Advocate for Your Wound Care Patients on the Proposed MAC Policy on CTPs

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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.

The Medicare Administrative Contractors (MACs) recently released proposed coverage policy updates for applying cellular- and tissue-based products (CTPs) for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).¹
 
Those providers who have been asking for more evidence-based coverage regarding the numerous CTPs on the market may find this a welcome change. The MACs have all found it to be medically necessary and reasonable to allow 4 applications of CTPs within a 12-week episode of care. The MACs have also decided on about 15 products with evidentiary coverage under the new Program Integrity Manual issued on January 23, mandating that the MACs use the GRADE method to determine product eligibility.²
 
However, I have personally found multiple errors and omissions in the proposed policy. First, the MACs have omitted numerous CTPs that have well-regarded randomized controlled trial (RCT) data that was not included in their technology assessment, which had a cut-off date of 2021. In my observation, many studies and products published since then have the required necessary data points for inclusion. Second, although DPMs are considered physicians in the Medicare system, the MACs have omitted the “podiatrist” or “DPM” as a provider listed specifically in the policy, which means a contractor could potentially deny DPM claims based on specialty.
 
Third, in my observation, the proposed policy is missing many ICD-10 diagnoses related to DFUs. This might have been an oversight, but the contractors need to be specific to the diagnosis codes allowable under the policy to qualify for payment. More importantly, I feel that the MACs have left the door open for vagueness and non-transparency in this policy release, which I strongly believe they must clean up before issuing a final policy.
 
There are many other areas of concern, specifically the limit on the number of applications, but the contractors have provided an off-ramp for additional applications if the qualifying care meets the threshold of “medically necessary and reasonable” via the -KX modifier. However, this also presents a problem if the contractor uses the -KX modifier as a pretense to deny services during a review of claims (which in my experience, I feel that they have zero capacity to deal with on the level necessary).

How You Can Submit Written Comments

Following recent open meetings where they considered verbal comments, the contractors, under the new Program Integrity Manual, are also considering submitted written comments. This is your opportunity to effect change by submitting comments to the MACs at the below links before the policy becomes final:

• CGS Administrators, LLC
• First Coast Service Options, Inc.
• National Government Services, Inc.
• Noridian Healthcare Solutions, LLC (J-E)
• Noridian Healthcare Solutions, LLC (J-F) 
• Novitas Solutions, Inc. 
• Palmetto GBA 
• WPS Insurance Corporation 

If you perform in-office, outpatient hospital or home-based wound care services, review the Coverage Policy and the Billing and Coding Document attached to the end of the policy document. You have a responsibility to know what is coming with CTP policy and how to plan for the future. Advocate for your wound care patients.
 
Eric J. Lullove, DPM, CWSP, is the Chief Medical Officer at West Boca Center for Wound Healing in Coconut Creek, FL.

References
 
1. Centers for Medicare and Medicaid Services. Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

2. Centers for Medicare and Medicaid Services. Medicare Program Integrity Manual. Chapter 13—Local Coverage Determinations.