CTP Access Limitations and Administrative Harm: Potential Regulatory Impact on Vulnerable Wound Care Populations

Dr. Laura Swoboda discusses the potential for patients who have wounds other than DFUs and VLUs falling prey to administrative harm and adverse consequences amidst the evolving CTP regulatory landscape. 

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• CMS (US) — DFU/VLU-only LCD: Limiting CTP coverage to diabetic foot ulcers and venous leg ulcers risks administrative denials for other wound types, creating administrative harm (paperwork, duplicated tasks, communication failures) that affects patients, clinicians, and health systems.
• Real-world wound complexity: Many patients present with non-DFU/VLU wounds (e.g., trauma hematomas, infection, steroid-impacted wounds, oncology-related care needs), for whom LCD chronicity requirements may delay needed CTP intervention.
• Standard-of-care concern: Mandated ≥4 weeks of standard care may prolong wound chronicity, disproportionately harming the sickest patients in settings where “standard care” often consists only of gauze, antibiotics, and bleach.

Please note: This content is a direct transcript, capturing the authentic conversation without edits. Some language may reflect the flow of live discussion rather than polished text. 

I’m very concerned about patients with alternative wound types falling prey to what is called administrative harm—so administrative decision made not by providers. Oftentimes, they're not made by wound specialists or even health care professionals. They're administrative decisions that contribute to adverse consequences. And these harms can be from excessive paperwork, duplicated tasks, communication breakdown. 
 
With the LCD focused on DFUs and VLUs, I can see administrative professionals refusing to allow processes that care for patients with wound types outside of this, which is a significant portion of the patients we see, that we would use these products on. So this is going to affect patients, clinicians and the organization itself. It’s one of the potential likely ripple effects of the volatility in the CTP market and that hospital systems are needing to create buffers and that buffer is what limits patient access. 
 
Right now, the LCD, you know, is just for DFU and VLU. This doesn't reflect a substantial proportion of our population. Patients have wounds from large hematomas from falls, they become infected, they have to take steroids because they're having a COPD exacerbation from wildfire smoke, and they need to heal quickly before they're starting colorectal cancer treatment. So people are incredibly complex. And these are the complex, real-world types of patient situations that we see, where the chronicity requirements in these LCDs can be most detrimental. 
 
I've seen standard of care at different facilities around the U.S., and a lot of times, it's unfortunately gauze and antibiotics and bleach. So to require four weeks of standard of care before a cellular tissue product is making these wounds more chronic. We're giving that four-week treatment before giving the care that could help them heal. And in that way, the sickest people, the people needing to expedite healing the most will be most affected by this.

Dr. Laura Swoboda is a translational scientist, family nurse practitioner, and wound specialist in Milwaukee, Wisconsin. Dr Swoboda serves as principal investigator for quality improvement, evidence-based practice, and research projects in complex wound care. They serve as treasuror of the AAWC, and on the board of directors for the ISTAP and the SALSAL Foundation. Dr Swoboda volunteers on various committees and task forces including the NPIAP's prophylactic dressing standards initiative task force and the American Heart Association's Peripheral Arterial Disease National Action Plan.