mp-124
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Myoelectric Prosthetic and Orthotic Components for the Upper Limb

Policy Number: MP-124

Latest Review Date: March 2021

Category: DME                                                                     

Policy Grade:  B

POLICY:

Myoelectric prostheses may be considered medically necessary for patients with upper limb amputations:

  • The patient has an amputation or missing limb at the wrist or above (e.g. forearm, elbow); AND
  • Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; AND
  • The remaining musculature of the arms(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; AND
  • The patient has demonstrated sufficient neurological and cognitive function to operate the prosthesis effectively; AND
  • The patient is free of comorbidities that could interfere with function of the prosthesis (e.g. neuromuscular disease); AND
  • Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual (e.g., gripping, releasing, holding, and coordination movement of the prosthesis) when performing activities of daily living.  This evaluation should consider the patient’s needs for control, durability (maintenance), function (speed, work capability), and usability. 
  • Children age 2 years or older who have shown at least 6 months successful use of a passive prosthetic device and have a minimum EMG signal of 6μV threshold.

One myoelectric prosthesis per limb per five years is covered when medically indicated. Coverage will not be provided if the prosthesis is functioning properly and in good general condition.

A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational. 

High-definition silicone used to make a prosthesis resemble a patient’s skin is considered not medically necessary and cosmetic.

Myoelectric prostheses are contraindicated, and therefore considered not medically necessary for patients with upper limb amputations:

  • Whose ADLs require frequent lifting of heavy objects (16lbs or greater);
  • Whose environments involve frequent contact with dirt, dust, grease, water, and solvent;
  • Whose neuromas and/or phantom limb pain are exacerbated with the use of the prosthesis.

Myoelectric controlled upper-limb orthoses are considered investigational.

Upper-limb prosthetic components with both sensor and myoelectric controls (LUKE/DEKA), is considered investigational. 

DESCRIPTION OF PROCEDURE OR SERVICE:

Myoelectric prostheses are powered by electric motors with an external power source. The joint movement of upper limb prosthesis (e.g., hand, wrist, and/or elbow) is driven by microchip-processed electrical activity in the muscles of the remaining limb stump.

Upper-Limb Amputation

The need for a prosthesis can occur for a number of reasons, including trauma, surgery, or congenital anomalies.

Treatment

The primary goals of the upper limb prostheses are to restore natural appearance and function. Achieving these goals also requires sufficient comfort and ease of use for continued acceptance by the wearer. The difficulty of achieving these diverse goals with an upper limb prosthesis increases as the level of amputation (digits, hand, wrist, elbow, and shoulder), and thus the complexity of joint movement increases.

Upper limb prostheses are classified into 3 categories depending on the means of generating movement at the joints: passive, body-powered, and electrically powered movement. All 3 types of prostheses have been in use for more than 30 years; each possesses unique advantages and disadvantages.

Passive Prostheses

The passive prostheses rely on manual repositioning, typically using the opposite arm and cannot restore function. This unit is the lightest of the 3 prosthetic types and is thus generally the most comfortable.

Body-Powered Prostheses

The body-powered prosthesis uses a body harness and cable system to provide functional manipulation of the elbow and hand. Voluntary movement of the shoulder and/or limb stump extends the cable and transmits the force to the terminal device. Prosthetic hand attachments, which may be claw-like devices that allow good grip strength and visual control of objects or latex-gloved devices that provide a more natural appearance at the expense of control, can be opened and closed by the cable system. Patient complaints with body-powered prostheses include harness discomfort, particularly the wear temperature, wire failure, and the unattractive appearance.

Myoelectric Prostheses

Myoelectric prostheses use muscle activity from the remaining limb for the control of joint movement. Electromyographic (EMG) signals from the limb stump are detected by surface electrodes, amplified, and then processed by a controller to drive battery-powered motors that move the hand, wrist, or elbow. Although upper arm movement may be slow and limited to one joint at a time, myoelectric control of movement may be considered the most physiologically natural.

Myoelectric hand attachments are similar in form to those offered with the body-powered prosthesis, but are battery-powered. Commercially available examples include:

  • The Michelangelo Hand (Advanced Arm Dynamics)
  • i-limb (Touch Bionics)
  • benionic (steeper)

A hybrid system, a combination of body-powered and myoelectric components, may be used for high-level amputations (at or above the elbow). Hybrid systems allow control of 2 joints at once (i.e., 1 body-powered and 1 myoelectric) and are generally lighter and less expensive than a prosthesis composed entirely of myoelectric components.

