This Audit Protocol is designed as the basis for an audit tool to complement analytic audits of a physician’s prescribing characteristics.  Most audit methods used by State and Federal authorities rely exclusively on analytics without considering the clinical circumstances of individual patients.  This methodology is designed to provide a comprehensive framework based on the universality of generally accepted principles and methods, guidelines and industry best practices with citations to applicable statutes.

Pain Mangement Protocol Development Methodology

This Audit Protocol was developed based on guidance from Federal and State standards, clinicians and experts.  It is used to provide a universal framework with defensible criteria that can support or find gaps in provider prescribing of controlled substances.

  1. Guidance from Federal sources:
    1. S. Department of Health and Human Services Centers for Medicare and Medicaid (CMS)
    2. S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC)
    3. S. Department of Justice Drug Enforcement Agency Office of Diversion Control (DOJ DEA ODC)
  2. Guidance from Medical Professional Associations Re: Audit Tools
    1. American Academy of Pain Medicine
    2. American Health Information Management Association (AHIMA)
  3. Guidance from the State(s) where the physician is domiciled
    1. Federation of State Medical Boards
    2. State Prescription Drug Monitoring Programs (PDMP)
    3.  State Consumer guidance
    4.  State legislative mandates
    5. Other state Pain Guidance, adopted in other States
  4. Developed by Clinicians and Experts
    1. Team Composition:
      1. Anesthesiologist
      2. Pharmacist
      3. Board Certified Orthopedic Surgeon
      4. Expert witness in medical coding and billing, Medicare and Medicare Fraud, electronic health records, HIPAA Privacy and Security certified by Federal and State Judges and Arbitrators
  • Team Experience:
    1. Opioid class action litigation
    2. Improper prescribing of Opioids in medical malpractice litigation
  • Fraud, waste and abuse litigation
  1. Prior experience of team with Federal contractor audit methods:
    1. Zone Program Integrity Program Contractor (ZPIC)
    2. Medicaid Integrity Contractor (Audit MIC)
    3. National Benefit Integrity Medicare Drug Integrity Contract (NBI MEDIC).
    4. Unified Program Integrity Contracts (UPICs) effective May 2016

Opioid Prescribing Audit Protocol Key Elements

Audit Protocol Development Methodology

Goals in Reviewing a Pain Management Practice

Audit Protocol : patient record random sample that is statistically projectable, provider interviews

Physician Prescribing Analytics

Examine Prescribing Volume and Days of Supply per Patient

All Providers and key medical specialties


Initial Patient Intake and Examination

Formulation of Treatment Plan

Pain Management Agreement


Objective Measures and Corrective Action

State PDMP Database Checks

Toxicology / Drug Screening

Titration / Weaning


Appendix A1 – A3 – Pain Screening Tools

Appendix B1– Guidelines

DOJ Diversion Control Division Controlled Substances Act Guidelines

Medical Necessity and the Controlled Substances Act

The Practitioners Manual, Section IV – Record Keeping

The Practitioners Manual, Section V – Valid Prescription Requirements

The Practitioners Manual, Section VI – Opioid Addiction Treatment Programs

Appendix C – State Treatment with Opioid Patient Agreement “Pain Management Contract”

Related Topics

Electronic Prescribing approved in Arkansas

Drug Pricing Expert Witness