SmartTRAK reviews CMS’ new WISeR model and its potential impact on the US Skin Substitutes Market.

 A new initiative launched by the Centers for Medicare & Medicaid Services (CMS)’s Innovation Center, which develops payment and service delivery model pilot programs, could impact the Skin Substitutes Market in several states in 2026 and beyond. Other models to come out of the Innovation Center are: Comprehensive Care of Joint Replacement Model and the Maryland Total Cost of Care Model. The newest model, the WISeR Model, short for Wasteful and Inappropriate Service Reduction, leverages AI technology along with human clinical review to streamline prior authorization processes for certain product categories.

 

The WISer Model hopes to use technology to root out wasteful services with limited clinical evidence of effectiveness. It targets many different product categories that CMS determined have a higher risk of waste, fraud and abuse. One such category is skin and tissue substitutes.

 

Caroline Fife, MD, CMO of Intellicure and Executive Director of the US Wound Registry, discusses real-world evidence in wound care and other topics in an interview with SmartTRAK. 

Caroline Fife, MD, discusses insights from the Intellicure database about what diabetic foot ulcer (DFU) and venous leg ulcer (VLU) patients look like, the role of real-world evidence in wound care and the challenges in treating wound care patients.

To find out more, including the challenges for manufacturers and the systemic issues in wound care and payment policies, click on the following video to listen to the interview (37:48 min). A link to download the complete transcript of the interview is provided below. Interview topics by timecode are also provided below. 

 

Interview Outline by Timecode: 

00:30 Overlap between diabetic foot ulcers and venous leg ulcers.
08:19 Challenges in wound classification and diagnosis.
14:02 Limitations of randomized controlled trials and the role of real-world evidence.
17:38 Potential for biomarkers and intermediate outcome measures.
21:57 Neglected wound types and nutritional deficiencies.
29:14 Barriers to wound care implementation.
32:50 Opportunities for change in wound care practices.
34:31 Local coverage determinations (LCDs) and manufacturer challenges.
35:16 Systemic issues in wound care and payment policies.

Click the button below to download and read the complete transcript of SmartTRAK's interview with Caroline Fife, MD, CMO of Intellicure, conducted by  Elizabeth Anderson, SmartTRAK Senior Analyst, Wound Biologics.

CAMPs 2025 meeting highlights the use of CAMPs in all sites of care.

SmartTRAK reports the latest news and trends in cellular, acellular and matrix-like products (CAMPs) from the CAMPs 2025 Wound Care Summit held February 28 to March 2 in Fort Lauderdale, Florida. Hosted by the Journal of Wound Care (JWC), CAMPs 2025 showcased new clinical research, consensus guidelines and presentations supporting the use of CAMPs amid uncertainties in reimbursement for these products in the US Market for Skin Substitutes.

The subjects discussed in this downloadable SmartTRAK Perspective article include:

• The Broad Use of CAMPs
  • Sessions at CAMPs 2025 supported the broad use of CAMPs, including applications for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) as well as those for limb salvage, acute care, tunneling wounds, Mohs surgery, trauma, burns and pressure ulcers (PrUs). SmartTRAK expects the use of CAMPs to ... (read more)
• LCD Discussions Taking Center Stage
  • With the implementation of the MAC LCDs delayed until April 13^th, a prevailing question among attendees at the conference was whether the LCDs would actually be implemented or further delayed. SmartTRAK spoke with clinicians and industry representatives to obtain their views on the LCDs and ... (read more)
• Market Disruption – 2025 Earnings Projections
  • For public companies providing skin substitutes to the market, uncertainty was a major theme in their 2025 guidance SmartTRAK  summarizes comments from companies that mentioned the LCD in their 2025 revenue projections ... (read more)

Although a significant amount of discussion with clinicians and industry focused on revising the reimbursement methodology for skin substitutes, companies are still moving forward with clinical studies. SmartTRAK is currently tracking 26 clinical trials for DFUs and VLUs, as mentioned earlier and ...

To find out more about news and trends from CAMPs 2025, just click the button below to download the complete market perspective article "LCD Uncertainty Bringing Disruption to CAMPs" by Susan Paquette, VP & General Manager, Wound.

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SmartTRAK is the Medtech industry’s only global Insights-as-a-Service solution for the Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapy markets. SmartTRAK’s propriety methodology turns disparate data from hundreds of sources into powerful insights customers can rely on as the trusted source for strategic decision-making. The SmartTRAK enterprise platform includes rich daily updates, comprehensive market coverage and simple-to-use tools and dashboards for market, product and financial analysis. Customers leveraging the SmartTRAK platform also have direct access to market experts for inquiries and advisory services. If you would like a demo of what SmartTRAK has to offer and see how we can help increase proficiency, improve productivity and reduce costs for your company, just click here.

SmartTRAK highlights four wound diagnostics companies utilizing artificial intelligence to watch in 2025.

Artificial intelligence (AI) is becoming increasingly ubiquitous in our personal and professional lives. AI is already being applied in healthcare in areas such as image analysis, personalized treatments and predictive care. Future potential applications include improved analysis of healthcare data, optimizing medication doses and enhancing patient education. The challenges of AI are also widely discussed, with ethical and legal concerns combined with a general worry that patient care could become dehumanized and distanced from healthcare professionals.

In this downloadable article, SmartTRAK identifies and discusses the following four diagnostic companies facilitating AI that should be watched in 2025:

• eKare
  • Wound assessment company eKare has been at the forefront of the conversation around AI in wound care. The core functionality of inSight, a 3D digital wound imaging system, includes AI aspects such as ... (read more)
• Mimosa Diagnostics
  • Canadian tissue oximetry company Mimosa Diagnostics primarily implements AI to enhance the usability of its Mimosa Pro device, which uses ... (read more)
• Spectral AI
  • Texas-based Spectral AI has undertaken significant fundraising over recent years. Over $150 million of Biomedical Advanced Research and Development Authority (BARDA) funding since 2013 has facilitated ... (read more)
• Swift Medical
  • Toronto-based Swift Medical saw a significant change in 2024. New leadership was announced in June as Dwayne Sansone and Stratos Davlos assumed the roles of CEO and CTO, respectively. The company received ... (read more)

The benefits of AI in wound care include accuracy and efficiency of wound characterization, remote monitoring, personalized care and increased accessibility to wound care ...

To find out more about how these companies are incorporating AI, just click the button below to download the complete market outlook article "Artificial Intelligence in Wound Diagnostics: Four Companies to Watch in 2025" by Kris Flinn, SmartTRAK General Manager, Wound.

SmartTRAK highlights the key trends in the US Compression Therapy market that will drive growth over the next few years.

In the US Market for Compression Devices, SmartTRAK projects revenues to reach a 5-year CAGR of +6.2%. In 2025, SmartTRAK expects mid-single-digit growth to continue and sees three key trends that will help drive growth over the next several years. These include: