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Monday, June 29, 2020

Injured Workers Pharmacy Enters into $11 Million Opioid Settlement for Illegal Dispensing and Sales

Massachusetts Attorney General Maura Healey announced a $11 million settlement with an Andover mail-order pharmacy resolving allegations that it failed to implement adequate safeguards against unlawful and dangerous dispensing, resulting in the shipment of thousands of potentially illegitimate controlled substance prescriptions across the country.


Consent Judgment

In the complaint, filed along with a proposed consent judgment in Suffolk Superior Court, the AG’s Office alleges Injured Workers Pharmacy (IWP) violated Massachusetts consumer protection law by failing to implement effective policies and procedures for reviewing prescriptions to determine whether they were legitimate and by engaging in unlawful marketing practices to drive sales, including paying law firms for patient referrals.

“Injured Workers Pharmacy created an illegal operation that put dispensing speed and volume over patient and public safety,” AG Healey said. “They dispensed thousands of prescriptions for dangerous drugs, including opioids like fentanyl, with a shocking lack of regard for whether those prescriptions were legitimate. Combatting the opioid epidemic remains a top priority of my office and we will aggressively pursue those who break our laws to profit from this crisis.”


Allegations

The AG’s Office began investigating IWP, which serves thousands of workers’ compensation patients nationwide, after learning that the pharmacy dispensed a high volume of controlled substances primarily to workers who had been injured on the job. The AG’s complaint alleges that IWP pressured pharmacists to dispense prescriptions faster and implemented programs that prioritized dispensing speed and volume over protecting its patients and preventing diversion. The complaint further alleges that IWP’s dispensing and sales practices effectively precluded it from complying with statutory mandates and meeting its responsibility to fill only legitimate prescriptions issued in the usual course of professional treatment.

According to the AG’s complaint, IWP also used unlawful tactics to drive sales, including entering into illegal agreements to buy patient referrals and incenting sales staff to engage in their own misconduct and ignore red flags by paying them based on dispensing volume.


Dispensing and Sales Practices

As a result of these unfair dispensing and sales practices, the complaint alleges IWP filled and shipped:
  • Thousands of prescriptions written by problem prescribers who were ultimately disciplined, indicted or convicted for improper opioid prescribing. IWP did not stop dispensing their prescriptions until long after their behaviors were or should have been apparent to pharmacy and sales staff.
  • Thousands of dangerous, high-dose prescriptions, including for fentanyl formulations known to be especially dangerous.
  • Thousands of prescriptions for dangerous drug combinations known to be indicators of drug misuse and potential overdose, including the so-called “holy trinity” – a combination of an opioid, a benzodiazepine, and a muscle relaxant.


Settlement

The proposed consent judgment, which remains subject to court approval, would require IWP to undertake significant changes to its operations and business practices. Among other things, it would require IWP to:
  • Hire a full-time Chief Compliance Officer to oversee IWP’s compliance obligations, help assess whether to block and report prescribers, and design and administer training programs to teach IWP staff about red flag prescribing behaviors.
  • Hire a data analyst to review dispensing data to identify at-risk patients and suspicious prescribers.
  • Hire a pain management specialty pharmacist to counsel at-risk patients and their doctors to reduce the risks of those patients’ treatment plans.
  • Undertake additional due diligence before dispensing certain initial high-risk prescriptions.
  • Consult state prescription drug monitoring programs prior to dispensing controlled substance prescriptions.
  • Offer to dispense naloxone to all patients receiving Schedule II and III controlled substances, including opioids, at no out-of-pocket cost to the patient.
  • Upgrade its dispensing software, including to enable pharmacists to see a prescriber’s entire prescribing history.
  • Eliminate incentive compensation based on volume of controlled substance prescriptions dispensed.
  • Stop making unlawful payments for referrals.
  • Hire an independent auditor approved by the AG’s Office to conduct a one-year compliance audit.

$11 Million Paid

The proposed judgment further requires IWP to pay $11 million to the Commonwealth.

Since taking office, AG Healey has prioritized combating the opioid epidemic through a multi-disciplinary approach that includes enforcement, policy, prevention and education efforts. In June 2018, the AG’s Office announced a lawsuit against Purdue Pharma and its board members and executives for illegally marketing opioids and profiting from opioid epidemic. AG Healey announced her investigation into drug makers in June 2017, along with a bipartisan coalition of attorneys general, to determine whether the companies sought to increase profits by misrepresenting the dangers of prescription painkillers and ignoring the public health risks of spiking opioid sales. In September 2017, the coalition expanded that investigation to include other manufacturers and distributors.

This matter was handled by Senior Enforcement Counsel Gillian Feiner, Assistant Attorney General David Kim, Legal Analyst Matthew Lashof-Sullivan, and Paralegals Philipp Nowak and Cara Souto of the AG’s Health Care and Fair Competition Bureau, with investigative assistance from Investigators Marlee Greer and Colleen Frost of the AG’s Civil Investigations Division and Diversion Investigators from the New England Field Division of the United States Drug Enforcement Administration.


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Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thomson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thomson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  has been representing injured workers and their families who have suffered occupational accidents and illnesses.

Twitter: jongelman
LinkedIn: JonGelman
Author: "Workers' Compensation Law" West-Thomson-Reuters