Latest Review Date: March 2025

Category: Surgery

POLICY:

Effective for Dates of Service on and after January 6, 2025:

1. Water vapor energy ablation (Rezum) for the treatment of benign prostatic hyperplasia (BPH) may be considered medically necessary when ALL of the following criteria are met:

• Moderate to severe lower urinary tract symptoms [e.g., International Prostate Symptom Score (IPSS) score ≥13]; AND
• Failure or inability to tolerate medical therapy (a1-adrenergic antagonists maximally titrated, 5a-reductase inhibitors, or combination medication therapy maximally titrated) over an adequate trial period; AND
• Prostate volume 30-80cm³; AND
• Appropriate testing to exclude diagnosis of prostate cancer has been completed; AND
• No contraindications to the procedure, including urinary retention, urinary tract infection, or recent prostatitis within the past year.

2. Waterjet tissue ablation (AquaBeam) for the treatment of benign prostatic hyperplasia (BPH) may be considered medically necessary when ALL of the following criteria are met: 

• Moderate to severe lower urinary tract symptoms [e.g., International Prostate Symptom Score (IPSS) score ≥13]; AND
• Failure or inability to tolerate medical therapy (a1-adrenergic antagonists maximally titrated, 5a-reductase inhibitors, or combination medication therapy maximally titrated) over an adequate trial period; AND
• Prostate volume 30-150cm³; AND
• Appropriate testing to exclude diagnosis of prostate cancer has been completed; AND
• No contraindications to the procedure, including urinary retention, urinary tract infection, or recent prostatitis within the past year.

3. Water vapor energy ablation (Rezum) or waterjet tissue ablation (AquaBeam) is considered investigational for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

Effective for Dates of Service October 03, 2022 through January 5, 2025:

1. Water vapor energy ablation (Rezum) or waterjet tissue ablation (Aquabeam) for the treatment of benign prostatic hyperplasia (bph) may be considered medically necessary when all of the following criteria are met:

• Moderate to severe lower urinary tract symptoms [e.g., International Prostate Symptom Score (IPSS) score ≥13]; AND
• Failure or inability to tolerate medical therapy (a1-adrenergic antagonists maximally titrated, 5a-reductase inhibitors, or combination medication therapy maximally titrated) over an adequate trial period; AND
• Prostate volume ≤80cm³; AND
• Appropriate testing to exclude diagnosis of prostate cancer has been completed; AND
• No contraindications to the procedure, including urinary retention, urinary tract infection, or recent prostatitis within the past year.

2. Water vapor energy ablation (Rezum) or waterjet tissue ablation (AquaBeam) is considered investigational for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

DESCRIPTION OF PROCEDURE OR SERVICE:

Benign prostatic hyperplasia (BPH) is a common condition in older men that can lead to increased urinary frequency, an urgency to urinate, a hesitancy to urinate, nocturia, and a weak stream when urinating. BPH prevalence increases with age and is present in more than 80% of individuals ages 70 to 79. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection.

Medical and surgical interventions are available for the treatment of BPH, including a-adrenergic blockers, 5a-reductase inhibitors, combination a-adrenergic blockers and 5a-reductase inhibitors, anti-muscarinic agents, and phosphodiesterase-5 inhibitors. 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. Historically, transurethral resection of the prostate has generally been considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate.

The Rezum System is a minimally invasive, transurethral treatment the uses convective radiofrequency water vapor energy to ablate the hyperplastic tissue. The system consists of a radiofrequency power generator and disposable delivery device. The shaft of the delivery system contains a needle which injects steam into the diseased prostate area, which immediately condenses to water, thereby dispersing thermal energy and destroying the surrounding cells.

The Rezum System received FDA 510(k) designation in August 2015. It is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH and is indicated for men ≥50 years of age with a prostate volume ≥30cm³ and ≤80cm³. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The AquaBeam Robotic System is an image-guided, heat-free robotic therapy also designed to treat lower urinary tract symptoms (LUTS) due to BPH. The device is able to image the treatment area and operates by using a pressurized jet of fluid delivered to the prostatic urethra.

