Open Payments / Physician Sunshine Act
What is the Physician Sunshine Act exactly?
Who is required to report information?
Applicable manufacturers of drugs and medical devices and applicable group purchasing organizations (collectively referred to in this document as “manufacturers”) must report information relating to payments to practitioners and teaching hospitals every year. Physicians, hospitals, and other payment recipients are not required to report information, but CMS encourages them to stay abreast of the Open Payments requirements, track their own receipts, and monitor the accuracy of reports that are issued with information about them.
I am a health care provider, but not a physician (e.g. nurse, physician assistant, physical therapist). Are payments to me reportable?
No, the reporting only applies to physicians and teaching hospitals. For the purposes of Open Payments, a “physician” is any of the following types of professionals that are legally authorized by the state to practice:
- Doctors of medicine or osteopathy practicing medicine or surgery
- Doctors of dental medicine or dental surgery practicing dentistry
- Doctors of podiatric medicine
- Doctors of optometry
Note: Medical residents are excluded from the definition of physicians for the purpose of this program.
What categories of information are reportable?
• Consulting fees
• Compensation for services other than consulting
• Charitable contribution
• Royalty or license
• Current or prospective ownership or investment interest other than stock in publicly-held companies or mutual funds
• Direct compensation for serving as faculty or as a speaker for a medical education program
What information specifically will be reported?
Manufacturers have to report information from three categories: transfer of value; drug, device, biologic, or medical supply; and research.
Transfer of value:
Information about what was actually transferred, including the amount, date, and form of payment.
Information about who received the transfer. If you received the payment directly, this includes your full name, business address, email address, type (e.g., M.D., D.O.), NPI, specialty, and license state and number. If the University or a hospital was the recipient, the manufacturer will report similar information about the University or the hospital. However, your identifying information will be reported if you are a Principal Investigator on the study.
Associated drug, device, biological, or medical supply:
Information relating to the identity of the product being tested.
If the payment you received is for research, the manufacturer must provide significant information about the research. This includes information about the study, along with information about each Principal Investigator (PI) who is also a licensed physician. This includes each PI’s full name, business address, email address, type (e.g., M.D., D.O.), NPI, specialty, and license state and number.
I received funding from a manufacturer to do research. What information will be reported?
If you are a Principal Investigator, the manufacturer will be required to report a broad swath of information about you, including your full legal name, primary business address, NPI, specialty, license state and number, information about the drug or device that was researched, and information about the payment or transfer of value that you received.
I’m just the PI on a study and the University is receiving all the funding. Will my information be reported?
Yes. Per the final rule, a manufacturer must report payments made for research pursuant to a written agreement or research protocol and must include the name of the research institution, regardless of whether that institution (here, the University) qualifies as a “teaching hospital”. Additionally, the manufacturer must provide the PI’s full legal name, primary business address, NPI, specialty, license state and number, as well as significant information about the drug or device that was researched, and information about the payment or transfer of value that received.
Will every payment be reported or are there some exceptions?
Not all payments are reportable. For example:
Payments under certain thresholds. These thresholds began in 2013 as $10 for individual payments and $100 for gross payments over the course of each calendar year, and are updated every year according to the Consumer Price Index.
Payments for speakers at accredited CME events (as defined below) if the manufacturer does not pay the speaker directly and does not have a role in selecting the speaker. The event must meet the accreditation or certification requirements and standards for continuing education of one of the following:
- The Accreditation Council for Continuing Medical Education
- The American Academy of Family Physicians
- The American Dental Association's Continuing Education Recognition Program
- The American Medical Association
- The American Osteopathic Association
Food or beverage provided to all attendees of large scale conferences or meetings where the manufacturer does not know the name of recipients or value of the food (e.g. food provided buffet-style).
Product samples or educational materials intended for use by patients.
When does reporting begin and when will the database be made public?
For the intial implementation of the database, manufacturers were required to report all payments or transfers of value as described above starting August 1, 2013. The Open Payments website then became viewable by the public on September 30, 2014.
