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OIG’s first-ever General Compliance Program Guidance covering all health care parties released

In November 2023, OIG released its first ever General Compliance Program Guidance (GCPG). The GCPG is a comprehensive document that applies to all individuals and entities involved in the health care sector....more

New Connecticut rules for drug makers employing sales reps take effect Oct. 1

The state of Connecticut recently enacted HB6669, which requires registration of pharmaceutical manufacturers employing sales representatives who interact with health care professionals (HCPs) in Connecticut. The portions of...more

Sixth Circuit weighs in on meaning of causation, remuneration for False Claims based on alleged kickbacks

The Sixth Circuit expanded the existing circuit split regarding when a kickback causes a federal health care claim to be false or fraudulent under the False Claims Act (FCA) and set out a new analysis for what constitutes...more

OIG green lights drug manufacturer-sponsored genetic testing program

On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical manufacturer’s sponsored genetic testing and...more

PhRMA responds: Code on Interactions with HCPs updated following fraud alert on speaker programs

On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals (HCPs). The updated Code will take effect...more

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

HHS-OIG launches portal for COVID-19 related questions about its enforcement authorities

The Office of Inspector General for the U.S. Department of Health and Human Services (HHS-OIG) announced the launch of a portal that will post announcements and information issued by OIG that are related to COVID-19. ...more

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

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

HHS OIG: Smartphone loaner to needy patients may not violate Anti-Kickback Statute

On Tuesday, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 19-02, advising that OIG would not pursue enforcement under the Anti-Kickback Statute (AKS) or the...more

New anti-kickback prohibition in opioid bill creates tangled web of compliance obligations

On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more

HHS watchdog eyes anti kickback safe harbors for care coordination beneficiary incentives and cost sharing

On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more

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 expected final rule is less...more

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 charitable foundations that assist...more

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, consider how they might engage with the...more

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