For a recent Federal Bar Association Qui Tam conference, I put together a slide presentation that addressed, among other things, issues that arise when a whistleblower is an attorney, or when a whistleblower shares potentially privileged documents with their attorney. I learned some things from researching these issues, so I thought I would share what . . .
Blog
Recent Settlement Highlights Perils of Outsourcing Diagnostic Work to Overseas Vendors
Until recently, federal healthcare regulations required that nonphysician personnel who performed diagnostic tests for an independent diagnostic testing facility (“IDTF”) must have a state license or certification to do such work. 42 C.F.R. § 410.33(c) (2021). On December 20, 2022, the United States Attorney’s Office for the Eastern District of Pennsylvania announced that BioTelemetry, Inc., and its subsidiary . . .
In latest EHR False Claims Act Settlement, Modernizing Medicine Agrees to Pay $45 Million
After losing a motion to compel production of a key document, the U.S. Attorney’s Office in Vermont nevertheless has managed to notch another large False Claims Act settlement with an electronic health record (“EHR”) company. On November 1, 2022, that office announced that Modernizing Medicine, Inc. (“ModMed”), a Florida-based electronic EHR technology vendor, has agreed to pay . . .
Recent Settlement with Florida Physician Practice Highlights Continuing Risks of Upfront “Rebates”
On October 3, 2022, the U.S. Attorney’s Office in Boston announced that a Florida physician practice, Southeast Florida Hematology and Oncology Group, P.A. (“SEFHOG”), had agreed to pay $130,000 to resolve allegations that, among other things, it took an upfront “transition rebate” from Cardinal Health, a large drug distributor, in exchange for agreeing to purchase 90 percent . . .
Repeat Offender Biotronik Settles Another Kickback Case, Again Without A Corporate Integrity Agreement
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’ . . .
Pfizer Fails Again in Its Quixotic Quest for Imprimatur of Its Proposal to Provide Direct Medicare Copay Assistance
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’s $900 Million False Claims Act Settlement: Kicking the Can Down the Road While Creating Great Case Law for Whistleblowers and the Government
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 . . .
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
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 . . .
Steward Health Care System Admits Engaging in Conduct that Violated Stark and Anti-Kickback Laws, according to Belated Public Announcements
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 . . .
In Healthcare, Paying Commissions to 1099 Sales Reps Violates the Anti-Kickback Statute – Will Labs and Pharmacies Ever Learn?
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 . . .