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Product ID: 399170EAU
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Changes to the 340B Program: What Covered Entitles Must Know

OnDemand Webinar (60 minutes)

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.


Richard Davis, J.D., Quarles & Brady LLP Michael French, J.D., Quarles & Brady LLP


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