Merle DeLancey’s practice focuses on a wide variety of government procurement law. He represents clients contracting with federal and state governments, with an emphasis in the healthcare industry. Merle has experience in a broad spectrum of government contracting issues and litigation, such as:
- Healthcare government contracts covering brand, authorized generic, and generic pharmaceuticals; medical/surgical supplies; capital equipment; services; compounding; complex vaccines; and biologics
- Federal and state court litigation involving False Claims Act allegations, false statements, and defective pricing, including Medicare, Medicaid, and TRICARE fraud
- The impact and nuances of commercial pricing and distribution channels on government price reporting and reimbursement
- Negotiation of highly technical government contracts, grants, and other transactions (“OTAs”), and cooperative agreements for complex biologics, vaccines, equipment, and manufacturing facilities with numerous agencies including the Department of Health Human Services, Biomedical Advanced Research and Development Authority (“BARDA”), the Centers for Disease Control and Prevention (“CDC”), Office of the Assistant Secretary for Preparedness and Response (“ASPR”), the National Cancer Institute (“NCI”), the Department of Defense (“DoD”), including the Defense Logistics Agency, and the Department of Veterans Affairs (“DVA”)
- Medicare and Medicaid price reporting compliance and reimbursement
- Department of Veterans Affairs and Public Health Service (340B) price reporting
- Cost accounting compliance including defending audits by agency offices of inspector general, DCAA, and DCMA
- All aspects of GSA and DVA federal supply schedule contracting including defective pricing and price reduction compliance
- Mandatory and voluntary agency disclosures
- Conducting internal investigations and performing compliance reviews and gap analyses
- Protests at the agency level, GAO, and the COFC
- Litigating claims at boards of contract appeals
- Negotiating requests for equitable adjustment
- Defending Congressional investigations and inquiries
- Agency suspension and debarment proceedings
- GSA leasing
- Mergers, acquisitions, novations, and change of name agreements
- Commercial disputes including between government prime contractors and subcontractors
- General FAR compliance including issues such as:
- Country of origin (BAA and TAA)
- Service Contract Act
- Commercial item and COTS contracting
- Small business subcontracting including mentor-protege agreements and joint venture agreements
- Teaming agreements
- Economic price adjustments
