Along these lines, BT was listed originally with a temporary set of Current Procedural Terminology (CPT) codes (0276T and 0277T) as an emerging technology, service, or procedure (category 3). The principal purpose of category 3 codes is to allow for data collection and for tracking of new procedures, often in an effort to establish universal application and to provide documentation in an effort to gain FDA approval. Conversely, category 1 CPT codes represent procedures that are consistent with contemporary medical practice and are recognized by all public Health and Care Pharmacy and private health insurance payers in the United States. Criteria to gain category 1 status include FDA approval, nationwide performance by health-care professionals, and proof of the clinical efficacy procedure, all current characteristics of BT. 
Current coverage policies governed by the Centers for Medicare and Medicaid Services (CMS) are appropriately driven by legislation requiring that coverage be based on items and services that are deemed to be “ reasonable and necessary.” Understandably, defining “reasonable and necessary” continues to be complex and challenging because a number of clinical, research, and risk/benefit considerations accompany such a determination. Past determinations of “reasonable and necessary” involved review by local contractors who had an understanding of new services or technology. Unfortunately, as medical advancement and technologic innovation progressed, coverage for similar treatments varied according to locality. Such variability in coverage approval led to the formal National Coverage Determination process to guide coverage decisions. Unfortunately, understanding the definition of “reasonable and necessary” by CMS continues to be elusive. The Coverage with Evidence Development policy developed from an attempt to resolve this issue, which allows Medicare to provide conditional coverage for certain medical technology as further safety and efficacy data are collected.
As a result of the difficulty in defining “reasonable and necessary,” pulmonary physicians and interventional pulmonologists at tertiary care medical centers are often faced with multiple, lengthy appeal processes to obtain coverage approval, which is far from guaranteed.
