Pharmacies increasingly operate under intense oversight from pharmacy benefit managers, making proactive compliance not just prudent but essential to preserving network status, reimbursement stability, and uninterrupted patient access. To mitigate the risk of audits, chargebacks, recoupments, and terminations, pharmacies should adopt a comprehensive policy framework that integrates rigorous documentation standards, prescriber and patient verification protocols, inventory and dispensing controls, fraud-waste-abuse monitoring, contract and reimbursement reconciliation, and robust audit-readiness procedures. Aligning daily operations with PBM contract terms and industry best practices, pharmacies reduce the likelihood of adverse PBM actions and mitigates their potential impact on network participation.
Beyond enabling prompt responses to audit requests, the implementation of these policies ensures that pharmacies consistently meet their contractual obligations. Below are essential policies and procedures that every pharmacy should implement, along with key consideration for each.
Copayment Collection and Financial Hardship Policies
- Ensure the pharmacy maintains sufficient documentation to support proof of copayment (i.e. point-of-sale system generates receipts that includes required elements).
- Maintain copies of register receipts, credit card merchant reports, copies of checks, cash deposits, and related documentation. to demonstrate collection.
- Document the application of manufacturer coupons, patient assistance programs, and any secondary claims submissions.
- Establish and document the pharmacy’s policy of dispensing medication when a copayment is not collected, ensuring alignment with applicable law.
- Describe the pharmacy’s financial hardship policy, including objective criteria in the assessment used to evaluate and approve hardship requests.
Prior Authorization Policy
- Identify the pharmacy’s role and level of involvement regarding the submission of prior authorization requests.
- Specify the prescriber’s role in the submission of prior authorization requests.
- Confirm compliance with applicable PBM requirements and/or limitations regarding the pharmacy’s ability to submit prior authorization requests.
Inventory Management
- Verify accreditation/licensure of wholesalers and outline authorization procedure for ordering inventory.
- Confirm that wholesaler and pharmacy invoices contain PBM-required information (i.e. NDC, lot number, expiration date, strength/dosage, package size, etc.).
- Maintain proof of payment and pedigree/ T3 documentation (where required), especially for purchases made through pharmacy marketplaces or other pharmacies.
- Conduct regular internal reconciliations to confirm that quantities of drug products dispensed correlate to the quantities of drug products purchased.
Prescription Verification and Claim Submission Policies
- Confirm authenticity of prescriptions received by the pharmacy.
- Contact patients to verify prescription authorization and confirm valid patient-prescriber relationship.
- Ensure the NDCs submitted on the claims correspond with the NDCs of the drug products being dispensed.
- Establish a process for addressing claim submission errors and resolving system-generated messages.
Fraud, Waste, and Abuse (FWA)/HIPAA Compliance
- Identify method of reviewing employees at the time of hire, including review of the OIG/GSA exclusion lists.
- Require regular employee training on pharmacy policies and procedures, including FWA and HIPAA certified training.
While this is not an exhaustive list of policies, it identifies essential areas of compliance that all pharmacies should ensure they consider. Pharmacies have been asked to provide copies of their policies, along with staff training logs, during the course of audits or network reviews. It is essential that pharmacies create policies that are specific and unique to their pharmacies.
How Frier Levitt Can Help
If your pharmacy requires assistance in developing, implementing, or reviewing your policies and procedures to assess your compliance with the terms and conditions of your PBM’s network, Frier Levitt can help. Frier Levitt has experienced attorneys that can assist your pharmacy in achieving compliance and addressing any PBM audits or network terminations. Contact us today to speak with an attorney.
