Hi Dr Khoury,
Thank you for your question. We've discussed your question and compiled the following information below:
Noridian doesn't have a specific local coverage determination (LCD) for application of cellular and/or tissue based products (CTPs) but other MACs (Novitas, FCSO and CGS) do - their LCDs focus only on the application of CTPs to diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) of the lower extremities.
For guidance on coverage pertaining to other ulcer etiologies, providers can seek direct clarification via email at medweb@noridian.com or through their provider portal. Please note that MACs may take up to 45 business days to respond to inquiries, so it's advisable to contact them well in advance of the planned treatment date. To increase chances of specific answers, it would be important to list specific information such as ICD-10s, product Q or A code, application codes and place of service.
Furthermore, documentation guidance provided by the manufacturer suggests that coverage for additional indications is possible, provided that the medical necessity is adequately demonstrated (see list below, specifically where it mentions "Description of the stage if wound is pressure ulcer", which seems to imply it might be covered for pressure ulcers if medical necessity is met). In addition, the manufacturer also offers a Patient Insurance Verification Service, which may be helpful in determining their products' coverage and eligibility by payers for a specific patient/condition.
Having listed the resources above, it is worthwhile mentioning that one of our editors who practices in California shared that she recently used Epifix for an ulcer on the scalp after removal of squamous cell carcinoma and both product and application service were reimbursed by Noridian, as her documentation was able to support medical necessity.
Here are some of our documentation checklists that can be used for DFU and VLU:
And below is the documentation list provided by the manufacturer:
"Providers must document the medical necessity for all services provided. If there is no documented evidence (i.e., objective measurements) of ongoing significant benefit, then the medical record documentation must provide other clear evidence of medical necessity for treatments. The medical record must also clearly indicate the complexity of skills required by the treating practitioner/clinician.
Documentation is key in demonstrating medical necessity for wound care services. Below is a list of a few examples of what to include in the patient’s medical record:
- Include documentation that reflects objective data and goals
- Include documentation that reflects services that are medically necessary and meet utilization guidelines
- Document ICD-10 codes to highest level of specificity
- Documentation should include the type of wound and location
- Description of the stage if wound is pressure ulcer
- Measurements after debridement and immediately prior to skin sub application
- Document progress (or lack of progress) that patient has experienced since prior application such as improvement in measurements, type of tissue in ulcer, and appearance of ulcer (drainage, redness, etc.)
- Include characteristics of tissue in wound bed (necrosis, granulation, infection)
- Description of any drainage (exudate) - none, low, moderate, high
- Description of condition of surrounding skin (red, dry, warming, scaling, thin, normal)
- Include documentation of indications of infection
- Description of pain (location, duration, intensity, quality)
- Document amount of product wasted
- Date and time
- Amount of product used (units)
- Amount of product wasted (units) along with reason for wastage
- Document as well if there is no wastage
Hope this helps!
Resources:
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