with SERIES ANALYTICAL SYSTEM Clinical, Billing & Orientation Reference Guide

with SERIES ANALYTICAL SYSTEM Clinical, Billing & Orientation Reference Guide

RM-3A Series Analytical System INTRODUCTION Thank you for purchasing your RM-3A Series Analytical System (RM-3A SAS)! We appreciate your business, and we are here to help! One way we can offer assistance is to provide you with suggested Current Procedural Technology (CPT) and International Classification of Diseases - 9th edition (ICD-9) and upcoming 10th editition (ICD-10) codes. Correctly coding and billing your charges means you get reimbursed quickly the first time. We have developed this booklet to enhance the billing of charges associated with the RM-3A SAS. By using this guide, you will not only avoid denials, appeals, processing, and lengthy turn-around times, but also maximize your reimbursement. This brief guide is an introduction to the suggested CPT and ICD-9 codes you can use to bill for services you render with the RM-3A SAS. Please use this information in addition to your current billing practices. Renua Medical has provided this information as suggestions only according to the intended uses of our products. You, as the practitioner, are responsible for compliance when using these codes, according to the procedures of the American Medical Association (AMA) and Medicare. Renua Medical shall not be liable for any errors, penalties or denials of reimbursement as a result of relying on this suggested information concerning CPT and ICD-9 codes, if there is a practitioner audit conducted. Also, be advised that the stated Medicare allowables in this document reflect an average reimbursement rate. Please check the National Medicare reimbursement chart for your state s particular reimbursement (beginning on page 18).

Table of Contents Introduction Use of the RM-3A SAS... 2 Billing Guidelines of CPT Code 93922... 3 Modifiers... 5 Tilt Table Testing Procedures... 5 Billable CPT Codes... 6 List of Payable ICD-9 Codes... 7 List of Payable ICD-10 Codes... 8 Physician s Report Sample Pages...10 Frequently Asked Questions (FAQ s)...17 Acronyms...18 RM-3A SAS Guide 1

Use of the RM-3A SAS: The ordering physician must establish medical need for testing. This includes completion of a thorough history and physical examination consistent with the nature and complexity of the patient s presenting complaint. This full patient assessment must be made prior to testing. Autonomic Nervous System (ANS) function testing is covered as reasonable and necessary when used to evaluate symptoms indicative of vasomotor instability such as hypotension, orthostatic tachycardia and hyperhidrosis after more common causes have been excluded by other means of testing and the ANS testing is directed at establishing a more accurate or definitive diagnosis or contributing clinically useful and relevant medical decision making. Factors to determine medical necessity... To diagnose the presence of autonomic neuropathy in a patient with signs or symptoms suggesting a progressive autonomic neuropathy To evaluate the severity and distribution of a diagnosed progressive autonomic neuropathy To differentiate the diagnosis between certain complicated variants of syncope from other causes of loss of consciousness To evaluate inadequate response to beta blockade in vasodepressor syncope To evaluate distressing symptoms in a patient with a clinical picture suspicious for distal small fiber neuropathy (SFN) in order to diagnose the condition To differentiate the cause of postural tachycardia syndrome To evaluate change in type, distribution or severity of autonomic deficits in patients with autonomic failure To evaluate the response to treatment in patients with autonomic failure who demonstrate a change in clinical exam To diagnose axonal neuropathy or suspected autonomic neuropathy in a symptomatic patient To evaluate and treat patients with recurrent unexplained syncope to demonstrate autonomic failure after more common causes have been excluded by other standard testing Reasons the test should not be used: To screen patients without signs or symptoms of autonomic dysfunction, including patients with diabetes To test for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic or renal disease To test where the results are not used in clinical decision making and patient management Testing performed by physicians who do not have evidence of training and expertise to perform and interpret these tests To providers: All indications must be clearly documented in the patient s medical record and made available to Medicare upon request. This documentation is critical and will reduce the risk of Recovery Audit Contractor (RAC) audits and recovery. Documentation must support Centers for Medicare and Medicaid Services (CMS) signature requirements. Physicians can bill an Evaluation and Management (E/M) code (office visit) along with these services. Also, physicians can bill one test more than once if they can document the need (i.e. borderline findings or inconsistency in critical values). 2 RM-3A SAS Guide

