MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

For services and technology subject to CED, CMS provides coverage to Medicare beneficiaries enrolled in CMS-approved clinical studies under the NCD. These studies aim to generate sufficient evidence that services or technology are reasonable and necessary for the Medicare population and justify CMS’s coverage without the need for a concurrent clinical study. However, CMS’s decision to subject a service or technology to CED is often regarded as so burdensome that studies are slow to start and continue into perpetuity or CMS never ends the evidence development requirement for coverage of the service or technology. This criticism was reiterated many times during the virtual MEDCAC meeting.

The MEDCAC roster included several medical professionals and advocates, such as staff at academic medical centers and medical policy experts. Dr. Jodi Segal, MD, MPH (Professor at Johns Hopkins) began the virtual meeting with an overview of research conducted by the Johns Hopkins University Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ).^[1] As part of this research, Dr. Segal and her team developed recommendations for new criteria that CMS should require for data collection as part of CED, which were ultimately voted (scoring as not important, important, or essential) and commented on by the MEDCAC Panel on the second day.^[2] CMS is not bound to accept the votes on each of the new recommendations, but may use them as guidance for any updates to the CED data collection requirements in the future.

There were several criteria that were heavily discussed by MEDCAC including requirements for diversity, which were viewed by committee members as a powerful tool to encourage manufacturers to increase clinical diversity in their studies, especially based on age. Committee members suggested that the diversity criterion (e.g., demographic and clinical diversity among the Medicare beneficiaries who are the intended users of the intervention) clarify the threshold for when study participants are diverse enough. Other topics of discussion focused on ensuring that CED studies focus on clinically meaningful patient-centered outcomes, providing timeliness requirements to ensure that studies are completed and the required evidence produced, and the role of real world evidence in CED.

Interestingly, one panel member, representing the Leaders Engaged on Alzheimer’s Disease group, voted against all of the recommendations on the basis that the panel member had concerns about how CMS would implement the criteria and that they could be used in practice to limit access to innovative new technologies. There was also robust discussion concerning the scope of the research presented and whether patient and provider groups were adequately represented; some participants expressed concern about the reliance on health insurer views in the development of AHRQ recommendations.

The MEDCAC meeting was limited to the recommended new criteria for CED studies and did not address some of the larger concerns industry has around coverage for innovative technology and how the new criteria will impact these technologies. CMS representatives have made public statements in other forums suggesting that there may be an evidence development component to coverage of innovative new technologies under a new Transitional Coverage of Emerging Technologies (TCET) rule that is under development.^[3] Thus, the MEDCAC meeting also presented an opportunity for stakeholders to urge CMS to provide an expedited coverage pathway for innovative technologies. In fact, statements were made by stakeholders, including from Cybil Roehrenbeck, Executive Director, AI Healthcare Coalition, and Partner, Hogan Lovells, urging CMS to create such a pathway for technologies like artificial intelligence (AI)-based health devices without delay. Others, like patient advocacy representatives from the Voices of Alzheimer’s organization, urged CMS to ensure that CED does not work as a barrier to access for innovative drugs and devices. It is still possible that changes to CED requirements discussed at the MEDCAC panel meeting will bear on a future TCET rule, but the public is still without details from CMS at this time.

CMS will be making the full transcript of the MEDCAC virtual meeting on CED publicly available on its website in the near future. It is unclear if or when CMS will make changes to CED study requirements in consideration of the MEDCAC Panel recommendations.

Authored by Stuart Langbein, Beth Halpern, Cybil Roehrenbeck, Victoria Wallace, and Ashley Grey