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February 19, 2019

Teva Pharmaceuticals Ltd. has reached a settlement agreement with the Federal Trade Commission resolving three separate antitrust lawsuits.  As part of the settlement, Teva agrees not to engage in so-called reverse-payment settlement agreements that can impede consumer access to generic drugs.  In such “pay-for-delay” settlements, the drug company patent-holder pays the generic drug manufacturer allegedly infringing its patent in exchange for the alleged infringer being in position to be awarded a six-month exclusive right to market the generic drug.  The settlement still requires court approval.  FTC

Tagged in: Pharma Fraud,

February 14, 2019

Compounding pharmacy Vital Life Institute LLC, formerly known as AgeVital Pharmacy LLC, will pay $775,000 to resolve claims that the company and its principals paid kickbacks to third-party marketing companies to solicit prospective patients, regardless of the patients' needs.  The investigation was initiated by the filing of a qui tam complaint under the False Claims Act by Manfred Knopf, who received unwanted compounded medications from AgeVital that were billed to Medicare.  Mr. Knopf will receive $139,500 as a whistleblower reward.  DOJ

Tagged in: Compounding Pharmacy Fraud, FCA Federal, Pharma Fraud, Whistleblower Case, Whistleblower Eligibility, Whistleblower Rewards,

February 12, 2019

Michael Frey of Ft. Myers, Florida, a physician specializing in pain management, was sentenced to 18 months in prison for his role in an illegal kickback scheme.  Frey was a co-owner of Advanced Pain Management Specialists, P.A., and received kickbacks from A&G Spinal Solutions, LLC (which made checks payable to his wife) for a share of its profits from patient referrals; from a compound pharmacy provider; and as "speaker fees" from Insys Therapeutics, a pain medication manufacturer.  Frey previously agreed to pay $2.8 million in civil settlement of claims under the False Claims Act.  USAO MD FL

Tagged in: Anti-Kickback and Stark, Criminal Proceedings, FCA Federal, Pharma Fraud, Provider Fraud,

February 8, 2019

A Texas-based marketing company, One Source Healthcare Organization, and its owner, James Paul Adams, have agreed to pay $339,412.50 to resolve allegations that it violated the Anti-Kickback Statute in accepting illegal payments from a compounding pharmacy to market their drug. Because the payments resulted in false claims being paid by Medicare and TRICARE, they were also alleged to be in violation of the federal False Claims Act. Two men affiliated with the compounding pharmacy, Oklahoma-based OK Compounding, LLC, were previously indicted on similar charges. USAO NDOK

Tagged in: Anti-Kickback and Stark, Compounding Pharmacy Fraud, FCA Federal, Healthcare Fraud, Medicare, Other Government Health Programs,

February 7, 2019

A former bus driver with the New York Metropolitan Transit Authority has been sentenced to 20 months in prison for defrauding the authority's health benefit plan of $2.8 million. Enver Kalaba, who was recruited into the scheme by former bus driver Christopher Frusci, worked on behalf of an unnamed company to pay bribes to fellow MTA employees in exchange for medically unnecessary prescription compounded medications. For each prescription for medications such as pain creams, scar creams, and metabolic supplements, Kalaba and Frusci paid $100. As part of his sentence, Kalaba must now forfeit $138,630 in fraudulent earnings and pay $2.9 million in restitution. Frusci is scheduled to be sentenced next month. USAO NJ

Tagged in: Compounding Pharmacy Fraud, Criminal Proceedings, Healthcare Fraud, Lack of Medical Necessity, Other Government Health Programs,

February 6, 2019

Abbott Labs has agreed to pay a total of $25 million to settle allegations of paying kickbacks to healthcare professionals in exchange for promotion of its drug, and inappropriately marketing its drug, TriCor, for cardiovascular events not approved by the FDA. The case was initiated by the State of North Carolina and joined by California, Illinois, Nevada, Maryland, Michigan, and Texas, as well as the federal government. NC AG

Tagged in: Anti-Kickback and Stark, Healthcare Fraud, Medicaid, Off-Label and Unapproved Use, Other Government Health Programs, Pharma Fraud,

February 4, 2019

Compounding pharmacy Pentec Health, Inc., which sells a drug Proplete for nutrition support for patients with end stage renal disease, has agreed to pay $17 million to settle claims under the False Claims Act.  Pentec was alleged to bill federal healthcare programs for product wasted during the compounding of Proplete, and for Proplete that was not medically necessary or was not actually received by patients, routinely waiving patient copays and deductibles to induce the prescription of the drug.  Pentec also entered into a corporate integrity agreement and will be excluded from participation on federal healthcare programs.  The case was initiated by whistleblower Jean Brasher, a former employee of Pentec, who will receive an undisclosed share of the settlement. USAO EDPA

Tagged in: Compounding Pharmacy Fraud, FCA Federal, Lack of Medical Necessity, Pharma Fraud, Whistleblower Case,

January 28, 2019

Ademola O. Adebayo, of Odessa, FL, was convicted for his role in a massive compounding pharmacy fraud scheme through which he submitted false and fraudulent claims for compounded drugs and other prescription medications that were not medically necessary, never provided, or both. The evidence established that in his role as the pharmacist at A to Z Pharmacy, now-defunct, Adebayo conspired to submit or cause the submission of claims that often amounted to several thousands of dollars for a single tube of pain or scar cream. When the fraud was uncovered, Adebayo became the straw owner of Havana Pharmacy & Discount in Miami, where Adebayo and his co-conspirators continued the fraud. Adebayo personally benefited from the fraud and received $1.5 million. DOJ

Tagged in: Compounding Pharmacy Fraud, Healthcare Fraud, Lack of Medical Necessity, Medicare, Other Government Health Programs,

January 22, 2019

Walgreens Co. will pay the U.S. and the State of Wisconsin $3.5 million to settle a case under the False Claims Act alleging that the retail pharmacy routinely dispensed stimulant medications to Wisconsin Medicaid beneficiaries without first verifying that the prescribing physician ordered the medication for medically appropriate treatment, such as treatment for attention deficit disorder. The case was initiated by unidentified whistleblowers, who will receive a share of the settlement to be determined. USAO EDWI

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

January 22, 2019

Walgreens Boots Alliance, Inc. will pay $60 million to settle a False Claims Act case brought by a whistleblower alleging that the retail pharmacy chain knowingly overcharged Medicaid when it charged the healthcare program more than "usual and customary price" for medications that participants in Walgreens "Prescriptions Savings Club" received at a lower price.  Of the settlement, approximately $32 million will be paid to the U.S. and $28 million to the affected states.  Whistleblower Marc D. Baker will receive a share of the total settlement, to be determined at a later date.  USAO SDNY

Tagged in: Drug and DME Pricing, FCA State, Medicaid, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

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