Life Science Compliance Update

140 posts categorized "Open Payments"

April 27, 2015

CMS Submits Report to Congress on First Year of Open Payments

Annual report to congress

Over the weekend, the Centers for Medicare and Medicaid Services (CMS) submitted their annual report to Congress on the first year of Open Payments. Each year, CMS is required to submit a report to Congress summarizing the payments made by applicable manufacturers and group purchasing organizations to physicians and teaching hospitals, as well as any penalties CMS assessed based on noncompliance with the program. The document is an interesting “inside-look” into CMS’s activity, and offers the industry an idea of where the agency is headed with Open Payments, including program implementation improvements, and, perhaps more importantly, where CMS is focusing their enforcement efforts. 

The report, available here, first provides a high level overview of the Open Payments reporting requirements, as well as highlights from the first year of the program. CMS includes a number of familiar summary statistics, including an aggregate payment chart as well as a 50+ page appendix that lists every reporting entity and the dollar amounts attributed to that company (Appendix B, p. 33).


The report is most interesting where CMS provides insight into its auditing process and its plans for the future. Since companies first began instituting aggregate spend systems to comply with the Sunshine Act, the question has always been, how will CMS interpret the complicated law for enforcement purposes? For now, it seems like the agency is focusing on companies who simply did not register or submit any data. 

To date, CMS has not imposed any civil monetary penalties against any applicable manufacturers or GPOs for noncompliance. However, CMS states that they will launch targeted audits to identify applicable manufacturers and GPOs that should have submitted payment information but did not for 2013.

“As of the date of this publication, CMS is engaged in an effort to increase submission compliance of specific entities that did not submit data,” CMS states. “The near-term objectives of the Open Payments compliance strategy are focused on alerting applicable manufacturers and GPOs to their failure to register and submit data in the Open Payments system." (emphases added)

Beyond the first program year, applicable manufacturers and GPOs will be notified of their failure to report in a timely, accurate and/or complete manner, notes CMS.  

Open Payments System: Planned Improvements for Program Participants

As we have outlined in a number of articles, the Open Payments platform has not always been very user friendly from either the submitting entity's standpoint, or the reviewing physician's. CMS states that they are making multiple system enhancements based on stakeholder feedback to address this.

The report states that the 2015 reporting cycle will include the following upgrades:

  • More intuitive and user-friendly system screens, including just-in-time guidance via on-screen messages, which provide guidance directly at the point in the process where users require it.
  • Record download capability for applicable manufacturers and GPOs, allowing them to download records already reported into the Open Payments system.
  • Improved user identity management approach that ensures fully synchronized user accounts between EIDM and Open Payments.
  • Enhancements to enable deactivation of users no longer requiring access to the system.
  • Enhancements to the review and dispute functionality for physicians and teaching hospitals, including enabling covered recipient primary investigators to dispute their associations with the research study to which the reported payment was related.
  • Enhanced matching logic used to attribute transactions reported by applicable manufacturers and GPOs to correct covered recipients. The upgraded matching logic will minimize the chances of conflicting data being processed by the system and data being attributed improperly.

Summary of System Enhancements

Planned Enhancements to Open Payments Website

The report also lays out CMS’s planned enhancements to the Open Payments website. CMS plans to provide summary information of all Open Payments data in a data dashboard layout. Similar to the data summary fact sheet CMS already provides on the Open Payments website, this dashboard will give visitors an aggregate view of all Open Payments data by providing statistics such as total dollar amount of all payments and transfers of value, total number of entities that made payments, and total number of physicians who received payments.

CMS also continues to solicit stakeholder assistance to make enhancements to the public website. "Combining this feedback with 2014 data to be published in June, 2015, CMS will provide more opportunities for all site visitors, from the advanced data user to the general public, to discover meaningful information in the Open Payments data published by CMS," the report states.


