Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.
- AMA denies Echo IQ’s Category III CPT code application for EchoSolv AS
- Company to consider AMA reconsideration request within 14 days
- Ongoing engagement with AMA on new AI-focused Clinically Meaningful Algorithmic Analysis (CMAA) codes
- Advancing FDA submission for EchoSolv HF alongside US deployment expansion
- Focus on increasing use of Miscellaneous Code 93799 and pursuing partnerships
Regulatory Hurdle in US Market
Echo IQ Limited, an Australian AI-driven medical technology company, has encountered a significant regulatory setback in its efforts to secure a dedicated reimbursement code in the United States. The American Medical Association (AMA) recently declined the company’s application for a Category III Current Procedural Technology (CPT) code for its EchoSolv AS technology. This code is crucial for standardising reimbursement and facilitating broader adoption within US healthcare systems.
The decision, announced on 3 October 2025, means Echo IQ must continue relying on the less specific Miscellaneous Code 93799 for reimbursement, which can complicate billing and limit commercial traction. However, the company is not standing still and is actively evaluating its options, including lodging a formal reconsideration request with the AMA within the next 14 days. This process allows applicants to challenge decisions if they believe relevant information was overlooked or procedural errors occurred.
Looking Ahead – New AI-Specific Coding Framework
Echo IQ’s management is also closely monitoring the AMA’s development of a new coding framework tailored specifically for AI-based medical technologies. The CPT Digital Medicine Coding Committee has proposed a novel category called Clinically Meaningful Algorithmic Analysis (CMAA), which aims to introduce codes that better capture the value of AI tools that augment physician decision-making and improve patient outcomes.
These CMAA codes are expected to be implemented in 2026 and could provide a more precise and supportive reimbursement pathway for Echo IQ’s products. The company views this as a promising avenue to secure more robust and standardised reimbursement, which is critical for scaling commercial operations in the US market.
Parallel Commercial and Regulatory Efforts
While navigating reimbursement challenges, Echo IQ is advancing other strategic initiatives. The company is progressing its FDA submission for EchoSolv HF, a complementary product, following the anticipated completion of a validation study with the Mayo Clinic. This regulatory milestone is expected to unlock further commercial opportunities.
Simultaneously, Echo IQ is expanding the deployment of its EchoSolv platform across US hospitals and clinics, leveraging the existing Miscellaneous Code 93799 to increase usage. The company is also pursuing licensing and partnership agreements to strengthen its commercial footprint and accelerate adoption.
CEO Dustin Haines acknowledged the disappointment but emphasised the company’s commitment to ongoing engagement with the AMA and regulatory bodies. He highlighted the parallel efforts to drive adoption and create long-term shareholder value despite the current setback.
Bottom Line?
Echo IQ’s path to US reimbursement remains complex but evolving AI-specific coding frameworks could unlock new opportunities.
Questions in the middle?
- Will Echo IQ’s reconsideration request with the AMA succeed in securing a Category III CPT code?
- How quickly will the new CMAA coding framework be implemented and adopted by payers?
- What impact will FDA clearance of EchoSolv HF have on the company’s US commercial prospects?