SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities

A57680

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Posted: 9/29/2023

Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L36377/A57680) will not become effective on 10/01/2023. A new Proposed LCD will be published for comment and presented at an Open Meeting in the near future. In the meantime, current coverage has not changed and you are viewing the existing policy in effect.

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A57680
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities
Article Type
Billing and Coding
Original Effective Date
10/03/2018
Revision Effective Date
08/13/2020
Revision Ending Date
02/11/2025
Retirement Date
N/A

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CMS National Coverage Policy

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.

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L36377 Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities. 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) definition, skin substitute grafts include non-autologous 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 codes are not to be reported for application of non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes.

Non-graft wound dressings or injected skin substitute codes are not used with skin replacement surgery application codes and are considered incorrect coding. Such products are bundled into other standard management procedures if medically necessary and not separately payable.

Application procedure and associated supply must be coded correctly. The units of service must be reported correctly. The units of service billed for the supply must be accounted for in the medical record (i.e., amount used, amount discarded and reason for the discarded amount).

Removal of current graft and/or simple cleansing of wound is included in the skin replacement surgery application codes. Active wound care management (CPT code 97602) procedures should never be reported.

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 show 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 treatment given and response. This information must be updated in the medical record throughout the episode of skin replacement surgery wound care. Wound description must also be documented pre- and post- treatment with the skin substitute graft being used. The reason(s) for any continued application should be specifically addressed in the medical record.
  5. Documentation should include an assessment (generally in an E/M service) 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 in 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). At a minimum, the operative note(s) should include pre and post op diagnosis, name of surgeon, anesthesia, reason for the procedure, 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 the following minimum information: Date, time and location of ulcer(s) treated; Name of skin substitute and how product supplied; Approximate amount of product unit used; Approximate amount of product unit discarded; Reason for the wastage; Manufacturer’s serial/lot/batch or other unit identification number of graft material. When manufacturer does not supply unit identification, record must document such.
  7. Documentation requirements include addressing how product supplied, any wastage, etc. The HCPCS code of the applicable skin substitute and the units billed must be consistent with medical record in regard to wound description and size. 

Response To Comments

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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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(1 Code)
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It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

Group 1 Codes
Code Description
XX000 Not Applicable
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1 Codes
Code Description
XX000 Not Applicable
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ICD-10-PCS Codes

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Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description

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Other Coding Information

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
08/13/2020 R1

Revision Number: 1
Publication: August 2020 Connection
LCR A/B2020-0063

Explanation of Revision: Based on review of this billing and coding article, the “Coding Guidance” section was updated to include proper coding information in regards to skin replacement surgery application codes and non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes. The effective date of this revision is based on process date.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
11/08/2024 02/12/2025 - N/A Future Effective View
08/06/2020 08/13/2020 - 02/11/2025 Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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