Open Payments / Physician Sunshine Act

Overview

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.

Physicians and teaching hospitals can register in CMS’ Enterprise Portal (Enterprise Identification Management system – EIDM). 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.

On August 15, CMS announced that the Open Payments system was once again available for physicians and teaching hospitals to register, review and, as needed, dispute financial payment information received from health care manufacturers. The system was taken offline on August 3 to resolve a technical issue. To account for system down time, CMS is extending the time for physicians and teaching hospitals to review their records to September 8, 2014. The public website will be available on September 30, 2014.


Two phases of registration

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 –  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 – The Open Payments data correction period began September 15, and will last for a minimum of 15 days. During this time, applicable manufacturers and group purchasing organizations (GPOs) have the opportunity to acknowledge and resolve disputes initiated by physicians and teaching hospitals.

Note: It is up to the applicable manufacturer or GPO to work directly with the physician or teaching hospital to resolve any disputes. The Centers for Medicare & Medicaid Services (CMS) is not responsible for mediating disputes. 

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 openpayments@cms.hhs.gov or call (855) 326-8366.

Open Payment provisions within the 2015 proposed Medicare physician fee schedule

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.

On August 1, the AAFP sent CMS a response letter. The final 2015 Medicare physician fee schedule is expected to be released in November. 


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