Lung screening as a precedent.

As of April 1, 2026, lung cancer screening using low-dose computed tomography has become a covered benefit under health insurance. What distinguishes this program from other radiological services is the regulatory framework behind it: The Cancer Screening Directive (KFE-RL) mandates the use of appropriate computer-assisted diagnostic software for the interpretation of findings. The use of this software is therefore not an optional add-on, but an integral part of the service definition — and thus a prerequisite for reimbursement.

This marks the first time in the German healthcare system that AI-powered software has been formally incorporated into regulations in this way.

Program Overview

Since April 1, 2026, lung cancer screening using low-dose computed tomography (LDCT) has been a standard benefit covered by statutory health insurance. To this end, the Federal Joint Committee (G-BA) has expanded the Cancer Screening Guidelines (KFE-RL) to include a separate section on lung cancer screening.

Eligible participants include current and former heavy smokers between the ages of 50 and 75. The screening is available once a year; referrals are made by general practitioners or internists, while qualified radiologists perform the screening and interpret the initial findings.

For billing purposes, eight new, extra-budgetary fee schedule items (GOP) were added to the EBM effective April 1 — for consultation, report preparation, initial diagnosis, second opinion in cases of abnormal findings, and follow-up consultation.

Software use as a regulatory requirement

The KFE-RL stipulates that LDCT scans must first be interpreted without the use of appropriate computer-assisted diagnostic software, and subsequently with such software. This two-step procedure is not merely recommended; it is mandatory. The software is therefore an integral part of the defined service delivery process—not an optional technical feature that the practice may use at its discretion.

Practices participating in the program that wish to bill for the new GOP must provide evidence of and document their use of the software accordingly.

Why this is structurally significant

Under the German reimbursement system, AI has so far had no direct bearing on billing. Medical practices that have invested in AI solutions have done so at their own financial risk. There has been no formal link between the use of AI and health insurance coverage.

With lung screening, a different approach is emerging for the first time:

• AI is a prerequisite, not a distinguishing feature
  
• Non-use is no longer a neutral decision, but rather excludes from participation in the program
  
• The choice of software becomes part of the quality assurance, not the practice strategy

For radiology practices, the question is no longer whether to use AI, but which solution meets regulatory requirements—and how it can be integrated into existing workflows.

What this means in practice

The requirements for participating radiologists are extensive: specialized training in lung cancer screening, minimum case volumes (100 low-dose CT scans in the first year, 200 in the second), approval from the Association of Statutory Health Insurance Physicians (KV), and a cooperation agreement with a second reader at a lung cancer center.

Added to this is the structured integration of the diagnostic software into the practice workflow. Specifically, this means: How is the two-step diagnostic process (with and without AI) mapped out procedurally? How is it documented and transmitted to the health insurance provider? How is the practice prepared to handle technical issues that may arise during the diagnostic process?

These questions do not primarily concern the IT infrastructure, but rather the practice’s organizational processes.

Analysis and outlook

Lung screening is a regulatory pilot program. The G-BA has established evaluation criteria that primary care physicians must submit to the KV on a quarterly basis. The program is being monitored and evaluated.

If AI-assisted diagnosis becomes established as a hallmark of quality, it is likely that similar requirements will follow in other clinical areas. For radiology practices that establish clear processes for this program today, this will also provide a strategic foundation for future developments.

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