AquaBeam received FDA 510(k) clearance in March 2021 for the same indication as the de novo approval that served as the predicate device. AquaBeam is intended for the resection and removal of prostate tissue in males suffering from LUTS due to BPH.

KEY POINTS:

Summary of Evidence

Patients with persistent symptoms related to benign prostatic hyperplasia (BPH) despite medical treatment may be considered for surgical treatment. Historically, transurethral resection of the prostate is the traditional standard treatment for and has generally been considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have also been developed, including water vapor energy ablation and waterjet tissue ablation. Evidence supporting the use of water vapor energy ablation includes randomized controlled trials and retrospective reviews. For waterjet ablation, the evidence includes a randomized controlled trial and multicenter, prospective, single-arm trials.

Water Vapor Energy Ablation

McVarey et al (2016) evaluated the Rezūm system for the treatment of benign prostatic hyperplasia in a multicenter, randomized controlled trial of 197 men (136 active, 61 control) over age 50, with an International Prostate Symptom Score (IPSS) of 13 or greater, maximum flow rate (Qmax) of 15 ml per second or less, and prostate size 30 to 80 cc. Primary endpoint was to demonstrate the reduction in IPSS at 3 months after treatment was greater than 125% of the control group. The control group had the option to receive the treatment after the 3-month end point. Thermal therapy and control IPSS was reduced by 11.2 ±7.6 and 4.3 ± 6.9 respectively. Treatment subject baseline IPSS of 22 decreased at 2 weeks (18.6, p=0.0006) and by 50% or greater at 3, 6 and 12 months, p<0.0001. The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p <0.0001). Adverse events were mild to moderate and quickly resolved. Investigators concluded that convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia symptoms and preserves erectile and ejaculatory function. However, there are limitations to this study, as there were no direct comparisons of the treatment with other minimally invasive treatments for lower urinary tract symptoms associated with BPH.

In 2017, Roehrborn et al, published 2-year outcomes from the RCT as well as 1-year results of the crossover trial initiated with the control group from the RCT. 53 of 61 control group participants who met IPSS and maximum flow (Qmax) criteria requalified for crossover to active treatment with Rezūm. Crossover subject symptoms, flow rate, and quality of life measures were markedly improved after thermal therapy compared to after the control procedure.

Darson et al (2017) reported on clinical outcomes with the Rezūm system in a retrospective, observational, multicenter study (n=131). Consecutive cases were accrued by seven community urologists for the treatment of moderate to severe LUTS associated with BPH. Urologists used their own discretion for patient selection, with variable prostate size, LUTS severity, urinary retention, or presence of an obstructing median lobe. Results showed sustained improvements in urinary symptoms, quality of life, and (post-void residual) PVR volume. Limitations of the study included a lack of comparator and short-term follow-up.

Mollengarden et al (2017) published a retrospective review of 129 patients who had undergone the Rezūm procedure, done by a single surgeon, at least 4 months previously. IPSS, Qmax, residual volumes, medication use, and adverse events were assessed. IPSS improved from a baseline of 18.3 to 6.9 and Qmax from 10.5 to 16.8 mL/s. Improvements were independent of starting symptom score, median lobe treatment, and prostate size. There was a 17% prostate volume reduction.

