All seven Part B Medicare Administrative Contractors have finalized new, identical coverage policies that will govern the application of skin substitutes/cellular and tissue-based products applied to diabetic foot ulcers and venous leg ulcers for Medicare Part B beneficiaries. These policies only rigidly apply to diabetic foot ulcers and venous leg ulcers. These policies take effect January 1, 2026.
Diabetic Foot Ulcers
The policies state the indication for coverage of skin substitute application to a diabetic foot ulcer is as follows:
“Non-infected and failed to achieve at least 50% ulcer area reduction with documented standard of care treatment for a minimum of 4 weeks with documented compliance.”
The policies state the “standard of care” for a diabetic foot ulcer referenced above must include documentation of the following:
- Assessment of Type 1 or Type 2 diabetes
- Management history of diabetes
- Assessment for vascular disease
- Assessment for neuropathy
- Assessment for osteomyelitis
- Review of current blood glucose levels
- Hemoglobin A1c (HbA1c)
- Diet
- Nutritional status
- Activity level
- Assessment of skin
- Ulcer exam
- Assessment for vascular perfusion (Vascular assessment)
- Assessment of off-loading devices or use of appropriate footwear.
- Offloading
Venous Leg Ulcers
The policies state the indication for coverage of skin substitute application to a venous leg ulcer is as follows:
“Non-infected and failed to respond to documented standard of care treatment for a minimum of 4 weeks with documented compliance.”
The policies state the “standard of care” for a venous leg ulcer referenced above must include documentation of the following:
- History of prior ulcers
- BMI
- History of pulmonary embolism?
- History of superficial/deep venous thrombosis?
- Number of pregnancies
- Physical inactivity?
- Exam relative to edema
- Exam relative to skin changes
- Exam for vascular competence
- Evaluation of venous reflux
- Evaluation of perforator incompetence
- Evaluation for venous thrombosis.
- Must have sustained use of a firm strength compression garment (>20 mmHg) or multi-layered compressive dressing
For both diabetic foot ulcer and venous leg ulcer application, the documentation must include:
- Debridement as appropriate to a clean granular base
- Infection control with removal of foreign body or focus of infection
- Management of exudate with maintenance of a moist environment
- Documentation of smoking history, and counselling on the effect of smoking on wound healing and outcome of counselling when indicated
- Treatments attempted and failed
- Medications
- Name of product
- Risks and complications
- Operative note detailing application procedure
- Quantity of product used and wasted
- Time of application
- Name of product applied and package size
- Manufacturer’s serial/lot/batch or other unit identification number of product applied
- Patient name and date of service on every page
- Legible signature of practitioner
- Why ulcer healing has stalled with standard ulcer care treatment of greater than 4 weeks
- Ulcer description pre- and post-treatment
- Plan for skin replacement therapy and the choice of skin substitute grafts/CTP for the 12-to-16-week period
- Any anticipated repeat applications within the 12-to-16-week period.
- Modifiable risk factors being addressed to improve likelihood of healing
Providers performing these services for Medicare Part B beneficiaries are encouraged to review their policy details.
One example of the policies that will apply to all Medicare Part B beneficiaries in the country can be found at the link below:
About the Author
Jeffrey D. Lehrman, DPM, FASPS, MAPWCA, CPC, CPMA is a podiatrist practicing in Fort Collins, CO and operates Lehrman Consulting, LLC which provides guidance regarding coding, compliance, and documentation. Dr. Lehrman is a Certified Professional Coder and Certified Professional Medical Auditor.
