Skip to main content
Reimbursement strategy

Market Access Strategy for Medical Devices in Europe

Strategic recommendations on the topic of market access pathways for medical devices and IVD tests

Learn more

White Paper: Market access for in-vitro diagnostic tests in Europe

Get insights from MTRC White Papers to advance your understanding of European market access for IVD tests

Request free of charge
See details

Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
See details

Upcoming changes in reimbursement of human genetics tests in Germany

On June 11, 2026, the National Association of Statutory Health Insurance Physicians (KBV) announced a number of changes to the reimbursement of human genetics tests to be introduced as of October 1, 2026.

The package of changes includes, among other measures, a reduction in the reimbursement values for human genetic services and the introduction of additional volume-based reimbursement reductions at the practice level. These measures are intended to reduce expenditure on human genetic in vitro diagnostics (EBM subchapter 11.4 “In vitro diagnostics of constitutional genetic alterations”) by 31%.

The statutory sickness funds, which submitted the corresponding proposal to the meeting of the Extended Evaluation Committee, justified the reductions by citing “significantly decreased” costs of analytical equipment and consumables.

Some of the expected changes include:

  • Restructuring of the relevant EBM subchapters, update of the service descriptions and/or billing conditions for multiple EBM codes;
  • The reimbursement tariffs for all molecular genetic tests listed under subchapter 11.4 “In vitro diagnostics of constitutional genetic alterations” of the EBM catalog will be reduced. Sequencing tests for the diagnosis of rare diseases, listed in subchapter 11.4.3 “In vitro diagnostics of constitutional genetic alterations in syndromic or rare diseases” of the EBM catalog, will be particularly affected: their reimbursement will be cut by up to 25%. Furthermore, mutation screening using sequencing, previously reimbursed under code 11513 “Postnatal mutation screening to detect or rule out a disease-relevant or disease-causing constitutional genomic mutation”, will be replaced by four new codes, depending on the sequence length analyzed;
  • A new EBM code will be introduced for a surcharge for overhead costs and the scientific medical assessment and evaluation of complex genetic analyses in the individual clinical context for rare diseases.

The corresponding decision was made by the Extended Evaluation Committee on June 9, 2026.

This news is just one of about 300 market access news collected by our team in the premium subscription service MTRC Access Intelligence every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.