In the Know

The HRSA Proposed 340B Pricing Program Omnibus Guidance: Best Compliance Practices Your Firm Should Know
AGG Seminars & Webinars
June 14, 2016
Internet

Arnall Golden Gregory's Healthcare practice would like to invite you to attend a live 2 hour CLE webcast hosted by The Knowledge Group.

The Health Resources and Services Administration (HRSA) in August 2015 issued a notice proposing guidance under the 340B Drug Pricing Program. The proposal is an attempt to clear up confusion about program rules and eliminate ambiguity in the marketplace for all 340B Program stakeholders. Although the proposed guidance is intended to clarify HRSA’s existing policy interpretations, a significant practical effect is to change the standard for 340B patient eligibility. It would also restrict the number of physicians who could write 340B-eligible prescriptions.

The program allows certain participating covered entities and other health care providers to obtain discounted prices on outpatient prescription drugs. These entities are required to prove compliance with 340B program requirements overseen by the HRSA within the Department of Health and Human Services (HHS), and are subject to audit. The “mega” guidance could have significant impact on plans and operations, once the final guidance is ultimately published.

AGG Partner Neil W. Hoffman, Ph.D. will participate in a panel discussion that will provide healthcare practitioners and professionals with an in-depth review of HRSA’s 340B Drug Pricing Program Omnibus Guidance. The panel will also help analyze the possible effects and challenges of the Guidance and will offer a roadmap on how to prepare and what needs to be done in order to ensure compliance.

Key Topics Include:

  • Proposed 340B Drug Program Guidance
  • Covered Entity Eligibility and Registration
  • Program Requirements
  • Contract Pharmacy Requirements
  • Manufacturer Responsibilities
  • Patient Definition
  • Scope of Eligible Drugs
  • 340B Prime Vendor Program
  • Medicaid Managed Care and Duplicate Discounts
  • Auditable Records and Audits
  • Who Will Be Impacted and How
  • Best Compliance Practices

Event Speakers:

  • Neil W. Hoffman, Ph.D. - Partner, Arnall Golden Gregory LLP
  • John A. Mills - Partner, Nelson Hardiman, LLP
  • Christine M. Morse - Principal, Ober | Kaler

Registration Details:

  • Arnall Golden Gregory LLP is offering complimentary passes for the first 30 registrants. Once these passes are allocated, attendees can register for the deeply discounted rate of $25 each.
  • CLE/CPE/CE credit requires a minimal Certificate of Attendance processing fee of $49 per participant (normally paid by the attendee) if credit is needed to apply to the bar.
  • Full registration options may be found here.