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

Policy Number: MP-506

Latest Review Date: November 2024

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 September 23, 2024.

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 4 nonrandomized registry studies comparing MSA to laparoscopic Nissen fundoplication (LNF), laparoscopic Toupet fundoplication (LTF), or anti-reflex mucosectomy (ARM),single-arm cohort studies, and systematic reviews comparing MSA to laparoscopic Nissen fundoplication (LNF). Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. An RCT comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and GERD-related 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. Four non-randomized comparative studies of MSA to laparoscopic fundoplication showed mixed outcomes, withsome studies indicating similar improvements in QOL, PPI use, and satisfaction, while others reported no significant differencesin symptom improvement but a higher rate of dysphagia in the MSA group, and another study observed transient differences infavor of fundoplication in QOL, with the MSA group having worse quality of life scores at final follow-up. Limitations in thesecomparative studies included a lack of randomization, blinding, heterogeneity in surgical techniques, outdated MSA protocols,imbalanced baseline patient characteristics, and selection bias in treatment choice. 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

National Institute for Health and Care Excellence

In 2023, the NICE issued an interventional procedure guidance on laparoscopic insertion of a magnetic ring for GERD. The following recommendations were based on a comprehensive literature search and review:

  • "Evidence on the safety and efficacy of laparoscopic insertion of a magnetic ring for GERD is adequate to support using this procedure provided that standard arrangements are in place for clinical governance, consent, and audit."
  • "Patient selection and the procedure should be done by clinicians who have specific training in the procedure and experience in upper gastrointestinal laparoscopic surgery and managing GERD."

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 Gastroenterological Association

The American Gastroenterological Association (AGA) issued a statement on the personalized approach to evaluating andmanaging individuals with GERD in 2022. The authors provided a best practice recommendation: "In patients with proven GERD, laparoscopic fundoplication and magnetic sphincter augmentation are effective surgical options, and transoral incisionless fundoplication is an effective endoscopic option in carefully selected patients."

Multi-society Consensus Conference

A multi-society consensus guideline on the treatment of GERD was issued by the SAGES, American Society for Gastrointestinal Endoscopy (ASGE), American Society for Metabolic and Bariatric Surgery (ASMBS), European Association for EndoscopicSurgery (EAES), Society for Surgery of the Alimentary Tract (SSAT), and The Society of Thoracic Surgeons (STS) in 2023.

Based on a review of the available evidence the consensus panel determined the following recommendations:

  • The panel suggests that adult patients with GERD may be treated with either MSA or Nissen fundoplication based onsurgeon and patient shared decision-making. (Conditional recommendation based on very low certainty of evidence)
  • The panel suggests that adult patients with GERD may benefit from MSA over continued PPI use. (Conditional recommendation based on moderate certainty of evidence)

American College of Gastroenterology

In January 2022, the American College of Gastroenterology (ACG) published a clinical guideline on the diagnosis and management of GERD. Relevant recommendations concerning surgical management of refractory GERD include:

  • "For patients who have regurgitation as their primary PPI [proton pump inhibitor]-refractory symptom and who have had abnormal gastroesophageal reflux documented by objective testing, we suggest consideration of antireflux surgery or TIF [transoral incisionless fundoplication] (conditional recommendation; low level of evidence).
  • We recommend antireflux surgery performed by an experienced surgeon as an option for long-term treatment of patients with objective evidence of GERD, especially those who have severe reflux esophagitis (LA grade C or D), large hiatal hernias, and/or persistent, troublesome GERD symptoms (strong recommendation; moderate level of evidence).
  • We recommend consideration of MSA as an alternative to laparoscopic fundoplication for patients with regurgitation who fail medical management (strong recommendation; moderate level of evidence)."

The guideline also notes that due to the paucity of long-term data on MSA outcomes and lack of randomized trials directly comparing MSA with fundoplication, "it is difficult to recommend one over the other at this time."

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 (Ethicon; formerly Torax Medical) 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 maximal therapy for the treatment of reflux. The FDA initially required a 5-year follow-up of 100 patients from the investigational device exemption 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."

In February 2024, the FDA revised the labeling for the LINX® Reflux Management System. They removed a precautionary statement about Barrett's Esophagus (BE) from the instructions for use. However, the updated labeling now includes this guidance: "LINX has not been proven to effectively treat BE by causing regression or preventing progression to cancer. Patients with BE who use LINX to manage GERD symptoms should consult their physician about ongoing BE treatment, which may include continued use of proton pump inhibitors (PPIs)."

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:

43284

Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed

43285

Removal of esophageal sphincter augmentation device

 

