The following is the latest health policy news from the federal government as of 3:15 p.m. on Monday, May 3.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Department of Health and Human Services

COVID-19

  • HHS and its Health Resources & Services Administration (HRSA) have announced a new program to cover the costs of administering COVID-19 vaccines for patients enrolled in health plans that either do not cover vaccination fees or that cover them with patient cost-sharing.  Since providers cannot bill patients for COVID-19 vaccination fees, this new program, the COVID-19 Coverage Assistance Fund (CAF), addresses an outstanding compensation need for providers.  Learn more about the program from HHS’s announcement about the new program and a new web page for the program.
  • To support the launch of this new COVID-19 Coverage Assistance Fund, HRSA will hold a webinar on Thursday, May 6 at 2:00 p.m. (eastern) to introduce stakeholders to what the program will do and how it will work.  Go here for further information and to register to participate.
  • HHS and HRSA have awarded more than $32 million in American Rescue Plan funds to 122 organizations that provide training and technical assistance support to HRSA Health Center Program-supported health centers nation-wide.  These organizations – Primary Care Associations (PCAs), National Training and Technical Assistance Partners (NTTAPs), and Health Center Controlled Networks (HCCNs) – will use the funds to provide health centers with COVID-19-related training, technical assistance, and health information technology support.  Learn more about the funding recipients and how and where the money will be used in this HHS news release.
  • HHS has updated the list of providers that have received grants from the CARES Act’s Provider Relief Fund.  Go here to explore the recipient database.

Health Policy News

  • CMS has extended and made some changes in its Comprehensive Care for Joint Replacement model.  The program has been extended for three years for some current participants; the basis for target price calculations has been changed; the definition of an episode of care has changed; and there are other changes.  See the final rule, which was published in the Federal Register, for further information about these and other changes.
  • CMS has announced changes in aspects of how the federal health insurance marketplace will operate in plan year 2022.  Among those changes is a provision that will lower maximum out-of-pocket costs to consumers by $400 while increasing competition among insurers.  CMS’s second 2022 Notice of Benefit and Payment Parameters final rule, also known as the “2022 payment notice,” includes several provisions to help consumers distinguish between plan options and increase opportunities to qualify for future special enrollment periods when consumers are eligible to enroll in marketplace plans outside annual open enrollment.  This includes laid-off workers, who will be eligible for a special enrollment period when their employer or federal subsidies end.  CMS expects these special enrollment period policies to offer greater flexibility for people who need health insurance.  Learn more about the changes these new policies will bring from the following sources:

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA has approved an abbreviated new drug application for 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) single-dose vial, indicated as an additive in parenteral (injection) fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion.
  • The FDA also has approved an abbreviated new drug application for Morphine Sulfate Injection USP, 30 mg/30 mL (1 mg/1 mL) single-dose (preservative-free Patient Controlled Analgesia [PCA] vial), indicated for the management of pain severe enough to require use of an opioid analgesic by PCA and for which alternative treatments are inadequate.
  • The FDA has revoked its emergency use authorization of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by health care personnel.  With supplies now improved, the FDA now discourages the reuse of N95 respirators.

National Institutes of Health

  • The NIH is awarding $29 million in grants funded by the American Rescue Plan for Community Engagement Alliance Against COVID-19 Disparities “To bolster research to help communities disproportionately affected by COVID-19…”  The awards will provide $15 million to 11 teams already conducting research and outreach to help strengthen COVID-19 vaccine confidence and access, testing, and treatment in communities of color.  An additional $14 million will fund 10 new research teams to extend the reach of COVID-19 community-engaged research and outreach.  Learn more from the NIH’s announcement about this initiative.

Stakeholder Events

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.

Wednesday, 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.

Wednesday, May 12

HHS Office of the Assistant Secretary for Preparedness and Response – Vaccine Promotion

Wednesday, May 12 at 1:30 pm ET.  Click here for further information and registration.

Speakers will discuss a New York City initiative dedicated to building confidence in COVID-19 vaccines; provide information about the current FDA-authorized COVID-19 vaccines and their safety and effectiveness; and share effective communication strategies to encourage friends, family, colleagues, and the community to get vaccinated.  The webinar will share additional educational resources and tools developed by local health care partners and there will be time for participant Q&A.