Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints

Objectives To generate insight into the differences between utility measures EuroQol 5D (EQ-5D), Health Utilities Index Mark II (HUI2) and Mark III (HUI3) and their impact on the incremental cost-effectiveness ratio (ICER) for hearing aid fitting
Introduction
Hearing loss affects the ability to exchange information and therefore affects a person’s quality of life [1]. Of the western adult population, approximately 15% are hearing impaired [2], and for these persons hearing aid use has proven to be effective [3, 4]. The growth of the elderly population has far-reaching implications for auditory health service delivery and expenditure since the prevalence increases heavily with age. As a result, increasingly more economic evaluations are undertaken on interventions such as hearing aid fitting. In economic evaluations health related quality of life (HRQoL) should be measured with a preference-based utility measure [5]. Until recently, the benefits of hearing aid fitting had not translated into a statistically significant improvement in health state utility [6–8]. In 2004 Barton et al [9] confirmed this for the EuroQol 5D (EQ-5D), but did find statistically significant utility gain after hearing aid fitting with the Health Utilities Index Mark III (HUI3). This difference may result from differences in the descriptive system, and the way the scoring function is derived.
Also with regard to other conditions, a number of studies have found that different utility measures tend to lead to different utility scores [10–22]. In general there is need for head-to-head comparisons of utility measures, in order to assess the implications for the interpretation and comparability of economic analyses, especially in conditions where only subtle changes after treatment are expected [23, 24]. In these comparisons the comparison of different tariffs should also be incorporated. But most importantly, the impact of the differences between measures on incremental cost-effectiveness ratios (ICERs) should be made apparent. Surprisingly, the latter has not yet received much attention.
The objective of this article is to compare the two most frequently used utility measures in economic analyses [25] in a Dutch population with hearing complaints. Utility scores derived with the EQ-5D UK tariff [26], the EQ-5D Dutch tariff [27], the Health Utilities Index Mark 2 (HUI2) and HUI3 [28] are compared to generate further insight into the differences between the measures, and the impact on the ICER for hearing aid fitting. In particular, this article considers:practicality of using the EuroQol and HUI in a population with hearing complaints;construct validity of the EQ-5D UK tariff, EQ-5D Dutch tariff, HUI2 and HUI3;agreement between the EQ-5D UK tariff, EQ-5D Dutch tariff, HUI2 and HUI3;responsiveness of the EQ-5D UK tariff, EQ-5D Dutch tariff, HUI2 and HUI3 after hearing aid fitting;and the impact of on the ICER for hearing aid fitting.
Methods
The EQ-5D, HUI2 and HUI3
The five questions of the EQ-5D descriptive system each represent one dimension of health-related quality of life (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) [29]. Each question has three levels and the questions together classify persons into one of 243 health states. The commonly used scoring function is based on a British study (EQ-5D UK tariff) [26], with preferences derived with the time trade-off (TTO) method, in a representative sample of the UK population of 2,997 respondents. The scoring function is additive and the possible range of utility scores is −0.59 to 1.00. Recently, Lamers et al [27] developed a Dutch scoring function for the EQ-5D (EQ-5D Dutch tariff), based on TTO in a sample of 298 respondents, with utility scores ranging from −0.33 to 1.00.
The 15 questions of the HUI descriptive system classify respondents into either HUI2 or HUI3 health states. The HUI system focuses on health ‘within the skin’, meaning that they purely focus on impairment and not on the social context of the impairment [28]. HUI2 consists of seven attributes (sensation, mobility, emotion, cognition, self-care, pain and fertility), with three to five levels, leading to 24,000 possible health states. The optional fertility attribute was not used in the present study. The multiplicative scoring function was derived using standard gamble (SG) and Visual Analogue Scale (VAS) in a random sample of 293 Canadian respondents and utility scores range from −0.03 to 1.00 [30]. HUI3 consists of eight attributes (vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain), with five to six levels and leads to 972,000 possible health states. The multiplicative scoring function was derived from SG and VAS, in a random sample of the Canadian general population (n = 504), resulting in possible utility scores varying from −0.36 to 1.00 [31].
Study population and data collection
Data were collected as part of a before-after study examining direct hearing aid provision versus provision by referral [32]. The study was carried out in 2004–2005 in three regions (Maastricht, Rotterdam and Amsterdam) in the Netherlands. Persons with hearing complaints were recruited from the participating Ear Nose and Throat (ENT) departments, audiological centres and hearing aid dispensers. Both EQ-5D and HUI were administered at the first visit to the ENT department. Questionnaires were completed at the department, and respondents were helped by a trained interviewer if requested. Patients who were fitted with a hearing aid were asked to attend the ENT department for a follow-up visit to evaluate the hearing aid fitting. During the evaluation at the ENT department this subset of patients completed both questionnaires for a second time. Again, questionnaires were completed at the department, and respondents were helped by a trained interviewer if requested.
Practicality of the questionnaires
Especially in an elderly population, an important aspect of a utility measure is the ease of completion. The practicality of using the EQ-5D and the HUI in a population with hearing complaints was therefore assessed by the completion rate, using a Wilcoxon Signed Ranks Test to test whether the completion rates were significantly different. Additionally we examined the item non-response.
Construct validity
In absence of a gold standard to measure health state utility, there is no clear technique to determine the construct validity of utility measures. A way to examine the construct validity is to examine whether utility scores are different for distinctive groups [33, 34]. Other studies have demonstrated differences of quality of life scores by sex [33, 35, 36] and age [35–38]. Comparisons were made between EQ-5D UK and Dutch tariff, HUI2 and HUI3 scores by age (above versus below median) and sex. It was expected that persons of a higher age and females have lower utility scores. In addition, the respondents were divided into five clinically distinctive groups, based on their hearing loss and hearing aid use. Hearing loss was defined as the better ear pure tone average (BEPTA) hearing loss for the frequencies 1000, 2000 and 4000 Hz. The groups were: persons who were not entitled to reimbursement of a hearing aid (BEPTA < 35 dB); persons who were entitled to reimbursement (BEPTA ≥ 35 dB) but did not apply for a hearing aid (non-applicants); first time hearing aid applicants; experienced hearing aid users who were about to have a new hearing aid fitted (re-applicants); and experienced hearing aid users who did not have a new hearing aid fitted.
It was expected that persons with a BEPTA smaller than 35 dB would have a higher quality of life score than persons in the other four groups, because they are likely to experience less problems with hearing. It was also expected that non-applicants had a higher utility score than first time applicants, since the latter group is expected to experience more hearing complaints, resulting in fitting a hearing aid as a solution for their hearing problems.
