Vitali Body 360 Analyzer 4-FDA REGISTRATION 510k W/6 CPT & 10 ICD CODES

Fast and noninvasive, the analyzer performs in 7 minutes multiple assessments:  

Technology Integration 1. Photoelectric Plethysmography2. Heart Rate Variability3. Galvanic Skin Response                                                             4. Blood Pressure Analysis HOW THE RM-3A WORKSA direct current of 1.28V is applied between six electrodes placed symmetrically on the forehead, hands, and feet of the study subject.  This allows the device electronically records data from 22 segments of the body, and transmit that information into charts, graphs and 3D images. Patient sits and places feet and hands on metal plates.  Disposable electrodes are attached to the forehead.  Blood pressure handcuff is part of the examination and Pulse oximeter is placed on the index finger. Measurement of over 30 physiological parameters during the 7-minute recording as well as Valsalva and change in standing position are required. All results are immediately displayed in a single screen; separate software guides the physician in his interpretation. 

DEVICE ANALYSES 100 BIOMARKERS IN 7-MINUTES

Body systems including: •Respiratory System •Digestive System •Immune System •Cardiovascular System •Brain and Nervous System •Hormones Neuromuscular system •Bladder and Kidney Function •General metabolic functions •Thyroid •Insulin, Leptin, arterial pH, •Body composition i.e., fat, muscle, fluid distribution, etc

Specific measurements of physiology, bio-chemistry and body functions:•Assess how well patient’s organs and glands are functioning •Study patient’s cellular activity and health •Evaluate patient’s circulation and microcirculation •Assess patient’s biochemistry for imbalances •Measure fat mass and muscle mass •Check hormone levels •Assess blood flow and neurotransmitter levels in the brain •Identify possible toxin and drug effects •Check patient’s hydration and oxygen levels •Assess patient’s cardiovascular health •Pinpoint areas that warrant further observation or treatment

 MEDICAL DEVICE

NONINVASIVE ***$600+ DOCTOR REIMBERMENT ***

Arterial Stiffnessindicators

Autonomic nervous system indicators

Sudomotor functionindicators

Body compositionindicators

Vitali Body 360 Analyzer

• User friendly• Non-invasive; time effective (takes 7 minutes); provides more information than most any other screening 

technique• Provides immediate determination of real time compressive conclusions• Provides risk factors for various disorders • Multi-department/inter-clinic communication; can review whole picture immediately • Remote viewing and operations performance capability to detect and prioritize specific system 

treatment/diagnosis  • Detects hidden medical challenges through observance of over 100 bio-markers.

Why is the Vitali Body 360 Analyzer Necessary for Case Management?

List of Billable CPT Codes

95921 - Testing of autonomic nervous system function; cardiovagal innervations (parasympathetic function) includes the following: Valsalva ratio and 30:15 ratio.

95922- Includes measurement of beat-to-beat blood pressure and R-R interval changes during valsalva maneuver and at least 5 minutes of passive tilt. This testing involves continuous heart rate recording and requires photoplethysmographic beat-to-beat blood pressure recording. Analysis of heart rate and blood pressure responses reflects the integrity of vasomotor adrenergic innervations.

95924 - Testing of autonomic nervous system function combined parasympathetic and sympathetic adrenergic function testing with at least 5 minutes of passive tilt.

95943 - This code has been established to report when an autonomic function testing does not include beat to beat recording, or for testing without the use of a tilt table. This is a simpler, automated procedure compared to the autonomic codes. Simultaneous, independent, quantitative measures of both parasympathetic and sympathetic function, based on time-frequency analysis of heart variability concurrent with time-frequency analysis of continuous respiratory activity with mean heart rate and blood pressure measures during rest and paced (deep) breathing. Valsalva maneuvers and heads up postural change.

(Please note that this CPT code is not payable in all states)

95923 - Testing of autonomic nervous system function; Sudomotor, including 1 or more of the following: quantitative sudomotor axon reflex test (QSART), silastic sweat imprint, thermoregulatory sweat test and changes in sympathetic skin potential.

93922 - Non invasive physiologic studies to upper extremity arteries, single level (e.g. Ankle/Brachial indices, Doppler waveform analysis, volume plethysmography, transcutaneuos oxygen tension measurement) The above CPT codes reflect the most recent updates from the American Medical Association (AMA).

