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Implantable ventricular assist devices

An overview of market access challenges for implantable VADs in European countries

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Procedure coding

Typically, procedure coding is well-established for ventricular assist devices in European countries. 

For example, in England, a specific OPCS code K54.1 “Open implantation of ventricular assist device” exists to cover implantable VADs. Percutaneous VADs are coded separately. 

In some countries, only a limited number of procedure codes exist, while in others, a very detailed classification of VADs is available. 

For example, in Germany, OPS procedure coding distinguishes between different types of VAD systems, including mono- and bi-ventricular, intra- or para-corporeal devices, etc. 


Payment mechanism

The payment model varies by country.

In England, Netherlands, Norway, and most of other EU countries, the implantation of VAD is reimbursed solely via the diagnosis-related group (DRG) mechanism. 

In some countries (e.g. France and Germany), ventricular assist devices attract additional (top-up) reimbursement, which is paid in addition to the DRG tariff. 

For example, in Germany, many add-on ZE categories exist depending on the type of VAD (mono-, bi-ventricular; intra- or para-corporeal) with pricing mostly determined at the local level.

Add-on reimbursement can be either generic (at the class level, as in Germany) or brand-specific (with specific LPPR codes for individual brands in France). 


Policy considerations

Due to high cost, VADs can be subject to specific policies from payers or national decision-makers in the countries where such frameworks exist. 

For example, in England, the national payer, NHS England, developed so-called Service Specifications for the use of ventricular assist devices, in which NHS England outlined patient pathways, eligible hospitals, responsibilities of different stakeholders, etc. 

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Health technology assessment

Due to the high cost and high clinical risks for patients, and the existence of different clinical indications (bridge-to-transplant vs destination therapy), VADs are often a subject of HTA in different European countries. 

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Future challenges 

Classic VADs have established reimbursement and funding in most of the European countries. New health technology assessments are unlikely to be relevant. 

Classic VADs are unlikely to benefit from the innovative payment schemes. 

Novel ventricular assist devices with unique designs or properties, or different cost profiles might need to develop specific procedure codes and adjust payment mechanisms to fully leverage their unique technology or cost profile. 

An important topic for VAD is the expansion of indications towards destination therapy (in the countries, where it is not yet established). 

MTRC has experience with more than 26 projects, related to implantable ventricular assist devices in Europe

News and insights

The amended 2023/25 NHS Payment Scheme in England came into force on April 1, 2024

In late March 2024, NHS England released the amended 2023/25 NHS Payment Scheme (NHSPS) to come into force on April 1, 2024. No changes were made to the general payment model. Eight new items were added to the High Cost Devices List, and one new device was added to the MedTech Funding Mandate. New reimbursement codes and tariffs for three types of specialist radiotherapy were introduced. Furthermore, HRG tariffs were uplifted for 2024/25.

Open consultation on changes to the NHS Payment Scheme from April 2024 in England

In December 2023, NHS England launched a consultation regarding proposed changes in the 2023/25 NHS Payment Scheme for the 2024/25 financial year. The key changes concerned the High Cost Device List, top-up payments for specialized services, and payment for radiotherapy. The deadline for submitting comments is January 26, 2024.

Rapid HTAs of nine medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 13989 of June 29, 2023, Tuscany Regional Healthcare has published assessments of nine medical devices in the cardiovascular, peripheral vascular, diagnostic imaging areas, and surgical procedures.

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