The following is the latest COVID-19 information from the federal governments as of 2:45 p.m. on Friday, December 4.

Centers for Medicare & Medicaid Services

  • CMS has updated its FAQs on Medicare fee-for-service billing with 14 new questions that address administration and billing for monoclonal antibody therapy.  The new questions can be found on pages 33-34, p. 34, pp. 120-121, p. 121, pp. 121-124, pp. 124-125, p. 125 (four questions), p. 126, pp. 126-127, p. 127, and pp. 127-128.
  • CMS covers much the same ground in an updated version of its document “Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction.”
  • CMS has published a statement on its intended use of its enforcement discretion on skilled nursing facility consolidated billing for COVID-19 vaccines and monoclonal antibody infusions.  Through the exercise of this discretion, CMS will permit Medicare-enrolled immunizers to bill directly and receive direct reimbursement from the Medicare program.  Go here to see the complete statement.


Coronavirus (COVID-19) Stakeholder Calls 

CMS hosts recurring stakeholder engagement sessions to share information about the agency’s response to COVID-19.  These sessions are open to members of the health care community and are intended to provide updates, share best practices among peers, and offer participants an opportunity to ask questions of CMS and other subject matter experts.

COVID-19 Office Hours Call

Tuesday, December 8 at 5:00 (eastern)

Toll Free Dial-In:  833-614-0820; Access Passcode:  3129517

Audio Webcast link:  go here.

Tuesday, December 22 at 5:00 (eastern)

Toll Free Dial In:  833-614-0820; Access Passcode:  3968359

Audio Webcast link:  go here.

Conference lines are limited so CMS encourages interested parties to join via audio webcast.

To listen to the audio files and read the transcripts for past stakeholder calls, go here.

Department of Health and Human Services

  • HHS has issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19, including greater use of telehealth.  Go here for a more detailed description of what the amendment authorizes.


Food and Drug Administration

  • On Tuesday, December 8 at noon (eastern) the FDA will host a webinar on its enforcement policy for sterilizers, disinfectant devices, and air purifiers during the COVID-19 pandemic as part of its series on respirators and other personal protective equipment for health care personnel use during the pandemic.  Go here for further information about the webinar and how to participate.
  • The FDA has issued emergency use authorization for a bioburden-reduced N95 respirator.  See the FDA’s letter of authorization and its fact sheet for health care providers.


Centers for Disease Control and Prevention