Neuromodulation and Private Practice: not an oxymoron

Mark Gudesblatt MD

South Shore Neurologic Associates

Suffolk County, Long Island, New York

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 …

“It’s hard to make predictions, especially about the future.” Yogi Berra

The Challenge of Predicting Prognosis, Treatment needs and response, and Disease Progression

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

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

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?

The first Neuromodulation clinical trial

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

The North American Neuromodulation Society

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

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

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

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.

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?

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?

Flexibility is the name of the game

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.

Parkinson’s Disease:What is in a name?

Treatment PlanCo-morbidities or

…Spectrum of diseaseAutonomicBP lability

Tremor vs. Akinetic Rigid

Freezing of Gait

CognitionMemory

Executive FunctionInformation Processing

AttentionApathy

PsychiatricAnxiety-depression

OCD-gamblingPanic

Sleep DisordersApnea

RLS/PLMSREM Sleep

Behavioral Disorder

Fall RiskAutonomicGI MotilityBalance

Vestibular

Fatigue

DystoniaDyskinesia

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?

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

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.

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

“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….

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

Communication is a 2 way street

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

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

agree

disagree

referralClinic

SSNA identify appropriate candidate

SpecialtyConsult

regarding candidacy

Pre-implant testing

Surgicalimplant

post-implant Initial

Programming

establish plan of care,

communicate

Ongoing local Care

reprogamming

Rehab

One practice practical approach

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

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

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

Potential Goals: keep it simple

ITB goals

ITB

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

Experience does count: if I can do this so can you.

Learning from each exposure leads to experience

Practice Does Improve Clinician Confidence & Performance

Neuromodulation

DBS Implant

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)

“We need a plan.”

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?

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

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 therapiesBrin 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

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

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

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.

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

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

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 …

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

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

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?

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)

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

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

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

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

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

DBSDBS

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

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

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

My brain is full of neuromodulation