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Treatment Modalities for Facetogenic Pain

Policy Number: MP-141

Latest Review Date: November 2024

Category:  Surgery                                                                 

 

POLICY:

Facet/Zygapophysial Joint Injections 

Facet joint injections may be considered medically necessary when all of the following criteria are met:

  • Performed under radiographic guidance (i.e., fluoroscopy or CT); and

  • Patient has a history of back pain that has failed to respond to three consecutive months of conservative therapy*; and

  • Used as a diagnostic trial to help determine the origin of the patient’s pain, establish effectiveness of facet injections in relieving pain, and to achieve a therapeutic effect; and

  • A diagnostic block provided pain relief (at least 50% pain relief with the ability to perform previous painful maneuvers).

Up to 4 facet joint injection sessions per affected region (i.e., cervical or lumbosacral*) within a 12-month period may be considered medically necessary once a diagnosis is established and the patient experiences symptom relief or functional improvement.

*Lumbar and sacral are considered as one region.

An injection session is defined as all facet injections administered per region during a 24-hour period for a specified date of service.

Thoracic facet injections are considered  investigational.

Subsequent facet injections are considered not medically necessary when the patient does not experience any symptom relief or functional improvement.

Facet joint injections using ultrasound guidance are considered investigational.

Facet Joint Denervation

Non-pulsed radiofrequency denervation of cervical facet joints (C3-4 and below) and lumbar facet joints may be considered medically necessary when all of the following criteria are met:

  • No prior spinal fusion surgery in the vertebral level being treated; AND

  • Disabling non-radicular low back (lumbosacral) or neck (cervical) pain, suggestive of facet joint origin as evidenced by absence of nerve root compression as documented in the medical record on history, physical, and radiographic evaluations; AND

  • Pain has failed to respond to three months of conservative therapy*; AND

  • There has been a successful trial** of diagnostic controlled medial branch blocks,; AND

  • If there has been a prior successful radiofrequency (RF) denervation, a minimum time of six months has elapsed since prior RF treatment (per side, per anatomical level of the spine).

**A successful trial of controlled diagnostic medial branch blocks consists of:

  • Two separate positive blocks on different days with local anesthetic only (no steroids or other drugs), or a placebo controlled series of blocks, under fluoroscopic guidance, that has resulted in at least a 50% reduction in pain for the duration of the local anesthetic used.

  • No therapeutic intraarticular injections (i.e., steroids, saline, or other substances) should be administered for a period of at least four weeks prior to the diagnostic medial branch block.

  • The diagnostic blocks should involve the levels being considered for RF treatment and should not be conducted under intravenous sedation unless specifically indicated (e.g., the patient is unable to cooperate with the procedure).

  • The diagnostic blocks should be targeted to the likely pain generator.

  • Single level blocks lead to more precise diagnostic information, but multiple single level blocks require several visits and additional exposure to radiation.

  • Repeat diagnostic blocks are not necessary, if symptoms and treatment are at the same location(s) or spinal level(s), and presentation is similar to that of initial or prior treatment.

Radiofrequency denervation is considered investigational for the treatment of chronic spinal/back pain for all uses that do not meet the criteria listed above, including but not limited to treatment of thoracic facet joint pain.

All other methods of denervation are considered investigational for the treatment of chronic spinal/back pain, including, but not limited to pulsed radiofrequency denervation, laser denervation, chemodenervation (e.g., alcohol, phenol, or high-concentration local anesthetics), and cryodenervation.

If there has been a prior successful radiofrequency (RF) denervation, additional diagnostic medial branch blocks for the same level of the spine is considered investigational.

*Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; participation in therapeutic physical medicine modality(ies) and/or manipulations when rendered by an eligible provider (including active exercise).

DESCRIPTION OF PROCEDURE OR SERVICE:

Facet joints, located on either side of the vertebrae, give the spine its flexibility. They are paired (right and left) and are surrounded by a joint capsule. Like other joints, the facet joints can be a source of pain when they become irritated or inflamed. Facet joints may also be referred to as zygapophysial joints.

