mp-358
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Functional Neuromuscular Electrical Stimulation

Policy Number: MP-358

Latest Review Date: April 2021

Category:  DME                                                                    

Policy Grade: B

POLICY:

Neuromuscular stimulation as a technique to restore function following nerve damage or nerve injury is considered investigational in the following situations:

  • As a technique to provide ambulation in patients with spinal cord injury; or

  • To provide upper extremity function in patients with nerve damage (e.g., spinal cord injury or post-stroke); or

  • To improve ambulation in patients with foot drop caused by congenital disorders (e.g., cerebral palsy) or nerve damage (e.g., post-stroke or in those with multiple sclerosis).

Functional electrical stimulation devices for exercise in patients with spinal cord injury are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Functional electrical stimulation (FES) involves the use of an orthotic device with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function to patients with damaged or destroyed nerve pathways (e.g., spinal cord injury (SCI), stroke, multiple sclerosis, cerebral palsy).

Functional Neuromuscular Electrical Stimulation

Functional electrical stimulation (FES) is an approach to rehabilitation that applies low-level electrical current to stimulate functional movements in muscles affected by nerve damage. It focuses on the restoration of useful movements, like standing, stepping, pedaling for exercise, reaching, or grasping.

FES devices consist of an orthotic and a microprocessor-based electronic stimulator with one or more channels for delivery of individual pulses through surface or implanted electrodes connected to the neuromuscular system. Microprocessor programs activate the channels sequentially or in unison to stimulate peripheral nerves and trigger muscle contractions to produce functionally useful movements that allow patients to sit, stand, walk, and grasp. Functional neuromuscular stimulators are closed-loop systems, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters, which are required for complex activities such as walking. These are contrasted with open-loop systems, which are used for simple tasks such as muscle strengthening alone and typically in healthy individuals with intact neural control benefit the most from this technology.

Applications, described in more detail in the Key Points section, include upper-extremity grasping function after spinal cord injury and stroke, lifting the front of the foot during ambulation in individuals with foot drop, ambulation and exercise for patients with spinal cord injury. Some devices are used primarily for rehabilitation rather than home use. This evidence review focuses on devices intended for home use.

KEY POINTS:

This policy was updated with the most recent literature through January 23, 2021.

Summary of Evidence

For individuals who have loss of hand and upper-extremity function due to SCI or stroke who receive FES, the evidence includes case series. The relevant outcomes are functional outcomes and QOL. Evidence on FES for the upper limb in patients with SCI or stroke includes a few small case series. The low number of patients studied and lack of data demonstrating the utility of FES outside the investigational setting limit interpretation of the evidence. It is uncertain whether FES can restore some upper-extremity function or improve the QOL. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have chronic foot drop who receive FES, the evidence includes RCTs and a systematic review. The relevant outcomes are functional outcomes and QOL. For chronic post stroke foot drop, two RCTs comparing FES with a standard AFO showed improved patient satisfaction with FES but no significant differences between groups in objective measures like walking. An RCT with 53 subjects examining neuromuscular stimulation for foot drop in patients with MS showed a reduction in falls and improved patient satisfaction compared with an exercise program but did not demonstrate a clinically significant benefit in walking speed. A reduction in falls is an important health outcome. However, it was not a primary study outcome and should be corroborated. The literature on FES in children with cerebral palsy includes a systematic review of small studies with within-subject designs. Further study is needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SCI at segments T4 to T12 who receive FES, the evidence includes case series. The relevant outcomes are functional outcomes and QOL. No controlled trials were identified on FES for standing and walking in patients with SCI. However, case series are considered adequate for this condition, because there is no chance for unaided ambulation in this population with SCI at this level. Some studies have reported improvements in intermediate outcomes, but improvements in health outcomes (e.g., ability to perform activities of daily living, QOL) have not been demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have SCI who receive FES exercise equipment, the evidence includes prospective within-subject comparisons. The relevant outcomes are symptoms, functional outcomes, and QOL. The evidence on FES exercise equipment consists primarily of within subject, pre- to post-treatment comparisons. Evidence was identified on two commercially available FES cycle ergometer models for the home, the RT300 series and the REGYS/ERGYS series. There is a limited amount of evidence on the RT300 series. None of the studies showed an improvement in health benefits and one analysis of use for 314 individuals over 20000 activity sessions with a Restorative Therapeutics device showed that a majority of users used the device for 34 minutes per week. Two percent of individuals with SCI used the device for an average of six days per week, but caloric expenditure remained low. Compliance was shown in one study to be affected by the age of participants and level of activity prior to the study. Studies on the REGYS/ERGYS series have more uniformly shown an improvement in physiologic measures of health and in sensory and motor function. A limitation of these studies is that they all appear to have been conducted in supervised in research centers. No studies were identified on long-term home use of ERGYS cycle ergometers. The feasibility and long-term health benefits of using this device in the home is uncertain. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

