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 . . .
Blog
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 . . .
New HHS-OIG Advisory Opinion Highlights Kickback Risks – And Whistleblower Opportunities – When Pharmaceutical Companies Provide Free Genetic Testing
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 . . .
Yet Another UDT Lab Pays Millions to Resolve Claims That It Billed Medicare for Unnecessary Confirmatory Testing and Paid Kickbacks to Referral Sources
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, . . .
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 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 . . .
$48.5 Million False Claims Act Settlement with Entities that Fraudulently Obtained Set-Aside Contracts Highlights Possibility for Further Whistleblower Action
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 . . .
Recent DOJ Settlement Shows Potential for Whistleblower Cases against Health Care Businesses that Employ “Excluded” Individuals
On February 23, 2022, the United States Attorney’s Office in Connecticut announced that it had entered into a $310,874 False Claims Act settlement with a psychiatry practice and its owner for knowingly employing an “excluded” physician as the practice’s clinical director. Although the settlement appears to be the result of an investigation the government initiated itself, the . . .
Brockton Urology Clinic Settles Case and Admits It Took Apparent Kickbacks. What About the Payer of the Kickbacks?
Late yesterday, February 15, 2022, the U.S. Attorney’s Office in Boston announced that Brockton Urology Clinic LLC (Brockton Urology), a physician practice located in North Easton, Massachusetts, agreed to pay $100,000 to resolve False Claims Act allegations that it took money from a hospital to run a clinical program that never existed. Specifically, according to the admitted . . .
DOJ’s $3.8 Million Settlement with Catholic Medical Center Alleges that Provision of Free “Call Coverage Services” Violates Anti-Kickback Statute
On February 9, 2022, the New Hampshire U.S. Attorney’s Office announced that Catholic Medical Center (CMC), a hospital in Manchester, New Hampshire, agreed to pay $3.8 million to resolve allegations that it violated the anti-kickback statute (AKS) and False Claims Act by arranging for a cardiologist to receive “call coverage services at no charge” in exchange for . . .