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Divisive Barth Syndrome Drug Underscores FDA’s Rare Disease, Ad Comm Challenges

An FDA advisory committee meeting Thursday (Oct. 10) on a divisive Bath Syndrome drug highlighted the continued difficulties faced by FDA in handling rare disease drug candidates and its advisory committees in voting on drug candidates -- coming as top FDA officials weigh moving the panels away from product-specific approval and efficacy deliberations to broader policy discussions.

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DEA May Temporarily Extend Telemedicine Prescription Flexibilities, OMB Post Suggests

A new rule before the White House Office of Management and Budget suggests the Drug Enforcement Administration plans to temporarily extend pandemic flexibilities that have enabled greater telemedicine access to prescriptions of certain controlled substances.

Twenty States Sue HHS Over Nurse Staffing Mandate

Twenty states filed a lawsuit in an Iowa district court Tuesday (Oct. 8) in a bid to overturn CMS’ nurse staffing final rule, alleging the rule exceeds the agency’s authority and will negatively impact the nursing home industry and residents.

FDA Allows Temporary Imports In Response To Hurricane Shortages

FDA is using temporary imports, including from China, to fill the continued IV solution production gap, as many in Congress seek to decrease U.S. reliance on medical products from overseas and express concerns about the quality of Chinese products in particular.

Bipartisan Lawmakers Urge CMS To Add Navigators, Cost Reimbursement To IOTA Model

CMS should consider reimbursing living donors’ out-of-pocket expenses and should fund staff dedicated to navigating the transplantation process as part of its demonstration model that aims to drive up the kidney transplant rate, a bipartisan group of 47 lawmakers say in a Sept. 19 letter to CMS administrator Chiquita Brooks LaSure and CMS Innovation Center Director Liz Fowler.

CMS: MA Star Ratings Lower As Cut Points Increase

Year-to-year star rating changes are normal and cut points for achieving higher ratings increased compared to 2024 Star Ratings, CMS explained Thursday (Oct. 10) while announcing that, when weighted by enrollment, about 62% of beneficiaries are currently enrolled in a plan that will have four or more stars in 2025, which is far lower than the 74% of enrollees last year.