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Reimbursement Analysis for Medical Devices in Europe

Procedure coding, payment mechanisms, reimbursement tariffs, policy, and HTA considerations

Reimbursement analysis is performed to understand the current market access situation for medical technology.

This includes the availability of procedure codes, medical device reimbursement codes, understanding the payment mechanism and reimbursement tariffs, as well as policy (coverage) and HTA considerations. 

Since reimbursement analysis for medical devices is always a starting point for med tech companies, an analysis thereof helps to establish whether technology is reimbursed or not. If it is reimbursed, is this tariff sufficient? Are there any restrictions for the use of the product? All these factors are considered as part of the reimbursement analysis process. 

Once the reimbursement situation is clear, we work on a reimbursement strategy to determine how to establish or improve the reimbursement and general market access situation for medical technology. 

What is Included 
in the Scope?

MTRC is the leader in reimbursement analysis for medical technologies in Europe. We provide services to most of the major corporations, numerous small- and medium-sized enterprises, as well as other life sciences consulting companies. Over many years of practice, MTRC has developed a robust analytical and reporting methodology that answers all your key questions.

The typical scope of the project includes:

Analysis

REIMBURSEMENT

  • Availability of procedure / reimbursement code

  • Reimbursement mechanism (diagnosis-related group or fee for service)

  • Availability of add-on reimbursement

  • Availability of innovation funding

  • Reimbursement tariffs

NATIONAL FUNDING

  • Statements from national commissioners (e.g., NHS England)

  • Health Benefit Catalogues (e.g. in Spain, LEA Levels in Italy)

  • National clinical guidance (e.g. NICE in the UK, Haute Autorité de Santé in France, Socialstyrelsen in Sweden)

  • National health technology assessments in connection with reimbursement decisions (e.g. NICE for Technology Appraisal in the UK, Haute Autorité de Santé in France)

  • Specific funding frameworks (e.g., “New method” in Norway)

How Does the Analysis Work?

A typical project includes several steps:

Once the contract is concluded, our team defines the detailed scope of the project

This includes specifics of the technology and procedure (mechanism of action, surgical access, duration of procedure, imaging required, pre- and post-procedure requirements, length of hospital and Intensive Care Unit stay, cost of device/procedure), and specifics of analysis (e.g., characteristics of patients, the necessity of day case or admitted hospital analysis)

Analysts start the analysis in every country by analyzing procedure coding systems

Procedure coding is important as it defines payment mechanism and tariffs in any healthcare system. Our teams use official nomenclatures and coding manuals from coding/reimbursement authorities. Where possible, the findings are validated with other sources

Analysts proceed with determining the payment model

This is another crucial step in the analysis. Payment model can vary significantly and can include reimbursement via Diagnosis-Related Groups (DRG), add-on reimbursement, innovation funding, unbundled (top-up DRGs), fixed payment for procedures, amongst others

Analysts determine reimbursement tariffs

Once the payment mechanism is clear, it is possible to define reimbursement tariffs. Both national and regional systems are analysed, where relevant (e.g., in Finland and Italy)

Analysts obtain policy and HTA information

Reimbursement works hand in hand with funding and advisory frameworks in individual countries. For example, Diagnosis-Related Groups (DRG) and a good tariff can be in place, but authorities restrict the use of the method to a certain population. MTRC analyses the necessary policy frameworks, clinical guidelines by governmental bodies, and health technology assessments

Presentation of results to the client

Our teams always propose a free-of-charge teleconference to discuss the findings of reimbursement analysis, since results in multiple countries could be very complex and hard to understand. We offer the interpretation and inform the client about the existence of reimbursement barriers in particular countries 

The next step would be to work on reimbursement strategy in the situations where payment, coverage, or HTA barriers have been identified for technology in individual markets

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