THANK YOU FOR JOINING ISMPP U TODAY!

Transcription

1 THANK YOU FOR JOINING ISMPP U TODAY! The program will begin promptly at 10:30am eastern August 14, 2013

2 ISMPP WOULD LIKE TO THANK the following Corporate Platinum Sponsors for their ongoing support of the society 2

3 ISMPP ANNOUNCEMENTS Abstracts for ISMPP s European Meeting (January 21-22, 2014) are now being accepted (at abstracts@ismpp.org); deadline for submission is 5:00 PM EST, Friday, September 27, 2013 This program qualifies for 1.5 credits towards recertification 3

4 THE SUN IS SHINING UPON US: THE SUNSHINE ACT AND MEDICAL PUBLICATIONS August 14, 2013

5 AGENDA ISMPP Member Sunshine Act Survey Results Overview and Impact of the Sunshine Act on Publication Managers ISMPP Sunshine Act Task Force Review of Suggestions Document Industry Perspective on the Sunshine Act Large Pharma Small Pharma Q&A 5

6 INTRODUCTIONS Speaker: Sarah M. Canberg is an associate of Porzio, Bromberg & Newman and a member of the firm s Life Sciences Compliance, Commercialization and Regulatory Counseling Department. She is also a Manager, Regulatory and Compliance Services for the firm's subsidiary, Porzio Life Sciences. Ms. Canberg counsels life sciences companies on a variety of compliance-related issues, including federal and state fraud and abuse laws, FDA promotional regulations, marketing disclosure and aggregate spend matters, industry standards regarding healthcare professional interactions, and sample compliance. Sarah is also a contributor to the Pharmaspective blog, which discusses emerging trends and issues impacting the life sciences industry. A graduate of Sarah Lawrence College (B.A., 2002) and Pace University School of Law (J.D., cum laude, 2006), Sarah is admitted to practice in New Jersey and New York. Speaker: Thomas Malieckal is currently the Director of Business Operations within the Global Medical Publications department at Bristol-Myers Squibb (BMS). He has been with BMS for 8 years in a variety of roles, including overseeing business operations and managing a medical writing team within the Global Medical Publications department, serving as a Neuroscience medical communications lead, and managing the neuroscience medical information team. Prior to joining BMS, Thomas was with Pfizer Inc for 4 years in medical affairs and with Eli Lilly and Company for 1 year in Sales. Thomas has a Doctor of Pharmacy degree from Shenandoah University and a Bachelor of Science in Pharmacy degree from Rutgers University. He is an ISMPP Certified Medical Publication Professional and currently serves as a member of the ISMPP Sunshine Act Taskforce. 6

7 INTRODUCTIONS Speaker: Kim Pepitone is a 20+-year veteran of the medical communications and publications industry. In her role at CACTUS, she is responsible for scientific direction and oversight for medical publications and communications projects. Kim also provides professional training for CACTUS staff worldwide to ensure currency with professional standards and guidelines regarding medical publication practices. Prior to joining CACTUS, Kim was Senior Director, Knowledge Management, at ISMPP. During her 5-year tenure at ISMPP, Kim was responsible for professional education program content provided by ISMPP to its membership. Kim was also integrally involved in the development and launch of the Certified Medical Publication Professional (CMPP) program, and was among the first to be awarded the professional certification. In addition to her position at CACTUS, Kim is the Vice Chair of the ISMPP Sunshine Act Task Force, and an adjunct associate professor at the University of the Sciences in Philadelphia, where she has taught a graduate level course in publication planning. 7

8 INTRODUCTIONS Speaker: Jennifer A. Romanski is counsel at the law firm of Porzio, Bromberg & Newman, PC, and Director of Regulatory and Compliance Services of its wholly-owned subsidiary, Porzio Life Sciences, LLC. Jennifer has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, and training activities necessary for implementation of such programs. She regularly reviews advertising and promotional materials and activities, such as product websites, sales materials, journal reprints, and formulary kits. She counsels on grants and educational programs, publication planning, and proposals for interactions with healthcare practitioners, including speaker programs and advisory boards. She has extensive experience counseling on FDA enforcement activity, and sample accountability and PDMA requirements. She has drafted contracts with co-promotion partners, direct mail companies, medical publication facilitators, and market research organizations. In addition, she regularly counsels clients on compliance with the Sunshine provisions of the Affordable Care Act, state marketing disclosure reporting laws, and compliance with industry standards, including the PhRMA Code on Interactions with Healthcare Professionals and the AdvaMed Code of Ethics for Interactions with Health Care Professionals. A graduate of the University of Pennsylvania (B.A., cum laude, 1994) and University of Pennsylvania Law School (J.D., 1997), Jennifer is admitted to practice in New Jersey and New York. 8

