Pharmacy Law CE Column

By Laura Carpenter, RPh, JD, attorney and pharmacist, founder Carpenter Law Firm, PLLC

Return-to-stock: How to reduce risk of fraud

One of the most common problems in patient compliance is that patients do not pick up their medications. Although the desired final destination for all filled prescriptions is in the patient's hands, approximately 1.5% of all community pharmacy prescriptions remain unclaimed.ⁱ These unclaimed prescriptions can cause many problems beyond the obvious potential harm to the patient's health; they take up valuable shelf space in the will-call area, make it more difficult to quickly locate other will-call prescriptions, create inaccuracies in the inventory count and create a false claim to the insurer.

The federal False Claims Act,ⁱⁱ or FCA, prohibits anyone from knowingly presenting a false or fraudulent claim to a governmental health plan, such as Medicare, Medicaid, CHAMPUS, etc. Private citizens, who are called "relators" and who are colloquially called "whistleblowers," may enforce the act by bringing a qui tam case which, if successful, will reward the relator with 15% to 30% of the government's recovery. In addition, the attorney general can institute civil actions under the FCA. If the government intervenes and prevails on the merits, it is awarded treble damages plus a $5,000 to $10,000 penalty for each false claim submitted.ⁱⁱⁱ

Unclaimed prescriptions as false claims

Although the law does not define which claims are "false," a basic rule of thumb is that any incorrect claim is a "false claim." Therefore, if a patient does not pick up her prescription, a claim to Medicare, Medicaid or other insurer is "false" because the patient did not receive the drug. Other less obvious false claims can include submitting a claim for the wrong drug (e.g., a misfill or dispensing the brand instead of the generic); wrong NDC (e.g., incorrect package size); wrong dosage; wrong quantity (e.g., a "partial-fill"); or the pharmacy submitted a claim for something different that what the patient received.

Minimum procedure for unclaimed prescriptions

There are at least three critical issues to address regarding unclaimed prescriptions. First, to avoid a false claim, all Medicare, Medicaid or third-party claims must be reversed. Second, to ensure that appropriate drug utilization reviews can be conducted, the patient profile must be corrected to indicate that the prescription was not picked up. Third, the unclaimed medication must be properly stored to avoid becoming misbranded. It is important to follow your company's policies and procedures regarding unclaimed prescriptions.

Reversal of claims

Insurance billings for unclaimed prescriptions must be reversed to avoid a false claim. Patients and third-party payers should not be billed for the value of a full prescription when the prescribed medication (or a portion of it) is not picked up. Check with your employer's policies and procedures for the specific procedure for reversing claims on your system.

Correct the patient profile

If reversing the claim does not correct your patient profile records, you must ensure that the patient profile reflects that the prescription was not picked up or only a partial fill was received.

Proper return-to-stock procedure

The contents of a returned prescription should not be combined with the contents of the bottle on the shelf. The shelf contents may have a different manufacturer or lot number, and therefore the vial or bottle must be placed on the shelf. Stock bottles must clearly identify the drug, strength, dosage form, manufacturer, lot number and expiration date. Bottles that do not contain this information are considered misbranded and adulterated.^iv As a result, the lot number and expiration date must be placed on the label of the "returned" bottle prior to returning it to stock.^v Also, it is important to ensure that all patient-specific information is removed from the vial or bottle prior to returning it to the shelf.

Conclusion

Checking the will-call bins for unclaimed prescriptions is a task that most pharmacists and pharmacy technicians dread. However, it is essential that unclaimed prescriptions be checked. In addition to helping ease some operational issues caused by overflowing will-call bins, properly returning unclaimed drugs to stock will avoid a false claim investigation.

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