Don’t Wait to Get Paid: Building a Compliant Path to Early Reimbursement

Bringing a medical device or diagnostic test to market is no small feat—but getting reimbursed for it is another challenge entirely. For many innovators, the early-stage path to reimbursement feels opaque, riddled with conflicting information, and full of pitfalls. That’s where a smart, compliant short-term strategy becomes crucial.

What Is a Short-Term Reimbursement Strategy?

When we talk about short-term reimbursement strategy, we’re talking about what happens right after your product launches. Specifically, how will physicians get reimbursed for using your device before there’s a dedicated billing code in place?

If you don’t have a Category I CPT code or a clear permanent reimbursement pathway, you need a plan to bridge the gap—and fast. This is the “short-term strategy.” It’s the financial lifeline that allows companies to generate early revenue, gather claims data, and support long-term reimbursement goals, all while remaining compliant.

Why It Matters

Many early-stage companies either don’t realize a short-term strategy is possible, or fail to take it seriously until it’s too late. That’s a costly mistake.

Done right, your short-term reimbursement approach can:

  • Generate early revenue to sustain your company through the pre-commercial and commercial phases.
  • Build the utilization and claims data needed to support your application for a permanent code.
  • Avoid long-term damage caused by underpricing or inappropriate billing practices.

Set your rates too low, and CMS may lock in reimbursement amounts far below what your product is worth. Use the wrong code, and you could face audits or denials. In short, a poorly planned short-term approach can create long-term problems.

The Truth About Miscellaneous Codes

One of the most common misconceptions we hear is that miscellaneous codes never get paid. That simply isn’t true.

In fact, we’ve helped clients run successful programs—including product reimbursement in the thousands—using only a single miscellaneous code. The key is understanding how to use them correctly and compliantly. That includes identifying which code to use, understanding documentation requirements, and being ready to respond to manual reviews and additional document requests.

Yes, it takes work. But it works.

What Does a Short-Term Strategy Include?

A well-executed short-term strategy should answer these questions:

  • Are there existing permanent codes the product could fit under?
  • If not, what is the most appropriate miscellaneous code?
  • What should the reimbursement rate be—and how do we justify it?

If your product doesn’t yet have a billing code, don’t wait. The decisions you make now will shape your reimbursement success for years to come.

How HcFocus Helps

At HcFocus, we specialize in finding viable, compliant short-term reimbursement paths for novel devices and diagnostics. We build tailored standard operating procedures (SOPs), documentation tools, and appeal templates. We also coach your team through what they legally must do, and take everything else off their plate.

Sometimes we’ll outline multiple options, weighing the pros and cons of each reimbursement path. Then we help you decide which route aligns best with your business goals—whether that’s rapid revenue generation, building long-term value, or preparing for acquisition.

If you’re developing a new medical device or diagnostic test and aren’t sure how to navigate early reimbursement, let’s talk. At HcFocus, we don’t just think one step ahead—we think three steps ahead.