What We’re Reading: MDMA for PTSD Voted Down; House Divided on 340B Changes; Judge Sides With SCAN Health Plan

FDA Advisers Vote Against MDMA Therapy for PTSD

FDA advisers voted overwhelmingly against the use of MDMA, or ecstasy, as a post-traumatic stress disorder (PTSD) treatment on Tuesday, according to CNN. After hearing presentations from the FDA, the treatment sponsor, and members of the public, the independent committee voted on FDA recommendations. Of the 11 committee members, 2 said they considered the treatment effective, while the majority said it was not. Also, 1 committee member said the treatment benefits outweigh the presented risks, but the rest disagreed. This was the first time FDA advisers considered MDMA for medical use; although it has the potential to transform the field, the committee had concerns about the integrity of the trials up for review.

House Committee Divided on 340B Program Changes

House members expressed support for the 340B drug discount program on Tuesday but disagreed on whether it needs tighter regulation, according to MedPage Today. Established in 1992, the 340B program mandates drug discounts for eligible organizations, like those who care for rural or underserved populations. Rep. Morgan Griffith (R, Virginia) noted abuses of the program, like hospitals inflating drug charges, and called for changes to prevent further abuse. Conversely, Rep. Frank Pallone (D, New Jersey) warned that the changes proposed by Republican representatives will not reduce drug costs or expand health care access, instead creating greater obstacles for patients struggling to receive affordable, accessible care. At the hearing, workers at included hospitals emphasized the 340B program's impact on their institutions’ financial stability. However, concerns raised about hospital consolidation and contract pharmacy use amid manufacturer limits sparked further debate.

Judge Sides With SCAN Health Plan in Dispute Over Medicare Advantage Star Ratings

A federal judge sided with SCAN Health Plan on Monday, agreeing that CMS inappropriately calculated its Star Ratings for the 2024 plan year, according to Fierce Healthcare. CMS recently made several changes to the methodology used to determine Star scores, resulting in multiple payers seeing a significant decline in their ratings. More specifically, SCAN’s 2024 Star Ratings decreased from 4.5 to 3.5, costing the insurer $250 million in bonus payments. Consequently, SCAN filed a lawsuit in late December, arguing that the CMS Star Rating calculations violated the Administrative Procedure Act. Sachin Jain, MD, MBA, CEO of SCAN Group, explained that SCAN closely studied the regulations and found that CMS took a different approach that did not align with SCAN’s interpretation. Federal judge Carl Nichols agreed that the interpretation of the relevant regulations requires a different calculation.