Understand the 340B Program and how the changes can affect multiple health care organizations.
The past few years have been an unusually tumultuous time in the 340B Program. This topic will outline the main challenges and opportunities for 340B Program stakeholders. The presenters will underline the practical steps that 340B Program stakeholders can take to ensure compliance and optimize 340B Program participation during the current shifting state of the 340B Program.
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Over 37 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.
Agenda
340B Background
- General Refresher on the History of the 340B Program
- High Level Overview of the Main Program Requirements and Regulations
- Eligible Patient Definition Discussion and Gray Areas in Interpretation
Recent Program Changes
- New Child Site Eligibility Rule
- Alternative Dispute Resolution (ADR) Process
- Medicare 340B Reimbursement Reductions
Legislative Updates
- General Summary of Introduced Legislation That Could Impact the 340B Program and Associated Regulations in the Future
Ongoing Manufacturer Disputes
- Background on Several Manufacturers' New Position on Offering 340B Pricing Through Contract Pharmacy Relationships
- Introduction and Withdrawal of HHS 340B Advisory Opinion
- Submission of HHS Enforcement Letters to Applicable Manufacturers
- Summary of Ongoing Lawsuits Between HHS and Manufacturers Over Enforcement Letters
Compliance Problem Areas and Best Practice Strategies
- HRSA Audit Preparations and Recent Trends in Areas of Review and Enforcement
- 340B Billing Requirements Changes (Medicare and Medicaid) and Best Practices for Avoiding Duplicate Discounts
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Why Lorman?
Over 37 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.
Credits
OnDemand Course
This course was last revised on December 16, 2021.
Call 1-866-352-9540 for further credit information.
This program does NOT qualify, nor meet the National Standard for NASBA accreditation.
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Why Lorman?
Over 37 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.
Faculty
Richard Davis, J.D.
Quarles & Brady LLP
- Partner at Quarles & Brady LLP
- Assists in implementing and enhancing 340B drug pricing programs across a wide variety of health systems, enabling the health systems to obtain millions of dollars in savings
- Provides ongoing compliance and operational support to 340B participating entities
- Successfully disputes and mitigates HRSA OPA audit findings, enabling these entities to retain their 340B savings in addition to contracting with various national retail pharmacy chains and 340B program software vendors
- Draft memoranda interpreting and analyzing HRSA OPA 340B program guidance based on relevant Medicare and Medicaid statutory and regulatory language
- Assists covered entities and contract pharmacies in navigating recent manufacturer disputes
- J.D. degree, with honors, University of Wisconsin Law School; B.A. degree in international affairs, George Washington University
Michael French, J.D.
Quarles & Brady LLP
- Attorney at Quarles & Brady LLP
- Assists with successfully navigating 340B HRSA audits, including data request submissions, support during the on-site portion of an audit, and drafting corrective action plans and/or Notice of Disagreements to mitigate the impact of findings
- Conducts client-facing 340B pharmacy operational assessments to assess compliance and identify opportunities to maximize available 340B savings
- Provides advice and counsel on strategies for avoiding 340B diversion and Medicaid duplicate discounts, including best practices for meeting associated federal and State-level billing requirements
- Draft 340B contract pharmacy services agreements to maintain compliance with associated 340B regulations and ensure operational efficiencies for all parties involved
- Assists covered entities and contract pharmacies with Third-Party Administrator (TPA) implementation, best strategies for configuration set-up, and maintenance of software settings to ensure compliance
- J.D. degree, magna cum laude, Loyola University Chicago School of Law; B.A. degree, University of Notre Dame
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Why Lorman?
Over 37 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.
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