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February 1, 2024

Hikma Pharmaceauticals has reached a settlement in principle with multiple states for $150 million following allegations that the opioid manufacturer failed to monitor and report suspicious orders.  From the settlement proceeds, $115 million will be paid in cash, while the remaining $35 million will be allocated toward opioid addiction treatment medications.  CA AG; NC AG; VA AG

December 21, 2023

Ultragenyx Pharmaceutical, Inc., maker of Crysvita, will pay $6 million for violating the False Claims Act. Crysvita is prescribed to treat a rare inherited blood disorder, which may require a genetic test to definitively diagnose. To induce purchases and referrals, Ultragenyx paid a laboratory to conduct genetic tests at no cost to healthcare providers or patients, and then provide the results reports to Ultragenyx. Ultragenyx then used the positive test results reports to target healthcare providers for Crysvita sales. Internally, Ultragenyx referred to this kickback scheme as their "sponsored" testing program. The program was exposed via a qui tam whistleblower, who will receive $1.07 million of the $6.7 million recovery. DOJ

December 21, 2023

Armando Herrera was sentenced to 51 months in prison for distributing at least $16.7 million worth of adulterated and misbranded prescription HIV drugs. Herrera and his co-conspirators operated companies in four states, creating false documentation to then pass off the drugs as legitimately acquired, and then sold to unwitting pharmaceutical suppliers who, in turn, sold them to unsuspecting HIV patients. DOJ

November 16, 2023

A Florida man who was the Chief Compliance Officer of pharmacy holding company A1C Holdings LLC has been ordered to pay $21.7 million in restitution for his role in a $50 million fraud scheme against Medicare.  Pharmacies associated with Steven King and his co-conspirators allegedly secured prescriptions and refills for medically unnecessary lidocaine and diabetic testing supplies, and took steps to avoid oversight by registering as brick-and-mortar pharmacies, concealing their ownership, and shipping expensive prescriptions without patient authorization.  DOJ

November 6, 2023

Drogueria Betances LLC will pay $12 million and will make extensive compliance and reporting improvements as required under a consent decree, for its failures to report suspicious orders and make required reports to the DEA. One of Puerto Rico's largest pharmaceutical drugs distributors, Betances failed to report to the DEA hundreds of "suspicious orders" for fentanyl and oxycodone from 2016 through at least June 2019. Additionally, from May 2017 to July 2018, Betances failed to report to the DEA all of the more than 7.8 million dosage units of Schedule II opioids distributed, committed hundreds of recordkeeping violations, filled orders placed with defective order forms, and gave inaccurate shipping or delivery information to the DEA. DOJ

October 30, 2023

Nostrum Laboratories Inc. and its founder, Nirmal Mulye, Ph.D., have agreed to pay up to $50 million, with a minimum of $3.8 million, to resolve allegations of defrauding Medicaid in connection with one of their drugs.  As part of the settlement, Nostrum and Mulye admitted that they knowingly failed to pay required drug rebates to Medicaid, in violation of the False Claims Act, despite being notified by CMS that they should do so.  DOJ

August 21, 2023

To resolve criminal charges of colluding to fix prices, mainly on a cholesterol medicine called pravastatin, Teva Pharmaceuticals USA, Inc. has agreed to pay a $225 million criminal penalty and donate $50 million in drugs to humanitarian organizations, while Glenmark Pharmaceuticals Inc., USA has agreed to pay $30 million criminal penalty.  The drugs that Teva has been ordered to donate, clotrimazole and tobramycin, were also part of the price fixing scheme.  DOJ

August 8, 2023

Pharmaceutical drug manufacturers Shire PLC, Baxter International Inc., Baxalta Inc., Viropharma Inc., Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America have agreed to pay more than $42 million to settle a qui tam suit alleging violations of the Texas Medicaid Fraud Prevention Act.  According to an unnamed whistleblower, the companies allegedly directly or indirectly provided payments or nursing services to Medicaid providers in exchange for referrals or recommendations of a particular drug.  TX AG

June 15, 2023

Two compounding pharmacies, Smart Pharmacy, Inc. and SP2, LLC, and their owner, Gregory Balotin, have agreed to pay at least $7.4 million to resolve two qui tam lawsuits by whistleblowers Amy Sanchez and Ashok Kohli, both former employees of Smart Pharmacy.  According to the suits, in order to increase orders for expensive compounded pain creams, the pharmacy routinely waived mandatory patient co-payments for them, and in order to boost reimbursements from Medicare and TRICARE, it added the antipsychotic drug aripiprazole to the topical creams.  DOJ

June 8, 2023

Steven King, chief compliance officer of A1C Holdings LLC, a pharmacy holding company, was convicted for violating Medicare and pharmacy benefit manager rules by securing prescriptions and refills for medically unnecessary lidocaine and diabetic testing supplies. King and his co-conspirators fraudulently billed Medicare over $50 million, taking steps to conceal their scheme by enrolling their mail order pharmacies as brick-and-mortar retail locations, shipping prescription refills for high-reimbursing medications and supplies without patient consent, concealing the ownership of A1C Holdings LLC and its pharmacies, and transferring patients among pharmacies without patient consent. King faces a maximum penalty of 20 years in prison for committing health care fraud and wire fraud. DOJ
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