A few days ago I posted a question about the legality of businesses who sell spinal braces to patients, ship them to the patients in a box, then bill Medicare and other third-party payers using the OTS (off-the-shelf) L code.
I received the following responses:
David Hendricks, CPO
Blue Diamond Orthopedic
Your question is one that keeps me up at night I have fought for an answer for years now and it is clear that mail order companies are legal in the eyes of CMS. To go one further, I am in a Licensure State (Alabama) and our current licensure law cannot stop this activity either. Licensure was created to “protect” the consumer!? What could more dangerous than a non certified person fitting a patient, maybe NO ONE FITTING THE PATIENT.
In my efforts, I have spoken to Dr. Hoover at Medicare and he has escalated this concern to the fifth level of the Z-Pic auditors. The response was, there is no violation of the current law. I tried to explain to Dr. Hoover that it is not only the “fitting” that concerns me, it is the clinical skills required to know which brace is appropriate for their condition overall. Ultimately, I hate to say that it is up to RAC auditors to save us. 99% of these mail order companies are using supplier generated forms and are not collecting the appropriate paperwork. Much like the scooter store regardless of the outcome, our industry will be damaged forever as a result! Today, it ultimately comes down to ethics and integrity, I still cannot mail a brace to an 80 year old person and have a good conscience!
Carey Jinright, LO, MSM
Hey Dave. So my impression of this is that they are billing medicare (most likely with an ABN) with the expectation that CMS is not going to pay and then they turn to the patient and say sorry they turned it down, you now owe us…. I have seen this locally and it isn’t pretty!
Gary M. Berke MS, CP, FAAOP
I believe where these companies that are sending the devices to the patient and getting away with it are utilizing the lower coding and not the “Prefabricated, custom fit” and they send fitting instructions along with it.
I used to question this myself and was told everything they do is quite legal as long as they use the proper coding.
The catch is, they have not lowered the reimbursement to reflect these differences yet.
Here is the descriptor as CMS explained it.
Off-the-shelf (OTS) orthotics are:
â€¢ Items that are prefabricated
â€¢ They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted
â€¢ OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit an individual
â€¢ This fitting does not require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthoses to fit the item to the individual beneficiary
The term “minimal self-adjustment” is defined at 42 CFR Â§414.402 as an adjustment the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and that does not require the services of a certified orthotist (that is, an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.
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