9 INTRODUCTIONS Speaker: Donna Simcoe is the Publications Director at Cadence Pharmaceuticals, Inc. Donna has 18 years of publication experience working previously at Cephalon, Wyeth and AstraZeneca. She holds 3 masters degrees, a MS in BioMedical Writing (Univ Sci Phila), a MS in Biotechnology (Drexel) and a MBA (Wilmington Univ). She is an active member in AMWA, ISMPP and TIPPA, and is chairing the ISMPP U committee this year. Moderator: Kathleen McConnell is Managing Director, SciFluent Communications, Inc. Kathleen s health care experience spans 20 years and includes positions in industry, agency, and clinical settings. Kathleen is an ISMPP Certified Medical Publications Professional and a member of the ISMPP-U committee. She also served as Secretary of the Credentialing Board and Vice Chair of the Standards Working Group. 9

10 DISCLAIMER Information presented reflects the speakers' personal knowledge and opinions and does not necessarily represent those of their current or past employers PLEASE NOTE: This presentation is not intended to offer legal advice regarding the Sunshine Act. For legal advice, please consult your corporate attorney 10

11 PRESENTATION OBJECTIVES At the end of this session, participants should be able to better understand: The impact the Sunshine Act will have on medical publication professionals How the ISMPP Sunshine Act Taskforce is providing guidance on this new mandate What industry is doing to address the Sunshine Act 11

12 ISMPP MEMBER SUNSHINE ACT SURVEY Kathleen McConnell, RPh, MBA, CMPP Managing Director, SciFluent Communications, Inc

13 SUNSHINE ACT TASK FORCE SURVEY: ISMPP MEMBER RE-ASSESSMENT Initial survey Conducted: July 11-23, 2012 Sent to full membership (1030) 186 respondents (18%) Re-assessment Conducted: July 29-Aug 6, 2013 Sent to full membership (1198) 126 respondents (10%) 13

14 SURVEY DESIGN 4 segments Biopharmaceutical Medical device Medical communications/publications agency Other (eg, software, medical writers) Survey questions addressed to specific segments questions (segment dependent) 14

15 RESPONSES BY SEGMENT Initial Survey Re-assessment 5% [7] 3% [4] 50% [95] 40% [77] 50% [64] 43% [54] 5% [7] Biopharm 4% [5] Biopharm Device Device Agency Agency Other Other 15

16 SIZES OF RESPONDENTS COMPANIES 79% 80% 76% 70% 60% 50% 40% 30% 20% 10% 0% 30% 25% 24% 27% 25% 22% 25% 23% Initial Survey Reassessment 16

17 INDUSTRY: COMPANY POLICY +/- PUBLICATIONS Initial Survey (%) Re-assessment (%) Internal policy for reporting physician payment Policy includes publications Author support considered TOV Engage outside vendors to assist in guidance to determine fair market value for professional publications support Informing/considering informing authors that professional MW assistance might be considered a reportable TOV

18 AGENCY: HAVE YOUR CLIENTS DISCUSSED THEIR VIEW ON THE SUNSHINE ACT AND PUBS SUPPORT? Initial Survey Re-assessment 41% 29% 59% 71% Yes No Yes No 18

19 OTHER AGENCY-SPECIFIC QUESTIONS Majority said clients were now discussing with authors and value for medical writing support has been/is being established Many responses indicate variance between clients in how value of publication support is being determined Few asked to assist with setting up system to help with tracking and determining value, but many asked to be involved in reporting process 19

