Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of delay and how industry players may choose to react.

On April 11, 2025, Centers for Medicare and Medicaid Services announced that the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Final Local Coverage Determinations (LCDs) effective date will be delayed until January 1, 2026. In this video (16:43 minutes), SmartTRAK Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of delay, and how industry players may choose to react.

The SmartTRAK Wound Team will be in attendance at the upcoming SAWC Spring conference in Grapevine, TX (April 30 to May 4). Please register here to meet the team.

On December 10, 2024, the Medicare Administrative Contractors (MACs) held a town hall session to discuss the Local Coverage Decisions (LCDs), “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers,” which were issued on November 14. The proposed LCDs were announced on April 25 of this year, a comment period followed, and then things went black as the MACs contemplated whether any changes should be made to the LCDs. Two key improvements in the final version included an increase in the number of skin substitute applications from four to eight and an increase in care time from 12 to 16 weeks. In this article, SmartTRAK will discuss the ongoing activities since these LCDs were announced, including the requirement for published peer-reviewed clinical evidence, market activities to shore up position and activities to rescind the LCDs. The article will close with SmartTRAK’s forward analysis of the impact of these LCDs on the market should they be implemented as planned.

Arrests were made at the Phoenix Sky Harbor airport in June when two individuals attempting to flee the country were charged by the DOJ for defrauding Medicare over $900.0MM. According to the DOJ case summary, the two individuals “were charged by indictment with various counts of conspiracy, health care fraud, receiving kickbacks, and money laundering in connection with an alleged scheme to fraudulently bill Medicare $900 million for highly expensive amniotic allografts. The defendants targeted elderly Medicare patients, many of whom were terminally ill in hospice care, through their companies—Apex Mobile Medical LLC, Apex Medical LLC, Viking Medical Consultants LLC, and APX Mobile Medical LLC. “

SmartTRAK believes these charges are just the tip of the iceberg in terms of the amount of fraud occurring in the US Market for Skin Substitutes. With a dramatic spike in Medicare claims in 2023, it’s clear widespread Medicare abuse has allowed the US Skin Substitute market to balloon, almost doubling in just one year! The abuse is primarily limited to amniotic tissue products, which held 52.5% of the US market in 2022 and 64.5% of the market in 2023.

In this downloadable article, SmartTRAK discusses in detail the DOJ investigation and its impact on the Skin Substitute market, including:

• SmartTRAK Financial Analysis of the Market
• The Impact on Established Market
• Potential Drivers for Change
• Criteria for Medicare Physician Fee Schedule Focused (MPFS) Players
• What Could Impact the Market
• What the Future Holds

Click the button below to download and read the complete "Skin Substitute Market Rocked by DOJ Investigations" article by Susan Paquette, SmartTRAK VP & General Manager, Wound.  

The proposed MAC LCDs for Skin Substitutes/CTPs was the hot topic of SAWC and will continue to be until the LCDs are finalized. In this article, SmartTRAK highlights new learnings from discussions at SAWC and the MAC open meetings.

The Symposium on Advanced Wound Care (SAWC) Spring 2024 meeting welcomed clinicians, researchers and industry to Orlando, FL, to learn, earn continuing education credits, share knowledge and network on the latest developments in advanced wound care. As is typical during SAWC, the Alliance of Wound Care Stakeholders also held a meeting of their members. With the Medicare Administrative Contractors (MACs) recently announced proposed changes in the Local Coverage Determination (LCD) governing Skin Substitutes/CTPs (cellular and/or tissue-based products), the Alliance pivoted and invited an expert to speak to the group about how the LCD process works and what laws govern what can be done at the MAC level versus the Center for Medicare & Medicaid Services (CMS) levels. Kudos go out to the team at the Alliance for bringing this meeting together. In addition to the Alliance meeting at SAWC, the MACs held open meetings for these LCDs from May 16 to May 29, and anyone, including manufacturers, could present comments, make a request and provide evidence. SmartTRAK participated in several of these meetings.

In this downloadable article, SmartTRAK gives an overview of LCDs, how they are drafted, the coverage limitations by wound type, issues surrounding evidence for inclusion on the covered list and an implementation timeline. For more information on what the proposed LCDs cover, see also “Medicare Administrative Contractors’ (MACs) LCD Changes: Impact on Skin Substitutes/CTPs.”

The following subjects are covered in detail in this downloadable article:

• The Process for Drafting LCDs
  As background, CMS governs the process for drafting the LCDs in their Medicare Program Integrity Manual (PIM) in Chapter 13, which was most recently updated in 2019 with almost every section re-written. These changes include ... (read more)
  
  
• Coverage Limitations
  The LCD is a literal guide to what is allowed and, conversely, what is automatically denied within the limits written in the LCD. The LCDs for Skin Substitutes/CTPs are for ... (read more)
  
  
• Missing or New Evidence and Reconsiderations
  One area that generated the most questions from manufacturers was how to address coverage decisions if the MAC working groups are missing recently published evidence or have evidence currently in development. The comment submission period was ... (read more)
  
  
• Timeline for LCD Implementation
  During the MAC open meetings, participants had several questions regarding the timeline for LCD implementation, and some requested a delay in implementation. The following timeline applies to all LCDs ... (read more)
  
  

" Perspective article by Jay Merkel, SmartTRAK Sr. Analyst.