Descriptive summary statistics were provided and normality was tested for all data using the Kolmogorov–Smirnov test. Kruskal–Wallis one way ANOVA and pairwise comparison tests (Mann–Whitney U) were used to explore the differences between the groups.
Agreement
To assess agreement between the measures, a Wilcoxon Signed-Rank test and a Paired t-test were used to test whether the scores of the EQ-5D (UK and Dutch tariff), HUI2 and HUI3 had the same distribution and mean. Correlations (Kendall’s Tau) and the Intra-class Correlation Coefficient (ICC) were computed. The ICC was based on a two-way mixed effect model, such that the subject effect was random and the instrument effect was fixed, and computed at the individual patient level. An ICC below 0.75 implies poor to moderate agreement; above 0.75 implies good agreement [34].
Responsiveness
Responsiveness was tested in the subpopulation with a valid score both before and after hearing aid fitting. Effect size and standardized response mean were calculated. Effect size is the change in score divided by the standard deviation of scores at baseline. Standardized response mean is the change in score divided by the standard deviation of the change in score. Both were interpreted using benchmarks for effect size: 0.20 through 0.49 is interpreted as small, 0.50 through 0.79 as moderate and ≥0.80 as large [39]. Also, a Wilcoxon Signed Ranks Test and a Paired t-test were conducted on the before and after scores. The change in score after hearing aid fitting was tested for differences between first time hearing aid applicants and re-applicants. It was expected that re-applicants had a smaller change in utility, since they already had a hearing aid and therefore expectedly less hearing problems at baseline.
Impact on the ICER
To illustrate the impact on the ICER, straightforward one year ICERs of hearing aid fitting versus no hearing aid fitting (doing nothing) were calculated. Quality Adjusted Life Years (QALYs) were calculated using the area under the curve method, for the EQ-5D (UK and Dutch tariff), HUI2 and HUI3 [5]. Baseline utility scores were used to estimate the effects of ‘no hearing aid fitting’. Costs of no hearing aid fitting were assumed to be zero. This was compared to the costs and effects after hearing aid fitting. The costs of hearing aid fitting were calculated prospectively for each respondent, including General Practitioner (GP) visit(s), ENT visit(s) and hearing aid(s). We used standard costs for medical consumption [40], and the actual price of the hearing aid. As costs and utility scores are generally not normally distributed, a non-parametric bootstrap sampling method was used to calculate the 95% confidence interval around the ICERs [41]. Cost-effectiveness acceptability curves for all measures were created to characterize the likelihood that hearing aid fitting will be deemed cost-effective based on the incremental costs and outcomes, for a range of ceiling ratios. Ceiling ratios reflect societies’ maximum willingness to pay for a unit of outcome.
Results
Practicality
Of the 337 persons with hearing complaints included in the study, in total 315 (93%) fully completed both the EQ-5D and the HUI descriptive system at baseline. Each item on the EQ-5D had six missing values, except for mobility (n = 5). Regarding the HUI, all questions had six or seven missing values, except for the questions on hearing in a group conversation (n = 12), pain and discomfort (n = 10), and hearing in a conversation with one other person (n = 8). Although completion rates were high for both questionnaires, EQ-5D was fully completed by 328 persons (97%), which is significantly more than the 318 persons (94%) who completed the HUI (P-value 0.012).
Of the 315 persons who completed both EQ-5D and HUI at baseline, 173 persons (55%) had a hearing aid fitted. Of them, 82 (47%) attended the ENT department for the follow-up visit after hearing aid fitting. Ninety-one respondents (53%) who had a hearing aid fitted did not show at the follow-up visit because they had not finished their hearing aid fitting before the end of the study (n = 37), or because they had a hearing aid fitted at a dispenser not participating in the study (n = 54), and were therefore lost to follow up. Of the 82 respondents who did attend the follow-up visit, 70 (85%) fully completed both the EQ-5D and HUI descriptive system. Each item on the EQ-5D had five missing values, except for pain/discomfort (n = 6). Regarding the HUI, the hearing questions both had four missing values, and the other questions had four to seven missing values. Seventy-six persons (93%) fully completed the EQ-5D, while 71 persons (87%) fully completed the HUI. This difference is not statistically significant (P-value 0.059).
Construct validity
Mean age of the respondents was 69.6 years (sd 8.9; median 70), and BEPTA was on average 42 dB. The respondents were divided into groups below 70 years old (n = 156) versus 70 years and older (n = 159) and male (n = 189) versus female (n = 126), see Table 1. The scores on the EQ-5D, HUI2 and HUI3 were not normally distributed (Kolmogorov–Smirnov test, P-value 0.000). Only the EQ-5D detected differences in reported health by both age and sex. HUI3 detected a difference in utility between the age groups, HUI2 did not detect any differences.
Table 1Comparison of mean scores, median scores and interquartile range (IR) at baseline according to different characteristics of the respondentsAgeSexBEPTAEQ-5D UK tariffEQ-5D Dutch tariffHUI2HUI3NMean % MaleMean MeanMedian (IR) MeanMedian (IR) MeanMedian (IR) MeanMedian (IR)Age<7015661.964%37.40.860.94 (0.24) 0.880.95 (0.20)0.780.79 (0.15)0.640.65 (0.36)≥7015977.057%47.10.810.80 (0.27)0.840.84 (0.23)0.760.80 (0.17)0.580.59 (0.38) P-value*0.0100.0250.1340.034SexMale18969.3100%43.40.850.88 (0.26)0.870.90 (0.19)0.770.80 (0.13)0.610.62 (0.37)Female12669.90%40.50.810.80 (0.27)0.830.84 (0.23)0.760.78 (0.18)0.610.63 (0.39)P-value*0.0190.0120.5750.965Clinically distinctive groupsBEPTA <35 dB6961.954%21.30.840.81 (0.27)0.860.84 (0.20)0.800.80 (0.20)0.700.66 (0.37)Non-applicants4674.259%42.10.800.87 (0.27)0.830.90 (0.23)0.770.78 (0.15)0.620.60 (0.41)First time applicants10871.262%46.90.840.85 (0.27)0.860.87 (0.23)0.760.78 (0.16)0.580.61 (0.28)Re-applicants6569.666%53.60.850.85 (0.27)0.880.86 (0.20)0.770.79 (0.17)0.560.61 (0.41)P-value**0.9960.9930.2640.004* Mann–Whitney U test** Kruskal–Wallis test
Furthermore, the respondents were divided into five clinically distinctive groups: BEPTA < 35 dB (n = 69), non-applicants (n = 46), first time hearing aid applicants (n = 108), re-applicants (n = 65), and experienced hearing aid users not applying for a new hearing aid (n = 12). The latter group was excluded from the analysis because of the small sample size. Fifteen persons could not be classified into a clinical group because they were lost to follow-up after the first visit.
Based on the EQ-5D and HUI2, no distinction could be made between any of the clinically distinctive groups. A logarithmic transformation was performed on the EQ-5D and HUI2 data to compensate for skewness. Even after transformation, and also when correcting for age, sex and BEPTA, no differences were found between the groups. Only HUI3 scores demonstrated a significant difference between the clinically distinctive groups (Kruskall–Wallis; P-value 0.004). More specifically, HUI3 found significant differences between persons with a BEPTA < 35 dB and first time applicants (Mann–Whitney U; P-value 0.002), and between persons with a BEPTA < 35 dB and re-applicants (P-value 0.001). HUI3 did not confirm our expectation that non-applicants had significantly higher utility scores than first time applicants. As expected, non-applicants stated less problems on the hearing attribute than first time applicants, but they also stated more problems on the ambulation and pain attributes.
Agreement
A summary of the utility scores is presented in Table 2. Mean utility scores for the population with hearing complaints were higher for the EQ-5D Dutch tariff (mean 0.86; standard deviation 0.18) and EQ-5D UK tariff (0.83; sd 0.21) than for the HUI2 (0.77; sd 0.14) and HUI3 (0.61; sd 0.24). The differences in mean scores and distributions are statistically significant. The UK and Dutch tariff of the EQ-5D and HUI2 and HUI3 were found to have good agreement, since they were strongly correlated (0.90; 0.71) and had an ICC of 0.98 and 0.74, respectively. The scores on all other measures showed statistically significant, but low correlations and their agreement was moderate to poor (Table 3).
Table 2Utility scores in baseline population with hearing complaints (n = 315)MeasureMinimumMaximumMedian*Interquartile rangeMean**Standard deviationEQ-5D UK tariff−0.251.000.850.270.830.21EQ-5D Dutch tariff−0.031.000.860.190.860.18HUI20.231.000.790.150.770.14HUI3−0.071.000.620.380.610.24* All statistically significantly different: Wilcoxon Signed-Rank test; P < 0.01** All statistically significantly different: Paired t-test; P < 0.01Table 3Agreement in the baseline population with hearing complaints (n = 315)Pairs of utility functionsKendall’s Tau*ICC(95% Confidence interval)EQ-5D UK tariff versus HUI2r = 0.410.51(0.42–0.59)EQ-5D UK tariff versus HUI3r = 0.370.47(0.38–0.55)EQ-5D UK versus Dutch tariffr = 0.900.98(0.97–0.98)HUI2 versus HUI3r = 0.710.74(0.68–0.78)HUI2 versus EQ-5D Dutch tariffr = 0.400.51(0.42–0.59)HUI3 versus EQ-5D Dutch tariffr = 0.360.44(0.35–0.53)* All statistically significant, P < 0.01
Ceiling effects were observed in the EQ-5D UK tariff (Figs. 1 and 2), results were similar for EQ-5D Dutch tariff. As measured with the EQ-5D (both UK and Dutch tariff), 44% of the respondents reported perfect health, despite their hearing complaints. Measured with the HUI2 or HUI3, less than 1% of the respondents reported perfect health. For respondents reporting perfect health on the EQ-5D, mean utility scores were 0.83 on the HUI2 (range 0.35–1.00) and 0.71 on the HUI3 (range 0.06–1.00).
Fig. 1Scatterplot of utility scores derived with EQ-5D UK tariff and HUI2Fig. 2Scatterplot of utility scores derived with EQ-5D UK tariff and HUI3
Responsiveness
Responsiveness was tested in the subpopulation with a valid score both before and after hearing aid fitting (n = 70). The effect size and standardized response mean of the EQ-5D UK (0.05; 0.05) and Dutch tariff (0.03; 0.02) were less than small. HUI2 and HUI3 were more responsive to change after hearing aid fitting, since both had a moderate effect size (0.64; 0.55) and standardized response mean (0.57; 0.66).
Mean change in utility after hearing aid fitting (Table 4) was highest when measured with the HUI3 (mean 0.12; sd 0.18) and HUI2 (0.07; sd 0.13), while almost no change was measured with the EQ-5D (UK tariff 0.01, sd 0.13; Dutch tariff 0.00, sd 0.12). The change in utility measured with HUI2 and HUI3 is statistically significant (Paired t-test, P-values 0.005 and 0.000). No change was observed in any attribute of the EQ-5D (Fig. 3a). The change in HUI2 utility score after hearing aid fitting occurred in the sensation attribute (Fig. 3b) and in the HUI3 score in the hearing attribute (Fig. 3c). Almost no change was observed in any of the other attributes of the HUI2 and HUI3.
Table 4Change in health state utility after hearing aid fitting and ICER with 95% Confidence Interval (CI) (n = 70)MeasureMeanStandard deviationMedianInterquartile rangeMinimumMaximumICERa €/QALY(95% CI) €/QALYEQ-5D UK tariff0.010.130.000.04−0.600.27286,866(inferiorb–47,082)EQ-5D Dutch tariff0.000.120.000.04−0.600.28647,209(inferiorb–61,934)HUI20.07*0.130.08**0.12−0.500.4025,337(19,356–38,012)HUI30.12*0.180.13**0.22−0.220.6015,811(11,664–24,654)* Statistically significant; Paired t-test; P < 0.01** Statistically significant: Wilcoxon Signed-Rank test; P < 0.01a ICER based on mean scoresb Inferior means higher costs and lower utilityFig. 3Percentage of responses for each level of each attribute before (b) and after (a) hearingaid fitting for EQ-5D, HUI2 and HUI3
The mean change in utility score after hearing aid fitting, when measured with HUI2 and HUI3, was higher for first-time hearing aid applicants (0.08; 0.13) than for re-applicants (0.06; 0.10). This outcome was in line with our expectations, but is not significantly different.
Impact on the ICER
Mean costs of doing nothing were zero. The mean costs of hearing aid fitting were €1,877. The latter consisted of GP visits (€37), ENT visits (€295) and hearing aid(s) (€1545). All hearing aids were digital, and hearing aids were bilaterally fitted in 83% of the respondents.
