PDAC Before CMS? What DME Companies Need to Know

One of the most common conversations I have with medical device companies starts the same way.

"We need our own HCPCS code."

Usually, the company has developed something genuinely innovative. The technology may be unlike anything else on the market. It may have received FDA clearance, generated compelling technical performance evidence, and addressed an unmet need. From the company's perspective, obtaining a unique HCPCS code feels like the natural next step.

What surprises many executives is that the path toward a unique code often starts somewhere other than CMS. It starts with PDAC.

For companies operating within the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) space, the Pricing, Data Analysis, and Coding contractor plays an outsized role in shaping coding strategy. Yet many reimbursement plans barely mention it.

PDAC's job is straightforward in theory. When a manufacturer submits a product for review, PDAC evaluates the product's characteristics, functionality, intended use, and labeling to determine whether it fits within an existing HCPCS code. In practice, however, PDAC is doing something much more important. It is answering the question that sits at the heart of nearly every coding strategy discussion:

"Can this product be adequately described by a code that already exists?"

That question matters because CMS is generally reluctant to create new codes simply because a product is novel. Innovation, while important, is not the standard. The standard is whether the existing coding framework is sufficient.

This distinction is subtle but critical.

A product can represent a major technical advancement and still fit comfortably within an existing HCPCS code. Conversely, a product may share some characteristics with existing technologies but possess differences significant enough that current codes fail to accurately describe it. The challenge is determining which situation applies to your technology.

That is where PDAC becomes so valuable. Too often, companies do not have PDAC on their radar at all, but it can be one of the most useful reimbursement intelligence activities a company undertakes. The determination provides an early indication of how Medicare views the product, which technologies it considers comparable, and whether existing coding categories are likely to accommodate the innovation.

In some cases, the outcome reinforces that existing coding pathways are entirely appropriate. While that may feel disappointing to a company hoping for a unique code, it can actually be good news. Leveraging an existing coding structure is often faster, less expensive, and less risky than pursuing a multi-year effort to establish a new code.

In other cases, PDAC's analysis reveals the opposite. The product may not fit neatly into existing categories. Existing codes may fail to capture important functional differences. Suppliers and providers may struggle to determine which code applies. Payment methodologies may produce distorted reimbursement outcomes. Utilization data may become difficult for CMS to track accurately.

These situations often form the foundation of a compelling argument for a new HCPCS code.

What many companies miss is that the strongest coding applications are rarely built around innovation alone. They are built around demonstrating that the current coding system is inadequate.

When CMS evaluates requests for new coding, it is not simply asking whether a technology is new. It is asking whether existing codes can still do the job. The more effectively a company demonstrates that they cannot, the stronger its position becomes.

For that reason, I often encourage clients to think of PDAC not as the end of a coding process but as the beginning of a broader strategic assessment. A coding determination can reveal competitive positioning, identify reimbursement risks, clarify payment implications, and help determine whether pursuing a unique code is likely to create value.

Sometimes the answer is yes. Sometimes the answer is no. Both outcomes are useful.

The companies that navigate reimbursement most effectively are rarely the ones that rush to file coding applications. They are the ones that first understand how the existing coding system views their technology and where the true gaps exist.

Before investing significant time and resources pursuing a new HCPCS code, it is worth asking a simple question:

What would PDAC say about our product?

Their determination is often the earliest indicator of whether a future HCPCS application has a realistic chance of success.

Do you have U.S. commercialization questions?

Whether it's how the multiple payer landscape works in the U.S., how to validate device or procedure coding, timelines associated with product uptake - we're happy to answer them.

Schedule and introductory call: https://calendly.com/nicolecoustier/introductions