BarbriSFCourseDetails
  1. keyboard_arrow_leftBack
BarbriPdBannerMessage

Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

  • work Practice Area

    Health

Date & Time
  • event Date

    Tuesday, March 19, 2019

  • schedule Time

    1:00 PM E.T.

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.


  • Live Online


    On Demand

$297.00

This course is $0 with these passes:

CLE
ALL

This CLE course will guide healthcare counsel on the changes to Anti-Kickback Statute (AKS) safe harbors. The panel will examine the removal of protection for rebates to pharmacy benefit managers (PBMs) and the new safe harbors for point-of-sale discounts and service fees. The panel will discuss how stakeholders in the healthcare industry can take advantage of the changes and ensure compliance.

Faculty

Clinton Mikel
The Health Law Partners, PC
Charles B. Oppenheim
Partner
Hooper, Lundy & Bookman PC

Mr. Oppenheim’s practice includes all aspects of transactional, operational and regulatory healthcare law, including mergers & acquisitions, affiliations, joint ventures and the formation of integrated delivery systems. Among his clients are many of the largest healthcare companies and hospital systems in the U.S. A nationally-recognized expert on anti-kickback and Stark Law issues, Mr. Oppenheim wrote the 2014 American Health Lawyers Association Monograph on Stark. He has served as an expert on anti-kickback and Stark Law issues in arbitration and litigation, in both civil and criminal proceedings. In addition, he creates and implements compliance programs, investigates compliance issues, responds to government enforcement actions, and negotiates settlements for many types of healthcare providers.

expand_circle_down Expand to View Full Bio expand_circle_up Collapse Bio
Jill Wright
Special Counsel
Foley & Lardner LLP

Description

The U.S. Department of Health and Human Services (HHS) and the Office of Inspector General (OIG) issued proposed regulations that amend the safe harbor provisions under the federal Anti-Kickback Statute (AKS) to exclude pharmaceutical manufacturer discounts to PBMs and Medicare Part D and Medicaid managed care plans from safe harbor protection.

Such rebates to health plan sponsors and PBMs have been a central piece in drug distribution and reimbursement in the U.S. These changes could dramatically impact consumers and supply chain stakeholders.

The amendments also create new safe harbor provisions for point-of-sale discounts on prescription drugs as well as PBM service fees. The point-of-sale-discounts safe harbor requires the discount to be set in advance and applied at the point of sale. A rebate may be involved only if the discount is given to the pharmacy through a chargeback.

OIG is requesting and accepting public comments until Apr. 8, 2019. The proposed rule would go into effect on Jan. 1, 2020.

Listen as our authoritative panel examines the proposed amendments to AKS safe harbor protection. The panel will explore the removal of protection for rebates to PBMs and health plans and the new safe harbors for point-of-sale discounts and service fees. The panel will discuss how those in the healthcare industry will be impacted and can take advantage of the changes and ensure compliance.

Outline

  1. Overview and background of proposed rulemaking
  2. Removal of safe harbor protections for PBM and health plan rebates
  3. New safe harbors
    1. Point-of-sale discounts
    2. PBM service fees
  4. Impact of the changes
  5. What stakeholders in the healthcare industry and counsel need to do

Benefits

The panel will review these and other key issues:

  • What is the impact of the changes on drug distribution and reimbursement?
  • What is the scope of application of the proposed changes?
  • What must stakeholders in the healthcare industry do to ensure compliance with the safe harbor changes?