Early-Stage MedTech Reimbursement Readiness Quiz

Answer these 9 questions to gauge whether now is the right time to start planning your reimbursement strategy—or if waiting could cost you down the road.

Is your clinical study design focused solely on gaining FDA Approval?

Choose an answer *

A. Yes, our main goal is FDA approval, and we haven’t factored in other requirements.

B. We’re aiming for FDA approval but considering additional endpoints that matter to payers.

C. No, we’re incorporating payer-related endpoints like improved patient outcomes from the start.

Have you identified the key stakeholders who will ultimately decide if your product gets reimbursed (e.g., payer medical directors, hospital procurement teams)?

Choose an answer *

A. No, we haven’t identified stakeholders beyond the regulatory path.

B. We have a general idea but haven’t engaged with them yet. One thing at a time!

C. Yes, we’ve identified key stakeholders and are planning or have already done some outreach.

Do you understand how reimbursement codes (e.g., CPT, HCPCS) might apply to your technology or procedure?

Choose an answer *

A. No, we haven’t looked into coding yet. It's not necessary at this stage.

B. We’ve started researching codes but need more information.

C. Yes, we’re aware of potential codes and their implications for coverage. (Besides, we want to be ready when potential investors ask!)

Are you aware of how payer expectations differ from FDA requirements in terms of clinical evidence?

Choose an answer *

A. There aren't really any differing expectations. Once you establish safety and efficacy, payers should be able to cover it just fine.

B. We’ve heard that payers look for different data, but we’re not sure what.

C. Yes, we know that payers require data on clinical utility and comparative effectiveness, and already have an idea of the different endpoints to plan for.

Have you considered how payer feedback might influence your product’s design or validation process?

Choose an answer *

A. No, our end users and patients are the most significant parties in design and validation, so we haven't bothered with payers.

B. We’re aware payer input is important but haven’t sought it yet.

C. Yes, we’ve started incorporating payer feedback into our development plans. (In some cases, we even pivoted slightly on our product design! Thank goodness we caught that early.)

Do you have a strategy for engaging payers early in your development process to validate your technology’s value proposition?

Choose an answer *

A. Oof, first thing's first. We've got to get through FDA.

B. We plan to engage payers early-ish, but haven’t started yet. (Actually, we have no idea what "early" means.)

C. Yes, we have a plan to engage payers all throughout the process, even in the earliest stages of development.

Have you validated your value proposition with multiple healthcare stakeholders (e.g., payers, physicians, hospital procurement, patients)?

Choose an answer

A. No, we’re only focused on product development and FDA approval.

B. We’ve considered it, but we feel different stakeholders come into play at different stages.

C. Yes, we’ve validated our value proposition with several key stakeholders in multiple categories to ensure alignment.

Are you tracking reimbursement policies for similar technologies or competitors in your space?

Choose an answer *

A. You can do that?

B. We have some awareness of the big ones making headlines but need more detailed research.

C. Yes, we’re actively tracking payer policies for similar technologies and modalities and have already gleaned some pitfalls to avoid.

Do you know the payer mix (Medicare, Medicaid, private) that will be most relevant to your target patient population?

Choose an answer *

A. Pretty much. (Medicare is for the elderly, right? Or is that Medicaid?)

B. We have an idea but need to dig deeper into the payer landscape.

C. Yes, we’ve identified the key payers and are considering how to engage them and position ourselves based on the populations they serve.

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