The Sunshine Act: Where it stands, where it s going and compliance implementation PRESENTED BY: Stacey A. Filice Jazz Pharmaceuticals
Disclaimer slide The views expressed in this presentation are my own based on my personal experience and do not necessarily represent the views of Jazz Pharmaceuticals or its employees. This presentation is solely intended for educational purposes and provides only a general description of upcoming Sunshine Act reporting requirements and various state gift reporting laws. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation nor anything I discuss in Q&A constitutes legal advice, and you should not rely legally on any information that I provide. I make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use of or reliance on this information. 2
Objectives and Agenda Objectives Briefly outline each state law and the Sunshine Act Small group discussions regarding questions, challenges and best practices Agenda State overview Sunshine Act overview High level comparison of state laws and Sunshine Act Discuss challenges Q&A 3
California - Compliance Program Law Annual spending limit on gifts Company established Per day spending limit No requirement Requirement to adopt Comprehensive Compliance Program consistent with Office of Inspector General (OIG) guidance No reporting required Publicly available declaration of compliance Annually How can you comfortably make this declaration? Drug Sample Reporting - None 4
Connecticut - Code of Conduct & Compliance Program Law Adoption of a Code of Conduct that is consistent with and incorporates the requirements of the PhRMA Code. Companies must also have a comprehensive compliance program consistent with OIG guidance Annual spending limit on gifts None Per day spending limit None No reporting required Drug Sample Reporting None 5
District of Columbia - Marketing Costs Disclosure Annual spending limit on gifts to Healthcare Professionals (HCPs) None Per day spending limit None, but gifts greater than $25 per day are reportable Annual reporting required Drug Sample Reporting None DC Safe RX Licensure requirement 6
Massachusetts - Marketing Code of Conduct Adopt a Code of Conduct in compliance with requirements of 105 C.M.R. 970.000 Annual certification of audit of compliance with 105 C.M.R. 970.000 7
Massachusetts - Payment Disclosure Law & Gift Ban Annual spending limit on gifts to HCPs None Gift Ban Per day spending limit None, but Allowable Expenditures greater than $50 per day are reportable Pre-July 2012 - Annual aggregate reporting of payments to each individual or office and the number of events reflected Post July 2012 waiting for final regs Quarterly reporting Change in Gift Ban Drug Sample Reporting None 8
Minnesota - Gift Prohibition Gift Prohibition Certain payments and gifts totaling over $50 per year per practitioner Annual spending limit on gifts to Practitioners How can you ensure that company-wide spend on a practitioner does not exceed this amount? Per day spending limit None Annual Reporting certain payments (not considered gifts or are non-prohibited gifts) if annual aggregate per practitioner exceeds $100 Drug Sample Reporting None 9
Nevada - Marketing Code of Conduct & Compliance Program Law Adoption of a Marketing Code of Conduct, Compliance training program and compliance officer Annual spending limit on gifts None Per day spending limit None Annual certification of audit for compliance with code of conduct Drug Sample Reporting - None 10
Vermont - Marketing Costs Disclosure Law Gift ban includes any HCP licensed in the state and members of the Green Mountain Care Board Annual spending limit - None Per day spending limit None Annual Reporting Allowable Gift & Expenditures if annual aggregate per practitioner exceeds $100 Drug Sample Reporting drug samples and coupons, vouchers, Point of Sale cards, etc. 11
West Virginia - Advertising Costs Reporting Law Annual spending limit on gifts None Per day spending limit None Annual reporting required Aggregate marketing costs Reportable Expenses over $99.99 Drug Sample Reporting None 12
Patient Protection & Affordable Care Act Two Parts to discuss (1) Federal Prescription Drug Sample Transparency & (2) Federal Physician Payment Sunshine Act Federal Physician Payment Sunshine Act Tracking and reporting transfers of value to physicians and teaching hospitals that either (1) are over $10, or (2) exceed an annual aggregate of $100 per physician or institution Reporting: the name of the covered recipient; the business address of the covered recipient; the amount of the payment or transfer of value; the dates on which the payment or transfer of value was provided to the covered recipient; a description of the form of the payment or transfer of value (e.g., cash, in-kind item, stock, etc.); a description of the nature of the payment or transfer of value (e.g., consulting fees, food, travel, etc.); the name of the product to which the payment relates (if the payment is related to a specific product) Awaiting final regulations from Centers for Medicare and Medicaid Services (CMS) Tracking to begin TBD First reporting due - TBD State law preemption not really 13
Patient Protection & Affordable Care Act, cont d. Federal Prescription Drug Sample Transparency First report due April 1, 2012 grace period until October 1, 2012 to ensure quality reporting submit annual reports to FDA through electronic submissions gateway submit the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under Section 503 of the Prescription Drug Marketing Act aggregated by: the name, address, professional designation, and signature of the practitioner making the request or of any individual who makes or signs for the request on behalf of the practitioner 14
State and Federal Overview Compliance Program and/or Code of Conduct Spending Limits CA X X CT DC X Gi8 Ban Annual Gi8/ Payment / other Repor>ng MA X X X MN X X X NV X X Drug Sample Repor>ng VT X X X WV Federal X X X 15
Challenges in Tracking and Reporting States have different definitions of what is a gift States and Federal have different rules around reporting of honoraria or consulting fees, marketing costs, aggregate costs of employees no consistency Different definitions of HCP and/or who is subject to the reporting requirements Indirect payments who gives you this information? Is it reliable? Is your current process for collection scalable for Sunshine? Internal systems capturing the right information in a meaningful way? 16
Other Challenges Relationships with HCPs Information is posted publicly who is looking? Company growth Organizational changes (ie, mergers, acquisitions) What is the legal structure? How to report for multiple entities? How do you know where all relevant data is? Who can tell you? How to merge multiple systems? 17
Q&A Did any questions come from your group discussions that we can open up to the larger group? 18
Thank you! 19
Wednesday through Friday September 19-21, 2012