As you likely know, Each MAC under Medicare issued newly revised Local Coverage Determinations (LCDs) scheduled to take effect on February 12, 2025. These changes would significantly impact the chronic wound care space, including the skin substitute/CTP products we currently represent.
In effort to provide clarity, we wanted to address the main areas of concern and give you a high-level look at what we are doing about it. We encourage you to review the LCD related documents attached below. This link has all the MACs future effective LCDs & LCAs as well as their Responses to Comments.
Future LCDs/LCAs
Arguably the most questionable section in these LCDs are of which brands/products would be covered or reimbursed. This LCD, if made effective, would remove coverage for roughly 95% of the products used today. The criteria for coverage reflects an overarching theme of CMS, requiring sufficient clinical evidence or “Real World Evidence” for DFUs & VLUs.
The majority of our manufacturers have already begun conducting various studies in line with the criteria outlined in the LCDs. These include a mix of randomized controlled trials (RCTs), observational studies, and retrospective studies—all of which were explicitly mentioned in the Responses to Comments section of the future LCDs as acceptable study types for consideration and review for approval.
While these efforts are ongoing, B&C is committed to preparing for all potential scenarios, including but not limited to:
- Future LCDs take effect with no adjustment
- Evaluating other opportunities that add value to our Agencies, and Customers; ancillary products, services, & technologies outside of Skin Subs like collagen.
- Evaluating and potentially contracting with some of the other products on the covered list.
- Future LCDs end up revised or modified
- The biggest part of the LCDs that could change are likely the covered vs non-covered products lists. We are working to uncover all the manufacturers/products that are close to having some form of “Real World Evidence” and the likelihood of those RWEs to be approved or accepted by Medicare, including Helicoll.
- Those that are closest to having approval of their RWEs will likely be on our list to contract with pending our standard manufacturer/product due diligence process.
- Future LCDs being Rescinded or Delayed due to Injunctions/Legal action, Complaints, Patient Advocacy campaigns, etc.
- If these Future LCDs do not come into effect we will continue to have the most robust and validated offering available. However the above preparations and their associated themes will continue to be pursued regardless of this potential path.
Barber & Casper, alongside the manufacturers we partner with, patient advocacy groups, alliances, and other stakeholders, strongly oppose the proposed Local Coverage Determinations (LCDs). Our opposition stems from a clear understanding of the significant disruptions these policies could cause to the supply chain and the availability of critical skin substitutes for the patients who rely on them most.
Many of our manufacturing partners are planning to file injunctions with CMS to inactivate, delay, or advocate for revisions to the current language and product coverage criteria.
Our team is actively monitoring these developments and formulating proactive strategies to mitigate disruptions while upholding our commitment to supporting you and our valued customers.
We will keep you updated on our preparations for various scenarios and share any critical updates from the industry or policymakers as they arise.
We understand the uncertainty these changes may bring, but we are confident in our collective ability to navigate this evolving landscape. Thank you for your continued dedication and partnership as we work together to adapt and innovate in the ever-changing healthcare environment.
Wound Care 2025 LCD Change Commentary
As you likely know, Each MAC under Medicare issued newly revised Local Coverage Determinations (LCDs) scheduled to take effect on February 12, 2025. These changes would significantly impact the chronic wound care space, including the skin substitute/CTP products we currently represent.
In effort to provide clarity, we wanted to address the main areas of concern and give you a high-level look at what we are doing about it. We encourage you to review the LCD related documents attached below. This link has all the MACs future effective LCDs & LCAs as well as their Responses to Comments.
Future LCDs/LCAs
Arguably the most questionable section in these LCDs are of which brands/products would be covered or reimbursed. This LCD, if made effective, would remove coverage for roughly 95% of the products used today. The criteria for coverage reflects an overarching theme of CMS, requiring sufficient clinical evidence or “Real World Evidence” for DFUs & VLUs.
The majority of our manufacturers have already begun conducting various studies in line with the criteria outlined in the LCDs. These include a mix of randomized controlled trials (RCTs), observational studies, and retrospective studies—all of which were explicitly mentioned in the Responses to Comments section of the future LCDs as acceptable study types for consideration and review for approval.
While these efforts are ongoing, B&C is committed to preparing for all potential scenarios, including but not limited to:
Barber & Casper, alongside the manufacturers we partner with, patient advocacy groups, alliances, and other stakeholders, strongly oppose the proposed Local Coverage Determinations (LCDs). Our opposition stems from a clear understanding of the significant disruptions these policies could cause to the supply chain and the availability of critical skin substitutes for the patients who rely on them most.
Many of our manufacturing partners are planning to file injunctions with CMS to inactivate, delay, or advocate for revisions to the current language and product coverage criteria.
Our team is actively monitoring these developments and formulating proactive strategies to mitigate disruptions while upholding our commitment to supporting you and our valued customers.
We will keep you updated on our preparations for various scenarios and share any critical updates from the industry or policymakers as they arise.
We understand the uncertainty these changes may bring, but we are confident in our collective ability to navigate this evolving landscape. Thank you for your continued dedication and partnership as we work together to adapt and innovate in the ever-changing healthcare environment.
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