1. Experiences with Sacral Neuromodulation for Urinary Control

2. Agenda Prevalence & Impact of Overactive Bladder
InterStim Therapy for Urinary Control
Efficacy & Safety Information
Test Procedure & System Overview
Medtronic Support
Q&A

3. Overactive Bladder: Prevalence & Impact
OAB1
Asthma2
Diabetes3
Osteoporosis4
Alzheimer’s5
It is estimated that overactive bladder (OAB) affects more than 33 million people in the U.S.1
OAB is more prevalent than many well-known diseases.2-5
The total U.S. economic cost of OAB is $12.6 billion (year 2000 dollars).6
Overactive bladder affects more than 33 million people. As you can see by this picture, it is more prevalent than some other common conditions such as asthma, diabetes, osteoporosis, and Alzheimer’s.
The total economic cost was calculated to be more than $12 billion in the US for OAB alone.
1. Serels S. The wet patient: understanding patients with overactive bladder and incontinence. Curr Med Res Opin. 2004;20(6):
2. Centers for Disease Control and Prevention Website. Accessed October 18, 2010.
3. National Diabetes Information Clearinghouse Website. Accessed October 18, 2010.
4. National Osteoporosis Foundation Website. Accessed October 18, 2010.
5. Alzheimer’s Association Website. Accessed October 18, 2010.
6. Hu, TW et al. Costs of Urinary Incontinence and Overactive Bladder in the United States: A Comparative Study.j.urology.2003:10.037:

4. Patient Survey Data*
NAFC survey data found OAB patients seek treatment for the following reasons:
Frustration from living with the symptoms (78%)
Embarrassment (42%)
Physical discomfort (38%)
74% of surveyed OAB patients said they waited longer than they should have to seek treatment
Only 20% of surveyed OAB patients are extremely satisfied with their current treatment
* Source: Survey for the National Association for Continence (NAFC), sponsored by Medtronic, Inc. and conducted by Kelton Research. April The online survey was conducted using an invitation. Respondents were 611 nationally representative American women ages with overactive bladder.

5. Pharmacotherapy Persistence & Adherence
OAB medications in the California Medicaid Program1
77%
73%
82%
> 70% discontinuation of prescribed therapy within 6 months
> 80% discontinuation of prescribed therapy within 1 year
> 50% chose not to restart their therapy after discontinuation
Three major drugs were analyzed in a large retrospective study.
70% of patients discontinued their prescribed therapy within 6 months.
More than 50% chose not to restart therapy after discontinuation.
1. Yu YF, Nichol MB, Yu AP, et al. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Value in Health. 2005;8(4):

6. Pharmacotherapy Persistence & Adherence
OAB medications compared to those for several other chronic conditions
OAB
Medications
Prostaglandins
Analogs
(indicated for glaucoma)
Bisphosphonates
(osteoporosis)
Statins
(hyperlipidemia)
ARBs
(hypertension)
Oral antidiabetics
(Type II)
Persistent at 6 months
Persistent at 1 year
Only 28% of patients on OAB medications remained persistent at 6 months
Only 18% of patients on OAB medications remained persistent at 1 year
Patients were less likely to remain on OAB medications than on any other drug class assessed
1. Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009;15:

7. Discussion Slide
Do these adherence & persistence data reflect what you see in your practice?

8. InterStim Therapy for Urinary Control
An established therapy that expands your treatment options for patients with:
urge incontinence,
urgency-frequency and
non-obstructive urinary retention
who have failed or could not tolerate more conservative treatments.
More than 85,000 patients worldwide have received InterStim Therapy

9. InterStim Delivers Clinical Efficacy
12-month clinical success1
79% of urge incontinence patients achieved clinical success
• 45% remained completely dry
• An additional 34% experienced 50% reduction in leaking
64% of urgency-frequency patients achieved clinical success
• 31% returned to normal voids (4 to 7 voids/day)
• An additional 33% experienced 50% reduction in number of voids
Urge Incontinence (n=38)
Urgency- Frequency (n=33)
Urinary Retention (n=38)
77% of urinary retention patients achieved clinical success
1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.
• 61% eliminated use of catheters
• An additional 16% experienced 50% reduction in catheterized urine volume

10. Lasting Efficacy - Proven in a 5-year Clinical Trial
Urge Incontinence1
Evaluable Patients – the subset of subjects for whom both baseline and year data were available
Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline
59% of urge incontinent patients achieved  50% reduction in leaks/day*
71% of those urge incontinent patients who reported heavy leaks at baseline achieved  50% reduction in leaks per day†
* 59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96)
† 71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84)
1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.

11. Lasting Efficacy - Proven in a 5-year Clinical Trial
Urgency-Frequency1
Evaluable Patients – the subset of subjects for whom both baseline and year data were available
Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline
56% of urgency-frequency patients achieved 50% increase in volume voided/void and improved degree of urgency*
* 56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25)
1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.

12. Lasting Efficacy - Proven in a 5-year Clinical Trial
Urinary Retention1
Evaluable Patients – the subset of subjects for whom both baseline and year data were available
Intent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline
78% of urinary retention patients achieved  50% reduction in volume/catheterization*
* 78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31)
1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.

13. Adverse Events
The most common adverse events experienced during clinical studies included:
Pain at implant sites
New pain
Lead migration
Infection
Technical or device problems
Adverse change in bowel or voiding function
Undesirable stimulation or sensations
Any of these may require additional surgery or cause return of symptoms. For additional safety information, please refer to the Important Safety Information on the last slide of this presentation.

14. Discussion Slide
What level of efficacy do you look for when considering adoption of a new therapy?

15. Test for Potential Success
In-office Test
A temporary lead is placed during a simple in-office procedure and connected to an external stimulator
You and your patient assess therapy effects for 3-7 days
If successful, patient may proceed directly to long-term lead and device implant through an outpatient procedure
If test is inconclusive or unsuccessful, the staged test is recommended
For the test stimulation, a lead is placed near the sacral nerves, and the patient wears an external, programmable neurostimulator. To assess whether the therapy is successful, the patient records his or her voiding behavior in a diary.

16. Test for Potential Success
Staged Test
Utilizes a tined lead to reduce migration
Placed in the OR during an outpatient procedure
With successful test results, the lead remains in place and the device & lead extension (if applicable) are implanted
Complications can occur with the test procedure, including movement of the wire, technical problems with the device, and some temporary pain.

17. Complete InterStim System
Tined lead is placed parallel to the sacral (S2, S3, or S4) nerve.
Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes.
Clinician and patient programmers are used to set the parameters of the electrical pulses. 3 2 2
The InterStim or InterStim II INS. The InterStim II INS is shown with the InterStim Tined Lead Model 3093.
The InterStim iCon® patient programmer Model 3037 supports both the InterStim and InterStim II INS devices with identical features.
With the Version B clinician programmer software, the N’Vision® clinician programmer can be used to program the InterStim II INS Model 3058 and the InterStim INS.
Please note both InterStim II (3058) and InterStim stimulators (3023) are shown, and 3023 requires an extension. 1

18. The Pelvic Floor
S3, the most distal common point of innervation for the bladder
InterStim Therapy stimulates S3 or S4

19. Evaluating for InterStim: Treatment Algorithm
Urge Incontinence & Urgency-Frequency
Initial Screening
Voiding Diary
Urodynamic
Work-up
Behavioral Techniques
Interventional Techniques
Medications - +
Continue as
Appropriate
InterStim Therapy
Test Stimulation

20. Evaluating for InterStim: Treatment Algorithm
Urinary Retention
Initial Screening
Voiding Diary
Urodynamic
Work-up
Rule Out Obstruction
Medications and/or
Catheterization - +
Continue as
Appropriate
InterStim Therapy
Test Stimulation

21. Discussion Slide
Do you believe your patients would be willing to try the temporary test procedure even if they feel unsure about the idea of the long-term implant?

22. Coverage for InterStim Therapy
The coverage profile for sacral nerve stimulation is strong:
Medicare National Coverage Determination
Medicare Local Coverage Determinations (many retired)
Most commercial payers have coverage policies in place
Common diagnoses include:
Retention of urine, unspecified
Incomplete bladder emptying
Other specified retention of urine
Urge incontinence
Urinary frequency
InterStim Therapy has established physician and facility coding. In terms of the outpatient facility payment method, the Ambulatory Payment Classification system, the devices are covered by the amounts the hospital receives.
Specifically for a physician in the office, a payment of $1,068 is received for an in-office (non-facility) percutaneous test. The American Medical Association has recently communicated that when physicians place two percutaneous leads, the second lead is reimbursed at 50%. (All amounts are national averages.)
Medtronic provides this information for your convenience only. It is not intended as a recommendation regarding clinical practice. It is always the provider’s responsibility to determine coverage and submit appropriate codes, modifiers, and charges for the services that were rendered. This document provides assistance for FDA approved or cleared indications. Where reimbursement is requested for a use of a product that may be inconsistent with, or not expressly specified in, the FDA cleared or approved labeling (e.g., instructions for use, operator’s manual or package insert) consult with your billing advisors or payers for advice on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related service. Contact your Medicare contractor or other payer for interpretation of coverage, coding, and payment policies.

23. Coding: CPT*
Unique codes included on the 2010 Medicare Physician Fee Schedule for placement of electrodes on the sacral nerve:
CPT 64561: Percutaneous implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) (2010 Medicare Physician Payment National Average: Non Facility Setting: $1,046/Facility Setting: $417)
CPT 64581: Incision for implantation of of neurostimulator electrodes; sacral nerve (transforaminal placement) (2010 Medicare Physician Payment National Average: Facility Setting: $826)
CPT 64590: Insertion or replacement of peripheral neurostimulator pulse generator or receiver, direct or inductive coupling (2010 Medicare Physician Payment National Average: Facility Setting: $177)
CPT 95972: Complex spinal cord or peripheral (except cranial nerve) neurostimulator pulse generator transmitter with intraoperative or subsequent reprogramming, first hour (2010 Medicare Physician Payment National Average: Non Facility Setting: $108/Facility Setting: $79)
*CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT) is a copyright 2009 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.
Medicare payment is determined by multiplying the sum of the three RVUs (work, practice expense and malpractice) by the conversion factor. The conversion factor for CY 2010 is $ On June 25, 2010 the President signed into law HR This provides a 2.2% increase to the Physician Medicare Fee Schedule from June 1, 2010 through November 30, The bill may be found at: National average Medicare rates are shown here. Also note that any applicable coinsurance, deductible, and other amounts that are patient obligations are included in the payment amount shown. Multiple surgical procedure reductions may apply and are not calculated here.
In addition to the outpatient hospital setting, the ambulatory surgery center (ASC) in also a potential setting for tests and implants.

24. Medtronic Reimbursement Resources
Medtronic has resources available to assist your practice with coding and reimbursement considerations:
Field Based Health Economics Managers (available for coding and reimbursement education, claims reviews, appeal assistance, meetings with facilities, etc.)
Coding Sheets (Procedural and Diagnosis)
Financial/Coding Models
Dictation Guides
Prior Authorization Guides and Sample Letters of Medical Necessity

25. Additional Resources for Physicians
Training & Education
Patient Awareness & Education Resources
Therapy Integration Consultation

26. Summary
The condition of OAB is common and persistence and adherence with medication therapy is suboptimal
InterStim is an established therapy with proven long-term clinical efficacy
A simple test procedure initiated in the office helps determine whether InterStim Therapy may help restore control over symptoms
Reimbursement for InterStim is generally favorable
Medtronic offers comprehensive support

27. Important Safety Information
InterStim® Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Contraindications: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
Precautions/Adverse Events:
Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins such as multiple sclerosis. The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. For full prescribing information, please call Medtronic at and/or consult Medtronic’s website at Product technical manual must be reviewed prior to use for detailed disclosure.
USA Rx Only. Rev 0409
Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

28. Questions? To take the next step:
Contact your local Medtronic Representative or
Call the clinician services line: