WE DID IT!!
Thanks to collaborative and tenacious advocacy from the wound care community, the local coverage determinations (LCDs) and local coverage articles (LCAs) that would have dramatically restricted use and access to CTPs starting Oct. 1st have now been WITHDRAWN. 

SEE NEWS RELEASE

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CLINICIAN AND PATIENT CALL TO ACTION!

What is the Issue?

In early August, Medicare Administrative Contractors (MACs) Novitas, First Coast Service Options (FCSO) and CGS Administrators released highly problematic local coverage determinations (LCDs) and accompanying local coverage articles (LCAs) guiding use of Cellular and/or Tissue-based Products (CTPs, also known as skin substitutes) for the treatment of diabetic foot ulcers and venous leg ulcers. The new policies are scheduled to go into effect on Oct. 1, 2023, causing concerning interruptions to patient care. The policies impact wound care clinicians and patients across 15 states, Washington DC and Puerto Rico.

How does this impact my clinical practice and my patients?

• CTPs which you are currently utilizing may be considered noncovered in these final policies. When issued as a proposed policies in 2022, the LCDs/LCAs had approximately 70 CTPs on its non-covered list. The final LCD/LCA released on Aug. 3rd, however, placed almost double that amount - 130 CTP products - on its non-covered list, removing coverage from a large number commonly used advanced wound care CTP products.  Insufficient evidence was provided regarding why coverage was removed. (See list of covered and non-covered CTPs) 

• Number of CTP applications will be capped at 4 versus the current allowable of 9. Beginning on the Oct. 1, 2023 implementation date, the number of CTP applications over a 12-week treatment episode will be limited to four, regardless of product labeling. This does not account for patients with wounds that are larger or more severe than those that were included in clinical trials, nor does it account for patients who are improving but not healed after 4 applications.

• Disruption of established patient plan of care. The removal of a significant number of products from Medicare coverage and the new utilization limitations are coupled with a tight implementation deadline of just eight weeks after the final policy was released. This does not accommodate CTPs with standard 12-week instructions for use. This will result in problematic interruptions in patient care, such as described below:

• • • If the clinician is adhering to a product label and plan of care (POC) that requires more than 4 applications over a 12-week period of time, clinicians must stop a patient’s care mid-treatment after the 4th application of the CTP, regardless of the wound healing progress, on Octt.1.

• • • If a patient is currently being treated 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 Oct. 1 regardless of the wound healing progress, to comply with the new policies.

how do i know if these policies apply to my practice/patients?

The coverage policies impact clinicians and patients in the states below: 

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

What Action can I take to protect my patients?

1) Email Your MAC and CMS to Request a Delay in the Policies’ Implementation
The Alliance of Wound Care Stakeholders and our 20+ clinical association and medical specialty society members encourage wound care providers in the impacted states to email their respective MAC, share real-life scenarios about the patients they treat and the impact that an interruption in care will have, and request:

• A delay in the implementation date to Jan. 1, 2024 in order for clinicians to have enough time to complete current patients’ plans of care. (The original implementation date of the policies, Sept. 17, was extended to Oct. 1 to accomodate a technical "system update." While this two week extension may have addressed some IT issues the MACs faced, it failed to address the patient care interruptions that will occur when only a 6-8 weeks coverage policy transition is being provided for products with 12 week care plans. An extension to January 2024 provides more appropriate transition time.)

• And/0r, as an alternative, ask that the MAC enable a “grandfather clause” which would permit clinicians treating patients under current policy requirements to continue to the end of their 12-week POC (even if that extends beyond the Oct. 1 deadline) so that care - and wound healing - is not interrupted.
• And/or, request a withdrawal of the policies so that Medicare beneficiaries can continue to have access to and benefit from medically necessary CTP treatments

See sample email to Customize and send

2) ASK YOUR PATIENTS to Email Their MAC and CMS to Request a Delay in the Policies’ Implementation
Patient voices are particularly compelling componenet of effective advocacy. If you have patients who may be willing to share their story and care impact concerns with the MACs, we've developed resources to facilitate their development and submission of emails: 

• Patient "call to action" with summary of the policy issues and impacts
• Sample patient email template with instructions on how to customize and send

Questions? Email This email address is being protected from spambots. You need JavaScript enabled to view it.