The scope of our country’s opioid epidemic is devastating.  From 1999 to 2017, more than 700,000 people have died from a drug overdose.  Two-thirds of these deaths involved an opioid.  On average, 195 Americans dies every day from an opioid overdose.  These numbers are tragic and mind-boggling.

In response, federal enforcement efforts have primarily focused on criminal prosecutions, but there have also been significant civil False Claims Act prosecutions.  Since 2017, the Justice Department has charged over 150 doctors with opioid-related crimes.

In June 2018, Attorney General Sessions announced the “National Health Care Fraud and Opioid Takedown,” resulting in charging 601 individuals, including 76 doctors, 23 pharmacists, 19 nurses and other medical personnel with more than $2 billion in medical fraud.

In the same month, the Justice Department announced the indictment of the CEO and four physicians involving a network of Michigan and Ohio pain clinics that engaged in a $200 million healthcare fraud scheme.  The defendants were charged with conspiracy to commit healthcare fraud and wire fraud.  Individual defendants were charged with healthcare fraud, conspiracy to defraud the United States, kickbacks and money laundering.

According to the indictment, the defendants engaged in the distribution of over 4.2 million medically unnecessary dosage units of controlled substances and medically unnecessary injections, including oxycodone, hydrocodone and oxymorphone.  The CEO paid the physicians based on the number of injections that Medicare paid for, regardless of the medical necessity of the injections.  Medicare’s review of the injection claims determined that all – 100 percent – of the claims were ineligible for Medicare reimbursement.  Medicare terminated the enrollment of the pain clinics but the CEO created new companies and re-enrolled into Medicare and resumed its illegal practices.  The pain clinics were also linked to a laboratory that conducted unnecessary and ineligible drug testing.

In a False Claims Act civil prosecution, on April 13, 2018, the United States intervened in five lawsuits against Insys Therapeutics, Inc., in relation to the marketing of Subsys, an opioid painkiller and form of fentanyl, an addictive painkiller.

The complaint alleges that Insys paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients.  The kickbacks took the form of speaker program speeches to physicians that were, in fact, shams; jobs for prescribers’ relatives and friends; and lavish meals and entertainment.  Insys also allegedly encouraged physicians to prescribe Subsys for patients who did not have cancer and lied to insurers about patients’ diagnoses in order to obtain reimbursement for Medicare and TRICARE beneficiaries.

The government’s investigation resulted in criminal prosecutions of several officers and employees from Insys, some of which are still ongoing.

In a separate and significant action, the Justice Department filed a statement of interest in a multi-district action regarding hundreds of lawsuits against opioid manufacturing and distribution companies.  The plaintiffs include numerous cities, municipalities and medical institutions that have incurred significant costs of the prescription opioid crisis.  The federal government will seek reimbursement of substantial costs incurred by federal healthcare programs from the opioid epidemic.

The Justice Department’s focus on opioid crimes and false claims has been buttressed by a new data analytics program adopted by DOJ to focus on opioid-related healthcare fraud.