The Sunshine Act and Medical Publications: Guidance from ...€¦ · literature in PubMed (dates...
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Presented at the 11th Annual Meeting of ISMPP; April 27-29, 2015; Arlington, VA, USA The Sunshine Act and Medical Publications: Guidance from Professional Associations 1 Hofstra University; 2 Amgen Inc; 3 Ashfield Healthcare Communications; 4 MedImmune; 5 Excerpta Medica BV; 6 ISMPP; 7 Cactus Communications Lisa de Tora, 1 Dikran Toroser, 2 Angela Cairns, 3 Renu Juneja, 4 Anna Georgieva, 5 Al Weigel, 6 and Kim Pepitone 7 38 • Transparency, in terms of financial relationships between industry and healthcare practitioners (HCPs) is essential in order to maintain public trust • The Patient Protection Affordable Care Act (PPACA), which includes the Sunshine Act (Section 6002; also known as Open Payments [the Act]), was the first transparency legislation for payments from industry to HCPs and teaching hospitals to be enacted at the US Federal level • The laws and guidances associated with reporting requirements cover direct and indirect payments and in-kind services, the latter also known as transfer of value (TOV) • The HCPs who participate in industry-sponsored research are frequently authors of the publications that disseminate the clinical trial results • Industry may provide support for the development of the clinical trial publication, which could be considered a reportable TOV Search strategy • Using “Sunshine Act” as a search term, we reviewed peer-reviewed publications indexed in PubMed (February 2013 [issue of final rule] to November 4, 2014) • “Grey literature” was surveyed using Google/Google Scholar with “Sunshine Act” as the search term • Websites of pre-identified professional medical societies were manually searched for guidance on the Act Data extraction • Articles were initially assigned to categories and assessed by content type (Figure 1) • In-depth reviews and data were consolidated into a central repository housed centrally at ISMPP • Articles were reviewed by 6 medical publication professionals and all discrepancies regarding relevance or categorization were resolved by discussion leading to agreement INTRODUCTION • There is a shortage of clear guidance from professional associations around the Sunshine Act • The literature debates potential impact of the Act and highlights concern that physician-enabled innovation may be hindered • Of importance for medical publication professionals is the lack of guidance to clinicians regarding the interpretation of the reportability of support for medical publications • The articles reviewed express concern that lack of context may impact industry/physician relationships The views expressed in this publication represent the authors’ opinions and not those of their employers or of ISMPP. The authors are fully responsible for the design of the research, analysis of the results, and writing of the poster. CONCLUSIONS DISCLAIMER RESULTS (Continued) • The majority of publications in the peer-reviewed and grey literature focused on industry/investigator relationships and within that category, most were considered either editorial or opinion (Figures 1 and 2) • Of the medical society websites assessed, most of the information about Sunshine describe details about the Act, and recommends that HCPs review their data. There is little in terms of recommendations or guidelines with respect to Sunshine and medical publications (Table 1) RESULTS Objective: Physicians often turn to their professional associations for guidance on clinical and ethical issues. We identified and analyzed recently published guidance from professional medical associations regarding the Sunshine Act. Research design and methods: Using “Sunshine Act” as a search term, we surveyed the peer-reviewed literature in PubMed (dates February 2013–November 2014). Based on subject matter expertise, “grey literature” was retrieved (12 articles) using search engines (Google/Google Scholar). Online information was extracted from websites of 17 professional medical societies. Articles were reviewed by 6 publication professionals using a central repository. Results: Some professional medical associations have published peer-reviewed recommendations (5 reviewed), position statements (3 reviewed), or general advice on their websites (17 reviewed). Associations had broad online educational resources for physicians around Sunshine Act. There was agreement between peer-reviewed publications, including guidelines, for full transparency and disclosure of industry support. Surveys by professional associations (eg, ASCO) showed variance in opinion on the forecasted impact of the Act on physician/industry relationships. Although the literature from professional associations contained general guidance, there was insufficient consistent guidance from associations around specific concerns, including transfers of value for medical publications. Conclusion: There is a shortage of clear guidance from professional associations around the Sunshine Act. Presently, information is fragmented, open to diverse interpretations and incomplete. The literature debates potential impact of the Act and highlights concern that physician-enabled innovation may be hindered. ABSTRACT METHODS Figure 1. Disposition of Publications Retrieved for Review* Table 1. Summary of Information From Professional Societies’ Websites Figure 2. Most Frequent Content in Publications by Content Type 59 articles retrieved based on search criteria 28 articles considered relevant by reviewers for inclusion and fell into 3 categories and 5 content types 31 articles considered by reviewers to be outside the scope