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Percutaneous Vertebroplasty and Sacroplasty

Policy Number: MP-004

Latest Review Date: May 2023

Category: Radiology/Surgical                                                

 

POLICY:

Percutaneous vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least six (6) weeks.

 

Percutaneous vertebroplasty may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

 

Percutaneous vertebroplasty may be considered medically necessary for the treatment of vertebral hemangiomas with severe pain or nerve compression.

 

Percutaneous vertebroplasty is considered investigational for all other indications.

 

Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Percutaneous vertebroplasty is an interventional technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. The technique has been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or in those with osteolytic lesions of the spine, i.e., multiple myeloma or metastatic malignancies. Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, and as a technique to limit blood loss related to surgery.

 

Osteoporotic Fracture

Vertebral Compression Fracture

Osteoporotic compression fractures are common. It is estimated that up to one-half of women and approximately one-quarter of men will have a vertebral fracture at some point in their lives. However, only about one-third of vertebral fractures actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month. Nonetheless, some individuals with acute fractures will have severe pain and decreased function that interferes with ability to ambulate and is not responsive to usual medical management.

Treatment

Chronic symptoms do not tend to respond to the management strategies for acute pain such as bedrest, immobilization or bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently does not improve with analgesics and may be better addressed through exercise. Improvements in pain and ability to function are the principal outcomes of interest for treatment of osteoporotic fractures.

 

Sacral Insufficiency Fractures

Sacral insufficiency fractures (SIFs) are the consequence of stress on weakened bone and often cause low back pain in the elderly population. Osteoporosis is the most common risk factor for SIF. Spontaneous fracture of the sacrum in patients with osteoporosis was described by Lourie in 1982 and presents as lower back and buttock pain with or without referred pain in the legs. Although common, SIFs can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention.

Treatment

Similar interventions are used for sacral and vertebral fractures and include bedrest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, resolution of all symptoms may not occur for 9 to 12 months.

 

Vertebral/Sacral Body Metastasis

Metastatic malignant disease of the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint.

Treatment

While radiation and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty or sacroplasty.

 

Percutaneous Vertebroplasty

Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (e.g., polymethylmethacrylate [PMMA], bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra. It has been suggested that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.

 

Percutaneous Sacroplasty

Percutaneous sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical, entails guided injection of PMMA through a needle inserted into the fracture zone. While first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive procedure employed as an alternative to conservative management for sacral insufficiency fractures (SIFs). SIFs are the consequence of stress on weakened bone and are often the cause of low back pain among the elderly population. Osteoporosis is the most common risk factor for SIF.

Pain and function are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may vary. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of vertebroplasty and sacroplasty over and above any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared with alternatives such as continued medical management.

In all clinical situations, adverse effects related to complications from vertebroplasty and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected PMMA or another injectate.

 

Vertebral Hemangiomas

Vertebral hemangiomas are relatively common lesions noted in up to 12% of the population based on autopsy series; however, only rarely do these lesions display aggressive features and produce neurologic compromise and/or pain. Treatment of aggressive vertebral hemangiomas has evolved from radiotherapy to surgical approaches using anterior spinal surgery for resection and decompression. There is the potential for large blood loss during surgical resection, and vascular embolization techniques have been used as adjuncts to treatment to reduce blood loss. Percutaneous vertebroplasty has been proposed as a way to treat and stabilize some hemangioma to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.

Kyphoplasty and mechanical vertebral augmentation are addressed separately in medical policy, #648- Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty and Mechanical Vertebral Augmentation.

 

KEY POINTS:

The most recent literature update for this policy was performed through March 6, 2023.

