Latest Review Date: August 2024

Category: Surgery                                                                 

POLICY:

Use of a prostatic urethral lift in individual’s ≥45 years of age with moderate to severe lower urinary tract obstruction due to benign prostatic hyperplasia may be considered medically necessary when ALL of the following criteria are met:

• The individual has persistent or progressive lower urinary tract symptoms despite medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months, or is unable to tolerate medical therapy; AND
• Prostate gland volume is ≤80 mL; AND
• Prostate anatomy demonstrates normal bladder neck; AND
• The individual does not have a current urinary tract infection, current gross hematuria, or recent prostatitis (within past year).

Use of a prostatic urethral lift in all other situations, including repeat procedures, is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Benign Prostatic Hyperplasia

BPH is a common disorder among older men that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. The clinical manifestations of BPH include increased urinary frequency, urgency, nocturia, hesitancy, and weak stream. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection. Benign prostatic hyperplasia prevalence increases with age and is present in more than 80% of individuals ages 70 to 79 years.

Two scores are widely used to evaluate BPH-related symptoms. The American Urological Association Symptom Index (AUASI) is a self-administered seven item questionnaire assessing the severity of various urinary symptoms. Total AUASI scores range from zero to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35). The International Prostate Symptom Score incorporates the questions from the AUASI and a quality of life question or “Bother score.”

Management of BPH

Evaluation and management of BPH include assessment for other causes of lower urinary tract dysfunction (eg, prostate cancer), symptom severity, and the degree that symptoms are bothersome to determine the therapeutic approach.

Medical Therapy

For individuals with moderate-to-severe symptoms (eg, an AUASI score of ≥8), bothersome symptoms, or both, a discussion about medical therapy is reasonable. Benign prostatic hyperplasia should generally be treated medically first. Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (eg, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (eg, finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (eg, darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (eg, tadalafil). In a meta-analysis of both indirect comparisons from placebo-controlled studies (including 6,333 patients) and direct comparative studies (including 507 patients), Djavan et al (1999) found that the IPSS improved by 30% to 40% and the Qmax score (mean peak urinary flow rate) improved by 16% to 25% in individuals assigned to α-adrenergic blockers. Combination therapy using an α-adrenergic blocker and 5α-reductase inhibitor has been shown to be more effective for improving IPSS than either treatment alone, with median scores improving by more than 40% over 1 year and by more than 45% over 4 years.

Surgical and Ablative Therapies

Patients who do not have sufficient response to medical therapy, or who are experiencing significant side effects with medical therapy, may be referred for surgical or ablative therapies. Various surgical and ablative procedures are used to treat BPH. Transurethral resection of the prostate (TURP) is generally considered the reference standard for comparisons of BPH procedures. In the perioperative period, TURP is associated with risks of any operative procedure (eg, anesthesia risks, blood loss). Although short-term mortality risks are generally low, a large prospective study with 10,654 patients by Reich et al (2008) reported the following short-term complications: "failure to void (5.8%), surgical revision (5.6%), significant urinary tract infection (3.6%), bleeding requiring transfusions (2.9%), and transurethral resection syndrome (1.4%)." Incidental carcinoma of the prostate was diagnosed by histologic examination in 9.8% of patients. In the longer term, TURP is associated with an increased risk of sexual dysfunction and incontinence.

Several minimally invasive prostate ablation procedures are available, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate. The minimally invasive procedures were individually compared with TURP at the time they were developed, which provided a general benchmark for evaluating those procedures. The American Urological Association (AUA) recommends surgical intervention for patients who have "renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with lower urinary tract symptoms (LUTS) attributed to BPH refractory to and/or unwilling to use other therapies."

KEY POINTS:

The most recent literature review was updated through June 14, 2024.

Summary of Evidence

For individuals who have lower urinary tract obstruction symptoms due to BPH who do not have sufficient response to medical therapy or are experiencing significant side effects with medical therapy and receive a PUL, the evidence includes systematic reviews, RCTs, and nonrandomized studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One RCT, the BPH6 study, compared the PUL procedure with TURP and reported that the PUL procedure was noninferior for the study's composite endpoint, which required concurrent fulfillment of 6 independently validated measures of symptoms, safety, and sexual health. While TURP was superior to PUL in managing lower urinary tract symptoms, PUL did provide significant symptom improvement over 2 years. PUL was further superior to TURP in preserving ejaculatory function. These findings were corroborated by another RCT (the LIFT study), which compared PUL with sham control. Patients underwent washout of BPH medications before enrollment. LIFT reported that patients with the PUL procedure, compared with patients who had sham surgery and no BPH medication, had greater improvements in lower urinary tract symptoms without worsened sexual function at 3 months. After 3 months, patients were given the option to have PUL surgery; 80% of the patients with sham procedures chose that option. Publications from this trial reported these findings were preserved in a subset of patients over 3 to 5 years; however, a high number of patients were either excluded or lost to follow-up during this time. The BPH6 and LIFT RCTs included men with a prostate volume up to 80 cm3 and excluded men with median lobe obstruction. The evidence is sufficient to determine that the technology results in improvement in the net health outcome.

For individuals who have lower urinary tract obstruction symptoms due to BPH who have had a prior PUL procedure who are treated with a repeat PUL, the evidence includes long-term follow-up data from the LIFT study, systematic reviews, and reports on clinical care setting real world experience. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Clinical data on the occurrence of repeat PUL, and consensus on clinically relevant definitions of retreatment/reintervention and subsequent outcomes are lacking. The 5 year surgical reintervention rate in the LIFT study was reported as 13.6%, while a meta-analysis concluded that the surgical reintervention rate following PUL is 6% per year. An analysis of clinical care setting real world experience reported the overall retreatment rate at 1 and 2 years to be 5.2% (95% confidence interval [CI], 4.2 to 6.1) and 11.9% (95% CI, 10.1 to 13.6), respectively, following an initial PUL. A retrospective healthcare system database analysis of endoscopic procedures for BPH found that patients treated with PUL were almost twice as likely to be retreated at 2-year follow-up compared to those receiving transurethral resection of the prostate (odds ratio, 1.78; p<.01). 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 2014, the National Institute for Health and Care Excellence published interventional procedural guidance on urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. The guidance stated: “Current evidence on the efficacy and safety of insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia is adequate to support the use of this procedure.”

In 2021, the National Institute for Health and Care Excellence published updated guidance on the use of UroLift for treating LUTS of BPH. The guidance stated: "the UroLift system relieves lower urinary tract symptoms, avoids risk to sexual function, and improves quality of life” and "the UroLift system should be considered as an alternative to transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). It can be done as a day-case or outpatient procedure for people aged 50 and older with a prostate volume between 30 and 80 mL."

American Urological Association

In 2018, the American Urological Association published guidelines on the surgical management of LUTS attributed to BPH; the 2018 guidelines were most recently amended in 2021. The guidelines made the following recommendations and statements regarding prostatic urethral lift (PUL).

• “PUL may be offered as an option for patients with LUTS [lower urinary tract symptoms]/ BPH [benign prostatic hyperplasia] provided prostate volume 30-80cc and verified absence of an obstructive middle lobe”
  • “Moderate Recommendation; Evidence Level: Grade C indicating “Benefits > Risks/Burdens (or vice versa); Net benefit (or net harm) appears moderate. Applies to most patients in most circumstances but better evidence is likely to change confidence”
• “PUL may be offered as a treatment option to eligible patients who desire preservation of erectile and ejaculatory function.”
  • “Conditional Recommendation; Evidence Level: Grade C indicating “Risks/Burdens unclear; alternative strategies may be equally reasonable. Better evidence likely to change confidence”
• "Clinicians should inform patients of the possibility of treatment failure and the need for additional or secondary treatments when considering surgical and minimally-invasive treatments for LUTS/ BPH."
• "Surgery is recommended for patients who have renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with LUTS/BPH refractory to or unwilling to use other therapies."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Prostate, LIFT, Prostatic urethral lift, BPH, benign prostatic hyperplasia, BPH6, NeoTract UroLift System, Urolift, PUL

APPROVED BY GOVERNING BODIES:

One implantable transprostatic tissue retractor system has been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In 2013, the NeoTract UroLift® System UL400 (NeoTract) was cleared (after receiving clearance through the FDA's de novo classification process in March 2013; K130651/DEN130023). In 2016, the FDA determined that the UL500 was substantially equivalent to existing devices (UL400) for the treatment of symptoms of urinary flow obstruction secondary to BPH in individuals ages 50 years and older. In 2017, the FDA expanded the indication for the UL400 and UL500 to include lateral and median lobe hyperplasia in men 45 years or older. An additional clearance in 2019 (K193269) modified an existing contraindication for use from men with a prostate volume of >80 cc to men with a prostate volume of >100 cc. FDA product code: PEW.

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. Bozkurt A, Karabakan M, Keskin E, et al. Prostatic urethral lift: a new minimally invasive treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urol Int. 2016; 96(2):202-206.
2. Cantwell AL, Bogache WK, Richardson SF, et al. Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. BJU Int. Apr 2014; 113(4):615-622.
3. Chin PT, Bolton DM, Jack G, et al. Prostatic urethral lift: two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology. Jan 2012; 79(1):5-11.
4. Eure G, Rukstalis D, Roehrborn C. Prostatic Urethral Lift for Obstructive Median Lobes: Consistent Results AcrossControlled Trial and Real-World Settings. J Endourol. Jan 2023; 37(1): 50-59.
5. Eure G, Gange S, Walter P, et al. Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study. J Endourol. Jul 2019; 33(7): 576-584.
6. Foster HE, Barry MJ, Dahm P, et al. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. J Urol. Sep 2018; 200(3): 612-619.
7. Franco JVA, Jung JH, Imamura M, et al. Minimally invasive treatments for benign prostatic hyperplasia: a Cochrane network meta-analysis. BJU Int. Aug 2022; 130(2): 142-156. 
8. Gaffney CD, Basourakos SP, Al Hussein Al Awamlh B, et al. Adoption, Safety, and Retreatment Rates of Prostatic Urethral Lift for Benign Prostatic Enlargement. J Urol. Aug 2021; 206(2): 409-415. 
9. Garrido Abad P, Coloma Del Peso A, Sinues Ojas B, et al. Urolift(R), a new minimally invasive treatment for patients with low urinary tract symptoms secondary to BPH. Preliminary results. Arch Esp Urol. Jul-Aug 2013; 66(6):584-591.
10. Gratzke C, Barber N, Speakman MJ, et al. Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJU Int. May 2017; 119(5):767-775
11. Hoffman RM, Monga M, Elliott SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev. Sep 12 2012; 9:CD004135.
12. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
13. Jones P, Rajkumar GN, Rai BP, et al. Medium-term Outcomes of Urolift (Minimum 12 Months Follow-up): Evidence from a Systematic Review. Urology. Nov 2016; 97: 20-24.
14. Jung, JJ, Reddy, BB, McCutcheon, KK. Prostatic urethral lift for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.. Cochrane Database Syst Rev, 2019 May 25;5(5):CD012832.
15. Kaplan SA. Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients. Letter. J Urol. Mar 2021; 205(3): 939-940.
16. Lerner LB, McVary KT, Barry MJ, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. Oct 2021; 206(4): 818-826. 
17. McNicholas TA, Woo HH, Chin PT, et al. Minimally invasive prostatic urethral lift: surgical technique and multinational experience. Eur Urol. Aug 2013; 64(2):292-299.
18. McVary KT, Kaplan SA. A Tower of Babel in Today's Urology: Disagreement in Concepts and Definitions of Lower UrinaryTract Symptoms/Benign Prostatic Hyperplasia Re-Treatment. J Urol. Aug 2020; 204(2): 213-214.
19. McVary KT, Gange SN, Shore ND, et al. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. Jan 2014; 11(1):279-287.
20. McVary KT, Roehrborn CG, Avins AL, et al. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). 2010 (affirmed 2014); www.auanet.org/guidelines/benign-prostatic- hyperplasia-(2010-reviewed-and-validity-confirmed-2014). 
21. McVary, KK, Dahm, PP, Kohler, TT. Surgical Management Of Lower Urinary Tract Symptoms Attributed To Benign Prostatic Hyperplasia: Aua Guideline Amendment 2019.. J. Urol., 2019 Sep; 202(3): 592-598
22. Miller LE, Chughtai B, Dornbier RA, et al. Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients. J Urol. Nov 2020: 204(5):1019-1026.
23. Miller LE, Chughtai B, Dornbier RA, et al. Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients. Reply. J Urol. Mar 2021; 205(3): 940-941.
24. National Institute for Health and Care Excellence (NICE). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia [IPG475]. 2014; www.nice.org.uk/guidance/ipg475/chapter/1-recommendations. 
25. National Institute for Health and Care Excellence (NICE). UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia [MTG58]. 2021; www.nice.org.uk/guidance/MTG58. 
26. Page T, Veeratterapillay R, Keltie K, et al. Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics. BMC Urol. Apr 07 2021; 21(1): 55.
27. Parsons JK, Dahm P, Kohler TS, et al. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. 2020. www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline. 
28. Patel, NN, Uppaluri, NN, Iorga, MM. Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database.. J. Endourol., 2019 Apr 17;33(6).
29. Perera M, Roberts MJ, Doi SA, et al. Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systematic review and meta-analysis. Eur Urol. Apr 2015; 67(4):704-713.
30. Ray A, Morgan H, Wilkes A, et al. The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. Oct 2016; 14(5): 515-26.
31. Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. Jun 2017; 24(3):8802-8813.
32. Roehrborn CG, Gange SN, Shore ND, et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol. Dec 2013; 190(6):2161-2167.
33. Roehrborn CG, Rukstalis DB, Barkin J, et al. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. Jun 2015; 22(3):7772-7782.
34. Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. May 2012; 187(5):1732-1738.
35. Roehrborn CG. Prostatic urethral lift: A unique minimally invasive surgical treatment of male lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urol Clin N Am. 2016 Aug; 43(3): 357-69.
36. Rukstalis D, Grier D, Stroup SP, et al. Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study. Prostate Cancer Prostatic Dis. Sep 2019; 22(3): 411-419.
37. Rukstalis D, Rashid P, Bogache WK, et al. 24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham. BJU Int. Oct 2016; 118 Suppl 3:14-22.
38. Rukstalis, DD, Grier, DD, Stroup, SS, Tutrone, RR, deSouza, EE, Freedman, SS, David, RR, Kamientsky, JJ, Eure, GG. Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.. Prostate Cancer Prostatic Dis., 2018 Dec 14.
39. Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. Jul 19 2012; 367(3):248-257.
40. Shah BB, Tayon K, Madiraju S, et al. Prostatic Urethral Lift: Does Size Matter?. J Endourol. Jul 2018; 32(7): 635-638.
41. Shin BNH, Qu L, Rhee H, et al. Systematic review and network meta-analysis of re-intervention rates of new surgical interventions for benign prostatic hyperplasia. BJU Int. Aug 2024; 134(2): 155-165.
42. Shore N, Freedman S, Gange S, et al. Prospective multi-center study elucidating patient experience after prostatic urethral lift. Can J Urol. Feb 2014; 21(1):7094-7101.
43. Shore N. A review of the prostatic urethral lift for lower urinary tract symptoms: symptom relief, flow improvement, and preservation of sexual function in men with benign prostatic hyperplasia. Curr Bladder Dysfunct Rep. 2015; 10(2):186-192.
44. Sievert KD, Schonthaler M, Berges R, et al. Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years. World J Urol. Jul 2019; 37(7): 1353-1360.
45. Sonksen J, Barber NJ, Speakman MJ, et al. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. Oct 2015; 68(4): 643-52.
46. Sundaram D, Sankaran PK, Raghunath G, et al. Correlation of Prostate Gland Size and Uroflowmetry in Patients with Lower Urinary Tract Symptoms. J Clin Diagn Res. May 2017; 11(5):AC01-AC04.
47. Tanneru K, Gautam S, Norez D, et al. Meta-analysis and systematic review of intermediate-term follow-up of prostatic urethral lift for benign prostatic hyperplasia. Int Urol Nephrol. Jun 2020; 52(6): 999-1008.
48. Woo HH, Bolton DM, Laborde E, et al. Preservation of sexual function with the prostatic urethral lift: a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med. Feb 2012; 9(2):568-575.
49. Woo HH, Chin PT, McNicholas TA, et al. Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. Jul 2011; 108(1):82-88.

POLICY HISTORY:

Medical Policy Panel, August 2015

Medical Policy Group, August 2015 (4): New policy adopted from Association.  Procedure previously considered

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4):  Update to Description, Key Points and References; no change to policy statement investigational.

Medical Policy Panel, December 2017

Medical Policy Group, March 2018 (4): Update to Description, Policy, Key Points, Key Words, and References.  Policy statements updated to include coverage for PUL effective 3/1/18.

Medical Policy Administrative Committee March 2018

Available for comment March 2 through April 15, 2018 (extended to) April 25, 2018

Medical Policy Panel, August 2018

Medical Policy Group, October 2018 (4): Updates to Description, Policy, Key Points, and References. Clarified policy statement regarding persistent or progressive lower UTI symptoms “despite medical therapy”.  Intent unchanged.

Medical Policy Group, April 2019 (4): Update to policy statement by removing “urinary retention” and “urinary incontinence” from the last bullet point.  Also added “current” before urinary tract infection.

Medical Policy Administrative Committee April 2019

Available for Comment April 5, 2019 through May 20, 2019.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, August 2020

Medical Policy Group, August 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. Policy Statement updated to include “repeat procedures” as not medically necessary and investigational. Available for comment August 31, 2020 through October 15, 2020.

Medical Policy Panel, August 2021

Medical Policy Group, August 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, August 2022

Medical Policy Group, August 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to remove the word “patient” and replace it with the word “individual.” No change to policy intent.

Medical Policy Panel, August 2023

Medical Policy Group, August 2023 (11): Updates to Description, Key Points, Benefit Application, and References. Minor editorial refinements to Policy Statement. No change to policy intent.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (11): Updates to Key Points, 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.