EVALUATING THE EFFICIENCY OF COVERAGE WITH EVIDENCE DEVELOPMENT IMPLEMENTATION

Author(s)

Chen S1, Carlson JJ2
1University of Washington, SEATTLE, WA, USA, 2University of Washington, Seattle, WA, USA

OBJECTIVES: The coverage with evidence development (CED) program within the Center for Medicare and Medicaid Services (CMS) is used to generate additional data to support national coverage decisions for medical technologies. Coverage for patients is provided, but only in the context of approved clinical studies including clinical trials or observational registries. In this study, we evaluated the time to implementation of clinical studies for CMS CED programs. METHODS: We reviewed CMS’s website for data on CED National Coverage Determinations (NCD) and abstracted the release date, date of first approved clinical study, and last modified date for each case. We estimated the mean time to study implementation overall and by type of study. We also used linear regression to assess the trend in mean time to implementation, as well as the impact of recency (NCD with past 5 years) on mean time to implementation. RESULTS: We found 22 CED NCD’s among which 17 had a study implemented. The mean time to implementation or end of study was 731 days. Among NCDs with a study implemented, the mean time was 405 days (clinical trials: 515 days; registries: 48 days). We found a trend toward a shorter time to CED implementation over time (155 days shorter each year, p = 0.035). Recent cases had a time lag 944 days shorter than older cases (p = 0.039) The majority of recent cases have their first related clinical study approved within 200 days after the release of NCD. CONCLUSIONS: Our findings suggest some difficulty implementing clinical studies following a CED determination, but less so with registries. However, these difficulties may be lessening over time.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PHP287

Topic

Health Policy & Regulatory

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways

Disease

Multiple Diseases

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