Tsev Cov Chaw Muab Kev Pabcuam & Cov Neeg Koom Tes Cov Kev Cai thiab Cov Txheej Txheem rau Kev Sau Npe Medi-Cal rau Cov Kws Muab Tshuaj uas Tuav Daim Ntawv Pov Thawj Tso Cai Kho Mob (CLIA)​​ 

Medi-Cal Kev Nkag Mus Nkag Siab thiab Cov Txheej Txheem rau Cov Chaw Kho Mob uas tuav Daim Ntawv Kho Mob Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Kho Mob (CLIA) Daim Ntawv Pom Zoo​​ 

Cov lus nug nquag nug los ntawm Cov Neeg Koom Tes Hauv Lub Rooj Sib Hais rau Lub Rau Hli 10, 2025​​ 

Hauv qab no yog cov lus teb rau feem ntau ntawm cov lus nug uas Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv (DHCS) tau txais thaum lub rooj sib hais ntawm cov koom nrog rau lub Rau Hli 10th. Yog tias koj tsis pom cov lus teb rau koj cov lus nug, thov xa email mus rau qhov chaw nyob email uas tsim nyog tau teev tseg hauv qab no:​​  

Kev tso npe rau tus kws kho mob​​  

1. Lub sijhawm ua haujlwm ntawm daim ntawv thov tshuaj tshiab yog dab tsi?​​ 

Lub xeev txoj cai lij choj feem ntau xav kom DHCS ua ib qho kev thov rau npe rau tus kws kho mob hauv 180 hnub. Yog tias daim ntawv thov raug xa rov qab mus rau tus kws kho mob kom kho, tus kws kho mob muaj 60 hnub los xa daim ntawv thov rov qab. DHCS yuav muaj 60 hnub ntxiv los tshuaj xyuas daim ntawv thov thaum nws tau xa rov qab. Yog tias daim ntawv thov raug xa mus rau kev tshuaj xyuas zoo, lub sijhawm tshuaj xyuas yuav raug ncua. Kev xa daim ntawv thov kom tiav thiab raug yuav txo DHCS lub sijhawm ua daim ntawv thov tag nrho.​​ 

2. Does a currently enrolled pharmacy provider have to submit a supplemental application to bill for the CLIA waived tests?​​ 

Yog lawm, tam sim no cov chaw muab tshuaj rau npe tuaj yeem xa daim ntawv thov ntxiv nrog ib daim qauv siv tau ntawm lawv daim ntawv pov thawj CLIA thiab daim ntawv pov thawj tam sim no ntawm California Clinical Laboratory Registration. CLIA Certificate of Waiver thiab Certificate of California Clinical Laboratory Registration service address yuav tsum phim qhov chaw nyob ntawm qhov chaw tshiab lossis rau npe.​​ 

3. Does this provider bulletin only apply to pharmacy providers or does it also include hospitals that have onsite pharmacies with a CLIA license?​​ 

Cov ntawv tshaj tawm no siv rau txhua lub tsev muag tshuaj uas tuav daim ntawv pov thawj CLIA ntawm Kev Zam Txim thiab npaj siab yuav sau Medi-Cal rau cov kev pabcuam hauv chaw kuaj mob raws li nws tus lej chaw muag tshuaj yuav tsum ua raws li cov lus qhia hauv tsab ntawv tshaj tawm. Qhov no suav nrog cov khw muag tshuaj uas ua haujlwm ua cov chav sib txawv hauv ib lub chaw kho mob uas muaj ntawv tso cai.​​ 

4. Peb tseem tsis tau lees paub tias CLIA zam tsis tau; Nws yuav siv sij hawm ntev npaum li cas thiaj tau lees paub raws li CLIA waived Pharmacy?​​ 

DHCS does not process the enrollment or issuance of the CLIA Certificates of Waiver. For guidance on how to obtain a CLIA Certificate of Waiver, please visit the Centers for Medicare & Medicaid Services How to Apply for a CLIA Certificate, Including International Laboratories web page.​​ 