This resulted in mean one-year incremental costs of hearing aid fitting versus doing nothing of €1,877. The mean utility gain of 0.01 (sd 0.13), measured with the EQ-5D UK tariff, resulted in a ratio of €286,866 per QALY, with a 95% confidence interval of inferior (higher costs, lower utility) to €47,082/QALY. There was a 36% probability that hearing aid fitting was both more costly and less effective (inferior). The mean utility gain of 0.003, measured with the EQ-5D Dutch tariff, resulted in an ICER of €647,209 per QALY (95% confidence interval: inferior to €61,934/QALY). There was a 42% probability that hearing aid fitting was inferior. Applying the HUI2 and HUI3, the ICER was €25,337 per QALY (95% confidence interval: €38,012/QALY to €19,356/QALY) and €15,811 per QALY (95% confidence interval: €24,654/QALY to €11,664/QALY) respectively. For both measures there was no probability that hearing aid fitting was inferior.
The informal Dutch ceiling ratio of €20,000/QALY [42] implied that hearing aid fitting was only cost-effective when utility was measured with the HUI3. A cost-effectiveness plane with incremental cost and effect pairs for 1,000 bootstrap replications, for all measures, is shown in Fig. 4. Figure 5 shows the cost-effectiveness acceptability curves for all measures.
Fig. 4Incremental cost-effectiveness ratio for hearing aid fitting. Incremental costs (euro) are displayed at the vertical line, incremental effects (QALYs) on the horizontal lineFig. 5Cost-effectiveness acceptability curves of EQ-5D UK and Dutch tariff, HUI2 and HUI3
Conclusion and discussion
Hearing loss affects the exchange of information and therefore affects a person’s quality of life [1]. Hearing impaired persons can benefit from using a hearing aid, since hearing aid use has proven to be effective, it improves social, emotional and communication functions and reduces depression [3, 4].
The results of this study in a relatively healthy population with hearing complaints provide insight in the differences between two widely used utility measures, the EQ-5D and the HUI system.
Regarding practicality, both questionnaires had high completion rates, with the EQ-5D having a higher completion rate than the HUI.
With the EQ-5D, differences were detected in utility by age and sex, indicating construct validity. The HUI3 detected differences by age, but not by sex. Differences between clinically distinctive groups were only detected by HUI3. However, the HUI3 did not confirm our expectation that non-applicants would have higher utility values than first-time applicants. An explanation for this may be that non-applicants had more health problems other than their hearing, as reflected in the ambulation and pain dimensions of the HUI3.
Overall, HUI2 and HUI3 scores were lower than EQ-5D scores and agreement was moderate to poor. Although these measures intend to assess the same construct, namely health state utility, this result was expected as the instruments differ in their underlying assumptions about what constitutes health state utility.
As to responsiveness, only HUI2 and HUI3 measured statistically significant improvement after hearing aid fitting, the EQ-5D UK and Dutch tariff both were not able to capture this effect. Half of the patients (53%) who were fitted with a hearing aid were lost to follow up, either because they had not finished their hearing aid fitting before the end of the study, or because they had their hearing aid fitted at a dispenser not participating in our study. As these patients did not differ from the follow-up group in baseline utility, hearing loss and age, we did not expect this low response rate to influence the results.
The HUI2 and HUI3 change scores resulted in smaller ICERs for hearing aid fitting. Although they were only illustrative, the different ICERs found in the present study clearly show that the choice of a utility instrument in the economic evaluation of hearing aid fitting may heavily influence the cost-effectiveness outcome.
To calculate the ICER of hearing aid fitting we included the total population of respondents considered for hearing aid fitting, regardless of the type of hearing aid fitting. This makes the ICERs found in the present study representative for hearing aid fitting in general in the Netherlands. However, the one year ICERs calculated in the present study were merely illustrative of the impact of different utility scores on the ICER of hearing aid fitting, as the cost-effectiveness of hearing aid fitting has thoroughly been examined by Joore et al [8].
Our results confirm Barton et al [9, 43], who compared the EQ-5D UK tariff and HUI3 before and after hearing aid fitting in a UK sample. However, the change in utility after hearing aid fitting derived with the HUI3 in the present study was twice the change in utility derived with the HUI3 in the study of Barton et al [9]. Respondents in the latter study had a lower baseline utility score and a higher range in utility change after hearing aid fitting, which suggests a somewhat different study population. Our results confirm previous studies that concluded that the EQ-5D lacks sufficient sensitivity to measure the benefit of hearing aid fitting [6, 7, 44]. The lower utility scores and higher responsiveness of the HUI3 in relation to the EQ-5D were also found in a population with visual impairment [22]. Joore et al [8] calculated that hearing aid fitting costs €15,807 per QALY, using the EQ-5D as utility measure. The results of the present study indicate that using the HUI3 as utility measure probably had resulted in a more favourable ICER for hearing aid fitting. Vuorialho et al [45] recently concluded that counseling of hearing aid users to reduce the number of non-users is highly cost-effective, although they were unable to measure any change in utility. As they used the EQ-5D, it is possible that they would have been able to demonstrate favourable costs per QALY when they would have used the HUI3 to measure change in utility.
Three questions arise from the results of the present study: can differences be explained by differences in the measures, are the differences observed between the measures important, and what are the implications of the findings for utility measurement and cost-utility analysis in populations with hearing complaints?
First, differences in utility scores can be explained by differences in the descriptive system and the way the utility scoring function is derived. Regarding the descriptive system, the focus of the EQ-5D on physical, mental and social functioning [46] differs from the ‘within-the-skin’ perspective of HUI, which focuses on the underlying level of impairment. However, this does not explain why the EQ-5D does not measure change after hearing aid fitting, as previous studies have found that hearing aid fitting improves social and emotional functioning [3, 4]. Also, the measures differ in the content and number of attributes, items and levels used, and therefore differ both in the number and in the content of possible health states. It has already been suggested not to use the EQ-5D in relatively healthy populations, given the presence of a ceiling effect [15]. The ceiling effect of the EQ-5D found in the present study is likely to contribute to the differences in responsiveness. When, as found in our study, 44% of the respondents report perfect health at baseline, it is unlikely to find a considerable utility gain from any intervention. Furthermore, since the HUI descriptive system pays explicit attention to hearing abilities, it is to be expected that in a relatively healthy population with hearing complaints HUI and EQ-5D utility scores differ, and HUI is more responsive. As the HUI3 also pays explicit attention to visual abilities, this may explain why comparisons of EQ-5D and HUI3 in hearing and vision show similar results [22].
There are also differences in the utility scoring functions. Although in general SG (used for HUI) leads to higher scores than TTO (used for EQ-5D) [5], in the present study the EQ-5D scores were considerably higher than the HUI scores. Although different populations do not necessarily yield different results [5], the population sample in which the preferences are measured may also have impact on the differences. In the present study, differences between utilities derived with the UK and Dutch tariff were observed. This difference may be the result of differences in health valuation between people from the Netherlands and the UK, but may also result from the somewhat questionable representativeness of the population sample used to develop the Dutch tariff [27].
