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Can corporatization contribute to quality assurance and cost control in the German hospital sector?
Health Policy 48 (1999) 207 – 218 www.elsevier.com/locate/healthpol
Can corporatization contribute to quality assurance and cost control in the German hospital sector? A pilot project for stem cell transplantation Ronald Walshe a, Norbert Schmitz b, Volker Diehl c,* a
Medical Economics Research Group, First Department of Internal Medicine, Uni6ersity of Cologne, Cologne, Germany b Second Department of Internal Medicine, Uni6ersity of Kiel, Kiel, Germany c First Department of Internal Medicine, Uni6ersity of Cologne, Joseph-Stelzmann-Strasse 9, 50924 Cologne, Germany Accepted 2 August 1999
Abstract Due to increasingly strained budgets in the German statutory health insurance system, new and expensive medical technologies have come under increased scrutiny. This also applies to stem cell transplantation (SCT), which is a highly costly treatment for certain types and stages of malignant diseases. In 1996, a large number of hospitals applied for licences to perform SCT, raising fears of deteriorating standards and a cost explosion, especially as new indications such as breast cancer emerged. To address this problem, the Concerted Action Stem Cell Transplantation (CASCT) was created. It consists of several scientific medical societies and the sickness funds. The steps taken by CASCT include binding standards for SCT and expert assessments of institutions wishing to perform SCT. This has successfully reduced the number of new hospitals performing SCT to 11 until June 1999. Recommended procedures for SCT were agreed with the sickness funds including experimental indications such as breast and lung cancer. A national registry for SCT has been set up which will publish data on a yearly basis. An important role of economic analyses for the evaluation of SCT has been agreed. CASCT is a development that extends elements of corporatist self-government found in the German ambulatory healthcare sector to the hospital sector. Its aim is to reconcile an expensive new medical modality with the requirements of quality assurance and cost control. Its long-term effects are as yet unclear and will require further investigation. © 1999 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Corporatization; Hospital sector; Quality management; Sickness funds; Stem cell transplantation
* Corresponding author. Tel.: + 49-221-478-4400; fax: +49-221-478-5455. 0168-8510/99/$ - see front matter © 1999 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 8 - 8 5 1 0 ( 9 9 ) 0 0 0 5 1 - 2
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1. Introduction Since the mid-1990s, new and expensive medical technologies have come under increased scrutiny in the German healthcare system. An important reason for this was the implementation of the Health Care Structure Act of 1993, which introduced fixed budgets and spending caps, and the Hospital Expenditure Stabilizing Act in 1996, which tied budget increases to wage rises in the German public service [1,2]. This political and legal framework has lead to tight budgets within the statutory health insurance system in which nearly 90% of the German population are covered. The high rate of unemployment, currently at more than 10%, moderate wage rises and the increasing average age of the population have contributed to low revenues and a high level of expenditure of the sickness funds, which are the purchasers of health services within the statutory health insurance system. Among the targets of the sickness funds’ cost-containment policy was the provision of high-dose chemotherapy (HDCT) and stem cell transplantation (SCT). HDCT followed by SCT is a highly intensive form of treatment. As HDCT irreversibly damages the patient’s bone marrow, it has to be followed by SCT in order to reduce the life-threatening risk of the treatment to an acceptable level. It is provided to selected patients suffering from haemato-oncologic disorders such as leukaemia and lymphoma as well as solid tumours like lung and breast cancer. Around 1600 patients receive this treatment in Germany every year and the cost to the statutory health insurance system of a SCT is between $60,000 and $80,000. SCT are refunded to hospitals by case fees, which are part of the prospective payment system in the German hospital sector introduced in 1996 as a result of the Health Care Structure Act of 1993. The financial considerations of the sickness funds were also influenced by the availability of new techniques such as peripheral blood stem cell transplantation, which resulted in the broad availability of SCT and emerging new indications for SCT [3]. Non-uniform data in some areas on the benefits of SCT added to the financial aspects. Evidence showing the superiority of this modality over conventional therapies was discarded by the sickness funds for alleged methodical insufficiencies. Although the costs of SCT were repaid to specialized centres on the grounds of individual agreements, oncologists were increasingly required to submit applications for the treatment to the sickness funds, giving detailed reasons. Reimbursement was usually subject to approval by the sickness funds’ medical service. Officially, the sickness funds, however, persisted in the point of view that they could in principle refuse reimbursement as there was no need and legal requirement to pay for a hazardous and expensive treatment that had not been demonstrated beyond doubt to be more effective than conventional therapy. They were also pointing to a lack of agreement within the medical profession on indications for SCT that, they argued, made an expansion of the modality unacceptable. In 1996, more than 250 medium-sized and small hospitals applied to German state and district authorities for permission to perform SCT. They were encouraged
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in their plans by indications that this treatment can be carried out safely in regional hospitals and even in the outpatient setting [4,5]. Also, their cost calculations for providing SCT can be assumed to be lower than those of large centres on which case fees are based. They could, therefore, expect high profits from SCT. This development caused two serious problems. First, it was doubtful whether many of the applying hospitals had sufficient professional experience and equipment to provide SCT at an acceptable level of quality. Second, the sickness funds feared the costs of a drastic increase in the number of SCTs and voiced serious concerns. As they again stressed the experimental nature of this modality, its continued financing and cautious expansion in line with scientific progress seemed in danger. A solution to this complex problem had to achieve two results. First, the provision of SCT at a sufficiently high level of quality to all patients with diseases and stages of diseases where scientific evidence supports this decision. Furthermore, the modality had to be made available at reasonable costs. Clearly, these aims required a coordinated effort of providers and purchasers within the statutory health insurance system. However, no institutional platform for such action was available in the hospital sector. In the ambulatory sector of the German healthcare system, the regulation of health technologies and their reimbursement are regulated by the Federal Standing Committee of Physicians and Sickness Funds. This committee depicts the important role of corporate self-governed bodies such as sickness funds and physicians’ associations to which certain state rights are delegated [1]. The corporate bodies have the legal power to negotiate agreements with one another which are binding in the statutory health insurance system and are responsible for the provision and payment of healthcare services. However, in the hospital sector, no equivalent corporate institutions exist and sickness funds usually negotiate contracts on the introduction of new technologies, per diem charges and other conditions with hospitals individually. In this situation of ‘institutional vacuum’, a plan for a concerted action was suggested by the German Society of Hematology and Oncology [6], which was intended to lead to a consensus among the parties concerned with the provision of SCT: physicians, represented by their scientific societies (German Society of Hematology and Oncology, German Association of Bone Marrow and Blood Stem Cell Transplantation, Association of Internal Oncology, German Society of Pediatric Oncology and Hematology, German Society of Transfusion Medicine and Immune Hematology, German Society of Radiological Oncology, Association of Gynaecological Oncology, Association of Urological Oncology); and the sickness funds, represented by the Verband der Angestellten-Krankenkassen, which is the association of seven German carriers of statutory health insurance and their medical service. This suggestion was welcomed by the named institutions and, in order to collectively draw up and implement the plan which will be presented in the following text, they formally founded the Concerted Action Stem Cell Transplantation (CASCT) in May 1997 [7].
