Latest Review Date: November 2024

Category: Pharmacology                               

POLICY:

Intravenous infusion of anesthetics (e.g., ketamine or lidocaine) for the treatment of chronic pain, including, but not limited, to chronic neuropathic pain, chronic daily headache, and fibromyalgia is considered investigational.

Intravenous infusion of anesthetics (e.g., ketamine or lidocaine) for the treatment of psychiatric disorders, including, but not limited to treatment-resistant depression, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Intravenous (IV) infusion of lidocaine or ketamine has been used for the treatment of chronic neuropathic pain. Chronic neuropathic pain disorders include phantom limb pain, post-herpetic neuralgia, complex regional pain syndromes, diabetic neuropathy, and pain related to stroke or spinal cord injuries. An IV infusion of ketamine has also been investigated for the treatment-resistant depression and obsessive-compulsive disorder.

Intravenous Anesthetic Agents

Courses of intravenous (IV) anesthetic agents may be given in the inpatient or outpatient setting as part of a pain management program, with the infusion of a subanesthetic dose preceded by a bolus infusion to achieve desired blood levels sooner. Treatment protocols for the initial cycle may include infusion of subanesthetic doses for 1 to 6 hours for up to 10 days.

Lidocaine

Lidocaine, which prevents neural depolarization through effects on voltage-dependent sodium channels, is also used systemically for the treatment of arrhythmias. Adverse effects for lidocaine are common and can be mild to moderate, including general fatigue, somnolence, dizziness, headache, periorbital and extremity numbness and tingling, nausea, vomiting, tremors, and changes in blood pressure and pulse. Severe adverse effects can be arrhythmias, seizures, loss of consciousness, confusion, or even death. Lidocaine should only be given IV to patients with normal conduction on electrocardiography and normal serum electrolyte concentrations to minimize the risk of cardiac arrhythmias.

Ketamine

Ketamine is an antagonist of the N-methyl-d-aspartate receptor and is a dissociative anesthetic. Respiratory depression may occur with over dosage or a rapid rate of ketamine administration. Ketamine is a schedule III controlled substance. Psychological manifestations vary in severity from pleasant, dream-like states to hallucinations and delirium; further, these manifestations can be accompanied by confusion, excitement, aggression, or irrational behavior. The occurrence of adverse events with IV anesthetics may be reduced by the careful titration of subanesthetic doses. However, the potential benefits must be carefully weighed against the potential for serious, harmful adverse events.

Indications

IV administration of anesthetic has been reported for a variety of conditions, including chronic pain of neuropathic origin, chronic headache, fibromyalgia, depression, and obsessive-compulsive disorders.

Chronic daily headache is defined as a headache disorder that occurs 15 or more days a month for more than 3 months. Chronic daily headache includes chronic migraine, new daily persistent headache, hemicranias continua, and chronic tension-type headache.

Neuropathic pain is often disproportionate to the extent of the primary triggering injury and may consist of thermal or mechanical allodynia, dysesthesia, and/or hyperalgesia. Allodynia is pain that occurs from a stimulus that normally does not elicit a painful response (e.g., light touch, warmth). Dysesthesia is a constant or ongoing unpleasant or electrical sensation of pain. Hyperalgesia is an exaggerated response to normally painful stimuli. In the latter, symptoms may continue for a period of time that is longer (e.g., ≥6 months) than clinically expected after an illness or injury. It is proposed that chronic neuropathic pain results from peripheral afferent sensitization, neurogenic inflammation, and sympathetic afferent coupling, along with sensitization and functional reorganization of the somatosensory, motor, and autonomic circuits in the central nervous system (CNS). Therefore, treatments focus on reducing activity and desensitizing pain pathways, thought to be mediated through N-methyl-D-aspartate (NMDA) receptors in the peripheral and CNS. Sympathetic ganglion blocks with lidocaine have been used for a number of years to treat sympathetically maintained chronic pain conditions, such as CRPS (previously known as reflex sympathetic dystrophy). Test infusion of an anesthetic has also been used in treatment planning to assess patient responsiveness to determine whether medications, such as oral mexiletine or oral ketamine, may be effective. A course of IV lidocaine or ketamine, usually at subanesthetic doses, has also been examined. This approach for treating chronic neuropathic pain differs from continuous subcutaneous or IV infusion of anesthetics for the management of chronic pain conditions, such as terminal cancer pain, which are not discussed in this policy.

