Requirements To Be Met by Disease Management Programmes for Type 2 Diabetes Mellitus

Transcription

1 Requirements To Be Met by Disease Management Programmes for Type 2 Diabetes Mellitus Annex 1 (to Sects. 28b to 28g) 1. Treatment according to the current state of medical science taking account of evidence-based guidelines or in accordance with the best available evidence as well as giving due consideration to the care provision sector concerned (Sect. 137f Para. 2 Sent. 2 No. 1 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]) 1.1 Definition of type 2 diabetes mellitus Type 2 diabetes mellitus is defined as such form of diabetes as is caused by relative insulin deficiency because of an insulin secretion defect and usually accompanied by insulin resistance 1 ). 1.2 Diagnosis (initial diagnosis) The diagnosis of diabetes mellitus is considered established if the following criteria are met: - evidence of typical symptoms of diabetes mellitus (e.g. polyuria, polydipsia, loss of weight that cannot be explained otherwise) and - fasting glucose (preferably in plasma) 7.0 mmol/l ( 126 mg/dl) or non-fasting plasma glucose 11.1 mmol/l ( 200 mg/dl). In the absence of diabetic symptoms: The diagnosis of diabetes mellitus is established irrespective of age and gender if increased blood glucose levels are measured several times on at least two different days: - evidence of fasting plasma glucose 7.0 mmol/l ( 126 mg/dl) (at least two times), - evidence of non-fasting plasma glucose 11.1 mmol/l ( 200 mg/dl) (at least two times) or - evidence of plasma glucose 11.1 mmol/l ( 200 mg/dl) 2 hours after oral glucose load (75 g of glucose). The venous and capillary whole-blood levels can be seen from the following table: Interpretation of a fasting blood-glucose level and a 2-hour blood-glucose level after oral glucose tolerance test (75 g OGTT) Plasma glucose Whole-blood glucose venous capillary venous capillary mmol/l mg/dl mmol/l mg/dl mmol/l mg/dl mmol/l mg/dl Fasting hours after OGTT The definition is based on the WHO definition (World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. Report of a WHO Consultation. Part 1: Diagnosis and Classification of Diabetes Mellitus. Geneva; 59p, WHO/NCD/NCS/99.2).

2 In the case of a suspicious clinical picture and contradictory measurement readings, diagnosis can be carried out via an oral glucose tolerance test. Any measurements for enrolment purposes must not be taken during a period in which the patient is suffering from acute disorders (e.g. infections) or during a period in which the patient is taking medicines that could falsify measurement readings (e.g. glucocorticoids) unless a chronic disorder necessitates the taking of such medicines in the long term. Whether a patient has type 1 or type 2 diabetes mellitus can be ascertained via his or her case history and clinical picture. For details of further enrolment criteria in respect of Disease Management Programmes please refer to Item 3. Care providers should check whether the patient would benefit from enrolment in view of the therapy objectives mentioned under Item and be able to assist with their realisation. 1.3 Type 2 diabetes mellitus therapy Therapy objectives The therapy serves to enhance life expectancy as well as maintain or improve the quality of life affected by diabetes mellitus, whereby the aim should be to set and meet individual objectives based on, for instance, the given patient s age and associated disorders: a) avoidance of diabetic symptoms (e.g. polyuria, polydipsia, weariness) including avoidance of neuropathic symptoms, avoidance of therapeutic side effects (particularly severe or recurrent hypoglycaemia) as well as severe hyperglycaemic metabolic imbalances, b) reduction of the increased risk of cardiac, cerebrovascular and other macroangiopathic morbidity and mortality, c) avoidance of microvascular secondary complications (particularly retinopathy with severely impaired vision or blindness as well as renal insufficiency requiring renal replacement therapy), d) avoidance of the diabetic foot syndrome with neuropathic, angiopathic and/or osteoarthropathic lesions and of amputations Differentiated therapy planning Based on general therapy objectives and taking account of individual risks in terms of the given patient s age and any secondary damage and/or associated disorders, individual therapy objectives should be set together with the patient and differentiated therapy planning undertaken. The individual therapy objectives concerned should take into account the therapy objectives mentioned under Item The care providers should examine whether the patient would benefit from a specific form of intervention in view of the therapy objectives mentioned under Item The execution of diagnostic and therapeutic measures should be coordinated with the patient following detailed clarification in terms of the benefits and risks involved. To the extent that measures other than those mentioned in this Annex are to be prescribed within the framework of individual therapy planning, the patient must be informed as to whether any evidence is available concerning the effectiveness of the given measures in respect of risk reduction of clinical endpoints.

