Recent Updates and Compliance Issues in the 340B Program

Event Information
Product Format
Prerecorded Event
Conference Date
Fri, Sep 28, 2018
60 minutes
Product Description

Learn How to Prepare for and Respond to 340B Audits, Changes in 340B Reimbursement by Medicare & Medicaid, and Recent Program Developments

Government audits of safety net hospitals and federally-funded clinics participating in the 340B drug discount program have been intensifying since the launch of the 340B audit program by Health Resources and Services Administration (HRSA). Plus, congressional scrutiny of the program has increased dramatically. Regulations issued by the Centers for Medicare and Medicaid Services (CMS) have reduced reimbursement and/or required claims identification of 340B drugs. What are you doing to keep up to date and to stay complaint with program changes so that your 340B drug discounts are not at risk?

Catch up on the current political and enforcement landscape of the 340B program, and find out how best to meet the regulatory and operational demands with industry veteran William von Oehsen. Learn how to navigate the 340B program – including audit, corrective action and self-disclosure requirements. Understand how federal and state policies are increasingly restricting how 340B hospitals and clinics can bill and be paid for 340B drugs by the Medicaid program. Get up to speed with the billing and reimbursement guidance from CMS governing Medicare Part B payment to 340B hospitals, as well as the latest legislative and regulatory developments regarding potential reform of the program.

After attending this information-packed webinar, you will be able to prepare for and respond to a 340B audit by HRSA, and appeal an adverse audit finding by HRSA. You will know how to address every element of a compliant corrective action plan, and assess whether to self-disclose based on whether a violation is “material.” You will understand the option of carving in/out Medicaid drugs from a covered entity’s 340B program, and know how to assess the risks and benefits of carving in/out with respect to Medicaid fee-for-service and managed care drugs. Plus, you will be able to comply with Medicare Part B billing and reimbursement requirements applicable to 340B hospitals, and know how to anticipate 340B reform measures under consideration by Congress and the Administration
At the end of the session, you will receive handouts, including a sample HRSA audit data request, corrective action plan template, Apexus guidance on evaluating “materiality”, and sample corrective action plan close-out letter.

Session Highlights

Here’s a taste of what you will learn:

  • Pre-audit and post-audit phases of a HRSA audit
  • Covered entity obligation to self-report 340B compliance issues
  • Options for developing and implementing a corrective action plan
  • Challenges and guidance in offering repayment to manufacturers
  • Regulations by the CMS reducing covered outpatient drug reimbursement to actual acquisition cost, and requiring Medicaid managed care organizations to identify 340B claims
  • State policy changes overhauling how hospitals and clinics bill are paid for 340B drugs in light of the CMS managed care regulation
  • Reduction in Medicare Part B reimbursement to 340B hospitals
  • The resulting compliance risks associated with the new 340B billing and reimbursement policies
  • Update on pending litigation and legislation intended to block or suspend the Medicare Part B cuts
  • The latest news on other activities within Congress, the White House, HRSA, and CMS relating to the 340B program

Session Agenda

  • 340B background
  • Affordable Care Act changes to 340B program
  • Bipartisan Budget Act changes
  • Recent developments
  • HRSA audit program
    • New guidance on termination
    • Typical areas of improvement
    • Appealing HRSA findings
  • Self-audits
  • Self-disclosures – when are they required
  • Corrective action
  • Manufacturer repayment
    • Repayment challenges and tips
  • Manufacturer audits and inquiries

Who Should Attend

  • CEOs and CFOs
  • Directors of pharmacy, pharmacy buyers and managers
  • In-house counsel, compliance officers, 340B coordinators
  • Outside counsel and consultants representing 340B hospitals and clinics
  • Representatives of 340B contract pharmacies, contract pharmacy administrators and split-billing software vendors
  • Representatives of government agencies that participate in the 340B program and/or oversee covered entity participation

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

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About Our Speaker

William Von Oehsen

William von Oehsen is a Principal in Powers, Pyles, Sutter and Verville, P.C., a law firm specializing in health care law and policy. Mr. Oehsen has more than 25 years’ experience on pharmaceutical pricing and reimbursement matters, including those involving the 340B drug discount program, the Medicaid drug rebate program, Medicare Part D, Robinson-Patman, and state Medicaid and pharmacy laws. He helped establish and serves as outside counsel...   More Info
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