Anti-Kickback and Stark

July 2, 2021

An Ohio-based hospital system that has since been acquired by the Cleveland Clinic Foundation has agreed to pay over $21 million to resolve alleged violations of the Anti-Kickback Statute, Physician Self-Referral Law, and False Claims Act.  Between 2010 and 2016, Akron General Health System (AGHS) allegedly paid area physician groups far above fair market value in order to induce referrals, then submitted claims arising from those illegal referrals to federal healthcare programs.  The settlement resolves a qui tam suit brought forth by former internal audit director at AGHS, Beverly Brouse, and Ethical Solutions LLC.  DOJ

June 30, 2021

Armed Forces Services Corporation (AFSC) d/b/a Magellan Federal has agreed to pay over $4.3 million to resolve its liability under the False Claims Act.  In a written disclosure to the U.S. Small Business Administration, AFSC revealed that a former executive had orchestrated kickbacks for himself and two other executives in exchange for awarding subcontractors work on federal contracts.  USAO EDVA

May 19, 2021

In one of the first settlements to resolve allegations under both the False Claims Act and the Open Payments Program (formerly the “Sunshine Act”), French medical device manufacturer Medicrea International and its American affiliate, Medicrea USA Inc., have agreed to pay $2 million to resolve whistleblower Dory Frain’s allegations that the companies violated the Anti-Kickback Statute while entertaining U.S.-based physicians at a conference in France in 2013.  The settlement also resolves allegations that the companies violated the Open Payments Program by failing to report those expenses to the Centers for Medicare & Medicaid Services.  USAO EDPA; CA AG; FL AG

May 10, 2021

The University of Miami, which operates multiple hospitals and other healthcare facilities, will pay $22 million to resolve claims arising from allegedly fraudulent billing submitted to federal healthcare programs for laboratory services.  The university was alleged to have billed certain laboratory tests as having been provided at hospital facilities instead of at physician offices, without satisfying the requirements for that more costly hospital facility billing, including notice requirements.  In addition, the university was alleged to have performed and billed for a pre-set panel of tests for all kidney transplant patients, although not all included tests were medically necessary.  Finally, the university and Jackson Memorial Hospital, which jointly operated the kidney transplant program, were alleged to have violated related party restrictions by billing for pre-transplant laboratory tests ordered by JMH from the university, and JMH will pay an additional $1.1 million to settle these allegations.  The settlement resolves claims made in three separate qui tam lawsuits; the whistleblower's share has not yet been determined.  DOJ; USAO SD FL

May 4, 2021

Delaware-based pharmaceutical company Incyte Corporation has agreed to pay $12.6 million to resolve allegations of violating the Anti-Kickback Statute and False Claims Act in connection with its myelofibrosis drug, Jafaki.  Despite federal laws against illegal remuneration to federal healthcare program beneficiaries, Incyte allegedly wielded its influence as the sole donor of a foundation to coerce the foundation into illegally covering the copays of Medicare and TRICARE patients taking Jafaki.  The misconduct continued from 2011 through 2014 before it was revealed in a qui tam suit by former compliance executive turned whistleblower, Justin Dillon.  Dillon will receive approximately $3.59 million for his efforts.  DOJ; USAO EDPA

May 4, 2021

After being convicted of running a $11 million healthcare fraud scheme, Brenda Rodriguez, the owner and operator of Texas-based QC Medical Clinic, has been ordered to spend 25 years in prison, followed by 3 years of supervised release.  As shown by evidence presented at trial, Rodriguez’s scheme involved paying doctors to approve Medicare beneficiaries for home health services, selling the approvals to various home health providers, and causing the providers to bill Medicare for services that were medically unnecessary, never provided, and/or arose from illegal inducements.  USAO SDTX

May 3, 2021

Two medical device distributorships, Medical Designs LLC and Sicage LLC, and their neurosurgeon owner, Wilson Asfora, have agreed to pay $4.4 million to resolve allegations of illegally inducing the use of certain medical devices, submitting false claims to federal healthcare programs for medically unnecessary procedures, and failing to disclose Asfora’s ownership interests or illegal payments made to him.  The settlement was not the first involving Asfora; the United States previously settled with Sanford Health for $20.25 million and Medtronic for $9.21 million on similar claims.  The whistleblowers in this case, Drs. Carl Dustin Bechtold and Bryan Wellman, will receive a $800,000 share of the settlement proceeds, while the defendants will all be excluded from participating in federal healthcare programs for six years.  DOJ; USAO SD