The following is the latest health policy news from the federal government as of 1:30 p.m. on Friday, August 13. Some of the language used below is taken directly from government documents.
Food and Drug Administration
- The FDA has amended the emergency use authorizations for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to authorize administering an additional dose of those vaccines to certain immunocompromised individuals, including solid organ transplant recipients and those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
- The FDA has revised its emergency use authorization for the monoclonal antibody REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. Learn more here.
The White House
- The White House has posted a transcript of the August 12 press briefing given by its COVID-19 response team and public health officials. View press briefing slides here.
- The White House announced a series of COVID-19-related initiatives, including:
- $8.5 billion in American Rescue Plan funding in the coming weeks to help compensate health care providers that serve rural Medicare, Medicaid, and CHIP patients for lost revenue and increased expenses associated with COVID-19.
- $500 million in American Rescue Plan funding to create the Emergency Rural Health Care Grant Program, which will provide at least $350 million to help rural hospitals and local communities improve access to COVID-19 vaccines and testing, medical supplies, telehealth, and food assistance, and support construction or renovation of rural health care facilities and up to $125 million in grants to plan and implement models that help improve the long-term viability of rural health care providers.
- $52 million from the American Rescue Plan to train a range of health care workers to fill in-demand professions in rural areas affected by the pandemic. Applications for this funding will be available in the coming weeks.
- A demonstration project to enhance access to pulmonary rehabilitation services in critical access hospitals that serve rural communities with high rates of chronic obstructive pulmonary disease.
- Expanded Veterans Affairs training programs for rural providers.
Centers for Medicare & Medicaid Services
- CMS announced that people with Medicare who qualify for an additional dose of COVID-19 can receive it at no cost. This is in response to the FDA’s recent action to authorize an additional dose of COVID-19 vaccine for immunocompromised individuals. CMS will share more information and guidance in the coming days about billing and coding for the additional dose of the COVID-19 vaccine for immunocompromised patients.
- CMS has written to state officials to outline how it will assist states with their planning to resume routine Medicaid, CHIP, and Basic Health Program operations for the eventual end of the COVID-19 public health emergency. Specifically, this letter provides updated guidance that extends the timeframe for states to complete pending eligibility and enrollment work to up to 12 months after the public health emergency ends and requires states to complete a redetermination of eligibility after the public health emergency for all beneficiaries prior to taking any adverse action.
- CMS has published the latest edition of MLN Connects, its online weekly bulletin. This week’s edition includes articles about CMS resuming the Targeted Probe & Education program and new waived laboratory tests, effective October 1. For this and more, go here.
Health Policy News
- The Health Affairs Blog posted an entry by CMS leaders that lays out their vision for the agency over the next ten years. This vision is built on five objectives: drive accountable care, advance health equity, support innovation, address affordability, and partner to achieve system transformation. Learn more from the article “Innovation at The Centers for Medicare and Medicaid Services: A Vision for The Next 10 Years.”
Department of Health and Human Services
- HHS announced that it will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19. This includes staff at the Indian Health Service, the NIH, and members of the U.S. Public Health Service Commissioned Corps. Read the press release here.
Centers for Disease Control and Prevention
- The CDC has updated its Advisory Committee on Immunization Practices
- The CDC has added operational recommendations for community isolation centers for COVID-19 in low-resource settings.
- The CDC has updated guidance for health care providers on Lab Tests to Collect Shortly After Severe Allergic Reaction/Anaphylaxis Following COVID-19 Vaccination. This provides an overview of the timing and procedure for collecting blood samples for these lab tests.
- The CDC has provided guidance to vaccination clinics and providers on vaccinating older adults and people with disabilities at vaccination sites.
- The CDC has updated operational guidance for COVID-19 Vaccination Program jurisdictions operations.
- The CDC has updated its guidance on testing strategies for COVID-19.
Monday, August 23 – CMS
Advisory Panel on Hospital Outpatient Payment
Monday, August 23 from 9:30 a.m. to 5:00 p.m. (eastern)
CMS’s Advisory Panel on Hospital Outpatient Payment will meet virtually to advise the agency about the clinical integrity of the Ambulatory Payment Classification groups and their associated weights and about supervision of hospital outpatient therapeutic services. The advice provided by the panel will be considered as CMS prepares its annual updates for the hospital outpatient prospective payment system.
The public may participate in this meeting by webinar or teleconference. Teleconference dial-in and webinar information will appear on the final meeting agenda, which will be posted here when available.