Publications

Hogan Lovells Publications

Massachusetts anti-opioid law bans manufacturer copay assistance

On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect...

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

New California law limits drug manufacturer co-pay cards and other discounts in California

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited...

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

New Jersey joins wave of states proposing new rules for drug marketing and HCP interactions

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully,...

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...

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