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IPSEN BIOPHARMACEUTICALS, INC. v. AZAR

No. 18-5299.

943 F.3d 953 (2019)

IPSEN BIOPHARMACEUTICALS, INC., Appellant, v. Alex Michael AZAR, II, in His Official Capacity as Secretary of the United States Department of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided December 3, 2019.

Attorney(s) appearing for the Case

Jeffrey S. Bucholtz , Washington, DC, argued the cause for appellant. With him on the briefs were John D. Shakow and Nikesh Jindal , Washington, DC.

Ruthanne M. Deutsch , Washington DC, Hyland Hunt , Washington DC, R. Craig Kitchen , Daryl L. Joseffer , and Michael B. Schon were on the brief for amicus curiae the Chamber of Commerce of the United States of America in support of plaintiff-appellant.

Matthew J. Glover , Attorney, U.S. Department of Justice, argued the cause for appellees. With him on the brief was Abby C. Wright , Attorney. Alisa B. Klein , Attorney, and R. Craig Lawrence , Assistant U.S. Attorney, entered appearances.

Before: Henderson, Millett and Wilkins, Circuit Judges.

This appeal arises out of Ipsen Biopharmaceuticals, Inc.'s challenge to the designation by Centers for Medicare and Medicaid Services (CMS)—a part of the United States Department of Health and Human Services—of the pricing information Ipsen must report to CMS for a drug that it manufactures....

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