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2. Methods In the following text, the steps agreed by CASCT and their implementation until June 1999 will be presented. The significance of institutional aspects of the German healthcare system for CASCT will be discussed. Using the tools of health economics and the economics of information, the decisions of CASCT and their possible effects on the quality and costs of the provision of HDCT and SCT will be analysed.
3. Results CASCT has developed a plan of six steps, presented in the following text. Its implementation until June 1999 will also be stated.
3.1. Step 1: official standards and guidelines for SCT A working group was formed to lay down professional standards, guidelines and quality assurance procedures for the provision of SCT. The detailed rules describe the organizational set-up of transplantation centres, requirements for the technical equipment used, and the qualification and experience of physicians, nurses and laboratory staff. They also include regulations on the preparation and storage of stem cells, the clinical documentation of SCT and quality-assurance guidelines. The working group consisted of all organizations within CASCT except the sickness funds, but included representatives from the Federal Institute for Sera and Vaccines (Paul Ehrlich Institute) and the German Chamber of Physicians. The regulations were published in June 1997 [8].
3.2. Step 2: compulsory expert assessments To safeguard compliance with the rules laid down in step 1 and other internationally accepted standards, a certification committee was formed. It is made up of 60 medical scientists with extensive experience in the field of SCT, and physicians from the sickness funds’ medical service. New hospitals wishing to perform SCT as a certified procedure must apply to the certification bureau of CASCT and supply detailed information concerning policy and procedures, qualification of staff, quality management and safety relating to SCT. For this purpose, an extensive questionnaire has been drawn up on the basis of standards published by the Foundation for the Accreditation of Hematopoietic Cell Therapy [9] and the Joint Accreditation Committee of the International Society for Hematotherapy and Graft Engineering – Europe and the European Group for Blood and Marrow Transplantation (EBMT) [10]. If the answers given by the applying hospital are satisfactory, CASCT will arrange for a site visit to be made by three or more members of the certification committee. The first such visits were carried out in April 1998. The cost of the
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Table 1 State of the certification process (June 1999) Applications and assessments
Number of institutions
Informal applications Formal applications Expert assessments completed
130 45 23
certification process, approximately 10,000 DM ($6,000) per visit, must be borne by the applying institution. If the results of the assessment meet the requirements, the applying hospital is awarded a certificate of quality. This certificate is a prerequisite to agree on a contract for the provision of SCT with the sickness funds. After 5 years, the validity of the certificate expires and a new assessment has to take place. Until June 1999, 130 informal and 45 formal applications have been received by the certification bureau, and 23 centres have been fully assessed. The results of the certification activities of CASCT are shown in Tables 1 and 2.
3.3. Step 3: recommended procedures for SCT In May 1997, a working group of CASCT, the indications committee, officially started to evaluate the scientific evidence supporting the use of SCT in distinct diagnoses and stages of malignant diseases. The current practice of SCT in Europe [11] served as a basis for the negotiations. A preliminary list of indications (Table 3) was agreed in June 1998 which is currently used for decisions on SCT for individual patients and further negotiations. Deviations are possible in special circumstances. The list comprises two categories: the first consists of diagnoses for which the benefit of HDCT and SCT for suitable patients is considered to be scientifically proven; the second is made up of conditions in which HDCT and SCT are considered likely to be beneficial. These conditions need further investigation and the treatment will only be refunded if carried out within a controlled clinical study. Due to the large number of patients and potentially high costs, the agreement on breast cancer was a major obstacle. The sickness funds agreed to Table 2 Results of expert assessments (June 1999) Result
Award of the certificate of quality Provisional award of the certificate of quality for 1 year Provisional award of the certificate of quality for 1 year after compliance with defined preconditions Refusal of the certificate of quality Total
Number of institutions 2 9 9 3 23
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Table 3 Recommended procedures for stem cell transplantation (June 1999) Category 1: benefits for selected patients considered pro6en Malignant disorders of the bone, articular cartilage and connective tissue Lymphocytic leukemias Myeloid leukemias Multiple myeloma Hodgkin’s lymphoma Other malignant disorders of the lymphatic and histiocytic systems Category 2: e6aluation within clinical trials Breast cancer: adjuvant therapy and metastatic disease Ovarian cancer: high risk patients after operation Small cell lung cancer: limited disease Germ cell tumours: high risk patients and after relapse
finance adjuvant HDCT and SCT for patients with more than nine positive axillary lymph nodes. SCT for metastatic breast cancer will only be reimbursed if carried out within one of three specified German clinical trials: a dose intensity study, a tandem versus single HDCT study and a HDCT versus taxol/adriamycin study.
3.4. Step 4: national registry for SCT Data on all SCT performed in Germany are being collected including information following EBMT Med A standards. In August 1997, the German Registry for Hematopoietic Stem Cell Transplantation (GRSCT), which is a joint undertaking of the University Hospital Essen and the German Registry of Bone Marrow Donors, was selected by CASCT to fulfil this task.
3.5. Step 5: annual data reporting CASCT has decided that once a year, details of SCT evaluated by GRSCT will be published. Among these will be statistical data and trends such as demographic data of patients, e.g. age and sex, the proportions of inpatient and outpatient treatments, and the proportion of patients treated within controlled clinical trials. Data on clinical results will also be analysed and be made available to member institutions of CASCT. They will not be made public as random variations might lead to strong fluctuations of patients’ preferences for individual institutions. The data are, however, supposed to facilitate clinical studies and enable transplantation centres to exert voluntary self-control of their clinical procedures. Outcome data from CASCT will be compared with data from corresponding geographical entities such as Europe or North America.
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3.6. Step 6: cost-benefit analyses relating to SCT CASCT has decided that the results of economic analyses shall be an important criterion for the evaluation of SCT. Using the tools of cost-benefit analysis [12], both medical and economic aspects will be taken into consideration. Data from GRSCT will be used for the analyses. Study designs will include cost analyses which can be employed to compare levels of resource utilization of different providers and cost-minimization analyses which serve to compare the costs of different therapeutic modalities of approximately equal clinical effectivity. Cost-effectiveness analyses will be employed to compare the financial resources used to gain clinical benefits such as survival in therapies which have different levels of clinical effectiveness. Finally, aspects of quality of life will be taken into consideration using quality-adjusted life years.
4. Discussion Standards, guidelines and quality assurance procedures such as those laid down in step 1 are essential elements of quality management in healthcare as they serve as objective criteria of the quality of medical services [13,14]. They can also contribute to cost-containment as they may be used to eliminate measures which are not necessary. Quality assurance procedures and guidelines are among the most important instruments to achieve high quality and cost-efficiency in systems of managed care [15]. Their widespread use in the US even outside managed care may be attributed to their substantial cost-saving potential [16]. Although expert assessments as in step 2 are widely considered as effective ways of measuring performance in the German healthcare system [17], they have so far not been used on a large scale. They may contribute to an improvement of the quality of SCT. The danger of a large number of badly-qualified institutions carrying out SCT which seemed realistic in 1996 has been eliminated as only a minority of the applying hospitals were awarded the certificate of quality (Table 3). The restriction of the number of institutions may lead to a containment of costs due to economies of scale, as unit costs tend to be lower in hospitals with large numbers of patients. In term of health politics, step 2 grants substantial power to the German sickness funds. Together with experts from the scientific societies, physicians from their medical service will examine the suitability of hospitals for SCT. In line with the recommendations of CASCT, the sickness funds will then agree contracts on the provision of this technology with suitable institutions. It is not yet clear on which criteria their negotiations of contracts will be based. The price of the therapy may, however, be expected to play an important role. This could endanger quality as a fall in the price may lead to the deterioration of standards after the certificate of quality has been awarded. The position of the sickness funds will, on the other hand, also be strengthened by their participation in the assessments, as they will obtain information on the
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suitability of individual transplantation centres to carry out SCT, which were previously unavailable to them. In terms of economic theory, the assessments reduce the asymmetry of information on the expected quality of SCT between providers and purchasers [18]. Asymmetric information has been shown to be a potential cause of adverse selection and inferior quality of the goods traded [19]. In principle, the sickness funds will now be put in a position to reject services which do not satisfy their quality requirements. Yet their increased knowledge might just as well be used to push down prices. From the physicians’ point of view, the optimization of quality at acceptable costs is desirable, but to the sickness funds, a reduction of charges at an acceptable level of quality may be more attractive. The direct involvement of the sickness funds in the process of choosing healthcare providers has so far focused on licences to open new ambulatory care practices (§96 of the Social Code Book V) and to contract hospitals outside the hospital plans maintained by the state governments (§108 of the Social Code Book V). In the framework of CASCT, this involvement has been extended to the choice of providers of a specific and highly expensive health technology in the hospital sector. Similar roles of healthcare purchasers are quite common in the US, although this varies considerably across different types of managed care organizations [20]. One possible development concerning SCT in Germany is that individual sickness funds will separately sign agreements with hospitals. This process would weaken the collective character of CASCT and parallel the US-type system of managed care, in which competing managed care organizations have medical services provided exclusively or on favourable conditions by a limited number of physicians and institutions [21]. The determination of recommended procedures for HDCT and SCT in step 3 is important as the sickness funds have, for the first time, been involved in detail in the determination of condition – treatment pairs for patients treated in hospitals. So far, this only happened in the ambulatory sector of the German healthcare system. In return, the sickness funds have officially acknowledged that SCT are necessary for suitable patients and must therefore be financed. Moreover, the procedures include treatments that are still being considered as experimental (Table 3, category 2). This is a new and important development in the German healthcare system, as the Social Code Book V is usually interpreted as prohibiting the financing of experimental healthcare technologies within the statutory health insurance system. Another noteworthy result is that in the case of breast cancer, the German sickness funds have for the first time explicitly accepted to refund treatment within clinical trials. In the past, any legal obligation to reimburse treatments performed in clinical trials was rejected by the sickness funds, which argued that clinical trials were part of scientific research and should be financed by other institutions. In return, the sickness funds have been given an unprecedented influence on the indications for specific therapies and on the decision of which clinical trial will be carried out. The list of indications will have to be followed by the physicians. This too is an important development as it involves a reduction of the autonomy of the medical profession. In managed care, guidelines constitute the bases of utilization reviews for a wide range of medical services and help to reduce costs and perform
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treatment according to accepted standards. The list of recommended procedures can be expected to have similar effects. One important aspect of the consensus on indications should, however, not be overlooked: CASCT could be reproached for withholding potentially life-saving treatments from patients with conditions no included on the list. This means that indications may not be left out for financial reasons but only on the grounds of fair and conscientious scientific consideration. Interestingly, the system of managed care in the US has experienced a comparable danger of loss of confidence [22]. The level to which the national registry for SCT (step 4) will be involved in quality management has not yet been decided. Suggested future tasks of the registry include the development of critical pathways, guidelines and performance standards, measurement of the quality of care and benchmarking. It is possible that the registry will become an institution which will initiate, coordinate and promote a wide range of measures of continuous quality management [23], which, until now, are not widely applied in Germany. The information made available in the annual publication of data (step 5) may be of considerable importance to the medical profession, the statutory health insurance system, political institutions and industry, as knowledge of the underlying trends of HDCT and SCT should facilitate planning and research in the German health care system. From a quality management perspective, the internal exchange of information on results within CASCT is beneficial, as unfavourable deviations in individual institutions will require explanations and possibly action. In certain cases, the withdrawal of the certificate of quality may be considered. The use of cost-benefit analyses in the evaluation of SCT (step 6) extends the role of economic aspects in the German healthcare system. First, financial aspects have, at least officially, rarely been given much weight when potentially life-saving therapies were considered. Second, economic analyses may now be increasingly applied to the hospital sector. In the ambulatory sector, the guidelines of the corporate Federal Standing Committee of Physicians and Sickness Funds for the evaluation and re-evaluation of new and existing technologies include the efficiency criterion. The scarcity of financial means implies that funds have to be allocated between conflicting potential uses. Spending money on one therapy means that funds will be lacking for the provision of another. In this context, cost-benefit analyses can be considered as means of scientifically based and justifiable rationing of medical services. It must, however, not be overlooked that cost-benefit analyses display methodical weaknesses and incorporate subjective assumptions, and thus have to be used with care [24]. It is important to point out that cost-benefit analyses may only constitute one of several criteria which influence a physician’s professional behaviour. Ethical considerations must outweigh financial aspects in a life-or-death situation. On the other hand, it is not yet clear whether SCT is, in fact, a cheaper alternative to conventional treatment. Taking the costs of several cycles of a conventional chemotherapy into account, the relatively high costs of a single SCT may prove to be a good investment in a longer perspective. This could especially be
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the case if clinical effectiveness of SCT is taken into account in cost-effectiveness analyses. However, the explicit acceptance by CASCT of the need to economically justify the provision of potentially curative health technologies for cancer patients means that physicians in Germany have more than ever come to terms with the fact that medicine is no longer autonomous from economic circumstances. The steps concluded by CASCT contain certain elements of managed care which have been introduced in an attempt to achieve high quality and cost-containment of HDCT and SCT. As CASCT concerns only a small fraction of the German healthcare market, it should not be seen out of proportion as a herald of managed care in Germany. A direct application of the US system of managed care to other healthcare systems may not be possible anyway for a number of reasons, including national differences in social, economic, legal and political structures [25]. Also, CASCT does not involve several key elements of managed care in the US sense such as utilization reviews, disease management and guidelines set by the purchasers of healthcare services. It rather represents a concept of ‘concerted care’. For it is important that the new elements already discussed were not caused by the search of companies for profits via market transactions directly involving the price mechanism, as is the case in managed care, but were agreed and introduced collectively. The member organizations of CASCT have realized the economic need to reconcile a new and expensive medical modality with financial facts, and have collectively anticipated and implemented what is thought to be an economically and politically stable equilibrium. This collective agreement is in line with the traditional German concept of self-government (Selbstverwaltung) in the healthcare system: Important developments have rarely been left solely to market forces or legal interventions but have been regulated by corporate institutions representing physicians and sickness funds in cooperation with political institutions [26]. Indeed, CASCT may be seen as an expansion of the German principles of joint ‘corporatist’ self-government into the hospital sector. However, the institutional structure of CASCT merits some attention as it only partially reflects traditional corporate bodies. The key corporate institutions in the ambulatory sector are the sickness funds and physicians’ and dentists’ associations. While the sickness funds and their medical service are represented in CASCT, no equivalent physicians’ association exists in the hospital sector. This vacuum was filled in CASCT by scientific societies representing highly heterogeneous disciplines. The fact that they succeeded in maintaining common positions in the negotiations with the sickness funds is noteworthy as their aims, e.g. regarding recommended procedures for SCT, can be expected to differ substantially. It is doubtful whether a loose cooperation of scientific societies would be able to find common positions on other fields of healthcare technologies in future. Therefore, the need for a more structured corporate body that speaks for all physicians may exist for future corporatist action in the hospital sector. Another important aspect is that the hospital associations have, so far, not been represented in CASCT. Although they are corporate bodies, they have traditionally enjoyed fewer rights than sickness funds and physicians’ associations [1].
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CASCT is considered by the involved parties to be a promising model of corporate action which, if successful, could be applied to other healthcare technologies in the German hospital sector. However, important institutional questions regarding the representation of physicians and hospitals in the corporatization of the German hospital sector will have to be addressed. Also, the long-term effects of corporatization on the quality and cost-containment of HDCT and SCT remain to be seen and will require further investigation.
References [1] Perleth M, Busse R, Schwartz FW. Regulation of health-related technologies in Germany. Health Policy 1999;46:105–26. [2] Busse R, Schwartz FW. Financing reforms in the German hospital sector. Med Care 1997;35:OS40–9. [3] Gianni AM. High-dose chemotherapy and autotransplants: a time for guidelines. Ann Oncol 1997;8:933–5. [4] Regazzoni S, Marini G, Grob A, et al. High-dose chemotherapy with autologous stem cell transplantation is feasible and safe in a regional hospital. A six year experience in southern Switzerland. Bone Marrow Transplant 1997;19:3 – 7. [5] Meisenberg BR, Miller WE, McMillan R, et al. Outpatient high-dose chemotherapy with autologous stem-cell rescue for hematologic and nonhematologic malignancies. J Clin Oncol 1997;15:11–7. [6] Diehl V. Konzertierte Aktion Stammzelltransplantation. Dtsch A8 rzteblatt 1997;36:2241. [7] Sachversta¨ndigenrat fu¨r die Konzertierte Aktion im Gesundheitswesen. Gesundheitswesen in Deutschland—Kostenfaktor und Zukunftsbranche, Vol. II. Bonn: Nomos, 1997. [8] Federal Chamber of Physicians (Scientific Council) and Paul Ehrlich Institute. Richtlinien zur Transplantation peripherer Blutstammzellen. Dtsch A8 rzteblatt 1997;23:1584 – 92. [9] Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT). Standards for Hematopoietic Progenitor Cell Collection, Processing and Transplantation, 1st ed. Omaha, NB: FAHCT, 1996. [10] Joint Accreditation Committee of ISHAGE-Europe and EBMT. Standards for Blood and Marrow Progenitor Cell Processing, Collection and Transplantation. London: EBMT, 1998. [11] Goldman JM, Schmitz N, Niethammer D, et al. Allogeneic and autologous transplantation for haematologic diseases, solid tumours and immune disorders: current practice in Europe in 1998. Bone Marrow Transplant 1998;21:1– 7. [12] Mishan EJ. Cost-Benefit Analysis. An Informal Introduction, 4th ed. London: Routledge, 1988. [13] Donabedian A. The quality of medical care. Science 1978;200:856 – 64. [14] Donabedian A. The quality of care: how can it be assessed? J Am Med Assoc 1988;260:1743– 8. [15] Iglehart JK. Physicians and the growth of managed care. New Engl J Med 1994;331:1167– 71. [16] Rheinhardt U. Economics. J Am Med Assoc 1996;275:1802– 4. [17] Federal Chamber of Physicians. Leitfaden: Qualita¨tsmanagement im Deutschen Krankenhaus. Bern: Zuckschwerdt, 1997. [18] Varian HR. Microeconomic Analysis. New York: WW Norton, 1978. [19] Akerlof G. The market for ‘lemons’: qualitative uncertainty and the market mechanism. Q J Econ 1970;84:488–500. [20] Gold MR, Hurley R, Lake T, et al. National survey of the arrangements managed care plans make with physicians. New Engl J Med 1995;333:1678 – 83. [21] Soper M, Ferriss D. The growth of managed care in the private sector. In: Gelijns AC, editor. Technology and Health Care in an Era of Limits. Washington, DC: National Academy Press, 1992:37–50.
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[22] Mechanic D, Schlesinger M. The impact of managed care on patients’ trust in medical care and their physicians. J Am Med Assoc 1996;275:1693 – 7. [23] Bernwick DM. Continuous improvement as an ideal in health care. New Engl J Med 1989;320:53 – 6. [24] Kissick WL. To manage or to be managed: that is the question. In: Jolt H, Leibovici MM, editors. Health Care Management—Managed Care: Prinicipals and Practice. Philadephia, PA: Hanley&Belfuss, 1995. [25] Luft HS. Health maintenance organizations: is the United States experience applicable elsewhere? In: Health: Quality and Choice. Paris: OECD, 1994:45 – 61. [26] Weil TP. Managed care merged with the German model. Am J Med Qual 1997;12(1):19 – 24.
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Can corporatization contribute to quality assurance and cost control in the German hospital sector? A pilot project for stem cell transplantation Ronald Walshe a, Norbert Schmitz b, Volker Diehl c,* a
Medical Economics Research Group, First Department of Internal Medicine, Uni6ersity of Cologne, Cologne, Germany b Second Department of Internal Medicine, Uni6ersity of Kiel, Kiel, Germany c First Department of Internal Medicine, Uni6ersity of Cologne, Joseph-Stelzmann-Strasse 9, 50924 Cologne, Germany Accepted 2 August 1999
Abstract Due to increasingly strained budgets in the German statutory health insurance system, new and expensive medical technologies have come under increased scrutiny. This also applies to stem cell transplantation (SCT), which is a highly costly treatment for certain types and stages of malignant diseases. In 1996, a large number of hospitals applied for licences to perform SCT, raising fears of deteriorating standards and a cost explosion, especially as new indications such as breast cancer emerged. To address this problem, the Concerted Action Stem Cell Transplantation (CASCT) was created. It consists of several scientific medical societies and the sickness funds. The steps taken by CASCT include binding standards for SCT and expert assessments of institutions wishing to perform SCT. This has successfully reduced the number of new hospitals performing SCT to 11 until June 1999. Recommended procedures for SCT were agreed with the sickness funds including experimental indications such as breast and lung cancer. A national registry for SCT has been set up which will publish data on a yearly basis. An important role of economic analyses for the evaluation of SCT has been agreed. CASCT is a development that extends elements of corporatist self-government found in the German ambulatory healthcare sector to the hospital sector. Its aim is to reconcile an expensive new medical modality with the requirements of quality assurance and cost control. Its long-term effects are as yet unclear and will require further investigation. © 1999 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Corporatization; Hospital sector; Quality management; Sickness funds; Stem cell transplantation
* Corresponding author. Tel.: + 49-221-478-4400; fax: +49-221-478-5455. 0168-8510/99/$ - see front matter © 1999 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 8 - 8 5 1 0 ( 9 9 ) 0 0 0 5 1 - 2
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1. Introduction Since the mid-1990s, new and expensive medical technologies have come under increased scrutiny in the German healthcare system. An important reason for this was the implementation of the Health Care Structure Act of 1993, which introduced fixed budgets and spending caps, and the Hospital Expenditure Stabilizing Act in 1996, which tied budget increases to wage rises in the German public service [1,2]. This political and legal framework has lead to tight budgets within the statutory health insurance system in which nearly 90% of the German population are covered. The high rate of unemployment, currently at more than 10%, moderate wage rises and the increasing average age of the population have contributed to low revenues and a high level of expenditure of the sickness funds, which are the purchasers of health services within the statutory health insurance system. Among the targets of the sickness funds’ cost-containment policy was the provision of high-dose chemotherapy (HDCT) and stem cell transplantation (SCT). HDCT followed by SCT is a highly intensive form of treatment. As HDCT irreversibly damages the patient’s bone marrow, it has to be followed by SCT in order to reduce the life-threatening risk of the treatment to an acceptable level. It is provided to selected patients suffering from haemato-oncologic disorders such as leukaemia and lymphoma as well as solid tumours like lung and breast cancer. Around 1600 patients receive this treatment in Germany every year and the cost to the statutory health insurance system of a SCT is between $60,000 and $80,000. SCT are refunded to hospitals by case fees, which are part of the prospective payment system in the German hospital sector introduced in 1996 as a result of the Health Care Structure Act of 1993. The financial considerations of the sickness funds were also influenced by the availability of new techniques such as peripheral blood stem cell transplantation, which resulted in the broad availability of SCT and emerging new indications for SCT [3]. Non-uniform data in some areas on the benefits of SCT added to the financial aspects. Evidence showing the superiority of this modality over conventional therapies was discarded by the sickness funds for alleged methodical insufficiencies. Although the costs of SCT were repaid to specialized centres on the grounds of individual agreements, oncologists were increasingly required to submit applications for the treatment to the sickness funds, giving detailed reasons. Reimbursement was usually subject to approval by the sickness funds’ medical service. Officially, the sickness funds, however, persisted in the point of view that they could in principle refuse reimbursement as there was no need and legal requirement to pay for a hazardous and expensive treatment that had not been demonstrated beyond doubt to be more effective than conventional therapy. They were also pointing to a lack of agreement within the medical profession on indications for SCT that, they argued, made an expansion of the modality unacceptable. In 1996, more than 250 medium-sized and small hospitals applied to German state and district authorities for permission to perform SCT. They were encouraged
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in their plans by indications that this treatment can be carried out safely in regional hospitals and even in the outpatient setting [4,5]. Also, their cost calculations for providing SCT can be assumed to be lower than those of large centres on which case fees are based. They could, therefore, expect high profits from SCT. This development caused two serious problems. First, it was doubtful whether many of the applying hospitals had sufficient professional experience and equipment to provide SCT at an acceptable level of quality. Second, the sickness funds feared the costs of a drastic increase in the number of SCTs and voiced serious concerns. As they again stressed the experimental nature of this modality, its continued financing and cautious expansion in line with scientific progress seemed in danger. A solution to this complex problem had to achieve two results. First, the provision of SCT at a sufficiently high level of quality to all patients with diseases and stages of diseases where scientific evidence supports this decision. Furthermore, the modality had to be made available at reasonable costs. Clearly, these aims required a coordinated effort of providers and purchasers within the statutory health insurance system. However, no institutional platform for such action was available in the hospital sector. In the ambulatory sector of the German healthcare system, the regulation of health technologies and their reimbursement are regulated by the Federal Standing Committee of Physicians and Sickness Funds. This committee depicts the important role of corporate self-governed bodies such as sickness funds and physicians’ associations to which certain state rights are delegated [1]. The corporate bodies have the legal power to negotiate agreements with one another which are binding in the statutory health insurance system and are responsible for the provision and payment of healthcare services. However, in the hospital sector, no equivalent corporate institutions exist and sickness funds usually negotiate contracts on the introduction of new technologies, per diem charges and other conditions with hospitals individually. In this situation of ‘institutional vacuum’, a plan for a concerted action was suggested by the German Society of Hematology and Oncology [6], which was intended to lead to a consensus among the parties concerned with the provision of SCT: physicians, represented by their scientific societies (German Society of Hematology and Oncology, German Association of Bone Marrow and Blood Stem Cell Transplantation, Association of Internal Oncology, German Society of Pediatric Oncology and Hematology, German Society of Transfusion Medicine and Immune Hematology, German Society of Radiological Oncology, Association of Gynaecological Oncology, Association of Urological Oncology); and the sickness funds, represented by the Verband der Angestellten-Krankenkassen, which is the association of seven German carriers of statutory health insurance and their medical service. This suggestion was welcomed by the named institutions and, in order to collectively draw up and implement the plan which will be presented in the following text, they formally founded the Concerted Action Stem Cell Transplantation (CASCT) in May 1997 [7].
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2. Methods In the following text, the steps agreed by CASCT and their implementation until June 1999 will be presented. The significance of institutional aspects of the German healthcare system for CASCT will be discussed. Using the tools of health economics and the economics of information, the decisions of CASCT and their possible effects on the quality and costs of the provision of HDCT and SCT will be analysed.
3. Results CASCT has developed a plan of six steps, presented in the following text. Its implementation until June 1999 will also be stated.
3.1. Step 1: official standards and guidelines for SCT A working group was formed to lay down professional standards, guidelines and quality assurance procedures for the provision of SCT. The detailed rules describe the organizational set-up of transplantation centres, requirements for the technical equipment used, and the qualification and experience of physicians, nurses and laboratory staff. They also include regulations on the preparation and storage of stem cells, the clinical documentation of SCT and quality-assurance guidelines. The working group consisted of all organizations within CASCT except the sickness funds, but included representatives from the Federal Institute for Sera and Vaccines (Paul Ehrlich Institute) and the German Chamber of Physicians. The regulations were published in June 1997 [8].
3.2. Step 2: compulsory expert assessments To safeguard compliance with the rules laid down in step 1 and other internationally accepted standards, a certification committee was formed. It is made up of 60 medical scientists with extensive experience in the field of SCT, and physicians from the sickness funds’ medical service. New hospitals wishing to perform SCT as a certified procedure must apply to the certification bureau of CASCT and supply detailed information concerning policy and procedures, qualification of staff, quality management and safety relating to SCT. For this purpose, an extensive questionnaire has been drawn up on the basis of standards published by the Foundation for the Accreditation of Hematopoietic Cell Therapy [9] and the Joint Accreditation Committee of the International Society for Hematotherapy and Graft Engineering – Europe and the European Group for Blood and Marrow Transplantation (EBMT) [10]. If the answers given by the applying hospital are satisfactory, CASCT will arrange for a site visit to be made by three or more members of the certification committee. The first such visits were carried out in April 1998. The cost of the
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Table 1 State of the certification process (June 1999) Applications and assessments
Number of institutions
Informal applications Formal applications Expert assessments completed
130 45 23
certification process, approximately 10,000 DM ($6,000) per visit, must be borne by the applying institution. If the results of the assessment meet the requirements, the applying hospital is awarded a certificate of quality. This certificate is a prerequisite to agree on a contract for the provision of SCT with the sickness funds. After 5 years, the validity of the certificate expires and a new assessment has to take place. Until June 1999, 130 informal and 45 formal applications have been received by the certification bureau, and 23 centres have been fully assessed. The results of the certification activities of CASCT are shown in Tables 1 and 2.
3.3. Step 3: recommended procedures for SCT In May 1997, a working group of CASCT, the indications committee, officially started to evaluate the scientific evidence supporting the use of SCT in distinct diagnoses and stages of malignant diseases. The current practice of SCT in Europe [11] served as a basis for the negotiations. A preliminary list of indications (Table 3) was agreed in June 1998 which is currently used for decisions on SCT for individual patients and further negotiations. Deviations are possible in special circumstances. The list comprises two categories: the first consists of diagnoses for which the benefit of HDCT and SCT for suitable patients is considered to be scientifically proven; the second is made up of conditions in which HDCT and SCT are considered likely to be beneficial. These conditions need further investigation and the treatment will only be refunded if carried out within a controlled clinical study. Due to the large number of patients and potentially high costs, the agreement on breast cancer was a major obstacle. The sickness funds agreed to Table 2 Results of expert assessments (June 1999) Result
Award of the certificate of quality Provisional award of the certificate of quality for 1 year Provisional award of the certificate of quality for 1 year after compliance with defined preconditions Refusal of the certificate of quality Total
Number of institutions 2 9 9 3 23
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Table 3 Recommended procedures for stem cell transplantation (June 1999) Category 1: benefits for selected patients considered pro6en Malignant disorders of the bone, articular cartilage and connective tissue Lymphocytic leukemias Myeloid leukemias Multiple myeloma Hodgkin’s lymphoma Other malignant disorders of the lymphatic and histiocytic systems Category 2: e6aluation within clinical trials Breast cancer: adjuvant therapy and metastatic disease Ovarian cancer: high risk patients after operation Small cell lung cancer: limited disease Germ cell tumours: high risk patients and after relapse
finance adjuvant HDCT and SCT for patients with more than nine positive axillary lymph nodes. SCT for metastatic breast cancer will only be reimbursed if carried out within one of three specified German clinical trials: a dose intensity study, a tandem versus single HDCT study and a HDCT versus taxol/adriamycin study.
3.4. Step 4: national registry for SCT Data on all SCT performed in Germany are being collected including information following EBMT Med A standards. In August 1997, the German Registry for Hematopoietic Stem Cell Transplantation (GRSCT), which is a joint undertaking of the University Hospital Essen and the German Registry of Bone Marrow Donors, was selected by CASCT to fulfil this task.
3.5. Step 5: annual data reporting CASCT has decided that once a year, details of SCT evaluated by GRSCT will be published. Among these will be statistical data and trends such as demographic data of patients, e.g. age and sex, the proportions of inpatient and outpatient treatments, and the proportion of patients treated within controlled clinical trials. Data on clinical results will also be analysed and be made available to member institutions of CASCT. They will not be made public as random variations might lead to strong fluctuations of patients’ preferences for individual institutions. The data are, however, supposed to facilitate clinical studies and enable transplantation centres to exert voluntary self-control of their clinical procedures. Outcome data from CASCT will be compared with data from corresponding geographical entities such as Europe or North America.
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3.6. Step 6: cost-benefit analyses relating to SCT CASCT has decided that the results of economic analyses shall be an important criterion for the evaluation of SCT. Using the tools of cost-benefit analysis [12], both medical and economic aspects will be taken into consideration. Data from GRSCT will be used for the analyses. Study designs will include cost analyses which can be employed to compare levels of resource utilization of different providers and cost-minimization analyses which serve to compare the costs of different therapeutic modalities of approximately equal clinical effectivity. Cost-effectiveness analyses will be employed to compare the financial resources used to gain clinical benefits such as survival in therapies which have different levels of clinical effectiveness. Finally, aspects of quality of life will be taken into consideration using quality-adjusted life years.
4. Discussion Standards, guidelines and quality assurance procedures such as those laid down in step 1 are essential elements of quality management in healthcare as they serve as objective criteria of the quality of medical services [13,14]. They can also contribute to cost-containment as they may be used to eliminate measures which are not necessary. Quality assurance procedures and guidelines are among the most important instruments to achieve high quality and cost-efficiency in systems of managed care [15]. Their widespread use in the US even outside managed care may be attributed to their substantial cost-saving potential [16]. Although expert assessments as in step 2 are widely considered as effective ways of measuring performance in the German healthcare system [17], they have so far not been used on a large scale. They may contribute to an improvement of the quality of SCT. The danger of a large number of badly-qualified institutions carrying out SCT which seemed realistic in 1996 has been eliminated as only a minority of the applying hospitals were awarded the certificate of quality (Table 3). The restriction of the number of institutions may lead to a containment of costs due to economies of scale, as unit costs tend to be lower in hospitals with large numbers of patients. In term of health politics, step 2 grants substantial power to the German sickness funds. Together with experts from the scientific societies, physicians from their medical service will examine the suitability of hospitals for SCT. In line with the recommendations of CASCT, the sickness funds will then agree contracts on the provision of this technology with suitable institutions. It is not yet clear on which criteria their negotiations of contracts will be based. The price of the therapy may, however, be expected to play an important role. This could endanger quality as a fall in the price may lead to the deterioration of standards after the certificate of quality has been awarded. The position of the sickness funds will, on the other hand, also be strengthened by their participation in the assessments, as they will obtain information on the
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suitability of individual transplantation centres to carry out SCT, which were previously unavailable to them. In terms of economic theory, the assessments reduce the asymmetry of information on the expected quality of SCT between providers and purchasers [18]. Asymmetric information has been shown to be a potential cause of adverse selection and inferior quality of the goods traded [19]. In principle, the sickness funds will now be put in a position to reject services which do not satisfy their quality requirements. Yet their increased knowledge might just as well be used to push down prices. From the physicians’ point of view, the optimization of quality at acceptable costs is desirable, but to the sickness funds, a reduction of charges at an acceptable level of quality may be more attractive. The direct involvement of the sickness funds in the process of choosing healthcare providers has so far focused on licences to open new ambulatory care practices (§96 of the Social Code Book V) and to contract hospitals outside the hospital plans maintained by the state governments (§108 of the Social Code Book V). In the framework of CASCT, this involvement has been extended to the choice of providers of a specific and highly expensive health technology in the hospital sector. Similar roles of healthcare purchasers are quite common in the US, although this varies considerably across different types of managed care organizations [20]. One possible development concerning SCT in Germany is that individual sickness funds will separately sign agreements with hospitals. This process would weaken the collective character of CASCT and parallel the US-type system of managed care, in which competing managed care organizations have medical services provided exclusively or on favourable conditions by a limited number of physicians and institutions [21]. The determination of recommended procedures for HDCT and SCT in step 3 is important as the sickness funds have, for the first time, been involved in detail in the determination of condition – treatment pairs for patients treated in hospitals. So far, this only happened in the ambulatory sector of the German healthcare system. In return, the sickness funds have officially acknowledged that SCT are necessary for suitable patients and must therefore be financed. Moreover, the procedures include treatments that are still being considered as experimental (Table 3, category 2). This is a new and important development in the German healthcare system, as the Social Code Book V is usually interpreted as prohibiting the financing of experimental healthcare technologies within the statutory health insurance system. Another noteworthy result is that in the case of breast cancer, the German sickness funds have for the first time explicitly accepted to refund treatment within clinical trials. In the past, any legal obligation to reimburse treatments performed in clinical trials was rejected by the sickness funds, which argued that clinical trials were part of scientific research and should be financed by other institutions. In return, the sickness funds have been given an unprecedented influence on the indications for specific therapies and on the decision of which clinical trial will be carried out. The list of indications will have to be followed by the physicians. This too is an important development as it involves a reduction of the autonomy of the medical profession. In managed care, guidelines constitute the bases of utilization reviews for a wide range of medical services and help to reduce costs and perform
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treatment according to accepted standards. The list of recommended procedures can be expected to have similar effects. One important aspect of the consensus on indications should, however, not be overlooked: CASCT could be reproached for withholding potentially life-saving treatments from patients with conditions no included on the list. This means that indications may not be left out for financial reasons but only on the grounds of fair and conscientious scientific consideration. Interestingly, the system of managed care in the US has experienced a comparable danger of loss of confidence [22]. The level to which the national registry for SCT (step 4) will be involved in quality management has not yet been decided. Suggested future tasks of the registry include the development of critical pathways, guidelines and performance standards, measurement of the quality of care and benchmarking. It is possible that the registry will become an institution which will initiate, coordinate and promote a wide range of measures of continuous quality management [23], which, until now, are not widely applied in Germany. The information made available in the annual publication of data (step 5) may be of considerable importance to the medical profession, the statutory health insurance system, political institutions and industry, as knowledge of the underlying trends of HDCT and SCT should facilitate planning and research in the German health care system. From a quality management perspective, the internal exchange of information on results within CASCT is beneficial, as unfavourable deviations in individual institutions will require explanations and possibly action. In certain cases, the withdrawal of the certificate of quality may be considered. The use of cost-benefit analyses in the evaluation of SCT (step 6) extends the role of economic aspects in the German healthcare system. First, financial aspects have, at least officially, rarely been given much weight when potentially life-saving therapies were considered. Second, economic analyses may now be increasingly applied to the hospital sector. In the ambulatory sector, the guidelines of the corporate Federal Standing Committee of Physicians and Sickness Funds for the evaluation and re-evaluation of new and existing technologies include the efficiency criterion. The scarcity of financial means implies that funds have to be allocated between conflicting potential uses. Spending money on one therapy means that funds will be lacking for the provision of another. In this context, cost-benefit analyses can be considered as means of scientifically based and justifiable rationing of medical services. It must, however, not be overlooked that cost-benefit analyses display methodical weaknesses and incorporate subjective assumptions, and thus have to be used with care [24]. It is important to point out that cost-benefit analyses may only constitute one of several criteria which influence a physician’s professional behaviour. Ethical considerations must outweigh financial aspects in a life-or-death situation. On the other hand, it is not yet clear whether SCT is, in fact, a cheaper alternative to conventional treatment. Taking the costs of several cycles of a conventional chemotherapy into account, the relatively high costs of a single SCT may prove to be a good investment in a longer perspective. This could especially be
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the case if clinical effectiveness of SCT is taken into account in cost-effectiveness analyses. However, the explicit acceptance by CASCT of the need to economically justify the provision of potentially curative health technologies for cancer patients means that physicians in Germany have more than ever come to terms with the fact that medicine is no longer autonomous from economic circumstances. The steps concluded by CASCT contain certain elements of managed care which have been introduced in an attempt to achieve high quality and cost-containment of HDCT and SCT. As CASCT concerns only a small fraction of the German healthcare market, it should not be seen out of proportion as a herald of managed care in Germany. A direct application of the US system of managed care to other healthcare systems may not be possible anyway for a number of reasons, including national differences in social, economic, legal and political structures [25]. Also, CASCT does not involve several key elements of managed care in the US sense such as utilization reviews, disease management and guidelines set by the purchasers of healthcare services. It rather represents a concept of ‘concerted care’. For it is important that the new elements already discussed were not caused by the search of companies for profits via market transactions directly involving the price mechanism, as is the case in managed care, but were agreed and introduced collectively. The member organizations of CASCT have realized the economic need to reconcile a new and expensive medical modality with financial facts, and have collectively anticipated and implemented what is thought to be an economically and politically stable equilibrium. This collective agreement is in line with the traditional German concept of self-government (Selbstverwaltung) in the healthcare system: Important developments have rarely been left solely to market forces or legal interventions but have been regulated by corporate institutions representing physicians and sickness funds in cooperation with political institutions [26]. Indeed, CASCT may be seen as an expansion of the German principles of joint ‘corporatist’ self-government into the hospital sector. However, the institutional structure of CASCT merits some attention as it only partially reflects traditional corporate bodies. The key corporate institutions in the ambulatory sector are the sickness funds and physicians’ and dentists’ associations. While the sickness funds and their medical service are represented in CASCT, no equivalent physicians’ association exists in the hospital sector. This vacuum was filled in CASCT by scientific societies representing highly heterogeneous disciplines. The fact that they succeeded in maintaining common positions in the negotiations with the sickness funds is noteworthy as their aims, e.g. regarding recommended procedures for SCT, can be expected to differ substantially. It is doubtful whether a loose cooperation of scientific societies would be able to find common positions on other fields of healthcare technologies in future. Therefore, the need for a more structured corporate body that speaks for all physicians may exist for future corporatist action in the hospital sector. Another important aspect is that the hospital associations have, so far, not been represented in CASCT. Although they are corporate bodies, they have traditionally enjoyed fewer rights than sickness funds and physicians’ associations [1].
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CASCT is considered by the involved parties to be a promising model of corporate action which, if successful, could be applied to other healthcare technologies in the German hospital sector. However, important institutional questions regarding the representation of physicians and hospitals in the corporatization of the German hospital sector will have to be addressed. Also, the long-term effects of corporatization on the quality and cost-containment of HDCT and SCT remain to be seen and will require further investigation.
References [1] Perleth M, Busse R, Schwartz FW. Regulation of health-related technologies in Germany. Health Policy 1999;46:105–26. [2] Busse R, Schwartz FW. Financing reforms in the German hospital sector. Med Care 1997;35:OS40–9. [3] Gianni AM. High-dose chemotherapy and autotransplants: a time for guidelines. Ann Oncol 1997;8:933–5. [4] Regazzoni S, Marini G, Grob A, et al. High-dose chemotherapy with autologous stem cell transplantation is feasible and safe in a regional hospital. A six year experience in southern Switzerland. Bone Marrow Transplant 1997;19:3 – 7. [5] Meisenberg BR, Miller WE, McMillan R, et al. Outpatient high-dose chemotherapy with autologous stem-cell rescue for hematologic and nonhematologic malignancies. J Clin Oncol 1997;15:11–7. [6] Diehl V. Konzertierte Aktion Stammzelltransplantation. Dtsch A8 rzteblatt 1997;36:2241. [7] Sachversta¨ndigenrat fu¨r die Konzertierte Aktion im Gesundheitswesen. Gesundheitswesen in Deutschland—Kostenfaktor und Zukunftsbranche, Vol. II. Bonn: Nomos, 1997. [8] Federal Chamber of Physicians (Scientific Council) and Paul Ehrlich Institute. Richtlinien zur Transplantation peripherer Blutstammzellen. Dtsch A8 rzteblatt 1997;23:1584 – 92. [9] Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT). Standards for Hematopoietic Progenitor Cell Collection, Processing and Transplantation, 1st ed. Omaha, NB: FAHCT, 1996. [10] Joint Accreditation Committee of ISHAGE-Europe and EBMT. Standards for Blood and Marrow Progenitor Cell Processing, Collection and Transplantation. London: EBMT, 1998. [11] Goldman JM, Schmitz N, Niethammer D, et al. Allogeneic and autologous transplantation for haematologic diseases, solid tumours and immune disorders: current practice in Europe in 1998. Bone Marrow Transplant 1998;21:1– 7. [12] Mishan EJ. Cost-Benefit Analysis. An Informal Introduction, 4th ed. London: Routledge, 1988. [13] Donabedian A. The quality of medical care. Science 1978;200:856 – 64. [14] Donabedian A. The quality of care: how can it be assessed? J Am Med Assoc 1988;260:1743– 8. [15] Iglehart JK. Physicians and the growth of managed care. New Engl J Med 1994;331:1167– 71. [16] Rheinhardt U. Economics. J Am Med Assoc 1996;275:1802– 4. [17] Federal Chamber of Physicians. Leitfaden: Qualita¨tsmanagement im Deutschen Krankenhaus. Bern: Zuckschwerdt, 1997. [18] Varian HR. Microeconomic Analysis. New York: WW Norton, 1978. [19] Akerlof G. The market for ‘lemons’: qualitative uncertainty and the market mechanism. Q J Econ 1970;84:488–500. [20] Gold MR, Hurley R, Lake T, et al. National survey of the arrangements managed care plans make with physicians. New Engl J Med 1995;333:1678 – 83. [21] Soper M, Ferriss D. The growth of managed care in the private sector. In: Gelijns AC, editor. Technology and Health Care in an Era of Limits. Washington, DC: National Academy Press, 1992:37–50.
218
R. Walshe et al. / Health Policy 48 (1999) 207–218
[22] Mechanic D, Schlesinger M. The impact of managed care on patients’ trust in medical care and their physicians. J Am Med Assoc 1996;275:1693 – 7. [23] Bernwick DM. Continuous improvement as an ideal in health care. New Engl J Med 1989;320:53 – 6. [24] Kissick WL. To manage or to be managed: that is the question. In: Jolt H, Leibovici MM, editors. Health Care Management—Managed Care: Prinicipals and Practice. Philadephia, PA: Hanley&Belfuss, 1995. [25] Luft HS. Health maintenance organizations: is the United States experience applicable elsewhere? In: Health: Quality and Choice. Paris: OECD, 1994:45 – 61. [26] Weil TP. Managed care merged with the German model. Am J Med Qual 1997;12(1):19 – 24.
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