OTS Orthotics Defined… AGAIN!

When CMS released the 2014 HCPCS update codes late last year, they also provided guidance on how they would define “off the shelf” orthotics, for the purpose of identifying what type of provider could provide certain noncustomized devices to beneficiaries. After debate, CMS recalled their original definitions of “off the shelf”, creating more confusion in the O&P profession.  Some of the codes listed in the off-the-shelf category are also parallel codes that can apply to custom fit versions of the same device.  The full updated 2014 DMEPOS fee schedule can be found here.  The new definitions from Medicare contractor CGS for what qualifies as off-the-shelf are below.

When providing these items suppliers must:

  • Provide the product that is specified by the ordering physician, i.e. (1) type of orthosis and (2) method of fitting (OTS or custom fitted)
  • Be sure that the medical record justifies the need for the type of product and method of fitting
  • Be sure only to use the code that accurately reflects both the type of orthosis and the appropriate level of fitting
  • Have detailed documentation that justifies the code selected for custom fitted versus OTS codes)

The following definitions will be used for correct coding of these items.

Off-the-shelf (OTS) orthotics are:

  • Items that are prefabricated
  • 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
  • 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
  • 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 §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.

Fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self-adjustment at delivery is considered as OTS.

Custom fitted orthotics are:

  • Devices that are prefabricated
  • 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
  • Classification as custom fitted requires substantial modification for fitting at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment
  • This fitting at delivery does require expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthosis to fit the item to the individual beneficiary

Substantial modification is defined as changes made to achieve an individualized fit of the item that requires the expertise of a certified orthotist or an individual who has equivalent specialized training in the provision of orthotics such as a physician, treating practitioner, an occupational therapist, or physical therapist in compliance with all applicable Federal and State licensure and regulatory requirements. A certified orthotist is defined as an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification.

Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered as custom fitted if the final fitting upon delivery to the patient requires substantial modification requiring expertise as described in this section.

A certified orthotist is defined as an individual who is certified by the American Board for Certification in Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist Certification. MORE

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