Proposed LCDs Raise Questions About ABNs That I Can’t Answer

Given that the new Local Coverage Determinations (LCDs) on CTPs/skin subs are almost surely going to be implemented on Feb 12^th, 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?