REDEFINING “REASONABLE AND NECESSARY”? AN EMPIRICAL, COMPARATIVE ASSESSMENT OF MEDICARE’S COVERAGE WITH EVIDENCE DEVELOPMENT

Author(s)

Chenoweth MD1, Chambers JD2
1Tufts University, Medford, MA, USA, 2Tufts Medical Center, Boston, MA, USA

OBJECTIVES:  Medicare employs coverage with evidence development (CED) to provide conditional coverage for an intervention to allow for the collection of evidence of its effectiveness. In this study, we examined how private payers cover interventions for which Medicare has employed CED. METHODS:  First, we identified all drugs, medical devices, clinical therapies, and diagnostic technologies that are covered under CMS’s Coverage with Evidence Development (CED) program. Second, we located coverage policies for CED interventions issued by the largest private payers that make their coverage policies publicly available. Third, to categorize coverage policy restrictiveness, we compared private payer coverage to corresponding FDA labels and categorized coverage as equivalent to, less restrictive, or more restrictive than the labeled indication. RESULTS:  Between September 1998 and February 2016, CMS completed 246 national coverage analyses, 18 of which (7.3%) applied Coverage with Evidence Development. We identified 258 coverage policies issued by private payers for these CED technologies. We identified significant variation in both the number of policies payers’ issued and their coverage of CED technologies. Private payers did not cover the majority of CED technologies (138 of 258 policies; 53.5%). Health Net and Highmark were the payers that most often covered CED technologies (62.5%). Private payer coverage was equivalent to corresponding FDA approval in 68.3% of cases, more restrictive in 25.0%, and less restrictive in 6.7%. CONCLUSIONS:  When covering health care technology, the conventional wisdom is that private payers follow Medicare’s lead. However, we found significant variation in private payer coverage of this set of innovative medical technologies. Overall, these findings provide insight into Medicare’s application of CED and suggest that patients enrolled in different health plans may have variable access to innovative medical technologies.

Conference/Value in Health Info

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

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

Code

PHP288

Topic

Health Policy & Regulatory

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways, Pricing Policy & Schemes

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×