3 1.4 Basic therapy Dietary advice Patients with type 2 diabetes mellitus should receive access to qualified, disease-specific dietary advice (above all with a view to weight reduction) within the framework of a Disease Management Programme (see Item 4.2) No smoking Within the framework of the Disease Management Programme, the aim is to inform patients about the specific risks of smoking for diabetics, with particular regard to macroangiopathic and microangiopathic complications, connected with the urgent recommendation to quit smoking Physical training The doctor should examine on at least one occasion per year whether the given patient would benefit from weight reduction and enhanced physical training. Any possible intervention must focus on motivating the patient concerned to take responsibility for sustainably integrating the desired amount of exercise into his or her life style Self-check of metabolic state Within the framework of the Disease Management Programme, the intention is for patients to be familiarised with the execution of self-checks of their metabolic state in line with their individual therapy plans as well as with the interpretation of the results. 1.5 Blood-glucose reduction therapy In order to achieve individual therapy objectives, the aim initially is to exhaust all non-medicinerelated measures as far as possible. Taking account of any counterindications and patient preferences, the primary aim is to use such medicines for blood-glucose reduction purposes as have been proven safe and effective in respect of achieving the therapy objectives mentioned under Item in prospective, randomised, controlled long-term trials. The substances concerned, used as primary monotherapy to reduce blood glucose levels, are the following: glibenclamide (for non-overweight patients), metformin (for overweight patients), human or porcine insulin. To the extent that substances other than those mentioned above are to be prescribed within the framework of individual therapy planning (e.g. insulin analogues, other oral antidiabetics), the given patient is to be informed that there is currently no sufficient evidence available to prove the safety of the medicine concerned in long-term usage or risk reduction of clinical endpoints. Moreover, the patient concerned is to be informed as to whether any data is available concerning the effectiveness, controllability and compatibility of the given substance.

4 1.6 Treatment of hyperglycaemic and hypoglycaemic metabolic imbalances In the case of hyperglycaemic metabolic imbalances, particularly when typical symptoms (e.g. loss of weight, thirst, polyuria, weariness, fatigue) are shown, the aim should be to improve the blood glucose level. As far as patients are concerned, in whose case absence of symptoms is the primary agreed therapy objective, the extent of blood glucose reduction should be set individually in order to avoid, for instance, hypoglycaemia and the serious consequences thereof. The occurrence of symptomatic hypoglycaemia necessitates prompt clarification of the causes, reexamination of therapy objectives and, if required, therapy adjustment once emergency therapeutic activities have been completed. 1.7 Associated and secondary disorders in respect of type 2 diabetes mellitus Macroangiopathy Macroangiopathy, especially in the form of coronary heart disease, is the main problem confronting type 2 diabetics. By lowering the increased blood pressure level in type 2 diabetes mellitus patients, cardiovascular and cerebrovascular morbidity and mortality can be reduced within a few years. Prior to therapy initiation, quantified individual risk assessment should be carried out. The prime aim with regard to influencing associated and secondary macroangiopathic disorders should be to carry out such interventions as have a proven positive impact on mortality and morbidity, in line with that formulated in the therapy objectives. The following measures are the main options available for preventing secondary macroangiopathic disorders: antihypertensive therapy (for primary and secondary prevention), administration of statins (to high-risk patients and for secondary prevention), inhibitors of platelet aggregation (for secondary prevention only) Antihypertensive therapy Arterial hypertonia in connection with type 2 diabetes mellitus: definition and establishment of diagnosis If there is no record of hypertonia, a diagnosis can be made as follows: A patient is suffering from hypertonia if blood pressure levels of 140 mmhg (systolic) and/or 90 mmhg (diastolic) are measured on at least two random occasions on two different days. This definition applies to manual auscultatory measurements made by trained medical personnel regardless of the patient s age or any given associated disorders. Blood pressure measurements are to be carried out in a methodologically standard manner in accordance with national recommendations. Secondary hypertonia Any indication of symptoms of secondary hypertonia requires clarification. The doctor should examine whether the patient need be referred to a doctor specialising in hypertonia diagnostics.

