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340B Program: What Covered Entities Must Know

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

The past few years have been an unusually tumultuous time in the 340B Program. This topic will outline the main challenges and opportunities for 340B Program stakeholders. The presenters will underline the practical steps that 340B Program stakeholders can take to ensure compliance and optimize 340B Program participation during the current shifting state of the 340B Program.

60 minutes
Course Exam
Certificate of Completion
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Why Lorman?

Over 37 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

340B Program Background

  • General Refresher on the 340B Program and Program History
  • A High-Level Overview of Main 340B Program Requirements and Regulations
  • Eligible Patient Definition Discussion

Recent Program Updates (Litigation)

  • Update on the Current State of Manufacturer Restrictions and Appellate Court Review of Ongoing Litigation
  • Update on Genesis Case and Impact on Eligible Patient Definition
  • Potential Impact on Loper Supreme Court Case on 340B Program

Recent Program Updates (Legislative)

  • Update on State-Level Contract Pharmacy Protection Laws
  • Update on State-Level Pbm 340B Anti-Discrimination Laws
  • Update on State and Federal 340B Transparency Initiatives

340B Optimization Strategies

  • Alternative Distribution Models for Contract Pharmacy Arrangements
  • Medication Therapy Management Clinics
  • Referral Prescription Capture
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Why Lorman?

Over 37 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

Applications have not yet been submitted for Delaware, Idaho, Kentucky, Maine, Ohio, Oklahoma, South Carolina, and Wyoming CLE for this course. However, if you are interested in obtaining CLE for any of the listed states or have any additional credit questions please email us at [email protected] or call us at 866-352-9540.

This course was last revised on April 18, 2024.

Call 1-866-352-9540 for further credit information.

  • AHIMA 1.0 including Health Law and Compliance 1
     
  • This program has been approved for 1.0 continuing education units for use in fulfilling the continuing education requirements of the American Health Information Management Association (AHIMA). Granting prior approval from AHIMA does not constitute endorsement of the program content or its program sponsor.
     
  • AR CLE 1.0
     
  • This course has been approved for 1.0 hours of CLE by the Arkansas CLE Board.
     
  • Arizona CLE 1.0
     
  • The Arizona State Bar does not pre-approve or pre-certify MCLE programs. However, records of this program and attendance will be maintained by Lorman Education Services for auditing purposes. This activity may qualify for up to 1.0 hours toward your annual CLE requirement for the State Bar of Arizona.
     
  • CA MCLE 1.0
     
  • Lorman Education Services is a State Bar of California approved MCLE sponsor and this course qualifies for 1.0 CLE hours of participatory credit.
     
  • GA CLE 1.0
     
  • This program has been approved by the Georgia Commission on Continuing Lawyer Competency for 1.0 CLE hours.
     
  • HI CLE 1.0
     
  • This program was approved by the Hawaii State Board of Continuing Legal Education for 1.0 CLE credit hours.
     
  • MO CLE 1.2
     
  • This course qualifies for self-study CLE credit in Missouri.
     
  • NH MCLE 1.0
     
  • NH MCLE does not approve or accredit CLE activities for the NH Minimum CLE requirement. Lorman Education Services believes this Ondemand course meets the requirement of NH Supreme Court Rule 53 and may qualify for CLE credit(s). Program Length: 59 Minutes.
     
  • NJ CLE 1.2
     
  • This program has been approved by the Board on Continuing Legal Education of the Supreme Court of New Jersey for 1.2 hours of total CLE credit.
     
  • NY CLE 1.0 including Areas of Professional Practice 1
     
  • This course has been approved in accordance with the requirements of the New York Continuing Legal Education Board for up to a maximum of 1.0 credit hours in the area(s) of Areas of Professional Practice for 1.00 hour. Each hour may be counted only as satisfying one category of credit. Duplicate credit for the same hour of instruction is not permitted. This course qualifies for both established and newly admitted attorneys. Lorman Education- Noggin Guru, Inc. has a financial hardship guideline. Please contact customer service at 1.866.352.9539 for instructions on how to apply.
     
