May 7, 2018
10:30 EDT/9:30 CDT/8:30 MDT/7:30 PDT
Attending: James Fiore, Co-Chair: Ilana Hardesty, Ed Kennedy, Joanne Krause, Kate Regnier, Valerie Smothers, and Julie White
Each member of the group provided brief introductions. Ilana mentioned BU is not using Activity Report because they are a grantee for REMS educational programs and want to understand how collecting learner level data will effect what they collect and report. Valerie noted the ACCME’s Maintenance of Certification is based on Activity Report standard. Ed added they use Activity Report for collecting learner data and MOC and this will be an extension of that.
Valerie reviewed the FDA Opioid REMS data exchange needs and requirements mapping. James noted using Activity Report made the most sense to cover the existing FDA requirements on learner level data sharing on the opioid crisis. Valerie noted that REMS is expanding to all opioids and the FDA wants de-identified learner data that includes specialty, years in practice and physical location. The FDA wants detailed information on state of primary practice, prescribers, and profession. Practice area includes questions about performing surgical procedures and length of time learner has been in practice. Cynthia questioned the breakdown of having less than five years posts training, then 6-10, was that addressed in the specification. Kate questioned the inclusion of performing surgical procedures, not appropriate for non-surgeons. Valerie noted they wanted to tease out who performs surgical procedures. Kate noted all these practice areas could be gateway to prescribing opioids. She suggested pushing back on including that question. James agreed applying more precision to the reasoning behind that field would be helpful. Valerie suggested a better venue for that feedback is the Conjoint Committee.
Valerie discussed how to modify the Activity Report specification to provide learner level data. Prasad, Francis, James, and Valerie met to discuss leveraging the Activity Report specification. Valerie walked through the specification revisions. Kate questioned adding commercial support. Valerie noted it is a requirement for REMS to be able to track which activities receive commercial support from the RPC.
Valerie clarified the proposal is for new activities to use Activity Report for all of the data and not use metrics at all for REMS reporting. Ed mentioned it is important not to make fields required at the standard level. Valerie emphasized everything with dotted line is optional and regulatory information is optional.
Ed thought some things should be required at the standard level. He asked for clarification on the requirement to de-identify provider and activity data. Ilana commented when entering activities into PARS, they becomes eligible for audit. Auditing is about the activity, not learners. James mentioned provider provides identified activity data to accreditors, and then accreditors pass that on to the RPC without details about learners.
James expressed concern about avoiding duplicating data when providers share information with the ACCME. At what point does de-identification occur, and how do we avoid duplication in Activity Report. Ed explained they have to verify and validate records related to REMS activity.
Valerie emphasized the need for consensus about information around activity and a minimal amount of data to do matching. James wanted assurance that data we expect is received; duplication of data is critical.
Valerie will schedule a follow-up call later this week with Ed, James, Prasad, on what is required and where de-duplication happens. Then she will update the proposed standard and report on the next call.
Notes from Subgroup, May 11
James noted that we need to clarify assumptions and better understand the potential for duplication of data. Ed explained that data collection by an accreditor can be ongoing. Kate noted that there are several fields that providers and accreditors have not collected, such as state of practice. Both accreditors and providers will need to modify their data collection systems.
James asked if the provider provides the same data to multiple accreditors. Kate replied that the FDA allows them to report to one accreditor. The activity is uniquely identified by a number, and learners are associated with that activity. If an activity is reported twice by mistake, that could be identified by the activity number. At added that providers will have to give a local identifier for the learner to establish uniqueness and track the learner for auditing purposes.
James asked about the collection of identified learner data for maintenance of certification. Ed noted that that would be separate. Not all learners eligible for maintenance of certification credit will opt in. Kate noted that they may provide two records for one person, one de-identified for REMS and one identified for maintenance of certification.
Valerie asked about the workflow. At noted that the activity is set up as a record and the reporting of learners occurs later. For rems reporting, the provider uses the web interface to designate an activity as REMS. Kate added that after the activity record is established, the provider enters learner data at a later date. Providers can upload a spreadsheet or XML. The unique identifiers for the activity are important.