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Transparency Associated With Interactions Between Industry and Physicians: Deficits in Accuracy and Consistency of Public Data Releases

Transparency Associated With Interactions Between Industry and Physicians: Deficits in Accuracy... The Physician Payments Sunshine Act, which became law in 2010 as part of the Affordable Care Act, requires the Centers for Medicare & Medicaid Services (CMS) to collect and publicly report payments and other transfers of value to physicians and teaching hospitals by manufacturers of drugs, medical devices, and medical supplies. In this issue of JAMA Dermatology, Feng and colleagues1 report on more than $34 million paid in 2014 to dermatologists by industry sources that were made public under the Open Payments program. Consistent with findings from other specialties,2-6 they noted wide ranges in the magnitude of payments (the top 1% of recipients [n = 83] each received at least $93 622, while the median payment per dermatologist across all recipients was only $298), as well as payments distributed across multiple categories (eg, speaker fees, consulting, research, food and beverage, travel, and honoraria).1 Feng and colleagues1 faced challenges delineating the exact nature of many payments. They conclude that while the Open Payments database provided valuable insights, it “does not offer an opportunity to accomplish the important and difficult task of differentiating nonbeneficial or even harmful relationships from beneficial ones that advance scientific knowledge and improve patient care.” Transparency is a laudable goal and, if done properly, may help patients make informed judgments about interactions between industry and physicians. Accurate and properly contextualized transparency can also help physicians evaluate the independence of colleagues writing or speaking about the risks and benefits of drugs or medical devices. There is substantial evidence that certain types of interactions can influence clinicians’ behavior in undesirable ways,7,8 and that even small gifts (eg, meals) are associated with increased prescribing of brand-name medications.9 However, ethical collaboration between industry and physicians that is meaningfully independent and focused on benefit to patients is essential in the development and implementation of new therapies, and the quest for transparency must be balanced with the risks that inaccurate or poorly explained data releases might inhibit innovative activities. The physician community, through our national professional societies including the American Medical Association, has strongly supported transparency and deeply engaged with Congress and CMS in attempts to make data collection and releases accurate, fair, meaningful, and minimally burdensome. The first years of the Open Payments program, however, have seen disappointing challenges. For the public to benefit from increased transparency, payments must be reported in categories that meaningfully separate and fairly describe types of interactions. Consulting payments are different from grants to support direct expenses for research studies, and payments for physician participation in speakers bureaus are different from unrestricted educational grants to independent providers of continuing medical education. Data presented without proper context and explanation risk creating an inaccurate perception that all reported interactions are evidence of unethical behavior. The table that CMS provides10 to explain their categories of consulting fees, honoraria, education, grants, and various classes of speaking fees is confusing and leaves room for differing interpretations and substantial overlap. Indeed, Feng and colleagues1 found evidence of “likely variability in the classification of payment activities among companies.” In some instances, contradictory guidance from CMS has generated additional confusion. To reduce complexity and avoid obscuring meaningful interactions with an excess of meaningless data, Congress placed limits on the types of payments that would be reportable, excluding transfers of value below $10, product samples, educational materials that directly benefit patients, and other items. Although the law clearly also excluded payments for activities in which the manufacturer is unaware of the recipient, and CMS’s initial rules affirmed the exclusion for independent continuing medical education unless the manufacturer requires, instructs, or directs a third party to provide payment to an individual recipient, poorly drafted subsequent subregulatory guidance and a medical journal article by CMS staff11 implied otherwise. This implication may have led manufacturers’ compliance departments, eager to mitigate any risk of large fines (up to $1 million), to overreport payments to physicians. The danger is that physicians, understandably concerned with the potential for unwarranted damage to their reputation, may curtail participation in high-quality, independently provided continuing medical education out of fear that their presence may lead to reporting (even when they may not have been aware of unrestricted grants provided to independent meeting organizers). Perhaps the largest concerns about the Open Payments program have been regarding accuracy of the data. The law requires that physicians have a 45-day opportunity to review and dispute reported payments before data are released. That process has been difficult to navigate and plagued by system failures—only 4.8% of physicians successfully reviewed their data in the program’s first year,12 and CMS has declined to publicize these statistics for subsequent years. The 2016 version of the Open Payments User Guide has 175 pages of instructions for physicians and hospitals who want