Prevent Care Interruptions with CTPs for DFU/VLU Patients

Advocacy Call to Action

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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Today’s Wound Clinic or HMP Global, their employees, and affiliates.

Medicare Administrative Contractors (MACs) Novitas, First Coast Service Options and CGS Administrators recently released highly problematic local coverage policies that significantly restrict the use of cellular- and/or tissue-based products (CTPs, or “skin substitutes”) for the treatment of diabetic foot ulcers and venous leg ulcers. The policies place 130 CTPs on the non-covered list, removing Medicare coverage from a large number commonly used products that previously have been covered and reimbursed by Medicare. For those CTPs still covered, the policies limit the number of applications over a 12-week treatment episode to four, regardless of product labeling and wound healing progression.
 
These policies were released on Aug. 3 with an effective date of Sept. 17. Six weeks is a problematic lead time for policies that guide use of a category of products with standard 12-week instructions for use. It is anticipated that this too-short transition period will result in concerning disruptions to care for those diabetic foot ulcer/venous leg ulcer (DFU/VLU) patients currently in the middle of a care plan that involves these CTPs. For example:
 
    •    Care interruption scenario 1: If a clinician is adhering to a product label and plan of care (POC) that requires more than 4 applications over a 12-week period, clinicians must stop a patient’s care mid-treatment after the fourth application of the CTP, regardless of the wound healing progress, on Sept.17.
 
    •    Care interruption scenario 2: If a clinician is currently treating a patient with a CTP that is currently covered but now listed on the new policies’ non-covered list, clinicians will need to stop utilizing that CTP on Sept. 17 regardless of the wound healing progress, to comply with the new policies.
 
These care disruptions are avoidable if the MACs delay the September implementation date. 
 
The Alliance of Wound Care Stakeholders is engaging upon a series of advocacy steps to address many problematic issues in the policies. Our first and most immediate action is pursuit of an implementation delay. Clinicians, join with the Alliance in elevating the voice of the wound care community and making your voice heard.      

Who is Impacted?

The geographic impact of the Novitas, FCSO and CGS policies spans across 15 states, the District of Columbia and Puerto Rico. So the impact is significant. Will this affect you and your patients? Yes, if you practice in the states below:

• Arkansas, Colorado, Delaware, Louisiana, Maryland (Montgomery and Prince George’s counties), Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, Texas, Virginia (Arlington and Fairfax counties, Alexandria), Washington, DC
  Medicare Administrative Contractor: Novitas. Coverage policy LCD L35041/ LCA A54117
• Florida, Puerto Rico, and U.S. Virgin Islands
  Medicare Administrative Contractor: FCSO. Coverage policy LCD L36377/ LCA A57680
• Kentucky, Ohio
  Medicare Administrative Contractor: CGS. Coverage policy LCD L36690/ LCA A56696     

Take Action: Email Your MAC and Request an Extension of Implementation Timeframe

The Alliance of Wound Care Stakeholders and our 20+ clinical association and medical specialty society members encourage individual wound clinics and wound care providers in the impacted states to email their respective MAC, share the clinical impact that interruption in care can have, and ask for:

• A delay in the implementation date from September 17, 2023 to January 1, 2024 in order for clinicians to have enough time to complete patients’ plans of care (POC) that have already been or will be established prior to Sept. 17 based on the coverage permitted under the LCD currently in effect, or
• Establishment of a “grandfather clause” to permit clinicians currently treating DFU/VLU patients with a CTP to continue to the end of the 12-week treatment episode—even if that extends beyond the Sept. 17 deadline—so that patient care and wound healing are not interrupted.

Send emails to:

• Clinicians practicing in regions covered by FCSO or Novitas jurisdictions should email: medicalaffairs@guidewellsource.com
• Clinicians practicing in CGS’ jurisdiction should email: CMD.INQUIRY@cgsadmin.com

 
There is a very small window of time to try to ensure that your current patients will not have disruptions to their care. Make your voices heard now and submit emails to your MAC by Sept. 8 so they have time to consider this request!

See Sample Emails on our Advocacy Action Center

Want to get involved but not exactly sure what to write? The Alliance has launched an advocacy action center with sample emails for clinicians—and even patients—to edit, customize and send.
 
Advocacy on behalf of your patients can have important outcomes. Your voice and direct clinical experience carry weight with policy makers. Clinicians are on the front-line of wound care when it comes to patient treatment and management, and we can also be on the front-line of advocacy when it comes to policies that have detrimental impact on patient care.
 
Marcia Nusgart, RPh, is founder and CEO of the Alliance of Wound Care Stakeholders, the leading voice of wound care advocacy for the past 20 years. The Alliance unites leading wound care organizations and experts through advocacy and educational outreach in the regulatory, legislative and public arenas to advocate on public policy issues that may create barriers to patient access to treatments or care. With a key focus on coding, coverage and reimbursement, quality measures and wound care research, the Alliance elevates the visibility and united voice of wound care providers to regulators and policymakers.