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November 6, 2023

One of Puerto Rico’s largest distributors of pharmaceutical drugs, Droguería Betances LLC has been ordered to pay $12 million following a DOJ complaint that it failed to report hundreds of suspicious ordered to the DEA.  According to the complaint, the suspicious orders included at least 655 for fentanyl and 113 for oxycodone.  Additionally, Betances committed recordkeeping violations by filling orders for these drugs using defective order forms and reporting inaccurate shipping and delivery information to the DEA.  Betances must now make extensive improvements to its compliance program.  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

October 18, 2023

The president of a California-based medical technology company has been sentenced to 8 years in prison and ordered to pay $24 million in restitution in the first COVID-related criminal securities fraud case charged by DOJ and the first COVID-related criminal healthcare fraud case brought to trial.  Among many things, Mark Schena of Arrayit Corporation was found to have taken advantage of the pandemic by claiming he and his company had developed a technology to test for just about any disease, including COVID, using a single drop of blood.  In doing so, Schena and Arrayit lied to investors to give them a false sense of credibility, paid illegal kickbacks to marketers to run deceptive plans about the accuracy of its tests, and submitted false claims to Medicare and private insurers for medically unnecessary allergy testing.  DOJ

October 10, 2023

Mobile cardiac PET scan provider Cardiac Imaging Inc. (CII), and its founder and owner Sam Kancherlapalli, have agreed to pay over $75 million and over $10 million, respectively, to resolve a qui tam case by former billing manager Lynda Pinto, which alleged the company, Kancherlapalli, and part-owner Richard Nassenstein defrauded Medicare.  In violation of the Anti-Kickback Statute, Stark Law, and False Claims Act, CII and Kancherlapalli allegedly paid kickbacks to referring cardiologists in the form of fees, ostensibly for supervising PET scans, that were far above fair market value.  The alleged misconduct occurred over a ten year period.  DOJ

October 2, 2023

BioTek reMEDys Inc. and its CEO, Chaitanya Gadde, have agreed to pay $20 million to resolve allegations of providing illegal kickbacks to patients and physicians, in violation of the False Claims Act and Anti-Kickback Statute.  Former employees Shantae Wyatt and Latoya Sparrow alleged in a qui tam suit that the specialty pharmacy induced patients to purchase drugs by routinely waiving mandatory copays, and induced physicians to make referrals by providing dinners, gifts, and free administrative or clinical support services.  One physician in particular who received kickbacks, Dr. David Tabby, has paid $480,000 to resolve allegations against him.  Wyatt and Sparrow will receive over $4 million from the settlement with BioTek and Gadde, and over $91,000 from the settlement with Tabby.  DOJ

October 2, 2023

Genomic Health, Inc. (GHI), a wholly-owned subsidiary of Exact Sciences Corporation that provides clinical diagnostic tests, has agreed to pay $32.5 million to resolve two separate qui tam suits alleging violations of the False Claims Act and Anti-Kickback Statute in connection with lab tests for cancer patients.  GHI allegedly evaded Medicare’s 14-Day Rule—which prohibits labs from separately billing for the same covered tests within 14 days of a patient’s discharge from a hospital—by canceling and reordering tests so they fell within appropriate time frames, seeking reimbursement directly from Medicare, and writing off unpaid lab fees owed by hospitals.  As a result of this settlement, the whistleblowers in the case will receive over $5.5 million.  DOJ

September 30, 2023

The Cigna Group has agreed to pay over $172 million and enter into a five-year Corporate Integrity Agreement in order to resolve allegations of violating the False Claims Act.  According to qui tam suit by a former part-owner of a Cigna vendor, Robert Cutler—who will receive an $8.1 million share of the settlement—the healthcare company knowingly submitted inaccurate and untruthful diagnosis codes on behalf of Medicare Advantage Plan beneficiaries in order to inflate their reimbursements from Medicare.  DOJ

September 13, 2023

Texas-based Oliver Street Dermatology Management LLC, which manages dermatology practices, surgical centers, and pathology labs across the country, has agreed to pay $8.9 million to resolve self-reported violations of the Anti-Kickback Statute, Stark Law, and False Claims Act.  The company revealed in 2021 that some of its former senior managers had fraudulently increased the purchase price of 11 dermatology practices acquired between 2013 and 2018 in exchange for referrals.  Claims arising from those referrals were found to have been submitted to Medicare.  USAO NDTX

September 8, 2023

Grocery store chain Kroger, which owns and operates a number of subsidiaries, has agreed to pay $1.37 billion to a number of states, including California, Illinois, North Carolina, Oregon, Tennessee, and Virginia.  The settlement in principle would absolve Kroger for its role in the opioid crisis.  CA AG; NC AG; OR AG
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