mp-506
print Print Back Back

Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease (GERD)

Policy Number: MP-506

Latest Review Date: November 2021

Category: Surgery                                                      

POLICY:

An implantable magnetic esophageal sphincter augmentation to treat gastroesophageal reflux disease (GERD) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

A laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores has been developed for the treatment of gastroesophageal reflux disease (GERD). The device is placed around the esophagus at the level of the gastroesophageal junction and is being evaluated in patients who have GERD symptoms, despite maximal medical therapy.

Gastroesophageal Reflux Disease (GERD)

Gastroesophageal reflux disease (GERD) is defined as the reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury. GERD is a common medical disorder, with estimates of 10-20% prevalence in developed countries. The severity of GERD is widely variable. Many patients have mild, intermittent symptoms that do not require treatment or only require episodic use of medications. Other patients have chronic, severe GERD that can lead to complications such as Barrett’s esophagus and esophageal cancer.

Treatment

For patients with severe disease, chronic treatment with acid blockers is one option. For some patients, medications are not adequate to control symptoms, and other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these patients, primarily a Nissen fundoplication performed either laparoscopically or by open surgery. A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery.

The LINX™ Reflux Management System (Torax Medical) is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. The target population is patients who have GERD symptoms despite maximum medical therapy (e.g., proton pump inhibitors) but who do not want to risk the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX™ Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging (MRI) is needed for another condition.

KEY POINTS:

The most recent literature update was performed through October 12, 2021.

Summary of Evidence

For individuals who have GERD who receive magnetic sphincter augmentation (MSA), the evidence includes 1 randomized controlled trial (RCT) comparing MSA to proton pump inhibitor (PPI) therapy, a single nonrandomized registry study comparing MSA to laparoscopic fundoplication, single-arm cohort studies, and systematic reviews of observational studies comparing MSA to laparoscopic Nissen fundoplication (LNF). Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. A RCT comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and quality of life (QOL) at 6 months. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. A prospective, observational registry study comparing MSA to laparoscopic fundoplication found similar improvements in QOL, satisfaction, and medication use. Limitations of the study included lack of randomization and blinding, heterogeneity in fundoplication techniques, use of an outdated MSA protocol, and selection bias as patients with less severe symptoms received MSA. In the 2 single-arm, uncontrolled pivotal trials submitted to the U.S. Food and Drug Administration with materials for device approval, subjects showed improvements in GERD-health-related QOL scores and reduced PPI use. Similarly, observational comparative studies included in systematic reviews, most often comparing MSA with LNF, generally have shown that GERD-health-related QOL scores do not differ significantly between fundoplication and MSA, and patients can reduce PPI use after MSA. However, the comparative studies are retrospective and nonrandomized, and may be affected by selection bias. Randomized comparisons of MSA with LNF are needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Society of American Gastrointestinal and Endoscopic Surgeons

The Society of American Gastrointestinal and Endoscopic Surgeons (2013; updated in 2017) published a Technology and Value Assessment Committee (TAVAC) analysis on the safety and effectiveness of the LINX Reflux Management System. The Society indicated that safety analyses of the LINX system suggested the procedure is associated with few serious adverse events and no reported mortality, and that currently available data demonstrated a reasonable assurance as to the efficacy of the system. The report concluded that direct comparative studies between the LINX procedure and Nissen fundoplication would be needed, although, based on the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory gastroesophageal reflux disease.

In April 2021, guidelines for the surgical treatment of GERD were reviewed and approved by the Board of Governors of the SAGES based on a systematic review of the evidence. Key questions presented in these guidelines do not address the use of MSA.

National Institute for Health and Care Excellence

In July 2017, the National Institute for Health and Care Excellence (NICE) issued an interventional procedures guidance on laparoscopic insertion of a magnetic titanium ring for GERD. While the recommendations conclude that there are no major safety concerns with the device, they note limited evidence of short-term efficacy with inadequate quality and quantity of evidence for long-term efficacy. Accordingly, "this procedure should only be used with special arrangements for clinical governance, consent, and audit or research," and note that "long-term outcome data and comparative trials with other anti-reflux surgery would be helpful."

