Weekly Spotlight
Well, there’s certainly not any slowing in fall out from the first days of President Trump’s second term. I’ve tried to capture a good deal of that here in our spotlight. If you’ve had quite enough of all of this, or if you’ve simply hit your weekly quota, feel free to save this part for later and skip to the other news below. We, at SHP, are all about setting healthy boundaries for our doomscrolling.
And so, without further “Ado*” this week before Valentine’s day…
…if [health policy] be the food of love, [read] on (sic).
*Don’t @ me! I know it’s Twelfth Night! Can’t you give a girl a Shakespeare pun every now and then!
RFK Jr.
With endorsement from critical Senate Finance Committee member and physician, Sen. Bill Cassidy (R-LA), it is very likely that the Senate will vote to confirm RFK Jr. as the next Secretary of the Department of Health and Human Services (HHS). Controversy over the RFK pick centers on his assertion that vaccines are unsafe. Here are a few pieces that discuss the dangers of Kennedy’s disproven claim:
- Opinion: Our Health in the Hands of a Man Who’d Make Us Sick
- Here is how we know that vaccines do not cause autism
The high drama of the confirmation hearing process piqued when Kennedy himself claimed that Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) were among the top political beneficiaries of pharmaceutical contributions. Reporters explain that, while this is an accurate representation of OpenSecrets data, it is a highly misleading interpretation. In fact, they received no contributions at all from political action committees affiliated with drug companies, or from top pharmaceutical executives. But because of a quirk in the site’s methodology, donations from individual, low-ranking employees are counted the same as official contributions from corporate PACs.
In slightly more reassuring news, Stat reports that Michael Kratsios, a 38-year-old technologist with experience in venture capital and President Trump’s pick to serve as science adviser and director of the Office of Science and Technology Policy, or OSTP is not nearly as controversial.
Coms Freeze and DEI Ban
‘Gender Ideology’ Ban Hits Health Websites, Then Partly Retreats
Two initiatives from the new Trump Administration regarding federal communications and priorities: a pause on any public communication until it has been reviewed by Trump officials, and a ban on any reference to or federal funds being used to support diversity, equity, and inclusion (DEI) initiatives. A Trump spokesperson reported this week that “several types of external communications” are no longer subject to any pause, including urgent public health alerts. As evidence, the CDC published a message to US Healthcare organizations updating them on an Ebola outbreak in Uganda. CDC also published its weekly MMWR after missing a number of weeks. However, Inside Medicine is reporting that CDC has instructed its scientists to retract or pause the publication of any research manuscript being considered by any medical or scientific journal, not merely its own internal periodicals and banned terms must be scrubbed from CDC-authored manuscripts. The Office of Climate Change and Health Equity at HHS, established in 2021 by President Joe Biden has completely disappeared.
The orders also caused a number of public-facing resources and data sources to be pulled down. Intense backlash prompted the reinstatement of some online resources but items like guidelines for safe contraception and information on racial inequities in health care remain missing. In addition, the FDA removed previously issued draft guidance on Congressionally-mandated diversity in clinical trials from its website. The move, made without public notice or explanation, was noted by the public on January 23, 2025, raising concerns about the agency’s stance on clinical trial diversity requirements and the statutory obligations of sponsors as the news spreads. One former FDA advisor says they will be back. A former surgeon general penned an opinion that America [in fact] needs better discourse on DEI.
The impact of these orders is not limited to the public sector. The Howard Hughes Medical Institute, the nation’s largest private funder of biomedical research, this week abruptly ended a $60 million program aimed at improving the retention of a diverse student body in undergraduate science and engineering programs. A medical advocacy group on Tuesday sued the main U.S. health agencies over the sudden removal of websites containing public health information and top advisers to the CDC sent a letter asking the agency’s acting director to explain the abrupt removal of information and data from CDC websites, and say when it will be restored. The CDC’s advisory board was created by Congress and includes 12 physicians and public health researchers. Politico reports the CDC’s online purge of guidelines for health providers considering prescribing HIV prevention and birth control medications could dissuade one type of provider whose role in community health care has grown — pharmacists.
