The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, January 3.  Some of the language used below is taken directly from government documents.

The White House

• President Biden has issued a memorandum to the Secretary of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Federal Emergency Management Agency on maximizing assistance to respond to COVID-⁠19.  Among other things, the memorandum calls for FEMA to provide emergency and disaster assistance, to establish or expand COVID-19 testing sites at the request of state governments, and to underwrite the full costs it incurs in such efforts.  Learn more from the memorandum.
• The White House has posted a transcript of the December 29 press briefing given by its COVID-19 response team and public officials.

Provider Relief Fund

• The Provider Relief Fund reporting portal is now open for reporting period 2 and will remain open through March 31, 2022.  Go here for more information about what organizations do and do not need to report and how to do so.

Centers for Medicare & Medicaid Services

COVID-19

• CMS has issued a letter to state survey agencies, such as state Medicaid programs and public health departments, outlining its requirements for COVID-19 vaccine immunization of staff among Medicare- and Medicaid-certified providers and suppliers.  Find that letter here.  The agency also has updated its FAQ on health care staff vaccination, including with information about the impact of current litigation on the vaccination mandate.
• CMS has published a series of infographics that illustrate different aspects of COVID-19 vaccination requirements for health care providers.  These graphs address:
  • to whom COVID-19 health care provider and supplier vaccine requirements apply
  • deadlines for meeting provider and supplier vaccination requirements
  • the federal process for enforcing vaccination requirements
  • a decision tree for determining to whom vaccination requirements apply.

Health Policy Update

• CMS’s Center for Medicare and Medicaid Innovation has a “Most Favored Nation Model” that seeks to test a way to lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other, similar countries. The program was schedule to begin in 2021 but was delayed when a federal court issued a preliminary injunction against that implementation.  Between the court’s ruling and stakeholder feedback, CMMI has decided to withdraw its Most Favored Nation Model and did so in this Federal Register notice.  Additional information can be found on CMMI’s Most Favored Nation Model web page.

Department of Health and Human Services

Health Policy Update

• HHS is working with states to promote access to Medicaid services for people with mental health and substance use disorder crises by giving states a new option for supporting community-based mobile crisis intervention services for individuals with Medicaid through newly available federal funds.  The American Rescue Plan grants CMS new authority to provide states with additional resources and tools to enhance these programs, including additional federal funding to states for qualifying mobile crisis intervention services for three years.  This new Medicaid option also offers flexibility for states to design programs that work for their communities, allowing states to apply for this new option under several Medicaid authorities.  Learn more from this HHS news release and this guidance letter CMS has sent to state Medicaid directors.
• HHS has published a Notice of Benefit and Payment Parameters 2023 Proposed Rule that seeks to make it easier for consumers to find affordable, comprehensive health coverage.  Among other steps, the proposed rule seeks to advance standardized plan options, implement network adequacy reviews, strengthen access to essential community providers, and prohibit discriminatory practices.  Learn more from this HHS news release, this HHS fact sheet, and the proposed rule itself.  Interested parties have until January 27 to submit formal written comments.

Occupational Safety and Health Administration (OSHA)

• In June, OSHA adopted a “Healthcare Emergency Temporary Standard” to protect workers from COVID-19 in settings where they provide health care or health care services, doing so with the expectation that this standard would be formalized in regulation within six months.  Now, OSHA has announced that while the regulation still has not been finalized it “…will vigorously enforce the general duty clause and its general standards, including the Personal Protective Equipment (PPE) and Respiratory Protection Standards, to help protect healthcare employees from the hazard of COVID-19” while modifying certain other aspects of the standard.  Learn more about the standard and the ways in which the agency intends to enforce and modify it in this OSHA statement.

Centers for Disease Control and Prevention

• The CDC has updated, and reduced, its recommended isolation and quarantine periods for people who have contracted or come into contact with individuals who have contracted COVID-19.  Find the details in this CDC news release and from this updated CDC guidance.  These new standards do not apply to health care providers.
• The CDC has updated its strategies for administering tests for COVID-19.
• The CDC has updated its FAQ about COVID-19 vaccines and its general and safety information about the Johnson & Johnson COVID-19 vaccine, and its information about COVID-19 vaccine boosters its guidance for receiving those boosters, including its preference that people receive Pfizer or Moderna boosters.
• The CDC has updated its reporting on people who have experienced adverse effects from COVID-19 vaccines and its research on the safety of COVID-19 vaccines for children between the ages of five and 11.
• The CDC has updated its information about the value of COVID-19 vaccinations for people with certain underlying medical conditions and its guidance for women who are breastfeeding and who either have been diagnosed with COVID-19 or have been exposed to someone who has been diagnosed with or exposed to someone with COVID-19.
• The CDC has posted information about improving equity in the administration of childhood COVID-19 vaccines and separate information about barriers to such equity.
• The CDC has updated its information about how to replace lost vaccination cards.

Food and Drug Administration

• The FDA has amended its emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to expand the use of a single booster dose to include use in individuals 12 through 15 years of age; to shorten the time between the completion of the original Pfizer vaccine regimen and a booster dose to at least five months; and to allow for a third primary series dose for certain immunocompromised children five through 11 years of age.  Learn more from this FDA news release.
• The FDA has updated its EUA for COVID-19 convalescent plasma by placing new limits on its use.  See the announcement here and the revised EUA here.
• The FDA is inviting industry organizations to participate in the selection of non-voting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health by nominating such individuals in writing.  The agency also seeks nominations for non-voting industry representatives to serve on certain device panels.  Learn more from this Federal Register notice.  The deadline for nominations is February 2.

Stakeholder Events

HHS Office of the Assistant Secretary for Preparedness – January 6

HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and Project ECHO will hold a “COVID-19 Clinical Rounds: A Peer-to-Peer Virtual Community of Practice” event on Thursday, January 6 at 12:00 (eastern).  COVID-19 Clinical Rounds are resource webinars intended for consultant physicians involved in critical care practice, fellows, residents, pharmacists, nursing staff, nurse practitioners, physician assistants, respiratory therapists, and allied health staff.  Go here to register for the January 6 event and find recordings of previous events here.

MedPAC – January 13-14

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on January 13 and 14.  Watch this space for a meeting agenda and information about virtual participation.

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Watch this space for a meeting agenda and information about virtual participation.