Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

Internet-Only Manuals (IOMs):

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
  ~ Chapter 15, Section 50.4.1 Approved Use of Drug
• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  ~ Chapter 17, Section 40 Discarded Drugs and Biologicals

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.

Code of Federal Regulations (CFR) References:

• CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based products

This Billing and Coding Article provides billing and coding guidance for Proposed Local Coverage Determination (LCD) DL36690 SDL Skin Substitute Grafts/Cellular and/or Tissue-Based Products 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/cellular and/or tissue-based products (CTP) and HCPCS 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/CTP and HCPCS application codes. Active wound care management (CPT code 97602) procedures should never be reported in conjunction with skin substitute graft /CTP and HCPCS application codes.

An evaluation and management (E/M) service should only be reported with a skin replacement surgical procedure (application of skin substitute graft/CTP) if the patient’s condition required a separately identified service.

If reporting a skin substitute product with HCPCS code Q4100 (Skin substitute, 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 graft/CTP HCPCS codes included in Group 2 below reported with any application or administration service NOT included in Group 1 below will be denied.

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

For all products, the size of the product that appropriately covers the wound must be utilized to limit wastage. Medical review may be conducted when a provider is not following these guidelines.

Consistent with the LCD, Satisfactory Evidence of Compliance with FDA Regulatory Requirements includes the following:

1. Satisfactory evidence of compliance with the U.S. Food and Drug Administration (FDA) regulatory requirements for the skin substitute grafts/cellular and/or tissue-based products included in this billing and coding article includes:
• A copy of the FDA 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,
• A Tissue Reference Group (TRG) letter from the FDA, or
• Information from the FDA’s Website regarding intended use of the product as approved/regulated by the FDA.

2. For skin substitute grafts/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/CTP obtain the appropriate evidence for FDA regulatory compliance (at least one of the items listed above that indicates the skin substitute graft/CTP provides scaffolding for skin growth, and is intended to remain on the recipient, and allows the recipient’s skin to grow into the implanted graft material) AND send it to the MAC along with any available peer reviewed evidence-based literature. Once this information has been received by the MAC, the product will be considered for coverage.

Utilization Parameters

A maximum of four skin substitute graft/CTP applications per ulcer will be allowed for the episode of skin replacement surgery (defined as 12-weeks from the first application of a skin substitute graft/CTP). Product change within the episode of skin replacement surgery may be appropriate. When more than one specific product is used during the 12-week period, it is expected that the total number of applications or treatments will still not exceed four. More than four applications of a skin substitute graft/CTP in a 12-week period will be denied. 

Application of a skin substitute graft/CTP beyond the 12-week episode of skin replacement surgery will be denied.

Documentation Requirements

The medical record documentation specifically addresses the circumstances regarding why the ulcer has failed to respond to standard ulcer care treatment of greater than 30 days and references the specific interventions that have failed based on the prior ulcer evaluation. The record must include an updated medication history, review of pertinent medical problems that may have arisen since the previous ulcer evaluation, and explanation of the planned skin replacement surgery with choice of skin substitute graft or CTP product. The procedure risks and complications must also be reviewed and documented.

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 ulcer(s) must be documented at baseline (prior to beginning standard of care treatment) relative to size, location, stage, duration, and presence of infection, in addition to the type of standard of care treatment given and the response. This information must be updated in the medical record throughout the patient’s treatment. It is expected that the response of the ulcer to treatment will be documented in the medical record at least once every 30 days. The ulcer description must also be documented pre- and post- treatment with the skin substitute graft /CPT 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 graft/CTP 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/CTP 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. Any amount of wasted skin substitute graft/CTP 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 graft/CTP 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 ulcer, if applicable); Manufacturer’s serial/lot/batch or other unit identification number of graft/CTP material. When the manufacturer does not supply unit identification, the record must document such.
6. The HCPCS code of the applicable skin substitute graft/CTP and the units billed must be consistent with the medical record regarding wound description and size.