Quarles & Brady has significant experience assisting all sectors of the pharmaceutical industry with a wide range of federal and state regulatory issues. We serve as national regulatory counsel for a number of large pharmacy, wholesale, and pharmacy benefits management companies, and we advise these clients on Medicare and Medicaid regulations and requirements regarding pharmacy operations, medical discount card regulation and contracting, fraud and abuse issues, responding to regulatory inquiries and investigations, and state licensing and general regulatory laws and reporting requirements.
Our pharmacy team has wide-ranging experience with licensing new pharmacy locations and advising clients on the necessary staffing, operational, and systems requirements for these locations. We also have extensive experience with the licensing and reporting requirements for pharmacist-administered vaccinations and screening tests and pharmacy wellness centers, including co-locating clinics within pharmacies. In addition, our team has significant experience helping clients develop complex new programs, which can include multiple points in the pharmacy distribution process and multi-state jurisdictional matters.
We also assist clients with all issues related to HIPAA and state privacy laws, including determining whether there has been a privacy or security breach and the required reporting of a such a breach under both state and federal law. We counsel on the uses of de-identified data and the related contracting required of covered entities and business associates.
Quarles & Brady understands the nuances of how prescription drugs are priced and how this pricing affects whether manufacturer rebates are permitted under the Anti-Kickback statute rebate safe harbor, and we are well-versed in the intricacies of the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers. As a result, our attorneys are uniquely able to advise retail and hospital pharmacies on regulatory issues, formularies, rebates, other payments, and “switching programs.”
Our attorneys advise clients on the appropriate billing of prescription medications, including auditing of pharmacies, developing internal audit procedures, corporate compliance guidelines, and compliance education. We have successfully represented multiple clients in obtaining reimbursement from government and third-party payors.
Our team also has experience with pharmacy billing and coding practices—for example, we have developed guidelines for avoiding unintentional mis-billing and overutilization of pharmacy services and products. Our team also has helped retailers with various issues related to their existing pharmacies, including Medicaid reimbursement, individual state board queries and reporting requirements, controlled substance requirements, prescription requirements, and Anti-Kickback issues related to coupons.