Explanations of the MiGeL (BAG)

The legal basis for the reimbursement of the costs of medicines and medical devices as compulsory benefits under statutory health insurance is the Federal Act of 18 March 1994 on Health Insurance (KVG; SR 832.10). Further details on this can be found in the Ordinance of 27 June 1995 on Health Insurance (KVV; SR 832.102), which is supplemented by the provisions of the Ordinance on Nursing Care Benefits of 29 September 1995 (KLV; SR 832.112.31) issued by the Federal Department of Home Affairs (EDI).

The following preliminary remarks and explanations (sections 2–5), as an administrative ordinance of the Federal Office of Public Health (FOPH) designed to guide implementation, specify the relevant federal legal requirements of the KVG, KVV and KLV in relation to health insurers that administer social health insurance under the KVG (Art. 2(1) of the Health Insurance Supervision Act [KVAG; SR 832.12]) and thus perform federal administrative tasks relating to the implementation of the KVG (Art. 178(3) of the Federal Constitution [BV; SR 101], Art. 2(4) of the Government and Administrative Organisation Act [RVOG; SR 172.010]).

The purpose of these preliminary remarks and explanations is to facilitate the implementation of the relevant provisions of the KVG, the KVV and the KLV in practice, to ensure a uniform and legally consistent application of the List of Medicines and Medical Devices (MiGeL), and to contribute to an interpretation of the applicable provisions of federal law that is tailored to and does justice to the individual case. The introductory remarks and explanatory notes are binding on health insurers and must be complied with when granting benefits under the MiGeL.

Under Article 25 of the Health Insurance Act (KVG), medicines and medical devices used for the treatment or diagnosis of an illness and its consequences are classified as compulsory benefits under the compulsory health insurance scheme (OKP). In this context, the examination of an illness as referred to in the MiGeL relates to the monitoring of the illness and its treatment. Under Article 32(1) of the KVG, the benefits referred to in Articles 25–31 of the KVG must be effective, appropriate and cost-effective, with their effectiveness having to be demonstrated using scientific methods. The effectiveness, appropriateness and cost-effectiveness of the services are reviewed periodically (Art. 32(2) KVG). In order to ensure high-quality and appropriate healthcare for the population at the lowest possible cost (Art. 43(6) KVG) and to define the obligation to provide benefits, the FDHA issues provisions on the obligation to provide benefits and the scope of reimbursement for medicinal products and medical devices listed in the MiGeL (Art. 52(1)(a)(3) KVG; Art. 33(e) KVV).

Until now, the OKP has only reimbursed separately those medical devices and items that can be fitted and/or used by the insured person directly or, where necessary, with the assistance of persons not professionally involved in the examination or treatment. Following the amendment to the KVG of 18 December 2020 (Art. 25a and 52(1)(a)(3) KVG; BBl 2020 9945), the OKP will now also reimburse separately, in accordance with the MiGeL, the remedies and items used by service providers (care homes, organisations providing nursing care and home help, registered nurses) as part of medically prescribed nursing services under Article 25a of the KVG. This also includes equipment and items that can be used exclusively by registered nurses under MiGeL (corresponding to Category C). Devices and items that are directly related to nursing services and can be used repeatedly for different patients (corresponding to category A) are not reimbursed via the MiGeL.

Not included in the MiGeL are medical devices and supplies that are not used by service providers under Article 35(2) of the KVG (doctors, hospitals or other medical and therapeutic professionals, such as physiotherapists / physiotherapists) as part of their professional activities for nursing services under Article 25a of the Health Insurance Act (KVG). Reimbursement for these is regulated in conjunction with the corresponding examination or treatment in the tariff agreements of the respective service providers (Art. 20(2) of the Health Insurance Tariff Ordinance (KLV)). Medicines and medical devices that do not serve the purpose of treatment or examination in the context of monitoring the treatment of a disease and its consequences, as well as medicinal products containing active substances authorised by Swissmedic, are also excluded.

Where used directly by insured persons, or where necessary with the assistance of persons not professionally involved in the examination or treatment, or where used in the context of the provision of care services by self-employed nursing professionals or organisations providing nursing and home help, the OKP will reimburse the medical devices and items listed in the MiGeL up to the maximum reimbursement amount for self-administration specified in the MiGeL (HVB self-application; Art. 24(1) KLV), provided that these:

1. correspond to the product description of a MiGeL item
2. have been placed on the market in accordance with federal or cantonal legislation
3. fulfil the required therapeutic purpose or the purpose of monitoring the treatment of a disease and its consequences
4. are prescribed by a doctor
5. are dispensed by a dispensing outlet authorised in accordance with Article 55 of the KVV.