5 Therapy objectives The aim of antihypertensive therapy is to achieve the therapy objectives mentioned under Item (above all those under the letters b and c), to which end blood pressure levels should be reduced to under 140 mmhg (systolic) and under 90 mmhg (diastolic). Basic therapy When selecting the measures mentioned under Item 1.4, special consideration should be given to the possible existence of arterial hypertonia in the patient concerned. Hypertonia management and training programme Any patient with type 2 diabetes mellitus and arterial hypertonia should be given access to a structured, evaluated and publicised Training and Disease Management Programme. In particular, such training courses should be offered as have been evaluated as being adequate for the patients concerned in terms of clinical endpoints. Medicinal measures for treating hypertonia Taking account of any counterindications and patient preferences, the primary aim is to use such medicines for blood-pressure reduction purposes as have been proven safe and effective in respect of achieving the therapy objectives mentioned under Item (above all those under the letters b and c) in prospective, randomised, controlled long-term trials. The substance groups concerned, used as monotherapy or combination therapy, are the following: diuretics, 1-receptor-selective beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors). The benefits and safety of the following substances of these substance groups have been proven within the framework of prospective, randomised long-term trials: Diuretics with normal renal function: hydrochlorothiazide or chlorthalidone, combined with potassiumsparing diuretics (amiloride, triamterene) if necessary, with restricted renal function: loop diuretics (furosemide); 1-receptor-selective beta-blockers: metoprolol, atenolol, bisoprolol; angiotensin-converting enzyme inhibitors (ACE inhibitors): captopril, enalapril, ramipril. To the extent that substances or substance groups other than those mentioned in this Annex are to be prescribed within the framework of individual therapy planning, the given patient is to be informed as to whether any evidence is available concerning the effectiveness of these substances or substance groups in respect of risk reduction of clinical endpoints.

6 Statin therapy As regards type 2 diabetes mellitus patients who have an increased risk of macroangiopathic complications or suffer from coronary heart disease, the use of lipid-modifying pharmacotherapy should be taken into consideration. The aim is to use such substance groups as have been proven safe and effective in respect of achieving the therapy objectives mentioned under Item in prospective, randomised, controlled long-term trials. Used as monotherapy, this applies to the HMG-CoA reductase inhibitors group (statins) and above all to the following substances of this substance group: pravastatin, simvastatin, atorvastatin Inhibitors of platelet aggregation Inhibitors of platelet aggregation, especially acetylsalicylic acid, should be administered to all patients with macroangiopathic disorders (e.g. cardiovascular and cerebrovascular disorders) taking into consideration any counterindications and/or intolerances Microvascular complications General measures As far as patients with the therapy objective of avoiding secondary microvascular disorders (especially diabetic retinopathy and nephropathy) are concerned, the reduction of blood glucose levels to within a near-normal range is necessary over a period of many years. Already existing microvascular complications may result in secondary damage, above all in impaired vision/blindness and/or renal insufficiency/dialysis requirement. To inhibit progression, it is of key importance to not only lower blood glucose to within a near-normal range, but also to bring down blood pressure levels to within a normal range (systolic pressure below 140 mmhg and diastolic pressure below 90 mmhg). Quantified, individual risk assessment in accordance with Item should be carried out prior to therapy initiation Type 2 diabetic nephropathy Patients with type 2 diabetes mellitus and a longstanding hyperglycaemic disorder are subject to a varyingly high risk of developing diabetes-specific nephropathy depending on their age and how long they have suffered from diabetes. Hyperglycaemia is seldom the sole cause of nephropathy in the first 15 years of diabetes; the risk of contracting nephropathy increases significantly after this time. In the case of patients with type 2 diabetes mellitus, inadequately treated hypertonia plays a key role in the development and progression of kidney damage. Patients with diabetes and progressive renal dysfunction (irrespective of the cause) require specialised treatment (see Item 1.8.2). The doctor has to check, based on a patient s individual risk profile (especially duration of diabetes, age, retinopathy, other associated disorders), whether regular determination of urine protein excretion may be beneficial to the patient concerned.

