Federal Health Policy Update for Tuesday, April 20

The following is the latest health policy news from the federal government as of 3:00 p.m. on Tuesday, April 20.

Congress

• This afternoon Senator John Cornyn (R-TX) put a hold on the president’s nomination of Chiquita Brooks-LaSure to be CMS administrator in response to the administration’s decision to revoke a Medicaid waiver the previous administration granted to his state.

The White House

COVID-19

• The White House has posted a transcript of the April 19 press briefing provided by its COVID-19 response team and public health officials.

Centers for Medicare & Medicaid Services

COVID-19

• CMS has issued section 1135 waivers to Colorado, Maine, and Tennessee.  1135 waivers give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 public health emergency.

Department of Health and Human Services

COVID-19

• HHS Secretary Xavier Becerra has renewed the COVID-19 public health emergency effective April 21, 2021.  The renewal is effective for 90 days.
• HHS has announced the availability of nearly $150 million in American Rescue Plan funds for community-based health care providers to aid their response to COVID-19.  These funds will support approximately 100 health center program look-alikes to respond to and mitigate the spread of COVID-19, strengthen vaccination efforts, and enhance health care services and infrastructure in communities across the country.  Applications are due in grants.gov by 11:59 p.m. (eastern) on May 14, 2021.  Visit the American Rescue Plan Funding for Look-Alikes technical assistance webpage for a complete list of eligible look-alikes, application instructions, deadlines, information about an applicant question and answer conference call, and other resources.

Food and Drug Administration

COVID-19

• The FDA has revoked its emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used to treat mild to moderate COVID-19 in adults and certain pediatric patients.  Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of COVID-19 variants that are resistant to bamlanivimab alone resulting in an increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.  For additional information, see the following resources:
  • The FDA’s announcement about this action
  • An FDA FAQ on the revocation
  • The FDA’s revocation letter to the manufacturer of bamlanivimab

• The FDA has authorized an amendment for many authorized COVID-19 tests that permits emergency use of such tests on pooled specimens for testing individuals without symptoms or other reasons when tested at least once a week as part of a serial testing program without prospective FDA review.  Learn more from this FDA announcement.

Centers for Disease Control and Prevention

COVID-19

• The CDC has updated a number of documents about COVID-19 vaccines, risks, and prevention.  The revised documents are:
  • “COVID-19 Vaccines for People at Increased Risk for Severe Illness from COVID-19”
  • “Key Things to Know About COVID-19 Vaccines”
  • “Reported Adverse Events”
  • “COVID-19 Vaccine Information for Specific Groups”
  • “Vaccination Considerations for Persons with Disabilities”
  • “Importance of COVID-19 Vaccination for Essential Workers”
  • “The Importance of COVID-19 Vaccination for Healthcare Personnel”
  • “When Vaccine is Limited, Who Gets Vaccinated First?”
  • “Frequently Asked Questions about COVID-19 Vaccination”
  • “Childhood Vaccination Toolkit for Clinicians”
  • “Guidance for Wearing Masks”
  • “Personal and Social Activities”
  • “People at Increased Risk”

National Institutes of Health

COVID-19

• The NIH announced that it will fund a large, randomized, placebo‑controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications for people to self-administer to treat symptoms of COVID-19.  Part of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership, the ACTIV-6 trial aims to provide evidence-based treatment options for the majority of adult patients with COVID-19 who have mild to moderate symptoms and are not sick enough to be hospitalized.  NIH will spend $155 million for the trial.  See the NIH announcement here.  Learn more about the ACTIV program here.

Medicaid and CHIP Payment and Access Commission

Health Policy News

• MACPAC has published an overview of the role Medicaid plays in rural health.  The brief describes the characteristics of rural residents generally, including socioeconomic factors, insurance status, and health status and then addresses provider availability, particularly for primary care services and rural hospitals. The brief concludes with a discussion of Medicaid policies and services that are particularly important for providing health care in rural areas.