01/17/2026 Paul Kesselman, DPM
CMS and Cellular Tissue Products
CMS’s recent decision to sharply reduce
reimbursement for all cellular tissue products
(CTPs) and to eliminate payment for wastage is,
paradoxically, both commendable and deserving of
strong criticism.
The explosive growth in CTP utilization over the
past five years was clearly unsustainable. CMS had
little choice but to take decisive action. Left
unchecked, CTP expenditures could have
significantly strained the Medicare Trust Fund and
potentially jeopardized CMS’s ability to fund
other critical, life-saving treatments—including
those for cancer, cardiovascular disease, and
countless other conditions affecting our families
and communities.
That said, as is often the case, the pendulum may
have swung too far. These sweeping cuts now risk
threatening both the limbs and lives of our most
vulnerable patients.
One constructive approach CMS has already
implemented is the WISeR program—a prior
authorization model currently limited to select
states. This program should have been expanded
nationwide. In the DME space, prior authorization
has existed for years and generally functions
well, particularly for providers who utilize DME
portals to submit required documentation.
Affirmation rates exceeding 80% for lower-
extremity orthotics and prosthetics demonstrate
that such systems can be both efficient and
effective. Prior authorization is typically
obtained within 3–7 business days, and any CTP
prior authorization program should be held to
similar standards.
For urgent clinical situations, DME already allows
use of a “STAT” modifier when immediate care is
required. A comparable mechanism could easily be
implemented for CTPs. Under such a model, urgent
cases would bypass prior authorization and instead
be subject to post-service pre-payment review.
Since most CTP applications are planned rather
than emergent, a WISeR-style prior authorization
program—modeled after the DME framework—could
substantially reduce fraud and abuse without
compromising patient care.
To be fair, a small segment of CTP providers bears
responsibility for CMS’s aggressive reaction,
particularly the elimination of payment for
wastage. Contractors paying 50% or more in wastage
costs is, at minimum, abusive. However, CMS’s
solution—categorizing CTPs as “incident-to”
medical supplies—fundamentally misses the mark.
CTPs should never have been lumped together with
syringes, gauze, alcohol wipes, or similar
disposable supplies.
A more reasonable approach would have required
providers to justify the clinical need for a
specific CTP and graft size, while simultaneously
giving manufacturers a grace period to develop
smaller graft options. Instead, manufacturers have
been forced into a costly and counterintuitive
position, requiring substantial investments in
additional studies and FDA clearance simply to
produce smaller product sizes.
Adding to the disruption, mounting pressure on CMS
and its contractors has led to last-minute
retractions of LCDs governing CTP applications in
many jurisdictions. While inherently restrictive,
these LCDs nevertheless provided a critical safety
net for providers who complied with their
requirements.
So who ultimately bears responsibility for this
chaos? CMS itself. Over the past decade, the HCPCS
workgroup approved more than 300 CTP products. Yet
LCD authors now contend that many of these
products fail to meet the very standards they are
imposing today. If that is the case, why were
these products approved in the first place? This
disconnect has fueled political pressure and
contributed to widespread LCD retractions, with
only a handful of MACs maintaining coverage.
What we must all hope to avoid is a downstream
increase in sepsis-related deaths from
inadequately treated wounds or a rise in limb
amputations as providers become reluctant to use
CTPs.
It will be important to monitor whether
utilization shifts toward other advanced wound
care modalities, including vaporous hyperoxia
therapy, MIST therapy, hyperbaric oxygen therapy,
or even the renewed use of tissue expanders for
decubitus and diabetic foot ulcers.
Alarmingly, there is already discussion within the
wound care community of layoffs and facility
closures as reimbursement instability takes its
toll.
Ultimately, the central question remains: how does
this upheaval benefit patient care—particularly
for those currently in active episodes of care
involving CTP applications?
One can only hope that CMS and all stakeholders in
the wound care community will come together to
craft a solution that is clinically sound,
fiscally responsible, and equitable for patients,
providers, and society as a whole.
Paul Kesselman, DPM, Oceanside, NY