Waterjet Tissue Ablation

Elterman et al (2021) published a meta-analysis of four international studies evaluating functional outcomes following aquablation (N = 425) including one randomized controlled trial, two single-arm controlled trials, and one observational study. All studies were prospective, multi-center trials and conducted with similar eligibility criteria and assessment tools. Studies were included if they had a minimum one year of follow-up. Average participant age was 66.9 years, and 91% of participants completed the one-year visit. Individual study inclusion criteria varied in regard to prostate size (i.e., 20-150mL), International Prostate Symptom Score (IPSS) (i.e., ≥12 or diagnosed with lower urinary tract symptoms due to BPH), and Qmax (i.e., <15mL/s or diagnosed with lower urinary tract symptoms due to BPH). Transurethral resection of the prostate served as the comparator in the randomized controlled trial (Gilling, below). The primary outcome measures were IPSS, uroflowmetry, postoperative Incontinence Severity Index (ISI) and surgical retreatment. Mean baseline IPPS was approximately 23 points. A statistically significant improvement of 16 points was noted at one year in IPSS scores. Baseline Qmax averaged 9.4mL/s (median 9mL/s, range 2–36). Qmax improved by 9.4mL at one year. Post-void residual urine volumes (PVR) improved at one year by 42–68% depending on baseline PVR. Surgical retreatment occurred in 0.7% of patients. All improvements were independent of prostate size and the presence or absence of a median lobe. Across multiple prostate anatomies, Aquablation demonstrated functional improvements following the index procedure. In addition, those patients with moderate to severe symptoms and overactive bladder showed a reduction in incontinence symptoms post-procedure.

Gilling et al (2020) reported on three-year results of the WATER study (NCT02505919), a prospective, double-blinded multi-center randomized controlled trial, to compare efficacy and safety between transurethral resection of the prostate (TURP) and Aquablation. The trial included men ages 45-80 years with prostate size between 30 and 80 cc. 187 men were randomized, 65 to TURP, 116 to Aquablation, following three withdrawals, and followed for three years postoperatively. Improvements in IPSS scores were statistically similar across groups. Mean 3-year improvements were 14.4 and 13.9 in the Aquablation and TURP groups respectively (difference of 0.6 points, 95% CI -3.3-2.2, p = .6848). 3-year improvements in Qmax were 11.6 and 8.2 cc/sec (difference of 3.3 [95% CI -0.5-7.1] cc/sec, p = .0848). At 3 years, prostate specific antigen (PSA) was reduced significantly in both groups by 0.9 and 1.1 mg/mL, respectively; the reduction was similar across groups (p = .5983). There were no surgical retreatments for BPH beyond 20 months for either Aquablation or TURP. Investigators concluded that three-year BPH symptom reduction and urinary flow rate improvement were similar after TURP and Aquablation.

The WATER II trial was a prospective, uncontrolled, multi-center international trial (n=101) to determine if aquablation was safe in adult men age 45-80 with larger prostates (80 -150 cm3). Originally planned as a 1-year study, follow-up was extended to 5 years to collect further information on safety and efficacy of the treatment. In addition to prostate volume, inclusion criteria included baseline IPPS ≥12, maximum urinary flow rate (Qmax) <15 mL/s, serum creatinine <2mg/dL, history of inadequate or failed response to medical therapy, and mental capability and willingness to participate. The mean prostate size was 107 mL. In 2-year outcomes, Desai et al (2020) found mean international prostate symptom score (IPSS) improved from 23.2 at baseline to 5.8 at 2 years (17-point improvement, p< 0.0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 2 years (p< .0001). Maximum urinary flow increased from 8.7 to 18.2 cc/sec. Two subjects underwent a repeat procedure for BPH symptoms over the 2-year follow up period. By 2 years or study exit, all but 2 of 74 subjects stopped taking alpha blockers. Similarly, all but 4 of 32 subjects stopped taking 5α-reductase inhibitors.

In 2020, Bach et al published results of OPEN WATER, a prospective, multicenter, single-arm, open-label clinical trial of Aquablation for the treatment of LUTS due to BPH (n = 178). Inclusion criteria included diagnosis of LUTS due to BPH and prostate size between 20 and 150 cc. Primary outcome was change in International Prostate Symptom Score (IPSS) from baseline to 3 months. Secondary outcomes measured as a comparison between baseline and 3-month follow-up included proportion of patients who were sexually active at the baseline, and experienced either ejaculatory or erectile dysfunction at 3 months, change from the baseline to 3 months in maximal flow rate (Qmax), prostate specific antigen (PSA) level, post-void residual (PVR), total Male Sexual Health Questionnaire (MSHQ) score and selected International Index of Erectile Function (IIEF-5) score. Mean age was 68 years and baseline IPSS was 21.7. Mean prostate volume was 59 cc. Mean (SD) IPSS improved from 21.7 at the baseline to 7.1 at the 3-month follow-up (a 14.5-point improvement, p < 0.0001), and 6.4 at the 12-month follow-up (a 15.3-point improvement, p < 0.0001). Mean (SD) IPSS QOL scores improved from 4.7 at the baseline to 1.5 at the 3-month follow-up, a 3.1-point improvement (p < 0.0001), and 1.4 at the 12-month follow-up (a 3.3-point improvement, p < 0.0001). Maximum urinary flow rate increased from 10 cc/s at the baseline to 20.8 cc/s at month 12 (increase of 11.8 cc, p < 0.0001). Prostate volume assessed with transrectal ultrasound decreased 36% by month three. Five patients (2.7%) underwent a transfusion in the first week after the procedure. Investigators, while acknowledging the lack of a comparator and short-term follow-up, concluded from this trial that Aquablation is a safe and effective treatment for BPH.

