,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #cecd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #bg1 #bjai ,mr4 ,ru% 7= himself1 ,mr4 ,david ,p4 ,roe ( ,t5nessee1 ,ms4 ,judy ,*u ( ,cali=nia1 & ,mr4 ,dunn7 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 ,,ix ( ! ,public ,heal? ,s]vice ,act to revise ! op]ations ( ! ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,usp/f ,transp>5cy & ,acc\ntability ,act ( #bjai4 #b4 ,*anges to ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce 7a7 ,9 g5]al ,subsection 7a7 ( section #iae ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bii;b-#d7 is am5d$-- 7#a7 by am5d+ ! head+ to read z foll[s3 ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce2 7#b7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,e/abli%m5t & purpose ,! ,director may e/abli% & p]iodically conv5e ! ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce 79 ?is section ref]r$ to z ! ,task ,=ce74 ,! ,task ,=ce %all review ! sci5tific evid5ce & new sci5ce relat$ to ! effectiv5ess & appropriat5ess ( cl9ical prev5tive s]vices = ! purpose ( develop+ recomm5dations = prim>y c>e cl9icians & ! heal? c>e community & updat+ previ\s cl9ical prev5tive recomm5dations4 2 7#c7 by /rik+ p>agraph 7#c72 7#d7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#g7 z p>agraphs 7#i7 ?r\gh 7#ab71 respectively2 7#e7 by ins]t+ aft] p>agraph 7#b7 ! foll[+ new p>agraphs3 7#c7 ,composition 7,a7 ,9 g5]al ,! ,task ,=ce %all be compos$ ( individuals t collectively h appropriate sci5tific exp]tise1 includ+ 9 fields ( heal? sci5ces rese>*1 heal? economics1 heal? promotion1 disease prev5tion1 & cl9ical c>e4 ,! ,task ,=ce %all include a balanc$ repres5tation ( practic+ prim>y & specialty c>e provid]s 7includ+ 9 ! fields ( heal? s]vices rese>*1 heal? economics1 & cl9ical c>e71 pati5ts1 & heal? c>e consum]s4 7,b7 ,notice ,be=e appo9t+ memb]s to ! ,task ,=ce1 ! ,director %all provide notice 9 ! ,f$]al ,regi/] to give p]sons an opportunity to nom9ate pot5tial memb]s4 7#d7 ,review & consultation 7,a7 ,rese>* plans 7i7 ,9 g5]al ,9 conduct+ its reviews "u p>agraph 7#a71 ! ,task ,=ce %all publi% "o or m propos$ rese>* plans 79 ?is subsection ref]r$ to z a rese>* plan7 to guide ! ,task ,=ce's sy/ematic review ( ! evid5ce ref]r$ to 9 su* p>agraph4 ,ea* su* plan %all include an analytic framework1 key que/ions1 & a lit]ature se>* /rategy or rese>* approa*1 & %all incorporate ! me?odological guidel9es develop$ "u clause 7iii74 7ii7 ,publication2 public comm5t p]iod ,! ,task ,=ce %all provide = ! publication 9 ! ,f$]al ,regi/] ( a reque/ = public comm5ts on ea* rese>* plan & %all accept comm5ts on su* plan dur+ a p]iod ( n less ?an #de days4 ,! ,director %all make publicly available comm5ts submitt$ 9 response to a reque/ = public comm5ts4 ,any f9al rese>* plan %all be made available to ! public & include a discussion ( ! comm5ts receiv$ ) respect to su* plan & responses to su* comm5ts4 ,! ,task ,=ce1 ) ! concurr5ce ( ! ,director1 may *ange su* a rese>* plan ?r\gh ! same process z appli$ to ! initial adoption ( su* plan4 7iii7 ,crit]ia ,! ,director %all design & regul>ly update guidel9es = prop] me?odological /&>ds = incorporation into su* rese>* plans4 ,su* guidel9es %all include measures = appropriate validity1 = risk adju/m5t1 = timel9ess1 = input f relevant exp]ts & pe]s 9 ! respective communities1 = acc\nt+ = all relevant subpopulations 7includ+ disp>ities by g5d]1 race1 e?nicity1 socioeconomic /atus1 & geographic location71 & = o!r heal? outcome measurem5ts4 ,su* guidel9es & me?odological /&>ds %all ensure ! consid]ation ( any evid5ce conc]n+ any relevant subpopulations 7includ+ disp>ities by g5d]1 race1 e?nicity1 g5etic pr$isposition1 socioeconomic /atus1 & geographic location71 any real _w evid5ce1 any rec5t evid5ce1 & any ,unit$ ,/ates-bas$ /udies4 7iv7 ,consultation on rese>* plans ,! ,director %all facilitate coord9ation & int]action ) o!r ag5cies & dep>tm5ts 9 ! prep>ation & publication ( rese>* plans 7tak+ into consid]ation rese>* & f9d+s by o!r ag5cies & dep>tm5ts7 & me?odological /&>ds "u clause 7iii71 includ+ ) ! ,national ,in/itutes ( ,heal?1 ! ,national ,canc] ,in/itute1 ! ,national ,in/itute on ,m9ority ,heal? & ,heal? ,disp>ities1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & ! ,pati5t-,c5t]$ ,outcomes ,rese>* ,in/itute4 7,b7 ,evid5ce reports 7i7 ,initial publication ,! ,director %all make publicly available ea* sy/ematic evid5ce review & any relat$ reports t s]ve z ! f\ndation = any recomm5dation ( ! ,task ,=ce & publi% 9 ! ,f$]al ,regi/] a reque/ = public comm5ts on su* review or relat$ reports4 7ii7 ,public comm5t p]iod ,! ,director %all accept comm5ts on any draft evid5ce report publi%$ "u clause 7i7 dur+ a p]iod ( at lea/ #de days4 ,! ,director %all make publicly available comm5ts submitt$ 9 response to a reque/ = public comm5t4 ,ea* f9al evid5ce review %all include a description ( comm5ts submitt$ on ! draft evid5ce review & ! response ( ! ,task ,=ce to su* comm5ts4 7iii7 ,review by ext]nal exp]ts ,no su* evid5ce report %all be publi%$ prior to x be+ review$ by a panel ( ext]nal subject matt] exp]ts t includes provid] & pati5t repres5tatives4 ,ea* su* report %all include a description ( ! panel t conduct$ su* review4 ,su* description %all include in=mation on ea* panel memb]1 includ+ "n1 academic degree 7or degrees71 affiliations1 & relat$ exp]tise4 7,c7 ,recomm5dation /atem5ts 7i7 ,publication ( draft recomm5dations ,! ,director %all make publicly available ea* draft recomm5dation /atem5t 7z t t]m is us$ = purposes ( section #g ( ! ,u4,s4 ,prev5tive ,s]vices ,task ,=ce ,proc$ure ,manual1 z 9 effect on ,april #a1 #bjai7 & %all provide = ! publication 9 ! ,f$]al ,regi/] ( a reque/ = comm5ts & accept comm5ts dur+ a p]iod ( n less ?an #de days4 7ii7 ,consultation on recomm5dations ,be=e vot+ on a draft or f9al recomm5dation /atem5t 7z t t]m is us$ = purposes ( section #g ( ! proc$ure manual ref]r$ to 9 clause 7i771 ! ,task ,=ce %all-- 7,i7 consult ) relevant /akehold]s1 includ+ provid] gr\ps1 practic+ speciali/s t treat ! specific disease "u review1 & relevant pati5t & disease advocacy organizations2 & 7,,ii7 take into acc\nt ! fe$back provid$ by ! bo>d4 7iii7 ,public availability ( comm5ts & inclusion ( description ( comm5ts 9 f9al /atem5t ,! ,director %all make comm5ts receiv$ pursuant to clause 7i7 publicly available4 ,any f9al recomm5dation /atem5t %all include a description ( comm5ts receiv$ on ! draft recomm5dation /atem5t & recomm5dations ( o!r ,f$]al ag5cies or organizations relat+ to ! topic ( ! /atem5t4 ,! ,director %all make f9al recomm5dation /atem5ts publicly available1 includ+ ?r\gh publication 9 ! ,f$]al ,regi/]4 7iv7 ,consid]ation ,9 publi%+ draft or f9al recomm5dation /atem5ts 7z ^? t]ms are us$ = purposes ( section #g ( ! proc$ure manual ref]r$ to 9 clause 7i771 ! ,task ,=ce %all consid]-- 7,i7 ! impact ( its recomm5dations on ! heal? c>e community2 7,,ii7 :e!r a prev5tive s]vice is b5eficial = "s individuals & ! ne$ to enc\rage a discussion ( b5efits & risks = ^? individuals2 & 7,,iii7 h[ its specific assignm5t ( a grade to a product or s]vice may affect cov]age & access to su* product or s]vice "u ,f$]al programs & private heal? insurance cov]age4 7v7 ,dissem9ation ( evid5ce-bas$ recomm5dations ,! ,task ,=ce %all publi% & dissem9ate ! evid5ce-bas$ recomm5dations aft] consultation ) ! foll[+3 7,i7 ,relevant pati5t organizations4 7,,ii7 ,provid]s ( cl9ical s]vices1 includ+ community-bas$ provid]s & specialty physicians4 7,,iii7 ,! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & ! ,c5t]s = ,disease ,control & ,prev5tion4 7,d7 ,grad+ sy/em ,subject to subp>agraph 7,e71 9 publi%+ recomm5dation /atem5ts 7z t t]m is us$ = purposes ( section #g ( ! proc$ure manual ref]r$ to 9 clause 7i771 ! ,task ,=ce %all grade products & s]vices consi/5t ) ! foll[+3 7i7 ,grade ,a ,! ,task ,=ce %all assign a product or s]vice ,grade ,a if ! ,task ,=ce concludes t ! curr5t evid5ce is suffici5t to assess ! balance ( b5efits & risks ( ! product or s]vice1 &1 on ! basis ( su* evid5ce1 recomm5ds ! product or s]vice & det]m9es t !re is high c]ta9ty t ! net b5efit f ! product or s]vice is sub/antial4 7ii7 ,grade ,b ,! ,task ,=ce %all assign a product or s]vice ,grade ,b if ! ,task ,=ce concludes t ! curr5t evid5ce is suffici5t to assess ! balance ( b5efits & risks ( ! product or s]vice1 &1 on ! basis ( su* evid5ce1 recomm5ds ! product or s]vice & det]m9es t !re is high c]ta9ty t ! net b5efit ( ! product or s]vice is mod]ate or !re is mod]ate c]ta9ty t ! net b5efit ( ! product or s]vice is mod]ate to sub/antial4 7iii7 ,grade ,c ,! ,task ,=ce %all assign a product or s]vice ,grade ,c if ! ,task ,=ce concludes t-- 7,i7 ! curr5t evid5ce is suffici5t to assess ! balance ( b5efits & risks ( ! product or s]vice2 7,,ii7 on ! basis ( su* evid5ce1 does n make a recomm5dation ( ! product or s]vice & cl9icians may provide ?is product or s]vice to select$ pati5ts dep5d+ on individual circum/ances2 & 7,,iii7 = mo/ individuals )\t signs or symptoms ( a p>ticul> disease or condition !re is at lea/ mod]ate c]ta9ty t ! net b5efit is small4 7iv7 ,grade ,d ,! ,task ,=ce %all assign a product or s]vice ,grade ,d if ! ,task ,=ce concludes t ! curr5t evid5ce is suffici5t to assess ! balance ( b5efits & risks ( ! product or s]vice1 &1 on ! basis ( su* evid5ce1 recomm5ds aga9/ ! product or s]vice & det]m9es t !re is mod]ate or high c]ta9ty t ! product or s]vice has no net b5efit or t ! h>m ( ! product or s]vice outweighs ! b5efits4 7v7 ,grade ,i ,! ,task ,=ce %all assign a product or s]vice ,grade ,i if ! ,task ,=ce concludes t ! curr5t evid5ce is n