Differences also exist in the type of scoring function. EQ-5D uses an additive system, assuming no interaction for preferences among attributes at all. The HUI uses a multiplicative scoring function, with the effect that the loss of utility associated with a particular dimension is dependent on the level of impairment on other dimensions [5]. For example, Barton et al [43] illustrated that hearing impairment (‘unable to hear at all’) has a greater impact on HRQoL as measured with the HUI3 when one has no other health problems (−0.53), than when one also has moderate to severe pain and is unable to see at all (−0.05). It seems rational that persons find their hearing loss a less important aspect of their health state utility when they experience more comorbidity. The multiplicative scoring function of HUI takes this influence of comorbidity into account and seems to be more suitable for modeling utility scores.
Are the differences observed between the measures important? The answer to this question is a clear ‘yes’. The impact of different utility measures on the ICER for hearing aid fitting is of a magnitude that can alter policy decisions and emphasizes that comparisons of QALYs across studies and interventions should be interpreted with caution [12]. The general purpose of a utility measure is to capture the health effects in terms of HRQoL of a policy or program for use in economic analyses. Health economic analyses are a tool to allocate resources in a way that maximizes health (or welfare). In order to use the outcomes of economic analyses for policy decisions, there should however be a clear notion of what should be maximized. The results of the present study show that the potential benefit of an intervention heavily depends on the assumptions of what constitutes health underlying the utility measure that is used. Beyond the apparent necessity of psychometric quality of a utility measure, an important area for future research is whether societies wish, or should, maximize life expectancy corrected for HRQoL from a more functional perspective as in the EQ-5D, or from a ‘within-the-skin’ perspective as in the HUI. Other studies that have thoroughly examined the psychometric differences between utility measures seem to pass over this important question [11, 13, 19, 21, 24].
What are the implications of the findings for utility measurement and cost-utility analysis in populations with hearing complaints? Generally, it has been recommended that the instrument that is most sensitive to the health states in which one is interested should be selected [5, 12, 47]. From clinical experience it is plain that hearing aid use is effective in alleviating hearing loss and does improve health-related quality of life, but the EQ-5D lacks the sensitivity to capture this improvement. In an otherwise healthy population, HUI3 has proven to be more responsive and therefore more appropriate for evaluating HRQoL in a population with hearing complaints, and is therefore the instrument of first choice in this population.

hearing loss
questionnaires
costs and cost analysis
quality-adjusted life years
outcome assessment (health care)


The “Health Benefit Basket” in Denmark

Until 2007, when the new legislation on health care becomes effective, the right to receive free health care services in Denmark, or “health benefits,” are described in a comprehensive set of legislation, including laws, executive orders and legal guidelines. This contribution provides an overview of the current main legislation regulating the Danish “health benefit basket” and describes the regulatory mechanisms for the provision of curative care at Danish hospitals and primary health care offices. Although the services are both financed and planned by the counties, they differ substantially in the way that benefits are regulated.
The Danish health care system offers a vast amount of benefits and entitlements to persons living in Denmark. The benefits are more or less specified health services provided at hospitals or in primary and tertiary health care institutions. Entitlements are rights to receive these services free of charge or against a fee covering a part of the costs. The benefits and entitlements altogether form the so-called “health benefit basket” or “basic package of health services” [1]. Although the notion of a benefit basket is not commonly used in Denmark, health benefits are indeed described in the legislation. The following pages provide an overview of the laws regulating health benefits and a description of the regulatory mechanism for the provision of curative care in hospitals and in primary care offices. Curative care services are financed and planned by the 14 counties and the municipal authorities of Copenhagen and Frederiksberg, and there are considerable differences between in- and outpatient services in the way in which benefits are regulated and services are provided and reimbursed.
Table 1 provides an overview of the four most important laws regulating benefits in the Danish health sector:Table 1 The Danish “health benefit basket”: overview of main legislationHospital Act (and ancillary legislation)Public Health Insurance Act (and ancillary legislation)Medicines Act (and ancillary legislation)Social Services Act (and ancillary legislation)Other (specific) legislationHC.1.1 Inpatient curative care+–(+)––HC.1.2 Day-cases of curative care+–(+)––HC.1.3 Outpatient care(+)+(+)––HC 1.4 Curative home care++(+)––HC.2.1 Inpatient rehabilitative care+––(+)–HC.2.2 Day cases of rehabilitative care+(+)–(+)–HC 2.3 Outpatient rehabilitative care(+)+–+–HC 2.4 Services of rehabilitative home care(+)(+)–++HC.3.1 Inpatient long-term care+––+–HC.3.2 Day cases of long-term care+––+–HC 4.1 Clinical laboratory +++––HC.4.2 Diagnostic imaging+++––HC.4.3 Patient transport ++–+–HC.4.9 All other miscellaneous services++–(+)–HC.5.1 Pharmaceuticals, etc.–++––HC 5.2 Therapeutic devices etc.(+)(+)–+–HC.6.1 Maternal and child care++–(+)+HC 6.2 School health services––––+HC.6.3 Prevention of communicable diseases–(+)––+HC.6.4 Prevention of noncommunicable diseases–(+)––+HC.6.5 Occupational health services––––+HC.6.9 All other services––––+Legal statusLawLawLawLawLawsDecision makerCounty + physicianCounty + GPCounty, GP (physician)Municipality + countyCounty + municipality + GPPurposeEntitlements, delegation and defining responsibility of countiesEntitlements, reimbursement, copaymentRole of Danish Medicines Agency, process of approval of medicinesEntitlements, delegation and defining responsibility of counties and municipalitiesEntitlements, defining roles and responsibilities of actors etcPositive/negative definition of benefitsPositivePositivePositivePositivePositive Degree of explicitnessa11 (2 and 3)2 (and 3)1 (2 and 3)1, 2, 3If itemized: goods, procedures, indicationsNot itemizedProcedures (indications)(Goods)(Goods, indications)IndicationsUpdatingNoNoNoNoNoCriteria used for defining benefits  Need+++++  Costs–––––  Effectiveness––+––  Cost-effectiveness–––––  Budget+––––  Other–+–––a 1, “All necessary”; 2, areas of care are described; 3, services are linked to specific itemsThe Hospital Act establishes the regulatory framework for all types of inpatient care and day care, patient transport, maternity care, ambulatory and rehabilitative care provided at hospitals (Bekendtgørelse af lov om sygehusvaesenet, LBK 766, 28 March 2003). The law delegates the responsibility for the planning, providing, and financing of hospital services to the county council. A number of executive orders and directives further specify this law.The Public Health Insurance Act (PHIA) and its supplementary legislation provides the regulatory frame for entitlements to outpatient care and to some extent to rehabilitative care, ancillary services for outpatients, maternity and child care, and reimbursement of pharmaceuticals (Lov om offentlig sygesikring, LOV 509, 1 July 1998; og DSK 9926, 20 January 1999; og LOV 467 og 469, 31 May 2000; og LOV 495, 7 June 2001; og LOV 1031, 23 November 2000; og LOV 1045, 23 December 1998; og LOV 1118, 29 December 1999; og LOV 1207, 27 December 2003; og LOV 1431, 22 December 2004). Benefits and services are further specified in a number of executive orders as well as in the used fee schedule.The Medicines Act regulates the population’s access to pharmaceuticals and specifies the process of approval of medicines by the Danish Medicines Agency, marketing authorizations, etc. (Bekendtgørelse af lov om laegemidler, LBK 656, 28 July 1995).The Consolidated Social Services Act provides the regulatory frame for social services (Bekendtgørelse af lov om social service, LBK 708, 29 June 1998). The law delegates the planning, financing and provision responsibility to the counties for the specialized care and to municipalities for the less specialized care. This law covers the long-term inpatient, outpatient and home care. It also describes the provision responsibility for rehabilitative care not following a hospital treatment and also regulates the entitlement to therapeutic devices, nonacute patient transport, and other services.
