Functional outcome data can assist surgical, interventional, and pharmacological decision making by precisely documenting the change; specifically, providing the objective confirmation of a patient’s functional status before and or after treatment.

Modern accepted statistical methods combined with profound clinical reasoning gives the clinical community appropriate tools for deciding whether a change observed is also a clinically meaningful one.

Interventional:

• Objectively justify the necessity for an interventional procedure.

• Pre:- Create a pre-procedure baseline.

• Post:- Ability to measure the outcome of the procedure with subsequent Functional tests.

• Post:- Continued ability to periodically monitor a patient’s condition with future Functional tests, for consideration of repeated and or future interventions.

Surgery:

• Pre:- Track a conservative trial and establish medical necessity objectively for surgery. For example, according to CMS MIPS Quality measures, patients with knee OA who are not obtaining adequate pain relief and functional improvement from a combination of non-pharmacological and pharmacological treatment should be considered for joint replacement therapy.

    • CMS protocols for E&M arthroplasty indicates documentation of a patient’s functional limitations as one of the guidelines.

    • Determine the functional impairments and activities of daily living (ADLs) limitations, PDQ, HOOS and/or KOOS.

• Post:- Assist post surgery therapy by effectively documenting medical necessity to help lift caps and achieve extensions of rehabilitation until a patient truly has reached maximum medical improvement, which in result, helps the patient reach optimal surgical outcome goals.

In 2012 the FDA updated the guidelines to include “improved functional abilities” to the analgesic goals of long-term Opioid use and “periodic functional ability assessment” to the reevaluations strategy, to assure appropriate therapy. So, when implementing a functional outcome program, pain management doctors will be able to:

1. Create an objective baseline of the patients’ functional abilities to justify the necessity for both interventional and conventional pharmacological treatments.

2. Have the ability to determine “improved functional abilities” and gather "periodic functional ability assessment”.

3. Determine optimum dosage the patient needs to have the best functional improvement with the lowest drug risks.

Goal: The maximum beneficial response achievable from a pharmaceutical drug with the lowest possible dosage.

With the help of functional impairment as an outcome measure tool, providers can track and determine the optimum safe dosage to achieve the desired maximum functional improvement.

Tracking function as well as pain is critical in determining the patient’s ongoing response to Opioids and whether any improvement is consistent with potential changes in Opioid dosing.

Because of the well-documented evidence of risk and the limited evidence of effectiveness beyond the period of acute pain, the use of Opioids should result in clinically meaningfully improvement in function and pain, and therefore, quality of life.

A decrease in pain intensity in the absence of improved function is not considered meaningful improvement except in very limited circumstances such as catastrophic injuries (e.g. multiple trauma, spinal cord injury, etc.).

During the chronic phase, providers should routinely review the effects of Opioid therapy on function to determine if Opioid therapy should continue.

Under MIPS guidelines, functional outcome performance testing provides the necessary information and data to report 7 outcome measures and 6 process measures.

• All high priority measures.
• Eligible patients: Aged 18 years or older who receive treatment for functional deficits.
• Rational: If the treatment is designed to improve functional deficits then it is logical to assess functional status using a standardized and objective tool to determine if the treatment improved the functional status of the patient over the treatment episode.
• Clinical recommendation: Functional status measures should be used to assist in the planning, implementing, and modification of treatment interventions, and should be used as measure of outcome.

❖ Process Measures: Evidence based practices that represent health system measures to systematize its improvement effort.

❖ Outcome Measures: High level clinical outcome measurements are a critical part of testing and implementing changes because it tells a team if the changes led to improvement.

MACRA: "Medicare Access & CHIP Reauthorization Act"

It replaces the three old Medicare reporting programs.

1- Medicare Meaningful Use→→→ replaced by Advanced Care Information.
2- PQRS→→→ replaced by Quality.
3- Value Based Modifier →→→ replaced by Cost.

MIPS: "Merit Incentive Based Payment System"

It is a performance based payment adjustment system focused on evidence and quality data practices.

