Checklist: Application of skin substitutes
This checklist is intended to provide health care providers with a reference for use when responding to additional documentation requests for skin substitutes. Health care providers retain the responsibility to submit complete and accurate documentation.
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Documentation is for the correct beneficiary and date of service. |
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Documentation is complete, legible, signed and dated by the physician or clinician. |
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Documentation includes physician’s order date(s) of service when medication(s) were administered, to include the medication name, dosage, frequency and method of administration. |
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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. |
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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. |
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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 the skin substitute and how the product is supplied/ reason for 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. |
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Documentation requirements include addressing how product supplied, any wastage, etc. The HCPS code of the applicable skin substitute and the units billed must be consistent with medical record in regard to the wound description and size. |
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Medical necessity supported by the medical record (e.g., office/progress notes, history and physical, laboratory test results, etc.) |
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Documentation for the procedures, operative reports and anesthesia reports (when applicable). |
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Documentation meets criteria specified in NCDs and LCDs. |
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Evidence that an Advance Beneficiary Notice of Non-coverage (ABN) was provided to the beneficiary. |
Disclaimer
This checklist was created as an aid to assist providers. This aid is not intended as a replacement for the documentation requirements published in national or local coverage determinations, or the CMS documentation guidelines. It is the responsibility of the provider of services to ensure the correct, complete, and thorough submission of documentation.