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Whither the “Improvement Standard”? Coverage for Severe Brain Injury after Jimmo v. Sebelius

Published online by Cambridge University Press:  01 January 2021

Joseph J. Fins ,
Megan S. Wright ,
Claudia Kraft ,
Alix Rogers ,
Marina B. Romani ,
Samantha Godwin  and
Michael R. Ulrich
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Abstract

As improvements in neuroscience have enabled a better understanding of disorders of consciousness as well as methods to treat them, a hurdle that has become all too prevalent is the denial of coverage for treatment and rehabilitation services. In 2011, a settlement emerged from a Vermont District Court case, Jimmo v. Sebelius, which was brought to stop the use of an “improvement standard” that required tangible progress over an identifiable period of time for Medicare coverage of services. While the use of this standard can have deleterious effects on those with many chronic conditions, it is especially burdensome for those in the minimally conscious state (MCS), where improvements are unpredictable and often not manifested through repeatable overt behaviors. Though the focus of this paper is on the challenges of brain injury and the minimally conscious state, which an estimated 100,000 to 200,000 individuals suffer from in the United States, the post-Jimmo arguments presented can and should have a broad impact as envisioned by the plaintiffs who brought the case on behalf of multiple advocacy groups representing patients with a range of chronic care conditions.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 1: Part II: Harmonizing Privacy Laws to Enable International Biobank Research , Spring 2016 , pp. 182 - 193
Copyright
Copyright © American Society of Law, Medicine & Ethics 2016

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References

Fins, J. J., “Rethinking Disorders of Consciousness: New Research and Its Implications,” Hastings Center Report 39, no. 2 (2005): 22-24, at 22.Google Scholar
Fins, J. J., Rights Come to Mind: Brain Injury, Ethics and the Struggle for Consciousness (New York: Cambridge University Press, 2015); J. T. Giacino et al., “Disorders of Consciousness after Acquired Brain Injury: The State of the Science,” Nature Reviews Neurology 10 (2014): 99-114, at 108.Google Scholar
Jimmo v. Sebelius, No. 5:11-CV-17, 2011 U.S. Dist. LEXIS 123743 (D. Vt. Oct. 25, 2011).Google Scholar
Id., at *5.Google Scholar
42 U.S.C. §1395y(a)(1)(A) (2006).Google Scholar
Jimmo, 2011 U.S. Dist. LEXIS 123743, at *61.Google Scholar
Id., at *62, *64.Google Scholar
Id., at *66–67.Google Scholar
Id., at *4–5, *25, *40.Google Scholar
Fins, supra note 2.Google Scholar
Giacino, J. T. et al., “The Minimally Conscious State: Definition and Diagnostic Criteria,” Neurology 58, no. 3 (2002): 349–353.CrossRefGoogle Scholar
Jennett, B., The Vegetative State (Cambridge: Cambridge University Press, 2002): at 127, 198.CrossRefGoogle ScholarPubMed
Jennett, B. and Plum, F., “Persistent Vegetative State after Brain Damage: A Syndrome in Search of a Name,” The Lancet 1, no. 7753 (1972): 734-737, at 734.Google Scholar
Schnakers, C. et al., “Diagnostic Accuracy of the Vegetative and Minimally Conscious State: Clinical Consensus Versus Standardized Neurobehavioral Assessment,” BMC Neurology 9, no. 35 (2009): 1-5, at 3.Google Scholar
Andrews, K. et al., “Misdiagnosis of the Vegetative State: Retrospective Study in a Rehabilitation Unit,” British Medical Journal 313, no. 7048 (1996): 13-16; N. L. Childs, W. N. Mercer, and H. W. Childs, “Accuracy of Diagnosis of Persistent Vegetative State,” Neurology 43, no. 8 (1993): 1456-1467; F. C. Wilson et al., “Vegetative State and Minimally Responsive Patients – Regional Survey, Long-Term Case Outcomes and Service Recommendations,” NeuroRehabilitation 17, no. 3 (2002): 231–236.CrossRefGoogle Scholar
Fins, J. J., “Constructing an Ethical Stereotaxy for Severe Brain Injury: Balancing Risks, Benefits and Access,” Nature Reviews Neuroscience 4 (2003): 323-327, at 325.CrossRefGoogle Scholar
Fins, supra note 1, at 22.Google Scholar
Fins, J. J., “Neuroethics, Neuroimaging, and Disorders of Consciousness: Promise or Peril?” Transactions of the American Clinical & Climatological Association 122 (2010): 336-346, at 337.Google Scholar
The Multi-Society Task Force on PVS, “Medical Aspects of the Persistent Vegetative State,” New England Journal of Medicine 330, no. 1 (1994): 1499-1508, at 1505; Jennett and Plum, supra note 12.Google Scholar
Zasler, N. D. et al., “Posttraumatic Pain Disorders: Medical Assessment and Management,” in Zasler, N., Katz, D. and Zafonte, R., eds., Brain Injury Medicine: Principles and Practice (New York: Demos Publishers, 2007).Google Scholar
Banja, J. D. and Fins, J. J., “Ethics in Brain Injury Medicine,” in Zasler, N., Katz, D. and Zafonte, R., eds., Brain Injury Medicine: Principles and Practice (New York: Demos Publishers, 2007).Google Scholar
Schiff, N. D. et al., “Behavioral Improvements with Thalamic Stimulation after Severe Traumatic Brain Injury,” Nature 448 (2007): 600-603, at 601.CrossRefGoogle Scholar
Fins, J. J and Hersh, J., “Solitary Advocates: The Severely Brain Injured and Their Surrogates,” in Hoffman, B. et al., eds., Transforming Health Care from Below: Patients as Actors in U.S. Health Policy (New Brunswick: Rutgers University Press, 2011): 21-42; J. J. Fins, “Disorders of Consciousness and Disordered Care: Families, Caregivers and Narratives of Necessity,” Archives of Physical Medicine and Rehabilitation 94, no. 10 (2013): 1934–1939.Google Scholar
Fins and Hersh, supra note 23; Fins, J. J., “Disorders of Consciousness and Disordered Care,” supra note 23.Google Scholar
Fins, supra note 2.Google Scholar
Jimmo v. Sebelius, No. 5:11-CV-17, 2011 U.S. Dist. LEXIS 123743 (D. Vt. Oct. 25, 2011), at *4–5.Google Scholar
Id., at *5.Google Scholar
Id., at *5–6.Google Scholar
Gladieux, J. E. and Basile, M., “Jimmo and the Improvement Standard: Implementing Medicare Coverage through Regulations, Policy Manuals and Other Guidance,” American Journal of Law and Medicine 40, no. 1 (2014): 7-25, at 11.Google Scholar
Jimmo, 2011 U.S. Dist. LEXIS 123743, at *61.Google Scholar
Id., at *59–60.Google Scholar
Id., at *61–65.Google Scholar
Id., at *66.Google Scholar
Settlement Agreement at 25, Jimmo v. Sebelius, No. 5:11-CV-17-CR (D. Vt. Oct. 25, 2011).CrossRefGoogle Scholar
Id., at 8–9.Google Scholar
Id., at 10–11.Google Scholar
Medicare Benefit Policy Manual: Chapter 7 – Home Health Services, Ctrs. for Medicare & Medicaid Services, § 20.1.2 (last revised, Jan. 14, 2014), available at <http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
Settlement Agreement, supra note 34, at 14.Google Scholar
Medicare Benefit Policy Manual, supra note 37, § 40.1.1. Though the use of “reasonable and necessary” is ambiguous in regard to numerous coverage determinations and not simply ones related to brain injuries, those considerations are beyond the scope of this paper.Google Scholar
Id.Google Scholar
Whyte, J. et al., “Medical Complications During Inpatient Rehabilitation among Patients with Traumatic Disorders of Consciousness,” Archives of Physical Medicine and Rehabilitation 94, no. 10 (2013): 1877-1883, at 1881-1882; Giacino et al., supra note 2, at 107.Google Scholar
Medicare Benefit Policy Manual, supra note 42, § 40.1.1.Google Scholar
Lammi, M. H. et al., “The Minimally Conscious State and Recovery Potential: A Follow-Up Study 2-5 Years after Traumatic Brain Injury,” Archives of Physical Medicine and Rehabilitation 86, no. 4 (2005): 746-754, at 751–752.Google Scholar
Medicare Benefit Policy Manual, supra note 42, § 110.2.Google Scholar
Id., at § 110.3.Google Scholar
Fins, J. J., “The Ethics of Measuring and Modulating Consciousness: The Imperative of Minding Time,” Progress in Brain Research 177 (2009): 371-382, at 379.CrossRefGoogle Scholar
Schiff, N. D. and Fins, J. J., “Hope for ‘Comatose’ Patients,” Cerebrum 5, no. 4 (2003): 7-24; J. J. Fins, “Lessons from the Injured Brain: A Bioethicist in the Vineyards of Neuroscience,” Cambridge Quarterly of Health Care Ethics 18, no. 1 (2009): 7-13, at 10; Fins, supra note 2.Google Scholar
Blake, R., The Day Donny Herbert Woke Up: A True Story (New York: Harmony Books, 2007); J. J. Fins, “A Review of The Day Donny Herbert Woke Up: A True Story by Rich Blake,” JAMA 299, no. 8 (2008): 959–960.Google Scholar
Fins, J. J., “Wait, Wait…Don’t Tell Me: Tuning in the Injured Brain,” Journal of the American Medical Association Neurology 69, no. 2 (2012): 158-160, at 159.Google Scholar
Schnakers et al., supra note 14, at 3.Google Scholar
Fins, J. J., “Neuroethics and Neuroimaging: Moving toward Transparency,” American Journal of Bioethics 8, no. 9 (2008): 46-52, at 48; J. J. Fins et al., “The Minimally Conscious State: A Diagnosis in Search of an Epidemiology,” Archives of Neurology 64, no. 10 (2007): 1400-1405, at 1400.CrossRefGoogle Scholar
Center for Medicare and Medicaid Services, Jimmo v. Sebelius Settlement Agreement Fact Sheet, available at <http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Jimmo-FactSheet.pdf> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
42 U.S.C. § 1395y(a)(1)(A) (2012).Google Scholar
Fins, supra note 2; Fins, supra note 23, at 1937.Google Scholar
American Academy of Neurology, “Guideline Projects in Process,” October 2014, available at <https://www.aan.com/Guidelines/home/UnderDevelopment> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
Royal College of Physicians, “Prolonged Disorders of Consciousness: National Clinical Guidelines,” available at <https://www.rcplondon.ac.uk/resources/prolonged-disorders-consciousness-national-clinical-guidelines> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
Id., at 36.Google Scholar
Id., at 37.Google Scholar
Id., at 36.Google Scholar
Although, technically, their adoption may need to be articulated in the context of proving that an intervention or treatment program will improve, or maintain, an individual’s medical condition.Google Scholar
Gladieux and Basile, supra note 34, at 12.Google Scholar
Giacino, J. T. et al., “Placebo-Controlled Trail of Amantadine for Severe Traumatic Brain Injury,” New England Journal of Medicine 366, no. 9 (2012): 819-826, at 823.Google Scholar
Whyte, J., “Zolpidem and Restoration of Consciousness,” American Journal of Physical Medicine and Rehabilitation 93, no. 2 (2014): 101–113.CrossRefGoogle Scholar
Schiff, N. D. et al., “Schiff et al. Reply,” Nature 452 (2008): E1-E2, at E1.Google Scholar
Fins, J. J., “Deep Brain Stimulation,” in Jennings, B., ed., Encyclopedia of Bioethics, 4th ed., Vol. II (Farmington Hills: Mac-Millan Reference, 2014): at 817-823; N. D. Schiff, J. T. Giacino, and J. J. Fins, “Deep Brain Stimulation, Neuroethics and the Minimally Conscious State: Moving beyond Proof of Principle,” Archives of Neurology 66, no. 6 (2009): 697-702, at 701.Google Scholar
Fins, “Neuroethics and Neuroimaging,” supra note 56, at 48; Giacino et al., supra note 2, at 99.Google Scholar
Forgacs, P. B. et al., “Preservation of Electroencephalographic Organization in Patients with Impaired Consciousness and Imaging-Based Evidence of Command Following,” Annals of Neurology 76, no. 6 (2014): 869-879, at 870.Google Scholar
Cruse, D. et al., “Bedside Detection of Awareness in the Vegetative State: A Cohort Study,” The Lancet 378, no. 9809 (2011): 2088-2094, at 2091.CrossRefGoogle Scholar
Goldfine, A. M. et al., “Reanalysis of ‘Bedside Detection of Awareness in the Vegetative State: A Cohort Study,’” The Lancet 381, no. 9863 (2013): 289-291; D. Cruse et al., “Reanalysis of ‘Bedside Detection of Awareness in the Vegetative State: A Cohort Study’ – Authors’ Reply,” The Lancet 381, no. 9863 (2013): 291–292.CrossRefGoogle Scholar
Fins, J. J. and Schachter, M., “Investigators, Industry, and the Heuristic Device: Ethics, Patent Law, and Clinical Innovation,” Accountability in Research 8, no. 3 (2001): 219-233; J. J. Fins, “Deep Brain Stimulation, Free Markets and the Scientific Commons: Is It Time to Revisit the Bayh-Dole Act of 1980?” Neuromodulation 13, no. 3 (2010): 153-159, at 154; J. J. Fins, G. S. Dorfman, and J. J. Pancrazio, “Challenges to Deep Brain Stimulation: A Pragmatic Response to Ethical, Fiscal, and Regulatory Concerns,” Annals of the New York Academy of Sciences 1265 (2012): 80–90.CrossRefGoogle Scholar
Fins, J. J. and Schiff, N. D., “Conflicts of Interest in Deep Brain Stimulation Research and the Ethics of Transparency,” Journal of Clinical Ethics 21, no. 2 (2010): 125-132; J. J. Fins et al., “Ethical Guidance for the Management of Conflicts of Interest for Researchers, Engineers and Clinicians Engaged in the Development of Therapeutic Deep Brain Stimulation,” Journal of Neural Engineering 8, no. 3 (2011): 1–6.Google Scholar
Fins, J. J., “A Proposed Ethical Framework for Interventional Cognitive Neuroscience: A Consideration of Deep Brain Stimulation in Impaired Consciousness,” Neurological Research 22, no. 3 (2000): 273–278.Google Scholar
Fins, J. J. et al., “Neuropsychiatric Deep Brain Stimulation Research and the Misuse of the Humanitarian Device Exemption,” Health Affairs 30, no. 2 (2011): 302-311, at 303.CrossRefGoogle Scholar
Fins, J. J. and Shapiro, Z. E., “Deep Brain Stimulation, Brain Maps & Personalized Medicine: Lessons from the Human Genome Project,” Brain Topography 27, no. 1 (2013): 55-62, at 58.CrossRefGoogle Scholar
Fins and Hersh, supra note 23; Suppes, A. and Fins, J. J., “Surrogate Expectations in Severe Brain Injury,” Brain Injury 27, no. 10 (2013): 1141-1147, at 1141; A. Suppes and J. J. Fins, “How Relationships Shape Medical Decision Making,” paper presented at the International Association of Relationship Research, Chicago, July 2012.CrossRefGoogle Scholar
Fins, J. J., “Deep Brain Stimulation: Calculating the True Costs of Surgical Innovation,” Virtual Mentor 12, no. 2 (2010): 114-118, at 115.Google Scholar
Strauss, D. J. et al., “Life Expectancy of Children in Vegetative and Minimally Conscious States,” Pediatric Neurology 23, no. 4 (2000): 312-319, at 316; Fins et al., supra note 51, at 1401.Google Scholar
One in every 66 children is diagnosed with an autism spectrum disorder. Center for Disease Control and Prevention, “Autism Spectrum Disorder Data & Statistics,” available at <http://www.cdc.gov/ncbddd/autism/data.html> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
In treating autism spectrum disorders, early intervention is particularly important. Center for Disease Control and Prevention, “Autism Spectrum Disorder Treatment,” available at <http://www.cdc.gov/ncbddd/autism/treatment.html> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
National Conference of State Legislatures, “Insurance Coverage for Autism,” December 2012, available at <http://www.ncsl.org/research/health/autism-and-insurance-coverage-state-laws.aspx> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
U.S. Department of Health & Human Services, “Our Commitment to Supporting Individuals on the Autism Spectrum and Their Families,” available at <http://www.hhs.gov/autism/factsheet_autism_support.html> (last visited February 23, 2016).+(last+visited+February+23,+2016).>Google Scholar
Nakase-Richardson, R. et al., “Longitudinal Outcome of Patients with Disordered Consciousness in the NIDRR TBI Model Systems Programs,” Journal of Neurotrauma 29, no. 1 (2012): 59-65, at 63.CrossRefGoogle Scholar
Fins, J. J., “Minds Apart: Severe Brain Injury,” in Freeman, M., ed., Law and Neuroscience, Current Legal Issues (Oxford University Press, 2010): 367–384.Google Scholar