The following discussion highlights key compliance considerations for both existing pharmacies and new market entrants looking to thrive in today’s competitive environment.
As the pharmacy supply chain continues to evolve, both new and established organizations are facing potential mergers, acquisitions, and consolidations, while private equity continues to introduce new players into the changing landscape of the industry. In this dynamic environment, the need for strong compliance and effective governance, and oversight programs remains critical. It is essential that organizations conduct thorough due diligence before any acquisition and implement robust compliance plans once deals have been finalized.
In today's rapidly evolving healthcare landscape, pharmacies face increasing scrutiny from payers and regulators to ensure compliance with contractual obligations, regulatory requirements, and patient safety. This can be effectively facilitated through the use of comprehensive pharmacy audit tools designed to examine the operations and dispensing roles performed within an organization and assess and enhance pharmacy oversight, monitoring, and auditing processes.
Audit Structure and Themes
The foundation of an effective auditing approach is grounded in establishing robust audit structures and themes. These themes should guide the audit process by identifying principal risks and audit concerns. The audit structure should mimic common approaches used by payers and regulators, ensuring audits are both comprehensive and focused. They should be designed to verify that patients receive the care and products billed by the pharmacy and confirm accurate submissions aligned with dispensing requirements. Furthermore, audits should provide assurance that the pharmacy is administering and adhering to thorough inventory management practices.
Creation of Universe and Sample Selection
Effective auditing begins with the creation of a broad universe of claims from which samples can be extracted. Consider emphasizing targeted sample selection, which focuses on claims that present elevated risk or are frequently audited, ensuring that pharmacies have robust processes for filling and billing prescriptions according to requirements. This approach not only streamlines the audit process but also enhances the accuracy and relevance of audit findings.
Claim Review
Audit tools and approaches should provide a comprehensive framework for claim review, encompassing all aspects of prescription management from receipt to delivery. This includes detailed documentation requests to verify compliance with prescription requirements, accurate billing, and patient pick-up or (when applicable) proof of delivery. Claim reviews should ensure alignment with payer/provider manuals and federal/state laws, emphasizing Medicare and Medicaid regulatory requirements.
Audit Tools and Documentation
Effective audit tools should be designed to support pharmacies in preparing for audits by organizing documentation systematically. This includes prescriptions, medication administration records, clinical interventions, procurement processes, delivery logs, patient signatures, and proof of payments. Proper documentation is vital for demonstrating compliance with payer requirements and regulatory standards.
Ankura Can Help
Ankura is committed to supporting pharmacies in navigating the complex landscape of healthcare regulations and payer requirements, positioning them for success in today’s competitive market.
Our experts have deep expertise in assisting regional and national retail pharmacies, long-term care pharmacies, and specialty pharmacies with the evaluation of existing programs as well as the creation of new protocols for implementation by their auditing and compliance departments. Our proprietary audit tools and methodologies provide pharmacies with the framework necessary to enhance their oversight, monitoring, and auditing processes. By adopting Ankura’s best practices, pharmacies can ensure compliance, improve operational efficiency, and ultimately enhance patient care.
For more information on how Ankura can assist your pharmacy with comprehensive audit solutions, reach out to us at https://ankura.com/contact
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© Copyright 2025. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC., its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.
