Billing and Coding: Skin Substitute Grafts/Cellular and 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 Local Coverage Determination (LCD) L35041 Skin Substitute Grafts/Cellular and 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 (GA, GX, GY, or GZ). For Part A and Part B use the GX modifier when issuing a voluntary ABN for a service that is never covered because it is statutorily excluded or is not a Medicare benefit. Use the GX modifier in combination with the GY modifier. Use the GY modifier when the item or service is statutorily excluded or does not meet the definition of any Medicare benefit. Use the GA modifier when the waiver of liability statement was issued as required and the item or service is expected to be denied as not reasonable and necessary. Use the GZ modifier when the notice of liability was not issued, and the item or service is expected to be denied as not reasonable and necessary.

• GA: Waiver of liability statement on file. Used when Advanced Beneficiary Notice (ABN) on file.
• GX: Notice of liability issues, voluntary under payer policy.
• GY: Item or service statutorily excluded, does not meet the definition of any Medicare benefit or, for non-Medicare insurers, is not a contract benefit.
• GZ: Item or service expected to be denied as not reasonable and necessary. Notice of liability was not issued.

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 grafts/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. Do not report 15271-15278 or C5271-C5278 when a skin substitute is used for anything other than skin replacement surgery.

Removal of a current graft and/or simple cleansing of the wound and other surgical preparation services are included in the skin substitute grafts/CTP and HCPCS application codes. Active wound care management (CPT code 97602; Removal of devitalized tissue from wound(s), non-selective debridement, without anesthesia [e.g., wet-to-moist dressings, enzymatic, abrasion, larval therapy], including topical application(s), wound assessment, and instruction(s) for ongoing care, per session) procedures should never be reported with skin substitute grafts/CTP and HCPCS application codes.

An evaluation and management (E/M) service should only be reported with a skin replacement therapy (application of skin substitute grafts/CTP) if the patient required a service that was separate and distinct from the skin replacement service.

If reporting a skin substitute product with HCPCS codes A4100 (Skin substitute, FDA cleared as a device, not otherwise specified) or 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 (RTP)/rejected.

For Part A claims:

Line Level Remarks for 837I Electronic Claim: 837I 2400 SV202-7
Claim Level Remarks for 837I Electronic Claim: 837I 2300 NTE*ADD
Block 80 for the UB04 claim form
“REMARKS” field for a DDE claim

For Part B claims:

Loop 2400 or SV101-7 for the 5010A1 837P
Box 19 for paper claim

• The name of the product, size, and the amount used must appear in the Documentation Field.
• If the charge matches the actual invoice cost, note "Actual Invoice Cost" in the Documentation Field. You are not required to submit invoice information with the claim; however, it must be available if requested.
• If you are submitting a charge greater than the actual invoice cost, please include the following information in the Documentation Field, using these abbreviations:
  • Des = Description/Name of skin substitute grafts/product
  • QS = Quantity shipped (e.g., QS=3 boxes)
  • TA = Total amount charged for quantity shipped (e.g., TA=$437.50)
  • UP = Unit Price (e.g., UP = $17.50 per 5x5cm) (Optional)
  • DG = Amount used (e.g., 25 cm)

The appropriate CPT or HCPCS application code must be reported on the same claim as the skin substitute graft/CTP HCPCS code. The claim will be returned to provider or rejected if the application code and skin substitute graft/CTP code are not submitted on the same claim. When the skin substitute graft/CTP HCPCS code is denied, the related application code will also be to be denied.

Utilization Parameters

A maximum of 8 skin substitute grafts/CTP applications per ulcer will be allowed for the episode of skin replacement surgery (defined as 12 to 16 weeks from the first application of a skin substitute grafts/CTP). Product change within the episode of skin replacement surgery may be appropriate. When more than one specific product is used during the 12-to-16-week period, it is expected that the total number of applications or treatments will still not exceed 8.

Modifier -KX

Modifier -KX must be used as an attestation by the practitioner and/or provider of the service that documentation is on file verifying that the patient meets the requirements for additional applications of skin substitute grafts/CTPs. Consistent with the LCD, more than 4 applications of a skin substitute grafts/CTP in a 12-to-16-week period must be appended with a -KX modifier. Failure to apply the -KX modifier for applications greater than 4 will result in claim denial. Aberrant use of the -KX modifier may trigger focused medical review.

