,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ihbc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #bb1 #bjbf,mr4 ,au*9closs 7= himself & ,mr4 ,ciscomani7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d title ,,xxvii ( ! ,public ,heal? ,s]vice ,act & title ,,xix ( ! ,social ,security ,act to require cov]age ( ,alzheim]'s biom>k] te/+ "u gr\p heal? plans1 gr\p & individual heal? insurance cov]age1 & ! ,m$icaid program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,alzheim]'s ,e>ly ,detection ,act ( #bjbf4 #b4 ,requir+ cov]age ( ,alzheim]'s biom>k] te/+ "u gr\p heal? plans1 gr\p & individual heal? insurance cov]age1 & ! ,m$icaid program 7a7 ,private insurance 7#a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #bgcj4 ,requir$ cov]age ( ,alzheim]'s biom>k] te/+ 7a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide b5efits "u su* plan or cov]age = ,alzh]im]'s biom>k] te/+4 7b7 ,mann] ( cov]age ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all ensure t1 ) respect to te/+ = :i* b5efits are requir$ to be provid$ "u su* plan or cov]age "u subsection 7a7-- 7#a7 ! f9ancial requirem5ts applicable to su* te/+ are no m re/rictive ?an ! pr$om9ant f9ancial requirem5ts appli$ to sub/antially all m$ical & surgical b5efits cov]$ by ! plan or cov]age & !re are no sep>ate co/-%>+ requirem5ts t are applicable only ) respect to su* te/+2 7#b7 ! treatm5t limitations applicable to su* te/+ are no m re/rictive ?an ! pr$om9ant treatm5t limitations appli$ to sub/antially all m$ical & surgical b5efits cov]$ by ! plan or cov]age & !re are no sep>ate treatm5t limitations t are applicable only ) respect to su* te/+2 7#c7 9 ! case su* plan or cov]age imposes any prior au?orization requirem5t ) respect to su* te/+1 ! plan or cov]age makes a det]m9ation ) respect to a reque/ = su* au?orization n lat] ?an #gb h\rs 7or #bd h\rs1 9 ! case ! provid] submitt+ su* reque/ atte/s t delay ( su* te/+ beyond #bd h\rs w\ld place an individual's life or heal? at s]i\s risk7 aft] receiv+ su* reque/2 7#d7 9 ! case su* plan or cov]age fails to make a det]m9ation ) respect to a prior au?orization reque/ = su* te/+ 9 accordance ) p>agraph 7#c71 ! plan or cov]age treats su* reque/ z hav+ be5 approv$2 7#e7 ! plan or cov]age does n apply any /ep !rapy requirem5t prior to provid+ b5efits = su* te/+2 & 7#f7 su* b5efits are provid$ 9 a mann] t promotes equitable access1 includ+ = rural & und]s]v$ populations1 & supports ! use ( m9imally invasive te/+ :]e cl9ically appropriate4 7c7 ,alzheim]'s biom>k] te/+ def9$ 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m ,alzheim]'s biom>k] te/+ means ! analysis ( an individual's tissue1 blood1 or o!r biospecim5 = ! pres5ce ( a biom>k]1 includ+ s+le-analyte te/s1 multiplex panel te/s1 prote9 expression1 & :ole g5ome1 :ole exome1 & :ole transcriptome sequ5c+1 furni%$ = a purpose specifi$ 9 p>agraph 7#b7-- 7,a7 9 accordance ) any ,food & ,drug ,adm9i/ration label+ indication2 7,b7 to det]m9e eligibility =1 or to manage treatm5t ( ,alzheim]'s disease )1 a drug approv$ by ! ,food & ,drug ,adm9i/ration2 7,c7 9 accordance ) any national cov]age det]m9ation "u title ,,xviii ( ! ,social ,security ,act2 or 7,d7 9 accordance ) applicable cl9ical practice guidel9es or cons5sus /atem5ts relat+ to ! diagnosis (1 treatm5t selection =1 managem5t (1 or monitor+ ( ,alzheim]'s disease4 7#b7 ,purposes specifi$ ,= purposes ( p>agraph 7#a71 ! purposes specifi$ 9 ?is p>agraph are ! e>ly detection1 risk /ratification1 diagnosis1 treatm5t1 appropriate managem5t1 or ongo+ monitor+ ( ,alzheim]'s disease4 7#c7 ,additional def9itions ,= purposes ( p>agraph 7#a73 7,a7 ,biom>k] ,! t]m biom>k] means a *>act]i/ic t is objectively measur$ & evaluat$ z an indicator ( normal biological processes1 pa?og5ic processes1 or ph>macologic responses to a specific !rapeutic int]v5tion1 includ+ g5e-drug int]actions4 7,b7 ,cons5sus /atem5t ,! t]m cons5sus /atem5t means /atem5ts develop$ by an indep5d5t1 multidiscipl9>y panel ( exp]ts t uses a transp>5t me?odology & report+ /ructure & include a conflict-(-int]e/ policy4 7,c7 ,cl9ical practice guidel9e ,! t]m cl9ical practice guidel9e means an evid5ce-bas$ guidel9e develop$ by an indep5d5t organization or m$ical pr(essional society t uses a transp>5t me?odology & report+ /ructure & includes a conflict-(-int]e/ policy4 4 7#b7 ,effective date ,! am5dm5t made by ?is subsection %all apply ) respect to plan ye>s beg9n+ on or aft] ! date t is #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7b7 ,m$icaid 7#a7 ,inclusion z m$ical assi/ance ,section #aije7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is am5d$-- 7,a7 9 p>agraph 7#ca71 by /rik+ & at ! end2 7,b7 by r$esignat+ p>agraph 7#cb7 z p>agraph 7#cc72 & 7,c7 by ins]t+ aft] p>agraph 7#ca7 ! foll[+ new p>agraph3 7#cb7 biom>k] te/+ 7z def9$ 9 section #bgcj7;c7 ( ! ,public ,heal? ,s]vice ,act72 & 4 7#b7 ,m&atory cov]age ,section #aijb7;a77#aj77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;a7a77#aj77;,a77 is am5d$1 9 ! matt] prec$+ clause 7i71 by /rik+ & 7#cj7 & ins]t+ 7#cj71 & 7#cb74 7#c7 ,mann] ( cov]age ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is am5d$-- 7,a7 9 p>agraph 7#hi71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#ij71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#ij7 ! foll[+ new p>agraph3 7#ia7 provide1 9 ! case ( biom>k] te/+ 7z def9$ 9 subsection 7c7 ( section #bgcj ( ! ,public ,heal? ,s]vice ,act71 = cov]age ( su* te/+ 9 ! same mann] z su* te/+ is requir$ to be cov]$ by a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age "u subsection 7b7 ( su* section4 4 7#d7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to cal5d> qu>t]s beg9n+ on or aft] ! date t is #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7c7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & on an annual basis = ! #b succe$+ ye>s1 ! ,director ( ! ,national ,in/itutes ( ,heal? %all1 ?r\gh contract ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e1 conduct a /udy & submit to ,congress a report on ! value ( biom>k] te/+ 9 detect+ & treat+ ,alzheim]'s disease4