Skin Substitute ADR Checklist
To help us complete a more efficient and expedited review, we recommend organizing medical record documentation in the order indicated in the checklist below. Please ensure you submit the requested documentation within 45 days of the Additional Documentation Request (ADR). If we don't receive a timely response, your claim will deny for non-receipt of records.
Submit all documentation pertinent to support that the services provided and billed during the review period are medically necessary and coded correctly. This may include documentation for services provided prior to the review period. Please note: The most common reason claim denials are overturned on appeal is because the redetermination (first level appeal) request included new documentation omitted from the initial submission for medical review.
*Please ensure all documentation contains the beneficiary's name, date of service, and an abbreviation key (if applicable). In addition, all documentation must be complete and legible, including signature(s) and date(s). If the legibility of a signature is questionable, include a signature log or attestation statement.
Before responding to an ADR, use the checklist below as a reference to ensure each claim meets Medicare's policy requirements. Please submit all required documentation outlined in the CMS Medicare Benefit Policy Manual and any applicable Local Coverage Determination (LCD) or National Coverage Determination (NCD). Providers are responsible for submitting complete and accurate documentation per regulatory guidelines for each claim. Ensure documentation within any aspect of the medical record that you submit belongs solely to the intended beneficiary, and documentation for another beneficiary isn't present.
| Check | Skin Substitute ADR Checklist – Preferred Order |
|---|---|
| 1. ADR letter and enclosed cover sheet with each DCN | |
| 2. UB-04 claim form, billing statement or summary | |
| 3. History and physical documentation | |
| 4. Operative or procedure report for any procedures performed during billed dates of service | |
| 5. All consultation reports and notes | |
| 6. Radiology/pathology/lab results to support medical necessity of diagnosis/treatment | |
| 7. Please submit all documentation to support the use of skin substitutes and medical necessity for the services billed. |
Resources
- Complying with Medicare Signature Requirements
MLN fact sheet - LCD L36690: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities

- LCD Article A56696: Billing and Coding: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities

- Social Security Act section 1862 (a)(1)(A)
: definition of "medically necessary"
How to Prevent Common Denials
Ensure documentation includes:
- Adequate documentation to support failure of wound healing after conservative treatments attempted for a minimum of 4 weeks prior to the placement of a skin substitute graft. (Repeat or alternative applications of skin substitute grafts are not medically reasonable when previous courses have been unsuccessful: increases in size and/or depth of wound, no changes from baseline.)
- Application is not intended for partial/full-thickness ulcers involving tendon, muscle, joint capsule, or exposed bone or sinus tracts.
- Wound must be free of necrotic debris, drainage.
- Adequate circulation/oxygenation exists to support tissue growth/wound healing.
- Documentation of skin deficit at least 1.0 sq cm in size
*Skin substitutes are not warranted if there is evidence of inadequate control of underlying conditions: active infection of the wound, edema, osteomyelitis, Charcot arthropathy, etc.*
You may include an outline or cover letter with your documentation for CGS Medical Review staff to use as an index and help locate key documentation that supports claim payment. However, the cover letter can't replace medical record documentation, and the documentation must support the cover letter contents to be useful.
In addition, you may use brackets [ ] { }, asterisks (*) or underlined text in the documentation to draw the reviewer's attention to important information. However, notations should not alter, or give the appearance of altering, the documentation. Use of a highlighter isn't recommended since documentation may not be legible.
Education
We encourage all CGS providers to use the myCGS portal. This free self-service option is available 24/7. Registered users can identify and respond to ADRs, determine review status, and receive immediate notifications.
Visit the Calendar of Events to register for our educational sessions.
For any additional questions, concerns, or educational needs related to the review process, please email J15AMREDUCATION@cgsadmin.com. Include your facility's name and provider number (PTAN) with your inquiry. Also, please use this email address to provide current contact information in case CGS identifies any educational outreach opportunity.

