Daily Briefing

Around the nation: FDA approves first drug to treat NASH


On Thursday, FDA approved the first drug specifically aimed at treating a serious liver condition known as noncirrhotic non-alcoholic steatohepatitis (NASH), in today's bite-sized hospital and health industry news from Maryland, Pennsylvania, and Texas.

 

  • Maryland: Bethesda-based Aledade — an accountable care organization (ACO) that helps manage independent primary care clinics and medical offices across over 40 states — is facing allegations that it defrauded Medicare by using billing software that was "rigged" to make patients seem more ill than they were. In a civil suit, a whistleblower claimed the ACO's billing software and guidelines provided to doctors increased revenues by overstating medical diagnoses to patients' EMRs. The case is currently still pending, and Aledade has not yet filed a legal response in court. Julie Bataille, Aledade's SVP for communications, denied the allegations in an interview, noting that "the whole case is totally baseless and meritless." (Schulte, KFF Health News/MedPage Today, 3/10)
  • Pennsylvania: FDA on Thursday approved the first drug developed to treat NASH — a serious liver condition also referred to as metabolic dysfunction-associated steatohepatitis (MASH). The drug, called Rezdiffra, is manufactured by Madrigal Pharmaceuticals. It is a once-daily oral medication that targets the underlying causes of NASH. Rezdiffra is intended to be used by individuals who have moderate to advanced liver fibrosis. "Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage," said Nikolay Nikolov of FDA's Center for Drug Evaluation and Research. "Today's approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise." (Monaco, MedPage Today, 3/14; Feuerstein, STAT+ [subscription required], 3/14)
  • Texas: In 1952, a man named Paul Alexander was diagnosed with polio at age six — a diagnosis he was not expected to survive. For much of his life, he was confined to an iron lung that kept him alive by forcing air in and out of his lungs. According to a Facebook post from his brother, Alexander died last week. He was one of the last people living inside an iron lung in the United States. During his final weeks, Alexander's TikTok account drew a following of more than 330,000 individuals. In his videos, he shared what it had been like living inside an iron lung for 72 years. While Alexander needed the iron lung every day to survive, he taught himself to breathe on his own for short periods of time. He was also able to attend college and obtain a law degree before practicing law for more than three decades. (Jiménez, New York Times, 3/13)

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