Latest Review Date: May 2023

Category:  Radiology/Surgical                                               

POLICY:

Mechanical vertebral augmentation or percutaneous balloon kyphoplasty with an FDA-cleared device* may be considered medically necessary for the treatment of the following conditions:

• 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.
• Severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.
• Vertebral hemangiomas with severe pain or nerve compression.

Mechanical vertebral augmentation or percutaneous balloon kyphoplasty with an FDA-cleared device* for any other indication not listed above do not meet medical criteria for coverage and is considered investigational.

Percutaneous radiofrequency kyphoplasty does not meet medical criteria for coverage and is considered investigational.

Vertebral body stenting does not meet medical criteria for coverage and is considered investigational.

* See Approved by Governing Bodies for list of FDA-cleared devices for kyphoplasty and vertebral augmentation.

DESCRIPTION OF PROCEDURE OR SERVICE:

Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation with Kiva are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as options 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, metastatic malignancies).

Osteoporotic Vertebral Compression Fractures

Vertebral compression fractures are the most common complication of osteoporosis, with 700,000 cases reported every year in the United States. The condition is more frequently seen in women than men, with an annual incidence of 10.7 per 1000women and 5.7 per 1000 men. Furthermore, the prevalence of these fractures increases with age and has been estimated to affect approximately 25% of postmenopausal women and 40% of women ≥80 years of age. Symptoms of vertebral compression fracture are non-specific, and more than two-thirds of fractures are detected incidentally when patients undergo imaging for other reasons. Most symptomatic fractures will heal within a few weeks or 1 month. A minority of patients will exhibit chronic pain and disability following osteoporotic compression fracture that present challenges for 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 is not improved with analgesics and may be better addressed through exercise. Conventional vertebroplasty surgical intervention may be required in severe cases not responsive to conservative measures.

Osteolytic Vertebral Body Fractures

Vertebral body fractures can also be pathologic, due to osteolytic lesions, most commonly from metastatic tumors. Metastatic malignant disease involving the spine generally involves the vertebral bodies, with pain being the most frequent complaint.

Treatment

While radiotherapy 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 vertebral body strength, which may necessitate supportive bracing to minimize the risk of vertebral body collapse during healing.

Kyphoplasty

Balloon kyphoplasty is a variant of vertebroplasty and uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of polymethylmethacrylate (PMMA). Radiofrequency kyphoplasty (also known as radiofrequency targeted vertebral augmentation) is a modification of balloon kyphoplasty. In this procedure, a small diameter articulating osteotome creates paths across the vertebra. An ultra-high viscosity cement is injected into the fractured vertebral body and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.

It has been proposed that kyphoplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, one of which is thermal damage to intraosseous nerve fibers, given that PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.

Another variant of kyphoplasty is vertebral body stenting, which utilizes an expandable scaffold instead of a balloon to restore vertebral height. The proposed advantages of vertebral body stenting are to reduce the risk of cement leakage by formation of a cavity for cement application and to prevent the loss of correction that is seen following removal of the balloon used for balloon kyphoplasty.

Vertebral Augmentation

Kiva is another mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body to provide a reservoir for bone cement. The Kiva VCF Treatment System consists of a shaped memory coil and an implant, which is filled with bone cement. The coil is inserted into the vertebral body over a removable guidewire. The coil reconfigures itself into a stack of loops within the vertebral body and can be customized by changing the number of loops of the coil. The implant, made from PEEK-OPTIMA, a biocompatible polymer, is deployed over the coil. The coil is then retracted and PMMA is injected through the lumen of the implant. The PMMA cement flows through small slots in the center of the implant, which fixes the implant to the vertebral body and contains the PMMA in a cylindrical column. The proposed advantage of the Kiva system is a reduction in cement leakage.

SpineJack is a mechanical vertebral augmentation technique that utilizes bipedicular 4.2 mm to 5.0 mm self-expanding jacks to restore vertebral height. Placement of the titanium devices are verified in AP and lateral view prior to expansion. Once the devices are expanded, a proprietary bone cement is injected. The proposed benefit is greater control over expansion and greater restoration of vertebral height compared to balloon kyphoplasty. The procedure requires good bone quality.

Note: Vertebroplasty and sacroplasty are addressed separately in medical policy, #004- Percutaneous Vertebroplasty and Sacroplasty.

KEY POINTS:

The most recent literature update was performed through February 17, 2023.

