10/04/2023    Eric J. Lullove, DPM

CMS Withdraws LCD Policies that Dramatically Restrict Access to CTPs (Paul Kesselman, DPM)

To note Dr. Kesselman (with whom I hold high
regard), the three CMS jurisdictions (CGS, Novitas
and FCSO) retracted their proposed cellular tissue
product for DFU/VLU was not because of spite or a
“Shot Across the Bow”.

There has been an explosion of Q-coded amniotic
allograft tissues on the market since 2016. More
so during Covid. Start-up companies paid to have
their AATB (American Association of Tissue Banks)
certification and came out with products that had
ZERO evidence for coverage under the LCDs.
However, they were granted through the FDA under
the Part 361 process of “homologous use” product
pathway. What these local MAC administrators found
was the significant uptick in POS 11 claim data
resulting in expenditures for tissues that were
either not medically necessary, or did not meet
the qualification of “homologous use”.

But that is not the end of the line with the
contractors. There needs to be comprehensive Local
Coverage policies developed for treatment of DFU
and VLUs. The basic problem with these new
policies as I understood (I represent the Wound
Healing Society to the Alliance for Woundcare
Stakeholders) were multiple legal and medical
clinical issues that plagued these policies from
the start.

First, the evidence they used (Armstrong, et al.
2019 Medicare Data Set) was horribly
MISINTERPRETED as to the 4-application rule. If
you had read Dr. Armstrong’s study, the data set
showed a standard deviation +1 of almost 7
applications as the median for healing a DFU with
cellular tissue products (and this data was from
2015-2019). Second, there was misinterpretation
of my clinical trial RCT with Kerecis (Marigen-
Omega 3) with the same interpretation of the
contractor with the data, and didn’t see our
results of median 6.5 applications. There are
other clinical studies that show similar results,
and those of us that practice and lecture on wound
management know this to be true.

Lastly, there were significant violations of
federal statutes at play. By introducing new
definitions of “Biological” and “Wound Covering”
without a forum for public comment, the
contractors were violating the Administrative
Services Act. When the contractors did not use all
of the CURRENT available evidence, including
registry data, there was a violation of the 21st
Century Cures Act. There were other issues at
play, mostly involving minority Medicare patients
with lack of access, transplant patients who would
never get their transplants with open DFU/VLUs,
etc. There became a massive beneficiary hardship
for those in rural communities or those in areas
of the country with decreased services. CMS (and
ultimately the Director of CMS) got wind of these
policies and ORDERED the contractors to withdraw.

In all, Dr. Kesselman is right. This is and has
always come down to documentation. This is where
CarePics and their SL2 program (free for APMA
members) can help (note: I am NOT engaged with
CarePics for any contractural advisor or KOL at
this time for full disclosure). This program is
FREE. It will allow you as a provider to photo
document and document all of the pre-questionnaire
validations for CTP use on a DFU/VLU. To trust
that you “know” the coverage policies and
documentation requirements in a digital age is
insane. Download the app to your iPhone or
Android. Use the platform to shield yourself from
your own mistakes.

Let’s see what the future brings. Be in the know
and the why. The more we act appropriately in our
medical reasoning and documentation, the less the
contractors have to pull monies back. Don’t give
them a reason to.

Eric J. Lullove, DPM, Coconut Creek, FL

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