Objective Using lung transplantation as a case study, this article add
ressed the problem of supporting innovative clinical surgery in an era
of increasing pressures for cost containment. Summary Background Data
After sporadic attempts at lung transplantation during the 1960s and
1970s, its clinical development began in earnest during the early 1980
s. As a result of a wide range of incremental advances, the results ha
ve improved significantly. The Health Care Financing Administration, h
owever, has not yet issued a national policy covering lung transplants
and has left the coverage decision to the discretion of its regional
contractors. Methods The authors surveyed the major commercial insurer
s, the Blue Cross Blue Shield Association, and a sample of Medicare in
termediaries to evaluate the coverage of lung transplantation. They al
so interviewed the National Heart, Lung, and Blood Institute and indus
trial firms about their support for clinical research. Results Governm
ent and industry funding were limited, and the development and assessm
ent of lung transplants have been financed predominantly by academic i
nstitutions through cross-subsidization from patient care and teaching
funds. The major private payers and Blue Cross Blue Shield decided to
cover this procedure in the early 1990s. Coverage decisions by Medica
re intermediaries, however, revealed considerable variability. Moreove
r, the absence of a specific diagnosis-related group for lung transpla
nts had considerable consequences for institutions in all-payer states
, in which payments appeared to be considerably lower than the mean co
sts of a transplant procedure (about $110,000). Conclusions This analy
sis indicated that there was a growing disparity between the increasin
g demand for outcomes data about new procedures and the limited resour
ces available for supporting the development and assessment of new ope
rations. If this disparity is not addressed, the rate of surgical inno
vation may be jeopardized, and timely outcomes data may not be acquire
d. It was concluded that provisional coverage within a predetermined r
esearch protocol may be a promising mechanism to remedy this situation
, providing timely assessment of new procedures before widespread appl
ication.