News Releases

Statement from the Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders is pleased that CMS’ Medicare Administrative Contractors (MACs) carefully considered stakeholder recommendations and made substantive changes following input from the wound care community in the recently released final Local Coverage Determinations (LCDs) and accompanying Coding and Billing Articles, “Skin Substitute Grafts/Cellular and Tissue-Based Products (CTPs) for the Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers.” With publication of the final policy by each MAC, the wound care community now has clearer understanding of Medicare coverage for the application of CTP/skin substitute products in treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

The Alliance and the larger wound care clinical community mobilized together, illustrating the power of tenacious advocacy and a unified voice to positively influence policies so that they reflect quality wound care practice. In a noted change that was in direct alignment with Alliance recommendations, the MACs increased the covered application limit from 4 to 8 in the final policy, now consistent with the supportive clinical evidence, treatment guidelines and current standard of care to promote wound healing. Similarly, the "episode of care" treatment duration increased from 12 to 16 weeks. The Alliance believes these are considerable improvements to the concerning limitations that had been included in the proposed policies issued for comment this past April. Under the finalized LCDs, providers have the application flexibility (supported by sufficient documentation) needed for wound healing and, importantly, Medicare beneficiaries with hard-to-heal DFUs/VLUs can benefit from improved outcomes.

The Alliance appreciates that the MACs also reviewed new studies submitted over the comment period and thus added three products to the final “covered” lists, which now includes a total of 18 HCPCS codes – 13 for DFU only (“Group 2”) and 5 for both DFU/VLU (“Group 3”). Approximately 204 products were deemed by the MACs to either not have any evidence or lacked sufficient efficacy evidence and placed on the non-covered list (“Group 4”). As a result, wound care providers across all sites of service will now quickly need to adjust their selection, prescribing, ordering patterns, formularies, and documentation requirements for their Medicare Part A and Part B patients. Fortunately, the MACs took into account Alliance requests for an extended implementation date to allow for this transition and avoid abrupt interruption of treatment plans. The implementation date of February 12, 2025, is 90 days from the date of issuance, rather than the 45 days that is standard for MAC policies.

While we are pleased with many of the changes incorporated into these final policies following stakeholder feedback, the Alliance intends to seek clarity and provide additional recommendations for improvements. We recognize that the next steps for many manufacturers of products on the noncovered list will likely be investing in studies to support the MACs’ new evidence standards for coverage. However, we are concerned that the policy fails to provide sufficient clarity regarding the process by which new data can be submitted and reviewed for coverage consideration and that the timelines included in the LCD are not sufficiently frequent or transparent. The LCDs’ concluding section states only that “the intent is this policy will be reviewed every 12 months with updates to products/coverage as indicated.” A clearer process is needed to establish a predictable pathway and timeline for coverage consideration following submission of new evidence supporting existing products on the non-covered list, as well as for new products to be considered for coverage. The Alliance will be working to seek additional clarification from the MACs on these issues.

Note: the Alliance and several of our members will share feedback and recommendations at the upcoming Town Hall that the Medicare Administrative Contractors are hosting on Dec. 10, 2024. We encourage other stakeholders to also share perspectives at this important MAC listening session. Register to attend and submit requests to speak to: This email address is being protected from spambots. You need JavaScript enabled to view it.

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The Alliance of Wound Care Stakeholders is pleased to announce the appointment of four new members to its Board of Directors. The expansion of the Board will strengthen and diversify the expertise of Alliance leadership and governance structure and enable us to make an even more significant impact by bringing in new perspectives and expertise to serve the wound care community and achieve our strategic objectives. Join us in welcoming Dr. David Alper, Michelle Cooper, Deanna Primozic, and Julie Rhodovi. Read more about these impressive individuals in the press release below. 

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Following tenacious collaborative advocacy from the Alliance of Wound Care Stakeholders and across the wound care community, three Medicare Administrative Contractors – Novitas, First Coast Service Options, and CGS Administrators – today withdrew their local coverage determinations (LCDs) and local coverage articles (LCAs) that that would have dramatically restricted Medicare patients’ access to cellular and tissue-based products for wounds (CTPs, or "skin substitutes”), advanced wound care treatments that are instrumental to wound healing. The policies were scheduled to go into effect on Oct. 1st but have now been pulled. “This was a collaborative effort across the wound care community and, with the withdrawal of the policies, our advocacy clearly had impact. The real winners here are Medicare beneficiaries with chronic wounds who now won’t face disruptions to care or unnecessary restrictions to treatments that can support wound healing,” said Marcia Nusgart, R.Ph., CEO of the Alliance. 

