International Reimbursement Pathways: Germany's DiGA, France's PECAN/LATM, and Where the US Still Lags

Clearance is not payment. A CE mark under the EU MDR or an FDA clearance tells you that you may sell a product; it tells you nothing about whether anyone will pay for it. What separates Germany and France from the United States right now is not the regulatory bar — it is that both countries built a named, dated, statutory route from authorisation to reimbursement for software, and the US did not.

For any digital health or software-as-a-medical-device company deciding where to launch first, that difference is often worth more than market size.

Germany: DiGA, the first statutory route for prescription software

Germany's Digital Healthcare Act created the DiGA pathway in 2019, and it remains the clearest example of a country treating software as a reimbursable treatment rather than an IT purchase. A manufacturer applies to BfArM, the federal regulator, through a fast-track process with a statutory review clock. Approved products are listed in the BfArM DiGA directory, prescribed by physicians, and paid for by statutory health insurance covering roughly 90 percent of the German population.

Two things make it commercially distinctive.

First, the provisional listing. A product that meets the safety, data protection, interoperability and quality requirements but cannot yet prove clinical benefit can be listed provisionally for a trial period of twelve months, during which it is fully reimbursed while the manufacturer runs the study needed to demonstrate a positive care effect. That is a paid evidence-generation window — the thing almost every software company says it cannot afford.

Second, the price reset. In the first year the manufacturer sets the price. After that, the price is negotiated with the GKV-Spitzenverband against a reimbursement framework, and in practice second-year prices fall substantially. Companies that model German revenue on year-one pricing consistently overshoot.

The market is real but smaller than early forecasts suggested: the directory holds several dozen listed applications, and cumulative spend and activation-code volumes have grown steadily each year since 2020 without reaching the scale originally projected. Treat Germany as a credible, well-defined route — not a volume windfall.

France: PECAN for early access, LATM for the durable line

France took a different shape but solved the same problem. PECAN — *prise en charge anticipée numérique* — provides one year of derogatory reimbursement by the national health insurer for therapeutic digital medical devices and remote-monitoring solutions that are mature enough to be used but not yet through full evaluation.

The mechanics matter. Applications are assessed by the Haute Autorité de Santé through its CNEDiMTS committee, submitted via the Sésame platform, and require a conformity certification from the Agence du Numérique en Santé covering interoperability and security. That certification step is the one most non-French manufacturers underestimate; it is a distinct workstream with its own lead time.

PECAN is explicitly a bridge. It buys a year of payment and real-world use while the manufacturer assembles the clinical and economic dossier needed for the permanent route — inclusion on the LPPR, or for remote monitoring, the LATM *ligne générique* for télésurveillance activities. A company that treats PECAN as the destination rather than the on-ramp will hit a payment cliff at month thirteen.

Where the US still lags

The United States has no single named pathway for software reimbursement. An FDA-cleared algorithm enters a coding and coverage process that is handled case by case: find or create a CPT or HCPCS code, argue a payment rate, then pursue coverage payer by payer. Products routinely spend years authorised and unpaid. Read our FDA pathways guide for how the authorisation side sequences.

Two things are finally moving.

CMS's CY2027 OPPS proposed rule introduces a "Software as a Medical Service" framework, with a dedicated payment status indicator and a defined set of HCPCS codes routed to New Technology APCs — the first time the agency has treated software as its own payment category rather than an incidental supply. We covered it in what the CY2027 OPPS rule means for you.

The Health Tech Investment Act (S.1399) would go further, writing a five-year guaranteed New Technology APC window into statute and basing rates on manufacturer-submitted cost data. It remains in Senate Finance Committee. See what S.1399 would change.

Both are real progress. Neither yet gives a US product the thing DiGA and PECAN give in Europe: a defined date on which payment begins.

Side by side

Entry trigger. Germany: BfArM fast-track application after CE marking. France: PECAN application to HAS plus ANS certification. US: code assignment, then payer-by-payer coverage.

Evidence bar at entry. Germany: safety, data protection, interoperability — clinical benefit can be deferred. France: sufficient maturity and preliminary clinical data. US: no defined bar, because there is no defined entry.

Guaranteed payment window. Germany: twelve months provisional. France: twelve months under PECAN. US: none today; five years if S.1399 is enacted.

Who sets the price. Germany: manufacturer in year one, negotiated thereafter. France: negotiated with the CEPS pricing committee. US: CMS methodology, or commercial contracting.

What happens after. Germany: permanent listing or delisting. France: transition to LPPR or the LATM line. US: unchanged, until the SaMS framework or legislation settles.

What to do about it

Sequence reimbursement as a market-selection input, not a post-clearance afterthought. Three concrete moves:

1. Design the German trial year into your evidence plan. A provisional DiGA listing pays for the study that unlocks the permanent one. That only works if the study protocol exists before you apply. 2. Start the French certification workstream early. ANS interoperability and security conformity is the long pole in a PECAN submission, and it does not compress. 3. Build the US cost-data file now. Invoice pricing, subscription structures, staffing and overhead, in auditable form. Both the SaMS framework and S.1399 are cost-data-driven, and the companies with that file assembled will move first.

If you are weighing which of these markets to enter and in what order, that is exactly the comparison MedTech Compass is built to run — scoring 25+ markets on regulatory burden, reimbursement route and payment forecast side by side. For the underlying regulatory work, see our EU MDR and UKCA guide and the market access guide.

Sources

1. BfArM — The Fast-Track Process for Digital Health Applications (DiGA): A Guide 2. BfArM — DiGA directory of approved digital health applications 3. GKV-Spitzenverband — DiGA report under §33a SGB V 4. Haute Autorité de Santé — Dispositifs médicaux numériques : la prise en charge anticipée 5. HAS / CNEDiMTS — Principes d'évaluation, Volume 4 : PECAN 6. G_NIUS / Agence du Numérique en Santé — Advance Digital Care (PECAN) 7. Agence du Numérique en Santé — PECAN conformity certification pathway 8. Congress.gov — S.1399, Health Tech Investment Act, 119th Congress

This briefing summarises national reimbursement policy for general strategic awareness. It is not legal, regulatory or reimbursement advice. Programme rules, pricing frameworks and pending US legislation are subject to change; consult qualified counsel and local market access advisors before making commercial decisions.