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 will cover the two federal Food and Drug Administration (FDA)-approved CGT medications identified by CMS for treatment of SCD. This includes, CASGEVY™, which is made by Vertex Pharmaceuticals, Inc., and LYFGENIA™, which is made by bluebird bio, Inc.
When can I start billing for CGT SCD medications under Medi-Cal’s CGT Access Model?
Enrolled providers may begin providing LYFGENIA to eligible Medi-Cal members for dates of service on or after July 1, 2025.
Enrolled providers may begin providing CASGEVY to eligible Medi-Cal members for dates of service on or after October 1, 2025.
Kev tsim nyog
Leej twg tsim nyog koom nrog Medi-Cal's CGT Access Model?
To be eligible for Medi-Cal’s CGT Access Model, Medi-Cal members must meet all of the following criteria:
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 yuav tsum muab cov txiaj ntsig dab tsi 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:
Ib qho ntawm ob cov tshuaj CGT rau SCD
CASGEVY los ntawm Vertex Pharmaceuticals, Inc.
LYFGENIA los ntawm bluebird bio, Inc.
Fertility Preservation Services
Raws li ib feem ntawm kev them nyiaj rov qab rau cov tshuaj CGT SCD, cov kws kho mob yuav tsum them:
Txog li peb ntu ntawm kev sau thiab khaws cia cov ntaub ntawv khaws cia, txog li kaum tsib xyoos rau cov tswv cuab tsim nyog.
Kev tsim nyog qhov chaw nyob, zaub mov, thiab cov nqi mus ncig kuj yuav raug them, yog tias tsim nyog tau txais cov kev pabcuam khaws cia muaj menyuam.
Kuv tsis tas yuav muab cov txiaj ntsig dab tsi raws li Medi-Cal's CGT Access Model?
Providers are only required to provide one of the two CGT SCD medications and, if needed, fertility preservation services (as noted above). Aside from this, all other medical and non-medical services are not covered under the CGT Access Model and will be provided and covered depending on the Medi-Cal member’s eligibility, as follows:
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: The member’s Medi-Cal managed care plan (MCP)is responsible for care coordination and assisting with accessing one of the two CGT sickle cell disease medications. For more information on Medi-Cal MCP care coordination and other requirements, please review the applicable All Plan Letter on DHCS’ website. In addition, Medi-Cal MCPs must cover all other medical and non-medical CGT-related services, including transportation (outside of the cost of the drug, fertility preservation, and qualifying lodging, meals, and travel expenses necessary to receive fertility preservation services, as noted above).
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 Cov Neeg Taw Qhia Rau Cov Neeg Mob uas tuaj yeem pab koj thiab koj tus neeg mob tshawb nrhiav seb kev kho mob gene puas yog ib qho kev xaiv, coj koj tus neeg mob mus rau cov kauj ruam mus rau kev kho mob, thiab txuas lawv nrog cov neeg thiab cov peev txheej pab tau raws txoj kev. Koj tus neeg mob tuaj yeem ua tiav Daim Ntawv Sau Npe Rau Kev Pabcuam ncaj qha ntawm lawv tus kheej. Los yog, koj tuaj yeem ua kom tiav Daim Ntawv Sau Npe Rau Kev Pabcuam rau tus neeg mob thiab kuv qhov kev pabcuam bluebird yuav tiv tauj koj tus neeg mob los piav qhia txog qhov kev pabcuam thiab lees paub lawv qhov kev txaus siab rau kev sau npe. DHCS sau tseg tias kuv qhov kev pab txhawb nqa bluebird muaj pub dawb, thiab tsis muaj lub luag haujlwm los mus tom ntej nrog kev kho mob CGT SCD.
Yog tias koj tau sau tshuaj CASGEVY rau koj tus neeg mob, koj tus neeg mob tuaj yeem sau npe rau hauv Vertex Connects Patient Support uas lawv yuav tau txais tus Case Manager uas yuav ua haujlwm ua tus neeg pab thoob plaws lawv txoj kev taug kev CGT. Cov Thawj Saib Xyuas Cov Ntaub Ntawv kuj pab sib koom tes txiav txim siab txog kev tso CASGEVY, teem sijhawm rau kev siv tshuaj apheresis, kev xa khoom thiab kev npaj khoom, muab cov xov xwm tshiab txog tus neeg mob txoj kev kho mob gene thaum lub sijhawm tsim khoom, thiab daws teeb meem. DHCS sau tseg tias kev sau npe rau hauv Vertex Connects Patient Support tsis tas yuav tsum tau txais CASGEVY. Txawm li cas los xij, yuav tsum muaj daim ntawv sau npe Vertex Connects uas ua tiav lawm kom tau txais cov kev pabcuam tswj xyuas cov ntaub ntawv thiab txiav txim siab seb puas tsim nyog rau qee qhov kev pabcuam. Cov tswv cuab yuav tau txais daim ntawv sau 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).
Yog xav paub ntxiv txog yuav ua kom tiav daim ntawv CMS-1500 (lossis 837P/I cov ntawv sib npaug hauv hluav taws xob), thov saib CMS-1500 Ua tiav (cms comp), CMS-1500 Cov Lus Qhia rau Kev Them Nqi (cms lus qhia), CMS-1500 Xa thiab Cov Lus Qhia Sijhawm Sijhawm (cms sub- 15) Cov Lus Qhia Tshwj Xeeb (cms sub-15) , thiab CMS ntawm Phau Ntawv Qhia Tus Muab Kev Pab.
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.
How are CGT SCD medications reimbursed?’
HCPCS codes J3392 and J3394 do not have established Medi-Cal FFS rates on file. As a result, these codes are paid “by report”, which means that providers must submit an invoice along with their claim for reimbursement. For more information on “by report” billing, refer to the CMS-1500 Special Billing Instructions (cms spec) section of the Medi-Cal Provider Manual.
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
Where can providers learn more about Medi-Cal’s CGT Access Model and/or offer feedback?
Information about Medi-Cal’s CGT Access Model is available on DHCS’ website, which is available at the following link: Feedback, questions, and comments may also be submitted to DHCS via email at dhcscgt@dhcs.ca.gov.