It’s no secret the American Amnion Association supports reform in the skin substitute market. We’ve been vocal since the beginning.
For years, the system drifted away from clinical value and toward pricing distortion. Medicare spending on skin substitutes surged at a pace that was impossible to ignore, climbing from the hundreds of millions into the tens of billions in just a few years. CMS was right to intervene as the status quo was simply not sustainable.
But recognizing the need for reform does not mean endorsing a rushed, very flawed rollout.
And that is where the current debate must become more honest.
Where We Agree With AATB
The Association for Advancing Tissue and Biologics (AATB) has raised legitimate concerns about the 2026 Medicare fee schedule changes, particularly the use of a flat $127 and some change per cm² rate and the way that rate was derived. AATB argues that the methodology relied on non-representative data and may threaten patient access, innovation and the sustainability of tissue providers.
On that point, we 100% agree.
A payment system that is implemented with flawed assumptions can create real harm – and we’re seeing this now. When reimbursement falls too far, too fast, the result can be predictable: fewer products, reduced provider participation, suspended clinical research, layoffs and reduced patient access.
We’ve seen this firsthand on all fronts – from layoffs to substandard patient care and everything in-between – it hasn’t been pretty and it’s been beyond messy.
AATB’s document outlines these risks clearly and the concern is very, very real. Patients should not become collateral damage in the attempt to correct a broken market, and that’s exactly what is occurring.
Where We Disagree
Where the American Amnion Association diverges is in the narrative surrounding how we got here and what should happen next.
AATB’s request to Congress centers heavily on reversing the move to the Physician Fee Schedule and using historical spending as a benchmark for future payment.
While understandable, this isn’t reform and that approach risks steering the field back toward the very structure CMS concluded was financially unsustainable.
We do not support a simple return to the old rates.
Why? Because the old system did not break by accident.
It was distorted by bad actors, pricing games and reimbursement practices that often completely ignored clinical evidence and/or patient outcomes.
Any policy solution that treats historical spending as a neutral baseline ignores the uncomfortable truth – some of that spending was inflated – and building a new framework on an inflated foundation is like rebuilding a house on wet sand. The shape may look familiar, but the floor still shifts – and even sinks – beneath your feet.
Reform Must Be Smarter, Not Just Softer
The answer is not to abandon reform.
The answer is to do it properly.
The American Amnion Association has long advocated for a reimbursement environment that rewards clinical value, not opportunism. In our statement last November, we said it plainly:
“Standardization is good. Simplification is good. Denial of medically necessary care is NOT.”
That remains our position.
We believe the next model must be built on evidence, not nostalgia and not a rerun of a broken system. It cannot be based solely on what was spent before. It must be based on:
- measurable clinical outcomes
- appropriate utilization
- product category differences
- legitimate acquisition and processing costs
- patient access needs
- safeguards against pricing abuse
We believe a sustainable payment approach should do three things at once:
First, preserve access for medically necessary care.
Patients with serious wounds and other complex conditions should not lose access because policy overcorrected. And that’s exactly what we’re seeing.
Second, remove the incentive for inflated pricing.
Reimbursement should not reward products simply for carrying an oversized price tag. This was rampant and out of control before CMS stepped in.
Third, support products that demonstrate real value.
If a product improves healing, reduces downstream complications and helps avoid hospitalization or amputation, that value should matter. And from what we’re seeing, that’s currently a crapshoot.
This is the lane the field must move into, a disciplined middle path grounded in evidence that places patients first.
The Stakes Are Bigger Than Reimbursement
This conversation is often framed as a dispute about policy mechanics.
It is not.
It is about what kind of market we want to preserve.
Do we want a field shaped by evidence, ethics and patient outcomes? Do we want to help patients, prevent amputations and even death? Or do we want a system defined by coding strategies and reimbursement arbitrage?
The AaA believes regenerative medicine deserves better than a binary fight between runaway spending and collapsed access. We believe every single donation should be honored and viewed as a gift, and at this point in time, we are dishonoring this gift in the form of denying patients the gift they need to heal.
We can acknowledge that CMS had a reason to act.
We can acknowledge that the implementation was flawed.
And we can insist that the next step must be smarter than either extreme.
Our Position
The American Amnion Association stands for reform with integrity.
We support efforts to correct abuse.
We support standardization.
We support simplification.
We support sustainable reimbursement.
We support and honor the gift of donation.
We support patient access and care.
What we don’t support is solving one distortion by restoring another.
When a market becomes distorted by inflated pricing and opportunistic behavior, the damage goes far beyond reimbursement policy. It undermines public trust. It destabilizes the recovery and processing organizations responsible for honoring donor intent.
And in this moment, it is not only patients who are being denied access to needed care. Donor mothers who want to give this gift are increasingly being denied the opportunity to do so because the infrastructure required to recover, process and deliver these tissues has been strained to the breaking point.
That is the tragedy inside the policy story.
A system built on pricing games does not honor the donor. A system that collapses access does not honor the patient. We need a path forward that does both – and this is built on evidence, medical necessity and patient need/accessibility.
And THIS is a standard worth defending.
Jerry Pascucci, AaA President
Theresa Hong, AaA Vice President