Applied Policy attended the Medical Device Manufacturers Association (MDMA) Annual Meeting in Washington, D.C., held from April 17-19. The event featured discussions with members of Congress and representatives from the FDA and the Center for Devices and Radiological Health (CDRH).
Dora Hughes, M.D., M.P.H., CMS’s Acting Chief Medical Officer and Acting Director of the Center for Clinical Standards & Quality (CCSQ) provided a CMS update on the conference’s first full day. As CMS’s second-largest Center, CCSQ oversees clinical standards and manages 20 quality and payment programs. Within CCSQ, the Coverage and Analysis Group (CAG) is responsible for formulating and updating National Coverage Decisions (NCDs) for medical items and services, including devices.
Hughes’s remarks on the Transitional Coverage of Emerging Technologies (TCET) rule, which falls under CAG’s jurisdiction, were of particular interest. CMS issued the Notice with Comment, including the TCET proposal, on June 22, 2023. This has been a long time in the making, as TCET replaces the Medicare Coverage for Innovative Technology (MCIT) pathway, which was finalized and then repealed in November 2021 due to safety concerns.
Hughes noted that she expects the final rule to be issued early this summer and that CMS has made changes to the proposal in response to the many public comments received. Additionally, she highlighted that CMS issued updated Coverage with Evidence Development (CED) guidance and NCD analysis guidance when the TCET proposed rule was released, aiming to make those processes more transparent for stakeholders.
However, this transparency has its limits. CMS representatives have often cited limited resources within CAG as a reason they are behind on updating coverage decisions. Before September 2023, the wait list showing the number of pending NCD requests had not been updated by CMS since 2020. It was last updated in February 2024, and at that time there were seven pending requests, two open NCDs, and CMS had only finalized three NCDs in the preceding 12 months.
Hughes cited the publishing of the waitlist as an effort to provide more transparency in the coverage process. However, when asked for an update on the NCD waitlist, she only responded that there is desire within the agency to begin moving on these requests. Since the meeting, CMS has taken up one of the requests on the waitlist for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management, leaving six requests currently remaining on the wait list.
Hughes was also asked about the virtual meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC), scheduled for May 21, at which CMS will discuss health outcomes in studies of devices for self-management of Type 1 and insulin-dependent Type 2 diabetes. She noted that MedCAC is convened when internal experts at CMS perceive open questions on an issue. Her response suggested that the agency is seeking feedback from stakeholders and experts due to a lack of internal consensus.
Hughes said that addressing diabetes is a priority for CMS. However, when asked about the status of the insulin pump NCD request already in front of the agency, she did not provide any additional insight.
Hughes also discussed the prioritization of actions on Medicare Advantage (MA), given the increase in MA enrollment and billing. She referenced the request for information issued by CMS in an effort to improve transparency around MA plans through data collection, with comments due May 29. Additionally, she indicated that CMS is being more intentional about working across Centers, citing the agency’s national quality strategy as an example. Lastly, she emphasized that CMS is taking its role in determining coverage of Artificial Intelligence and Software as a Service very seriously. She noted that Jon Blum, Principal Deputy Administrator and Chief Operating Officer, has convened multiple meetings with senior leadership to discuss AI with both internal and external stakeholders and experts.