| The Trump administration released its list of expected regulatory actions for this year, offering a fresh look yet at where federal health regulators are headed. The list, called the Unified Agenda, is published twice a year. There are more than 180 regulatory actions listed for agencies at the Department of Health and Human Services, including about 65 at the Food and Drug Administration and 44 at the Centers for Medicare and Medicaid Services. A majority of the actions are proposed rules, which could take months or years to go through the process once they’re released. The Unified Agenda comes along with projected dates for when the actions are anticipated to be released, but those timelines often slip. Other regulations not included in the Unified Agenda can also appear, so it may not be comprehensive. → Still, it gives hospitals, insurers, providers, drugmakers and other industry lobbyists the ability to plan for what could be the administration’s next focus. There are many significant moves in the Unified Agenda, but here are some that caught my eye. What’s new — Vaccines are still on the docket. The department plans to propose a new table identifying specific injuries presumed to be caused by covid-19 vaccines and treatments, along with the timeframes in which those injuries must occur to qualify for compensation. The move makes it easier for individuals who claim to be injured by these products to receive benefits, though it’s uncertain which conditions will be added to the list. HHS plans to kick off the rulemaking process in November. — Bolstering direct-to-consumer advertising rules for drugmakers. The FDA wants to strengthen requirements for how companies present risk information and communicate benefits of their medications to consumers. The agency acknowledges that the rule could be economically significant — meaning that compliance could cost at least $100 million per year — which has prompted questions about whether the rules could make ads with the additional disclosures too costly to produce. The rulemaking process could begin in December. — Updates to compounding regulations. The FDA has four anticipated actions affecting compounding pharmacies, including proposed and final updates to the list of bulk drug substances that can be used to make compounded medications. The rules could shape the availability of certain compounded products, including peptides, as the administration weighs broader changes to peptide policy. Health Secretary Robert F. Kennedy Jr. has said that he wants to expand access to peptide products, and an FDA advisory panel is set to meet this month to discuss whether seven should have the ability to be compounded. — Alternative payment models for providers. CMS intends to propose a mandatory pilot program to test “ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care” for patients. There aren’t additional details about what the model will look like, but the agency could release the initial notice as early as this month. What’s continuing There are some efforts that began or advanced during the Biden administration, including broadly bipartisan rules surrounding price and coverage transparency and protecting patients’ health information. — Transparency efforts aren’t going away. The agenda keeps work alive on insurer price transparency and the long-delayed advanced explanation of benefits requirements for health plans that explain to patients details about their insurance coverage and how much they’re likely to pay for doctors’ visits or health services. Action on these is projected in the next couple of months. — Updating health privacy regulations. There are three separate proposed rules in the Unified Agenda involving HIPAA, the federal law that protects patient privacy. One finalizes a Biden-era effort to expand patients’ access to their health information, ease information sharing between providers to improve coordination, and streamline compliance requirements for providers and health plans. Industry advocates have been pushing the Trump administration to modernize the rule — first proposed in 2021 — which they argue is now outdated as technology has advanced in recent years. The rule is projected to land in August. — Surprise medical bill rulemaking continues. Additional regulations implementing the No Surprises Act’s independent dispute resolution process remain on the agenda, indicating that the administration still has unfinished work on one of the most consequential health laws enacted in recent years. The final rule, which would implement provisions surrounding air ambulance services, is expected in September. — Formaldehyde ban effort persists. The FDA is continuing work on regulations that would prohibit formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products. The rule has been years in the making and follows longstanding concerns about exposure risks for consumers and salon workers. Action could resume in November. What’s under review There are many pending rules already under review at the White House, but these are three key regulations that are among the closest watched: — Physician fee schedule. CMS’s annual Medicare physician payment rule proposal will ultimately determine next year’s payment policies for doctors and other clinicians. The Trump administration capped payments for skin substitutes — pricey bandages made out of placenta — in last year’s rule, which manufacturers have been urging the agency to roll back in its annual update. Industry experts expect to see the rule released soon. — Most-favored nation models. Pilot programs that would tie some Medicare drug prices to those paid in other developed countries remain under White House review. The two models — covering medications in the Medicare Part B and Part D programs — were submitted to the Office of Management and Budget for review last month. The industry has objected to these mandatory pilot programs, with some of the comments on the proposals calling them executive overreach. — Generally recognized as safe (GRAS). The FDA is considering changes to the framework governing when ingredients can be designated as safe for use in food without premarket