By outlining the Sunshine Act's reporting requirements, providing an overview of the first year of data collection, and shedding a bit of Sunlight onto CMS's own internal processes and future plans, the report is an important document for both those newly acquainted with Open Payments, and seasoned aggregate spend experts. 

View CMS's report on Open Payments to Congress here.

April 17, 2015

Open Payments Dispute Resolution Call Reveals Tension Between Manufacturers and Covered Recipients


On Wednesday afternoon, the Centers for Medicare and Medicaid Services (CMS) held a teleconference for physicians and teaching hospitals to help them through the process of reviewing their Open Payments data and potentially disputing their information. Notably, CMS has streamlined their teaching tools for physicians to a manageable 38-page PowerPoint (from over a hundred pages before, see p. 200). CMS re-iterated their position that they will not be involved in mediating disputes. However, “CMS will monitor disputes and resolutions to inform the program auditing process,” they stated. “How many disputes are initiated as well as the volume of unresolved disputes,” will be of particular interest to the government. 

Physicians, teaching hospitals, principal investigators, or their agents may review records, affirm records, initiate disputes, or withdraw disputes on the Open Payments website. But even if covered recipients do not check on their data and affirm their records, the payment data will still be published regardless of whether recipients ever log in to the Open Payments system. Thus, manufacturers have the final say regarding disputes, but are kept in check by the fact that physicians can continually dispute payments after manufacturers remove the disputes. This seems to encourage an open dialogue between the two parties to collaborate and work through this process.

A troublesome point for physicians and teaching hospitals that consistently came up during the call is the lack of context or consistent reporting of the “Nature of Payments” categories by manufacturers. For example, one caller articulated the process of reviewing payments for physicians who received a device or instrument loan. “One manufacturer reported it as a gift, some as space rental, and some as consulting payments,” the caller noted. Indeed, it is up to the manufacturer to determine the nature of payment of certain transfers of value. For compliance personnel working in hospitals attempting to verify whether or not these payments are correct, it can be very difficult to determine the accuracy of such varying payment titles. This is especially true when manufacturers report payments to physicians as aggregate totals throughout a given year.

CMS agreed that the nature of payment categories may be expanded or clarified in the future, but noted that a public forum—with input from all parties—would be necessary to change the system.

Another important point is that the deadline for recipient disputes is until the end of the reporting year for the particular payment. “Physicians, teaching hospitals, and principal investigators have until the end of the 2015 calendar year to initiate disputes of data submitted in 2015,” states CMS. While disputes made outside of the initial 45-day window will not immediately show up, they will be on the database by CMS’s next data refresh, which comes at least once a year, according to the agency.  Disputes about 2013 payment, however, are past the due date.

Some other important notes brought up during the call included the fact that there is currently no download functionality on the Open Payments review and dispute program. For hospitals that employ a large number of physicians with many pages of payments, this becomes a major inconvenience for those that simply want to download and print out their list of reported transfers of value. Also, hospitals will continue to be listed exactly as they appear in CMS’s teaching hospital list. Many had requested that manufacturers list the department of a given teaching hospital where payments were made, given the size of many institutions. CMS confirmed that the master hospital list is the guiding document.  

The PowerPoint has a good deal of important information for covered recipients, so it is worth looking at. CMS listed a number of tips for successful physician vetting (where CMS vets doctor profiles against “CMS-approved sources to confirm the registrant is a covered recipient”) that are important to point out:

  • Make sure the name used for registration matches exactly with the name in the National Plan and Provider Enumeration System (NPPES). CMS notes: “If you changed your name in NPPES after Dec. 31, 2014, use the earlier version of your name that was in NPPES.”
  • Enter NPI, if available. “Enter exactly as listed in NPPES for the current calendar year,” CMS states. “Do not enter NPI if it was obtained after Jan. 1, 2015.”
  • Enter all active state license(s)
  • “Provide as much information as possible – more information can speed vetting and ensure all records associated with the physician will be accurately matched to them,” CMS states.

View the PowerPoint for 2015 review and disputes here.



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