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Stark Law Violations

A person or organization may violate both the “Stark Law” (42 U.S.C. § 1395nn), the Medicare anti-kickback statute (42 U.S.C. § 1320a-7b(b)) and the False Claims Act (31 U.S.C. § 3729, et seq.) by giving or receiving improper incentive payments for Medicare or Medicaid patient referrals. The Stark Law forbids a health care provider from billing Medicare or Medicaid for certain healthcare services referred by physicians who have a financial relationship with the provider ( a practice known as “self-referrals”) –unless that relationship falls within certain safe harbor exceptions. A prohibited financial relationship includes a provider’s agreement to compensate a physician in a manner that takes into account the volume of the physician’s referrals or the revenue realized through those referrals. The Government prohibits improper self-referrals because of the fear that referring physicians and billing providers will advance their own financial interests and not the healthcare interests of Medicare and Medicaid patients.

A Stark Law violation can also result in a False Claims Act violation. That is because a healthcare provider that accepts a prohibited referral is also prohibited from presenting a claim or bill for its services to the government or any third-party intermediary. If such claims are presented, Stark mandates that no payment may be made. Typically, a whistleblower alleges that the healthcare provided made “false certifications” in their cost reports or claim forms to the effect that the provider had complied with the laws and regulations dealing with the provision of healthcare services, when, in fact, they had not because they had violated the Stark provisions. A whistleblower can bring a case based on the False Claims Act violation and possibly share in any recovery by the Government.

"Tim McInnis is an amazing attorney. He is intelligent, thorough, ethical, kind and he works very strategically in order to insure the best outcome for his clients. I would trust him with my life. He is not only an excellent attorney, but he is a compassionate person."
Denise A. Romano, January 2004

"Tim McInnis is a superb lawyer for whistleblowers. As both a relator and a lawyer I worked with for more than three and a

On October 14, 2020, medical device maker Merit Medical Systems Inc. (MMSI), of South Jordan, Utah, agreed to pay $18 million to settle allegations the company helped submit false claims to the federal Medicare and TRICARE programs and numerous state Medicaid programs by giving kickbacks to physicians and hospitals to induce the purchase and use of MMSI’s durable medical equipment devices and products. NYC attorney Timothy J. McInnis was a member of the legal team that successfully represented the whistleblower in the case, Charles J. (“CJ”) Wolf, M.D., who was the former Chief Compliance Officer of MMSI.

 

According to Dr. Wolf’s complaint and the government’s settlement agreement, for over six years MMSI paid kickbacks to physicians, medical practices, and hospitals. The payments were made indirectly under the guise of free advertising assistance, practice development, practice support, and so-called “educational” grants. All of this was intended to induce the healthcare providers to purchase and use MMSI’s products, including EmboSphere devices, which are used for uterine fibroid embolization procedures, and QuadraSphere devices, which are used for other types of embolization procedures. Among other things, MMSI used local advertising campaigns to steer patients to healthcare providers as a reward for past sales and to increase future purchases of MMSI products. Dr. Wolf and the government further alleged that MMSI disregarded numerous internal warnings, including from Dr. Wolf, that MMSI’s sales practices potentially violated the healthcare Anti-Kickback Statute (AKS).

 

The lawsuit was filed in the federal court in District of New Jersey, where attorney McInnis formerly served as an Assistant U.S. Attorney. The case is captioned United States ex rel. Wolf v. Merit Medical Systems, Inc., No. 2:16-cv-01855-CCC-MF (D.N.J.). Of the $18 million MMSI is paying to settle the case, $15.21 million will be go to the U.S. Treasury, and the remaining $2.79 million will go to the approximately 30 individual states that also joined the lawsuit.

half years and his counsel and perseverance were always spot on. His work was critical to a successful settlement of the case."
Stephen B. Diamond, Esq., August, 2016

"Tim McInnis Law represented my case with the up most professionalism. He communicated with me at every turn of the case ensuring I understood the process as well what was to come next. His patience, comprehension of Qui Tam Law and persistence in getting me the highest amount possible out of the case is unmatched. I wouldn't hesitate to recommend his law firm for a minute."
Don A. Briscoe, September 2016

"Tim McInnis Law represented my case with the up most professionalism. He communicated with me at every turn of the case ensuring I understood the process as well what was to come next. His patience, comprehension of Qui Tam Law and persistence in getting me the highest amount possible out of the case is unmatched. I wouldn't hesitate to recommend his law firm for a minute."
Don A. Briscoe, September 2016

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