Using clinical trials as a condition of coverage: lessons from the National Emphysema Treatment Trial.

In making evidence-based coverage decisions, The Centers for Medicare & Medicaid Services (CMS) often must balance the need for rigorous evaluation of medical technologies with the public's demand for rapid access to new services. During the mid-1990s, this dilemma was apparent with regard to a promising, yet unproven, new procedure for emphysema patients known as lung volume reduction surgery (LVRS). In a unique decision, CMS provided coverage for LVRS only under the protocol of the National Emphysema Treatment Trial (NETT), which it cosponsored with the National Heart, Lung, and Blood Institute. The CMS has recently revised its coverage policy for LVRS based on the results of the NETT. This paper provides a history and rationale for CMS's approach to paying for LVRS. It also discusses lessons learned from the NETT experience and potential implications for future collaborations between health plans and the clinical research enterprise that would provide better information for coverage treatment decisions.