FairWoundCare.org
Medicare decision may reduce access to clinically-proven wound care products
Now is the time to act to prevent CMS from reducing access to clinically-proven wound care products.
Click the buttons below to send a letter to your elected officials in the US Congress or to tell your wound care story in video form.
BACKGROUND
The Medicare program has historically provided coverage for “skin substitutes” (products derived primarily from donated human tissue) which are clinically-proven in the care of persistent and painful chronic wounds, including diabetic foot ulcers, venous leg ulcers, and pressure wounds.
On April 25, 2024, all of the nation’s Medicare Administrative Contractors (“MACs”— private companies that administer the government’s Medicare program) issued nearly identical proposed coverage policies eliminating Medicare coverage for the vast majority of skin substitute products and severely restricting use of the few remaining products.
If the proposed policy is finalized, 90% of these effective products that are currently in high use, would no longer be accessible. This will lead to significant shortages of skin substitute products for seniors with serious, painful wounds, which will lead to increased risk of sepsis, amputation and death. Furthermore, the proposed policy would limit skin substitute use to 4 applications, other than in "exceptional" cases, which is outside the current standard of care.
Ready to act to help keep these productS available to the patients who need them?
ABOUT FairWoundCare.org
FairWoundCare.org was founded by wound care providers, manufacturers, distributors, and consultants and is dedicated to ensuring that access to high-quality and effective wound care treatments remain available to all patients.
Here is where FairWoundCare.org stands on skin substitute use in wound care:
The current state of skin substitute use in wound care is not sustainable largely due to lack of proper pricing policy and abuse. The Centers for Medicare and Medicaid Services (CMS) is right to seek appropriate controls regarding skin substitute price and usage, but attempting to achieve this measure through product exclusion is the wrong approach and will have detrimental impacts.
The rationale for the covered/non-covered list segmentation is not in alignment with FDA’s regulation of tissue products. If CMS is not going to cover products which are permitted to be marketed by FDA, CMS should set out clear requirements for evidence such that products can be covered fairly.
The limit of 4 applications means that statistically almost half of the wounds treated with HCT/P will be considered “exceptional” cases. This limit will almost certainly result in poorer outcomes, including morbidity. In many cases, these poorer short-term wound outcomes will translate to higher overall costs of care due to amputation.
Manufacturers should invoke pricing policies that favor a long-term, sustainable policy which maximizes the number of wounds treated.
CMS and the MACs should abandon the current LCD and draft a more thoughtful and workable policy which will not limit the number of wounds treated or negatively impact outcomes.
You can help ensure that CMS and the MACs do not move forward with the current proposal. Act now and let your voice be heard!