Given that the new Local Coverage Determinations (LCDs) on CTPs/skin subs are almost surely going to be implemented on Feb 12th, it’s likely that patients are going to be asked to sign Advanced Beneficiary Notices (ABNs) around their use. I got an interesting email from a patient asking some questions around the use of skin substitutes for her venous leg ulcer (VLU). I was able to answer a few of them, but I could not answer several around the ABN process. I asked for your help. Pay special attention to her last question.
One respondent suggested that she go to an office-based practice rather than a hospital-based one, but frankly that would make her problem WORSE. Why? Costs will actually be HIGHER in an office-based practice because she might have to pay the cost of an incredibly expensive product in that setting, whereas in a hospital-based setting, the cost of the product is “package priced” and can’t exceed about $1700.
Based on analysis by SmartTrak, among the products marketed by the “established” CTPs/skin sub manufacturers, the average ASP is $134.68. However, among the groups marketed almost exclusively in the “non-package price” environment, the average ASP is $1,013.49.
I would still like to answer these questions:
- Does the patient have to sign an ABN?
- 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?
- What charges does the ABN obligate the patient to pay?
- 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?
- If anyone hands me an ABN for a skin sub application, I would like to understand just what charges that obligates me to pay.
- How would the clinician know whether a service won’t be covered when applications in excess of the LCD might have been charged by another doctor?
- 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?
- Some hospitals and doctors are having patients sign a “blanket” ABN for any services that are not covered, is that legal?
- What if the doctor uses an uncovered product when they could have used a covered one?
- What if the doctor just uses a product that is not on the covered list – is that MY fault? Can they make me pay for the product because they used an UNCOVERED product when they could have used a covered one?
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.
Wow, these questions are very interesting, and clinics that are providing these services should really be informed if using an approved product is being used on the patients .
The size of the patients VLU should be considered. If it is over 100cm2 the HOPD Bundle payment model is very limiting for CTP wounds.
Dr. Fife, I have been following your articles and posts with great respect for your assertiveness in advocating for reduction in healthcare costs to the government. Unfortunately, it seems that many decisions of CMS are prearranged by lobbying groups orchestrated by certain large pharma companies manufacturing skin substitutes who seek illegitimate financial gain.
You may also know that several objections have already been filed with CMS regarding their unethical rulings. It is evidenced through CMS accepting fraudulently reported RCT clinical studies by selecting those products which have failed to complete the results as per the requirements of ClinicalTrials.gov. This is an example of wrongful judicial stance of CMS in assessing the inclusion of product coverage to treat Diabetic Foot Ulcer (DFU).
It is also very sad to say that some of these illegitimate decisions of CMS are supported by some clinicians who claim to be the Key Opinion Leaders (KOLs). Unfortunately such activities are supported through the Donors of the American Medical Association (AMA), either directly or indirectly through subsidiary clinical associations. Unless those ethical providers unite to strongly oppose these improper, dictatorial rulings from CMS, no meaningful change in the system will occur.
Finally, to answer your question, Dr. Fife, the decision on whether a product should be covered is also controlled by the independent MACs, which are again dominated and mismanaged by lobbying groups. Without a thorough investigation by the OIG (Office of Inspector General) and the FBI (Federal Bureau of Investigation) to uncover these illegal activities, none of your efforts will likely lead to a response from CMS.
I wish you all the best in your genuine advocacy. I hope that, one day, someone within CMS will step up to take the necessary action to stop the waste of funds by reimbursing products through illicit, fraudulent, and unlawful practices.