Global Health Technology Assessment Road Maps

Switzerland - Medical Devices and Diagnostics


UpdatedPosted: January 2012
Validated by: SwissDRG (only the section: In-patient DRG System)
Switzerland

Decision Makers and Decision-Making Processes Diagram

Decision-Making Processes Diagram

Model description and Symbols:

The ultimate decision maker is listed at the top of the model
Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision
*Medical items are medical devices which can be used by the patient himself or his assistance without professional medical assistance. For e.g. , bandage or inhalers

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BACKGROUND

Switzerland (pop. 7.8 million) is a multilingual, federal state made up of 26 states known as cantons. Health care is the responsibility of three levels of government: the federal government, the cantons and the communities. The Swiss health care system can be described as a mandatory private social health insurance system with unrestricted access to health care and free choice of providers. The Health Insurance Act (HIA/KVG) is the federal law on compulsory social health insurance and requires every Swiss resident to buy a basic health insurance offered by around 84 competing private health insurers (i.e. health insurance providers). The benefit package is defined by federal law and identical for all health insurers. The benefit package includes a positive list for drug coverage and only a negative list for medical services provided by hospitals and physicians.

The basic health insurance is financed by a uniform per capita premium which is independent of gender, age and pre-existing conditions. Premiums are only dependent on the canton of residence, the chosen health insurer, the chosen deductible level (300 up to 2,500 CHF) and the chosen insurance model (standard versus managed care model). 75% of the population has selected a standard insurance model with a low deductible level (santésuisse 2008). Even when a rebate of 10-20% is offered, the gate keeping model (GP’s without capitation) plays still a minor role with a market share of 21% (santésuisse 2008). Patients have to pay 10% co-pay up to a maximum of 700 CHF per year in addition to the health care premium and the chosen deductible. The federal and state governments are subsidizing low income individuals to pay the health insurance premium. In fact around 30% of people can profit from subsidies. Risk selection is still attractive for health insurers as risk adjustment payment across health insurers considers currently only gender and age but not morbidity levels.

About 70% of persons have some kind of additional health insurance covering mainly private room and hospital care outside the patient’s canton. The additional health insurance differs in the way that health insurers can make profits, ask for risk adjusted premiums, make limitation for pre-existing conditions or exclude insurance applicants. Work accidents, non-work accidents and occupational diseases are covered by a compulsory accident insurance which is provided by the employer; non-employees can get accident insurance coverage from a health insurer for a minimal premium.

Switzerland has 186 public and 128 private hospitals (BFS 2010). Hospitals’ operational and investment costs are co-financed by cantonal taxes (55 %) and health insurance premiums (45 %). Hospital financing will translate from per diem to DRG payment by 2012. Cantons are responsible for hospital planning and control. Cantons are setting up hospital lists including public and private hospitals based on a health service performance mandate.

Two third of Swiss physicians in ambulatory care are self-employed and one third work in a group practice. Half of ambulatory care physicians are member of some form of a provider network (FMH 2009). Physicians are paid on a fee-for-service level based on a federal tariff system which is negotiated between the association of physicians and the association of all insurers. Finally, fees are negotiated on a cantonal level.

Switzerland has the third highest health care spending with 10.7% of GDP (6.3 public and 4.4 private) and 4,627 USD/PPP per capita. However, the annual growth in per capita health spending between 1993 and 2008 is 2.1%, lower than other western countries even though Switzerland has no budget caps in place. Switzerland has a relatively high share of out-of-pocket payment (around 30%) both for total health care expenditure and pharmaceutical spending (OECD 2010).

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DECISION-MAKERS AND INFLUENCERS

Federal Council (Der Bundesrat)
The Swiss government (the executive authority) is made up of the seven members of the Federal Council who are elected by the United Federal Assembly for a four-year term of office.

