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Changes to the 340B Program: What Covered Entitles Must Know

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.

60 minutes
Course Exam
Certificate of Completion
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Over 35 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 35 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

MP3 Download

  • Arizona CLE 1.0
     
  • CA MCLE 1.0
     
  • HI CLE 1.0
     
  • NJ CLE 1.2
     
  • VT CLE 1.0
     
  • WA CLE 1.0
     
  • WV MCLE 1.2
     
The CLE Code is ONLY a requirement when applying for CLE Credit in California (for participatory credit), Kansas, New Jersey or New York. Other states do not need to supply the CLE Code to apply for CLE credit.

This program does NOT qualify, nor meet the National Standard for NASBA accreditation.

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 35 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.

Richard Davis, J.D.

Quarles & Brady LLP

  • Associate 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
  • Drafts 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.

Michael French, J.D.

Quarles & Brady LLP

  • Associate 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
  • Drafts 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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Over 35 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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Product ID: 399170
Published 2021
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