of the research question Ethical considerations 2: Opinion Guideline or recommendation 1: Editorial 1: Opinion Industry/investigator relations 2: Position 3: Guideline 11:Editorial 7: Opinion 1: Data *Full reference list available from the authors upon request Professional Association / URL/No. members Resources Information specific to medical publications American Medical Association (AMA) http://www.ama-assn.org accessed on 3/9/2015 ~225,000 Webinar and slides: Preparing for the Sunshine Act Sunshine Act FAQs Sunshine Act brochure Speech by Jeremy A Lazarus, President of AMA, on June 15, 2013 None American Association of Family Practice (AAFP) http://www.aafp.org accessed on 3/9/2015 115,900 General information on Sunshine with ongoing updates None American Osteopathic Association (AOA) http://www.osteopathic.org accessed on 3/9/2015 110,000 Summary of Sunshine Act Final Rule: February 15, 2013 General description of the Sunshine Act and AOA position None American College of Physicians (ACP) http://www.acponline.org accessed on 3/9/2015 141,000 Are You Ready for the National Physician Payment Transparency Program? General information on the Sunshine Act Mobile App to track TOV None American Association of Clinical Endocrinologists (AACE) https://www.aace.com ~6,500 accessed on 3/9/2015 General Resources for Physician Payment Sunshine Act None American College of Rheumatology (ACR) http://www.rheumatology.org/ ~9,400 accessed on 3/9/2015 General Resources for Physician Payment Sunshine Act Sunshine Act Tool Kit None American Heart Association (AHA) http://www.heart.org ~32,000 accessed on 3/9/2015 Limited general information on Sunshine Act None American Society of Hematology (ASH) http://www.hematology.org ~15,000 accessed on 3/9/2015 Resources for physicians and on-going updates Statement from ASH President Linda J. Burns, MD, on Release of Sunshine Act Data; published September 30, 2014 President’s letter reinforces the criticality of industry-physician relationships American Society of Clinical Oncology (ASCO) http://www.asco.org ~35,000 accessed on 3/9/2015 Dedicated page on Physician Payment Sunshine Act Brief information on TOV reporting for text books, journal reprints, and manuscripts. American Academy of Dermatology (AAD) https://www.aad.org ~17,000 accessed on 3/9/2015 General information on the Sunshine Act None American Academy of Pediatrics (AAP) https://www.aap.org 62,000 accessed on 3/9/2015 Toolkit for Physician Financial Transparency Reports Mobile app for Physicians CMS Open Payments Frequently Asked Questions None 0 10 20 30 40 50 60 70 80 90 100 Concerns over lack of context and consistency in reporting Importance of industry- physician relationships Importance of transparency 5 5 5 2 1 1 3 2 5 Editorial Guideline Position Opinion Percentage
Transcript of The Sunshine Act and Medical Publications: Guidance from ...€¦ · literature in PubMed (dates...
Presented at the 11th Annual Meeting of ISMPP; April 27-29, 2015; Arlington, VA, USA
The Sunshine Act and Medical Publications: Guidance from Professional Associations
1Hofstra University; 2Amgen Inc; 3Ashfield Healthcare Communications; 4MedImmune; 5Excerpta Medica BV; 6ISMPP; 7Cactus CommunicationsLisa de Tora,1 Dikran Toroser,2 Angela Cairns,3 Renu Juneja,4 Anna Georgieva,5 Al Weigel,6 and Kim Pepitone7
38
• Transparency, in terms of financial relationships between industry and healthcare practitioners (HCPs) is essential in order to maintain public trust
• The Patient Protection Affordable Care Act (PPACA), which includes the Sunshine Act (Section 6002; also known as Open Payments [the Act]), was the first transparency legislation for payments from industry to HCPs and teaching hospitals to be enacted at the US Federal level
• The laws and guidances associated with reporting requirements cover direct and indirect payments and in-kind services, the latter also known as transfer of value (TOV)
• The HCPs who participate in industry-sponsored research are frequently authors of the publications that disseminate the clinical trial results
• Industry may provide support for the development of the clinical trial publication, which could be considered a reportable TOV
Search strategy• Using “Sunshine Act” as a search term, we reviewed peer-reviewed publications indexed in
PubMed (February 2013 [issue of final rule] to November 4, 2014)• “Grey literature” was surveyed using Google/Google Scholar with “Sunshine Act” as the
search term• Websites of pre-identified professional medical societies were manually searched for
guidance on the ActData extraction• Articles were initially assigned to categories and assessed by content type (Figure 1)• In-depth reviews and data were consolidated into a central repository housed centrally at
ISMPP• Articles were reviewed by 6 medical publication professionals and all discrepancies regarding
relevance or categorization were resolved by discussion leading to agreement
INTRODUCTION
• There is a shortage of clear guidance from professional associations around the Sunshine Act
• The literature debates potential impact of the Act and highlights concern that physician-enabled innovation may be hindered
• Of importance for medical publication professionals is the lack of guidance to clinicians regarding the interpretation of the reportability of support for medical publications
• The articles reviewed express concern that lack of context may impact industry/physician relationships
The views expressed in this publication represent the authors’ opinions and not those of their employers or of ISMPP. The authors are fully responsible for the design of the research, analysis of the results, and writing of the poster.