Committee for Social Security and Health of the National Council
(CSSH-N / SGK-NR) and that of the Council of States (CSSH-S / SGK-SR)

The Committees deal mainly with issues concerning the health system, health policy, social security, housing and welfare. Working closely with the Federal Council, the committees carry out a preliminary examination of issues allotted to them. CSSH-N and CSSH-S evaluate new health care legislations and bring forward a motion to the full parliamentary meeting. Based on their recommendations, the parliament has been revisiting the Health Insurance Act (HIA/KVG) since 2004.

Federal Department of Home Affairs (FDHA / EDI)
The FDHA is headed by the responsible Federal Councilor. The FDHA (“equivalent to a Ministry of Health”) is mainly responsible for public health, social insurance, education, culture, statistical office and Swissmedic, the Swiss Agency for Therapeutic Products. The FDHA executes the legal and regulatory framework for health care interventions and the Health Insurance Act (KVG: Federal Social Health Insurance Law). The FDHA is the very final decision maker for reimbursement of medical services, medical devices and for reimbursement and pricing of analytics and medical items.

Federal Office of Public Health (FOPH / BAG)
The FOPH is part of the Federal Department of Home Affairs (FDHA/EDI) with the key task to promote and maintain the health of all people living in Switzerland. The FOPH has the responsibility for health system regulation, definition of benefit baskets, price regulation and controls of the social health insurance. The FOPH is the final decision making body for pricing & reimbursement of drugs.

Swissmedic (Swiss Agency for Therapeutic Products– Schweizerisches Heilmittelinstitut)
Swissmedic is the central Swiss supervisory authority for therapeutic products including market authorization and market surveillance. It is a public service organization of the federal government and linked to the Federal Department of Home Affairs (FDHA/EDI). Swissmedic activities are based on the Swiss Law on Therapeutic Products (LTP/Heilmittelgesetz).

Federal Commission for Medical Benefits and Principles (FCMBP / ELGK)
The FCMBP is currently made up by 20 members and advising the FDHA/EDI on medical benefits and fundamental issues concerning the compulsory social health insurance. Advice and recommendation of the commission are in line with FOPH/BAG guidelines and based on effectiveness, appropriateness and cost-effectiveness. The commission covers a wide range of issues as: reimbursement & coverage, data protection, performance appraisal, admission requirements and collaboration with other commissions. The FCMBP plays a key role in the evaluation and appraisal of new medical benefits and medical devices. It may collaborate with experts.

Federal Analyses and Medical Items Commission (FAMIC / EAMGK)
The FAMIC is made up by 20 members. Its key task is to advise the FDHA/EDI both in setting up the positive list of analyses and in appraisal and reimbursement of medical items. The FAMIC forms two sub-committees one for analyses (FAMIC-AL / 13 members) and one for medical items (FAMIC-MI / 12 members). Advice and recommendation of the commission and its committees are in line with FOPH/BAG guidelines and based on effectiveness, appropriateness and cost-effectiveness. The commissions and committees are collaborating with experts.

Organization of Swiss Health Insurers (OSHI / santésuisse)
Santésuisse is the umbrella organization of the Swiss social health insurers. The OSHI is active in public health insurance policies, collaboration with institutions and negotiation of tariffs on the national level. The OSHI offers specific services for its member insurance companies.

SwissDRG AG (Corp.)
SwissDRG is a non-profit corporation founded in 2008 by Cantons (Federal States) and tariff partners. Shareholders are: Conference of the Cantonal Ministers of Public Health (SCCMPH/GDK), Organization of Swiss Health Insurers (OSHI/santésuisse), Swiss Hospital Association (H+), Swiss Medical Association (SMA/FMH), Service Center for Medical Tariff (ZMT). The key task of SwissDRG is to set up and maintain a uniform hospital tariff system in line with the Health Insurance Act (KVG).

Swiss Conference of the Cantonal Ministers of Public Health (SCCMPH / GDK)
The Swiss Conference of the Cantonal Ministers of Public Health serves as a political coordination body for the health ministers of the twenty-six Cantonal States of Switzerland. Its aim is to promote cooperation among the Cantons. It deals with important issues at the national level such as coordination of highly specialized medical services.

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REGUALTORY PATHWAY/ MARKET APPROVAL PROCESS

The Swiss regulations for medical devices (classical medical devices, in vitro diagnostics and active implantable medical devices (e.g. cardiac pacemaker)) are in line with European regulations. This means that the European directives 93/42/EEC, 90/385/EEC, and 98/79/EC are also valid for Switzerland and are enforced by national law, the Medical Devices Ordinance, MepV. Conformity assessment by a notified body (CE marking followed by the identification number) is required for the first placing on the market of medical devices of classes Is (sterile), Im (measuring function), IIa, IIb, III, active implantable medical devices and in vitro diagnostics of type annex II list A and B and self-testing. A duty to notify with Swissmedic according to Art. 6 of MepV has to be met for certain medical devices and for all medical devices which are derived from human tissue if the medical devices are placed on the Swiss market. The person who first places the medical device on the Swiss market or in a treaty country must establish a system for product surveillance and notify serious adverse incidents, which occurred in Switzerland, to Swissmedic (Articles 14 and 15 of MepV).Detailed information is provided at: http://www.swissmedic.ch/php/modules/leitfaden/leitfaden.html?lang=en

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REIMBURSEMENT AND COVERAGE/ PAYEMENT FLOW MAP AND PROCUREMENT PROCESS

Medical Services & Benefits
There is only a negative & conditional list for medical services and procedures in place in Switzerland. This means that Swiss physicians and hospitals enjoy the principle of trust. All medical services or procedures, which are efficient, appropriate and cost-effective, are basically covered by the social health insurance unless challenged by a health insurer (i.e. health insurance provider) and its medical examiner. Therefore, it is recommended to report new, modified or controversial medical services to the FOPH/BAG which will then decide whether an assessment and appraisal is necessary based on its internal review and written statements from the Swiss Medical Association (SMA/FMH) and the Organization of Swiss Health Insurers (OSHI/santésuisse). If assessment and appraisal are necessary the FOPH/BAG will inform the applicant which application pathway has to be followed. It is the responsibility of the applicant to provide scientific and economic evidence e.g. HTA reports. The FOPH/BAG will then assess the information in a standardized way including burden of disease; ethical, social and legal aspects; efficacy and effectiveness; appropriateness; cost-effectiveness. This assessment report goes to the Federal Commission for Medical Benefits and Principles (FCMBP/ELGK) for appraisal. The FCMBP/ELGK makes recommendation to the FDHA /EDI for final decision. The FDHA/EDI decides whether a medical service or procedure is “reimbursed”, “conditionally reimbursed” or “not reimbursed”. “Not reimbursed and conditionally reimbursed” medical services and procedures are listed in the “negative & conditional list”. The criteria for conditional reimbursement of medical services, procedures and devices are described in the “negative & conditional list”. Conditional reimbursement can include for example, a specific indication group, second line therapy, specific medical centers, ongoing evaluation with data gathering and annual reporting (“Coverage with Evidence Development”). Conditional reimbursement is valid until revocation.

Medical Devices
Medical devices must comply with the Swiss Law on Therapeutic Products (Heilmittelgesetz) for marketing approval (e.g. directives 90/385 and 93/42 EEC; CE-certification). The reimbursement process is pretty much in line with the one described above for medical services and procedure. Medical devices, which are efficient, appropriate and cost-effective, are basically covered by the social health insurance unless challenged by a health insurer and its medical examiner. It is recommended for the medical device company to complete first the report form and send it to the FOPH/BAG which will inform the company whether or not an assessment and appraisal process is necessary for coverage. If the answer is yes, then the medical device company has to submit scientific and economic evidence e.g. HTA report and follows the identical reimbursement decision process as outlined for medical services and procedures.