suffici5t to assess ! balance ( b5efits & risks ( ! product or s]vice4 7,e7 ,*anges 9 grad+ sy/em 7i7 ,9 g5]al ,! ,director may provide1 by regulation1 = *anges 9 ! grad+ sy/em describ$ 9 subp>agraph 7,d74 7ii7 ,impact ( *anges ,if ! ,director makes a *ange 9 ! grad+ sy/em "u clause 7i7 = a p>ticul> grade1 ! ,task ,=ce %all review & re-grade ! products or s]vices previ\sly classifi$ )9 t grade4 ,any su* review & regrad+ may be done ?r\gh an exp$it$ process s long z any *ange 9 grade does n take effect be=e ! review ( t *ange 9 grade is complet$4 7#e7 ,role ( ag5cy ,! ,ag5cy %all provide ongo+ adm9i/rative1 rese>*1 & te*nical support = ! op]ations ( ! ,task ,=ce1 includ+ coord9at+ & support+ ! dissem9ation ( its recomm5dation /atem5ts1 ensur+ adequate /aff res\rces1 & assi/ance to ^? organizations reque/+ x = implem5tation ( ! recomm5dations ( ! ,task ,=ce4 7#f7 ,prev5tive s]vices advisory bo>d 7,a7 ,9 g5]al ,! ,task ,=ce %all conv5e a prev5tive s]vices advisory bo>d 79 ?is subsection ref]r$ to z ! bo>d7 compos$ ( repres5tatives ( appropriate public & private entities ) an int]e/ 9 cl9ical prev5tive s]vices to advise ! ,task ,=ce ?r\gh\t ! developm5t ( evid5ce-bas$ recomm5dations on ! use ( cl9ical prev5tive s]vices4 7,b7 ,memb]%ip ,! memb]s ( ! bo>d %all include repres5tatives ( ! foll[+3 7i7 ,pati5t gr\ps4 7ii7 ,provid]s ( cl9ical s]vices1 includ+ community-bas$ provid]s & specialty physicians4 7iii7 ,f$]al dep>tm5ts & ag5cies t h exp]tise 9 ! cl9ical prev5tive s]vice be+ review$4 7,c7 ,responsibilities ,! bo>d %all-- 7i7 recomm5d cl9ical prev5tive s]vices = review by ! ,task ,=ce2 7ii7 sugge/ sci5tific evid5ce = consid]ation by ! ,task ,=ce relat$ to reviews und]tak5 by ! ,task ,=ce2 7iii7 provide fe$back reg>d+ ! rese>* plan1 ! evid5ce report1 & draft recomm5dations by ! ,task ,=ce2 & 7iv7 assi/ ) ef=ts reg>d+ dissem9ation ( recomm5dations by ! ,director4 7,d7 ,meet+s ,! bo>d %all meet z ! *air ( ! bo>d det]m9es to be appropriate to fulfill ! responsibilities describ$ 9 p>agraph 7,c71 b n few] ?an #b times ea* ye>4 7#g7 ,disclosure & conflicts ( int]e/ ,prior to p>ticipat+ 9 a meet+ ( ! ,task ,=ce or bo>d1 ea* memb] ( ! ,task ,=ce or bo>d1 respectively1 %all disclose to ! ,director any pot5tial1 relevant f9ancial int]e/s 9 ! same mann] & to ! same ext5t z an employee ( ! executive bran* ( ! ,unit$ ,/ates1 if ! employee 7 p>ticipat+ 9 su* meet+1 w\ld be requir$ to disclose su* int]e/s "u section #bjh ( title #ah1 ,unit$ ,/ates ,code4 7#h7 ,no pay2 receipt ( travel exp5ses ,memb]s ( ! ,task ,=ce or ! bo>d %all n receive any pay = s]vice on ! ,task ,=ce or bo>d1 b may receive travel exp5ses1 includ+ a p] diem1 9 accordance ) applicable provisions ( sub*apt] ,i ( *apt] #eg ( title #e1 ,unit$ ,/ates ,code4 2 & 7#f7 by am5d+ p>agraph 7#aj71 z r$esignat$ by p>agraph 7#d71 to read z foll[s3 7#aj7 ,application ( ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all apply to ! ,task ,=ce except t section #ad ( su* ,act 7relat+ to t]m9ation ( advisory committees7 %all n apply to ! ,task ,=ce4 4 7b7 ,effective date2 transition 7#a7 ,9 g5]al ,! ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce %all n publi% any draft or f9al recomm5dations on or aft] su* date except 9 accordance ) su* am5dm5ts4 7#b7 ,recon/itution ( ,task ,=ce ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality %all take /eps to recon/itute ! memb]%ip ( ! ,task ,=ce consi/5t ) section #iae7;a77#c7 ( ! ,public ,heal? ,s]vice ,act1 z am5d$ by subsection 7a74 7#c7 ,previ\sly publi%$ recomm5dations ,) respect to recomm5dations or guidel9es publi%$ by su* ,task ,=ce be=e ! date ( ! enactm5t ( ?is ,act1 "u proc$ures e/abli%$ by ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 ! recon/itut$ ,task ,=ce %all und]take a review process consi/5t ) ! foll[+3 7,a7 ,an organization may reque/ ! ,task ,=ce to review any su* previ\s recomm5dation or guidel9e if su* organization has additional pe]-review$ sci5tific evid5ce t provides new in=mation relevant to ! previ\s recomm5dation or guidel9e4 7,b7 ,bas$ ^u su* reque/s1 ! ,task ,=ce %all e/abli% a process = ! review ( previ\s recomm5dations or guidel9es4 7,c7 ,su* process %all include public notice ?r\gh ! ,f$]al ,regi/] & opportunity = comm5t & a det]m9ation to confirm or modify su* recomm5dations or guidel9es4 7,d7 ,! process %all1 to ! ext5t feasible1 be consi/5t ) ! proc$ures appli$ "u ! am5dm5ts made by subsection 7a7 = ! promulgation ( new recomm5dations4 7c7 ,elim9ation ( ,secret>ial discretion ,to remove c]ta9 prev5tive s]vices "u ! ,m$ic>e program ,section #ahcd7n7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7n77 is am5d$-- 7#a7 by /rik+ p>agraph 7#b72 7#b7 by /rik+ 2 & at ! end ( p>agraph 7#a77;,b7 & ins]t+ a p]iod2 7#c7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 z p>agraphs 7#a7 & 7#b71 respectively1 & mov+ _! m>g9s #b ems to ! left2 & 7#d7 by /rik+ may & all t foll[s ?r\gh modify & ins]t+ may modify4 7d7 ,application to secret>ial discretion ,to remove c]ta9 prev5tive s]vices "u ! ,m$ic>e program ,section #ahcd7n7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7n771 z am5d$ by subsection 7c71 is fur!r am5d$ by add+ at ! end ! foll[+ flu% s5t5ce3 ,effective on ! date ( enactm5t ( ! ,,usp/f ,transp>5cy & ,acc\ntability ,act ( #bjai1 ! ,secret>y may use ! au?ority "u ?is subsection only to modify cov]age ( a prev5tive s]vice bas$ on ! recomm5dation or grade ( ! ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce ) respect to ! s]vice if su* recomm5dation or grade 0 develop$ or updat$ 9 accordance ) ! am5dm5ts made by section #b7;a7 ( su* ,act & if ! ,secret>y has concurr$ ) su* recomm5dation or grade aft] consultation ) o!r ,f$]al heal? ag5cies & relevant pati5t & provid] gr\ps44 7e7 ,application to physician quality measures "u ! ,m$ic>e program ,section #ahdh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7t7 ,measures relat$ to ,,usp/f recomm5dations ,effective on ! date ( enactm5t ( ! ,,usp/f ,transp>5cy & ,acc\ntability ,act ( #bjai1 not)/&+ any o!r provision ( ?is title1 a quality measure relat$ to a recomm5dation ( ! ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce may be appli$ "u ?is section only if su* recomm5dation 0 develop$ or updat$ 9 accordance ) ! am5dm5ts made by section #b7;a7 ( su* ,act & if ! ,secret>y has concurr$ ) su* recomm5dation or grade aft] consultation ) o!r ,f$]al heal? ag5cies & relevant pati5t & provid] gr\ps4 4