Summary of Evidence

For individuals who have symptomatic osteoporotic vertebral fractures of between 6 weeks and 1 year old who receive vertebroplasty, the evidence includes 2 randomized sham-controlled trials, nonblinded randomized controlled trials (RCTs) comparing vertebroplasty with conservative management, and systematic reviews of these RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. Despite the completion of numerous RCTs, including 2 with sham controls, the efficacy of vertebroplasty for painful osteoporotic compression fractures remains uncertain. Two meta-analysis studies which included the 2 sham-controlled trials have demonstrated mixed results. The 2 studies had methodologic issues, including the choice of sham procedure and the potential effect of the sham procedure having a therapeutic effect by reducing pain. Questions have also been raised about the low percentage of patients screened who participated in the trial, the volume of polymethylmethacrylate injected, and the inclusion of patients with chronic pain. Overall, conclusions about the effect of vertebroplasty remain unclear. However, clinical input in 2008 provided uniform support for the use of vertebroplasty in painful osteoporotic fractures. After consideration of the available evidence and input, the consistent results of numerous case series, including large prospective reports, were sufficient to determine that vertebroplasty was a reasonable treatment option in patients with vertebral fractures who have failed to respond to conservative treatment (at least 6 weeks with analgesics, physical therapy, and rest). It is also clinically reasonable to consider the evidence supporting the clinical benefit of vertebroplasty in osteoporotic vertebral fracture to support its use in osteolytic lesions of the spine (e.g., multiple myeloma, metastatic malignancies).

For individuals with symptomatic osteoporotic vertebral fractures less than 6 weeks old who receive vertebroplasty, the evidence includes a randomized sham-controlled trial and other nonblinded RCTs comparing vertebroplasty with conservative management. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. For acute fractures, conservative therapy consisting of rest, analgesics, and physical therapy is an option, and symptoms will resolve in a large percentage of patients with conservative treatment only. However, a sham-controlled randomized trial in patients who had severe pain of less than 6 weeks in duration found a significant benefit of vertebroplasty for the treatment of osteoporotic vertebral fracture at the thoracolumbar junction. Other RCTs without sham controls have reported that vertebroplasty is associated with significant improvements in pain and reductions in the duration of bedrest. Given the high morbidity associated with extended bedrest in older adults, this procedure is considered to have a significant health benefit. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with sacral insufficiency fractures who receive sacroplasty, the evidence includes two prospective cohort studies, several retrospective reviews, and a case series. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. No RCTs have been reported. The prospective cohort studies and retrospective series with 243 patients have reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional literature has mostly reported immediate improvements following the procedure. However, due to the small size of the evidence base, the harms associated with sacroplasty have not been adequately studied. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Radiology

In 2022, the American College of Radiology (ACR) revised its Appropriateness Criteria for the use of percutaneous vertebral augmentation in the management of vertebral compression fractures. The table below shows the appropriateness categories for each variant.

ACR Appropriateness Criteria for the use of Percutaneous Vertebral Augmentation for the Management of Vertebral Compression Fractures

Variants

Appropriateness Category

"Asymptomatic, osteoporotic VCF. Initial treatment"

Usually Not Appropriate

"Symptomatic osteoporotic VCF with bone marrow edema or intravertebral cleft. Initial treatment"

Usually Appropriate

"New symptomatic VCF. History of prior vertebroplasty or surgery. Initial treatment."

Usually Appropriate

"Benign VCF with worsening pain, deformity, or pulmonary dysfunction. Initial treatment"

Usually Appropriate

"Pathological VCF with ongoing or increasing mechanical pain. Initial treatment"

Usually Appropriate

CT: computed tomography; MRI: magnetic resonance imaging; ACR: American College of Radiology.

In 2014, the ACR and 7 other medical specialty associations, including the Society for Radiology, updated a 2012 joint position statement on percutaneous vertebral augmentation. The statement indicated that percutaneous vertebral augmentation with the use of vertebroplasty or kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures, when performed in accordance with public standards. The document also stated that these procedures are offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering patients’ quality of life.

Society for Interventional Radiology

In a 2014 quality improvement guideline for percutaneous vertebroplasty from the Society of Interventional Radiology, failure of medical therapy was defined as follows:

  1. A patient rendered nonambulatory as a result of pain from a weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy;
  2. A patient with sufficient pain from a weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy; or
  3. Any patient with a weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.

 

American Academy of Orthopaedic Surgeons

In 2011, the American Academy of Orthopaedic Surgeons (AAOS) published practice guidelines on the treatment of osteoporotic spinal compression fractures. The AAOS approved "a Strong recommendation against the use of vertebroplasty for patients who present with an acute osteoporotic spinal compression fracture and are neurologically intact."