20 TOP CONCERNS (AGGREGATE RESPONSES) Potential for inconsistent and inaccurate valuation Establishing FMV for MW assistance How to account split value across multiple authors How to account for industry authors Negative effect on industry-hcp collaboration Authors declining medical writing support Inconsistent interpretation and application Potential delay in publication of clinical trial results Confusion/application beyond US borders 20

21 THE SUNSHINE ACT: OVERVIEW AND IMPACT ON PUBLICATION MANAGERS Jennifer A. Romanski, Esq. Sarah M. Canberg, Esq. Porzio, Bromberg & Newman, P.C. Porzio Life Sciences

22 WHY ARE WE DOING THIS? Transparency Disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine. The lack of transparency regarding payments made by the pharmaceutical and medical device community to physicians has created a culture that this law should begin to change substantially. The reform represented by the Grassley Kohl Sunshine Law is in patients' best interests. Senator Charles Grassley,co author of the Sunshine Act 22

23 THE PUSH FOR TRANSPARENCY A BRIEF HISTORY Massachusetts Connecticut Minnesota Vermont District of Columbia Maine West Virginia California Nevada District of Columbia (Detailer) West Virginia Vermont Federal Federal Law Enacted State Law Enacted Regulations Adopted Emergency Rule Adopted Law Repealed Maine District of Columbia West Virginia Nevada District of Columbia (Detailer) Massachusetts Maine Federal 23

24 WHY MEDICAL PUBLICATIONS? Research has found that industry-sponsored studies are significantly more likely to reach conclusions favorable to the sponsor than non-industrysponsored studies Research also suggests that bias in industrysponsored drug trials is common and such bias often favors the sponsor s product. Industry sponsorship is associated with publication bias (publishing positive results more frequently than negative results) and withholding. MedPac 2009 Report, Public Reporting of Physicians Financial Relationships 24

25 WHY MEDICAL PUBLICATIONS? In the setting of medical education, the question is not whether assistance by professional writers and others may improve publications and help busy researchers get important, objectively presented findings into print; it may do both. The questions are whether the assistance is hidden, whether it is intended to promote a company s interests rather than present unbiased information, and whether the author takes credit for work that he or she did not do and thus misrepresents the provenance of the article. Such arrangements (which are essentially gifts) send the wrong message about the values of intellectual independence, professional ethics, accountability, and evidence-based medicine. Institute of Medicine, Conflict of Interest in Medical Research, Education and Practice (2009) 25

26 WHO IS SUBJECT TO REPORTING? Applicable Manufacturer Applicable manufacturer means an entity that is operating in the United States and falls within one of the following categories: 1) An entity that is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply, but not if such covered drug, device, biological or medical supply is solely for use by or within the entity itself or by the entity's own patients. This definition does not include distributors or wholesalers (including, but not limited to, repackagers, relabelers, and kit assemblers) that do not hold title to any covered drug, device, biological or medical supply. 2) An entity under common ownership with an entity in paragraph (1) of this definition, which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological or medical supply. 26

27 WHO IS SUBJECT TO REPORTING? Common Ownership refers to circumstances where the same individual, individuals, entity, or entities directly or indirectly own 5 percent or more total ownership of two entities. This includes, but is not limited to, parent corporations, direct and indirect subsidiaries, and brother or sister corporations. Assistance and Support means providing a service or services that are necessary or integral to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, medical supply. 27

28 WHO IS SUBJECT TO REPORTING? Covered Recipient Physicians Except for a physician who is a bona fide employee of the applicable manufacturer that is reporting the payment Physicians includes: Medical Doctor; Doctor of Osteopathy, Dentistry, Podiatric Medicine, Optometry; and Chiropractor (*does not include residents) Teaching Hospitals Any institution that received a payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Act during the last calendar year for which such information is available CMS will publish a list of teaching hospitals 90 days prior to the start of data collection 28

29 WHAT IS SUBJECT TO REPORTING? Payment or other transfer of value A transfer of anything of value Covered drug, device, biological, or medical supply Any drug, device, biological, or medical supply for which payment is available under Medicare, Medicaid, or CHIP May be reimbursed separately (such as through a fee schedule or formulary) or as part of a bundled payment Drug or biological requires a prescription to be dispensed Device (including a medical supply that is a device) requires premarket approval by or premarket notification to FDA With some exceptions, if a company has covered products, all payments and transfers of value are reported, whether or not they relate to covered products 29

30 PAYMENT REPORTING Forms of Payment Cash or cash equivalent In-kind items or services Stock, stock option, or any other ownership interest Dividend, profit or other return on investment Nature of Payment Consulting fee Compensation for services other than consulting, including serving as faculty or a speaker at an event other than continuing education Honoraria Gift Entertainment Food and beverage Travel and lodging (including the City, State, Country) Education Research Charitable contribution Royalty or license Current or prospective ownership or investment interest Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program Grant, or Space rental or facility fees (teaching hospitals only) 30

31 RESEARCH Payments made in connection with research that are subject to a written agreement OR research protocol are subject to special reporting requirements Includes payments and transfers of value related to pre-clinical, phases I through IV, and investigator-initiated research Research payments must be reported to CMS separately Payments for medical research writing and/or publication would be included in the research payment, if the activity was included in the written agreement or research protocol and paid as a part of the research payment. 31

32 ASSUMPTIONS DOCUMENT Applicable manufacturers/gpos may submit an assumptions document including information on their assumptions and methodologies when reporting payments or other transfers of value, or ownership or investment interests. Voluntary It will not be made available to the public, covered recipients or physician owners or investors Provides CMS with information to help identify areas where additional guidance and clarity is needed If a statement within the assumptions document pertains to a particular section of the report, applicable manufacturers should explicitly refer to that section in the assumptions document 32

33 IMPORTANT DATES August 1, 2013 Data collection begins March 31, 2014 First reports due to CMS (data from August 1 - December 31, 2013) Q Projected Dispute Resolution timeframe September 30, 2014 Online Publication on CMS website April 1, 2015 First report due to Congress (will include data submitted on March 31, 2014 reports) 33

34 REVIEW AND DISPUTE PERIOD 45 Day Review and 15 Day Correction Period CMS will provide notification to manufacturers, GPOs and covered recipients when the data is ready for review. Covered Recipients and Physician Owners may review data and initiate a dispute during the 45- day period. If a dispute is resolved within the 45 days or the extra 15 days following the 45 day review period, CMS will publish the corrected data. If a dispute in the data cannot be resolved within 15 days following the 45 day review period, CMS will post the manufacturer s data as submitted and mark it as disputed. 34

35 ARE STATE LAWS PREEMPTED? State laws that require manufacturers to disclose or report, in any format, payments of any kind to covered individuals that are required to be disclosed under this law are preempted. State and local entities may require reporting of non-required categories of information for payments or other transfers of value reported to CMS, which are not required under Federal law. 35

36 ISMPP SUNSHINE ACT TASK FORCE Kim Pepitone, BA, CMPP Scientific Director, Cactus Communications Adjunct Associate Professor, University of the Sciences in Philadelphia

37 DISCLAIMER Information provided in this presentation is for educational purposes only The approaches and suggestions regarding interpretation and implementation of the Sunshine Act offered to ISMPP members are based on the research of the Task Force and should not be construed as legal advice. Members are advised to seek individual legal guidance on how their company interprets the law. The opinions expressed herein are those of my own and may not necessarily reflect those of my employer 37

38 ISMPP SUNSHINE ACT TASK FORCE: ACTIVITIES UPDATE Task Force overview Activities to date Suggestions for implementation of the Sunshine Act 38

39 WHAT IS THE ISMPP SUNSHINE ACT TASK FORCE? ISMPP established the Sunshine Act Task Force to follow the issues, understand the details and implications, and, most importantly, provide information and tools to our membership with respect to the Physician Payment Sunshine Act and medical publications 39

