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The Centers for Medicare and Medicaid Services (CMS) is expected to publicly release its Open Payments data(sometimes called Sunshine Act data) about financial interactions between physicians and the medical device and

pharmaceutical industries tomorrow The American Medical Association has some serious concerns about the datarelease and has developed the below !uide to reportin! on Open Payments "ata to help explain them # hope you find ithelpful if you are coverin! the story $est%&andi

AMA 'uide for Media &eportin! on Open Payments "ata &elease

Media Should erify the Accuracy of "ata *nderstand the Context of +inancial &elationships between Physicians and#ndustry ,hen &eportin! on Open Payments "ata

The American Medical Association (AMA) is committed to transparency and supports the release of data that can helpimprove -uality of care for patients% includin! information about physician.s financial interactions with the industrywhich could help promote understandin! and trust and stren!then the patient/physician relationship +or that reason% theAMA supported the Sunshine Act when it was passed by Con!ress 0owever% because of issues with the implementationof the law% the AMA believes that certain safe!uards are needed to ensure the information is depicted correctly and incontext to be useful for patients and fair to physicians Thus% the AMA stron!ly encoura!es media to consider thefollowin! in their covera!e to ensure data is indeed presented in an accurate and informative way to help patientsunderstand and interpret the information correctly

About the Open Payments Pro!ram

*nder the Sunshine Act passed by Con!ress in 1232% industry is re-uired annually to report financial interactionswith individual physicians to the Centers for Medicare and Medicaid Services (CMS)% and this information is then to

be made public To implement the law% CMS developed the Open Payments pro!ram

Are Open Payments "ata Accurate4

Patients deserve to have access to accurate information Publishin! inaccurate data can lead to misinterpretations%harm reputations and cause patients to -uestion their trust in their physicians #t can also unfairly impact physicians.

ability to attain or 5eep research !rants and other employment opportunities that re-uire disclosure

AMA has stron!ly ur!ed the federal !overnment to adopt sensible measures to ensure that the information releasedis accurate *nfortunately% the CMS. Open Payments pro!ram has to date been pla!ued by si!nificant shortcomin!sthat call into -uestion the accuracy of information that will be published on September 62th% includin! an inade-uateopportunity for physicians to review their individual data and technical problems with the system.s website

7 #nade-uate opportunity for physician review

+or the estimated 122%222 physicians affected by the Sunshine Act% CMS provided a short% 89 day window to reviewand correct any inaccurate data *nfortunately% several factors hindered participation by many of the physiciansimpacted includin!:

• Conflictin! and inade-uate notification to the physician community about 5ey implementation deadlines for the pro!ram CMS i!nored its !uidance that physicians would be able to be!in the re!istration process on;anuary 3% 1238% condensin! the re!istration and review timeframe to <ust 89 days Physicians also did notreceive timely notice when the 89 day deadline was extended because of service interruptions on the OpenPayments website

• A time/consumin!% non/user friendly and complicated re!istration process% which physicians were re-uiredto complete in order to review information bein! reported about them Many physicians reported ma5in!numerous calls to the CMS 0elp "es5 for assistance in re!isterin!

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• A 6=2 pa!e !uidance document that CMS ori!inally provided to help physicians throu!h the process failedto detail all the steps involved to re!ister with the system% review personal reports% and see5 correction ofany inaccurate data

• A belea!uered or troubled system that has been pla!ued by repeated shut downs Many physiciansexpressed frustration that the system was not wor5in! when they attempted to use it Some physicians whohad set aside time specifically to re!ister and review their data while the system was not functionin! may

not have been able to schedule more time away from their patients to accomplish the tas5 Conse-uently%we are concerned that a lar!e number of physicians may not have been able to complete the process

7 CMS concerns about the accuracy of reported data

Concerns about accuracy have prompted CMS to hold bac5 3>6 of the data reported to the Open Payments system inthe current cycle and the a!ency has also expressed concern about more of the reported information Althou!h thedecision !ives the impression that the A!ency is actively verifyin! the accuracy of data submitted to OpenPayments% this is unfortunately not the case

,hat "oes 0avin! +inancial &elationships with #ndustry &eally Mean4

Publicly reportin! industry payments to individual physicians can imply% wron!ly% that such payments are alwaysinappropriate Some may be% but to be able to ma5e an informed <ud!ment% it is vital to be able to set the financialinformation in context ;ust because a physician has a relationship with industry does not automatically mean thathis or her professional <ud!ment has been influenced inappropriately

AMA stron!ly opposes inappropriate% unethical interactions between physicians and industry 0owever%relationships with industry also drive innovation in patient care% contribute to the economic well/bein! ofcommunities% and provide si!nificant resources for professional medical education% to the ultimate benefit of

patients An ur!ent challen!e for both physicians and industry is to preserve stron!% productive collaborations for the benefit of patients and the public and at the same time ta5e clear% effective action to avoid conflicts of interest andrelationships that would undermine trust

Meanwhile% CMS is re-uired by the Sunshine Act to provide context for the data released throu!h the Open

Payments pro!ram AMA and other sta5eholders have repeatedly ur!ed CMS to provide this information% but theA!ency has not yet done so% even thou!h the public release of Open Payments data is imminent

AMA stron!ly encoura!es members of the media to provide examples of interactions between physician andindustry in user/friendly lan!ua!e to help the public understand the important role that appropriate relationships

between physicians and industry has in advancin! the practice of medicine

Some examples of appropriate interactions include:

• Advancin! Medical ?nowled!e / &esearch to develop new treatments and improve patient care is costly #tta5es time and money to carry out clinical trials and !et demonstrated new therapies throu!h the approval

process and into clinical use Physicians in academic medical centers and other or!ani@ations receivefundin! from industry as investi!ators in clinical research and as consultants who help desi!n and evaluateclinical trials or develop new medical technolo!ies #n some cases% industry support for multiple pro<ects isreported under the name of the academic dean or pro!ram director% which can ma5e it seem as if theindividual received a lar!e dollar amount from industry when in fact the money financed the cost of theclinical trial and was distributed to several endeavors actually led by other physicians

• Advancin! Physician ?nowled!e / #ndustry also supports physician education% and in some instances thatwill be reported as payments to individual physicians% even if the physicians are not aware +or example% a

physician may receive an honorarium from his or her medical society for bein! on the faculty of aneducational pro!ram put on by the society #f the society received a !rant from industry to help support the

pro!ram% that honorarium may be reported as indirect payment from industry throu!h the Open Payments

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system% even thou!h the physician received the honorarium directly from the medical society and wasn.taware of the industry support Continuin! Medical ducation courses funded by the industry as well asvisits from pharmaceutical representatives to physician offices or health care or!ani@ations to tal5 aboutnew research and treatment options can also supplement physicians. 5nowled!e about new advances inmedicine Additionally% industry sometimes provides physicians with reprints of peer/reviewed medical

<ournal articles and medical textboo5s% which li5ewise help physicians stay abreast of the latest medicaltreatments