| | | | |  | | By Ben Leonard and Chelsea Cirruzzo | Presented by the Coalition to Strengthen America’s Healthcare | With help from Daniel Payne, Kelly Hooper and Carmen Paun
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President Joe Biden is expected to issue multiple health-related regulations before his term runs out. | Patrick Semansky/AP | THE REGS ARE COMING — The first Trump administration took or mulled a slew of regulatory actions in its final weeks, including significant changes to Medicaid, term limits for top federal health scientists and a plan to lower drug prices by tying government payments for medicines to lower prices paid abroad. “The Trump administration opened up the fire hose in [its] last month,” said Jeffrey Davis, health policy director at McDermott+ Consulting. A similar flood of Biden administration regulatory actions could be forthcoming, though the incoming Congress or the Trump administration could overturn or discard them — Biden, for example, pulled Trump’s drug price proposal and Medicaid changes. The incoming administration is expected to put a freeze on Biden’s regulations like it did in 2017. HHS recently proposed a sweeping reinterpretation of a 2003 law to allow Medicare to cover drugs for obesity, and more significant regulations could be on the way. Here are some worth watching: Drug price negotiations: CMS is required to release the next slate of drugs set for Medicare price negotiation under the Inflation Reduction Act by Feb. 1. But the agency could do so before Biden leaves office on Jan. 20. Before the election, HHS Deputy Secretary Andrea Palm said CMS plans to work with the president-elect’s team on the issue. No Surprises: The Biden administration could soon finalize changes to the independent dispute resolution process for so-called surprise bills under the No Surprises Act. The proposal would address the burden of a flood of cases, including many that aren’t eligible for the process. The rule hasn't yet reached the White House for review. “We don't know whether it's going to cross the finish line,” Davis said. “Some provider groups are already planning what would happen if it pushed over to the Trump administration.” Health data: A proposal dubbed HTI-2 from HHS’ assistant secretary for technology policy that would advance how health data is shared is pending White House review; a final rule is expected to be published soon. The DEA and telemedicine: Although the DEA extended rules allowing the prescribing of controlled substances without an in-person visit through the end of 2025, punting the issue to the Trump administration, Biden officials could still release a longer-term proposal to shape future regulation. A proposal is undergoing White House review. Cybersecurity updates: Changes to HIPAA that would bolster cybersecurity have reached the White House for review. WELCOME TO FRIDAY PULSE. The Senate will be in session five days a week at the beginning of this year. The horror! Send your tips, scoops and feedback to bleonard@politico.com and ccirruzzo@politico.com and follow along @_BenLeonard_ and @ChelseaCirruzzo.
| | | | A message from the Coalition to Strengthen America’s Healthcare: NEW REPORT: Hospitals and health systems provide access to around-the-clock emergency and specialty care that other providers typically cannot offer, making them crucial access points for care 24 hours a day, 7 days a week, 365 days a year. ACCESS THE REPORT. | | | | | | | 
Venture capitalist David Sacks has been chosen by President-elect Donald Trump to be "A.I. & Crypto Czar" and head the President's Council of Advisors on Science and Technology. | Getty | TRUMP PICKS ‘AI CZAR’ — President-elect Donald Trump said Thursday on Truth Social that he’s choosing venture capitalist David Sacks to be his White House “A.I. & Crypto Czar” and lead the President's Council of Advisors on Science and Technology. Trump said Sacks will focus on “making America the clear global leader” in artificial intelligence. Sacks, a prominent Silicon Valley donor, has invested in many tech companies and has signaled he’s opposed to sweeping regulation of the technology. Republicans have increasingly focused on ensuring AI regulation does not impede innovation. “We have one unparalleled asset as a country: cutting-edge innovation in AI driven by a completely free and unregulated market for software development,” Sacks said in a post on X responding to President Joe Biden’s 2023 executive order promising coordinated approach to AI. “That just ended.” He’s admitted he’s not much of a health care expert. “I think every American should have health care. The best way to get there is something I would need to research,” Sacks said in a 2023 post on X. “I have not purported to be an expert on this topic.”