7 To exclude diabetic nephropathy, evidence of a normal urinary albumin excretion rate or normal urinary albumin concentration in the first morning urine is sufficient. Once a year, renal function must be checked in type 2 diabetes mellitus patients, primarily by calculating the glomerular filtration rate (GFR) on the basis of the serum creatinine level Diabetic retinopathy Diabetics may contract diabetes-associated eye complications (e.g. diabetic retinopathy and maculopathy) in the course of their disease. To early detect such complications, all insured persons enrolled in a Disease Management Programme must undergo ophthalmologic retinal examination (with mydriasis) or retinography (fundus photography) at least once a year. If diabetes-associated eye complications have been diagnosed, such interventions are necessary as have been proven to have a beneficial impact in terms of preventing blindness. These include blood glucose and blood pressure control to reach and maintain near-normal levels as well as early and adequate laser treatment if necessary Diabetic neuropathy As far as the treatment of diabetic neuropathy is concerned, such measures should always be taken as result in an optimisation of metabolic levels. In the case of neuropathic disorders with disturbing symptoms (above all painful polyneuropathy), the employment of additional medicinal measures is beneficial. Taking account of any counterindications and patient preferences, the primary aim is to use such medicines for treatment of symptomatic painful neuropathy as have been proven safe and effective in prospective, randomised, controlled trials. The substances concerned are in particular the following: amitriptyline and carbamazepine. If there are indications of autonomous diabetic neuropathy (e.g. cardiac autonomous neuropathy, stomach or bladder emptying disorders), specialised further diagnostics and therapy must be taken into consideration Diabetic foot syndrome Patients with type 2 diabetes mellitus, especially those with peripheral neuropathy and/or peripheral arterial occlusive disease, risk developing a diabetic foot syndrome with the enhanced danger of amputation. All patients should undergo a foot examination including neuropathy and pulse status checks at least once a year. In the case of patients with enhanced risk levels, the examination including a shoewear check should occur on a quarterly basis. In the case of any indication of a diabetic foot syndrome (with epithelial lesion, suspected or apparent soft-tissue or bone infection or suspected osteoarthropathy), additional treatment is necessary at a facility specialising in the treatment of the diabetic foot syndrome in accordance with the referral regulations set out under Item Following successful completion of the treatment of a lesion in connection with a diabetic foot syndrome, the doctor should check that the patient is regularly examined at a facility specialising in the treatment of the diabetic foot syndrome. Documentation is to be made according to the Wagner/Armstrong classification.

8 1.7.3 Psychological, psychosomatic and psychosocial imbalance On account of the complex interaction between somatic, psychological and social factors affecting patients with type 2 diabetes mellitus, the doctor treating the patient should check to what extent the patient concerned would benefit from psychotherapeutic, psychiatric and/or behavioural therapeutic measures. In the case of a psychological imbalance serious enough to be considered a disorder, the treatment should be supplied by a qualified care provider. In view of the frequent and significant nature of comorbidity in patients with type 2 diabetes melitus, depression should be given special consideration. 1.8 Cooperation between the various care provision sectors The treatment of patients with type 2 diabetes mellitus necessitates cooperation between all the sectors (outpatient, inpatient) and facilities concerned. Appropriately qualified treatment must be guaranteed along the entire care provision chain Coordinating doctor The long-term treatment of a given patient and the associated documentation work required under the Disease Management Programme must be carried out by the patient s family doctor (general practitioner) within the scope of his or her duties set out and described in Sect. 73 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]. In exceptional cases, a patient with type 2 diabetes mellitus can choose to have the long-term treatment, documentation work and coordination of further activities within the framework of the Disease Management Programme carried out by a doctor specialising in diabetes and participating in the provision of specialised medical care or by a facility specialising in diabetes that is licensed or authorised to provide the contractually agreed medical care or is participating in the provision of outpatient medical care in accordance with Sect. 116b of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]. This applies above all in cases where the patient concerned has already been treated by the given doctor or facility on a long-term basis prior to enrolment in the Disease Management Programme or where care provision in this form is considered necessary for medical reasons. The referral regulations set out under Item require due consideration on the part of the doctor or facility chosen if their specific qualifications are insufficient for treating the patients for the referral reasons mentioned therein Referral by the coordinating doctor to a specialist doctor or facility In the event that the following symptoms are identified, the given patient must be referred to an appropriately qualified specialist or facility and/or to a doctor or facility specialising in the treatment of diabetes: for ophthalmologic examination: at least once a year to exclude diabetic eye complications in patients with a diagnosis of type 2 diabetes mellitus, in the case of impaired renal function with a GFR of less than 40 ml/min or in the case of significant progression of impaired renal function (yearly decrease of GFR by more than 5 ml/min) to a doctor or facility specialising in nephrology, in the case of Wagner stage 2 to 5 and/or Armstrong class C or D foot lesions to a facility specialising in the treatment of the diabetic foot syndrome, in the case of a planned or existing pregnancy to a doctor or facility specialising in diabetes.

