8:15 am
Richard H. Williams
Richard H. Williams, R.Ph
Senior Vice President
CSI Specialty Group

8:45 am

Health care stakeholders are in the midst of radical change, with a shift to value-based care and an increase in stakeholder consolidations and acquisitions. Larger commercial entities continue to form with the increased acquisitions of specialty pharmacies and hub service providers by PBMs, health plans, and wholesalers. In this session, explore specialty pharmacy and distribution trends reshaping the industry. As part of this cross-stakeholder discussion, explore how each stakeholder views the current landscape and uncover strategies to work together to improve the patient journey.

  • Examine payers’ growing influence on patient support services and network designs
  • Explore opportunities to advance cross-stakeholder collaborations to deliver better patient care
  • Explore innovative distribution models to design an effective channel strategy

Moderator:

Snehal Patel
Snehal Patel, PharmD
Vice President, Pharmacy & Access Solutions
Asembia

Panelists:

Jeff Henderson
Jeff Henderson
Vice President, Head of Market Access and Government Affairs
Sobi

Rob Osborne
Rob Osborne
Vice President, Pharma Business Development & Contracting
Express Scripts, Accredo, CuraScript SD

Stephen Perkins
Stephen Perkins, MD
Chief Medical Officer, Commercial and Medicare Services
UPMC Health Plan

9:30 am

Recent anti-kickback investigations of several drug companies include a focus on their patient assistance programs, co-payment cards, drug pricing, and charitable donations. As a result, teams are reviewing compliance guidelines, processes throughout the product lifecycle, and overall strategy of their programs to safeguard against potential risks. Hear from senior legal and compliance officers on how to appropriately structure your patient service compliance program and internal operations to provide patient support.

  • Enhance cross-functional compliance integration to ensure product launch success
  • Examine all aspects of a patient service program to mitigate risk and ensure compliance
  • Customize patient support service compliance strategies for rare and orphan disease populations

Moderator:

L. Stephan Vincze
L. Stephan Vincze, JD, LLM, MBA
President and Chief Executive Officer
Trestle Compliance

Panelists:

Matthew Holley
Matthew Holley
General Counsel
Pharming Healthcare Inc.

Jennifer McGee
Jennifer McGee
Vice President, Chief Compliance Officer
Otsuka

Chris Primiano
Chris Primiano
Executive Vice President, Chief Business Officer, General Counsel
Karyopharm Therapeutics

10:45 am

It is imperative to understand the patient experience in order to leverage a patient-centric approach within patient support service design and channel operations. Hear firsthand experiences patients’ with specialty therapy management, specialty pharmacy visits, encounters with patient support services and access assistance, as well as key concerns regarding data sharing and compliance.

  • Explore best practices when implementing patient support services that enhance the patient experience with education, adherence, and access
  • Identify a successful channel strategy that optimizes the patient experience and ensures access to therapies in a timely manner
  • Examine key concerns around data sharing to ensure patient services compliance and mitigate internal risk
  • Discover how patients are using digital to engage with patient groups, pharmaceutical organizations, and pharmacies to enhance services

Moderator:

Paul N. Urick
Paul N. Urick, R.Ph.
Chief Executive Officer
URx, LLC

Panelists:
Taren Grom
Taren Grom
Co-Founder, Editor
PharmaVOICE

Carol Kivler
Carol Kivler, MS, CSP, CMT
Mental Health Speaker, Author, Advocate

John Linnell
John Linnell
COPD Patient and Patient
Advocate

11:30 am

Plan sponsors have shifted pharmacy benefit designs to implement more co-pay accumulators and maximizers. The challenges that arise include high out-of-pocket costs for patients, high list prices for specialized therapies, and hidden rebates retained by plan sponsors. How can manufacturers limit the use of accumulators and maximizers and ensure patients with serious conditions receive the medications they need at an affordable cost? Implement key channel strategies to ensure patient access to specialty therapies.

  • Analyze the current landscape of co-pay accumulator and maximizer models
  • Examine the gross-to-net impact of accumulators
  • Discuss current patient access challenges and consequences of cost-shifting pharmacy benefits
  • Discuss state and legal challenges to accumulator programs
  • Gain insight into the future of co-pay accumulators and maximizers
Matt Turner
Matt Turner
Vice President, Business Development
Paysign

Stella K. Vnook
Stella K. Vnook
Chief Executive Officer
Diverse Biotech

12:15 pm
1:30 pm
John C. Richter
John C. Richter
Partner Special Matters and Government Investigations
King and Spalding

1:45 pm

In recent years, the Office of Inspector General has rescinded advisory opinions and the Department of Justice has publically issued subpoenas on misuse of patient assistance programs, resulting in several settlements with top pharmaceutical companies. In order to prepare for 2019 and beyond, manufacturers must understand the evolving enforcement priorities for the DOJ and examine top risk areas related to patient assistance programs.

  • Gain insight into factors to consider within a patient support service risk assessment to develop frameworks and controls to mitigate risk
  • Discuss top trends in enforcement and learnings from recent settlements
  • Develop insight into operational safeguards around co-pay assistance operations
Michael S. Macko
Michael S. Macko
Assistant U.S. Attorney
United States Attorney's Office For the Eastern District of Pennsylvania, DOJ

John C. Richter
John C. Richter
Partner Special Matters and Government Investigations
King and Spalding

2:30 pm

The pharmaceutical industry continues to see tremendous government and whistleblower interest around patient support programs. The uncertainty created by lengthy ongoing investigations and whistleblower lawsuits, as well as settlements often lacking in specificity and clarity, are why it is imperative that pharmaceutical executives, in-house counsel, and compliance officers understand the evolving regulatory and enforcement landscape for patient support services and hub design. Gain insight into key risk areas relating to patient support services.

  • Explore risk areas in patient services and access assistance
  • Examine manufacturers interactions with patients to ensure compliance and mitigate risk
  • Ensure hub designs and patient services are developed in compliance with PAP regulations
Terry Milton
Terry Milton, JD
Director, Ethics and Compliance
Lilly USA, LLC

Kelly Pitt
Kelly Pitt
Director, Legal and Compliance
Sobi North America

Desiree Priestley
Desiree Priestley
Director, Patient Support, Strategy and Insights
Otsuka

3:45 pm

Violations of the Anti-Kickback Statute and price reporting regulations have led the OIG to release special advisory bulletins for donations to charitable foundations. With increased scrutiny around the financial relationships between non-profits, manufacturers, and hubs, manufacturers are being advised to increase transparency efforts and limit the amount of communication between these stakeholder groups. During this session, examine the risk areas around charitable assistance programs and measures to mitigate risk.

  • Ensure compliance with the Anti-Kickback Statute and accurate price reporting regulations
  • Maintain accurate documentation of interactions with non-profit organizations and hub providers
  • Develop safeguards around co-pay assistance and co-pay cards within charitable donations
Ayesha Azam
Ayesha Azam, MSHIA
Senior Director of Medical Affairs
PAN Foundation

Richard Liner
Richard Liner
Senior Compliance Counsel
Bayer

4:30 pm

Manufacturers turn to third party vendors to develop compliant patient support programs and deliver these programs on behalf of manufacturers. To ensure compliant program delivery, manufactuers must identify third party vendors that meet commercial and compliance goals, and support patient access to better serve patient populations.

  • Examine requirements for selecting a hub partner and ensuring data privacy
  • Construct a program needs assessment to identify a suitable third party provider that meets program objectives
  • Ensure compliance with third party vendors through examining risk mitigation strategies that should be put in place for both internal and external patient support and access teams
  • Define evaluation standards and performance measures within contract agreements
  • Audit your vendor relationship to ensure your hub partner is meeting compliance measures
Kevin Espinoza
Kevin Espinoza
SVP Corporate Compliance & Privacy Officer
BTG International Inc.

Jennifer McGee
Jennifer McGee
Vice President, Chief Compliance Officer
Otsuka

Pam Politis
Pam Politis
Executive Director, US Legal
Incyte Corporation