Weekly Spotlight
At the risk of being unoriginal: January has been a really long year.
The new Administration has wasted no time in testing the waters on executive powers. We highlight some of the more notable health care actions below.
Fierce Healthcare reports on the Administration canceling prescription drug payment models at the Centers for Medicare and Medicaid Innovation as well as some of the Biden Administration’s efforts to lower the prices of prescription drugs by capping prices on essential medicines like insulin. The Administration also proceeded what initially appeared like a pro-forma ban on external communications from federal agencies and a hiring freeze until Trump appointees are able to assume their roles. Many initially thought that the severity of these moves was amplified, at least in part, by Trump’s non-traditional approach to presidential transition. More simply put, there simply weren’t enough Trump people in place to get things moving on day one. However, it has quickly become evident that these moves are having a more significant impact than in transitions past.
Several scientific meetings involving the NIH, including health study sections, which review applications for fellowships and grants, were canceled without being rescheduled this week, leaving researchers concerned about their work and the implications for science under the second Trump administration. In addition, for the first time in its more than 60-year history, the CDC’s Morbidity and Mortality Weekly Report (MMWR) did not go out as scheduled.
President Trump also took specific executive actions to reverse long-standing and/or Biden era policy. For example, Stat reports that following an executive order eliminating diversity, equity, and inclusion (DEI) efforts at the federal level, the FDA purged material on clinical trial diversity from its site. Trump also announced that “It will henceforth be the official policy of the United States government that there are only two genders, male and female,” which scientists have pointed out is not factually acurate. In addition, federal employees were ordered to name colleagues who work in DEI roles within the next 10 days or risk ‘adverse consequences. President Trump also announced plans to pull the United States out of the World Health Organization on Jan. 22, 2026. The President has accused the agency of mishandling the pandemic and other international health crises. In an opinion published in the New York Times, former HHS Secretary, Kathleen Sebelius, urged the President to reconsider. In addition, the Trump Administration lifted restrictions on Immigration and Customs Enforcement (ICE) and Customs and Border Protection (CBP) officers, allowing enforcement actions, including arrests, to take place in previously protected “sensitive” areas like hospitals. Providers and others are concerned the directive could dissuade patients from seeking necessary care due to the fear of being arrested.
Meanwhile, the Presidents health care nominees will have quite a gauntlet to travail in order to be confirmed by the Senate. Three former FDA officials have penned a message to Trump appointees, offering their insights and recommendations. Health and Human Services Secretary nominee Robert Kennedy Jr. confronts critics from the right on abortion and the left on vaccines as the Senate sets hearings for next week. In resposed, he is reportedly distancing himself from his previous anti-vaccine work but would keep his stake in an HPV vaccine suit if confirmed. Democratic Senators met with a panel of experts in preparation for the hearings, peppering experts with questions about ideas espoused by vaccine critics, the powers of the Secretary of Health and Human Services, and the best strategies to highlight the benefits of vaccines and Senator Elizabeth Warren (D-MA) has sent RFK Jr. a list of 175 questions.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Opinion: Medicare drug price negotiations need something new: a floor
Peer-reviewed evidence clearly shows that medical innovation suffers when innovators earn less. Paying less for drugs that matter most to patients will stifle innovation in valuable areas. However, a letter from several Democratic Senators urged Trump to use his deal-making skills to “flat out reject any request to end negotiations.”
#Drug
Use and Costs of Supplemental Benefits in Medicare Advantage, 2017-2021
Though Medicare Advantage beneficiaries are more likely to have coverage of vision, dental and hearing services, they are not more likely to use these services than their peers in traditional Medicare
#Payer, #Patient
Food and Drug Administration (FDA)
Navigating FDA’s Draft Guidance for AI-Enabled Medical Devices
A look at how FDA’s new draft guidance outlines recommendations for lifecycle management and marketing submissions of AI-enabled medical devices, emphasizing a total product lifecycle (TPLC) approach to address transparency, bias, data management, and risk management throughout the device’s development, deployment, and ongoing monitoring.
#Device
Trump administration withdraws FDA plan to ban menthol cigarettes – Reuters
The U.S. Food and Drug Administration had in April 2022 proposed to ban the sale of flavored cigars and menthol cigarettes after several health advocacy groups said they were highly addictive, and played a role in luring young people to smoking. A Jan. 21 filing by the Office of Information and Regulatory Affairs, a White House agency, showed the proposal has been “withdrawn“.