Medicines and medical devices used by insured persons directly or, where applicable, with the assistance of persons not professionally involved in the examination or treatment may also be prescribed by a chiropractor under Article 4(c) of the Health Insurance Ordinance (KLV).

Where the remedies and items are used whilst the insured person is staying in a care home, or where invoices are issued by nursing staff or by organisations providing nursing care and home help, the OKP will reimburse the remedies and items listed in the MiGeL up to the reduced HVB rate specified in the MiGeL (= HVB care; Art. 24(2) KLV), provided that the conditions set out above under points (a) to (d) are met.

Medical devices and supplies that do not correspond to the product description of a MiGeL item must not be billed to the OKP. Billing under a similar item number is not permitted.

If the medical devices and supplies are products falling within the scope of the Medical Devices Ordinance (MepV; SR 812.213), they must comply with the requirements of the MepV regarding their placing on the Swiss market (Art. 23 KLV). Supervision and enforcement of the MepV are the responsibility of Swissmedic, the Swiss Agency for Therapeutic Products, Medical Devices Division, Hallerstrasse 7, P.O. Box, CH-3012 Bern.

Where the products and articles are foodstuffs as defined in Article 2(d) of the EDI Ordinance on Foodstuffs for Persons with Special Nutritional Needs (VLBE; SR 817.022.104) (foodstuffs for special medical purposes; see also Chapter 3 of the VLBE), they must comply with the requirements of the VLBE when placed on the Swiss market (Art. 23 KLV). Supervision and enforcement of the VLBE are the responsibility of the cantons.

The HVB is specified for each product type of products and devices. For products and devices which are used by the insured person themselves or with the assistance of a person not professionally involved in the examination or treatment, the HVB self-application applies. For medicinal products and medical devices which can be used both by the insured person themselves (or with the assistance of a person not professionally involved in the examination or treatment) and as part of a care service under Article 25a of the KVG, the reduced HVB care applies if the product is used during the insured person’s stay in a care home or is invoiced by nursing staff or by organisations providing nursing care and home help. The HVB rates listed in the MiGeL represent the maximum amount that can be reimbursed by insurers under the OKP (Art. 24(3) KLV). The insured person is free to choose a specific suitable product within the scope of this HVB, in which case any additional cost (Art. 24(3) KLV) shall be borne by the insured person. When dispensing medical supplies and equipment during the insured person’s stay in a care home, whether by nursing staff or by organisations providing nursing care and home help, cost-effective products should be chosen wherever possible so that the maximum reimbursement limit can be adhered to. It is the duty of service providers to inform the insured person of any costs not covered by the OKP. Medical aids and equipment are not included in tariff cover (Art. 44(1) KVG). Insurers may agree tariffs with care homes, home nursing and care organisations or nursing staff, in accordance with Article 46 of the KVG, for the reimbursement of medical devices and supplies listed in the MiGeL (Art. 24(6) KLV).

Value added tax (VAT) is included in these amounts. The actual price including VAT (currently 8.1% for products falling within the scope of the Medical Devices Ordinance and 2.6% for products falling within the scope of the FDHA Ordinance on Foodstuffs for Persons with Special Nutritional Needs) is decisive for billing purposes.

The MiGeL reference prices generally correspond to the average price of suitable products available on the market. Prices abroad are taken into account in the cost-effectiveness assessment.

Furthermore, for medicinal products and medical devices, the insured person’s contribution to costs in the form of an excess and a deductible (see Art. 64 KVG, Art. 103 KVV) also applies to the maximum reimbursable amount.

In the case of medicines and medical devices that may also be provided under the scope of the Old Age and Survivors’ Insurance (AHV), Disability Insurance (IV), Accident Insurance (UV) or Military Insurance (MV), the following distinction must be observed with regard to compulsory health insurance (OKP):

With regard to the coordination of benefits across the various social insurance schemes, reference is made to Article 63 et seq. of the Federal Act on the General Part of Social Insurance Law (ATSG).

Furthermore, Article 27 of the Health Insurance Act (KVG) specifically mentions coordination in the case of congenital conditions, according to which the OKP covers the costs of the same benefits as in the case of illness for congenital conditions not covered by disability insurance (age-related after the age of 20, or where a child with a congenital condition does not meet the insurance requirements of disability insurance).

Where the use of medical aids and equipment is indicated by a congenital condition, special provisions applicable to congenital conditions apply (Art. 27 KVG, Art. 52(2) KVG, Art. 35 KVV). In the case of congenital disabilities, there is an obligation to provide benefits from the age of 20 onwards for those medical measures that have previously been reimbursed by the IV, provided that the WZW criteria are still met. This is because, under Article 52(2) of the KVG, additional costs for medical measures included in the IV’s catalogue of benefits are covered in the case of congenital disabilities.

