DRAFT

Latest Review Date: December 2024

Category: Surgery                                                                 

POLICY:

Effective for dates of service February 16, 2025 and after:

Radiofrequency ablation and ultrasound ablation of the renal sympathetic nerves for the treatment of uncontrolled hypertension is considered not medically necessary.

Effective for dates of service prior to February 16, 2025:

Radiofrequency ablation of the renal sympathetic nerves for the treatment of uncontrolled hypertension is considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

Radiofrequency ablation (RFA) of the renal sympathetic nerves is thought to decrease both the afferent sympathetic signals from the kidney to the brain and the efferent signals from the brain to the kidney. This procedure is said to decrease sympathetic activation, decrease vasoconstriction, and decrease activation of the renin-angiotensin system. RFA of the renal sympathetic nerves may act as a nonpharmacologic treatment for hypertension and has been proposed as a treatment option for patients with uncontrolled hypertension despite the use of antihypertensive medications.

Uncontrolled Hypertension

Hypertension is a widely prevalent condition, which is estimated to affect approximately 30% of the population in the United States. It accounts for a high burden of morbidity related to strokes, ischemic heart disease, kidney disease, and peripheral arterial disease. 

An estimated 1 in 4 adults with hypertension have their hypertension under control, but the remaining 77% (93 million) remain uncontrolled. Uncontrolled hypertension is diagnosed when an individual's blood pressure remains above targeted levels (typically ≥140/90 mmHg) when a patient either:

• is not using, or is unable to use, treatments to control blood pressure; or
• when hypertension persists despite antihypertensive therapies.

The definition of uncontrolled hypertension is inclusive of resistant hypertension in which blood pressure remains above the targeted range despite the use of 3 or more antihypertensive medications, including a diuretic, with complementary mechanisms of action. There are a number of factors that may contribute to uncontrolled hypertension, including nonadherence to medications, excessive salt intake, inadequate doses of medications, excess alcohol intake, volume overload, drug-induced hypertension, and other forms of secondary hypertension. Also, sometimes it is necessary to address comorbid conditions, i.e., obstructive sleep apnea, to adequately control BP.

Radiofrequency Denervation of the Renal Sympathetic Nerves

Increased sympathetic nervous system activity has been linked to essential hypertension. Surgical sympathectomy has been shown to be effective in reducing blood pressure but is limited by the adverse effects of surgery and was largely abandoned after effective medications for hypertension became available. The renal sympathetic nerves arise from the thoracic nerve roots and innervate the renal artery, the renal pelvis, and the renal parenchyma. Radiofrequency ablation (RFA) is thought to decrease both the afferent sympathetic signals from the kidney to the brain and the efferent signals from the brain to the kidney. This procedure decreases sympathetic activation, decrease in vasoconstriction, and a decrease activation of the renin-angiotensin system.

The procedure is performed percutaneously with access at the femoral artery. A flexible catheter is threaded into the renal artery and controlled energy source, most commonly low-power radiofrequency (RF) energy is delivered to the arterial walls where the renal sympathetic nerves are located. Once adequate RF energy has been delivered to ablate the sympathetic nerves, the catheter is removed.

Ultrasound Denervation of the Renal Sympathetic Nerves

Ultrasound renal denervation (usRDN) is a minimally invasive procedure designed to treat hypertension by disrupting renal sympathetic nerves. The procedure targets the same physiological mechanism as radiofrequency ablation, aiming to decrease both afferent and efferent sympathetic signaling between the kidneys and the brain. This reduction in sympathetic activation is thought to decrease vasoconstriction and inhibit the renin-angiotensin system, ultimately leading to blood pressure reduction. The usRDN procedure is typically performed under local anesthesia with conscious sedation. Access is obtained through the femoral artery, and the catheter is advanced to the renal artery under fluoroscopic guidance. Once positioned, the catheter's balloon is inflated with cooling fluid, and ultrasound energy is delivered. Usually, 2-3 ultrasound emissions are delivered per renal artery, with the ability to treat both main renal arteries and accessory renal arteries when present.