Summary of Evidence

For individuals who have osteoporotic vertebral compression fractures who receive balloon kyphoplasty, or mechanical vertebral augmentation (Kiva), the evidence includes an AHRQ comparative effectiveness review, randomized controlled trials (RCTs) and meta-analyses of RCTs. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. The Agency for Healthcare Research and Quality (AHRQ) review concluded that vertebroplasty was probably more effective at reducing pain and improving function in patients >65 years of age, but benefits were small. Kyphopasty was found to be probably more effective than usual care for pain and function in older patients with vertebral compression fracture at up to 1 month and may be more effective at >1 month to ≥1 year but has not been compared against sham therapy. A meta-analysis and moderately sized unblinded RCTs have compared kyphoplasty with conservative care and found short-term benefits in pain and other outcomes. Other RCTs, summarized in a meta-analysis, have reported similar outcomes for kyphoplasty and vertebroplasty. Two randomized trials that compared mechanical vertebral augmentation (Kiva or SpineJack) with kyphoplasty have reported similar outcomes for both procedures.

For individuals who have osteolytic vertebral compression fractures who receive balloon kyphoplasty or mechanical vertebral augmentation (Kiva), the evidence includes RCTs, case series, and a systematic review of these studies. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Two RCT have compared balloon kyphoplasty with conservative management and another has compared Kiva with balloon kyphoplasty. Results of these trials, along with case series, would suggest a reduction in pain, disability, and analgesic use in patients with cancer-related compression fractures.

After consideration of the available evidence and uniform clinical input, it was concluded that kyphoplasty may alleviate pain and improve function in patients with vertebral fractures who fail to respond to conservative treatment (at least 6 weeks) with analgesics, physical therapy, and rest. More recent randomized trials that compare kyphoplasty with medical management have also reported benefit. Given the absence of alternative treatment options and the morbidity associated with extended bed rest, kyphoplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy and for patients who have severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

For individuals who have osteoporotic or osteolytic vertebral compression fractures who receive radiofrequency kyphoplasty, the evidence includes a systematic review and RCT. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. The only RCT (n=80) identified showed similar results between radiofrequency kyphoplasty and balloon kyphoplasty. The systematic review suggested that radiofrequency kyphoplasty is superior to balloon kyphoplasty in pain relief, but the review itself was limited by the inclusion of a small number of studies as well as possible bias. Corroboration of these results in a larger number of patients would be needed to determine with greater certainty whether radiofrequency kyphoplasty provides outcomes similar to balloon kyphoplasty. The evidence is insufficient to determine the effects of the technology on health outcomes.

Early evidence suggests that vertebral body stenting may have worse outcomes compared with balloon kyphoplasty and is considered investigational.

Practice Guidelines and Position Statements

American College of Radiology et al

The American College of Radiology and 7 other surgical and radiologic specialty associations published a joint position statement on percutaneous vertebral augmentation in 2014.  This document stated that percutaneous vertebral augmentation, using vertebroplasty or kyphoplasty and performed in a manner consistent with public standards, is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures. The statement also indicated that these procedures be offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering the patient's quality of life.

A joint practice parameter for the performance of vertebral augmentation was updated in 2017.

Society of Interventional Radiology

In a 2014 quality improvement guideline on percutaneous vertebroplasty from the Society of Interventional Radiology, vertebral augmentation was recommended for compression fractures refractory to medical therapy. Failure of medical therapy includes the

following situations:

1. Patients who are "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. Patients 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. Patients with "a weakened or fractured vertebral body, and 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."

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence issued a guidance (2013) that recommended percutaneous vertebroplasty and percutaneous balloon kyphoplasty as treatment 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 through physical exam and imaging at the level of the fracture. This guidance did not address balloon kyphoplasty with stenting, because the manufacturer of the stenting system (Synthes) stated there is limited evidence for vertebral body stenting given that the system had only recently become available.

