Treatment of the Prostate

Policy ID: S-97-032

Section: Surgery

Effective Date: July 01, 2018

Revised Date: March 15, 2021

Revision Effective Date: May 03, 2021

Last Reviewed: March 17, 2021

Description

A wide variety of minimally invasive therapies and surgeries are available for enlarged prostate and may include but are not limited to:

Cryoablation of the prostate; or
Holmium laser:
- Ablation of the prostate [HoLAP]; or
- Enucleation of the prostate [HoLEP]; or
- Resection of the prostate [HoLRP]; or
Photoselective laser vaporization (PVP); or
Prostatic urethral lift (PUL); or
Radical prostatectomy; or
Simple prostatectomy; or
Transurethral electrovaporization of the prostate (TUEVP, TUVAP or TUEVAP); or
Transurethral microwave thermotherapy (TUMT); or
Transurethral resection of the prostate (TURP); or
Transurethral ultrasound-guided laser-induced prostatectomy (TULIP); or
Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy; or
Water vapor thermal therapy (e.g., Rezum) when prostate volume is less than 80 grams.

Conditions requiring treatment of the prostate gland may include but are not limited to:

Benign prostatic hyperplasia (BPH); or
Prostate cancer; or
Prostatitis

Oral pharmacological treatments and hydrogel spacer are not addressed in this policy.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The surgical and minimally invasive treatment (e.g., HoLAP, HoLEP, HOLRP, PVP, TUEVP, TUVAP, TUEVAP, TUMT, TURP, TULIP, WIT) of urinary outlet obstruction due to BPH may be considered medically necessary when ALL the following criteria are met:

The individual has a diagnosis of lower urinary tract symptoms (LUTS) secondary to BPH that interfere with activities of daily living; and
The individual has a peak urine flow rate (Qmax) less than 15 cc/sec on a voided volume that is greater than 125 cc; and
The individual has failed a trial of satisfactory voiding with medication (alpha blocker and/or alpha-reductase inhibitor) or intolerance to medication (alpha blocker and/or 5-alpha-reductase inhibitor).

The surgical and minimally invasive treatment (e.g., HoLAP, HoLEP, HOLRP, PVP, TUEVP, TUVAP, TUEVAP, TUMT, TURP, TULIP, WIT) of urinary outlet obstruction due to prostate cancer may be considered medically necessary when ONE the following criteria are met:

The individual with a diagnosis or history of prostate cancer and is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required; or

The individual with a diagnosis or history of prostate cancer and is clinically in remission as evidenced by a prostate specific antigen (PSA) less than1.0 ng/mL.

The use of any treatments/procedures not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

52450	52601	52630	52640	52647	52648	52649
53850	53852	53854	55821	55831	55866

Prostatectomy

A simple or radical prostatectomy may be considered medically necessary for individuals with a diagnosis of localized prostate cancer.

A simple or radical prostatectomy not meeting the criteria as indicated in this policy is considered not medically necessary

Procedure Codes

55801

55810

55812

55815

55840

55842

55845

Prostatic Urethral Lift (PUL)

PUL in individuals 45 years of age or older with moderate-to-severe lower urinary tract obstruction due to BPH may be considered medically necessary when ALL the following criteria are met:

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 six (6) months, or is unable to tolerate medical therapy; and
Prostate gland volume is less than or equal to 100 mL; and
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; and
Individual does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); and
Individual has had appropriate testing to exclude diagnosis of prostate cancer; and
Individual does not have a known allergy to nickel, titanium or stainless steel.

PUL not meeting the criteria indicated in this policy is considered not medically necessary.

Procedure Codes

52441

52442

Cryoablation

Whole gland cryoablation of the prostate gland as treatment of clinically localized (organ-confined) prostate cancer may be considered medically necessary when performed:

As initial treatment; or
As salvage treatment of disease that recurs following radiotherapy.

Whole gland cryosurgical ablation of the prostate gland not meeting the criteria as indicated in this policy is considered not medically necessary.

Subtotal Prostate Cryoablation

Subtotal prostate cryoablation for the treatment of prostate cancer is considered E/I experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

55873

55899

High-Intensity Focused Ultrasound (HIFU)

Whole gland HIFU may be considered medically necessary as a local treatment for recurrent prostate cancer following radiation therapy when individual meets ALL the following criteria:

Original clinical stage (Please see staging tables below):
- T_{1 –} T_2; and
- NX or NO; and
Life expectancy of greater than 10 years; and
PSA of less than 10 ng/mL; and
Positive post-RT transrectal (TRUS) biopsy; and
No evidence of metastatic disease.

