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AKS

The Medicare and Medicaid Anti-Kickback Statute (or “AKS”) is a federal criminal law that is found at 42 U.S.C. §1320a-7b(b). Under this law it is illegal to knowingly or willfully offer, pay, solicit, or receive “remuneration,” directly or indirectly, in exchange for referring a patient or furnishing or arranging for a healthcare good or service, for which payment may be made under Government insurance programs, such as Medicare or Medicaid. The Government has used the AKS in addition to various other civil fraud statutes in its arsenal to fight healthcare fraud.

akbs

1. Is illegal “remuneration” under the AKS limited to cash?

No. It can also include (and often does) other things of value beyond outright case payments, including: kickbacks, bribes, rebates, gifts, leased space at commercially unjustified rates, and free or discounted supplies, services or equipment, forgiven or reduced loan payments, special credit arrangements, etc. In other words, it covers just about anything of economic or monetary value.

2. In what context do Anti-Kickback Statute violations typically arise?

Historically, some of the most significant AKS cases involve Durable Medical Equipment (“DME”) manufactures paying what are (or are in effect) bribes to physicians and their staff members to prescribe the DME’s product to Medicare and Medicaid patients. But, there are examples of such cases involving all types of healthcare providers, including, hospitals, clinics, physician practice groups, stand-alone diagnostic facilities, laboratories, pharmaceutical companies, substance abuse treatment centers, ambulance companies or patient transportation services, and so on.

3. What are some of the safe harbors for AKS violations?

The Anti-Kickback “Safe Harbors” are set out in 42 C.F.R. § 1001.952. They include:

Wages, salaries, benefits and other payments to bona fide Employees;

Legitimate personal services and management contracts;
Space and equipment rental and lease agreements at fair market prices;
Proceeds from the sale of medical practices at commercially reasonable prices;
Investment interests for publicly traded companies and smaller entities;
Group purchasing organizations and discounts;
Waiver of beneficiary co-insurance and deductible amounts;
Product warranties;
and Health Plan/Managed care.

4. Are safe harbor arrangements sometimes fraudulent?

Without a doubt. Some unscrupulous healthcare providers study the safe harbor rules and try to construct arrangements that look like they are legitimate when, in fact, they are really disguised forms of unlawful remuneration. For example, you may need to closely decipher a personal services or management contract and compare it to the activities that are actually provided and the market value of the services to know if the arrangement is proper or improper. That is why this is one of the most challenging types of fraud to prove.

5. If someone is convicted of violating the Anti-Kickback Statute, what are the criminal penalties?

He or she will be deemed guilty of a federal felony offense and can be fined up to $25,000 or imprisoned for up to five years, or both.

6. Is an AKS violation also a False Claims Act violation, allowing for additional civil fines, penalties and whistleblower rewards?

Yes, sub-section §1320a-7b (g) specifically says that, in addition to the AKS’ criminal penalties, a government healthcare claim for reimbursement that includes items or services resulting from an AKS violation also constitutes a false or fraudulent claim for purposes of the False Claims Act.

"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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