Fibromyalgia is a chronic state of widespread pain and tenderness. Although fibromyalgia is generally considered to be a disorder of central pain processing or central sensitization, others have proposed that the nerve stimuli causing pain originates mainly in the muscle, causing both widespread pain and pain on movement. There are focal areas of hyperalgesia, or tender points, which tend to occur at muscle tendon junctions. Biochemical changes that have been associated with fibromyalgia include alterations in NMDA receptors, low levels of serotonin, suppression of dopamine-releasing neurons in the limbic system, dysfunction of the hypothalamic-pituitary-adrenal axis, and elevated substance P levels. Fibromyalgia is typically treated with neuropathic pain medications such as pregabalin, non-narcotic pain relievers, or low doses of antidepressants.

Use of IV ketamine has also been reported for treatment-resistant depression, defined as depression that does not respond adequately to appropriate courses of antidepressant medications. Particularly challenging are patients with treatment-resistant depression with suicidal ideation. Several studies are ongoing to test the efficacy of IV ketamine in patients with suicidal ideation who present to the emergency department.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through September 24, 2024.

Summary of Evidence

For individuals who have chronic pain syndromes (e.g., neuropathic pain or fibromyalgia) who receive a course of IV anesthetics (e.g., lidocaine, ketamine), the evidence includes systematic reviews, several RCTs, and observational studies. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, QOL, medication use, and treatment-related morbidity. Many RCTs have been performed using IV lidocaine for PHN, CRPS, and diabetic neuropathy. These trials have failed to show a durable effect of lidocaine infusion on chronic pain. Two trials with a total of 100 patients provide limited evidence that courses of IV ketamine may provide temporary relief (2 to 4 weeks) to some chronic pain patients in some settings. Neither of the RCTs used an active control, raising concerns about placebo effects. A third trial found no benefit from a single infusion of ketamine or ketamine/magnesium. Overall, the intense treatment protocols, the severity of adverse events, and the limited treatment durability raise questions about the net health benefit of this therapy. Additional clinical trials are needed to evaluate the long-term efficacy and safety of repeat courses of IV anesthetics for chronic pain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment-resistant depression who receive a course of IV ketamine, the evidence consists of systematic reviews, RCTs, and case series. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, quality of life, medication use, and treatment-related morbidity. Two publications of double-blind trials were identified that compared repeated ketamine infusion with an infusion of saline for treatment-resistant depression. Additionally, 2 open-label randomized trials comparing ketamine infusion to electroconvulsive therapy (ECT) were identified. There is a possibility of publication bias due to the lack of publication of many other small trials. Systematic reviews in patients with unipolar depression or depression related to bipolar disorder have identified numerous studies evaluating the efficacy of ketamine infusion. While the analyses indicate depression improvement in the short-term, there is limited evidence beyond a single infusion. One study with 26 patients found no significant difference in a depression scale at the end of infusion. A larger RCT (N=68) found a significantly greater improvement in a depression scale during the 4-week infusion period, but the effect diminished over 3 weeks post-infusion. The trial did not use an active control, raising the possibility of placebo effects and unblinding of patients and investigators. The open-label randomized trials comparing ketamine with ECT produced mixed results, with the first trial indicating ketamine was not noninferior to ECT in inducing remission and the second trial indicating ketamine was noninferior to ECT in inducing response. These divergent findings may be attributable to differences in the populations studied, as the first trial was conducted in severely ill inpatients and the second trial was conducted in a less severely ill, predominantly outpatient sample. Large observational studies in patients with depression indicate improvement on depression rating scales following ketamine infusions; however, these studies lack a control group, and no firm conclusions on the effectiveness or safety of serial ketamine infusions can be drawn from this evidence. Common side effects of ketamine infusion include headache, anxiety, dissociation, nausea, and dizziness. The intense treatment protocols, the severity of adverse events, and the short treatment durability limit the clinical utility of the treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have psychiatric disorders (e.g., obsessive-compulsive disorder) who receive a course of IV ketamine, the evidence consists of RCTs and case series. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, quality of life, medication use, and treatment-related morbidity. One double-blind placebo-controlled trial and case series for OCD treatment, and 1 double-blind trial comparing multiple ketamine infusions with midazolam in chronic post-traumatic stress disorder (PTSD) were identified. There is a possibility of publication bias due to the lack of publication of many other small trials. One double-blind, crossover RCT in patients with serotonin reuptake inhibitor (SRI)-resistant OCD (N=15) found that ketamine infusion provided a higher frequency of Yale-Brown Obsessive Compulsive Scale (YBOCS) response at day 7 compared with placebo; however, unblinding was suspected and only data from the first phase were analyzed because of a carryover effect of ketamine. A case series (N=14) identified only 1 patient who demonstrated prespecified significant YBOCS response after 2 to 3 weeks. A single small RCT in patients with chronic PTSD (N=30) found that ketamine infusion produced significantly greater improvements in a PTSD symptom scale at 2 weeks compared to midazolam. Common side effects of ketamine infusion include headache, anxiety, dissociation, nausea, and dizziness. The intense treatment protocols, the severity of adverse events, and the short treatment durability limit the clinical utility of the treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Society of Regional Anesthesia and Pain Medicine et al

