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January 5, 2015

Final Rule Changes for CMS Open Payments to Be Implemented for 2016 Program Year

January 5, 2015—As part of the 2015 Medicare Physician Fee Schedule publication, the Centers for Medicare & Medicaid Services (CMS) has announced four revisions that are based on public comments and other changes. The revisions will be implemented for the 2016 program year, with reporting to CMS in 2017.

The four revisions are:

  1. Deleted the provision excluding compensation provided to physician speakers at continuing education events.

  2. Required reporting of the marketed name and therapeutic area or product category of the related covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or noncovered drug, device, biological, or medical supply.

  3. Required reporting of stocks, stock options, or any other ownership interest as distinct categories.

  4. Deleted definition of “covered device.” This is a technical change and will have no impact because the definition of covered drug, device, biological, or medical supply is already included in the Open Payments rule.

According to CMS, the first revision—eliminating the exemption for payments to speakers at certain accredited or certified continuing medical education events—creates a more consistent reporting requirement and will also be more consistent for consumers who will ultimately have access to the reported data.

Starting in 2016, when an applicable manufacturer provides an “indirect payment” or other transfer of value to a continuing education organization for a continuing education event to physicians and knows or finds out the identity of the physician attendees/speakers within the reporting year or by the end of the second quarter of the following reporting year, that payment must be reported to CMS in 2017.

Starting in 2016, when an applicable manufacturer provides an indirect payment or transfer of value to a continuing education organization for payment to a physician speaker at a continuing education event, regardless of the accreditation status of the organization, the payment must be reported to CMS in 2017.

The Open Payments final rule previously included a reporting exclusion for indirect payments made to the physicians speaking at continuing education programs that were sponsored by certain accredited organizations (several specifically listed organizations at §403.904[g][1][i] sponsoring continuing education events). The agency noted that it received feedback from numerous stakeholders that the listing of accepted accredited organizations named in the final rule was incomplete, and the listing should either be expanded or the exclusion removed.

The second revision—aligning the requirements to report the marketed name, not only for drugs and biologicals, but also for all devices and medical supplies—facilitates consistent reporting for the consumers and researchers using the Open Payments data.

With the third revision, applicable manufacturers and group purchasing organizations will now be required to report the following distinct forms of payment as distinct categories: stock, stock options, or any other ownership interests. This will enable Open Payments to collect more specific data regarding the forms of payment made by applicable manufacturers.

More details are outlined in the notice on the Open Payments website. CMS also recommends that interested parties learn more about the final rule changes by reviewing the official CMS fact sheet for the Medicare Physician Fee Schedule, reviewing the sections of the Final Rule that pertain to Open Payments, and reading the full final rule, which was published in the Federal Register on October 31, 2014.

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January 5, 2015

FDA Approves Medtronic's In.Pact Admiral DCB to Treat SFA and Popliteal Artery Disease

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