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Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.  Earlier this month, the Department of Justice (DOJ) announced that a Michigan physician, Dr. Rodney Moret, was sentenced to 75 months in prison for his role in conspiracies to distribute prescription pills illegally and to defraud Medicare. The conduct alleged against Dr. Moret is particularly extreme, but nevertheless reflects the government’s commitment to ferreting out opioid-related misconduct.

The government contended that Dr. Moret was involved in a scheme in which he was the sole practitioner at a medical clinic that purported to be a pain management and HIV infusion clinic but in fact was just a “pill mill.” As part of this scheme, Dr. Moret allegedly would conduct a cursory (if any) examination of patients, which were billed to Medicare, before writing a prescription for controlled substances. Once those prescriptions were filled, patient marketers would sell those drugs on the street in Southeast Michigan. This clinic operated from 2010 to 2015.

As part of this scheme, Dr. Moret was alleged to be responsible for illegally distributing over 700,000 dosage units of Hydrocodone, more than 240,000 dosage units of Alprazolam, and more than 2 million milliliters of promethazine with codeine cough syrup. These drugs had a street value of more than $15 million. Dr. Moret was also responsible for over $6 million in health care fraud. He pled guilty to one count each of conspiracy to commit health care fraud and conspiracy to illegally distribute prescription drugs. In its comments on this sentencing, the U.S. Attorney’s Office for the Eastern District of Michigan made clear that one of the government’s main concerns with Dr. Moret’s conduct was his role in exacerbating the opioid crisis in his community.

A few weeks before DOJ announced Dr. Moret’s sentencing, DOJ announced that a Tennessee chiropractor and a pain clinic nurse practitioner had entered into settlement agreements to resolve allegations under the False Claims Act that they had improperly billed Medicare and TennCare for painkillers, including opioids.

Matthew Anderson, a chiropractor, and his management company, PMC, LLC, managed four pain clinics in Tennessee. Anderson and PMC entered into a settlement agreement to pay $1.45 million to resolve the claims that from 2011 through 2014 they caused pharmacies to submit requests for Medicare and TennCare payments for pain killers, including opioids, which were dispensed based upon prescriptions that had no legitimate medical purpose. The government also alleged that (1) Anderson caused all four clinics to bill Medicare for upcoded claims for office visits that were not reimbursable at the levels sought and (2) Anderson and PMC caused the submission of Medicare claims for services provided by two nurse practitioners who were not meeting applicable supervision requirements.

The United States will receive $1,040,275 of the $1.45 million at issue, while the State of Tennessee will receive $163,225. Anderson and PMC also agreed to be excluded from billing federal health care programs for five years. In addition, the settlement agreement requires Cindy Scott, a nurse practitioner from Nashville, to pay $32,000 and to surrender her DEA registration until October 2021.

While enforcement focus in the first weeks of 2018 appears to have remained largely on individual providers and practices, it remains to be seen whether the government (and whistleblowers) will turn their attention to larger companies and providers. As we reported in our year-end post, in September of last year Galena Biopharma, Inc. agreed to pay $7.55 million to resolve allegations under the FCA that it paid kickbacks to physicians to encourage them to prescribe an opioid product (Abstral). Last month, DOJ announced that Costco Wholesale agreed to pay $11.75 million to settle allegations that its pharmacies violated the Controlled Substances Act by improperly filing prescriptions for controlled substances. Although the allegations against Costco involved lax controls surrounding compliance with requirements related to filling prescriptions (and not the same kind of misconduct related to opioid prescriptions alleged against other providers), the government emphasized that it was undertaking its enforcement efforts with an eye toward the opioid epidemic.  The U.S. Attorney for the Eastern District of Michigan commented that “[i]n light of the prescription pill and opioid overdose epidemic we are seeing across the country, compliance with regulations governing pharmacies is more important than ever” and applauded Costco for working with DEA and shoring up its compliance efforts “to ensure that prescription pills do not end up on the street market.”

We will continue to monitor this trend to see if government enforcement efforts remain focused on individuals, or whether these initial cases against larger companies signal a shift in focus to include bigger providers and companies.

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Samantha advises clients on regulatory and enforcement matters. She has deep experience handling violations of the federal ant-kickback statute and FCA investigations for clinical laboratories and hospitals.