No matter where your pharmacy is located, how busy it is, or how long it has been in business, it will face audits and reviews by PBMs and third-party payors. Investigations, audits, and other actions by PBMs are on the rise and have dramatically increased in number and scope. Adverse audit outcomes often include the termination of provider agreements, which, in most cases, can lead to the pharmacy’s demise.

Most on-site and desktop audits can be resolved with better outcomes if experienced counsel is engaged early in the process. Ideally, audit preparation should begin long before an audit notice is received, through ongoing collaboration between counsel and the pharmacy. The preparation process should include compliance and best practices reviews, developing and implementing effective policies and procedures, as well as record-keeping and risk assessment.

Unfair and abusive practices by PBMs, their third-party contractors, and health plans can be neutralized through various situation-appropriate and assertive approaches. Counsel well-versed in the process, if engaged at the early stages of an audit, can assist in many different ways. Strong and appropriate responses to commonly encountered audit scenarios will help the pharmacy avoid pitfalls and successfully complete an audit. When unfavorable findings are inevitable, experienced counsel can help avoid large recoupments, termination, and possibly referrals to law enforcement and administrative agencies.

Through years of defending audits and other actions by CVS Caremark, OptumRx, Express Scripts, Humana, Horizon, Envision Rx, Prime Therapeutics, Magellan Rx and others, our attorneys have developed numerous successful approaches to the full range of issues that arise in PBM audits.

In addition to dealing with audits and reviews by PBMs and third-party payors, we also defend pharmacies in Medicaid and Medicare audits and investigations. The scrutiny from government agencies in these areas has intensified, and pharmacies can encounter various challenges in navigating these investigations. Medicaid and Medicare audits, conducted by agencies such as the Centers for Medicare & Medicaid Services (CMS) and state Medicaid programs, pose a significant risk to pharmacies.

Similar to PBM audits, adverse outcomes in Medicaid and Medicare investigations can lead to severe consequences, including the termination of provider agreements, financial penalties, and potential legal actions. Engaging experienced counsel early in the process is crucial for a favorable resolution. The preparation process for Medicaid and Medicare investigations should involve a comprehensive review of compliance, adherence to best practices, and the development of robust policies and procedures.

Counsel familiar with the nuances of Medicaid and Medicare investigations can assist in formulating effective responses to inquiries, ensuring compliance with regulations, and mitigating potential risks. The collaboration between pharmacy and legal counsel should encompass a thorough understanding of the specific requirements and regulations associated with Medicaid and Medicare programs.

Given the complex and evolving nature of healthcare regulations, staying abreast of compliance measures, implementing proactive strategies, and having a solid defense plan in place are essential for pharmacies facing Medicaid and Medicare investigations. Through years of experience in handling a spectrum of legal challenges, our attorneys have successfully navigated Medicaid and Medicare investigations, providing pharmacies with comprehensive and effective guidance to safeguard their interests and ensure compliance with governmental regulations.