National Institute for Health and Care Excellence

The U.K.’s National Institute for Health and Care Excellence (NICE) concluded in its 2003 guidance on percutaneous vertebroplasty that the current evidence on the safety and efficacy of vertebroplasty for vertebral compression fractures appeared “adequate to support the use of this procedure” to “provide pain relief for people with severe painful osteoporosis with loss of height and/or compression fractures of the vertebral body….”The guidance also recommended that the procedure be limited to patients whose pain is refractory to more conservative treatment. A 2013 NICE guidance, which was reaffirmed in 2016, indicated that percutaneous vertebroplasty and percutaneous balloon kyphoplasty “are recommended as options for treating osteoporotic vertebral compression fractures” in persons having “severe, ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management” and whose “pain has been confirmed o be at the level of the fracture by physical examination and imaging.”

In 2008, NICE issued guidance on the diagnosis and management of adults with metastatic spinal cord compression. This guidance indicated that vertebroplasty or kyphoplasty should be considered for “patients who have vertebral metastases and no evidence of MSCC [metastatic spinal cord compression] or spinal instability if they have: mechanical pain resistant to conventional pain management, or vertebral body collapse.”

American Society of Pain and Neuroscience

In 2021, the American Society of Pain and Neuroscience (ASPN) published practice guidelines for the interventional management of cancer-associated pain. The guideline included a best practice statement that stated "vertebral augmentation should be strongly considered for patients with symptomatic vertebral compression fractures from spinal metastases (evidence level 1-A)." However, ASPN noted that there is little data to suggest the superiority of either vertebroplasty or kyphoplasty when treating malignant vertebral compression fractures.

U.S Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Percutaneous vertebroplasty, vertebroplasty, polymethylmethacrylate, PMMA, osteoporosis, vertebral body compression fracture, vertebral fracture, vertebral compression fracture, PV, VCF, optiplasty, OptiMesh, Arcuate XP device, Arcuplasty, ARCUATE™ Vertebral Augmentation System, sacroplasty, Cortoss Bone Augmentation Material, Osteopal, SpineFix, Parallax Contour Vertebral Augmentation device, Balex Bone Expander System, Arcadia Balloon Catheter, Kyphon Element Inflatable Bone Tamp

APPROVED BY GOVERNING BODIES:

Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval.

Polymethylmethacrylate (PMMA) bone cement was available as a drug product before enactment of FDA’s device regulation and was at first considered what FDA terms a “transitional device.” It was transitioned to a class III device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In October 1999, PMMA was reclassified from class III to class II, which requires future 510(k) submissions to meet “special controls” instead of “general controls” to assure safety and effectiveness. Thus, use of PMMA in vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, PMMA bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were issued 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.

The use of PMMA in sacroplasty represents an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement [Teknimed] and Osteopal® V [Heraeus]), as the 510(k) marketing clearance was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included.

In May 2009, Cortoss® (Stryker) Bone Augmentation Material was cleared for marketing by FDA through the 510(k) process. Cortoss® is a nonresorbable synthetic material that is a composite resin-based, bis-glycidal dimethacrylate. FDA classifies this product as a PMMA bone cement.

In February 2010, the Parallax® Contour® Vertebral Augmentation Device (ArthroCare) was cleared for marketing by FDA through the 510(k) process. There have been several other augmentation and bone expander devices (e.g., Balex® Bone Expander System, Arcadia® Ballon Catheter, Kyphon Element® Inflatable Bone Tamp) that were also cleared for marketing by FDA through the 510(k) process. These devices create a void in cancellous bone that can then be filled with bone cement.

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:

0200T

Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, one or more needles, includes imaging guidance and bone biopsy, when performed

0201T

         ; two or more needles includes imaging guidance and bone biopsy, when performed

22510

Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic

22511

Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral

22512

Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure)

64999

Unlisted procedure, nervous system

PREVIOUS CODING: 

CPT Codes:

01936

Anesthesia for percutaneous image guided procedures on the spine and spinal cord; therapeutic (Deleted 12/31/21)

REFERENCES:

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  6. Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. Feb 2014;25(2):171-181.
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  13. Dehdashti AR, Martin JB, Jean B, et al. PMMA cementoplasty in symptomatic metastatic lesions of the S1 vertebral body. Cardiovasc Intervent Radiol. May-Jun 2000;23:235-237.
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  16. Edidin AA, Ong KL, Lau E, et al. Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population. J Bone Miner Res. Jul 2011;26(7):1617-1626.
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POLICY HISTORY:

Medical Policy Group, November 1999

Medical Review Committee, January 2000

TEC Review, April 2000

Medical Policy Group, January 2001

Medical Review Committee, March 2001

TEC Review, May 2001

Medical Policy Group, February 2002 (2)

Medical Review Committee, March 2002

Available for Comment April 15-May 29, 2002

Medical Policy Group, June 2003 (2)

Medical Review Committee, June 2003

Medical Review Committee, July 2003

Medical Policy Administration Committee, July 2003

Available for comment July 28-September 10, 2003

Medical Policy Group, August 2003 (2)

Medical Review Committee, September 2003

Medical Policy Administration Committee, October 2003

Available for comment October 7-November 20, 2003

Medical Policy Group, October 2005 (2)

Medical Policy Administration Committee, November 2005

Available for comment November 30, 2005-January 13, 2006

Medical Policy Group, July 2006 (1)

Medical Policy Administration Committee, July 2006

Available for comment July 18-August 31, 2006

Medical Policy Group, January 2007 (2)

Medical Policy Group, June 2007 (2)

Medical Policy Group, July 2007 (2)

Medical Policy Administration Committee, July 2007

Available for comments July 16-September 3, 2007

Medical Policy Group, March 2008 (2)

Medical Policy Administration Committee, April 2008

Available for comment April 4-May 18, 2008

Medical Policy Group, May 2008 (2)

Medical Policy Administration Committee, June 2008

Available for comment June 11-July 26, 2008

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Panel, February 2010

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 12-May 26, 2010

Medical Policy Panel, February 2011

Medical Policy Group, June 2011 (2): Key Points and Reference Updated

Medical Policy Group, December 2011 (3): Updated verbiage on CPT 22520 & 22521 for 2012 code update.

Medical Policy Panel, April 2013

Medical Policy Group, August 2013 (2): Title change to include Mechanical Vertebral Augmentation.   Policy statement added that all other percutaneous mechanical vertebral augmentation devices, including but not limited to Kiva are investigational.   Description, Key Points, Approved by Governing Bodies, Key Words, and Reference updated to support new policy statement and literature search.  

Medical Policy Administration Committee, September 2013

Available for comment September 19 through November 2, 2013

Medical Policy Group, March 2014 (2): Corrected policy statement with addition of coverage for vertebral hemangiomas with severe pain or nerve compression.

Medical Policy Group, March 2014 (5): Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; no change in policy statements; removed policy statements for 2010 & prior years

Medical Policy Group, November 2014 (3): 2015 Annual Coding update; added CPT codes 22510-22515 and moved previous codes 22520-22525 and 72291-72292; changed verbiage on 0200T & 0201T by adding ‘includes imaging guidance and bone biopsy, when performed.

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (2): 2015 Updates to Description, Key Points, Current Coding, and References; no change to policy statement. 

Medical Policy Group, November 2015:  2016 Annual Coding Update; Moved HCPCS codes S2360 and S2361 from current coding to previous coding.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (7): 2016 Updates to Key Points, Coding- Removed previous codes deleted in 2006 and ICD-9 and ICD-10-CM diagnosis under Coding Section. No change to policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (7): 2018 Updates to Title, Description, Key Points, Key Words, Approved by Governing Bodies and References; removed all aspects of kyphoplasty and mechanical augmentation, now in separate policy, #648. Policy Statement clarified- removed “including use in acute vertebral fractures due to osteoporosis or trauma”. No change in intent.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, June 2021 (7): Updates to Key Points and References. Investigational policy statement edited for clarity. No change in intent of policy.

Medical Policy Group, December 2021 (7): 2022 Annual Coding Update. Moved CPT 01936 from Current coding section.  Created Previous Coding section to include code 01936.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Key Points, Approved by Governing Bodies and References. Added Keywords: “Balex Bone Expander System, Arcadia Balloon Catheter, Kyphon Element Inflatable Bone Tamp.” No change in Policy Statement.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023(7): Updates to Key Points, Benefit Application, 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.