#aae? ,,congress #b;d ,session ,h4 ,r4 #cfce ,,an ,,act ,to am5d title ,,xviii ( ! ,social ,security ,act 9 ord] to improve ! process :]eby m$ic>e adm9i/rative contractors issue local cov]age det]m9ations "u ! ,m$ic>e program1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,local ,cov]age ,det]m9ation ,cl>ification ,act ( #bjah4 #b4 ,improvem5ts 9 ! ,m$ic>e local cov]age det]m9ation 7,,lcd7 process = specifi$ ,l,c,ds 7a7 ,developm5t process = specifi$ ,l,c,ds ,section #ahfb7l77#e77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77;,d77 is am5d$ to read z foll[s3 7,d7 ,process = issu+ specifi$ local cov]age det]m9ations 7i7 ,9 g5]al ,9 ! case ( a specifi$ local cov]age det]m9ation 7z def9$ 9 clause 7iii77 )9 an area by a m$ic>e adm9i/rative contractor1 su* m$ic>e adm9i/rative contractor mu/ take ! foll[+ actions ) respect to su* det]m9ation be=e su* det]m9ation may take effect3 7,i7 ,publi% on ! public ,int]net website ( ! int]m$i>y or c>ri] a propos$ v]sion ( ! specifi$ local cov]age det]m9ation 79 ?is subp>agraph ref]r$ to z a draft det]m9ation71 a writt5 rationale = ! draft det]m9ation1 & a description ( all evid5ce reli$ ^u & consid]$ by ! int]m$i>y or c>ri] 9 ! developm5t ( ! draft det]m9ation4 7,,ii7 ,n lat] ?an #fj days aft] ! date on :i* ! int]m$i>y or c>ri] publi%es ! draft det]m9ation 9 accordance ) subclause 7,i71 conv5e "o or m op51 public meet+s to review ! draft det]m9ation1 receive comm5ts ) respect to ! draft det]m9ation1 & secure ! advice ( an exp]t panel 7su* z a c>ri] advisory committee describ$ 9 *apt] #ac ( ! ,m$ic>e ,program ,integrity ,manual 9 effect on ,augu/ #ca1 #bjae7 ) respect to ! draft det]m9ation4 ,! int]m$i>y or c>ri] %all make available means = ! public to att5d su* meet+s remotely1 su* z via teleconf]5ce4 7,,iii7 ,) respect to ea* meet+ conv5$ pursuant to subclause 7,,ii71 po/ on ! public ,int]net website ( ! int]m$i>y or c>ri]1 n lat] ?an #ad days aft] su* meet+ is conv5$1 a record ( ! m9utes = su* meet+1 :i* may be a record+ ( ! meet+4 7,,iv7 ,provide a p]iod = submission ( writt5 public comm5t on su* draft det]m9ation t beg9s on ! date on :i* all records requir$ to be po/$ ) respect to su* draft det]m9ation "u subclause 7,,iii7 are s po/$ & t is n few] ?an #cj days 9 duration4 7ii7 ,f9aliz+ a specifi$ local cov]age det]m9ation ,a fiscal int]m$i>y or c>ri] t has ent]$ into a contract ) ! ,secret>y "u section #ahgd;,a %all1 ) respect to a specifi$ local cov]age det]m9ation1 po/ on ! public ,int]net website ( ! fiscal int]m$i>y or c>ri] ! foll[+ in=mation be=e ! specifi$ local cov]age det]m9ation 79 ?is subp>agraph ref]r$ to z ! f9al det]m9ation7 takes effect-- 7,i7 a response to ! relevant issues rais$ at meet+s conv5$ pursuant to clause 7i77,,ii7 ) respect to ! draft det]m9ation2 7,,ii7 ! rationale = ! f9al det]m9ation2 7,,iii7 9 ! case t ! int]m$i>y or c>ri] consid]$ qualify+ evid5ce 7z def9$ 9 clause 7v77 t 0 n describ$ 9 ! writt5 notice provid$ pursuant to clause 7i77,i71 a description ( su* qualify+ evid5ce2 & 7,,iv7 an effective date = ! f9al det]m9ation t is n less ?an #cj days aft] ! date on :i* su* det]m9ation is s po/$4 7iii7 ,specifi$ local cov]age det]m9ation def9$ ,= purposes ( ?is subp>agraph1 ! t]m specifi$ local cov]age det]m9ation means1 ) respect to ! relevant geographic area-- 7,i7 a new local cov]age det]m9ation2 7,,ii7 a revis$ local cov]age det]m9ation = su* geographic area t re/ricts "o or m exi/+ t]ms ( cov]age = su* area 7su* z by add+ requirem5t to an exi/+ local cov]age det]m9ation t results 9 decreas$ cov]age or by delet+ previ\sly cov]$ ,,icd-#i or ,,icd-#aj codes 7= reasons o!r ?an r\t9e cod+ *anges772 7,,iii7 a revis$ local cov]age det]m9ation t makes a sub/antive revision to "o or m exi/+ local cov]age det]m9ations2 or 7,,iv7 any o!r local cov]age det]m9ation specifi$ by ! ,secret>y pursuant to regulations4 7iv7 ,qualify+ evid5ce def9$ ,= purposes ( ?is subp>agraph1 ! t]m qualify+ evid5ce means publicly available evid5ce ( g5]al acceptance by ! m$ical community1 su* z publi%$ orig9al rese>* 9 pe]-review$ m$ical j\rnals1 sy/ematic reviews & meta-analyses1 evid5ce-bas$ cons5sus /atem5ts1 & cl9ical guidel9es4 4 7b7 ,,lcd reconsid]ation process ,section #ahfi7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;ff7f77 is am5d$-- 7#a7 9 p>agraph 7#b77;,a71 by ins]t+ 7includ+ ! reconsid]ations describ$ 9 p>agraphs 7#h7 & 7#i77 aft] local cov]age det]m9ation2 7#b7 9 p>agraph 7#e71 by ins]t+ 7except = a reconsid]ation describ$ 9 p>agraphs 7#h7 & 7#i77 aft] ! cov]age det]m9ation2 7#c7 by r$esignat+ p>agraph 7#h7 z p>agraph 7#ac72 & 7#d7 by ins]t+ aft] p>agraph 7#g7 ! foll[+ new p>agraphs3 7#h7 ,c>ri] or fiscal int]m$i>y reconsid]ation process = specifi$ local cov]age det]m9ations ,^u ! fil+ ( a reque/ by an int]e/$ p>ty 7z def9$ 9 p>agraph 7#aa77;,b77) respect to a specifi$ local cov]age det]m9ation by a fiscal int]m$i>y or c>ri] t has ent]$ into a contract ) ! ,secret>y "u section #ahgd;,a1 ! int]m$i>y or c>ri] %all reconsid] su* det]m9ation 9 accordance ) ! foll[+ process3 7,a7 ,n lat] ?an #cj days aft] su* a reque/ is fil$ ) ! fiscal int]m$i>y or c>ri] by ! int]e/$ p>ty ) respect to su* det]m9ation1 ! int]m$i>y or c>ri] %all-- 7i7 det]m9e :e!r ! reque/ is an applicable reque/2 & 7ii7 9 ! case t ! reque/ is n an applicable reque/1 in=m ! int]e/$ p>ty ( ! reasons :y su* reque/ is n an applicable reque/4 7,b7 ,9 ! case t ! int]m$i>y or c>ri] det]m9es "u subp>agraph 7,a7 t ! reque/ describ$ 9 su* subp>agraph is an applicable reque/1 ! int]m$i>y or c>ri] %all1 n lat] ?an #ij days aft] ! date on :i* ! reque/ 0 fil$ ) ! int]m$i>y or c>ri]1 take ! actions describ$ 9 subp>agraphs 7,c71 7,d71 & 7,e7 ) respect to ! det]m9ation4 7,c7 ,! action describ$ 9 ?is subp>agraph is ! action ( specify+ :e!r any ( ! foll[+ /atem5ts is applicable to ! det]m9ation3 7i7 ,! det]m9ation did n reasonably consid] qualify+ evid5ce relevant to su* det]m9ation4 7ii7 ,! det]m9ation us$ language t exce$$ ! scope ( ! int5d$ purpose ( ! det]m9ation4 7iii7 ,! det]m9ation 0 incorrect 9 its det]m9ation ( :e!r su* item or s]vice is reasonable & necess>y = ! diagnosis or treatm5t ( illness or injury "u section #ahfb7;a77#a77;,a74 7iv7 ,! det]m9ation fail$ to describe1 ) respect to su* an item or s]vice1 ! cl9ical conditions to be us$ = purposes ( det]m9+ :e!r su* item or s]vice is reasonable & necess>y = ! diagnosis or treatm5t ( illness or injury "u section #ahfb7;a77#a77;,a74 7v7 ,! det]m9ation does n apply ) respect to items or s]vices to :i* x 0 int5d$ to apply4 7vi7 ,! det]m9ation is errone\s = ano!r reason t ! int]m$i>y or c>ri] id5tifies4 7,d7 ,! action describ$ 9 ?is subp>agraph1 ) respect to ! det]m9ation1 is ! action ( tak+1 bas$ on ! specification "u subp>agraph 7,c7 ( :e!r any ( ! /atem5ts 9 su* subp>agraph appli$ to su* det]m9ation1 "o or m ( ! foll[+ actions3 7i7 ,mak+ no *ange 9 ! det]m9ation4 7ii7 ,resc9d+ all or a "p ( ! det]m9ation4 7iii7 ,modify+ ! det]m9ation to re/rict ! cov]age provid$ "u ?is title = an item or s]vice t is subject to ! det]m9ation4 7iv7 ,modify+ ! det]m9ation to exp& ! cov]age provid$ "u ?is title = an item or s]vice t is subject to ! det]m9ation4 7,e7 ,! action describ$ 9 ?is subp>agraph is ! action ( mak+ publicly available a writt5 description ( ! action tak5 "u subp>agraph 7,d7 ) respect to ! det]m9ation1 includ+ ! evid5ce consid]$ by ! m$ic>e adm9i/rative contractor4 7#i7 ,ag5cy review ( reconsid]ation decision ,! ,secret>y %all e/abli% a process to review a m$ic>e adm9i/rative contractor's te*nical compliance ) ! requirem5ts1 includ+ ensur+ t ! m$ic>e adm9i/rative contractor indep5d5tly review$ ! evid5ce involv$1 ( ! reconsid]ation "u p>agraph 7#h74 7#aj7 ,rule ( con/ruction ,no?+ 9 p>agraph 7#h7 may be con/ru$ z affect+ ! "r ( an aggriev$ p>ty to file a compla9t "u p>agraph 7#b77;,a7 & receive a det]m9ation 9 accordance ) ! provisions ( su* p>agraph4 ,an aggriev$ p>ty is n requir$ to file a reque/ "u p>agraph 7#h7 or 7#i7 prior to fil+ a compla9t "u p>agraph 7#b74 7#aa7 ,def9itions applicable to p>agraphs 7#h7 & 7#i7 ,= purposes ( p>agraphs 7#h7 & 7#i73 7,a7 ,! t]m applicable reque/ means a reque/ t is submitt$ 9 fiscal ye> #bjai or a subsequ5t fiscal ye>1 t is solely ) respect to a specifi$ local cov]age det]m9ation1 & t includes a description ( ! rationale = su* reque/ & any in=mation or evid5ce support+ su* reque/4 ,= purposes ( ! prec$+ s5t5ce1 ! ,secret>y may n require1 z a condition ( treat+ a reque/ ) respect to su* a det]m9ation z an applicable reque/1 t ! reque/ conta9 qualify+ evid5ce t 0 n consid]$ 9 ! developm5t ( su* det]m9ation4 7,b7 ,! t]m int]e/$ p>ty means1 ) respect to a specifi$ local cov]age det]m9ation )9 an area by a fiscal int]m$i>y or c>ri] t has ent]$ into a contract ) ! ,secret>y "u section #ahgd;,a1 a b5efici>y or /akehold] 7includ+ a m$ical pr(essional society or physician74 7,c7 ,! t]m qualify+ evid5ce has ! mean+ giv5 su* t]m by clause 7iv7 ( section #ahfb7l77#e77;,d74 7,d7 ,! t]m specifi$ local cov]age det]m9ation has ! mean+ giv5 su* t]m by clause 7iii7 ( su* section4 7#ab7 ,report ,n lat] ?an ,decemb] #ca ( ea* ye> 7beg9n+ ) #bjai71 ! ,secret>y %all submit to ,congress a report conta9+ ! foll[+3 7,a7 ,! numb] ( reque/s fil$ ) fiscal int]m$i>ies & c>ri]s "u p>agraph 7#h71 & ! numb] ( appeals fil$ ) ! ,secret>y "u p>agraph 7#i71 dur+ ! #a-ye> p]iod end+ on su* date4 7,b7 ,) respect to su* reque/s fil$ ) su* int]m$i>ies & c>ri]s "u p>agraph 7#h7 dur+ su* p]iod1 ! numb] ( times t int]m$i>ies & c>ri]s took1 ) respect to ! actions describ$ 9 subp>agraphs 7,c7 ?r\gh 7,e7 ( su* p>agraph1 ea* su* action4 7,c7 ,) respect to su* appeals fil$ ) ! ,secret>y "u p>agraph 7#i7 dur+ su* p]iod1 ! numb] ( times t ! ,secret>y took1 ) respect to ! actions describ$ 9 subp>agraph 7,d7 ( p>agraph 7#h71 ea* su* action4 7,d7 ,recomm5dations on ways to improve-- 7i7 ! efficacy & ! effici5cy ( ! process describ$ 9 p>agraph 7#h72 & 7ii7 communication ) individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b1 provid]s ( s]vices1 & suppli]s reg>d+ su* process4 4 #c4 ,promulgation ( regulations2 application date ,! ,secret>y ( ,heal? & ,human ,s]vices %all promulgate regulations to c>ry out p>agraph 7#e77;,d7 ( section #ahfb7l7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l771 z am5d$ by subsection 7a71 & p>agraphs 7#h7 & 7#i7 ( section #ahfi7;f7 ( su* ,act 7#db ,u4,s4,c4 #acie;ff7f771 z ins]t$ by subsection 7b71 9 su* a mann] z to ensure t ! processes describ$ 9 su* p>agraphs are fully implem5t$ by ,janu>y #a1 #bjbj4 ,pass$ ! ,h\se ( ,repres5tatives ,septemb] #ab1 #bjah4;,cl]k4