Facet injections, in the cervical and lumbar regions of the spine, are divided into 2 phases: the diagnostic phase and the therapeutic phase. In the diagnostic phase, an injection is given and if there is pain relief (positive block), additional injections are given as part of the therapeutic phase. If there is no pain relief after the diagnostic injection (negative block), the therapy is not continued. There are no historical, physical or imaging studies that are diagnostic of facet joint pain. The diagnosis is one of exclusion that is facilitated by performing a diagnostic block of the facet joint or nerves (medial branch of the posterior primary ramus) innervating the joints.

If the patient feels pain relief immediately after intraarticular or medial branch blocks, this confirms that the facet joint was the source of pain. Pain may return after local anesthetic effect ends. Usually, it takes about a week to reduce inflammation and pain. Pain relief can last up to several months.

Radiofrequency Facet Denervation

Percutaneous radiofrequency (RF) facet denervation is used to treat neck or back pain originating in facet joints with degenerative changes. Diagnosis of facet joint pain is confirmed by response to nerve blocks. The goal of facet denervation is long-term pain relief. However, the nerves regenerate, and repeat procedures may be required.

Radiofrequency (RF) facet denervation is performed under local anesthetic and with fluoroscopic guidance. A needle is directed to the median branch of the dorsal ganglion in the facet joint, where multiple thermal lesions are produced, typically by a radiofrequency generator. The procedure is usually performed with conscious sedation. A variety of terms may be used to describe radiofrequency (RF) denervation (e.g., rhizotomy, rhizolysis). In addition, the structures to which the RF energy is directed may be referred to as facet joint, facet nerves, medial nerve or branch, median nerve or branch, or dorsal root ganglion.

Alternative methods of denervation include pulsed RF, laser, chemodenervation, and cryoablation. Pulsed RF consists of short bursts of electric current of high voltage in the RF range but without heating the tissue enough to cause coagulation. It is suggested as a possibly safer alternative to thermal RF facet denervation. Temperatures do not exceed 42°C at the probe tip versus temperatures in the 60°C range reached in thermal RF denervation, and tissues may cool between pulses. It is postulated that transmission across small unmyelinated nerve fibers is disrupted but not permanently damaged, while large myelinated fibers are not affected. With chemical denervation, injections with a diluted phenol solution, a chemical ablating agent, are injected into the facet joint nerve.

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through October 6, 2024.

Summary of Evidence

For individuals with suspected facet joint pain who receive diagnostic medial branch blocks, the evidence includes systematic reviews, a small randomized trial, and observational studies. Relevant outcomes are other test performance measures, symptoms, and functional outcomes. There is considerable controversy about the role of these blocks, the number of positive blocks required, and the extent of pain relief obtained. Studies have reported the use of single or double blocks and at least 50% or 80% improvement in pain and function. This evidence has suggested that there are relatively few patients who exhibit pain relief following 2 nerve blocks, but that these select patients may have pain relief for several months following radiofrequency (RF) denervation. Other large series have reported the prevalence and false-positive rates following controlled diagnostic blocks, although there are issues with the reference standards used in these studies because there is no criterion standard for the diagnosis of facet joint pain. There is level I evidence for the use of medial branch blocks for diagnosing chronic lumbar facet joint pain and level II evidence for diagnosing cervical and thoracic facet joint pain. The evidence available supports a threshold of at least 75% to 80% pain relief to reduce the false-positive rate. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have facet joint pain who receive radiofrequency ablation, the evidence includes a systematic review of randomized controlled trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. While evidence is limited to a few randomized controlled trials with small sample sizes, RF facet denervation appears to provide at least 50% pain relief in carefully selected patients. Diagnosis of facet joint pain is difficult. However, response to controlled medial branch blocks and the presence of tenderness over the facet joint appears to be reliable predictors of success. When RF facet denervation is successful, repeat treatments appear to have similar success rates and durations of pain relief. Thus, the data indicate that, in carefully selected individuals with lumbar or cervical facet joint pain, RF treatments can result in improved outcomes. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have facet joint pain who receive alternative methods of facet joint denervation or therapeutic medial branch blocks, the evidence includes uncontrolled case series and randomized trials without a sham control. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Pulsed RF does not appear to be as effective as conventional RF denervation, and there is insufficient evidence to evaluate the efficacy of other methods of denervation (e.g., alcohol, laser, cryodenervation) for facet joint pain. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

Agency for Healthcare Research and Quality (AHRQ)

The Agency for Healthcare Research and Quality issued an evidence-based practice center systematic review protocol in 2014. Pain Management Injection Therapies for Low-Back Pain states that between 1994 and 2001, the “use of epidural injections increased by 271 percent and facet joint injections increased by 231 percent among Medicare beneficiaries. Despite these dramatic increases, use of injection therapies for low back pain remains controversial. Systematic reviews of injection therapies have come to conflicting conclusions regarding the benefits of injection therapies, and clinical practice guidelines provide discordant recommendations regarding their use. Important challenges in conducting a review of this topic include sparse data from randomized trials for most injection therapies (with the exception of epidural steroids), inconsistency of results across trials, as well as variability across studies in the methods used to select patients for inclusion, the specific techniques used, the comparisons evaluated, and the outcomes assessed.”

American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS)

In 2014, the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) published updated guidelines on the treatment of degenerative disease of the lumbar spine. AANS/CNS recommended to use a double-injection technique with an improvement threshold of 80% or greater to establish a diagnosis of lumbar facet-mediated pain (Grade B), that this is an option for predicting a favorable response to facet medial nerve ablation by thermocoagulation (Grade C), and that there is no evidence to support the use of diagnostic facet blocks as a predictor of lumbar fusion outcome in patients with chronic low-back pain from degenerative lumbar disease (Grade I: Inconclusive). AANS/CNS gave Grade B recommendations that 1) intraarticular injections of lumbar facet joints are not suggested for the treatment of facet-mediated chronic low back pain; 2) medial nerve blocks are suggested for the short-term relief of facet-mediated chronic low back pain; and 3) lumbar medial nerve ablation is suggested for the short-term (3- to 6-month) relief of facet-mediated pain in patients who have chronic lower back pain without radiculopathy from degenerative disease of the lumbar spine.

American Society of Interventional Pain Physicians (ASIPP)

In 2020, the American Society of Interventional Pain Physicians published guidelines on use of facet joint interventions for management of chronic spinal pain. Use of facet joint nerve blocks for diagnosis of facet joint pain is recommended with a moderate to strong strength of recommendation for the lumbar spine (evidence level I to II), moderate strength for the cervical spine (evidence level II), and moderate strength for the thoracic spine (evidence level II); a criterion standard of ≥80% pain relief was included for these recommendations. Radiofrequency ablation is recommended for treatment of pain in the lumbar spine (moderate strength recommendation; evidence level II), cervical spine (moderate strength recommendation; evidence level II), and thoracic spine (weak to moderate strength recommendation; evidence level III). Facet joint nerve blocks are recommended for treatment of pain in the lumbar spine (moderate strength recommendation; evidence level II), cervical spine (moderate strength recommendation; evidence level II), and thoracic spine (weak to moderate strength recommendation; evidence level III). Treatment of facet joint pain with intraarticular injections is a weak strength recommendation with lower levels of evidence (level III, IV, and V evidence for the thoracic, lumbar, and cervical spine respectively).

American Pain Society

A 2009 American Pain Society Clinical Practice Guideline on nonsurgical interventions for low back pain states that “there is insufficient (poor) evidence from randomized trials (conflicting trials, sparse and lower quality data, or no randomized trials) to reliably evaluate” a number of interventions including facet denervation.

American Society of Regional Anesthesia & Pain Medicine, et al.

International consensus guidelines published by the American Society of Regional Anesthesia & Pain Medicine and including 13 different pain societies (2020) provide recommendations regarding interventions for lumbar facet joint pain specifically. When used for diagnosis, the guidelines suggest that intra-articular injections are more diagnostic than medial branch blocks, but note that intra-articular injections have a high technical failure rate and provide less predictive value when administered prior to radiofrequency ablation (grade B evidence, low level of certainty). For therapeutic treatment of lumbar facet pain the guideline recommends against use of medial branch blocks or intra-articular injections (grade D evidence, moderate level of certainty), although acknowledges certain clinical scenarios which may warrant these techniques, such as a contraindication to radiofrequency ablation.

Similarly, 18 pain societies created consensus guidelines on interventions for cervical spine joint pain (2022). The group states, "Medial branch RFA is considered to be a definitive durable analgesic treatment for patients with neck pain arising from the cervical facet joints." They also state, "...MBB meet most criteria as a diagnostic intervention for cervical joint-mediated pain...."

The World Federation of Neurosurgical Societies Spine Committee

The World Federation of Neurosurgical Societies Spine Committee (2020) released recommendations on the treatment of and pain relief techniques in patients with lumbar spinal stenosis. Statements that reached a positive committee consensus regarding facet joint pain are listed below.

  • "Statement 10: Facet joint injections provide a useful diagnostic tool for LBP [lower back pain]."

National Institute for Health and Clinical Excellence (NICE)

The National Institute for Health and Clinical Excellence (NICE) published guidance in 2016 entitled “Low back pain and sciatica in over 16 years of age: assessment and management.” NICE recommended that RF denervation can be considered for patients with chronic low back pain “when other non-surgical treatment has not worked for them and the main source of pain is thought to come from structures supplied by the medial branch nerve and they have moderate or severe levels of localized back pain”. Radiofrequency denervation should only be performed after a positive response to a diagnostic medial branch block. NICE cautioned that the length of pain relief after RF denervation is uncertain, and that results from repeat RF denervation procedures are also uncertain.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Facet joint injections, percutaneous radiofrequency facet denervation, radiofrequency facet denervation, zygapophyseal joint, radiofrequency ablation, neurotomy, therapeutic medial nerve branch block, radiofrequency denervation, pulsed radiofrequency denervation, laser denervation, cryodenervation, chemodenervation, SIngery®, medial branch block, Dorsal root ganglion, Non pulsed radiofrequency ablation

APPROVED BY GOVERNING BODIES:

A number of radiofrequency generators and probes have been cleared for marketing through the FDA 510(k) process.

One device, the SInergy® by Kimberly Clark/Baylis, is a water-cooled single-use probe that received FDA clearance in 2005, listing the Baylis Pain Management Probe as a predicate device.  The intended use is in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue.

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:

CPT codes:

64490

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; single level

64491

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) withy image guidance (fluoroscopy or CT), cervical or thoracic; second level (List separately in addition to code for primary procedure)

64492

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; third and any additional level(s) (List separately in addition to code for primary procedure)

64493

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; single level

64494

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; second level (List separately in addition to code for primary procedure)

64495

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third and any additional level(s) (List separately in addition to code for primary procedure)

64633

Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint

64634

 

                     ; each additional facet joint (List separately in addition to code for primary procedure)

64635

                     ; lumbar or sacral, single facet joint

64636

 

                     ; lumbar or sacral, each additional facet joint (List separately in addition to code for primary procedure)

64999

Unlisted procedure, nervous system. (should be used for pulsed radiofrequency ablation as opposed to specific codes.

0213T

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; single level

0214T

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; second level (List separately in addition to code for primary procedure)

0215T

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; third and any additional level(s) (List separately in addition to code for primary procedure)

0216T

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, lumbar or sacral; single level

0217T

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; second level(s) (List separately in addition to code for primary procedure)

0218T

Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, lumbar or sacral; additional level(s) (List separately in addition to code for primary procedure)

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  61. Tekin I, Mirzai H, Ok G et al. A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain 2007; 23(6):524-529.
  62. van Boxem K, van Eerd M, Brinkhuizen T, et al. Radiofrequency and pulsed radiofrequency treatment of chronic pain syndromes: the available evidence. Pain Practice 2008; 8(5):385-393.
  63. van Eerd M, de Meij N, Kessels A, et al. Efficacy and Long-term Effect of Radiofrequency Denervation in Patients with ClinicallyDiagnosed Cervical Facet Joint Pain: A Double-blind Randomized Controlled Trial. Spine (Phila Pa 1976). Mar 01 2021; 46(5): 285-293.
  64. van Wijk RM, Geurts JW, Wynne HJ et al. Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain: a randomized, double-blind, sham lesion-controlled trial. Clin J Pain 2005; 21(4):335-344.
  65. van Zundert J, Patijn J, Kessels A et al. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial. Pain 2007; 127(1-2):173-182.
  66. Watters WC, 3rd, Resnick DK, Eck JC, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion. J Neurosurg Spine. 2014; 21(1):79-90.

