Open Payments marks its ninth anniversary this year, but many physicians still may not be entirely aware of how this CMS program applies to them. In short, any transfer of value from industry to clinicians above specific thresholds is reported by the payer (aka the reporting entity) and made public each June.
Before CMS releases the yearly report, though, there's an opportunity to review, affirm, dispute, and correct the information. ACP Internist recently talked to Veronika Peleshchuk Fradlin, director of the Division of Transparency Projects in the Center for Program Integrity Data Analytics & Systems Group, to learn more about the program, including why physicians may want to make timely review of their data a priority.
Q: Briefly, how does Open Payments work?
A: The Open Payments Program is a national transparency initiative administered by CMS and mandated by the Affordable Care Act. It requires certain pharmaceutical companies and device manufacturers, referred to as reporting entities, to report any payments or other transfers of value they make to covered recipients, who are physicians, teaching hospitals, and certain nonphysician practitioners. The Open Payments System is a very large database where the data from the industry is collected. The same database supports a prepublication review and dispute period, during which covered recipients have an opportunity to look at the data that was reported about them before it becomes published on the CMS Open Payments website. The system has been refined multiple times since its inception, most notably in 2021 to include nonphysician practitioners, such as advanced practice nurses and physician assistants, as mandated by the SUPPORT Act of 2018.
Q: What types of payments are reported?
A: There are three broad categories: general payments, research payments, and ownership and investment interest records. Research payments are, as the name indicates, related to research activity or a formal research agreement or protocol. General payments can be things like travel honoraria or any type of education funds that are not specifically tied to a research study. Ownership and investment interests are not exactly payments, but financial information about the investments of covered recipients or their immediate family members in entities defined as applicable manufacturers or GPOs [group purchasing organizations] under the Open Payments Program.
Q: How small a payment gets reported?
A: There is a reporting threshold for individual payments and an aggregate reporting threshold for the year. These started at $10 and $100 in year one of the Open Payments Program and have been adjusted yearly with the Consumer Price Index. Currently, the individual payment threshold is $11.64, and the aggregate threshold is $116.35. If any single payment is above the individual threshold, it needs to be reported to Open Payments, regardless of the total reported amount for the year. With the aggregate threshold, if multiple payments made to a provider over the course of a year add up to $116.35 or higher, they must be reported even if the individual payments were below the $11.64 threshold. It's important to note that these thresholds are being applied to the reporting entity, so the reporting requirement is on them. Physicians and other covered recipients need to know these thresholds so that they can identify any payments during data review that didn't meet them but were still reported.
Q: Why is it important for physicians to review the data?
A: One good reason for physicians to review their data is that it will become public and visible to patients and other stakeholders. Patients may see data on the site and ask their physician about it, and physicians may not even be aware of some payments, particularly related to conference attendance or similar events that they may not consider a transfer of value. That's what's in it for the physicians. It's also important that the Open Payments data is accurate and clear and accessible to the public. We want to make sure the data is as valid and reliable and timely as it can be for public use.
Q: When is data posted and available for review?
A: It's a standard timeline on a yearly cycle. Industry collects the data for the duration of the calendar year and reports it to CMS between the start of February and March 31, our statutory reporting deadline. After that, every spring between April and May, there is a 45-day period, basically April 1 to mid-May, when the data is available for providers to review within the Open Payments System before it becomes publicly available.
The Open Payments System is available through the CMS Enterprise Portal, and registration is required. CMS maintains a covered recipients webpage that provides step-by-step instructions about how to access the Open Payments System and how to register. Once registration is complete, the provider will be able to see the data and take any actions on it, including filing a dispute, if necessary.
It's best to handle reviews and disputes right after the data is reported for the first time and before it becomes publicly available. It's also a good way to ensure as speedy a resolution as possible. If there are any issues, inaccuracies, questions, that is when reporting entities have the resources available and are monitoring any disputes or inquiries about the data. Physicians should mark their calendars for April as a reminder to see if any relevant payments have been reported. They can also sign up to receive reminders from CMS about the review and dispute period via its Open Payments listserv. After the 45-day review and dispute period ends, the reporting entities have an additional 15-day period to make any changes or modifications to the data before publication.
Q: If a physician notices a mistake within that initial 45 days, is it generally corrected before the data is made public?
A: For the most part, reporting entities are responsive to disputes within that first 45 days and the additional 15-day resolution timeframe. It is the reporting entity who needs to make the correction. CMS does not take part in the process other than providing the software platform.
Q: What happens if a dispute is not resolved at the end of that 60 days?
A: The data goes public, and it's marked as disputed, and it can be corrected later. If the dispute is resolved at a later time, the updated data point will be reflected in the next publication or data refresh. The initial yearly publication of the data takes place by the end of June each year, and a refresh happens once a year in January.
Q: If a physician finds a mistake in publicly posted data, what's the process for correction?
A: We know that a number of covered recipients only look at the data when it becomes public, and then try to take action on it. The data remains available within the Open Payments System for review and dispute until the end of the year in which it was published. If a covered recipient notices an error on the Open Payments website before the end of the calendar year of that initial publication, they can still register and log into the Open Payments System and dispute the data there. In that case, we would go through the normal process and it would be updated in the next applicable publication year.
If they notice an error after the data is no longer available in the Open Payments System for review and dispute, they would need to contact the reporting entity directly. The legislation does require reporting entities to correct the data as soon as they learn of any omissions or inaccuracies, and the database supports that functionality year-round. CMS is not alerted to inquiries that happen outside of the Open Payments System, and CMS does not make any modifications to the data received. The compliance burden is entirely on reporting entities.
Q: How common are disputes and mistakes?
A: The dispute rate is very low, less than 1% of the data. The mistake rate is harder to pinpoint, because not everybody reviews their data prepublication. We hope the low dispute rate reflects a low mistake rate as well, but it's impossible to know without broader participation of the provider community in the review and dispute process.