Technology in this area is rapidly changing, driven by advances in biomedical engineering and by the U.S. Department of Defense Advanced Research Projects Agency (DARPA), which is funding a public and private collaborative effort on prosthetic research and development. Areas of development include the use of skin-like silicone elastomer gloves, “artificial muscles,” and sensory feedback. Smaller motors, microcontrollers, implantable myoelectric sensors, and re-innervation of remaining muscle fibers are being developed to allow fine movement control. Lighter batteries and newer materials are being incorporated into myoelectric prostheses to improve comfort.

The LUKE Arm (previously known as the DEKA Arm System) was developed in a joint effort between DEKA Research & Development and the U.S. Department of Defense Advanced Research Projects Agency program. It is the first commercially available myoelectric upper limb that can perform complex tasks with multiple simultaneous powered movements (e.g., movement of the elbow, wrist, and hand at the same time). In addition to the EMG electrodes, the LUKE Arm contains a combination of mechanisms including switches, movement sensors, and force sensors. The primary control resides with inertial measurement sensors on top of the feet. The prosthesis includes vibration pressure and grip sensors.

Myoelectric Orthoses

The MyoPro (Myomo) is a myoelectric powered upper-extremity orthotic. This orthotic device weighs about 1.8 kilograms (4 pounds), has manual wrist articulation, and myoelectric initiated bi-directional elbow movement. The MyoPro detects weak muscle activity from the affected muscle groups. A therapist or prosthetist/orthoptist can adjust the gain (amount of assistance), signal boost, thresholds, and range of motion. Potential users include patients with traumatic brain injury, spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis, and multiple sclerosis. Use of robotic devices for therapy has been reported. The MyoPro is the first myoelectric orthotic available for home use.

KEY POINTS:

The most recent literature update was performed through December 13, 2020.

SUMMARY OF EVIDENCE:

For individuals who have a missing limb at the wrist or higher who receive myoelectric upper-limb prosthesis components at or proximal to the wrist, the evidence includes a systematic review and comparative studies. Relevant outcomes are functional outcomes and quality of life. The goals of upper-limb prostheses relate to restoration of both appearance and function while maintaining sufficient comfort for continued use. The identified literature focuses primarily on patient acceptance and rejection; data are limited or lacking in the areas of function and functional status. The limited evidence suggests that, when compared with body-powered prostheses, myoelectric components possess the similar capability to perform light work; however, myoelectric components could also suffer a reduction in performance when operating under heavy working conditions. The literature has also indicated that the percentage of amputees who accept the use of a myoelectric prosthesis is approximately the same as those who prefer to use a body-powered prosthesis, and that self-selected use depends partly on the individual’s activities of daily living. Appearance is most frequently cited as an advantage of myoelectric prostheses, and for patients who desire a restorative appearance, the myoelectric prosthesis can provide greater function than a passive prosthesiswith equivalent function to a body-powered prosthesis for light work. Because of the different advantages and disadvantages of currently available prostheses, myoelectric components for persons with an amputation at the wrist or above may be considered when passive, or body-powered prostheses cannot be used or are insufficient to meet the functional needs of the patient in activities of daily living. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a missing limb at the wrist or higher who receive sensor and myoelectric controlled upper-limb prosthetic components, the evidence includes a series of publications from a 12-week home study. Relevant outcomes are functional outcomes and quality of life. The prototypes for the advanced prosthesis were evaluated by the U.S. military and Veterans Administration. Demonstration of improvement in function has been mixed. After several months of home use, activity speed was shown to be similar to the conventional prosthesis, and there were improvements in the performance of some activities, but not all. There were no differences between the prototype and the participants’ prostheses for outcomes of dexterity, prosthetic skill, spontaneity, pain, community integration, or quality of life. Study of the current generation of the sensor and myoelectric controlled prosthesis is needed to determine whether newer models of this advanced prosthesis lead to consistent improvements in function and quality of life. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a missing limb distal to the wrist who receive a myoelectric prosthesis with individually powered digits, no peer-reviewed publications evaluating functional outcomes in amputees were identified. Relevant outcomes are functional outcomes and quality of life. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with upper-extremity weakness or paresis who receive a myoelectric powered upper-limb orthosis, the evidence includes a small within-subject study. Relevant outcomes are functional outcomes and quality of life. The largest study (N=18) identified tested participants with and without the orthosis but did not provide any training with the device. Performance on the tests was inconsistent. Studies are needed that show consistent improvements in relevant outcome measures. Results should also be replicated in a larger number of patients. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Myoelectric hand, myoelectric arm, myoelectric elbow, electric prosthesis, electronic prosthesis, Utah Arm and Hand System, Otto Bock myoelectric prosthesis, LTI Boston Digital arm System,  SensorHand™, ProDigits™ and i-LIMB™, LIVINGSKIN™, MyoPro™, MyoMo, Inc., LUKE™ arm, The Michelangelo Hand (Advanced Arm Dynamics), DEKA Gen 2 and DEKA Gen 3

