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Anti-Kickback Statute › Safe Harbors › Life Sciences

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

Baker Donelson on

Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Fenwick & West LLP

Compensating Physician Advisors with Equity: Considerations for Life Sciences Companies

Fenwick & West LLP on

Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more

Hogan Lovells

HHS tackles barriers to value-based care: Part 1 – new protections for value-based arrangements under Stark and the AKS and other...

Hogan Lovells on

Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Due Diligence: A Reference Guide for Your Life Sciences Corporate Transactions

Akin Gump Strauss Hauer & Feld LLP on

• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

Hogan Lovells on

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

King & Spalding

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

King & Spalding on

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

Thomas Fox - Compliance Evangelist

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

Thomas Fox - Compliance Evangelist on

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

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