Criteria for lung volume reduction surgery reimbursement: too many questions, not enough answers

Abstract

doi:10.1016/j.jtcvs.2003.11.023 T he report by Meyers and colleagues in this edition of the Journal regarding lung volume reduction surgery (LVRS) in high-risk patients raises some interesting methodologic and ethical questions. The article was designed to assess the validity of patient selection criteria outlined in the first clinical publication of the National Emphysema Treatment Trial (NETT). In that article, NETT investigators identified a high-risk patient subset characterized by the combination of a forced expiratory volume in 1 second (FEV1) less than or equal to 20% of predicted and either a homogeneous pattern of disease or a diffusing lung capacity for carbon monoxide (DLCO) less than or equal to 20% of predicted. This subgroup experienced a high mortality and morbidity that outweighed the clinical benefit from the procedure. The report herein disputes this conclusion by demonstrating that patients with an FEV1 less than or equal to 20% and a DLCO less than or equal to 20% but who have a heterogeneous pattern of disease can benefit from LVRS. The argument goes that such patients should not be prevented from undergoing LVRS, as has been specified in the recent Medicare coverage decision, which used the NETT results as a guideline for reimbursement. Therefore, the NETT suggests that a specific subset of patients constitute a high-risk group that should not undergo LVRS, whereas Meyers and colleagues believe that further subselection in this high-risk group can cull a subgroup with an acceptable risk-benefit ratio. Who’s right? Some readers will take this article at face value and agree with the conclusion of Meyers and colleagues on the basis of reputation alone. The investigators at Washington University have one of the largest and certainly the longest experiences with LVRS and are acknowledged leaders in the field. However, there could be unintended consequences if their criteria were universally followed. Their report documents that this patient subset, although deriving significant benefit, is certainly at high risk, with an increased chance of prolonged air leak and gastrointestinal morbidity and an incidence of reoperation 3 times as great as that quoted in their recent report of long-term results. Although it is true that their 5% mortality is laudable, it is important to ask whether similar results can be achieved at other institutions with less experience and expertise in LVRS. The Centers for Medicare and Medicaid Services (CMS) has agreed to reimburse for LVRS at the 17 participating NETT centers and 31 non-NETT Medicare-approved lung transplant centers around the country. Whereas the NETT institutions have documented their expertise in LVRS, fewer than half of the non-NETT CMS-approved lung transplant centers have a published experience with LVRS, and many have no ongoing programs. Is it really ethical to suggest that these high-risk patients undergo LVRS at institutions with little or no experience? Other readers will agree with the NETT perspective, believing that a prospective randomized controlled trial involving more than 1200 patients provides what are arguably the best and most definitive data available on LVRS. The trial was designed specifically to address the shortcomings, both theoretical and practical, of the early LVRS reports; these included selection bias, survivorship bias, aggregate data reporting, incomplete follow-up, and lack of medical controls. The recently published report represents the best clinical and academic efforts of 18 centers (17 clinical centers and 1 coordinating center) recognized for their expertise in the arena