On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. The EUA Fact Sheet is
here. Subsequently, the Centers of Medicare and Medicaid Services (CMS) issues a
Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction indicating that 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 nursing homes, and entities with whom nursing homes contract for this, to administer this treatment in accordance with the EUA. Health care providers, including SNF, administering this monoclonal antibody infusion will follow the same
enrollment process as those administering the other COVID-19 vaccines.
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% of the average wholesale price for many health care providers, consistent with usual vaccine payment methodologies. Additionally, Medicare anticipates establishing codes and rates for the administration of the product.
See the
Program Instruction for currently available coding and rate information. Of note, is that CMS states that “
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”).”
Not all details related to coding and billing have been issued yet. In recent communications with CMS related to SNF coverage, particularly the impact of the consolidated billing “enforcement discretion” provisions, the Agency stated to AHCA that “CMS can confirm the correctness of the summary…provided below. As more information becomes available, CMS will post the necessary information to the CMS website.”
Summary:
When looking at the current COVID-19 monoclonal antibody coverage policy documents in total, it appears that:
- CMS is approving coverage of monoclonal antibody treatment for COVID-19 for residents in a SNF.
- CMS is using enforcement discretion of SNF consolidated billing requirements so that all such treatments to SNF residents during the PHE can be paid under Medicare Part B (i.e. the services can be billed separately under Part B during a Part A covered stay);
- To the SNF if the SNF is enrolled as a Medicare immunizer and furnishes the services directly to the resident during a part A stay or a long stay resident; or
- To the SNF if the SNF has an arrangement with an outside entity that is enrolled as a Medicare immunizer and furnishes the services to the resident during a part A stay or a long stay resident; or
- To other Medicare enrolled immunizers who are not under arrangement with the SNF who vaccinate Medicare SNF residents during a part A stay or a long stay resident.
- The duration of this policy applies;
- During the PHE and ending on the last day of the calendar quarter in which the last day of such emergency period occurs; or
- So long as CMS determines that there is a public health need for mass COVID-19 vaccinations in congregate care settings—whichever is later.
AHCA will disseminate further guidance from CMS as it becomes available. Questions related to this topic may be submitted to
covid19@ahca.org.