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Quantitative Sensory Testing (QST)

Policy Number: MP-066

Latest Review Date: July 2021

Category:  Medical                                                  

Policy Grade:  B

POLICY:

Quantitative sensory testing (QST) is considered investigational. 

Current perception threshold (CPT) testing is considered investigational.  

Pressure-specified sensory device (PSSD) testing is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Quantitative sensory testing (QST) systems are used for the noninvasive assessment and quantification of sensory nerve function in patients with symptoms of or the potential for neurologic damage or disease.  Types of sensory testing include current perception threshold testing, pressure-specified sensory testing, vibration perception testing, and thermal sensory testing. Information on sensory deficits identified using QST has been used in research settings to better understands neuropathic pain. It could potentially be used to diagnose conditions linked to nerve damage and disease, and to improve patient outcomes by impacting management strategies.

Nerve Damage and Disease

Nerve damage and nerve diseases can reduce functional capacity and lead to neuropathic pain.

Treatment

There is a need for tests that can objectively measure sensory thresholds. Moreover, quantitative sensory testing (QST) could aid in the early diagnosis of disease, before patients would be diagnosed clinically. Also, although the criterion standard for evaluation of myelinated, large fibers is electromyography nerve conduction study, there are no criterion standard reference tests to diagnose small fiber dysfunction.

Quantitative Sensory Testing

Quantitative sensory testing (QST) systems measure and quantify the amount of physical stimuli required for sensory perception to occur. As sensory deficits increase, the perception threshold of QST will increase, which may be informative in documenting progression of neurologic damage or disease. QST has not been established for use as a sole tool for diagnosis and management but has been used with standard evaluative and management procedures (e.g., physical and neurologic examination, monofilament testing, pinprick, grip and pinch strength, Tinel sign, and Phalen and Roos test) to enhance the diagnosis and treatment-planning process, and to confirm physical findings with quantifiable data. Stimuli used in QST includes touch, pressure, pain, thermal (warm and cold), or vibratory stimuli.

The criterion for evaluation of myelinated large fibers is the electromyographic nerve conduction study (EMG-NCS). However, the function of smaller myelinated and unmyelinated sensory nerves, which may show pathologic changes before the involvement of the motor nerves, cannot be detected by nerve conduction studies. Small fiber neuropathy has traditionally been a diagnosis of exclusion in patients who have symptoms of distal neuropathy and a negative nerve conduction study.

Depending on the type of stimuli used, QST can assess both small and large fiber dysfunction. Touch and vibration measure the function of large myelinated A-alpha and A-beta sensory fibers. Thermal stimulation devices are used to evaluate pathology of small myelinated and unmyelinated nerve fibers; they can be used to assess heat and cold sensation, as well as thermal pain thresholds. Pressure-specified sensory devices (PSSD) assess large myelinated sensory nerve function by quantifying the thresholds of pressure detected with light, static, and moving touch. Finally, current perception threshold testing involves the quantification of the sensory threshold to transcutaneous electrical stimulation. In current perception threshold testing, typically three different frequencies are tested: 5 Hz, designed to assess C fibers; 250 Hz, designed to assess A-delta fibers; and 2,000 Hz, designed to assess A-beta fibers. Results are compared with those of a reference population.

Because QST combines the objective physical sensory stimuli with the subject patient response, it is psychophysical in nature and requires patients who are alert, able to follow directions, and cooperative. In addition, to get reliable results, examinations need to be standardized with standardized instructions to the patients, and stimuli must be applied in a consistent manner by trained staff. Psychophysical tests have greater inherent variability, making their results more difficult to standardize and reproduce.

KEY POINTS:

The most recent literature review was updated through April 19, 2021.

