Revised DME MAC Guidance for Split Code Orthoses:
OTS vs. Custom Fitted and Subsequent Medical Policy Revisions
March 31st, 2014 — The Centers for Medicare and Medicaid Services (CMS) with the release of the 2014 HCPCS codes created a new subset of prefabricated codes, 55 in total, which they deemed to be off-the-shelf (OTS) orthoses. They also created a series of 23 “split codes” or orthoses that can be provided either off the shelf or customized to fit a specific patient by an individual with expertise. The creation of the split codes and the OTS codes raised many questions, including who will make the decision whether an orthoses requires proper fitting by a trained individual or can be delivered as an off the shelf item without additional fitting and training, and what documentation will be required to support claims for services that require proper fitting by a qualified individual?
On February 28, 2014, the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) released a joint policy bulletin entitled, “Correct Coding – Definitions Used for Off-the-Shelf, Custom Fitted and Custom Fabricated Orthotics (Braces).” This policy bulletin was subsequently retracted on March 7, 2014 without explanation as to the reason for the retraction. On March 27, 2014, The DME MACs released a revised version of the policy bulletin entitled, “Correct Coding – Definitions Used for Off-the-Shelf, Custom Fitted Prefabricated Orthotics (Braces)-Revised.”
While the revised policy bulletin removed all references to custom fabricated orthoses, it remained substantially unchanged regarding the provision of off the shelf orthoses and custom fitted orthoses. Below is a summary of the key points of DME MAC correct coding announcement. The full announcement may be accessed by clicking here.
• The policy bulletin states that off-the-shelf orthoses are prefabricated items that may be provided as part of a kit requiring some assembly or installation of add-on components and that this assembly does not reclassify an item from OTS to custom fitted.
AOPA believes that items that must be assembled by the provider prior to delivery to the patient may be classified as custom fitted orthoses according to the type of assembly required and the potential need for clinical expertise in proper assembly to ensure a correct fit for the patient.
• The policy bulletin states that OTS items require minimal self adjustment for fitting at the time of delivery and the fitting does not require the expertise of a certified orthotist or an individual with equivalent specialized training in the provision of orthoses.
AOPA believes this statement is overly broad and ignores both the way this term is defined in the statute, and the recognition of properly credentialed individuals such as certified orthotic fitters as individuals who are qualified to fit non-OTS orthoses.
• The policy bulletin points to the expanded regulatory definition of “minimal self adjustment” contained in 42 CFR 414.402 which includes adjustments made by the beneficiary, caretaker for the beneficiary, or supplier and does not require the services of a certified orthotist or an individual who has specialized training.
AOPA remains gravely concerned that the use of the regulatory definition of “minimal self adjustment” far exceeds the intent of the original statute which limited the term “minimal self adjustment” to those that the beneficiary themselves could make to adjust the fit of the orthosis.
• The policy bulletin states that fabrication of an orthosis using CAD/CAM or similar technology without the creation of a positive model with minimal self adjustment at delivery is considered as OTS and the use of CAD/CAM or similar technology without the creation of a positive model, but with the requirement for substantial modification at delivery is considered custom fitted.
AOPA believes that current and future CAD/CAM technology may not require creation of a positive model in order to fabricate custom fitted or even custom fabricated orthoses. The use of CAD/CAM or similar technology in fabricating an orthosis bears no relevance on how that orthosis is classified.
• The policy bulletin states that “classification as custom fitted requires substantial modification for fitting at the time of delivery” and subsequently defines substantial modification 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 a physical therapist in compliance with all applicable Federal and state licensure and regulatory requirements.”
AOPA believes that the introduction of the term “substantial modification” (this term is not mentioned at all in the statute) further expands the misinterpretation of the statutory definition of “minimal self adjustment” and applies a standard that far exceeds the intent of the statutory definition of off-the-shelf orthoses.
• The policy bulletin indicates that the ordering physician will be the one in charge of determining which item is provided to the patient. The bulletin states that the supplier must provide the item that is specified by the ordering physician, for example the type of orthosis and the method of fitting and/or fabrication and there must be detailed documentation that justifies the code selected for custom fitted versus OTS codes.
AOPA supports open communication between O&P providers and referral sources but also believes that in many cases the determination of what type of orthosis the patient requires will not be made by the physician alone. The physician typically relies on the expertise and knowledge of the orthotist to recommend, through a professional evaluation, the most appropriate orthosis for the patient’s medical needs. The decision must be made with the best interest of the patient in mind and must be made by the physician and the orthotist together. In addition, the medical records of the orthotist must be considered when reviewing patient files for proper documentation. Such important decisions affecting documentation and continuity of care for these patients cannot be made by regulators without involvement and input from all stakeholders—including health professionals and patients.
In addition to the publication of the revised policy bulletin on the proper coding of OTS versus custom fitted orthoses, the DME MACs simultaneously published revisions to the LCDs and Policy Articles for AFOs/KAFOs, Knee orthoses, and Spinal orthoses that incorporated the provisions of the policy bulletin into the actual medical policies. These policies are being applied retroactively for claims with a date of service on or after January 1, 2014. AOPA believes that the DME MACs do not have the authority to make claim decisions using policies that were not published at the time the service was delivered.
AOPA already expressed serious concerns on some of these topics in our March 28 comments on the CMS Rulemaking Notice relating to competitive bidding. Additionally, AOPA is preparing correspondence to CMS that will, once again, express our concern, specific to this recent DME MAC publication, over the creation and implementation of policy by CMS contractors without any regard to required compliance with the notice and rulemaking provisions of the Administrative Procedures Act.