Coverage with evidence development: The path forward

Coverage with evidence development, a provisional reimbursement strategy that provides coverage for promising new technologies under the condition that providers collect clinical data, has been touted as a strategy to boost clinical evidence and curb unnecessary healthcare costs. However, much room for improvement remains, and was outlined in a viewpoint published May 6 in JAMA Internal Medicine.

The coverage with evidence development strategy offers a number of advantages, according to Gregory W. Daniel, PhD, MPH, from The Brookings Institution in Washington, D.C., and colleagues. It can help payers understand and justify the dissemination of reimbursement to new populations or settings, determine if outcomes evidence is lacking and identify safety issues.

Previous successful applications included The Stenting and Aggressive Medicinal Management for Preventing Recurrent Stroke in Intracranial Stenosis trial in 2006, which expanded coverage for certain stent systems and determined a significantly greater risk of death or stroke with the new procedure, which informed an FDA safety communication and halted further expansion of coverage.

The Centers for Medicare & Medicaid Services (CMS) also used coverage with evidence development in 2012 with the coverage of transcatheter aortic valve replacement in conjunction with data collection through a registry.

Despite some successes, coverage with evidence development poses some challenges, including a limited number of determinations annually, time limits to determine details, a lack of well-defined funding sources to conduct such studies and a lack of criteria and methods for such studies.  

As the Obama administration inches toward further application of coverage with evidence development, Daniel and colleagues offered some suggestions to better the process.

“In our view, coverage with evidence development should reflect a broader strategy for making use of the rapid expansion of electronic health data (e.g. claims, electronic health records) generated as part of routine patient care.” They offered the FDA Sentinel Initiative as an example of a secure and private data network that may serve as a model for coverage with evidence development.

The Patient-Centered Outcomes Research Institute and National Institutes of Health also may offer infrastructure to enable data collection that would reduce costs associated with coverage with evidence development.

CMS could learn from FDA processes, according to the authors. Infrastructure improvements such as networks to support rapid and less expensive trials, standard data fields for use in registries and greater use of claims and clinical data could help improve coverage with evidence development, according to Daniel et al.

“With broad support from physicians, industry, insurers, and regulators, coverage with evidence development could do much more to deliver on its promises of providing timely coverage of new drugs and devices for patients and developing needed evidence to support increasingly effective use of technologies after coverage begins,” they concluded.