Opioid Fraud: Off-Label Promotion, Kickbacks and Diversion
Opioid fraud under the False Claims Act includes promoting or dispensing opioids for uses federal programs do not cover, paying prescribers to write scripts, and filling prescriptions outside legitimate medical practice. Our attorneys obtained a 9 million dollar settlement in a fentanyl case the government declined to join.
$9 million settlement in a non-intervened fentanyl qui tam case
The mechanism behind most opioid False Claims Act cases
Federal healthcare programs pay for drugs prescribed for medically accepted indications. A rapid-onset fentanyl product approved only for breakthrough cancer pain in opioid-tolerant adults is not a medically accepted indication for back pain, migraine, or fibromyalgia.
When a manufacturer promotes that use, a prescriber writes for it, and a pharmacy fills and bills it to Medicare, Medicaid, or TRICARE, each claim in that chain can be false. The parties are separately liable and often separately sued.
Where the money moves
Opioid schemes are usually financial rather than clinical, and the payments follow recognizable patterns.
- Speaker programs and consulting fees paid to high-volume prescribers
- Reimbursement support services that coach prescribers on how to get prior authorization approved for off-label use
- Copay assistance structured to remove the patient cost signal on federal beneficiaries
- Pharmacy arrangements that reward dispensing volume for a specific product
- Prescriber ownership interests in the dispensing entity
The corresponding responsibility doctrine
Pharmacies are not passive. Under 21 C.F.R. 1306.04(a) a pharmacist shares a corresponding responsibility to ensure that a controlled substance prescription was issued for a legitimate medical purpose in the usual course of professional practice.
That duty is what converts a pattern of obviously improper prescriptions into pharmacy liability. Filling scripts the pharmacist knew were outside legitimate practice breaches the duty, and billing them to a federal program makes them false claims.
The case our attorneys resolved
Our attorneys obtained a 9 million dollar settlement in a non-intervened case involving Subsys, a sublingual fentanyl spray. The complaint alleged that mail-order specialty pharmacies under private equity control dispensed thousands of prescriptions nationwide for off-label and non-medically necessary uses billed to Medicare, Medicaid, and TRICARE.
Two features are worth noting. The government declined to intervene and the case was carried anyway. And liability reached the private equity owner and its principals personally rather than stopping at the operating pharmacies.
Who is positioned to report
Pharmacists and pharmacy technicians who filled the prescriptions, sales representatives who ran the speaker programs, reimbursement staff who worked prior authorizations, and clinicians who declined to participate all hold pieces of these cases.
Frequently asked questions
Is prescribing off-label illegal?
No. A physician may prescribe off-label as a matter of clinical judgment. The issues are whether a manufacturer promoted the off-label use, whether payments induced the prescribing, and whether a federal program was billed for a use it does not cover.
I am a pharmacist who filled these prescriptions. Am I exposed?
Participation does not disqualify you as a relator, though it can reduce your share. Pharmacists who raised concerns and were overruled are common and credible relators. Discuss your own role candidly at the first conversation.
Do the opioid settlements by states affect a qui tam case?
The multistate opioid settlements resolved different claims brought by different parties. They do not by themselves bar a False Claims Act case, though prior public disclosure of the specific fraud can matter.
Can the private equity owner really be liable?
Yes, where the fund and its principals directed the conduct. Our own case established that, and holding investors accountable in healthcare fraud is a stated Department of Justice priority.
The attorneys who handle these cases
Related reading
Talk to a whistleblower attorney before you report
A conversation costs nothing and is confidential. We will tell you honestly whether what you have describes a case, and what the first-to-file rule means for your timing.