PATIENT SERVICES, INC. “Overcoming New Challenges to Patient Assistance” Presentation to RDLA Thursday, October 16, 2014 Background Leading to May 21, 2014 Special Advisory Bulletin (OIG) • One NPO exceeded the OIG guidelines • Barron’s Oct 18, 2013/ Oct 22, 2013 Seeking Alpha publications • Single Rx program increased donors quarterly cash dividends by 20%. Acthar for MS • Created alleged fraud and abuse • Report reached Dept. of Justice, DOJ inquired of OIG who granted opinion Compliance is a High Priority (New Office of Inspector General Special Advisory Bulletin, May 21, 2014) 1. Disease Funds will… a. Be legitimately defined in accordance with “widely recognized clinical standards” (e.g. FDA, CMS???) b. Be defined “in a manner that covers within each fund a broad spectrum of products wherever possible including generics”. c. “Not be defined by reference of specific symptoms, severity of symptoms, method of administration, stages of particular disease, type of drug treatment, or any other way of narrowing” d. Not be defined as “high cost or specialty drug funds” and must consider other financial variables beyond income (e.g. costs of living, debt) Compliance is a High Priority (New Office of Inspector General Special Advisory Bulletin, May 21, 2014) 2. No single-drug funds… a. Providing copayment for only one drug or only one manufacturer. b. Unless fund is legitimately defined, includes combining two or more related disease funds, covers any drugs needed by patient, covers all copayments for items and services needed by patients and is submitted for consideration to OIG on a case by case basis. Compliance is a High Priority (New Office of Inspector General Special Advisory Bulletin, May 21, 2014) 3. 4. Diluting Funds May Be Acceptable… a. According to legal counsel discussions with OIG, OIG may consider single drug funds if they are “diluted”. (1). Dilution means: Premium , Copayment, Travel Expenses, and Ancillary Expenses (Nursing, labs, diagnostic test, physician copays, infusion costs, etc.) Reporting must be OIG compliant and not correlate donation amount with patient usage Consequences to Manufacturers and Patients Manufacturers • Add more drugs to the “fund” including generics –supporting other drugs • Add premium assistance if a “copayment” program • Provide “copayment” assistance for only private patients • If single donor program; dilute with copay, premium, travel expense, ancillary services Patients • No access to rare and orphan drugs • Barrier to assistance: adverse health; life/death • Most vulnerable populations (Medicare beneficiaries); establishes a class medical society PSI Legislative Response • Develop partnership with patient communities • Developed bipartisan letter Congress – Working with Caucus Co-Chair Leonard Lance & Congresswoman Matsui to anchor letter • Met with Congressional Offices regarding issue including House Majority Whip, Steve Scaliece (R-LA) What Can Your Organization Do to Help? • Sign Organizational Support Letter to Congressman Leonard Lance (R-NJ). • Work with PSI to activate patient advocates to send letters to Members of Congress.