The professional society for microbiologists began stripping content about Black, female, and LGBTQ+ scientists from its website in the last few days, angering its members and highlighting the reach of President Trump’s directives to federal agencies to halt activities that promote diversity and inclusion. Conversely, the American College of Obstetricians and Gynecologists (ACOG) decided to host PDFs of government-issued ob/gyn-related guidance at risk of being purged. The organization has long listed and linked out to clinical guidance from the CDC and other medical professional associations that it endorses. In a perhaps well-intentioned move that could have the opposite of its intended impact, leaders from the American Journal of Public Health (AJPH) said studies censored by government employees will have a tough time getting published.
Acknowledging the widespread fear of retaliation among early-career researchers if they speak out, a number of the laureates called on the National Academies to lead the charge in resisting the Trump administration’s attacks.
Federal Funding Freeze and Tariffs
Trump administration orders on communications are not the only ones causing confusion. Freezes in federal spending, which may or may not have been rescinded, are cutting off the lifeblood to a number of critical public health resources. Some groups said their funding was still blocked, even after the freeze had been rescinded. Others saw their money reinstated but worried about future cuts. On Tuesday morning, the National Institutes of Health hosted the first study section to review grant applications in over two weeks, Such meetings — in which expert scientists from around the country consider whether the agency should support proposed research projects — are a core part of how the NIH fulfills its mission to improve human health and reduce illness and disease. Meanwhile, rural hospitals are pushing for exemptions from potential changes to federal policy that may limit Medicaid or Medicare funding and the broader is petitioning President Trump to grant carve-outs for medical devices and pharmaceutical products to the tariffs his administration has enacted, or may soon enact, on Mexico, Canada and China.
PEPFAR, the main U.S.-funded global AIDS program was given a waiver from the foreign aid freeze, but there is still uncertainty and interruptions, partly because many PEPFAR programs are implemented through USAID, which has been largely shutdown by the news administration and the New York Times reports that lifesaving health initiatives and medical research projects have shut down around the world in response to the Trump administration’s 90-day pause on foreign aid and stop-work orders.
On Sunday, the National Science Foundation announced that its payment system was back online to comply with a judge’s order, five days after the agency froze funding to researchers.
DOGE and Federal Employees (Health Sector)
Dem Appropriators Call on OPM to Rethink Federal Buyout Offers
A federal judge on Thursday temporarily blocked the Trump administration and DOGE head Elon Musk from implementing their “Fork in the Road” federal employee buyout offer until at least Monday afternoon. Members of Congress wrote a letter to OPM saying “there is at best, questionable legal authority for the Administration to offer buy-outs to federal workers, and it is not contemplated in appropriations law. It should be rescinded immediately. ” Employees at HHS and its various sub-agencies are struggling to figure out how to implement President Donald Trump’s executive order requiring them to report in-person to their work sites full-time and reports suggest the White House is working on an executive order to fire thousands of U.S. Department of Health and Human Services workers. Conversely, public health experts are worried that workers, including those at the Food and Drug Administration, will leave their government jobs — impeding the agency’s ability to review new medicines, move science forward, and protect public health.
The Department of Government Efficiency, led by Elon Musk, aims to reduce federal spending by $1 trillion, with Medicaid emerging as a likely target, The New York Times reported Feb. 3. Members of DOGE have been granted access to payment and contracting systems at CMS. Attorneys general across 14 states have shared plans to file a lawsuit over the Musk’s DOGE accessing payment systems that contain Americans’ “sensitive personal information.” Privacy experts are keeping a nervous eye on the potential for compromises involving Americans’ personal and health information.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
He ruled the operating room and then daytime TV. Now, Dr. Oz is set to take over a $1.5 trillion health agency
Just three years after jumping into politics with a failed run for Senate as a Republican in Pennsylvania in 2022, Oz is poised to become administrator of the Centers for Medicare and Medicaid Services, after Trump nominated him to lead the vast agency that regulates Medicare, Medicaid, health coverage for children, quality in nursing homes and clinical labs, patient privacy, and the Affordable Care Act.
#All
HHS, CMS improper payments: $88.5B in 2024
Improper payments made through programs of the Health and Human Services Department, which ballooned during the COVID-19 pandemic, are on the decline but still amounted to more than 5% of outlays by the agency last year — or about $88.5 billion.