Billing Guidelines on CPT Code 93922 This code can be billed as long as the ankle brachial indices are performed. The key components of limited bilateral noninvasive physiologic studies are: Volume plethysmography Bidirectional doppler waveform Ankle brachial indices (ABI) Transcutaneous oxygen tension measurement (SP-02) With these components, you can bill CPT Code 93922 with no billing issues. What the test actually looks for: This test is done by measuring blood pressure (BP) at the ankle and in the arm while a person is at rest using the ABI machine designed for this type of measurement. Some people also do an exercise test. In this case, the BP measurements are repeated at both sites after a few minutes of walking on a treadmill. The ABI result is used to predict the severity of peripheral artery disease (PAD). A slight drop in your ABI with exercise means that you probably have PAD. This drop may be important, because PAD can be linked to a higher risk of heart attack or stroke. Normal Results: A normal resting ABI is 1.0 to 1.4. This means that your BP at your ankle is the same or greater than the pressure at your arm, and suggests that you do not have significant narrowing or blockage of blood flow. Abnormal Results: Abnormal values for the resting ABI are 0.9 or lower and 1.40 or higher. If the ABI is 0.91 to 1.00, it is considered borderline abnormal. Abnormal values might mean you have a higher chance of having narrowed arteries in other parts of your body. This can increase your risk of a heart attack or stroke. RM-3A SAS Guide 3

Billing Guidelines on CPT Code 93922 - Cont d If the test is performed without the ankle brachial indices... It should be billed as an unlisted vascular diagnostic study CPT 93998. Billing the code in this fashion requires the following information if the claim is being submitted to Medicare. 1. Prior to billing the procedure, you must be able to choose a CPT code that closely resembles the testing that you conducted. 2. You must be able to compose a letter that includes: (A) the reason as to why you are using an unlisted code and (B) how you were able to compare the CPT code 93998 to the actual testing that was performed. 3. Explain how you were able to determine a charge for this CPT code. 4. Give a detailed explanation as to the actual testing and results (documentation in medical records). 5. Claim must be submitted to Medicare via electronic submission and must be followed up with the Medicare PWK (paperwork) form (this is where you submit all the above information to Medicare). 6. Do not submit the additional information to Medicare prior to submitting the claim. Please keep in mind that the unlisted vascular diagnostic study (CPT) 93998 has no assigned value. The documentation must reflect the medical need for the testing and the reason as to why the testing was done in that particular manner. The same should be performed when billing the insurance companies. Insurance companies may deny this claim. Be prepared to file an appeal. 4 RM-3A SAS Guide

Modifiers USAGE 25 Significant, separately identifiable evaluation and management service by the same provider on the day of the procedure. 52 Reduced services. Should only be used if a unilateral exam is performed. 59 Distinct procedural service indicates two separate procedures performed on the same day by the same physician.* 76 Repeat procedure by the same physician (use when necessary to report repeat procedure performed on the same day). EFFECTIVE JANUARY 1, 2015 CMS has implemented new modifier codes. These codes are meant to replace modifier 59. XE Separate Encounter. A service that is distinct because it occurred during a separate encounter. XS Separate Structure. A service that is distinct because it was performed on a separate organ/structure. XP Separate Practitioner. A service that is distinct because it was performed by a different practitioner. XU Unusual Non-Overlapping Service. The use of a service that is distinct because it does not overlap usual components of the main service. Beginning January 1, 2015, modifier XU should be used to report a second procedure. *Some payers and states require a 59 modifier be affixed to all testing codes. Please check with your payers to ensure their requirements. Unbundling of Codes: CPT codes 95921 and 95922 are considered bundled codes. In order to unbundle these codes, use a 59 modifier. Repeat Procedures: To report a repeat procedure performed on the same day by the same physician, use modifier 76. Tilt Table Testing Procedures with RM-3A SAS 1. Conduct sudomotor testing with the hands and feet on foot and hand plates and TM-Oxi sensor on the finger. This portion of the test takes approximately 3 minutes. 2. Once the sudomotor testing is completed, place patient on the tilt table. Make sure the BP cuff and the TM Oxi sensor remain attached to the patient. 3. Tilt the patient to a 45 degree angle as required by the tilt table. 4. With the patient in the 45 degree tilt position, wait 2 minutes and begin the Valsalva maneuver. 5. Next, complete the deep breathing test. 6. Next, simultaneously tilt the table (either manually or electronically depending on which type of Tilt Table you have) to the standing position and start the standing test on the RM-3A SAS 7. Once you have completed this test, you are now qualified to bill for the 95922 as well as the 95921 (which can be billed for without passive tilt) and for the 95922 separately by applying a 59 modifier to separate/unbundle the two codes. The 95924 code can also be billed separately. This CPT code incorporates both CPT codes 95921 and 95922. RM-3A SAS Guide 5

