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

Relevant CMS manual instructions and policies regarding bioengineered skin substitutes are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

• CMS Internet-Only Manual (IOM), Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40.
• CMS Internet-Only Manual (IOM). Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 270.13.
• CMS Change Request, CR 8213; Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds; issued June 10, 2013

Social Security Act (XVIII) Standard References:

• Title XVIII of the Social Security Act, 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

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.