Why Evidence Matters or Why O&P Cannot Use Evidence - Yet

Sunday, Jun 7, 2020

All would agree, evidence matters in healthcare to achieve the best possible outcome for the patient, the provider, and the payer – i.e. society. Healthcare providers are encouraged to use the best possible research-based evidence in making decisions about the care provided. As clinicians our patients confront us with problems needing to be solved. To solve these problems, we continually educate ourselves through attending conferences and/or reading relevant research. Then we apply what we learned to solve our patient’s problems, based on the best evidence available. Indeed, our credentialing organizations long ago mandated continuing educational criteria.

Evidence Based Healthcare, when properly supported and deployed has many benefits such as:

  • Reducing overall cost of care
  • Deceasing or eliminating fragmentation of care
  • Reduce stress level of all healthcare workers
  • Can help to create a collaborative, versus combative, relationship with payers
  • Can help to reduce/eliminate service denials
  • Creates a patient-centric value orientation
  • Leads to objective improvement in patient function and quality of life
  • And many more……

So why is it difficult for O&P to use evidence to support its practices for the betterment of its patients? Quite simply because we have not done the requisite relevant research to objectively prove what we do matters in the functional daily lives of our patients. Remember, the CMS Consensus Report on Lower Limb Prosthetics concluded by stating “…in general, this information does not adequately provide the evidence necessary to inform Medicare policy in the provision of the most appropriate prosthesis to its beneficiaries. The operative word is relevant and thus, the question relevant to whom? Now that’s a bold statement given the volume of research which has been published around O&P. But we must be able to differentiate between research, which is simply interesting, interesting and relevant to the researcher, and research, which is interesting and relevant to the patient. So, then the question becomes how to determine relevancy, i.e. value to the patient? Who determines this?

The answer here is the same as in a previous post; the payer and policymakers determine coverage guidelines, and like you, they use the best evidence available. They will vet the available research and will generally include a synopsis of the coverage policy decisions at the end of their policy decisions, which will include a bibliography of all the research they reviewed. The real-life story below actually occurred and highlights the above scenario.

In 2015, a relatively new start-up company produced a very innovative powered prosthetic foot/ankle device. The company had only one piece of published research, albeit in a very well-respected peer-reviewed biomechanical journal, which demonstrated a significant metabolic reduction in energy to walk a given distance. The company sought additional research to help support this early finding to eventually seek a new code for this device. New research proposals were drawn up and opinions sought from various payers, medical directors, and researchers, key among them the CMS. Inarguably the CMS is the most influential payer/policymaker, so their opinion mattered.

In short, after two key meetings with four research orientated physicians who were responsible for creating policy and guidance on newly covered items, they told the company their evidence of metabolic reduction was nice, but it did not matter to them. What? How could this fact not matter? What followed was a wonderful education in what O&P should be focused on in its research to be able to achieve the Holy Grail of EBP.

The CMS was very upfront on what they look for in any research. The following four key points are what all O&P researchers should be focused on:

  1. Show how your “gizmo” (their words) keeps the Medicare Beneficiary in their own home.
    1. They explained they inherently knew a beneficiary taking care of themselves in their own home costs them less money and keeps the beneficiary healthier.
  2. Show durability of effect.
    1. In other words, regardless of what your “gizmo” (their words) does, does it do it for the life of the device? Of the patient? Or once the acclimation period is over does the benefit disappear?
  3. How does the benefit of your “gizmo” relate to a medical condition?
    1. Pretty self-explanatory, but something which has been hard for O&P manufacturers and clinicians to grasp. Payers do not pay to make life easier, more comfortable, more normal, etc. And only rarely do they pay to “prevent.” They pay to fix broken things. This is “HEALTH” insurance so how does your gizmo relate to a health issue.
  4. Show how the “gizmo” relates to a “functional endpoint” vs. an “intermediate endpoint.”
    1. the difference? An intermediate endpoint is the metabolic energy reduction. The functional endpoint is how the patient remains independent in their own home. There is no guarantee every patient receives the intermediate endpoint! Who receives the benefit and who does not, how does this keep the patient at home and, how does this relate to their specific medical condition matters.

Two years later in September 2017 the CMS published a report titled, “Lower Limb Prosthetic Workgroup Consensus Document.” The Workgroup was put together as a response to public comment (i.e. the O&P community) relative to the draft Lower Limb LCD. Its stated purpose and findings were reported in my April post. A year later in 2018, the AHRQ (Assoc. for Healthcare Research and Quality) published a report, “Lower Limb Prostheses: Measurement Instruments, Comparison of Component Effects by Subgroups, and Long-Term Outcomes.” The purpose of this review was:

“To assess validity of instruments used in adult lower limb amputees, whether patient characteristics can predict relative effectiveness of different lower limb prosthesis (LLP) components, and long-term LLP use.”

In this lengthy report they noted many published evidences used non-validated instruments, analysis was inadequate, and many studies had important methodological issues. One of the most important questions raised by this group was, which lower limb prosthetic configuration (i.e. components) would best enable maximal health, function, and quality of life for a given individual. They noted the plethora of potential options and how complex decision-making can be. Likewise, they noted suboptimal matching of components to patients may unnecessarily increase utilization, prevent the patient from reaching their maximal functional capabilities and quality of life, and increase overall cost.

So, what have we learned from this?

  1. Not all research is good and valuable. The research may be interesting, but it is not relevant. Published research, which may be poorly conducted and/or analyzed can be harmful, leading to fodder for denials by payers.
  2. Only by serving our customer’s needs, wants, and desires do we achieve our needs, wants, and desires.
  3. We need to begin to collect data on the human impact we have on our patients methodically by first measuring their stated function and quality of life in a defined way, which will be meaningful to payers and policymakers.
  4. We need to properly analyze findings creating standards of care related to achieving high quality patient-centric outcomes.
  5. We need to adapt our educational system to these new standards of patient-centricity vs. the current device-centricity. Currently there is far too much emphasis placed on the manufacturing of a device vs. what device should be manufactured and why.

Only when we begin to address the needs of those we serve (patients and payers) can we effect change in coverage policy, reimbursement, and credibility issues.

Vanguard Metrics and Analytics can help you be part of this change by participating in its Lower Limb Mobility Management Program (L2M2P), which measures your patients function and quality of life.

Contact Brian Gustin, CP at blg.gustin@gmail.com, 920-544-5045, or www.vanguardmetrics.biz to learn more about how this can help you sustain your business into the future.