THE OTS Saga Continues

OTS headacheAOPA has closely followed the issue surrounding what orthotic devices are considered to be “off the shelf” items that may be subject to Medicare competitive bidding as it has unfolded over the last several years. What began as a very small subset of HCPCS codes that represented truly off the shelf (OTS) orthotic devices that could reasonably be adjusted by the patient themselves, as stated in the law, and without any expertise from certified, trained professionals, has been repeatedly expanded through regulation and policies that are not consistent with the statute, to where we now have a set of more than 50 codes that CMS considers off the shelf, i.e., if they can be adjusted by the patient, caregiver for the patient, or by the provider of the device.
A significant development in this continuing expansion of what was considered OTS orthoses occurred when the DME MACs published revised medical policy that further defined the qualifications necessary to fit and provide custom fitted orthoses to Medicare beneficiaries. The medical policy was expanded to include the following definition of the term “substantial modification” as it relates to the provision of custom fitted orthoses.
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.
This definition fails to recognize the scope of practice of certified orthotic fitters, whether certified by ABC or BOC, and their role in the provision of custom fitted orthoses, very typically working under the supervision of a certified orthotist. In addition, the definition that was published by the DME MACs was extracted essentially verbatim from a definition that was included in a CMS proposed rule (which when CMS published it in July, 2014 was intended to cover OTS, End-Stage Renal Disease and a range of other topics) in a DME MAC announcement before the open public comment period had concluded. Subsequently, CMS elected not to include anything relating to OTS orthotics in the final rule on several other topics that CMS ultimately published.
Despite repeated communications from AOPA and others challenging the authority of the DME MACs to memorialize this definition in policy before the proposed rule was finalized, and despite the fact that CMS chose not to include the proposed definition of “substantial modification” in its final rule, a CMS Frequently Asked Questions document that was updated on February 18, 2015, indicates that the policy guidance regarding who may provide custom fitted orthoses to Medicare beneficiaries remains in effect as the “DME MACs have discretion to define what constitutes custom fitting for accurate coding and payment of claims.”
AOPA’s Take on this issue is that this is yet another example of CMS’ inability or convenient refusal to exercise appropriate control over the actions of its contractors. The DME MACs have repeatedly established policy without regard to the Administrative Procedures Act requirement for due process through the issuance of proposed rules with appropriate opportunity for public comment and input followed by the issuance of a final rule. When AOPA has challenged the DME MACs or CMS regarding the lack of due process, the response has always been that the contractors are acting within the right to establish local policy to govern Medicare coverage of specific items and or services. AOPA believes that that a contractor hired by the government cannot have authorities greater than the Congress has delegated and articulated for the agency that hires the contractor. In this case, if CMS initiates a rulemaking to establish what constitutes an OTS orthotic device, and who may and may deliver custom fitted orthotics, the requirement that Congress imposed on CMS, namely that such rules may only be finalized after providing the opportunity for stakeholder input, cannot be circumvented by CMS claiming that these rules do not apply if the action or rules are advanced by a contractor CMS hires. AOPA will continue to challenge this policy specifically, and more generally instances of policy overreach by contractors acting under CMS’s authority at every opportunity.
AOPA’s Take. Where you go….when you need to know!