By Sarah Hull FNP, WCC, DWC is the CEO and Nurse Practitioner at Caring Wounds Unlimited LLC in Farmington, Missouri
Published originally in the St. Louis Post-Dispatch

Medicare has proposed several changes to coverage and reimbursement for wound care.  These changes threaten my ability to treat patients in rural Southeastern Missouri. My patients, including police officers, veterans, diabetics, and other Medicare beneficiaries, have wounds requiring specialized life-saving products to treat chronic wounds often found on their feet and legs. If these products are not used, these wounds will not heal or will leave the patient with a much longer healing time. Longer healing times can have life threatening outcomes including sepsis, amputation, and death.

I personally serve a patient population across a 3-hour driving radius, which includes in-clinic, in-facility and in-home care. My patients are often confined to a wheelchair or bed, which makes wound care incredibly challenging. The specialized products we rely on are called “skin substitutes” are made from donated tissue and are expensive to manufacture. The faster I can treat chronic wounds with these products, the better the outcome for both the patient and for the Medicare program. Left untreated, these wounds can get infected leading to serious consequences including lengthy hospital stays, amputation, and at times death. Medicare pays far more for this type of hospitalization than the cost of skin substitute treatments. Amputations have unique challenges that can greatly increase both Medicare costs and the risk of early death.

Two years ago, Medicare attacked providers like me with a proposal to eliminate coverage for nearly all skin substitute products. This meant that providers would not be paid by Medicare for these products, meaning we could not use them for patients. Although Medicare paused that plan, next they audited my practice and clawed back over $750,000 in payments that I had to appeal to win back (and win I did). Sadly, not every provider can withstand these audits and some have been forced out of business.

After surviving the nightmare of the audit, I had hoped that things would improve under the new Administration. In April, the Trump Administration delayed the plans to eliminate Medicare coverage for these products, which gave me hope that the government would support the needs of my patients. However, this summer Medicare released its latest proposal which will drastically reduce payment rates for skin substitutes to an amount so low that it will force small clinicians like me to shut our doors. If you remove my clinic and our treatment options from the equation, my patients will have no one.

I recognize that there are some bad actors that manipulated the system to make more money. However, we cannot create policy that hurts patients, penalizes the manufacturers, and attacks providers who are playing by the rules. The majority of us agree that Medicare should fix the pricing issues involved with these products. This is why I have worked with the MASS Coalition to try to reform the payment system for these treatments in a way that is fair to all and does not punish everyone for the bad actions of a few. But Medicare’s latest plan is not the solution. Tragically, if Medicare implements its proposed payment plan, there will be a reduction in the quality of patient care, causing hospitalization, amputations, and, of course, Medicare spending more money.

This is also why I support Senator Bill Cassidy’s recent legislation, S. 2561, which will set a fair price for these treatments, keep coverage for patients, and encourage medical innovation while saving Medicare a lot of money. This is the common sense middle ground we need to truly solve this problem instead of ‘throwing the baby out with the bathwater’ approach Medicare continues to take. However, if Medicare finalizes its proposal in the July 2025 Physician Fee Schedule Proposed Rule, I can assure you American lives will be lost.

From my practice in Farmington, Missouri (population 20,000) I’m the only wound care provider to treat patients across ten counties. If Medicare drastically cuts payments as proposed, I cannot afford to travel to treat my home-bound and elderly patients, and these rural patients will suffer needlessly. My situation is very typical of rural America, where hospitals are hours away and hard to come by. The government’s proposal, and its impact, are unacceptable.

I am asking President Trump and our other elected officials to come together to urge Medicare to implement a reasonable plan to improve today’s system. But this plan should not involve slashing payments so deeply that it prevents rural care and completely cuts off patient access to these life-saving treatments. Further, elected officials should support Senator Cassidy’s legislation and stop Medicare from running wound care into the ground. My patients’ lives depend on it.

July 15^th 2025

New payment rates will lead to limited supply, shuttered businesses, and reduced access to care for patients with chronic wounds

July 15, 2025 – The MASS Coalition firmly opposes the drastically reduced 2026 payment rates for skin substitutes in the proposed Physician Fee Schedule released yesterday by the Centers for Medicare & Medicaid Services (CMS). This change will have devastating consequences for patients suffering from chronic wounds who rely on life-saving skin substitute treatments. Without access to this crucial care, these patients will be much more likely to experience chronic pain, amputations, and premature deaths.

While the MASS Coalition supports restructuring the payment rates to a commonsense amount and methodology that works across all parties, the new rate of $125 per sq. cm. for 2026 proposed by CMS ignores the realities of manufacturing, distributing and applying these treatments. The proposed rate does not consider the true cost associated with the full supply chain of skin substitutes and unquestionably overlooks the impact severely lowered rates will have on rural care across the country. As a result, the companies producing skin substitutes will no longer be able to operate, providers won’t be able to afford to continue to treat many within their patient base, and the patients most in need will be the ones who suffer greatest. CMS has taken an already broken system and dismantled it beyond repair with its proposed rates. The MASS Coalition calls on CMS to fix their error and institute appropriate payment rates for skin substitutes. American lives depend on it.

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