Where there is an obligation to provide benefits under the AHV, IV, UV or MV for medical aids and equipment, reimbursement is processed in accordance with the provisions of the relevant social insurance scheme. For example, in the case of accidents, the costs of medical aids and equipment are borne by the accident insurance scheme if cover is provided by compulsory accident insurance. In particular, the IV also covers the costs of walking aids, hearing aids, spectacles and contact lenses, orthopaedic footwear, orthoses and prostheses, as well as electronic speech-assistance devices. The AHV also covers the costs of orthopaedic custom-made and mass-produced footwear, hearing aids, magnifying glasses and electronic speech assistance devices.

If there is no insurance cover provided by another social insurance scheme, insured persons receive reimbursements in accordance with the provisions of the KVG and the conditions set out in the MiGeL.

The OKP does not provide any supplementary benefits to those provided by the AHV, IV, UV or MV if any of these social insurance schemes is liable to pay benefits. For example, the OKP does not cover the cost shares for medical aids that are not reimbursed by the AHV.

The list is divided into product groups according to the function of the products. A distinctive feature of the MiGeL, compared with other lists under compulsory health insurance, is that it only lists general product descriptions and does not include individual brand names.

Provisions listed under the heading of a product group or sub-group apply to all items within that group (e.g. different formats for dressing materials).

The existing product groups list products which may be used either by the insured person themselves or with the assistance of a person not professionally involved in the examination or treatment, as well as within the framework of a care service under Article 25a of the Health Insurance Act (KVG) (corresponding to Category B). Where the product is used by the insured person themselves (or with the assistance of a person not professionally involved in the examination or treatment), the HVB applies (= HVB self-application; Art. 24(1) KLV). Where the product is used whilst the insured person is staying in a care home, or where it is invoiced by nursing staff or by organisations providing nursing care and home help, a reduced HVB care applies (= HVB care; Art. 24(2) KLV).

Medicines and medical devices which can only be administered or applied by nursing staff, and not by the insured person themselves or by a person not involved in a professional capacity, are classified in Category C of the MiGeL. As these products can only be administered or applied by nursing staff, there is only one HVB care co-payment.

Simple consumables directly related to nursing care (e.g. gloves, gauze, disinfectants, masks and protective clothing), as well as materials and items for multiple use across different patients (e.g. blood pressure monitors, stethoscopes, clinical thermometers, special ergonomic pillows, reusable instruments such as scissors and tweezers) are classified in category A. Category A products are not included in the MiGeL and are reimbursed in accordance with the rules on nursing care funding set out in Articles 25 and 25a of the Health Insurance Act (KVG) and Articles 7 et seq. of the Health Insurance Ordinance (KLV).

The first two digits of the item number indicate the product group. The following pairs of digits, separated by a full stop, indicate, in turn, the category and sub-categories, the specific product and the accessories / consumables. The final single digit indicates whether the item is applicable under the hire and/or purchase scheme. Digit 1 = purchase, 2 = hire, 3 = purchase and hire. An item number for the purchase of a device ends with the digit 1, and an item number for the hire of a device ends with the digit 2. For items relating to accessories, consumables and other charges (e.g. delivery) associated with a device, items ending in 1 may only be charged additionally when the corresponding device is purchased, and items ending in 2 may only be charged additionally when the device is hired. Items ending in 3 may be charged additionally in relation to a purchased or rented item of equipment.

Separate items are listed for hire and purchase (Art. 24(4) KLV). The unit of the amount listed (e.g. unit price, daily hire charge, etc.) is specified for each item. Insurers shall cover the costs, within the limits of the applicable HVB, only for aids and appliances that are in a ready-to-use condition. In the case of aids and appliances acquired by purchase, the insurer shall cover the costs of any necessary adaptation and maintenance, provided this is specified in the list. In the case of hire, maintenance and adaptation costs are included in the hire price (Art. 24(5) KLV).

Items with different therapeutic or diagnostic functions may generally be combined. Accessories and consumables may only be combined with the corresponding product. Any exceptions or notes are listed in each case.

Products may generally be subject to restrictions regarding their medical indication, quantity and duration of use. A product subject to a restriction is marked with an ‘L’ after the item number. Restrictions may apply to individual products, product sub-groups or entire product groups. Relevant information is provided for each item.

Appliance repairs are included in the rent. Appliance repairs under the purchase scheme: costs are reimbursed on a cost-plus basis in the event of careful use and where the damage is not the customer’s fault, after the warranty has expired and only subject to prior approval of the costs by the health insurer.

Treatment, or the purchase of relevant products, often does not begin on 1 January of a given year. Reimbursement under an HVB ‘per year (pro rata)’ always relates to the portion of the calendar year during which the treatment was actually used.