Billable CPT Codes NV Medicare Allowable $ 93.21 $ 111.99 $ 217.17 $ 151.39 $ 168.76 of the 3 codes. This is a "C" status code and paid at carrier discretion. Consult your local carrier(s). $ 93.66 6 RM-3A SAS Guide

List of Payable ICD-9 Codes Use these ICD-9 Codes for CPT Codes 95921, 95922, 95923, 95924 and 95943 250.60 Diabetes with neurological manifestations, Type II or unspecified not stated as uncontrolled 250.61 Diabetes with neurological manifestations, Type I juvenile) not - stated as controlled 250.62 Diabetes with neurological manifestations, Type II uncontrolled 250.63 Diabetes with neurological manifestations, Type I juvenile) uncontrolled 277.31 Familial Mediterranean Fever; Hereditary amyloid nephropathy 277.39 Other Amyloidosis; Inherited systemic amyloidosis 333.0 Other degenerative disease of basal ganglia 337.00 Idiopathic peripheral autonomic neuropathy unspecified 337.09 Other idiopathic peripheral autonomic neuropathy 337.20 Reflex sympathetic dystrophy, unspecified; Complex regional pain syndrome Type I, unspecified 356.4 Idiopathic peripheral polyneuropathy 356.8 Other specified idiopathic peripheral neuropathy 356.9 Hereditary and idiopathic peripheral neuropathy; unspecified 357.2 Polyneuropathy in diabetes 458.0 Orthostatic hypotension 780.2 Syncope and collapse 780.8 Generalized Hyperhidrosis; diaphoresis; excessive sweating; secondary hyperhidrosis 785.0 Tachycardia unspecified; Rapid heart beat Use these Codes for CPT Code 93922 250.70 Diabetes Mellitus with peripheral circulatory disorders, Type II not stated as controlled 250.71 Diabetes Mellitus with peripheral circulatory disorders, Type I not stated as controlled 250.72 Diabetes Mellitus with peripheral circulatory disorders, Type II or unspecified type, uncontrolled 250.73 Diabetes Mellitus with peripheral circulatory disorders, Type I uncontrolled 440.00 Atherosclerosis of aorta 440.20 Atherosclerosis of native arteries 440.21 Atherosclerosis native arteries with intermittent claudication 440.22 Atherosclerosis native arteries with rest pain 440.23 Atherosclerosis native arteries with ulceration 440.24 Atherosclerosis native arteries with gangrene 440.30 Atherosclerosis of bypass graft extremities 440.31 Atherosclerosis of autologous vein bypass graft extremities 440.32 Atherosclerosis non autologous biological bypass graft extremities 442.00 Aneurysm of artery upper extremity 442.20 Other Aneurysm of iliac artery 442.30 Aneurysm of artery of lower extremity 443.90 Peripheral vascular disease RM-3A SAS Guide 7

New Payable ICD-10 Codes 8 RM-3A SAS Guide

New Payable ICD-10 Codes RM-3A SAS Guide 9

Physician Report Sample Pages 10 RM-3A SAS Guide

. On this page, the software analyzes HR time intervals at rest to understand regulation of HR by the ANS through sympathetic and parasympathetic innervations. The sympathetic nervous system releases epinephrine and norepinephrine (increasing HR, vasoconstriction). The parasympathetic nervous system releases acetylcholine (decreasing HR). Important markers: HR, Standard Deviation of Normal to Normal (SDNN), Total Power (TP), low frequency/high frequency (LF/HF). The diagram showing sympathetic and parasympathetic levels is on the right in the ANS Balance box. HRV score is based on SDNN and TP. The more variation in time between each beat the better. If there is a lack of variation in heartbeat (RR time intervals), SDNN and Total Power are reduced creating a higher risk for cardiovascular disease (CVD) and autonomic neuropathy in the diabetic population. LF/HF ratio (ANS balance) is increased in a patient with mental stress. The software analyzes the changes in HR and beat-to-beat BP between a resting state and after the Valsalva maneuver, deep breathing, and active standing (also known as the Ewing test). These exercises challenge the ANS regulation as follows: During the Valsalva: BP falls and triggers a tachycardia; sympathetic system releases norepinephrine and epinephrine resulting in an overshoot of BP and bradycardia During deep breathing: HR increases during inhale phase and parasympathetic decreases HR during exhale phase During active standing: sympathetic system activation increases HR and BP to sustain blood level in the brain CAN will be evaluated in the case that sympathetic or parasympathetic response fails to happen in more than 2 of these phases Failure of sympathetic or parasympathetic system to regulate BP and/or HR will result in risk of autonomic neuropathy and therefore increased risk of death (cardiac events x 3) and hypoglycemia Reference: Cardiac autonomic neuropathy in patient with diabetes mellitus - World Journal of Diabetes 2014 - February 2015 RM-3A SAS Guide 11

