Sunshine Act/Open Payments Alert

by LeClairRyan
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On Monday, May 5, 2014, CMS published in the Federal Register an unexpected notice seeking additional public comment specifically around the Dispute Resolution process, which is the process CMS is establishing to give physicians who receive payments from pharmaceutical or medical device manufacturers an optional way to review, and if necessary to dispute, the payment information submitted to CMS by the manufacturers before the information is published. Comments are due to CMS by June 2, 2014. 

Also on Monday, CMS announced that physicians and teaching hospitals will be able to register as an Open Payments system user starting on June 1, 2014. Once registered, physicians will be able to access and review their own data beginning on a date in July that CMS will announce later.

Context
The April 2014 release by CMS of raw, uncontextualized Medicare physician payment data for 2012 has taught many providers a difficult lesson in the dangers inherent in releases of unreviewed data: errors in the data, inconsistencies, and anomalies resulting in some cases of unjustified accusations of fraud or other improprieties, with attendant undesired attention by law enforcement, regulators, and the media. However, in contrast to the blindsiding nature of the physician payment date, in this instance CMS is giving physicians at least a chance to review data before it becomes public.

Take-Aways
Physicians or their employers need to be aware that while they are not required to take any action whatsoever with regard to CMS’s Open Payments/Sunshine Act, they do have the option to register with CMS so they can review their own personal information regarding any payments that manufacturers have reported to CMS.

  • CMS on Monday, May 5 also announced that physicians will be able to register into CMS’s Open Payments system on June 1, 2014, and once registered, will be able to access and review their own data in July, with the specific date to be determined later by CMS. CMS has repeatedly committed to providing physicians with at least 60 days’ notice before publication to review, and if needed to dispute, any information about their own payments. Physicians will have at least 45 days to review their own information and lodge any disputes, followed by a 15-day dispute resolution period

Physicians, physician employers, or other stakeholders with concerns or questions about the Dispute Resolution process should take the opportunity to file a comment with CMS by the June 2, 2014 deadline.

Recommendations
LeClairRyan therefore makes two recommendations:

  • 1) Strongly recommend that all physicians, teaching hospitals or physician employers plan registering with the Open Payments system soon after the system opens on June 1, 2014, and then plan on reviewing their own Open Payments data as soon as CMS opens up the system for data review sometime in July 2014.
  • 2) Also, recommend physicians, physician employers, or other stakeholders should consider filing comments with CMS before June 2, 2014 with any concerns or recommendations, such as recommending that in order to provide patients and other consumers of the Open Payments data with as much context as possible, CMS should add a data field to its final information release allowing physicians who access their system to include a very brief contextual comment about any payment that physician is reported as receiving, especially payments that the physician disputed in whole or in part.

 

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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