For example: A first-time purchase of consumables for regular use is made with an HVB of CHF 400 per year, pro rata from 1 October. In the year of the first purchase, the corresponding proportion of the annual reimbursement limit remaining for that calendar year (3 months) is to be reimbursed, i.e. CHF 100 (pro rata). In the following year, the treatment continues on a permanent basis and a maximum of CHF 400 may be reimbursed for the entire calendar year. If supplies amounting to CHF 100 are purchased as early as October, this falls within the annual reimbursement limit ‘per year (pro rata)’, even if the monthly cost works out at CHF 33.33. The annual (pro rata) reimbursement limit allows for fluctuations in requirements during the course of treatment. The rounding rule is that reimbursement is usually rounded up to whole units, e.g. if a product needs to be replaced every two weeks.

HVB ‘per year’ is mostly used for devices or medical aids that are not purchased several times a year, or that are used irregularly. It is understood to be the maximum possible reimbursement over the 365 days from the first date of purchase. This does not mean per calendar year, but per year of ongoing treatment.

For example: spectacle lenses and contact lenses are reimbursed under an HVB a maximum of once a year until the age of 18. If the first purchase is made on 31 October 2015, reimbursement can be claimed again at the earliest for a purchase in November 2016.

As an exception, items that are purchased several times a year but used irregularly may also be eligible for one HVB per year. One example is blood glucose test strips for people with diabetes who do not require insulin. In this case, once-daily use (corresponding to a pro rata reimbursement) is medically justified only in a few exceptional cases. However, short periods of more frequent testing, e.g. for changes in treatment, should be permitted. At the same time, this takes into account that even if blood glucose monitoring begins towards the end of the year, a small pack of test strips can still be reimbursed initially.

HVB ‘per calendar year’ can be reimbursed up to a maximum in the relevant calendar year, regardless of when the first prescription was issued. It is used when, in the case of long-term treatment, the initial costs for supplies are high and may therefore no longer be covered by a ‘pro rata’ arrangement if treatment only begins towards the end of the year.

An example: A person is discharged from hospital on 1 October with a newly performed tracheostomy. For the remaining 3 months of the year, the full HVB is available ‘per calendar year’ for consumables. This contrasts with the HVB ‘per year (pro rata)’, under which only a quarter of the HVB would be reimbursed for a period of 3 months.

As a general rule, the HVB column contains the maximum reimbursement amount. In exceptional cases, a MiGeL item may not contain an HVB care or a note:

• The following items do not contain an HVB specification:
  • Remuneration in accordance with items in the SVOT tariff
  • Remuneration in accordance with items in the OSM tariff
  • Remuneration in accordance with the UV / MV / IV commercial goods tariff
  • Remuneration in accordance with the provisions of the AHV / IV
  • Dressing aids: reimbursement only for self-administration
  • Reimbursement in accordance with the rules on nursing care funding under Articles 25 and 25a of the Health Insurance Act (KVG) and Articles 7 et seq. of the Health Insurance Ordinance (KLV)
• ‘Category A’ comprises items that are reimbursed in the context of self-application in accordance with the HVB self-application guidelines. Where administered by nursing staff, reimbursement is made in accordance with the rules on care funding under Articles 25 and 25a of the KVG and Articles 7 et seq. of the KLV

For formats, volumes or weights not listed here or which differ from those listed, the maximum reimbursement amount for the format, volume or weight closest in size shall apply. Areas falling midway between two sizes are allocated to the smaller size, whilst volumes or weights falling midway are allocated to the smaller entry.

Products for the removal of liquid or solid substances present in the body.

Products that enable or assist in the administration of medicines and/or medically indicated nutritional solutions.

Medical bandages are orthopaedic aids used to treat conditions affecting the muscles and ligaments. They are primarily used to treat acute injuries to the limbs and trunk, but are also employed in the treatment of chronic conditions. In cases of chronic injuries that cannot otherwise be treated therapeutically and which lead to permanent limitations in activity, they are also used to compensate for disabilities.

Medical bandages can be flat-knitted or circular-knitted; they are aids that either enclose or fit snugly against the body part. Their function is to provide compression and/or support. The basic components are made of flexible materials and may be fitted with rigid textile components, pads, reinforcements and functional elements. Compression therapy aids used to treat venous or lymphatic drainage disorders, as well as burn scars, are reimbursed in accordance with Chapter 17 on compression therapy aids. The use of bandages solely for prophylactic reasons, without any underlying medical condition – for example, to protect against injuries during sporting or occupational activities – falls within the insured person’s own responsibility and is not a compulsory benefit under the OKP.

Radiation devices are used to deliver energy to the human body.