  • PA CLE 1.0
     
  • This Distance Learning program has been approved by the Pennsylvania Continuing Legal Education Board for 1.0 hours of substantive law, practice and procedure CLE credit.
     
  • RI CLE 1.0
     
  • This program has been approved by the Rhode Island Mandatory Continuing Legal Education Commission for 1.0 hours of CLE credit.
     
  • VT CLE 1.0
     
  • This self-study program has been approved by the Mandatory Continuing Legal Education Board of Vermont for 1.0 hour(s) of CLE credit. Please note: Attorneys may only claim 12 credits per compliance period in this format. This course is considered "Non-Moderated Programming without Interactivity".
     
  • WI CLE 1.0
     
  • This program qualifies for 1.0 hour(s) of ondemand CLE through the WI Board of Bar Examiners.
     
  • WV MCLE 1.2
     
  • This program has been approved by the West Virginia State Bar MCLE Commission for 1.2 MCLE hours.
     
The CLE Code is ONLY a requirement when applying for CLE Credit in New York. Other states do not need to supply the CLE Code to apply for CLE credit.

To earn each credit Lorman offers through the OnDemand learning platform, you need to watch 100% of the program. Also, for certain credits you will need to fulfill additional requirements which will be displayed on the "credits" tab when viewing the course.

This program does NOT qualify, nor meet the National Standard for NASBA accreditation.

MP3 Download

  • Arizona CLE 1.0
     
  • CA MCLE 1.0
     
  • HI CLE 1.0
     
  • NJ CLE 1.2
     
  • NM CLE 1.0
     
  • NY CLE 1.0 including Areas of Professional Practice 1
     
  • VT CLE 1.0
     
  • WV MCLE 1.2
     
The CLE Code is ONLY a requirement when applying for CLE Credit in California (for participatory credit), Kansas, New Jersey or New York. Other states do not need to supply the CLE Code to apply for CLE credit.

This program does NOT qualify, nor meet the National Standard for NASBA accreditation.

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Why Lorman?

Over 37 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 Davis, J.D.

Richard Davis, J.D.

Quarles & Brady LLP

  • Partner at Quarles & Brady LLP
  • Assists in implementing and enhancing 340B drug pricing programs across a wide variety of health systems, enabling the health systems to obtain millions of dollars in savings
  • Provides ongoing compliance and operational support to 340B participating entities
  • Successfully disputes and mitigates HRSA OPA audit findings, enabling these entities to retain their 340B savings in addition to contracting with various national retail pharmacy chains and 340B program software vendors
  • Draft memoranda interpreting and analyzing HRSA OPA 340B program guidance based on relevant Medicare and Medicaid statutory and regulatory language
  • Assists covered entities and contract pharmacies in navigating recent manufacturer disputes
  • J.D. degree, with honors, University of Wisconsin Law School; B.A. degree in international affairs, George Washington University
Michael French, J.D.

Michael French, J.D.

Quarles & Brady LLP

  • Attorney at Quarles & Brady LLP
  • Assists with successfully navigating 340B HRSA audits, including data request submissions, support during the on-site portion of an audit, and drafting corrective action plans and/or Notice of Disagreements to mitigate the impact of findings
  • Conducts client-facing 340B pharmacy operational assessments to assess compliance and identify opportunities to maximize available 340B savings
  • Provides advice and counsel on strategies for avoiding 340B diversion and Medicaid duplicate discounts, including best practices for meeting associated federal and State-level billing requirements
  • Draft 340B contract pharmacy services agreements to maintain compliance with associated 340B regulations and ensure operational efficiencies for all parties involved
  • Assists covered entities and contract pharmacies with Third-Party Administrator (TPA) implementation, best strategies for configuration set-up, and maintenance of software settings to ensure compliance
  • J.D. degree, magna cum laude, Loyola University Chicago School of Law; B.A. degree, University of Notre Dame
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Why Lorman?

Over 37 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.

All of your training, right here at Lorman

All of your training, right here at Lorman.

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Product ID: 411220
Published 2024
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