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Regulatory Sprint: Understanding the Impact on the Stark Law, Anti-kickback Statute, and Value-based Arrangements

The Department of Health and Human Services has released extensive and significant revised final rules governing the Physician Self-Referral Law (the Stark law) and the Medicare Anti-Kickback Statute (AKS) in furtherance of...more

HHS/OIG Finalizes Rule Stripping PBM Rebates of Safe Harbor Protection

On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more

Volume Value Take 2

The CMS proposed regulation issued on October 17, 20191 provides much needed clarity on the question of when compensation is deemed to vary with the volume or value of referrals or other business generated between the...more

HHS Proposes Removing Anti-Kickback Safe Harbor Protection for PBM Rebates, Proposes Two New Safe Harbors

On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more

District Court Issues First Decision Interpreting ACA's 60-day Rule

The first case to interpret when the clock begins to run on the “60-Day Rule” did not go well for health care providers. On August 3rd, the Southern District of New York rejected defendants HealthFirst, Inc.’s and Continuum...more

Stark Litigation: The Tuomey Saga Draws to a Close

In what may be the penultimate chapter of the long–running saga of the Tuomey case, the Fourth Circuit affirmed the final judgment and award in favor of the government in its case against Tuomey Healthcare System, Inc....more

Pricing Issues Affecting Laboratories

Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence. Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from...more

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