COVID-19 off-label and/or investigational drugs

The California Department of Health Care Services (DHCS) will cover and reimburse for Fee-for-Service Medi-Cal beneficiaries off-label and/or investigational drugs for use in COVID-19.  A Treatment Authorization Request (TAR) or Service Authorization Request (SAR) is not required.

FDA-approved drugs being used off label to treat COVID-19 must either be used as part of a registered clinical trial, or the treating physician must put appropriate documentation in the medical record.  Non-FDA-approved drugs must be used as part of a registered clinical trial or be used in accordance with the FDA’s Expanded Access pathway (sometimes called compassionate use).

Because of its need for other uses, DHCS is limiting Hydoxychloroquinine to 120 tablets per prescription and Chloroquinine to 60 tablets per prescription.  If a beneficiary needs a larger quantity, a TAR or SAR establishing medical necessity will be required.  (DHCS notice, April 3, 2020.)