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.  

Over the last 10+ years, the market for skin substitutes has been turbulent with new technologies and products being launched and reimbursement changes occurring for the various sites of care. SmartTRAK highlights a few of these based on the recent SAWC Fall meeting.

Skin substitutes, also referred to as CTPs (cellular and/or tissue-based products) or CAMPs (cellular, acellular and matrix‑like products), remained front and center at the Symposium on Advanced Wound Care (SAWC) Fall meeting held in Las Vegas on November 2-5, 2023. The strong presence of these products mirrors a similar trend in the overall US Advanced Wound Care (AWC) market. For Q323, skin substitutes alone account for 37% of the US AWC market, more than Negative Pressure Wound Therapy (NPWT) or Advanced Dressings, according to an analysis of SmartTRAK Financial Dashboard.

In this article, SmartTRAK discusses in detail:

• The Migration of Skin Substitutes Over the Years
• Which Synthetics are Gaining Attention
• New Companies–Unique Technology and Innovations
• Health Policy Dynamics–Reimbursement and Advocacy
• The Future of US-Based AWC Companies
• The Potential for Acquisitions on the Horizon

To download and read the complete detailed "SAWC Fall 2023: Skin Substitutes Reign Again" article by SmartTRAK's Susan Paquette, VP & General Manager, Wound and Terry Hayslett, Sr. Analyst, Wound, just click the button below.

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.

Fertram Sigurjonsson, CEO of Kerecis, discusses the recent acquisition, how the Company has evolved over the last decade and key milestones along its “Road to Success” in an interview with SmartTRAK.

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.

Biologics had a whopping quarter, Advanced Dressings saw strong gains and External Devices continue to show minimal gains due to traditional NPWT holding down the segment.

The global AWC market is split geographically, with the US accounting for just over half, followed by Europe and then ROW, due to the US using higher technology products and their allowed reimbursement. SmartTRAK has noted shifts in market share, largely driven by currency movements. In Q123, there was less of an impact. From Q221 to Q123, the US went from 52.6% share to 53.1%, Europe from 27.9% to 28.6% and ROW from 19.5% to 18.2%.

Among the many topics covered in detail in SmartTRAK's comprehensive Q123 Advanced Wound Care Market Recap* are:

• Complete Q123 Advanced Wound Care Market Overview
• SmartTRAK's Expert Market Analysis and Insights
• All AWC Companies' News, Revenues, Data, Charts and Market Shares
• WW Advanced Dressings: Acceleration of Continued Solid Growth
• Biologics: An Impressive Quarter
  
  • Skin Substitutes/CTPs
  • Topical Delivery/Drug
  • Collagen/Active Dressings
• External Devices: Single-use NPWT and Topical Oxygen Therapy Drive Growth
• Growth Analysis – Currency Having a Less Strong Impact
  • Growth Details for Key Companies in Q123
• Other Notable Q123 AWC Events

3M remained the global revenue leader in the Q123 WW AWC market, with Smith+Nephew (SNN) is in second place and Mölnlycke rounding out the top three,  with revenues of ...

Read the entire Q123 AWC Market Recap, including SmartTRAK's expert analysis, news, data, charts, company revenues and shares*

*These links and the complete unedited article can only be viewed by SmartTRAK subscribers to this module. For more information on SmartTRAK, including how to receive a demo and subscribe, please click the button below.

Among the many topics covered in detail in SmartTRAK's comprehensive Q422/FY22 AWC Market Recap* are:

• Complete Q422/FY22 AWC Market Overview and Highlights
• SmartTRAK's Expert Market Analysis and Insights
• All Company News, Revenues, Data, Charts and Shares
• WW Advanced Dressings: Continued Solid Growth
• Biologics: Growth Remains Healthy but Dips Slightly in Q422
  • Skin Substitutes/CTPs
  • Topical Delivery/Drug
  • Collagen/Active Dressings
  • Traditional NPWT Performance
  • Single-use NPWT Performance 
  • Topical Oxygen and Debridement
• Growth Analysis – Currency Having a Strong Impact Throughout 2022

The US went from 51.9% share market to 55.3% of the global AWC market, Europe from 29.5% to 26.4% and ROW from 18.6% to 18.3%. The primary reason is ...

Read the entire Q422/FY22 AWC Market Recap, including SmartTRAK's expert analysis, news, data, charts, company revenues and shares.*

*These links and the complete unedited article can only be viewed by SmartTRAK subscribers to this module. For more information on SmartTRAK, including how to receive a demo and subscribe, please click the button below.