#PATIENT
Health and Human Services (HHS)
Health Secretary Defends Biden’s Covid Vaccine Mandates and Social Media Efforts
In a wide-ranging interview, Xavier Becerra, President Biden’s health secretary, defended his tenure and hinted that he might run for governor of California.
#ALL
Novartis sues HHS over 340B pricing model
Pharmaceutical company Novartis has filed a lawsuit against the HHS over the way drugs are priced under the 340B program.
#DRUG
Hill Happenings
Republicans want to make deep cuts in Medicaid. Can they?
House GOP leaders are eying Medicaid cuts exceeding $2 trillion, but some lawmakers and analysts warn they will face tough resistance from back home.
#PATIENT
Notable Notes
Trump to Tap Don Dempsey for Health Programs at OMB
Trump is “poised to appoint” Don Dempsey as associate director of the Office of Management and Budget’s health programs. The appointment would give Dempsey “sweeping power over the $1.8 trillion U.S. healthcare budget and responsibilities of the 13 divisions and agencies,” the newspaper noted. Dempsey is currently the vice president of policy and research at the Better Medicare Alliance, a lobbying organization that describes itself as “the nation’s leading research and advocacy organization supporting Medicare Advantage.”
#ALL
Travel time is better indicator of access than zip codes, study suggests
Patients who travel longer distances to emergency facilities are more likely to present with more severe medical conditions, highlighting travel time as a key indicator of healthcare access, according to a study published Jan. 21 in JAMA Network Open.
#Patient
Lost in Modern Medicine: What Happened to the Hippocratic Oath?
Medical schools are increasingly adopting modernized versions of the Hippocratic Oath to reflect current societal issues, sparking debate about their effect on medical ethics.
#Provider
Legal overreaction to Supreme Court ban on race fueling loss of diversity at medical schools
Medical schools are being told by their lawyers to stop using strategies to diversify classes that are still legally permitted, despite a Supreme Court ruling against the use of affirmative action in admissions.
#Provider
Independent Surgeons Are Disappearing. Here’s Why That Matters.
Private practices offer personalized care, expanded access, and physician autonomy
#Provider
Hospitals, medtech companies partner on devices to lower costs
Health systems are forming multi-year partnerships with medtech companies, investing millions of dollars to keep up with the latest technology and develop a more holistic way of managing their operations. It’s an involved process that pairs a company’s technology consultants, technicians and program managers with health systems to evaluate their equipment and operations, advise on upgrades and provide service, training and consulting.
#HOSPITAL, #DEVICE
Valve durability after TAVR: Cardiologists track how deterioration influences outcomes
Researchers have made it a priority to learn as much about the durability of TAVR valves as possible. A new study in JACC: Cardiovascular Interventions used updated VARC-3 definitions to identify signs of hemodynamic valve deterioration in nearly 2,500 patients.
#Patient, #Provider
Surgeons make history again with world’s first robotic implant of Abbott heart device
The historic LVAD implant was performed on a 35-year-old patient with advanced heart failure. His symptoms included kidney and lung deterioration.
#Patient, #Provider
AI-powered heart assessments of NFL veterans could help cardiologists tackle CVD
Retired NFL players Joel Dreessen and Le-Lo Lang are among the first athletes participating in a new registry launched by HeartFlow and the Boone Heart Institute.
#Patient, #Provider
Q&A: Society of Thoracic Surgeons president previews the trends and technologies of STS 2025
It looked like the wildfires in Los Angeles could force STS to cancel its annual meeting, but the group worked with city officials and was able to carry on as planned. STS President Jennifer C. Romano, MD, MS, discussed that difficult decision and previewed the three-day event in a new interview.
#Provider
Cardiac surgery consortium leverages data for improved clinical outcomes, savings in direct costs and bed days
The University of California’s five medical centers have collected and pooled cardiac surgery data for more than a decade, allowing the system to streamline care and improve financial margins. Subsequent data analysis has resulted in 132 bed days saved and a financial margin improvement of about $15 million.
#Provider
American College of Cardiology announces late-breaking clinical trials for ACC.25
The presentations will cover a variety of topics, including coronary artery disease, semaglutide, artificial intelligence, TAVR, heart failure, PCI and much more. ACC.25 takes place March 29-31 in Chicago.
#Provider
Early outcomes with Myval TAVR valve comparable to popular devices from Medtronic, Edwards
Meril Life Sciences has been manufacturing its Myval heart valves for years. The devices are approved and available in both India and Europe, but they have not been approved by the FDA.
#Device
