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Stark Law Violations

1. What might constitute an unlawful self-referral?

The starting point is where a physician refers a Medicare or Medicaid patient to a medical facility in which the referring physician has a financial interest, be it ownership, investment, or a structured compensation arrangement. One then needs to whether that referral comes within any safe harbor provision.

2. What types of facilities or services are subject to the Stark Law?

Prior to 1994, the focus was on clinical laboratory services, but the Omnibus Budget Reconciliation Act of 1993 (so-called Stark II) expanded the prohibition on physician self-referrals from clinical laboratory services to reach a wider array of eleven “designated health services,” which includes, clinical laboratory services, radiology services, radiation therapy, durable medical equipment and supplies, home health services, and various in-patient and out-patient services.

3. Does Stark Law only cover outright cash payments to referring physicians?

No. In fact, many cases involve uncovering disguised kickback arrangements. These include bogus service contracts, leases and other indirect arrangements for giving something of value to the physician in exchange for Medicare and Medicaid patient referrals.

4. What are the penalties for violating the Stark Law and the False Claims Act?

Both the Stark Law and the False Claims Act provide substantial financial fines and penalties for their violations. A whistleblower may be entitled to share in any recovery under the False Claims Act. This could add up to three times the amount of the improper payments to the healthcare provider that billed the Government, plus a per claim fine of up to $11,500.

"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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