Devices which, via electrodes, deliver electrical current to body tissue in a precisely defined manner for therapeutic purposes.

Walking aids are intended to enable walking which, due to the consequences of an illness or accident, would no longer be possible without them, or to relieve pressure on a lower limb during the healing and convalescence phase.

Walking aids for everyday use outside the healing and convalescence phases are also covered by the IV, subject to its eligibility criteria (see also the explanations under 2.3).

Hearing aids are technical devices designed to compensate for congenital or acquired hearing impairments that cannot be treated by causal therapy. Reimbursement for hearing aids and the associated batteries is generally provided in accordance with the provisions (contractual provisions, tariff, degree of hearing loss) of the AHV, IV or UV (see also the explanations under 2.3).

In cases where the person does not meet the eligibility criteria for benefits from the relevant social insurance scheme, the OKP will cover these costs. Reimbursement is made in accordance with the provisions (contractual provisions, tariff, severity of hearing loss) of the AHV / IV.

These products exert their therapeutic effect via the respiratory tract. The products serve the following purposes:

• To support or replace respiratory function in the event of respiratory disorders or respiratory pump failure
• To support or improve coughing function and to help keep the airways clear of secretions (secretion mobilisation)
• Administration of therapeutic aerosols via the respiratory tract; support for powder inhalation

Devices for measuring respiratory function are listed in product group 21: Measuring devices for bodily conditions/functions.

Inhalation and respiratory therapy devices comprise the following product sub-groups:

Inhalation devices

These devices are used to deliver therapeutic aerosols into the airways (inhalation devices). Particle size and mass, measured as MMAD (Mass Median Aerodynamic Diameter, median size of the aerosols in µm), are crucial for the site of deposition (for example, for bronchodilator drugs) when the patient uses the correct inhalation technique. Droplet sizes of 2–5 µm (proportion given as the fine particle fraction in %) are required for deposition in the lung parenchyma, for example, for vasodilator medicines. Devices for metered-dose inhalers and powder inhalers are specific to particular brand-name products and are therefore not listed in the MiGeL but in the Specialities List (SL).

Pre-chambers for metered-dose inhalers

These devices are designed to improve drug deposition when using metered-dose inhalers, particularly in cases of difficulty coordinating the simultaneous inhalation and triggering of the aerosol burst, or where the patient’s willingness to cooperate is limited.

Device repairs under the purchase scheme: reimbursement on a cost basis in cases of careful use where the damage was not self-inflicted, after the warranty has expired and only following prior approval of costs by the health insurer.

Respiratory therapy devices for secretion mobilisation

These devices are designed to facilitate the loosening and removal of mucus from the airways.

Respiratory therapy devices for respiratory muscle training

Respiratory therapy devices for respiratory muscle training promote the mobilisation of secretions and the cough reflex by strengthening the respiratory muscles.

Oxygen therapy

Oxygen therapy is used as short-term therapy (for temporary or end-stage respiratory failure in severe illnesses), as long-term treatment for acute episodes (for cluster headaches) or as long-term oxygen therapy (for chronic lung or respiratory tract diseases).

Long-term oxygen therapy (also known as LTOT):

To achieve the treatment objectives (reduction of pulmonary arterial hypertension, improved life expectancy), oxygen administration is necessary, usually at a low flow rate for at least 16 hours a day.

Indications

Oxygen therapy is administered in accordance with current evidence-based treatment guidelines, even if there is no explicit reference to these in the MiGeL. The basic prerequisite for cost coverage is a diagnosis of cluster headache or a deficiency in oxygen levels (age-adjusted values). Consequently, palliative care patients with dyspnoea but no hypoxaemia should not be treated primarily with oxygen. Opioids are more effective for relieving dyspnoea.

As the complexity of the treatment or the system increases, and for therapies lasting longer than three months, an appropriate indication from a specialist or subspecialist (in exceptional cases in the form of a case assessment based on medical records) is expected. Further prescriptions for long-term, unchanging therapy with simple systems may be issued on a case-by-case basis by GPs. Certain systems require regular specialist assessment.

Choice of system

Depending on the individual situation (indication for oxygen therapy, daily duration of treatment, level of additional oxygen requirement during exertion, living arrangements, changing mobility outside the home), various systems or combinations may be effective, appropriate and cost-effective.

Long-term oxygen therapy using pressurised gas cylinders is obsolete and extremely uneconomical.

Pressurised oxygen cylinders may still be used for short-term therapy, for the long-term treatment of cluster headache attacks, and for the mobile supply of paediatric patients with very low oxygen requirements during long-term oxygen therapy.