#All
May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace
CMS and HHS recently released the “HHS Notice of Benefit and Payment Parameters for 2026” setting new and updated standards for Health Insurance Marketplaces and health insurance issuers, brokers, and agents who help connect millions of consumers to health insurance coverage. The Rule finalizes additional safeguards for marketplace coverage beginning plan year 2026, protecting consumers from unauthorized changes to their health care coverage, ensuring the integrity of the federally facilitated Marketplaces, and making it easier for consumers to understand their costs and enroll in coverage through HealthCare.gov. The changes in this Rule aim to minimize administrative burden, ensure program integrity, advance health equity, and mitigate health disparities.
#All
Trump’s CMS signals flexibility on Medicare drug price negotiation, sparking new questions for RFK Jr.
CMS has signaled that it will be revamping the process of negotiating prices for certain Medicare Part D drugs with input from external stakeholders, sparking some alarms from Democrats who support the program.
#DRUG, #PATIENT
Food and Drug Administration (FDA)
Gotleib: New FDA Policies Could Limit the Full Value of AI in Medicine
Artificial intelligence tools with advanced analytical capabilities used in clinical practice, especially tools that synthesize complex clinical information from distinct sources, may automatically be classified as medical devices, regardless of their intended use.
#All
FDA Publishes Guidance for IRBs
This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
#Device. #Drug, #Hospital, #Patient
Health and Human Services (HHS)
Opinion: NIH must address the twin crises of long Covid and ME/CFS — together
The National Institutes of Health is at a crossroads with the RECOVER Initiative, its flagship program to address long Covid. Designed to provide answers and treatments for the millions suffering from long-term effects of SARS-CoV-2 infection, the initiative has already received significant criticism for failing to prioritize the needs of patients and advance meaningful clinical trials. As Congress, the scientific community, and advocates call for the inclusion of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) within the RECOVER framework, NIH has an historic opportunity to transform post-viral illness research.
#All
HHS probes antisemitism allegations at 4 medical schools
HHS has launched investigations into four medical schools following alleged antisemitic incidents during their graduation ceremonies last year, the agency said in a statement Feb. 3. Allegations involve medical schools at Cambridge, Mass-based Harvard University, New York City-based Columbia University, Providence, R.I.-based Brown University and Baltimore-based Johns Hopkins University.
#All
States attempt to protect 340B with new bills: 7 notes
As pharmaceutical companies push back against the 340B Drug Pricing Program, several states, including Utah, Colorado, Arkansas, Maine and Nebraska, are introducing legislation to protect the program and ensure continued access to discounted medications for safety-net hospitals and clinics.
#Drug, #Hospital, #Patient
Opinion: U.S. taxpayers should stop funding clinical trials of industry-owned drugs
The National Cancer Institute (NCI) has had a taxpayer-funded drug development program for nearly 70 years, initiated at a time when there was no private investment in oncology drugs. I worked closely with NCI’s Investigational Drug Branch (IDB) from 1990-2016, including as a principal investigator of one of only six contracts with NCI to conduct Phase 1 clinical trials from 1990-1995, and serving as co-chair of NCI’s Investigational Drug Steering Committee from 2005-2008. Today, global oncology sales exceed $200 billion and are growing faster than any other therapeutic area. At this stage, U.S. taxpayers should stop funding clinical trials of industry-owned drugs.
#Drug, #Patient
Hill Happenings
CRS: Report on Exemptions to the Fiscal Responsibility Act’s Discretionary Spending Limits
The Fiscal Responsibility Act of 2023 (FRA, P.L. 118-5) established statutory limits on discretionary spending (also known as “spending caps”) for FY2024 and FY2025. The FRA created two separate caps for each fiscal year: a limit for defense (or “security”) discretionary spending and a limit for nondefense (or “nonsecurity”) discretionary spending.
#ALL
Notable Notes
THT 2025: Late-breaking clinical trials announced for CRF’s heart failure conference
The Cardiovascular Research Foundation (CRF) has announced the full lineup of late-breaking clinical trials for THT 2025, its annual Technology and Heart Failure Therapeutics (THT) conference. THT 2025 will be held Feb. 11-13 at the Omni Boston Hotel at the Seaport in Boston.