| | | | REGISTER NOW: As the 118th Congress ends, major decisions loom, including healthcare appropriations. Key focus: site neutrality. Can aligning hospital and clinic costs cut federal spending, reflect physician costs, and lower patient expenses? Join policymakers and providers to discuss. | | | | | | | | SENATORS GO TO THE (FOOD) SOURCE — Senators on the HELP Committee grilled FDA Commissioner Robert Califf about his agency’s food and beverage regulations and how they could be related to Americans’ rising rates of obesity and health issues, Daniel reports. Lawmakers on both sides of the aisle made their cases. Chair Bernie Sanders (I-Vt.) said the U.S. needed to catch up with other countries in making food labels clearer and cracking down on advertising, especially to children — possibly teeing up areas of cooperation with an incoming Trump administration. Ranking member Bill Cassidy (R-La.), who will lead the Health, Education, Labor and Pensions Committee next Congress, also nodded to the possibility of working on the issue, saying the conversation was about “making America healthy again,” a nod to HHS selection Robert F. Kennedy Jr.’s movement. There was widespread disappointment among senators in how the FDA regulates food and beverages, with several asking for more to be done — faster. Califf also made several pitches to lawmakers regarding the FDA’s future. He nodded to a recent decision from the Supreme Court — likely the court striking down Chevron deference, which gave more latitude to agencies to interpret ambiguous laws — to say lawmakers might consider putting programs they want to see in legislation instead of leaving them to agencies. He also asked for more agency funding. BIOSECURE LATEST — Lawmakers are floating a compromise to break an impasse on a bill that would significantly hamper Chinese biotech firms’ ability to do business in the U.S., three people familiar with the negotiations said. The BIOSECURE Act, which the House passed 306-81 in September, would halt federal contracts for companies partnering with specific Chinese biotech companies, and calls out five firms. Because the firms partner with U.S. pharmaceutical companies, supporters of the measure warn that they could gain access to Americans’ genomic data, which the Chinese government could then access under the country’s intelligence laws. The named companies have denied their data could be compromised. The proposal: POLITICO first reported that the potential compromise would allow those firms to undergo a review process to determine whether punitive measures should be imposed. One of the people familiar with the situation said Republicans offered the compromise to Democrats but haven’t won them over yet. Rand Paul (R-Ky.), who will take over as chair of the Senate Homeland Security Committee in January, opposed the bill, arguing it would advantage some biotech companies over others. And there’s also significant Democratic opposition.
| | | | A message from the Coalition to Strengthen America’s Healthcare:   | | | | | CONSEQUENCES OF SUBSIDY EXPIRATION — If Congress allows enhanced premium subsidies for Affordable Care Act plans to expire at the end of 2025, many Americans could lose health coverage and others could face higher premiums, the Congressional Budget Office said Thursday. Without a permanent extension, CBO projects that gross benchmark premiums would rise by 4.3 percent in 2026, 7.7 percent in 2027 and 7.9 percent on average between 2026 and 2034. The scorekeeper found that the number of people who are uninsured would rise by 2.2 million in 2026, 3.7 million in 2027 and 3.8 million on average between 2026 and 2034. Next year, GOP control of Congress and the White House will reduce the chances of extending the subsidies, which have helped boost signups for ACA plans to record highs. But a permanent extension would increase the deficit by $335 billion from 2025 through 2034, according to a June 2024 CBO estimate. ANTHEM BACKTRACKS ON ANESTHESIA POLICY — Anthem Blue Cross Blue Shield is reversing its decision to limit coverage of anesthesia during surgery amid “widespread misinformation” about the policy update, according to a company spokesperson, Kelly reports. The health insurer said last month it would use metrics from CMS to cap the amount of time it would cover the care during surgery, beginning Feb. 1, 2025. The policy was set to take effect for plans in Connecticut, New York and Missouri, according to the American Society of Anesthesiologists, which derided the decision and called on Anthem to reverse the plan. After the policy change prompted a wave of online vitriol this week, Anthem said Thursday it wouldn’t move forward with it. “It never was and never will be the policy of Anthem Blue Cross Blue Shield to not pay for medically necessary anesthesia services,” a company spokesperson said in a statement. “The proposed update … was only designed to clarify the appropriateness of anesthesia consistent with well-established clinical guidelines.” Key context: The policy change sparked social media fury Wednesday after the fatal shooting of UnitedHealthcare CEO Brian Thompson in what police believe was a targeted attack. While the motive of the homicide is unknown, the slaying led to outrage on social media over health insurers’ coverage decisions and business practices, including the Anthem decision.
| | | | Billions in spending. Critical foreign aid. Immigration reform. The final weeks of 2024 could bring major policy changes. Inside Congress provides daily insights into how Congressional leaders are navigating these high-stakes issues. Subscribe today. | | | | | | | | | HOUSE REAUTHORIZED DRUG OFFICE — The House voted Thursday by a 399 to 1 vote to reauthorize the Office of National Drug Control Policy until 2031. The ONDCP coordinates the U.S. drug control policy across 19 federal agencies and oversees a $41 billion budget, Carmen reports. Its authorization expired on Sept 30, 2023. Why it matters: While drug overdose deaths have decreased from an all-time high of some 111,000, lawmakers and drug policy advocates insist that all measures to lower drug demand, increase access to treatment and overdose reversal drugs and fight drug trafficking must continue in earnest. The reauthorization bill also renews two grant programs the ONDCP administers: the High Intensity Drug Trafficking Areas, which aids local law enforcement in areas considered critical drug-trafficking regions in the U.S., and the Drug-Free Communities Program, which gives grants to community organizations to reduce substance use among young people.
| | STAT reports on falling enrollment in plans with high deductibles. The Wall Street Journal reports that the “Wayne Gretzky of vasectomies” has died at 68.
| | | | A message from the Coalition to Strengthen America’s Healthcare: NEW REPORT: Hospitals are uniquely equipped to treat complex conditions that cannot be treated elsewhere. Hospitals also provide life-saving care beyond what other care settings offer 24 hours a day, 7 days a week, 365 days a year. Policymakers must protect hospital care.
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