Analyses & Diagnostics
To be reimbursed, Analyses & Diagnostics must be included in the positive Analyses List, which is updated on an annual basis. All interested parties are eligible to apply for new diagnostics if it concerns the main section of the List. However, application for the general practitioners section (appendix A) requires a Federal organization e.g. Swiss Medical Association (SMA/FMH) as applicant. Specific regulations exist for other sections. An applicant submits the reporting form for a new or modified analysis or diagnostics to the FOPH/BAG. The FOPH may request additional data (application form) on a modular approach depending on novelty and changes. New analyses and diagnostics must be efficient, appropriate and cost-effective in comparison with existing methods. Then, the FOPH submits information and recommendation to the corresponding commission FAMIC/EAMGK (FAMIC-AL), which makes final recommendation to the FDHA/EDI for final decision.

Medical Items
Medical items are products used by the patient himself or by his assistance to control or treat a disease. Typical medical items are for example bandage, inhaler ...etc. Please note that implants or products with drug substance do not belong to this group. Medical items are medical products which must comply with the Swiss Law on Therapeutic Products (Heilmittelgesetz) for marketing approval and to fulfill the criteria’s of effectiveness, appropriateness and cost-effectiveness. The medical item list is divided into product groups and subgroups based on application and functionality, for e.g. inhalers, pumps, hearing aids, bandage, ...etc. The Medical items in a group or subgroup are only described in general terms (no brands). Approved handover points e.g. pharmacies must have contracts with health insurers. Everybody is entitled to submit an inquiry (reporting form) to the FOPH/BAG for a new entry, change or deletion of a product group. The FOPH/BAG is then asking to fill out the short application form for medical item changes and a long application form for a new, innovative or expensive product or concept. The FOPH/BAG submits information and recommendation to the corresponding commission FAMIC/EAMGK (FAMIC-MI), which makes final recommendation to the FDHA/EDI for final decision.

PAYMENT SYSTEMS

Out-patient Tariff System
TARMED is the Swiss Federal tariff system for medical services in the out-patient setting which covers all diagnostic and therapeutic services provided by a physician. Basically it is a Fee-For-Service (FFS) system with a uniform tariff point system at the federal level and a state-wide tariff point value negotiated between providers and health insurers. Reimbursement may be linked to provider’s qualification. Additional reimbursement can be claimed for medical disposables, consumables and implants exceeding a certain threshold of costs (General Interpretation GI-20). A public online tariff browser is available at: http://onb.TARMEDsuisse.ch/

In-patient DRG System
Switzerland had a fragmented payment landscape from per diem up to DRG payment. However, on January 1st 2012, a uniform Federal DRG system was introduced based on an adoption of the German DRG system. Medical services of all private and public hospitals, that have the canton’s permission to provide care covered by the social health insurance, are reimbursed based on Diagnosis Related Groups (DRG). The compensation for a DRG is calculated on the equation DRG = Cost Weight x Base Rate. Cost Weights are uniform on the Federal level but Base Rates will be negotiated between providers and health insurers and must be approved by the state government. Swiss DRG is using ICD-10 GM and Swiss procedure code (CHOP). DRG’s are co-financed by states (min. 55%) and health insurers (max. 45%). Investment costs are included in the DRG but public services are excluded. Nevertheless, a new health care financing system cannot be perfect from the beginning and adjustments will have to be made continuously over time. Current key issues are: quality of cost and performance data, data gap for Swiss cost weights, calculation of investment costs, prompt reimbursement of innovations and transitional arrangements for hospitals. At present, extra payment is only granted in five cases, especially in the area of dialysis. However, there is a general agreement that innovations must have the option for interim financing to bridge the time lag between new code/DRG application and implementation in the DRG tariff system which may take up to 5 years. Temporary finance of innovations is still in discussion and may include additional payment outside the DRG system for indisputable benefits, payer negotiation for inclusion in the Base Rate (assessed DRG) or Tariff negotiation with payers for non assessed DRG’s.

