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HHS appeals ruling that stalled many of Kennedy’s vaccine policy changes
The Department of Justice is appealing a ruling by a federal judge which stalled many of health secretary Robert F. Kennedy Jr.’s changes to federal vaccine policy.
The appeal, filed Wednesday, is the latest twist in the closely watched lawsuit filed by the American Association of Pediatrics along with several other professional organizations and several anonymous women. The organizations argued that in reconstituting a federal vaccine advisory committee and changing the childhood vaccine schedule, Kennedy’s health department violated the Administrative Procedures Act, which governs how federal agencies consider and implement policy changes.
The Department of Justice is appealing a ruling by a federal judge which stalled many of health secretary Robert F. Kennedy Jr.’s changes to federal vaccine policy.
The appeal, filed Wednesday, is the latest twist in the closely watched lawsuit filed by the American Association of Pediatrics along with several other professional organizations and several anonymous women. The organizations argued that in reconstituting a federal vaccine advisory committee and changing the childhood vaccine schedule, Kennedy’s health department violated the Administrative Procedures Act, which governs how federal agencies consider and implement policy changes.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
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STAT+: CMS recalculates Medicare Advantage star ratings again, adding more volatility to program
Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.
Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.
Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020.
Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.
Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.
Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020.
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STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy
A panel of advisers to the Food and Drug Administration gave its endorsement Thursday to a seasonal mRNA flu vaccine that was developed by Moderna and that earlier this year became the subject of controversy when a top agency official briefly refused to even consider accepting it for review.
The Vaccines and Related Biological Products Advisory Committee — known as VRBPAC — voted unanimously that the benefits of the vaccine outweigh the risks for both adults aged 50 to 64, and those 65 and older. It remains to be seen what the FDA will decide, but staff presentations during the meeting suggested the agency sees the vaccine as having cleared sufficient hurdles to be licensed via a traditional pathway for the younger group, and an accelerated pathway for the older group.
Multiple flu vaccines currently on the market were first licensed using an accelerated pathway, Wellington Sun, a former FDA employee, noted during the meeting’s public comment period. (After leaving FDA, Sun worked for Moderna, but he is no longer with the company.)
A panel of advisers to the Food and Drug Administration gave its endorsement Thursday to a seasonal mRNA flu vaccine that was developed by Moderna and that earlier this year became the subject of controversy when a top agency official briefly refused to even consider accepting it for review.
The Vaccines and Related Biological Products Advisory Committee — known as VRBPAC — voted unanimously that the benefits of the vaccine outweigh the risks for both adults aged 50 to 64, and those 65 and older. It remains to be seen what the FDA will decide, but staff presentations during the meeting suggested the agency sees the vaccine as having cleared sufficient hurdles to be licensed via a traditional pathway for the younger group, and an accelerated pathway for the older group.
Multiple flu vaccines currently on the market were first licensed using an accelerated pathway, Wellington Sun, a former FDA employee, noted during the meeting’s public comment period. (After leaving FDA, Sun worked for Moderna, but he is no longer with the company.)
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