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France, Germany, Hungary, Poland, Spain, Switzerland, United Kingdom

Austria, Greece, Italy, Ireland, Portugal, Sweden, The Netherlands, Turkey

Belgium, Denmark, Finland, Luxembourg

Fig. 5. Access to dialysis reimbursement for private and public providers in selected European countries. In many countries, private providers still have limited or no access to reimbursement.

Components included in the 'base' reimbursement in most of the countries analyzed

Core disposables Machines Infrastructure Physician fees Nursing service

Standard pharmaceuticals

(e.g. heparin, analgesics)

Components NOT included in the 'base' reimbursement in most of the countries analyzed Special pharmaceuticals {e.g. EPO, iron, phosphate binders) Diagnostics Laboratory work Nutritional products Vascular access Transportation Hospitalization

Generally separately reimbursed

Fig. 6. Product and service cost factors generally included or excluded from the reimbursement rate in selected European countries. Countries analyzed: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, The Netherlands, Poland, Portugal, Spain, Slovenia, Sweden, and Turkey.

Looking at the dialysis reimbursement modalities, again the picture is not homogeneous among European countries [16]. There are three main types of reimbursement modalities in Europe [16]: budget transfer, 'fee for service' and flat rate. In some cases, the reimbursement modality varies within the same country depending on the type of provider (public or private).

Budget transfer is a reimbursement modality used mainly for public providers in most of the countries where the funding is based on taxation and in some of the countries where it is based on social security (e.g. Spain, Czech Republic).

' Fee for service' is the most common reimbursement modality for private providers in all countries (an exception is, for example, Hungary where reimbursement to private providers is based on budget) and for the public providers in countries where the funding system is based on social security payments.

Germany is particular in that it is the only country in Europe in which the reimbursement modality is a flat weekly rate independent of both the type of provider and the type of dialysis therapy provided.

The larger variety of situations comes when analyzing the reimbursement rates in the different European countries. The rates may vary as a function of various factors:

(1) the number and types of products and services included; (2) the type of dialysis modality, e.g., HD, ambulatory peritoneal dialysis, continuous ambulatory peritoneal dialysis, hemodiafiltration (HDF), hemofiltration, online HDF; (3) the kind of provider, i.e. public, private, nonprofit organization, and (4) the place of the treatment, e.g. a dialysis center, a limited care center, at home. Even within the same country there are often several reimbursement rates, each of them corresponding to different combinations of these factors.

Any comparison of rates between different countries is very complex and the combination of the factors to which the rate refers is almost never the same because the cost elements covered by the reimbursement rates are considerably different and regulated in different ways from country to country (labor costs, utilities, infrastructure and drug prices).

Reimbursement rates for standard HD treatments in private clinics can vary by more than 100% within Europe. A lot of this variability can of course be explained by country-specific regulations and cost factors (e.g. labor, utilities), but a lot also comes from the number and type of products and services included in the rate. As an example, in some countries (e.g., Poland, Romania and Slovenia), erythropoietin, which can represent a significant part of the cost of the treatment, is included in the reimbursement rate for private providers, while in other countries it is reimbursed separately. The same can apply, for example, to patient transportation or to physician's fees. Figure 6 shows which product and service elements are generally included in the reimbursement rate and which are generally reimbursed separately in a selected group of European countries.

The general structure of the reimbursement and the combination of the factors that determine the reimbursement rate determine the way the dialysis provider operates in different countries, thereby determining a variety of business models involving various levels of risk. For example erythropoietin, its inclusion in dialysis reimbursement is a clear allocation of the financial risk of anemia management to the dialysis service provider. The higher the number of products and services included in the reimbursement the higher the number and level of economical risks that the provider has to undertake (fig. 7).

Dialysis Centers: Categories Responding to Patients'

or Payers' Needs?

Dialysis patients can be treated in three main types of locations: the dialysis center offering full medical and nursing assistance (either in a hospital setting or in dialysis clinics); the limited care center offering limited medical and/or nursing assistance, and the home environment (main location of treatment for peritoneal dialysis patients).

In 2005, of the 340,000 European dialysis patients about 36,000 were treated at home (94% of them with peritoneal dialysis therapies and 6% with home HD therapy), around 17,000 were treated in limited care centers (of this figure more than 15,000 are in France and Italy), and the remaining 288,000 were treated in dialysis centers with full assistance.

The offer of HD service locations is, once again, not homogeneous in Europe. Country regulations sometimes limit the offer to centers with full medical and nursing assistance (e.g. Czech Republic, Greece, Slovenia, Turkey). In Spain home HD is allowed but limited care centers are not permitted as the full time presence of a ne-phrologist is required by law. In 2005, eight European countries were treating patients in limited care centers while home HD was practiced in almost 20 countries.

France is the European country in which the largest variety of treatment locations is possible. Patients can be treated in five different types of location: the dialysis center, the 'unités de dialyse médicalisée', the 'unités d'autodialyse assistée', the 'unités d'autodialyse simple', and the patient's home. The dialysis centers are normally placed in hospital structures and must have the possibility to supply hospitalization services. In dialysis centers full medical and nursing assistance is assured. The 'unités de dialyse médicalisée' must work under the supervision of a team of nephrologists but the presence of a ne-phrologist during the dialysis session is not compulsory. The 'unités d'autodialyse simple or assistée' only assure the presence of nursing personnel during the dialysis session and are operated with special low patient/machine ratios.

Different Environments, One Commitment:

The Best Dialysis according to the Resources Available

Within Europe dialysis is unanimously recognized as a life-saving treatment for patients suffering from ESRD. In the European Union access to therapy is in most cases assured for patients requiring it and, in general, the costs of dialysis therapy are fully covered by country healthcare systems with no or extremely low patient participation in payments.

Despite the variety of reimbursement systems, regulations and organization of service provisions between the different countries, a high and uniform level of quality

Quality assurance risks

Nursing services risks

Medical doctors risks

Drugs risks

Laboratory risks

Catering risks

Hospitalization risks

Vascular access risks

Patient transport risks

Type of business

Dialysis Service Provider

Type of payment

Reimbursement/treatment

Player

FME patient care services

Other dialysis network

Patients and self-care organizations

Fig. 7. Business-related risks for dialysis providers.

Fig. 7. Business-related risks for dialysis providers.

care must be assured and delivered by a dialysis provider operating across all these different economic, political and legal environments [15, 17].

Respecting international outcome guidelines, the strict monitoring of the activities in all countries to assure compliance with these guidelines, and the provision of as comparable as possible treatments for all patients are simultaneously the aim and the challenge of any dialysis service provider operating in Europe.

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