Summary of Evidence

For individuals who have conditions linked to nerve damage or disease (e.g., diabetic neuropathy, carpal tunnel syndrome) who receive current perception threshold testing, the evidence includes several studies on technical performance and diagnostic accuracy. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. The existing evidence does not support the accuracy of current perception threshold testing for diagnosing any condition linked to nerve damage or disease. Studies comparing current perception threshold testing with other testing methods have not reported on sensitivity or specificity. Also, there is a lack of direct evidence on the clinical utility of current perception testing and, because there is insufficient evidence on test performance, an indirect chain of evidence on clinical utility cannot be constructed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have conditions linked to nerve damage or disease (e.g., diabetic neuropathy, carpal tunnel syndrome) who receive pressure-specified sensory testing, the evidence includes several studies on diagnostic accuracy. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. Current evidence does not support the diagnostic accuracy of pressure-specified sensory testing for diagnosing any condition linked to nerve damage or disease. A systematic review found that pressure-specified sensory testing had low accuracy for diagnosing spinal conditions. Also, there is a lack of direct evidence on the clinical utility of current perception testing and, because there is insufficient evidence on test performance, an indirect chain of evidence on clinical utility cannot be constructed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have conditions linked to nerve damage or disease (e.g., diabetic neuropathy, carpal tunnel syndrome) who receive VPT, the evidence includes several studies on diagnostic accuracy. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. A few studies have assessed the diagnostic performance of vibration testing using devices not cleared by the FDA. Also, there is a lack of direct evidence on the clinical utility of VPT and, in the absence of sufficient evidence on test performance, an indirect chain of evidence on clinical utility cannot be constructed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have conditions linked to nerve damage or disease (e.g., diabetic neuropathy, carpal tunnel syndrome) who receive thermal sensory testing, the evidence includes diagnostic accuracy studies. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. Two studies identified evaluated the diagnostic accuracy of thermal QST using the same FDA -cleared device. Neither found a high diagnostic accuracy for thermal QST but both studies found the test had potential when used with other tests. An additional study using a different device also supports the potential of thermal QST in combination with other tests. The optimal combination of tests is currently unclear. Also, there is a lack of direct evidence on the clinical utility of thermal sensory testing and, because there is insufficient evidence on test performance, an indirect chain of evidence on clinical utility cannot be constructed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Neurology

The American Academy of Neurology (2003; reaffirmed 2019)) concluded that quantitative sensory testing (QST) is probably (level B recommendation) an effective tool for documenting of sensory abnormalities and for documenting changes in sensory thresholds in longitudinal evaluation of patients with diabetic neuropathy.  Evidence was weak or insufficient to support the use of QST in patients with other conditions (small fiber sensory neuropathy, pain syndromes, toxic neuropathies, uremic neuropathy, acquired and inherited demyelinating neuropathies, or malingering).

American Association of Neuromuscular & Electrodiagnostic Medicine

The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) published a technology literature review on QST (light touch, vibration, thermal, pain) in 2004. The review concluded that QST is a reliable psychophysical test of large- and small-fiber sensory modalities but is highly dependent on the full patient cooperation. Abnormalities do not localize dysfunction to the central or peripheral nervous system, and no algorithm can reliably distinguish between psychogenic and organic abnormalities. The AANEM review also indicated that QST has been shown to be reasonably reproducible over a period of days or weeks in normal subjects, but, for individual patients, more studies are needed to determine the maximum allowable difference between two QSTs that can be attributed to experimental error.

In 2005, the AANEM with AAN and American Academy of Physical Medicine & Rehabilitation developed a formal case definition of distal symmetrical polyneuropathy based on a systematic analysis of peer-reviewed literature supplemented by consensus from an expert panel. QST was not included as part of the final case definition, given that the reproducibility of QST ranged from poor to excellent, and the sensitivities and specificities of QST were found to vary widely among studies. The American Association of Electrodiagnostic Medicine (AAEM) published a technology literature review on quantitative sensory testing (light touch, vibration, thermal, and pain) in 2004. The review concluded that QST is a reliable psychophysical test of large- and small-fiber sensory modalities but is highly dependent on the full cooperation of the patient. Abnormalities do not localize dysfunction to the central or peripheral nervous system, and no algorithm can reliably distinguish between psychogenic and organic abnormalities. The AAEM technology review also indicated that QST has been shown to be reasonably reproducible over a period of days or weeks in normal subjects, but for individual patients, more studies are needed to determine the maximum allowable difference between two QSTs that can be attributed to experimental error.

