Plan for Coverage. Not Just Authorization.
Reimbursement & Market Access
Every decision in your device program, from the first clinical endpoint to market access, shapes your path to coverage. Mittal Consulting connects coding, coverage, and payment strategy with your regulatory and clinical planning from the start, so the evidence you build for FDA also makes a compelling case for commercial coverage.
Reimbursement Services
In-Depth Strategy
Reimbursement decisions carry through every stage of a device program, from early development and clinical studies to launch and adoption. Mittal Consulting builds reimbursement strategy alongside regulatory and clinical planning from the start, so the evidence built for FDA also builds the case for coverage. As an extension of the client's team, Mittal Consulting sets regular touchpoints matched to where the client is in their journey, from early planning through market access.
Reimbursement and Market Landscape Analysis
How a device is understood by payers early shapes every reimbursement decision that follows. Each Reimbursement and Market Landscape Analysis is built on in-depth knowledge of the device, its intended use and the procedure it supports. Our expert team examines how comparable procedures are coded, where Medicare and commercial payers currently stand on coverage, and how payment is structured across care settings. The analysis identifies the stakeholders whose decisions influence access, from payers to the clinicians and hospital leaders who choose new technology, and studies how comparable devices earned coverage. Clients receive the opportunities, barriers and key action items for their device, structured for board and investor conversations, and a foundation for the reimbursement roadmap that follows.
Coding, Coverage and Payment
Coding, coverage and payment are interdependent, and a decision in one carries into the other two. Each strategy draws on a deep understanding of the device and current CMS and commercial payer policy. Our team examines whether current codes fit the device and procedure as they are used in practice, and where a new code may be warranted. Coverage strategy begins with existing payer policy and connects study endpoints to the evidence payers look for, while study design can still be shaped. Payment is assessed in each care setting, along with add-on pathways such as NTAP and transitional pass-through where they apply. Clients move forward with a coordinated plan across all three, built in step with their regulatory strategy and positioned for adoption by the hospitals and physicians who use the device.
Ongoing Market Access Support
Reimbursement continues to evolve after launch, as CMS rulemaking and coding updates reshape the landscape each year. As an extension of the client's team, Mittal Consulting supports the program through launch and beyond, bringing a reimbursement perspective into commercial decisions as they are made. Policy and coding changes relevant to the device are tracked and assessed against the client's strategy, and the plan is refined as new evidence emerges. Clients keep a reimbursement strategy that stays current with policy and with their own growing body of evidence.
Reimbursement Strategy FAQ
Why should a medical device company plan its reimbursement strategy from the start?
FDA authorization brings your device to market, and coverage shapes how widely it is adopted. Many of the factors payers weigh, from the evidence you generate to how your device is positioned in clinical practice, are set long before launch. Planning reimbursement from the start lets your team shape those factors deliberately, with a clear view of what payers will need.
Can a novel medical device use existing CPT or HCPCS codes, or does it need a new code?
The answer depends on how your device and its use fit within the current coding landscape, and it shapes your coverage and payment strategy from there. Mittal Consulting evaluates that fit as part of your coding strategy, so your team understands the implications early and plans accordingly.
How can FDA clinical evidence also support payer coverage for a medical device?
FDA and payers ask different questions of the same data. Mittal Consulting aligns your clinical endpoints, populations, and follow-up with both in mind, so the evidence you build for FDA also makes a compelling case for commercial coverage.
How does reimbursement strategy strengthen investor and board conversations?
Investors look for a credible route to coverage alongside a pathway that will hold. A reimbursement strategy built in step with your regulatory plan gives your leadership team a clear, defensible answer to how your device reaches the market and gets paid for.
Make the case for coverage from day one.
Give payers a clear, compelling case for your device, aligned with your regulatory pathway from early planning through market access.