CONCLUSIONS
DISCLAIMER
RESULTS (Continued)
• The majority of publications in the peer-reviewed and grey literature focused on industry/investigator relationships and within that category, most were considered either editorial or opinion (Figures 1 and 2)
• Of the medical society websites assessed, most of the information about Sunshine describe details about the Act, and recommends that HCPs review their data. There is little in terms of recommendations or guidelines with respect to Sunshine and medical publications (Table 1)
RESULTS
Objective: Physicians often turn to their professional associations for guidance on clinical and ethical issues. We identified and analyzed recently published guidance from professional medical associations regarding the Sunshine Act. Research design and methods: Using “Sunshine Act” as a search term, we surveyed the peer-reviewed literature in PubMed (dates February 2013–November 2014). Based on subject matter expertise, “grey literature” was retrieved (12 articles) using search engines (Google/Google Scholar). Online information was extracted from websites of 17 professional medical societies. Articles were reviewed by 6 publication professionals using a central repository.Results: Some professional medical associations have published peer-reviewed recommendations (5 reviewed), position statements (3 reviewed), or general advice on their websites (17 reviewed). Associations had broad online educational resources for physicians around Sunshine Act. There was agreement between peer-reviewed publications, including guidelines, for full transparency and disclosure of industry support. Surveys by professional associations (eg, ASCO) showed variance in opinion on the forecasted impact of the Act on physician/industry relationships. Although the literature from professional associations contained general guidance, there was insufficient consistent guidance from associations around specific concerns, including transfers of value for medical publications. Conclusion: There is a shortage of clear guidance from professional associations around the Sunshine Act. Presently, information is fragmented, open to diverse interpretations and incomplete. The literature debates potential impact of the Act and highlights concern that physician-enabled innovation may be hindered.
ABSTRACT
METHODS
Figure 1. Disposition of Publications Retrieved for Review*
Table 1. Summary of Information From Professional Societies’ Websites
Figure 2. Most Frequent Content in Publications by Content Type
59 articles retrieved based on search criteria
28 articles considered relevant by reviewers for inclusion and fell into 3 categories and 5
content types
31 articles considered by reviewers to be outside the scope of the research question
Ethical considerations2: Opinion
Guideline or recommendation1: Editorial1: Opinion
Industry/investigator relations2: Position
3: Guideline11:Editorial7: Opinion
1: Data
*Full reference list available from the authors upon request
Professional Association / URL/No. members Resources Information specific to medical publications
American Medical Association (AMA) http://www.ama-assn.org
accessed on 3/9/2015
~225,000
Webinar and slides: Preparing for the Sunshine ActSunshine Act FAQsSunshine Act brochureSpeech by Jeremy A Lazarus, President of AMA, on June 15, 2013
None
American Association of Family Practice (AAFP) http://www.aafp.org
accessed on 3/9/2015
115,900
General information on Sunshine with ongoing updates None
American Osteopathic Association (AOA) http://www.osteopathic.orgaccessed on 3/9/2015110,000
Summary of Sunshine Act Final Rule: February 15, 2013General description of the Sunshine Act and AOA position None
American College of Physicians (ACP)
http://www.acponline.org
accessed on 3/9/2015
141,000
Are You Ready for the National Physician Payment Transparency Program?General information on the Sunshine ActMobile App to track TOV
None
American Association of Clinical Endocrinologists (AACE) https://www.aace.com~6,500accessed on 3/9/2015
General Resources for Physician Payment Sunshine Act None
American College of Rheumatology (ACR) http://www.rheumatology.org/
~9,400
accessed on 3/9/2015
General Resources for Physician Payment Sunshine Act Sunshine Act Tool Kit None
American Heart Association (AHA)
http://www.heart.org
~32,000
accessed on 3/9/2015
Limited general information on Sunshine Act None
American Society of Hematology (ASH) http://www.hematology.org
~15,000accessed on 3/9/2015
Resources for physicians and on-going updates
Statement from ASH President Linda J. Burns, MD, on Release of Sunshine Act Data; published September 30, 2014
President’s letter reinforces the criticality of industry-physician relationships
American Society of Clinical Oncology (ASCO) http://www.asco.org
~35,000
accessed on 3/9/2015
Dedicated page on Physician Payment Sunshine Act Brief information on TOV reporting for text books, journal reprints, and manuscripts.
American Academy of Dermatology (AAD) https://www.aad.org
~17,000
accessed on 3/9/2015
General information on the Sunshine Act None
American Academy of Pediatrics (AAP)
https://www.aap.org
62,000accessed on 3/9/2015
Toolkit for Physician Financial Transparency Reports
Mobile app for Physicians
CMS Open Payments Frequently Asked Questions
None
0102030405060
70
80
90
100
Concerns over lack ofcontext and consistency in
reportingImportance of industry-physician relationships Importance of transparency
55
5
2
1
1
3 2
5
EditorialGuidelinePositionOpinion
Perce
ntage