Cost approval

To ensure cost-effective treatment, in certain situations (e.g. prior to purchasing expensive systems, before commencing treatment with liquid oxygen, or when combining certain systems), prior special authorisation must be obtained from the insurer, who will take into account the recommendation of the medical examiner.

In the case of liquid oxygen, a cost estimate for the planned supply (oxygen requirement, number and size of tanks, delivery frequency) must already be available prior to the start of treatment in order to obtain the necessary cost approval; this is required to compare the cost-effectiveness and suitability of the supply with other systems.

Similarly, such a cost estimate must be available for the purchase of oxygen concentrators, setting out the specific and expected replacement intervals for the molecular sieve and, where applicable, batteries – including their prices – for the selected model.

Portable systems

Long-term oxygen therapy using a portable system requires a prior, correct assessment and a regularly updated medical indication from specialist doctors, and necessitates specific instruction from specialist support staff.

Mobility whilst travelling and outside the home refers to situations that regularly arise in the course of the insured person’s normal daily life, where they are beyond the reach of a stationary oxygen source and therefore require off-grid systems. Thus, the use of an oxygen concentrator at second homes with an existing mains supply does not constitute portable use, as stationary oxygen concentrators are suitable for carrying in a car. The medical indication for portable systems is determined in accordance with current treatment guidelines. In the case of reimbursement for portable systems intended for use whilst travelling and outside the home (portable oxygen concentrators, liquid oxygen), a special annual authorisation from the insurer is sometimes required in order to accommodate any changes in the insured person’s mobility outside the home. For people who no longer leave their home, more suitable and cost-effective systems may be available. Even without the need for special authorisation, the insurer may require evidence that, in the individual case, no other system is appropriate and that the system remains cost-effective in comparison.

When renting a portable oxygen concentrator, authorisation for costs must be obtained from the insurer before continuing treatment after 3 months. During this period, the treatment – including any trigger function – should have been sufficiently tested, and the therapeutic benefits achieved and expected must be demonstrated. With regard to the cost-effectiveness of the planned treatment, this must now be weighed up against the purchase of the device.

Spare parts for oxygen concentrators following purchase

The service life of molecular sieves varies depending on the device model. Batteries for portable oxygen concentrators must be replaced at varying intervals, depending on usage and the device model. The market prices of both spare parts vary considerably and, over several years of use, influence the cost-effectiveness of the chosen treatment. For this reason, the application for prior authorisation of costs must be accompanied by the relevant device-specific details for the intended supply before the device is purchased. The actual reimbursement will be based on this estimate, but will not exceed the maximum reimbursement amount.

Consumables

Only one of the consumables items per insured person is reimbursed per year, regardless of the number of oxygen systems used. A change to the flat-rate allowance during the course of the year is possible, e.g. in the event of a corresponding adjustment to the treatment. Persons who utilise the consumables item for oxygen requirements under physical exertion of 6 l/min or higher must also use a correspondingly high-capacity oxygen source or system (liquefied gas, stationary concentrator with high oxygen flow, or compressed gas in the case of cluster headaches).

Technical notes

Medical oxygen is a medicinal product whose reimbursement is, exceptionally and on a temporary basis, still regulated under the MiGeL until it is listed in the Specialities List. Pressurised gas cylinders:

They are filled to 200 bar (MPa). One litre of pressurised gas yields 200 litres of gaseous oxygen.

Liquid oxygen:

It is stored in a thermally insulated container. Boiling point of O₂ = –183 °C. 1 litre of liquid oxygen yields 860 litres of gaseous oxygen.

Devices for the treatment of sleep-related breathing disorders

Devices for the ventilatory treatment of sleep-related breathing disorders (CPAP [Continuous Positive Airway Pressure] devices, servo-ventilation devices, bi-level PAP devices) generate a constant positive pressure in the airways, which ‘keeps them open’. Devices for non-ventilatory respiratory support (mandibular advancement splints) prevent obstruction of the pharynx by mechanically advancing the lower jaw.

In accordance with Article 17(f) of the Health Insurance Cost Reimbursement Ordinance (KLV) and Article 19(e) of the KLV, the insurer covers the costs of dental treatment.

Devices for mechanical home ventilation

Ventilators which, in the event of ventilatory insufficiency, temporarily support (respiratory support devices) or replace (devices for people who are permanently dependent on the device) respiratory function.

This product group includes absorbent and drainage incontinence aids, as well as accessories and therapeutic devices. Incontinence is the inability to voluntarily control the passage of urine and/or faeces, resulting in the involuntary loss of urine and/or faeces.

Degrees of incontinence in adults:

Mild incontinence does not qualify for reimbursement of absorbent incontinence products by the OKP. This includes stress incontinence, characterised by the loss of small amounts of urine during certain physical activities such as sneezing, coughing, laughing or exercise. In such cases, incontinence products are the patient’s own responsibility until other, long-term forms of treatment prove effective.

Moderate incontinence: Unintentional leakage of urine (part of the bladder’s contents) at irregular intervals, up to several times a day.

Severe incontinence: Involuntary, sudden and complete emptying of the bladder, up to several times a day.

Total incontinence: Frequent and constant involuntary leakage of urine and/or faeces.

During normal childhood development, bowel and bladder control are acquired gradually. A distinction must be made between daytime bowel and bladder control – which develop largely at the same time – and night-time bladder control, which usually does not develop until later.

Entitlement to reimbursement for products used to treat medical conditions under item 15.01 (absorbent incontinence products) therefore arises at the earliest from the age of 42 months. By this age, the majority of children have acquired daytime bowel and bladder control. Due to medical conditions, it may be that this function is only acquired at a later stage.

Incontinence pads

Technical specifications:

Absorbent, liquid-retaining material as an absorbent pad. Back-wetness protection / non-woven layer on the inside. Liquid-impermeable outer layer. Leak protection around all edges. All-round edge-to-edge bonding of the inner and outer layers. Skin-friendly materials.

Vaginal pessaries

Vaginal pessaries correct the position of the pelvic organs, thereby improving continence function.

Vaginal pessaries can be cleaned with warm water and reinserted repeatedly over a period of months or even years. Depending on the situation and requirements, various shapes are used, such as ring pessaries, cup/sieve-cup pessaries, cube pessaries, urethral pessaries, etc.

Disposable and short-term pessaries made from special foams, vinyl and/or cellulose can, depending on the material, be used once or reinserted repeatedly for a few days to a few weeks after cleaning with warm water. They are usually sold in multipacks.

Contraceptive pessaries, such as intrauterine devices or diaphragms, are excluded from reimbursement.

These are products designed for the external application of heat or cold.

Compression therapy products include items designed for the therapeutic application of external pressure to treat venous and lymphatic drainage disorders, as well as burn scars. ‘Anti-thrombosis stockings’ and other support stockings that do not meet the criteria for Class 2 medical compression stockings are not covered by compulsory health insurance. Other non-mandatory benefits include, in particular, compression therapy devices intended to enhance sporting performance, prevent travel-related thrombosis and for purely preventative use during pregnancy.

Compression therapy devices differ fundamentally in their intended use from bandages (Chapter 05), which exert a compressive and/or function-preserving (supportive, stabilising, movement-guiding) effect.

Devices for measuring bodily conditions or functions are used by the insured person to monitor their own functional parameters, where this is necessary for managing their condition and/or where independent adjustment of their medication is required.

Orthoses for everyday use (for mobility, interacting with the environment and personal care) are also covered, particularly by the IV and AHV, outside the treatment and convalescence phase (see also the explanations under 2.3). For persons insured under the AHV who have previously received benefits from the IV for orthoses, the entitlement to these benefits, in terms of type and scope, remains as provided by the IV, provided that the relevant IV eligibility criteria continue to be met.

Orthoses are medical aids that enclose or fit against a part of the body. They have a stabilising, supporting, guiding, relieving, immobilising, mobilising or corrective function; they ensure proper function and can replace lost bodily functions. Unlike bandages, orthoses are predominantly made of inelastic materials and also feature stabilising support elements made of mouldable rigid materials, which mechanically limit joint mobility. Hybrid products comprising elastic and/or compressive components with rigid stabilising elements, as well as removable aids, are classified as orthoses.

Orthoses can be categorised into different types based on their manufacture:

• Industrially manufactured, ready-made orthoses (off-the-shelf products) require no or minimal adjustment (adjusting or replacing pre-set joint stops, shortening Velcro fastenings). This also includes products that combine the material properties of bandages and orthoses.
• Industrially manufactured, partially ready-made orthoses (semi-finished products, modular system) are adapted to the patient’s individual measurements by qualified specialists (e.g. orthopaedists holding the Higher Professional Examination (HFP) or master orthopaedic shoemakers holding the HFP) using specialised tools (Adjustments that go beyond the modifications listed in the product documentation – which may be carried out by untrained staff – and therefore no longer qualify for the manufacturer’s warranty in accordance with the Medical Devices Ordinance [MePV]).
• Custom-made orthoses are produced to the patient’s individual measurements using models of the affected body parts (plaster casts, specific measurements, 3D models) by appropriate qualified personnel (e.g. a qualified orthopaedic technician (HFP) or a master orthopaedic shoemaker (HFP)).

In principle, treatment is provided using a ready-made orthosis (MiGeL Chapter 22). If the insured person’s individual anatomical conditions and/or functional requirements do not permit the provision of ready-made orthoses, a custom-made product is required (MiGeL Chapter 23).

