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

CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1 Approved Use of Drug

CMS IOM Publication on 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40 Discarded Drugs and Biologicals

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.

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) DL39760 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

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. For Part A use the GY modifier. For Part B use GY or GZ 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 therapy (application of skin substitute graft/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 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/rejected.

Part A:

Line SV202-7 for 837I electronic claim

Block 80 for the UB04 claim form

Part B:

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. 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 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 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 and 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).

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.
6. 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.
7. 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.
8. 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.
9. The medical record documentation specifically addresses the circumstances regarding why the ulcer healing has stalled with 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 therapy with choice of skin substitute graft or CTP product. The procedure risks and complications must also be reviewed and documented.