This Billing and Coding Article provides billing and coding guidance for Proposed Local Coverage Determination (LCD) DL35041 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.
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.
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) procedures should never be reported in conjunction 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 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/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 agent (e.g., Des=TC99m MDP)
- QS = Quantity shipped (e.g., QS=100 mci)
- TA = Total amount charged for quantity shipped (e.g., TA=$57.40)
- UP = Unit Price (e.g., UP = $0.57 per mci) (Optional)
- DG = Dosage given (e.g., DG=25 mci)
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 denied 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 4 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 4.
- More than 4 applications of a skin substitute graft/CTP in a 12-week period or extension of treatment beyond 12 weeks must be appended with a KX modifier.
- 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 control, 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.
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.
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
- 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.
- The medical record documentation must specifically address the circumstances regarding why the ulcer healing has stalled with standard ulcer care treatment of greater than 30 days 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.
- 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/CTP being used. The reason(s) for any repeat application should be specifically addressed in the medical record.
- 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 grafts/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.
- Graphic evidence of ulcer size, depth, and characteristics of the ulcer or photodocumentation of the ulcer at baseline and follow-up with measurements of wound including size and depth should be part of the medical record.
- 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. The amount billed as wastage cannot exceed the price of the package.
- 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.
