Macaulay Jamerson & Sessa has more than 25 years of experience representing pharmacies in legal and regulatory compliance and serving as defense counsel for pharmacies in state and federal audits and investigations. Our attorneys have written many of the laws and regulations governing pharmacies operating in Virginia. We are one of the few law firms in the country able to provide thorough counsel and oversight regarding the pharmaceutical industry’s legal and regulatory issues today.
Compliance and Defense Counsel for Pharmacies and Other Entities
In addition to representing pharmacies across the country, we represent group purchasing organizations (GPOs), pharmacy services administration organizations (PSAOs), durable medical equipment (DME) companies, pharmacy networks, wholesalers, and other entities. Our clients range from small, local pharmacies to regional and national corporations. Our representation includes:
- Legal and Regulatory Compliance – Assistance with compliance under the Controlled Substances Act (CSA), Food, Drug and Cosmetic Act (FDA Act), Health Insurance Portability and Accountability Act (HIPAA), and other pertinent federal and state laws and regulations. Development of policies and procedures, implementation, training, and compliance auditing.
- PBM Compliance and Audit Defense – Evaluation of pharmacy benefit manager (PBM) contracts, representation for PBM audits, and assistance with PBM-related issues during pharmacy sales and closings.
- DEA Registration, Inspections, and Investigations – Representation for all matters involving the U.S. Drug Enforcement Administration (DEA), including registration, inspections, and investigations. Assistance with DEA subpoena response, DEA notifications for pharmacy sales and closings, and other DEA compliance matters.
- Other Government Investigations and Enforcement Actions – Representation for investigations and enforcement actions involving the U.S. Department of Justice (DOJ), U.S. Department of Health and Human Services Office of Inspector General (DHHS OIG), Medicaid Fraud Control Units (MFCUs), Virginia Department of Medical Assistance Services (DMAS), and other state and federal authorities.
- Employment and Corporate Law – Representation on employment and human resources (HR) matters. Counseling concerning entity selection, governance, and other corporate matters.
- Opening, Closing, and Selling – Advice and representation in all aspects of opening or closing a pharmacy in Virginia, including negotiation of PBM agreements, developing compliance policies and procedures, securing licenses and registrations, audit defense, completing inspections contract negotiations, state and federal compliance, and PBM compliance.