Federal Health Policy Update for Tuesday, April 27

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

Health Policy News

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

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

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 SeriesCoronavirus (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.