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My question is regarding qualification for skin substitutes. Per the CMS LCD: "For purposes of this LCD a Failed Response is defined as an ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, has increased in size or depth, or has not changed in baseline size or depth and has no indication that improvement is likely (such as granulation, epithelialization or progress towards closing)."

We have a patient that has the following documentation:
The wound has been treated with compression as well as hydrofera blue, multidex and prisma with some improvement but the wound at this time is still open after 3 months, patient has not responded to standard of care treatment
5/9/24 L LOWER LEG VENOUS ULCER measures 1.1cmx1.cmx0.1cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted.
5/2/24 L LOWER LEG VENOUS ULCER measures 1.7cmx1.5cmx0.1cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted.
4/25/24: L LOWER LEG VENOUS ULCER measures 2.4cmx1.5cmx0.cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted.
4/18/24 L LOWER LEG VENOUS ULCER measures 2.3cmx1.9cmx0.2cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted
4/11/24: 2cmx1.8cmx0.2cm
4/10/24 PCP: 2.5 x 3.5 dark red granulation (PCP office)

Over the most recent 30 days, the wound has improved in size. The wound has been present since February 2024. The wound remains unhealed despite partial improvement. Because there has been a lack of complete healing, does this still meet the requirements for continued advanced therapies like bioengineered skin substitutes, even though the most recent 30 days have shown improvement?
May 15, 2024 by Sarah Karson, RN, BSN
4 replies
Elaine Horibe Song
MD, PhD, MBA
Hi Sarah

Dr White, Jeff and I discussed your question. As you mentioned, the CMS LCD states that "For purposes of this LCD a Failed Response is defined as an ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, has increased in size or depth, or has not changed in baseline size or depth and has no indication that improvement is likely (such as granulation, epithelialization or progress towards closing)."

Since the case you shared shows signs of improvement (i.e. changed the baseline size and depth and has shown progress towards closing), then the case does not meet the description of "failed response" and as a result, does not meet the requirements for cellular and/or tissue products as outlined by the LCDs. Of note, the wound has shown a decrease in size of more than 50% in 4 weeks, which shows that the wound is healing as expected using standard therapy.

Hope that helps!

May 16, 2024
Sarah Karson
RN, BSN
Thank you so much for confirming. My original question included the pre debridement measurements. Perhaps I should have listed both.
5/9/24 L LOWER LEG VENOUS ULCER measures 1.1cmx1.cmx0.1cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted. Post debridement measurements 2cmx1.5cmx0.3cm
5/2/24 L LOWER LEG VENOUS ULCER measures 1.7cmx1.5cmx0.1cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted. Post debridement measurements 2cmx1.7cmx0.3cm
4/25/24: L LOWER LEG VENOUS ULCER measures 2.4cmx1.5cmx0.cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted. No debridement.
4/18/24 L LOWER LEG VENOUS ULCER measures 2.3cmx1.9cmx0.2cm. Wound bed with red granular tissue. Small amount serous drainage. No odor, no erythema noted. No debridement.
4/11/24: 2cmx1.8cmx0.2cm No debridement.
4/10/24 PCP: 2.5 x 3.5 dark red granulation (PCP office) No debridement.

Does this change things looking at 4/10 PCP office (2.5x3.5) - (8.75 sq cm, no debridement) to 5/9 2cmx1.5cmx0.3cm (3 sq cm) post debridement? But our facility's wound care measurements on 4/11 were 2cmx1.8cmx0.2cm (3.6 sq cm). There's quite a difference between 4/10 and 4/11 with 2 different people measuring, so which do we refer to for improvement?

Thank you for providing clarification.
May 16, 2024
Elaine Horibe Song
MD, PhD, MBA

Hi Sarah

It'd be beneficial to take a step back and look at the LCD requirements as a whole, as well as the debridement documentation/indications, in order to make a determination on eligibility of CTP application.

To recap, here is a summary of the LCD requirements, as you already stated: 

Chronic, non-infected ulcers having failed to respond to documented standard of care treatment for a minimum of four weeks (defined as 30 days) with documented compliance to prescribed treatment.

Failed to respond means that ulcer has increased in size or depth, or has not changed in baseline size or depth

No indication that improvement is likely (such as granulation, epithelialization or progress towards closing)

For VLUs, documented standard of care treatment includes (see checklist): 

  • Diagnosis - ICD-10
  • Name of previous provider(s) and dates of care or intervention
  • Prior medical, surgical and/or treatment(s) provided.
  • Assessment of clinical history (prior ulcers, thrombosis risks)
    • o Management of comorbidities (e.g. vascular insufficiency, thrombosis risks)
    • o Documentation that the patient is under the care of a qualified physician/NPP for the treatment ofthe systemic disease process(es) etiologic for the condition (e.g.venous insufficiency,lymphedema)
  • Assessment of edema, skin changes.
  • Ankle-Brachial Index[ABI] or other appropriate noninvasive arterial test
  • Diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic(or acute) venous thrombosis.
  • Evaluation of diet and nutritional status.
  • Documented patient adherence to plan of care.
  • Physical exam that includes assessment of skin and ulcer including.
    • o Size
    • o Location/ Laterality
    • o Stage (if appropriate)
    • o Duration
    • o Presence of infection, in addition to type of treatment, dates given and response.
  • Documentation of previously implemented standard of care treatment(s):
    • o Documented patient adherence to plan of care.
    • o Albumin is within normal limits.
    • o HgbA1c is not above 9%.
    • o Blood flow to the area is adequate to encourage wound healing.
    • o Debridement as appropriate.
    • o Wound is free of necrotic material and debris.
    • o Documented form of compression for VLUs.
    • o Ulcer is free of signs or symptoms of infection.
    • o Management of exudate - maintenance of a moist environment. Dressing choice has been adequate and applied as ordered.
  • Documentation of smoking history.
    • o Smoking cessation measures (if applicable).
    • o Documentation that the patient has received counseling on the effect of smoking on surgical outcomes and treatment (if applicable) as well as outcome of counseling (if applicable).
  • Legible signature of the QHP responsible for and providing the care to the patient.

Assuming standard wound care has been implemented and documented for 4 weeks, it'd be important to understand how to assess signs of improvement within the 4 week period. 

To do so, the following questions would be helpful: 

1) In regards to wound measurement, which baseline measurement should be considered? It'd be important to standardize wound measurement as much as possible. For instance, since the wound has been treated/measured by the wound care facility, one could use measurements taken at the wound care facility on 4/11 vs. the one taken at the PCP office on 4/10 as a starting point. 

2) Which datapoint should the baseline measurement be compared with? If one considers data collected on 5/9, a critical question would be in regards to the debridement performed on that date. What was the indication for debridement? What kind of tissue was removed? For instance, if necrotic/nonviable tissue was removed and the post debridement measure was 2cmx1.5cmx0.3cm, then one could consider this measurements as the actual dimensions of the wound, and use them to compare with the initial measurements of 2cmx1.8cmx0.2cm. In this scenario, the VLU likely did not show improvement after 4 weeks of documented standard therapy. If necrotic tissue was not removed during debridement (because there was no necrotic/nonviable tissue), one could consider the pre-debridement measurement as the actual size of the wound. In this situation, signs of improvement over 4 weeks would be demonstrated by a decrease in ulcer dimensions. It'd be important to ensure that indications for debridement are adequately documented. 

Hope this helps!

May 19, 2024
Sarah Karson
RN, BSN
Thank you! This is very helpful.
Jun 5, 2024
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