Prescription Audits: Anticipating and Responding to Increased Scrutiny of Prescribing and Dispensing Practices

The DEA and state AGs are increasing scrutiny on medical providers at all levels who are involved in prescribing, administering, and/or dispensing controlled substances, especially opiates and other abused drugs. Counsel should prepare providers for DEA or state AG audits and investigations of their practices and meet varying recordkeeping requirements, including those for prescribing and/or dispensing buprenorphine.

Providers should be aware of the extent to which regulators are "mining" prescribing patterns by reviewing various state prescription-drug monitoring programs and used as a basis for further investigation. Investigations also stem from wholesaler reports of suspicious transactions.

Providers with prescription authority must comply with both federal and state drug regulations. Failure to comply--whether negligent or intentional--could result in penalties, including fines and potential criminal prosecution. The DEA is also turning to revocation of controlled substance registrations, thereby stripping pharmacies, pharmacists, and prescribers from being able to dispense or prescribe federally controlled substances.

Counsel and providers should understand their potential liability exposure, develop effective policies and procedures, and be prepared to encounter and respond to an audit and to take corrective steps to ensure federal and state law compliance and mitigate damages.

Listen as our authoritative panel of healthcare attorneys discusses current trends in DEA and state AG enforcement of prescribing practices and the audit process. The group will examine the steps necessary to prepare for an audit and offer best practices to respond when the government comes knocking.

1. Current trends in prescribing and dispensing enforcement
2. Audit process
   1. DEA
   2. State AGs
3. Audit preparedness
   1. Maintaining records
   2. Policies and procedures
   3. Risk issues
4. Responding to an audit

The panel will review these and other crucial issues:

• What should providers and counsel expect when the DEA or state AG conducts a prescription audit?
• What policies and procedures should be in place to ensure compliance with federal regulations?
• What are best practices for counsel to providers facing a DEA or state AG audit?