RISE summarizes recent regulatory-related headlines.
CMS to appeal UnitedHealth’s MA Star ratings recalculation win
The Centers for Medicare & Medicaid Services (CMS) plans to appeal a federal judge’s order to recalculate the Medicare Advantage carrier’s Star ratings. The news was first reported by Modern Healthcare.
In November, UnitedHealth won a partial victory in its lawsuit against CMS, claiming that its quality score was downgraded on an arbitrary and capricious assessment of how its call center handled a single phone call from a CMS test caller that lasted less than 10 minutes. Judge Jeremy Kernodle of the U.S. District Court for the Eastern District of Texas ordered the agency to recalculate UnitedHealthcare’s Star rating without consideration of the disputed call.
This week, attorneys for CMS filed a notice to appeal the decision but didn’t include the grounds for the appeal.
Trump administration announces ‘regulatory freeze’
President Trump has ordered a government-wide freeze on regulatory actions while the new administration reviews existing and proposed regulations by the Biden administration. The freeze prevents all departments and agencies from issuing proposed or final rules until a department head or agency head appointed or designed by President Trump reviews and approves the rule. The executive order also calls for the immediate withdrawal of any rules sent to the Office of Financial Research but not yet published in the Federal Register. The freeze also suggests postponing for 60 days any published rules that have yet to take effect.
Confirmation hearings set for RFK Jr. nomination to HHS
The United States Senate Committee on Finance has scheduled a confirmation hearing to consider the nomination of Robert F. Kennedy, Jr., of California, to be secretary of Health and Human Services. The hearing will take place on Wednesday, January 29 and the Finance Committee will decide whether to advance his nomination to the full Senate. The next day he will appear before the Senate Health, Education, Labor, and Pensions (HELP) Committee, The nomination of RFK Jr. has raised concerns due to his anti-vaccination beliefs and false claims linking vaccines to autism. However, the fact that the committees have scheduled back to back hearings appear to suggest confidence by the White House and Senate leaders that Kennedy will be confirmed, Modern Healthcare reported.
US to leave WHO next year
President Donald Trump has signed an executive order to withdraw the United States from the World Health Organization over the organization’s handling of the COVID-19 pandemic. The withdrawal is due to take effect January 22, 2026. The United States joined WHO as a founding member in 1948. During his first term in office, President Trump took steps to withdraw from the organization, but Biden reversed the decision. WHO said it regrets the announcement and hopes that Trump will reconsider the decision.
“For over seven decades, WHO and the USA have saved countless lives and protected Americans and all people from health threats,” WHO said in the statement. “Together, we ended smallpox, and together we have brought polio to the brink of eradication. American institutions have contributed to and benefited from membership in WHO.”
Lawsuits block rule to crackdown on agent, broker inappropriate sales tactics
A Commonwealth Fund blog post reviews the lawsuits that have prevented the implementation of certain provisions within a Centers for Medicare & Medicaid Services (CMS) final rule that crackdowns on incentives to agents and brokers to steer Medicare beneficiaries into particular plans. Blog post authors from the Center for Medicare Advocacy note that the provision within the 2025 Medicare Advantage Final Rule, which was finalized in April 2024, was supposed to take effect in October 2024. At issue is whether CMS has the authority to regulate the payments. Field marketing organizations and trade organizations have filed three lawsuits to nullify the broker provisions. Two of the cases have been consolidated and in July, U.S. District Judge Reed O’Connor paused the implementation of the provisions to cap compensation for administrative costs and restrict field marketing organization contract terms. What happens next is unclear due to the new White House administration. The authors say the new administration may decide not to defend the case or could issue a new rule that addresses broker and agent compensation and sales tactics.
Moderna receives $590M to develop bird flu vaccine
The U.S. Department of Health and Human Services (HHS) announced it will provide approximately $590 million to Moderna to accelerate the development of mRNA-based pandemic influenza vaccines and enhance mRNA platform capabilities so that the U.S. is better prepared to respond to other emerging infectious diseases.
The award was made through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR).
This funding allows Moderna to accelerate development of an H5N1 mRNA influenza vaccine that is well matched to strains currently circulating in cows and birds and expands the clinical data supporting the use of mRNA vaccines that may be needed if other influenza strains emerge with pandemic potential.
“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past. That is why this response has been a top priority for the Biden-Harris Administration and HHS,” said former HHS Secretary Xavier Becerra in a statement released January 17. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”