Additionally, for information on how to obtain a Certificate of California Clinical Laboratory Registration, please visit the California Department of Public Health CLIA Certificate Information web page.​​  

5. Hais txog CLIA Certificate of Waiver, peb tuav daim ntawv pov thawj siv tau, tab sis peb tsis xyaum ua ib lub chaw kuaj mob ntxiv lawm txij li tus kab mob COVID-19 tau ploj mus lawm. Peb puas yuav tsum tso npe rau hauv qhov kev pab cuam Medi-Cal?​​ 

Tsis yog, tsis tas yuav tso npe kawm yog tias koj tsis ua CLIA-tso xeem. Cov ntawv xov xwm qhia meej tias yuav pib lub Yim Hli Ntuj 1, 2025, cov chaw muag tshuaj uas tuav daim ntawv pov thawj CLIA siv tau thiab daim ntawv pov thawj tam sim no ntawm California Clinical Laboratory Registration tej zaum yuav tau them nqi rau CLIA-tso cov kev xeem nyob rau hauv tus kws muag tshuaj qhov kev coj ua. Txawm li cas los xij, yog tias koj lub tsev muag tshuaj tsis ua qhov kev sim no lawm, kev tso npe hauv Medi-Cal rau lub hom phiaj no tsis tsim nyog.​​ 

6. Peb muaj CLIA zam raws li kev kuaj sim; puas muaj dabtsi rau peb ua ntawm no?​​ 

Tsis yog, yog tias koj twb tau cuv npe ua chav kuaj, koj tsis tas yuav xa daim ntawv thov ntxiv. Yog tias koj tsis yog ib lub chaw muag tshuaj, cov kev cai tshwj xeeb rau npe yuav tsis siv. Cov ntawv tshaj tawm tsuas yog siv rau cov chaw muab tshuaj nrog CLIA Daim Ntawv Pov Thawj Kev Zam. Yog tias koj lub chaw kuaj mob tsis ua haujlwm raws li lub chaw muab tshuaj, koj yuav tsis raug rau cov txheej txheem sau npe Medi-Cal tshwj xeeb uas suav nrog hauv daim ntawv tshaj tawm no.​​ 

Federally Qualified Health Centers (FQHC)​​ 

1. Would this include clinic sites (FQHC) with a pharmacy permit for a dispensary and with CLIA certification, or does the site need to be specifically a pharmacy?​​ 

Cov kev cai rau npe kawm uas tau teev tseg hauv tsab ntawv tshaj tawm no siv tshwj xeeb rau cov chaw muab tshuaj. Cov ntawv xov xwm qhia txog cov txheej txheem rau cov chaw muag tshuaj uas tuav daim ntawv pov thawj CLIA ntawm Kev Zam, tsis yog FQHC's. Yog tias lub chaw kho mob FQHC npaj siab yuav sau nqi rau CLIA-tso kev xeem, lawv twb muaj peev xwm sau npe thiab sau nqi rau cov kev pabcuam no thiab yuav tsis tas yuav nqis tes ua ntxiv raws li daim ntawv tshaj tawm kev cai tswjfwm no.​​ 

2. What are the enrollment and billing requirements for FQHCs whose pharmacists may want to bill for CLIA waived labs for health centers that (a) have pharmacy carved into their Prospective Payment System (PPS) rate and (b) have pharmacy carved out of their PPS rate?​​ 

The requirements depend on whether pharmacy services are included in the FQHC’s PPS rate:​​ 

Pharmacy Carved Into PPS Rate: Yog tias cov kev pabcuam hauv tsev muag tshuaj suav nrog PPS tus nqi, CLIA-tso kev kuaj sim los ntawm cov kws muag tshuaj yuav tsum raug them nqi raws li ib feem ntawm FQHC ntsib. Cais cov nqi them rau cov kev xeem no nyob rau hauv ib lub tsev muag tshuaj naj npawb yog tsis tso cai. FQHC yuav tsum muaj daim ntawv pov thawj CLIA ua haujlwm ntawm Kev Zam Txim rau qhov chaw pabcuam qhov chaw kuaj mob.​​ 

