Dive Insight:
Abenzi bezixhobo kunye nabameli besigulane baye batyhala i-CMS kwindlela ekhawulezayo yokubuyisela ubugcisa obutsha bezonyango.Kuthatha iminyaka engaphezu kwemihlanu ukuphumelela kwetekhnoloji yezonyango ukufumana ukhuseleko lweMedicare oluyinxenye emva kokuvunywa kuLawulo lokuTya kunye neDrugs, ngokophando oluvela kwiZiko laseStanford Byers leBiodesign kwiYunivesithi yaseStanford.
Isiphakamiso esitsha seCMS sijolise ekuququzeleleni ukufikelela kwangaphambili kwabaxhamli be-Medicare kwizixhobo ezithile ezichongiweyo ze-FDA ngelixa zikhuthaza uphuhliso lobungqina ukuba kukho izikhewu.
Isicwangciso se-TCET sifuna ukuba abavelisi bajongane nobungqina bezithuba ngezifundo ezenzelwe ukuphendula imibuzo ethile.Izifundo ezibizwa ngokuba "zilungele injongo" ziya kujongana noyilo, isicwangciso sokuhlalutya kunye nedatha efanelekileyo ukuphendula loo mibuzo.
Indlela iya kusebenzisa i-CMS ye-National coverage determination (NCD) kunye ne-coverage kunye neenkqubo zophuhliso lobungqina ukukhawulezisa i-Medicare imbuyekezo yezixhobo ezithile zokuphumelela, i-arhente yatsho.
Ukufumana izixhobo ezinempumelelo kwindlela entsha, injongo yeCMS kukugqibezela i-TCET NCD kwisithuba seenyanga ezintandathu emva kogunyaziso lwentengiso lwe-FDA.I-arhente ithe ijonge ukuba ne-inshorensi ixesha elide ngokwaneleyo ukuququzelela ukuveliswa kobungqina obunokukhokelela ekuzimiseleni kwexesha elide le-Medicare.
Indlela ye-TCET nayo iya kunceda ukulungelelanisa ukumiselwa kwecandelo lenzuzo, ukubhalwa kweekhowudi kunye nophononongo lwentlawulo, itshilo iCMS.
U-AdvaMed's Whitaker uthe iqela liyaqhubeka nokuxhasa ukhuseleko olukhawulezileyo lwetekhnoloji evunyiweyo yi-FDA, kodwa waphawula ukuba ishishini kunye ne-CMS babelana nenjongo efanayo yokuseka inkqubo yokugubungela ngokukhawuleza "ngokusekwe kubungqina bezonyango obuvakalayo ngokwesayensi kunye nokhuseleko olufanelekileyo, kubuchwephesha obuvelayo obuya kunceda iMedicare. -abaguli abafanelekileyo."
Ngo-Matshi, abameli beNdlu yase-US bazisa uMthetho wokuqinisekisa ukuFikelela kweSigulane kwi-Critical Breakthrough Products Act eyayiza kufuna ukuba i-Medicare ihlawule okwethutyana izixhobo zonyango kwiminyaka emine ngelixa i-CMS iphuhlise ukuzimisela okusisigxina.
I-CMS ikhuphe amaxwebhu amathathu esikhokelo acetywayo ngokunxulumene nendlela entsha: Ukubonelela ngoPhuhliso loBungqina, ukuPhononongwa koBungqina kunye neNkcazo yeNkcazo yeNkcazo yeSikhokelo seKnee Osteoarthritis.Uluntu luneentsuku ezingama-60 zokuphefumla ngesi sicwangciso.
(Uhlaziyo olunengxelo evela kwi-AdvaMed, imvelaphi yomthetho ocetywayo.)
Ixesha lokuposa: Jun-25-2023