Presentation on theme: "Experiences with Sacral Neuromodulation for Urinary Control"— Presentation transcript:
1Experiences with Sacral Neuromodulation for Urinary Control
2Agenda Prevalence & Impact of Overactive Bladder InterStim Therapy for Urinary ControlEfficacy & Safety InformationTest Procedure & System OverviewMedtronic SupportQ&A
3Overactive Bladder: Prevalence & Impact OAB1Asthma2Diabetes3Osteoporosis4Alzheimer’s5It is estimated that overactive bladder (OAB) affects more than 33 million people in the U.S.1OAB is more prevalent than many well-known diseases.2-5The total U.S. economic cost of OAB is $12.6 billion (year 2000 dollars).6Overactive 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:
4Patient 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 treatmentOnly 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.
5Pharmacotherapy Persistence & Adherence OAB medications in the California Medicaid Program177%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 discontinuationThree 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):
6Pharmacotherapy Persistence & Adherence OAB medications compared to those for several other chronic conditionsOABMedicationsProstaglandinsAnalogs(indicated for glaucoma)Bisphosphonates(osteoporosis)Statins(hyperlipidemia)ARBs(hypertension)Oral antidiabetics(Type II)Persistent at 6 monthsPersistent at 1 yearOnly 28% of patients on OAB medications remained persistent at 6 monthsOnly 18% of patients on OAB medications remained persistent at 1 yearPatients were less likely to remain on OAB medications than on any other drug class assessed1. 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:
7Discussion SlideDo these adherence & persistence data reflect what you see in your practice?
8InterStim Therapy for Urinary Control An established therapy that expands your treatment options for patients with:urge incontinence,urgency-frequency andnon-obstructive urinary retentionwho have failed or could not tolerate more conservative treatments.More than 85,000 patients worldwide have received InterStim Therapy
9InterStim Delivers Clinical Efficacy 12-month clinical success179% of urge incontinence patients achieved clinical success• 45% remained completely dry• An additional 34% experienced 50% reduction in leaking64% 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 voidsUrge Incontinence (n=38)Urgency- Frequency (n=33)Urinary Retention (n=38)77% of urinary retention patients achieved clinical success1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.• 61% eliminated use of catheters• An additional 16% experienced 50% reduction in catheterized urine volume
10Lasting Efficacy - Proven in a 5-year Clinical Trial Urge Incontinence1Evaluable Patients – the subset of subjects for whom both baseline and year data were availableIntent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline59% 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.
11Lasting Efficacy - Proven in a 5-year Clinical Trial Urgency-Frequency1Evaluable Patients – the subset of subjects for whom both baseline and year data were availableIntent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline56% 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.
12Lasting Efficacy - Proven in a 5-year Clinical Trial Urinary Retention1Evaluable Patients – the subset of subjects for whom both baseline and year data were availableIntent-to-Treat Patients – all implanted subjects, including those who dropped out and were imputed as no change from baseline78% 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.
13Adverse EventsThe most common adverse events experienced during clinical studies included:Pain at implant sitesNew painLead migrationInfectionTechnical or device problemsAdverse change in bowel or voiding functionUndesirable stimulation or sensationsAny 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.
14Discussion SlideWhat level of efficacy do you look for when considering adoption of a new therapy?
15Test for Potential Success In-office TestA temporary lead is placed during a simple in-office procedure and connected to an external stimulatorYou and your patient assess therapy effects for 3-7 daysIf successful, patient may proceed directly to long-term lead and device implant through an outpatient procedureIf test is inconclusive or unsuccessful, the staged test is recommendedFor 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.
16Test for Potential Success Staged TestUtilizes a tined lead to reduce migrationPlaced in the OR during an outpatient procedureWith successful test results, the lead remains in place and the device & lead extension (if applicable) are implantedComplications can occur with the test procedure, including movement of the wire, technical problems with the device, and some temporary pain.
17Complete 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.322The 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
18The Pelvic FloorS3, the most distal common point of innervation for the bladderInterStim Therapy stimulates S3 or S4
20Evaluating for InterStim: Treatment Algorithm Urinary RetentionInitial ScreeningVoiding DiaryUrodynamicWork-upRule Out ObstructionMedications and/orCatheterization-+Continue asAppropriateInterStim TherapyTest Stimulation
21Discussion SlideDo 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?
22Coverage for InterStim Therapy The coverage profile for sacral nerve stimulation is strong:Medicare National Coverage DeterminationMedicare Local Coverage Determinations (many retired)Most commercial payers have coverage policies in placeCommon diagnoses include:Retention of urine, unspecifiedIncomplete bladder emptyingOther specified retention of urineUrge incontinenceUrinary frequencyInterStim 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.
23Coding: 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.
24Medtronic 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 ModelsDictation GuidesPrior Authorization Guides and Sample Letters of Medical Necessity
25Additional Resources for Physicians Training & EducationPatient Awareness & Education ResourcesTherapy Integration Consultation
26SummaryThe condition of OAB is common and persistence and adherence with medication therapy is suboptimalInterStim is an established therapy with proven long-term clinical efficacyA simple test procedure initiated in the office helps determine whether InterStim Therapy may help restore control over symptomsReimbursement for InterStim is generally favorableMedtronic offers comprehensive support
27Important 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 0409Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
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