FDA is launching a National Priority Voucher program to accelerate the review process for certain new drugs, in today's bite-sized hospital and health industry news from Maryland and Missouri.
- Maryland: FDA is launching a new voucher program to help speed up the review process for certain new drugs. Under the National Priority Voucher program, FDA will distribute a limited number of vouchers to drug manufacturers who are "aligned with U.S. national priorities." The vouchers will allow drugmakers to qualify for priority reviews, which aim to shorten the review process for new drug applications from 10 to 12 months to just one or two. Instead of going through the traditional review process, FDA will assemble a multidisciplinary team of physicians and scientists to pre-review drug applications and convene for a one-day tumor board-style meeting. If appropriate, FDA will grant accelerated approval for new drug candidates. "Using a common-sense approach, the national priority review program will allow companies to submit the lion's share of the drug application before a clinical trial is complete so that we can reduce inefficiencies," said FDA Commissioner Marty Makary. "The ultimate goal is to bring more cures and meaningful treatments to the American public." (Bean, Becker's Hospital Review, 6/18)
- Maryland: Several hospital groups have criticized CMS' Inpatient Prospective Payment System rule for fiscal year 2026. In public comments, hospital groups argued that the 2.4% payment increase for inpatient hospitals was not enough to offset growing expenses, including from labor, drugs, and administrative need. According to the American Hospital Association, the pay increase is "simply inadequate given the unrelenting financial headwinds faced by hospitals and health systems." The Federation of American Hospitals, America's Essential Hospitals, Premier, and Vizient all expressed similar sentiments and called for increased inpatient pay. Several groups also expressed "numerous concerns" about CMS' Transforming Episode Accountability Model (TEAM), a mandatory payment model that will require certain acute care hospitals to participate in episode-based payments for five common surgical procedures starting Jan. 1, 2026. In its comments, Vizient said that making TEAM participation mandatory is "disruptive to healthcare providers as alternative payment models generally require significant planning for success and these steps may not be feasible for all types of providers." (Muoio, Fierce Healthcare, 6/12)
- Missouri: Ascension recently announced plans to acquire AmSurg and its 250 ambulatory surgery centers (ASCs) in 34 states. According to Ascension, it will continue the AmSurg model of physician-led joint ventures and governance. According to the health system, doing so will help ensure clinical leadership is central to each ASC's success, and that physicians will be able to shape care delivery in their communities. "This acquisition is deeply aligned with Ascension's mission to provide compassionate, personalized care to all, especially those most in need," said Ascension CEO Joe Impicciche. "It reflects our steadfast commitment to expanding access to care in a way that is more affordable, more local and more centered around the dignity and well-being of those we serve." Recently, the ASC market has been growing, with data from Technavio estimating that the global ASC market size would grow by $25.4 billion between 2024 and 2028. (Morse, Healthcare Finance, 6/18)
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