As CTP Coverage Changes, Focus on What You Can and Should Do!

© 2023 HMP Global. All Rights Reserved.
Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Today’s Wound Clinic or HMP Global, their employees, and affiliates.

Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure accuracy. However, HMP and the author do not represent, guarantee, or warranty that coding, coverage, and payment information is error-free and/or that payment will be received.

On August 3, 2023, three A/B Medicare Administrative Contractors (MACs)—CGS Administrators, LLC; Novitas Solutions, Inc.; and First Coast Service Options, Inc.—released final local coverage determinations (LCDs), final local coverage articles (LCAs), and response to comments articles that clearly changed the Medicare fee-for-service coverage for skin substitute grafts/cellular and/or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers. See Table 1 for an overview of the states, number of Medicare beneficiaries, number of physicians, number of Medicare hospitals, and annual claims volume in the Medicare jurisdictions managed by the three A/B MACs.

By now most ulcer management stakeholders are probably aware that 58 cellular and/or tissue-based products (CTPs) for skin wounds are on the “covered” product list and 130 CTPs are on the “non-covered” product list. However, these LCDs and LCAs contain other important guidance for ulcer management physicians, qualified healthcare professionals (QHPs), and facilities. Therefore, every stakeholder should read the entire LCD and LCA that is pertinent to them.

In addition, each MAC carefully responded to all comments received pertinent to the draft LCDs. Therefore, every stakeholder should also read the article that itemizes the MAC’s Responses to the Comments, which clearly describe 1) how the MAC refined the final LCD to incorporate acceptable recommendations submitted during the comment period, and 2) the published clinical evidence that the MAC used to create the coverage criteria and guidelines. The 3 MACs implemented most of the recommendations of the commenters and based many of their coverage determinations on published evidence. See Table 2 for links to the LCDs, LCAs, and Responses to the Comments.

These final coverage documents will become effective on September 17, 2023. Therefore, the stakeholders who apply CTPs to Medicare beneficiaries in the affected states must act quickly to educate the pertinent professionals and revenue cycle team members and to refine their product selection, utilization, documentation, and coding processes.

Following are some of the important do’s and don’ts that ulcer management professionals and revenue cycle team members should focus on and implement prior to September 17, 2023.

Do’s

✓  Review the list of CTPs that will be covered and those that will not be covered.
NOTE: The MACs placed CTPs on the non-covered list when:

• The MAC did not have evidence of FDA regulatory compliance, or
• The product had FDA designation as a wound covering, or
• The MAC lacked evidence that the CTP improved health outcomes or provided benefits relative to established alternatives or standard of care when used as an ulcer treatment by forming a sheet scaffolding for skin growth.

✓  Plan to use covered CTPs.
✓  Add the covered CTPs, that you intend to use to your coding and billing systems.
✓  Remove the non-covered CTPs from your coding and billing systems unless you intend to still offer them to the Medicare beneficiaries and to charge the beneficiaries for the procedure and the product.
✓  Educate the clinical and revenue cycle teams about all the coverage criteria and guidelines.
✓  Select the correct size CTP to fit the ulcer size and to minimize wastage.
✓  Ensure that patients receiving the skin replacement surgery with a CTP are under the care of a physician/QHP for the treatment of their systemic disease process (e.g., diabetes mellitus, chronic venous insufficiency, and/or peripheral vascular disease.
✓  Include the following information on each claim (in the narrative/remarks) when you report HCPCS code Q4100 (Skin substitute, not otherwise specified) or HCPCS Code A4100 (Skin substitute, FDA cleared as a device, not otherwise specified):     

• Product name
• Package size purchased
• Amount applied
• Amount wasted

✓  Report the skin replacement surgery application code and the CTP product code on the same claim if you are a hospital owned outpatient provider-based department (PBD) or a physician/QHP office.
✓  Document the discarded CTP in the patient’s medical record and include the date and time, amount wasted, and reason for the wastage. Report the discarded amount on a separate claim line and append the JW modifier. NOTE: The JW modifier should not be reported by PBDs.
✓  Append the JZ modifier to the CTP code on the claim to attest that all the CTP was applied to the ulcer.
NOTE: The JZ modifier should not be reported by PBDs.
✓  To support the medical necessity for the covered CTP applied, report the diagnosis codes to the highest level of specificity.
✓  Read and follow the documentation guidelines in the LCD and LCA. See Donna Cartwright’s article entitled: "What Are the Documentation Requirements in the New LCDs for CTPs?"

Don’ts

X      Apply CTPs to patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy or the ulcer extremity, active vasculitis)
X      Waste excessive amounts of the CTP
X      Apply more than 4 applications to any ulcer in a 12-week episode of care.
X      Perform 4 applications on every patient.
X      Perform additional applications after the 12-week episode of care.
X      Repeat CTP applications if the ulcer increases in size or depth, if there is no change in the baseline size or depth, and if there is no sign of improvement or indication that improvement is likely (e.g., granulation, epithelialization, or progress towards closing).
X      Use surgical preparation services, such as debridement, in conjunction with routine, simple and/or repeat skin replacement surgery of a CTP.
X      Report non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected CTPs with the CTP application codes.
X      Report a covered CTP’s HCPCS code to disguise the use of a non-covered CTP.
X      Report a non-covered CTP on the same claim with any other procedure (e.g., debridement) or evaluation & management services.
X      Apply CTPs if all aspects of the care are not within your scope of practice and your professional license, and if you are not appropriately trained to perform the skin replacement surgery procedure, and if the surgical procedure is not performed in an appropriate setting.
X      Report removal of a CTP and/or simple cleansing of the ulcer and other surgical preparation services when you report reapplication of a CTP.
X      Report an evaluation & management service with the skin replacement surgical procedure (application of the CTP) unless the patient’s condition requires a separately identified service.
 
If stakeholders wish to request one or more revisions to the LCDs which will be implemented on September 17, 2023, they can submit the request, along with published evidence to support the request, through the LCD Reconsideration Process. Each MAC publishes the LCD Reconsideration Process guidelines on their website. See Table 3 for links. For now, ulcer management stakeholders should focus on what CTPs they can use and, on the coding, coverage, and documentation guidelines that they should implement.

Kathleen D. Schaum oversees her own consulting business and is a founding member of the Today’s Wound Clinic editorial advisory board. She can be reached for consultation and questions at kathleendschaum@gmail.com.

Click here to download a PDF of this article.