Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Administration Previews Booster Shot Recommendations

President Joe Biden announced last week that the U.S. will likely advise most Americans to get a coronavirus vaccine booster shot. The mRNA booster should be administered eight months after an individual received their second dose of either the Moderna or Pfizer vaccine; boosters will be made available as early as mid-September. Regulators are still awaiting the results of Johnson & Johnson’s clinical trial examining a two-dose regimen. The results are expected to be released later this month, though officials stated that they anticipate that booster shots will be needed for people who received the J&J vaccine as well. A statement from top individuals at the U.S. Department of Health and Human Services (HHS) asserts that the “COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection...we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.” Administration of booster shots will likely follow in the same tiered eligibility system used when vaccinations first began in late 2020, with nursing home residents, health care workers, and older people being first in line. The administration is expected to recommend that people receive a booster from the same manufacturer of their initial vaccine. The announcement comes amidst the surge of the Delta variant and concerns that Delta is able to evade the vaccine and that vaccine effectiveness has waned over time. The booster shot policy is dependent upon authorization of the additional shots by the Food and Drug Administration (FDA). The agency recently authorized third doses of both Pfizer and Moderna vaccines for certain populations with weakened immune systems. The nation’s top public health officials have also continued to emphasize “the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world,” following criticism from the World Health Organization (WHO) toward nations who are moving to administer booster shots despite shortages of the vaccine globally.

Pfizer COVID-19 Vaccine Expected to Receive Full Approval Soon

Reportedly, the Food and Drug Administration (FDA) is expected to grant full approval of Pfizer’s COVID-19 vaccine as early as this week. To date, the vaccine has been available under emergency use authorization.

WH to Tie Receipt of Federal Funds to Vaccination for Staff at Nursing Homes

President Biden announced that nursing homes currently participating in the Medicare and Medicaid programs will be required to vaccinate their staff against COVID-19 to continue receiving federal funds. In response, the American Health Care Association and National Center for Assisted Living wrote HHS Secretary Becerra and CMS Administrator Brooks-LaSure outlining concerns related to workforce shortages, access to quality care, and the disproportionate impact on women of color. The letter provides suggestions including a vaccine mandate for all health care workers in federally funded certified settings, education to address vaccine hesitancy, federally funded testing for unvaccinated staff, $3 billion from the Provider Relief Fund to recruit/replace and test staff, reopening the Provider Relief Fund, and allowing providers to ask visitors about their vaccination and test results.

Sources Say Woodcock No Longer Under Consideration to Lead FDA

The White House has ruled out Janet Woodcock as a potential nominee to serve as Commissioner of Food and Drugs, according to anonymous sources inside the administration. Woodcock, the Food and Drug Administration’s (FDA) acting commissioner, has been with the agency in various capacities for 35 years, most recently serving as the Director of the Center for Drug Evaluation and Research (CDER). She is eligible to remain acting commissioner until November 15, unless President Joe Biden nominates another candidate for the job. In this case, she could remain at her post throughout the nominee’s Senate confirmation process. Woodcock has faced criticism from lawmakers, including Democratic Sen. Joe Manchin (D-W.Va.), for her role in the approval of certain pain medications that contributed to the opioid epidemic and more recently for the accelerated approval of the Alzheimer’s treatment Aduhelm.

August 23, 2021: | Page 1 Page 2



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