40 TASK FORCE MEMBERS Robert J. Matheis, PhD, CMPP (Chair) Senior Director, Medical Communications, Evidence Based Medicine, Sanofi US ISMPP Past President ( ) Kim Pepitone, BA, CMPP (Vice Chair) Scientific Director, Cactus Communications; Adjunct Associate Professor, University of the Sciences in Philadelphia Bob Norris Founder, CHC Group ISMPP Past President ( ) and Founding Member, ISMPP Angela Cairns, BSc, CMPP SVP, Medical & Scientific Services and Global Compliance Team Leader, KnowledgePoint360 Group Samantha Gothelf, PharmD Executive Director, Global Medical Publications, Bristol-Myers Squibb Thomas Malieckal, PharmD, CMPP Director, Business Operations, Global Medical Publications, Bristol-Myers Squibb 40

41 TASK FORCE ACTIVITIES TO DATE Submitted response to Federal Register proposed rules Presented ISMPP Sunshine Act position to HHS/CMS Created educational materials (FAQ; journal article; slide set; presentations) Conducted member survey and shared key learnings In-person meeting with CMS staff (March 26, 2013) with follow-up questions Developed and launched suggestions document 41

42 IN-PERSON CMS MEETING Met with 5 staff from 2 departments Introduced ISMPP and members role in disseminating scientific/ clinical information via publications Opened door to ongoing dialogue between CMS and ISMPP Received non-binding indication regarding reportability of publications support 42

43 MEETING AT CMS: SUMMARY We left the meeting with the impression that publication assistance of any type provided by Applicable Manufacturers (pharmaceutical, biotech, and medical device companies) to Covered Recipients (physicians and teaching hospitals) would be a reportable transfer of value under the law We also gained the impression that the details of reporting the amount reported and the methods to determine the reportable amount would be left to individual companies to determine, and their rationale should be accompanied by documented assumptions 43

44 SUGGESTIONS FOR IMPLEMENTATION: STEP-WISE APPROACH In-depth review of implementation rules issued February 8, 2013 Submitted for peer review AMs, legal counsel, and ISMPP BOT Revised document based on reviewers feedback March, met with representatives from CMS Drafted preliminary suggestions document Final review and approval by ISMPP BOT March-June, met with various industry stakeholders in the medical publications space Based on research & meetings Task Force believes publications support could be reportable TOV Suggestions document released August 13,

45 SUGGESTIONS DOCUMENT: STRUCTURE Scope of reportable activities Suggested Activities Comprising Publication Support Research versus Stand-Alone Activities Allocation of value Include the Work That an Author Most Likely Would Do Do Not Include Work an Author Most Likely Would Not Do Assigning value Project-by-Project Determination Average Fair Market Value Reporting date As of August 1, 2013 Prior to August 1, 2013 Communication with covered recipients Acknowledgements 45

46 CRITICAL QUESTIONS How to determine the value that is transferred? How to apportion that value among CRs? 46

47 SUGGESTED ACTIVITIES COMPRISING PUBLICATION SUPPORT Medical writing and editing under the direction of the authors Statistical support performed specifically for the publication Literature searches and provision of references Graphic support Securing permissions/permission fees Journal submission Submission and publication fees (includes fees associated with open-access journals) Direct costs for travel, meals, and other expenses associated with performance of work associated with publications (eg, congress attendance; publication steering committee meeting) 47

48 ALLOCATION OF VALUE: TASKS FOR CONSIDERATION Include the Work That an Author Would Most Likely Do Time to develop submission-ready abstract and time associated with the submission process Time to develop oral or poster presentation following acceptance of abstract Time to develop content, incorporate co-author comments, and create graphics for submissionready manuscript for publication Statistical analyses and support specifically for the publication Time associated with journal submission Time to revise manuscript based on peerreviewers feedback Direct costs associated with any of the above activities; eg, copyright permissions, reference purchasing Do Not Include the Work That an Author Most Likely Would Not Do* Time spent to develop a contract or author agreements and time spent for review (direct client, legal, etc) and revisions Schedule development, time tracking, proposal development, general project management Information management (eg, publication planning database input, financial tracking, status reports) Status meetings Author training on good publication practices (if/as needed) *Assumes these tasks would most likely not be of value to an author 48

49 SUGGESTED APPROACHES TO ASSIGNING VALUE: I. PROJECT BY PROJECT Take total cost of the publication support Subtract non-author-value tasks Divide by number of authors on publication Internal/company and ex-us authors are included in the calculation, but the TOV for these authors is not reportable 49