• Documentation must support medical necessity for the use of additional applications or time and include:
• Explanation of why extended time or additional applications is medically necessary for the specific patient.
• That the current treatment plan has resulted in wound healing and expectation that the wound will continue to heal with this plan. Documentation should include estimated time for extended treatment, number of additional applications anticipated, and plan of care if healing is not achieved as planned.
• What modifiable risk factors, such as diabetes optimization, are being approached to improve likelihood of healing.
• For venous leg ulcers, it is expected that appropriate consultation and management be obtained for the diagnosis and stabilization of any venous related disease.

Multiple Wounds

To determine the surface area for application of skin substitute graft codes for multiple wounds, all wound areas within the same anatomic site should be added. If the skin substitute graft is applied to wounds on a different anatomic site, the corresponding application code for the anatomical site for each date of service (DOS) should be reported.

Do not code modifier -59 on skin substitute graft application or skin substitute product codes. Skin substitute graft application codes are appropriately coded based upon total surface area of anatomical locations and not by number of ulcers.

Modifier -50 and modifiers -LT and -RT are not appropriate to append to skin substitute graft codes. Coding for skin substitute graft application is based upon total surface area of the ulcers, therefore, Modifiers -50, -LT and -RT are not required for proper claim adjudication.

JW and JZ Modifiers

When billing for Part B drugs and biologicals (except those provided under a competitive acquisition program [CAP]), 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.

Any amount wasted must be clearly documented in the medical record and should include the date and time, amount of medication wasted, and the reason for the wastage.

The use of the JZ modifier (attesting that there were no discarded amounts) is required on claims to report there are no discarded amounts of unused drugs or biologicals from single use vials or single use packages.

Claims for drugs separately payable under Medicare Part B from single-dose containers are required to report either the JW or JZ modifier to identify any discarded amounts or to attest that there are no discarded amounts, respectively. Part B claims for these products submitted without the JW or JZ modifier appended will be rejected.

The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.

The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator “N1” (ASC).

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 documentation must specifically address the circumstances regarding why the ulcer healing has stalled with standard ulcer care treatment of greater than 4 weeks and reference 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 therapy with choice of skin substitute graft or CTP product. The procedure risks and complications must also be reviewed and documented.
5. 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 4 weeks. The ulcer description must also be documented pre- and post- treatment with the skin substitute grafts/CTP being used. The reason(s) for any repeat application should be specifically addressed in the medical record, whether the current treatment plan has resulted in wound healing, and expectation that the wound will continue to heal with this plan. Documentation should include estimated time for extended treatment, number of additional applications anticipated, and plan of care if healing is not achieved as planned.
6. Documentation must include an assessment outlining the plan for skin replacement therapy and the choice of skin substitute grafts/CTP for the 12-to-16-week period as well as any anticipated repeat applications within the 12-to-16-week period.
7. Documentation that modifiable risk factors, such as diabetes optimization, are being addressed to improve likelihood of healing must be included in the medical record. For venous leg ulcers, it is expected that appropriate management and consultation, if indicated, be obtained for the diagnosis and stabilization of any venous related disease.
8. An operative note must support the procedure (e.g., application of skin substitute grafts/CTPs to legs) for the relevant DOS (first application starts the 12-to-16-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.
9. Graphic evidence of ulcer size, depth, and characteristics of the ulcer or photo documentation of the ulcer at baseline and follow-up with measurements of wound including size and depth should be part of the medical record.
10. Any amount of wasted skin substitute grafts/CTP must be clearly documented in the procedure note with ALL the following information (at a minimum):
    • Date, time, and location of ulcer(s) treated.
    • Name of skin substitute grafts/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 grafts/CTP material. When the manufacturer does not supply unit identification, the record must document such. The amount billed as wastage cannot exceed the price of the package.
11. The HCPCS code of the applicable skin substitute grafts/CTP and the units billed must be consistent with the medical record regarding wound description and size.