Pharma Fraud

November 9, 2021

Kaléo, Inc., a pharmaceutical manufacturer in Virginia, has agreed to pay $12.7 million to resolve a whistleblower’s allegations that it violated the Anti-Kickback Statute and False Claims Act in claims submitted to Medicare, TRICARE, and the Federal Employees Health Benefits Program.  Between 2017 and 2020, kaléo allegedly provided kickbacks to physicians and their staff to induce and reward them for prescribing Evzio, a higher-priced version of a drug used to reverse opioid overdoses and which often requires prior authorization.  Kaléo also allegedly directed pharmacies to submit false prior authorizations and dispense Evzio without collecting required co-pays.  USAO MA

October 1, 2021

Pharmaceutical manufacturers Taro Pharmaceuticals USA, Inc., Sandoz Inc. and Apotex Corporation have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act and Anti-Kickback Statute arising from unlawful compensation received through arrangements on price, supply and allocation of customers with other pharmaceutical manufacturers of various generic drugs.  In connection with the FCA settlements, Taro will pay $213.2 million, Sandoz will pay $185 million, and Apotex will pay $49 million.  The civil settlements are in addition to previous deferred prosecution agreements resolving related criminal charges, pursuant to which Taro paid a criminal penalty of $205.6 million, Sandoz paid a criminal penalty of $195 million, and Apotex paid a criminal penalty of $24.1 million.  DOJ

August 9, 2021

The owners of North Carolina compounding pharmacy Wellcare Compouding, David Tsui and Lois Tsui, paid $1.1 million to resolve allegations that they violated the False Claims Act by submitting false claims for payment to the TRICARE program in 2014 and 2015.  The government alleged that Wellcare made improper payments to physicians and “marketers” in violation of the Anti-Kickback Statute and encouraged medically unnecessary prescriptions consisting of high-margin ingredients in order to maximize the pharmacy’s reimbursement. David Tsui had been convicted of healthcare fraud in 2009 and was excluded from participation in federal healthcare programs; the government alleged that his involvement and ownership was intentionally concealed.  USAO MD NC

July 21, 2021

For their part in creating and fueling the opioid epidemic, three of the nation’s largest drug distributors—McKesson Corporation, Cardinal Health Inc., and AmerisourceBergen Drug Corporation—as well as one of the nation’s largest drug manufacturers, Johnson & Johnson, have agreed to pay $26 billion over the next 18 years to resolve claims from nearly 4,000 lawsuits, including multiple state and local governments.  In addition to the monetary settlement, the companies have signed onto a 10-year injunctive relief agreement that will require them to implement certain data-driven oversight measures and not fund or lobby to promote opioids, among other things.  CA AG; FL AG; MI AG; NY AG; PA AG

June 14, 2021

Centene Corp. will pay a total of $143.8 million to resolve claims by Ohio and Mississippi that it overbilled the states' Medicaid programs in its role as a pharmacy benefit manager.  The states alleged that Centene engaged in practices including "spread pricing," charging more than allowed price caps based on industry standards, inflation of dispensing fees, failure to disclose discounts received, and claiming reimbursement for prescriptions already paid for by third parties.  Ohio will receive $88.3 million, and Mississippi will receive $55.5 million.  OH; MS

May 28, 2021

Erik Santos of Georgia was sentenced to more than 11 years in prison following his guilty plea on healthcare fraud charges.  Santos conspired with Florida compounding pharmacy Patient Care America and others to recruit Tricare beneficiaries to fill prescriptions for expensive, supposedly tailor-made, compounded medications that consisted of little more than common pain or scar creams, but came with price tags as high as $10,000-$15,000 per month.  The beneficiaries did not need the medications, which had little to no therapeutic value, and Santos secured the prescriptions by paying doctors, who had not actually seen the beneficiaries, to approve pre-printed prescriptions for large amounts of these medications.  Santos’s fraudulent referrals caused an actual loss to the Tricare program of approximately $12 million.  PCA pharmacy paid Santos over $7 million in prescription referral kickbacks.  In addition to the prison sentence, the Court imposed restitution in the amount of $11.8 million and entered a forfeiture judgement of approximately $7.6 million.  USAO SD FL