CMS Doubts Power Of Purse To Stem Public Health Crises With Compounded Drugs
Medicare agency disagrees with HHS Office of Inspector General recommendation that providers be required to identify the source of compounded drugs submitted for Part B payment.
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CMS instructions to Part D sponsors cite elimination of waste as a reason to require plans to confirm members want a refill. Draft call letter also addresses expanding drug utilization reviews beyond opioids, added controls on compounded drugs.
Public Citizen asks whether CMS policy could have helped prevent the drug contamination at New England Compounding Center as Senate committee wants more information on states’ regulatory practices.
Experience and data from the study, which will use the same vector platform to deliver different transgenes for different diseases, could feed into the US FDA’s efforts to establish a public-private partnership to enable manufacturing of gene therapies for ultra-rare diseases.