Federal Health Policy Update for Wednesday, April 14

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, April 14.

Temporary Halt to Use of the Johnson & Johnson Janssen Vaccine

• The White House held a press briefing on Tuesday, April 13 during which the White House press secretary, its COVID-19 response coordinator, and Dr. Anthony Fauci discussed the decision to halt administration of the Johnson & Johnson (Janssen) vaccine until its safety can be further examined.  Learn more from a transcript of that briefing.
• Representatives of the FDA and CDC briefed the news media on the situation involving the Johnson & Johnson vaccine.  Listen to that briefing here.
• The FDA and CDC issued a joint statement noting some adverse effects from the Johnson & Johnson COVID-19 vaccine and explaining that

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.

• The CDC has published a health alert about its recommended pause in the use of the Johnson & Johnson COVID-19 vaccine, in part to ensure that providers are aware of the potential for adverse events and can provide proper management due to the unique treatment required with this type of blood clot.  This alert includes specific recommendations for clinicians.  Find that alert here.
• The CDC also published an explanation of its decision to halt use of Johnson & Johnson’s Janssen COVID-19 vaccine and updated the following vaccine-related guidance and informational documents:
  • Information About Johnson & Johnson’s Janssen COVID-19 Vaccine
  • Selected Adverse Events Reported after COVID-19 Vaccination
  • Key Things to Know About COVID-19 Vaccines
  • Understanding Viral Vector COVID-19 Vaccines
  • Different COVID-19 Vaccines
  • Frequently Asked Questions about COVID-19 Vaccination
  • Vaccines for COVID-19
  • Ensuring the Safety of COVID-19 Vaccines in the United States

Congress – Medicare Sequestration Legislation

COVID-19

• The House has passed a bill to extend the moratorium on the two percent Medicare sequestration cut that has been delayed throughout the pandemic; this latest delay would extend to December 31, 2021.   President Biden is expected to sign the bill and then CMS will begin processing the claims it has been holding since April 1 in anticipation of the bill’s passage.  Those claims will be paid without the two percent sequestration deduction.

The White House

COVID-19

• The White House has posted a transcript of the April 14 press briefing provided by its COVID-19 response team and public health officials.

Centers for Medicare & Medicaid Services

COVID-19

• CMS is terminating some of its COVID-19 waivers for health care providers that apply to long-term-care settings.  Find the terminated waivers, marked in red with “terminated effective,” followed by a May 9 or May 10, 2021 date, on pages 18 and 19 of its compendium of COVID-19 emergency blanket waivers.

Health Policy News

• CMS has extended the deadline for interested parties to apply to participate in its Primary Care First Cohort 2 to May 21, 2021 and the deadline for payer applications has been extended to June 18, 2021.  Learn more from the following resources:
  • A fact sheet about the program.
  • The primary care first web page.
  • Register here for a May 5 webinar during which CMS officials will answer  questions about eligibility, payment design, attribution, and more.
  • Register here for a similar webinar on May 12.
  • Consult resources from two March webinars:  Introduction to PCF and Ready, Set, Apply.

Department of Health and Human Services

COVID-19

• HHS’s Office for Civil Rights, Administration for Community Living, and Office of the Assistant Secretary for Planning and Evaluation have published several new resources to help states, vaccination providers, and others’ COVID-19 response activities improve access to vaccines for people with disabilities and older adults.  These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and offer strategies for ensuring accessibility.  These resources include:
• New guidance from the Office for Civil Rights outlining legal standards under federal civil rights laws prohibiting disability discrimination and providing examples of the application of legal standards in the context of COVID-19 vaccine programs and how to implement them.
• An Office of Civil Rights fact sheet presenting specific steps that those involved in the planning and distribution of vaccines to combat the COVID-19 pandemic may wish to consider to promote compliance with disability rights laws and provide access to vaccination programs for people with disabilities.
• The Administration for Community Living has compiled strategies and best practices for helping older adults and people with disabilities gain access to COVID-19 vaccines.
• Learn more about these activities and other relevant resources from these agencies in the HHS news release announcing this initiative.

Health Policy News

• HHS marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventive care in rural areas to improve maternal health outcomes.  HHS also announced that Illinois will be the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery.  In addition, HHS announced a Notice of Funding Opportunity that will make $12 million available over four years for a Rural Maternity and Obstetrics Management Strategies program that will enable awardees to test models to address unmet needs for their target population, with applicants required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.  Three award recipients will each receive up to $1 million annually for up to four years to test models to address unmet needs for their target population.  Learn more from the following resources:
  • HHS’s announcement about this initiative.
  • HHS’s letter to Illinois authorizing the section 1115 waiver to extend Medicaid eligibility to women for one year after they give birth.
  • The Health Resources and Services Administration (HRSA) news release announcing the Rural Maternity and Obstetrics Management Strategies program.
  • HRSA’s web page for this program and the grant funding opportunity.
  • HHS is proposing a new rule to revise the Title X family planning program regulations.  Its Notice of Proposed Rulemaking, entitled “Ensuring access to equitable, affordable, client-centered, quality family planning services,” will be open for comment for 30 days starting Thursday, April 15, 2021.  Go here to see its announcement about its intentions and here to see a pre-publication version of the notice itself.
• HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Training in Primary Care Medicine and Dentistry.  Nominations are due September 30.  See the HRSA notice here.

Food and Drug Administration

COVID-19

• The FDA has issued new guidance to describe how it will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under its bioresearch monitoring program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

Government Accountability Office

COVID-19

• The GAO has published a new report titled “Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation.”  Find a brief summary of the report here and the entire report here.