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  • videocam On-Demand
  • card_travel Health
  • schedule 90 minutes

Charitable Patient Assistance Programs: Ensuring Compliance

Establishing and Maintaining Arrangements With PAPs, Monitoring and Auditing PAPs

$297.00

This course is $0 with these passes:

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Description

PAPs provide financial assistance to patients using free products and copayment assistance through programs run by drug manufacturers and independent charities that assist with copays and other out-of-pocket costs. With rising drug prices, many patients rely on PAPs to afford necessary medications.

Over the past two decades, contributions to PAP programs from the pharmaceutical industry have skyrocketed from $376 million to over $6 billion. In the recent past, a growing number of governmental investigations and settlements have raised questions about pharmaceutical companies' practice of donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients.

In September 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion, declining to approve a pharmaceutical manufacturer's proposal to provide cost-sharing assistance directly to Medicare beneficiaries who are prescribed the manufacturer's drugs.

Listen as our authoritative panel of healthcare attorneys examines the legal issues surrounding PAPs. The panel will discuss establishing and maintaining arrangements with PAPs. The panel will discuss traditional government concerns, including fraud and abuse, and OIG guidance, as well as compliance considerations and potential risks. The panel will offer best practices for structuring a PAP and compliance, including monitoring and auditing PAPs.

Presented By

Alison Fethke
Counsel
Ropes & Gray

Ms. Fethke provides regulatory advice on a wide range of issues, including healthcare and FDA regulatory matters and compliance program development and support. She regularly advises medical device and pharmaceutical companies on legal issues related to sales, marketing, medical and research activities, including federal and state laws and industry codes regulating manufacturer interactions with providers, payors and patients. In addition, Ms. Fethke provides advice with respect to FDA requirements related to the testing, sales and promotion of prescription drugs and medical devices. She works with healthcare institutions and life sciences companies to implement and enhance comprehensive compliance programs both domestically and globally, including structural design, operational support, and external assessments of program effectiveness.

William T. Mathias
Bass Berry & Sims Plc

Mr. Mathias represents clients across the U.S. in all areas of the health care industry, with a particular emphasis on fraud and abuse, internal and government investigations, and corporate compliance matters. His practice focuses on advising clients on compliance with the federal antikickback law, the Stark physician self-referral statute and the federal civil monetary penalty provisions. He also advises health systems and GPOs on compliance with the discount and GPO safe harbors as well as strategies for reducing legal risks associated with cutting edge supply chain management and purchasing programs. He is a former vice chair of the American Health Lawyers Association’s Fraud & Abuse Practice Group.

William Mathias
Shareholder
Baker, Donelson, Bearman, Caldwell & Berkowitz PC
Jennifer E. Michael
Miscellaneous

Ms. Michael’s practice focuses on fraud and abuse and federal and state regulatory compliance. Before joining the firm, Ms. Michael served as Chief of the Industry Guidance Branch at the U.S. Department of Health & Human Services, Office of Counsel to the Inspector General. In that role, she led a team of attorneys responsible for interpreting and applying federal fraud and abuse statutes to a wide variety of arrangements across all segments of the health care industry. Under her leadership, the Industry Guidance Branch issued dozens of advisory opinions, the first-ever rescission of an advisory opinion, Special Fraud Alerts, policy statements, and various other guidance documents. In addition, Ms. Michael supervised rulemakings involving the federal anti-kickback statute and the federal civil monetary penalty law prohibiting inducements to beneficiaries. Her duties also included advising the Chief Counsel and other senior leaders at the Office of Inspector General (OIG) regarding the application of federal fraud and abuse laws to healthcare arrangements. As the leading source of knowledge on federal fraud and abuse statutes, she provided and supervised technical assistance to government officials at the Department of Justice (DOJ), the Centers for Medicare & Medicaid Services, and other state and federal agencies.

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


  • Live Online


    On Demand

Date + Time

  • event

    Tuesday, February 2, 2021

  • schedule

    1:00 p.m. ET./10:00 a.m. PT

  1. Arrangements with PAPs
  2. Governmental concerns
  3. OIG guidance
  4. Best practices for structuring a PAP
    1. Compliance
    2. Auditing
    3. Monitoring

The panel will review these and other relevant issues:

  • What key considerations should manufacturers keep in mind when establishing sponsored PAPs?
  • What are the potential risks of donations to independent PAPs?
  • What lessons can be learned from recent OIG guidance and settlements?