CMS updated its COVID-19 billing FAQs on October 28 to address billing scenarios for potential monoclonal antibody treatments.
The two new FAQs, which appear in section BB. Drugs and Vaccines under Part B, address billing for monoclonal antibody treatments provided in the hospital outpatient setting.
CMS notes that if a monoclonal antibody product is granted an emergency use authorization that limits its use to the inpatient setting, organizations cannot bill Medicare for providing it to hospital outpatients.
If the product is approved for use in the hospital outpatient setting, organizations may use existing drug administration codes to bill for associated treatment services.
CMS will issue codes for the products themselves soon after they receive FDA approval or emergency use authorization.
In the interim period after a product is granted FDA approval or emergency use authorization and before CMS issues new codes, organizations should use HCPCS code C9399 (unclassified drugs or biologicals).
If a product with FDA approval or emergency use authorization is provided to an organization for free, the organization should bill the appropriate drug administration code, but it will not receive payment for the product itself.
If the organization acquires the product at a cost, it should follow its existing process for reporting the appropriate HCPCS codes, revenue codes, and charges.