9 In the event that the following symptoms are identified, the given patient should be referred to an appropriately qualified specialist or facility and/or to a doctor or facility specialising in the treatment of diabetes: in the case of new microvascular complications (nephropathy, retinopathy) or neuropathy, to a doctor or facility specialising in diabetes, in the case of diabetic foot lesions, to a facility specialising in the treatment of the diabetic foot syndrome, if a systolic blood pressure level < 140 mmhg and a diastolic level < 90 mmhg is not reached within a period of six months at maximum, to a doctor or facility specialising in the treatment of hypertonia, if the target HbA1c level set individually on the basis of the given therapy objective is not reached within a period of six months at maximum, to a doctor or facility specialising in diabetes. In all other cases the doctor should decide, according to his or her best judgment, whether a referral is necessary Admission to hospital for inpatient treatment The following are the main indications requiring admission to a suitable hospital for inpatient treatment: emergencies (to any hospital), alarming metabolic disorders, special severe metabolic imbalances (e.g. frequent nocturnal hypoglycaemia, hypoglycaemic disorders of perception), suspected diabetic foot infection of neuropathic or angiopathic origin or acute neuroosteopathic foot complications, for additional treatment of associated or secondary disorders in respect of type 2 diabetes mellitus if necessary. In case of non-compliance with the target HbA1c level set individually on the basis of the given therapy objective after 12 months treatment as an outpatient, the doctor should examine whether the patient concerned would benefit from diagnostic and therapy services provided by a hospital specialising in the treatment of diabetes on an inpatient basis. In all other cases the doctor or facility should decide, according to their best judgment, whether admission to hospital is necessary Prescription of rehabilitation services Within the framework of the Disease Management Programme, the doctor should examine whether a given patient with type 2 diabetes mellitus would benefit from rehabilitation services, particularly in cases where complications and/or associated disorders have been identified. The provision of rehabilitation services should be given particular consideration in cases where they would promote the given patient s ability to work, autonomy and equal participation in life in society and in cases where disadvantages due to type 2 diabetes mellitus and/or associated and secondary disorders would be avoided or countered.

10 2. Quality assurance measures (Sect. 137f Para. 2 Sent. 2 No. 2 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]) 1 Plausible and relevant objectives are to be agreed and documented as the basis of quality assurance activities. 2 They should incorporate, above all, the following areas: compliance with the requirements set out in Sect. 137f Para. 2 Sent. 2 No. 1 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch] (including therapy recommendations), compliance with a quality-assured and economically viable pharmacotherapy, compliance with the cooperation regulations of the care provision sectors in accordance with Item 1.8, compliance with the structural quality requirements to be agreed in contracts, completeness, quality and availability of the documentation in accordance with Annexes 2a and 2b, active participation of insured party. 3 The contracting parties must prove vis-à-vis the German Federal Insurance Office which measures they have taken to meet the above-mentioned objectives and/or implement the documentation of quality indicators. 4 The Federal Joint Committee is expected to recommend further core quality assurance objectives to the German Ministry of Health and Social Security as a constituent part of its annual recommendations in respect of updating requirements. 5 Within the framework of Disease Management Programmes, such measures are to be taken as support the achievement of the agreed objectives. 6 The application of the measures concerned can be restricted to such groups of patients and care providers to be specified in the given Disease Management Programme as can be expected to offer sufficient improvement potential. 7 They include above all: measures with recall and feedback functions (e.g. reminder systems) for both insured parties and care providers, structured feedback on the basis of documentation data for care providers with the option of regular self-checks; the regular organisation of quality circles is a possible feedback method for participating care providers, measures promoting the insured person s active participation and own initiative, assurance of the systematic, up-to-date informing of care providers and enrolled insured parties. 8 Measures with regard to the care providers are to be appropriately agreed. 9 Moreover, within the framework of the programmes concerned, structured methods for the specific counselling of insured persons by health funds or third parties health funds appoint for the purpose are to be implemented, the ongoing documentation of which includes any indications of the inadequate support of the disease management process by the insured person concerned. 10 Within the framework of Disease Management Programmes, requirements in respect of the evaluation of the data needed for quality assurance activities are to be stipulated. 11 To this end, both the documentation data kept by the health funds in accordance with Annexes 2a and 2b as well as the health funds service provision data are to be incorporated. 12 Appropriate risk adjustment is to be assured for result interpretation purposes.

