What is the Sunshine Act (Open Payments)?
Open Payments requires manufactures of covered drugs, devices, biologics, or medical supplies to collect detailed information about payments and other "transfers of value" worth over $10 from manufacturers to physicians and teaching hospitals. This information will be made available to the public in 2014 in the Centers for Medicare & Medicaid Services (CMS) Open Payments Database, a publicly accessible, searchable, website with downloadable information about these payments.Open Payments applies to payments made to physicians with an active license to practice, including: Doctors of medicine, osteopathy, dentists, podiatrists, optometrists, and licensed chiropractors. Residents are not included.
The Open Payments database will provide information about payments made by industry, but does not seek to explain or make judgements about which if any of those relationships are potentially problematic. Relationships with industry are not inherently suspect and public insight into those relationships is welcome and represents an important opportunity to begin a discussion with patients about healthcare innovation and advancing health and patient care through productive and principled partnerships with industry.
What are Manufacturers required to report to CMS?
- Any type of payments or transfers of value to physicians including:
- Consulting fees
- Compensation for services other than consulting, such as speaker fees
- Food and beverage
- Travel and lodging
- Educational materials including journal reprints
- Ownership & Investment Interest
- These types of payments are exempt:
- Honoraria for speaking at Certified and accredited CME programs
- Educational materials that directly benefit patients
- Buffet meals provided to all participants of a large-scale conference
- Discounts or in-kind items for the provision of charity care
- Reportable payments to teaching hospitals:
- Charitable Contributions
- Royalty or license
- Space rental or facility fees
- Equipment / Device loans when over 90 days
Note: Even indirect payments to physicians and teaching hospitals must be reported. For example, if the manufacturer provides a payment to the OHSU Foundation that is directed for the use of a specific physician, that payment will be reported in the open payments database as an indirect payment to that physician.
- August 1, 2013: Industry entities began collecting the required data
- June 1, 2014: Physicians & teaching hospitals are now permitted to register on CMS Enterprise Portal
- July 14, 2014 - September 10, 2014: Phase II of registration for the Open Payments system and review and dispute period (Extended due to technical difficulties)
- September 30, 2014: First public reports
Note: Registration and review of data reported about you in the open payments database by manufactures is voluntary. The only way to determine whether information about transfers of value as described above are accurate is to track this information yourself and to register for the review and dispute process as described below.
- Track all the interactions you have with industry involving payments or transfers of value to ensure accuracy. There are apps that have been designed specifically for this purpose.
- Always ensure that you have an up to date CoI disclosure by familiarizing yourself with OHSU policies and resources about the CoI disclosure requirements, including the OHSU Sunshine Act Guide for Physicians. Contact the CoI office with any questions (503-494-7887 or email@example.com).
- Phase 1 Registration - Active Now: In order to review and dispute data, you must complete EIDM (Enterprise Portal) registration for access to the Open Payments system. There are Phases I and II to the registration process. Before Registering for Phase II, you MUST first register in the CMS EIDM to complete Phase I registration, accessed here: https://portal.cms.gov/wps/portal/unauthportal/registration.
- *NEW* Phase 2 Registration Open - July 14, 2014: Register in the Open Payments System for Phase II by going to the following link: https://eidm.cms.gov/EIDMLoginApp/userlogin.jsp to complete the registration process and have the opportunity to review and dispute data submitted by applicable manufacturers and GPOs prior to public posting.
- *NEW* Review & Dispute: This process spans a total of 60 days. Because of technical issues of the CMS website, the review & dispute process has been extended. The new timeframe is as follows:
- Review & dispute: 7/14/2014 - 9/10/2014. This is for physicians and teaching hospitals to review and initiate any disputes they may have regarding the data reported about them.
- Correction period: 9/11/2014 - 9/25/2014. This is additional time that has been provided to industry to submit dispute corrections.
- Public website launch: 9/30/2014 (This date has not changed).
- Stay tuned by watching for future announcements!
How Physicians Can Prepare for the Review and Dispute Process:
- Register in the Open Payments system (have your CMS Enterprise Portal user ID and password readily available - created in Phase 1);
- Delegate roles and responsibilities by nominating system users to fill specific user roles (think of individuals you want to interact with the Open Payments system on your behalf, such as a department representative if authorized by the department). However, note that this individual would need to have access to specific information about transfers of value to the physician in order to be able to determine if certain transfers of value should be questioned;
- Gather any records of payments, transfers of value, ownership or investments that you may have received between August 1, 2013 and December 31, 2013;
- Note: Initial public posting will contain data only from August 1, 2013 - December 31, 2013. Future cycles will contain a full calendar year of data.
- Review and dispute data submitted by applicable manufacturers and applicable GPOs prior to public posting of the data. 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 by visiting the review and dispute webpage of the Open Payments website.
- Organize your industry contact information as you will be working directly with them to resolve any disputes or answer any questions as you may have in regards to the data they've reported.
Sunshine Act Resources
*New* Streamlined Registration Guide
*New* Sunshine Act FAQs
1 Page Sunshine Act Summary
OHSU Policy Sunshine Act Guide for Physicians
CMS Enterprise Portal for Registration