Danish legislation on health care furthermore contains a number of specific laws dealing with preventive services, for example, for children (Forebyggende sundhedsordninger for børn og unge, LOV 438, 14 June 1995), with explicit and specific definitions of benefits. The main decision makers in the Danish health sector at political and administrative levels are the local governing bodies responsible for the service, hence the elected politicians for the county and the municipal councils. At clinical level especially the general practitioner plays a very important gate-keeper role, but hospital physicians are also important in defining medical needs. Most benefits are explicitly but vaguely defined by the law, leaving it to decision makers to specify which services to offer to patients. The Hospital Act states that “the county shall provide hospital treatment free of charge for its citizens” (Sect. 5). The degree of explicitness is described as “all necessary” (1) by all laws; some laws further describe areas of care (2) and some are linked to items (3). The PHIA and the Social Services Act are to some extent more explicit, by linking benefits to items.
This contribution is confined to curative health services, and the description of benefits in curative health services in Denmark is divided into three sections. First, the main actors along with their roles and responsibilities are outlined and differences between in- and outpatient services are emphasized. Second, benefits in the hospital sector are described and third, an outline of benefits under the Health Care Reimbursement Scheme (HCRS) for outpatient services is provided. Benefits are described with regard to the legislation and other regulatory mechanisms defining them, how they are classified, and how the fee schedule under the HCRS, a benefit “catalogue,” is structured.
Main actors in defining benefits: their roles and responsibilities
The Danish Parliament (Folketing) legislates on health care. The Minister for the Interior and Health is responsible for further specifying the law, setting rules in certain areas and initiating reforms and bills. Unless it is explicitly mentioned that the Minister is empowered to specify the law, it can only be changed by the Folketing. Regarding outpatient care the Minister must approve all negotiated agreements between the Health Care Reimbursement Negotiation Committee (HCRNC) and the health personnel trade unions.
The National Board of Health (NBH) is a subdivision of the Ministry of the Interior and Health. The NBH is responsible for supervising and providing advice to “health care persons” (the Danish word sundhedspersoner used in the legislation refers to all types of health care professionals) and health administrative authorities, for elaborating and issuing guidelines and reference programs as well as for monitoring and documenting health services. Guidelines from the NBH define the current best practice within specific health care programs or interpret the law. The “health care persons” are for their part obliged to show clinical diligence and act according to “best practice.”
According to the Hospital Act, the counties and the Copenhagen Hospital Corporation are responsible for the planning and financing of hospital services (Sect. 1) and for providing free hospital treatment for their citizens (Sect. 5). The providers of hospital services may be county-owned hospitals, private hospitals, or foreign hospitals (Sect. 3). Regarding outpatient care the county reimburses the services provided by private specialists and general practitioners (GPs). County representatives in a subcommittee under the HCRNC decide on the actual supply of services, for example, who is allowed to establish a private practice in which county.
A county health plan coordinating health services in the county is to be elaborated every 4 years (Hospital Act, Sect. 11; PHIA Sect. 27e). The plan includes a description of the county’s population health status (premise of the plan), the physical capacity of the county hospitals, including how and where specialties are represented, and the number of beds and employees etc. in each specialty. Furthermore, preventive services, outpatient services, and cooperation between GPs, specialists, dentists, and the hospital sector, cooperation with municipalities, ambulance services, and local emergency services are coordinated and described in the plan. The NBH supervises and comments on the plan. However, the counties are not, in any legal sense, obliged to follow the advice provided by the NBH.
Hospital and clinical department managers have considerable freedom within the legal, clinical, and economic framework set by their superiors at national and county level. The heads of department may therefore establish treatment protocols and indications for treatment for different patient categories as well as set up guidelines for prioritizing between patients on waiting lists.
In general the Danish legislation is rather vague with regard to the specification of services and very often leaving decisions about benefits to medical judgement. Thus physicians play a certain role in the definition of benefits. Especially, the GP is important, as she/he is responsible for referring patients from general practice to practically all parts of the health sector.
Definition of benefits
Hospital care
Benefits provided in the Danish hospital sector are defined at four levels of decision making: at national level by means of legislation, at county level by planning and supply control, and at hospital and clinical level by local guidelines and clinical decision making. According to the Hospital Act, citizens have the right to free hospital treatment (Sect. 5) at any hospital in the country (Sect. 5b) which they choose. If the waiting time for treatment exceeds 2 months, they have the right to be treated at a private hospital in Denmark or abroad at their county’s expense (Sect. 5 g). The Act includes inpatient care, hospital ambulatory (day) care and in some cases home care for somatic and mental patients. Benefits are explicitly but vaguely formulated by the law. In principle, patients are entitled to any treatment that is clinically indicated, but in practice limitations apply. At national level the Hospital Act and its amendments directly or indirectly specify which services to offer (positive definition of benefits) or not to offer (negative definitions of benefits) to whom and under which circumstances:
Positive definition of benefits (examples):For persons suffering from a “life-threatening” disease, defined as patients with certain heart conditions or cancer patients, a maximum national waiting time is defined.The county offers a breast examination (mammography) to women aged 50–69 years every second year (Hospital Act; Sect. 5e). However, this benefit is accompanied by a clause stating that the Minister will decide when this service is to be implemented in the counties. The service is expected to be implemented by 2008. Today it is only offered in three counties.Patients with a clinically defined need for rehabilitation have the right to receive a plan from the hospital describing when and where rehabilitation is to take place at discharge, and who will coordinate between the county and municipal providers (Hospital Act; Bekendtgørelse om udarbejdelse af genoptraeningsplaner ved udskrivning fra sygehus, BEK 1009, 9 December 2003).
