Ipsen Biopharmaceuticals, Inc. v. Azar, No. 18-5299 (D.C. Cir. 2019)
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Ipsen challenged CMS's designation of the pricing information Ipsen must report to CMS for a drug that it manufactures. At issue was whether a series of letters CMS sent Ipsen constitutes final agency action under the Administrative Procedure Act (APA).
The DC Circuit reversed the district court's grant of summary judgment to CMS, holding that Ipsen has plausibly argued that receipt of the letters significantly increased its risk of a statutory civil penalty being levied for knowingly providing false information. The court explained that this increased risk was a legal consequence sufficient to make the agency action final under the second prong of the test pronounced by the United States Supreme Court in Bennett v. Spear, 520 U.S. 154, 177–78 (1997).
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