In January 2009, the National Institute for Health and Clinical Excellence (NICE) published guidance stating that the current evidence on functional electrical stimulation (FES) for drop foot of neurologic origin appears adequate to support its use, provided that normal arrangements are in place for clinical governance, consent, and audit. They noted that patient selection should involve a multidisciplinary team. NICE advises that further publication on efficacy of FES would be useful specifically including patient-reported outcomes, such as quality of life and activities of daily living, and these outcomes should be examined in different ethnic and socioeconomic groups.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Functional Neuromuscular Stimulation, Stimulation, Electrical, Functional Neuromuscular, Parastep, WalkAide, Handmaster, Bioness NESS L300, Odstock Foot Drop Stimulator, ReGrasp (Rehabtronics), NeuroControl Freehand®, MyGait® Stimulation System

Functional electrical stimulation, Freehand®, NESS H200®, MyndMove System, ReGrasp, WalkAide® System, ODFS® (Odstock Dropped Foot Stimulator), ODFS® Pace XL, L300 Go, Foot Drop System, MyGait® Stimulation System, ERGYS, RT300, Myocycle Home, StimMaster Orion, cycle ergometer

APPROVED BY GOVERNING BODIES:

A variety of FES devices have been cleared by the U.S. Food and Drug Administration (FDA) and are available for home use. Table 1 provides examples of devices designed to improve hand and foot function as well as cycle ergometers for home exercise. The date of the FDA clearance is for the first 510(k) clearance identified for a marketed device. Many devices have additional FDA clearances as the technology evolved, each in turn listing the most recent device as the predicate.

Table 1. Functional Electrical Stimulation Devices Cleared by the FDA

Device

Manufacturer

Device Type

Clearance

Date

Product Code

Freehand®

No longer manufactured

Hand stimulator

 

1997

 

NESS H200® (previously Handmaster)

Bioness

Hand stimulator

K022776

2001

GZC

MyndMove System

MyndTec

Hand stimulator

K170564

2017

GZI/IPF

ReGrasp

Rehabtronics

Hand stimulator

K153163

2016

GZI/IPF

WalkAide® System

Innovative Neurotronics (formerly NeuroMotion)

Foot drop stimulator

K052329

2005

GZI

ODFS® (Odstock Dropped Foot Stimulator)

Odstock Medical

Foot drop stimulator

K050991

2005

GZI

ODFS® Pace XL

Odstock Medical

Foot drop stimulator

K171396

2018

GZI/IPF

L300 Go

Bioness

Foot drop stimulator

K190285

2019

GZI/IPF

Foot Drop System

SHENZHEN XFT Medical

Foot drop stimulator

K162718

2017

GZI

MyGait® Stimulation System

Otto Bock HealthCare

Foot drop stimulator

K141812

2015

GZI

ERGYS (TTI Rehabilitation Gym)

Therapeutic Alliances

Leg cycle ergometer

K841112

1984

IPF

RT300

Restorative Therapies, Inc. (RTI)

Cycle ergometer

K050036

2005

GZI

Myocycle Home

Myolyn

Cycle ergometer

K170132

2017

GZI

StimMaster Orion

Electrologic (no longer in business)

 

 

 

 

FDA: Food and Drug Administration.

To date, the Parastep® Ambulation System (Sigmedics) is the only noninvasive functional walking neuromuscular stimulation device to receive premarket approval from the FDA. The Parastep device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6-T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury.”  FDA product code: MKD.

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply

FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

There are no specific CPT codes for these devices and associated services.

97116

Therapeutic procedure, one or more areas, each 15 minutes; gait training (includes stair climbing)

97530

Therapeutic activities, direct (one-on-one) patient contact (use of dynamic activities to improve functional performance), each 15 minutes

97760

Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(ies), lower extremity(ies), and/or trunk, initial orthotic(s) encounter, each 15 minutes

97763

Orthotic(s)/prosthetic(s) management and/or training, upper extremity (ies), lower extremity (ies), and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 minutes (effective 01/01/18)

HCPCS:

E0764

Functional neuromuscular stimulator, transcutaneous stimulation of muscles of sequential muscle groups of ambulation with computer control, used for walking by spinal cord injured, entire system after completion of training program

E0770

Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified

REFERENCES:

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  2. Alon G, McBride K and Ring H. Improving selected hand functions using a noninvasive neuroprosthesis in persons with chronic stroke. J Stroke Cerebrovasc Dis, Mar-Apr 2002; 11(2): 99-106.

  3. Alon G, Levitt AF and McCarthy PA. Functional Electrical stimulation enhancement of upper extremity functional recovery during stroke rehabilitation: A pilot study. Neurorehabilitation and Neural Repair 2007; 21(3): 204-215.

  4. Alon G, Levitt AF and McCarthy PA. Functional electrical stimulation (FES) may modify the poor prognosis of stroke survivors with severe motor loss of the upper extremity. American Journal Physical Medicine Rehabilitation, August 2008, Vol. 87, NO. 8, pp. 627-636.

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  6. Barrett CL, Mann GE, Taylor PN and Strike P. A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Mult Scler, April 2009; 15(4): 493-504.

  7. Berenpas F, Geurts AC, den Boer J, et al. Surplus value of implanted peroneal functional electrical stimulation over ankle-foot orthosis for gait adaptability in people with foot drop after stroke. Gait Posture. Jun 2019; 71: 157-162.

  8. Bethoux F, Rogers HL, Nolan KJ, et al. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. Sep 2014; 28(7):688-697.

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  16. Esnouf JE, Taylor PN, Mann GE et al. Impact on activities of daily living using a functional electrical stimulation device to improve dropped foot in people with multiple sclerosis, measured by the Canadian Occupational Performance Measure. Mult Scler 2010; 16(9):1141-7.

  17. Everaert DG, Stein RB, Abrams GM et al. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair 2013; 27(7):579-91.

  18. Guest RS, Klose J, Needham-Shropshire BM, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 4. Arch Phys Med Rehabil 1997; 78(8):804-7.

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  23. Hausdorff JM and Ring H. Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil 2008; 87(1):4-13.

  24. Hooker, SS, Figoni, SS, Rodgers, MM, Glaser, RR, Mathews, TT, Suryaprasad, AA, Gupta, SS. Physiologic effects of electrical stimulation leg cycle exercise training in spinal cord injured persons. Arch Phys Med Rehabil, 1992 May 1; 73(5).

  25. Hunt, KK, Fang, JJ, Saengsuwan, JJ, Grob, MM, Laubacher, MM. On the efficiency of FES cycling: a framework and systematic review. Technol Health Care, 2012 Oct 20; 20(5). 

  26. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.

  27. Jacobs PL, Nash MS, Klose KJ, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 2. Effects on physiologic responses to peak arm ergometry. Arch Phys Med Rehabil 1997; 78(8):794-8.

  28. Jaqueline da Cunha M, Rech KD, Salazar AP, et al. Functional electrical stimulation of the peroneal nerve improves post-stroke gait speed when combined with physiotherapy. A systematic review and meta-analysis. Ann Phys Rehabil Med. May 24 2020: 101388.

  29. Johnston, TT, Smith, BB, Mulcahey, MM, Betz, RR, Lauer, RR. A randomized controlled trial on the effects of cycling with and without electrical stimulation on cardiorespiratory and vascular health in children with spinal cord injury. Arch Phys Med Rehabil, 2009 Aug 5; 90(8).

  30. Klose KJ, Jacobs PL, Broton JG, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 1. Ambulation performance and anthropometric measures. Arch Phys Med Rehabil 1997; 78(8):789-93.