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, Apr 2018;52:82-88.
  2. Alicuben, E.T., Bell, R.C.W., Jobe, B.A. et al. Worldwide Experience with Erosion of the Magnetic Sphincter Augmentation Device. J Gastrointest Surg (2018) 22(8): 1442-1447.
  3. American Foregut Society (AFS). American Foregut Surgery Statement on Appropriate Patient Selection and Use of Magnetic Sphincter Augmentation (LINX). n.d.; www.americanforegutsociety.org/wp-content/uploads/2021/04/AFS-LINX-Final.pdf. 
  4. ASGE Technology Committee.  Magnets in the GI tract.  Gastrointest Endosc 2013; 78(4):561-7.
  5. Asti E, Milito P, Froiio C, et al. Comparative outcomes of Toupet fundoplication and magnetic sphincter augmentation. DisEsophagus. Jun 15 2023; 36(Supplement_1).
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  9. 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.
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  11. Bologheanu M, Matic A, Feka J, et al. Severe Dysphagia is Rare After Magnetic Sphincter Augmentation. World J Surg.Sep 2022; 46(9): 2243-2250.
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  20. Eriksson SE, Maurer N, Zheng P, et al. Impact of Objective Colonic and Whole Gut Motility Data as Measured by WirelessMotility Capsule on Outcomes of Antireflux Surgery. J Am Coll Surg. Feb 01 2023; 236(2): 305-315.
  21. Fadel MG, Tarazi M, Dave M, et al. Magnetic sphincter augmentation in the management of gastro-esophageal reflux disease: A systematic review and meta-analysis. Int J Surg. May 09 2024; 110(10): 6355-66.
  22. 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. 
  23. 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.
  24. Fletcher R, Dunst CM, Abdelmoaty WF, et al. Safety and efficacy of magnetic sphincter augmentation dilation. SurgEndosc. Jul 2021; 35(7): 3861-3864.
  25. 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.
  26. Ganz RA, Peters JH, Horgan S et al.  Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med Feb 21 2013; 368(8): 719-27.
  27. Gottlieb KT, Banerjee S, Barth BA, et al. Magnets in the GI tract. Gastrointest Endosc. Oct 2013; 78(4): 561-7.
  28. 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, Nov 13 2019; 32(9).
  29. Ibach MJ, Dahlke PM, Wiegrebe S, et al. Medium-term outcomes after magnetic sphincter augmentation vs. fundoplication for reflux disease due to hiatal hernia: a propensity-score matched comparison in 282 patients. Surg Endosc. Sep 2024; 38(9): 5068-5075.
  30. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  31. Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. Jan 01 2022; 117(1): 27-56. 
  32. Khaitan L, Hill M, Michel M, et al. Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity. Obes Surg. Jan 2023; 33(1): 387-396. 
  33. 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.; www.americanforegutsociety.org/wp-content/uploads/sites/21/2021/04/AFS_MSA_Bariatric_Surgery_Final-1.pdf. 
  34. 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.
  35. Leeds SG, Ngov A, O Ogola G, et al. Safety of magnetic sphincter augmentation in patients with prior bariatric and anti-reflux surgery. Surg Endosc. Sep 2021; 35(9): 5322-5327.
  36. 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.
  37. 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 2015 May-Jun;28(4):305-11.
  38. Louie BE, Smith CD, Smith CC, et al. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: OneYear Results From a Post Approval Study. Ann Surg. Aug 2019; 270(2): 302-308.
  39. 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.
  40. National Institute for Health and Care Excellence (NICE). Laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease [GID-IPG749]. 2022; www.nice.org.uk/guidance/ipg749. 
  41. Nikolic M, Matic A, Feka J, et al. Expanded Indication for Magnetic Sphincter Augmentation: Outcomes in Weakly Acidic Reflux Compared to Standard GERD Patients. J Gastrointest Surg. Mar 2022; 26(3): 532-541.
  42. O'Neill SM, Jalilvand AD, Colvin JS, et al. S148: Long-term patient-reported outcomes of laparoscopic magnetic sphincteraugmentation versus Nissen fundoplication: a 5-year follow-up study. Surg Endosc. Sep 2022; 36(9): 6851-6858.
  43. Rausa E, Ferrari D, Kelly ME, et al. Efficacy of laparoscopic Toupet fundoplication compared to endoscopic and surgicalprocedures for GERD treatment: a randomized trials network meta-analysis. Langenbecks Arch Surg. Jan 21 2023;408(1): 52.
  44. 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.
  45. 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.
  46. 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.
  47. 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.
  48. 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.
  49. Sarici IS, Eriksson SE, Zheng P, et al. Need for frequent dilations after magnetic sphincter augmentation: an assessmentof associated factors and outcomes. Surg Endosc. Sep 2023; 37(9): 7159-7169.
  50. Sheu EG, Nau P, Nath B et al.  A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication.  Surg Endosc 2015 Mar;29(3):505-9.
  51. Slater BJ, Collings A, Dirks R, et al. Multi-society consensus conference and guideline on the treatment ofgastroesophageal reflux disease (GERD). Surg Endosc. Feb 2023; 37(2): 781-806.
  52. 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.
  53. 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 Jun;27(6):586-591.
  54. 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/. 
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  62. 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 2017; 266(1): 99-104.
  63. 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.
  64. Wisniowski P, Putnam LR, Gallagher S, et al. Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis. Surg Endosc. Apr 2024; 38(4): 1944-1949.
  65. Yadlapati R, Gyawali CP, Pandolfino JE, et al. AGA Clinical Practice Update on the Personalized Approach to theEvaluation and Management of GERD: Expert Review. Clin Gastroenterol Hepatol. May 2022; 20(5): 984-994.e1.
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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.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (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 2023

Medical Policy Group, November 2023 (11): Updates to Key Points, Current Coding, Benefit Application, and References. Removed 43289, 0392T, 0393T & C9737 from previous coding section. No change to Policy Statement.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Key Points, Approved by Governing Bodies, and References. 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.