In 2018, the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine and the American Society of Anesthesiologists issued a joint consensus guideline on the use of intravenous (IV) ketamine for treatment of chronic pain. The guideline found:

• Weak evidence supporting use of IV ketamine for short-term improvement in patients with spinal cord injury pain.
• Moderate evidence supporting use of IV ketamine for improvement in patients with chronic regional pain syndrome CRPS up to 12 weeks.
• Weak or no evidence for immediate improvement with IV ketamine use for other pain conditions, including mixed neuropathic pain, fibromyalgia, cancer pain, ischemic pain, headache and spinal pain.

American Psychiatric Association

The American Psychiatric Association (2017) published an evidence review and consensus opinion of the use of ketamine in treatment-resistant depression. The Association noted that "while ketamine may be beneficial to some patients with mood disorders, it is important to consider the limitations of the available data and the potential risk associated with the drug when considering the treatment option."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Pain, Chronic, Intravenous Lidocaine, Chronic Pain, Fibromyalgia, Ketamine, Neuropathic pain disorders, complex regional pain syndrome (CRPS), N-methyl-D-aspartate (NMDA), Psychiatric disorders, spinal cord injury, headache, IV anesthetic agents, dissociative anesthetics, post-herpetic neuralgia (PHN).

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (FDA) approve IV lidocaine for systemic use in the acute treatment of arrhythmias and locally as an anesthetic. IV lidocaine for the treatment of chronic pain is an off-label use.

Ketamine hydrochloride injection is FDA-indicated for diagnostic and surgical procedures that do not require skeletal muscle relaxation, for the induction of anesthesia before the administration of other general anesthetic agents, and to supplement low-potency agents, such as nitrous oxide. IV ketamine for the treatment of chronic pain is an off-label use.

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

CURRENT CODING: 

CPT Codes:  

 HCPCS:       

REFERENCES:

