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340B After Genesis and Other Recent Developments: Definition of Patient, Registration of Child Sites, 340B Repayment

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Tuesday, April 9, 2024

Recorded event now available

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This CLE webinar will guide healthcare counsel on recent 340B developments. The panel will examine the Genesis decision and its impact on covered entities. The panel will also discuss the Health Resources and Services Administration's (HRSA) notice re: child sites and what it means for child site eligibility as well as the CMS' final rule providing reimbursement for 340B hospitals. The panel will address the implications of these developments for the healthcare industry.

Description

In November 2023, the U.S. District Court of South Carolina addressed the definition of a patient under the 340B statute. In Genesis Health Care Inc. v. Becerra, the district court looked to both the plain language of the statute and the congressional intent and determined the government's interpretation of "patient" in a covered entity audit was contrary to the statute. This decision could significantly impact 340B covered entities.

Around the same time, HRSA issued a notice regarding its policy for registering off-site outpatient departments of a hospital (child sites), announcing that registration of these sites is required for them to access 340B drug pricing. Following this notice, several hospitals sued, challenging the notice.

Also, in November 2023, the CMS issued a final rule under which 340B hospitals will receive repayment for the reimbursement cuts put in place from 2018 through 2022 that were found unlawful by the U.S. Supreme Court.

Listen as our authoritative panel of healthcare attorneys examines the Genesis decision and its impact on covered entities. The panel will also discuss the HRSA's notice re: child sites and what it means for 340B access as well as the CMS' final rule providing reimbursement for 340B hospitals. The panel will address these recent developments and the implications for the healthcare industry.

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Outline

  1. Genesis Health Care Inc. v. Becerra and its impact
  2. Child sites
    1. HRSA notice
    2. Recent litigation
  3. CMS repayment final rule
  4. Best practices

Benefits

The panel will review these and other key issues:

  • What impact will the Genesis decision have for covered entities seeking to use 340B drugs?
  • What does the hospitals' challenge of HRSA's child site policy mean for 340B drug use in hospital child sites?

Faculty

Cook, Emily
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

Davis, Jeffrey
Jeffrey I. Davis

Member
Bass Berry & Sims

Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special...  |  Read More

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