Does My Patient Qualify For A Cellular/Tissue-Based Product?

I recently moved from practicing in Washington, DC to Charlotte, NC and had to revisit the criteria for use of cellular/tissue-based products on wounds since the Medicare carrier is different. About 15 years ago, there were only two products on the market: Apligraf (Organogenesis) and Dermagraft (Organogenesis). There are now over 75 cellular/tissue-based products, also called skin substitutes, on the market today.

It can be difficult to determine which cellular/tissue-based product is right for your patient. First, you need to know if your patient qualifies for one. Here are some important things to document:

• You must state that the cellular/tissue-based product is medically necessary and why.
• Document that the patient is a non-smoker or that you have counseled the patient on smoking cessation.
• Document that you have attempted four weeks of documented conservative care or that the patient’s prior clinician has attempted conservative care.
• Document the current offloading for the patient.
• Document the size of the wound. A wound must have a total surface area of 1 cm or larger for the patient to qualify for a cellular/tissue-based product. (In my area, Palmetto is the Medicare carrier. Wound size requirements may be different in other service areas.)
• Be sure to get pre-authorization to use a cellular/tissue-based product. I have recently seen that different cellular and tissue-based products require different diagnoses.
• Check your local coverage determinations for coverage based on the diagnosis.

You can use 10 cellular and tissue-based products in a 12-week period. This is for the life of a wound, not a calendar year.

This is just a general guideline. Please check your local area of coverage and current guidelines. Always get pre-authorization prior to the use of each application. What has been your experience with the use of cellular and tissue-based products and approvals?