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Court finds False Claims Act whistleblower provisions unconstitutional

Since June 2023, the False Claims Act (FCA) bar has waited with baited breath for district courts to address Justice Thomas’s dissent in United States ex rel. Polansky v. Executive...

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Texas AG uses consumer protection law to enforce against B2B clinical health GenAI company

Texas Attorney (“AG”) General Ken Paxton announced a first-for-Texas settlement against a generative AI company using patient data and providing products to health care...

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CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates...

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Life Sciences Procurement Update: FY2025 NDAA would change rules of origin for drugs

In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining...

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Life Sciences Procurement Update: FY2025 NDAA would change rules of origin for drugs

In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining...

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Life Sciences Procurement Update: Changes to Rules of Origin for Drugs in FY 2025 NDAA Senate Bill

In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining...

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Breaking News for Breakthrough Devices: CMS Finalizes Transitional Coverage for Emerging Technologies Pathway

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The...

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MedTech companies’ hopes betrayed: Italian Constitutional Court confirms medical device payback

Expectations of MedTech companies on a possible repeal of the payback mechanism for medical devices have been disappointed by two recent rulings of the Italian Constitutional Court (no....

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CMS issues updates regarding ASP: negative ASP, radiopharmaceuticals, restatements, and skin substitutes

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for...

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