This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L35041, Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds. Please refer to the LCD for reasonable and necessary requirements.
The addition of Skin Substitutes, Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing.
The individual products will continue to be identified with a Level II Healthcare Common Procedure Coding System (HCPCS) supply code from the section of the manual entitled “Skin Substitutes”.
The Current Procedural Terminology (CPT) application CPT codes 15271-15278 intended for the use of skin substitutes is entitled “Skin Substitute Grafts”. The skin replacement surgery Skin Substitute Grafts application guidelines in the current CPT codebook provide an overview of the types of procedures performed, measurement of the wound surface area, and reporting of skin closure, biological dressing, and supply of the skin substitute graft material.
These procedures are not to be reported for application of non-graft wound dressings or for a biologic implant for soft tissue reinforcement.
Coding Guidance:
Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.
Per the Current Procedural Terminology (CPT) definition, skin substitute grafts include non-autologous skin (dermal or epidermal, cellular and acellular) grafts (e.g., homograft, allograft), non-human skin substitute grafts (i.e., xenograft), and biological products that form a sheet scaffolding for skin growth. Skin substitute graft codes are not to be reported for application of non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes.
Non-graft wound dressings or injected skin substitue codes are not used with skin replacement surgery application codes and are considered incorrect coding. Such products are bundled into other standard management procedures if medically necessary and not separately payable.
Claims reporting skin substitute grafts must contain the presence of an appropriate application CPT code.
If the service for the application code is denied, the service for the skin substitute will also be denied.
Effective 01/01/2017, per CR 9603, when billing for Part B drugs and biologicals (except those provided under Competitive Acquisition Program [CAP] for Part B drugs and biologicals), the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.
Novitas expects that where multiple sizes of a specific product are available, the size that best fits the wound with the least amount of wastage will be utilized.
When a portion of a drug/biological is discarded, the medical record must clearly document the amount administered and the amount wasted. The documentation must include the date, time, amount of medication wasted, and the reason for the wastage.
In situations where a portion of a single use package must be discarded, payment will be made for the portion discarded along with the amount applied up to the amount of the product on the package label. Medical record documentation must clearly indicate the information noted above.
Note: The unused portion must actually be discarded and may not be used for another patient.
Documentation Requirements
- All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