  31. Kluding PM, Dunning K, O'Dell MW et al. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke 2013; 44(6):1660-9.

  32. Kressler, JJ, Ghersin, HH, Nash, MM. Use of functional electrical stimulation cycle ergometers by individuals with spinal cord injury. Top Spinal Cord Inj Rehabil, 2014 Dec 6; 20(2). 

  33. Laufer Y, Hausdorff JM and Ring H. Effects of a foot drop neuroprosthesis on functional abilities, social participation, and gait velocity. Am J Phys Med Rehabil 2009; 88(1):14-20.

  34. Meilahn JR. Tolerability and effectiveness of a neuroprosthesis for the treatment of foot drop in pediatric patients with hemiparetic cerebral palsy. PM R. 2013 Jun; 5(6):503-9.

  35. Mulcahey MJ, Betz RR, et al. Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques. Spinal Cord, March 2004; 42(3): 146-155.

  36. Mulcahey MJ, Betz RR, et al. Implanted functional electrical stimulation hand system in adolescents with spinal injuries: An evaluation. Arch Phys Med Rehabil, June 1997; 78(6): 597-607.

  37. Mutton, DD, Scremin, AA, Barstow, TT, Scott, MM, Kunkel, CC, Cagle, TT. Physiologic responses during functional electrical stimulation leg cycling and hybrid exercise in spinal cord injured subjects. Arch Phys Med Rehabil, 1997 Jul 1; 78(7).

  38. Nascimento LR, da Silva LA, Araujo Barcellos JVM, et al. Ankle-foot orthoses and continuous functional electrical stimulation improve walking speed after stroke: a systematic review and meta-analyses of randomized controlled trials. Physiotherapy. Dec 2020; 109: 43-53.

  39. Nash MS, Jacobs PL, Montalvo BM, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 5. Arch Phys Med Rehabil 1997; 78(8):808-14.

  40. National Institute for Health and Clinical Excellence. Functional electrical stimulation for drop foot of central neurological origin. 2009. Available online at: www.nice.org.uk/nicemedia/pdf/IPG278Guidance.pdf. Accessed April 1, 2020.

  41. Needham-Shropshire BM, Broton JG, Klose KJ, et al. Evaluation of a training program for persons with SCI paraplegia using the Parastep®1 Ambulation System: Part 3. Arch Phys Med Rehabil 1997; 78(8):799-803.

  42. O'Dell MW, Dunning K, Kluding P, et al. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM R. Jul 2014; 6(7):587-601; quiz 601.

  43. Pollack, SS, Axen, KK, Spielholz, NN, Levin, NN, Haas, FF, Ragnarsson, KK. Aerobic training effects of electrically induced lower extremity exercises in spinal cord injured people. Arch Phys Med Rehabil, 1989 Mar 1; 70(3). 

  44. Prokopiusova T, Pavlikova M, Markova M, et al. Randomized comparison of functional electric stimulation in posturally corrected position and motor program activating therapy: treating foot drop in people with multiple sclerosis. Eur J Phys Rehabil Med. Aug 2020; 56(4): 394-402.

  45. Prosser LA, Curatalo LA, Alter KE et al. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol 2012; 54(11):1044-9.

  46. Renfrew LM, Paul L, McFadyen A, et al. The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial. Clin Rehabil. Jul 2019; 33(7): 1150-1162.

  47. Ring H, Treger I, Gruendlinger L, et al. Neuroprosthesis for foot drop compared with ankle-foot orthosis: Effects on postural control during walking. J Stroke Cerebrovasc Dis 2009; 18(1):41-7.

  48. Ring and Rosenthal. Controlled study of neuroprosthetic functional electrical stimulation in sub-acute post-stroke rehabilitation. Journal of Rehabilitation Medicine 2005; 37: 32-36.

  49. Rohde LM, Bonder BR, Triolo RJ. Exploratory study of perceived quality of life with implanted standing neuroprostheses. J Rehabil Res Dev 2012; 49(2):265-78.

  50. Sadowsky, CC, Hammond, EE, Strohl, AA, Commean, PP, Eby, SS, Damiano, DD, Wingert, JJ, Bae, KK, McDonald, JJ. Lower extremity functional electrical stimulation cycling promotes physical and functional recovery in chronic spinal cord injury. J Spinal Cord Med, 2013 Oct 8; 36(6). 

  51. Sheffler LR, Hennessey MT, et al. Neuroprosthetic effect of peroneal nerve stimulation in multiple sclerosis: A preliminary study. Arch Phys Med Rehabil, February 2009; 90(2): 362-365.

  52. Snoek GJ, Ijzerman MJ, et al. Use of the NESS handmaster to restore handfunction in tetraplegia: Clinical experiences in ten patients. Spinal Cord, April 2000; 38(4): 244-249.

  53. Stein RB, Everaert DG, Thompson AK et al. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair 2010; 24(2):152-67.

  54. Sykes L, Ross ER, Powell ES, et al. Objective measurement of use of the reciprocating gait orthosis (RGO) and the electrically augmented RGO in adult patients with spinal cord lesions. Prosthet Orthot Int 1996; 20(3):182-90.

  55. Taylor PN, Burridge JH, Dunkerley AL et al. Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking. Arch Phys Med Rehabil 1999; 80(12):1577-83.

  56. Taylor P, Esnouf J Hobby J. The functional impact of the Freehand System on tetraplegic hand function. Clinical Results. Spinal Cord, November 2002; 40(11): 560-566.

  57. Triolo RJ, Bailey SN, Miller ME et al. Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. Arch Phys Med Rehabil 2012; 93(5):896-904.

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  59. Van Swigchem R, Vloothuis J, den Boer J et al. Is transcutaneous peroneal stimulation beneficial to patients with chronic stroke using an ankle-foot orthosis? A within-subjects study of patients' satisfaction, walking speed and physical activity level. J Rehabil Med 2010; 42(2):117-21.

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POLICY HISTORY:

Medical Policy Group, June 2009 (3)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Group, November 2009 (1)

Medical Policy Administration Committee, November 2009

Available for comment November 6-December 21, 2009

Medical Policy Group, March 2010 (3)

Medical Policy Administration Committee, April 2010

Available for comment April 15-May 29, 2010

Medical Policy Group, March 2011

Medical Policy Group, February 2012 (2): 2012 Update-Key Points, References and Key Words; no change in policy statement

Medical Policy Group, December 2012 (3): 2013 Coding Updates: Verbiage change to Code 97530 – removed “by the provider”.

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3): 2013 Updates: Policy statement updated to include congenital disorders; Description, Key points and References also updated.

Medical Policy Committee February 2013

Available for comment February 21 through April 7, 2013

Medical Policy Group, November 2013 (2): New literature search. No change in policy statement. Title updated.

Medical Policy Panel February 2014

Medical Policy Group February 2014 (4): Updated Description, Key Points, Approved Governing Bodies, References.  No change to policy statement at this time.

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (6):  Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group August 2016 (6): Updates to Description, Key Points, Key Words, Summary and References. No change to policy statement.

Medical Policy Group, February 2017 (6): For information regarding Functional Electrical Stimulation cycle devices refer to medical policy #132, Rehabilitative/Habilitative Medical Criteria for Physical/Occupational Therapy added to Description.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (6): Updates to Description and Key Points. No change to policy statement.

Medical Policy Group, December 2017. Annual Coding Update 2018. Updated verbiage for revised CPT code 97760.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points, Key Words and Coding.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (6): Updates to Description, Key Points, Key Words (Functional electrical stimulation, Freehand®, NESS H200®, MyndMove System, ReGrasp, WalkAide® System, ODFS® (Odstock Dropped Foot Stimulator), ODFS® Pace XL, L300 Go, Foot Drop System, MyGait® Stimulation System, ERGYS, RT300, Myocycle Home, StimMaster Orion) , Governing Bodies and References. FES cycle ergometer transferred from MP#132 Rehabilitative/Habilitative Medical Criteria for Physical/Occupational Therapy. Functional electrical stimulation devices for exercise in patients with spinal cord injury are considered investigational.

Medical Policy Panel, May 2020

Medical Policy Group, July 2020 (3): 2020 Updates to Key Points, Approved By Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, March 2021

Medical Policy Group, April 2021(3): 2021 Updates to Key Points and References. Policy section updated to remove not medically necessary from statement. No change in intent.

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.