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2. Anand A, Mathew SJ, Sanacora G, et al. Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression. N Engl J Med.Jun 22 2023; 388(25): 2315-2325.
3. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) Assessment, Section: Prescription Drug. August 2011.
4. Cohen SP, Bhatia A, Buvanendran A, et al. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. Jul 2018; 43(5): 521-546.
5. de Carvalho JF, Skare TL. Lidocaine in fibromyalgia: A systematic review. World J Psychiatry. Apr 19 2022; 12(4): 615-622.
6. Dean RL, Hurducas C, Hawton K, et al. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. Sep 12 2021; 9: CD011612.
7. Dean RL, Marquardt T, Hurducas C, et al. Ketamine and other glutamate receptor modulators for depression in adults with bipolar disorder. Cochrane Database Syst Rev. Oct 08 2021; 10: CD011611.
8. Ekstrand J, Fattah C, Persson M, et al. Racemic Ketamine as an Alternative to Electroconvulsive Therapy for Unipolar Depression: A Randomized, Open-Label, Non-Inferiority Trial (KetECT). Int J Neuropsychopharmacol. May 27 2022; 25(5): 339-349.
9. Feder A, Costi S, Rutter SB, et al. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. Feb 01 2021; 178(2): 193-202.
10. Ferraro MC, Cashin AG, Wand BM, et al. Interventions for treating pain and disability in adults with complex regional pain syndrome- an overview of systematic reviews. Cochrane Database Syst Rev. Jun 12 2023; 6(6): CD009416.
11. Grasso V, Gutierrez G, Alzbeidi N, et al. Cognitive changes in patients with unipolar TRD treated with IV ketamine: A systematic review. Prog Neuropsychopharmacol Biol Psychiatry. Dec 20 2024; 135: 111095.
12. Gutierrez G, Kang MJY, Vazquez G. IV low dose ketamine infusions for treatment resistant depression: Results from a five-year study at a free public clinic in an academic hospital. Psychiatry Res. May 2024; 335: 115865.
13. Gwathmey KG, Pearson KT. Diagnosis and management of sensory polyneuropathy. BMJ. May 08 2019; 365: l1108.
14. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. Jan 2018; 38(1): 1-211.
15. Israel JE, St Pierre S, Ellis E, et al. Ketamine for the Treatment of Chronic Pain: A Comprehensive Review. Health Psychol Res. 2021;9(1): 25535.
16. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
17. Ionescu DF, Bentley KH, Eikermann M et al. Repeat-dose ketamine augmentation for treatment-resistant depression with chronic suicidal ideation: A randomized, double blind, placebo-controlled trial. J Affect Disord, 2018 Oct 5; 243:516-524.
18. Kim YC, Castaneda AM, Lee CS, et al. Efficacy and safety of lidocaine infusion treatment for neuropathic pain: a randomized, double-blind, and placebo-controlled study. Reg Anesth Pain Med. May 2018; 43(4):415-424.
19. Lee JH, Koutalianos EP, Leimer EM, et al. Intravenous Lidocaine in Chronic Neuropathic Pain: A Systematic Review. Clin J Pain. Dec01 2022; 38(12): 739-748.
20. Liu H, Lu F, Zhou D et al. The Analgesic and Emotional Response to Intravenous Lidocaine Infusion in the Treatment of Postherpetic Neuralgia: A Randomized, Double-Blinded, Placebo-controlled Study. Clin J Pain, 2018 Apr 27; 34(11).
21. Mangnus TJP, Dirckx M, Bharwani KD, et al. Effect of intravenous low-dose S-ketamine on pain in patients with Complex Regional Pain Syndrome: A retrospective cohort study. Pain Pract. Jul 07 2021.
22. McInnes LA, Qian JJ, Gargeya RS, et al. A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings. J Affect Disord. Mar 15 2022; 301: 486-495
23. McIntyre RS, Alsuwaidan M, Baune BT, et al. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. World Psychiatry. Oct 2023; 22(3): 394-412.
24. Moulin DE, Morley-Forster PK, Pirani Z et al. Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a randomized-controlled trial. Can J Anaesth, 2019 May 18; 66(7). 
25. Motov S, Mai M, Pushkar I, et al. A prospective randomized, double-dummy trial comparing IV push low dose ketamine to short infusion of low dose ketamine for treatment of pain in the ED. Am J Emerg Med. Aug 2017; 35(8):1095-1100.
26. Noppers I, Niesters M, Swartjes M et al. Absence of long-term analgesic effect from a short-term S-ketamine infusion on fibromyalgia pain: a randomized, prospective, double blind, active placebo-controlled trial. Eur J Pain 2011; 15(9):942-9.
27. O'Connell NE, Wand BM, McAuley J et al. Interventions for treating pain and disability in adults with complex regional pain syndrome. Cochrane Database Syst Rev 2013; 4:CD009416.
28. Oliver PA, Snyder AD, Feinn R, et al. Clinical Effectiveness of Intravenous Racemic Ketamine Infusions in a Large Community Sample of Patients With Treatment-Resistant Depression, Suicidal Ideation, and Generalized Anxiety Symptoms: A Retrospective Chart Review. J Clin Psychiatry. Sep 12 2022; 83(6).
29. Patil S, Anitescu M. Efficacy of outpatient ketamine infusions in refractory chronic pain syndromes: a 5-year retrospective analysis. Pain Med 2012; 13(2):263-9.
30. Peyrovian B, McIntyre RS, Phan L, et al. Registered clinical trials investigating ketamine for psychiatric disorders. J PsychiatrRes. Aug 2020; 127: 1-12.
31. Pfeiffer PN, Geller J, Ganoczy D, et al. Clinical Outcomes of Intravenous Ketamine Treatment for Depression in the VA Health System. J Clin Psychiatry. Jan 08 2024; 85(1). PMID 38206011.
32. Pickering G, Pereira B, Morel V, et al. Ketamine and Magnesium for Refractory Neuropathic Pain: A Randomized, Double blind, Crossover Trial. Anesthesiology. Jul 2020; 133(1): 154-164.
33. Przeklasa-Muszynska A, Kocot-Kepska M, Dobrogowski J, et al. Intravenous lidocaine infusions in a multidirectional model of treatment of neuropathic pain patients. Pharmacol Rep. Oct 2016; 68(5):1069-1075.
34. Rodriguez CI, Kegeles LS, Levinson A, et al. Randomized controlled crossover trial of ketamine in obsessive-compulsive disorder: proof-of-concept. Neuropsychopharmacology. Nov 2013; 38(12): 2475-83.
35. Sanacora G, Frye MA, McDonald W, et al. A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders. JAMA Psychiatry. Apr 01 2017; 74(4): 399-405.
36. Sigtermans MJ, van Hilten JJ, Bauer MC, et al. Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1. Pain 2009; 145(3):304-11.
37. Singh JB, Fedgchin M, Daly EJ et al. A Double Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression. Am J Psychiatry, 2016 Apr 9;173(8).
38. Schwartzman RJ, Alexander GM, Grothusen JR et al. Outpatient intravenous ketamine for the treatment of complex regional pain syndrome: a double-blind placebo-controlled study. Pain 2009; 147(1-3):107-15.
39. Sharma LP, Thamby A, Balachander S, et al. Clinical utility of repeated intravenous ketamine treatment for resistant obsessive-compulsive disorder. Asian J Psychiatr. Aug 2020; 52: 102183.
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42. Winslow BT, Vandal C, Dang L. Fibromyalgia: Diagnosis and Management. Am Fam Physician. Feb 2023; 107(2): 137-144.
43. Yousefshahi F, Predescu O, Francisco Asenjo J. The Efficacy of Systemic Lidocaine in the Management of Chronic Pain: A Literature Review. Anesth Pain Med. Jun 2017; 7(3): e44732.
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POLICY HISTORY:

Medical Policy Group, August 2010 (3)

Medical Policy Administration Committee, September 2010

Available for comment September 22-November 5, 2010

Medical Policy Group, September 2011 (3): Updated Key Points and References

Medical Policy Group, October 2012 (3): Updated Key Points and References

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (3):  Updated Key Points and References; no change in policy statement

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (3): 2014 Updates to Title, Description, Key Points & References; policy statement clarified as follows: “Intravenous infusion of anesthetics (e.g., ketamine or lidocaine) for the management treatment of chronic neuropathic pain, including, but not limited to chronic neuropathic pain, chronic daily headache, and fibromyalgia, do not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage and are considered investigational.” – No change in context due to all investigational, therefore no effective dates added.

Medical Policy Panel, October 2015

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

Medical Policy Panel, November 2017

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

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (3): Updates to Key Points, References, and Key Words: added CRPS, N-methyl-D-aspartate (NMDA), Psychiatric disorders, spinal cord injury, headache, IV anesthetic agents, post-herpetic neuralgia (PHN) and dissociative anesthetic. Psychiatric disorders added to investigational policy statement; policy statement otherwise unchanged.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (3): 2019 Updates to Description, Key Points and References. No changes to policy statement or intent.

Medical Policy Panel, November 2020

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

Medical Policy Panel, November 2021

Medical Policy Group, December 2021 (3): 2021 Updates to Key Points and References. Policy statement updated to remove “not medically necessary.” No other changes to policy statement or intent.

Medical Policy Panel, November 2022

Medical Policy Group, December 2022 (3): 2022 Updates to Description, Key Points, and References. No changes to policy statement or intent.

Medical Policy Panel, November 2023

Medical Policy Group, December 2023 (6): Updates to Description, Key Points, Benefit Application and References. Policy title updated: Intravenous Anesthetics for the Treatment of Chronic Pain and Psychiatric Disorders.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (7): Updates to Key Points, Key Words, References, and Current Coding. Added HCPC codes- J2002, J2003, J2004. Added Key Words- “depression, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD)”. Clarification to the Policy Statement- separated chronic pain and psychiatric disorders into individual investigational statements; added “treatment-resistant depression, obsessive-compulsive disorder, and post-traumatic stress disorder” to the noncovered indications. No change in 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 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.