340B Compliance: Overcoming Challenges With Diversion, Duplicate Discounts, and Orphan Drug Restrictions
Recording of a 90-minute CLE webinar with Q&A
This CLE course will provide guidance to healthcare counsel for providers who participate in the 340B drug discount program. The panel will discuss key program requirements and compliance concerns, will outline best practices to help ensure compliance with the program requirements, and will address recent developments in 340B program guidance.
- Compliance concerns for providers in the 340B program
- Duplicate discount
- GPO prohibition (for certain covered entity types)
- Orphan drug exclusion (for certain covered entity types)
- Best practices for creating and implementing effective programs to ensure compliance
- Tips for preparing for audits
- Considerations relating to HRSA’s new mega-guidance and proposed rule on CMPs and ceiling price calculations
The panel will review these and other key issues:
- What are the key compliance challenges for providers in the 340B drug discount program?
- What steps should providers and their counsel take to help ensure compliance and be prepared for a 340B audit?
- What policies and procedures should providers have in place to maintain 340B program compliance?
- What changes are expected with the HRSA new mega-guidance?
Stephanie P. Hales
Ms. Hales regularly counsels clients on healthcare legislative and regulatory developments and their impact, providing... | Read More
Ms. Hales regularly counsels clients on healthcare legislative and regulatory developments and their impact, providing strategic advice, analysis and advocacy targeted to clients’ internal leadership and personnel as well as to courts, Congress, policymakers at federal and state agencies and other stakeholders. She focuses her practice on healthcare regulatory, compliance and legislative matters, including strategic counseling in connection with public policy proposals and implementation issues. Ms. Hales has experience in healthcare coverage, coding and reimbursement issues; government price reporting; administrative litigation; managed care and market access matters; healthcare contracting; healthcare compliance; government agency and congressional investigations; and health information privacy and security. She advises clients on a broad range of issues and provisions under Medicare, Medicaid, the 340B Drug Pricing Program and the Affordable Care Act.Close
Kathryn R. Watson
Feldesman Tucker Leifer Fidell
Ms. Watson works with nonprofit healthcare organizations and federal grantees, seeking to identify and implement... | Read More
Ms. Watson works with nonprofit healthcare organizations and federal grantees, seeking to identify and implement flexible solutions for clients based on their transactional, compliance and litigation needs. She assists health center clients in preparing for government audits and conducting internal investigations. Ms. Watson also reviews bylaws and other corporate documents, as well as agreements including 340B drug discount agreements, community benefit grant agreements, and managed care contracts.Close