What do I have to do to comply with the Act?
The burden of complying with Open Payments is placed upon manufacturers, not practitioners. You do not have to do anything to comply with Open Payments; however, the University strongly recommends that you do the following:
Become familiar with the information that will be reported.
Register with CMS’ Open Payments system.
Look at the information applicable manufacturers submit about you.
Work with applicable manufacturers to make sure the information submitted about you is correct.
How do I find out if a report has been made about me?
You must register with CMS’ Open Payments system to see information reported about you. You can register by going to the CMS’ Enterprise Portal.
For step-by-step instructions on how to register, and what information you will need to verify your identity, go here (registration information starts on slide 8).
Once registered, you may start reviewing and disputing information submitted about you. For additional instructions on how to navigate the database once you are registered, please click here.
When should I register to be able to view reports?
There is no end date by which you must finish registration. Note, however, that the first reporting period covers transactions from the last 5 months of 2013. Future reports will be published every year and will include a full 12 months of payment data beginning next spring.
How exactly do I dispute an erroneous report?
When you initiate a dispute within the Open Payments system, an email notification will be sent to the individual that has been designated as the submitter. Once the dispute is reviewed, it can be resolved in one of three ways:
- Resolved – the manufacturer updates and resubmits the disputed data.
- Resolved, no change - indicates that the manufacturer doesn't agree with the dispute or has discussed the dispute you and determined that it didn’t need to change the data. You may initiate a new dispute if you disagree with the “resolved, no change” status.
- Withdrawn – you can withdraw a dispute initiated against a record.
When a dispute is resolved by making updates to a disputed record(s), the manufacturer must resubmit and re-attest to the corrected record(s). Once this step is completed, the review and dispute status will automatically be updated to “resolved” in Open Payments. If the manufacturer determines that no changes need to be made to the disputed record, the status will be updated to “resolved no change” in Open Payments. If a dispute cannot be resolved, then the latest, attested-to data the manufacturer submitted will be published and marked under dispute.
What if I dispute information about me within the 45-day dispute period, but the manufacturer and I have not resolved the dispute by the time the information in the database goes public?
Any data that is disputed, if not corrected by industry, will still be made public but will be marked as disputed.
The information reported in the Open Payments database does not match the information I reported on my University Outside Activity Report (OAR) Form. Can there be a valid reason for the discrepancy?
Yes, there could be a valid reason why the information a manufacturer reported about you in the Open Payments database and the information you reported on your University OAR or on your UWMF annual report to the Interactions with Industry Review Committee (IIRC) does not match. Manufacturers must report a broad range of payments, including for example those payments that actually are made to the University for which you are PI on the research protocol. In this case, your activities as PI are within the scope of your employment. On the other hand, you are only required to report on your University OAR payments made to you as an outside activity (i.e. not within the scope of your University employment). The same is true of your annual report to the UWMF IIRC.
Additionally, manufacturers must track all payments, including indirect payments or any transfer of value, so long as it is more than $10. This includes providing meals, snacks and soft drinks at conferences or educational events, unless the meal, snack or soft drink was generally available to all participants of a large-scale conference or part of a buffet (where it would not be possible to track who consumed the food or drink). The same is true for educational materials such as handouts or printed slides if provided at a CME event, if the event does not meet certain criteria as outlined in the regulations for being exempt. As a result, it is possible that you accepted food, beverages, or educational materials totaling $11 or more at conference or other educational event which were provided by an applicable manufacturer without realizing the manufacturer’s involvement. In this case, your OAR might be erroneous, but understandably so. Physicians are encouraged going forward to be cognizant of accepting food, beverages or educational materials at CME events and conferences, and maintain documentation if such items were provided by a manufacturer.
Who can I talk to with questions I have about Open Payments?
Please call the UW-Madison Office of Legal Affairs at 263-7400 and ask to speak with a health law attorney.