OTS Regulations


OTS Orthoses – A New CMS Proposed Rule that could Limit your Patients’ Access to Care and Eliminate Orthotic Fitters

CMS released a proposed rule on July 11 that addresses Off-the-shelf Orthoses and the definition of Minimal Self-Adjustment.

In an effort to define the scope of individuals authorized to fit orthotic devices deemed by CMS to be off-the-shelf (OTS), the proposed rule will add physicians, treating practitioners, PTs and OTs as “individuals with specialized training” to the current definition that includes certified orthotists as qualified individuals to provide custom fitting of orthoses.

The proposed rule states that orthotic assistants and fitters are not considered to have specialized training for the purposes of providing custom fitting of orthoses and therefore any devices they fit or adjust will be considered OTS.

CMS has previously defined “minimal self-adjustment” in expansionist terms for defining OTS orthotics, which could have later implications for competitive bidding of products not appropriate for delivery without service. The new rule compounds instead of corrects the issue, and could limit your patients’ access to care.

Campaign Results
AOPA has submitted comments to CMS on behalf of members. Using AOPAvotes.org and the patient postcards, 378 members and 203 patients submitted comments. Click here to read AOPA’s submitted comments.

If  you have questions, please contact us at 571/431-0876 or scuster@AOPAnet.org.