POLICY HISTORY:

Medical Policy Group, October 2003

Medical Policy Administration Committee, October 2003

Medical Policy Group, September 2005 (1)

Medical Policy Group, September 2008 (1)

Medical Policy Group, September 2009 (3)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, October 2010 (1): Key Points update, references added, no change in policy statement

Medical Policy Group, November 2010 Codes updated for 1/1/2011

Medical Policy Group, November 2011(1): Added/Deleted CPT Codes for 2012 effective 1/1/12

Medical Policy Panel, October 2011

Medical Policy Group, December 2011 (2): Policy, Key Words, Key Points, References updated

Medical Policy Administration (3): January 2012

Available for comment January 11 – February 27, 2012

Medical Policy Panel, October 2012

Medical Policy Group, October 2012 (2): Chemodenervation added to investigational policy statement. Sacroiliac joint removed for the investigational policy statement. Description, Key Points, Key Words, Approved by Governing Bodies, & References were updated.

Medical Policy Administration, November 2012

Available for comment November 14 through December 28, 2012

Medical Policy Group February 2013 (4): added (e.g., alcohol, phenol, or high-concentration local anesthetics) to policy statement. Added 64999 as unlisted codes to be used for pulsed radiofrequency ablation and updated Key Points, Key Words & References.

Medical Policy Panel, October 2013

Medical Policy Group, September 2014 (3): 2013 Updates to references; no change in policy statement; removed old policy statements (prior to 2009)

Medical Policy Group, September 2014 (3): added word “modality(ies)” to description of physical therapy in conservative therapy definition per Medical Director

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (3): 2014 Updates to Key Points & References; no change in policy statement.

Medical Policy Panel, October 2015

Medical Policy Group, October 2015 (2): 2015 Updates to Key Points and References; no change in policy statement.

Medical Policy Group, November 2015 (2): 2015 Updates to Key Points and References; no change in policy statement.

Medical Policy Group, November 2016 (7): 2016 Clarification to Policy Statement- added “diagnostic” to controlled medial branch blocks under criteria for coverage. No change in intent.

Medical Policy Group, February 2017 (7): 2017 Updates to Title. Added facet joint injection material from MP#303. Clarification to Policy statement- added “three consecutive” to months of conservative therapy to facet injection criteria; added “injection session” and definition; removed statement re: additional facet injections for acute injury. Removed Previous Coding section- codes that were deleted in 2012. No change in intent of denervation policy section- clarification to repeat diagnostic blocks statement.

Medical Policy Administration, March 2017

Available for comment February 17 through April 2, 2017

Medical Policy Group, April 2017 (7): Clarification to diagnostic blocks; removed example regarding bupivacaine and lidocaine. No change in policy intent. Clarification to “conservative therapy” definition.

Medical Policy Panel, November 2017

Medical Policy Group, November 2017 (7): 2017 Updates to Description, Key Points, and References. No change in Policy Statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (7): Minor update to Key Points, no new literature to add. No change in Policy Statement.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (7): Minor update to Key Points, no new literature to add. Removed previous Policy Statement from 2016. No change in policy intent.

Medical Policy Panel, November 2020

Medical Policy Group, December 2020 (7): Updates to Key Points and References. Removed previous Policy Statement from 2017. No change in policy intent.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, November 2023

Medical Policy Group, December 2023 (7): Updates to Key Points, Benefit Application, and References. No change in Policy Statement.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (7): Updates to Key Points and References. No change in Policy Statement.

 

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.