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Major Changes Finalized to Stark Rules, Anti-Kickback Statute Safe Harbors and the Beneficiary Inducements CMP

CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more

Major Changes to the Medicare Shared Savings Program Impact Current and Prospective ACOs

CMS issued final rules on December 21, 2018, that were published in the December 31, 2018 Federal Register (ACO Final Rules), adopting major changes to the Medicare Shared Savings Program (MSSP) which impact currently...more

U.S. District Court Holds that a State University Is Immune from False Claims Act Liability Despite Intervention by United States

On April 11, 2017, the U.S. District Court for the District of Oregon granted Oregon Health and Sciences University’s (OHSU) motion to dismiss a qui tam False Claim Act (FCA) suit, holding that (1) OHSU is an “arm of the...more

Fourth Circuit Declines to Review Issue of Statistical Sampling Use in FCA Case

On February 14, 2017, the U.S. Court of Appeals for the Fourth Circuit issued a long-awaited opinion in the case U.S. ex rel. Michaels v. Agape Senior Community, Inc. et al. (case number 15-2145 and 15-2147). In this FCA...more

HRSA Withdraws 340B Program “Mega Guidance” from OMB Review

On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the...more

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