American Foregut Society

The American Foregut Society (AFS) issued a statement on appropriate patient selection and use of MSA, and noted that "patient selection criteria for MSA do not differ in principle from those of any other surgical procedure for reflux disease." Indications for MSA include:

  • "Typical GERD symptoms (ie, heartburn, regurgitation) with break-through symptoms, intolerance to medical therapy, and/or unwillingness to take anti-reflux medications long term.
  • Regurgitation despite optimized medical therapy and lifestyle modification.
  • Extraesophageal symptoms with objective evidence of significant reflux disease (ie, endoscopic evidence of [Los Angeles] Class C or D esophagitis, Barrett's esophagus or positive pH study."

The statement additionally notes that "MSA candidacy largely mirrors that for laparoscopic fundoplication. Low dysphagia rates for MSA have been found when performed in patients with normal esophageal motility." The AFS also recommends that a full hiatal dissection and cruroplasty be performed prior to implantation of an MSA device.

The AFS Bariatric Committee also issued a statement regarding the concurrent use of MSA at the time of primary bariatric surgery, noting that this practice "violates many basic surgical principles and is not considered judicious use by the American Foregut Society." The statement also notes that prospective trials demonstrating the safety and efficacy of concurrent MSA are needed.

American Society for Gastrointestinal Endoscopy

A report on emerging technology from the American Society for Gastrointestinal Endoscopy (2013) concluded that long-term data about the safety and efficacy of the LINX device are needed. The document indicates that the LINX band is currently being deployed laparoscopically; however, a natural orifice transluminal endoscopic surgery approach could be explored.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Gastroesophageal Reflux, GERD, LINX™, The LINX™ Reflux Management System (Torax Medical), magnet esophageal ring

APPROVED BY GOVERNING BODIES:

In 2012, the LINX® Reflux Management System (Torax Medical, Shoreview, MN) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (P100049) for patients diagnosed with GERD, as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum therapy for the treatment of reflux. The FDA initially required a five-year follow-up of 100 patients from the investigational device exemption (IDE) pivotal study to evaluate the safety and efficacy of the device, which was completed in March 2016. In 2018,the manufacturer initiated a device recall due to a possible separation of the bead component with the adjacent wire link causing a potential discontinuous or open LINX device. This recall was terminated on November 4, 2020.

In March 2018, the FDA approved an update of the LINX® Reflux Management System precautions statement, stating that the use of the system "in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm and that the LINX Reflux Management System has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm, add a hiatal hernia clinical data summary in the instructions for use, update the instructions for use section to highlight the recommendation to repair a hiatal hernia, if present, at the time of the LINX Reflux Management System implantation, and update the patient information booklet to align with the instructions for use and include 5 year clinical study results."

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

CURRENT CODING: 

CPT Codes:

Effective 01/01/17, there are specific CPT codes for this procedure:

43284              Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed (Effective 01/01/17)
43285

Removal of esophageal sphincter augmentation device (Effective 01/01/17)

PREVIOUS CODING:

CPT Codes:

43289              unlisted laparoscopy procedure, esophagus (Replaced effective 07/01/2015)
0392T             Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band) (Deleted 12/31/16)
0393T             Removal of esophageal sphincter augmentation device (Deleted 12/31/16)

HCPCS:

C9737            

Lap esoph augmentation (Deleted 07/01/2015)

REFERENCES:

  1. Aiolfi A, Asti E, Bernardi D et al. Early results of magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: Systematic review and meta-analysis. Int J Surg, 2018 Feb 23;52:82-88.
  2. Alicuben, E.T., Bell, R.C.W., Jobe, B.A. et al. J Gastrointest Surg (2018) 22: 1442. https://doi.org/10.1007/s11605-018-3775-0
  3. American Foregut Society (AFS). American Foregut Surgery Statement on Appropriate Patient Selection and Use of Magnetic Sphincter Augmentation (LINX). n.d.; https://www.americanforegutsociety.org/wp-content/uploads/sites/21/2021/04/AFS-LINX-Final.pdf. Accessed October 12, 2021.
  4. Ann Surg. 2018 Apr 24 Published online 2018 Apr 24. doi: 10.1097/SLA.0000000000002789
  5. ASGE Technology Committee.  Magnets in the GI tract.  Gastrointest Endosc 2013; 78(4):561-7.
  6. Asti E, Bonitta G, Lovece A, et al. Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis. Medicine (Baltimore). Jul 2016;95(30):e4366.
  7. Bell R, Lipham J, Louie B et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest. Endosc., 2018 Jul 22;89(1). 
  8. Bell R, Lipham J, Louie B, et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc. Jan 2019; 89(1):14-22.e1.
  9. Bell R, Lipham J, Louie BE, et al. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin Gastroenterol Hepatol. Jul 2020; 18(8): 1736-1743.e2.
  10. Bonavina L, DeMeester T, Fockens P et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg 2010; 252(5):857-62.
  11. Bonavina L, Horbach T, Schoppmann SF, et al. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. Jul 2021; 35(7): 3449-3458.
  12. Bonavina L, Saino G, Bona D et al. Magnetic Augmentation of the Lower Esophageal Sphincter: Results of a Feasibility Clinical Trial. Gastrointestinal Endoscopy 2008.
  13. Bonavina L, Saino G, Bona D, et al. One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center. J Am Coll Surg. Oct 2013;217(4):577-585.
  14. Brian E. Louie, C. Daniel Smith, Christopher C. Smith, Reginald C. W. Bell, George Kevin Gillian, Jeffrey S. Mandel, Kyle A. Perry, Walter Kurt Birkenhagen, Paul A. Taiganides, Christy M. Dunst, et al.
  15. Buckley III FP, Bell RC, Freeman K, et al. Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation. Surg Endosc. Sept 2017. Epub ahead of print.
  16. Chen, M. Y., Huang, D. Y., Wu, A., Zhu, Y. B., Zhu, H. P., Lin, L. M., & Cai, X. J. (2017). Efficacy of Magnetic Sphincter Augmentation versus Nissen Fundoplication for Gastroesophageal Reflux Disease in Short Term: A Meta-Analysis. Canadian journal of gastroenterology & hepatology, 2017, 9596342. doi:10.1155/2017/9596342
  17. DeMarchi J, Schwiers M, Soberman M, et al. Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation. Dis Esophagus. Jun 11 2021.
  18. Dunn CP, Zhao J, Wang JC, et al. Magnetic sphincter augmentation with hiatal hernia repair: long term outcomes. Surg Endosc. Oct 2021; 35(10): 5607-5612.
  19. FDA. Gastroenterology and urology devices panel of the medical devices advisory committee. LINX™ reflux management system. 2012; www. Wayback.archive-it.org/7993/20170113140208/. www.fda.gov/downloads/Advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/gastroenterology-urologydevicespanel/ucm286236.pdf. Accessed October 2017.
  20. Ferrari D, Asti E, Lazzari V, et al. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. Aug 13 2020; 10(1): 13753.
  21. Ganz RA, Edmundowicz SA, Taiganides PA, et al. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. May 2016; 14(5):671-677.
  22. Ganz RA, Gostout CJ, Grudem J et al. Use of a magnetic sphincter for the treatment of GERD: a feasibility study. Gastrointestinal Endoscopy 2008; 67(2):287-94.
  23. Ganz RA, Peters JH, Horgan S et al.  Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 2013; 368(8): 719-27.
  24. Gottlieb KT, Banerjee S, Barth BA, et al. Magnets in the GI tract. Gastrointest Endosc. Oct 2013; 78(4): 561-7.
  25. Guidozzi N, Wiggins T, Ahmed AR et al. Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis. Dis. Esophagus, 2019 May 10.
  26. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  27. Khaitan L, Abu Dayyeh BK, Lipham J, et al. American Foregut Society (AFS) Committee Statement on Combined Magnetic Sphincter Augmentation and Bariatric Surgery. n.d.; https://www.americanforegutsociety.org/wp-content/uploads/sites/21/2021/04/AFS_MSA_Bariatric_Surgery_Final-1.pdf. Accessed October 10, 2021.
  28. Kothari BL, Borgert AJ, Kallies KJ, et al. Lack of Correlation Between Subjective and Objective Measures of Gastroesophageal Reflux Disease: Call for a Novel Validated Assessment Tool. Surg Innov. Jun 2021; 28(3): 290-294.
  29. Lipham JC, Demeester TR, Ganz RA et al. The LINX((R)) reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc 2012; 26(10): 2944-9.
  30. Lipham JC, Taiganides PA, Louie BE et al. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus 2014.
  31. Louie BE, Farivar AS, Shultz D et al. Short-Term Outcomes Using Magnetic Sphincter Augmentation Versus Nissen Fundoplication for Medically Resistant Gastroesophageal Reflux Disease. Ann Thorac Surg 2014.
  32. National Institute for Health and Care Excellence (NICE). Laparoscopic insertion of a magnetic titanium ring for gastro-esophageal reflux disease [IPG585]. July 26, 2017; https://www.nice.org.uk/guidance/ipg585/. Accessed October 12, 2021.
  33. Reynolds JL, Zehetner J, Bildzukewicz N, et al. Magnetic sphincter augmentation with the LINX device for gastroesophageal reflux disease after U.S. Food and Drug Administration approval. Am Surg. Oct 2014; 80(10):1034-1038.
  34. Reynolds JL, Zehetner J, Wu P, et al. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. J Am Coll Surg. Jul 2015; 221(1):123-128.
  35. Riegler M, Schoppman SF, Bonavina L, et al. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. May 2015; 29(5):1123-1129.
  36. Rona KA, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. May 2017; 31(5):2096-2102.
  37. Rona KA, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. Aug 23 2016.
  38. Saino G, Bonavina L, Lipham JC, et al. Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement. J Laparoendosc Adv Surg Tech A. Oct 2015; 25(10):787-792.
  39. Sheu EG, Nau P, Nath B et al.  A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication.  Surg Endosc 2014.
  40. Smith CD, DeVault KR, Buchanan M. Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption. J Am Coll Surg. Apr 2014; 218(4):776-781.
  41. Smith CD, Ganz RA, Lipham JC, et al. Lower esophageal sphincter augmentation for gastroesophageal reflux disease: The safety of a modern implant. Journal of Laparoendoscopic & Advanced Surgical Techniques. 2017.
  42. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).  TAVAC Safety and Effective Analysis: LINX® Reflux Management System. 2017.  Available online at:  www.sages.org/publications/guidelines/tavac-safety-and-effectiveness-analysis-linx-reflux-management-system/.  Last accessed October 2017.
  43. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Technology and Value Assessment Committee (TAVAC) Safety and Effectiveness Analysis: LINX Reflux Management System. 2017; https://www.sages.org/publications/tavac/tavac-safety-and-effectiveness-analysis-linx-reflux-management-system/. Accessed October 12, 2021.
  44. U.S. Food and Drug Administration. Class 2 Device Recall LINX Reflux Management System. May 31, 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163589. Accessed September 28, 2020.
  45. U.S. Food and Drug Administration. LINX™ Reflux Management System. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee 2012. Available online at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM286236.pdf. Last accessed June, 2014.
  46. Warren HF, Louie BE, Farivar AS, et al. Manometric changes to the lower esophageal sphincter after magnetic sphincter augmentation in patients with chronic gastroesophageal reflux Disease. Ann Surg. Jul 26 2016
  47. Warren HF, Reynolds JL, Lipham JC, et al. Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease. Surg Endosc. Aug 2016; 30(8):3289-3296.

