Reemtsma K, Gelijns A C, Sisk J E, Arons R R, Boozang P M, Berland G K, Evans C M, Smith C R
Habif Center for Surgical Studies, Columbia University, College of Physicians and Surgeons, New York, NY.
Ann Surg. 1993 Oct;218(4):465-73; discussion 474-5. doi: 10.1097/00000658-199310000-00007.
Using lung transplantation as a case study, this article addressed the problem of supporting innovative clinical surgery in an era of increasing pressures for cost containment.
After sporadic attempts at lung transplantation during the 1960s and 1970s, its clinical development began in earnest during the early 1980s. As a result of a wide range of incremental advances, the results have improved significantly. The Health Care Financing Administration, however, has not yet issued a national policy covering lung transplants and has left the coverage decision to the discretion of its regional contractors.
The authors surveyed the major commercial insurers, the Blue Cross Blue Shield Association, and a sample of Medicare intermediaries to evaluate the coverage of lung transplantation. They also interviewed the National Heart, Lung, and Blood Institute and industrial firms about their support for clinical research.
Government and industry funding were limited, and the development and assessment of lung transplants have been financed predominantly by academic institutions 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 Medicare intermediaries, however, revealed considerable variability. Moreover, the absence of a specific diagnosis-related group for lung transplants had considerable consequences for institutions in all-payer states, in which payments appeared to be considerably lower than the mean costs of a transplant procedure (about $110,000).
This analysis indicated that there was a growing disparity between the increasing demand for outcomes data about new procedures and the limited resources available for supporting the development and assessment of new operations. It this disparity is not addressed, the rate of surgical innovation may be jeopardized, and timely outcomes data may not be acquired. It was concluded that provisional coverage within a predetermined research protocol may be a promising mechanism to remedy this situation, providing timely assessment of new procedures before widespread application.
本文以肺移植为例，探讨了在成本控制压力不断增大的时代，支持创新性临床手术所面临的问题。
在20世纪60年代和70年代进行了零星的肺移植尝试之后，其临床发展于20世纪80年代初正式开始。由于一系列渐进的进展，结果有了显著改善。然而，医疗保健财务管理局尚未发布涵盖肺移植的国家政策，而是将保险范围的决定权留给其地区承包商自行决定。
作者调查了主要商业保险公司、蓝十字蓝盾协会以及医疗保险中介机构的样本，以评估肺移植的保险范围。他们还就国家心肺血液研究所和工业公司对临床研究的支持情况进行了访谈。
政府和行业资金有限，肺移植的开发和评估主要由学术机构通过患者护理和教学资金的交叉补贴来资助。主要的私人支付方和蓝十字蓝盾在20世纪90年代初决定承保这一手术。然而，医疗保险中介机构的承保决定显示出很大的差异。此外，缺乏针对肺移植的特定诊断相关组对所有支付方州的机构产生了相当大的影响，在这些州，支付额似乎远低于移植手术的平均成本（约11万美元）。
该分析表明，对新手术结果数据的需求不断增加与支持新手术开发和评估的可用资源有限之间的差距越来越大。如果不解决这一差距，手术创新的速度可能会受到影响，并且可能无法获得及时的结果数据。得出的结论是，在预定的研究方案内进行临时承保可能是纠正这种情况的一种有前景的机制，可在广泛应用之前及时评估新手术。