50 SUGGESTED APPROACHES TO ASSIGNING VALUE: II. AVERAGE FAIR MARKET VALUE Determine average fair market value (FMV) for each publication type (eg, one for abstracts, one for manuscripts) Total average costs associated with publication (average internal or vendor costs for medical writing, statistical support, congress/ submission fees, and other costs deemed reportable by the AM) Divide by average number of authors on that publication type (each AM to determine a representative sample size) Same FMV amount would always be reported per author regardless of actual number of authors 50

51 ADDRESSING THE SUNSHINE ACT: AN INDUSTRY PERSPECTIVE Thomas Malieckal, PharmD, CMPP Director, Business Operations Global Medical Publications Department Bristol-Myers Squibb

52 DISCLAIMER Information provided in this presentation is for educational purposes only and should not be construed as legal advice The opinions expressed herein are those of my own and do not reflect those of my employer, Bristol-Myers Squibb 52

53 PUBLICATION SUPPORT SCOPE CMS provides applicable manufacturers flexibility in determining the value of the payments or support provided we agree and support that applicable manufacturers should be allowed flexibility to determine value, so we do not plan to create numerous rules for calculating value. Scope Medical writing: agency or internal medical writer Submission / publication fees: Abstract submission fees Journal publication-related fees (e.g., page charges, color figures) 53

54 TRACKING & REPORTING Developing a custom report by author in publication management tool to export list of completed publications (submitted abstracts / manuscripts; presented posters / orals) Assign value to each author based on value calculations 54

55 COMMUNICATION TO EXTERNAL AUTHORS New publications initiated after August 1, 2013 Communicate reporting requirements to U.S. licensed physician authors along with the author invitation Publications in development on August 1, 2013 Communicate reporting requirements to U.S. licensed physician authors prior to August 1,

56 CONSIDERATIONS Internal medical writers Alliances Sponsor employee authors who leave company Rejected publications 56

57 ADDRESSING THE SUNSHINE ACT: AN INDUSTRY PERSPECTIVE - EPRINT LINKS Donna Simcoe, MS, MS, MBA, CMPP Publications Director Cadence Pharmaceuticals

58 EPRINT LINKS Following an unsolicited request for an article we have available as an eprint, the eprint link is sent to the health care professional The healthcare professional fills in their information if they wish to download an article 58

59 EPRINT DOWNLOAD 59

60 U.S. LICENSED PHYSICIAN - YES 60

61 U.S. LICENSED PHYSICIAN - NO 61

62 EPRINT LINKS - SUMMARY Once a month, we receive a database from the vendor with information about the individual eprint downloads and we upload this to our tracking system Tracking actual downloads, not just sent links User-driven 62

63 RESOURCES Agrawal S, Brennan N, Budett P. The Sunshine Act Effects on Physicians. N Engl J Med 2013; 368: Silverman E. Everything you need to know about the Sunshine Act. BMJ 2013;347:f Guidance for Clinical Investigators, Industry,and FDA Staff Financial Disclosure by Clinical Investigators American Medical Association American Society Clinical Oncology Association of Corporate Counsel ISMPP 63

64 HOW TO CONTACT ISMPP S SUNSHINE ACT TASK FORCE We encourage you to submit your questions, comments, and/or concerns regarding the Sunshine Act and Open Payments Program and its impact on medical publications. We d also like to hear from you about what you and/or your organization has done or is in the process of implementing to meet the reporting requirements. Please us at: sunshine.act@ismpp.org 64

65 THANK YOU

66 QUESTIONS... To ask a question, please type your query into the Q&A chat box at the bottom left of your screen. Every attempt will be made to answer all questions.

67 UPCOMING ISMPP U TOPICS Stay tuned for the upcoming ISMPP U topics SPIRIT Guidelines: Tuesday, August 20 th at 10:00am (ET) / 3:00pm (GMT) 67

68 THANK YOU FOR ATTENDING! We hope you enjoyed today's presentation. We will be providing a link to the survey rather than the form itself. Please take a moment to click on the link and fill out the survey, so your valuable feedback can be used to develop future educational offerings. 68