The following is the latest health policy news from the federal government as of 3:00 p.m. on Wednesday, December 1. Some of the language used below is taken directly from government documents.
- The CDC has confirmed the first case of the COVID-19 omicron variant on U.S. soil. Learn more from this CDC news release.
Health Care Employee Vaccine Mandate
- A federal court has issued a preliminary injunction blocking enforcement of the federal government’s requirement that health care workers receive COVID-19 vaccines by December 6. Find the court’s ruling here. The ultimate ruling will be made by a higher court.
No Surprises Act
- CMS has released a series of documents addressing implementation of the No Surprises Act, the surprise medical billing law that takes effect on January 1. Go here for a link to a zip file of those documents.
- A reminder: stakeholder comments on the most recent regulation implementing the No Surprises Act are due this coming Monday, December 6,
The White House
- The White House has posted a transcript of the November 30 press briefing given by its COVID-19 response team and public officials. Go here for the slides presented during the briefing.
Centers for Medicare & Medicaid Services
- CMS has issued guidance to inform Medicare Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s) for COVID-19 if such drug(s) become available under FDA emergency use authorization and are procured by the federal government. Find that guidance here.
- CMS has updated its compendium of Medicare emergency declaration blanket waivers for health care providers with two changes: one, on page 21, addresses requirements for individuals employed as directors of food and nutrition services in long-term-care facilities and another, on page 33, alters Medicare ground ambulance data collection reporting requirements. Find the revised blanket waivers document here.
Health Policy Update
- CMS has published a request for public comments on potential changes in the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet to participate in the Medicare and Medicaid programs. Learn more about what CMS seeks in this Federal Register notice. Stakeholder comments are due in 60 days.
- CMS has announced that it will not move forward with the Seriously Ill Population component of its Primary Care First Model. That component was designed to have advanced primary care practices coordinate care for high-need, seriously ill beneficiaries. After review, CMS concluded that the program’s outreach methodology was unlikely to result in sufficient beneficiary participation to allow for model evaluation. Learn more from this CMS announcement.
- CMS has published two documents addressing Medicaid and CHIP in the post-COVID-19 world: “Strategies States and the U.S. Territories Can Adopt to Maintain Coverage of Eligible Individuals as They Return to Normal Operations” and “Connecting Kids to Coverage: State Outreach, Enrollment and Retention Strategies.”
- CMS has posted the latest edition of MLN Connects, its online publication addressing Medicare payment matters. This edition includes items on new 2022 web pricers for inpatient prospective payment system hospitals, inpatient rehabilitation facilities, and long-term-care hospitals; information about the 2022 physician fee schedule rule; news about telehealth originating site facility payments; information about disproportionate share hospital (DSH) payments; and more. Go here for the new MLN Connects.
Department of Health and Human Services
Health Policy Update
- HHS has launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program. The purpose of the site is to provide the health care and public health sectors “…with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector.” The website features health care-focused resources such as cybersecurity posters and infographics, installments of a bi-monthly newsletter, webinar recordings, and threat-specific products to support cybersecurity awareness and training. Learn more from this HHS news release and go here to find the new site.
Centers for Disease Control and Prevention
- The CDC has issued a news release strengthening its recommendation on booster doses for individuals who are 18 years and older. The agency now encourages everyone ages 18 and older to get a booster shot either when they are six months after their initial Pfizer or Moderna series two 2 months after their initial Johnson & Johnson vaccine.
- The CDC has updated its reference guide for clinic administrators and health care professionals to document vaccinations at third-party clinics, including backdating vaccination events, bulk uploading past vaccinations, and editing or invalidating vaccination records. Find the guide here.
- The CDC has posted updated information about:
Food and Drug Administration
- The FDA has updated its guidance on the use of the monoclonal antibodies amlanivimab and etesevimab when administered together, expanding their authorized use to all U.S. states and territories. Find that guidance here.
- The FDA has issued emergency use authorization for the emergency use of the unapproved monoclonal antibody product sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct COVID-19 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death. Go here for an FDA fact sheet on the drug’s use.
- The FDA has issued a statement outlining its efforts to investigate and address the potential impact of the COVID-19 omicron variant. Find that statement here.
CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2
The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model. The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority. The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern). Go here for more information about the webinar and to register to participate.
Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8
CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity. The agency also invites written comments on the subject. For further information about the roundtable and to register to participate, go here.
CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9
The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19. Go here to learn more about the webinar and how to participate.
MEDPAC – commission meeting – December 9-10
Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10. Information about how to join the meeting will be forthcoming; when it is, that information will be posted here.