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

This article gives guidance for billing, coding, and other guidelines in
relation to local coverage policy Wound Application of Cellular and/or Tissue
Based Products (CTPs), Lower Extremities L36690 .

**General Guidelines for Claims submitted to Part A or Part B MAC:**

Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to
billing Medicare. For services requiring a referring/ordering physician, the
name and NPI of the referring/ordering physician must be reported on the
claim. A claim submitted without a valid ICD-10-CM diagnosis code will be
returned to the provider as an incomplete claim under Section 1833(e) of the
Social Security Act. The diagnosis code(s) must best describe the patient's
condition for which the service was performed. For diagnostic tests, report
the result of the test if known; otherwise the symptoms prompting the
performance of the test should be reported.



**Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines**

An ABN may be used for services which are likely to be non-covered, whether
for medical necessity or for other reasons. Refer to CMS Publication 100-04,
Medicare Claims Processing Manual, Chapter 30, for complete instructions.

Effective from April 1, 2010, non-covered services should be billed with
modifier -GA, -GX, -GY, or -GZ, as appropriate.

The -GA modifier ("Waiver of Liability Statement Issued as Required by Payer
Policy") should be used when physicians, practitioners, or suppliers want to
indicate that they anticipate that Medicare will deny a specific service as
not reasonable and necessary and they do have an ABN signed by the beneficiary
on file. Modifier GA applies only when services will be denied under
reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e),
or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC
systems will automatically deny services billed with modifier GA. An ABN, Form
CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts
responsibility for payment. The -GA modifier may also be used on assigned
claims when a patient refuses to sign the ABN and the latter is properly
witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the
date of the ABN is required.



Modifier GX ("Notice of Liability Issued, Voluntary Under Payer Policy")
should be used when the beneficiary has signed an ABN, and a denial is
anticipated based on provisions other than medical necessity, such as
statutory exclusions of coverage or technical issues. An ABN is not required
for these denials, but if non-covered services are reported with modifier GX,
will automatically be denied services.



The -GZ modifier should be used when physicians, practitioners, or suppliers
want to indicate that they expect that Medicare will deny an item or service
as not reasonable and necessary and they have not had an ABN signed by the
beneficiary. If the service is statutorily non-covered, or without a benefit
category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN
is not required for these denials, and the limitation of liability does not
apply for beneficiaries. Services with modifier GY will automatically deny.



**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. Medical record documentation must support the medical necessity of the services as directed in this policy.
  5. The documentation must support that the service was performed and must be included in the patient's medical record. This information is normally found in the history and physical, office/progress notes, hospital notes, and/or procedure report.
  6. The medical record must clearly show that the criteria listed under the "Indications and Limitations of Coverage and/or Medical Necessity" sections have been met, as well as, the appropriate diagnosis and response to treatment.
  7. The documentation must support the need for CTP application and the product used.
  8. A description of the wound(s) must be documented at baseline (prior to beginning conservative treatment) relative to size, location, stage, duration, and presence of infection, in addition to type of treatment given and response.   

    1. This information must be updated in the medical record throughout treatment.
    2. Wound description must also be documented pre and post treatment with the skin substitute graft being used.
    3. If obvious signs of worsening or lack of treatment response is noted, continuing treatment with the skin substitute would not be considered medically reasonable and necessary without documentation of a reasonable rationale for doing so.
  9. Documentation of smoking history, and that the patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation (if applicable) as well as outcome of counselling must be in the medical record.
  10. The amount of utilized and wasted skin substitute must be clearly documented in the procedure note with the following minimum information:   
  

    * Date, time and location of ulcer treated;
    * Name of skin substitute and how product supplied;
    * Amount of product unit used;
    * 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.
  
**Note:** CGS Administrators expects that where multiple sizes of a specific
product are available, the size that best fits the wound with the least amount
of wastage will be utilized. Each product material is for a single-use only
and is not for use on a multiple patients.

  
**Utilization Guidelines**  
  
In accordance with CMS Ruling 95-1 (V), utilization of these services should
be consistent with locally acceptable standards of practice.  
  
It is the expectation that a specific CTP product will be used for the episode
of each documented wound, and in compliance with FDA assessments and submitted
guidelines for the specific product. Greater than ten (10) applications for
the treatment of a single wound within a 12-week period of time, will be
considered Not Reasonable and Necessary and will be subject to review.  
  
Separately billed repeated use of the skin substitute after 12 weeks for a
single wound or episode is non-covered. Alternative or additional skin
substitute products used within the 12 week initial wound episode are
similarly non-covered when the sum of applications of all Skin Substitutes is
greater than ten (10) for a single wound.  
  
The utilization of a CTP non-compliant with medical necessity or designated
guidelines for that specific product may necessitate review or non-coverage as
not medically necessary.  
  
Labeling for most skin substitute grafts include language suggesting multiple
applications; however, Medicare does not expect that every ulcer in every
patient will require the maximum number of applications listed on the product
label or allowed for reimbursement.  
  
Utilization rates that exceed peer norms, identified through data analysis may
prompt prepayment or post payment medical review.