In 2020, Kasraeian et al, published the results of a single center retrospective review (n = 55) of prospectively collected data to assess the safety and efficacy of robotically guided waterjet-based prostate resection. Mean prostate volume was 100 cc, and 85% had a prominent, obstructing middle lobe. No previous BPH surgery or treatment of urinary stricture or prostate cancer was reported. Outcome measures included BPH symptom score, measurement of post-void residual urine volume, interval urinary flow rate measurement, and sexual function. At follow-up, mean IPSS had improved to 5.0 points, an average of a 17.2-point improvement (p < .0001). IPSS quality of life improved from 4.2 to 1.1, a 3.3-point improvement (p < .0001). Mean Qmax improved from 7.4 cc/second preoperatively to 20.6 cc/second postoperatively (a 13.5 cc per second increase, p < .0001). There was no decline in erectile functionality following the procedure. Investigators in this single-center experience concluded that aquablation is a safe and effective alternative for the management of BPH.

Nguyen et al (2020) compared aquablation therapy in 30- 80 mL prostates and 80- 150 mL in the WATER vs. WATER II studies. Baseline parameters and 12-month outcomes in 116 WATER patients and 101 WATER II patients were compared. The mean change in IPSS was substantial, averaging (at 12 months) 15.1 in WATER and 17.1 in WATER II (p = 0.605). Authors concluded that the clinical benefits of aquablation for LUTS due to BPH in small-to-moderate sized prostates (30- 80 mL) transfers to large-to-very-large prostates (80- 150 mL) and is a safe and effective treatment option.

Practice Guidelines and Position Statements

In 2021, the American Urological Association (AUA) published a guideline on the management of lower urinary tract symptoms (LUTS) attributed to BPH (most recently amended in 2023). The guideline gives a conditional recommendation for the robotic waterjet treatment and states that the treatment “may be offered as a treatment option to patients with LUTS/BPH provided prostate volume is 30 to 80 mL.” The guideline also states that water vapor thermal therapy should be considered as a treatment option for patients with LUTS/BPH provided prostate volume is 30 to 80 mL.

Centers for Medicare & Medicaid Services (CMS):

Medicare covers use of the fluid jet system as treatment of lower urinary tract symptoms attributable to benign prostatic hyperplasia (LUTS/BPH) and includes the following criteria:

Indications including ALL of the following:

1. Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)
2. Persistent moderate to severe symptoms despite maximal medical management including ALL of the following:
   1. International Prostate Symptom Score (IPSS) ≥12
   2. Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc)
   3. Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDES Inhibitor, finasteride/dutasteride).

Only treatment using an FDA approved/cleared device will be considered reasonable and necessary. The complete coverage policy is found in the Medicare Local Coverage Determinations (LCD) Manual, Policy L38367.

