SWISSTEP / KNOWLEDGE LIBRARY
Regulation and reimbursement
US and EU pathways for clinical movement-monitoring products and services.
Three separate questions
Does the product meet the applicable medical-device requirements? Is there clinical evidence for the intended use? Will a payer reimburse the service? Each requires a separate answer. A sensor’s authorization does not authorize every algorithm or clinical claim built around it. This overview is educational, current to 19 Sep 2026, and is not billing or legal advice.
United States
For medical uses, assess the complete product’s intended use and applicable FDA pathway. Research use and commercial clinical use are distinct contexts. The FDA’s digital health technology guidance addresses remote data acquisition in clinical investigations; it is not a blanket marketing authorization.
Medicare distinguishes remote physiologic monitoring from remote therapeutic monitoring (RTM). A gait-related service is not automatically eligible for either. Confirm the device, condition, practitioner, data requirements, documented work, patient consent and payer policy. CMS remote-monitoring guidance.
Selected US RTM codes: 2026 orientation
| Code | Plain-language orientation | Important limit |
|---|---|---|
| 98975 | Initial RTM setup and patient education | Check initiation and billing requirements. |
| 98985 | Musculoskeletal device data: 2–15 days within 30 days | New 2026 option; not interchangeable with a longer collection period. |
| 98977 | Musculoskeletal device data: 16–30 days within 30 days | The 2026 descriptor specifies the collection interval. |
| 98979 | Treatment management: first 10 minutes in a calendar month | Requires qualifying real-time interaction; check time and combination rules. |
| 98980 / 98981 | Initial 20 minutes / additional 20-minute management increments | Do not double-count work or assume these combine with 98979. |
Paraphrased orientation, not the complete CPT descriptors. CMS transmittal R13431CP documents the 2026 changes; the CMS booklet covers broader rules. CPT is a registered trademark of the American Medical Association. Check current CPT instructions and the payer before billing; no payment amounts or PAtch coverage are asserted.
European Union: market access
Under the Medical Device Regulation (EU) 2017/745, intended purpose determines whether software is a medical device. Annex VIII Rule 11 addresses software classification, with higher classes for certain consequential decisions or monitoring functions. Determine the actual classification rather than treating all movement software as one class. Clinical evaluation, risk management and post-market obligations apply as relevant.
Read MDCG 2019-11 revision 1 (June 2025) alongside the regulation. Guidance is not legislation. Data protection and, where applicable, AI-specific requirements need a separate product-level assessment.
European reimbursement: national pathways
| Market | Example pathway | What it does not mean |
|---|---|---|
| Germany | BfArM DiGA directory under §139e SGB V | A CE mark alone does not grant DiGA listing or reimbursement; the application and evidence must meet the pathway’s requirements. |
| France | PECAN for eligible digital medical devices; transition toward LPPR or LATM as applicable | PECAN is time-limited early reimbursement, not automatic permanent coverage. |
| Other EU countries | National or regional coverage, procurement and contracting arrangements | There is no single EU equivalent of a universal US gait-monitoring billing code. |
France’s HAS evaluation overview separates assessment for reimbursement from CE marking. Obtain country-specific advice before making commercial coverage claims.