Vitali Body 360 Analysis System is FDA Cleared, and it is one of the most sophisticated, evolutionary, electro-physiology, analytical devices available.

1. Full Autonomic Nervous System Evaluation: “Automatic Nervous system” (ANS) that automatically runs all our organ. Studies have shown that when the ANS is out of balance, the body will develop disease(s) and other health issues such as diabetes and heart disease.

2. Arterial Stiffness Assessment: a Risk Factor shows “hardening” of the coronary arteries which is an early sign of cardiovascular disease(s).

3. Sudomotor Function Assessment: circulation indicators in the hands and feet provide the physician an understanding of circulation disorders and early signs of neuropathy.

4. Blood Pressure and oxygen intake and delivery indicates both heart and circulation problems.

Interpretation is made easy using statistical software, charts and graphs.

What are the Analysis Systems?

Why perform Autonomic Nervous System & Sudomotor function assessments

Galvanic skin / Sympathetic skin response to electrical stimulation acts as a predictive tool for early signs of distal peripheral neuropathy in people with diabetes by measuring the Sudomotor function.

Diabetes is shown to be the primary cause of small fiber neuropathy and the American Diabetes Association recommends including Sudomotor function assessment in the current panel of diagnostic tests for the detection of peripheral neuropathies.

Autonomic Nervous System testing helps to differentiate progressive diseases and serves as a means of monitoring disease progression and response to treatment.

It can also distinguish primary from secondary autonomic disorders, pure autonomic failure (PAF) or postural orthostatic tachycardia syndrome (POTS).

25% to 50% of patients with symptomatic autonomic dysfunction are likely to die within 1 to 5 years.

Any patient with diseases and symptoms suggesting autonomic neuropathy - i.e. tingling sensation in the feet, numbness in the feet, numbness in the feet or hands, etc.

Autonomic neuropathy is a nerve disorder and is often associated with the following diseases:

Diabetes Thyroid Disease Autoimmune Disorders Liver Disease Kidney Disease HIV

Autonomic neuropathy is associated with variety of symptoms:

Pain, numbness, tingling or burning in the feet or hands, Sleep Apnea Digestive Disorders (nausea, constipation, diarrhea…etc) Dizziness, syncope (faint), headaches, fatigue Exercise intolerance Bladder urgency Chest palpitations

Which patient requires ANS testing

TEST PROCEDURE

Calibration / occlusion

test

Oximeter + GSR devices

Valsalva maneuver

Deep breathing Standing CAN

Score

Test is performed in less then 10 minutes and is completely non-invasive. Recording includes a base line phase where the patient is relaxed and a testing phase where the patient is asked to perform breathing exercises.

CMRS stands for Cardio Metabolic Risk Score which is calculated based on several recorded parameters and allows a fast and intuitive interpretation of the results. CMRS is a marker for pre-diabetes, diabetes and CVD (Cardio Vascular Disease) risk as a stated by University of Miami in their latest study. CAN score stands for the Care Assessment Need Score.

Autonomic Nervous System

Weight Assessments

• FM – Fat Mass• FFM – Fat Free Mass• TW – Total Weight• EWC – Extreme Weight Conditions• BMI – Body Mass Index

       What is Oxygen Saturation (SpO2)Pulse Oximeter Score

Oxygen saturation is defined as the ratio of oxy-hemoglobin to the total concentration of hemoglobin present in the blood (ie Oxy-hemoglobin + reduced hemoglobin).

Hemoglobin is an iron-containing protein bound to red blood cells and makes up nearly all the oxygen presence (there is a minute amount dissolved in the plasma). Hemoglobin is responsible for transporting oxygen from lungs to other parts of the body, where the oxygen can be used by other cells. Oxy-hemoglobin (HbO2) is the bright red hemoglobin that is a combination of hemoglobin and oxygen from the lungs.

A hemoglobin molecule can carry a maximum of four oxygen molecules. 1000 hemoglobin molecules can carry a maximum of 4000 oxygen molecules; if they together were carrying 3600 oxygen molecules, then the oxygen saturation level would be (3600/4000)*100 or 90%.