1- Program started on January 1st 2017.
2- Failure to participate and report results in a -4% fee schedule penalty in 2019.
3- Successful participation and reporting: +5% in 2019 with a 9% potential in 2022.

*The more you report the higher the incentive.

Quality:

• Single practitioners are required to report 6 quality measures, including a minimum of 1 outcome measure.
• Group practitioners are required to report 15 measures.

The most common definition of medical necessity revolves around the patient's FUNCTIONAL ABILITIES, NOT a reduction in symptoms.

We can take a look at the Blue Shield Association General Policy regarding medical necessity. The policy states: “Manipulation is a covered service when performed with the expectation of restoring the patient's level of FUNCTION which has been lost or reduced by injury or illness. Manipulation should be provided in accordance with ongoing, written treatment plan.”

Virtually all insurance companies (including Medicare) base their medical necessity determination on this functional improvement paradigm and not a symptom paradigm. By utilizing Functional Performance Evaluation testing, physicians can provide the objective evidence to the third-party payers and show that not only is the patient dysfunctional in some capacity, but the care that is being provided is effective at returning the patient to a more functional status.

The first rule of the insurance industry, and perhaps the most important, is that doctors must document properly and in this proper documentation must include the rationale for the care to be deemed “medically necessary”.

To appropriately adjudicate a claim it is essential to use an objective Functional Performance Evaluation that can provide an unbiased scientific understanding of a persons undeniable functional ability.

Principle #1 says that medical care and treatment must be focused on restoring function to meet daily and work activities and return to work.

In providing the documentation or in meeting the burden of proof, the physician needs to look at the Medical Treatment Guidelines, review the criteria, and apply the general principles. Medical care and treatment should be focused on restoring functional ability to meet daily and work activities. There should be a positive patient response with functional gains which can be objectively measured.

There must be reevaluation of the efficacy of treatment. Importantly, if treatment is not producing positive results, the provider should modify or discontinue the treatment regimen or reconsider the diagnosis.

The objective functional gains become your short-term and long-term goals.

Objective functional improvement, basically, has three components:

• 1. An initial evaluation - Where was the patient at baseline, either pre-injury or at the initial evaluation or assessment?

• 2. Number two, re-evaluation now - What is the patient doing now in comparison to a previous therapy session?

• 3. And finally, goals - And goals, I divide into long-term and short-term.

   a) A short-term goal is where do you expect the patient to be at the next evaluation? What type of treatment is planned in order to help the patient reach the short-term goals?

   b) The ultimate goals, which will evolve as the treatment progresses, should always be focused on return to work, work activities and identified limitations, and links us directly to general principle #1.

(Dr. Elain Sobel Berger, Associate Medical Director and Senior Policy Advisor at the New York State Worker’s Compensation Board, 2013 NYS Medical Treatment Guidelines (MTG) Understanding Variances)

By using objective data, the judge can give the evidence full weight because it is no longer opinion but, a fact. If the defense attorney attempts to discredit the objective facts presented, they lose credibility with the jury. A doctor must take the patients subjective data and make it objective data for a courtroom situation.

Without data you're just another person with an opinion (W. Edwards Deming, Data Scientist).

In court, lawyers understand other lawyers, and doctors understand other doctors, but mutual understanding is in valid scientific data. Our patented functional evidence is considered Daubert Law, factual objective data.

Far too often attorneys are presented with medical records which fail to reflect even the most basic information relating to a patient’s case. The insufficient nature and content of these records often create more problems than they are intended to solve.

The evolution of medicine has brought with it a need for objective evidence based practices to replace subjective diagnostic tools. With over 20 years of research and development, our technology delivers a defensible Functional Performance Evaluation, which consistently proves itself in the most litigious jurisdiction in the Unites States.

Daubert Standard Definition: This is the standard used by a trial judge to assess whether an expert witness’s scientific testimony is based on scientifically valid reasoning that which can properly be applied to the facts at issue. (Cornell Law school)