Unilateral or bilateral LVRS by open or thoracoscopic approach is not generally covered, because there is insufficient medical evidence available to base a determination that this procedure is generally safe and effective. Therefore, LVRS generally cannot be considered reasonable and necessary under §1862(a)(1)(A) of the Act in most cases.
When this policy was first established in December 1995, HCFA committed Medicare to reviewing the scientific literature as it was published in order to modify coverage policy as clinical data were developed. HCFA has reviewed data that suggest the need for a randomized clinical trial regarding the safety and effectiveness of LVRS. On April 24, 1996, the Health Care Financing Administration (HCFA) and the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health announced their intention to collaborate on a multi-center, randomized clinical study evaluating the effectiveness of LVRS. On December 20, 1996, HCFA and NHLBI announced the clinical centers and the data coordinating center that will be participating in the study. HCFA has determined that LVRS is reasonable and necessary when it is provided under the conditions detailed by the protocol of the HCFA/NHLBI clinical study. Therefore, Medicare will cover LVRS in those limited circumstances when it is provided to a Medicare beneficiary under the protocols established for the study. Coverage will be provided where the care is furnished in facilities that are approved as meeting the criteria established by HCFA and NHLBI for this study.
This study will consist of a registry of all patients referred to the participating clinical centers for LVRS. In addition, a subset of patients from the registry who meet specific inclusion criteria will be invited to participate in the randomized trial. All randomized patients will receive intensive medical therapy and pulmonary rehabilitation. Half will be selected randomly to undergo LVRS, which will be performed via median sternotomy or video-assisted thoracoscopy.
Medicare will provide coverage to those beneficiaries who may participate in the randomized trial for all services integral to the study and for which the Medicare statute does not prohibit. This includes tests performed to determine whether a beneficiary qualifies for randomization, LVRS, and follow-up tests that are necessary during participation in the randomized study. However, Medicare will not provide coverage for those services that are prohibited by the Act. For example, Medicare will provide coverage for pulmonary rehabilitation and pulmonary function testing, but will not provide coverage for oral steroids provided as part of a physician's service under §1862(s)(2) of the Act because they are self-administrable and thus statutorily excluded from coverage.
Payment for these services will be provided under the usual payment systems. For example, Part A services will be paid for according to the DRG system, and Part B physician services will be paid for according to the physician fee schedule.
The data from the randomized phase of the study will be analyzed and monitored continuously in order to determine any appropriate changes in Medicare coverage. These determinations will include if and how coverage will be continued.