to register in the Open Payments program and review or dispute their data.13 Simply signing up to review whether I had any transactions in the database required hours of work and several telephone calls to CMS’s help desk to resolve problems with the web site. Among 12 579 disputed records from the 2014 data set, about 9000 remained unresolved at the end of the review period.14 As a result of unsettled disputes and difficulty verifying payments, more than $1 billion in transfers from 2014 were withheld from the initial data release.14 The Open Payments database also leaves out payments made to nurses, physician assistants, and pharmacists despite their frequent interactions with industry.15 Transparency for physician interactions with industry is important, especially given the findings presented by Feng and colleagues1 in this issue of JAMA Dermatology showing individual consulting payments to dermatologists (even excluding research categories and royalties) as high as $249 643. However, the rollout of the Open Payments program has frustrated physicians and failed to provide the public with information of sufficient accuracy and meaning they could use to make fair conclusions. Some straightforward changes would substantially improve the situation. Physicians should have the opportunity to preview data before manufacturers transmit it to CMS. The administrative burden inherent in the current CMS data review portal and dispute process should be reduced. A common reporting method, including very clear definitions of meaningful categories of payments, should be standardized across companies. The Centers for Medicare & Medicaid Services should issue clear guidance that reduces fear among manufacturers and decreases overreporting. Continuing medical education programs that adhere to rigorous existing standards of independence should continue to be exempt from reporting. These changes would help to balance the clear benefits of transparency with the risks of discouraging those physician-industry interactions that benefit patients by furthering innovation and independent education. Back to top Article Information Corresponding Author: Jack S. Resneck Jr, MD, Department of Dermatology, University of California–San Francisco School of Medicine, PO Box 0316, San Francisco, CA 94143 (resneckj@derm.ucsf.edu). Published Online: October 5, 2016. doi:10.1001/jamadermatol.2016.3279 Conflict of Interest Disclosures: Dr Resneck serves on the Board of Trustees of the American Medical Association. No other disclosures were reported. Disclaimer: The views expressed in this manuscript are those of the author, and do not necessarily represent the views of the American Medical Association. References 1. Feng H, Wu P, Leger M. Exploring the industry-dermatologist financial relationship: insight from the Open Payment data [published online October 5, 2016]. JAMA Dermatol. doi:10.1001/jamadermatol.2016.3037Google Scholar 2. Lopez J, Ahmed R, Bae S, et al. A new culture of transparency: industry payments to orthopedic surgeons [published online July 27, 2016]. Orthopedics. PubMedGoogle Scholar 3. Ahmed R, Bae S, Hicks CW, et al. Here comes the sun shine: industry’s payments to cardiothoracic surgeons [published online June 25, 2016]. Ann Thorac Surg. 2016;S0003-4975(16)30764-0. doi:10.1016/j.athoracsur.2016.06.053PubMedGoogle Scholar 4. Parikh K, Fleischman W, Agrawal S. Industry relationships with pediatricians: findings from the Open Payments Sunshine Act. Pediatrics. 2016;137(6):e20154440.PubMedGoogle ScholarCrossref 5. Fleischman W, Ross JS, Melnick ER, Newman DH, Venkatesh AK. Financial ties between emergency physicians and industry: insights from Open Payments data. Ann Emerg Med. 2016;68(2):153-158.e4.PubMedGoogle ScholarCrossref 6. Tierney NM, Saenz C, McHale M, Ward K, Plaxe S. Industry payments to obstetrician-gynecologists: an analysis of 2014 Open Payments data. Obstet Gynecol. 2016;127(2):376-382.PubMedGoogle ScholarCrossref 7. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283(3):373-380.PubMedGoogle ScholarCrossref 8. Robertson C, Rose S, Kesselheim AS. Effect of financial relationships on the behaviors of health care professionals: a review of the evidence. J Law Med Ethics. 2012;40(3):452-466.PubMedGoogle ScholarCrossref 9. DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical industry-sponsored meals and physician prescribing patterns for Medicare beneficiaries. JAMA Intern Med. 2016;176(8):1114-1122.PubMedGoogle ScholarCrossref 10. Centers for Medicare & Medicaid Services. Natures of payment. https://www.cms.gov/OpenPayments/About/Natures-of-Payment.html. Accessed July 28, 2016. 11. Agrawal S, Brown D. The Physician Payments Sunshine Act—two years of the Open Payments Program. N Engl J Med. 2016;374(10):906-909.PubMedGoogle ScholarCrossref 12. Santhakumar S, Adashi EY. The Physician Payment Sunshine Act: testing the value of transparency. JAMA. 2015;313(1):23-24.PubMedGoogle ScholarCrossref 13. Centers for Medicare & Medicaid Services. Part IV: physicians and teaching hospitals. In: User Guide: Open Payments: Creating Public Transparency Into Industry-Physician Financial Relationships. Baltimore, MD: Centers for Medicare & Medicaid Services; January 2016:223-398. https://www.cms.gov/OpenPayments/Downloads/Open-Payments-User-Guide.pdf. Accessed July 28, 2016. 14. Centers for Medicare & Medicaid Services. Open Payments data fact sheet. https://www.cms.gov/OpenPayments/Downloads/Fact-Sheet-Sept-30-2014-Published-Data.pdf. Published October 1, 2014. Accessed July 28, 2016. 15. Grundy Q, Bero L, Malone R. Interactions between non-physician clinicians and industry: a systematic review. PLoS Med. 2013;10(11):e1001561.PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Dermatology American Medical Association

