This email inquiry is from a real patient who is a retired nurse.  I can answer some of her questions but not all of them, particularly the ones around when a patient might be required to sign an ABN for skin subs. I will post any helpful answers that you send me, particularly around the questions regarding when a patient has to sign an ABN and what that ABN obligates them to pay when it comes to skin sub applications.

–Caroline

Dr. Fife,

I am a patient with a chronic ulcer, and I have questions about Medicare coverage for “skin substitutes” and the possible requirement for an Advance Beneficiary Notice (ABN). I have many serious medical problems including a clotting disorder which causes severe venous hypertension. I am also a diabetic and wheelchair bound for neurological reasons. I have a venous leg ulcer on my left ankle that has recurred several times and is very hard to heal. (I have had every venous surgery possible, and I stay in strong compression all the time – 24 hours a day. I am a retired nurse so believe me when I say that there is nothing else to do from the standpoint of ulcer prevention.) There have been times when good wound care has healed my ulcer but when that fails, it has healed with the application of “skin subs”.

This year, in 2024, I have had 7 applications of one specific skin sub product [Brand name redacted by CF-but it is one that is in the final LCD coverage list for DFUs but NOT for VLUs Cellular Tissue Products / Skin Substitutes: The Naughty and Nice List for DFUs and VLUs – Caroline Fife M.D.] which did help make it much smaller and less painful. When the wound improvement slowed down, I got 3 additional applications of a different skin sub product [Brand name redacted by CF, but this product, too is on the list for DFUs but NOT for VLUs]. That means I have had a total of 10 skin sub applications in 2024. My VLU is now between the size of a quarter and a nickel, but it isn’t gone.

I have traditional Medicare plus a supplement. As a result, so far, I have not had any out-of-pocket costs for this treatment. However, my doctor is worried that if I have any more skin sub applications, Medicare will not pay for them, and he has warned me that the hospital may require me to sign an ABN. Because I have wound problems, I follow your blog and I have a lot of questions about this issue which include:

1. I read that there is a Medicare coverage policy starting on 2/12/2025. Between now and Feb 12, 2025, will whatever care I get will be under the current policy (I live in Texas)?

Answer from CEF: Yes. The Novitas policy (which includes Texas) that is in effect until 2/11/2025 can be found here: LCD – Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds (L35041)

2. Between now and 2/12/25, how many more skin sub applications are covered by Medicare in Texas for my venous leg ulcer? Can I get more, or have I reached the limit?

Answer from CEF: There is a lot of fine print in both the current and future LCDs about when CTPs are and are/not covered. The small excerpt from the soon-to-be-expired policy does not capture all that is relevant around coverage, but the short answer is that it is that under the CURRENT policy, only 10 CTP applications are allowed.  Thus, between now and the end of the year, you cannot have any more applications per the current coverage policy.

• “Skin substitute grafts will be allowed for the episode of wound care in compliance with FDA guidelines for the specific product (see utilization guidelines) not to exceed 10 applications or treatments. In situations where more than one specific product is used, it is expected that the number of applications or treatments will still not exceed 10.
• Simultaneous use of more than one product for the episode of wound is not covered. Product change within the episode of wound is allowed, not to exceed the 10-application limit per wound per 12-week period of care.
• Treatment of any chronic skin wound will typically last no more than twelve (12) weeks.”

3. Is there currently a restriction on WHICH skin subs can be used on my leg ulcer?

Answer: The LCD that is active in Texas until 2/11/2025 places very few restrictions on which CTPs/skin subs can be used (for example, liquids and powders are excluded, but the soon-to-be-replaced policy does not come with a list of covered products like the new one does). See the current Novitas LCD for more details. AFTER 2/12/2025, only a specific list of products can be used for venous ulcers. Here the products for VLUs that can be used on or after 2/12/2025:

4. When the new policy kicks in, will any applications that I have after January 1, 2025, but before 2/12/25, “count” for 2025?

Answer from CEF: I do not know for sure, but I do not think that any applications from 1/1/2025 to 2/11/2025 would “count” towards the annual limit under the new policy when it takes effect on 2/12/2025. The new policy limits the number of applications to 8, and there is a LOT of fine print around when CTPs are and are not covered for a VLU or a DFU.

Here are her questions about ABNs and I can’t answer them (CEF):

5. My doctor has warned me that the hospital might require me to sign an Advanced Beneficiary Notice (ABN) because future skin sub applications may not be covered by Medicare. Do I have to do that?

6. If I sign the ABN, does that mean I am only responsible for the Medicare allowable charges, or can the hospital charge me for the full cost of the skin sub product and all the related services? (I am VERY worried about this because I see on my explanation of benefits that the hospital charges are incredibly high for everything –but Medicare pays only the allowable rates). If anyone hands me an ABN for a skin sub application, I would like to understand just what charges that obligates me to pay.

7. How will a hospital or doctor’s office figure out that a given skin sub application will not be paid for? I mean, if I go to another doctor, how will that doctor know that I have already had several skin sub applications by someone else? What if the doctor just uses a product that is not on the covered list – is that MY fault?

Thank you for any help you can offer.

[Patient name withheld]

Caroline Fife, M.D.

Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos

The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.