# Emergency Care Reform 2026: EMS Innovation & Trial Reimbursement | Ethical Saving

> Current Ethical Saving position paper on opening §137e SGB V to emergency medical services and creating a temporary transport-independent trial reimbursement route under §133 SGB V.

- Canonical: https://ethicalsaving.org/en/position-paper-emergency-care-reform-2026/
- Markdown: https://ethicalsaving.org/en/position-paper-emergency-care-reform-2026/index.md
- Language: en
- Last modified: 2026-08-23T17:05:39+00:00

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

- Initiation: eligible manufacturers and other applicants remain able to apply; EMS providers and responsible state authorities should be able to trigger an evaluation.
- G-BA potential assessment: novelty, benefit hypothesis, safety profile, evidence and suitability for prehospital use.
- Evaluation directive: indication, comparator, endpoints, safety criteria, qualification, documentation and duration.
- Lawful product use: only within applicable medical-device law or a lawfully authorised clinical investigation.
- Temporary trial reimbursement: reimbursement of necessary additional costs without tying payment to patient transport.
- Independent study and registry data: use existing data structures and independent scientific evaluation.
- 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](https://ethicalsaving.org/en/ems-fees-germany-districts/) 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.