The Centers for Medicare and Medicaid Services (CMS) released updated guidance last month, that represents the agency’s perspective regarding the factors it considers in making National Coverage Determinations (NCDs) using the Coverage Evidence Development (CED) paradigm. The guidance document is intended to address factors CMS considers when making NCDs using the CED paradigm. CED provides an opportunity for beneficiaries and the medical community to participate in medical research for promising treatments, but where the evidence is not yet adequate for Medicare coverage under the reasonable and necessary statute. This guidance describes the history of CED, and its statutory basis, and establishes principles for CED studies supported by the Agency for Healthcare Research and Quality (AHRQ). In August 2023, the American College of Radiology® (ACR®) submitted comments in response to the CMS proposed Coverage with Evidence Development (CED) guidance document.
CMS received 30 comments on the proposed guidance posted on June 22, 2023, and has developed an appendix to the final guidance summarizing and responding to the major themes of the public’s comments. Comment sources included 10 advocacy organizations, eight device or drug manufacturers, three trade associations, two medical specialty societies, one pharmacy professional society, four academic medical centers, one nonprofit research organization that maintains an extensive outcomes registry and one nonprofit organization.
In its guidance, CMS endorses the concept that CED studies should be fit-for-purpose (FFP). That is, the study design, analysis plan, and data source(s) are sufficient to credibly answer the questions posed by the CED. CMS expects to publish proposed fit-for-purpose study guidance to address concerns raised during the public comment period, particularly for studies that rely on real-world data. CMS also clarifies it does not believe that an NCD that requires CED as a condition of coverage should last indefinitely. If the evidence supports a favorable coverage decision under CED, coverage should be time-limited to facilitate the timely generation of sufficient evidence to inform patient and clinician decision-making and to support a Medicare coverage determination. CMS is exploring options to ensure timely evidence generation; the new Transitional Coverage for Emerging Technologies (TCET) pathway illustrates one new approach to time-limited CED.
To minimize delays in transitioning from a CED NCD to coverage without evidence development requirements, sponsors should build interim analyses into their study design and communicate these results to CMS. If the final results support consideration of a change in the coverage status of the item or service, a revised NCD could be expedited once the study is completed, and the results are published.
CMS would also accept a peer-reviewed manuscript accepted for publication or studies that are otherwise published in the public domain. The agency also modified the guidance to state, “New technologies often lack sufficient clinical evidence to support broad national coverage and have found that sufficient evidence is often not available to support national coverage for Medicare patients when novel technologies first receive market authorization.”
If you have questions regarding NCDs, contact Alicia Blakey, ACR Principal Economic Policy Analyst.