Negative definition of benefits (examples):Induced abortions after week 12 of pregnancy are only allowed after permission from the Minister of Justice and upon medical or social indication (Bekendtgørelse af lov om svangerskabsafbrydelse og fosterreduktion, LBK 541, 16 June 2004, og BEK 540, 16 June 2004, og VEJ 57, 16 June 2004). Sterilization cannot be provided to persons below the age of 25 years (Bekendtgørelse af Lov om sterilisation og kastration, LBK 661, 12 July 1994, og BEK 1131, 13 December 1996).Unmarried women and women over the age of 45 years are exempt from in vitro fertilization treatment by a physician (specialist; Lov om Kunstig befrugtning i forbindelse med laegelig behandling, diagnostik, forskning mv, LOV 460, 10 June 1997; Bekendtgørelse om kunstig befrugtning, BEK 728, 17 September 1997).Free choice of private hospitals (in the case the waiting time for treatment at county hospitals exceeds the limit of 2 months) does not include transplantation, sterilization, reproductive health services, hearing aid, cosmetic surgery, sex change, psychiatric treatment, alternative treatment, or treatment characterized as research (Bekendtgørelse om amtskommuners betaling for sygehusbehandling ved en anden amtskommunes sygehusvaesen, BEK 594, 23 June 2003).
In general, conventional treatments not included in the benefit package are not offered. For patients suffering from life-threatening cancer a referral needs to be approved by a board of specialists, a “Second Opinion Panel” established under the NBH (information available at: http://www.sst.dk/planlaegning_og_behandling/second opinion.aspx, accessed 4 August 2005). If the alternative such as conventional treatment is approved by the board, the expenses are covered by a special government grant. However, nonconventional treatment, such as a spa therapy, zone therapy, and homeopathy are not included in the benefit package [2].
Financial instruments
Hospitals are financed by the counties through tax revenue and block grants from the state. Following the annual negotiations between the counties and the government on the level of taxation and size of block grant the government has introduced new financial measures as a means to influence the development of the health sector. Special block grants are earmarked to high priority areas such as heart surgery and cancer treatment. These grants accompany recommendations from the NBH on treatment improvements and expansion of the capacity, as described in the “Heart Plan” and the “Cancer Plan.” Furthermore, with the aim of shortening waiting lists, a provision of activity-based funding for additional production has been made available from 2002 for counties which can document an increase in their activity (Hospital Act; (Cirkulaer om udbetaling af statstilskud i 2004 til øget aktivitet på sygehusområdet CIR 6, 5 January 2004. Bekendtgørelse om økonomiske rammer for frit valg til private specialsygehuse, BEK 627, 20 June 2004.). Financial restrictions are imposed on the counties as their obligation to finance care at certain private hospitals including hospices, sclerosis hospitals, arthritis sanatoria, and brain rehabilitation hospitals is limited to a certain annual amount. Thus patients are either referred to a waiting list or must pay for the treatment themselves at a private clinic. At county level the counties determine the content and costs of hospital activity through the use of detailed budgets, enabling them to specify treatments offered, technologies used, service standards, and capacity available. There is an indirect regulation of benefits available to county inhabitants through the control of the supply. In principle, the county can decide not to offer a certain treatment, for example, in vitro fertilization treatment to women who have already had one child by this means, or an expensive cancer treatment. However, the patient can choose to be treated in another county due to the right of free choice of hospital with the home county having to pay for it, which actually displays certain limitations to the county’s planning freedom. In the hospital sector there are no benefit “catalogues” as such. However, a wide number of classifications are used to document the activity and prices based on diagnosis-related groups (DRG). DRGs are used for the remuneration of hospital services provided in other counties or at private hospitals.
Outpatient services: the Health Care Reimbursement Scheme
Unlike hospital services, benefits regarding outpatient services are under the HCRS explicitly and specifically detailed by the law and in a fee schedule negotiated on services and prices between the private providers and the HCRNC. The PHIA states that primary health care is available to (almost) everyone with a permanent address in Denmark. All citizens must choose between insurance groups I and II with a trade-off in terms of free choice of the provider and the size of reimbursement. Persons in group I, more than 98% of the population, are entitled to free services from GPs and to partial reimbursement of dentist services, physiotherapy treatment, etc. With a few exceptions public reimbursement of specialist and paramedic services are subject to GP referral. Persons in group II, fewer than 2% of the population, have a wider choice of providers, but are less entitled to reimbursement. Everyone receives a personal card clearly stating the entitlements to the services (PHIA; Bekendtgørelse om valgfri indplacering i sygesikringsgrupper, udstedelse af sygesikringsbevis mv, BEK 198, 21 March 2003; Bekendtgørelse om begraensning i adgang til ydelser efter sygesikringsloven for visse persongrupper, BEK 119, 17 March 1976, og BEK 115 af 21 February 1990). A large number of executive orders and the fee schedule for reimbursement of private providers further specify entitlements and benefits laid down by the PHIA (PHIA; Bekendtgørelse om befordringsgodtgørelse efter sygesikringsloven, BEK 3, 3 January 2001; Bekendtgørelse om tilskud efter sygesikringsloven til fodbehandling, BEK 129, 18 March 2003; Bekendtgørelse om tilskud efter sygesikringsloven til kiropraktisk behandling, BEK 181, 22 March 2004; Bekendtgørelse om tilskud efter sygesikringsloven til fysioterapeutisk behandling, BEK 405, 18 May 2001; Bekendtgørelse om tilskud efter sygesikringsloven til psykologbehandling for saerligt udsatte grupper, BEK 472, 18 June 2002; Bekendtgørelse om tilskud efter sygesikringsloven til sondeernaering og andre ernaeringspraeparater, BEK 531, 18 June 2003; Bekendtgørelse om tilskud efter den offentlige sygesikring til betaling af briller til børn under 16 år, BEK 543, 8 December 1980; Bekendtgørelse af lov om tandpleje, LBK 1261, 15 December 2003, og BEK 1073, 11 December 2003; Bekendtgørelse om tilskud efter sygesikringsloven til tandpleje, BEK 147, 6 March 2004; Bekendtgørelse om adgang til laegehjaelp efter sygesikringsloven, BEK 180, 18 March 2003).
