2. Neuromodulation and Private Practice: not an oxymoron Mark Gudesblatt MD South Shore Neurologic Associates Suffolk County, Long Island, New York

3.  Know your diseases  Know your options both as a clinician and as a patient  Know your therapies  Be the best you can, always give your best effort  An uninformed advocate is not an effective advocate  Neuromodulation: The best therapies that no one has ever heard of  Lack of awareness of treatment options is not the same as lack of efficacy  A treatment not utilized is a treatment not effective  Not all treatments are appropriate for all patients  Not all treatments produce desired outcomes Summary for those who are hungry, like to read the end of the story first or leave early …

4.  “It’s hard to make predictions, especially about the future.” Yogi Berra The Challenge of Predicting Prognosis, Treatment needs and response, and Disease Progression

5. Classic Education, Traditional Care  Who are you as a clinician?  Who do you want to be as a clinician?  How do you get from where you are to where you might want to be?  “The times they are a changing…”  Concurrent & simultaneous evolution and revolution

6. Neurology, Therapeutics, & The Concept of Actually Offering Treatment: Oxymoron? Appreciation that the disease or symptoms are truly a problem for the patient Accurate and comprehensive analysis of the problem or problems reported Diagnosis of the disease problem followed by an actual interest and intent to treat Identification of the issues that have a potential treatment and need to treat Intention to treat followed by action and actual treatment Treatment & Intervention followed by ongoing care, monitoring and management  Not diagnose and adios

7.  What Neuromodulation therapies are available?  Are Neuromodulation therapies effective? No therapy is effective for all patients Goal setting: appropriate, realistic, mutually agreed upon Inappropriate or unrealistic goals can lead to dissatisfaction and apparent therapy failure  Why offer Neuromodulation in general or private practice? Why not?  Which Neuromodulation Therapy to offer in practice? Neuro What?

8. The first Neuromodulation clinical trial

9.  Why should these therapies be utilized?  Why should I do this?  Why shouldn't i do this?  How can I offer these treatments?  Why don’t others offer these treatments?  Which one(s) should I be involved with? The Problem

10. The North American Neuromodulation Society

14. Why is it a problem?  Lack of awareness at multiple levels  Patient, family, caregiver, and staff fear  Lack of knowledgeable advocacy of available effective treatment  Lack of comfort for patient, caregiver, and clinician in utilizing “novel therapies” ITB therapy gained U.S. Food and Drug Administration (FDA) approval for managing severe spasticity of spinal origin in 1992 ITB therapy gained U.S. Food and Drug Administration (FDA) approval for managing severe spasticity of cerebral origin in 1996 The (FDA) approved DBS as a treatment for Essential Tremor in 1997, for Parkinson’s Disease in 2002, and Dystonia in 2003  Physician fear and limited training in these therapies Medical School, Residency, Fellowship, Post-graduate CME  Lack of exposure

15.  Making the jump from diagnosing and implementation of standard neurological care models to awareness, offering and implementing available and effective or evolving therapies that have developed in the past 25 years can be a difficult transition.  Hakuna Matata – “change can be difficult” - Rafiki

16. The Challenge of Fear  Address issues of fear  Address issues of uncertainty  Address issues of concern  Address issues that arise  Address lack of awareness  Address misconceptions  Address lack of exposure With apologies to the movie

17.  Offering effective therapies often times requires more than just treatments administered orally.  To adequately and effectively address symptoms and to treat disease progression from some neurological disorders treatment requirements might include: Parenteral or intravenous treatments Intrathecal delivery of medication Neuromodulation interventions.

19. Offering Hope can be contagious  Is an effective clinician something more than just a diagnostician?  Are you just a diagnostician or a clinician who will not only diagnose but manage the neurological disorder?  Are you a clinician that will only go so far in the care of your patients?  What is the role of advocacy in neurological care?  What is the role of objective analysis?

20.  Effective disease management might require more than just standard traditional evaluations, treatments and interventions.  A comprehensive armamentarium of treatment opportunities offer more hope and options for effective and satisfying care than does limited choices or options.  As diseases evolve or progress treatment decisions and treatment requirement may become more complex.  Are you interested and ready to offer treatments that can be effective, dramatic and satisfying if they require more time, effort, and involvement beyond a prescription or a brief discussion?  What is comprehensive care?

21. Flexibility is the name of the game

22. What is in a name, anyway?  Evaluating care needs goes beyond a diagnosis or a disease name.  Disease management requires addressing not only the underlying disorder but as many of the concurrent associated symptoms or problems as possible.  These symptoms or problems may evolve or appear over time despite adequate use or adjustment of first line standard or conventional treatments.

23. Parkinson’s Disease: What is in a name? Treatment Plan Co-morbidities or …Spectrum of disease Autonomic BP lability Tremor vs. Akinetic Rigid Freezing of Gait Cognition Memory Executive Function Information Processing Attention Apathy Psychiatric Anxiety-depression OCD-gambling Panic Sleep Disorders Apnea RLS/PLMS REM Sleep Behavioral Disorder Fall Risk Autonomic GI Motility Balance Vestibular Fatigue Dystonia Dyskinesia

24.  As diseases evolve or progress treatment decisions and treatment requirement may become more complex.  Patient needs may change over time.  What is a significant change or threshold of change that needs to be addressed?  Are you interested and ready to offer treatments that can be effective, dramatic and satisfying if they require more time, effort, and involvement beyond a prescription or a brief discussion?

25. Challenging Neurological Disorders may require adjunct use of novel technology or treatment  Identifying Appropriate Candidates or people in need who can benefit from neuromodulation They are really just all around …. Open your eyes Look, listen, question Just ask – be proactive Educate others Don’t be afraid to advocate or discuss options

26.  Effective disease management might require more than just standard traditional evaluations, treatments and interventions or oral medications.  Effective evaluations and treatments of complex and evolving or progressing neurological disorders might require an arsenal of analysis, documentation, and treatment methods and tools.  Objective documentation of change is better than a subjective report  A comprehensive armamentarium of treatment opportunities offer more hope and options for effective and satisfying care than does limited choices or options.

27. The Challenge of Patient Selection  Successful patient selection simply starts with awareness of therapeutic options  Awareness starts with education, hope, proactive concern and communication as well as elimination of the concept of therapeutic nihilism.  Demystification of “Neuro-mythology” lack of effective and available treatment options.  Be proactive, be involved ITB

28. “The more convincing you have to do to get a patient to undergo a screening test, the less likely the patient is to be satisfied with the outcome.” Janet Gianino, R.N., M.S.N. Rush-Presbyterian-St. Luke’s Medical Center, Chicago No matter what the therapy is….

29.  Treatment team must continuously work closely with patients, families/caregivers to establish functional goals tailored to the patients level of disability and reinforce them post-implant  Goals should be realistic, reasonable, explicit, mutually agreed upon, collective, and established prior to intervention  Patience is needed to achieve goals  Unstated and/or unrealistic expectations and impatience can lead to disappointment and perceptions of treatment failure  Communication is key  It is not the speed of adjustment or reprogramming but achieving the goals desired The Challenge of Effective Communication

30. Communication is a 2 way street

31. Patience, Patient, Patients  The challenge of being a patient, encouraging, proactive advocate, communicator and clinician  The challenge of being a reasonable, reliable, responsible, and patient patient  The challenge of being a reasonable, reliable, responsible, and patient caregiver  Put yourself in someone else’s shoes  Let the patient and family/care-giver be your guide  Let the clinician be your guide  Opportunities for trust and cooperation are all around  Make allies not enemies

32.  Program development is a process  Evolution takes time (just ask Darwin) The “what is needed or not” changes with time, clinical experience, and patient needs  Treatment or therapeutic interventions require modification over time to address patient needs that "appear" or develop  Experience and awareness of what is needed for effective & satisfying implementation develops over time A vision for a Neuromodulation center or team is modified and achieved over time

33. agree disagree referral Clinic SSNA identify appropriate candidate Specialty Consult regarding candidacy Pre-implant testing Surgical implant post-implant Initial Programming establish plan of care, communicate Ongoing local Care reprogamming Rehab One practice practical approach

34. Teamwork and Communication are key  Can comprehensive care be delivered in isolation by one clinician?  Experienced Implanter and Team Deciding on roles for MD, NP, PA and RN partners in care: what are the personalities and work relationship of team members...  Effective ongoing communication  In-Network insurance coverage  Follow plan of care  Co-management with seamless cooperation and communication offers better care opportunities and all providers have improved satisfaction and likely improved outcomes What can you do to improve care efficacy & efficiency?  Trouble shooting

35. One Example: The Challenge of An Effective ITB Trial  Goal setting prior to ITB trial  Mutually agreed upon, appropriate, collective, realistically obtainable goals  Choosing dose to administer  Outcome goals to be measured at ITB trial  Allaying patient & care-giver fear of test dose  Educating regarding effective spasticity management

36. Goals of ITB Therapy Predictable  Reduce tone in extremities  Reduce spasms in extremities or trunk  Control clonus in extremities  Reduce spasticity-related pain  Improve sleep  Reduce side effects of oral antispasmodic medications  Improve quality of life  Ease care giving tasks, performance of hygiene, dressing, bathing  Ease positioning in wheelchair Unpredictable  Improve quality of gait  Reduce spasticity-related pain with ambulation  Increase independence in transfers  Increase upper extremity control and function  Improve bladder and bowel function  Reduce incidence of skin breakdown  Improve oral motor control and vocal cord dysfunction Barbara Ridley, Patrice Korth Rawlins, Intrathecal Baclofen Therapy: Ten Steps Toward Best Practice. Journal of Neuroscience Nursing, April 2006 Volume 38, Number 2

37. Potential Goals: keep it simple ITB goals ITB

38.  Goals must be: Reasonable, realistic, mutually agreed upon  Not all goals identified and planned for might be achieved  Goal setting can be modified ongoing or after implementation of neuromodulation  Feedback from patient, care-giver, staff, therapist is important  Communication to set or change goals  Clinician: Let the patient, family, caregiver be your guide  Patient/Family: Let the clinician be your guide  Put yourself in someone else’s shoes  Opportunities for trust, communication and cooperation are everywhere, and must be identified and pursued

39. Experience does count: if I can do this so can you. Learning from each exposure leads to experience

40. Practice Does Improve Clinician Confidence & Performance Neuromodulation DBS Implant

41. Roles constantly change and evolve  MD ITB involvement >15 years, >250 active ITB pumps, >350 ITB trials  MD initially - initial evaluation, trial, post trial review, post implant adjust, refills & adjustment, house calls  NP involvement – teamwork and close involvement >10 years with ongoing collective discussions and co- management  MD or NP currently does initial spasticity evaluation; trial done together (MD does LP and injection), post ITB trial review and initiation of plan of care (NP), post implant adjustment & refills (NP), trouble shooting with catheter line check (NP)

42. “We need a plan.”

43.  Effective treatment is often not accomplished in a single office visit. Not all issues can be addressed in one visit  Effective treatments require consideration, communication, thought, comprehensive care, ongoing care, feedback and concerned proactive management. Did it work out for you or not?  What is comprehensive care?  What is the standard of care?  Are all current care guidelines appropriate and up to date?

44.  Therapy availability, access, implementation and ongoing management and adjustment should be seamless. Know your resources Teamwork  Promote ease of access and community awareness  Continuity of providers and communication offers an effective avenue and opportunity for satisfying care delivery and collaboration

45. Post-implant Plan of Care Reassess adjunctive therapies Modify procedure/dose Reevaluate patient selection/goals Yes No Continuous reevaluation at follow-up to review – treatment strategy – Reassessment of adjunctive therapies Brin MF et al. Muscle Nerve. 1997;20(suppl 6):S208-S220. Review outcomes: Were functional objectives met? Physician extenders can help coordinate and effectively implement the plan of care

46. The Challenge of Individualization of any Neuromodulation Therapy  Post implant management is not just about dose adjustments, refills, or change in stimulator settings  Individualized dosing patterns and speed of titration or adjustment that enhance patient satisfaction and outcomes should be used  Neuromodulation is a program, not simply just a procedure

47. The Challenge of Setting Appropriate & Effective Goals Post Implant  Improve ease of care & comfort  Improve function and or independence  Prevent deformity or contracture  Pick another goal  Clarify expectations  Realistic and individualized for each patient  Commitment, understanding, motivation  Document Change and response

48. Establishing liaisons and relationships with company representatives and academic centers Education if exposure did not occur during training Expand and increase awareness of options for effective therapy utilization Help identifying candidates for appropriate effective treatment Advocacy Developing awareness of availability of an effective therapy and awareness of local expertise. Not all centers do all aspects of treatment from implementation, evaluation, goal setting, screening for candidacy, trial or implant, post implant management (early vs. late) Co-management can be effective for not only refining care needs but transitioning and optimizing patient care from tertiary centers back to the community for local care.

49. ITB  Initial spasticity evaluation and determining plan of care  ITB trial- goal setting, education, evaluation of response  Post trial review, education, and confirming plan of care  Coordinating plan of care  Post implant adjustment, monitoring and management  Refills  Trouble shooting Office issues & catheter dye studies

50. DBS - VNS  Co-management of care When to be seen in the office again Establish a plan of care Flexibility is important  Identification of candidates DBS:ET, PD vs atypical PD, Dystonia, ? Other VNS: refractory, not surgical candidate, organic epilepsy Inclusion vs exclusion Goal setting must be appropriate  Education  Post-implant programming or ramp-up and review of clinical response or therapeutic gains

51. Neuromodulation Reprogramming & Fear: Error messages you will not see..  Adjustable, Reversible, not permanent or destructive  There is no Geek Squad to call but technical services can be helpful  Before any change the message will remind you.. Are you certain you want to do that?.. Stop and think …

52.  Post implant management (surgical – wound issues by NSG), post implant initial programming and determination of initial responses (MP)  After several adjustments (MP) notes sent back to us and patient referred back for ongoing care and reprogramming  Initial return reprogramming (initially MD -> over time MD or NP for initial visit and ongoing reprogramming) – and if need be for trouble shooting additional opinion (MP)  Visit for DBS PD-ET management includes history, examination, and reprogramming Code for procedure, length of time, complex office visit

53. Different diagnosis – Same overall plan of co-management: team care  Epilepsy care – ongoing management (MD or NP)  Refractory Epilepsy – adjustment of medications/doses and determination of care plan (MD & NP) – co- management  EMU referral (MD or NP)  Post EMU evaluation and decision management (MD or NP)  VNS implant referral and post implant programming (MD or NP)  VNS programming ramp up (NP)  Office visit – history, examination, VNS reprogramming Complex visit, procedure code Duration of visit predicated on needs of patient and care

54. Special considerations on management of Neuromodulation patients  Obsessive behavior regarding control of care  Deciding on roles for MD, NP, PA and RN partners in care: what are the personalities and work relationship of team members...  experience, interest, training  Time management and complex patients ?how much time is needed  how much time do you have? which clinician co-management What are the roles of ancillary clinicians to help with time, access to care, and clinical management What can you do to improve care efficacy & efficiency?

55.  One clinician to address and review plan of care and assess response to dose adjustment.  How much time is needed for history, evaluation of spasticity response to treatment, clinical examination, ITB refill and adjustment by reprogramming? High level of complexity of service Bill for prolonged time of service if needed Bill for office visit and procedure code Bill for medications (buy & bill) depending upon insurance Medtronic has reimbursement specialist to help with this  Spasticity management evaluation separate from routine care evaluation (specialty visit)

56. The financial considerations and opportunities of Neuromodulation  Effective therapy can be safe and rewarding both personally, professionally as well as financially.  You cannot offer a therapy that is - not effective, not safe, not insurance covered, and not fiscally viable. Schedule  The examination will vary with experience of the clinician  How much time do you need to discuss the diagnosis/differential diagnosis, plan of evaluation and treatment plan? Visits: (average)  CNC.................................30 minutes  OV....................................15 minutes  Re-evaluation...................30 minutes  Specialty Clinics CNC.......45 minutes  Specialty OV....................30 minutes

57. ITB: (per visit/per unit) not including visit code  62368 Analysis reprogramming (no drugs)……….......... $ 58.65  62369 refill/programming by non MD...............................$107.57  62370 refill/programming by an MD.................................$133.56  (95990 and 95991) refill/programming prior to 1/1/2012..$ 72.39  J0475 baclofen Lioresal per unit.......................................$189.89  J0475 Gablofen per unit....................................................$137.67

58. DBS: (per) not including visit code  95970 w/o reprogramming.........................................$ 55.47  95978 programming 1st hour....................................$232.66  95979 programming each add'tl 1/2 hour.................$180.37 VNS: (per) not including visit code  95970 w/o reprogramming.........................................$ 55.47  95974 programming 1st hour....................................$170.02

59. South Shore Neurologic Associates: A comprehensive private practice  Diagnosis: accurate diagnosis by history, examination and relevant diagnostic testing. Computerized Cognitive Testing, Electrodiagnostic testing, Evoked Potentials, MRI, PET, EMU, Transcranial Doppler (bubble tests), Vestibular Testing, Polysomnography, Autonomic Testing. Epilepsy Monitoring Unit  Treatment: effective treatment to target disease and associated symptoms.  Ongoing disease monitoring and management.  If appropriate offering treatment with Interventional Neurology with Neuromodulation ITB, DBS, VNS, Neurotoxin, Functional Electric Stimulation, Peripheral Nerve Stimulation, Interventional Pain management (epidural injections, facet blocks, nerve blocks) Liberatory Maneuvers for particle repositioning, Acupuncture Infusion services (Tysabri, Remicade, Rituxan, IVIG, Steroids) Capture of objective metrics of disease by computerized analysis (gaitrite, smart balance master, computerized cognitive testing

60. Neuromodulation Made Easy Neuromodulation For DUMMIES ITB There is so much Neuromodulation to learn. It should be this easy…. Know your resources Use your resources DBS

61. The Challenge of just taking that step, others will be glad you did as treatments have evolved …  Be an effective therapeutic leader  Be a Neuromodulation champion  Offer hope and accurate information  Offer appropriate knowledgeable advocacy  Offer safe, effective, available and satisfying treatment for a problem that is often under “appreciated”, under-treated and in general treated ineffectively and with poor patient and clinician satisfaction

62. The best may be yet to come…  Development of novel therapeutics targeted for specific genetic or immune disorders  Delivery of novel therapeutics may require novel methods  Objective measures to accurately assess disease change or response to treatments.  Objective metrics to validate therapies and responses with clinically meaningful correlates and identified economic impact

63. Learning from others can make the experience more rewarding both personally and professionally  Special Thank you to those who helped with the process SSNA: Carol Seidel, Barbara Bumstead, Cliff Miller, Laura Buck, Patricia Grant Physicians: Alon Mogilner, Michael Pourfar, Ron Alterman, Jeff Epstein, Melinda Morrissey, Hu Xian Industry: Victor Vozzo, Therese LaSpisa, Joseph Pagano, Lee Calves, Jill Guimont, Linnea Burman, Shirley Picka, Susan Johnson

64. My brain is full of neuromodulation