In mid-October 2020, Merit Medical Systems, Inc. (MMSI) agreed to pay $18 million to resolve allegations that the company violated the False Claims Act and Anti-Kickback Statute by paying kickbacks to physicians and hospitals to induce the use of MMSI products.
As we covered in our September 2020 issue of our sister publication, Policy & Medicine Compliance Update, this case is somewhat unique because the qui tam suit was brought by the company’s former compliance officer.
Background
Charles Wolf, MD was the Chief Compliance Officer for MMSI until October 2015. Six months after he left his role as Chief Compliance Officer, in April 2016, he filed a qui tam complaint against the company, alleging that MMSI: caused the submission of false claims for services; made misrepresentations to the Food and Drug Administration (FDA) and others; engaged in false and misleading off-label marketing of its QuadraSphere Microsphere, Embosphere, and Endotek devices, as well as its CO2 kits; and systematically violated the Federal Anti-Kickback Statute.
Under the guise of an internal program known as the Local Advertising Program, MMSI allegedly provided remuneration to healthcare providers in the form of millions of dollars in free advertising assistance, practice development, practice support, and purported unrestricted “educational” grants to induce the healthcare providers to purchase and use a wide variety of MMSI products. Despite publicly claiming that its financial assistance was designed to “increase the awareness” of medical treatments, MMSI allegedly provided it only to select healthcare providers to reward past sales, induce future sales, and steer business to MMSI and away from MMSI’s competitors.
The complaint alleges that management at MMSI often spoke openly about compliance and even went so far as to create a numeric system to discuss how risky certain proposals would be. The risk evaluation system included a “chili pepper” scale from 1-3, indicating how much “heartburn” a particular action would give the company as far as compliance and ethics were concerned, the complaint said.
The government alleged that MMSI disregarded numerous warnings that its conduct may violate the Anti-Kickback Statute, including warnings from MMSI’s own Chief Compliance Officer, during the course of the alleged kickback scheme.
The Settlement
MMSI refused to acknowledge any wrongdoing but entered into a settlement agreement that resolves the above allegations taking place over a six-year period. The settlement, totaling $18 million, will be split between the federal government ($12.56 million), individual states ($2.79 million), and the whistleblower Dr. Wolf ($2.65 million).
Corporate Integrity Agreement
Along with the civil settlement, MMSI entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA requires MMSI to hire a compliance expert and an independent review organization to analyze its systems and transactions. “No health care company’s compliance program can be effective without commitment and support from the company’s leaders,” said HHS-OIG Chief Counsel Gregory Demske. “As happened here, ignoring your compliance officer’s concerns about payments to referral sources is a great way to become a defendant in a kickback case.”
Additional Coverage
As indicated above, Policy & Medicine Compliance Update covered the detailed background of this case in the September 2020 issue. The publication also anticipates publishing a future article covering the settlement and CIA.
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