Start Earlier Than You’d Think: Why Early Coding Strategy Is a Game Changer for Medtech Innovators

When you’re bringing a new technology to market, reimbursement may feel like something you can tackle “after FDA.” The reality is very different. The pathway to coverage and payment starts far earlier than most founders and executives realize. Waiting until clearance or approval to think about coding can add years of unnecessary delay to your commercialization timeline.

The Value of Starting Early

An early coding assessment helps you understand whether your technology can fit into existing CPT® or HCPCS codes—or whether it will require its own pathway. If a suitable existing code is available, you can plan a market access strategy around it, which is often the most efficient option. When no existing code applies, a new code application becomes necessary. That process runs on the fixed calendars of the AMA CPT® Editorial Panel or the CMS HCPCS process, which means missing a cycle can set you back a full year.

Beginning this work early avoids scrambling later. Coding can then be integrated into the clinical and regulatory strategy rather than being addressed under pressure when timelines are tight and investors are looking for traction.

The Category III to Category I Journey

For physician services, the first step is often a Category III CPT code. Category III codes are temporary tracking codes that signal innovation by allowing new procedures and services to be documented in claims data, even before coverage is widespread. They serve as a bridge between early clinical adoption and mainstream reimbursement.

The ultimate goal is conversion to a Category I CPT code, which reflects broad clinical adoption and medical necessity and is paired with predictable coverage and payment policies. Making that transition requires time, data, and advocacy. It is not fast, and it is not automatic.

A Case Study: HeartFlow

HeartFlow, a non-invasive test for coronary artery disease, illustrates why beginning the coding process early is so important.

• 2011: Category III CPT codes were secured before FDA clearance, creating a foothold in the coding system.
  

• 2014: FDA clearance was achieved, and physicians could bill the Category III codes.
  

• 2018: After years of evidence generation and payer engagement, HeartFlow earned Category I CPT codes.
  

• 2021: National Medicare payment rates were established, solidifying reimbursement across the U.S.
  

From the first Category III code to national payment, the journey took a decade. Without those early moves, commercialization could have been delayed for years rather than months.

The Role of Specialty Societies and the AMA Panel

Coding strategy is not only about technical accuracy. It also involves coordination with stakeholders and careful navigation of politics. Specialty societies play a central role in determining whether a new code moves forward. Their endorsement ensures that the service is clinically relevant and appropriately defined. Without their support, applications can stall.

Even with society backing, the AMA CPT Editorial Panel presents another layer of complexity. Applicants must present their case in front of a voting panel of physicians, policymakers, and advisors. They need to demonstrate the clinical utility of the service, respond to questions, and sometimes address tensions among specialties with overlapping interests. Having experienced guidance in these moments makes a difference. A partner who has successfully prepared and defended hundreds of code applications brings both credibility and confidence to the process.

What If Separate Coding Isn’t in Your Future?

Not every technology receives its own code. Early analysis sometimes shows that a payer or society views a new service as bundled into an existing procedure, or that it is more appropriately captured by a supply or device code rather than a physician service code.

Learning this information early creates opportunity. Companies then have the runway to pivot toward alternate strategies. That might mean pursuing device-intensive APC assignments, focusing on hospital value analysis committees, or supporting customers with case-by-case payer engagement. Knowing in advance that a unique code is not likely allows a company to redirect its energy without losing momentum.

What This Means for You

The lesson is not that Category III codes are limited. The lesson is that early planning creates options. With the right strategy, you can:

• Map out realistic timelines for coding, coverage, and payment.

• Engage specialty societies well in advance so their support is secured.

• Equip your early customers to navigate payer processing on a case-by-case basis.

• Build the evidence base that payers expect to see for broader coverage.

• Defend your code application with preparation and confidence.

• Adjust course if separate coding is not achievable, ensuring other pathways are ready.
  

Reimbursement is not a switch that turns on once the FDA says “yes.” It is a parallel track that must be built alongside regulatory and clinical strategy. Beginning early allows innovators to create a bridge from initial clinical use to sustainable reimbursement.

Start earlier than you’d think. The companies that do are the ones that get it right!

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