Problem

New medical technologies often generate significant demand for coverage by patients and physicians even though critical questions about the risks and benefits of these technologies remain unanswered   Extending CMS’s “Coverage with Evidence Development” (CED) beyond the Medicare population has great appeal as a creative approach to encourage decision-maker-oriented research into important—but inadequately proven—emerging technologies. With CED, plan members willing to participate in research studies gain access to the new treatments they want, while purchasers control coverage until the supporting evidence base grows stronger.

Several obstacles currently stand in the way of this approach, however. For example, current benefit language may limit coverage for clinical research only to participants with life-threatening illnesses, or to those receiving investigational cancer drugs. Policies are also inconsistent across health plans, limiting the ability of major purchasers to work cooperatively on CED initiatives.

Project

Under a grant from the California HealthCare Foundation, the Center for Medical Technology Policy has partnered with a group of health plans, patients, physicians, employers and policy leaders to develop a conceptual framework for CED that includes:

1.      A model for CED development and implementation, including definition of the roles for different CED participants;

2.      Criteria to: i) select appropriate technologies for CED development; ii) evaluate proposed research; iii) guide the decisions of individual health plans and other purchasers (both public and private) on whether or not to participate in a particular CED initiative; and

3.      Different approaches to incorporate CED within existing health benefits programs, including model benefit language

Next Steps

Members of the project workgroup will participate in CMTP’s on-going efforts to inform various constituencies (e.g., employers, labor trusts, regulators, legislative staff and the broader public) about the framework and model language.  The workgroup has also indicated a desire to test the conceptual framework through implementation of a pilot CED project, perhaps CMTP’s pilot project around radiation therapy for prostate cancer.

Working Group Members