By Fisher, JD, CHC, CCEP
DOJ Opioid Settlement Highlights Compliance Risks for Healthcare Providers
Summary: A recent Department of Justice opioid settlement underscores the compliance risks healthcare providers face when prescribing, documenting, and billing for pain-management services involving controlled substances.
Opioid Prescribing Compliance Risks for Healthcare Providers
Recent federal opioid enforcement activity shows that prescribing practices can create fraud and controlled-substance exposure when medical necessity, documentation, and billing accuracy are not clearly established. The Department of Justice settlement discussed below illustrates how opioid-related prescribing and reimbursement issues are increasingly being treated as core compliance risks for healthcare providers.
A recently announced Department of Justice settlement reflects the government’s continued use of fraud enforcement tools to combat the opioid epidemic. Healthcare providers should take notice because these actions signal that opioid prescribing, documentation, and billing practices remain significant compliance risk areas.
Key Takeaways: Opioid Prescribing and Healthcare Compliance Risks
For a quick overview, the main compliance lessons are:
- Opioid prescribing can create compliance risk when medical necessity, documentation, and billing accuracy are not clearly supported.
- DOJ opioid enforcement activity may involve both fraud enforcement and controlled-substance violations.
- Medicare and Medicaid billing for pain-management services requires careful review to reduce false-claims exposure.
- Healthcare providers should strengthen internal controls, compliance audits, and education around opioid prescribing and billing practices.
DOJ Opioid Settlement Highlights Medicare, Medicaid, and False Claims Act Risk
The government alleged that a chiropractor improperly billed Medicare and a state Medicaid program for pain-management services involving painkillers, including opioids.
The case involved four pain-management clinics, all of which closed during the course of the matter. The settlement also required a nurse practitioner to pay $32,000 and surrender her DEA registration to resolve allegations that she violated the Controlled Substances Act.
Healthcare Fraud Enforcement Focus on Opioid Prescribing and Billing Practices
The Department of Justice press release announcing the settlement addressed the opioid issues directly, leaving little ambiguity about the government’s enforcement focus.
The opioid-related statements were more pointed than the standard language often included in settlement announcements, suggesting that similar language may become more common as the government continues to focus on these cases.
Controlled Substances Act Compliance for Opioid Prescribers
“More Americans are dying because of drugs today than ever before—a trend that is being driven by opioids,” said Attorney General Jeff Sessions in the Department’s official statement.
The statement emphasized the government’s commitment to holding healthcare providers accountable for improper prescribing and billing practices, particularly where those practices contribute to the opioid crisis. The case reflects an increasing willingness by federal authorities to pursue civil and criminal actions against individuals and entities that fail to comply with rules governing controlled substances.
Opioid Compliance Controls: Documentation, Billing Audits, and Provider Education
For providers and compliance professionals, these developments underscore the need for robust internal controls, thorough documentation, and ongoing education on opioid prescribing and billing.
As enforcement efforts intensify, organizations should prioritize proactive risk assessments and compliance audits to mitigate exposure and support adherence to applicable laws and regulations. The evolving enforcement landscape requires vigilance and a proactive compliance approach to protect patients and organizational reputations.
Practical Steps for Healthcare Compliance Programs
In summary, the Department of Justice’s recent settlement is a clear signal that opioid-related compliance risks remain under heightened scrutiny. Healthcare organizations and their advisors should focus on practical steps that reduce enforcement exposure and strengthen compliance readiness.
- Evaluate opioid prescribing practices for medical necessity and documentation support.
- Review Medicare and Medicaid billing controls for pain-management services.
- Conduct targeted compliance audits and risk assessments.
- Educate providers and staff on controlled-substance requirements and enforcement trends.
