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December 12, 2017

Med-Fast Pharmacy, Inc. agreed to pay roughly $2.7 million to resolve both criminal and civil charges of violating the False Claims Act relating to the conduct of Iserve Technologies, Inc., a company co-located with and operated out of Med-Fast, filling prescriptions for nursing homes with recycled unused drugs that were commingled with drug stocks on hand at Med-Fast’s Institutional Pharmacy. The settlement also resolves allegations that Med-Fast sought Medicare and Medicaid reimbursement for the retail-packaged version of diabetes testing strips while actually supplying patients with cheaper mail-order-packaged version of the same strips. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act. The whistleblower will receive a yet-to-be-determined award from the proceeds of the government's recovery. DOJ (WDPA)

Tagged in: Healthcare Fraud, Medical Billing Fraud, Off-Label and Unapproved Use, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

December 20th, 2017

California announced a $13.5 million multistate settlement with pharmaceutical company Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) for its deceptive and misleading representation and off-label marketing of its prescription drugs. California will receive $857,000. The settlement resolves allegations that BIPI misled the public about the uses and efficacy of prescription drugs, including Micardis, Aggrenox, Atrovent, and Combivent. The settlement comes after a multistate investigation found that BIPI engaged in deceptive practices. BIPI represented that its prescription drugs had sponsorship, approval, characteristics, ingredients, uses and benefits that they did not have. For example, BIPI engaged in off-label marketing and promoted its drugs to treat life-threatening conditions, such as heart attacks, congestive heart failure, and strokes, without evidence to substantiate their claims. CA

Tagged in: Healthcare Fraud, Off-Label and Unapproved Use, Pharma Fraud,

December 13th, 2017

Illinois announced a $12 million settlement with a company that manufactures a device used primarily in spinal surgeries. The settlement with Medtronic Sofamor Danek, Inc. and Medtronic Sofamor Danek USA, Inc. (Medtronic) resolves allegations that the company misled consumers about the safety of its Infuse® Bone Graft Device. According to Madigan’s complaint, Medtronic used deceptive company-sponsored scientific literature to make false and misleading claims about Infuse’s safety, effectiveness and quality. The false marketing created an artificial demand for Infuse in a range of fusion surgeries. The company’s fraudulent conduct was the subject of a 16-month investigation by the U.S. Senate Finance Committee. IL

Tagged in: Defective Products, Healthcare Fraud,

November 30, 2017

Florida-based Express Plus Pharmacy, LLC and its owner Antonio Primo agreed to pay $170,000 to resolve allegations they violated the False Claims Act by submitting fraudulent claims to Tricare for compounded medications such as pain creams that were not reimbursable because they were not issued pursuant to valid physician-patient relationships, were issued after brief phone calls with patients that violated applicable law on telemedicine, were medically unnecessary, and/or were tainted by kickbacks to marketers.  DOJ (SDFL)

Tagged in: Compounding Pharmacy Fraud, FCA Federal, Lack of Medical Necessity, Medical Billing Fraud, Other Government Health Programs, Pharma Fraud,

September 22, 2017

The Securities and Exchange Commission today filed fraud charges against Aegerion Pharmaceuticals for exaggerating how many new patients actually filled prescriptions for an expensive drug that was its sole source of revenue. Aegerion, now a subsidiary of Novelion Therapeutics, has agreed to pay a $4.1 million penalty to settle the charges that it misled investors on multiple occasions in 2013.  The SEC’s complaint alleges that Aegerion told investors that the number of unfilled prescriptions for Juxtapid was not material and the “vast majority” of patients receiving prescriptions ultimately purchased the drug.  The SEC alleges that Aegerion’s records reflect that it was actually around 50 percent of prescriptions that resulted in actual drug purchases. SEC

Tagged in: Misrepresentations, Pharma Fraud, Securities Fraud,

October 4, 2017

Med-Fast Pharmacy, Inc. and its owner Douglas Kaleugher agreed to pay roughly $2.7 million to settle charges of violating the False Claims Act by distributing and submitting claims to Medicare for medication that it had either recycled from long-term care facilities serviced by its institutional pharmacy, or that otherwise differed from the medications identified as part of the claims submitted to the government.  The government further alleged the company sought reimbursement for the retail-packaged version of diabetes testing strips, while actually supplying patients with cheaper mail-order-packaged version of the same strips.  The allegations originated in two whistleblower lawsuits filed under the qui tam provisions of the False Claims Act.  The whistleblowers will receive an award from the proceeds of the government's recovery. DOJ (WDPA)

Tagged in: FCA Federal, Off-Label and Unapproved Use, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

October 3, 2017

Michigan physician Abdul Haq pleaded guilty to conspiracy to commit health care fraud for his role in an approximately $19 million Medicare fraud scheme involving three Detroit area providers.  Haq admitted he conspired with the owner of the Tri-County Network and others to prescribe medically unnecessary controlled substances, including Oxycodone, Hydrocodone and Opana, to Medicare beneficiaries, many of whom were addicted to narcotics. DOJ

Tagged in: Lack of Medical Necessity, Pharma Fraud, Provider Fraud,

September 22, 2017

Aegerion Pharmaceuticals Inc., the Massachusetts-based subsidiary of Novelion Therapeutics Inc., agreed to plead guilty to charges relating to its prescription drug Juxtapid.  Specifically, Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy.  Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising out of violations of the False Claims Act and Federal Food, Drug, and Cosmetic Act.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Aegerion former employees Michele Clarke, Tricia Mullins, and Kristi Winge.  They will receive a whistleblower award of $4.7 million from the proceeds of the government's recovery. DOJ

Tagged in: FCA Federal, FDA Fraud, Off-Label and Unapproved Use, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

September 20, 2017

Miami physician Roberto A. Fernandez was sentenced to 97 months in prison and to pay $4.8 million in restitution for his role in a $4.8 million health care fraud scheme that involved the submission of false and fraudulent claims to Medicare and the illegal prescribing of controlled substances, including oxycodone and hydrocodone. DOJ

Tagged in: Lack of Medical Necessity, Pharma Fraud, Provider Fraud,

September 8, 2017

Galena Biopharma Inc. agreed to pay more than $7.55 million to resolve allegations it violated the False Claims Act by paying kickbacks to doctors to induce them to prescribe its fentanyl-based drug Abstral.  These included providing more than 85 free meals to doctors and staff from a single, high-prescribing practice; paying doctors thousands of dollars to attend an “advisory board,” and paying roughly $92,000 to a physician-owned pharmacy under a performance-based rebate agreement.  Two of the doctors who received remuneration from Galena were convicted and later sentenced to prison.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Lynne Dougherty.  She will receive a whistleblower award of more than $1.2 million from the proceeds of the government's recovery. DOJ

Tagged in: FCA Federal, Lack of Medical Necessity, Pharma Fraud, Provider Fraud, Whistleblower Case, Whistleblower Rewards,

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