The DRG process is outlined below. It’s a two step process with coding, cost weights and DRG on the one side and pricing on the other side. A public grouper is available at: https://webgrouper.swissdrg.org/

SWISS-DRG Process Diagram

PRICING PROCESS

Medical Devices
All medical devices, which are efficient, appropriate and cost-effective, are basically covered by the social health insurance unless challenged by a health insurer (health insurance provider) and its medical examiner. There is a negative & conditional list in place covering not reimbursed or only conditional reimbursed medical services and procedures. If the reimbursement status is not challenged by a health insurer (health insurance provider/ health plan) or affirmed by the FDHA/EDI, payment will follow the DRG-Tariff in the in-patient setting. DRG pricing depends on two factors: first cost weight calculation by SwissDRG Corporation and second price negotiation between hospitals and health insurers (health insurance providers) on a state level or even on a hospital level. This means that DRG payment may differ from state to state or from hospital to hospital. Medical devices are subject to contracts with hospitals. The costs of medical devices are included in the flat rate DRG-tariff system. Therefore pricing for medical devices is strongly linked to DRG tariffs. Consequently, “real life” payment of a DRG-group is of utmost importance to the medical device industry. Normally innovations are linked with the application of new procedure codes and new or modified DRG-groups. However, it may take up to five years until such applications are implemented in DRG tariff system. Therefore hospitals may apply for interim financing of innovations for a limited period of time. Interim financing of an innovation may then be negotiated between hospitals and health insurers (health insurance provider). The health service provider must prove evidence that the new procedure or medical service is not included in the current DRG framework.

Analyses & Diagnostics
Analyses are reimbursed if they are included in the positive Analyses List. This list is only valid for the outpatient setting; in-patient prices of analyses are included in the DRG’s. Pricing and reimbursement of listed analyses are based on a federal regulated tariff system with federal tax points and a federal tax point value. The list of analyses is split into different parts; a systematic part and health service provider specific parts (appendixes A to C). Health service providers may earn additional tariff points based on their infrastructure and economic setting. Health service providers of basic medical care (General Practitioners) can only charge analyses of appendix A but negotiate tariff point value of sub list 1of appendix A. Specialist physicians, for example, in  immunology, haematology or microbiology can charge analyses of the extended list.

Medical Items
Medical items are products used by the patient himself or by his assistance to control or treat a disease. Typical medical items are e.g. bandage, inhaler etc. Please note that e.g. implants or products with an active substance do not belong to this group. The products are reimbursed if they are listed on the positive Medical Item list, prescribed by a physician and handed over by an approved handover point e.g. pharmacy. List prices are maximal allowable prices which are in line with average market prices. Health service providers as physicians, hospitals and long term care centers cannot claim reimbursement for medical items as they are compensated by the tariff system. Basically the reimbursement of all products may be limited to medical indications, quantity and usage duration.

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DATA REQUIREMENTS (HTA, PAYMENT DECISIONS)

Medical Services & Benefits
  • Basic information in the report form
  • Information on market approval and reimbursement status in other countries
  • It is the responsibility of the applicant to provide scientific and economic evidence that a new medical service or procedure is effective, appropriate and cost-effective  
  • Burden of disease
  • Legal, ethical and social aspects
  • Efficacy and safety
  • Effectiveness
  • Published cost-effectiveness studies; normally no specific CE-study required
  • Cost impact
  • Subcomponent procedure and cost details
  • Implementation information
Medical Devices
  • In line with the requirements for medical services and benefits
Analyses & Diagnostics
  • Basic information in the report form
  • Information on epidemiology
  • Prove of effectiveness, appropriateness and cost-effectiveness in comparison with existing methods
  • Proof of clinical benefit
  • Proof how to improve clinical pathway and how to assure quality
  • Proof of test parameter accuracy
  • Efficiency of the tariff
  • Cost-Impact
  • Cost-Effectiveness based on literature
Medical Items
  • Short application form
    • Outline of cost impact
  • Long application form
    • Efficacy, appropriateness and cost-effectiveness
    • Cost impact

