2017 saw a significant escalation in the federal government crackdown on health care fraud claims, especially against compounding pharmacies.[1] Allegations of allegedly false claims dominated the DOJ’s 2017 investigatory efforts.[2] Continuing this emphasis on perceived health care fraud, in 2018 the DOJ made public its vigorous attack on what it views as the participates in the opioid crisis, with Attorney General Jeff Sessions declaring, “[o]ur great country is currently in the midst of the deadliest drug crisis in our history,” and pointed the finger at “some trusted medical professionals like doctors, nurses and pharmacists [who] have chosen to violate their oaths and exploit this crisis for cash.”[3] As a result, the DOJ has kept compounding pharmacies intensely under its microscope.;[4] In most instances, the anti-kickback statute remains preeminent, but the DOJ also expanded its focus to the compounding pharmacies’ role in opioid distribution – an apparent effort to respond to two hot-button issues, compounding pharmacies and the opioid crisis, with a single stroke.
The article provides a high-level look into recent compounding pharmacy investigations and prosecutions, starting with the government’s full-throated statements about pursuing even lower-dollar offenders, and then moving to cases reflecting 2018 trends. Ultimately, the main thrust of the article is this: the best medicine is prevention – it may be time for a legal checkup to ensure your pharmacy or medical practice avoids the DOJ crosshairs.
To read the full article, please click here.
Bell Nunnally represents compounding pharmacies and their personnel, physicians, and individuals under investigation for or charged with the activities discussed in the article. The circumstances of your situation are unique and may not be covered by the overview. For further information, or to schedule a consultation, please contact Jeff Ansley for help.
[1] The authors previously published a 2017 article offering a primer on recent compounding pharmacy prosecutions, including commonly investigated activities: “Compound Pharmacy Crackdown – New Trends In Government Enforcement.”
[3] Quoted in USDOJ Press Release Number 18-383 (March 29, 2018) (available at:
https://www.justice.gov/opa/pr/houston-physician-and-pain-management-clinic-owner-convicted-running-pill-mill-provided); see also National Enforcement Action Brings Charges against 601 Individuals Responsible for Over $2 Billion in Fraud Losses and 84 Opioid Cases Involving 13 Million Illegal Dosages, US DOJ website (June 28, 2018) (available at: https://www.justice.gov/usao-ndal/pr/five-nw-alabama-compounding-pharmacy-employees-charged-multi-million-dollar.
[4] See, e.g., USDOJ Press Release Number 18-536 (On April 26, 2018, the owner of a Florida pharmacy was sentenced to 180 months in prison and ordered to pay $54M in restitution for submitting false compound-pharmacy-reimbursement claims to private insurance companies, Medicare, and TRICARE.).