Cell thiab Gene Therapy (CGT) Access Model
Cov Lus Nug Nug Txog Tus Kws Kho Mob (FAQs)
Hloov kho Lub Yim Hli 1, 2025
Cov FAQs hauv qab no muab kev taw qhia ntxiv thiab qhia meej rau cov kws kho mob Medi-Cal txog CGT Access Model. Raws li Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv (DHCS) tau txais cov lus nug ntxiv, FAQ no yuav raug hloov kho. Yog xav paub ntxiv txog CGT Access Model, thov xa mus rau General FAQs.
General
Cov tshuaj twg yuav raug them raws li Medi-Cal's CGT Access Model?
Medi-Cal's CGT Access Model yuav them rau ob lub tseemfwv qibsiab Food and Drug Administration (FDA)-pom zoo CGT tshuaj uas tau txheeb xyuas los ntawm CMS rau kev kho SCD. Qhov no suav nrog, CASGEVY ™ , uas yog tsim los ntawm Vertex Pharmaceuticals, Inc., thiab LYFGENIA ™ , uas yog tsim los ntawm bluebird bio, Inc.
Thaum twg kuv tuaj yeem pib them nqi rau CGT SCD cov tshuaj raws li Medi-Cal's CGT Access Model?
Cov kws kho mob sau npe tuaj yeem pib muab LYFGENIA rau cov tswv cuab Medi-Cal tsim nyog rau cov hnub ua haujlwm rau lossis tom qab Lub Xya Hli 1, 2025.
Cov kws kho mob sau npe tuaj yeem pib muab CASGEVY rau cov tswv cuab Medi-Cal tsim nyog rau cov hnub ua haujlwm rau lossis tom qab Lub Kaum Hli 1, 2025.
Kev tsim nyog
Leej twg tsim nyog koom nrog Medi-Cal's CGT Access Model?
Txhawm rau tsim nyog rau Medi-Cal's CGT Access Model, Medi-Cal cov tswv cuab yuav tsum ua raws li tag nrho cov hauv qab no:
Muaj cov ntaub ntawv kho mob ntawm SCD;
Nkag mus rau npe rau hauv Medi-Cal puv npo thaum lub sijhawm tau txais cov tshuaj CGT (ceeb toom: ob qho tib si Medi-Cal tswj hwm kev saib xyuas thiab tus nqi-rau-kev pabcuam (FFS) cov tswvcuab yuav tsim nyog tau txais kev kho CGT);
Muaj Medi-Cal ua lawv tus thawj them nyiaj;
Tau txais ib qho ntawm ob qho tshuaj CGT los ntawm tus kws kho mob koom nrog; thiab
Txaus siab rau tag nrho cov kev cai Medi-Cal uas tau tshaj tawm thiab CGT Access Model yuav tsum tau ua.
Yog xav paub ntxiv, thov xa mus rau cov txheej txheem kev pov hwm, suav nrog cov kev tso cai ua ntej, uas muaj nyob hauv online ntawm lub vev xaib no.
Cov txiaj ntsig
Kuv xav tau cov txiaj ntsig dab tsi los muab raws li Medi-Cal's CGT Access Model?
Raws li CGT Access Model, cov chaw muab kev pabcuam yog lub luag haujlwm muab cov hauv qab no:
Fertility Preservation Services
Kuv tsis xav tau cov txiaj ntsig dab tsi los muab raws li Medi-Cal's CGT Access Model?
Cov kws kho mob tsuas yog yuav tsum tau muab ib qho ntawm ob qho tshuaj CGT SCD thiab, yog tias xav tau, cov kev pabcuam tiv thaiv kev xeeb tub (raws li tau sau tseg saum toj no). Tsis tas li ntawd, tag nrho lwm yam kev kho mob thiab tsis yog kev kho mob tsis raug them raws li CGT Access Model thiab yuav muab thiab them raws li Medi-Cal tus tswv cuab txoj kev tsim nyog, raws li hauv qab no:
Medi-Cal FFS: Cov kws kho mob FFS yuav tsum xa thiab xa daim nqi DHCS ncaj qha rau tag nrho lwm yam kev kho mob thiab tsis yog kev kho mob CGT cov kev pabcuam, suav nrog kev thauj mus los (tawm ntawm tus nqi ntawm cov tshuaj, kev khaws cia muaj menyuam, thiab qhov chaw nyob tsim nyog, zaub mov, thiab kev mus ncig uas tsim nyog tau txais cov kev pabcuam fertility preservation raws li tau hais saum toj no).
