April 11^th 2025

Delay Gives Trump Administration Time to Further Evaluate Coverage Policy and Payment Reform

The MASS Coalition applauds the Trump Administration’s decision to delay the effective date for the Medicare Local Coverage Determinations (LCDs) restricting access to skin substitute products to January 1, 2026. This action by President Trump, HHS Secretary Kennedy, and CMS Administrator Dr. Oz will enable the new Administration to formulate a revised coverage policy to protect Medicare beneficiaries, especially those in rural America suffering from conditions such as diabetic foot ulcers and venous leg ulcers, and ensure they remain able to receive vital, lifesaving care. The MASS Coalition is committed to continuing to work with the Trump Administration to make sure that reimbursement policies for skin substitutes create a fair system that addresses coverage and payment issues without risking patients’ lives, blocking innovation, and hurting healthcare providers who follow the law. The Trump Administration has taken an important step toward making America healthy again by delaying the LCDs and attempting to right the wrong started by the Biden Administration that would threaten patients’ health and cost American lives.

April 10^th 2025

Report Ignores Medicare Contractors’ Attack on Patient Care and the Biden Administration’s Inaction on Payment Reform

The New York Times recently published an unbalanced and one-sided article unfairly tarnishing the value of skin substitutes, the manufacturers and providers who bring needed treatments to diabetics and others with wounds that would otherwise not heal. It is reprehensible to see an esteemed newspaper miss the heart of a story so significantly. The article inappropriately calls the products “bandages” and inaccurately frames the issuance of Medicare Contractor “Local Coverage Determinations” as addressing fraud and abuse, while the real point is cast aside. The current Medicare contractor proposal would do nothing to address fraud but instead would eliminate 85% of the products from the market altogether, causing an immediate treatment shortage and condemning thousands of Medicare beneficiaries to further suffering and the increased risk of amputations. Instead of highlighting sensational allegations of provider misuse, The Times should have examined why the Biden Administration identified this problem and attempted to resolve it by allowing Medicare contractors to severely limit patients’ access to treatment options, rather than fixing the payment system. The Biden Administration’s CMS leadership created this problem and could have resolved it years ago without risking the life and limbs of vulnerable Americans.

There has been a significant increase in skin substitute innovation and success in treating chronic wounds, which the Times wrongly oversimplified as “reusing medical waste.” Medicare facilitated this increase a few years ago when CMS expanded access to skin substitute products prescribed outside of physicians’ offices. The manufacturers have always and will continue to follow Medicare payment rules, which CMS has the authority to adjust to benefit patients, providers and the Medicare program. Instead, ill-advised Biden-era coverage policies, if they become effective, will seriously harm patients who are not responding to other available treatments by eliminating access to 85% of the products on the market.

Many wounds won’t heal without skin substitute treatment and when patients aren’t getting the care they need, their health will decline. With chronic wounds, this can mean increased sepsis, amputations, and premature death. Treatments for sepsis and amputation involve expensive hospitalization that can come at a much higher Medicare price tag than skin substitutes. The MASS Coalition is focused on engaging with HHS officials to implement a revised payment methodology that pays providers appropriately and supports innovation so patients can continue to benefit from these critical wound care products. For the Times to imply an entire industry is unethical is ludicrous and unsubstantiated.

Contrary to the Times’ claims, the MASS Coalition has shared information on this issue with Republican and Democratic Members of Congress, as well as both Biden and Trump Administration officials, as we have worked towards solutions to the coverage and payment issues for skin substitutes since 2023. Donating to political candidates is a standard business practice for American companies, and the MASS Coalition members have followed the law and ethical guidelines for doing so as they have urged the federal government to take action that will save lives.

The New York Times has missed the mark when it comes to telling the real story of how the prior Administration’s Medicare contractors proposed severely reducing access to a crucial treatment for vulnerable Americans. We call on the Times to correct its story. Lives are at stake, and the MASS Coalition is hopeful that the Trump Administration will further its mission to protect patients and the Medicare program by rescinding the LCDs and reforming the payment system for skin substitutes. This is why members of the skin substitute industry formed the MASS Coalition and is what we have been asking for and supporting over the last two years.

March 7^th 2025

President Trump says “help is on the way” for patients who need skin substitutes

The MASS Coalition extends its appreciation to President Trump for his promise of help for Medicare patients with diabetes whose lives depend on skin substitute therapy. As the President correctly stated, without access to skin substitutes to help treat chronic wounds, hundreds of thousands of Medicare recipients will face unnecessary limb amputations and even death.

The MASS Coalition is grateful for the President’s assurances, especially after a previous freeze order by the Administration delayed the start date of this policy from February 12, 2025 to April 13, 2025. As the new coverage cutoff date approaches, the Coalition is hopeful the President will act to have the Medicare program cancel the Local Coverage Decisions and protect Medicare beneficiary access to life-saving treatment.

January 27^th 2025

President Trump’s Freeze Order Applies to Skin Substitute LCDs – LCDs will not be effective until at least April 13, 2025

The MASS Coalition applauds President Trump for his bold action ordering a freeze of all regulatory guidance not yet in effect, which includes the recent Medicare Local Coverage Determinations restricting access to skin substitute products. The “Freeze Order” specifically encompasses “guidance documents,” which include the recent Skin Substitute LCDs. We thank the Department of Health and Human Services for taking the necessary steps to withdraw the LCDs until at least April 13, 2025, so that the Department can engage in further evaluation and public comment. The Department’s action is particularly good news for Medicare beneficiaries suffering from diabetic foot ulcers and venous leg ulcers. These patients will be able to access needed treatments in order to avoid sepsis and amputations that can lead to increased costs to Medicare for lengthy in-hospital treatment, as well as premature death, for at least the next two months.

As the Coalition previously noted, the LCDs are precisely the type of Biden-era behind-closed-doors regulatory action that the Freeze Order was intended to stop. The MACs, without promised stakeholder consultation and working at the behest of a few companies, operated in secret to coordinate the LCDs. In doing so, the MACs ignored the pain and suffering of everyday Americans and threaten to create a healthcare crisis for diabetics who will face an immediate shortage of treatments and end up in the hospital – creating unnecessary delays for other Americans and increasing the cost for Medicare. The MACs do not treat patients. America’s doctors and practitioners treat patients and know what works best for them. President Trump’s Freeze Order and the upcoming actions of the Department of Health and Human Services can end the prior Administration’s misuse of the regulatory process and ensure that Americans have access to skin substitute products prescribed by their physicians. By completely rescinding the LCDs, the Trump Administration can further deliver on its promise to make America healthy again and avoid the catastrophic treatment shortage set in motion by the prior Administration that would threaten the health of millions of Americans.

Skin substitutes made from donated amniotic tissue are used in dermatology to transform chronic wounds into an acute state, improving the healing environment. These substitutes significantly enhance healing rates, reduce emergency admissions, and decrease the need for amputations when used alongside quality care practices like debridement and offloading.

Proposed Medicare changes that could limit access to these products would negatively impact patient care by reducing treatment options and potentially increasing infection risks and hospitalizations, underscoring the need for comprehensive coverage and interdisciplinary management.

Physician’s Weekly (PW) spoke with David Armstrong, MD, PhD, professor of surgery and neurological surgery at the Keck School of Medicine of the University of Southern California, to better understand the benefits of skin substitutes and how treatment could change under the proposed Medicare changes.

Read more: https://buff.ly/3yc1oJZ