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www.mghcme.org/spauldingtbi
Joseph T. Giacino, PhD Director of Rehabilitation Neuropsychology
Spaulding Rehabilitation Hospital Associate Professor, Harvard Medical School
Spaulding-Harvard TBIMS
Severe TBI Stakeholder Summit U.S. Access Board Washington, DC May 16-17, 2016
Department of Physical Medicine & Rehabilitation
Harvard Medical School
Spaulding Rehabilitation Hospital
Massachusetts General Hospital
Brigham & Women’s Hospital
Outcome Following Severe TBI: Bridging the Gaps Between Evidence, Practice and Policy
www.mghcme.org/spauldingtbi
Disclosure
Dr. Giacino has no significant financial relationship with any
commercial or proprietary entity that produces healthcare-related
products and/or services relevant to the content of this presentation.
Dr. Giacino occasionally receives honoraria for conducting CRS-R
training seminars.
Dr. Giacino receives grant funding from the National Institute of
Neurological Disorders and Stroke, the National Institute on Disability,
Independent Living and Rehabilitation Research, U.S. Department of
Defense and the James S. McDonnell Foundation.
www.mghcme.org/spauldingtbi
Gaps between evidence, practice and policy
Why gaps matter
(Photo and name used with permission)
Intensity of care
Aggressive care
Withdrawal of care
High Stakes Decisions
Key Drivers • Surrogate substituted judgment • Physician attitudes
www.mghcme.org/spauldingtbi
Mortality associated with withdrawal of life-sustaining therapy for patients with severe TBI: A Canadian multicenter cohort study
(Turgeon, et al., CMAJ, 2011)
Intensity of care
Aggressive care
Survival
Type of care
Specialized inpatient
rehab
SNF/Nursing home
Death
Withdrawal of care
High Stakes Decisions
Key Drivers • Surrogate substituted judgment • Physician attitudes
Key Drivers • Physician recommendation • Surrogate judgment • Authorization guidelines
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CMS Authorization Guidelines for Inpatient Rehabilitation
“The patient must reasonably be expected to actively participate in, and benefit significantly from, the intensive rehabilitation therapy program…
The patient can only be expected to benefit significantly from the intensive rehabilitation therapy program if the patient’s condition and functional status are such that the patient can reasonably be expected to make measurable improvement (that will be of practical value to improve the patient’s functional capacity or adaptation to impairments)…
and if such improvement can be expected to be made within a prescribed period of time…”
www.mghcme.org/spauldingtbi
Interpretation of CMS Guideline as per InterQual Criteria
11. “McKesson consultants agree that a Rancho Level of III or greater is required to ensure the patient can cognitively participate in a 3-hour therapy program…” 15. “Full participation requires the patient to be medically-stable, cognitively-capable, and willing to participate in an intensive program...”
Intensity of care
Aggressive care
Survival
Type of care
Specialized inpatient
rehab
SNF/Nursing home
Death
Withdrawal of care
High Stakes Decisions
??
www.mghcme.org/spauldingtbi
(Edlow, Wu, et al)
Aims of Inpatient
Rehabilitation
• Specialized diagnostic and prognostic assessment
• Standardized neurobehavioral metrics • Advanced neuroimaging studies
• Treatment trials • Pharmacologic • Physical medicine
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SNF/custodial care settings
• Broad mix of patients with different treatment needs
• Focus on common long-term care needs with limited attention to the unique needs of persons with sTBI.
• Staff lack training required to conduct specialized assessment and treatment procedures.
• No mechanism to fluently upgrade rehab intensity if clinical condition improves.
Intensity of care
Aggressive care
Survival
Type of care
Specialized inpatient
rehab
Length of care
Extend specialized
care
Downgrade to lower-intensity
care
SNF/Nursing home
Death
Withdrawal of care
High Stakes Decisions
Key Drivers • Surrogate substituted judgment • Physician attitudes
Key Drivers • Rehab team recommendation • Insurance authorization
Key Drivers • Physician recommendation • Authorization guidelines
• CMS/InterQual
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Q6: Did your insurance plan cover all the services you need related to your brain injury?
Answer Choices Responses
Yes 35.14%
65
No 64.86%
120
Total 185
BIAA Consumer Survey Related to Brain Injury Coverage Under the ACA
(Survey Monkey: Since 11/13/2014)
www.mghcme.org/spauldingtbi
Q8: Why was coverage for your brain injury services denied? (select all that apply)
Answer Choices Responses
–My injury happened too long ago. 14.13% 13
–I have used all my allowable benefits. 22.83% 21
–I will no longer improve with additional services.
16.30% 15
–The services I need are not covered under my health plan.
64.13% 59
–The services are not available in the provider network.
29.35% 27
–I was unable to afford the co-payments.
26.09% 24
Total Respondents: 92
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“Enrollees with TBI were more likely to change coverage than those without and to demonstrate accelerated coverage change.”
“The severity of the TBI was associated with accelerated coverage change in a dose-response manner; compared with patients without TBI, patients with TBI who had an AIS score of 2 demonstrated 8% shorter coverage, patients with TBI who had an AIS score of 3 demonstrated 19% shorter coverage, patients with TBI who had an AIS score of 4 demonstrated 23% shorter coverage, and patients with TBI who had an AIS score of 5 to 6 demonstrated 44% shorter coverage (145 vs 258 days).”
Continuity of Private Health Insurance Coverage After Traumatic Brain Injury
(Lin JA, Canner JK, Schneider EB. JAMA Surg 2016 )
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Day 8 Day 44 Day 198 Day 366
(Edlow, Giacino, et al, Neurocrit Care, 2013)
Day 744
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Sample: • 337 patients not following commands on admission to rehab w/ at
least 1 f-u between 1 and 5 yrs post-injury
Results:
• Functionally-independent = 20% (n=66) • Employable = 23% (n=63)
Longitudinal outcome of patients with prolonged disorders of consciousness in the NIDRR TBI Model Systems:
(Nakase-Richardson, Whyte, Giacino, et al, J Neurotrauma, 2011)
How unusual is Dylan?
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Functional Recovery Over 5 Years in Patients Admitted to Inpatient Rehab Not Following Commands
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pe
rce
nta
ge o
f P
atie
nts
In
de
pe
nd
en
t
Discharge
1 YR F/U
2 YR F/U
5 YR F/U
n=108
(Whyte, Nakase-Richardson, Giacino, et al, APM&R, 2013)
www.mghcme.org/spauldingtbi
Belief: Functional recovery after sTBI with prolonged DoC is rare and the window of opportunity closes after 12 mths
Truth: ≈20% of persons with sTBI and prolonged DoC regain functional independence with meaningful changes evident
out to 5 years
Gaps in need of closure
Belief: Active participation is required to benefit from intensive rehabilitation
Truth: There is no evidence of differential improvement in outcome from active v. passive rehabilitation
www.mghcme.org/spauldingtbi
Gaps in need of closure
Belief: It is possible to accurately project the duration of time needed to achieve functional milestones at the single-case level
Truth: All established prognostic markers have very wide confidence intervals
Belief: 30-60 days of insurance coverage is sufficient to meet the basic healthcare needs of persons with sTBI
Truth: Most persons with sTBI experience late complications requiring medical intervention and experience chronic care needs
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Acknowledgements
Spaulding Rehabilitation Hospital: Cornell-Weill Medical School -Yelena Guller, PhD - Nicholas Schiff, MD -Therese O’Neil-Pirozzi, PhD - Joseph Fins, MD - Mel Glenn, MD - Ron Hirschberg, MD Boston University Medical School - Matt Doiron, BA - Douglas Katz, MD - Cecilia Carlowicz, BA - Sabrina Taylor, PhD - Ross Zafonte, DO Brigham and Women’s Hospital: Moss Rehabilitation Research Institute - Emily Stern, MD - John Whyte, MD, PHD - Hong Pan, PhD - Martha Shenton, PhD James A. Haley Veterans Medical Center - Sylvain Boiux, PhD - Risa Nakase-Richardson, PhD - Ben Fuchs, BA - Courtney Chaley, BA Mt. Sinai Medical Center - Emilia Bagiella, PhD Massachusetts General Hospital: Athinoula A. Martinos Center for Biomedical Imaging - Brian Edlow, MD - Ona Wu