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Open heart valve replacement and repair

An overview of market access challenges for open heart valve replacement and repair in European countries

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Procedure coding

Procedure coding for open heart valve replacement and repair is well-established in European countries. Procedure codes may differ depending on the anatomical site (heart valve treated). The type of valve (biological, mechanical, etc.) can be specified in the code description or coded separately. Extracorporeal circulation support during surgery is typically coded separately.

For example, in the Netherlands, open aortic valve replacement with biological valve is described via the combination of procedural code 033079 “Heart valve replacement, open procedure” and material code 190618 “Allograft heart valve prosthesis”.  Extracorporeal circulation support is coded separately via the code 032671 “ECC perfusion per operating room session”.

Procedure coding for open heart valve repair in some European countries differs depending on the type of intervention. For example, in Denmark, procedure coding for open mitral valve repair includes code KFKC00 for suture of the mitral valve, code KFKC20 for plasty of the mitral valve, and code KFKC60 for resection and reconstruction of mitral valve leaflets.

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Payment mechanism

In most EU countries, DRG is the key reimbursement model for open heart valve replacement and repair procedures. The cases with complications or combined interventions can be allocated to the DRGs with higher reimbursement tariffs. For example, in Norway, open heart valve replacement procedures are allocated to the DRG “Heart valve operation without complications” with a tariff of 253,873 NOK, whereas in the presence of complications or combined heart valve operations are reimbursed via DRG 104B “Multiple heart valve surgery or a heart valve operation with complications” with a tariff of 398,078 NOK.

The devices for open heart valve repair and replacement procedures typically do not attract additional reimbursement in European countries. However, in England, there is a specific category in the High Cost Devices List “Sutureless aortic heart valve / rapid deployment aortic heart valve replacement”. 

In some countries, the type of device used for the intervention might impact the DRG allocation. For example, in Switzerland, the use of self-expanding sutureless xenograft for open aortic valve replacement is allocated to the DRG F03C with a higher tariff of 48,840 CHF for an ordinary hospital stay compared to DRG F03E with a tariff of 36,180 CHF for the replacement procedure with conventional biological valve.

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Policy considerations

As open heart valve repair and replacement procedures are well-established technologies, they are unlikely to be subject to specific policies from payers or national decision-makers in the countries where such frameworks exist. 

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Health technology assessment

Due to established reimbursement in European countries, devices for open heart valve repair and replacement procedures rarely become a subject of HTA. 

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Future challenges 

Open heart valve repair and replacement procedures have established reimbursement and funding in most European countries. New health technology assessments are unlikely to be relevant. Open heart valve repair and replacement procedures are unlikely to benefit from the innovative payment schemes. 

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

MTRC has experience with more than 6 projects related to open heart valve replacement and repair in Europe

News and insights

The 2024 list of medical technologies approved for innovation funding (NUB) released in Germany

On January 30, 2024, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2023. The medical technologies of cardiovascular, ENT, extracorporeal, gastrointestinal, neuromodulation, and other technology groups obtained positive status 1.

Recommendations about add-on reimbursement for medical devices in France in August 2023

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2023. Eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular and neurovascular devices, as well as medical aids.

MedTech-related technology assessments and clinical guidelines from NICE in August 2023

In August 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (aortic valve reconstruction with glutaraldehyde-treated autologous pericardium for aortic valve disease) and one new Diagnostic Guidance (quantitative faecal immunochemical testing to guide colorectal cancer pathway referral in primary care). Also, five clinical guidelines were updated.

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