The following is the latest health policy news from the federal government as of 3:00 p.m. on Tuesday, April 27.
The White House
COVID-19
- The White House has posted a transcript of the April 23 press briefing provided by its COVID-19 response team and public health officials.
Health Policy News
- The White House has nominated Miriam Delphin-Rittmon to serve as Assistant Secretary for Mental Health and Substance Use in the Department of Health and Human Services. The nomination is subject to Senate confirmation.
Congress
- The New Democrat Coalition is a group of 94 mostly centrist Democrats working to bridge the gap between left and right on health care by offering proposals that seek to build on the policy infrastructure that currently exists rather than replacing it. The coalition has written to President Biden with its list of policy recommendations that it asks him to incorporate into the American Families Plan. Learn more about the New Democrat Coalition here and learn more about the health care policies it espouses in its recent letter to President Biden.
- A group of 17 Democratic senators has written to President Biden asking him to pursue expansion of Medicare in his soon-to-be-unveiled American Families Plan. Read that letter here.
Department of Health and Human Services
COVID-19
- HHS has published a fact sheet for uninsured patients about free COVID-19 tests, vaccines, and care. The fact sheet also is available in Spanish.
- Another HHS fact sheet reminds providers that COVID-19 vaccines are free for all individuals in the U.S. and that only insurance companies and the federal government, not patients, can be billed for vaccine administration. This fact sheet, too, is available in Spanish.
Health Policy News
- HHS has announced the availability of $1 billion in American Rescue Plan money for Health Resources and Services Administration (HRSA)-Health Center Program-funded health centers to support major construction and renovation projects across the country. Health centers that receive this funding will be able to use it for COVID-19-related capital needs and to construct new facilities, renovate and expand existing facilities, and purchase new equipment. All of the nation’s nearly 1,400 HRSA-funded health centers will be eligible for these funds. See the HHS announcement here and find information about submitting applications, which are due June 24, here.
- HHS has released new buprenorphine practice guidelines that, among other things, remove a long-time requirement tied to training, which some practitioners have cited as a barrier to treating more people. The order exempts eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from federal certification requirements related to training, counseling, and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine. For additional resources, consult:
- HHS has published a request for information in the Federal Register about the development of a national public health strategy for the prevention and control of vector-borne diseases in humans. The RFP solicits “…specific input regarding strategic goals, benchmarks, gaps, duplicative federally funded programs, and opportunities to enhance coordination data collection, research, and the development of diagnostics, treatments, vaccines and other related activities…” Submissions are due by June 11. Go here to see the notice.
- The administration has announced a new round of appointments to staff positions at HHS. They are:
Office of the Secretary
Cynthia Palafox (she/her), Director of Scheduling and Advance
Karuna Seshasai (she/her), Executive Secretary
Alia Schechter (she/her), Special Assistant to the Secretary
Office of Intergovernmental and External Affairs
Carrie Pugh (she/her), Director of External Affairs
Office of the Assistant Secretary for Public Affairs
Tericka Lambert (she/her), Director of Digital Engagement
Office of the Assistant Secretary for Legislation
Rose Sullivan (she/her), Principal Deputy Assistant Secretary for Legislation
Office of the Assistant Secretary for Health
Arsenio Mataka (he/him), Senior Advisor for Health Equity and Climate
Administration for Children and Families
Kathryn “Kate” Wolff (she/her), Senior Advisor
Centers for Medicare and Medicaid Services
Hannah Katch (she/her), Senior Advisor
Food and Drug Administration
Erica Jefferson (she/her), Associate Commissioner for External Affairs
Food and Drug Administration
COVID-19
- The FDA and CDC have lifted the pause on use of the Johnson & Johnson Janssen vaccine. See the agencies’ joint news release announcing and explaining their decision.
- The FDA has published a notice in the Federal Register about the authorization of emergency use of certain medical devices during the COVID-19 emergency. The notice, found here, includes COVID-19 diagnostic tests.
Centers for Disease Control and Prevention
COVID-19
- In light of the FDA/CDC decision permitting providers to resume use of the Johnson & Johnson Janssen vaccine, the FDA has revised its update on this vaccine.
- The CDC also has posted the updated recommendations of its Advisory Committee on Immunization Practices for use of the Johnson & Johnson Janssen vaccine.
- The CDC has posted guidance about enrolling to become a provider of COVID-19 vaccines.
- The CDC has updated its FAQs about COVID-19 vaccines.
- The CDC has updated its information about adverse effects from receiving COVID-19 vaccines.