11 13 Within the framework of Disease Management Programmes, effective sanctions should be put in place for cases where the partners to the contracts agreed for the purpose of executing Disease Management Programmes do not comply with the programme requirements. 14 Evidence of the quality assurance measures implemented is to be provided to the relevant monitoring authority; the quality assurance measures implemented are to be made public on a regular basis. 15 The aim is to develop a common quality assurance system within the framework of Disease Management Programmes in order to implement cross-sector quality assurance procedures. 16 The parties responsible are to be involved in this on an equal basis. 17 Until such time as a cross-sector quality assurance system is introduced, the existing separate responsibilities and competencies will continue to apply in the case of Disease Management Programmes too. 3. Participation requirements and duration of participation of insured persons (Sect. 137f Para. 2 Sent. 2 No. 3 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]) The doctor treating the given patient should check whether the patient concerned would benefit from enrolment in respect of the therapy objectives mentioned under Item and would be able to participate actively in their realisation. 3.1 General participation requirements 1 The requirements for enrolment of insured persons are written confirmation of the established diagnosis provided by the doctor treating the patient concerned in accordance with Item 1.2, written agreement to participation and associated collection, processing and usage of the given patient s data and comprehensive information, also in written form, provided to insured parties concerning programme content, the collection, processing and usage of their data associated with programme participation, above all to the effect that findings can be forwarded to the given health fund and processed and utilised by it within the framework of the Disease Management Programme concerned and that, in cases such as those set out in Sect. 28f Para. 2 Sent. 1 No. 1, the data can be forwarded to a study group for pseudonymisation of the reference to the insured party or forwarded by same to an authorised third party, concerning the distribution of duties and care objectives, the voluntary nature of participation, the possibility of revoking their consent, their obligation to actively assist and concerning the fact that a lack of active assistance may result in the termination of their participation in the given programme. 2 The insured parties confirm by way of their participation declaration that they are familiar with the programme and care objectives and intend actively assisting in achieving them, are familiar with the distribution of duties among the various care levels and intend supporting them, have been informed of the possibility of being supplied with a list of available care providers, have been informed about the voluntary nature of their participation, the possibility of revoking their consent, their obligation to actively assist and the consequences of a lack of active assistance and

12 have been informed about the collection, processing and usage of their data associated with programme participation, above all that findings can be forwarded to the given health fund and processed and utilised by it within the framework of the Disease Management Programme concerned and that, in cases such as those set out in Sect. 28f Para. 2 Sent. 1 No. 1, the data can be forwarded to a study group for pseudonymisation of the reference to the insured party or forwarded by same to an authorised third party. 3.2 Special participation requirements Patients with type 2 diabetes mellitus can be enrolled in the Disease Management Programme if the diagnosis of type 2 diabetes mellitus is established in accordance with Item 1.2 (Diagnosis) or the patient concerned is already undergoing a therapy with diabetes-specific, blood glucose reducing medicines. Female patients suffering from gestational diabetes do not qualify for enrolment in a Disease Management Programme. 4. Training courses (Sect. 137f Para. 2 Sent. 2 No. 4 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]) 1 The health funds are to inform insured persons and care providers about the objectives and content of the Disease Management Programmes. 2 To this end, the contractually agreed care objectives, cooperation and referral regulations, underlying care remits and valid therapy recommendations must also be presented in a transparent manner. 3 The given health fund may appoint a third party to carry out this task. 4.1 Training courses for care providers 1 Training courses for care providers serve the purpose of helping to achieve the contractually agreed care objectives. 2 The content of the training courses is tailored to cater for the agreed management components, above all with regard to cross-sector cooperation. 3 The contracting parties are to define requirements to be met by the regular training of participating care providers relevant to the Disease Management Programmes concerned. 4 They can make the long-term participation of care providers conditional upon the provision of appropriate attendance confirmations. 4.2 Training courses for insured persons 1 Any patient with type 2 diabetes mellitus should be given access to a structured, evaluated, target group-specific and publicised Training and Disease Management Programme. 2 Training courses for patients serve the purpose of enabling the patient concerned to better manage the course of his or her disease and make informed decisions. 3 To this end, a link should be established to the programme s underlying structured medical content in accordance with Sect. 137f Para. 2 Sent. 2 No. 1 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]. 4 The existing level of training of the insured person concerned should be given due consideration. 5 At the application stage, the training programmes to be applied must be notified to the German Federal Insurance Office and evidence provided of their focus on the therapy objectives mentioned under Item The appropriate qualifications of the care providers concerned are to be verified.

