Sodium and potassium intake and risk of cardiovascular events and all-cause mortality : the Rotterdam Study Background Dietary electrolytes influence blood pressure , but their effect on clinical outcomes remains to be established . We examined sodium and potassium intake in relation to cardiovascular disease -LRB- CVD -RRB- and mortality in an unselected older population . Methods A case -- cohort analysis was performed in the Rotterdam Study among subjects aged 55 years and over , who were followed for 5 years . Baseline urinary samples were analyzed for sodium and potassium in 795 subjects who died , 206 with an incident myocardial infarction and 181 subjects with an incident stroke , and in 1,448 randomly selected subjects . For potassium , dietary data were additionally obtained by food-frequency questionnaire for 78 % of the cohort . Results There was no consistent association of urinary sodium , potassium , or sodium/potassium ratio with CVD and all-cause mortality over the range of intakes observed in this population . Dietary potassium estimated by food frequency questionnaire , however , was associated with a lower risk of all-cause mortality in subjects initially free of CVD and hypertension -LRB- RR = 0.71 per standard deviation increase ; 95 % confidence interval : 0.51 -- 1.00 -RRB- . We observed a significant positive association between urinary sodium/potassium ratio and all-cause mortality , but only in overweight subjects who were initially free of CVD and hypertension -LRB- RR = 1.19 -LRB- 1.02 -- 1.39 -RRB- per unit -RRB- . Conclusion The effect of sodium and potassium intake on CVD morbidity and mortality in Western societies remains to be established . Introduction Observational and experimental data support an independent , positive relationship between sodium intake and blood pressure , most clearly in hypertensive populations -LSB- 1 -- 3 -RSB- . Potassium intake , on the other hand , has been inversely related to blood pressure -LSB- 3 , 4 -RSB- . Since hypertension is a strong predictor of cardiovascular disease -LRB- CVD -RRB- , especially stroke , inadequate intake of sodium and potassium is likely to be associated with increased cardiovascular morbidity and mortality -LSB- 1 -RSB- . Only recently , population-based studies on dietary salt intake in relation to CVD and non-cardiovascular events have received priority -LSB- 5 -RSB- . Alderman et al. were among the first to report an increased risk of myocardial infarction with low urinary sodium in treated hypertensive men -LSB- 6 -RSB- . In a subsequent analysis of NHANES I data , an inverse association of sodium intake with all-cause and cardiovascular mortality was found -LSB- 7 -RSB- . Estimation of salt intake by 24-h dietary recall and other methodological aspects of this analysis , however , have been criticized -LSB- 8 -- 10 -RSB- . Salt intake was not significantly related to coronary or all-cause mortality in the large cohorts of the Scottish Heart Health Study -LSB- 11 -RSB- and the MRFIT trial -LSB- 12 -RSB- . A recent systematic review of 11 randomized trials showed no effect of long-term sodium reduction on overall mortality , but this meta-analysis included only 17 fatal events and should be interpreted with caution -LSB- 13 -RSB- . He et al. showed that high sodium intake was a strong risk factor for congestive heart failure in overweight participants of the NHANES I follow-up study -LSB- 14 -RSB- , and also predictive for CVD and all-cause mortality in this group -LSB- 15 -RSB- . Similarly , in a Finnish cohort , 24-h urinary sodium excretion predicted mortality and risk of coronary heart disease only in the presence of overweight -LSB- 16 -RSB- . With regard to incidence of stroke , the Finnish study showed no association with urinary sodium -LSB- 16 -RSB- . Stroke mortality was neither predicted by dietary sodium intake in MRFIT -LSB- 12 -RSB- . In the WHO Cardiovascular Diseases and Alimentary Comparison -LRB- CARDIAC -RRB- Study in 24 countries , however , sodium intake appeared to be a risk factor for stroke in men -LSB- 17 -RSB- . As a consequence of these inconsistent findings , there is currently no consensus as to the cardiovascular risks of salt intake . Tobian et al. demonstrated a lower risk of hemorrhagic stroke and mortality in hypertensive rats that had been given potassium supplements , an effect that was not mediated by blood pressure reduction -LSB- 18 -RSB- . Khaw and Barrett-Connor confirmed this independent protective effect of dietary potassium against stroke in humans -LSB- 19 -RSB- . Also in the CARDIAC study -LSB- 17 -RSB- , the Cardiovascular Health Study -LSB- 20 -RSB- and the Nurses Health Study -LSB- 21 -RSB- the intake of potassium was inversely related to risk of stroke . Data on dietary potassium in relation to coronary and all-cause mortality in humans are scanty . We examined the relationship of sodium and potassium intake with cardiovascular events and all-cause mortality in the older cohort of the population-based Rotterdam Study . Methods The Rotterdam Study This case -- cohort analysis formed part of the Rotterdam Study , a population-based prospective study among 7,983 men and women aged 55 years and older in the Netherlands -LSB- 22 -RSB- . The Medical Ethics Committee of the Erasmus Medical Centre Rotterdam approved the study , and written informed consent was obtained from all participants . From August 1990 until June 1993 , a trained research assistant collected data on health , medication use , lifestyle , and risk indicators for chronic diseases during a home interview . Subjects were subsequently invited at the study centre for clinical examination and assessment of diet . Assessment of diet Subjects were interviewed at the study centre by a trained dietician , who used a validated , semi-quantitative food frequency questionnaire -LSB- 23 -RSB- . The intake of total energy , alcohol , macronutrients , and a large number of micronutrients was computed using Dutch food composition tables -LSB- 24 -RSB- . No information on salt use was obtained and therefore data on dietary sodium were considered unreliable for this analysis . Clinical examination Height and body weight were measured with the subject wearing indoor clothing without shoes . The body mass index was computed as weight divided by height squared . A trained research assistant measured sitting systolic and diastolic blood pressure twice with a random-zero sphygmomanometer after a 5-min rest , and values were averaged . Hypertension was defined as a systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg or use of antihypertensive medication . Diabetes mellitus was considered present when the subject reported antidiabetic treatment , or when random or post-load plasma glucose levels were 11.1 mmol/l or higher . CVD was considered present in case of a verified history of myocardial infarction , stroke , coronary bypass grafting , or percutaneous transluminal coronary angioplasty . Serum total and HDL cholesterol level -LRB- mmol/l -RRB- were determined by standard laboratory methods -LSB- 25 -RSB- . Assessment of sodium and potassium excretion Participants collected an overnight urine sample before visiting the research centre and recorded collection times on the jar . They were not aware that samples would be used for estimation of electrolyte intake . At the research centre , volumes were recorded , urines were swirled and 100 ml samples were taken . Samples were stored in plastic tubes at − 20 °C for future laboratory determinations . Urinary sodium , potassium and creatinine determinations were performed by Vitros ® 250 -LRB- formerly Ektachem 250 -RRB- Chemistry System -LRB- Johnson & Johnson , Ortho-Clinical Diagnostics Inc. , Rochester , New York -RRB- . Determination of electrolytes and creatinine were based on potentiometry and enzymatic conversion , respectively . Urinary sodium and potassium concentrations -LRB- mmol/l -RRB- were standardized to 24-h values using recorded collection times and urinary volumes -LRB- ml -RRB- . In addition , urinary sodium/potassium ratio was computed . Follow-up procedures The present analysis is based on follow-up data collected from baseline -LRB- 1990 -- 1993 -RRB- until 1 January 1998 . Informed consent for collection of follow-up data was obtained from 7,802 participants -LRB- 98 % -RRB- . Information on vital status was obtained at regular intervals from municipal population registries . General practitioners -LRB- GPs -RRB- used a computerized information system to record fatal and non-fatal events in the research area -LRB- covering 85 % of the cohort -RRB- . In the Netherlands , the GP forms the link to all specialized medical care and clinical events are unlikely to be missed by this follow-up procedure . Research physicians verified all information on incident events using GP records and hospital discharge letters . Events were coded independently by two physicians according to the International Classification of Diseases , 10th revision -LRB- ICD-10 -RRB- -LSB- 26 -RSB- . Coded events were reviewed by a medical expert in the field , whose judgment was considered definite in case of discrepancies . Myocardial infarction comprised ICD-10 code I21 and stroke comprised ICD-10 codes I60-I67 . Both fatal and non-fatal incident events were recorded . For the present study , only first events were considered . Events followed by death within 28 days were classified as fatal . CVD mortality comprised fatal myocardial infarction , fatal stroke , sudden cardiac death and other forms of fatal CVD -LRB- ICD-10 codes I20-I25 , I46 , I49 , I50 , I60-I67 , I70-I74 , and R96 -RRB- . Study population Of 7,129 subjects who visited the research centre , 6,605 adequately performed a timed overnight urine collection for which collection times were recorded and volumes exceeded 150 ml . Of those , 5,531 had blood pressure readings and these subjects were eligible for the present analysis . We followed a case -- cohort approach for efficiency reasons . Assessment of urinary sodium , potassium and creatinine excretion was performed in all subjects who died -LRB- n = 795 , including 217 cardiovascular deaths -RRB- , and in those who experienced a myocardial infarction -LRB- n = 206 -RRB- or stroke -LRB- n = 181 -RRB- during follow-up . A random sample of 1,500 control subjects was taken from the eligible cohort for assessment of electrolyte excretions . Urine samples could not be retrieved for 52 of these subjects , and data on urinary sodium , potassium and creatinine were thus obtained in 1,448 subjects . Dietary data were available for 1,205 subjects -LRB- 83 % -RRB- of the random sample , 518 subjects -LRB- 65 % -RRB- who died during follow-up , 157 subjects -LRB- 72 % -RRB- who died from CVD , 170 subjects -LRB- 83 % -RRB- with an incident myocardial infarction and 147 subjects -LRB- 81 % -RRB- with an incident stroke . Reasons for missing dietary data were participation in the pilot phase of the Rotterdam Study , low cognitive function , and logistic reasons , as described in more detail elsewhere -LSB- 23 -RSB- . Of the random sub-cohort -LRB- n = 1,448 -RRB- , 783 subjects -LRB- 54 % -RRB- were free of CVD and hypertension at baseline . Data analysis Pearson correlations were computed to examine inter-relationships between urinary and dietary measures of electrolyte intake and associations with total energy intake . The association of urinary and dietary electrolytes with incident myocardial infarction , incident stroke , cardiovascular mortality and all-cause mortality was evaluated in a case -- cohort design with standard Cox proportional-hazards models with modification of the standard errors based on robust variance estimates -LSB- 27 , 28 -RSB- . We used the method according to Barlow in which the random cohort is weighted by the inverse of the sampling fraction from the source population . Members of the random cohort are included from baseline until failure or censoring , whereas cases outside the cohort are included at the time of their event . For the Cox models we used Proc MI and Proc MIanalyze , in conjunction with Proc Phreg -LRB- SAS 8.2 -RRB- . Relative risks -LRB- RR -RRB- with 95 % confidence intervals -LRB- 95 % - CI -RRB- were computed per 1 standard deviation increase in urinary sodium -LRB- mmol/24 h -RRB- , urinary potassium -LRB- mmol/24 h -RRB- and dietary potassium intake -LRB- mg/day -RRB- , and per 1 unit increase in urinary sodium/potassium ratio . Two-sided P-values below 0.05 were considered statistically significant . Adjustment was made for age , sex and , in urinary analyses , for 24-h urinary creatinine excretion -LRB- model 1 -RRB- . In a second analysis -LRB- model 2 -RRB- , additional adjustment was made for body mass index -LRB- kg/m2 -RRB- , smoking status -LRB- current , past , or never -RRB- , diabetes mellitus -LRB- yes/no -RRB- , use of diuretics -LRB- yes/no -RRB- , and highest completed education -LRB- three categories -RRB- . In a third analysis -LRB- model 3 -RRB- , dietary confounders were additionally adjusted for , i.e. daily intake of total energy -LRB- kJ -RRB- , alcohol -LRB- g -RRB- , calcium -LRB- g -RRB- , and saturated fat -LRB- g -RRB- . In the analysis for urinary sodium we additionally included urinary potassium in this model , and vice versa . Analyses were repeated after exclusion of subjects with a history of CVD or hypertension to avoid biased risk estimates due to intentional dietary changes . Within this sub-cohort , a predefined stratified analysis of urinary sodium and urinary sodium/potassium ratio with cardiovascular and all-cause mortality was performed in subjects with a high body mass index -LRB- i.e. , ≥ 25 kg/m2 -RRB- , using model 3 . Also in the sub-cohort free of CVD and hypertension , the distribution of 24-h urinary sodium excretion was divided into quartiles to be able to examine the relationship with all-cause mortality at extreme intakes . Quartiles of urinary sodium -LRB- cut-off levels : 66 , 105 and 151 mmol/24 h -RRB- were entered categorically into the fully adjusted model -LRB- model 3 -RRB- , using the lower quartile as the reference . Results The study had a median follow-up of 5.5 years . Baseline characteristics of the study population are shown in Table 1 . Randomly selected controls -LRB- n = 1,448 -RRB- were expectedly healthier at baseline than cases , as indicated by a lower prevalence of hypertension , diabetes , and CVD . Table 1Baseline characteristics of the study populationRandom sampleCasesIncident MIIncident strokeCVD mortalityAll-cause mortalityNo . of subjects1 ,448206181217795 In random sample -LRB- % -RRB- 31312829Age -LRB- year -RRB- 69.2 -LRB- 8.7 -RRB- 71.0 -LRB- 8.0 -RRB- 74.0 -LRB- 8.5 -RRB- 76.8 -LRB- 8.4 -RRB- 76.9 -LRB- 8.9 -RRB- Men -LRB- % -RRB- 4162455149Body mass index -LRB- kg/m2 -RRB- 26.4 -LRB- 3.8 -RRB- 26.3 -LRB- 3.4 -RRB- 26.0 -LRB- 3.3 -RRB- 26.2 -LRB- 3.8 -RRB- 25.7 -LRB- 3.8 -RRB- Smoking status -LRB- % -RRB- a Current2329282326 Former4148424740 Never3623292935Alcohol use -LRB- % -RRB- 8174807173Educational level -LRB- % -RRB- a , b Low5861606566 Intermediate3231343028 High108656Serum cholesterol -LRB- mmol/l -RRB- Total6 .6 -LRB- 1.2 -RRB- 6.3 -LRB- 1.3 -RRB- 6.5 -LRB- 1.2 -RRB- 6.6 -LRB- 1.4 -RRB- 6.3 -LRB- 1.3 -RRB- HDL1 .4 -LRB- 0.4 -RRB- 1.3 -LRB- 0.4 -RRB- 1.3 -LRB- 0.4 -RRB- 1.2 -LRB- 0.4 -RRB- 1.3 -LRB- 0.4 -RRB- Blood pressure -LRB- mmHg -RRB- Systolic140 -LRB- 22 -RRB- 145 -LRB- 23 -RRB- 149 -LRB- 24 -RRB- 146 -LRB- 25 -RRB- 145 -LRB- 25 -RRB- Diastolic74 -LRB- 11 -RRB- 74 -LRB- 12 -RRB- 75 -LRB- 13 -RRB- 73 -LRB- 13 -RRB- 73 -LRB- 14 -RRB- Hypertension -LRB- % -RRB- c3744535547Diabetes mellitus -LRB- % -RRB- d1021222621History of CVD -LRB- % -RRB- e1735173928Values are means with standard deviations , or percentages ; CVD , cardiovascular disease ; MI , myocardial infarctionaValues not always add up to 100 % due to roundingbHighest achieved level of education ; low , primary education , or less ; intermediate , secondary general or vocational education ; high , higher vocational education , universitycSystolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg or use of antihypertensive medicationdPlasma glucose ≥ 11.1 mmol/l or treated with oral antidiabetes medication or insulineVerified history of cardiovascular disease , i.e. myocardial infarction , stroke , coronary bypass-grafting , or percutaneous transluminal coronary angioplasty Baseline urinary excretions and dietary intakes are presented in Table 2 . In the random sample , 24-h urinary sodium excretion estimated from overnight urine collection was 117 mmol -LRB- i.e. , 2.7 g/day , which corresponds to a NaCl intake of 6.8 g/day -RRB- . Urinary potassium excretion was 45 mmol/24 h -LRB- 1.8 g/day -RRB- , which was half the amount estimated by food frequency questionnaire -LRB- 3.6 g/day -RRB- . The correlation between urinary and dietary potassium was 0.21 -LRB- P < 0.001 -RRB- . Table 2Baseline urinary excretions and dietary intakes of Dutch men and women aged 55 years and over : The Rotterdam StudyRandom subcohortCasesIncident MIIncident strokeCVD mortalityAll-cause mortalityUrinary excretionaVolume -LRB- l/24 h -RRB- 1.4 -LRB- 0.6 -RRB- 1.4 -LRB- 0.6 -RRB- 1.4 -LRB- 0.6 -RRB- 1.3 -LRB- 0.6 -RRB- 1.3 -LRB- 0.6 -RRB- Sodium -LRB- mmol/24 h -RRB- 117 -LRB- 69 -RRB- 124 -LRB- 68 -RRB- 115 -LRB- 72 -RRB- 99 -LRB- 61 -RRB- 107 -LRB- 66 -RRB- Potassium -LRB- mmol/24 h -RRB- 45 -LRB- 22 -RRB- 47 -LRB- 22 -RRB- 45 -LRB- 23 -RRB- 44 -LRB- 24 -RRB- 44 -LRB- 22 -RRB- Sodium/potassium2 .8 -LRB- 1.5 -RRB- 2.7 -LRB- 1.3 -RRB- 2.7 -LRB- 1.3 -RRB- 2.5 -LRB- 1.4 -RRB- 2.6 -LRB- 1.6 -RRB- Creatinine -LRB- mmol/24 h -RRB- 9.2 -LRB- 4.9 -RRB- 9.8 -LRB- 4.7 -RRB- 8.4 -LRB- 4.4 -RRB- 8.1 -LRB- 4.7 -RRB- 8.1 -LRB- 4.4 -RRB- Sodium/creatinine13 .8 -LRB- 6.6 -RRB- 13.6 -LRB- 6.1 -RRB- 14.6 -LRB- 7.1 -RRB- 14.0 -LRB- 8.0 -RRB- 14.8 -LRB- 7.9 -RRB- Potassium/creatinine5 .4 -LRB- 2.2 -RRB- 5.3 -LRB- 2.1 -RRB- 5.8 -LRB- 2.1 -RRB- 6.1 -LRB- 2.6 -RRB- 6.1 -LRB- 2.5 -RRB- Dietary intakebTotal energy -LRB- mJ/day -RRB- 8.3 -LRB- 2.1 -RRB- 8.6 -LRB- 2.2 -RRB- 8.4 -LRB- 2.2 -RRB- 8.3 -LRB- 2.0 -RRB- 8.5 -LRB- 2.2 -RRB- Saturated fat -LRB- g/day -RRB- 32 -LRB- 12 -RRB- 34 -LRB- 13 -RRB- 34 -LRB- 13 -RRB- 33 -LRB- 13 -RRB- 34 -LRB- 12 -RRB- Calcium -LRB- g/day -RRB- 1.1 -LRB- 0.4 -RRB- 1.1 -LRB- 0.4 -RRB- 1.1 -LRB- 0.4 -RRB- 1.1 -LRB- 0.5 -RRB- 1.1 -LRB- 0.4 -RRB- Sodium -LRB- g/day -RRB- c2 .2 -LRB- 0.7 -RRB- 2.3 -LRB- 0.6 -RRB- 2.2 -LRB- 0.6 -RRB- 2.2 -LRB- 0.7 -RRB- 2.2 -LRB- 0.7 -RRB- Potassium -LRB- g/day -RRB- 3.6 -LRB- 0.8 -RRB- 3.7 -LRB- 0.8 -RRB- 3.6 -LRB- 0.8 -RRB- 3.6 -LRB- 0.9 -RRB- 3.6 -LRB- 0.9 -RRB- Values are means with standard deviations ; CVD , cardiovascular disease ; MI , myocardial infarctionaBased on one timed overnight urine samplebDietary data were available for 1,205 subjects of the random sample -LRB- 83 % -RRB- , 170 MI cases -LRB- 83 % -RRB- , 147 stroke cases -LRB- 81 % -RRB- , 157 CVD deaths -LRB- 72 % -RRB- , and 518 deaths from any cause -LRB- 65 % -RRB- cOnly from foods , discretionary sources not included RR for cardiovascular events and all-cause mortality per 1-SD increase in 24-h urinary sodium are presented in Table 3 . Urinary sodium was not significantly associated with incident myocardial infarction , incident stroke , or overall mortality . For CVD mortality , however , a borderline significant inverse association was observed -LRB- RR = 0.77 -LRB- 0.60 -- 1.01 -RRB- per 1-SD , model 3 -RRB- but the relationship was attenuated after excluding subjects with a history of CVD or hypertension -LRB- RR = 0.83 -LRB- 0.47 -- 1.44 -RRB- per 1-SD , model 3 -RRB- . In subjects initially free of CVD , the risk of all-cause mortality was also examined across quartiles of 24-h urinary sodium -LRB- median values : 45 , 87 , 125 and 190 mmol , respectively -RRB- . RR in consecutive quartiles , using the lower quartile as the reference , were 0.80 -LRB- 0.43 -- 1.49 -RRB- , 0.66 -LRB- 0.34 -- 1.27 -RRB- and 0.98 -LRB- 0.54 -- 1.78 -RRB- , respectively -LRB- model 3 -RRB- . In a subgroup analysis of CVD free subjects with a body mass index ≥ 25 kg/m2 , the association of urinary sodium with CVD mortality or all-cause mortality was neither statistically significant -LRB- RR = 0.91 -LRB- 0.44 -- 1.89 -RRB- and RR = 1.19 -LRB- 0.86 -- 1.66 -RRB- per 1-SD , respectively ; model 3 -RRB- . Table 3Relative risk of urinary sodium with cardiovascular events and all-cause mortality in Dutch men and women aged 55 years and overAll subjectsaSubjects initially free of CVD and hypertensionaIncident MIRR , model 1b1 .13 -LRB- 0.95 -- 1.34 -RRB- 1.04 -LRB- 0.75 -- 1.43 -RRB- RR , model 2c1 .16 -LRB- 0.98 -- 1.39 -RRB- 1.07 -LRB- 0.77 -- 1.50 -RRB- RR , model 3d1 .19 -LRB- 0.97 -- 1.46 -RRB- 1.14 -LRB- 0.77 -- 1.69 -RRB- Incident strokeRR , model 11.09 -LRB- 0.89 -- 1.33 -RRB- 1.16 -LRB- 0.84 -- 1.61 -RRB- RR , model 21.09 -LRB- 0.87 -- 1.35 -RRB- 1.15 -LRB- 0.81 -- 1.62 -RRB- RR , model 31.08 -LRB- 0.80 -- 1.46 -RRB- 1.02 -LRB- 0.66 -- 1.58 -RRB- CVD mortalityeRR , model 10.74 -LRB- 0.60 -- 0.91 -RRB- 0.84 -LRB- 0.59 -- 1.22 -RRB- RR , model 20.83 -LRB- 0.68 -- 1.02 -RRB- 0.95 -LRB- 0.66 -- 1.39 -RRB- RR , model 30.77 -LRB- 0.60 -- 1.01 -RRB- 0.83 -LRB- 0.47 -- 1.44 -RRB- All-cause mortalityRR , model 10.90 -LRB- 0.81 -- 1.02 -RRB- 1.00 -LRB- 0.83 -- 1.20 -RRB- RR , model 20.96 -LRB- 0.84 -- 1.09 -RRB- 1.10 -LRB- 0.91 -- 1.34 -RRB- RR , model 30.95 -LRB- 0.81 -- 1.12 -RRB- 1.12 -LRB- 0.86 -- 1.46 -RRB- RR , Relative risk with 95 % confidence interval per standard deviation increase in urinary sodium -LRB- mmol/24 h -RRB- , obtained by Cox proportional hazard analysisaNumber of cases and subjects in random sample given in Table 1bAjusted for age , sex and -LRB- for urinary sodium -RRB- 24-h urinary creatinine excretioncAs model 1 , with additional adjustment for body mass index , smoking status , diabetes , use of diuretics , highest completed educationdAs model 2 , with additional adjustment for daily intake of total energy , alcohol , calcium , saturated fat and 24-h urinary potassium excretioneCardiovascular mortality comprises fatal myocardial infarction , fatal stroke , sudden cardiac death and other forms of fatal CVD Findings for potassium are presented in Table 4 . Urinary potassium tended to be positively associated with incident CVD events or mortality , especially in subjects who were initially free of CVD and hypertension . After full adjustment for confounders -LRB- model 3 -RRB- , however , none of these associations were statistically significant . Urinary potassium did neither predict all-cause mortality . For dietary potassium , similar results were obtained except for risk of all-cause mortality that was significantly reduced both in the entire cohort -LRB- RR = 0.78 -LRB- 0.65 -- 0.94 per 1-SD -RRB- and in subjects initially free of CVD and hypertension -LRB- RR = 0.71 -LRB- 0.51 -- 1.00 -RRB- , model 3 -RRB- . Table 4Relationship of urinary and dietary potassium with cardiovascular events and all-cause mortality in Dutch men and women aged 55 years and overAll subjectsaSubjects initially free of CVD and hypertensionaUrinary excretion -LRB- mmol/24 h -RRB- Dietary intake -LRB- mg/day -RRB- Urinary excretion -LRB- mmol/24 h -RRB- Dietary intake -LRB- mg/day -RRB- Incident MIRR , model 1b1 .10 -LRB- 0.89 -- 1.35 -RRB- 0.98 -LRB- 0.85 -- 1.13 -RRB- 1.15 -LRB- 0.84 -- 1.59 -RRB- 1.14 -LRB- 0.85 -- 1.54 -RRB- RR , model 2c1 .16 -LRB- 0.94 -- 1.43 -RRB- 0.94 -LRB- 0.81 -- 1.09 -RRB- 1.25 -LRB- 0.94 -- 1.74 -RRB- 1.07 -LRB- 0.78 -- 1.46 -RRB- RR , model 3d1 .11 -LRB- 0.87 -- 1.43 -RRB- 0.90 -LRB- 0.65 -- 1.24 -RRB- 1.22 -LRB- 0.79 -- 1.87 -RRB- 1.32 -LRB- 0.65 -- 2.67 -RRB- Incident strokeRR , model 11.09 -LRB- 0.87 -- 1.36 -RRB- 0.99 -LRB- 0.84 -- 1.17 -RRB- 1.12 -LRB- 0.79 -- 1.60 -RRB- 1.07 -LRB- 0.79 -- 1.43 -RRB- RR , model 21.12 -LRB- 0.89 -- 1.42 -RRB- 0.99 -LRB- 0.84 -- 1.16 -RRB- 1.15 -LRB- 0.77 -- 1.71 -RRB- 1.20 -LRB- 0.86 -- 1.68 -RRB- RR , model 31.17 -LRB- 0.86 -- 1.58 -RRB- 1.02 -LRB- 0.71 -- 1.46 -RRB- 1.11 -LRB- 0.61 -- 2.04 -RRB- 1.06 -LRB- 0.50 -- 2.29 -RRB- CVD mortalityeRR , model 11.13 -LRB- 0.90 -- 1.41 -RRB- 0.97 -LRB- 0.82 -- 1.14 -RRB- 1.63 -LRB- 1.14 -- 2.33 -RRB- 1.23 -LRB- 0.83 -- 1.84 -RRB- RR , model 21.14 -LRB- 0.92 -- 1.42 -RRB- 0.95 -LRB- 0.81 -- 1.12 -RRB- 1.66 -LRB- 1.08 -- 2.56 -RRB- 1.19 -LRB- 0.78 -- 1.83 -RRB- RR , model 31.23 -LRB- 0.94 -- 1.60 -RRB- 0.97 -LRB- 0.72 -- 1.31 -RRB- 1.45 -LRB- 0.84 -- 2.54 -RRB- 1.43 -LRB- 0.67 -- 3.03 -RRB- All-cause mortalityRR , model 11.04 -LRB- 