1834 () (4) of he ocil ecuiy c by dding cluse h in cse of wheelchi funished on o fe Jnuy 1, 1992, he wheelchi shll be eed s cusomized iem if he wheelchi hs been mesued, fied, o dped in consideion of he pien s body size, disbiliy peiod of need, o inended use, nd hs been ssembled by supplie o odeed fom mnufcue who mkes vilble cusomized feues, modificion o componens fo wheelchis h e inended fo n individul pien s use in ccodnce wih insucions fom he pien s physicin. The mendmen fuhe noed h his cluse pplied only o iems funished on o fe Jnuy 1, 1992, unless he ecey developed specific ciei befoe h de fo he emen of wheelchis s cusomized iems fo puposes of secion 1834() (4) of he ocil ecuiy c (in which cse he mendmen mde by such cluse would no become effecive. issued n ineim finl ule on Decembe 20, 1991 ( ) o nnounce he decision no o use he opionl definiion of cusomized wheelchis in secion 1834 () (4) of he c nd dd new secion o 42 o povide in egulion ciei h mus be me fo coveed iem o be consideed cusomized iem fo pymen puposes. The finl ule ( ) ws published on June 30, NOT: oncos mus obseve h he lenive definiion of cusomized wheelchis found in secion 1834()(4) of he c ws neve doped fo edice pymen puposes nd should no be confused wih he definiion of cusomized iems B. olicy: n ccodnce wih 42 ecion , in ode o be consideed cusomized iem, coveed iem (including wheelchi) mus be uniquely consuced o subsnilly modified fo specific beneficiy ccoding o he descipion nd odes of physicin nd be so diffeen fom nohe iem used fo he sme pupose h he wo iems cnno be gouped ogehe fo picing puposes. ecion (b) povides h pymen is mde fo he lump sum puchse of he iem bsed on he conco s individul consideion nd judgmen of esonble pymen moun fo ech cusomized iem. The conco s individul consideion kes ino ccoun wien documenion on he coss of he iem including les he cos of he lbo nd meils used in cusomizing n iem. oncos shll submi quely epos o on he iems hey hve deemined mee he definiion of cusomized iems nd how hey eched he conclusion fo ech iem. oncos shll include in hese epos he esonble pymen moun deeminions nd fcos hey consideed in deemining he esonble pymen moun fo ech iem.

3 . BUN QUNT TBL Numbe equiemen esponsibiliy /B D hed- ysem inines V W Ohe oncos shll pocess clims fo cusomized D iems in ccodnce wih he new infomion povided in he nul (ecion 30.3 of hpe 20 of he edice lims ocessing nul ) nd pe he eguloy definiion fo cusomized D ems se foh ecion B oncos shll submi quely epos o on he iems hey hve deemined mee he definiion of cusomized iems nd how hey eched he conclusion fo ech iem. oncos shll include in hese epos he esonble pymen moun deeminions nd fcos hey consideed in deemining he esonble pymen moun fo ech iem oncos shll submi quely epos by he ls clend dy of he fis monh of ech que beginning Ocobe oncos shll submi quely epos h do no conin nd e encyped o psswod poeced vi secue emil o sndhy.gilkeson@cms.hhs.gov nd ken.jcobs@cms.hhs.gov

4 . OVD DUTON TBL Numbe equiemen esponsibiliy /B D Ohe LN icle : povide educion icle eled o his insucion will be vilble hp:// sholy fe he is elesed. You will eceive noificion of he icle elese vi he esblished "LN es" lissev. oncos shll pos his icle, o diec link o his icle, on hei Web sies nd include infomion bou i in lissev messge wihin one week of he vilbiliy of he povide educion icle. n ddiion, he povide educion icle shll be included in he conco s nex egully scheduled bullein. oncos e fee o supplemen LN es icles wih loclized infomion h would benefi hei povide communiy in billing nd dminiseing he edice pogm coecly. B V. UOTNG NOTON ecion : ecommendions nd suppoing infomion ssocied wih lised equiemens: N/ -ef equiemen Numbe ecommendions o ohe suppoing infomion: ecion B: ll ohe ecommendions nd suppoing infomion: N/ V. ONTT e-mplemenion onc(s): ndhy Gilkeson, sndhy.gilkeson@cms.hhs.gov, Ken Jcobs, ken.jcobs@cms.hhs.gov os-mplemenion onc(s): onc you oncing Office's epesenive (O) o onco nge, s pplicble. V. UNDNG ecion : o iscl nemediies (s), egionl ome elh nemediies (s), nd/o ies:

5 No ddiionl funding will be povided by ; onco s civiies e o be cied ou wihn hei opeing budges. ecion B: o edice dminisive oncos (s): The edice dminisive onco is heeby dvised h his consiues echnicl diecion s defined in you conc. do no consue his s chnge o he emen of Wok. The conco is no obliged o incu coss in excess of he mouns lloed in you conc unless nd unil specificlly uhoized by he oncing Office. f he conco consides nyhing povided, s descibed bove, o be ouside he cuen scope of wok, he conco shll wihhold pefomnce on he p(s) in quesion nd immediely noify he oncing Office, in wiing o by e-mil, nd eques foml diecions egding coninued pefomnce equiemens.

6 edice lims ocessing nul hpe 20 - Duble edicl quipmen, osheics, Ohoics, nd upplies (DO) ein usomized ems (ev.2687, ssued: , ffecive: , mplemenion: ) usomized iems e ely necessy nd e ely funished. n ccodnce wih 42 ecion , in ode o be consideed cusomized iem, coveed iem (including wheelchi) mus be uniquely consuced o subsnilly modified fo specific beneficiy ccoding o he descipion nd odes of physicin nd be so diffeen fom nohe iem used fo he sme pupose h he wo iems cnno be gouped ogehe fo picing puposes. o exmple, wheelchi h is cusom fbiced o subsnilly modified so h i cn mee he needs of wheelchi-confined, conjoined wins fcing ech ohe is unique nd cnno be gouped wih ny ohe wheelchi used fo he sme pupose. is one-of-kind iem fbiced o mee specific needs. ems h e mesued, ssembled, fied, o dped in consideion of pien s body size, weigh, disbiliy, peiod of need, o inended use (i.e., cusom fied iems) o hve been ssembled by supplie o odeed fom mnufcue who mkes vilble cusomized feues, modificion o componens fo wheelchis h e inended fo n individul pien s use in ccodnce wih insucions fom he pien s physicin do no mee he definiion of cusomized iems. These iems e no uniquely consuced o subsnilly modified nd cn be gouped wih ohe iems fo picing puposes. The use of cusomized opions o ccessoies o cusom fiing of cein ps does no esul in wheelchi o ohe equipmen being consideed s cusomized. The iem mus be uniquely consuced using w meils o hee mus be necessy, subsnil modificion o he bse equipmen (e.g., wheelchi fme) fo he iem o be consideed cusomized iem. ecion (b) povides h pymen is mde fo he lump sum puchse of he iem bsed on he conco s individul consideion nd judgmen of esonble pymen moun fo ech cusomized iem. The conco s individul consideion kes ino ccoun wien documenion on he coss (including design, fbicion, nd ssembly coss) of he iem including les he cos of lbo, o he exen h hey e esonble, of hose cully pefoming he cusomizion. The conco s individul consideion lso kes ino ccoun he cos of he ypes of meils, o he exen h hey e esonble, used in cusom fbicing o subsnilly modifying n iem. The conco my need o equie deiled descipion of ech phse of he consucion pocess nd lbo skills needed o fbice o modify he iem in ode o deemine esonble moun. oncos shll submi quely epos o on he iems hey hve deemined mee he definiion of cusomized iems nd how hey eched he conclusion fo ech iem. oncos shll include in hese epos he esonble pymen moun deeminions nd fcos hey consideed in deemining he esonble pymen moun fo ech iem. The definiion of cusomized D se foh in egulions 42 ecion is bsed on he longsnding definiion of cusomized D used in mking decisions egding when o mke individul pymen deeminions ouside he noml pocess fo clculing cusomy nd peviling chges unde he esonble chge pymen mehodology used fo D pio o ublic Lw , Omnibus Budge econciliion c (OB), Novembe 5, 1990 ( ) mended he ciei fo emen of wheelchi s cusomized iem secion 1834 () (4) of he ocil ecuiy c by dding cluse h in cse of wheelchi funished on o fe Jnuy 1, 1992, he wheelchi shll be eed s cusomized iem if he wheelchi hs been mesued, fied, o dped in consideion of he pien s body size, disbiliy peiod of need, o inended use, nd hs been ssembled by supplie o odeed fom mnufcue who mkes vilble cusomized feues, modificion o componens fo wheelchis h e inended fo n individul pien s use in ccodnce wih insucions fom he pien s physicin. The mendmen fuhe noed h his cluse pplied only o iems funished on o fe Jnuy 1, 1992,

7 unless he ecey developed specific ciei befoe h de fo he emen of wheelchis s cusomized iems fo puposes of secion 1834() (4) of he ocil ecuiy c (in which cse he mendmen mde by such cluse would no become effecive. issued n ineim finl ule on Decembe 20, 1991 ( ) o nnounce he decision no o use he opionl definiion of cusomized wheelchis in secion 1834 () (4) of he c nd dd new secion o 42 o povide in egulion ciei h mus be me fo coveed iem o be consideed cusomized iem fo pymen puposes. The finl ule ( ) ws published on June 30, NOT: oncos mus obseve h he lenive definiion of cusomized wheelchis found in secion 1834()(4) of he c ws neve doped fo edice pymen puposes nd should no be confused wih he definiion of cusomized iems

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