CMS Temporarily Suspends Open Payments System

by King & Spalding
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On August 7, 2014, CMS announced via email that it has temporarily suspended the Open Payments system “to investigate a reported issue.” Although CMS did not offer further explanation, our understanding is that the system has been shut down since Monday, August 4, amid complaints from some physicians that they have been able to view within their Open Payments data dashboards data that was reported about other physicians with the same name. As a result of the suspension, covered recipients are not currently able to register and review data, and the 45-day review and dispute period is effectively on hold.

CMS noted in an email announcement that “[f]or each day the Open Payments system is offline for this incident, CMS will adjust the Open Payments review and dispute deadline and the following 15-day corrections period deadline accordingly.” CMS indicated that it would follow up with stakeholders “when the Open Payments system is scheduled to go back online.”

CMS’s announcement did not address whether the current suspension would impact its plans to publish the data by September 30, 2014. The suspension and related issues, however, may increase the likelihood that CMS will seriously consider calls from the American Medical Association (“AMA”) and others to push back the first publication deadline.

On Tuesday, August 5, more than 100 physician professional societies, including the AMA, signed on to a letter to CMS to express “serious concerns regarding how the Open Payments System has been implemented.” The letter, sent to CMS Administrator Marilyn Tavenner, urged CMS to postpone the first publication of the Sunshine data until March 31, 2015, to allow physicians sufficient time to register, review, and dispute data reported about them before CMS makes it public.

The letter notes that CMS’s short timeframe for uploading data, processing registrations, generating aggregated, individualized reports, managing disputes, and incorporating the necessary data updates, “will likely lead to the release of inaccurate, misleading, and false information.” The letter also notes that the complex registration process in combination with the condensed timeframe make the task of reviewing and disputing records by August 27 “effectively impossible” for physicians.

Notably, the letter also describes the groups’ concerns that manufacturers have the power to unilaterally dismiss disputes initiated by covered recipients, even if the covered recipients do not agree with the dismissal. The letter references a June 24 meeting between CMS and society staff, where CMS officials apparently stated their intent to issue clarifying guidance that manufacturers are not authorized to unilaterally dismiss disputes. The groups request that CMS issue clarifying guidance on that point.

The groups also voiced concern over CMS’s proposed change to the Sunshine Final Rule that would remove the exclusion for payments for serving as faculty at a continuing medical education program, and CMS’s current belief that textbooks, journal article supplements, and reprints are reportable.

The letter came a little more than a week after 26 physician professional societies and industry associations, including PhRMA and BIO, sent another letter to Administrator Tavenner. That letter requested that CMS provide physician stakeholders with a preview of the contextual information that will accompany the public release of the Open Payments data. The groups noted that without the contextual information mandated by Congress, there exists an opportunity for “confusion and misinterpretation.” The groups also urged CMS to increase educational outreach efforts to physicians and to simplify the physician registration process. The groups request that the education include “more information on what will be reported, when it will be reported, what the reporting will look like, and how [physicians] can see what will be reported about them.” The groups also requested that CMS share the number of physicians who have registered in Open Payments so that the groups can evaluate what additional efforts are needed to increase physician awareness and potentially help with physician registration.

Copies of the letters can be accessed here and here.

Reporter(s), Brian A. Bohnenkamp, Washington, D.C., +1 202 626 5413, bbohnenkamp@kslaw.com.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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