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Cognitive/Neurobehavioral/Neurorestorative Rehabilitation

Policy Number: MP-600

Latest Review Date: April 2019

Category:  Therapy                                                                

Policy Grade:  B

POLICY:

:

Cognitive/Neurobehavioral/Neurorestorative rehabilitation (as a distinct and definable component of the rehabilitation process) is considered not medically necessary and investigational for any indication, including but not limited to traumatic brain injury, dementia (including Alzheimer Disease), post-encephalopathy, stroke, epilepsy/seizure disorders, Autism Spectrum Disorders, multiple sclerosis, and cancer.

*Note: There are varying benefit plans for these services. Please verify benefits prior to applying policy criteria, as benefit coverage will supersede this policy.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Cognitive rehabilitation sometimes referred to as neurobehavioral or neurorestorative rehabilitation is a therapeutic approach designed to improve cognitive functioning after central nervous system insult. It includes an assembly of therapy methods intended to retrain or improve deficits in attention, visual processing, language, memory, reasoning, problem solving, and executive functions. Cognitive rehabilitation comprises tasks to reinforce or re-establish previously-learned patterns of behavior or to establish new compensatory mechanisms for impaired neurologic systems. Cognitive rehabilitation may be performed by a physician, psychologist, or a physical, occupational, or speech therapist.

The term cognitive rehabilitation is applied to various intervention strategies or techniques that attempt to help patients reduce, manage, or cope with cognitive deficits caused by brain injury. The desired outcome of cognitive rehabilitation is to improve quality of life or to improve ability to function in home and community life. The term rehabilitation broadly encompasses reentry into familial, social, educational, and working environments, the reduction of dependence on assistive devices or services, and the general enrichment of quality of life. Cognitive rehabilitation is considered a separate service from other rehabilitative therapies, with its own specific procedures.

Sensory and auditory integrative therapy and constraint induced movement or language therapy may be considered components of cognitive rehabilitation. However, sensory and auditory integration therapy is considered separately in medical policy #333 Sensory Integration Therapy and Auditory Integration Therapy, and constraint induced movement or language therapy is considered in medical policy #188 Constraint Induced Movement or Language Therapy.

KEY POINTS:

The most recent update with literature review covered the period through January 9, 2019.

Summary of Evidence

For individuals who have cognitive deficits due to traumatic brain injury who receive cognitive rehabilitation delivered by a qualified professional, the evidence includes randomized controlled trials, nonrandomized comparison studies, case series, and systematic reviews. Relevant outcomes are functional outcomes and quality of life. The cognitive rehabilitation trials have methodologic limitations and report mixed results, indicating that there is not a uniform or consistent evidence base supporting the efficacy of this technique. Systematic reviews have generally concluded that efficacy of cognitive rehabilitation is uncertain. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cognitive deficits due to dementia who receive cognitive rehabilitation delivered by a qualified professional, the evidence includes RCTs, nonrandomized comparison studies, case series, and systematic reviews. Relevant outcomes are functional outcomes and quality of life. Systematic reviews of RCTs have generally shown no benefit of cognitive rehabilitation or effects that were not clinically important. One large RCT with a goal-oriented cognitive rehabilitation program reported significantly less functional decline in 1 of 2 functional scales and lower rates of institutionalization in the cognitive rehabilitation group compared to usual care at 24 months. These results need replication. The evidence is insufficient to determine the effect of the technology on health outcomes.

For individuals who have cognitive deficits due to stroke who receive cognitive rehabilitation delivered by a qualified professional, the evidence includes RCTs and systematic reviews. Relevant outcomes are functional outcomes and quality of life. Four systematic reviews evaluating 3 separate domains of cognitive function have shown no benefit of cognitive rehabilitation or effects that were not clinically important. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cognitive deficits due to multiple sclerosis who receive cognitive rehabilitation delivered by a qualified professional, the evidence includes RCTs and systematic reviews. Relevant outcomes are functional outcomes and quality of life. Systematic reviews of RCTs have shown no significant effects of cognitive rehabilitation on cognitive outcomes. Although numerous RCTs have investigated cognitive rehabilitation in multiple sclerosis, high-quality trials are lacking. The ability to draw conclusions based on the overall body of evidence is limited by the heterogeneity of patient samples, interventions, and outcome measures. Further, results of the available RCTs have been mixed, with positive studies mostly reporting short-term benefits. Evidence for clinically significant, durable improvements in cognition is currently lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cognitive deficits due to epilepsy, ASD, post-encephalopathy, or cancer who receive cognitive rehabilitation delivered by a qualified professional, the evidence includes RCTs, nonrandomized comparison studies, and case series. Relevant outcomes are functional outcomes and quality of life. The quantity of studies for these conditions is much less than that for the other cognitive rehabilitation indications. Systematic reviews generally have not supported the efficacy of cognitive rehabilitation for these conditions. Relevant RCTs have had  , methodologic limitations most often very short lengths of follow-up, that do not permit strong conclusions about efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Congress of Rehabilitation Medicine

Based on a 2013 systematic review, the task force recommended process-based cognitive rehabilitation strategies (e.g., attention process training, strategy acquisition and internalization, self-monitoring, and corrective feedback) to treat attention and memory deficits in children and adolescents with brain cancers who undergo surgical resection and/or radiotherapy.

National Institute for Health and Care Excellence

National Institute for Health and Care Excellence guidance in 2013 on stroke rehabilitation recommends cognitive rehabilitation for visual neglect and memory and attention deficits that impact function. Interventions should focus on relevant functional tasks, e.g., errorless learning and elaborative techniques (mnemonics, encoding strategies) for memory impairments.

Institute of Medicine

The Institute of Medicine published a report in October 2011 on cognitive rehabilitation for traumatic brain injury that included a comprehensive review of the literature and recommendations. The report concluded that “current evidence provides limited support for the efficacy of CRT interventions. The evidence varies in both the quality and volume of studies and therefore is not yet sufficient to develop definitive guidelines for health professionals on how to apply CRT in practice.” The report recommended that standardization of clinical variables, intervention components, and outcome measures was necessary to improve the evidence base for this treatment. They also recommended future studies with larger sample sizes and more comprehensive sets of clinical variables and outcome measures.

Veterans Administration

The Veterans Administration/Department of Veterans Affairs published guidelines on the treatment of concussion/mild traumatic brain injury in 2009, which were updated in 2016. These guidelines address cognitive rehabilitation in the setting of persistent symptoms. The 2016 guidelines state:

“Individuals with a history of mTBI who present with symptoms related to memory, attention, and/or executive function problems that do not resolve within 30 to 90 days and have been refractory to treatment for associated symptoms should be referred as appropriate to cognitive rehabilitation therapists with expertise in TBI rehabilitation. The Work Group suggests considering a short-term trial of cognitive rehabilitation treatment to assess the individual patient responsiveness to strategy training, including instruction and practice on use of memory aids, such as cognitive assistive technologies (AT). A prolonged course of therapy in the absence of patient improvement is strongly discouraged.”

The strength of the recommendation was rated as “weak.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cognitive Rehabilitation, Neurobehavioral, Neurorestorative, Neuro-Restorative

APPROVED BY GOVERNING BODIES:

Cognitive rehabilitation is not a U.S. Food and Drug Administration-regulated procedure.

BENEFIT APPLICATIONS:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

**Note: There are varying benefit plans for these services. Please verify benefits prior to applying policy criteria, as benefit coverage will supersede this policy.

CURRENT CODING:

CPT Codes:

97129

Therapeutic interventions that focus on cognitive function (eg, attention, memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to manage the performance of an activity (eg, managing time or schedules, initiating, organizing, and sequencing tasks), direct (one-on-one) patient contact; initial 15 minutes (Effective 01/01/2020)

97130

Therapeutic interventions that focus on cognitive function (eg, attention, memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to manage the performance of an activity (eg, managing time or schedules, initiating, organizing, and sequencing tasks), direct (one-on-one) patient contact; each additional 15 minutes (List separately in addition to code for primary procedure) (Effective 01/01/2020)

Previous Coding:

CPT Codes:

97127

Therapeutic interventions that focus on cognitive function (eg, attention, memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to manage the performance of an activity (eg, managing time or schedules, initiating, organizing and sequencing tasks), direct (one-on-one) patient contact (Effective 01/01/2018, Deleted 12/31/2019)

97532

Development of cognitive skills to improve attention, memory, problem solving (include compensatory training), direct (one-on-one) patient contact by the provider, each 15 minutes. (Deleted 12/31/2017)

HCPCS Coding

G0515

Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes (Effective 01/01/2018, Deleted 12/31/19)

REFERENCES:

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  2. Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2013; 6:CD003260.
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  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Cognitive rehabilitation. TEC Assessments. 1997; Volume 12, Tab 6.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Cognitive rehabilitation for traumatic brain injury in adults. TEC Assessments. 2008; Volume 23, Tab 3.
  6. Bonavita S, Sacco R, Della Corte M, et al. Computer-aided cognitive rehabilitation improves cognitive performances and induces brain functional connectivity changes in relapsing remitting multiple sclerosis patients: an exploratory study. J Neurol. Jan 2015; 262(1):91-100.
  7. Bowen A, Hazelton C, Pollock A, et al. Cognitive rehabilitation for spatial neglect following stroke. Cochrane Database Syst Rev. 2013; 7:CD003586.
  8. Brunelle-Hamann L, Thivierge S, Simard M. Impact of a cognitive rehabilitation intervention on neuropsychiatric symptoms in mild to moderate Alzheimer's disease. Neuropsychol Rehabil. Oct 14 2014:1-31.
  9. Butler RW, Copeland DR, Fairclough DL, et al. A multicenter, randomized clinical trial of a cognitive remediation program for childhood survivors of a pediatric malignancy. J Consult Clin Psychol. Jun 2008; 76(3):367-378.
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  12. Chiappedi M, Beghi E, Ferrari-Ginevra O, et al. Response to rehabilitation of children and adolescents with epilepsy. Epilepsy & Behavior. 2011; 20(1):79-82.
  13. Chiaravalloti ND, DeLuca J, Moore NB, et al. Treating learning impairments improves memory performance in multiple sclerosis: a randomized clinical trial. Mult Scler. Feb 2005; 11(1):58-68.
  14. Chiaravalloti ND, Moore NB, Nikelshpur OM, et al. An RCT to treat learning impairment in multiple sclerosis: The MEMREHAB trial. Neurology. Dec 10 2013; 81(24):2066-2072.
  15. Chiaravalloti ND, Sandry J, Moore NB, et al. An RCT to Treat Learning Impairment in Traumatic Brain Injury: The TBI-MEM Trial. Neurorehabil Neural Repair. Sep 10 2015.
  16. Chung CS, Pollock A, Campbell T, et al. Cognitive rehabilitation for executive dysfunction in adults with stroke or other adult non-progressive acquired brain damage. Cochrane Database Syst Rev. 2013; 4:CD008391.
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  18. Cicerone KD, Mott T, Azulay J, et al. Community integration and satisfaction with functioning after intensive cognitive rehabilitation for traumatic brain injury. Arch Phys Med Rehabil. Jun 2004; 85(6):943-950.
  19. Clare L, Linden DE, Woods RT, et al. Goal-oriented cognitive rehabilitation for people with early stage Alzheimer disease: a single-blind randomized controlled trial of clinical efficacy. Am J Geriatr Psychiatry. Oct 2010; 18(10):928-939.
  20. das Nair R, Cogger H, Worthington E, et al. Cognitive rehabilitation for memory deficits after stroke. Cochrane Database Syst Rev. Sep 01 2016; 9:CD002293
  21. das Nair R, Ferguson H, Stark DL, et al. Memory Rehabilitation for people with multiple sclerosis. Cochrane Database Syst Rev. 2012; 3:CD008754.
  22. das Nair R, Martin KJ, Lincoln NB. Memory rehabilitation for people with multiple sclerosis. Cochrane Database Syst Rev. Mar 23 2016; 3:CD008754.
  23. De Giglio L, De Luca F, Prosperini L, et al. A Low-Cost Cognitive Rehabilitation with a Commercial Video Game Improves Sustained Attention and Executive Functions in Multiple Sclerosis: A Pilot Study. Neurorehabil Neural Repair. Nov 14 2014.
  24. Department of Veteran Affairs Department of Defense. VA/DoD clinical practice guideline for management of concussion/mild traumatic brain injury. Washington (DC): Department of Veteran Affairs, Department of Defense; 2009.
  25. Diamond PT. Rehabilitative management of post-stroke visuospatial inattention. Disabil Rehabil. Jul 10 2001; 23(10):407-412.
  26. Eack SM, Greenwald DP, Hogarty SS, et al. Cognitive enhancement therapy for adults with autism spectrum disorder: results of an 18-month feasibility study. J Autism Dev Disord. Dec 2013; 43(12):2866-2877.
  27. Engelberts NH, Klein M, Ader HJ, et al. The effectiveness of cognitive rehabilitation for attention deficits in focal seizures: a randomized controlled study. Epilepsia. Jun 2002; 43(6):587-595.
  28. Ercoli LM, Petersen L, Hunter AM, et al. Cognitive rehabilitation group intervention for breast cancer survivors: results of a randomized clinical trial. Psychooncology. Nov 2015;24(11):1360-1367.
  29. Farina E, Raglio A, Giovagnoli AR. Cognitive rehabilitation in epilepsy: An evidence-based review. Epilepsy Res. Jan 2015; 109C:210-218.
  30. Gich J, Freixanet J, Garcia R, et al. A randomized, controlled, single-blind, 6-month pilot study to evaluate the efficacy of MS-Line!: a cognitive rehabilitation programme for patients with multiple sclerosis. Mult Scler. Feb 25 2015.
  31. Gillespie DC, Bowen A, Chung CS, et al. Rehabilitation for post-stroke cognitive impairment: an overview of recommendations arising from systematic reviews of current evidence. Clin Rehabil. Jun 18 2014.
  32. Hanssen KT, Beiske AG, Landro NI, et al. Cognitive rehabilitation in multiple sclerosis: a randomized controlled trial. Acta Neurol Scand. Jan 2016; 133(1):30-40.
  33. Hardy KK, Willard VW, Allen TM, et al. Working memory training in survivors of pediatric cancer: a randomized pilot study. Psychooncology. Aug 2013; 22(8):1856-1865.
  34. Helmstaedter C, Loer B, Wohlfahrt R, et al. The effects of cognitive rehabilitation on memory outcome after temporal lobe epilepsy surgery. Epilepsy Behav. Apr 2008; 12(3):402-409.
  35. Huntley JD, Gould RL, Liu K, et al. Do cognitive interventions improve general cognition in dementia? A meta-analysis and meta-regression. BMJ Open. 2015; 5(4):e005247.
  36. Institute of Medicine National Academies Press. Cognitive rehabilitation therapy for traumatic brain injury. 2011; iom.edu/Reports/2011/Cognitive-Rehabilitation-Therapy-for-Traumatic- Brain-Injury-Evaluating-the-Evidence.aspx.
  37. Kesler S, Hadi Hosseini SM, Heckler C, et al. Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Clin Breast Cancer. Aug 2013; 13(4):299-306.
  38. Koorenhof L, Baxendale S, Smith N, et al. Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: A preliminary report. Seizure. 2012; 21(3):178-182.
  39. Kurz A, Thone-Otto A, Cramer B, et al. CORDIAL: cognitive rehabilitation and cognitivebehavioral treatment for early dementia in Alzheimer disease: a multicenter, randomized, controlled trial. Alzheimer Dis Assoc Disord. Jul-Sep 2012; 26(3):246-253.
  40. Langenbahn DM, Ashman T, Cantor J, et al. An evidence-based review of cognitive rehabilitation in medical conditions affecting cognitive function. Arch Phys Med Rehabil. Feb 2013; 94(2):271- 286.
  41. Lindgren A, Hagstadius S, Abjornsson G. Neuropsychological rehabilitation of patients with organic solvent-induced chronic toxic encephalopathy, a pilot study. Neuropsychol Rehabil. 1997; 7(1):1-22.
  42. Loetscher T, Lincoln NB. Cognitive rehabilitation for attention deficits following stroke. Cochrane Database Syst Rev. 2013; 5:CD002842.
  43. Loewenstein DA, Acevedo A, Czaja SJ, et al. Cognitive rehabilitation of mildly impaired Alzheimer disease patients on cholinesterase inhibitors. Am J Geriatr Psychiatry. Jul-Aug 2004; 12(4):395- 402.
  44. Management of Concussion-mild Traumatic Brain Injury Working Group. VA/DoD clinical practice guideline for the management of concussion-mild traumatic brain injury, Version 2.0. Washington, DC: Department of Veterans Affairs, Department of Defense; 2016.
  45. Mantynen A, Rosti-Otajarvi E, Koivisto K, et al. Neuropsychological rehabilitation does not improve cognitive performance but reduces perceived cognitive deficits in patients with multiple sclerosis: a randomised, controlled, multi-centre trial. Mult Scler. Jan 2014; 20(1):99-107.
  46. Martin M, Clare L, Altgassen AM, et al. Cognition-based interventions for healthy older people and people with mild cognitive impairment. Cochrane Database Syst Rev. 2011(1):CD006220.
  47. Nair RD, Lincoln NB. Cognitive rehabilitation for memory deficits following stroke. Cochrane Database Syst Rev. 2007(3):CD002293.
  48. National Institute for Health and Care Excellence. Stroke rehabilitation (CG162), June 2013. guidance.nice.org.uk/CG162. Accessed February 16, 2018.
  49. Poppelreuter M, Weis J, Mumm A, et al. Rehabilitation of therapy-related cognitive deficits in patients after hematopoietic stem cell transplantation. Bone Marrow Transplant. Jan 2008; 41(1):79-90.
  50. Regan B, Wells Y, Farrow M, et al. MAXCOG-Maximizing Cognition: a randomized controlled trial of the efficacy of goal-oriented cognitive rehabilitation for people with mild cognitive impairment and early Alzheimer disease. Am J Geriatr Psychiatry. Mar 2017; 25(3):258-269.
  51. Reichow B, Servili C, Yasamy MT, et al. Non-specialist psychosocial interventions for children and adolescents with intellectual disability or lower-functioning autism spectrum disorders: a systematic review. PLoS Med. Dec 2013; 10(12):e1001572; discussion e1001572.
  52. Rosti-Otajarvi EM, Hamalainen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database Syst Rev. 2014; 2:CD009131.
  53. Rosti-Otajarvi E, Mantynen A, Koivisto K, et al. Neuropsychological rehabilitation has beneficial effects on perceived cognitive deficits in multiple sclerosis during nine-month follow-up. J Neurol Sci. Nov 15 2013; 334(1-2):154-160.
  54. Salazar AM, Warden DL, Schwab K, et al. Cognitive rehabilitation for traumatic brain injury: A randomized trial. Defense and Veterans Head Injury Program (DVHIP) Study Group. JAMA. Jun 21 2000; 283(23):3075-3081.
  55. Schmidt J, Drew-Cates J, Dombovy M. Anoxic encephalopathy: outcome after inpatient rehabilitation. J Neurologic Rehabilitation. 1997; 11(3):189-195.
  56. Sitzer DI, Twamley EW, Jeste DV. Cognitive training in Alzheimer's disease: a meta-analysis of the literature. Acta Psychiatr Scand. Aug 2006; 114(2):75-90.
  57. Spector A, Thorgrimsen L, Woods B, et al. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. Sep 2003; 183:248-254.
  58. Thivierge S, Jean L, Simard M. A randomized cross-over controlled study on cognitive rehabilitation of instrumental activities of daily living in Alzheimer disease. Am J Geriatr Psychiatry. Nov 2014; 22(11):1188-1199.
  59. Wang M, Reid D. Using the virtual reality-cognitive rehabilitation approach to improve contextual processing in children with autism. ScientificWorldJournal. 2013; 2013:716890.
  60. Zeng Y, Cheng AS, Chan CC. Meta-analysis of the effects of neuropsychological interventions on cognitive function in non-central nervous system cancer survivors. Integr Cancer Ther. Dec 2016; 15(4):424-434.
  61. Zucchella C, Capone A, Codella V, et al. Assessing and restoring cognitive functions early after stroke. Funct Neurol. Dec 16 2014:1-8.
  62. Zucchella C, Capone A, Codella V, et al. Cognitive rehabilitation for early post-surgery inpatients affected by primary brain tumor: a randomized, controlled trial. J Neurooncol. Aug 2013; 114(1):93-100.

POLICY HISTORY:

Medical Policy Panel, February 2015

Medical Policy Group, June 2015 (4):  Adoption of new policy for cognitive rehabilitation performed outside of an acute setting

Medical Policy Administration Committee, July 2015

Available for comment July 4 through August 17, 2015

Medical Policy Group, September 2015 (4): Policy statement updated to remove “when performed outside of an acute setting.” Updated Description section

Medical Policy Administration Committee, October 2015

Available for comment September 29 through November 12, 2015

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (4): Updates to Description, Key Points, and References. No change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Group, December 2017: Annual Coding Update 2017: Added new CPT code 97127 and new HCPCS code G0515 to Current Coding. Created Previous Coding section and moved deleted CPT code 97532 to this section.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (4): Updates to Key Points, and References.  No change to policy statement.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (4): Updates to Key Points. Removed effective for dates of service on and after July 4, 2015 and prior to November 13, 2015 from policy section.

Medical Policy Group, December 2019: 2020 Annual Coding Update.  Added new CPT codes 97129 and 97130 to Current Coding. Moved CPT code 97127 and HCPCS code G0515 from Current Coding to Previous Coding.


This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.