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David McGill Blogger

Long-Awaited Lower Limb Prosthesis "Consensus Document" Published

Posted by David McGill | June 13, 2018

​The Interagency Workgroup convened by Medicare in 2015 to publish a "Consensus Document" summarizing current lower limb prosthetic care best practices and identifying clinical evidence gaps has published its findings. Here are the top 10 things you need to know (in the order in which they appear in the document, with minor exceptions).

  1. The Workgroup supported the continued use of "potential" as a consideration when classifying patients for functional level purposes. 


  2. The Workgroup suggested that Medicare permit prior authorization "to ensure the provision of the most appropriate prosthesis to the Medicare beneficiary." It proposed requiring the DME MACs to respond to prior-authorization submissions within 10 days (2 days for emergency situations).


  3. The Workgroup reinforced the primacy of the physician in determining the patient's functional level: "the referring physician will determine the patient's current or potential use for a prosthesis" based on the patient's history and physical exam, as well as any other information obtained from "consultants" - a term that appears to refer to prosthetists, PTs and OTs.


  4. In instances where the physician believes a patient has the potential to reach a higher functional level, the Workgroup proposed that "the physician must provide a comprehensive treatment plan with compensatory techniques" to achieve the improvement. It further suggested that the plan should also "specify a reasonable and predetermined period of time in which to address the factors currently limiting the patient's physical performance or safety." It would be up to the prior authorization team - the DME MACs - to allow or deny the prescribed prosthesis.


  5. The prosthetist's record may not be used as the sole justification for medical necessity.


  6. The Workgroup recommended using the prior authorization not only for new prostheses, but for replacements of prosthetic parts that are less than 3 years old when prescribed due to a change in the patient's physiologic condition. It suggested not requiring prior authorization for adjustments or repairs that have rendered the prosthesis inoperable or unsafe.


  7. The Workgroup acknowledged that a K2 user might benefit from microprocessor knees. It recommended a "trial of usage" and the inclusion of the results of that trial as part of a prior authorization submission.


  8. The Workgroup upheld the current determination of the DME MACs that "the literature does not support coverage of the power assist ankle for Medicare beneficiaries" at this time.


  9. The Workgroup acknowledged that "multiple suspension systems ... may be complementary in order to maintain adequate suspension and alignment of a prosthetic leg."


  10. The Workgroup concluded that "the current literature does not support improved functional health outcomes" for patients using vacuum systems. It recommended that prosthetists provide patients a trial period using these devices before submitting a prior authorization request. It further recommended including the trial results in the prior authorization submission.


Based on all of its findings, the Workgroup encouraged CMS to (a) retire the 2015 Draft LCD (which is currently "on hold"), (b) leave the current LCD for lower limb prostheses in effect, (c) create an interagency federal research group to create a guidance document to promote industry research standards for lower limb prosthetic devices, and (d) consider creating a National Coverage Determination addressing use of microprocessor knees by K2 patients.

What does this mean for you?

Accurately assessing the potential impact of the Consensus Document is a difficult exercise and we could easily author a 10,000-word post doing a deep pe into all of its intricacies. However, based on our initial review - and we may supplement this post in the near future after having had more time to analyze the Consensus Document - we think there are four key takeaways that are of central importance.

First, the continued inclusion of "potential" in the functional levels is the right result. The ability to consider not only what patients can do today but what they are likely to do in the future helps ensure that they get access to the most medically appropriate prosthetic solutions. In a related vein, assuming CMS adopts the Workgroup's recommendation regarding prior authorization, actual access would be determined by the DME MACs on a claim-by-claim basis, so we would need to see how authorization requests actually get processed in order to understand the practical effect of this suggestion.

Second, the characterization of prosthetists as "consultants" to the physician - along with PT's and OT's - is likely to be the most controversial aspect of the Consensus Document. The implications of this language would only be fully understood upon adoption of these policies by Medicare and the DME MACs. However, at a high level, this would seemingly have the effect of either continuing or increasing the documentation challenges that many prosthetists have getting adequate notes from physicians, many of whom do not specialize in prosthetics and who express confusion and concern about what they see as already-burdensome documentation requirements.

Third, the acknowledgement by the Workgroup of the potential benefits that microprocessor knees may provide K2 patients is an important and welcome conclusion. While we cannot predict whether access to MPKs by K2 patients would actually increase - that decision would rest on a claim-by-claim basis in the hands of the DME MACs - the simple fact that the Workgroup recognized the need to create a pathway for access when appropriate is a significant step forward.

Fourth, the determinations regarding "power assist" ankles and vacuum systems raise serious concerns. The latter, especially, has a long history of Medicare payment, with tens of thousands of patients relying on these devices. While a theoretical pathway to accessing vacuum devices would still exist via the prior authorization process, it seems highly unlikely that many patients would be able to obtain ongoing access to them in the future given the overall tenor of the Consensus Document's conclusions.

We should emphasize in conclusion: the Consensus Document is not the same thing as a rule that CMS has agreed to implement. Rather, it is a series of findings and recommendations. It is also unclear at this time whether there will be a formal process by which the public can respond to the Consensus Document or not. We will keep you apprised of further information about the Consensus Document as it becomes available.

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