American Diabetes Association

In 2021, the American Diabetes Association published an updated standard for microvascular complications and foot care. Although temperature and vibration testing are recommended as part of the evaluation of small fiber and large fiber function, respectively, the specific screening tests for diabetic peripheral neuropathy that are described in the standard are manual/clinical rather than quantitative. Therefore, QST does not appear to have a role in the routine evaluation or diagnosis of diabetic peripheral neuropathy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Neurometer, current perception threshold testing, CPT, nerve conduction study, NCS, Medi-Dx 7000, quantitative sensory testing, sensory testing, pressure-specified sensory devices, PSSD, vibration perception threshold devices, VPT, CASE IV, CASE IV Computer Aided Sensory Evaluator, Thermal Threshold Tester, TTT, Thermal Sensory Analyzer, TSA, Nk Pressure-Specified Sensory Device, Medi-Dx 7000®

APPROVED BY GOVERNING BODIES:

A number of QST devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples are listed in Table 1.

Table 1. FDA-Approved Quantitative Sensory Testing Devices

Device

Manufacturer

Date Cleared

510(k)

Indications

FDA product code: LLN

 

 

 

 

Neurometer®

Neurotron

Jun 1986

K853608

Current perception threshold testing

NK Pressure-Specified Sensory Device, Model PSSD

NK Biotechnical Engineering

Aug 1994

K934368

Pressure specified sensory testing

AP-4000, Air Pulse Sensory Stimulator

Pentax Precision Instrument

Sep 1997

K964815

Pressure specified sensory testing

Neural-Scan

Neuro-Diagnostic Assoc.

Dec 1997

K964622

Current perception threshold testing

Vibration Perception Threshold (VPT) METER

Xilas Medical

Dec 2003

K030829

Vibration perception testing

FDA product code: NTU

 

 

 

 

Contact Heat-Evoked Potential Stimulator (Cheps)

Medoc, Advanced Medical Systems

Feb 2005

K041908

Thermal sensory testing

FDA: Food and Drug Administration.

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

CURRENT CODING: 

CPT codes:

0106T

Quantitative sensory testing (QST), testing and interpretation per extremity; using touch pressure stimuli to assess large diameter sensation

0107T

Quantitative sensory testing (QST), testing and interpretation per extremity; using vibration stimuli to assess large diameter fiber sensation

0108T

Quantitative sensory testing (QST), testing and interpretation per extremity; using cooling stimuli to assess small nerve fiber sensation and hyperalgesia

0109T

Quantitative sensory testing (QST), testing and interpretation per extremity; using heat-pain stimuli to assess small nerve fiber sensation and hyperalgesia

0110T

Quantitative sensory testing (QST), testing and interpretation per extremity; using other stimuli to assess sensation

HCPCS:

G0255

Current perception threshold/sensory nerve conduction test (SNCT), per limb, any nerve

                       

The following codes should NOT be billed for these procedures:

CODING:

CPT codes:

95925

Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper limbs

95926

Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in lower limbs

95927

Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in the trunk or head

95937

Neuromuscular junction testing (repetitive stimulation, paired stimuli), each nerve, any one method

REFERENCES:

  1. Abraham A, Albulaihe H, Alabdali M, et al. Elevated vibration perception thresholds in CIDP patients indicate more severe neuropathy and lower treatment response rates. PLoS One. 2015; 10(11):e0139689.
  2. Ahmad S, De Oliveira GS, Jr., Bialek JM, et al. Thermal quantitative sensory testing to predict postoperative pain outcomes following gynecologic surgery. Pain Med. May 2014; 15(5):857-864.
  3. American Academy of Neurology. Quantitative Sensory Testing (Reaffirmed 2019). 2003;
  4. https://www.aan.com/Guidelines/home/GuidelineDetail/87. Accessed August 20, 2020.
  5. American Academy of Neurology American Academy of Neurology. Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Available online at: www.guideline.gov. Last accessed August, 2012.
  6. American Academy of Neurology. Quantitative Sensory Testing (reaffirmed 2016). 2003; https://www.aan.com/Guidelines/home/GuidelineDetail/87. Accessed May 18, 2018.
  7. American Association of Electrodiagnostic Medicine. Technology review: The Neurometer® current perception threshold (CPT). Muscle and Nerve, April 1999; 22: 523-531.
  8. Anand P, Privitera R, Yiangou Y, et al. Trench foot or non-freezing cold injury as a painful vaso-neuropathy: clinical and skin biopsy assessments. Front Neurol. Sep 2017; 8:514.
  9. Attal N, Bouhassira D, Gautron M et al. Thermal hyperalgesia as a marker of oxaliplatin neurotoxicity:  a prospective quantified sensory assessment study. Pain 2009; 144(3):245-52.
  10. Azzopardi K, Gatt A, Chockalingam N, et al. Hidden dangers revealed by misdiagnosed diabetic neuropathy: A comparison of simple clinical tests for the screening of vibration perception threshold at primary care level. Prim Care Diabetes. Apr 2018; 12(2):111-115.
  11. Ben Eliyahu, DJ, Tartaglia SV, and Spinelle R. Current perception threshold/quantitative sensory testing and MRI findings in patients with signs and symptoms of cervical or lumbar disc herniation: A correlative study of the neurosensory diagnosis of discogenic pain. American Journal of Pain Management 2000; 10: 60-66.
  12. Blue Cross Blue Shield Association, Medical Policy Reference Manual. Current perception threshold testing, January 2004.
  13. Blue Cross Blue Shield Association, Medical Policy Reference Manual. Quantitative sensory testing, April 2008.
  14. Centers for Medicare & Medicaid Services (CMS). Decision Memorandum for Reconsideration of National Coverage Determination: Sensory Nerve Conduction Threshold Testing, July 8, 2003.
  15. Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Issues Manual, Current perception threshold/sensory nerve conduction threshold test (sNCT). Section 50-57, Transmittal 156, CMS-Pub. 6, April 2004.
  16. Chong PS and Cros DP. Technology literature review: Quantitative sensory testing. Muscle Nerve 2004; 29(5): 734-747.
  17. Chu, Nai-Shin. Current perception thresholds in toe-to-digit replantation. Muscle and Nerve, February 1996; 19: 183-186.
  18. Cruccu G, Anand P, Attal N, et al. EFNS guidelines on neuropathic pain assessment. Eur J Neurol 2004; 11(3): 153-162.
  19. Cruccu G, Sommer C, Anand P et al. EFNS guidelines on neuropathic pain assessment: revised 2009. Eur J Neurol 2010; 17(8):1010-8.
  20. Devigili G, Tugnoli V, Penza P et al. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain 2008; 131(Pt 7):1912-25.
  21. England JD, Gronseth GS, Franklin G et al. Distal symmetrical polyneuropathy: definition for clinical research. Muscle Nerve 2005; 31(1):113-23.
  22. Fabry V, Gerdelat A, Acket B, et al. Which Method for Diagnosing Small Fiber Neuropathy?. Front Neurol. 2020; 11: 342.
  23. Ferdousi M, Kalteniece A, Azmi S, et al. Corneal confocal microscopy compared with quantitative sensory testing and nerve conduction for diagnosing and stratifying the severity of diabetic peripheral neuropathy. BMJ Open Diabetes Res Care. Dec 2020; 8(2).
  24. Grosen K, Fischer IW, Olesen AE et al. Can quantitative sensory testing predict responses to analgesic treatment? Eur J Pain 2013; 17(9):1267-80.
  25. Goel A, Shivaprasad C, Kolly A, et al. Comparison of electrochemical skin conductance and vibration perception threshold measurement in the detection of early diabetic neuropathy. PLoS One. Sep 2017; 12(9):e0183973.
  26. Heldestad V, Linder J, Sellersjo L et al. Reproducibility and influence of test modality order on thermal perception and thermal pain thresholds in quantitative sensory testing. Clin Neurophysiol 2010; 121(11):1878-85.
  27. House R, Krajnak K, Manno M et al. Current perception threshold and the HAVS Stockholm sensorineural scale. Occup Med 2009; 59(7):476-82.
  28. Howard M, Lee C, Dellon AL. Documentation of brachial plexus compression (in the thoracic inlet) utilizing provocative neurosensory and muscular testing. J Reconstr Microsurg 2003; 19(5):303:12.
  29. Hubscher M, Moloney N, Leaver A et al. Relationship between quantitative sensory testing and pain or disability in people with spinal pain-A systematic review and meta-analysis. Pain 2013; 154(9):1497-504.
  30. Kang EK, et al. Comparison between nerve conduction studies and current perception threshold test in carpal tunnel syndrome. Neurophysiology Clinics, April 2008; 38(2): 127-131.
  31. Katims, Jefferson J. Electrodiagnostic functional sensory evaluation of the patient with pain: A review of the neuroselective current perception threshold and pain tolerance threshold, Pain Digest, 1998; 8: 219-230.
  32. Kincaid JC, Price KL, Jimenez MC and Skljarevski V. Correlation of vibratory quantitative sensory testing and nerve conduction studies in patients with diabetes. Muscle Nerve 2007; 36(6): 821-827.
  33. Krishnan ST, Quattrini C, Jeziorska M et al. Abnormal LDIflare but normal quantitative sensory testing and dermal nerve fiber density in patients with painful diabetic neuropathy. Diabetes Care 2009; 32(3):451-5.
  34. Lefaucheur JP, Wahab A, Plante-Bordeneuve V, et al. Diagnosis of small fiber neuropathy: A comparative study of five neurophysiological tests. Neurophysiol Clin. Dec 2015; 45(6):445-455.
  35. Long-Sun, Ro, et al. Current perception threshold testing in Fabry’s disease. Muscle and Nerve, November 1999; 22: 1531-1537.
  36. Moloney NA, Hall TM, Doody CM. Reliability of thermal quantitative sensory testing: A systematic review. J Rehabil Res Dev 2012; 49(2):191-208.
  37. Mythili A, Kumar KD, Subrahmanyam KA et al. A comparative study of examination scores and quantitative sensory testing in diagnosis of diabetic polyneuropathy. Int J Diabetes Dev Ctries 2010; 30(1):43-8.
  38. Nath RK, Bowen ME, Eichhorn MG. Pressure-specified sensory device versus electrodiagnostic testing in brachial plexus upper trunk injury. J Reconstr Microsurg 2010; 26(4):235-42.
  39. Palmer ST, Martin DJ. Thermal perception thresholds recorded using method of limits change over brief time intervals. Somatosen Mot Res 2005; 22(4):327-34.
  40. Papanas N, Pafili K, Demetriou M, et al. The Diagnostic Utility of VibraTip for Distal Symmetrical Polyneuropathy in Type 2 Diabetes Mellitus. Diabetes Ther. Jan 2020; 11(1): 341-346.
  41. Park R, et al. Relative sensitivity to alfentanil and reliability of current perception threshold vs. von Frey tactile stimulation and thermal sensory testing. Journal Peripheral Nervous System 2001; 6(4): 232-240.
  42. Rendell MS, Katims JJ, et al. A comparison of nerve conduction velocities and current perception thresholds as correlates of clinical severity of diabetic sensory neuropathy, Journal of Neurology, Neurosurgery, and Psychiatry 1989; 52: 502-511.
  43. Scott AC, McConnell S, Laird B et al. Quantitative Sensory testing to assess the sensory characteristics of cancer-induced bone pain after radiotherapy and potential clinical biomarkers. Eur J Pain 2011; 5(2): 123-133.
  44. Shy ME, et al. Quantitative sensory testing: Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology. Neurology 2003; 60(6): 898-904.
  45. Siao P and Cross DP. Quantitative sensory testing. Physical Medicine Rehabilitation Clinics North America 2003; 14(2): 261-286.
  46. Suokas AK, Walsh DA, McWilliams DF et al. Quantitative sensory testing in painful osteoarthritis: A systematic review and meta-analysis. Osteoarthritis Cartilage 2012 Oct; 20(10):1075-85.
  47. Takekuma, Kiyoshi, et al. Age and gender differences in skin sensory threshold assessed by current perception in community-dwelling Japanese, J Epidemiology, Vol. 10, No. 1, pp. 533-538.
  48. Vuilleumier PH, Biurrun Manresa JA, Ghamri Y, et al. Reliability of quantitative sensory tests in a low back pain population. Reg Anesth Pain Med. Jul 28 2015.
  49. Weber R, Schuchmann J, Albers J et al. A prospective blinded evaluation of nerve conduction velocity versus Pressure-Specified Sensory Testing in carpal tunnel syndrome. Ann Plast Surg 2000; 45(3):252-7.
  50. Wylde V, Palmer S, Learmonth ID et al. Test-retest reliability of Quantitative Sensory Testing in knee osteoarthritis and healthy participants. Osteoarthritis Cartilage 2011; 19(6):655-8.
  51. Yamashita T, et al. A quantitative analysis of sensory function in lumbar radiculopathy using current perception threshold testing. Spine 2002; 27(14): 1567-1570.
  52. Ziccardi VB, Dragoo J, Eliav E et al. Comparison of current perception threshold electrical testing to clinical sensory testing for lingual nerve injuries. J Oral Maxillofac Surg 2012; 70(2):289-94. 