ANSD R. (ANS Dysfunction Risk) is presented as a score in the box on the upper right side above. ANS Balance is shown in the box on the left side above: Stress. I (stress index) is correlated to C Reactive Protein and is a marker of sympathetic failure. C Reactive Protein is produced by the liver & increases with inflammation. High numbers indicate a risk for heart disease. Low numbers have not shown any specific risk at this stage. HF - Indicator of the parasympathetic system activity. Low number indicates fatigue. HF is usually increased during recovery time. LF/HF - indicates ANS balance. If the value is high (greater than 2), it indicates sympathetic system predominance and possibility of mental stress or anxiety. If the value is low (less than 0.5), it indicates parasympathetic system predominance and possibility of fatigue or depression. ANS Activity is shown in the box 2nd from the left above. SDNN is a marker of ANS activity and VO2, (maximum oxygen consumption in the muscles). A low number indicates a sedentary life style. High numbers are usually seen in athletes. RMSSD (Root Mean Square of the Successive Differences) is an indicator of parasympathetic activity and reflects electrical stability of the heart. TP is the main indicator of ANS activity. Low numbers may indicate a sedentary lifestyle and may indicate the need to increase activity. TP may also define the variability, or degree of fluctuation in the length of the intervals between beats. A low HRV score is associated with poor prognosis for patients who are post MI (Myocardial Infarction) and increased risk of autonomic neuropathy in diabetes population. 12 RM-3A SAS Guide

On this page, the software analyzes sweat response after exposure to electrical stimulation. Sudomotor function (sweat gland activity) is controlled by a division of the sympathetic nervous system and the postsympathetic cholinergic nerve fibers, which release acetylcholine. The acetylcholine increases microvascular flow and provokes sweat output. Causes of C-fiber damage: diabetes, high blood glucose, poor vascularizaton, and other diseases or treatment. ESR NO is a marker of electrical skin response to nitric oxide (NO) production and vasodilation. This marker reflects microcirculation blood flow. Decreased ESR NO indicates decreased microcirculation. A low number indicates signs of poor micro-vascularization and increased risk of distal neuropathy. High numbers indicate good vascularization. ESR L is a marker of sweat gland nerve density. This marker reflects postsympathetic nerve density. The peak reflects C-fiber density. Low number indicates early detection of Peripheral Distal Neuropathy (PDN). Peak C is a marker of sweat gland function and reflects maximum number of water and chlorine released on the electrode plate after stimulation. Decreased Peak C is either due to nerve damage or hypohydrosis. An abnormal number (high or low) can be attributed to hyperhydrosis; a low number is found with nerve damage. The results are represented as a risk bar on the left side of the above screenshot where dysfunction is color coded in yellow or orange bars (when bar is decreased), as 3 digits in the middle of the box to the right of the color bars where normal range is indicated, and finally on the right side as a Sudomotor Response Score Significant Risk. In this example, the score is 80%. Reference: Detection of neuropathy using a sudomotor test in type 2 diabetes - Degenerative neurological and neuromuscular disease - Dovepress - January 2015. RM-3A SAS Guide 13

On this page, the software analyzes the pulse wave detected from the pulse oximeter as well as the data from BP and the marker of micro-circulation (ESRNO) from the sudomotor function testing. The cardiometabolic risk (CMR) score has been shown to have a very high correlation with the 2h-OGTT test to detect type 2 diabetes. In the meantime, PTG analysis (see page 13) has been shown to be a valuable marker for CVD. Therefore, the cross analysis of all these markers allows the detection of patient CMR. Fig. A: CMR score is calculated based on the first 3 block of markers listed in this part of the above screen Fig. B: CVD score is calculated based on the last 2 block of markers listed in this part of the above (Fig. A) Fig. C: A high percentage suggests the need to run further lab test(s) and examinations to identify risk of diabetes and CVD screen. Fig. D: PTGTP helps to identify risk of insulin resistance and, therefore, pre-diabetes as well as possible heart disease and metabolic disorders. High numbers may be associated with fatty liver and arteriosclerosis; may indicate a need to (Fig. B) modify diet and increase exercise. Low numbers have not (Fig. C) shown any specific risk. PTGVLFi is a marker of impaired glucose tolerance (IGT) and microcirculation complications. Studies have shown very high correlation with OGTT. High numbers indicate a risk for diabetes. Low numbers have not shown any specific risk. (Fig. D) Insulin Resistance (IR) Markers: high numbers indicate need of weight optimization/diet modification; increases the risk for heart and metabolic disease; FM - indication of fat mass percentage (FM is only displayed in the diet section of the report) Stress I. - correlated to C Reactive Protein and is a marker of sympathetic failure; C Reactive Protein is produced by the liver and increases with inflammation. High numbers indicate a risk for heart disease. Low numbers have not shown any specific risk. Reference: A cross sectional assessment to detect type 2 diabetes with endothelial and autonomic nervous markers using a novel system - Journal of Diabetes and Metabolic Disorders - December 2014. 14 RM-3A SAS Guide

