What Pharmacists Need to Know About DOH Inspections, DEA Investigations, Medicaid Audits

Opioid Prescription Drugs

Ronald Chapman Sr., Juan Santos Lead Continuing Educational Session on DOH, DEA, Medicaid for Florida Pharmacy Association

In addition to being heavily regulated by a vast body of state and federal laws and regulations, Florida pharmacies and pharmacists also are subject to Department of Health inspections, DEA investigations, and Medicaid audits. Chapman Law Group’s Ronald W. Chapman Sr. and Juan Santos recently hosted a CLE session at the Florida Pharmacy Association Law & Regulatory Conference in Sarasota, on what pharmacist and pharmacy technicians need to know about these kinds of inquiries.

We’ve included a copy of the presentation here, which discusses:

Audits vs. Investigations

The Florida Agency for Health Care Administration (AHCA) performs audits for overpayment and compliance, while the Medicaid Fraud Control Unit (MFCU) does investigations to seek evidence of fraud.

Entities Conducting Audits and Investigations

These include Medicaid, MFCU, AHCA, managed care, third party, law enforcement, federal agencies (DEA, HEAT, DOJ, FBI, OIG), and the state

How to Respond to Request for Records

Provide complete, well-organized records; conduct a self-audit prior to delivering records; and use physician records to support, if necessary.

What Auditors Look for

    • Was correct quantity delivered to recipient?
    • Does quantity dispensed correlate with peers?
    • Were additional amounts billed to recipient, excluding co-pays, co-insurance, deductibles?
    • Were Medicaid, DEA, and Board of Pharmacy (BOP) rules complied with?
    • Do documents support medical necessity?

What the DOH Inspects

Records (patient, prescription, drug); labeling requirements; facility; and staff.

What are Possible DOH Sanctions?

    • Suspension
    • Revocation
    • Correct deficiencies
    • Fines
    • Reimbursement of prosecution costs
    • Sister state action
    • Negative NPDB entry 
    • Probation/monitoring (requiring additional inspections)
    • Additional continuing education

Surviving a DEA Search Warrant and an Inspection

  • How can I tell if a search warrant is being executed? Can I refuse?
  • What are the limits of inspection?
  • What should a pharmacy do post-inspection?
  • What if the DEA asks me to “voluntarily surrender” (DEA-104)?

From DEA to FDA, and from Audits to Inspections, Chapman Law Group is Your National Pharmacy Law Partner

Chapman Law Group is dedicated to the defense of health professionals nationwide, and is experienced with the regulatory and enforcement issues that impact professionals working in the pharmacy industry. We regularly represent pharmacists across the U.S. with matters, including licensure, disciplinary action, impairment matters, and drug diversion allegations.

Our attorneys for pharmacists also handle ownership issues such as buying and selling pharmacies, employment matters, licensure, permits, DEA and FDA registration, audits, inspections and enforcement action. In addition, we represent manufacturers and distributors with matters ranging from DEA and FDA registration, state permitting and certification to the defense of administrative and criminal enforcement action.

Chapman Law Group appreciates the hard work it takes to become a pharmacist and build a business in the pharmaceutical industry. Our national pharmacist defense attorneys are dedicated to the defense of pharmacies as well as pharmacists, and work aggressively to help pharmacists maintain their pharmaceutical license, career, assets, and freedom. 

Pharmacy Clients We Regularly Represent

    • Pharmacists (pharmacists in charge, consulting pharmacists, prescription drug department managers, community pharmacists, clinical pharmacists, hospital pharmacists, nuclear pharmacists, interns and technicians)
    • Pharmacies (community, retail, special, sterile-compounding, outsourcing facilities, institutional, hospital, central fill and nuclear)
    • Pharmacy owners
    • Pharmacy technicians
    • Drug manufactures
    • Device manufactures
    • Drug distributors

Pharmacy Law-Related Matters We Handle

Our offices are in Detroit (where we serve Dearborn, Troy, Ann Arbor and Grand Rapids, and the rest of Michigan); Miami and Sarasota, Florida (for Jacksonville, Tampa, Orlando, West Palm Beach, and all of Florida); Los Angeles/Southern California; and Chicago

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Ronald W. Chapman Sr., M.P.A., LL.M.
Founding Shareholder

President & CEO

All Offices – Main Office Sarasota
6841 Energy Court
Sarasota, FL 34240
Phone: (941) 893-3449

Juan C. Santos, LL.M.

Senior Attorney

Miami Office
701 Waterford Way, Suite 340
Miami, FL 33126
Phone: (305) 712-7177

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