POLICY HISTORY:

Medical Policy Group, September 2002 (1)

Medical Policy Administration Team, September 2002

Available for comment October 29-December 12, 2002

Medical Policy Group, July 2005 (1)

Medical Policy Administration Committee, July 2005

Available for comment August 6-September 19, 2005

Medical Policy Group, September 2006 (1)

Medical Policy Group, September 2008 (1)

Medical Policy Group, April 2009 (1)

Medical Policy Administration Committee, May 2009

Available for comment May 12-June 24, 2009

Medical Policy Group, June 2010 (1)

Medical Policy Panel September 2010

Medical Policy Group, February 2011 (2): Key Points, References Updated

Medical Policy Group, September 2011 (1): Update to Key Points and References

Medical Policy Group, October 2012 (1): 2012 Update to Key Points and References

Medical Policy Panel, October 2013

Medical Policy Group, January 2014 (2): Policy statement unchanged.  Key Point, Key Words, References updated with findings from literature search.

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (5):  Policy statement unchanged.  Key Points and References updated with findings from literature.

Medical Policy Panel, November 2015

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

Medical Policy Panel, June 2017

Medical Policy Group, June 2017 (6):  Updates to Description, Key Points, Coding and References; no change to policy statement.

Medical Policy Panel, June 2018

Medical Policy Group, July 2018 (6): Updates to Key Points and References.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (3): Updates to Description, Key Points, and References. No change to Policy Statement.

Medical Policy Panel, October 2020

Medical Policy Group, November 2020 (3): Updates to Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Panel, June 2021

Medical Policy Group, July 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements, and References. Added HCPCS code: G0255 to Current Coding Section. Policy statement updated to remove “not medically necessary,” no change to policy statement or 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.