APPROVED BY GOVERNING BODIES:

Manufacturers must register prostheses with the Restorative and Repair Devices Branch of the U.S. Food and Drug Administration (FDA) and keep a record of any complaints, but do not have to undergo a full FDA review.

Available myoelectric devices include ProDigits™ and i-limb™ (Touch Bionics), the SensorHand™ Speed and Michelangelo® Hand (Otto Bock), the LTI Boston Digital Arm™ System (Liberating Technologies), the Utah Arm Systems (Motion Control), and bebionic (steeper).

In 2014, the DEKA Arm System (DEKA Integrated Solutions, now DEKA Research & Development), now called the LUKE™ Arm (Mobius Bionics), was cleared for marketing by FDA through the de novo 513(f)(2) classification process for novel low- to moderate-risk medical devices that are first-of-a-kind.

The MyoPro® (Myomo) is registered with the FDA as a Class 1 limb orthosis.

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 contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS codes:

L3999

Upper limb orthosis, not otherwise specified

L6026

Transcarpal/metacarpal or partial hand disarticulation prosthesis, external power, self-suspended, inner socket with removable forearm section, electrodes and cables, two batteries, charger, myoelectric control of terminal device, excludes terminal device(s)

L6629

Upper extremity addition, quick disconnect lamination collar with coupling piece, otto bock or equal

L6672

Upper extremity addition, harness, chest or shoulder, saddle type

L6680

Upper extremity addition, test socket, wrist disarticulation or below elbow

L6682

Upper extremity addition, test socket, elbow disarticulation or above elbow

L6684

Upper extremity addition, test socket, shoulder disarticulation or interscapular thoracic

L6686

Upper extremity addition, suction socket

L6687

Upper extremity addition, frame type socket, below elbow or wrist disarticulation

L6688

Upper extremity addition, frame type socket, above elbow or elbow disarticulation

L6689

Upper extremity addition, frame type socket, shoulder disarticulation

L6690

Upper extremity addition, frame type socket, interscapular-thoracic

L6715

Terminal device, multiple articulating digit, includes motor(s), initial issue or replacement.

L6880

Electric hand, switch or myoelectric controlled, independently articulating digits, any grasp pattern or combination of grasp patterns, includes motor(s).

L6890

Terminal device, glove for above hands, production glove

L6895

Terminal device, glove for above hands, custom glove

L6925

Wrist disarticulation, external power, self-suspended inner socket, removable forearm shell, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6935

Below elbow, external power, self-suspended inner socket, removable forearm shell, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6945

Elbow disarticulation, external power, molded inner socket, removable humeral shell, outside locking hinges, forearm, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6950

Above elbow, external power, molded inner socket, removable humeral shell, internal locking elbow, forearm, otto bock or equal switch, cables, two batteries and one charger, switch control of terminal device

L6955

Above elbow, external power, molded inner socket, removable humeral shell, internal locking elbow, forearm, otto bock or equal electrodes, cables two batteries and one charger, myoelectronic control of terminal device

L6965

Shoulder disarticulation, external power, molded inner socket, removable shoulder shell, shoulder bulkhead, humeral section, mechanical elbow, forearm, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L6975

Interscapular-thoracic, external power, molded inner socket, removable shoulder shell, shoulder bulkhead, humeral section, mechanical elbow, forearm, otto bock or equal electrodes, cables, two batteries and one charger, myoelectronic control of terminal device

L7007

Electric hand, switch or myoelectric controlled, adult

L7008

Electric hand, switch or myoelectric, controlled, pediatric

L7009

Electric hook, switch or myoelectric controlled, adult

L7045

Electric hook, switch or myoelectric controlled, pediatric

L7180

Electronic elbow, Boston, Utah or equal, myoelectronically controlled

L7190

Electronic elbow, adolescent, Variety Village or equal, myoelectronically controlled