POLICY HISTORY:

Medical Policy Group, August, 2102 (4)

Medical Policy Administration Committee, September, 2012

Available for comment September 18 through November 1, 2012

Medical Policy Group, April, 2013 (4): Updated references

Medical Policy Panel, August 2013

Medical Policy Group, August 2013 (3):  2013 Updates to key points and references; no change in policy statement

Medical Policy Panel, August 2014

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

Medical Policy Group, July 2015 (4): 2015 Quarterly Coding Update.  Added CPT code 0392T and 0393T to Current Coding and previous coding section created for CPT code C9737.

Medical Policy Panel, August 2015

Medical Policy Group, August 2015 (4):  Updates to Key Points and References. Removed unlisted code 43289 from Current Coding and added to Previous coding. No change in policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (4): Updates to Key Points, Approved Governing Bodies, Coding, and References. Added new codes 43284 and 43285 to current coding, and moved 0392T and 0393T to previous coding. No change to policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, November 2017 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points. No change to policy statement.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (5): Updates to Description, Approved by Governing Bodies, Key Points, Practice Guidelines, and References. Title and Policy statement verbiage changed from Magnetic Esophageal “Ring” to Magnetic Esophageal “Spincter Augmentation.” No change in policy intent.

Medical Policy Panel, November 2020

Medical Policy Group, December 2020 (5): Updates to Description, Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Description, Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. Policy Statement updated to remove “not medically necessary,” no change to 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 (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.