05/27/2024    Eric J. Lullove, DPM

Medicare MACs Release New Cellular Tissue Product LCD for DFU and VLU

In case you live in a closet or under a rock, the
Medicare Administrative Contractors (MACs) have
released proposed coverage policy updates to their
Application of Skin Substitute and Cellular Tissue
Products for Diabetic Foot Ulcers and Venous Leg
Ulcers on April 24.

This new policy is a welcome change for most of the
providers who have been asking for more evidence-
based coverage in relation to the numerous products
on the market without clinical evidence. The MACs
have answered the question: when is this going to
happen and how many applications am I allowed?

The MACs have uniformly decided that 4 applications
within a 12-week episode of care is medically
necessary and reasonable. They have also decided
on about 15 products that have evidentiary coverage
under the new Program Integrity Manual that was
released on January 23, 2024, mandating that the
MACs use the GRADE method to determine product
eligibility.

Notwithstanding that of course, this being a
proposed policy, there are plenty of errors and
omissions in the policy.

First, they have omitted numerous products that
have well-regarded RCT data that was not included
in their technology assessment, which had a cut-off
date of 2021. There have been many studies and
products published since then that have the
required necessary data points for inclusion.

Second, the contractor has omitted the “podiatrist”
or “DPM” as a provider listed specifically in the
policy.

Now, while DPMs are considered physicians in the
Medicare system, this could easily allow a rogue
contractor to deny DPM claims based on specialty
since DPM/Podiatrist is not specifically listed in
the policy.

Third, there are many ICD-10 diagnoses related to
diabetic ulcer anatomy that is missing from the
policy. 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, the contractors have
left the door open for vagueness and non-
transparency in this policy release which they must
clean up before a final is issued.

There are many more things that I can list that
DPMs should be upset about, specifically the number
of application limitation, but the contractors have
given an off-ramp for additional applications
should the qualifying care meet the threshold of
“medically necessary and reasonable” via the -KX
modifier, which also presents a problem if the
contractor uses the -KX modifier as a pretense to
deny services while they review claims (which they
have ZERO capacity to deal with on the level
necessary).

Here is a compiled list of the Medicare Contractors
and the links to their websites for submission of
public comments:

I am including the links below.

•CGS Administrators, LLC –
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39755&ver=35
•First Coast Service Options, Inc. –
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39870&ver=4
•National Government Services, Inc. –
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39827&ver=4
•Noridian Healthcare Solutions, LLC (J-E) –
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39759&ver=11
•Noridian Healthcare Solutions, LLC (J-F) --
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39763&ver=8
•Novitas Solutions, Inc. –
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39823&ver=11
•Palmetto GBA – https://www.cms.gov/medicare-
coverage-database/view/lcd.aspx?lcdid=39805&ver=16
•WPS Insurance Corporation –
https://www.cms.gov/medicare-coverage-
database/view/lcd.aspx?lcdid=39864&ver=2

The contractors will have completed their open
forum meetings for verbal comments by 5/29/2024.
This is not the pathway for your voice to be heard.
The contractors, under the new Program Integrity
Manual, can only affect changes to the proposed
coverage policy via WRITTEN SUBMITTED COMMENTS
ONLY. This is YOUR opportunity to affect change
before this policy becomes final, and this policy
on its face – will become FINAL.

Do not sit idly by and wait for your component
state organizations or the national organization to
deal with this. Take a stand, review the policy,
and submit your comments. They can be 5 lines or
multiple pages – it does not matter. Submit your
voice to your local Medicare Contractor and take a
stand. These policies when finalized will be the
law of the land for the next 5 years.

Review the Coverage Policy and the Billing and
Coding Document attached to the end of the policy
document. Take a few minutes if you perform in-
office, outpatient hospital or home-based wound
care services. This is YOUR responsibility to know
what is coming and how to plan for its future. Be
a voice for your patients.

Eric J. Lullove, DPM, Coconut Creek, FL

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