13 5. Evaluation (Sect. 137f Para. 2 Sent. 2 No. 6 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch]) 1 The fundamental objective of evaluation is to check the attainment of the objectives set out in the given Disease Management Programme, compliance with the enrolment criteria and the costs of care within the framework of the given Disease Management Programme. 2 The objectives of the programme concerned are based on the requirements set out in Sect. 137f Para. 2 Sent. 2 No. 1 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch] (Requirements to be met by the treatment according to the current state of medical science taking account of evidence-based guidelines or in accordance with the best available evidence as well as giving due consideration to the care provision sector concerned) and Sect. 137f Para. 2 Sent. 2 No. 2 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch] (Quality assurance measures to be implemented) as well as on the agreements in respect of quality assurance measures. 3 The basis of evaluation is formed by the documentation related to the given insured person and of relevance for the evaluation period concerned in accordance with Sect. 28f of the Risk Structure Compensation Ordinance [RSAV] as well as all service provision data and accounts data from the participating care providers for the insured person enrolled during the given evaluation period. 4 The data is pseudonymised for the purposes of evaluation. 5 When evaluating the effectiveness of the given Disease Management Programme, a distinction should be made between the functionality of the programme concerned and its impact on the care situation. 6 When evaluating the functionality of the given programme, particular attention should be given to the evaluation of the requirements set out in Sect. 137f Para. 2 Sent. 2 Nos. 1 and 2 of the Fifth Book of the German Social Security Code [Sozialgesetzbuch] including the procedure used for agreeing individual therapy objectives. 7 The gauge for measuring the impact on the care situation is the change in the levels of parameters of the process and result quality of the minimum data record relative to the initial levels determined. 8 The option of using a control group of non-enrolled insured persons/non-participating care providers by way of comparison should be examined. 9 The evaluation may occur on the basis of a representative, random sample of enrolled insured persons; it enables observation of the insured persons ongoing development to be carried out over the evaluation period. 10 The percentage of the participating insured parties per health fund as well as their structure should be taken into account. 11 Insured persons leaving the Disease Management Programme voluntarily or by exclusion are to be given special consideration. 12 The evaluation should also encompass subjective result quality parameters (quality of life, level of satisfaction) based on a one-off random sample survey among enrolled insured parties to be carried out at least at the start and the end of the given evaluation period. 13 To this end, an address identification procedure should be organised via the given health fund. 14 Taking account of the database required, the contracting parties may agree on the extent to which it should be evaluated whether the given programmes impact on the care provided to nonenrolled insured persons. 15 The evaluation should encompass the period of licensing. 16 After initial licensing, the following should be supplied to the given health fund:

14 an initial interim report covering the period from the start of the programme to the end of the calendar half-year in which the programme has been licensed for one year, a second interim report covering the period from the start of the programme to the end of the calendar half-year in which the programme has been licensed for 18 months, and a final report covering the period from the start of the programme to the end of the calendar half-year in which the period of licensing ends. 17 After extension of programme licensing, the following should be supplied to the given health fund: an updated interim report covering the period from the start of the programme to the end of the calendar half-year in which the programme has been licensed for an extended period of 18 months, and an updated final report covering the period from the start of the programme to the end of the calendar half-year in which the extended period of licensing ends. 18 The reports mentioned in Sentences 16 and 17 are each to be forwarded to the German Federal Insurance Office within one year of the end of the period covered and published within a further eight weeks.