(212) 292-4573 tmcinnis@mcinnis-law.com

Timothy McInnis/McInnis Law and whistleblower law team obtain government intervention in large anti-kickback statute (AKS) and False Claims Act (FCA) case against durable medical equipment (DME) supplier Merit Medical Systems

by | Jun 24, 2020 | Uncategorized

GREENBELT, MD – June 15, 2020 – The United States joined a lawsuit filed by Joseph,

Greenwald & Laake, P.A. on behalf of a former Chief Compliance Officer and whistleblower against Utah-based medical device company, Merit Medical Systems, Inc. The False Claims Act (qui tam) complaint alleges fraud schemes involving unlawful kickbacks to physicians to induce their use of Merit’s devices over those of its competitors. The whistleblower, (or “Relator”), Dr. Charles Wolf, is a non-practicing medical doctor and an accredited healthcare compliance professional with over 20 years of experience.

The complaint recounts how Dr. Wolf reported his concerns about the alleged fraud to Merit’s management during his tenure as its Chief Compliance Officer, all to no avail. Unable to effect change from within, Dr. Wolf resigned from Merit and reported his information to the Department of Justice, which undertook a thorough investigation before deciding to intervene. The lawsuit was made public on June 12, 2020, after the United States filed its notice of intervention and the Court unsealed the case. The federal government is expected to file its own complaint in intervention by July 13. In addition, 29 states are included in the lawsuit and will have an opportunity to join it also.

The complaint focuses on kickback allegations where Merit provided paid advertising for loyal Merit users and paid consulting fees in order to influence physicians to use Merit devices – which are expected to be included in the federal government’s forthcoming complaint. The lawsuit alleges that Merit “paid for advertising for high-volume users of its medical devices and continues to pay consulting fees to high-use providers for little-to-no-work.” Disguised as educational in nature, the suit claims that, instead, the money paid to physicians was meant to effect and “induce hospitals and physicians to purchase additional equipment, supplies and/or products from Merit.”

Federal and state laws prohibit payments of any kind to physicians – including marketing dollars and consulting fees – to influence physician choice of medical devices. “Prosecuting these cases protects patients. When medical device companies pay something of value to induce physicians to use their devices to the exclusion of others, that can effect independent medical judgment and patient care,” said Veronica Nannis, who, with her partner Jay Holland, represents the whistleblower in this case along with former Assistant United States Attorney, Timothy J. McInnis of McInnis Law.

Private insurance companies that offer Medicare Advantage to American seniors as an alternative to traditional Medicare face increasing scrutiny

by | Aug 7, 2019 | Uncategorized

 

 

Under traditional Medicare, beneficiaries receive an array of inpatient and outpatient healthcare services from hospitals, doctors and other providers who are reimbursed on a “fee-for-service” basis. In that environment billing fraud typically arises where the provider does not render the reported service and/or provides medically unnecessary services. Medicare Advantage, in contrast, is a managed care program that utilizes a “capitated” payment system. In that context private Medicare Advantage organizations (MAOs) receive a fixed amount of money per patient from the government and pay healthcare providers for their member-patients’ covered services, keeping what is not paid out as their profits. The amount of the capitated payment depends on the member-patients’ age, health, diagnoses and other physical and medical conditions (known as the risk adjustment score), as determined and reported by the MAOs. In an audit released on July 19, 2019, the Centers for Medicare & Medicaid Services (CMS), the agency overseeing the Medicare and Medicaid programs, estimated approximately $16 billion (or nearly 10%) of its payments to MAOs were improper because of incorrect risk adjustment scores.

 

Recent whistleblower cases have also revealed a number of schemes by which MAOs “game the system” by falsifying risk adjustment scores to make their member-patients appear sicker than they are in order to fraudulently obtain higher capitated payments. For example, in October 2018, HealthCare Partners Holdings LLC, a company owned by DaVita, agreed to a $270 million false claims settlement with the Department of Justice and a whistleblower. HealthCare Partners allegedly overstated its patients’ diagnoses and engaged in a “one-way” review of past diagnoses, looking for mistakes that led to lower payments from the government while ignoring mistakes that led to higher ones. The whistleblower in the case received more than $10 million.

 

Similarly, in December 2018, the Department of Justice joined a whistleblower lawsuit against Sutter Health, a California health system with 24 hospitals and more than 5,000 physicians. In that case, Sutter Health allegedly submitted false diagnosis codes for its patients. The whistleblower there reportedly tried to bring this to light internally before starting her lawsuit, but was ignored by the company.

 

And in January 2019, a federal whistleblower lawsuit against St. Louis-based Essence Group Holdings Corp. was unsealed. That case alleges Essence Group and its technology arm, Lumeris, and its local partner, Lester E. Cox Medical Centers, used data-mining software to identify patients for an “enhanced encounter” that artificially raised patients’ risk adjustment scores to boost Medicare payments. The company disputes these allegations and says it intends to fight the lawsuit. However, on July 15, 2019, a federal judge denied the defendants’ attempt to dismiss the whistleblower’s complaint. Relatedly, an April 2019 government audit found that Essence Group could not substantiate fees for a significant percentage of patients diagnosed with stroke or depression.

"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

Read More Testimonials

Call us anytime 212-292-4573

"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

Read More Testimonials

Call us anytime 212-292-4573

Pharmaceutical Off-label Marketing

Pharmaceutical Off-label Marketing

by | Jan 27, 2014 | Uncategorized

Healthcare-fraud-nursing-home-kickbacks-attorney

Settlement Announced: $40 Million Healthcare Fraud (Kickbacks and Off-label Marketing). CareFusion Corp. has agreed to pay the U.S. government $40.1 million to settle allegations that it violated the False Claims Act by paying kickbacks and promoting its pharmaceutical products for uses that were not approved by the Food and Drug Administration, the Justice Department announced today. CareFusion, a California-based medical technology company, develops, manufactures and sells pharmaceutical products, including products sold under the trade name ChloraPrep. The lawsuit is captioned United States ex rel. Kirk v. CareFusion et al., No. 10-2492 (D. Kan.)

Read more here:
http://www.justice.gov/opa/pr/2014/January/14-civ-021.html