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


Conducted on Tuesday, October 13, 2015

Recorded event now available

or call 1-800-926-7926
Program Materials

This CLE webinar 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.

Description

The U.S. Department of Health and Human Services released the long-awaited 340B Drug Pricing Program guidance on Aug. 27, 2015. The 340B guidance seeks to provide clarity on several matters, including drug eligibility and which healthcare providers are eligible to participate in the 340B Program, and prevent duplicate discounts for Medicaid managed care patients.

The definition of an eligible patient is one of the most anticipated areas in the 340B guidance. The guidance proposes significant changes to the definition of patient for the 340B Program, which is restated as a six-part test. The guidance proposes to limit the covered entity’s ability to provide 340B drugs due to the physician’s lack of affiliation with the covered entity, but a patient’s physician having privileges or credentials at the covered entity is not enough to demonstrate patient eligibility.

Covered entities have until Oct. 27, 2015, to provide comments on the proposed guidance. With the many significant changes and clarifications to the current guidance, healthcare counsel must understand the impact of the guidance to prepare and respond.

Listen as our authoritative panel examines the proposed guidance, analyzes who will be impacted—and how—and addresses 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.

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Outline

  1. The proposed guidance
    1. Covered entity eligibility and registration
    2. Eligible patients
    3. Scope of eligible drugs
    4. Medicaid managed care and duplicate discounts
    5. Auditable records and audits
  2. Who will be impacted and how
  3. Likelihood of the guidance being adopted and expected challenges
  4. 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
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

David S. Ivill
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

Joseph M. Parise
Joseph M. Parise

McDermott Will & Emery

Mr. Parise focuses his practice on regulatory and transactional matters for healthcare providers, including hospitals,...  |  Read More

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