Medi-Cal Managed Care: Tus tswv cuab ntawm Medi-Cal tswj hwm txoj kev npaj kho mob (MCP) yog lub luag haujlwm rau kev saib xyuas kev sib koom tes thiab pab nkag mus rau ib qho ntawm ob qho tshuaj CGT mob kab mob ntawm tes. Yog xav paub ntxiv txog Medi-Cal MCP kev saib xyuas kev sib koom tes thiab lwm yam uas yuav tsum tau ua, thov tshuaj xyuas Daim Ntawv Qhia Tag Nrho uas siv tau ntawm DHCS lub vev xaib. Tsis tas li ntawd, Medi-Cal MCPs yuav tsum them tag nrho lwm yam kev kho mob thiab tsis yog kev kho mob CGT ntsig txog, suav nrog kev thauj mus los (sab nraum tus nqi ntawm cov tshuaj, kev txuag kev xeeb tub, thiab qhov chaw nyob tsim nyog, pluas noj, thiab kev mus ncig uas tsim nyog tau txais kev pabcuam fertility preservation, raws li tau hais saum toj no).
Kuv tuaj yeem txuas kuv tus neeg mob mus rau kev pabcuam li cas?
Yog tias koj tus neeg mob xav tau LYFGENIA, kuv qhov kev txhawb nqa bluebird muab Tus Neeg Mob Navigators uas tuaj yeem pab koj thiab koj tus neeg mob tshawb nrhiav seb txoj kev kho noob yog ib qho kev xaiv, coj koj tus neeg mob mus rau theem kev kho mob, thiab txuas lawv nrog cov neeg muaj txiaj ntsig thiab cov peev txheej ntawm txoj kev. Koj tus neeg mob tuaj yeem ua tiav Daim Ntawv Sau Npe Kawm Ntawv ncaj qha ntawm lawv tus kheej. Xwb, koj tuaj yeem ua tiav Daim Ntawv Teev Npe Kawm Ntawv rau tus neeg mob sawv cev thiab kuv qhov kev txhawb nqa bluebird yuav ncav cuag koj tus neeg mob los piav qhia txog qhov kev zov me nyuam thiab paub meej tias lawv txaus siab rau npe. DHCS sau tseg tias kuv qhov kev txhawb nqa bluebird muaj nyob rau tsis muaj nqi, thiab tsis muaj lub luag haujlwm los mus tom ntej nrog CGT SCD kev kho mob.
Yog tias koj tau sau CASGEVY rau koj tus neeg mob, koj tus neeg mob tuaj yeem tso npe rau hauv Vertex Connects Patient Support los ntawm qhov lawv yuav raug xa mus rau Tus Thawj Saib Xyuas Case uas yuav ua cov peev txheej thoob plaws lawv txoj kev taug kev CGT. Cov Thawj Saib Xyuas Cov Ntaub Ntawv kuj tseem pab tswj xyuas qhov kev txiav txim ntawm CASGEVY, teem caij ntawm apheresis, shipping thiab logistics, muab kev hloov kho ntawm tus neeg mob txoj kev kho noob thaum lub sij hawm tsim khoom, thiab daws teeb meem. DHCS sau tseg tias kev cuv npe hauv Vertex Connects Patient Support tsis tas yuav tau txais CASGEVY. Txawm li cas los xij, yuav tsum tau ua tiav daim ntawv teev npe Vertex Connects kom tau txais cov kev pabcuam tswj xyuas thiab txiav txim siab tsim nyog rau qee qhov kev pabcuam. Cov tswv cuab yuav tau txais daim ntawv teev npe Vertex Connects thaum lawv tau txais kev kho mob CASGEVY los ntawm lawv pab neeg kho mob.
Kev them nqi
Yuav them cov tshuaj CGT SCD li cas?
Txhua qhov kev thov rau cov tshuaj CGT yuav tsum tau them ncaj qha rau DHCS siv tus lej them nqi tsim nyog (xws li J3392 lossis J3394) thiab xa mus rau cov ntaub ntawv kho mob uas siv CMS-1500 (lossis 837P / I cov ntawv sib npaug hauv hluav taws xob).
Puas yog CGT SCD cov tshuaj tau muab tshem tawm los ntawm kev tswj xyuas tus me nyuam?
