Session 3: Communication of HTE to Key Stakeholders Daniel Arthur - PowerPoint PPT Presentation

Session 3: Communication of HTE to Key Stakeholders Daniel Arthur Caños, PhD, MPH Director, Evidence Development Division Coverage and Analysis Group Center for Clinical Standards and Quality CMS

Challenge Question • Ho w do e s CMS pro mo te the a sse ssme nt o f he te ro g e ne ity o f tre a tme nt e ffe c ts while c linic a l e vide nc e is b e ing de ve lo pe d? • Wha t sub -g ro ups a re o f inte re st to Me dic a re whe n g e ne ra liza b ility is c o nside re d fo r Na tio na l Co ve ra g e De te rmina tio ns?

42 CFR § 405.212 Medicare Coverage IDE study criteria (1) T he princ ipal purpo se o f the study is to te st whe the r the de vic e impro ve s he a lth o utc o me s o f a ppro pria te ly se le c te d pa tie nts. (2) T he ra tio na le fo r the study is we ll suppo rte d b y a va ilable sc ie ntific a nd me dic a l info rma tio n, o r it is inte nde d to c la rify o r e sta b lish the he a lth o utc o me s o f inte rve ntio ns a lre a dy in c o mmo n c linic al use . (3) T he study re sults a re no t a ntic ipa te d to unjustifia b ly duplic a te e xisting kno wle dg e . (4) T he study de sig n is me tho do lo g ic ally a ppro priate a nd the a ntic ipate d numb e r o f e nro lle d sub je c ts is a de q ua te to c o nfide ntly a nswe r the re se a rc h q ue stio n(s) b e ing a ske d in the study. (5) T he study is spo nso re d b y a n o rg a niza tio n o r individua l c a pa b le o f suc c e ssfully c o mple ting the study. (6) T he study is in c o mplianc e with a ll a pplic a ble F e de ra l re g ula tio ns c o nc e rning the pro te c tio n o f huma n sub je c ts fo und a t 21 CF R pa rts 50, 56, a nd 812 a nd 45 CF R pa rt 46. (7) Whe re a ppro pria te , the study is no t de sig ne d to e xc lusive ly te st to xic ity o r dise a se pa tho physio lo g y in he a lthy individua ls. Studie s o f a ll me dic a l te c hno lo g ie s me a suring the ra pe utic o utc o me s a s o ne o f the o b je c tive s ma y b e e xe mpt fro m this c rite rio n o nly if the dise a se o r c o nditio n b e ing studie d is life thre a te ning a nd the pa tie nt ha s no o the r via b le tre a tme nt o ptio ns. (8) T he study is re g iste re d with the Na tio nal Institute s o f He a lth's Na tio nal L ib ra ry o f Me dic ine 's Clinic alT rials.g o v. (9) T he study pr otoc ol de sc r ibe s the me thod and timing of r e le ase of r e sults on all pr e - spe c ifie d outc ome s, inc luding r e le ase of ne gative outc ome s and that the r e le ase should be haste ne d if the study is te r minate d e ar ly . (10) T he study pr otoc ol must de sc r ibe how Me dic ar e be ne fic iar ie s may be affe c te d by the de vic e unde r inve stigation, and how the study r e sults ar e or ar e not e xpe c te d to be ge ne r alizable to the Me dic ar e be ne fic iar y population. Ge ne r alizability to populations e ligible for Me dic ar e due to age , disability, or othe r e ligibility status must be e xplic itly de sc r ibe d.

Evidence-based Medicare Coverage Na tio na l Co ve ra g e De te rmina tio n (NCD): • Suffic ie nt e vide nc e to c o nc lude tha t the ite m o r se rvic e impro ve s c linic a lly me a ning ful he a lth o utc o me s fo r the Me dic a re po pula tio n • Ba se d o n a c o mpre he nsive re vie w o f pub lishe d e vide nc e

Medicare Beneficiaries in Clinical Studies • I nitia l studie s o n ne w te c hno lo g ie s ma y no t inc lude ma ny older adults ≥ 65 years of age for several reasons inc luding : • He te ro g e ne ity – ma y ha ve multiple c o mo rb iditie s a nd/ o r b e ta king multiple me dic a tio ns • No n-a dhe re nc e - ma y ha ve diffic ulty fo llo wing pro to c o ls a nd/ o r ma king a ll study fo llo w-up visits • Othe r c o nside ra tio ns – me a sure me nt issue s, c o g nitive func tio n

Coverage with Evidence Development (CED) • Co ve ra g e in the c o nte xt o f a ppro ve d c linic a l studie s o r with the c o lle c tio n o f a dditio na l c linic a l da ta • Allo ws fo r po sitive c o ve ra g e whe n e vide nc e is insuffic ie nt fo r a mo re fa vo ra b le de c isio n • E vide nc e g a ps ma y b e due to lo w numb e r o f b e ne fic ia rie s in c linic a l studie s, la c k o f me a ning ful he a lth o utc o me s, limite d g e ne ra liza b ility, inc o nsiste nc y o f study finding s. • Witho ut CE D, the ite m o r se rvic e wo uld b e no n-c o ve re d • Ma y invo lve ra ndo mize d c o ntro lle d tria ls, o b se rva tio na l studie s a nd/ o r re g istrie s • spe c ific inte rve ntio n, • b e ne fits a nd ha rms, • he a lth o utc o me s