Anti-Kickback and Stark

October 9, 2019

Genetic testing company UTC Laboratories, Inc. (RenRX), along with three principals, have agreed to pay a combined $42.6 million to settle six suits alleging violations of the Anti-Kickback Statue and False Claims Act.  Between 2013 and 2017, RenRX and principals Tarun Jolly, M.D., Patrick Ridgeway, and Barry Griffith allegedly paid cash bribes to physician entities and individuals to induce orders of medically unnecessary pharmacogenetic tests that were subsequently billed to Medicare.  As part of the settlement, RenRX also agreed to a twenty-five year period of exclusion from participating in any federal healthcare program.  USAO EDLA

October 4, 2019

Florida man Brock Lovelace has been sentenced to nearly six years in federal prison following his conviction at trial on charges related to his payment of kickbacks to medical clinics in the Miami area in exchange for the clinics providing him with DNA samples for submission to a DNA testing laboratory between 2013 and 2014.  Lovelace requested that the medical clinics collect the DNA of all the patients who visited the clinics; in turn, the clinics provided food and other inducements to beneficiaries to get them to visit.  Lovelace then submitted the DNA swabs to a testing lab, which billed Medicare.  The patients were not provided with the results of the DNA testing, and typically did not have any medical need for the DNA testing.  Lovelace was previously sentenced to 14 years in prison on other healthcare fraud charges; he will serve the present sentence consecutively.  DOJ

October 3, 2019

Glenn A. Kline and Community Surgical Associates of Lancaster, Pennsylvania, will pay $4.25 million to resolve claims that Dr. Kline entered into an unlawful kickback arrangement with two hospitals owned by Health Management Associates in exchange for his referral of patients to the hospitals.  The hospitals paid Dr. Kline far above fair market value for his services, and made additional payments to Community Surgical Associates, structuring those payments to conceal their purpose.  HMA previously paid $260 million to resolve related claims; physician groups, EmCare Inc. and Physician’s Alliance Ltd, agreed to pay more than $33 million; and, former HMA CEO Gary Newsome agreed to pay $3.5 million.  The claims against Kline and Community Surgical were original made in a qui tam complaint filed by former HMA executives George Miller and Michael Metts; they will receive $1.05 million of the settlement.  USAO ED PA

September 27, 2019

In an investigation dubbed Operation Double Helix, charges have been brought against 35 defendants associated with a number of telemedicine and cancer genetic testing laboratories involved in a scheme that resulted in the submission of more than $2.1 billion in fraudulent Medicare claims.  Cancer genetic testing laboratories involved in the scheme are alleged to have paid illegal kickbacks to providers and others working with fraudulent telemedicine companies in exchange for the referral of Medicare beneficiaries for expensive and medically unnecessary cancer genetic tests, which Medicare was then billed for. Some of the defendants allegedly controlled a telemarketing network that lured hundreds of thousands of elderly and/or disabled patients into signing up for unnecessary genetic tests, often without any interaction with the provider who would prescribe the testing.  DOJ; USAO ED LA

September 26, 2019

Pharmaceutical manufacturer Avanir Pharmaceuticals will pay approximately $116 million to resolve civil and criminal charges related to its marketing of Nuedextra for off-label purposes and payment of kickbacks to prescribers and others.  The government alleged that Avanir marketed Nuedextra to long-term care facilities, suggesting that it could be used as an alternative to anti-psychotics for dementia patients, even though Nuedextra had only been approved by the FDA for treatment of particular symptoms secondary to a neurologic disease or brain injury.  In addition, Avanir provided certain physicians and other healthcare professionals with unlawful remuneration in the form of money, honoraria, travel, and food to induce them to write prescriptions for Nuedexta. The civil settlement for $103 million, which includes a five-year corporate integrity agreement, resolves whistleblower actions brought under federal and state False Claims Acts by former Avanir employees Kevin Manieri, Duane Arnold, and Mark Shipman.  Manieri will receive $12.4 million, and Arnold and Shipman will receive $5.4 million. In addition to the civil settlement, Avanir will pay a criminal penalty of $7.8 million, forfeit $5.1 million, and enter into a deferred prosecution agreement admitting to payment of kickbacks and requiring cooperation in ongoing in ongoing criminal investigations of individuals involved in marketing and prescribing Nuedextra.  Indictments against four individuals, including former Avanir employees and one of the top prescribers of Nuedexta in the country, were announced, charging the individuals with conspiracy to solicit, receive, offer and pay health care kickbacks.  DOJ

September 25, 2019

Mobile diagnostic service provider Trident USA Health Services LLC has agreed to pay $8.5 million to settle two whistleblower cases alleging violations of the False Claims Act.  Trident’s CIO, Ravi Srivastava, and a regional sales manager, Peter Goldman, had each filed their own qui tam suits alleging Trident had been engaged in a kickback scheme with skilled nursing facilities between 2006 and 2019.  For their efforts, Srivastava will receive $2 million and Goldman will receive $106,250 of the government’s recovery.  USAO EDPA

September 18, 2019

Florida-based compounding pharmacy Diabetic Care Rx LLC, also known as Patient Care America, together with two of its executives, CEO Patrick Smith and VP of Operations Matthew Smith, and the private equity firm Riordan, Lewis & Haden Inc., will pay $21.36 million to resolve a case brought by two whistleblowers under the False Claims Act alleging that they paid unlawful kickbacks to secure referrals for patients covered by TRICARE, the federal healthcare program that covers military members and their families.  The pharmacy paid patient recruiters to target military members and their families for the prescription of compounded creams and vitamins formulated to ensure the highest possible reimbursement from TRICARE.  The marketers in turn paid doctors who issued the prescriptions, often without seeing or even speaking to the purported patients.  In addition, the pharmacy and marketing company often covered patient copayments through a sham charitable organization affiliated with the marketing company.  Private equity investor RLH was alleged to have known about and agreed to the kickback scheme.  Whistleblowers Marisela Medrano and Ada Lopez were, respectively, the former Director of Marketing and the Reimbursement Services Manager of PCA.  They will receive a yet-to-be-determined share of the U.S. recovery.  DOJ; SD FL