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

Understand the 340B Program and how the changes can affect multiple health care organizations.

The federal 340B Drug Pricing Program (340B Program) has grown rapidly in recent years, with more hospitals and health systems recognizing the valuable role the Program can play in expanding access to health care for patients of safety net facilities. This topic will describe recent proposed changes to the 340B Program stemming from Omnibus Guidance released by the Health Resources and Services Administration (HRSA) in August 2015. In this topic, Richard P. Church will describe the history of the Omnibus Guidance and the 340B Program more broadly, then will describe in detail the proposals contained in the Omnibus Guidance that could impact hospitals and other 340B covered entities - as well as contract pharmacies, drug manufacturers, and others - across the country. Finally, it will discuss potential next steps on the Omnibus Guidance and the future direction of the 340B Program before providing an opportunity for questions from the audience. Gain key insights into the 340B Program, including current HRSA policies and enforcement priorities, the complexities of the Program, and updates on issues that could have a significant impact on the finances of safety net facilities in the years ahead.

Runtime: 83 minutes
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Over 33 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

Background

  • Brief History of the 340B Program
  • History of the Omnibus Guidance

340B Omnibus Guidance Summary

  • New Patient Definition
  • 340B Eligibility Standards
  • Duplicate Discounts and Medicaid MCOs
  • Covered Outpatient Drug Definition
  • GPO Prohibition Guidance
  • Contract Pharmacy Registration and Oversight Requirements
  • 340B Compliance Requirements
  • Manufacturer Changes of Note
  • What Was Missing From the Omnibus Guidance

The Path Forward for the Omnibus Guidance

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Why Lorman?

Over 33 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

OnDemand Course

This course was last revised on March 3, 2016.

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 33 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 P. Church

Richard P. Church

K&L Gates

  • Health care partner at K&L Gates, whose health care practice is ranked in the Top 20 nationally by Modern Healthcare
  • Listed in Band 1 in Chambers USA 2014 and 2015 for health care, North Carolina
  • Recent articles include: “340B Program Omnibus Guidance: Mega-Changes on the Horizon?”, American Health Lawyers Association Rap Sheet Article, November 2015; “340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B Orphan Drug Rules”, October 2015; “HRSA Issues 340B Program Omnibus Guidance”, September 2015; “Preparing for Successful Medicare Shared Savings Program Enrollment”, AHLA Connections Magazine, July 2015, and “340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities”, June 2015
  • Recent presentations include: “340B Program Omnibus Guidance”, webinar presented to the North Carolina Society for Health Care Attorneys, October 2015; “340B Compliance in a Fast-Changing and Heightened Regulatory Environment”, webinar presented to Healthcare Financial Management Association, May 2015
  • Recent representative work include representation of hospitals and health systems with respect to OPA audits and manufacturer enquiries; development of comments on HRSA’s 340B Program Omnibus Guidance for a leading academic medical center, contract pharmacy provider, and other safety net providers; execution of a complete review and overhaul of academic medical center’s 340B Program operations and policies; facilitation of the transfer of a 340B covered entity’s Ryan White grant to ensure a seamless transition in care for the entity’s patients and enrollment in the 340B Program; representation of a mail order contract pharmacy in operational and compliance matters, assisting on issues ranging from day-to-day compliance to strategic discussions on 340B policies and procedures
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Product ID: 397276
Published 2016
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