On this page, the software analyzes the pulse wave detected from the pulse oximeter. The software uses the PTG wave to assess the compliance of the arteries and possibilities of arterial stiffness or dysfunctional blood flow. This is an example of someone in abnormal range. Important markers are: RI (reflection index): small and medium arterial stiffness; marker of atherosclerosis Scoring system based on PTGi, PTGVLFi and PTGR markers. This score is a marker of endothelial function, blood flow and autonomic nervous system regulation. PTG type as shown is a useful marker to assess risk of coronary artery diseases. Endothelial Dysfunction Risk --- Based on clinical studies, SD Da is an indicator that correlates with angiotensin system level activity. High numbers are associated with increased angiotensin activity. This page also shows the risk for cardiovascular events by the calculations based on several markers: PTGi, PTGR, PTGVLFi, CVD score, respectively, along with the endothelial marker, blood flow marker, homeostasis marker and ANS marker. This page also shows Patients with high CAD risk should go under further CVD examinations. It is important to note that endothelial dysfunction is the earliest sign of CVD. Once endothelial dysfunction is identified, we can expect to see a NO production issue, decreased permeability to cholesterol, and stiffness of the artery wall over time. Reference: The spectral analysis of photoplethysmography to eveluate an independent cardiovascular risk factor - International Journal of General Medicine - Dovepress - December 2014. Reference: Correlation of HOMA2 and HbA1c with algorithms derived from Bio-impedance and spectrophotometric devices - Obesity Surgery Journal - December 2012. RM-3A SAS Guide 15

The software analyzes these various risk factors and markers of CAN: Sympathetic Response - SPRV2 is correlated with norepinephrine response. Low number may indicate orthostatic hypotension; high numbers indicate increased sympathetic response and release of norepinephrine (often associated with increased vascular constriction). SPRV 4 is correlated with epinephrine response. Low number may indicate orthostatic hypotension. High numbers indicate increased sympathetic response and released of epinephrine (often associated with increased cardiac output). DPRS reflects the sympathetic adrenergic response. High number may indicate orthostatic hypotension. Low numbers are considered normal. Parasympathetic Response - Vals.R reflects parasympathetic response. High score may indicate dysautonomia and/or vagal syndrome. K30:15 reflects parasympathetic response to change in posture. High score may indicate problems with autonomic nerve disorders (dysautonomic). E/I R reflects the parasympathetic response to a challenge. High number may indicate problem with autonomic nerve (dysautonomia). 16 RM-3A SAS Guide

Frequently Asked Questions Q. What if my reimbursement rate with a commercial carrier is too low? A. Check your signed contract with this carrier. Your contract should have come with a table of payable codes and the reimbursement amounts. You can try to renegotiate your contract. Q. What if Medicare denied the charges for not deemed a medical necessity? A. Review your diagnosis codes and ensure that the correct diagnosis codes are reporting to the correct CPT codes. Then appeal with your medical records that show medical necessity. Q. If Medicare denied CPT 95921 as being mutually inclusive of 95922, what can I do? A. CPT 95921 and 95922 are bundled codes. In order to unbundle the codes use a 59 modifier, distinct procedural service indicates two separate procedures performed on the same day by the same provider. Some states require that modifier 59 be placed on all testing codes. Please check with your state s payors to ensure their particular practices. Q. If Medicare does not pay the allowable for a code, the denial code is CO253. Can I bill the patient? A. Medicare did process the claim correctly; but because of the reduction in federal spending or sequestration, it is a mandatory 2% reduction on payment to all physicians. Unfortunately we cannot bill the patient for this. Q. What if we had to repeat a test on a patient. Can we bill for this? A. Yes you can. Affix the modifier 76 to the repeated test. Make sure that the reason is documented in the records for the repeat testing (borderline findings/critical tests negative). Q. Can we bill for an office visit? A. Yes! Make sure that a complete and thorough history and physical are done that is consistent with the patient s presenting complaints. RM-3A SAS Guide 17

Acronyms 18 RM-3A SAS Guide

Notes:

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