The Centers for Medicare & Medicaid Services (CMS) announced that Medicare beneficiaries can receive coverage for monoclonal antibody infusions to treat COVID-19 with no cost-sharing during the COVID-19 Public Health Emergency (PHE), according to a press release from the agency.
CMS said its decision to cover monoclonal antibody infusions applies to bamlanivimab, which received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on November 9.
During the COVID-19 public health emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA). This would allow a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract for this, to administer this treatment in accordance with the EUA.
Medicare will not pay for the monoclonal antibody products that providers receive for free. If providers begin to purchase monoclonal antibody products, Medicare anticipates setting the payment rate for the product, which will be 95 percent of the average wholesale price for many healthcare providers, consistent with usual vaccine payment methodologies. Additionally, Medicare anticipates establishing codes and rates for the administration of the product.
In order to facilitate the efficient administration of COVID-19 vaccines to SNF residents, CMS will exercise enforcement discretion with respect to certain statutory provisions as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance (collectively, “SNF Consolidated Billing Provisions”). Through the exercise of that discretion, CMS will allow Medicare-enrolled immunizers including, but not limited to, pharmacies working with the United States, as well as infusion centers, and home health agencies to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare SNF residents.
Healthcare providers administering this monoclonal antibody infusion will follow the same enrollment process as those administering the other COVID-19 vaccines. Review provider enrollment information.
When healthcare providers begin to purchase monoclonal antibody products, Medicare anticipates setting the payment rate in the same way it set the payment rates for COVID-19 vaccines, such as based on 95 percent of the average wholesale price for COVID-19 vaccines in many provider settings. CMS said it will issue billing and coding instructions for health care providers in the coming days.
Initially, for the infusion of the bamlanivimab product, the Medicare payment rate for the administration of bamlanivimab will be $309.60. This payment rate is based on one hour of infusion and post-administration monitoring in the hospital outpatient setting. This rate will also be geographically adjusted. At a later date, we may use a similar methodology to determine the payment rate for the infusion of additional monoclonal antibody products based on the expected infusion time, consistent with the FDA emergency use authorization or FDA approval of such products.
- People with Medicare pay no cost sharing for these monoclonal antibody infusions:
- No copayment/coinsurance
- No deductible
- Billing for Monoclonal Antibody COVID-19 Infusion Administration
- Healthcare providers can bill for the administration of the monoclonal antibody infusion on a single claim for COVID-19 monoclonal antibody administration or submit claims on a roster bill, in accordance with the FDA EUA.
- The EUA for COVID-19 monoclonal antibody treatment bamlanivimab contains specific requirements for administration that are considerably more complex than for other services that are billed using roster billing. CMS expects that health care providers will maintain appropriate medical documentation that supports the medical necessity of the service. This includes documentation that supports that the terms of the EUA are met, including that it is being used for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) for a patient that is at high risk for progressing to severe COVID-19 and/or hospitalization. The documentation should also include the name of the practitioner who ordered or made the decision to administer the infusion, even in cases where claims for these services are submitted on roster bills.
- When COVID-19 monoclonal antibody doses are provided by the government without charge, providers should only bill for the administration. Health care providers should not include the monoclonal antibody codes on the claim when the product is provided for free.
- Health care providers who participate in a Medicare Advantage Plan should submit claims for bamlanivimab administration to Original Medicare for all patients enrolled in Medicare Advantage in 2020 and 2021.