Pharmacy Carved Out of PPS Rate: Yog tias cov chaw muag tshuaj raug muab tshem tawm, lub tsev muag tshuaj yuav tsum tau cais rau npe ua ib lub chaw muag tshuaj Medi-Cal thiab muaj CLIA Daim Ntawv Pov Thawj Ua Haujlwm rau qhov chaw pabcuam. Nyob rau hauv rooj plaub no, lub tsev muag tshuaj tuaj yeem sau nqi Medi-Cal ncaj qha rau CLIA-tso cov kev kuaj sim raws li qhov kev coj ua thiab tag nrho cov kev cai them nqi.​​ 

Nyob rau hauv ob qho xwm txheej, CLIA-tso kev xeem yuav tsum ua raws li lub xeev thiab tseem fwv cov cai, suav nrog daim ntawv tso cai tsim nyog thiab kev coj ua rau cov kws muag tshuaj.​​ 

Cov txiaj ntsig​​ 

1. What are the CLIA Waiver tests that Pharmacies are now able to perform?​​ 

Raws li Kev Lag Luam thiab Kev Ua Haujlwm (B&P) Txoj Cai Tshooj 4052.4 (b)(1)(A), cov kev xeem CLIA-waived no yuav tsum kuaj xyuas lossis tshuaj xyuas rau SARS-CoV-2 (COVID-19) lossis lwm yam mob ua pa, mononucleosis, kis kab mob sib deev, strep caj pas, anemia, kab mob plawv, kab mob raum, mob raum, mob raum, mob ntshav qab zib mellitus. Kev siv yeeb tshuaj, lossis ntshav qab zib.​​  

Tsis tas li ntawd, cov kws muag tshuaj raug tso cai ua lwm yam kev xeem CLIA-raug zam uas raug zam raws li cov cai tswj hwm los ntawm tsoomfwv Saib Xyuas Nyiaj Txiag Saib Xyuas Kev Noj Qab Haus Huv thiab tau pom zoo los ntawm California State Board of Pharmacy, koom nrog Pawg Saib Xyuas Kev Kho Mob ntawm California thiab CDPH, raws li tau hais hauv B&P Code Tshooj 4052.4 (b)(1)(B). Cov kev ntsuam xyuas uas cov kws muag tshuaj yuav ua tau yuav tsum tsis txhob siv cov khoom uas sau los ntawm qhov chaw mos swab, venipuncture, los yog sau cov kua dej seminal.​​ 

2. Will this service include the Medi-Cal Medi-Cal Managed Care Organizations (MCOs) and/or Independent Physician Associations (IPAs)?​​ 

This provider bulletin applies specifically to providers enrolling in and billing fee-for-service (FFS) Medi-Cal for CLIA-waived tests. Pharmacies seeking to enroll and bill under FFS Medi-Cal must follow the requirements outlined in the bulletin. The bulletin does not apply to providers billing through MCOs or IPAs, which may have separate enrollment and billing processes.​​ 

Kev Them Nqi & Cov Nyiaj Them Rov Qab​​ 

1. Cov nyiaj them rov qab Medi-Cal yog dab tsi (cov nqi teem caij) rau cov kev xeem no?​​ 

For the most current Medi-Cal reimbursement rates for CLIA-waived tests, providers should refer to the Medi-Cal Rates webpage or contact the Medi-Cal Benefits Division at Medi-Cal.Benefits@dhcs.ca.gov.​​  