Transparency Associated With Interactions Between Industry and Physicians: Deficits in Accuracy and Consistency of Public Data Releases

JAMA Dermatology , Volume 152 (12) – Dec 1, 2016

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References (12)

Publisher
American Medical Association
Copyright
Copyright © 2016 American Medical Association. All Rights Reserved.
ISSN
2168-6068
eISSN
2168-6084
DOI
10.1001/jamadermatol.2016.3279
pmid
27706480
Publisher site
See Article on Publisher Site

Abstract

The Physician Payments Sunshine Act, which became law in 2010 as part of the Affordable Care Act, requires the Centers for Medicare & Medicaid Services (CMS) to collect and publicly report payments and other transfers of value to physicians and teaching hospitals by manufacturers of drugs, medical devices, and medical supplies. In this issue of JAMA Dermatology, Feng and colleagues1 report on more than $34 million paid in 2014 to dermatologists by industry sources that were made public under the Open Payments program. Consistent with findings from other specialties,2-6 they noted wide ranges in the magnitude of payments (the top 1% of recipients [n = 83] each received at least $93 622, while the median payment per dermatologist across all recipients was only $298), as well as payments distributed across multiple categories (eg, speaker fees, consulting, research, food and beverage, travel, and honoraria).1 Feng and colleagues1 faced challenges delineating the exact nature of many payments. They conclude that while the Open Payments database provided valuable insights, it “does not offer an opportunity to accomplish the important and difficult task of differentiating nonbeneficial or even harmful relationships from beneficial ones that advance scientific knowledge and improve patient care.” Transparency is a laudable goal and, if done properly, may help patients make informed judgments about interactions between industry and physicians. Accurate and properly contextualized transparency can also help physicians evaluate the independence of colleagues writing or speaking about the risks and benefits of drugs or medical devices. There is substantial evidence that certain types of interactions can influence clinicians’ behavior in undesirable ways,7,8 and that even small gifts (eg, meals) are associated with increased prescribing of brand-name medications.9 However, ethical collaboration between industry and physicians that is meaningfully independent and focused on benefit to patients is essential in the development and implementation of new therapies, and the quest for transparency must be balanced with the risks that inaccurate or poorly explained data releases might inhibit innovative activities. The physician community, through our national professional societies including the American Medical Association, has strongly supported transparency and deeply engaged with Congress and CMS in attempts to make data collection and releases accurate, fair, meaningful, and minimally burdensome. The first years of the Open Payments program, however, have seen disappointing challenges. For the public to benefit from increased transparency, payments must be reported in categories that meaningfully separate and fairly describe types of interactions. Consulting payments are different from grants to support direct expenses for research studies, and payments for physician participation in speakers bureaus are different from unrestricted educational grants to independent providers of continuing medical education. Data presented without proper context and explanation risk creating an inaccurate perception that all reported interactions are evidence of unethical behavior. The table that CMS provides10 to explain their categories of consulting fees, honoraria, education, grants, and various classes of speaking fees is confusing and leaves room for differing interpretations and substantial overlap. Indeed, Feng and