approval, a move that could affect manufacturers and nutrition policy debates. A proposed rule has been under review at the White House for seven months. The Unified Agenda projects action on the rulemaking in December. The Senate Health, Education, Labor and Pensions Committee will initiate confirmation hearings for some of the Trump administration’s health nominees, which could provide insight into the administration’s priorities for public health and pandemic preparedness. Next Wednesday, lawmakers will consider the nominations of Sean Kaufman to serve as assistant secretary for preparedness and response at the Department of Health and Human Services and Erica Schwartz to lead the Centers for Disease Control and Prevention. Both nominees are expected to face questions about how they would lead agencies that have been a part of the health agency upheaval over the past year and how they plan to prepare for future public health emergencies. The founder and former CEO of digital mental health company Done Global was sentenced to six years in prison for orchestrating a scheme that prosecutors said used the company’s telehealth platform to unlawfully distribute more than 37 million Adderall pills and generate rapid growth at the expense of patient safety. Ruthia He, along with Done’s former clinical president, David Brody, was convicted of conspiracy to distribute controlled substances and conspiracy to commit health care fraud, among other crimes. Brody was sentenced to two years in prison and must pay a $1 million fine. He, who the Justice Department also alleges defrauded insurers out of millions of dollars and obstructed the subsequent federal investigation, will also have to pay $1 million in fines. Prosecutors said Done built a model that relied on subscription payments, aggressive advertising and clinical practices designed to make it easier for patients to obtain stimulant medications. The Wall Street Journal reported on Tuesday that He expressed no remorse for her crimes, but told the court that she thought about the company’s patients “every day.” Why it matters: The case is one of the most significant federal actions targeting a digital health company and went after its business model, rather than individual prescribers. The Justice Department alleged that Done spent more than $40 million on advertising that encouraged people to believe they had ADHD while pressuring clinicians to prescribe stimulants in short virtual visits. The company allegedly paid up to $60,000 per month to doctors who effectively agreed to issue prescriptions for Adderall every 30 seconds. Prosecutors said some clinicians issued prescriptions without reviewing medical records, while the company submitted false information to insurers to obtain coverage for medications. → In 2024, a similar telehealth company called Cerebral agreed to pay more than $3.6 million to resolve a federal investigation into its prescribing practices for ADHD medications. The Federal Trade Commission hit the company with $5 million in fines related to allegations of deceptive cancellation practices. Health insurers are signaling that 2027 could bring another difficult year, with rising medical costs colliding with less healthy patients resulting in increasing premiums. That’s the topic of the latest report from WP Intelligence Lead Health Care Analyst Rebecca Adams, who dug into the numbers. Why it matters: The latest rate filings suggest insurers are pricing for a market they believe has become riskier. If those assumptions prove correct, the exchanges could see additional premium hikes, fewer participating insurers and continued enrollment declines. Insurers in states that have released preliminary filings are seeking a median 14 percent premium increase for 2027, according to KFF, after roughly 20 percent average increases for 2026. The underlying medical costs that drive up premiums are likely to rise 9 percent in 2027 for group health insurance, which is how a majority of Americans under age 65 get insurance, and 8.5 percent for insurance offered through Affordable Care Act marketplaces, according to a PwC survey that included interviews with 27 insurers. That follows similar price jumps from 2025 to this year. What’s driving it: - Insurers continue to cite higher hospital spending, specialty drugs and GLP-1 weight-loss medications as major cost pressures.
- Several plans also say Trump administration policies — particularly the expiration of enhanced ACA premium tax credits and new marketplace rules — have changed who remains enrolled, leaving a less healthy risk pool. And sicker patients cost more to insure.
- At the same time, providers’ growing use of AI-assisted documentation and coding is boosting reimbursements by capturing more diagnoses and patient complexity, according to PwC.
“The cost is untenable right now,” Glenn Hunzinger, health industries leader at PwC US told Rebecca, noting that national health care costs comprise more than $5.5 trillion annually. “That’s a curve that we need to bend.” The bigger picture: Enrollment in individual ACA marketplace plans has fallen by nearly 3 million people this year, six insurers have announced plans to leave the marketplaces, and many carriers assume the remaining enrollees will require more medical care. That combination makes pricing more uncertain and could reinforce a cycle of higher premiums leading to lower enrollment. What to watch: Final rates won’t be set until this fall, but insurers’ filings will offer one of the clearest windows into how they view the health of the ACA market heading into 2027 — and whether more carriers decide the exchanges are no longer worth the risk. Read the full report: “Why health insurance premiums are set to skyrocket in 2027” “Almost $1 billion later, the US still can’t make a medical glove,” writes Anna Edney at Bloomberg. “Chinese fentanyl makers find new U.S. market in peptides,” Tina Reed reports at Axios. “Private Equity Makes Deals With Healthcare Nonprofits,” Cheryl Clark reports at MedPage Today. This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from The Washington Post newsroom. Learn more about WP Intelligence. | 
