Connie Wilkinson concentrates her practice on pricing and reimbursement policy, commercial pricing, federal health care and health benefits program issues, and contracting strategies—including health care fraud and abuse considerations—for the pharmaceutical, medical devices and products, and biotechnology industries. Based in the Washington, DC, office, she also serves as a member of the firm’s Board of Directors.
- Advises direct and indirect providers in the health care industry regarding pharmaceutical pricing and program compliance under Medicare Parts B and D, the Medicaid Drug Rebate Program, the 340B Drug Discount Program, the Veterans Health Care Act/Federal Supply Schedule Program, and the DoD TRICARE program
- Conducts due diligence and internal reviews, performs and responds to fraud and abuse investigations, prepares and negotiates voluntary disclosures and restatements, and assists in implementing Corporate Integrity Agreements, including providing counsel regarding reviews conducted by Independent Review Organizations
- Develops and reviews corporate compliance programs for federal contractors and for direct and indirect providers of health care services, including manufacturers of drugs, devices, and biologicals
Some of Connie’s recent engagements include the following:
- Assisting a pharmaceutical manufacturer in developing a full suite of government program compliance and price reporting policies
- Drafting and negotiating commercial supply, distribution, and pricing agreements for pharmaceuticals and biologicals
- Structuring and performing risk assessments of value-based contracting arrangements in the context of the current legal and policy landscape
- Developing and delivering training modules on legal and regulatory requirements for federal government contractors
Connie is a former Co-Chair of the ABA Public Contracts Section Health Care Contracting Committee. She has authored numerous articles on the procurement, pricing, and reimbursement of pharmaceuticals, medical devices, and supplies, and she lectures frequently on these topics.