The Physician Payments Sunshine Act requires drug and device manufacturers to report transfers of value to physicians and teaching hospitals publicly. As a result, manufacturers and group purchasing organizations must disclose to the Centers for Medicare & Medicaid Services (CMS) any physician ownership or investment interests.
The law is intended to help reduce potential conflicts of interest that could arise from relationships between physicians or teaching hospitals and manufacturers. The AAFP supports reasonable transparency efforts, but believes physicians should be given the opportunity to preview and appeal data before the information is made publicly available.
While AAFP supports the spirit of transparency promoted by the Sunshine Act, we oppose rules that could result in the publication of misleading information or impose costly and burdensome paperwork requirements on family physicians.
Beginning on June 1, 2014, physicians and teaching hospitals can register in CMS’ Enterprise Portal (Enterprise Identification Management system – EIDM). Registration for physicians and teaching hospitals will be conducted in two phases for this first Open Payments reporting year. There is no official end date for when physicians need to finish the registration steps. But, if the physician wants to participate in the review or dispute period for 2013 Open Payments data, CMS advises that they complete registration in EIDM and Open Payments by the end of the initial 45-day review/dispute period (the exact date the 45-day review and dispute period will begin will be announced in the coming weeks). Identity verification for registration will take some time, so CMS recommends completing the registration process as soon as possible and not waiting until close to the end of the initial 45-day review/dispute period.
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CMS Official Website for Open Payments(www.cms.gov)
Phase 1: Register in the CMS Portal: Register in CMS’ Enterprise Portal (the gateway to EIDM). Use the Phase 1 Step-by-Step CMS Enterprise Portal Registration for Physicians and Teaching Hospitals presentation for guidance on how to complete this first portion of the registration.
Phase 2: Register in the Open Payments System – Physicians and teaching hospitals can begin registering in the Open Payments system on July 14. Although registering in the Open Payments system is voluntary, it becomes a mandatory process if physicians and teaching hospitals want the opportunity to review and dispute data submitted by applicable manufacturers and applicable group purchasing organizations (GPOs) prior to public posting on September 30, 2014.
In order to review or dispute data submitted by industry for the 2013 reporting period, physicians must be registered—and have reviewed any data reported about them—on or before August 27, 2014, the end of the initial 45-day review and dispute period. And with identity verification as part of the registration process, which can take some time, CMS recommends completing the registration process as soon as possible and not waiting until the end of this initial 45-day review and dispute period.
Review – beginning in mid-July through August: For 45 days immediately following the initial availability of the Open Payments system, review your data. If you have any concerns about its accuracy, this is also the time (plus an additional 15 days) to dispute and correct the data submitted by industry.
Note: Any data that is disputed, if not corrected by industry, will still be made public but will be marked as disputed. Learn more about the review and dispute process.
CMS will release majority of the data to the public on September 30, 2015 and December 31, 2015 is the last day to file a dispute for 2013 reports.
Questions? E-mail the CMS Open Payments Help Desk at email@example.com or call (855) 326-8366.
On July 3, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and rates for services furnished under the Medicare physician fee schedule beginning January 1, 2015. Citing a need to respond to questions and experience administering the program, CMS unexpectedly proposed four changes to the Open Payments program:
• Delete the definition of “covered device” as it is duplicative of the definition of “covered drug, device, biological or medical supply,” which is already defined in regulation.
• Delete the Continuing Education Exclusion in its entirety. CMS asserts that eliminating the exemption for payments to speakers at certain accredited or certifying continuing medical education events will create a more consistent reporting requirement for industry and be more consistent for consumers who access reported data.
• Require the reporting of 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.
• Require applicable manufacturers to report stocks, stock options, or any other ownership interest as distinct categories.
The AAFP will send CMS extensive regulatory comments on this proposed regulation before the comment period closes on September 2, 2014. The final 2015 Medicare physician fee schedule is expected to be released in November.
AAFP Letter to CMS in Response to CME Changes in the 2015 Proposed MPFS - August 1, 2014(4 page PDF)
AAFP Executive Summary of Open Payments in the Proposed 2015 MPFS - July 10, 2014(2 page PDF)
Joint Letter to HHS on Potential Impacts to Medical Education and Patient Care - October 28, 2013(3 page PDF)
AAFP Letter to CMS on Open Payment Data Collection - May 29, 2013(2 page PDF)
National Physician Payment Transparency Program - February 11, 2013(4 page PDF)
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Open Payments/Physician Sunshine Act