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Around the nation: FDA narrowly expands approval for leucovorin


FDA has narrowly expanded the approval of leucovorin to treat a rare condition called cerebral folate deficiency in the folate receptor 1 gene, going against its earlier announcement that the treatment would be approved broadly for autism, in today's bite-sized hospital and health industry news from Maryland, Minnesota, Pennsylvania, and Washington.  

  • Maryland: Last year, HHS Secretary Robert F. Kennedy Jr. released a report on the causes of autism and named leucovorin, also known as folinic acid, as a potential treatment. In response to the report, FDA Commissioner Marty Makary said that FDA planned to modify leucovorin's label so that it would "be available for children with autism." However, last week, FDA expanded the approval of leucovorin to treat cerebral folate deficiency in the folate receptor 1 gene (CFD-FOLR1), a rare genetic condition. CFD-FOLR1 affects fewer than one in a million people, and only 50 cases have been identified to date. During a briefing, senior FDA officials said there wasn't "sufficient data" to "… establish [leucovorin's] efficacy for autism more broadly." Some parents and families of children with autism have expressed disappointment with FDA's decision. However, some autism organizations have praised the decision, saying that it was an evidence-based approach to treatment. According to an FDA official, patients with autism who want to try leucovorin as a treatment should talk to physicians to determine if it is right for them. (Ruprecht, CNN, 3/11; George, MedPage Today, 3/10)
  • Minnesota/Washington: Optum* is partnering with Microsoft to speed up the claims and reimbursement process through Optum Real, a real-time claims system that connects payers and providers. According to Healthcare Finance, the partnership will introduce new provider-focused capabilities in Optum Real, including smarter coverage prediction to reduce manual work for coders, AI-powered documentation and chart intelligence, and AI-assisted support for prior authorization. So far, Optum reports that Optum Real pilot programs have reduced avoidable denials by up to 80%, cut call volume by 25%, and eliminated up to 75% of reimbursement errors. "Providers are overwhelmed by disconnected systems and manual processes that take time away from patients," said Kristie Richardson, chief product and services officer at Optum Insight. "Optum Real, and our collaboration with Microsoft, is about solving these pain points at scale, bringing together deep subject matter expertise, trusted cloud and AI technology, and an ecosystem perspective to deliver real, measurable impact." (Morse, Healthcare Finance, 3/6)
  • Pennsylvania: Universal Health Services (UHS) has agreed to acquire Talkspace, a virtual behavioral health company, for $835 million in efforts to grow its outpatient and mental health businesses. According to UHS leaders, the deal will help address staffing shortages that have bottlenecked behavioral health services and bring more consumers to the organization. Through Talkspace, which has a network of roughly 6,000 behavioral health clinicians, UHS will be able to provide a full range of behavioral health services, including inpatient, intensive outpatient, and therapy sessions. "There's really no other provider in the behavioral space that offers the continuum of services that we'll now be able to," said UHS CFO Steve Filton. UHS expects Talkspace to generate around $280 million in revenue this year for its behavioral segment, and it will be slightly accretive to UHS' adjusted earnings in the first year excluding one-time costs related to the acquisition. (Parduhn, Healthcare Dive, 3/9)

*Advisory Board is a subsidiary of Optum. All Advisory Board research, expert perspectives, and recommendations remain independent.  


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