Publications

Hogan Lovells Publications

New Jersey issues rules to chill drug manufacturer payments to prescribers

The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the...

Hogan Lovells Publications

A path forward: Corporate Integrity Agreement sheds light on manufacturer interactions with independent charitable foundations

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent...

Hogan Lovells Publications

To the spoiler go the spoils: OIG approves limited product replacement program

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, ...

Hogan Lovells Publications

HHS OIG Finalizes New Exclusion Rules as Administration Exits

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations ...

Hogan Lovells Publications

HHS-OIG Finalizes Wide-Ranging Amendments to Civil Monetary Penalties Regulations and Anti-Kickback Statute Safe Harbors

On December 7, 2016, the HHS-Office of Inspector General (OIG) released two long-awaited final rules relating to its enforcement of the Anti-Kickback Statute (AKS) and Civil Monetary...

Hogan Lovells Publications

GAO Report Suggests Data Needed for CMS to Evaluate How Coupon Discounts Impact Medicare Part B Spending

On August 26, 2016, the U.S. Government Accountability Office (GAO) issued a report on drug coupon discount programs for privately insured patients and their potential impact on Medicare...

Hogan Lovells Publications

Implied Certification Under the FCA: Unanimous Supreme Court Raises the Bar

In the most closely watched False Claims Act case in recent memory, the Supreme Court issued a unanimous opinion yesterday upholding the concept of "implied certification" as a basis for...

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