CHRISTOPHER R. SMITH is a Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the Washington, DC, office of Epstein Becker Green. His practice focuses on pharmacy law, drug distribution, and reimbursement issues.
Mr. Smith:
- Advises on pharmaceutical supply chain law and regulations, including the Drug Supply Chain Security Act, EPA pharmaceutical hazardous waste regulations, consumer drug take-back and disposal regulations, and legislative proposals for foreign drug importation
- Counsels retail and specialty pharmacies, pharmacy benefit managers (PBMs), insurers, and other health care providers and suppliers on a range of pharmacy law and drug distribution issues, including pharmacy licensure and regulation; drug reimbursement by private insurers and under the federal health care programs; compounding, repackaging, and physician dispensing; contract disputes between PBMs and pharmacies; and the structuring of specialty pharmacy distribution arrangements
- Works with 340B covered entities, contract pharmacies, and 340B management service providers on 340B compliance, outlook, and strategy, and represents covered entities in connection with the implementation of 340B compliance policies and procedures, contract pharmacy arrangements, self-assessments, and independent audits
- Advises on the interplay of the Affordable Care Act and pharmacies, including the role of pharmacies and prescription benefit designs within the health insurance exchanges, provider network requirements, and regulations governing nondiscrimination in health care
- Defends clients in criminal and civil investigative and enforcement matters, including Anti-Kickback Statute and False Claims Act cases (including qui tam litigation)
- Represents clients in civil rights disputes, including employers in employment discrimination cases
- Provides litigation counsel in complex civil litigation matters involving health care issues
Before joining Epstein Becker Green, Mr. Smith worked as a Director of Federal Public Policy at a nonprofit trade association that advocates for pro-patient and pro-pharmacy public policy and as a Director of Policy and Regulatory Affairs at a national trade association representing the pharmacist owners, managers, and employees of independent community pharmacies nationwide. He also has a lobbying certificate from the Association of Government Relations Professionals. In addition, he previously served as a Special Assistant Attorney General in the Office of the Attorney General of Maryland and as a litigation attorney at national and regional law firms, where he provided criminal defense and witness counseling in federal terrorism cases, defended alleged funders of the September 11 attacks in multidistrict civil litigation, and defended a state police department against Section 1983 multi-plaintiff racial profiling claims.