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The Alliance commemorated its 20th anniversary with a video highlighting its work and impact driving change and moving wound care forward over the past twenty years. 

Sept. 19, 2022 – The Alliance of Wound Care Stakeholders urged the Centers for Medicare and Medicaid Services to update inadequate payment methodologies for cellular and/or tissue-based products for skin wounds (CTPs, or “skin substitutes”) to ensure appropriate access to care in the hospital outpatient/provider-based department (PBD) site of service. In comments submitted to CMS’s proposed 2023 Hospital Outpatient Prospective Payment System updates, the Alliance forwarded specific recommendations to correct policy and payment challenges that are negatively impacting access to CTPs in provider-based departments. These include...
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• CMS
• CTPs/(skin substitutes)
• HOPPS

Sept. 13, 2022 - The Alliance of Wound Care Stakeholders, the leading voice for wound care advocacy and education to address public policy issues impacting patient access to care, marks two decades of experience in addressing many issues of commonality for its members that include clinical and patient associations, wound care clinics and business entities spanning manufacturers and distributors, providers, researchers and reimbursement experts. The Alliance takes pride in its role as a key collaborator and resource for numerous government agencies, providing insights and guidance on issues impacting coding, coverage and payment, as well as quality measures and wound care research. “As we look back on our 20 years of serving multiple stakeholders across the wound care community, we are gratified to reflect on significant advocacy and educational outreach activities in the regulatory, legislative and public arenas,” says Marcia Nusgart, R.Ph., CEO, The Alliance. 
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Sept. 7, 2022 - The Alliance alerted the Centers for Medicare and Medicaid Services (CMS) that changes to the way cellular and/or tissue-based products for skin wounds (CTPs, or “skin substitutes”) are coded and paid for in the physician office under the proposed 2023 Physician Fee Schedule will create barriers to care that could ultimately lead to increased amputations and infections for patients with chronic non-healing wounds. The Alliance urged CMS to delay implementation of the proposed provisions until patient access issues can be further studied. “Under the proposed 2023 policy, payments for CTPs and their application will simply not cover the costs to physician offices. Without adequate reimbursement, many physicians will no longer be able to afford to provide these medically necessary and successful advanced treatments to their patients. This would deprive patients these valuable treatment options which, in turn, could ultimately result in an increase in infections as well as amputations," the Alliance told CMS in submitted comments.
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• CMS
• CTPs/(skin substitutes)
• Physician Fee Schedules

September 2021 – The Alliance of Wound Care Stakeholders voiced opposition to payment cuts that would negatively impact wound care providers and their patients in recent comments to the Center for Medicare and Medicaid Services’ (CMS) proposed CY2022 Physician Fee Schedule and proposed Hospital Outpatient Prospective Payment System (HOPPS) regulations. The Alliance challenged cuts to surgical procedures, physical therapy services, disposable negative pressure wound therapy and compression payment as well as provided recommendations to remove barriers to CTPs. The final regulations from CMS are expected to issue in November.
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• CMS
• CTPs/(skin substitutes)
• Negative Pressure Wound Therapy (NPWT)
• Physician Fee Schedules
• Pneumatic Compression
• HOPPS

August 26, 2021 – At its public meeting on August 23, the Advisory Panel on Hospital Outpatient Payment unanimously approved two recommendations made by the Alliance of Wound Care Stakeholders that, if accepted and implemented by CMS, would positively impact wound care by correcting flaws in the payment that have negatively impacted reimbursement for cellular and tissue-based products for wounds (CTPs, also known as skin substitutes) and removing barriers to access for these important wound care products. While the Advisory Panel submits recommendations to CMS for consideration, the Agency is not obligated to move its recommendations forward. That is why now is the time for the wound care community to make its voice heard to CMS so that these recommendations are included in the OPPS policy as it is revised and finalized. Here's how.

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• CMS
• CTPs/(skin substitutes)
• Prospective Payment System (PPS)
• HOPPS

October 2020 - The Center for Medicare and Medicaid Services’ (CMS) Durable Equipment Medical Administrative Contractors (DMEMACs) updated its “Local Coverage Article: Surgical Dressings” to include payment for secondary, as well as primary, use of alginate and other fiber gelling dressings. Prior to the October 15, 2020 Policy Article Update (A54563), these products were only reimbursed when used as primary dressings - limiting healthcare providers’ discretion and choices in properly treating their wound patients.
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