Knowledge Base Article

On March 5th, CMS updated their COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing document. Below is one of the recently added FAQs regarding payment for administering Remdesivir in the outpatient setting.  Note, I encourage you to check for updates to this document as it gets updated frequently.

Q:

“The current FDA approval for Veklury (Remdesivir) indicates that the drug “should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.” (Indications and Usage section at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0978fa8-53ff-4ca2-82a7-567fd3e958ca retrieved February 18, 2021). Will CMS pay for Remdesivir if it is administered in the outpatient setting?

A:

CMS expects that the vast majority of infusions of Remdesivir will take place in inpatient settings, consistent with the current drug labeling. These inpatient infusions could occur in traditional inpatient settings, or in alternate care sites that furnish inpatient care and bill under the Inpatient Prospective Payment System. Additional information regarding hospital flexibilities in place during the COVID-19 Public Health Emergency is available here: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

Questions about coverage of Remdesivir when a patient is not an inpatient, such as treatment occurring in outpatient hospital departments or in physician offices, should be directed to the Medicare Administrative Contractor that processes a provider or supplier’s claims. This includes questions about off label uses of Remdesivir, such as its use in outpatient acute care settings.”