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Free analytical and research White Papers on the topic of reimbursement, HTA and evidence requirements for medical devices and IVD tests in Europe

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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.
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The revised EBM catalog for the third quarter of 2024 published in Germany

The reimbursement of services in the public outpatient sector in Germany is regulated in the EBM catalog (Einheitlicher Bewertungsmaßstab), updated once a quarter (four times a year). The adaptation timeframe of the EBM catalog for a specific code is around five years but varies depending on the evidence. The latest EBM (German Uniform Evaluation Standard) catalog for the third quarter of 2024 was published on July 2, 2024.

The changes introduced mainly concern updating the content of several EBM sections with the respective comments and/or clarifications and introducing the new EBM codes for several companion diagnostics tests, for follow-up and evaluation of the “Kranus Lutera” health app, and for the services provided within the co-funded study on bronchoscopic lung volume reduction in severe pulmonary emphysema using thermal ablation (rp-RL BTVA).

The examples of the introduced changes are provided below:

  • The new code 01478 “Additional flat rate for follow-up and evaluation of the digital health application (DiGA) Kranus Lutera in line with the Directory for digital health applications according to §139e SGB V” with a tariff of €7.64 was introduced in the catalog;
  • Two new codes for companion diagnostics in breast cancer were introduced in the EBM catalog, for example:
    • 19466 “Targeted determination of ESR1 mutations using circulating tumor DNA to indicate a targeted treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer whose disease has progressed after at least one line of endocrine therapy, including a CDK 4/6 inhibitor, if this is mandatory according to the product information” with a tariff of €250.61. It will cover targeted detection of the activating mutations E380Q, L536H, Y537C/N/S, and D538G, as well as up to 4 further activating mutations in the ligand binding domain. The testing will be performed using PCR-based methods. The code can be billed twice in the case of the disease;
  • The following examples of codes for the services provided within the co-funded study on bronchoscopic lung volume reduction in severe pulmonary emphysema using thermal ablation (rp-RL BTVA) were introduced in the EBM catalog:
    • 61110 “Outpatient follow-up examination within the framework of the Erp-RL BTVA for patients in the control group” with a tariff of €55.02;
    • 61112 “CT examination of the thorax as part of the Erp-RL BTVA” with a tariff of €69.93;
    • 61114 “Flat rate for consultation hours in connection with the provision of the services under Section 61.9.2” [services listed above] with a tariff of €4.72.

The full details in German can be found here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor 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.