As we reported in July, the Centers for Medicare and Medicaid Services (CMS) was proposing changes to the CME industry and Open Payments in Medicare’s 2020 Physician Fee Schedule. Many groups submitted comments in response to the proposed rule. Now, on November 1, 2019, CMS issued its final 2020 Physician Fee Schedule. In this rule, CMS finalized several changes to Open Payments and impacting the CME industry.
In its news release on the final rule, CMS notes the program has disclosed over 64 million records since August 2013. The agency continues to make adjustments to the program based on new laws and stakeholder feedback. Generally, CMS is finalizing three changes to the program:
1) expanding the definition of “covered recipient;” (as required by the SUPPORT Act)
2); modifying payment categories; and
3) standardizing data on reported medical devices.
In expanding the definition of “covered recipient” the agency is now including Pas, NPs, CNSs, CRNAs, and CNMs. This was required by the recent SUPPORT Act legislation, which requires these changes to be in effect on or after January 1, 2022. Although some commenters asked for a delay, the agency notes it does not have the authority to alter the statutory requirement.
CMS further seeks to add clarity to the types of payments or transfers of values made by applicable manufacturers and applicable GPOs to covered recipients. To accomplish this goal, the agency finalized its proposal to revise the “Nature of Payment” categories by consolidating two categories for continuing education programs and by adding three new categories: debt forgiveness, long-term medical supply or device loan, and acquisitions.
Furthermore, the agency seeks to standardize data on reported covered drugs, devices, biologicals, or medical supplies. CMS notes that when applicable manufacturers or applicable GPOs report payments or transfers of value related to specific drugs and biologicals, it currently requires names and NDCs to be reported to the Open Payments program. Since there was a lack of federally-recognized medical device identifiers (DIs) when CMS started the Open Payments program, it did not require analogous reporting for the manufacturers of such devices. The agency proposed that the DI component, the mandatory fixed portion of the UDI assigned to a device, if any, should be incorporated into Open Payments reporting that applicable manufacturers or applicable GPOs provide.
CMS is finalizing this proposal. However, it commits to providing guidance, explanations, and examples of how to report DIs, as well as how to report when there are multiple DIs, to industry on the CMS website and through other outreach efforts. CMS will also provide technical support through direct outreach, outreach to industry groups, the issuance of guidance, informational webinar sessions, and direct assistance via the program help desk. CMS plans to have this provision be effective for data collected during the year 2021 and it will be reported in 2022.
CME in MIPS
CMS also finalized an minor change to the CME improvement activity under Quality Payment Program MIPS called “Completion of an Accredited Safety or Quality Improvement Program.” In its description, CMS weighs this as a medium weight activity. The following criteria must be met for the CME program that addresses performance or quality improvement to receive credit:
- The activity must address a quality or safety gap that is supported by a needs assessment or problem analysis, or must support the completion of such a needs assessment as part of the activity;
- The activity must have specific, measurable aim(s) for improvement;
- The activity must include interventions intended to result in improvement;
- The activity must include data collection and analysis of performance data to assess the impact of the interventions; and
- The accredited program must define meaningful clinician participation in their activity, describe the mechanism for identifying clinicians who meet the requirements, and provide participant completion information.
New to this year, CMS included an example of an activity that could satisfy this improvement activity is completion of an accredited continuing medical education program related to opioid analgesic risk and 02evaluation strategy (REMS) to address pain control (that is, acute and chronic pain).
We will be including several other stories about payment changes in upcoming stories.