Press release

MEDICARE ANNOUNCES INTENTION TO COVER LUNG VOLUME REDUCTION SURGERY

The Centers for Medicare & Medicaid Services (CMS) today announced it intends to make lung volume reduction surgery (LVRS) available to certain Medicare beneficiaries who are expected to benefit from the surgery based on results of the National Emphysema Treatment Trial (NETT).

"This decision follows years of research and an exhaustive evaluation of the available scientific evidence," said CMS Administrator Tom Scully, "and reflects CMS' efforts to bring the latest and best medical care to its 41 million beneficiaries."

The new coverage CMS intends to provide will be available to certain Medicare patients with severe emphysema who meet criteria outlined by the NETT.

Emphysema is a progressive disabling disease affecting nearly 2 million Americans and is most common among people over 65. The disease is characterized by the irreversible destruction of air sacs in the lungs, which makes oxygen transfer through the body more difficult and leads to shortness of breath.

LVRS is designed to improve overall lung function for some patients with emphysema. The procedure entails removing diseased portions of the lung in order to provide space for remaining healthy lung tissue.

LVRS has been non-covered by Medicare because of a lack of sufficient medical evidence supporting the health benefit of the procedure. The NETT, a five-year, multi-center, randomized study, provided new evidence regarding the effectiveness, safety and cost-effectiveness of adding LVRS to medical therapy for patients with advanced emphysema.

Results of the NETT, the largest study of bilateral LVRS to treat severe emphysema, indicated that, on average, patients who undergo LVRS with medical therapy are more likely to function better after two years and do not face an increased risk of death compared with those who receive medical therapy only.

The NETT was a cooperative effort by CMS, the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health, and the Agency for Healthcare Research and Quality.

The study began in 1996, and results were published in the New England Journal of Medicine in May of this year. NHLBI funded and administered the study, and CMS supported participants' care costs. Both are agencies of the U.S. Department of Health and Human Services (HHS). In addition, HHS' Agency for Healthcare Research and Quality contributed support for an analysis of the cost effectiveness of LVRS based on NETT data.

Findings from the NETT suggest that the estimated three-year cost-effectiveness ratios for LVRS as compared to medical therapy alone are unfavorable. However, CMS believes that the benefits of LVRS outweigh the costs and that LVRS is likely to compare favorably with other surgical procedures when additional years of data are available.

"This clinical trial reflects a unique collaboration which enabled Medicare beneficiaries to participate in a study of a promising, yet unproven, procedure. Because of this trial, we now have reliable information about the risks and benefits of LVRS and can ensure that those Medicare patients likely to benefit from this surgery will have access to it," said Sean Tunis, M.D., CMS' chief medical officer. "We are basing our recommendations largely on the results of this important study."

Details of the decision memorandum announced today can be found on the CMS web site at http://www.cms.gov/ncdr/searchdisplay.asp?id=96.

More information about NETT and LVRS can be found on the NHLBI web site at http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm.