|Implemented in this survey?|
In 2003 the first disease management programs (DMPs) were implemented in the German statutory health insurance system to improve care of chronic disease. Participation in DMPs was a separate category in the risk structure compensation scheme, giving sickness funds a strong incentive to implement them. After morbidity-oriented risk structure compensation was introduced in 2009, DMPs in Germany will depend solely on their ability to improve quality of care for patients with chronic conditions.
Management of chronic diseases
DMPs are an approach in the field of chronic disease management which has gained importance due to aging populations and an increasing number of patients with chronic conditions. DMPs have been introduced by many European and other countries to improve quality of chronic care and contain costs at the same time. The core objective is to improve coordination by focusing on the care process as a whole, building on scientific evidence and patient involvement.
Characteristics of Disease Management Programs
There are several definitions of disease management programs, but most share the following main features:
DMP in the risk structure compensation scheme
In the case of Germany, DMPs are not only an approach to improve the quality of care for chronically ill patients. Until 2008, they were also an instrument of resource allocation between the statutory health insurance (SHI) sickness funds. Patients who were enrolled in a DMP were treated as a separate category in the risk structure compensation scheme (RSA) beside age, sex and entitlement to invalidity pension. SHI sickness funds received higher payments if they set up certified disease management programs and motivated patients to enroll.
From January 2009, DMP participation alone is no longer used as a separate risk-adjustment factor in Germany. Instead, the risk structure allocation includes supplements for persons suffering from one of 80, mainly chronic, diseases. For every insured classified as suffering from one (or several) of these conditions, the sickness funds get an additional allocation to cover costs (c.f. HPM report "Morbidity-based risk structure compensation").
As a consequence of the introduction of the morbi-RSA, the sickness funds will no longer have an incentive to stimulate patients' enrolment. Improvements in the care for the chronically ill have become the focal point of interest. Cost-effectiveness of DMP will become more important.
Financial: Until the introduction of the morbi-RSA in 2009, SHI sickness funds received a higher compensation for patients enrolled in a DMP. Today, they only receive a flat rate for administrative services, i.e. their financial attractiveness and viability depends on their cost-effectiveness. Some sickness funds offer special tariffs for patients who are involved (e.g. exemption of co-payments). GPs get an average flat-rate of about €100 per year for each enrolled patient.
SHI sickness funds, GPs, patients with chronic conditions
|Medienpräsenz||sehr gering||sehr hoch|
Degree of innovation: DMPs are a fairly new approach to cope with the challenge of managing patients with chronic diseases. The linkage between DMP enrollment and risk structure compensation until 2008 was unique in Germany.
Degree of controversy: The introduction of DMPs was subject to considerable debate between the different stakeholders. While the physicians and their associations criticized some characteristics of DMP, e.g. the need to adhere to standardized guidelines, some sickness funds complained about the close link to the RSA.
Structural or Systematic Impact: DMP as a financial incentive for sickness funds has had a strong impact on the organization of care.
Public visibility: The topic is very prominent among patients with chronic diseases and their representative organizations.
Transferability: DMPs exist in several countries in Europe and the USA as a means to improve quality of care. The utilization of DMPs as a financial instrument within the RSA was only the case in Germany.
The implementation of DMPs in Germany's Statutory Health Insurance was driven by deficits in the quality of care for the chronically ill and increasing expenditures on health care. In 2001, the Advisory Council on the Assessment of Developments in the Health Care System reported a lack of incentives for the care of people with chronic conditions and the inadequate use of scientific knowledge. The reasons for this were seen in
Based on the Health Care Structure Act of 1992, SHI-insured persons were given free choice of sickness funds to be effective from 1996. The aims of the reform were to introduce equal choice for all enrollees and to promote managed competition between the sickness funds. In 1994, the risk structure compensation scheme (RSA) was introduced with the aim to avert risk selection and to adjust differences in contribution rates that are due to the risk portfolio of sickness funds. Age, sex and invalidity were chosen as risk adjusters but morbidity remained unconsidered. Nevertheless, differences in contribution rates among sickness funds remained, which were politically interpreted as being due mainly to uncompensated differences in the risk structure (and less due to sickness funds' efficiency).
The RSA was reformed in 2001 to improve risk compensation using latest scientific evidence and to make it more morbidity oriented. Two more instruments were introduced: (1) a risk-pool as a compensation for high medical expenses and (2) using enrollment in a DMP as a separate category in the RSA (as a predecessor for a full-fledged morbidity-adjusted RSA, originally planned for 2007) (c.f. HPM report "Morbidity-based risk structure compensation", survey no (13)2009)).
The Act to Strengthen Competition in Statutory Health Insurance was passed in 2007 and introduced the health fund on January 2009 (c.f. HPM reports "Health care reform in Germany: Not the big bang" , survey no (8)2006, "Health Fund now operational", survey no (13)2009). The newly introduced morbi-RSA contains risk adjusters for morbidity and redistributes half the money of the health fund according to those new categories. Enrolment in a DMP is no longer a risk-adjuster.
|Implemented in this survey?|
Structured disease management programs for selected conditions were originally developed in the United States before being introduced in a range of European countries. The approach seems promising in terms of quality and efficiency gains, particularly when health care is funded through social insurance. As these systems tend to allow patients to choose family practitioners and some specialists, doctors are more likely to work as single-handed practitioners. This leads to a separation between the ambulatory and hospital sector, and disease management programs could overcome this.
DMPs were introduced in Germany in 2002 and now cover diabetes type 1 and 2, asthma/COPD, coronary heart disease and breast cancer. In December 2006 there were 10,580 programs with nearly 2.7 million patients. By April 2008, this number had risen to 4.7 million. Programs for Diabetes mellitus type 2 had the highest number of involved patients (2.7 million), followed by coronary heart disease (1.2 million). According to the Federal Social Insurance Authority the number of running accredited and re-accredited DMPs in March 2009 was about 14,800, around 2,500 per indication, with more than 5.5 million patients (Federal Social Insurance Authority 2009).
The approach of the idea is described as:
new: First developed in the USA during the 1990s, the concept of DMPs entered the debate in Germany in 2001. Along with the reform of the risk structure compensation scheme, the introduction of DMPs was enacted in the same year.
The red-green coalition between social democrats (SPD) and the green party (Die Grünen), which was in power between 1998 and 2005, supported 'managed competition'. They strived to develop a completely morbidity-oriented RSA. Adding enrolment in a DMP as a risk adjuster can be seen as a first step to achieve this goal.
In 2001, the Advisory Council on the Assessment of Developments in the Health Care System gave the impetus for the implementation of DMPs.
The strong financial incentives of having DMPs in place motivated the sickness funds to set up DMPs and contract as many physicians as possible. Reactions of sickness funds in Germany were mixed. Funds which were net contributors in the RSA experienced the expansion of the RSA transfer-volume as an obstacle to free competition. Sickness funds which were net beneficiaries supported the development of the RSA towards a completely morbidity oriented system (which was eventually introduced in 2009).
In 2002, a national assembly of all regional physicians' associations, which formed the strongest opposition, took place. They called on their members not to sign a DMP contract. The requested documentation process was associated with a substantial bureaucratic and administrative burden for the physicians and they felt it restricted their therapeutic freedom due to the requirement of strict treatment guidelines and clinical pathways (Busse 2004).
|Federal Ministry of Health||sehr unterstützend||stark dagegen|
|Federal Social Insurance Authority||sehr unterstützend||stark dagegen|
|Regional Physicians' Association||sehr unterstützend||stark dagegen|
|GPs||sehr unterstützend||stark dagegen|
|SHI sickness funds (net beneficiaries)||sehr unterstützend||stark dagegen|
|SHI sickness funds (net contributors)||sehr unterstützend||stark dagegen|
|Advisory Council on the Assessment of Developments in the Health Care System||sehr unterstützend||stark dagegen|
In 2002, the legal basis for DMP was introduced in the Social Code, Book V, §137 f.
|Federal Ministry of Health||sehr groß||kein|
|Federal Social Insurance Authority||sehr groß||kein|
|Regional Physicians' Association||sehr groß||kein|
|SHI sickness funds (net beneficiaries)||sehr groß||kein|
|SHI sickness funds (net contributors)||sehr groß||kein|
|Advisory Council on the Assessment of Developments in the Health Care System||sehr groß||kein|
The Federal Joint Committee suggests indications for DMPs based on criteria that have to be met. These criteria include high prevalence of the indication, variations in care, potential to alter the course of the disease by improved patient participation, availability of evidence-based treatment guidelines and high costs induced by the indication. To date, DMPs for diabetes mellitus 1 and 2, breast cancer, coronary heart disease and asthma/COPD have been approved.
Sickness funds can apply for a DMP accreditation at the Federal Social Insurance Authority for each indication in each region. The Federal Social Insurance Authority certifies the applications along the requirements for DMPs. These include evidence-based treatment guideline for providers; necessary quality assurance measures; defined conditions and process of patient enrolment; patient and provider education; documentation; and evaluation of costs and effectiveness. Using these requirements sickness funds can contract providers.
In spite of the large number of applications, contracts between sickness fund and providers are highly standardized regarding documentation and patient enrollment. This should make the administrative burden of procedure more manageable for physicians.
The implementation of DMPs was initially very slow due to a strong opposition consisting of the regional physicians associations. They expected a decrease of quality of care and the loss of their professional autonomy and therapeutic freedom due to the standardized guidelines and clinical pathways. Their resistance became less pronounced after the re-election of the red-green government in autumn 2002. The first DMP was accredited in 2003.
The evaluation of a DMP is indication specific and can examine (1) the effectiveness of parts of the program or (2) the DMP as a whole.
In Germany, the evaluation of DMP is mandatory for sickness funds every three years after the initial accreditation, which is a precondition for receiving a re-accreditation. This mandatory evaluation includes the achievement of medical parameters, the observation of rules of enrollment and the capturing of costs for services. The quality of a program is measured by the extent to which the targets have been reached. All three components of quality, that is structure, process and result, have to be evaluated.
The evaluations of DMPs are commissioned by the Federal Association of Sickness Funds and conducted by independent scientific institutes that fulfill certain requirements set by the Federal Social Insurance Authority. The study design is an uncontrolled, non-randomized, prospective cohort study. The cohort consists of all patients who have been enrolled in a specific program for at least six months. The evaluation starts six months after the accreditation of a program.
The Federal Social Insurance Authority, together with selected experts, defines the methods and parameters used for the evaluation of the effects of the DMP on the quality and costs of care. Based on the results of the evaluation, they decide on the continuation of a specific program.
Halbzeitevaluation, Abschlussevaluation (intern), Abschlussevaluation (extern)
Today, the mandatory evaluation of those DMPs that were implemented between 2003 and 2006 is completed. According to a statement of the general regional sickness funds (AOK), clinical parameters developed positively for DMP diabetes type 2 and coronary heart disease. The mandatory evaluation noticed decreasing blood pressure, fewer comorbidities and stable blood sugar levels in patients with diabetes type 2. Furthermore, a positive impact on smoking cessation and patient satisfaction was reported. Effects on the patients' body mass index (BMI) and on the adherence to diabetic foot care could not be found. Evaluation results of the second generation of DMPs are expected to be published this year (AOK 2008). Evaluations of other sickness funds, ie. the Techniker Krankenkasse and the BIG-Gesundheit, came to the same conclusions as the AOK for diabetes type 2 (Münscher and Potthoff 2008). None of the evaluations implies a comparison of costs or cost-effctiveness between standard care and care in a DMP due to the absence of a control group.
The evaluation of the DMP for coronary heart disease in Germany identified several factors of DMP participation. The probability of enrollment in the DMP for coronary heart disease is higher for younger persons who suffered their last heart attack very recently and for patients with diabetes. Furthermore, selection seems to depend on sickness fund membership. The actual enrolment in a DMP varies between the different sickness funds (Gapp et al. 2008).
DMP evaluation has also been examined by independent research institutes that are not commissioned by the Federal Association of Sickness Funds. A DMP is an intervention of high complexity and demands exact methods. There is a lack of systematic evaluations of population-based chronic disease management programs in Germany, but also in the rest of Europe. This is partly because DMPs have been introduced relatively recently, and partly because politicians do not demand evaluation as strict as they do for example for newly developed pharmaceuticals. One should concede, however, that the impact of DMPs depends heavily on their context, so studies from high-income countries outside Europe are of limited value.
