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- CAP urges CMS to Increase Transparency and Endpoints for Clinical Studies to Expand Coverage for Medicare Patients
The CAP improved both local and national coverage processes to ensure access to timely, quality care for Medicare patients over the years. This work includes ensuring appropriate conditional coverage through an effective and efficient coverage with evidence development (CED) process. In a letter to the Centers for Medicare and Medicaid Services (CMS) on August 21, the CAP recommended further improvements to the CED process and the general requirements for clinical studies submitted to the CMS. The CAP believes the CED process must be selectively utilized and intended only to provide for evidence-based coverage that accelerates and expands access to services for patients, rather than restrict their use by physicians and other providers, the CAP said.
The CAP also expressed concern about the lack of transparency around the funding and maintenance of data collection for CED and the CAP urges the CMS to make this information available to the public.
The CAP said that for any technology or service provided coverage through CED, an endpoint should be established for when the process is complete. We are hopeful that the inclusion of a written plan that describes the schedule for completion of key study milestones, including results reporting, will help ensure timely completion of the CED process.
Overall, the CAP supports expedited coverage that ensures Medicare beneficiaries receive predictable access to new and innovative medical technologies.