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coverage articles (LCAs) that would have dramatically restricted use and access to CTPs starting Oct. 1st have now been WITHDRAWN.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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Call to Action: Prevent Patient Care Disruptions by sending an email to your mac and CMS Requesting a Delay in LCD Implementation  

ISSUE OVERVIEW

Who Is Impacted and Where Should Emails Be Sent?

The problematic policies impact clinicians and patients across the 15 states under Novitas, FCSO and CGS jurisdictions. The list below shows the states in these jurisdictions and, if you/your patients are impacted, the contact at each MAC to direct your email to.

•  If you treat 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), Washington DC
  • Medicare administrative contractor: Novitas
  • Send email to Novitas Medical Director Dr. Leslie Stevens at This email address is being protected from spambots. You need JavaScript enabled to view it. with a CC to This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it. 
  • Refer to Novitas coverage policy LCD (L35041) / LCA (A54117)

• If you treat patients in Florida, Puerto Rice, and/or the U.S. Virgin Islands:
  • Medicare administrative contractor: First Coast Service Options
  • Send email to FCSO Medical Director Dr. Alicia Campbell at This email address is being protected from spambots. You need JavaScript enabled to view it. with a CC to This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it. 
  • Refer to FCSO coverage policy LCD (L36377) / LCA (A57680)

• If you treat patients in Kentucky and/or Ohio:   
  • Medicare administrative contractor: CGS Administrators 
  • Send email to CGS Medical Director Dr. Meredith Loveless at This email address is being protected from spambots. You need JavaScript enabled to view it. with a CC to This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.     
  • Refer to CGS coverage policy LCD (L36690) / LCA (A56696)             

After submitting your email to your MAC medical director, please consider forwarding a copy of it to the Alliance of Wound Care Stakeholders at This email address is being protected from spambots. You need JavaScript enabled to view it.. As lead advocates on this issue, we'd like to be able to have a selection of submitted emails to reference in conversations we are scheduling with Medicare leadership. 

Suggested Email Outline:

Below is a suggested email outline for clinicians to customize with their own perspective on real-world impact to their patients. 

1. Intro: Who you are, where you work, patients you treat and identification of why you are writing.
2. Summary of concerns with specific examples of real-world patient care impacts in your practice
3. Request to delay implementation and/or add a grandfather clause for patients currently receiving care

 Send your email by Mon., Sept. 25 so that Medicare policymakers have time to consider your request ahead of the Oct. 1 implementation date. 

Sample Email to Edit and Customize in Your Own Voice
DOWNLOAD EDITABLE WORD DOCUMENT

To [MAC NAME] Medical Director [NAME]:

1: Intro - Who you are, where you work, patients you treat and identification of why you are writing.

Example: I am a [CREDENTIALS] at [ORGANIZATION] in [CITY, STATE]. I treat patients with chronic, non-healing wounds with a range of advanced treatment modalities. I am writing to you today because I have significant concerns about your newly released local coverage determination and local coverage article on Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. [ENTER POLICY NUMBERS NOTED ABOVE]

2: Summary of concerns with real-world patient care impacts

Example: The policy was released on Aug. 3^rd and has an implementation date of Oct. 1, 2023. As a result of this tight implementation timeframe, I have concerns about interruptions in treatment that will negatively impact my patients and their wound healing.  In my practice [insert your own real word examples]:

[Scenario A: If a CTP/skin substitute product you are using is still considered “covered," but the treatment protocol – and product label – is for more than 4 applications, clinicians now must stop mid-treatment after 4 applications, prior to the wound being healed, once the Oct. 1 date hits.]

• [placeholder example to replace with write-up from your own practice] I have a (or multiple patients) patient with [diagnosis] that I am treating with [product], which I’d selected based on [rationale]. The patient’s wound healing is in progress, and we will be well within the standard 12-week treatment plan of care for CTPs come mid-September. Come Oct. 1, per your revised policy I will not be able to continue treatment if I’ve already applied 4 applications at that point in time and will need to disrupt the plan of care developed based on the patient’s condition and the current coverage policy that has been in effect and that is still in effect until your specified Oct. 1 date.  The patient is going to bear the impact if there is no grandfather clause in place to continue treatment to the conclusion of the 12-week plan of care already established.
• Add other examples 

[Scenario B: If a patient is currently mid-treatment with a CTP that was moved to the non-covered list, clinicians will need to stop treatment midstream regardless of wound healing progress, to comply with the new coverage requirements and Oct. 1 implementation date of this LCD/LCA.]

• [placeholder example to replace with write-up from your own practice] I have a patient with [diagnosis] that I recently started treating with [product]. I’ve known and worked with this product for my patients as I have seen very good results. We will be in the middle of the 12-week plan of care (POC) when the Oct. 1 implementation date hits. Under the new policy, [product] is no longer covered and I will be in the untenable position of halting this treatment for this patient and changing product. I will not know how my patient will respond to the new product but have been seeing good results with the one I am currently using. I know the products I’ve chosen to use in my practice and for my patients. I’ve seen the value of the products I’ve used, and now many of them have been moved to your non-covered list. Yet you’ve not provided sufficient time for me as a provider to familiarize myself with your more limited list of covered products so that I can transition care in the most informed way. Furthermore, if a product is working, it is not beneficial to my patient to move them to a different (covered) product in which we will not know the results.  I should be able to continue the treatment protocol established in my patient's POC prior to this LCD/LCA being implemented. I urge you to permit me to do so.
• Add other examples

 

3: Request to delay implementation and/or include a "grandfather clause" fo patients currently receiving care

As a wound care clinician facing these challenges, I ask that [MAC NAME] delay the implementation of this local coverage determination and local coverage article until January 2024, so that I – and my follow clinician colleagues -  have sufficient time to permit our patients to continue to receive the care developed under their current plan of care that was initiated based on the current local coverage that had been in place. We simply need more time to transition our patients and our practice to the new policy parameters. At very least, I ask that you consider a “grandfather clause”  for patients who are in the middle of a 12-week plan of care with a CTP or skin graft, so that coverage is continued through the end of this care protocol rather than forcing an interruption of care due to shifts in coverage. This will enable us to continue the healing progress for those patients whose wounds are improving.

Interruptions in CTP protocols are clinically detrimental to patient care. I hope you will consider delaying implementation for the sake of the many patients with DFU/VLU who are in the middle of a CTP treatment protocol, so that their care does not need to be interrupted and so that we clinicians have more time to put product transition plans and formulary changes in place.

Thank you for your consideration,

Reminder:  Send your email by Monday, Sept. 25 so that Medicare policymakers have time to consider your request ahead of the Oct. 1 policy implementation date.