Some benefits are defined very explicitly, e.g., a specific maximum amount in Danish crowns to be covered for spectacle lenses and spectacle frames; (BEK 543, 8 Decemberr 1980, see above), while others are defined in more general or vague terms, e.g., proportional reimbursement of negotiated fee for physiotherapy treatment (PHIA; BEK 405, 18 May 2001, see above), or proportional reimbursement of negotiated rates for dental treatment (LBK 1261, 15 December 2003; og BEK 1073, 11 December 2003, see above; BEK 147, 6 March 2004, see above). There are positively defined benefits (e.g., the right to spectacle lenses and frames) and exclusions through negatively defined benefits, e.g., a service excluded from reimbursement from the public travel insurance benefits (Bekendtgørelse om befordringsgodtgørelse efter sygesikringsloven, BEK 3, 3 January 2001). While, for example, GP services, ear nose and throat medicine, psychiatric, and oculist services are free of charge for patients, dentist services are only partly covered by public funds. Some services are regulated by legislation but not included in the benefit basket, unless certain specific criteria are fulfilled (e.g., psychologist counseling, chiropody, and chiropractic services (BEK 129, af 18 March 2003, see above; BEK 181, af 22 March 2004, see above; BEK 472, 18 June 2002, see above). Table 2 provides an overview of the main services under the HCRS, showing the extent and criteria for coverage and whether the services are subject to a referral from the GP.Table 2 Benefits regarding outpatient services according to the Health Care Reimbursement Scheme. Services fully, partially or not covered by public fundsType of service/providerCoverage by public fundsCoverage for special groupsReferral from GP required (Group I insured)General practiceFull––Dentist servicesPartialFull coverage for children at school age, disabled, low income elderlyNoTube feeding/nutritional preparationsFull–YesPhysiotherapyPartialFull coverage for patients with specific diagnoses (muscular-skeletal) YesPsychiatristFull–YesPsychologistNone/(partial)Partial coverage for persons exposed to traumatic incidentsYesChiropodistPartialPartial coverage for diabetics and low-income elderlyYesChiropractorPartial–YesOpthalmologistsFull–NoEar-nose-throat physiciansFull–NoDieticiansNone–NoOther specialistsFull–Yes
“Other specialists” whose services are fully part of the benefit basket upon GP referral include: anesthetists, specialists in dermatology and venereal diseases, specialists in diagnostic radiology, gynecologists, obstetricians, internists, surgeons, biochemists, neurologists, orthopedics, specialists in pathological anatomy or plastic surgery, pediatricians, rheumatologists, and specialists in tropical medicine or laboratory examinations.
The fee schedule
Whereas the laws describe mainly the extent to which outpatient services are included in the benefit basket, for example, the proportion of public funding and the criteria for coverage, the fee schedule negotiated between the HCRNC and the health personnel trade unions specifies the services for which the providers are paid. Since the schedule lists services which are reimbursed from public funds and are therefore provided free of charge to the patients, the fee schedule may—in an indirect way—be regarded as a benefit catalogue (Sygesikringens Forhandlingsudvalg, takstkatalog, April 2005).
Items in the fee schedule are negotiated every 3 years while the tariffs are revised twice a year. Health technology assessments, cost-effectiveness analyses, and clinical studies are adduced by the professional committees and included in the negotiation but they are not mandatory. Criteria for the decisions concerning the inclusion or the exclusion of an item are neither systematic nor public. An example of an argument over the inclusion of services regards progress in treatment methods (substitution of outdated services with more up-to-date procedures). There is usually a reimbursement rate when benefits such as those for contraceptive advice from the GP are specifically stated by the law (A. Bonne, HCRNC, personal communication).
The catalogue is divided into specialties with a subdivision into type of services offered (items). Items may be directly linked to the legislation that specifies the benefits, for example, antenatal care consultation and first child health check-up at the age of 5 weeks (general practice). They are also directly linked to the logic applied by the legislation, for example, following certain age groups, certain timing (week 12, first and second consultations, etc.), or specific agreement, such as on working hours or transport fees for the professional group involved. When the legislation does not specify the benefits, items are either linked to consultation type (visits), goods (e.g., laboratory tests) procedures (e.g., spirometry) or even indications (e.g., podiatry for diabetics) in some rare cases. There is generally no specification of the technology to be used with a few exceptions.
Concluding remarks
The Danish benefit basket for curative services is regulated directly by law and influenced indirectly by more “soft” regulatory mechanisms. In the hospital sector which is the main part of the health sector in terms of expenditure, the law delegates the responsibility for providing, financing, organizing, and planning services to the 14 counties. Thus there may be regional variations in the services offered. Benefits are explicitly defined but not specified by the law. In principle, all clinically indicated hospital services are included in the benefit basket. However, central initiatives, such as legislation on the patient’s free choice of hospital, waiting time guarantees for some patient groups and financial constraints influence the counties’ decisions and narrow the room for regional variation. Regarding outpatient services the picture differs slightly as benefits in the HCRS are regulated at central level through explicit and specific legislation while being further specified in agreements about items and tariffs between county and provider representatives.
In 2007 the Danish health sector will be subject to a structural reform which will significantly influence the way in which health services are financed and organized. The current political layer of 14 counties will be abolished and be replaced by five regions responsible for providing hospital services but without the taxation rights that they have today. The municipalities will merge into fewer units, assume financing responsibilities for more health services than today and will purchase hospital services from the regions.
The reform’s immediate impact on health benefits is hard to predict, but there will be some modification as to legislation at least. A law, “the Health Act” (Sundhedsloven, LOV nr. 546, 24 June 2005), recently passed by the Folketing, collects the previous vast amount of legislation on health care into a single document. Among other things the goals of Danish health care services, for example, that citizens should have easy and equal access to health care, have now been made explicit. The rights to health care services do not change fundamentally, nor do decision makers and their roles and responsibilities. The Act contains many clauses empowering the Minister for the Interior and Health to set specific rules, thus giving the Minister much more decision-making power than today. However, the Health Act provides a regulatory framework with explicitly mentioned rights to health services not being different from what is outlined here. The specification of benefits will still take place at the lower levels of decision making, by specifications of the law by the Minister, by the National Board of Health, in agreements between regions and municipalities, through a payment schedule, or at clinical level.

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