Prosthetics are products designed to replace parts of the body.

Prosthetics for everyday use (for mobility, interacting with the environment and personal care) are, outside the treatment and convalescence phase, also covered in particular by the IV (see also the explanations under 2.3.).

For persons insured under the AHV who have previously received benefits from the IV for prostheses, the entitlement to these benefits, in terms of both type and scope, remains with the IV as long as the relevant IV eligibility criteria continue to be met.

Visual aids are optical devices used to correct refractive errors or to compensate for, improve or treat other eye conditions. Glasses and contact lenses are also covered by the IV and AHV (see also the explanations under 2.3).

Orthopaedic shoes are generally covered in accordance with the provisions of the AHV, IV or UV. In cases where the person does not meet the eligibility criteria for benefits under the relevant social insurance scheme, the OKP will cover these costs. Distinction from benefits provided by other social insurance schemes: see the explanations under ‘Preliminary Remarks’ in Chapter 2.3. An orthopaedic shoe provides support, guidance, correction and pressure relief, and is used to treat a medical condition. The term ‘orthopaedic’ means that the product is individually made to measure for corrective purposes.

The term ‘ostomy products’ refers to products used to manage openings in the small intestine, large intestine or ureter in the anterior abdominal wall (ostomies and fistulas) that have been created surgically or as a result of medical complications.

Therapeutic exercise equipment comprises products used in the treatment of disorders of the musculoskeletal system.

Tracheostomy aids are used to manage a tracheostomy (a surgical or dilation-induced opening in the windpipe at the neck).

A tracheotomy (incision in the trachea) is performed, for example, in cases of airway narrowing, where ventilation via a tracheal cannula is required, or where there are severe secretion problems requiring suctioning. Depending on the method of creation, the stoma is mechanically unstable and a tracheal cannula must be in place at all times to secure the airways. Insured persons who have undergone a tracheotomy can speak using a voice valve fitted onto the tracheal cannula, provided the cannula is slotted (speaking cannula) and the larynx can therefore be used.

A laryngectomy (removal of the larynx) is often necessary in the case of a tumour. During this procedure, the windpipe and oesophagus are separated, and the windpipe ends at the tracheostoma on the neck. As the tracheostoma created during a laryngectomy is very stable, not all insured persons need to have a tracheal cannula in place permanently. For the majority of insured persons, a voice prosthesis is implanted between the windpipe and the oesophagus, which allows them to use the air they breathe to produce speech.

The MiGeL classifies electronic speech-assistance devices as including the electronic speech aid and the electronic voice amplifier. Electronic speech-assistance devices are also covered by the IV and AHV (see also the explanations under 2.3).

In specific medically justified cases, subject to prior special approval from the insurer – who takes into account the recommendation of the medical examiner – reimbursement may be granted for higher costs up to a maximum of twice the maximum reimbursement amount specified for the relevant item. This may be necessary, in particular, in situations where, for medical or anatomical reasons, materials need to be replaced more frequently in the long term or where the use of more expensive materials is required, such as custom-made cannulas or cannulas for subglottic suction. Corresponding applications must be justified on medical grounds. Any short-term increase in consumption should be balanced out over the course of the year. The use of a hands-free system for laryngectomised insured persons or sub-optimal advice to insured persons regarding materials does not constitute a medical reason.

The ‘Dressing Materials’ product group includes products used for the external treatment and protection of skin lesions. It also includes products used both to stabilise wound dressings and to stabilise the musculoskeletal system, which do not fall within the category of orthoses and bandages (e.g. elastic bandages, etc.). There is no general prohibition on cumulation in the MiGeL. Thus, compresses and swabs may also be reimbursed if they are used for disinfection in the context of bladder catheterisation. However, such cumulation would not be permitted if the item description excludes it (e.g. a wound irrigation solution cannot be reimbursed for bladder irrigation).

Where artificial nutrition is used in connection with congenital disorders, the explanations set out in the general preliminary remarks 2.3 apply. For dietary products intended for congenital disorders, the HVB corresponds to the reimbursement applicable to the relevant product under the IV scheme. Coverage of the costs by the OKP is subject to the fulfilment of the WZW criteria.

Digital health applications (dGA) for medical purposes are products that utilise digital technologies. These take the form of software or an app. In addition, artificial intelligence (AI) and/or a physical product may be used. On the basis of digitally recorded data, medical assessments can be carried out and personalised recommendations for action can be provided.

dHAs intended for medical purposes are medical devices and must comply with the requirements of Swiss medical device legislation (Therapeutic Products Act [HMG; SR 812.21], MepV).

This section lists products for which there is no specific product group in the MiGeL.