News & Analysis as of

Anti-Kickback Statute Regulatory Requirements Prescription Drugs

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 -
Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

Ropes & Gray LLP on

On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more

Hogan Lovells

Investigation highlights risks of collaboration between pharmaceutical manufacturers and telehealth providers

Hogan Lovells on

Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more

Hogan Lovells

An evolving ‘nexus’: OIG approves sponsored testing program involving companion diagnostic

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Faegre Drinker Biddle & Reath LLP

The Latest on Pharmaceutical Company-Sponsored Diagnostic Testing Programs

Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Polsinelli

OIG Issues Guidance on Speaker Programs By Drug and Device Companies

Polsinelli on

This week, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert providing insight into speaker programs put on by drug and medical device companies that the OIG considers signs of potential fraud. Generally,...more

Hogan Lovells

Massachusetts anti-opioid law bans manufacturer copay assistance

Hogan Lovells on

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 immediately. ...more

Jones Day

DOJ Pursues PE Firm Based on Portfolio Company's Alleged Payment of Kickbacks

Jones Day on

The Situation: In what may indicate a sea change in terms of who the Department of Justice ("DOJ") is willing to pursue in False Claims Act cases, a private equity firm has been named as a co-defendant in a False Claims Act...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide