Sudoscan An Overview

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Objectives

1. What is SUDOSCAN2. How does SUDOSCAN work3. Benefits of utilizing SUDOSCAN4. American Diabetes Association Screening Mandate5. Billing and Reimbursement6. Next Steps

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SUDOSCAN in clinical practice

• A critical tool in the era moving more to preventive medicine• Regular AN screening is now mandated by the ADA in the DM

population• SUDOSCAN is the easiest, most practical tool for AN screening in ANY

patient population• Diabetic peripheral neuropathies are among the most frequent

complications of diabetes mellitus, affecting up to 70% of patients over a lifetime.

• Diabetic sensorimotor polyneuropathy is insidious and up to 50% of patients with neuropathy may be asymptomatic

• An objective assessment in cases of unclear neuropathy• Patients with no clinical exam abnormalities complaining of severe

pain or burning

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How does SUDOSCAN work?SUDOSCAN is an innovative technology used to assess sudomotor function and how it

relates to peripheral autonomic neuropathies

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A non-invasive device which quickly assesses sudomotor (sweat gland) function via Reverse Iontophoresis and Chronoamperometry

Sudomotor function is used as a marker for small fiber peripheral neuropathy

Abnormal sweat response is often associated with populations at risk for diabetes

What is SUDOSCAN?

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•No Patient preparation•Easy to use•Fast•Immediate results•Quantitative•Reproducible

Benefits of Sudoscan

There is currently no other tool on the market that is as easy to use, as fast and clinically proven to be as accurate as Sudoscan to test for:

a. Initial evaluation of autonomic neuropathy/autonomic symptoms

b. Evaluation of peripheral small fiber neuropathy, especially painful peripheral neuropathy

There is currently no other sudomotor function test on the market that is as cost-effective as Sudoscan while also rigorously clinically proven to be medically accurate

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Why Test Sweat Gland Function?

• Sweat glands are innervated by long and small sympathetic C-fibers within the peripheral nervous system. Sweat dysfunction can be one of the earliest detectable neurophysiologic abnormalities in small fiber neuropathies

• The bottom line: Structure and Function

• Sweat glands don’t just decide independently to produce sweat; they are each attached to a nerve ending which commands them. If sweat glands don’t sweat correctly, there’s something wrong with the nerves controlling them

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Sudorimetry

• Measuring sweat gland function as a biomarker for ANS function

• Sympathetic innervation• Thin, unmyelinated C-fibers: no

protective coating – easily damaged

• Long: from spine to soles of feet: sensitive to length-dependent damage (dying back disorders)

• Therefore sweat dysfunction will be the first detectable damage to the small fibers of the peripheral nervous system – BEFORE ANY CLINICAL SIGNS OR SYMPTOMS

Illigens et al. Clin Auton Res 2009

What is SUDOSCAN used for?• Screening for AN:

• Per ADA Position Statements 2012 & 2013• At the time of diagnosis for T2DM, 5 years after diagnosis for T1DM (earlier if

high risk)• Elicit autonomic dysfunction history

• Symptomatic patients: orthostatic hypotension, exercise intolerance, nocturnal diarrhea, bladder dysfunction, gastroparesis, hyperhidrosis, ED

• Suggestive medical history: alcoholism, hypothyroidism, neurotoxic meds, Vitamin B12 deficiency, autoimmune disease

• Response of AN to intervention:• Damage to small nerve fibers is reversible, unlike most damage to large

myelinated fibers• AN may be asymptomatic – but if detected early by SUDOSCAN, you can

measure any improvement or worsening from a change in treatment

• Prevention of complications:• Early screening and regular follow-up of AN with a simple test like SUDOSCAN

can lead to referral for cardiac autonomic neuropathy assessment before a sudden death ensues

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SUDOSCAN and peripheral neuropathy• Distal symmetrical polyneuropathy (DSP) is

the most common complication of diabetes, affecting 50 to 90% of patients

• Many are asymptomatic; almost 30% have painful symptoms

• About 15% of diabetic patients will develop a foot ulcer, 1 in 6 will need an amputation

• Ulcer = 45% risk of death in the next 5 years• DSP usually affects both sensory and motor

nerves, with small nerve fibers in the feet being damaged first

• Many peripheral small fiber neuropathies present with pain/burning, are idiopathic, and have no clinical abnormalities

• SUDOSCAN may detect early DSP or small fiber neuropathy before any other signs or symptoms

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How do you select patients for Sudoscan?

• All DM patients at least yearly• Monitoring of autonomic neuropathy

• Monitoring for compliance• Visual objective evidence of compliance with exercise, diet, glucose

control• Patients with unexplained pain in the feet or hands

• Is it a small fiber neuropathy?• Patients with autonomic symptoms

• Is the dizziness from autonomic dysfunction and does the patient need to see a cardiologist?

