Last week, the Department of Justice (DOJ) announced that pacemaker manufacturer Biotronik Inc. (Biotronik) had agreed to pay $12.95 million to resolve allegations that, from 2013 to 2021, it had illegally induced physicians to implant its devices using kickbacks such as payments for participation in trainings that were unnecessary or did not occur, and payments for physicians’ . . .
In a perhaps final coda to Pfizer’s bizarre attempt to get the government or a court to bless blatant violations of the anti-kickback statute (AKS), the Second Circuit ruled today that the Department of Health and Human Services Office of Inspector General (HHS-OIG) did not err in issuing an unfavorable advisory opinion on Pfizer’s proposed “Direct Copay . . .
Biogen Inc. (Biogen), the Massachusetts-based pharmaceutical company, recently agreed to pay $900 million to resolve a ten-year-old qui tam case in which the whistleblower, Michael Bawduniak, alleged that Biogen paid a variety of kickbacks to induce physicians to prescribe Biogen’s expensive multiple sclerosis drugs. The settlement is notable not only because of its size – it is . . .
In further fallout from last year’s Department of Justice settlement with kaléo, the manufacturer of Evzio, an expensive naloxone drug, a Florida specialty pharmacy, Solera, has entered into a deferred prosecution agreement and agreed to pay $1,310,000 to resolve allegations that it obtained fraudulent prior authorizations from Medicare Part D Plans and paid kickbacks to patients by . . .
Read More from Specialty Pharmacy Solera Agrees to Pay $1.3 Million and Enter into Deferred Prosecution Agreement to Resolve Allegations that It Fraudulently Obtained Prior Authorizations from Medicare Part D Plans and Paid Kickbacks to Patients by Waiving Medicare Co-Pays
Almost four months ago, I posted about a curious settlement involving a Massachusetts urology practice, Brockton Urology Clinic LLC (Brockton Urology), that agreed to pay $100,000 to resolve False Claims Act allegations that it took money from a Steward Health System (Steward) hospital to run a “Prostate Center of Excellence” that never existed. At the time, I . . .
Earlier this year, I posted about a lab that agreed to pay over $11.6 million to resolve various allegations, including that it violated the AKS through its compensation of “sales organizations on a commission basis for their referrals.” That got me thinking about these types of commission arrangements, which of course are very common outside of the health care . . .
On April 11, 2022, the Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion, Advisory Opinion 22-06, highlighting the risks pharmaceutical companies may encounter if they try to incorporate free genetic testing into their marketing plans. Indirectly, the opinion also shows how whistleblowers can identify promising False Claims Act qui tam cases . . .
On March 31, 2022, the United States Attorney’s Office in the District of Massachusetts announced that Radeas LLC, a North Carolina-based lab, agreed to pay over $11.6 million to resolve allegations that it billed Medicare for unnecessary urine drug testing (UDT). According to the settlement agreement, Radeas admitted that, when health care providers submitted urine samples to Radeas, . . .
On March 7, 2022, the government announced one of the biggest settlements ever involving the Medicaid Drug Rebate Program: Mallinckrodt, which just emerged from bankruptcy, has agreed to pay $233.7 million over seven years to resolve allegations that it schemed to avoid paying inflationary rebates to the Medicaid program for its drug, Acthar Gel. Mallinckrodt . . .
Read More from Pharmaceutical Company Mallinckrodt Agrees to Pay Over $233 Million to Resolve Allegations that It Cheated the Medicaid Program by Falsely Claiming It Was Selling a New Form of Acthar Gel
On February 23, 2022, two United States Attorney’s Offices, in Albany, NY, and Spokane, WA, jointly announced a record $48.5 million False Claims Act settlement with TriMark, a large foodservice equipment supplier, two TriMark subsidiaries, and one of its executives to resolve allegations that they obtained government set-aside contracts under the false auspices of three small businesses . . .