Successful 340B programs require awareness and understanding of the full landscape surrounding 340B participation. 340B covered entities, pharmacies, and 340B service providers rely on Bass, Berry & Sims attorneys for full-service support related to 340B program matters, including counsel related to:
- 340B program compliance.
- Pharmacy operations.
- Hospital and health system reimbursement and operations.
- Healthcare regulatory and fraud and abuse considerations.
- Litigation support to analyze and understand the latest 340B court decisions.
- 340B public policy developments and considerations.
340B Program Compliance
Our full-service 340B support starts with deep 340B program knowledge, including assistance from attorneys who are nationally recognized for their experience in 340B compliance. The firm’s 340B practice includes a former in-house counsel for 340B Health, an association of more than 1,500 hospitals and health systems participating in the 340B program. Our attorneys are often asked to provide insight to media outlets and speak on 340B matters on webinars and at conferences, including the 340B Coalition Annual Conference and Winter Conference, and they are a go-to resource for 340B compliance assistance.
We counsel clients on a variety of 340B issues, including:
- Covered entity and child site eligibility.
- Contract pharmacy arrangements.
- 340B claim identification and other billing requirements.
- Medicare and Medicaid billing and reimbursement policies.
- Third party administrator and pharmacy service agreements.
- HRSA audits of covered entities.
- Drug manufacturer inquiries.
- Self-disclosures.
- Corrective action plans.
Pharmacy Operations
We couple our 340B compliance counseling with a deep understanding of pharmacy operations and regulatory compliance. Our 340B practice is complemented by our nationally recognized Specialty Pharmacy & Pharmaceuticals Team that is one of the nation’s largest specialty and home infusion pharmacy practices and serves as operational and transactional counsel to pharmacies.
Our team includes industry veterans who have experience as both in-house general counsel and outside counsel for national pharmacies and pharmacy service providers. The firm’s specialty pharmacy practice includes a former Chief Counsel & VP of Strategic Development of Accredo Health Group and former Assistant General Counsel of Medco Health Solutions.
We regularly provide practical business advice and legal guidance to help with trade and distribution matters facing pharmacy clients and assist pharmacy clients in navigating and complying with the contractual, regulatory, and operational requirements unique to the pharmacy industry. This work includes regular engagement with boards of pharmacy in states across the country on licensing and distribution issues, as well as knowledge of federal laws impacting the pharmacy supply chain and drug distribution, including the Drug Supply Chain and Security Act (DSCSA).
Hospital & Health System Reimbursement & Operations
Hospitals participating in 340B need to understand the intersection between 340B policies implemented by the Health Resources and Services Administration (HRSA) and Medicare rules, including the Medicare provider-based regulations and Medicare cost reports. Our Healthcare Reimbursement Team has decades of combined experience counseling provider clients, including large health systems, on health care reimbursement matters related to Medicare, Medicaid, and other payers.
Healthcare Regulatory & Fraud & Abuse Considerations
Participation in any federal healthcare program requires awareness and consideration of federal and state fraud and abuse laws.
A number of our attorneys previously held leadership roles in the Department of Justice (DOJ), Department of Health and Human Services Office of the Inspector General (HHS-OIG), and other government agencies providing valuable insight in advising clients concerning enforcement matters and counseling clients on fraud and abuse issues.
Litigation Support to Analyze & Understand the Latest 340B Court Decisions
340B stakeholders should stay informed on the latest developments in lawsuits related to 340B, including active cases in federal court related the 340B patient definition and contract pharmacy use.
Bass, Berry & Sims is a recognized leader in healthcare industry litigation, with more than 50 attorneys who have a deep understanding of the heightened enforcement scrutiny and regulatory risk confronting healthcare providers.
340B Public Policy Developments & Considerations
Decision-making on 340B matters should account for both compliance considerations and the political debate surrounding the 340B program in Washington, D.C. Attorneys in our Washington, D.C. office include former HHS leaders and congressional staff, and we are well-versed on 340B public policy matters and disputes among program stakeholders, including scrutiny by Congress, drug manufacturers, and national news media outlets. We advocate on behalf of 340B providers at the federal level before Congress and the administration and track federal legislative and administrative developments related to 340B, drug pricing, and safety net providers.