Yog lawm, cov tshuaj CGT rau SCD cov lus qhia tsuas yog raug muab tshem tawm ntawm txoj kev tswj xyuas kev noj qab haus huv, uas txhais tau hais tias Medi-Cal MCPs tsis muaj lub luag haujlwm rau cov tshuaj CGT SCD (lossis cov nqi khaws cia fertility). Qhov no txhais tau hais tias cov kws kho mob yuav tsum tsis txhob xa cov ntawv thov rau CGT cov nyiaj them rov qab rau Medi-Cal MCPs. Txhua daim ntawv thov tshuaj CGT SCD yuav tsum raug xa ncaj qha mus rau DHCS uas cais tawm cov nqi tshuaj CGT SCD los ntawm ib qho kev cuam tshuam, tsis yog kev kho mob lossis tus nqi kho mob hauv tsev kho mob. Tom qab ntawd cov kws kho mob yuav xa ib daim ntawv thov rau CGT SCD cov nyiaj them rov qab ncaj qha rau DHCS thiab lwm qhov, cais thov mus rau Medi-Cal MCP uas muaj feem cuam tshuam, tsis yog kho mob lossis tus nqi kho mob hauv tsev kho mob. Txawm li cas los xij, thov nco ntsoov tias Medi-Cal MCPs tseem muaj kev cog lus thiab nyiaj txiag rau cov tshuaj CGT rau lwm yam, FDA pom zoo, tsis yog-SCD cov lus qhia nrog rau txhua yam cuam tshuam, tsis yog kho mob lossis cov nqi kho mob cuam tshuam nrog cov tshuaj CGT.
Puas yog cov tshuaj CGT SCD tau muab tshem tawm los ntawm Pawg Neeg Mob Mob (DRG) cov txheej txheem them rov qab rau cov neeg mob nyob hauv tsev kho mob?
Yog lawm, cov tshuaj SCD raug muab tshem tawm ntawm DRG cov txheej txheem them rov qab rau cov neeg mob nyob hauv tsev kho mob. Qhov no txhais tau hais tias cov neeg muab kev pabcuam xa cov ntaub ntawv thov rau CGT SCD cov tshuaj yuav tsum cais tawm cov nqi tshuaj CGT SCD los ntawm ib qho kev cuam tshuam, uas tsis yog kho mob lossis tus nqi kho mob hauv tsev kho mob. Tom qab ntawd cov kws kho mob yuav xa ib daim ntawv thov rau CGT SCD cov nyiaj them rov qab ncaj qha rau DHCS thiab lwm qhov, cais thov mus rau Medi-Cal MCP uas muaj feem cuam tshuam, tsis yog kho mob lossis tus nqi kho mob hauv tsev kho mob. DHCS tsis ntev los no tau tshaj tawm tsab ntawv ceeb toom rau pej xeem txog Kev Hloov Kho Lub Xeev (SPA) 25-0022.
Cov tshuaj CGT SCD tau them rov qab li cas?'
HCPCS cov lej J3392 thiab J3394 tsis tau tsim Medi-Cal FFS cov nqi ntawm cov ntaub ntawv. Raws li qhov tshwm sim, cov lej no tau them "los ntawm kev tshaj tawm", uas txhais tau hais tias cov neeg muab kev pabcuam yuav tsum xa daim ntawv them nqi nrog rau lawv daim ntawv thov nyiaj rov qab. Yog xav paub ntxiv txog "los ntawm kev tshaj tawm" kev them nqi, xa mus rau CMS-1500 Cov Lus Qhia Txog Kev Them Nqi Tshwj Xeeb (cms spec) ntu ntawm Medi-Cal Phau Ntawv Qhia.
Center for International Blood and Marrow Transplant (CIBMTR) Research Requirements
Lub chaw kho mob dab tsi yog lub luag haujlwm ntawm CGT Access Model Study?
Cov chaw kho mob yuav yog lub luag haujlwm rau kev mus cuag cov neeg mob kom thov lawv qhov kev pom zoo los koom nrog CIBMTR Research Database Protocol raws li qhov kev tshawb fawb no yuav raug tswj hwm thiab xa cov ntaub ntawv mus rau CIBMTR, raws li CGT Access Model txoj kev kawm.
Cov chaw kho mob puas tuaj yeem nrhiav cov ntaub ntawv hais txog CGT Access Model kawm?
CIBMTR cov koom haum yuav tau txais cov ntaub ntawv hais txog CGT Access Model kawm ncaj qha los ntawm CIBMTR.
Tawm tswv yim
Qhov twg cov kws kho mob tuaj yeem kawm paub ntxiv txog Medi-Cal's CGT Access Model thiab/lossis muab cov lus tawm tswv yim?
Cov ntaub ntawv hais txog Medi-Cal's CGT Access Model muaj nyob rau ntawm DHCS' lub vev xaib, uas muaj nyob rau ntawm qhov txuas hauv qab no: Cov lus teb, cov lus nug, thiab cov lus pom tuaj yeem xa tuaj rau DHCS ntawm email ntawm dhcscgt@dhcs.ca.gov.