L7191

Electronic elbow, child, Variety Village or equal, myoelectronically controlled

L7259

Electronic wrist rotator, any type

L7261

Electronic wrist rotator, for Utah arm

L7360

Six volt battery, otto bock or equal, each

L7362

Battery charger, six volt, otto bock or equal

L7364

Twelve volt battery, Utah or equal, each

L7366

Battery charger, twelve volt, Utah or equal

L7499

Upper extremity prosthesis, not otherwise specified

L8465

Prosthetic shrinker, upper limb, each

L8701

Powered upper extremity range of motion assist device, Elbow, wrist, hand device, powered, with single or double upright(s), any type joint(s), includes microprocessor, sensors, all components and accessories, custom fabricated (Effective 01/01/2019, Revised 10/1/2020)

L8702

Powered upper extremity range of motion assist device, Elbow, wrist, hand, finger device, powered, with single or double upright(s), includes microprocessor, sensors, all components and accessories custom fabricated (Effective 01/01/2019, Revised 10/1/2020)

REFERENCES:

  1. Atkins DJ, Heard DCY and Donovan WH. Epidemiologic overview of individuals with upper-limb loss and their reported research priorities. J Pros and Orth, 1996: 8(1).
  2. Berke GM and Nielsen CC. Establishing parameters affecting the use of myoelectric prostheses in children: A preliminary investigation. J Pros and Orth, 1991: 3(4).
  3. Biddiss EA and Chau TT. Upper limb prosthesis use and abandonment: A survey of the last 25 years. Prosthet Orthot Int, September 2007; 31(3): 236-257.
  4. Biddiss E and Chau T. Upper-limb prosthetics: Critical factors in device abandonment. Am J Phys Med Rehabilitation, December 2007; 86(12): 977-987.
  5. Blue Cross Blue Shield Association. Myoelectric prosthesis for the upper limb. Medical Policy Reference Manual, December 2008.
  6. Bonivento C, Davalli A, Fantuzzi C, Sacchetti R and Terenzi S. Automatic tuning of myoelectric prostheses. J Rehab Research and Develop, 1998: 35(3); 294-304.
  7. Edelstein JE and Berger N. Performance comparison among children fitted with myoelectric and body-powered hands. Arch Phys Med Rehabil, April 1993; 74(4): 376-380.
  8. Egermann M, Kasten P, Thomsen M. Myoelectric hand prostheses in very young children. Int Orthop 2009; 33(4):1101-5.
  9. Greatting, MD, Creek B, Hill JJ and Supan TJ. Myoelectric prostheses in upper extremity amputees: Cost, mechanical reliability and long-term wear rate. American Academy of Orthopaedic Surgeons 1991 Annual Meeting-Scientific Program; Paper No. 314.
  10. James MA, Bagley AM, Brasington K, et al. Impact of prostheses on function and quality of life for children with unilateral congenital below-the-elbow deficiency. J Bone Joint Surg Am, November 2006; 88(11): 2356-2365.
  11. Kampas P. The optimal use of myoelectrodes, Translation of: Med Orth Tec 2001; 121: 21-27.
  12. Kruger LM and Fishman S. Myoelectric and body-powered prostheses. J Pediatr Orthop, Jan-Feb 1993; 13(1): 68-75.
  13. Lindner HY, Linacre JM, Norling Hermansson LM. Assessment of capacity for myoelectric control: evaluation of construct and rating scale. J Rehabil Med 2009;41(6):467-74.
  14. McFarland LV, Hybbard Winkler SL, Heinemann AW et al. Unilateral upper-limb loss: satisfaction and prosthetic device use in veterans and service members from Vietnam and OIF/OEF conflict. J Rehabil Res Dev 2010;47(4):299-316.
  15. Moseley Chris. A study of upper-extremity myoelectric prosthetics and their external power sources. The Official Journal of ISPE, March/April 2002, Vol. 22, No. 2.
  16. Peters HT, Page SJ, Persch A. Giving them a hand: wearing a myoelectric elbow-wrist-hand orthosis reduces upper extremity impairment in chronic stroke. Ann Rehabil Med. Sep 2017; 98(9):1821-1827.
  17. Pylatiuk C, Schulz S and Doderlein L. Results of an Internet survey of myoelectric prosthetic hand users. Prosthet Orthot Int, December 2007; 31(4): 362-370.
  18. Resnik LJ, Borgia ML, Acluche F. Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use. PLoS One. Jun 2017; 12(6):e0178640.
  19. Resnik L, Cancio J, Klinger S, et al. Predictors of retention and attrition in a study of an advanced upper limb prosthesis: implications for adoption of the DEKA Arm. Disabil Rehabil Assist Technol. Feb 2018; 13(2):206-210.
  20. Resnik L, Klinger S. Attrition and retention in upper limb prosthetics research: experience of the VA home study of the DEKA arm. Disabil Rehabil Assist Technol. Nov 2017; 12(8):816-821.
  21. Resnik LJ, Borgia ML, Acluche F, et al. How do the outcomes of the DEKA Arm compare to conventional prostheses? PLoS One. Jan 2018; 13(1):e0191326.
  22. Resnik L, Acluche F, Lieberman Klinger S, et al. Does the DEKA Arm substitute for or supplement conventional prostheses. Prosthet Orthot Int. Sep 1 2017: 309364617729924.
  23. Resnik L, Acluche F, Borgia M. The DEKA hand: A multifunction prosthetic terminal device-patterns of grip usage at home. Prosthet Orthot Int. Sep 1 2017: 309364617728117.
  24. Silcox III DH, Rooks MD et al. Myoelectric prostheses. A long-term follow-up and a study of the use of alternate prostheses. J Bone Joint Surg Am, December 1993; 75(12): 1781-1789.
  25. Sjoberg L, Lindner H, Hermansson L. Long-term results of early myoelectric prosthesis fittings: A prospective case-control study. Prosthet Orthot Int. Sep 1 2017: 309364617729922.
  26. Skewes E, Haas J and Kruger AM. Surlyn sockets for below-elbow myoelectric prostheses, Journal of Association of Children’s Pros-Ortho Clin, 1988; 23(1): 19-20.

POLICY HISTORY:

Medical Policy Group, June 2003 (2)

Medical Policy Administration Committee, June 2003

Available for comment July 1-August 14, 2003

Medical Policy Group, December 2004 (1)

Medical Policy Group, April 2005 (2)

Medical Policy Administration Committee, April 2005

Available for comment April 27-June 10, 2005

Medical Policy Group, April 2006 (1)

Medical Policy Group, April 2007 (1)

Medical Policy Group, May 2009 (1)

Medical Policy Panel, February 2010

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Panel, March 2011

Medical Policy Group, June 2011 (2): Key Points, Key Words, Regulatory Status updated

Medical Policy Group, December 2011 (1): 2012 Code Updates; Delete code L7274 effective January 1, 2012

Medical Policy Panel, June 2012

Medical Policy Group, June 2012 (2): Updated policy to indicate a prosthesis with individually powered digits as investigational.  Description, Key Words, Approved by Governing Bodies, Coding, References updated. Key Points rewritten.

Medical Policy Administration Committee, June 2012

Available for comment June 29, 2012 through August 12, 2012

Medical Policy Panel, June 2013

Medical Policy Group, September 2013 (2): title changed to Myoelectric Prosthetic Components for the Upper Limb, Policy statements unchanged, Codes added for partial hand myoelectric prosthesis, child and adolescent myoelectric arm prosthesis. 

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (5): Policy updated with literature review through May 23, 2014; Updated Approved by Governing Bodies; no references added; policy statement unchanged.

Medical Policy Group, November 2014: 2015 Annual Coding update. Added HCPCS L6026 and L7259 and moved deleted HCPCS code L6025 to previous coding.

Medical Policy Group, December 2014 (5) Added statement of coverage of one computerized prostheses per limb per five years when medically indicated.  Coverage will not be provided if the prosthesis is functioning properly and in good general condition. This language of limits has always been applied to prosthesis.

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (6): Updates to Key Points and Approved by Governing Bodies; no change to policy statement.

Medical Policy Group, August 2015 (6): Updates to Title, Description, Key Points, Approved by Governing Bodies, Key Words and Coding sections to include myoelectric orthotic upper extremity devices. Policy statement updated to include myoelectric orthotic devices for the upper extremity as investigational. No changes in coverage as these devices have been considered investigational.

Medical Policy Panel, December 2016

Medical Policy Group, December 2016 (6): Updates to Description, Key Points, Key Words, Governing Bodies and Summary. No change in policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (6): Updates to Description and Key Points.

Medical Policy Panel, March 2018

Medical Policy Group, April 2018 (6): Updates to Policy statement to include investigational status of LUKE/DEKA prosthetic, Key Points, Key Words and References.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added HCPCS codes L8701 and L8702 to the Current coding section.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Key Points and Approved by Governing Bodies. No change in policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points.

Medical Policy Group, September 2020: Quarterly coding update. Revised HCPCS codes L8701 and L8702.

Medical Policy Group, March 2021

Medical Policy Panel, March 2021 (6): Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy 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.