colleagues1 found evidence of “likely variability in the classification of payment activities among companies.” In some instances, contradictory guidance from CMS has generated additional confusion. To reduce complexity and avoid obscuring meaningful interactions with an excess of meaningless data, Congress placed limits on the types of payments that would be reportable, excluding transfers of value below $10, product samples, educational materials that directly benefit patients, and other items. Although the law clearly also excluded payments for activities in which the manufacturer is unaware of the recipient, and CMS’s initial rules affirmed the exclusion for independent continuing medical education unless the manufacturer requires, instructs, or directs a third party to provide payment to an individual recipient, poorly drafted subsequent subregulatory guidance and a medical journal article by CMS staff11 implied otherwise. This implication may have led manufacturers’ compliance departments, eager to mitigate any risk of large fines (up to $1 million), to overreport payments to physicians. The danger is that physicians, understandably concerned with the potential for unwarranted damage to their reputation, may curtail participation in high-quality, independently provided continuing medical education out of fear that their presence may lead to reporting (even when they may not have been aware of unrestricted grants provided to independent meeting organizers). Perhaps the largest concerns about the Open Payments program have been regarding accuracy of the data. The law requires that physicians have a 45-day opportunity to review and dispute reported payments before data are released. That process has been difficult to navigate and plagued by system failures—only 4.8% of physicians successfully reviewed their data in the program’s first year,12 and CMS has declined to publicize these statistics for subsequent years. The 2016 version of the Open Payments User Guide has 175 pages of instructions for physicians and hospitals who want to register in the Open Payments program and review or dispute their data.13 Simply signing up to review whether I had any transactions in the database required hours of work and several telephone calls to CMS’s help desk to resolve problems with the web site. Among 12 579 disputed records from the 2014 data set, about 9000 remained unresolved at the end of the review period.14 As a result of unsettled disputes and difficulty verifying payments, more than $1 billion in transfers from 2014 were withheld from the initial data release.14 The Open Payments database also leaves out payments made to nurses, physician assistants, and pharmacists despite their frequent interactions with industry.15 Transparency for physician interactions with industry is important, especially given the findings presented by Feng and colleagues1 in this issue of JAMA Dermatology showing individual consulting payments to dermatologists (even excluding research categories and royalties) as high as $249 643. However, the rollout of the Open Payments program has frustrated physicians and failed to provide the public with information of sufficient accuracy and meaning they could use to make fair conclusions. Some straightforward changes would substantially improve the situation. Physicians should have the opportunity to preview data before manufacturers transmit it to CMS. The administrative burden inherent in the current CMS data review portal and dispute process should be reduced. A common reporting method, including very clear definitions of meaningful categories of payments, should be standardized across companies. The Centers for Medicare & Medicaid Services should issue clear guidance that reduces fear among manufacturers and decreases overreporting. Continuing medical education programs that adhere to rigorous existing standards of independence should continue to be exempt from reporting. These