Vitali Body 360 Analysis Systems

Take blood pressure

Metal plates measure the electrical frequency of organs through bio-impedance (electrical conductivity)

Oximetry produces digital pulse wave analysis via plethsmography (finger clip)

Measure galvanic skin response (A measure of electrical resistance as a reflection of changes in emotional arousal, taken by recording changes in moment-to-moment perspiration and related activity of the autonomic nervous system) body composition and blood pressure

Results are immediately displayed on a single screen assisting the physician interpreting the results

What do the Vitali Body 360 Analysis Systems do?

Utilized in any facility requiring immediate/real-time bio-physiology results: Post trauma

Any department treating diabetic neuropathy, peripheral neuropathy, peripheral artery disease, and cardiology. Patient education: 3D modeling with color coded graphic display rotates internal image of the organs 360 degrees over 4 different condition patterns:

i. Cardiacii. Diabetesiii. Narrowing of the arteriesiv. Neuro transmitters

Who can use the Vitali 360 Series Analysis Systems?

1. Bones & spine2. Arms and legs3. Lungs4. Esophagus5. Face, teeth, and neck6. Male organs 7. Female organs8. Kidneys

What it DOES NOT look at:

Vitali Body 360 Analysis Systems DO NOT…1. Diagnose2. Treat3. Fix4. Correct

CPT : Current Procedural Terminology is a system developed by the American Medical Association for standardizing the terminology and coding used to describe medical procedures and services

ICD-10: International Classification of Disease, 10th edition, is a standardized classification of disease, injuries and causes of death, by etiology and anatomic localization and codified into a six digit number, which allows clinicians, statisticians, health planners and others to speak a common language both US and internationally

Codes for Diagnosis: All doctors have a medical billing expert who works in his/her practice who knows these codes, and how to use them

Almost ALL insurance companies reimburse, except for chiropractors Reimbursement varies. It could range from $400-600

Definitions:

95921

95922

95923

Bundle code: 95921 + 95922 = 95924 (with tilt table) or 95943 (without tilt table)

Examples of ANS CPT CODES

Autonomic function testing is covered as reasonable and necessary when used as a analytical tool to evaluate symptoms indicative :

1. To evaluate the presence of autonomic neuropathy in a patient with signs or symptoms suggesting a progressive autonomic neuropathy.

2. To evaluate the severity and distribution of a diagnosed progressive autonomic neuropathy.

3. To differentiate between certain complicated variants of syncope from other causes of loss of consciousness.

4. To evaluate inadequate response to beta blockade in vasodepressor syncope.

5. To evaluate distressing symptoms in a patient with a clinical picture suspicious for distal small fiber neuropathy in order to diagnose the condition.

6. To differentiate the cause of postural tachycardia syndrome.

7. To evaluate change in type, distribution, or severity of autonomic deficits in patients with autonomic failure.

8. To evaluate the response to treatment in patients with autonomic failure who demonstrate a change in clinical exam.

9. To evaluate axonal neuropathy or suspected autonomic neuropathy in the symptomatic patient.

10. To evaluate recurrent unexplained syncope to demonstrate autonomic failure after more common causes have been excluded by other standard testing.

Examples of claim reimbursements?

The following indications are NOT considered medically reasonable and necessary and will not be covered:

To screen patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic, or renal disease

Testing for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic, or renal disease

Testing where the results are NOT used in clinical decision-making and patient management

Limitations

BODY 360 ANALYZER DASHBOARD

ANS DYSFUNCTION RISK INFO

ANS RISK FACTOR EXPLANATION

SUDOMOTOR DYSFUNCTION RISK INFO

SUDOMOTOR RISK EXPLANATION

ENDOTHELIAL DYSFUNCTION RISK INFO

ENDOTHELIAL RISK EXPLANATION

CARDIOMETABOLIC RISK INFO

CARDIOMETABOLIC RISK EXPLANATION

IMPAIRED GLUCOSE TOLERANCE (IGT) RISK INFO

IMPAIRED GLUCOSE TOLERANCE (IGT) RISK EXPLANATION

PERIPHERAL DISTAL NEUROPATHY RISK INFO

PERIPHERAL DISTAL NEUROPATHY RISK EXPLANATION

CARDIAC AUTONOMIC NEUROPATHY RISK INFO

CARDIAC AUTONOMIC NEUROPATHY RISK EXPLANATION

CORONARY ARTERY DISEASE RISK INFO

CORONARY ARTERY DISEASE RISK EXPLANATION