Dive Insight:
Vagadziri vemidziyo uye vamiriri vevarwere vanga vachisundira CMS yekukurumidza nzira yekudzosera matekinoroji matsva ekurapa.Zvinotora anopfuura makore mashanu kuti tekinoroji yekurapa ibudirire kuwana kunyange chikamu cheMedicare chekuvhara mushure memvumo kubva kuFood and Drug Administration, sekutsvagurudza kubva kuStanford Byers Center yeBiodesign kuStanford University.
Chikumbiro chitsva cheCMS chine chinangwa chekufambisa mukana wekare kune vanozobatsirwa neMedicare kune mamwe maFDA-akasarudzwa ekubudirira michina uku ichikurudzira humbowo kuvandudzwa kana mikaha iripo.
Chirongwa cheTCET chinodaidzira kuti vagadziri vagadzirise mikaha yeuchapupu kuburikidza nezvidzidzo zvakagadzirirwa kupindura mibvunzo chaiyo.Izvo zvinodaidzwa kuti "kukodzera chinangwa" zvidzidzo zvaizogadzirisa dhizaini, chirongwa chekuongorora uye data yakakodzera kupindura mibvunzo iyoyo.
Iyo nzira yaizoshandisa CMS 'National coverage determination (NCD) uye kufukidzwa nehurongwa hwekuvandudza humbowo kuti ikurumidze kudzoserwa kweMedicare kwemamwe maturusi ebudiriro, agency yakadaro.
Kune michina yekubudirira munzira itsva, chinangwa cheCMS ndechekupedzisa TCET NCD mukati memwedzi mitanhatu mushure memvumo yemusika weFDA.Sangano iri rakati rinotarisira kuve nekuvhara kwenguva yakakwana chete kuti ifambise kugadzirwa kwehumbowo hunogona kutungamira mukutemerwa kwenguva refu kweMedicare.
Iyo TCET nzira zvakare yaizobatsira kuronga bhenefiti yeboka, kukodha uye ongororo yekubhadhara, CMS yakati.
AdvaMed's Whitaker akati boka iri rinoramba richitsigira kuvharwa nekukurumidza kweFDA-yakatenderwa matekinoroji, asi akacherekedza indasitiri neCMS vanogovana chinangwa chakafanana chekumisikidza nzira yekuvhara "zvichienderana nesainzi humbowo hwekiriniki hune dziviriro dzakakodzera, kune ari kusimukira matekinoroji anozobatsira Medicare. - varwere vanokodzera. "
Muna Kurume, vamiriri vedare reUS House vakaunza iyo Ensuring Patient Access to Critical Breakthrough Products Act iyo yaizoda kuti Medicare ivhare kwenguva pfupi michina yekurapa kwemakore mana uku CMS ichigadzira danho rekuvhara zvachose.
CMS yakaburitsa magwaro matatu akarongwa ekutungamira ane chekuita negwara idzva: Kuvhara neEvidence Development, Evidence Ongororo uye Clinical Endpoints Guidance yeKnee Osteoarthritis.Veruzhinji vane mazuva makumi matanhatu ekuti vataure nezvehurongwa uhu.
(Zvigadziriso zvine chirevo kubva kuAdvaMed, kumashure kwemutemo wakarongwa.)
Nguva yekutumira: Jun-25-2023