Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers
and Venous Leg Ulcers

This Billing and Coding Article provides billing and coding guidance for
Proposed Local Coverage Determination (LCD) DL35041 Skin Substitutes for the
Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Please refer to the
LCD for reasonable and necessary requirements.

**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) codebook definition, skin
substitute grafts include non-autologous human 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 application codes are not
to be reported for application of non-graft wound dressings (e.g., gel,
powder, ointment, foam, liquid) or injected skin substitutes.

Do not report non-graft wound dressings or injected skin substitute HCPCS
codes with skin substitute graft application codes as this would be considered
incorrect coding. Such products are bundled into other standard management
procedures if medically necessary and are not separately payable.

Removal of a current graft and/or simple cleansing of the wound and other
surgical preparation services are included in the skin substitute graft
application codes. Active wound care management (CPT code 97602) procedures
should never be reported in conjunction with skin substitute graft application
codes.

One would not expect an evaluation and management (E/M) service with each skin
replacement surgical procedure (application of skin substitute graft) in an
episode of care unless the patient's condition required a separately
identified service.

If reporting a skin substitute product with HCPCS code Q4100 (Skin substitute,
not otherwise specified) or HCPCS code A4100 (Skin substitute, FDA cleared as
a device, not otherwise specified), the product name, package size purchased,
amount applied and amount wasted must be reported in the claim
narrative/remarks or the claim will be returned to the provider.

Skin substitute HCPCS codes included in Group 2 below reported with any
application or administration service NOT included in Group 1 below will be
denied.

Application codes billed **must** use the appropriate modifier (e.g., RT, LT)
to identify the location where the skin substitute was applied, or the service
will be denied.

The appropriate application code must be reported on the same claim as the
skin substitute graft code. When the skin substitute graft is denied, the
related application code will also be subject to denial.

**Satisfactory Evidence of FDA Regulatory Requirements**

  1. Satisfactory evidence of the U.S. Food and Drug Administration (FDA) regulatory requirements for the skin substitute grafts or cellular and/or tissue-based products (CTPs) included in this billing and coding article includes: 
    * A copy of the FDA's letter to the drug's manufacturer approving the new drug application (NDA),
    * A listing of the drug or biological in the FDA's "Approved Drug Products" or "FDA Drug and Device Product Approvals",
    * A copy of the manufacturer's package insert approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it, or
    * Information from the FDA's Website.
  2. For skin substitute grafts or CTPs classified as human cells, tissues, and cellular and tissue-based products (HCT/Ps), a letter from the FDA indicating that the HCT/P has met regulatory guidance is acceptable evidence of the FDA regulatory compliance for HCT/Ps regulated under section 361 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act.

It is recommended that the manufacturer of the particular skin substitute
graft or CTP product obtain the appropriate information for FDA regulatory
compliance and send to the MAC along with evidence-based literature, if
available. Once this information has been received by the MAC, the product
will be considered for coverage and placed into the appropriate Code Group.

**Utilization Parameters**

Application frequency must follow the product labeling. A maximum of two skin
substitute graft product applications per wound will be allowed for the
episode of skin replacement surgery for wound care (defined as 12-weeks from
the first application of a skin substitute graft) for those products
recommended per the labeling to require a second application.

Application of a skin substitute graft product beyond the 12-week episode of
skin replacement wound care will not be allowed.

**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.
  4. The medical record must clearly document that the criteria listed in the LCD has been met, as well as the appropriate diagnosis and response to treatment. Description of the wound(s) must be documented at baseline (prior to beginning conservative wound care measures) relative to size, location, stage, duration, and presence of infection, in addition to the type of conservative treatment given and the response. This information must be updated in the medical record throughout the episode of skin replacement surgery for wound care. The wound description must also be documented pre- and post- treatment with the skin substitute graft being used. The reason(s) for any repeat application should be specifically addressed in the medical record.
  5. Documentation must include an assessment outlining the plan for skin replacement surgery and the choice of skin substitute product for the 12-week period as well as any anticipated repeat applications within the 12-week period. An operative note must support the procedure (e.g., application of skin substitute graft to legs) for the relevant date of service (first application starts the 12-week episode of care) and include the reason for the procedure and a complete description of the procedure including product used (with identifying package label in the chart), and relevant findings.
  6. Any amount of wasted skin substitute must be clearly documented in the procedure note with ALL of the following information (at a minimum): Date, time and location of ulcer(s) treated; Name of skin substitute and package size; Approximate amount of product unit used; Approximate amount of product unit discarded; Reason for the wastage (including the reason for using a package size larger than was necessary for the size of the wound, if applicable); Manufacturer's serial/lot/batch or other unit identification number of graft material. When the manufacturer does not supply unit identification, the record must document such.
  7. The HCPCS code of the applicable skin substitute and the units billed must be consistent with the medical record regarding wound description and size.