A blog by attorneys for anyone interested in or affected by The Sunshine Act.

CMS Announces Proposed Changes to Sunshine Act Regulations

July 7, 2014
Ruselle W. Robinson

Just days after the reporting period for 2013 payment and physician ownership data came to a close on June 30, 2014, CMS announced that it is proposing four changes to the Sunshine Act (also known as Open Payments) rule.  The most significant revision to the Sunshine Act rule is deletion of the continuing education exclusion.

Here are the four proposed changes:

  1. Delete the Continuing Education Exclusion.  CMS is eliminating the CME exclusion because:

“Eliminating the exemption for payments to speakers at certain accredited or certifying continuing medical education events will create a more consistent reporting requirement, and will also be more consistent for consumers who will ultimately have access to the reported data.”

  1. Delete the definition of “covered device” as duplicative of the definition for  “covered drug, device, biological or medical supply”.
  2. Require that applicable manufacturers report the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.
  3. Require applicable manufacturers to report stocks, stock options or any other ownership interest as distinct categories.  CMS believes this requirement will enable it “to collect more specific data regarding the forms of payment made by applicable manufacturers”.

The CMS proposed rule will be published in the Federal Register on Friday, July 11, 2014.  CMS will accept comments on the proposed rule through September 2, 2014.  I will provide an update after I have reviewed the full text of the proposed changes in the Federal Register.

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