CRF is the organization behind TCT, New York Valves and other educational conferences focused on the diagnosis, treatment and long-term management of cardiovascular disease. THT, now in its fourth year, was developed specifically to help care teams take on the rising rates of heart failure in the United States and beyond.
#DEVICE, #PATIENT, #PROVIDER
TAVR patients admitted on weekend face greater risk of death, complications
The so-called “weekend effect” seen with other cardiovascular diseases appears to exist for patients with severe aortic stenosis as well.
#PATIENT, #DEVICE
Tariffs on medical devices will raise costs. Here’s what to know
The tariffs will boost medical device prices, but hospitals may be temporarily shielded by their contracts.
#DEVICE, #HOSPITAL, #PATIENT
Capturing the child’s voice’ in oncology: Why self-reporting is key
Enabling pediatric cancer patients to electronically self-report their symptoms helped physicians manage care more quickly and effectively, according to research published Nov. 13 in JAMA.
#PATIENT
Assessing the Biosimilar Void in the U.S. Achieving Sustainable Levels of Biosimilar Competition
A new report from health data firm IQVIA released Monday found that of the 118 biologics with expiring patient protections in the next decade, only 12 have biosimilars in development as of last June.
#DRUG, #PATIENT
Pharmacy Middlemen Face NY Crackdown Under Gov. Hochul Plan
New York would become the first state to force pharmacy benefit managers to publicly reveal how much they profit from rebates issued by drug manufacturers under a measure backed by Gov. Kathy Hochul.
#DRUG, #PATIENT, #PAYER
COVID-19 linked to accelerated plaque growth, long-term risk of heart attack or stroke
These risks appear to be present regardless of a person’s age or health at the time of infection.
#PATIENT
Press Ganey, Microsoft team up: 5 things to know
Press Ganey is partnering with Microsoft to develop AI-powered tools to improve safety, quality and patient experience in healthcare.
#PATIENT
The QALY Has Turned 50. Some Think It Should Get Early Retirement
The quality-adjusted life years has shown staying power in cost-effectiveness calculations, but some say it has major flaws and have proposed alternatives.
#PATIENT
Class action suit over UnitedHealth’s AI care denials nears key moment
A federal judge will soon decide whether a class action lawsuit against UnitedHealth Group and a subsidiary over algorithm-based care denials can move forward. If it does, the suit (filed in 2023 following STAT’s reports) could open the door for attorneys to sift through the company’s internal communications
#PATIENT, #PAYER
Cigna announces changes to improve prior authorization, customer satisfaction
The insurance giant said it will link executive compensation to provider and patient satisfaction, in addition to releasing an annual transparency report on claims reimbursement and denials.
#PAYER, #PATIENT
The prior authorization reform push continues
Prior authorization reforms remain a major advocacy priority for provider trade groups in 2025, and several state lawmakers have also introduced legislation to bring changes to the process.
https://www.beckerspayer.com/payer/the-prior-authorization-reform-push-continues.html
Pay, prior authorizations top providers’ policy agenda for 2025
Money and health insurance red tape remain central to healthcare interest groups such as the American Hospital Association, the American Medical Association and the American Health Care Association.
#PROVIDER, #HOSPITAL, #PATIENT
RAND Study Finds Evidence of Upcoding by Hospitals
Two-thirds of high severity likely due to upcoding, according to a RAND study of hospitalizations in five states.
#HOSPITAL, #PAYER
The reality of private equity in hospital ownership
Private equity ownership, though deserving some regulatory changes to level the playing field, is not the real issue, says healthcare analyst Paul Keckley.
#HOSPITAL
Why private equity is chasing revenue cycle management companies
Private equity firms have locked in on revenue cycle management as a good investment opportunity as demand for the services rises among providers.
#Provider, #Hospital
Physicians working more but generating less revenue
Physician productivity and pay increased during the fourth quarter of 2024, but reimbursement for hospitals remained low, according to Kaufman Hall’s “Physician Flash Report.”
#Provider, #Hospital
