| A federal court has paused key parts of the Trump administration’s overhaul of the Affordable Care Act days before the rules were set to go into effect, siding with a coalition of advocacy groups and local governments. The ruling, which prevents eight policies from going into effect, represents the latest blow to the Trump administration’s efforts to reshape the individual health insurance marketplace. U.S. District Judge Brendan Hurson said the plaintiffs were likely to succeed on several of their claims, and would suffer irreparable harm if the rule took effect. Citing documnets submitted by the plaintiffs, Hurson concluded it was “reasonably predictable” that the rule would cause some consumers to choose less generous coverage, which would push more costs onto patients or ‘drop out of the market altogether” — and increase uncompensated care costs for providers and local governments. → The opinion echoes the court’s rulings against multiple similar provisions in last year’s payment rule, including certain income-verification requirements. Hurson said the administration has not adequately justified policies that plaintiffs argued would reduce enrollment, raise premiums for many consumers and increase uncompensated care costs. What’s new: It also blocks the administration’s newer efforts to expand access to catastrophic health plans that come with low monthly costs but high deductibles and skimpy overall coverage. It also pauses a provision that permits insurers to offer bronze plans that exceed the maximum out-of-pocket (MOOP) limits allowed by law by up to 130 percent (which equals $15,600 for an individual and $31,200 for a family in 2027). The Centers for Medicare and Medicaid Services, which issued the rules, has said it does not comment on pending litigation. The Trump administration is likely to file an appeal to the ruling. On Thursday, the federal government appealed a June ruling from the same judge that vacated several parts of last year’s health insurance market rules. Why it matters: The ruling injects fresh uncertainty for insurance companies, which are in the midst of designing their health plan offerings for next year. If the court hadn’t stepped in, the rules would have taken effect on Monday. → The legal limbo “puts plans in a tough position in the middle of rate filing,” an insurance industry advocate, who spoke on the condition of anonymity to discuss the state of internal planning at health insurance companies, told me. David Merritt, the senior vice president of external affairs at the Blue Cross Blue Shield Association, told me that “shifting marketplace rules late in the planning cycle can create confusion for consumers trying to understand their coverage options and what to expect.” Merritt says that plans need “adequate lead time” to implement any changes and communicate them to consumers. But it’s unclear how long it will take the case — if appealed — to wind its way through the legal system, thus keeping insurers in the dark for now about how to proceed. There are additional parts of the rules being challenged, which will be reviewed at a later date. The lawsuit was filed by legal advocacy group Democracy Forward on behalf of the cities of Columbus, Baltimore, Chicago and Pima County, Arizona, and advocacy groups Doctors for America and the Main Street Alliance. Read more: WP Intelligence Lead Health Care Analyst Rebecca Adams detailed some of the potential implications of the administration’s proposal in March, and I wrote about the rules when they were finalized in May. Officials at the Food and Drug Administration voiced apprehension about appointing people with ties to peptide businesses and clinics to a federal panel reviewing a handful of controversial peptides, Rachel Roubein reports from The Washington Post newsroom. - The officials had warned that the members could present potential conflicts of interest. Even former FDA commissioner Marty Makary, who resigned from the post in May, had flagged to senior health department officials about his own concerns about potential conflicts months ago.
- However, the Department of Health and Human Services moved forward with selecting roughly a half-dozen physicians and others who promote peptides or work for companies that sell them to serve on the advisory committee — which is set to meet next week.
- Another new member on the panel is a Tennessee state senator and the son of a Republican congresswoman who has asked Health Secretary Robert F. Kennedy Jr. — himself a self-described “big fan” of the products — to loosen the restrictions on a half-dozen peptides.
Former health department and FDA officials told Rachel that it was highly unusual for the names of new panelists to come from the health department. Peter Lurie, president and executive director of the nonprofit Center for Science in the Public Interest and a former FDA official, said it “implies a degree of political involvement.” - The panel, called the Pharmacy Compounding Advisory Committee, will evaluate whether to allow compounding pharmacies to make seven peptides that have been restricted because of safety concerns.
- Ahead of the meeting, career FDA scientists released documents arguing that there is insufficient evidence on the peptides’ safety and effectiveness to support broader access.
- FDA spokesperson Benjamin Nichols told Rachel all committee members underwent the agency’s standard ethics review, and that anyone who failed to meet conflict-of-interest requirements was removed from consideration.
Peptides have surged in popularity despite limited evidence behind many of their promised benefits, purchased through gray-market online shops and wellness clinics as a fix for aging, weight loss, and other health conditions despite limited support for many of their promised benefits. → Peptide proponents argue that bringing the products into the regulatory fold can only help consumers ensure they’re getting quality products. But the shift would also represent a lucrative opportunity for the burgeoning industry. ICYMI: My Q&A with Jeff Cohen, a co-founder of the American Peptide Association Scott Brunner, CEO of the Alliance for Pharmacy Compounding, defended the panel’s industry ties, saying clinicians who treat patients using peptides bring valuable real-world experience. “FDA is far too rigorous in enforcing conflicts of interest,” he told Rachel last month, arguing that compounding pharmacists and prescribers have more firsthand knowledge of patients’ experiences than the academics who have historically served on the panel. Read the full story: “FDA raised conflict of interest concerns ahead of new peptide panel.” “Insurers Hedge on Trump-Backed Pledge To Improve Denials Process,” report Lauren Sausser and Renuka Rayasam at KFF Health News. “Fresh turmoil roils American Diabetes Association following controversy at conference,” Elizabeth Cooney reports at STAT. “Health department abruptly cancels health research grants worth millions,” Politico’s Carmen Paun reports. “Abbott discloses cyberattack on cancer diagnostics business,” Ricky Zipp reports at MedTech Dive. 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. |