Billing and Coding: Application of Bioengineered Skin Substitutes to Lower
Extremity Chronic Non-Healing Wounds

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**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. 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.
  3. 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.