Medicare previously had an LCD for use of water vapor thermal therapy to treat lower urinary tract symptoms attributable to benign prostatic hyperplasia.  This LCD (L37808) was retired in February 2024, however it included the following criteria:

ONE treatment for LUTS/BPH treatment is covered ONCE in patients with BOTH the following:

1. Indications including ALL of the following:
   1. Age ≥50
   2. Symptomatic despite maximal medical management including ALL of the following:
      1. International Prostate Symptom Score (IPSS) ≥13
      2. Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc)
      3. Failure, contraindication or intolerance to at least three months of conventional medical therapy for BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)
   3. Prostate volume of 30-80 cc,
   4. Poor candidate for other surgical interventions for BPH due to underlying disease (e.g., cardiac disease, pulmonary disease, etc.), or at high risk of bleeding.
2. No contraindications including ALL of the following:
   1. Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines) or a prostate specific antigen (PSA) >10 ng/mL
   2. Active urinary tract infection
   3. History of bacterial prostatitis in the past three months
   4. Prior prostate surgery
   5. Neurogenic bladder
   6. Active urethral stricture (i.e., the source of the current LUTS).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

HCPCS Codes:

REFERENCES:

1. Bach T, Gilling P, El Hajj A, et al. First Multi-Center All-Comers Study for the Aquablation Procedure. J Clin Med. 2020;9(2):603.

2. Bhojani N, Bidair M, Kramolowsky E, et al. Aquablation therapy in large prostates (80-150 mL) for lower urinary tract symptoms due to benign prostatic hyperplasia: Final WATER II 5-year clinical trial results. J Urol. 2023;210(1):143-153.

3. Bhojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019:129:1-7.

4. Centers for Medicare & Medicaid Services (CMS). Local Coverage Determination for Fluid Jet System Treatment for LUTS/BPH (L38367). 2024; www.cms.gov.

5. Centers for Medicare & Medicaid Services (CMS). Local Coverage Determination for Water Vapor Thermal Therapy for LUTS/BPH (L37808). 2018; www.cms.gov.

6. Darson MF, Alexander EE, Schiffman ZJ, et al. Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezūm system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Res Rep Urol 2017;9:159-168.

7. Desai M, Bidair M, Bhojani N, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020;27(2):10147-10153.

8. Desai M, Bidair M, Zorn KC, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU Int. 2019;124(2):321-328.

9. Elterman D, Gilling P, Roehrborn C, et al. Meta-analysis with individual data of functional outcomes following Aquablation for lower urinary tract symptoms due to BPH in various prostate anatomies. BMJ Surg Interv Health Technol. 2021;3(1):e000090.

10. Gilling P, Barber N, Bidair M, et al. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020;27(1):10072-10079.

11. Kasraeian A, Alcantara M, Alcantara KM, et al. Aquablation for BPH: United States single-center experience. Can J Urol. 2020;27(5):10378-10381.

12. Lerner LB, Barry MJ, Das AK, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline. PART II-Surgical evaluation and treatment. J Urol. 2021;206(4):818-826.

13. McVary KT, Gange SN, Gittelman MC, et al. Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2016; 195(5):1529-1538.

14. Mollengarden D, Goldberg K, Wong D, Roehrborn C. Convective radiofrequency water vapor thermal therapy for benign prostatic hyperplasia: a single office experience. Prostate Cancer Prostatic Dis. 2018;21(3):379-385.

15. Nguyen DD, Barber N, Bidair M, et al. Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates. BJU Int. 2020;125(1):112-122.

16. Roehrborn CG, Gange SN, Gittelman MC, et al. Convective thermal therapy: durable 2-year results of randomized controlled and prospective crossover studies for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. J Urol. 2017;197(6):1507-1516.

17. Sandhu JS, Bixler BR, Dahm P, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023. J Urol. 2024;211(1):11-19.

POLICY HISTORY:

Reviewed and posted August 16, 2022.

August 2022: New policy created. Effective for Dates of Service on and after October 03, 2022. Available for comment August 16, 2022 through October 2, 2022.

March 2023: Update to Current Coding section to remove CPT code 53899. No change to policy intent.

February 2024: Annual review completed. No change to policy intent.

November 2024: Updates Key Points added, Approved By Governing Bodies added, and References added. Policy Statement updated to add criteria for Waterjet tissue ablation (AquaBeam). Policy on draft November 20, 2024, through January 5, 2025.

March 2025: Annual review completed. Updates to Key Points and References. 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.