- The CDC has updated its advice about COVID-19 vaccines for people with various underlying medical conditions and living arrangements and different types of employment.
- A separate, updated CDC document focuses more specifically on vaccines for people with underlying medical conditions.
- During the April 23 briefing by the White House COVID-19 response team and public health officials, CDC director Rochelle Walensky, MPH, MD, pointed out a new study published in the New England Journal of Medicine about pregnant women and COVID-19 vaccines and said that “…CDC recommends that pregnant people receive the COVID-19 vaccine.” Find a transcript of that briefing here.
- The CDC has updated its information about COVID-19 variants and definitions.
- The CDC has updated its data on COVID-19 variants, including data on where these variants are being found and in what proportions the different variants are being identified.
- The CDC has updated its information about nucleic acid amplification tests (NAATs), a type of viral diagnostic test for COVID-19 that detects genetic materials – specifically, the RNA sequences that comprise the genetic material of the virus.
- The CDC has updated its guidance on infection prevention and control for people who have been vaccinated against COVID-19. This guidance is for health care workers while at work and patients and residents while they are being cared for in health care settings.
- The CDC has updated its guidance for people who have been vaccinated against COVID-19. This is the newly updated guidance that addresses revised practices for wearing masks and participating in various types of indoor and outdoor gatherings.
- The CDC has updated its guidance on how people can protect themselves after they have been vaccinated against COVID-19.
- The CDC has updated its guidance on daily activities and going out after being vaccinated against COVID-19.
- The CDC has updated its guidance on domestic travel during the COVID-19 pandemic.
Medicaid and CHIP Payment and Access Commission
COVID-19
- MACPAC has published a report on provider use of Medicaid retainer payments during the COVID-19 pandemic. Retainer payments are temporary payments intended to preserve the financial viability of providers during disruptions in care, and unlike most other types of Medicaid payments, they are not tied to specific services used by a Medicaid enrollee. During the COVID-19 pandemic, many states have used retainer payment authority as a source of relief for home and community-based providers experiencing decreases in utilization, temporary practice closures, or other circumstances that limit their ability to provide covered services to Medicaid beneficiaries. See the MACPAC report here.
Stakeholder Events
Tuesday, April 27
FDA Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Tuesday, April 27 at 12:00 pm ET. Click here for connection information.
The FDA hosts a webinar series to keep stakeholders informed about the latest resources and news related to PPE use during the COVID-19 pandemic.
Wednesday, April 28
FDA Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
Wednesday, April 28 at 12:15 pm ET. Click here for connection information.
The FDA will host a virtual town hall for COVID-19 test developers. The purpose of this event is to help answer technical questions about the development and validation of tests for COVID-19.
Thursday, April 29
FEMA National Business Emergency Operations Center Business & Infrastructure Conference Call
Thursday, April 29 at 3:00 pm ET. Conference Dial-in: 800-619-3427, Participant PIN: 2725748.
This is a business and infrastructure partners call in alignment with President Biden’s plan to respond to COVID-19. FEMA will work with other federal agencies to coordinate with state, tribal, and territorial authorities and private sector partners and others to assist, augment, and expedite vaccinations in the United States.
Wednesday, May 5
FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs
Wednesday, May 5 at 9:00 am – 12:30 pm ET. Click here for connection information.
The FDA will provide an overview of product-specific guidances, including how they are developed and revised and their role in facilitating generic drug development and generic drug application review. The FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development.
Wednesday, May 5
CDC Zoonoses and One Health Update (ZOHU) Call
Wednesday, May 5, at 2:00 pm – 3:00 pm ET. Click here to learn more.
ZOHU calls are one-hour monthly webinars that provide education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.
Friday, May 7
FDA -Common Labeling Deficiencies and Tips for Generic Drug Applications
Friday, May 7 at 1:00pm – 2:00pm ET. Click here for connection information.
The FDA will discuss the most common labeling mistakes found in abbreviated new drug applications (ANDAs) and how to avoid them and offer other labeling tips. The FDA also will provide answers to common labeling questions asked by generic drug applicants.
Friday, May 12
Cybersecurity and Infrastructure Security Agency (CISA)
CISA 2021 Hurricane Webinar
Wednesday, May 12 at 10:30 am – 12:00pm ET. Click here for registration.
This webinar will focus on providing awareness of CISA’s role and resources in hurricane preparedness and response activities associated with systems that make landfall on the continental U.S. or U.S. territories while in a COVID-19 environment. It will also feature presentations from the NOAA Liaison to the National Operations Center and FEMA’s National Business Emergency Operations Center.