Why was this panel formed? This panel was convened due to the enormous industry outrage over the draft Lower Limb Prosthetics LCD released in July 2015 (The CMS was being polite when they said they were requested by the industry). To be sure the draft LCD was poorly crafted, but the intent was clear, our best customer, the CMS, did not like the way we were selling our services/products to them and they intended to change the rules. A number of these proposed changes were recommendations from the 2011 OIG report to the CMS, which found numerous abuses of program integrity. There were many ways in which the industry could have negotiated a deal, but the decision was to force a public hearing, which only stoked the flames of the medical directors. Additionally, and unrelated, the industry had sued the CMS over a separate matter, which was subsequently dismissed, so the lines of contention had been drawn. The result is classic win the battle loose the war. The industry succeeded in getting the draft LCD withdrawn, but subsequently unleashed the resources of the government to prove its point. This panel was one of two convened by the government. The other was the AHRQ report on lower limb prosthetics.

This statement should be taken as instructional. Indeed, the industry is lacking in its ability to evaluate a patient’s functional needs based on their systemic – morbid and co-morbid - conditions. This is evident in the many documentation audits I have performed over the years. It is a rare patient file where I find a complete ROM or MMT. Measurements of the patient do exist but typically only when a new device is being proposed. This speaks to the transactional nature of O&P vs. a focus on patient management. Often these measurements are taken inconsistently and lack details. Overall body weight is often missing. Dates with years often do not exist.

I have yet to come across a company who routinely follow patients post-delivery and administers a validated Quality of Life (QoL) survey. The industry has two such surveys, the PEQ and OPUS, and I have never seen one of these used as standard protocol. Again, this indicates O&P’s focus is really focused on the transaction of a device and not on the long-term care of a patient. Care of a patient goes beyond the subjective hugs and kind letters you get from patients. In today’s world of healthcare and value demonstration you must quantify your care is effective.

The good news is this panel has just told us what we need to do going forward. The fortunate, or not so fortunate, news depending on how one looks at the situation, is what we need to do is not much different than what was required via the Dear Physician letter of August 2011. While recent legislation will make your notes part of the medical record, one has to wonder if they are helpful? The physician’s notes are still primary and of course all other notes must corroborate the physician’s notes. So, while your notes will not solely be used to approve a course of treatment they can be used to deny. So, did we really gain, or did we lose with the passage of this legislation?

What you need to do now is to review all aspects of the clinical process – who does what, when do they do it, why do they do it, how much does it cost to do it, and even does “it” even need to be done – relative to the guidance provided by not only this panel but also the AHRQ report.

They are providing our documentation guidelines here and we need to alter our processes and forms to obtain this information. The reference to “any other information…used to evaluate the function of the beneficiaries…” is a reference to items like the TUG, FSST, 6 or 2 MWT, ABC, etc. We need to begin to incorporate these into a definable and repeatable process of how we engage a patient.

This is an important distinction and clarification for the industry to understand. Most do not remember life before K-Levels and their real purpose. For clarity, the tiered K-Levels were implemented in 1994 as a means to limit Medicare’s exposure to the high cost of technology, which was entering the field primarily with microprocessor knees. It was felt the Medicare beneficiary would not attain the level of potential function required of the K3 Level because of their advanced age, morbid, and co-morbid conditions.

Therefore, performing the specific measures used to evaluate the function of the beneficiaries mentioned above such as the TUG, etc. to determine the K-Level of the patient is necessary, but it should not be re-administered multiple times as evidence of actual function over time. Using diagnostic functional assessment tests multiple times is referred to as testing against the test and academia warns against this practice. Further these tests are clinical tests, not real-life tests, and at best are measures of potential, not actual function, thus are not evidence of the efficacy of your treatment. Those who test against the test, while well intentioned, are device centric. Evidence of actual function over a longitudinal period of time should be measured with a patient centric self-report, which has been validated.

What this statement is really saying is we do a great job of documenting what we are doing for the patient, but we do a really awful job of documenting why we are doing it, based on the overall status (health) of the patient. They are making a point of clarifying what is a physiologic change because they are frustrated with how often entire devices and component parts are replaced. Again, this is evidence of the transactional nature of O&P. Our education is focused on making devices and increasingly our customer is telling us they don't care how the device is made (i.e. 3D printing, etc.), they care about why the device is made.

What is missing however is what the policy will be for replacement of a prosthetic part over three years of age.

As a result of their statement, we need to understand the primary role of the O&P clinician has radically shifted from what we have traditionally known. We can no longer be device makers when our customers want us to be care managers (tell us the why of the what). Our role is to effectively evaluate patients for the appropriate assistive technology and clearly document this relative to policy parameters. If we cannot do this then patients go unserved, under-served, or over-served and this is called bad care. Those who “get’ the statement the panel made on physiologic change will win. They will gain approvals faster than colleagues down the street and eventually they will gain their colleagues patients.

Do you bill for repairs/adjustments now? Many do not simply because it is difficult to get paid so little. However, are you aware this can be construed as fraud? This is a form of inducement and is considered fraud. Yes, I said fraud. Fraud is providing something of value and not charging for it in hopes of retaining/attracting business. Also, by not billing for these services you are sending a message to all payers these services are valueless. If you are willing to do them for free, then why should they pay you and why should they increase the reimbursement? If we hope to be able to charge for our time, then we need to start doing it when we can, or the argument is easily dismissed.

The best those in favor of allowing K2 patients to utilize MPK’s could say was “…those who utilize their prosthesis at the K2 level MIGHT (emphasis added) improve their functional abilities…” Others argued the literature were significantly flawed for various reasons. The point being, O&P has not conducted valid and reliable, and most importantly, relevant research for the claims we make relative to the benefit of MPK’s. We need to get beyond the marketing claims of manufacturers who want to sell product and address the patient functional independence issues.

The phrase, “…does not support coverage…” is significant as anything deemed non-covered is as if it does not exist (not real). This is very much different than if they would have said does not support the medical necessity. Not being considered medically necessary, means the item is covered (recognized as being real), it just is not medically necessary in all cases. You could still bill the item using a NOC code (’99) and argue the case on appeal, but if the item is classified as non-covered, you have no opportunity to use a NOC code because the item essentially does not exist. But does the patient benefit functionally? Perhaps, but what this report is saying is meaningful evidence does not exist.

In their eyes, they recognize a custom liner is intended for a specific patient and a non-custom liner is intended for the general population, however the fabrication of the liner is over a mold. The cost to fabricate a custom liner is no different than the cost to fabricate a non-custom liner once the mold is provided. In an era of code consolidation expect to see custom codes disappear.

Note, THERE IS NO CODE WHICH DESCRIBES ELEVATED VACUUM SUSPENSION! The code L5781, typically used for this, says nothing about suspension. The code was originally granted as there was evidence presented in the code application to control residual limb volume and to remove moisture from the socket via a vacuum pump. We also need to recognize there is a difference between a vacuum and suction, which there is a code used for suspension. Vacuum and suction are not synonyms, they are distinct and different. A vacuum is a state of being while suction is an action, which can produce a vacuum. This is a code, which has seen large utilization increases and could be on an audit list at some point.