In recent months, pharmacy benefit manager (PBM) audits and investigations targeting pharmacies suspected of prescription solicitation have surged dramatically. What was once an occasional compliance concern has become a recurring issue across the pharmacy industry, with PBMs increasingly flagging solicitation-related activity as a basis for heightened scrutiny, recoupment demands, and even network termination. This trend signals a broader shift in how PBMs are policing pharmacy conduct, and it carries serious financial and operational consequences for pharmacy owners who are unprepared to defend how prescriptions are sourced and generated.
Claim Validity Concerns
PBM audits are fundamentally designed to verify the validity of claims submitted by pharmacies for reimbursement. When a PBM conducts an audit, the PBM examines whether the prescriptions underlying those claims were obtained, processed, and dispensed in accordance with applicable laws, regulations, and the terms of the pharmacy’s provider agreement and manual with the relevant PBM. The manner in which a pharmacy obtains its prescriptions is central to this inquiry, because a prescription that was improperly obtained (e.g., through patient or prescriber solicitation) may lack the genuine clinical basis that legitimizes the resulting claim.
Therefore, if a pharmacy actively solicits prescriptions (for example, through unsolicited outreach to patients or providers, incentive arrangements, or other methods that prioritize prescription volume over patient need) PBMs may take the position that the resulting claims are not the product of a legitimate, independent prescriber-patient relationship. When a prescriber’s only interaction with a patient is a brief, solicited call initiated by a third-party, the relationship that results is fundamentally different from one in which a patient seeks out a physician for a genuine health concern.
This is why allegations of improper solicitation draw heightened scrutiny during audits: the method by which the prescription was generated goes to the very heart of the claim’s validity, and a pharmacy that cannot demonstrate that its prescriptions originated from bona fide clinical encounters may find itself facing significant recoupment demands and other adverse audit findings, including network termination.
Compliance Concerns
Many PBM provider manuals require general compliance with the Anti-Kickback Statute (AKS) as a condition of network participation.
When a pharmacy enters into arrangements that involve payments or other forms of remuneration (whether to prescribers, marketing companies, telehealth platforms, patient brokers, or other intermediaries) in exchange for the generation or referral of prescriptions, those arrangements may constitute violations of the AKS. The statute reaches any form of remuneration, whether in the form of direct payments, discounts, free services, data-sharing fees, or other economic benefits, provided that one purpose of the remuneration is to induce or reward referrals of federally reimbursable business.
The implications of any violation of applicable law is far-reaching, and pharmacies that enter into relationships or arrangements aimed at marketing the pharmacy or generating prescriptions to the pharmacy should be particularly attentive to the nature of such relationships. Moreover, because PBM provider manuals require general compliance with applicable law, allegations of improper solicitation of prescriptions can serve as a basis for monetary recoupments and network terminations and may escalate to further regulatory scrutiny.
How Frier Levitt Can Help
If your pharmacy is undergoing an audit or investigation with concerns regarding prescription validity or solicitation, or if you are contemplating entering into arrangements with third-parties, Frier Levitt can help. Our attorneys regularly assist pharmacies nationwide in defending PBM audits, responding to network termination actions, and evaluating telehealth, marketing and referral arrangements for compliance risks under PBM provider manuals and applicable fraud and abuse laws. We also help pharmacies implement proactive compliance strategies designed to withstand increasing PBM scrutiny. Contact us today to speak with an attorney.
