Last week CMS issued a final rule relating to Medicare’s competitive bidding program (CBP), the inclusion of off the shelf orthotics in the CBP and the definitions surrounding “minimal self-adjustment” and “specialized training” for providers that are eligible to provide certain types of orthotic services and devices. The rule lays out a pilot program for bundled payment on certain types of durable medical equipment and also creates a mechanism to set national ceiling and floor pricing for items included in CBP for areas that are not covered by an existing competitive bidding area, as mandated by January 1, 2016.
The full rule, released on October 31st, 2014 largely leaves unanswered the questions of the O&P community governing who can bill for orthotics and the overall definition “minimal self-adjustment” from their previous guidance. Specifically, CMS states
At this time, we have decided not to finalize any changes to the definition of minimal self-adjustment in §414.402 to recognize as an individual with specialized training. We may address this provision in future rulemaking.
Sections of the proposed rule are below, as is a link to the federal register release of the proposed rule.
Since adoption of the minimal self-adjustment definition there has been some concerns raised by industry and other stakeholders regarding who is considered an individual with specialized training. We have had many inquiries and comments that this term is too ambiguous and left open for interpretation.
In addition, questions were raised regarding when it is appropriate for a supplier to bill for a prefabricated orthotic as having been custom fitted versus one furnished OTS. In order to address this specific question, the DME MACs issued a policy article on March 27, 2014, which details what custom fitting of an orthotic involves and indicating that furnishing custom fitted orthotics “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.” The DMEPOS quality standards have been updated to reflect this requirement and we decided to revise the definition of minimal self-adjustment in the regulation to address this issue as well.
In order to identify OTS orthotics for the purpose of implementing CBPs for these items and services in accordance with the statute, we need a clearer distinction between OTS orthotics and those that require more than minimal self-adjustment and expertise in custom fitting. In doing so, we believed it was essential to identify the credentials and training a supplier needs to have in order to be considered a supplier with expertise in custom fitting; therefore, we believed the term “individual with specialized training” must be clarified… READ FINAL RULE BEGINNING ON PAGE 442