ACFAS Call to Action on Skin Substitute Local Coverage Determinations

Some good news on the previously finalized local coverage determinations regarding the use of cellular or tissue-based products (CTPs), or skin substitutes. The three Medicare Administrative Contactors (MACs), Novitas, First Coast Service Options (FSCO), and CGS Administrators have announced the withdrawal of local coverage determinations that would have negatively impacted the treatment of diabetic foot ulcers and venous leg ulcers. A new Proposed LCD will be published for comment and presented at an open meeting in the near future. We will keep ACFAS members posted as these new proposals are announced.

ACFAS has been made aware of an issue with recently finalized local coverage determinations regarding the use of cellular or tissue-based products (CTPs), or skin substitutes, from Novitas, First Coast Service Options (FSCO), and CGS Administrators.


Principles for Sound Local Coverage Policies

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 September 17, 2023, which may cause interruptions to patient care. The policies impact wound care clinicians and patients across 15 states, Washington DC and Puerto Rico, as well as the Indian Health Service and Veterans Affairs nationally.

The coverage policies impact clinicians and patients in the states below, including links to the coverage policies:

  • 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

  • CTPs currently being utilized may be considered noncovered in the final policies. When issued as proposed policies in 2022, the LCDs/LCAs had approximately 70 CTPs on its non-covered list. The final LCD/LCA released this month placed almost double that amount - 130 CTP products - on its non-covered list, removing coverage from a large number of commonly used advanced wound care CTPs.  (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 Sept. 17, 2023, the number of CTP applications over a 12-week treatment episode will be limited to 4, 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 six 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:
  1. If the clinician is adhering to a product label and plan of care (POC) that requires more than 4 applications over a 12-week time period, clinicians may be required to stop a patient’s care mid-treatment after the 4th application of the CTP, regardless of the wound healing progress, on September 17.
  2. 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 September 17 regardless of the wound healing progress, to comply with the new policies.

Email Your MACs and Request a Delay in Implementation of the Policies

Wound care providers in the impacted states are requested to email their respective MAC to request the following:

  • 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’ POC that have already been or will be established prior to Sept. 17, based on the coverage permitted under the current LCD.
  • Or, 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 Sept. 17 deadline) so that care - and wound healing - is not interrupted.

You can also include real-life scenarios about the patients you treat and the impact that an interruption in care will have.

  • Medicare Administrative Contractor: Novitas (Applies to patients in Arkansas, Colorado, Delaware, Louisiana, Maryland (Montgomery & Prince George’s counties), Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, Texas, Virginia (Arlington & Fairfax counties, Alexandria), and/or Washington DC)
  1. Address email to Novitas Medical Director Dr. Leslie Stevens: medicalaffairs@guidewellsource.com
  2. Refer to Novitas coverage policy LCD (L35041) / LCA (A54117)

 

  • Medicare Administrative Contractor: First Coast Service Options (Applies to patients in Florida, Puerto Rice, and/or the U.S. Virgin Islands)

 

  • Medicare Administrative Contractor: CGS Administrators (Applies to patients in Kentucky and/or Ohio) 
  1. Refer to CGS coverage policy LCD (L36690) / LCA (A56696)     


ACFAS members can use this draft email as reference.