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.

Anyone wishing to have items added to, amended or removed from the MiGeL should, as a first step, send a written enquiry by email to [email protected] or by post to:

Federal Office of Public Health (FOPH), Health and Accident Insurance, Analysis, Medicines and Medical Devices Section (AMG), EAMGK-MiGeL Secretariat, Schwarzenburgstrasse 157, 3003 Bern

Applications are processed by the aforementioned department. Once the necessary clarifications and market analyses have been carried out, the applications are submitted to the competent Federal Commission for Analyses, Medicines and Medical Devices (EAMGK), which issues a recommendation to the Federal Department of Health (EDI). The Department makes the final decision on whether to approve or reject the application.

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.

Abs.

Paragraph

AHV

Old-Age and Survivors’ Insurance

Art.

Article

BAG

Federal Office of Public Health

Bst.

Sub-paragraph

BBL

Federal Office for Buildings and Logistics

BSV

Federal Office for Social Insurance

EDI

Federal Department of Home Affairs

HVB

maximum reimbursement amount

IV

Disability insurance

KLV

Ordinance of the Federal Department of Home Affairs (EDI) of 29 September 1995 on Benefits under Compulsory Health Insurance (Health Insurance Benefits Ordinance)

KVG

Federal Act of 18 March 1994 on Health Insurance

KVV

Ordinance of 27 June 1995 on Health Insurance

L

Limit

MepV

Medical Devices Ordinance (SR 812.213)

MiGeL

List of Medicines and Medical Devices

MV

Military Insurance

MWST

Value Added Tax

OSM-Tarif

Tariff for orthopaedic and footwear-related work of the Swiss Association of Master Shoemakers and Orthopaedic Shoemakers (SSOMV)

Rev.

Revision: Type of revision for an item in the current MiGeL:

B

Change to the maximum reimbursement amount for self-administration

C

textual modification

N

New item

P

Change to the maximum reimbursement amount for care

S

Deletion

V

Extension of the obligation to provide benefits

SL

List of specialities

SVOT

Swiss Association of Orthopaedic Technicians

TP-Wert

Tax point value

UV

Accident insurance

UVG

Federal Act of 20 March 1981 on Accident Insurance

WHO

World Health Organisation

Ziff.

Item