Transcript Neuromodulation and Private Practice: oxymoron?

Neuromodulation and Private Practice:
not an oxymoron
Mark Gudesblatt MD
South Shore Neurologic Associates
Suffolk County, Long Island, New York
Summary for those who are hungry, like to
read the end of the story first or leave early …
 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
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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
The Challenge of Predicting Prognosis,
Treatment needs and response, and Disease
Progression
 “It’s hard to make predictions, especially about the future.”
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Yogi Berra
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?
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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
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Not diagnose and adios
Neuro What?
 What Neuromodulation therapies are available?
 Are Neuromodulation therapies effective?
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No therapy is effective for all patients
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Goal setting: appropriate, realistic, mutually agreed
upon
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Inappropriate or unrealistic goals can lead to
dissatisfaction and apparent therapy failure
 Why offer Neuromodulation in general or private practice?
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Why not?
 Which Neuromodulation Therapy to offer in practice?
The first Neuromodulation clinical trial
The Problem
 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 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”
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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
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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:
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Parenteral or intravenous treatments
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Intrathecal delivery of medication
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Neuromodulation interventions.
Offering Hope can be contagious
 Is an effective clinician something more than just a
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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
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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.
Cognition
Psychiatric
Memory
Anxiety-depression
Executive Function
OCD-gambling
Information Processing
Panic
Attention
Apathy
Tremor vs.
Akinetic Rigid
Sleep Disorders
Apnea
RLS/PLMS
REM Sleep
Behavioral Disorder
Parkinson’s Disease:
What is in a name?
Dystonia
Dyskinesia
Freezing of
Gait
Fatigue
Treatment Plan
Co-morbidities or
…Spectrum of disease
Autonomic
BP lability
Balance
Vestibular
Fall Risk
Autonomic
GI Motility
 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
No matter what the therapy is….
“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
The Challenge of Effective Communication
 Treatment team must continuously work closely with
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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
Communication is a 2 way street
Patience, Patient, Patients
 The challenge of being a patient, encouraging, proactive
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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)
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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
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A vision for a Neuromodulation center or team is
modified and achieved over time
One practice practical approach
Specialty
Consult
regarding
candidacy
Clinic
SSNA identify
appropriate
candidate
Ongoing local
Care
reprogamming
Surgical
implant
establish plan
of care,
communicate
Rehab
Pre-implant
testing
post-implant
Initial
Programming
Teamwork and Communication are key
 Can comprehensive care be delivered in isolation by one
clinician?
 Experienced Implanter and Team
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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
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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
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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
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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
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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
ITB goals
 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
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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
DBS Implant
Neuromodulation
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 comanagement
 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
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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.
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Know your resources
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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
Review outcomes:
Were functional objectives met?
Yes
No
• Continuous reevaluation at
follow-up to review
– treatment strategy
– Reassessment of
adjunctive therapies
• Reassess adjunctive therapies
• Modify procedure/dose
• Reevaluate patient
selection/goals
Brin MF et al. Muscle Nerve. 1997;20(suppl 6):S208-S220.
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
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Education if exposure did not occur during training
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Expand and increase awareness of options for effective therapy
utilization
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Help identifying candidates for appropriate effective treatment
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Advocacy
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Developing awareness of availability of an effective therapy and
awareness of local expertise.
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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)
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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
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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
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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
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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
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and determination of care plan (MD & NP) – comanagement
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
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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
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partners in care: what are the personalities and work
relationship of team members ...
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experience, interest, training
 Time management and complex patients
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?how much time is needed
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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)
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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
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Diagnosis: accurate diagnosis by history, examination and relevant
diagnostic testing.
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Computerized Cognitive Testing, Electrodiagnostic testing, Evoked
Potentials, MRI, PET, EMU, Transcranial Doppler (bubble tests),
Vestibular Testing, Polysomnography, Autonomic Testing. Epilepsy
Monitoring Unit
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Treatment: effective treatment to target disease and associated symptoms.
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Ongoing disease monitoring and management.
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If appropriate offering treatment with Interventional Neurology with
Neuromodulation
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ITB, DBS, VNS, Neurotoxin, Functional Electric Stimulation, Peripheral
Nerve Stimulation, Interventional Pain management (epidural injections,
facet blocks, nerve blocks)
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Liberatory Maneuvers for particle repositioning, Acupuncture
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Infusion services (Tysabri, Remicade, Rituxan, IVIG, Steroids)
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Capture of objective metrics of disease by computerized analysis
(gaitrite, smart balance master, computerized cognitive testing
Neuromodulation Made Easy
DBS
DBS
ITB
There is so much
Neuromodulation to learn.
It should be this easy….
Know your resources
Use your resources
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
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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