0.91 -- 1.18 -RRB- 0.91 -LRB- 0.82 -- 1.01 -RRB- 1.06 -LRB- 0.88 -- 1.28 -RRB- 0.95 -LRB- 0.78 -- 1.17 -RRB- RR , model 21.06 -LRB- 0.86 -- 1.31 -RRB- 0.89 -LRB- 0.80 -- 0.99 -RRB- 1.06 -LRB- 0.86 -- 1.31 -RRB- 0.90 -LRB- 0.73 -- 1.12 -RRB- RR , model 31.08 -LRB- 0.91 -- 1.28 -RRB- 0.78 -LRB- 0.65 -- 0.94 -RRB- 0.95 -LRB- 0.71 -- 1.26 -RRB- 0.71 -LRB- 0.51 -- 1.00 -RRB- RR , Relative risk with 95 % confidence interval per standard deviation increase in urinary or dietary potassium , obtained by Cox proportional hazard analysisaNumber of cases and subjects in random sample given in Table 1bAjusted for age , sex and -LRB- for urinary potassium -RRB- 24-h urinary creatinine excretioncAs model 1 , with additional adjustment for body mass index , smoking status , diabetes , use of diuretics and highest completed educationdAs model 2 , with additional adjustment for daily intake of total energy , alcohol , calcium , saturated fat and 24-h urinary sodium excretioneCardiovascular mortality comprises fatal myocardial infarction , fatal stroke , sudden cardiac death and other forms of fatal CVD Data for urinary sodium/potassium ratio -LRB- Table 5 -RRB- showed no relationship with CVD events and mortality . When restricting this analysis to CVD free subjects with a body mass index ≥ 25 kg/m2 , urinary sodium/potassium ratio was significantly associated with all-cause mortality -LRB- RR = 1.19 -LRB- 1.02 -- 1.39 -RRB- per unit , model 3 -RRB- , but not with CVD mortality -LRB- RR = 0.86 -LRB- 0.60 -- 1.25 -RRB- -RRB- . Table 5Relationship of urinary sodium/potassium ratio with cardiovascular events and all-cause mortality in Dutch men and women aged 55 years and overAll subjectsaSubjects initially free of CVD and hypertensionaIncident MIRR , model 1b1 .03 -LRB- 0.93 -- 1.14 -RRB- 0.92 -LRB- 0.76 -- 1.13 -RRB- RR , model 2c1 .02 -LRB- 0.92 -- 1.13 -RRB- 0.90 -LRB- 0.73 -- 1.10 -RRB- RR , model 3d1 .04 -LRB- 0.93 -- 1.17 -RRB- 0.91 -LRB- 0.72 -- 1.16 -RRB- Incident strokeRR , model 11.01 -LRB- 0.89 -- 1.13 -RRB- 1.01 -LRB- 0.83 -- 1.23 -RRB- RR , model 20.99 -LRB- 0.86 -- 1.13 -RRB- 0.99 -LRB- 0.77 -- 1.20 -RRB- RR , model 30.99 -LRB- 0.83 -- 1.18 -RRB- 0.90 -LRB- 0.66 -- 1.22 -RRB- CVD mortalityeRR , model 10.88 -LRB- 0.77 -- 1.01 -RRB- 0.85 -LRB- 0.65 -- 1.11 -RRB- RR , model 20.93 -LRB- 0.81 -- 1.06 -RRB- 0.86 -LRB- 0.66 -- 1.13 -RRB- RR , model 30.92 -LRB- 0.80 -- 1.07 -RRB- 0.91 -LRB- 0.65 -- 1.27 -RRB- All-cause mortalityRR , model 10.99 -LRB- 0.91 -- 1.06 -RRB- 1.04 -LRB- 0.91 -- 1.18 -RRB- RR , model 20.99 -LRB- 0.92 -- 1.08 -RRB- 1.06 -LRB- 0.93 -- 1.22 -RRB- RR , model 31.01 -LRB- 0.91 -- 1.12 -RRB- 1.13 -LRB- 0.93 -- 1.36 -RRB- RR , Relative risk with 95 % confidence interval per 1 unit increase in urinary sodium/potassium ratio , obtained by Cox proportional hazard analysisaNumber of cases and subjects in random sample given in Table 1bAdjusted for age , sex and 24-h urinary creatinine excretioncAs model 1 , with additional adjustment for body mass index , smoking status , diabetes , use of diuretics and highest completed educationdAs model 2 , with additional adjustment for daily intake of total energy , alcohol , calcium , and saturated fateCardiovascular mortality comprises fatal myocardial infarction , fatal stroke , sudden cardiac death and other forms of fatal CVD Discussion In an unselected population of older Dutch subjects we found no consistent association of urinary sodium and potassium with CVD events or mortality . Dietary potassium estimated by food frequency questionnaire , however , was associated with a lower risk of all-cause mortality . Urinary sodium/potassium ratio was positively associated with mortality risk , but only in overweight subjects without CVD and hypertension at baseline . Electrolyte intake was assessed from one overnight urine collection , which provides a crude estimate of short-term intake -LSB- 29 , 30 -RSB- . Luft et al. examined the utility of nocturnal sodium excretion under controlled intake conditions , in which daily sodium intake was randomly varied -LSB- 31 -RSB- . In that study , on a randomly selected day , both 24-h and nocturnal sodium excretion estimated the daily intake reasonably well . Nevertheless , it is likely that misclassification has attenuated the relationships with CVD events and mortality in our study . Incomplete urine collection was partly adjusted for by adding urinary creatinine excretion to the multivariate models . In addition , we examined the urinary sodium/potassium ratio , which is less influenced by incomplete urine collection . To exclude bias due to dietary changes , we repeated all analyses in a subgroup without CVD or hypertension at baseline . Salt intake was not consistently related to CVD or mortality in our study . An explanation for the absence of a positive relationship , apart from regression dilution bias , may be the relatively narrow range of salt intake in the Netherlands and the lack of contrast in exposure within a single population . An increased risk of mortality was observed for high salt intake in overweight Finnish subjects with 24-h urinary excretions close to 200 mmol -LRB- RR = 1.56 per 100 mmol -RRB- -LSB- 16 -RSB- . However , this could not be confirmed in our analysis of quartiles of sodium intake in relation to overall mortality -LRB- RR = 0.98 in CVD free subjects with median sodium excretion of 190 mmol/24 h -RRB- . The absence of a relationship between salt intake and mortality in our study corroborates the findings from the large Scottish Heart Health Study among almost 12,000 middle-aged subjects with 24-h urine samples -LSB- 11 -RSB- . Follow-up data of the MRFIT trial neither showed a relationship between dietary sodium intake estimated by 24-h recall and cardiovascular events or mortality -LSB- 12 -RSB- . However , other prospective epidemiological studies do suggest that sodium intake is related to morbidity and mortality -LSB- 6 , 7 , 15 , 16 -RSB- , although this may be confined to specific subgroups with overweight , hypertension or high salt intake . In overweight subjects , we did find a positive relationship between urinary sodium/potassium ratio and overall mortality -LRB- 19 % increase in risk per unit change in sodium/potassium ratio -RRB- . A protective effect of potassium intake against stroke , as previously reported -LSB- 19 -- 21 -RSB- , could not be confirmed by our data . We neither observed an association between potassium intake and coronary events . Long-term rather than short-term intake may be relevant and therefore we estimated habitual potassium intake during the preceding year by food frequency questionnaire . Mortality risk was reduced by 29 % per 1-SD increase in dietary potassium , although only in subjects initially free of CVD and hypertension . Except for misclassification , although less likely than for sodium , we have no explanation for the absent relationship between potassium intake and CVD events . In the Scottish Heart Health Study , 24-h urinary potassium excretion was inversely related to all-cause mortality and coronary events -LSB- 11 -RSB- . Data on potassium intake in relation to mortality , however , are sparse and more prospective population-based studies are needed to draw conclusions . Preferably , the effect of dietary potassium on CVD should be examined in a randomized trial . Prolonged differences in blood pressure of 5 mmHg may result in a one-third reduction in stroke and one-fifth reduction in coronary events -LSB- 32 -RSB- . Meta-analysis of randomized controlled trials showed that sodium reduction around 2 g per day could lower blood pressure by 2 -- 3 mmHg , with the effect being twice as large in hypertensives -LSB- 33 -RSB- . The World Health Organization recommends that people should consume less than 5 g of salt -LRB- i.e. 2 g of sodium -RRB- per day in order to prevent CVD -LSB- 34 -RSB- . From this and other epidemiological studies we conclude that effect of dietary salt on clinical cardiovascular endpoints and overall mortality within the range of intake commonly observed in Western countries has not yet been established . More research is needed to settle the discussion regarding this major public health issue .

B O B O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O B O O O O B I O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O B O O O O O O O O O O B I O O O O O O B O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O B O O O O O O O O B O O O O O O O O O O O B O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O B O O O O O B O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O B O O O O B O B O O O O O O O O O O B O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O B O O O O O O O O O O O O O O O O O O O O O B O O O O O B O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O 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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O B O O B I O O B O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O B I O O B O O O O O O O O O O O O O O O O O O O O O O O O O O B O B O O O O B O O B O O O O O O O O O O O O O O O O B O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O B O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O B O O O O O O O O O O B O O O O O O O O O O O O O B O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O B O O O O O O O O O O O O O B O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O B O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O B O O O O O O O O O O B O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O B O O O O O O O O O O O O O O B O O O O O O B O O O O O O O O O B O O O O B O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O

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stroke


Defining

the

Health

Benefit

Basket

in

nine

European

countries

This

article

identifies

and

analyses

a

framework

for

health

baskets

the

taxonomy

of

benefit

catalogues

for

curative

services

and

the

criteria

for

the

in

or

exclusion

of

benefits

in

nine

EU

member

states

-LRB-

Denmark

England

France

Germany

Hungary

Italy

The

Netherlands

Poland

and

Spain

-RRB-

Focusing

on

services

of

curative

care

it

is

found

that

the

explicitness

of

benefit

catalogues

varies

largely

between

the

countries

In

the

absence

of

explicitly

defined

benefit

catalogues

in

and

outpatient

remuneration

schemes

have

the

character

of

benefit

catalogues

The

criteria

for

the

in

or

exclusion

into

benefit

catalogues

are

often

not

transparent

and

-LRB-

cost

-RRB-

effectiveness

is

applied

only

for

certain

sectors

An

EU-wide

harmonization

of

benefit

baskets

does

not

seem

realistic

in

the

short

or

medium

term

as

the

variation

in

criteria

and

the

taxonomies

of

benefit

catalogues

are

large

but

not

insurmountable

There

may

be

scope

for

a

European

core

basket

The

Kohll/Decker

judgments

of

the

European

Court

of

Justice

and

more

recently

the

Geraets-Smits/Peerbooms

cases

have

demonstrated

that

health

services

can

no

longer

be

regarded

as

operating

in

isolation

from

other

EU

member

states

-LSB-

-RSB-

Increasingly

there

are

flows

of

patients

from

one

member

state

to

another

sometimes

due

to

individual

choice

sometimes

induced

by

sickness

funds

or

even

by

health

ministries

Such

movements

have

the

potential

to

stimulate

competition

between

health

care

systems

of

the

member

states

However

the

average

volume

of

imported

health

care

services

in

the

EU

has

been

rather

small

with

approx

per

person

as

yet

-LRB-

-RRB-

-LSB-

-RSB-

One

major

reason

for

this

low

volume

of

cross

country

flows

is

the

lack

of

accurate

information

as

the

basis

for

competitive

behavior

Actors

in

one

health

care

system

for

example

sickness

funds

do

not

have

sufficient

information

on

benefit

catalogues

and

prices

for

benefits

in

other

health

care

systems

in

order

to

induce

in

or

exports

of

health

services

So

far

research

has

mainly

focused

on

health

services

for

selected

indications

or

on

the

comprehensiveness

of

services

but

information

on

the

benefit

catalogues

their

taxonomy

and

inclusion

criteria

in

each

country

is

widely

lacking

-LSB-

-RSB-

As

one

result

of

the

project

Health

Benefits

and

Service

Costs

in

Europe

Health

BASKET

funded

by

the

European

Commission

this

article

identifies

and

analyses

the

framework

for

health

baskets

the

taxonomy

of

benefit

catalogues

for

curative

services

and

the

criteria

for

in

or

exclusion

of

benefits

in

nine

EU

member

states

-LRB-

Denmark

England

France

Germany

Hungary

Italy

The

Netherlands

Poland

and

Spain

-RRB-

It

focuses

on

services

of

curative

care

although

an

in-depth

analysis

of

all

other

health

sectors

is

also

available

as

part

of

the

project

results

-LRB-

Reports

of

the

EU

Health

BASKET

project

on

health

benefit

baskets

in

each

of

the

nine

countries

are

available

at

-RRB-

One

of

the

main

hypotheses

of

the

study

is

that

in

the

absence

of

explicit

benefit

catalogues

inpatient

and

outpatient

remuneration

schemes

have

the

character

of

-LRB-

less

explicit

-RRB-

benefit

catalogues

After

introducing

the

terminology

and

methodology

of

the

analysis

different

regulatory

frameworks

for

the

definition

of

the

overall

benefit

basket

in

each

country

are

compared

and

analyzed

Finally

the

taxonomy

and

the

inclusion

criteria

of

benefit

catalogues

and

their

substitutes

for

curative

services

are

compared

and

analyzed

Methodology

In

general

we

differentiate

between

the

terms

benefit

basket

-LRB-

also

benefit

package

-RRB-

and

benefit

catalogues

The

benefit

basket

refers

to

the

totality

of

services

activities

and

goods

covered

by

publicly

funded

statutory/mandatory

insurance

schemes

-LRB-

social

health

insurance

SHI

-RRB-

or

by

National

Health

Services

-LRB-

NHS

-RRB-

In

contrast

we

define

benefit

catalogues

as

the

document

-LRB-

s

-RRB-

in

which

the

different

components

of

the

benefit

basket

are

stated

in

detail

i.e.

which

enumerate

the

services

activities

and

goods

in

a

more

detailed

way

listing

single

interventions

-LRB-

i.e.

specific

technologies

-RRB-

Thus

a

benefit

basket

may

be

further

defined

by

one

or

more

benefit

catalogues

Basically

the

coverage

of

a

given

population

for

health

services

can

be

characterized

in

three

dimensions

breadth

as

the

extent

of

covered

population

depth

as

the

number

and

character

of

covered

services

and

height

as

the

extent

to

which

costs

of

the

defined

services

are

covered

by

prepaid

financial

resources

as

opposed

to

cost-sharing

requirements

Services

or

goods

which

are

not

covered

at

all

-LRB-

i.e.

with

a

copayment

of

-RRB-

are

not

considered

to

be

part

of

the

benefit

basket

Figure

summarizes

the

three

dimensions

of

a

benefit

basket

This

article

mainly

focuses

on

the

coverage

of

services

-LRB-

depth

of

benefit

coverage

-RRB-

-LSB-

-RSB-

Fig.

Three

dimensions

of

coverage

An

open

questionnaire

was

developed

to

explore

the

different

benefit

baskets

and

their

underlying

benefit

catalogues

of

the

participating

nine

countries

and

this

served

as

guide

in

compiling

standardized

country

reports

To

scan

the

different

health

systems

in

search

for

existing

benefit

catalogues

we

followed

the

framework

of

functional

categories

of

health

care

services

and

goods

proposed

by

the

OECD

in

its

System

of

Health

Accounts

-LRB-

Table

-RRB-

-LSB-

-RSB-

As

an

initial

step

the

researchers

in

each

country

were

asked

to

identify

the

decision-making

processes

on

the

benefit

basket

as

a

whole

in

their

country

As

a

second

step

they

were

asked

to

provide

a

detailed

description

of

the

existing

benefit

catalogues

for

each

functional

category

the

actors

involved

in

decision

making

and

the

decision

criteria.Table

Framework

of

health

care

functional

categories

system

of

health

accountsHC

Services

of

curative

care

HC

In-patient

curative

care

HC

Day

cases

of

curative

care

HC

Out-patient

care

HC

Basic

medical

and

diagnostic

services

-LRB-

primary

health

care

-RRB-

HC

Out-patient

dental

care

HC

All

other

specialized

care

HC

All

other

out-patient

curative

care

HC

Services

of

curative

home

careHC

Services

of

rehabilitative

care

HC

In-patient

rehabilitative

care

HC

Day

cases

of

rehabilitative

care

HC

Out-patient

rehabilitative

care

HC

Services

of

rehabilitative

home

careHC

Services

of

long-term

nursing

care

HC

In-patient

long-term

nursing

care

HC

Day

cases

of

long-term

nursing

care

HC

Long-term

nursing

care

at

homeHC

Ancillary

services

to

health

care

HC

Clinical

laboratory

HC

Diagnostic

imaging

HC

Patient

transport

and

emergency

rescue

HC

All

other

miscellaneous

servicesHC

Medical

goods

dispensed

to

out-patients

HC

Pharmaceuticals

and

other

medical

non-durables

HC

Prescription

medicines

HC

Over-the-counter

medicines

HC

Therapeutic

appliances

and

other

medical

durables

HC

Glasses

and

vision

products

HC

Orthopedic

appliances

and

other

prosthetics

HC

Hearing

aids

HC

Medico-technical

devices

HC

All

other

miscellaneous

medical

durablesHC

Prevention

and

public

health

services

HC

Maternal

and

child

health

family

planning

and

counseling

HC

School

health

services

HC

Prevention

of

communicable

diseases

HC

Prevention

of

non-communicable

diseases

HC

Occupational

health

care

HC

All

other

miscellaneous

public

health

services

Establishing

and

shaping

health

baskets

A

generic

pattern

of

establishing

and

shaping

health

baskets

is

found

in

most

of

the

countries

consisting

of

two

levels

At

the

higher

level

legislation

passed

by

the

national

parliaments

-LRB-

sometimes

even

rooted

in

the

country

's

constitution

e.g.

Poland

-LSB-

-RSB-

-RRB-

establishes

the

general

framework

by

enumerating

the

areas

of

health

care

often

similar

to

the

OECD

health

care

categories

included

in

the

benefit

basket

At

the

lower

level

the

benefit

basket

is

further

shaped

by

specifying

certain

procedures

provided

within

each

area

of

health

care

as

part

of

the

benefit

catalogues

These

catalogues

contain

recommendations

as

well

as

explicit

in

or

exclusions

of

services

The

extent

to

and

the

way

in

which

this

shaping

actually

takes

place

varies

considerably

from

country

to

country

and

within

each

country

from

sector

to

sector

of

health

care

There

are

several

ways

used

to

establish

benefit

catalogues

such

as

legislations

passed

by

central

or

regional

parliaments

decrees

issued

by

national

or

regional

governments

directives

issued

by

self-governing

bodies

or

by

national

and/or

local

authorities

and

other

documents

considered

as

quasilaws

-LRB-

rules

without

legal

character

e.g.

clinical

guidelines

-RRB-

In

all

countries

studied

a

general

definition

of

a

benefit

basket

could

be

identified

at

the

higher

level

Depending

on

the

organization

of

the

system

-LRB-

NHS

or

SHI

-RRB-

the

logic

underlying

the

general

definition

of

the

benefit

basket

differs

In

NHS

countries

the

definition

of

a

benefit

basket

refers

to

the

specification

of

the

duties

and

obligations

of

the

purchasing

organization

-LRB-

regional

health

authorities

-RRB-

and

in

SHI

countries

the

issue

of

the

benefit

basket

is

more

related

to

the

specification

of

entitlements

of

the

insured

persons

However

it

can

not

be

said

that

either

NHS

or

SHI

countries

generally

define

their

benefits

more

explicitly

than

the

other

In

most

NHS

countries

a

coherent

legislation

contains

a

list

of

the

areas

of

care

to

be

provided

by

the

respective

NHS

including

regional

health

services

as

part

of

the

benefit

basket

of

regions

in

decentralized

NHS

systems

for

example

Italy

and

Spain

Denmark

represents

an

exception

from

this

as

the

legislation

consists

of

separate

acts

concerning

the

categories

of

hospital

primary

and

long-term

care

and

pharmaceuticals

-LSB-

-RSB-

The

level

of

explicitness

varies

considerably

from

country

to

country

The

vaguest

definition

of

a

benefit

basket

may

be

that

of

the

NHS

Foundation

Act

-LRB-

-RRB-

in

England

and

related

posterior

documents

where

the

Secretary

of

State

for

Health

is

legally

required

to

provide

services

to

such

extent

as

he

considers

necessary

to

meet

all

reasonable

requirements

-LSB-

-RSB-

The

responsibility

for

making

available

general

practitioner

dental

ophthalmic

and

pharmaceutical

services

lay

until

with

health

authorities

and

since

then

with

Primary

Care

Trusts

In

contrast

the

framework

of

the

Italian

and

Spanish

benefit

baskets

each

of

which

was

established

in

recently

implemented

legal

documents

is

structured

in

more

detail

-LSB-

-RSB-

Common

to

all

four

however

is

the

differentiation

between

hospital

care

and

primary

care

including

specialist

outpatient

services

as

well

as

preventive

or

health

promotion

services

The

level

of

explicitness

is

not

only

heterogeneous

across

different

countries

but

also

within

the

same

country

For

instance

in

Spain

some

areas

of

health

care

may

be

further

shaped

by

mentioning

specific

services

or

in

some

cases

even

specific

procedures

or

technologies

being

in

or

excluded

from

the

benefit

basket

Thus

the

definition

of

the

benefit

basket

within

NHS

countries

does

not

always

follow

a

systematic

approach

of

going

into

further

detail

It

rather

addresses

shortcomings

perceived

by

decision

makers

of

each

health

care

system

not

necessarily

being

based

on

evidence

Concerning

the

origin

of

more

detailed

benefit

catalogues

some

similarities

are

observed

across

countries

with

similar

organization

of

the

health

care

system

or

with

similar

organizational

demands

-LRB-

i.e.

the

need

to

reimburse

providers

in

free

practice

-RRB-

In

the

two

countries

with

regionalized

NHS

Italy

and

Spain

the

motivation

for

defining

a

detailed

benefit

catalogue

is

to

be

seen

in

the

autonomous

status

of

regions

The

national

benefit

basket

can

be

regarded

as

a

minimum

basket

of

health

services

that

must

be

provided

by

the

regional

health

authorities

Therefore

the

regions

in

both

countries

are

free

to

offer

additional

services

not

included

in

the

national

benefit

basket

Health

baskets

in

SHI

countries

stem

from

two

different

roots

On

the

one

hand

SHI

countries

formulate

the

basket

as

an

entitlement

for

persons

insured

under

the

respective

statutory

health

insurance

schemes

The

main

reason

for

this

lies

in

the

fact

that

SHI

schemes

have

evolved

from

fragmented

voluntary/statutory

health

insurance

schemes

not

covering

the

whole

population

and

only

covering

certain

services

for

example

sickness

benefits

Statutory

health

insurance

in

Germany

as

well

as

in

The

Netherlands

does

still

not

cover

the

whole

population

-LSB-

-RSB-

Therefore

in

SHI

countries

the

health

basket

is

also

used

to

indicate

the

boundaries

between

those

insured

under

the

statutory

health

insurance

and

those

insured

under

other

schemes

The

second

root

are

fee

catalogues

which

were

originally

more

prevalent

in

SHI

than

in

NHS

countries

due

to

the

frequently

used

fee-for-service

reimbursement

system

at

least

in

ambulatory

specialist

care

Another

common

characteristic

of

decision

making

on

health

baskets

in

most

SHI

countries

is

the

role

of

the

self-governing

institutions

Within

a

general

framework

stipulated

by

laws

self-governing

institutions

-LRB-

e.g.

sickness

funds

physician

associations

-RRB-

specify

the

rules

to

explicit

benefit

catalogues

or

remuneration

schemes

with

the

character

of

benefit

catalogues

limiting

the

scope

of

service

provision

As

observed

in

NHS

countries

the

level

of

explicitness

also

varies

considerably

among

SHI

countries

Poland

has

by

far

the

most

explicit

benefit

basket

which

is

even

rooted

in

the

constitution

Different

legal

acts

define

benefit

catalogues

specifying

detailed

procedures

or

even

technologies

being

provided

At

the

other

extreme

Germany

probably

has

the

vaguest

legal

definition

of

the

benefit

basket

among

the

SHI

countries

with

the

Social

Code

Book

as

a

general

framework

For

instance

inpatient

services

in

Germany

are

limited

to

only

a

certain

extent

by

the

diagnosis-related

group

-LRB-

DRG

-RRB-

reimbursement

system

because

they

can

be

provided

unless

they

are

explicitly

excluded

by

directives

-LSB-

-RSB-

There

is

a

trend

in

all

SHI

countries

towards

more

explicit

benefit

baskets

In

The

Netherlands

a

system

of

diagnosis-procedure

combinations

has

been

introduced

in

defining

procedures

provided

in

inpatient

care

and

by

specialists

in

outpatient

care

-LSB-

-RSB-

In

France

a

similar

list

is

currently

being

prepared

while

Germany

and

Hungary

recently

updated

their

outpatient

remuneration

schemes

specifying

certain

procedures

that

are

reimbursed

by

the

statutory

health

insurance

-LSB-

-RSB-

Definition

of

benefit

catalogues

for

curative

services

Benefit

catalogues

for

inpatient

care

As

in

other

sectors

of

the

health

care

system

the

provided

inpatient

services

can

either

be

listed

as

procedures

being

part

of

an

explicit

benefit

catalogue

or

indirectly

determined

by

grouping

systems

that

serve

remuneration

purposes

for

example

DRGs

France

Poland

and

Spain

have

defined

explicit

benefit

catalogues

grouped

according

to

medical

specialties

for

inpatient

services

listing

detailed

procedures

serving

as

positive

lists

-LSB-

-RSB-

While

there

are

clear

decision

criteria

for

the

inclusion

of

benefits

in

the

benefit

catalogue

in

France

and

Spain

no

transparent

criteria

are

applied

in

Poland

In

all

other

countries

DRG

and

other

grouping

systems

serve

as

a

tool

for

estimating

resource

consumption

supporting

budget

assignations

or

providing

the

basis

for

remuneration

In

general

they

classify

a

single

episode

of

care

according

to

main

diagnoses

comorbidities

and

main

surgical

interventions

into

one

of

a

limited

number

of

groups

Thus

each

classified

episode

is

assumed

to

require

more

or

less

homogeneous

resource

consumption

independently

of

whether

exactly

the

same

items

-LRB-

e.g.

drugs

diagnostics

-RRB-

are

used

As

finally

monetary

values

are

attached

to

the

different

groups

the

use

of

drugs

diagnostics

etc.

is

confined

to

the

given

monetary

scope

of

each

group

In

our

study

four

countries

have

introduced

DRG

systems

Italy

-LSB-

-RSB-

Germany

-LSB-

-RSB-

Hungary

-LSB-

-RSB-

and

Denmark

-LSB-

-RSB-

England

and

The

Netherlands

have

DRG-like

grouping

systems

called

respectively

health

care

resource

groups

and

Diagnose

Behandeling

Combinaties

The

main

features

of

the

DRG

and

other

grouping

systems

are

very

similar

-LRB-

Table

-RRB-

-LSB-

-RSB-

In

each

country

the

groups

have

been

developed

from

data

collected

on

resource

consumption

clustering

in

homogeneous

resource

consumption

groups

The

observed

variability

in

the

number

of

classified

groups

in

each

system

may

be

explained

by

the

different

criteria

used

to

classify

them

-LRB-

Table

-RRB-

Another

possible

explanation

is

the

creation

of

additional

groups

in

certain

countries

to

increase

the

scope

for

the

use

of

new

innovative

technologies

-LRB-

devices

procedures

and

even

drugs

theoretically

-RRB-

which

are

considered

to

be

worth

the

promotion

-LRB-

i.e.

because

of

higher

efficacy

-RRB-

This

has

been

the

case

in

Italy

where

the

regional

health

authority

of

Lombardy

added

three

new

DRGs

to

its

system

in

order

to

specifically

consider

the

use

of

drug-eluting

stents

and

to

encourage

its

utilisation

-LSB-

-RSB-

Table

Inpatient

benefit

catalogues

or

substitutesCountryName

of

taxonomy

year

of

introductionApplied

geographical

areaTaxonomy

-LRB-

and

grouping

criteria

-RRB-

Actors

involved

in

decision

makingCriteria

for

in

exclusion

of

benefitsDenmarkDRG

system

-LRB-

Nordic-DRG

-RRB-

MDC

-LRB-

anatomical

etiological

other

-RRB-

with

DRG

special

category

for

chemotherapy

and

radiotherapy

Grouping

criteria

main

diagnosis

procedures

sex

age

cause

of

dischargeLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Need

budgetMinistry

for

the

Interior

and

Health

-LRB-

approval

-RRB-

National

Board

of

Health

-LRB-

DRG

catalogue

-RRB-

County

level

-LRB-

budgeting

hospital

plan

-RRB-

Clinicians

-LRB-

priority

setting

in

hospital

-RRB-

FranceCommon

Classification

of

Medical

Procedures

-LRB-

CCAM

-RRB-

lists

reimbursable

and

excluded

medical

procedures

thus

being

a

positive

and

negative

list

Grouping

criteria

anatomic

classification

medical

specialtiesNational

level

-LRB-

law

general

framework

-RRB-

Effectiveness

safetyMinistry

of

Health

-LRB-

approval

-RRB-

National

Union

of

Health

Insurance

Funds

-LRB-

in

and

exclusion

of

services

-RRB-

High

Health

Authority

-LRB-

advisory

body

on

in

and

exclusion

of

services

-RRB-

GermanyG-DRG

system

-LRB-

based

on

AR-DRG

-RRB-

stepwise

MDC

-LRB-

anatomical

etiological

other

-RRB-

with

DRG

extra

remunerations

for

special

services

-LRB-

in

-RRB-

Grouping

criteria

main

diagnosis

procedures

age

comorbidity

cause

of

dischargeLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Services

can

be

provided

as

long

as

they

are

not

explicitly

excluded

Adequate

expedient

and

cost-effectiveMinistry

of

Health

-LRB-

approval

-RRB-

Federal

Joint

Committee

-LRB-

exclusion

of

benefits

-RRB-

Institute

for

Hospital

Reimbursement

with

assistance

of

the

Committee

of

on

HospitalPayment

-LRB-

DRG

catalogue

-RRB-

Clinicians

-LRB-

priority

setting

in

hospital

-RRB-

HungaryDRG

system

-LRB-

US-DRG

-RRB-

MDC

-LRB-

anatomical

etiological

other

-RRB-

with

DRG

Grouping

criteria

main

diagnosis

procedures

age

comorbidityLegislation

at

the

national

level

-LRB-

law

general

framework

budgeting

-RRB-

Costs

effectivenessMinistry

of

Welfare

Health

division

-LRB-

DRG

catalogue

-RRB-

National

Health

Insurance

FundAdministration

especially

-LRB-

prepares

decisions

-RRB-

Clinicians

-LRB-

priority

setting

in

hospitals

-RRB-

ItalyDRG

system

-LRB-

HCFA

no.

-RRB-

reference

list

with

regional

MDC

-LRB-

anatomical

etiological

other

-RRB-

with

to

DRG

exceptional

DRGs

-LRB-

e.g.

liver

and

bone

marrow

transplantation

-RRB-

Grouping

criteria

main

diagnosis

procedures

age

comorbidity

cause

of

dischargeLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Effectiveness

costsCentral

level

-LRB-

national

DRG

catalogue

-RRB-

Regional

level

-LRB-

redefines

DRG

catalogue

sets

tariffs

-RRB-

Clinicians

-LRB-

priority

setting

in

hospitals

-RRB-

The

NetherlandsDiagnose

Behandeling

Combinaties

-LRB-

DBC

-RRB-

-LRB-

DRG-like

system

-RRB-

Jan.

procedures

regarding

diagnosis

and

therapy

-LRB-

DBCs

-RRB-

are

combined

to

product

groups

DBCs

are

on

three

different

lists

determining

the

status

for

tariff

negotiations

or

excluding

DBCs

from

the

benefit

package

Grouping

criteria

medical

specialty

product

groupLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Costs

effectiveness

Ministry

of

Health

-LRB-

decrees

-RRB-

DBC

Maintenance

Organization

-LRB-

DBC

system

-RRB-

Clinicians

-LRB-

priority

setting

in

hospitals

-RRB-

PolandGovernmental

decrees

and

catalogue

of

benefitsNationalCatalogue

lists

all

services

covered

under

social

health

insurance

scheme

services

are

linked

to

the

respective

regulation/law

Grouping

criteria

area

of

care

-LRB-

e.g.

hospital

care

-RRB-

medical

specialtyLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Ministry

of

Health

-LRB-

regulations

decrees

-RRB-

National

Health

Fund

-LRB-

catalogue

-RRB-

SpainRoyal

Decree

Law

on

cohesion

and

qualtiy

of

the

National

Health

SystemNational

with

regional

differencesServices

are

listed

explicitly

in

decree

In

some

cases

services

are

restricted

to

specific

patient

groups

Grouping

criteria

area

of

care

medical

specialtyLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Safety

efficacy

efficiencyFederal

Government

-LRB-

decree

-RRB-

Inter-territorial

Council

and

Council

of

the

State

-LRB-

inclusion

of

new

benefits

-RRB-

Clinicians

-LRB-

provision

of

services

relating

to

entitlements

defined

by

decree

-RRB-

EnglandHealth

care

resource

group

-LRB-

DRG-like

system

-RRB-

stepwise

April

there

were

only

HRGs

in

use

Grouping

criteria

diagnosis

complexity

procedureLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Costs

budgetMinistry

of

Health

-LRB-

catalogue

-RRB-

Primary

Care

Trusts

-LRB-

negotiate

with

providers

on

quantity

and

tariffs

-RRB-

The

fact

that

specific

procedures

and

technologies

drive

the

development

of

DRG

systems

confirms

our

hypothesis

that

they

serve

as

some

kind

of

benefit

catalogues

Technologies

specifically

mentioned

in

certain

groups

may

not

be

used

if

less

resource

consuming

alternatives

are

available

In

this

way

a

less

specific

DRG

system

may

act

as

a

hidden

negative

list

of

technologies

which

de

facto

are

not

available

for

beneficiaries

of

publicly

financed

care

since

the

monetary

value

assigned

to

certain

groups

does

not

cover

the

actual

resource

consumption

associated

with

its

use

Furthermore

in

most

applied

grouping

systems

certain

groups

-LRB-

e.g.

in

DRG

systems

so-called

surgical

DRGs

-RRB-

are

even

defined

by

specific

procedures

or

specific

technologies

such

as

drug-eluting

stents

These

groups

can

therefore

be

considered

as

a

kind

of

explicitly

defined

benefits

similar

to

a

positive

list

Thus

it

can

be

assumed

that

grouping

systems

are

applied

as

substitutes

for

benefit

catalogues

containing

incentives

to

limit

the

provision

of

benefits

for

those

services

not

being

explicitly

mentioned

Benefit

catalogues

for

outpatient

care

In

the

outpatient

sector

benefit

catalogues

are

again

often

replaced

by

grouping

systems

serving

remuneration

purposes

Although

they

generally

seem

to

be

more

explicit

than

the

inpatient

catalogues

the

explicitness

varies

even

more

than

in

the

inpatient

sector

-LRB-

Table

-RRB-

These

different

degrees

of

explicitness

are

due

mainly

to

the

applied

remuneration

schemes

in

each

country

If

physicians

receive

fixed

budgets

or

capitations

the

benefit

catalogue

-LRB-

i.e.

the

procedures

that

they

can

offer

-RRB-

is

indirectly

restricted

by

the

amount

of

money

allocated

to

them

Therefore

in

these

countries

the

benefit

package

for

outpatient

care

is

regulated

rather

implicitly

through

decrees

issued

by

national

or

regional

health

authorities

describing

the

obligation

of

physicians

to

provide

those

benefits

that

are

considered

necessary

Examples

of

these

kind

of

implicit

benefit

catalogues

are

the

Health

Insurance

Treatment

and

Services

Decree

for

care

provided

by

general

practitioners

in

The

Netherlands

and

the

General

Medical

Services

Contract

in

England

These

decrees

do

not

mention

specific

procedures

although

in

the

case

of

The

Netherlands

the

general

practitioners

association

the

Landelijke

Huisartsen

Vereniging

defined

a

basic

general

practitioner

benefit

package

in

the

-LSB-

-RSB-

Table

Outpatient

benefit

catalogues

or

substitutesCountryName

of

taxonomyApplied

geographical

areaTaxonomy

-LRB-

and

grouping

criteria

-RRB-

Actors

involved

in

decision

makingCriteria

for

in

exclusion

of

benefitsBenefits

procedures

explicitly

excludedDenmarkHealth

Care

Reimbursement

Scheme

Fee

ScheduleNationalServices

are

grouped

according

to

medical

specialty

and

for

GPs

additionally

in

basic

supplementary

laboratory

and

miscellaneous

services

Each

service

has

an

item

number

It

is

referred

to

the

respective

legislation

decree

specifying

the

benefit

certain

goods

procedures

or

in

rare

cases

indicationsNational

level

-LRB-

law

general

framework

-RRB-

NeedAlternative

careMinistry

for

the

Interior

and

Health

-LRB-

approval

-RRB-

Counties

-LRB-

budgeting

health

plan

-RRB-

Health

care

Reimbursement

Negotiating

Committee

and

health

professional

associations

-LRB-

negotiate

catalogue

-RRB-

FranceCommon

Classification

of

Medical

Procedures

-LRB-

CCAM

-RRB-

NationalLists

all

medical

procedures

reimbursable

and

excluded

Grouping

criteria

anatomic

classification

medical

specialtiesNational

level

-LRB-

law

general

framework

-RRB-

Effectiveness

safetySpa

treatments

cosmetic

surgeryMinistry

of

Health

-LRB-

approval

-RRB-

National

Union

of

Health

Insurance

Funds

-LRB-

in

and

exclusion

of

services

-RRB-

High

Health

Authority

-LRB-

advisory

body

on

in

and

exclusion

of

services

-RRB-

GermanySHI-EBM

SHI-BEMA

SHI-BEL-IINationalServices

are

grouped

according

to

the

medical

specialty

allowed

to

provide

the

service

Each

service

is

assigned

a

numeric

code

in

accordance

with

the

subjection

of

the

catalogueNational

level

-LRB-

law

general

framework

-RRB-

Diagnostic

and

therapeutic

expedience

medical

necessity

and

cost-effectivenessOrthopedic

services

after

the

age

of

yearsFederal

Joint

Committee

-LRB-

approval

of

new

benefits

-RRB-

Valuation

Committee

-LRB-

negotiates

EBM

-RRB-

Dental

Valuation

Committee

-LRB-

negotiates

BEMA

BEL-II

-RRB-

HungaryGovernmental

decrees

and

reimbursement

cataloguesNationalSimilar

services

are

listed

in

groups

Governmental

decrees

relate

to

different

areas

of

care

-LRB-

e.g.

dental

care

specialist

services

-RRB-

Items

in

reimbursement

catalogues

are

listed

with

the

respective

ICPM

code

and

a

point

valueLegislation

at

the

national

level

-LRB-

law

general

framework

budgeting

-RRB-

Costs

effectiveness

Ministry

of

Welfare

-LRB-

decrees

approval

-RRB-

National

Health

Insurance

FundAdministration

especially

-LRB-

prepares

decisions

-RRB-

Payment

Codes

Updating

Committee

-LRB-

reimbursement

catalogues

-RRB-

ItalyNational

contract

for

primary

care

decree

on

specialist

outpatient

servicesNational

benefit

package

regions

include

additional

servicesContract

for

primary

care

describes

obligations

of

GP

Individual

services

are

not

further

itemized

Decree

on

specialist

outpatient

services

lists

services

in

three

sections

available

availability

restricted

to

specific

indications

excludedGovernment

at

national

level

-LRB-

sets

decree

negotiates

contract

-RRB-

Effectiveness

costsNonconventional

treatments

-LRB-

e.g.

acupuncture

phytotherapy

-RRB-

vaccination

for

traveling

purposesRepresentatives

of

GPs

-LRB-

negotiate

contract

-RRB-

Ministry

of

Health

-LRB-

transfers

contract

into

law

-RRB-

Government

at

regional

level

-LRB-

negotiates

additional

contracts

-RRB-

The

NetherlandsHealth

Insurance

-LRB-

Treatment

and

Services

-RRB-

Decree

Diagnose

Behandeling

Combinaties

-LRB-

DBC

DRG-like

system

-RRB-

Jan.

services

are

regulated

in

generic

terms

only

by

decree

DBC

catalogue

-LRB-

DBCs

-RRB-

combine

information

on

diagnosis

and

treatment

for

medical

specialists

DBCs

are

on

three

different

lists

determining

the

status

for

tariff

negotiations

or

excluding

DBCs

from

the

benefit

package

Grouping

criteria

medical

specialty

product

groupLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Costs

effectiveness

Ministry

of

Health

-LRB-

decrees

-RRB-

DBC-Maintenance

Organization

-LRB-

DBC-System

-RRB-

Physicians

-LRB-

priority

setting

-RRB-

PolandGovernmental

decrees

and

catalogue

of

benefitsNationalCatalogue

lists

all

services

covered

under

social

health

insurance

scheme

Services

are

linked

to

the

respective

regulation/law

Grouping

criteria

area

of

care

medical

specialtyLegislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Vaccination

acupuncture

unless

part

of

chronic

pain

managementMinistry

of

Health

-LRB-

regulations

-RRB-

National

Health

Fund

-LRB-

catalogue

-RRB-

SpainRoyal

Decree

with

regional

differencesServices

are

listed

explicitly

in

decree

In

some

cases

services

are

restricted

to

specific

patient

groups

Decree

lists

services

in

areas

of

care

-LRB-

e.g.

primary

care

specialized

care

pharmaceutical

care

-RRB-

which

are

further

subdivided.Legislation

at

the

national

level

-LRB-

law

general

framework

-RRB-

Safety

efficacy

efficiencyCosmetic

surgery

-LRB-

transplantation

of

hair

and

nails

-RRB-

sex

changeFederal

Government

-LRB-

decree

-RRB-

Inter-territorial

Council

and

Council

of

the

State

-LRB-

inclusion

of

new

benefits

-RRB-

Clinicians

-LRB-

provision

of

services

relating

to

entitlements

defined

by

decree

-RRB-

EnglandNational

Service

Framework

NationalHealth

Resource

Groups

are

linked

to

procedures

Currently

only

HRGs

are

in

use

Guidelines

recommend

services

to

be

used

on

certain

indicationsLegislator

at

national

level

-LRB-

law

general

framework

-RRB-

Need

effectivenessCosmetic

dental

treatmentsGeneral

Medical

Services

ContractNational

with

possible

variation

at

PCT-levelNHS

Confederation

and

General

Practitioners

Committee

-LRB-

negotiate

contract

-RRB-

Need

costsClinical

GuidelinesNationalPrimary

Care

Trusts

-LRB-

PCT

-RRB-

-LRB-

negotiate

additional

contracts

-RRB-

Need

costs

effectivenessNICE

-LRB-

clinical

guidelines

-RRB-

In

contrast

the

countries

remunerating

providers

on

the

basis

of

fee-for-service

schemes

need

detailed

lists

of

procedures

or

at

least

of

service

complexes

-LRB-

aggregated

multiple

procedures

-RRB-

to

be

able

to

negotiate

on

price

and/or

volumes

These

lists

can

therefore

be

interpreted

as

substitutes

for

benefit

catalogues

as

physicians

are

usually

reimbursed

only

for

those

items

listed

The

explicitness

of

these

lists

differs

largely

Some

countries

issue

detailed

lists

of

all

procedures

to

be

performed

by

physicians

-LRB-

e.g.

the

Common

Classification

of

Medical

Procedures

in

France

-LSB-

-RSB-

-RRB-

while

other

countries

list

service

complexes

making

physicians

responsible

for

the

priority

setting

within

such

a

service

complex

-LRB-

e.g.

SHI-EBM

or

SHI-BEMA

in

Germany

-LSB-

-RSB-

and

the

Health

Care

Reimbursement

Scheme

Fee

Schedule

in

Denmark

-LSB-

-RSB-

-RRB-

Interestingly

taxonomy

and

structure

are

very

similar

in

all

countries

For

example

in

Denmark

France

Germany

Hungary

and

The

Netherlands

services

are

grouped

according

to

medical

specialty

Certain

outpatient

benefits

are

also

linked

to

indications

or

special

patient

groups

in

Poland

and

Spain

-LSB-

-RSB-

The

high

degree

of

explicitness

regarding

the

definition

of

the

benefit

package

is

also

underlined

by

the

diverse

lists

of

excluded

services

common

in

all

countries

Exclusion

practices

vary

from

issuing

negative

lists

-LRB-

e.g.

Spain

Poland

-RRB-

and

directives

of

self-governmental

institutions

with

the

character

of

negative

lists

-LRB-

e.g.

Germany

-RRB-

to

excluded

services

within

the

framework

of

the

national

law

-LRB-

e.g.

England

-RRB-

However

most

countries

exclude

similar

benefits

such

as

cosmetic

surgery

-LRB-

if

not

closely

linked

to

certain

treatments

-RRB-

vaccination

for

nonstandard

diseases

-LRB-

e.g.

for

traveling

purposes

-RRB-

and

certain

nonconventional

treatments

-LRB-

e.g.

acupuncture

-RRB-

Benefits

of

dental

care

are

either

restricted

to

specific

treatment

methods

or

age

groups

-LRB-

e.g.

Germany

-RRB-

Discussion

The

analysis

of

benefits

defined

in

the

countries

under

study

reveals

that

there

is

a

clear

trend

towards

a

more

explicit

definition

of

benefit

baskets

and

their

benefit

catalogues

Those

countries

which

recently

introduced

new

health

care

legislations

such

as

Italy

Poland

and

Spain

have

more

explicitly

defined

benefit

catalogues

Other

countries

with

older

health

care

legislations

for

example

the

UK

's

English-NHS

Foundation

Act

-LRB-

-RRB-

and

Germany

's

Social

Code

Book

-LRB-

-RRB-

have

rather

implicitly

defined

benefit

catalogues

but

increasingly

work

with

negative

lists

based

on

evidence

provided

by

independent

institutions

such

as

the

Englisch

NICE

and

the

German

Institute

for

Quality

and

Efficiency

-LRB-

IQWiG

-RRB-

-LSB-

-RSB-

Apart

from

negative

lists

remuneration

schemes

for

example

DRGs

and

procedures

catalogues

used

for

grouping

are

more

and

more

used

as

benefit

catalogues

These

developments

indicate

that

all

included

countries

move

towards

a

more

explicit

definition

of

benefit

catalogues

Explicitly

defined

benefit

catalogues

however

require

clear

and

transparent

decision

criteria

for

the

in

or

exclusion

of

benefits

Most

countries

officially

state

that

-LRB-

cost

-RRB-

effectiveness

is

an

important

decision

criteria

However

further

inquiries

often

demonstrate

that

there

is

no

rational

process

of

reviewing

the

available

evidence

on

specific

procedures

or

technologies

-LSB-

-RSB-

In

reality

the

decision-making

process

is

rather

guided

by

lobbying

activities

of

certain

actors

in

the

system

Especially

those

countries

with

very

explicit

benefit

baskets

e.g.

Poland

often

lack

transparency

of

decision

criteria

-LSB-

-RSB-

In

contrast

to

this

countries

with

rather

implicitly

defined

benefit

baskets

such

as

England

and

Germany

define

very

transparent

criteria

for

benefit

exclusion

although

lists

with

excluded

services

are

minor

compared

to

explicitly

oriented

countries

In

addition

criteria

such

as

cost-effectiveness

and

even

effectiveness

are

often

restricted

to

one

or

few

sectors

of

the

health

care

system

for

example

pharmaceuticals

or

medical

devices

and

are

not

generalizable

to

all

products

or

services

-LSB-

-RSB-

In

general

the

transparency

of

decision

criteria

must

be

improved

in

all

countries

in

order

to

achieve

accountability

for

all

actors

of

the

health

care

systems

as

well

as

consumers

This

contribution

as

well

as

the

overall

EU

Health

BASKET

project

provides

useful

information

for

health

care

providers

and

industrial

companies

willing

to

invest

in

EU

countries

but

do

not

have

the

necessary

information

on

benefit

baskets

and

their

underlying

decision-making

processes

However

to

improve

the

environment

for

investments

and

to

provide

confidence

for

foreign

investors

public

documents

should

be

regularly

prepared

by

each

country

giving

a

transparent

overview

of

the

health

baskets

and

the

decision-making

criteria

The

information

provided

will

be

beneficial

especially

to

decision

makers

at

all

levels

of

health

policy

enabling

them

to

compare

different

approaches

of

benefit

definitions

in

order

to

develop

their

own

position

The

need

for

benchmarking

will

grow

in

line

with

the

further

development

of

cross

boarder

flows

and

the

establishment

of

coherent

benchmark

criteria

as

part

of

the

Open

Method

of

Coordination

initiated

by

EU

policy

makers

-LSB-

-RSB-

However

the

project

results

also

demonstrate

that

a

harmonization

of

health

baskets

of

EU

countries

which

in

the

view

of

certain

decision

makers

could

be

the

final

stage

after

identifying

best

practice

in

benchmarking

is

not

realistic

in

the

short

or

medium

term

since

the

definitions

of

benefit

baskets

vary

substantially

Additionally

as

shown

in

the

cases

of

Italy

and

Spain

especially

in

NHS

countries

there

is

rather

a

trend

towards

more

decentralization

of

decision

making

on

benefits

delegating

to

regions

the

autonomy

to

offer

certain

benefits

in

addition

to

nationally

defined

health

baskets

-LSB-

-RSB-

On

the

other

hand

this

could

also

mean

that

in

future

a

minimum

basket

of

health

benefits

may

be

defined

by

all

countries

on

the

national

level

which

could

be

harmonized

on

the

EU

level

at

a

certain

stage

due

to

systems

competition

as

a

result

of

increased

cross-border

flows

Beyond

this

minimum

basket

there

could

be

regional

variations

reflecting

differences

in

wealth

and

of

preferences

O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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