On April 26-27, the Medical Device Manufacturers Association (MDMA) held their Annual Meeting to discuss topics impacting medical device manufacturers. Food and Drug Administration (FDA) representatives, Centers for Medicare & Medicaid Services (CMS) representatives, industry representatives, and others presented and held discussions at the forum. The agenda and full list of speakers can be found here. Highlights include:

• Announcement of Tamara Syrek Jensen as Acting Deputy Director of the CMS Center for Clinical Standards and Quality (CCSQ) and Dr. Joe Chin as the Director of the CMS Coverage and Analysis Group (CAG).
• Update that the proposed rule on transitional coverage of emerging technologies (TCET) will be released in the coming weeks. The rule is currently still under review at OMB. CMS representatives could not discuss details of the rule, but indicated the pathway for coverage for FDA breakthrough devices will likely look like a National Coverage Determination (NCD) with Coverage of Evidence Development (CED).
• Announcement that CMS is experimenting with outsourcing tasks to become more efficient and address staffing shortages and backlogs. This includes trials outsourcing some of the evidence review required for NCD requests. CMS would still make the final coverage decisions in these cases.

CMS Town Hall: Changes to DME coming in future rule making

The CMS Town Hall was moderated by Dan Waldmann of MDMA and included the following CMS representatives:

• Jason Bennett, Director, Technology, Coding and Pricing Group (TCPG), CMS
• Carol Blackford, Director, Hospital and Ambulatory Policy Group, CMS
• Tamara Syrek-Jensen, Director, Coverage and Analysis Group, CMS Center for Clinical Standards and Quality, CMS

Key Takeaways from the town hall included:

• Priorities for CAG include the proposed TCET rule, updating CED clinical study criteria following the recent Feb. 13 MEDCAC meeting, and addressing the NCD waitlist. To address the NCD waitlist and improve efficiency, CMS is experimenting using a contractor to review evidence related to NCD requests.
• There are many issues related to medical devices that CMS is looking to address in the upcoming rulemaking cycle, including addressing a category for lymphedema compression garments and other challenging benefit cateogry issues as new items and technology come to the market. CMS also plans to address issues affecting persons in wheelchairs and power wheelchairs, and changes related to the NTAP program under the hospital inpatient payment system due to the volume of new technologies.
• CMS is reviewing software as a service in the outpatient ASC setting, and issued a comment solicitation in rulemaking last year to address how to look at software as a service for packaging policies and when items should be thought of outside of packaging policies. CMS representatives noted the difficulty in addressing and paying for algorithms, AI, and new technologies in various policy areas and indicated it is looking at these issues on a case-by-case basis.
• When asked about the NCD waitlist, Tamara Syrek-Jensen did not confirm how many NCDs are on the waitlist or how many the Agency has recently addressed, stating that Dr. Chin will be the new lead on NCDs.
• When asked about the new TCET rule and whether a randomized control trial will be required as part of the coverage with evidence development (if TCET is looking more like CED), CMS responded that most NCDs with CED are using some form of real-world evidence.

CMS representatives spoke more broadly about other CMS priorities, including:

• CMS is working to implement the provision in the Infrastructure Act related to discarded drug refund policy. CMS is also looking to address the delays in PAMA (Protecting Access to Medicare Act) reporting under the clinical lab fee schedule, payment for new family therapy and mental health services, telehealth flexbility extensions and the end of the COVID-19 PHE, and payment for newly Medicare-covered dental services under the Physician Fee Schedule.
• CMS is also working to implement recent legislation including the Inflation Reduction Act and the Consolidated Appropriations Act of 2023, including Part B and Part D drug changes and the ability for Medicare to negotiate some drug prices.
• When asked whether CMS will consider site-neutral payment across ambulatory settings given that new MedPAC recommendations would give CMS broader authority on this issue, Carol Blackford noted it is something the Agency is considering in Post-Acute Care and ambulatory settings. She explained that the Agency will be reviewing the MedPAC report very closely and thinking about this issue moving forward.
• CMS also indicated that they will be thinking further about packaging policies related to paying for new technologies, particularly alternatives to opioids, and working to implement legislation in this area.

CMS Update: TCET Rule Coming Soon

Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, presented an update on CMS priorities and then answered questions. He discussed the CMS National Quality and Value Strategy at length, indicating that CMS’s goal is to improve quality across the care journey with a focus on maternal health, hospice program integrity, and the collection of social determinants of health data. He mentioned the recent article published in New England Journal of Medicine that he coauthored with other CMS leaders on defining and aligning quality measures across CMS.[1]

On the TCET rule, Dr. Fleisher noted that the rule is under review at the Office of Management and Budget, and that it would be released in the coming weeks. He also mentioned that CMS is looking to outsource some of the technology assessments to address an increased workload.

When asked about Medicare Advantage (MA) enrollees becoming the majority of the Medicare population over Medicare fee-for-service (FFS) and how CMS is going to deal with that transition, Dr. Fleisher responded that CMS is looking at whether they can collect more data on all Medicare beneficiaries, not just FFS.

Dr. Fleisher also stated that CMS is concerned about artificial intelligence (AI) and wants to ensure the correct approach is taken so that inequities are not further exacerbated and institutionalized through AI.

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This Applied Policy® Summary was prepared by April Gutmann with support from the Applied Policy team of health policy experts. If you have any questions or need more information, please contact her at agutmann@appliedpolicy.com or at 202-558-5272.

[1] Authors of the article included: Dr. Douglas Jacobs (Chief Transformation Officer, CMS), Dr. Michelle Schreiber (Deputy Director for Quality and Value at the Center for Clinical Standards and Quality, CMS), Dr. Meena Seshamani (Director of Center for Medicare, CMS), Daniel Tsai (Deputy Administrator and Director of Center for Medicaid and CHIP services, CMS), and Elizabeth Fowler (Deputy Administrator and Director of the Center for Medicare and Medicaid Innovation, CMS),