Documentation in a Changing CTP Regulatory Landscape

• Clear, consistent documentation matters more—not less—without prescriptive LCD checklists. Clinicians must now tell a complete clinical story across the record. 
• Baseline data and standard-of-care evidence remain nonnegotiable. Incomplete histories, vague descriptors, and inconsistent measurements create risk. 
• Well-designed EHR tools can reduce burden and protect compliance. Guardrails, prompts, and trending data help clinicians document appropriately without slowing care. 

As the regulatory environment surrounding cellular and tissue-based products (CTPs) continues to shift, clinicians are navigating increased uncertainty around documentation expectations. Kimberly Smith, RN, CWON, FACCWS, shares her perspective on what has changed, where documentation risks remain, and how clinicians can protect themselves—and their patients—by focusing on clear, objective, and well-supported clinical records. 

What’s interesting is that 2025 was really a year of “hurry up and wait.” We had LCDs that were expected to go into effect in January, then February, then they were pushed out again—and ultimately, on Christmas Eve, they were withdrawn altogether. 

A lot of people were excited about that and felt that a less restrictive LCD or less prescriptive documentation would be better. But for me, it actually raises concern. I like to think about it like a recipe: would you rather cook based on instinct, or would you rather have a very clear checklist that tells you exactly what needs to happen to get the right result? I’m definitely the latter. 

That’s what the LCDs were doing: they gave us a very descriptive checklist of what needed to be documented to receive approval for CTP application. Without that, documentation is still required, but it’s more vague. 

The biggest shift is that clinicians can no longer rely solely on a procedure note that says a product was changed or applied. We have to tell a full clinical story—clearly, consistently, and in the right sequence. Any gaps or inconsistencies in that story can really hinder us during review or audit. 

There are core components that absolutely have to be present, whether CMS spells them out in an LCD or whether they’re being reviewed during an audit—which we all experience. 

First, you need a strong baseline. That means a clear wound etiology, consistent measurements, and ideally photos. Photos aren’t currently required, but I strongly recommend them because they help paint the clinical picture in a way words alone often can’t. 

Second, you must show proof of standard of care. What was done before advancing to a CTP? How long was it tried? Did it work? Is there objective evidence that the wound is not healing? You also need to document contributing factors outside of the dressing itself—nutrition, compression management, offloading—those all matter. 

Finally, you need an objective response to care. I often see documentation that says, “the wound is stalled,” but what does that actually mean? We need measurable, objective documentation; consistent measurements, timelines, and clear evidence of progress or lack thereof. 

These elements should be in place regardless of whether a CTP is being used. This is what good documentation looks like, and it’s how you clearly tell the clinical story. 

The biggest risk I see isn’t inappropriate care. Most clinicians I work with are providing excellent wound care and are very patient-focused. The risk comes when the documentation doesn’t reflect the level of care that’s actually being delivered. 

If it’s not documented, it’s as if it didn’t happen. We’re not giving ourselves credit for the good work we’re doing. Documentation isn’t just about coverage and billing—it’s also about showing that what we’re doing is producing the best possible patient outcomes. 

Some of the most common gaps include missing or inconsistent measurements. Measuring wounds consistently is hard—they’re not perfectly symmetrical, and different clinicians may measure differently. But consistency is critical to showing progress over time. 

Another common gap is an unclear standard-of-care history. We often assume it’s obvious that the patient was compliant, that compression was used, that offloading occurred, or that debridement was performed—but those things must be explicitly documented. 

Simply stating that a wound is stalled isn’t enough. Clinicians need to explain why. Are measurements unchanged? Is there persistent slough? Has drainage failed to decrease? We need to clearly document why standard of care was insufficient and why advancing to a CTP is justified. 

This is where technology can really take stress off clinicians. The goal isn’t to turn clinicians into compliance officers—that’s not realistic. The goal is to make the right documentation the easiest documentation. 

When digital tools are designed well, they support clinicians rather than slow them down. That’s a win for auditors, clinicians, and most importantly, patients—because it allows more time for patient care and less time spent documenting. 

Key EHR features include standardized baseline and follow-up assessments with required elements like measurements, tissue type, exudate, and photos. Again, photos aren’t required, but they’re incredibly valuable during audits because they show what words sometimes can’t. 

Guided procedure documentation is also critical. Required fields—product details, amount wasted, lot and expiration numbers—should be built directly into the workflow so clinicians are prompted to enter them every time. 

Prompts or guardrails are another important tool. For example, if a diabetic ulcer is selected, the system can prompt for a Wagner grade. If it’s a venous ulcer, it can prompt for compression and lower extremity assessments. These gentle nudges help ensure important details aren’t missed when clinicians are busy. 

Trending data is also incredibly helpful—being able to see measurements and photos over time clearly supports standard-of-care response and helps justify both initiating and continuing CTP therapy. 

Finally, reporting and internal audits are essential. Being able to identify where documentation frequently breaks down allows teams to improve workflows and focus on patient care, rather than scrambling during an external audit. 

I think we covered a lot, but I’d emphasize the importance of having tools you can trust—partners in your tool bag, so to speak. When regulations are changing, having reliable systems and workflows that support compliance is huge. That confidence allows clinicians to focus on what matters most: caring for patients. 

Kimberly Smith is a Senior Clinical Solutions Executive for NetHealth, a certified wound and ostomy nurse, and a Fellow of the American College of Clinical Wound Specialists.