Off-label and Investigational Drugs to Treat COVID-19

April 7, 2020

On March 23, 2020, the Department of Health Care Services (DHCS) received approval of a federal waiver allowing specific flexibilities in response to the COVID-19 public health emergency. Further, on March 28, 2020, the Food and Drug Administration (FDA) issued guidance specific to the use of Chloroquine Phosphate and Hydroxychloroquine Sulfate. As a result, on April 3, 2020, DHCS issued updated guidance relative to temporary flexibilities in dispensing/administration policies governing off-label and investigational use of medications used to treat COVID-19 under the Medi-Cal fee-for-service pharmacy benefit. The policy document is published on the COVID-19 webpage titled: Off-label and/or Investigational Drugs Used to Treat COVID 19 and/or Related Conditions. The policy is temporary and remains in effect until further notice.