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Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

FDA Law Blog

Circuit, but today, the Supreme Court reversed again and upheld the District Court’s opinion in American Hospital Assn v. Writing for a unanimous court, Justice Kavanaugh explained that the Medicare statute provides CMS a choice between two options on how to set reimbursement rates for drugs provided in the hospital outpatient setting.

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4th Circuit En Banc Judgment Affirms District Court Decision in Best Price Stacking Case

FDA Law Blog

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates.

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Money for safety-net hospitals at stake in dispute over Medicare payment formula

SCOTUSBlog

Natural Resources Defense Council , determines when a federal court must defer to an agency’s interpretation of a statute it administers. First, under step one, if the court determines Congress’ intent is clear and unambiguous in the statute, the court will interpret the statute according to its terms, without deferring to the agency.

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COVID – Consolidated Appropriation Act “CAA” and Bankruptcy 12-27-20

Diane Drain

December 27, 2020 Congress passed the longest bill ever – 5,600 pages. It is possible that these interpretations of the new Act will change with new legislation or court decisions, so never assume what you read one day will be interpreted the same way the next day. 2020 WL 7579338 (11th Cir. December 22, 2020).

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. The statute defines a “line extension” as a “new formulation” of an existing drug, with certain exceptions. Vanda Pharmaceuticals, Inc. 23-1457 (4th Cir.

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Why the ‘Machinery of Death’ Keeps Running

The Crime Report

And in November 2020 America elected its first president ever to openly oppose capital punishment. Some states, such as Louisiana and North Carolina, enacted mandatory death penalty statutes, eliminating discretion entirely from the death penalty system. This time the court’s verdict was less equivocal, though no less divided.

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

FDA Law Blog

But all kidding aside, some of the recent decisions we found are rather distressing. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § Despite a rather long history of granting multiple PTEs, in 2020, in an about-face, the PTO took the position that multiple PTEs are no longer supported by the statute.

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