340B Drug Pricing Program Omnibus Guidance: Preparing for HHS' Long-Awaited Guidance
Navigating Covered Entity Eligibility and Drug and Patient Eligibility; Preventing Duplicate Discounts in Medicaid Managed Care
Recording of a 90-minute CLE webinar with Q&A
This CLE course will provide healthcare counsel with an in-depth review of the U.S. Department of Health and Human Services’ long-awaited 340B Drug Pricing Program guidance, which makes significant changes and provides clarity on several matters, including patient eligibility and which healthcare providers are eligible to participate in the 340B Program. The panel will analyze who will be impacted—and how—and address the likelihood of the guidance being adopted and expected challenges. The panel will also address what counsel needs to do now regarding compliance that could be impacted if/when the guidance is adopted.
Outline
- The proposed guidance
- Covered entity eligibility and registration
- Eligible patients
- Scope of eligible drugs
- Medicaid managed care and duplicate discounts
- Auditable records and audits
- Who will be impacted and how
- Likelihood of the guidance being adopted and expected challenges
- What counsel needs to do now regarding compliance that could be impacted if/when the guidance is adopted
Benefits
The panel will review these and other key issues:
- How does the proposed guidance change the definition of patients? Of covered entities eligible to participate in the 340B program?
- How has the guidance addressed prevention of duplicate discounts for Medicaid managed care patients?
- What are the potential compliance impacts under the guidance?
- What challenges to the guidance can be expected?
Faculty
Emily J. Cook
Partner
McDermott Will & Emery
Ms. Cook focuses her practice on providing complex regulatory and reimbursement counsel to health care providers... | Read More
Ms. Cook focuses her practice on providing complex regulatory and reimbursement counsel to health care providers including hospitals, health systems, laboratories, durable medical equipment suppliers, ambulatory surgical centers, diagnostic imaging centers and physician practices. She has significant experience counseling health care providers, pharmaceutical manufacturers and group purchasing organizations on issues related to 340B drug pricing program implementation, compliance and advocacy.
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David S. Ivill
Partner
McDermott Will & Emery
Mr. Ivill is the partner-in-charge of the Health Industry Advisory practice in New York. He has significant... | Read More
Mr. Ivill is the partner-in-charge of the Health Industry Advisory practice in New York. He has significant experience working with federally qualified health centers and advising clients with respect to the 340B Federal Drug Pricing Program. He also has extensive experience in statutory and regulatory issues affecting the provision of health care services, particularly with respect to New York State; his practice includes counseling with respect to operational and management issues, fraud and abuse, Medicaid Managed Care, compliance programs, as well as reimbursement matters, corporate practice of medicine issues and not-for-profit/tax-exempt matters.
CloseJoseph M. Parise
McDermott Will & Emery
Mr. Parise focuses his practice on regulatory and transactional matters for healthcare providers, including hospitals,... | Read More
Mr. Parise focuses his practice on regulatory and transactional matters for healthcare providers, including hospitals, health systems, clinical laboratories, pharmacies, and physician practices. He has specific experience counseling clients on issues related to the 340B Federal Drug Pricing Program.
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