TRUMP EYEING O’NEILL — President-elect Donald Trump is considering a former HHS staffer under George W. Bush to be HHS deputy secretary next year, three people familiar with the deliberation granted anonymity to discuss transition planning told POLITICO’s David Lim, Adam Cancryn and Lauren Gardner. Jim O’Neill, who held several roles at HHS during the Bush administration, including principal associate deputy secretary, is an associate of billionaire investor and early Trump backer Peter Thiel. He doesn’t have formal medical training. What to know about him: O’Neill has advocated for people to be allowed to take medicines once the FDA reviews their safety — but without first establishing their effectiveness. “We should reform FDA so that it is approving drugs after their sponsors have demonstrated safety ... let’s prove efficacy after they’ve been legalized,” O’Neill said in a 2014 talk. Trump’s team considered O’Neill to lead the FDA in his first term before picking Dr. Scott Gottlieb. Eric Hargan, a Bush-era health official who Trump subsequently nominated to fill the HHS deputy secretary role, won Senate confirmation by a 57-38 vote. A longtime close adviser to Thiel with ties across Silicon Valley, O’Neill reentered the mix in recent days for the No. 2 HHS spot as transition officials race to fill out the remaining senior health roles. Why it matters: One former administration official granted anonymity to discuss the transition argued that HHS secretary pick Robert F. Kennedy Jr. should enlist a deputy who knows how to navigate the sprawling health department and implement administration policy priorities. WEIGHT-LOSS DRUG BLOCKBUSTER — The Biden administration is making a last-ditch effort to expand coverage of popular weight-loss drugs. The administration today proposed to require Medicare and state Medicaid programs to cover obesity drugs, a move that would dramatically expand access to the popular treatments. This would mark the first time Medicare could cover the popular weight-loss drugs known as GLP-1s solely for weight loss. Congress banned Medicare from covering such treatments in a 2003 law, and many state Medicaid programs and private insurers do not cover the drugs. Medicare can cover the drugs for other indications like diabetes and heart conditions. If the proposal in the waning weeks of the Biden administration is finalized and survives expected court challenges and the Trump administration, it would be a significant win for drugmakers, who are fighting new Medicare drug price negotiations in court. It would also likely increase premiums. With less than two months remaining in the Biden administration, there likely won’t be sufficient time to finalize the rule through the traditional process. While it’s not clear how the Trump administration will handle the proposal, the drugs’ popularity could pressure them to continue the policy. However, Robert F. Kennedy Jr., Trump’s pick to run HHS, has been skeptical of the weight-loss drugs. ORGAN, DATA RULES AT OMB — As the clock runs down on the Biden administration, several rules still linger or have recently been cleared and could be released soon from the Office of Management and Budget. Here are the ones we’re watching: — Interoperability: A final rule proposed by the HHS’ Office of the National Coordinator for Health IT was received at OMB on Nov. 22. While the details of the rule, known as HTI-2, are unclear, it builds on previous HTI-1 regulations on artificial intelligence and interoperability. The agency has said it would improve public health IT through technology certification requirements and have new provisions meant to prevent information blocking. — Organ care: A proposed mandatory program to improve access to kidney transplants cleared OMB on Nov. 22. The model would incentivize hospitals to increase the number of kidney transplants they perform. However, CMS recently said it would delay indefinitely the proposed January start date. Another rule that would loosen requirements for transplanting kidneys and livers from HIV-positive donors to HIV-positive recipients has also recently cleared OMB. — Payment rules: A rule from CMS would enact changes to Medicare Advantage — the privately run alternative to Medicare — and Medicare Part D, the program’s prescription drug benefit. The rule, which has cleared OMB and could drop as soon as this week, would codify provisions in the Inflation Reduction Act that capped out-of-pocket costs in Medicare Part D. The Biden administration could also use the rule to crack down on Medicare Advantage insurers, as the industry has come under scrutiny from lawmakers over allegations of excessive care denials.
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