Pharmacy Audit Checklist: Considerations When Preparing for PBM Audits

From recoupments and network terminations, to governmental investigations, pharmacies face serious PBM risks when issues that arise in audits are not properly addressed. Preparation and preventative measures are key to ensuring a positive audit result. Even though CMS has provided a pharmacy audit checklist, there are some other issues pharmacies should consider before any PBM audit:

Common PBM Audit Issues:

  • Is your Pharmacy properly contracted with each PBM based on your provider type (i.e., retail pharmacy, specialty pharmacy, mail order pharmacy)? Are you operating in compliance with your current contracts?
  • Are you proactively reviewing your PSAO portal or PBM portal to be aware of any communicated changes to your contractual agreement with PBMs and plan sponsors?
  • Are you properly following any written policies or procedures implemented by your pharmacy? Do you document adherence to these policies or procedures?

Is your pharmacy licensed in every State in which it dispenses medications?

Your Pharmacy:

  • PBM auditors will have access to your entire pharmacy during an on-site audit
    • Is the pharmacy clean?
    • Do you have a system for proper handling and destruction of PHI?
    • Is your drug refrigerator in operation?
    • Do you have drugs on the pharmacy shelves that are either: expired, recalled, damaged/altered?
    • Do you quarantine drugs that are close to expiration?
    • Do you have a system for the proper handling of controlled dangerous substances?

Recordkeeping is Key:

  • Do you have a recordkeeping protocol in place?
  • In the context of an on-site audit with a masked list of prescriptions, have you fully prepared the documents as requested by the PBM?
  • Do you retain the original prescription sent by the doctor, whether the prescription is a hand-written hard copy, phone-in, fax, or electronic?
  • Do you retain a full copy of any records provided to the auditor?

Copayment Collection:

  • Are you collecting copayment from the patient for each prescription?
  • Is each copayment collected being documented?
  • Are you using any manufacturer coupons or any patient assistance programs (i.e. prescription discount cards) to reduce or eliminate the patient pay amount?

These are just some of the basic questions pharmacies should ask themselves when gearing up for an audit. Frier Levitt assists pharmacies in preparing for audits, responding to initial audit discrepancies, appealing final audit results, minimizing risks of PBM contract renegotiations, and challenging PBM contract terminations. We also help pharmacies develop business plans and establish standard operating procedures to prepare for audits long before they begin. If your pharmacy has received notice of either a desktop or onsite audit or is interested in planning ahead, contact Frier Levitt today to speak to an attorney.