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Date: Wednesday, April 24, 1996 FOR IMMEDIATE RELEASE Contact: HCFA Press Office(202)690-6145, NHLBI Press Office(301) 496-423, AHCPR Press Office(301)594-1364, ext. 174
The National Institutes of Health and the Health Care Financing Administration today announced their intention to collaborate on a multi-center, randomized clinical study of the effectiveness of lung reduction surgery. Medicare will cover the patient care costs for beneficiaries who participate in the study.
Lung reduction surgery is a procedure that some physicians recommend for the treatment of patients in the last stages of emphysema. The procedure involves removal of damaged, non-functional lung tissue.
"I am pleased that NIH and HCFA are working together to advance our knowledge of this treatment," said HHS Secretary Donna E. Shalala.
The decision to undertake a study is based on an assessment by the Center for Health Care Technology at the Agency for Health Care Policy and Research (AHCPR), another agency in the Department of Health and Human Services. Last month, AHCPR officials briefed HCFA's Technology Advisory Committee on the results of this assessment of more than 3,000 procedures involving lung reduction surgery from 27 medical centers across the country.
AHCPR found the current data inconclusive regarding the risks and benefits of this surgery, and recommended limited Medicare reimbursement as part of a national study of the procedure.
"This study will allow us to determine whether lung volume reduction surgery is safe and effective, and to identify the patients for whom it may be appropriate," said NIH Director Harold Varmus. "It is important that we obtain this kind of scientific evidence on this procedure before the method becomes widely used. Support by Medicare is a very significant aspect of this trial at a time when many health care providers are reluctant to fund clinical research."
The study, which will be conducted by the NIH's National Heart, Lung, and Blood Institute, will involve creation of a registry of patients referred to identified clinical centers throughout the country for lung volume reduction surgery, lung transplantation, or pulmonary rehabilitation. Approximately 3,000 patients from the registry who meet eligibility criteria will be randomly selected to participate in the trial. All participants will receive intensive medical therapy and rehabilitation; half also will be randomly assigned to undergo lung volume reduction surgery. Patients are enrolled in NIH-sponsored clinical trials by their physicians, who contact the centers involved in the study. For Medicare patients who become enrolled in the study, Medicare will cover the costs of treatment.
"This study is important for determining the benefits of lung reduction surgery," said AHCPR Administrator Clifton R. Gaus, Sc.D. "Lung volume reduction surgery appears to benefit some patients, but many significant factors remain unresolved regarding patient selection, the operative procedure of choice, and safety issues for patients."
In January, HCFA had decided not to pay for lung volume reduction surgery performed on Medicare beneficiaries because its long-term benefits in treating emphysema have not been established. Now, in response to the new recommendations, Medicare will pay for lung reduction surgery for beneficiaries enrolled in the clinical study.
HCFA Administrator Bruce C. Vladeck said, "The study's findings will help ensure that the 13 million Americans with emphysema and other chronic obstructive pulmonary disease get the best treatment available. The study also will enable us to provide Medicare reimbursement at the centers participating in the trial while we obtain more definitive data on this issue."
Chronic obstructive pulmonary disease, a disease category that includes emphysema and chronic bronchitis, occurs almost exclusively in smokers. It is the fourth leading cause of death in the United States today, claiming more than 90,000 lives each year.