US market access strategy that brings regulatory, reimbursement, and commercial planning together from the start.

Regulatory pathway and claims

We advise clients on regulatory pathways for their products (510(k), De Novo, PMA), Breakthrough Device designation, or, where appropriate, a non-device route for general wellness or clinical decision support products, with evidence planning to support product claims and communication with FDA to confirm the intended approach.

FDA follows how companies and their customers promote new products on their websites, in marketing materials, and on social media, and reads claims made as evidence of intended use. We help clients build a claims architecture in which the indication, the label, and the commercial message are consistent and comply with all applicable regulations. We also help clients monitor promotion after authorization.

Care pathway and site of service

Patients move through the health system along evidence-based care pathways. Some products can be meaningfully introduced at different points along the treatment pathway. We analyze the volume of patients at different nodes along the pathway to advise clients on where appropriate patients can be identified and reached, and help them prioritize steps to enter the market at each of these points over time. In some cases, engaging patients earlier on the care pathway can help grow the number of accessible patients downstream.

In addition, the same product may be paid differently depending on the site of service in which it is used.

Coding, coverage, and payment

A reimbursement roadmap is built around the site of service in which medical products are used. In some settings, new, product-specific coding helps differentiate product value and drives adoption; in others, where no product-specific coding or additional product-specific payment is available, new products are valued through the existing payment for the procedure or episode of care, and adoption depends on the savings or efficiencies they bring to clinicians, hospitals, and health systems.

The same technology may be paid separately in some sites of service and bundled into existing payments in others.

The roadmap sets out whether existing CPT and HCPCS codes describe the service or whether new, unique coding is needed, how coverage will be established with Medicare contractors, Medicare Advantage plans, and commercial payers, and what payment level the service can support. Payment targets are benchmarked to comparable services, and a claims record is built from the first commercial use so that new codes can be valued on documented experience, in addition to specialty society questionnaires.

Customer value and adoption

Clinicians, hospitals, and health systems respond to product value when it is presented in the terms most relevant to them: improved clinical outcomes, patient satisfaction, increased throughput, lower cost per episode of care, improved margins, etc. We build customer-specific economic models and help identify clinical champions and leading hospitals and health systems where clients may establish a US beachhead from which they can build a clinical and commercial network. Real-world data and a US track record then strengthen a company's position as it reaches out to subsequent customers.

Evidence across stakeholders

Robust clinical and economic evidence is the connective tissue across all of these. FDA, payers, clinicians, hospitals, health systems, investors, and patient groups each ask different questions of the same data.

An integrated evidence development plan inventories existing evidence assets, including evidence developed both in the US and in other markets where study subjects are similar to US patient populations, and identifies the gaps. It then lays out a single plan, with study options, timelines, and costs, that answers as many of those questions as possible, so the company can grow its evidence base over time with new studies and analyses.

Clinical trial reimbursement and early payment pathways

For some investigational devices, Medicare may cover the routine costs of care in qualifying clinical studies conducted before marketing authorization, which can reduce trial cost.

Soon after marketing authorization, other pathways can help build the experience and evidence needed for payment and product adoption, including Medicare coverage pathways for devices with Breakthrough designation, and pilot studies or shared-savings arrangements with integrated delivery networks and Medicare Advantage plans.