Position paper · German source dated 5 August 2026

Innovation, evaluation and reimbursement pathway for emergency medical services

This English version reflects the current German source. In case of legal interpretation differences, the German text remains the reference version.

Core proposal

The German emergency-care reform should open the existing evidence-generation mechanism under §137e SGB V specifically to emergency medical services and complement it with an EMS-specific temporary trial reimbursement route under §133 SGB V.

The G-BA should remain responsible for assessment of potential and benefit, requirements for the evaluation programme and the final evidence-based decision. Federal states, EMS authorities and medical directors should retain planning, commissioning and operational implementation.

What the proposal does not do

It creates no automatic market access, no product-specific privilege and no reduction of medical-device, ethics, data-protection or clinical-trial requirements.

Why a gap remains

Emergency medical care is being recognised more clearly as a distinct health-care service, but innovative prehospital diagnostic and treatment methods still lack a complete route from potential assessment through reimbursable controlled evaluation to a possible decision on routine care.

Proposed process

1. Initiation: eligible manufacturers and other applicants remain able to apply; EMS providers and responsible state authorities should be able to trigger an evaluation.
2. G-BA potential assessment: novelty, benefit hypothesis, safety profile, evidence and suitability for prehospital use.
3. Evaluation directive: indication, comparator, endpoints, safety criteria, qualification, documentation and duration.
4. Lawful product use: only within applicable medical-device law or a lawfully authorised clinical investigation.
5. Temporary trial reimbursement: reimbursement of necessary additional costs without tying payment to patient transport.
6. Independent study and registry data: use existing data structures and independent scientific evaluation.
7. Final decision: routine care, further research or termination.

Patient safety

Key safeguards include lawful regulatory status, ethics review and protocol, independent safety monitoring, predefined stopping rules, no delay of established lifesaving measures and patient-relevant outcomes.

Example: early temperature control

Medicalcooling is used only as an example of a class of prehospital innovations. Mechanistic, preclinical and external clinical signals support a focused test of earlier temperature control. AIRCHILL has treated 0 patients; the next task is therefore to determine safety, thermal exposure, suitable patient population and the size of any possible patient effect prospectively.

Submission-ready review request

Parliamentary health-policy rapporteurs should examine whether §137e SGB V can be opened sector-specifically for new diagnostic and treatment methods in emergency medical services and whether a complementary rule under §133 SGB V can enable temporary, transport-independent trial reimbursement.

EMS reimbursement reality

German EMS fees and purchasing responsibilities vary regionally. Our district-level EMS reimbursement atlas documents sourced RTW, NEF, emergency-physician and dispatch fees, responsible bodies, payer logic and data gaps.

Conclusion

The aim is a legally clear, product-neutral and scientifically controlled route into evaluation — connecting innovation with patient safety and usable evidence.