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Sudoscan Result

Radar Views

Patient info

Symmetry

Quantitative

Reimbursement

• Our current CPT code is 95923: “Testing of autonomic nervous system function; sudomotor, including one or more of the following: quantitative sudomotor axon reflex test (QSART), silastic sweat imprint, thermoregulatory sweat test, and changes in sympathetic skin potential”

• Sympathetic skin potential is the old term for galvanic skin response

• Therefore ALL devices listed under GSR can use this CPT code for reimbursement

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Reimbursement• “Suggested” ICD-9 codes for 95923• The ICD-9 is the responsibility of the physician• We are actively preparing suggested ICD-10 codes for

our customers

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Reimbursement

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LEGEND: Data Input (assumptions) Fields

Spreadsheet calculations

Straight Purchase

reimbursement per patient per test $200 $200

cost of Sudoscan instrumentation $35,000 $35,000

number of patients per day 2 6

working days per month 21 21

staff assistant annual salary $0 $0

minutes per patient cycle (**Actual test takes 3-5 min) 15 15

consumables per test $20 $20

gross margin per test $180 $180

net revenues per month $7,560 $22,680

net revenues per year $90,720 $272,160

number of months to breakeven 4.6 1.5

TestingHow often can Sudoscan testing be performed on a patient and still be reimbursed?•There is no officially prescribed interval between 2 scans•For the diabetic population, the ADA guidelines (2012, 2013) state the following:

• All diabetics should be monitored for autonomic neuropathy at least yearly

•Autonomic nerves recover function, and their speed of regeneration can help define scanning intervals:

• Autonomic nerves recover function in 30 days after damage from capsaicin in healthy individuals

• Autonomic nerves recover structural integrity in 58 days after capsaicin application in healthy individuals

• Nerve regeneration in diabetic and neuropathic patients may be somewhat slower than the timelines determined in healthy subjects

•The bottom line is that retesting can be performed at 90 day intervals if:• An intervention/change in therapy has been implemented• Medical necessity (a change in patient status) mandates retesting

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The Specialties

• Clinicians most likely to need a Sudoscan include:• Those with a large diabetes patient population

• GPs and Endocrinologists

• Those who see idiopathic and small fiber neuropathies

• Neurologists, PM&R, pain clinics

• Those who see patients for autonomic neuropathy• GPs, cardiologists

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General Practice and Internal Medicine

• Uses of Sudoscan in their practice• Initial evaluation and follow-up of peripheral pain syndrome • Initial evaluation and follow-up of autonomic symptoms (orthostatic

hypotension, gastroparesis, exercise intolerance, etc) • Early detection and follow-up of autonomic and peripheral neuropathy in

diabetic patients; aid in determining need for in-depth work-up• Detection of patients with dysglycemia/metabolic syndrome based on

peripheral neuropathy symptoms; follow-up after intervention• Recommended articles

• Neurovascular function and Sudorimetry in Health and Disease. A.I. Vinik, M. Nevoret, C. Cassellini, H. Parson. Curr Diab Rep. 2013 Aug;13(4):517-32.

• Vinik AI, Maser RE, Ziegler D. Neuropathy: the crystal ball for cardiovascular disease? Diabetes Care. 2010 Jul;33(7):1688-90.

• Eranki VG, Santosh R, Rajitha K, Pillai A, Sowmya P, Dupin J, Calvet JH. Sudomotor function assessment as a screening tool for microvascular complications in type 2 diabetes. Diabetes Res Clin Pract. 2013 Jul 20. pii: S0168-8227(13)00242-8.

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Endocrinology• Uses of Sudoscan in their practice

• Follow-up autonomic and peripheral neuropathy in diabetic patients, especially response to therapeutic intervention. Decision for referral to neurology or cardiology

• Recommended articles• Casellini CM, Parson HK, Richardson MS, Nevoret M, Vinik AI. Sudoscan, a Noninvasive Tool for Detecting

Diabetic Small Fiber Neuropathy and Autonomic Dysfunction. Diabetes Technol Ther. 2013;15(11)• Smith et al. SUDOSCAN as a Diagnostic Tool for Peripheral Neuropathy. Poster presentation at Peripheral

Nerve Society. Jun-Jul 2013. Saint-Malo (France). • Calvet JH, Dupin J, Winiecki H, Schwarz PE. Assessment of small fiber neuropathy through a quick, simple and

non invasive method in a German diabetes outpatient clinic. Exp Clin Endocrinol Diabetes. 2013 Feb;121(2):80-3.

• Calvet JH, Dupin J, Deslypere JP. Screening of Cardiovascular Autonomic Neuropathy in Patients with Diabetes by Quick and Simple Assessment of Sudomotor Function. J Diabetes Metab. 2012;3:192.

• A new tool to detect kidney disease in Chinese type 2 diabetes patients—comparison of EZSCAN with standard screening methods. R. Ozaki, KKT Cheung, E. Wu, A. Kong, X. Yang, E. Lau, P. Brunswick, JH. Calvet, JP. Deslypere, JCN. Chan. Diabetes technology & therapeutics. 2011;13(9):937-43.