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ACRONYMS

  • Federal Council: Der Bundesrat
  • FDHA (Federal Department of Home Affairs): EDI (Eidgenössisches Departement des Innern)
  • CSSH-N (Committee for Social Security and Health of the National Council):  SGK-NR (Kommission für soziale Sicherheit und Gesundheit des Nationalrates)
  • CSSH-S (Committee for Social Security and Health of Council of States): SGK-SR (Kommission für soziale Sicherheit und Gesundheit des Ständerates)
  • FOPH (Federal Office of Public Health): BAG (Bundesamt für Gesundheit)
  • FCMBP (Federal Commission for Medical Benefits and Principles):  ELGK (Eidgenössische Leistungs- und Grundsatzkommission)
  • FAMIC (Federal Analyses and Medical Item Commission): EAMGK (Eidg. Kommission für Analysen, Mittel und Gegenstände)
  • FAMIC-AL (Committee for Analyses / FAMIC): Ausschuss für Analysen der EAMGK
  • FAMIC-MI (Committee for Medical Items / FAMIC): Ausschuss für Mittel und Gegenstände der EAMGK
  • SCCMPH (Swiss Conference of the Cantonal Ministers of Public Health): GDK (Schweizerische Konferenz der kantonalen Gesundheitsdirektorinnen und – Direktoren)
  • SMA (Swiss Medical Association): FMH (Verbindung der Schweizer Ärztinnen und Ärzte)
  • SAMS (Swiss Academy of Medical Sciences): SAMW (Schweizerische Akademie der Medizinischen Wissenschaften)
  • OSHI (Organization of Swiss Health Insurers): santésuisse (Branchenverband der schweizerischen Krankenversicherer)
  • FSO (Federal Statistical Office): BFS (Bundesamt für Statistik)
  • Swissmedic (Swiss Agency for Therapeutic Products): Schweizerisches Heilmittelinstitut
  • LTP (Swiss Law on Therapeutic Products): Schweizerisches Heilmittelgesetz
  • HIA (Health Insurance Act): KVG (Bundesgesetz über die Krankenversicherung)
  • DIMDI (German Institute of Medical Documentation and Information): Deutsches Institut für Medizinische Dokumentation und Information
  • CHOP (Swiss Procedure Code): Schweizerischer Operationen und Prozeduren Kode
  • ICD-10-GM (German Modification of ICD-10): Deutsche Version von ICD-10
  • CE – Marking (European conformance mark): Europäische Konformitätsbezeichnung

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SUGGESTED READING

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USEFUL LINKS

Health Information Sources:

National Information Sources:

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REFERENCE

  • Please refer to useful links above. Official statements and wording may have been used in part
  • Tsung-Mei Cheng. Understanding the „Swiss watch“ function of Switzerland’s health system. Health Aff August 2010: 29(8), 1442-1451. (Interview with Thomas Zeltner M.D. former head of the FOPH)
  • The Swiss health system: structure, service providers, the health insurance act. FOPH 2nd revised edition December 2005 FOPH publication number: BAG KOM 10ext05010
  • FMH- Ärztestatistik 2009. Schweizer Ärztezeitung 2010; 91 (11), 431- 435.
  • Meyer B and Ingenpass P. SwissDRG Version 1.0: eine Einschätzung der FMH.
    Schweizerische Ärztezeitung 2011;92 (20), 733-734.
  • Wettstein J. Eine Übergangsregelung ist für die Einführung von SwissDRG zwingend. Interview mit Pierre-François Cuénod. Schweizerische Ärztezeitung 2011;92 (10), 354 - 356.

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AUTHORS & CONTRIBUTORS

Author: Kurt R. Müller, PhD, MSc, BBA; pharmaLevers GmbH, Switzerland

CONTRIBUTOR
Dr. Hermann Amstad, Secretary General of the Swiss Academy of Medical Sciences (SAMW)
Randa Eldessouki MBBCH, MSc, MD, Director, ISPOR Scientific Initiatives, ISPOR

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