AOPA 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!

On February 12, 2015, the DME MACs released a joint article that discussed the proper format for proof of delivery documentation to support Medicare claims. The joint publication indicated that medical reviewers have consistently seen a list of HCPCS codes and their descriptors used on proof of delivery documentation, especially for orthotic and prosthetic claims.

According to the DME MACs, this practice is not acceptable for proof of delivery purposes as it does not allow the medical reviewer to make a determination of what was billed and if it was coded correctly. The joint DME MAC publication provides the following recommendation for maintaining proper proof of delivery documentation:

“The preferred method is use of a brand name and model number, brand name and serial number or manufacturer name and part number to identify the product. If this type of information is not available for the product, suppliers may use a detailed narrative description of the item; however, it must contain sufficient descriptive information to allow a proper coding determination. This “narrative description” of the item is not the HCPCS code narrative.”

AOPA’s Take on this issue is that this is yet another hurdle to reimbursement for providers who are providing medically necessary O&P care to Medicare beneficiaries. The documentation of HCPCS codes and their complete descriptors has been acceptable for proof of delivery purposes for many years. The sudden change in policy appears to be inconsistent with what is in the Program Integrity Manual and other CMS policy documents. AOPA will be communicating its concern regarding this policy change with the DME MACs and CMS,

AOPA’s Take. Where you go….When you need to know!

As I sat with my family this past Sunday and got ready to watch the Super Bowl with the rest of the world, I had no idea that my favorite highlight would have nothing to do with the game.

Like most viewers, I was excited to watch the action on the field but also looking forward to the creative and always entertaining commercials that receive so much hype leading up to the big game. With advertisers literally spending millions of dollars for 30 seconds of airtime, the most creative minds in the world are tasked with capturing the hearts of the audience for that one brief, shining moment.

This year, two different advertisers chose to use the inspiring stories of amputees as the backdrop for their Super Bowl ads. Microsoft featured young Braylon O’Neill in its ad for advanced analytic technology and Toyota featured Amy Purdy, a double amputee who gained fame on Dancing with the Stars, to showcase it’s newly remodeled Camry sedan.

AOPA’s take on these commercials is that while they were only 30 seconds long, the motivation of both Braylon and Amy to live life to the fullest despite the physical challenges they face shone through and sent an amazing message of inspiration and hope. I sat on the couch and beamed with pride knowing that I work for an industry that does so much for people, often because it is simply the right thing to do.

As folks get frustrated with continued scrutiny and audits by federal and private payers, it is easy to forget why most of you are in the business of O&P. You desire to help people with physical challenges return to a normal life. First and foremost, it is about the patients you serve. That is why I am so proud of what I do and the people I work for.

AOPA’s Take. Where You Go……When You Need to Know!