• Vinik AI, Maser RE, Ziegler D. Neuropathy: the crystal ball for cardiovascular disease? Diabetes Care. 2010 Jul;33(7):1688-90.

• Freedman BI, Bowden DW, Smith SC, Xu J, Divers J. Relationships between electrochemical skin conductance and kidney disease in Type 2 diabetes. J Diabetes Complications. 2013 Oct 16. pii: S1056-8727(13)00209-2.

• Eranki VG, Santosh R, Rajitha K, Pillai A, Sowmya P, Dupin J, Calvet JH. Sudomotor function assessment as a screening tool for microvascular complications in type 2 diabetes. Diabetes Res Clin Pract. 2013 Jul 20. pii: S0168-8227(13)00242-8.

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Neurology• Uses of Sudoscan in their practice

• Investigation and follow-up of painful, suspected small fiber, or autonomic neuropathy

• Investigation and follow-up of any other unusual neuropathy when nerve conduction study is inconclusive

• Recommended Articles• Therapath Explanation• Neurovascular function and Sudorimetry in Health and Disease. A.I. Vinik, M.

Nevoret, C. Cassellini, H. Parson. Curr Diab Rep. 2013 Aug;13(4):517-32.• Smith et al. SUDOSCAN as a Diagnostic Tool for Peripheral Neuropathy. Poster

presentation at Peripheral Nerve Society. Jun-Jul 2013. Saint-Malo (France). • Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a

Noninvasive Tool for Detecting Diabetic Small Fiber Neuropathy and Autonomic Dysfunction. Diabetes Technol Ther. 2013;15(11)

• Quick and simple evaluation of sudomotor function for screening of diabetic neuropathy. CS. Yajnik, V. Kantikar, AJ. Pande, JP. Deslypere. ISRN Endocrinology. doi:10.5402/2012/103714.

• Non invasive and quantitative assessment of sudomotor function for peripheral diabetic neuropathy evaluation. H. Gin, R. Baudouin, C. Raffaitin, V. Rigalleau, C. Gonzalez. Diabetes & Metabolism. 2011;11(6):527-32.

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Cardiology• Uses of Sudoscan in their practice

• Initial evaluation for cardiac autonomic neuropathy in a symptomatic patient

• Follow-up of its progression after therapeutic intervention• Recommended articles

• Screening of cardiovascular autonomic neuropathy in patients with diabetes using non-invasive quick and simple assessment of sudomotor function. C.S. Yajnik, V. Kantikar, A. Pande, J.-P. Deslypere, J. Dupin, JH. Calvet, B. Bauduceau. Diabetes & Metabolism. In press.

• Calvet JH, Dupin J, Deslypere JP. Screening of Cardiovascular Autonomic Neuropathy in Patients with Diabetes by Quick and Simple Assessment of Sudomotor Function. J Diabetes Metab. 2012;3:192.

• Pavy-Le Traon A, Mouly C, Gerdelat A, Calvet JH, Hanaire H, Senard JM. Comparison of Sudoscan and cardiovascular testing for assessment of cardiovascular autonomic neuropathy. Poster presentation at Neurodiab. Sep 2013. Barcelona (Spain).

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PM&R• Uses of Sudoscan in their practice

• Initial evaluation and follow-up of peripheral pain syndromes • Investigation of autonomic symptoms (orthostatic hypotension,

gastroparesis, exercise intolerance, etc) and follow-up after intervention

• Recommended articles• Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI.

Sudoscan, a Noninvasive Tool for Detecting Diabetic Small Fiber Neuropathy and Autonomic Dysfunction. Diabetes Technol Ther. 2013;15(11)

• Smith et al. SUDOSCAN as a Diagnostic Tool for Peripheral Neuropathy. Poster presentation at Peripheral Nerve Society. Jun-Jul 2013. Saint-Malo (France).

• Therapath Explanation• Calvet JH, Dupin J, Deslypere JP. Screening of Cardiovascular

Autonomic Neuropathy in Patients with Diabetes by Quick and Simple Assessment of Sudomotor Function. J Diabetes Metab. 2012;3:192.

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Pain Clinics

• Uses of Sudoscan in their practice• Evaluation and follow-up of suspected small fiber or painful

neuropathy • Identification of small fiber neuropathy in patients with various

indeterminate peripheral pain syndromes (e.g. fibromyalgia)• Recommended articles

• Casellini CM, Parson HK, Richardson MS, Névoret ML, Vinik AI. Sudoscan, a Noninvasive Tool for Detecting Diabetic Small Fiber Neuropathy and Autonomic Dysfunction. Diabetes Technol Ther. 2013;15(11)

• Smith et al. SUDOSCAN as a Diagnostic Tool for Peripheral Neuropathy. Poster presentation at Peripheral Nerve Society. Jun-Jul 2013. Saint-Malo (France).

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