Delivering to a Clinic? Avoid Audit Risks!
Traditional dispensing for independent pharmacies continues to transform. Beyond dispensing prescriptions at the pharmacy counter, some pharmacies are providing patient-specific prescriptions directly to clinics for administration. Pharmacies must be aware and protect themselves from the heightened audit risks.
While PAAS National® has written countless Newsline articles on signature, delivery, and mailing requirements to help our members ensure proper documentation is being obtained, additional consideration should be given for medications delivered to clinics for administration. Pharmacies are often under the assumption once the medication is delivered and signed for by clinic staff that their responsibility has ended; however, PAAS has seen many pharmacies run into PBM audit issues where additional controls were absent.
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Long-acting antipsychotic injectables are a frequent audit target due to their complexity and high cost. Additionally, the [potentially transient] patient population is more likely to create patient denial discrepancies (an auditor’s best friend). While PAAS has written articles about passive denials (the patient never acknowledges the auditor’s inquiry), this dispensing practice is more likely to lead to active denials. Do these patients know that your pharmacy provides the medication? In many cases, the answer might be no; so, having documentation and controls in place becomes paramount.
Moreover, given the patient population, how likely are they to miss appointments? Does the clinic communicate with the pharmacy if the patient cancels? PAAS has seen pharmacies continue to deliver medications for extended periods of time only to find out the patient hasn’t been keeping their appointments, and the clinic has been stockpiling the medication. Without additional measures in place, the pharmacy carries the financial burden.
Insurance companies will simply not pay for medications the patient never actually receives. Setting up policies and procedures with the clinics you deliver to should be mandatory to protect your claims. Remember, you are the only one with money at stake. While there are no specific requirements, questions to consider include:
- How are patient copays collected (when applicable)?
- Who will oversee receiving and signing for delivery?
- How will the medication be stored at the clinic prior to administration?
- What is the targeted timeframe from delivery to administration?
- How will the clinic and pharmacy communicate to confirm patient receipt?
- What will happen with medication a patient never receives (e.g., change in therapy, cancelled appointment)?
- How quickly will the clinic notify you (consider return to stock timeframes)?
- Does your state allow for medication reclamation under certain conditions?
PAAS Tips:
- Maintain good communication with the clinic you are working with
- Avoid automatic refills for these medications; only fill upon request or coordinate based on scheduled appointments
- See the June 2025 Newsline article, Proof of Patient Consent for Refill Request: What You Need to Know
- Be mindful of REMS delivery requirements
- See the March 2025 Newsline article, Understanding Spravato® Strict Delivery Requirements
- Adhere to return to stock policies
- See the June 2025 Newsline article, Why Adhering to Your Return to Stock Policy Is So Important
- Check your state laws on medication returned to pharmacy
- 340B clinics have a conflict of interest with 340B-eligible prescriptions; consider additional controls (e.g., mandatory evidence of administration) to reduce audit risk
I attended Madison College in nearby Madison, WI (PAAS headquarters are in the Madison suburb of Stoughton). Prior to coming to work at PAAS, I worked as a Certified Pharmacy Technician in a retail setting for 25+ years. Pharmacy has been my life’s work.
Helping our members have a successful audit experience is very rewarding. Celebrating with them, when PAAS often helps generate positive post-audit results, is the best part of my work.
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