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Top news of the day from across the health care landscape.
Stricter rules for private insurance plans such as limiting profits, easing enrollment, and requiring minimum levels of participating doctors has been placed on plans that provide a majority of Medicaid benefits for the poor, reported Kaiser Health News. This change by the Obama administration may affect consumers by eventually changing to quality ratings that reflect Medicaid plan health results and customer experiences. However, this regulation will change many aspects of how UnitedHealthcare, Aetna, and other large contractors conduct business. The administration has agreed to move slowly and will begin implementation on July 1, 2017 and continue in phases over the next 3 years.
Yesterday, the FDA voted against the recommended approval for eteplirsen for the treatment of Duchenne muscular dystrophy. According to The Wall Street Journal, the advisory committee voted 7 to 3, with 3 abstentions, on whether a small study provided evidence of the efficacy of the drug. Those who abstained did so after hearing moving testimonies from parents who believed the drug helped their children, leaving the 3 panel members undecided. FDA reviewers concluded that the study didn’t provide enough evidence to gain a recommended approval. “Although FDA is prepared to be flexible with respect to a devastating illness with no treatment options, flexibility does not mean approving drugs for which substantial evidence of effectiveness has not been established,” reported FDA reviewers in a report to the panel.
Under the terms of agreements with the office of State Attorney General Eric Schneiderman, 7 New York health insurance companies will change their criteria for covering costly hepatitis C (HCV) drugs, reported The Wall Street Journal. An investigation was conducted last year by Schneiderman’s office in the coverage of chronic HCV drugs. A wide discrepancy was found, with some insurers who largely covered only patients with advanced stages of HCV. In fact, 5 of the insurers had denied 30% to 70% of claims. The agreements are expected to be announced Tuesday and will require insurers to cover HCV medications for almost all patients who have commercial insurance plans in the state.
FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a