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11th Circuit: Difference in Opinion Not Enough for FCA Liability

The 11th Circuit’s long-awaited AseraCare opinion requires more than mere disagreement regarding clinical judgment to prove falsity under the False Claims Act. The 11th Circuit rejected the government’s theory of falsity...more

Drug Pricing and Payment Policy: Sweeping HHS Rebate Reform Proposal and First 2019 Congressional Hearings

HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts. On January 31, 2019, the Department of Health and Human Services (HHS) announced a...more

Drug Pricing and Payment Policy: Key 2018 Developments and Potential 2019 Changes and Challenges

Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more

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