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Legal Insights and Perspectives for the Healthcare Industry

In the complex world of Medicare reimbursement, there are a multitude of payment formulae, mathematical adjustments, and reimbursement calculations that translate congressional policy into operational payments for hospital providers. But sometimes the Centers for Medicare and Medicaid Services (CMS) doesn’t get the math right. Recently, the US District Court for the District of Columbia found that academic medical centers have been subject to one such calculation error that implicates the amount such teaching hospitals receive as payment in support of direct graduate medical education (GME). Milton S. Hershey Med. Ctr. v. Xavier Becerra, Civ. Action No. 19-2680 (May 17, 2021). Based on the court’s reasoning, teaching hospitals operating above their full-time equivalent (FTE) resident cap may have been systematically underpaid as a result of the regulatory payment formula for determining the weighted FTE amount of residents used to calculate the GME payment. Other hospitals have recently followed Hershey Medical into the DC District Court seeking similar decisions.

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.