On October 31, 2014, CMS released the final rule: Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.
The provision that the bracing industry has been following pertains to the definition of minimal self-adjustment of orthotics. In the fact sheet accompanying the ESRD/DMEPOS provisions (http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2014-Fact-sheets-items/2014-10-31-3.html), CMS notes that it is not changing regulatory requirements for specialized training, but program guidance remains in effect:
This rule will not finalize an update to the regulation reflecting program guidance on what specialized training is needed to provide custom fitting services if providers are not certified orthotists. Although the regulation is not being updated at this time, the program guidance still stands.
The program guidance that remains in effect may be referenced here: http://cgsmedicare.com/jc/pubs/news/2014/0314/cope25125.html. There is no prohibition on manufacturer reps (or orthotic fitters, athletic trainers, etc.) providing the fitting if the standards below are met.
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.
As a result of this rule and the lack of CMS clarification around an individual with specialized training, manufacturer’s sales reps may continue to fit custom fitted orthotics as long as the above listed requirements are met.