Modernize Patient Assistance Programs 
Agenda Day Two
Friday, September 19th, 2008
| 8:00 | Morning Coffee |
| 8:30 | Chair’s Recap of Day One |
| 8:45 | CASE STUDY: Identify Strategies That Biotech Manufacturers are Taking to Get Patients Access To Their High Cost Products Given that the burden on patients is increasing, as demonstrated by higher co-pays and cost-sharing, and more high-cost therapies are now available in the marketplace, what are these manufacturers doing to ensure patient's have access to these new and innovative therapies? • Sharing the positive experience of donating to independent non-profit organizations, who provide co-pay assistance • Patient Assistance Program enhancements addressing reimbursement challenges and benefit design changes over time • Challenging the industry to improve the customer experience Renee Shiota, Associate Director, Patient Assistance Programs, GENENTECH |
| 9:30 | CASE STUDY: Providing Patient Assistance To Supply Specialty Products To People with Rare Diseases Drugs and biologics developed for low-incidence disease populations are mainly found in the specialty product arena. It is a given that orphan products and especially “ultra orphans” will be costly. Both uninsured and under-insured populations have come to rely heavily on knowing that there are safety nets in place to allow access to these critical therapies. Several charities and foundations exist primarily to serve as a lifeline that connects the patients to the providers. This role is becoming even more crucial as more and more specialty products are approved. What role do charities and foundations find themselves in today that is different from the past? • Identify the forces that require constant monitoring by involved charities and foundations. • Hear about new collaborative efforts of some charities and foundations to address the challenges. Maria Hardin, Vice President of Patient Services, NATIONAL ASSOCIATION FOR RARE DISEASES, Inc. (NORD) |
| 10:00 | PANEL DISCUSSION: Innovative Specialty and Biotech PAP Strategies Panelists: Renee Shiota, Manager, Patient Assistance Programs, GENENTECH Beth Barrientos, RN, MS, Director, Case Management, ALEXION PHARMACEUTICALS Fran Olsen, Director of Commercial Operations, QUESTCOR (invited) Maria Hardin, Vice President of Patient Services, NATIONAL ASSOCIATION FOR RARE DISEASES, Inc. (NORD) |
| 10:30 | 30 Minute Networking & Refreshment Break |
| 11:00 | THREE-PART CASE STUDY: Implementing Technology Advances Into Your PAP for Faster Enrollment and Improved Patient Care Part I: Automating the Patient Assistance Program (PAP) Application Process Patient care facilities nationwide are completing Patient Assistance Program (PAP) applications in record time, improving patient care, and getting help with administrative and fundraising challenges - all thanks to the remarkable processing and reporting capabilities of computer software. • Introduce RxAssist Plus and its Electronic Medical Records capabilities • Automatically complete PAP applications • Consider the significance of operational reports on day-to-day routines • Produce reports that highlight your organization’s worth to the community Norman H. G. Moore, Jr., Business Administration, RxAssist Plus Program Manager, SYSTEMETRICS, INC. Part II: Explore How Automating the PAP Application Process Can Serve as a Tool For Unlocking Patient Demographics • Uncover how implementing and integrating a PAP automated application process enhances our ability as healthcare providers to steer our patients toward the path to better, more effective disease management. • Describe how utilizing a PAP can augment the care delivered to Adult Primary Care and Diabetic Resource Center patients ability. • Provide an accurate representation of patients who use the Pharmacy Assistance Program, using the software demographic and economic statistical reporting function. • Present an overview of actual costs for patients to purchase medications had there no PAP in place. • Offer recommendations on how to incorporate a PAP into a clinic site, highlighting features that are especially helpful. Kathy Monteith, R.N., CDE, CDOE, Diabetes Resource Center, ST. JOSEPH HEALTH SERVICES OF RHODE ISLAND Catherine Cabral, Chronic Disease Assistance Specialist, ST. JOSEPH HEALTH SERVICES OF RHODE ISLAND Part III: Evaluate the Impact of the Patient Assistance Liaison (PAL) Program on Insured vs. Uninsured Diabetics Part III evaluates the impact of the PAL Program on individualized diabetes management by looking at patient health markers such as weight, blood pressure, hemoglobin A1c, and lipid profiles. This comparative analysis approach illustrates how the health status of these two cohorts statistically parallel baseline values. We present conclusions based on the results obtained from our study, and answer the essential question of whether or not the enrollment into the PAL Program is associated with a significantly better clinical impact on the disease management of our diabetic patients. We also look at the question of whether or not having health insurance affects the delivery of health care at the Diabetes Resource Center. • Describe the process by which patients from the two groups were selected for our study. • Explain the method by which clinical data were gathered to compare the health status of patients who are enrolled into the PAL Program versus those who are not enrolled. • Aggregate the data and provide an analysis of the health statistics of both patient groups using baseline values as a guideline. • Discuss the results obtained and offer conclusions regarding the PAL Program based on these results. Ronalyn Julian, Diabetes Resource Center, ST. JOSEPH HEALTH SERVICES OF RHODE ISLAND Edward (Ted) Doyle, Pharm.D. Candidate, Diabetes Resource Center, UNIVERSITY OF RHODE ISLAND |
| 12:15 | Update on Universal Application Form for Patient Assistance Programs Christian Clymer, Senior Director, Affordability & Access, Partnership for Prescription Assistance, PhRMA |
| 12:45 | Luncheon |
| 1:45 | Legal Considerations in Developing Patient Assistance Programs • Understand how the Federal Anti-Kickback Statute and the Beneficiary Inducement Statute potentially relate to PAPs • Understand key PAP risk areas the OIG has identified • Understand how a PAP’s structure could impact Federal price reporting • Understand the rules around PAPs assisting Medicare Part D patients Perry Elizabeth Knight, JD, MHA, Attorney, SIDLEY AUSTIN |
| 2:30 | CASE STUDY: Removing Obstacles – How a Small Nonprofit & a Big OIG Opinion Helped Patients in Need In its first advisory opinion of 2008, the OIG approved an arrangement involving the participation of Federally Qualified Health Centers (FQHCs) and free clinics in Rx Partnership’s innovative and successful bulk replacement patient assistance program model. This opinion represents the first time that the OIG has specifically ruled on the application of the anti-kickback statute to bulk replacement PAPs. Within just two months, this OIG Opinion was the catalyst for policy change with one of Rx Partnership’s pharmaceutical partners resulting in free product being provided to more eligible patients in need. The Opinion is expected to have positive implications for other patient assistance programs. • Understand how a request for an OIG Opinion is prepared • Learn about the key concerns of the OIG that were successfully addressed • Empower other organizations to remove barriers to program success Mark Fitzgerald, Principal, POWERS, PYLES, SUTTER & VERVILLE, P.C. Amy Yarcich, Executive Director, RX PARTNERSHIP |
| 3:15 | Conference Concludes. Safe Travels Home! See You Next Year! |
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