The Institute issued guidance (2008) on the diagnosis and management of adults with metastatic spinal cord compression. It was last reviewed in 2019,and a decision was made that the guideline required updating as "since its publication, there have been advances in the diagnosis and management of metastatic spinal cord compression. The guidance currently still states that vertebroplasty or kyphoplasty should be considered for patients who have vertebral metastases, and no evidence of spinal cord compression or spinal instability if they have mechanical pain resistant to conventional pain management and vertebral body collapse. Surgery should only be performed when all appropriate specialists, agree. Despite a relatively small sample base, the Institute concluded the evidence suggests, in a select subset of patients, that early surgery may be more effective at maintaining mobility than radiotherapy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Percutaneous kyphoplasty, polymethylmethacrylate, PMMA, vertebral fracture, vertebral compression fracture, skyphoplasty, SKy bone expander, mechanical vertebral augmentation, Kiva®, VCF Treatment System, KyphX , StabiliT®, AVAmax®, Vertebral Balloon system, NeuroTherm Parallax®   Balloon Inflatable Bone Tamp (NeuroTherm), Stryker iVAS®, Balloon catheter, Synthes Synflate™ Vertebral Balloon System (Synthes), radiofrequency kyphoplasty, vertebral body stenting, SpineJack, SpineKure, Kyphon HV-R Bone cement, Modified Winch Kyphoplasty, 13G InterV Kyphoplasty, 11G InterV Kyphoplasty, Mini-Flex, Micro, Medinaut, Osteopal Plus, AVAflex Vertebral Balloon System, Osseoflex SB, Guardian-SG Inflatable Bone Expander, ZVplasty, Joline, TRACKER, TRACKER Plus, KYPHON^TM VuE^TM

APPROVED BY GOVERNING BODIES:

Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Polymethylmethacrylate bone cement was available as a drug product before enactment of the FDA's device regulation and was at first considered what the FDA termed a "transitional device." It was transitioned to a class III device and then to a class II device, which required future 510(k) submissions to meet "special controls" instead of "general controls" to assure safety and effectiveness. In July 2004, KyphX®   HV-RTM bone cement was cleared for marketing by the FDA through the 510(k) process for the treatment of pathologic fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Subsequently, other products such as Spine-Fix®   Biomimetic Bone Cement, KYPHON®   HV-R®   Bone Cement, KYPHON^TM VuE^TM Bone Cement, and Osteopal®   V (Heraeus) have received 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

Balloon kyphoplasty requires the use of an inflatable bone tamp. In July 1998, one such tamp, the KyphX®   inflatable bone tamp (Medtronic), was cleared for marketing by the FDA through the 510(k) process. In 2014, the Kiva®   VCF Treatment System (Benvenue Medical) and in 2018 the SpineJack Expansion Kit (Vexim) were cleared for marketing by the FDA through the 510(k) process. FDA product code NDN. StabiliT®   Vertebral Augmentation System (Merit Medical) for radiofrequency vertebral augmentation was cleared for marketing in 2009. FDA product code NDN.

The table below lists examples of FDA-cleared devices for kyphoplasty and vertebral augmentation.

Kyphoplasty and Vertebral Augmentation Devices Cleared by the U.S. 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: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING: 

CPT Codes:

REFERENCES:

1. ACR–ASNR–ASSR–SIR–SNIS Practice guideline for the performance of vertebral augmentation 2012. www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Vertebral_Augmentation.pdf.
2. Alsoof D, Anderson G, McDonald CL, et al. Diagnosis and Management of Vertebral Compression Fracture. Am J Med. Jul 2022;135(7): 815-821.
3. Baerlocher MO, Saad WE, Dariushnia S, et al. Quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. Feb 2014; 25(2):165-170.
4. Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. Mar 2011; 12(3):225-235.
5. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. Jul 2011; 26(7):1627-1637.
6. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. Aug 6 2009; 361(6):557-568.
7. Chou R, Fu R, Dana T, et al. Interventional treatments for acute and chronic pain: systematic review [Internet]. AHRQ Comparative Effectiveness Reviews. Rockville (MD): Agency for Healthcare Research and Quality; 2021 Sep. Report No.: 21-EHC030.
8. 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.
9. Feng L, Shen JM, Feng C, et al. Comparison of radiofrequency kyphoplasty (RFK) and balloon kyphoplasty (BKP) in the treatment of vertebral compression fracturs: A meta-analysis. Medicine (Baltimore). Jun 2017; 96(25):e7150.
10. Halvachizadeh S, Stalder AL, Bellut D, et al. Systematic Review and Meta-Analysis of 3 Treatment Arms for Vertebral Compression Fractures: A Comparison of Improvement in Pain, Adjacent-Level Fractures, and Quality of Life Between Vertebroplasty, Kyphoplasty, and Nonoperative Management. JBJS Rev. Oct 25 2021; 9(10).
11. Hinde K, Maingard J, Hirsch JA, et al. Mortality Outcomes of Vertebral Augmentation (Vertebroplasty and/or Balloon Kyphoplasty) for Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. Radiology. Apr 2020; 295(1): 96-103.
12. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. May 24 2001; 344(21):1594-1602.
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. Jarvik JG, Deyo RA. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol. Sep 2000; 21(8):1373-1374.
15. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. Aug 6 2009; 361(6):569-579.
16. Korovessis P, Vardakastanis K, Repantis T et al. Balloon Kyphoplasty Versus KIVA Vertebral Augmentation-Comparison of 2 Techniques for Osteoporotic Vertebral Body Fractures: A Prospective Randomized Study. Spine (Phila Pa 1976). Feb 15 2013; 38(4):292-299.
17. Korovessis P, Vardakastanis K, Vitsas V, et al. Is Kiva implant advantageous to balloon kyphoplasty in treating osteolytic metastasis to the spine? Comparison of 2 percutaneous minimal invasive spine techniques: a prospective randomized controlled short-term study. Spine (Phila Pa 1976). Feb 15 2014; 39(4): E231-9. 
18. Mattie R, Brar N, Tram JT, et al. Vertebral Augmentation of Cancer-Related Spinal Compression Fractures: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). Dec 15 2021; 46(24): 1729-1737. 
19. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. Mar 19 2002; 136(6):471-476.
20. National Institute for Health and Care Excellence (NICE). Metastatic spinal cord compression in adults: risk assessment, diagnosis and management [CG75]. 2014; https://www.nice.org.uk/guidance/cg75/chapter/1-Guidance.
21. National Institute for Health and Care Excellence (NICE). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures [TA279]. 2013; https://www.nice.org.uk/guidance/ta279.
22. Noriega D, Marcia S, Theumann N et al. A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). Spine J. 2019 Nov;19(11).
23. Ong KL, Beall DP, Frohbergh M et al. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?. Osteoporos Int. 2018 Feb;29(2).
24. Petersen A, Hartwig E, Koch EM, et al. Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study. Eur J Orthop Surg Traumatol. Jan 2016; 26(1):67-75.
25. Pron G, Holubowich C, Kaulback K. Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: A Systematic Review. Ont Health Technol Assess Ser. 2016; 16(11): 1-202. 
26. Sun HB, Jing XS, Tang H, et al. Clinical and radiological subsequent fractures after vertebral augmentation for treating osteoporotic vertebral compression fractures: a meta-analysis. Eur Spine J. Oct 2020; 29(10): 2576-2590.
27. Tutton SM, Pflugmacher R, Davidian M, et al. KAST Study: The Kiva System as a vertebral augmentation treatment-a safety and effectiveness trial: a randomized, noninferiority trial comparing the Kiva System with balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). Jun 15 2015; 40(12):865-875.
28. Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976). May 20 2013; 38(12):971-983.
29. Vase L, Riley JL, 3rd, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain. Oct 2002; 99(3):443-452.
30. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. Mar 21 2009; 373(9668):1016-1024.
31. Yi X, Lu H, Tian F, et al. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. Jan 2014; 134(1):21-30.
32. Zhao S, Xu CY, Zhu AR, et al. Comparison of the efficacy and safety of 3 treatments for patients with osteoportoic vertebral compression fractures: A network meta-analysis. Medicine (Baltimore). Jun 2017; 96(26):e7328.

POLICY HISTORY:

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (7): New Policy. Kyphoplasty and mechanical vertebral augmentation material removed from MP#004 to create separate policy; refer to MP# 004 for policy history details. Policy statement updated to include coverage for mechanical vertebral augmentation using Kiva. Also, percutaneous radiofrequency kyphoplasty listed as investigational. Description and Key Points updated with current literature. Updated Key Words and Approved by Governing Bodies.

Medical Policy Administration Committee, May 2018

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (7): Updates to Description, Key Points, Key Words, and References.  No change to policy statement.  Added Key Words:  SpineJack, SpineKure, Kyphon HV-R Bone cement, Modified Winch Kyphoplasty, 13G InterV Kyphoplasty, 11G InterV Kyphoplasty, Mini-Flex, Micro, Medinaut, Osteopal Plus, AVAflex Vertebral Balloon System, Osseoflex SB, Guardian-SG Inflatable Bone Expander, ZVplasty.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (7): Updates to Key Points, Approved by Governing Bodies and References. Policy Statement clarification: the tradename "Kiva" was removed and added "FDA-cleared device". No change in intent.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Key Points and References.  Removed previous Policy Statement prior to April 2018. No change in intent.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Key Points, Approved by Governing Bodies and References. Added Keywords: “Joline, TRACKER, TRACKER Plus.” Removed previous Policy Statement prior to May 2018. No change in intent.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023 (7): Updates to Description, Key Points, Approved by Governing Bodies, Benefit Application, and References. Added Key Words: KYPHONTM VuETM. No change to 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.