Tagged: AKS

HHS-OIG Warns Drug and Device Companies on Speaker Program Fraud

In a far-reaching action, the Health and Human Services – Office of Inspector General (HHS-OIG) issued a Special Fraud Alert underscoring the “inherent fraud and abuse risks” associated with company-sponsored speaker programs.  Copy of Special Alert Here.  HHS-OIG’s Fraud Alert is an important warning to pharmaceutical and medical device companies.  It directly applies to U.S. companies’ domestic speaker programs, but the analysis and observations have...

Episode 168 — Review of Merit Medical False Claims Act Settlement

Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to induce increased use of MMS products. Dr. Charles J. Wolf, Merit’s former chief compliance officer, filed a whistleblower complaint against the firm in April 2016 following his resignation, in which he...

Oklahoma City Hospital, Management Company, And Physician Group To Pay $72.3 Million To Settle Federal And State False Claims Act

The Justice Department’s enforcement programs are resuming – False Claims Act, FCPA and other programs will continue.  The rate of enforcement, however, is subject to change once again from the impact of the pandemic. As the pandemic continues to spread, DOJ focus on pandemic related fraud and other scams will divert resources from “traditional” priorities. DOJ’s commitment to False Claims Act prosecutions in the health...

Pharmaceutical and Medical Device Company Payments to Healthcare Professionals (Part II of III)

Given the significant risks posed by transfers of money and other items of value to physicians, pharmaceutical and medical device companies have to implement appropriate controls governing such payments.  The federal Anti-Kickback Statute (“AKS”) prohibits the offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal health care program business.  The statute defines “anything of value” broadly; criminal penalties...

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

Jacqui Merrill, an Associate at The Volkov Law Group, rejoins us for a posting on DOJ’s largest healthcare fraud takedown.  Jacqui’s profile is here and she can be reached at jmerrill@volkovlaw.com. On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...

Anti-Kickback Enforcement – Steady and Aggressive

When commentators criticize the FCPA for its broad coverage of international business operations, these same commentators would have real trouble with the US Anti-Kickback statute. Talk about broad coverage and then complicate it with specific exemptions that are challenging to interpret and apply. When it comes to fraud enforcement in the healthcare industry, the Justice Department wields a mighty stick – the False Claims Act....