Evaluation of effectiveness
Evidence on the effectiveness of disease management programs comes from several systematic reviews and meta-reviews.
One large-scale study using a three-armed prospective cluster-randomized design was the German ELSID-Diabetes study. It was set up in 2005 to assess the effectiveness of a diabetes disease management program in primary care in two German federal states. Early results show that the death rate among patients in the program was significantly lower over two and a half years (10.9%) compared with those receiving 'standard' care (18.8%). Age-adjusted evaluations among severely ill women also showed a significant variation: a 9.5% death rate for those on the program compared with a 12.3% rate for those receiving 'standard' care. The data for men are not yet available. The study also found that patients taking part in a program perceived their care as more structured and coordinated than did those receiving standard care (Szecsenyi et al. 2008).
A number of international evaluations looked at the effectiveness of different strategies in chronic disease management. Those using provider education, feedback, and/or reminders produced better adherence by providers to care guidelines. However, it was not shown which approaches produced the greatest relative improvement as the studies did not directly compare different approaches.
A review commissioned by WHO concluded that appropriately evaluated DMPs improved the quality of care as measured by the provider's increased adherence to evidence-based standards and by disease control (Velasco-Garrido et al. 2003). However, evidence for effectiveness of the programs was found only for diabetes, depression, coronary heart disease and heart failure (Weingarten et al. 2002). For other chronic conditions the results were inconclusive. Effectiveness referred only to process and structure, and no study found any statistically significant impact on (long-) term health outcomes.
It was found that improvements in quality of care, as measured by patient satisfaction, were greatest with treatment, patient adherence to treatment recommendations, and measures of disease control. Disease management may be an effective way of changing the behavior of patients and providers (Mattke et al. 2007).
These are preliminary findings, because most of the empirical work looked at small-scale programs run for high risk individuals as a demonstration project on a single site. These pilot projects mostly combined individual patient education, care planning, and follow-up delivered by a nurse or case manager. Such levels of support would be difficult in large scale DMPs.
Generally, the evidence suggests that DMPs can improve the care process. Improvements in clinical care affect intermediate outcomes and disease control. The impact of these programs on long-term outcomes is not yet established, so it is impossible to draw any general conclusions.
Evaluation of cost-effectiveness
The original goal of DMPs when first introduced in the USA was to reduce costs. Also in Germany, it was expected that using the programs to change utilization would lower hospitalization and complication rates and be more efficient.
However, few studies included measures of utilization, such as emergency department visits or hospitalizations. Economic evaluations of DMPs tend to focus only on costs, while benefits and cost benefits are rarely considered.
Available studies conclude that there is no evidence that DMPs are more cost-effective than standard care (Velasco-Garrido et al. 2003; Ofman et al. 2004). It must be considered that many studies have methodological flaws, such as incompletely accounting for costs or lacking a suitable control group. Even looking at the reported costs and the generated savings rarely brings any conclusive evidence that disease management brings net savings on direct medical costs.
Furthermore, the long-term and medium-term impact of disease management programs has not yet been studied exhaustively. This requires long-term observations, which examine the prevention of severe diagnosis. The avoidance of severe diagnosis, e.g. an amputation, can compensate high costs. As a consequence, no conclusions can be drawn about the financial returns on investment.
Overall, the evidence on disease management programs is far from satisfactory, given its prominent role. Few studies have looked at the effects of large population-based interventions.
As noted above, the numbers of DMPs and participants were still high as of March 2009. However, these are all programs which have started under the previous incentives. It remains to be seen how rapidly the number of DMPs will decline - or whether sickness funds really feel that they produce added value and are cost-effective.
|Qualität||kaum Einfluss||starker Einfluss|
|Gerechtigkeit||System weniger gerecht||System gerechter|
|Kosteneffizienz||sehr gering||sehr hoch|
Impact on quality of health care services: The improvement of process and outcome parameters regarding the quality of care is evident for patients enrolled in a DMP.
Level of equity: The link between DMP and RSA was a first step to achieve more equity for chronically ill patients in the SHI. The introduction of the morbi-RSA focuses even more on this issue.
Impact on cost-efficiency: At this point cost-efficiency is low due to high costs of implementation. In a long-term perspective DMPs are quite possible to be cost-efficient.
Blümel, Miriam and Reinhard Busse