2. Is this carved out FFS similar to Medication Therapy Management (MTM) billing?​​ 

Pursuant to Executive Order N-01-19 pharmacy services are carved out, so all pharmacy providers that are billing Medi-Cal for pharmacy services are enrolling in FFS Medi-Cal. Therefore, this bulletin would apply to any pharmacy provider that is enrolled in FFS Medi-Cal, either by submitting a full application for new enrollment or by submitting a supplemental form if the provider is already enrolled. Pharmacy providers will be able to bill FFS Medi-Cal for these services.​​ 

Qhov no tsis zoo li MTM. MTM Pharmacy Services yuav tsum tau them nqi los ntawm Medi-Cal cov chaw muag tshuaj kho mob sab nraud thiab lub tsev muag tshuaj yuav tsum muaj daim ntawv cog lus ntxiv nrog DHCS los muab cov kev pabcuam MTM.​​   

3. Koj puas tuaj yeem qhia meej tias lub sijhawm them nqi Medi-Cal tam sim no tau tsim kho li cas rau cov chaw muag tshuaj ua cov kev xeem CLIA-tso, thiab seb cov nqi puas cuam tshuam txog cov nqi ua haujlwm tiag tiag thiab lub sijhawm kho mob cuam tshuam nrog cov kev pabcuam no?​​ 

Raws li Daim Ntawv Txuas 4.19-B, Nplooj Ntawv 3d, DHCS tau tso cai los tsim lossis kho cov nqi rau cov kev pabcuam kuaj mob hauv chaw kuaj mob kom tsis pub tshaj 100 feem pua ntawm daim ntawv teev nqi kuaj mob hauv chaw kuaj mob hauv tebchaws Medicare thiab daim ntawv teev nqi kws kho mob hauv chaw kuaj ... Yog xav paub txog tus nqi tam sim no, thov mus saib daim ntawv teev nqi ntawm DHCS Clinical Laboratory and Laboratory Services (CLLS).​​ 

4. Koj puas tuaj yeem hais meej yog tias cov kev pabcuam them rov qab yog rau tus nqi ntawm kev xeem CLIA zam lossis nws puas suav nrog lub sijhawm rau kev soj ntsuam kuaj mob thiab/lossis kev kho lossis kev xa mus raws li cov txiaj ntsig?​​ 

Please review the Medi-Cal Pathology: Billing and Modifiers (path bil) Billing Manual for more information about billing for CLIA waived tests.​​  

5. Yuav kom paub meej, peb yuav muaj peev xwm them nqi kuaj rau txhua tus neeg mob tab sis tsis yog kev pabcuam thaum tus neeg mob muaj MCO raws li lawv txoj kev npaj khomob?​​ 

Cov khw muag tshuaj tuaj yeem sau nqi Medi-Cal rau CLIA-tso cov kev xeem tsuas yog rau cov neeg mob cuv npe hauv tus nqi-rau-kev pabcuam Medi-Cal. Yog tias tus neeg mob tau cuv npe hauv Medi-Cal MCO, kev them nyiaj rov qab rau CLIA-tso kev xeem yuav tsum ua raws li cov cai thiab cov txheej txheem ntawm cov phiaj xwm kho mob tshwj xeeb ntawd. MCOs tsim lawv tus kheej cov chaw muab kev pabcuam thiab cov nqi them nqi, thiab kev pab them nqi ntawm CLIA-tso kuaj yuav txawv.​​ 

Cov tsev muag tshuaj yuav tsum txheeb xyuas tus neeg mob txoj kev npaj rau npe kawm thiab hu rau MCO uas tsim nyog los txiav txim seb qhov nqi them rau CLIA-tso kuaj tau tso cai thiab nyob rau hauv cov xwm txheej twg.​​  

6. Who should we contact for questions related to payment and access disparities caused under Assembly Bill (AB) 1114 transfer of responsibilities?​​ 

For questions related to payment and access disparities caused under AB 1114, please contact:​​ 

  • Pharmacy Benefits Division (rau Medi-Cal Rx thiab carve-out guidance):​​ 
  • CA-MMIS Help Desk (rau qhov tsis lees paub qhov kev thov thiab cov lus nug txog kev them nqi):​​