KEY POINTS:

The most recent literature review was updated through August 26, 2024.

Summary of Evidence

For individuals who uncontrolled hypertension, despite the use of anti-hypertensive medications, who receive RFA of the renal sympathetic nerves, the evidence includes several RCTs, numerous systematic reviews of the RCTs, and a multinational registry study. Relevant outcomes are symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. The proof of principle SPYRAL HTN-OFF MED study found that multielectrode renal denervation was superior to sham in the absence of background antihypertensive medication therapy, with between-group differences of -4.0 mmHg for 24-h SBP and -6.6 for office SBP at 3 months. The unpowered SPYRAL HTN-ON MED study also found significant between-group differences of -7.4 mmHg for 24-h SBP and -6.8mmHg for office SBP at 6 months; however, results were only significant for the subgroup of patients non-adherent to medications. Long-term data from the SPYRAL HTN-ON MED study suggest that blood pressure reductions with multielectrode renal denervation are progressive and sustained over time. The SPYRAL HTN-ON MED Expansion study failed to meet its primary efficacy endpoint and found only 0.03 mmHg difference between renal denervation and sham control groups at 6 months follow-up. A significant reduction in office blood pressure was noted at 6 months (-4.1 mmHg). Confounding of these outcome estimates by unbalanced medication changes, missing 24-h SBP outcome data, and timing of antihypertensive medications related to 24-h SBP assessment may explain the discordant results between the pilot and expansion phases of this trial. Study interpretation is also complicated by short-term blinded follow-up and imputation of excluded crossover patient data. It is unclear which patients are most likely to derive benefit, and currently, there is no practical method to verify nerve destruction following ablation. Evidence from systematic reviews and meta-analyses are conflicting, but all available studies included evidence from both first and second-generation Symplicity catheters as well as multiple renal denervation methodologies such as ultrasound. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have uncontrolled hypertension, despite the use of anti-hypertensive medications, who receive ultrasound renal denervation (usRDN), the evidence includes 4 randomized sham-controlled trials, 1 RCT comparing usRDN to radiofrequency-based renal denervation, and a pooled analysis of 3 sham-controlled RCTs. Relevant outcomes are changes in blood pressure, medication use, and treatment-related morbidity. Two trials, RADIANCE-HTN SOLO and RADIANCE II evaluated usRDN in patients with no antihypertensive medication usage for 2 months post-intervention. The RADIANCE-HTN SOLO trial demonstrated that usRDN was superior to sham, with a between-group difference of -6.3 mmHg for daytime ambulatory systolic blood pressure (SBP) at 2 months. The RADIANCE II trial showed similar results, also showing a -6.3 mmHg difference in daytime ambulatory SBP at 2 months. The RADIANCE-HTN TRIO trial, focusing on resistant hypertension inpatients with a standardized triple combination antihypertensive treatment, found a -4.5 mmHg difference in daytime ambulatory SBP at 2 months. The REQUIRE trial, conducted in Asian populations, did not show a significant difference between usRDN and sham control, possibly due to study design limitations. Long-term data from these trials show mixed results: while studies suggest that BP reductions with usRDN are sustained over time, the differences between usRDN and sham control groups diminished at 6 or 12 months after medication titration in some trials. However, the FDA's summary of safety and effectiveness data for the RADIANCE-HTN TRIO and SOLO trials demonstrated superior office systolic blood pressure reductions with usRDN compared to sham control at 24 and 36 months. Notably, these improved outcomes in the usRDN group were achieved despite patients using fewer antihypertensive medications than the sham control group. A meta-analysis of the sham-controlled RADIANCE trials showed that fewer usRDN patients required additional antihypertensive medications and demonstrated significant reductions in ambulatory, home, and office SBP at 6 months. Adverse events were infrequent and similar between usRDN and sham groups across studies. The RADIOSOUND-HTN trial compared 3 renal denervation techniques in patients with resistant hypertension who were on a stable regimen of antihypertensive medications. The trial found that usRDN showed superiority over radiofrequency ablation (RFA) of main renal arteries in reducing daytime ambulatory SBP at 3 months, while RFA of main arteries plus branches did not significantly differ from the other groups. While these results are promising, there was high variability in patient responses suggesting that further research may be needed to identify who is most likely to benefit from usRDN. Additionally, there is currently no practical method to verify nerve destruction following ablation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Heart Association et al

The AHA (2024) published a Scientific Statement on renal denervation for the treatment of hypertension. The AHA concluded:

• Although further research is needed, particularly in the realms of patient selection and long-term efficacy, renal denervation is a promising new therapeutic approach for some patients with uncontrolled hypertension, particularly patients with resistant hypertension or who have multiple medication intolerances.
• As with any procedure, safety remains a concern. That said, both short-term and ongoing medium- to longer-term studies have demonstrated reassuring safety profiles.
• A multidisciplinary team approach that includes hypertension specialists and proceduralists is important both for identifying the right candidates for renal denervation and for following them after the procedure.
• Much, if not all of our current literature and experience with renal denervation in the United States have been in the context of clinical trials. Therefore, little is currently known about the cost of renal denervation as it compares with conventional treatment options, many of which are now generic and lower-cost pharmacological options.

National Institute for Health and Care Excellence

In 2023, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance on the use of percutaneous transluminal radiofrequency sympathetic denervation of the renal artery for resistant hypertension, recommending that the procedure should only be used with special arrangements for clinical governance, consent, and audit or research due to limited evidence.

Society for Cardiovascular Angiography & Interventions

In 2023, the Society for Cardiovascular Angiography & Interventions (SCAI) published a position statement on patient selection, operator competence, training and techniques, and organizational recommendations for the use of renal denervation for the treatment of hypertension. The following selection criteria were issued concerning renal denervation:

• Patients with resistant hypertension, defined by blood pressure >130/80 mmHg despite being on 3 medications with maximally tolerated doses from classes with outcomes data (angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, calcium channel blockers, thiazide diuretics, and beta blockers)

• Patients with uncontrolled hypertension despite attempting lifestyle modification and antihypertensive medication but who are either intolerant of additional medication or do not wish to be on additional medications and who are willing to undergo renal denervation after shared decision-making
• Priority may be appropriately given to patients with higher cardiovascular risk (e.g., comorbidities of coronary artery disease, diabetes, prior transient ischemic attack/cerebrovascular accident, or chronic kidney disease) who may have the greatest benefit from blood pressure reduction

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Renal artery denervation, Radiofrequency ablation of the renal sympathetic nerves, EnligHTN, One-Shot Renal Denervation System™ Simplicity, Thermocouple Catheter™, V2 renal denervation system, Vessix™, Paradise, Paradise Ultrasound Renal Denervation System, Symplicity Spyral

APPROVED BY GOVERNING BODIES:

Two renal denervation devices have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension (FDA product code: QYI):

The Paradise® Ultrasound Renal Denervation System (ReCor Medical, Inc) was approved by the FDA on November 7, 2023, and the Symplicity Spyral™ Renal Denervation System (Medtronic, Inc) was approved by the FDA on November 17, 2023. Both systems are indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.

No other renal denervation devices are currently FDA approved for the treatment of hypertension. Several other devices that were previously in development, such as the EnligHTN™ system (St. Jude Medical) and Vessix™ system (Boston Scientific), are no longer being marketed for this indication.

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:

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7. Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. Jun 09 2018;391(10137): 2335-2345.
8. Azizi M, Schmieder RE, Mahfoud F, et al. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTNSOLO Trial. Circulation. May 28 2019; 139(22): 2542-2553.
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30. Fadl Elmula FE, Jin Y, Yang WY, et al. Meta-analysis of randomized controlled trials of renal denervation in treatment-resistant hypertension. Blood Press. Oct 2015;24(5):263-274.
31. Fengler K, Rommel KP, Blazek S, et al. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. Jan 29 2019; 139(5): 590-600.
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33. Food and Drug Administration (FDA) Circulatory System Devices Panel. FDA Executive Summary, Premarket Application (PMA) for Pxxxxxx Medtronic, Inc. Symplicity Spyral Renal Denervation System. 2023; https://www.fda.gov/media/171411/download.
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35. Gosse P, Cremer A, Pereira H, et al. Twenty-four-hour blood pressure monitoring to predict and assess impact of renal denervation: The DENERHTN Study (Renal Denervation for Hypertension). Hypertension. Mar 2017;69(3):494-500.
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38. Jin Y, Jacobs L, Baelen M, et al. Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial. Blood Press. Jun 2014; 23(3):138-146.
39. Kaiser L, Beister T, Wiese A, et al. Results of the ALSTER BP real-world registry on renal denervation employing the Symplicity system. EuroIntervention. May 2014; 10(1):157-165.
40. Kandzari DE, Bhatt DL, Sobotka PA et al. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 trial. Clin Cardiol 2012; 35(9):528-535.
41. Kandzari DE, Bohm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. Jun 092018; 391(10137): 2346-2355.
42. Kandzari DE, Kario K, Mahgoud F, et al. The SPYRAL HTN global clinical trial program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. Jan 2016;171)1): 82-91.
43. Kandzari DE, Townsend RR, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. Nov 07 2023; 82(19): 1809-1823.
44. Kario K, Bhatt DL, Brar S, et al. Effect of catheter-based renal denervation on morning and nocturnal blood pressure: insights from SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. Dec 2015; 66(6):1130-1137.
45. Kario K, Mahfoud F, Kandzari DE, et al. Long-term reduction in morning and nighttime blood pressure after renal denervation: 36-month results from SPYRAL HTN-ON MED trial. Hypertens Res. Jan 2023; 46(1): 280-288.
46. Kario K, Ogawa H, Okumura K, et al. SYMPLICITY HTN-Japan - first randomized controlled trial of catheter- based renal denervation in Asian patients. Circ J. Apr 2015;79(6):1222-1229.
47. Kario K, Yokoi Y, Okamura K, et al. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial. Hypertens Res. Feb 2022; 45(2): 221-231.
48. Korovesis S, Giazitzoglou E, Pantos I, et al. Renal denervation for resistant hypertension: acute results and long-term follow-up. Hellenic J Cardiol. May-Jun 2014; 55(3):211-216.
49. Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. Feb 15 2014; 383(9917):622-629.
50. Kwok CS, Loke YK, Pradhan S, et al. Renal denervation and blood pressure reduction in resistant hypertension: a systematic review and meta-analysis. Open Heart. 2014; 1(1):e000092.
51. Lobo MD, de Belder MA, Cleveland T, et al. Joint UK societies' 2014 consensus statement on renal denervation for resistant hypertension. Heart. Jan 2015; 101(1):10-16.
52. Lu D, Wang K, Liu Q, et al. Reductions of left ventricular mass and atrial size following renal denervation: a meta-analysis. Clin Res Cardiol. Aug 2016; 105(8):648-656.
53. Mahfoud F, Bakris G, Bhatt DL, et al. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. Jan 7 2017;38(2):93-100.
54. Mahfoud F, Cremers B, Janker J et al. Renal hemodynamics and renal function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension 2012; 60(2):419-424.
55. Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensivedrugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. Apr 09 2022; 399(10333): 1401-1410.
56. Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. Aug 2023;80(8): 1759-1770.
57. Mathiassen ON, Vase H, Bech JN, et al. Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. J Hypertens. Aug 2016; 34(8):1639-1647.
58. McEvoy JW, McCarthy CP, Bruno RM, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. Oct 07 2024; 45(38): 3912-4018.
59. Miroslawska A, Solbu M, Skjolsvik E, et al. Renal sympathetic denervation: effect on ambulatory blood pressure and blood pressure variability in patients with treatment-resistant hypertension. The ReShape CV-risk study. J Hum Hypertens. Mar 2016; 30(3):153-157. 
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61. Ogoyama Y, Tada K, Abe M, et al. Effects of renal denervation on blood pressures in patients with hypertension: a systematic review and meta-analysis of randomized sham-controlled trials. Hypertens Res. Feb 2022; 45(2): 210-220.
62. Pancholy SB, Shantha GP, Patel TM, et al. Meta-analysis of the effect of renal denervation on blood pressure and pulse pressure in patients with resistant systemic hypertension. Am J Cardiol. Sep 15 2014; 114(6):856-861.
63. Pappaccogli M, Covella M, Berra E, et al. Effectiveness of renal denervation in resistant hypertension: a meta- analysis of 11 controlled studies. High Blood Press Cardiovasc Prev. May 11 2018.
64. Rader F, Kirtane AJ, Wang Y, et al. Durability of blood pressure reduction after ultrasound renal denervation: three-year follow-up of the treatment arm of the randomised RADIANCE-HTN SOLO trial. EuroIntervention. Oct 07 2022; 18(8):e677-e685.
65. Rosa J, Widimsky P, Tousek P, et al. Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study. Hypertension. Feb 2015; 65(2):407-413.
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67. Schirmer SH, Sayed MM, Reil JC, et al. Atrial Remodeling Following Catheter-Based Renal Denervation Occurs in a Blood Pressure- and Heart Rate-Independent Manner. JACC Cardiovasc Interv. Jun 2015; 8(7):972-980.
68. Schirmer SH, Sayed MM, Reil JC, et al. Improvements in left ventricular hypertrophy and diastolic function following renal denervation: effects beyond blood pressure and heart rate reduction. J Am Coll Cardiol. May 13 2014; 63(18):1916-1923.
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74. Townsend RR, Ferdinand KC, Kandzari DE, et al. Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED. Hypertension. May 2024; 81(5): 1095-1105.
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POLICY HISTORY:

Medical Policy Panel, August 2012

Medical Policy Group, August 2012 (4): New policy

Medical Policy Administration Committee, August 2012

Available for comment September 18 through November 1, 2012

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (4): Updated Key Points, Key Words, Approved Governing Bodies and References. No changes to the policy statement at this time.

Medical Policy Group, December 2013 (1): 2014 Coding Update: added new codes 0338T and 0339T, effective 01/01/2014

Medical Policy Panel, September 2014

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

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (4): Updates to Description, Key Points, Key Words, Coding and References; no change in policy statement.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (4):  Updates to Description, Key Points, and References; no change in policy statement.

Medical Policy Panel, September 2017

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

Medical Policy Panel, September 2018

Medical Policy Group, September 2018 (4): Updates to Key Points, Governing Bodies, Practice Guidelines and References.

Medical Policy Panel, September 2019Medical Policy Group, September 2019 (4): Updates to References. No change to policy statement.

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (4):  Updates to Key Points, Approved by Governing Bodies, Previous Coding section, and References.  Removed 64999 from Previous Coding section.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References.  Policy statement updated to remove “investigational”. No change to policy intent. References removed.

Medical Policy Panel, October 2022

Medical Policy Group, November 2022 (4): Updates to Title, Description, Key Points, Approved by Governing Bodies, and References.  Title and Policy statement updated to include “uncontrolled” hypertension. No change in policy intent.

Medical Policy Panel, October 2023

Medical Policy Group, October 2023 (4): Updates to Policy, Description, Key Points, Approved by Governing Bodies, Benefit Application, and References.  Removed “resistant” from policy statement. Policy intent unchanged, resistant is being encompassed under uncontrolled.

Medical Policy Group, December 2024 (4): Updates to Policy Title, Policy, Description, Key Points, Approved by Governing Bodies, Key Words, and References.  Removed “Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment” from the title and added “Renal Denervation” for Resistant or Uncontrolled Hypertension.  Added ultrasound ablation as an investigational treatment to the policy statement.  RFA remains IV.  Added key words Paradise, Paradise Ultrasound Renal Denervation System, and Symplicity Spyral.

Medical Policy Administration Committee, January 2025

Available for comment January 1, 2025 – February 15, 2025

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.