Three MACs rocked the Skin Substitute/CTP market with changes in coverage in their final LCDs implemented in September. SmartTRAK takes a look at the overall impact on the market.

SmartTRAK has covered the highly active, ever-growing Skin Substitute/CTP market for over ten years. During that time, the market has grown at a CAGR of over +13%. Most years it experienced strong double-digit growth except those years impacted by reimbursement changes, Department of Justice (DOJ) investigations or the COVID-19 pandemic. Skin Substitute/CTPs are primarily used on Medicare patients with non-healing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The Center for Medicare & Medicaid Services (CMS) primarily pays for health care services for people aged 65 and older. Individuals can receive health care benefits via traditional Medicare or Medicare Advantage, which is run by private health insurance plans. Traditional Medicare contracts with Medicare Administrative Contractors (MACs) to process claims for reimbursement and write local coverage determinations (LCDs). Currently, there are twelve regions in the US managed by seven MACs.

Among the topics covered in this extensive article are:

• Key Policy Changes
• Impact on Patients
• Market Impact

On August 3, 2023, three MACs issued final LCDs governing the use of Skin Substitutes/CTPs in treating DFUs and VLUs. The release of the final LCDs, which are effective September 17, 2023, was not surprising to the market, given that the proposed LCDs were issued in 2022. The proposed LCDs allowed ...

To download and read the complete "Impact of Medicare Administrative Contractor LCD Changes on Skin Substitute/CTP Market" article by Susan Paquette, SmartTRAK's VP & General Manager, Wound and Terry Hayslett, Sr. Analyst, Wound just click the button below.

This SAWC Spring 2023 perspective article extensively covers a wide range of topics pertaining to skin substitutes and Cellular and Tissue-based Products (CTPs), offering in-depth insights and analysis, and highlights a multitude of areas for discussion. Some of the key topics explored in this article include:

• CAMP Companies and Products Dominate
  • Spring SAWC was dominated by companies showcasing their CAMPs, with nearly 30 companies exhibiting this year. The market is currently led by ...
    
• Reimbursement: It’s Complicated
  • Skin substitute utilization is heavily influenced by reimbursement and setting of care. The physician office currently captures the largest share of the skin substitutes market. This is primarily driven by ...
    
• Emerging Sites of Care
  • In its Site of Care module, SmartTRAK currently tracks the use of CTP or CAMP products in the surgical suite, HOPD, physician office, VA Health system and burn center. In discussions at SAWC, SmartTRAK learned ...
• Future Growth
  • Despite reimbursement hurdles, SmartTRAK projects strong growth for this segment in the coming years, primarily due to ...
    

To download and read the complete "SAWC Spring 2023: Spotlight on the Skin Substitute Market" market perspective article by Susan Paquette, SmartTRAK's VP & General Manager, Wound, just click the button below.

Treating burns with skin substitutes dominated the clinical presentations and discussions on the exhibit hall floor. A close second discussion point was the role of proper wound bed preparation or debridement. This article highlights new products from Kerecis*,Vericel*, Epien Medical, PixaMedand the role of debridement in wound healing.  

Among the many topics covered in detail in the complete article, which is available as a download, are:

Surgeons are concerned about the cost of breast matrices in an increasingly restrictive environment, but alternatives may be on the horizon according to key discussions at the 2022 Plastic Surgery: The Meeting.

To read the complete "Trends in ADM Use from ASPS 2022" article by Doug Devens, SmartTRAK's Product Director/Sr. Analyst - Wound, in which  he shares observations from the ASPS sessions and the potential implications for the Breast Matrices Market, just click the following link.

The potential of US reimbursement changes to Skin Substitutes weighed heavily on companies at SAWC Fall, yet subsequently, CMS decided to delay finalizing its proposed changes.

The Symposium on Advanced Wound Care (SAWC) Fall 2022 gathered for another year in Las Vegas. The exhibit hall was filled with most wound care manufacturers and though booth hours were short, the clinical attendees made the best of their time searching out the latest in wound care technologies.

In this article, SmartTRAK discusses:

• Alternative Product Developments to the Skin Substitute Market 
• Potential Impact of Proposed Reimbursement Changes
• The Top Four Companies by Revenue 
• CMS' Proposed Terminology Change from “Skin Substitute”
• Packaging Skin Substitutes as “Incident to” Supplies