Entities that submitted Sunshine Act reports are now able to review and correct the 2013 “Open Payments” records returned from the intermingled data fix that resulted in CMS withholding a significant portion of the data.  The agency expects the corrected intermingled data—which accounts for approximately a third of the Open Payments database – to be available around the middle of next year.

But we understand from discussions with the industry that more than “intermingled” data may have been withheld.  For example, certain reporting entities have noted the absence of other data from publication, including disputed data for which the entity submitted corrections after resolving the matter with the relevant physician or teaching hospital.  Further, the published data may still contain unidentified errors.

As a result, the published data provides only a limited perspective on the reporting of industry-physician relationships, which could affect how applicable manufacturers are benchmarked against their peers.  Despite the partial publication of the data, we expect from recent remarks from government officials that regulators are already mining the data to substantiate whistleblower allegations and identify potential industry-wide issues for investigation.

Next steps: review and resubmission

Through an October 30 announcement, CMS has asked reporting entities to download a Removed Records Report that will show the records across all three payment types (general, research, and ownership/investment interests) that were removed from the published identified data, and that will explain why each individual record was removed.  At that point, reporting entities will be able to re-submit corrected records to the Open Payments system.

Guidance and deadlines 

More information will also be available at a CMS webinar on Thursday, November 13.  Reporting entities will need to submit corrected records to CMS no later than the end of the 2014 data submission and attestation period, to be published in the data release projected for June 30, 2015.

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