Over the past decade, many branded pharmaceutical manufacturers have developed copay coupon programs to help defray the costs associated with patients’ copays in an effort to drive adherence to their branded products and to stave off generic competition. These manufacturer-sponsored programs have expanded from just covering the copays remaining after the pharmacy submits the claim to the patient’s insurer, to also covering a portion of the patient’s costs when the patient does not have insurance or where the patient’s insurance does not cover the branded product. Manufacturers typically hire third party companies to administer these programs, produce the coupon cards, adjudicate claims and process payments to pharmacies.
Historically, these third party administrators of manufacturer-sponsored coupon programs had not applied the same scrutiny of claims submitted by pharmacies, certainly when compared to Pharmacy Benefits Managers (PBMs), and had generally not conducted audits of pharmacies submitting claims to the coupon programs. However, in the recent weeks, pharmacies have experienced a string of new audits from these companies, focusing on both primary and secondary claims submitted to the processors. Auditing firms, like Codoxo, have issued “records request” notices to pharmacies, seeking broad sets of documents related to claims submitted to the programs. Documents being sought include copies of prescriptions, signature/delivery logs, dispensing records, and other documentation to support the appropriateness and accuracy of the billing. The audits threaten recoupment of the total amounts paid to the pharmacy if the pharmacy does not comply, and given that many of these involve high cost branded products, such as Ozempic or other GLP-1’s, the financial risk could be quite large.
In responding to these audits, pharmacies should carefully examine the documentation to ensure that it is accurate and complete. In addition, pharmacies should be aware of several potential pitfalls or issues that have led manufacturers to seek recovery in the past. Common pitfalls include:
- Billing for claims not purchased and dispensed
- Submitting claims for the brand NDC number but dispensing a generic NDC number (even if it is an authorized generic)
- Violation of the terms and conditions of the coupon program as listed on the card (such as using the coupon in conjunction with another prescription discount card, etc.)
- Using the coupon for Medicare or Medicaid patients
Fortunately, strategies exist to mitigate some of these issues and to combat recoupment efforts. Frier Levitt has represented pharmacies facing audits from third party administrators of manufacturer-sponsored coupon programs and can assist in responding to these requests. If you have received a request for records, contact Frier Levitt today.