changes would help to balance the clear benefits of transparency with the risks of discouraging those physician-industry interactions that benefit patients by furthering innovation and independent education. Back to top Article Information Corresponding Author: Jack S. Resneck Jr, MD, Department of Dermatology, University of California–San Francisco School of Medicine, PO Box 0316, San Francisco, CA 94143 (resneckj@derm.ucsf.edu). Published Online: October 5, 2016. doi:10.1001/jamadermatol.2016.3279 Conflict of Interest Disclosures: Dr Resneck serves on the Board of Trustees of the American Medical Association. No other disclosures were reported. Disclaimer: The views expressed in this manuscript are those of the author, and do not necessarily represent the views of the American Medical Association. References 1. Feng H, Wu P, Leger M. Exploring the industry-dermatologist financial relationship: insight from the Open Payment data [published online October 5, 2016]. JAMA Dermatol. doi:10.1001/jamadermatol.2016.3037Google Scholar 2. Lopez J, Ahmed R, Bae S, et al. A new culture of transparency: industry payments to orthopedic surgeons [published online July 27, 2016]. Orthopedics. PubMedGoogle Scholar 3. Ahmed R, Bae S, Hicks CW, et al. Here comes the sun shine: industry’s payments to cardiothoracic surgeons [published online June 25, 2016]. Ann Thorac Surg. 2016;S0003-4975(16)30764-0. doi:10.1016/j.athoracsur.2016.06.053PubMedGoogle Scholar 4. Parikh K, Fleischman W, Agrawal S. Industry relationships with pediatricians: findings from the Open Payments Sunshine Act. Pediatrics. 2016;137(6):e20154440.PubMedGoogle ScholarCrossref 5. Fleischman W, Ross JS, Melnick ER, Newman DH, Venkatesh AK. Financial ties between emergency physicians and industry: insights from Open Payments data. Ann Emerg Med. 2016;68(2):153-158.e4.PubMedGoogle ScholarCrossref 6. Tierney NM, Saenz C, McHale M, Ward K, Plaxe S. Industry payments to obstetrician-gynecologists: an analysis of 2014 Open Payments data. Obstet Gynecol. 2016;127(2):376-382.PubMedGoogle ScholarCrossref 7. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283(3):373-380.PubMedGoogle ScholarCrossref 8. Robertson C, Rose S, Kesselheim AS. Effect of financial relationships on the behaviors of health care professionals: a review of the evidence. J Law Med Ethics. 2012;40(3):452-466.PubMedGoogle ScholarCrossref 9. DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical industry-sponsored meals and physician prescribing patterns for Medicare beneficiaries. JAMA Intern Med. 2016;176(8):1114-1122.PubMedGoogle ScholarCrossref 10. Centers for Medicare & Medicaid Services. Natures of payment. https://www.cms.gov/OpenPayments/About/Natures-of-Payment.html. Accessed July 28, 2016. 11. Agrawal S, Brown D. The Physician Payments Sunshine Act—two years of the Open Payments Program. N Engl J Med. 2016;374(10):906-909.PubMedGoogle ScholarCrossref 12. Santhakumar S, Adashi EY. The Physician Payment Sunshine Act: testing the value of transparency. JAMA. 2015;313(1):23-24.PubMedGoogle ScholarCrossref 13. Centers for Medicare & Medicaid Services. Part IV: physicians and teaching hospitals. In: User Guide: Open Payments: Creating Public Transparency Into Industry-Physician Financial Relationships. Baltimore, MD: Centers for Medicare & Medicaid Services; January 2016:223-398. https://www.cms.gov/OpenPayments/Downloads/Open-Payments-User-Guide.pdf. Accessed July 28, 2016. 14. Centers for Medicare & Medicaid Services. Open Payments data fact sheet. https://www.cms.gov/OpenPayments/Downloads/Fact-Sheet-Sept-30-2014-Published-Data.pdf. Published October 1, 2014. Accessed July 28, 2016. 15. Grundy Q, Bero L, Malone R. Interactions between non-physician clinicians and industry: a systematic review. PLoS Med. 2013;10(11):e1001561.PubMedGoogle ScholarCrossref

Journal

JAMA DermatologyAmerican Medical Association

Published: Dec 1, 2016

There are no references for this article.