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Around the nation: FDA advisory panel voted against treating PTSD with MDMA


An FDA advisory panel on Tuesday voted against using MDMA-assisted therapy to treat PTSD, leading to a setback for potential psychedelic treatments, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and New York. 

  • District of Columbia: Judge Carl Nichols for the U.S. District Court for the District of Columbia on Monday ruled that CMS violated the Administrative Procedure Act of 1946 when it changed for the method for calculating Medicare Advantage (MA) Star Ratings in 2022. In 2020, the agency announced it would introduce a new tool to smooth over outliers in quality data, but it didn't include these provisions in a proposed rule published in 2022. CMS then restored the language in a different regulation published later that year. The agency finalized that rule in 2023 and implemented the new system for the 2024 plan year. In the lawsuit, SCAN Health Plan argued that CMS broke the Administrative Procedure Act, which is designed to ensure federal agencies abide by rulemaking standards, including providing the public opportunities to comment on proposals. SCAN said it lost more than $250 million in quality bonuses because of the lower rating. In his ruling, Nichols said that while CMS was able to eliminate outlier quality measures, it did not apply "guardrails" to ensure that companies' star ratings did not significantly decline. After the ruling, SCAN CEO Sachin Jain said he expects CMS to recalculate the plan's scores and provide it with the quality bonuses. According to Modern Healthcare, the ruling only applies to SCAN Health Plan, but it could have a significant impact on other health plans going forward. Currently, several other MA carriers, including Elevance Health, Zing Health, and Hometown Health Plan, have filed similar lawsuits against CMS over MA star ratings. (Tepper, Modern Healthcare, 6/5; Herman, STAT+ [subscription required], 6/4)
  • Maryland: On Tuesday, an FDA advisory panel voted against recommending MDMA-assisted therapy to treat PTSD. In a staff report released ahead of the panel's meeting, FDA researchers said that it was difficult to assess the safety and effectiveness of clinical trials on MDMA as a treatment for PTSD. According to the report, the studies didn't have sufficient data on how MDMA induces euphoria or elated mood to make recommendations for monitoring potential abuse of the drug. FDA staff also raised concerns about bias in the trial, since the drug's notable effects made it easy for patients to tell if they received the drug, even if they weren't explicitly informed. Aside from MDMA's effect on the mind, FDA staff also noted that it could significantly increase blood pressure and pulse, which could lead to cardiovascular events. The advisory panel voted 9-2 against MDMA's effectiveness to treat PTSD and 10-1 against whether the benefits of the drug outweighed its risks. During the meeting, panel members raised concerns about missing safety data, alleged misconduct during clinical trials, and the difficulty of determining whether MDMA or the psychotherapy it was paired with led to reported benefits for patients. "It seems like there are so many problems with the data," said Melissa Decker Barone, a member of the panel and a psychologist at the VA Maryland Health Care System. "Each one alone might kind of be OK, but when you pile them up on top of each other … there's just a lot of questions." Although FDA typically follows the recommendations of its advisory panels, it does not have to. The agency is expected to make a final decision on the treatment before Aug. 11. (Bettelheim, Axios, 5/31; Jacobs, NY Times , 6/5; Goldman, Axios, 6/4; Goldhill/Keshavan, STAT+ [subscription required], 6/4; Stone, NPR, 6/4)
  • New York: A group of healthcare workers have launched the American Jewish Medical Association (AJMA), a nonprofit organization that aims to combat antisemitism in the healthcare profession. AJMA was founded in November after the start of Israel-Hamas war by Yael Halaas, a plastic surgeon based in New York City. According to Halaas, the association is nonpolitical, bipartisan, and focuses on domestic issues. Going forward, AJMA hopes to become a resource to help fight antisemitism in the medical field. The organization also plans to develop classes and seminars, including those on the Holocaust and its impact on medicine, and contribute scholarly articles. "We're working on a curriculum for all medical schools and nursing schools," Halaas said. "It will be our first rollout that really evaluates critical thinking, civil discourse, professionalism, education about who the Jewish people are." (DeSilva, Modern Healthcare, 6/5)

Cheat sheet: Psychedelic-assisted therapy

Learn how psychedelic-assisted therapy is disrupting care delivery and generating evidence to change clinical practice.


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