US Reimbursement for Medical Devices and IVDs
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Reimbursement Medical Devices and IVDs
Market entry is only the first hurdle. For novel medical technologies in particular, clinical adoption can be a far greater challenge, one that in the US is often determined by reimbursement.
NAMSA partners with medical device and IVD manufacturers to design and execute US reimbursement strategies that support payer relations, medical policy research, coverage advocacy, HCPCS and CPT code analysis/applications, clinical trial coverage, and health economic analysis, while aligning with your clinical and regulatory roadmap from early development through commercialization.
Our US Reimbursement Offering
NAMSA brings deep experience in US reimbursement consulting tailored to the unique challenges of medical devices and diagnostics, across all product classes and technology types. We help you anticipate reimbursement barriers, generate the right evidence, and navigate payer requirements with confidence.
MedTech Reimbursement Strategy
NAMSA understands US government and private payer coverage and payment policies under a health economics environment. As such, our team designs strategies surrounding specific objectives that are targeted toward reimbursement barriers that would otherwise limit broad market adoption of emerging medical technology, including the use of clinical and health economics evidence to secure coverage.
- Coding Analysis: Our coding analysis ensures that the medical device is associated with the most relevant and up-to-date codes, maximizing the chances of accurate and timely reimbursement. In addition, it contributes to the successful market access of our clients’ medical devices, fostering a positive environment for product adoption.
- Coverage Policy Research and Payer Interviews: NAMSA helps you open the doors to coverage through targeted medical policy research and payer engagement. Through primary research with health plan Medical Directors and clinician advisors, NAMSA evaluates payer and provider perceptions of new technologies, either prior to market entry or before final design decisions. These insights help de‑risk investment, inform product strategy, and guide medical policy engagement.
- Reimbursement Landscape Assessment: We evaluate coding, coverage, and payment dynamics across care settings (inpatient, outpatient, hospital, clinic, home care), payer mix, and comparable technologies. This assessment forms the basis of a practical, adoption‑focused reimbursement strategy.
- Reimbursement Due Diligence: NAMSA can perform Reimbursement Due Diligence for venture capital companies and other investors to assess market risk for reimbursement prior to investment.
Coding Applications
A proactive coding strategy is essential for many MedTech reimbursement plans. NAMSA successfully guides clients through the process of securing temporary or new codes, providing strategic support throughout what can be a lengthy process in gaining the clinical evidence and support necessary. Although it can be a long process, it can catapult a new technology into the payment pipeline.
Health Economics Analysis
As payers consider evidence of cost, as well as clinical effectiveness, before covering new technology and services, health economics analysis has become essential to coverage decisions. NAMSA works with MedTech companies and payers, considering the varying types of analyses required to demonstrate cost-effectiveness and to accelerate favorable medical policy coverage.
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Coverage Throughout IDE Clinical Trials
Many device manufacturers do not realize that Medicare, as well as some commercial insurers, will cover new devices during a Category B Investigational Device Exemption (IDE) clinical study. We work with Medicare and health insurance providers to set -up payment and billing systems for IDE studies to support ongoing provider enrollment within clinical studies.
Deep Expertise Across the Product Lifecycle
NAMSA brings decades of experience supporting medical device and IVD manufacturers, from early innovation through post‑market expansion. Our reimbursement experts work collaboratively with regulatory, clinical, and biostatistics teams to ensure strategies are cohesive, defensible, and execution‑ready.
Unlike standalone reimbursement consultancies, NAMSA aligns reimbursement strategy with:
This integrated approach ensures your reimbursement plan is built on the right evidence from the start, not retrofitted after approval. Whether you are in early development, preparing for FDA submission, or planning US market entry, NAMSA helps you anticipate reimbursement challenges, align evidence to payer expectations, and accelerate patient access.
Frequently Asked Questions (FAQ)
What is reimbursement for medical devices and IVDs?
Reimbursement refers to the process by which healthcare providers receive payment for using a medical device or performing a diagnostic test. In the US, reimbursement is determined through three interrelated components: coverage (whether a payer will pay), coding (how the service or technology is described), and payment (how much is paid).
When should reimbursement planning begin?
Reimbursement strategy should begin early in product development, ideally before pivotal clinical studies are designed. Early planning ensures that clinical, regulatory, and economic evidence is aligned with payer expectations and reduces the risk of delays or gaps after market entry.
Is FDA approval enough to secure reimbursement?
No. FDA approval demonstrates safety and effectiveness, but payers require additional evidence to assess clinical value, medical necessity, and economic impact. A reimbursement strategy helps bridge the gap between regulatory approval and payer decision‑making.
What evidence do payers expect for reimbursement decisions?
Payers typically look for evidence that demonstrates: clinical benefit compared to the current standard of care; impact on patient outcomes; relevance to real‑world clinical practice, and economic or system‑level value. Evidence expectations vary by payer and should be planned proactively.
What role does Medicare play in US reimbursement?
Medicare often sets the precedent for reimbursement pathways in the US. Medicare coverage, coding, or payment decisions can significantly influence commercial payer adoption, making early Medicare strategy a key component of US reimbursement planning.
Can reimbursement challenges be fixed after product launch?
While post‑launch remediation is possible, it is often costly, time‑consuming, and disruptive. Addressing reimbursement early, before clinical and regulatory decisions are finalized, reduces risk and supports faster, more predictable market access.
Meet Our Reimbursement Experts
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Investigational Device Exemptions (FDA IDE)
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