HIFU not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

55880

55899

The use of ANY focal therapy modality, including but not limited to the following procedures, for individuals with localized prostate cancer is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

Radiofrequency ablation; or
Photodynamic therapy.

Procedure Codes

55899

The following procedures/treatments for BPH, including but not limited to the following procedures, are considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

HIFU ablation for the treatment for BPH;
Placement of temporary prostatic stents for the treatment for BPH;
Prostatic arterial embolization;
Focal laser ablation (Visualase).

Procedure Codes

37243

53855

53899

55873

55880

55899

Outpatient HCPCS (C Codes)

C9739

C9740

C9769

Tumor (T) Staging

T₁	The tumor is too small to be seen on scans or felt during examination of the prostate (it has been discovered by needle biopsy).
T₂	The tumor is completely inside the prostate gland.
T₃	The tumor has broken through the capsule of the prostate gland.
T₄	The tumor has spread into other body organs.

Lymph Node (N) Staging

NO	No cancer cells found in any lymph nodes
N1	One positive lymph node smaller than 2 cm across.
N2	More than 1 positive lymph node; or one that is between 2cm and 5 cm across.
N3	Any positive lymph node that is bigger than 5 cm across.
NX	Lymph nodes cannot be assessed

Diagnosis Codes

Covered diagnosis codes for procedure codes: 52441, 52442, 52450, 52601, 52630, 52640, 52647, 52648, 52649, 53850, 53852, 53854, 55801, 55810, 55812, 55815, 55821, 55831, 55840, 55842, 55845, and 55866.

D29.1	D40.0	D49.59	N32.0	N32.89	N32.9	N39.41
N39.42	N39.43	N39.44	N39.45	N39.46	N40.0	N40.1
N40.2	N40.3	N41.0	N41.1	N41.2	N41.3	N41.4
N41.8	N41.9	N42.83	N42.89	N42.9

Covered diagnosis codes for procedure codes: 52441, 52442, 52601, 52630, 52640, 52647, 52648, 52649, 53850, 53852, 55866, 55873 and 55880

C61

C79.82

D07.5

Z85.46

Covered diagnosis codes for procedure codes: 55810, 55812, 55815, 55840, 55842, 55845 and 55866

C61

C79.82

D07.5

D40.0

Professional Statements and Societal Positions Guidelines

National Comprehensive Cancer Network – 2020

The National Comprehensive Cancer Network guidelines (v.3.2020) for prostate cancer indicate cryosurgery and high-intensity focused ultrasound are options for radiotherapy recurrence in individuals who have no evidence of metastatic disease.

American Urological Association – 2020

In 2018, the American Urological Association published guidelines on the surgical management of LUTS attributed to BPH; the 2018 guidelines were amended in 2019 and 2020. The guidelines made the following recommendations and statements:

Conditional recommendations regarding prostatic urethral lift (PUL):
- "PUL may be offered as an option for individuals with LUTS [lower urinary tract symptoms] attributed to BPH [benign prostatic hyperplasia] provided prostate volume <80g and verified absence of an obstructive middle lobe "
- "PUL may be offered to eligible individuals concerned with erectile and ejaculatory function for the treatment of LUTS attributed to BPH."
- "Clinicians should inform individuals of the possibility of treatment failure and the need for additional or secondary treatments when considering surgical and minimally-invasive treatments for LUTS secondary to BPH."
Conditional recommendations regarding water vapor thermal therapy:
- Water vapor thermal therapy may be offered to individuals with LUTS attributed to BPH provided prostate volume <80g.
- Water vapor thermal therapy may be offered to eligible individuals who desire preservation of erectile and ejaculatory function.

ND Committee Review

Internal Medical Policy Committee 9-21-2020 Coding update: Added C9769 to Outpatient HCPCS (C Codes)

Internal Medical Policy Committee 1-19-2021 Coding update: Added 55880

Internal Medical Policy Committee 3-17-2021 Revision - several changes; Removed C9747

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-97-031

Section: Surgery

Effective Date: July 01, 2018

Revised Date: December 21, 2020

Revision Effective Date: March 01, 2021

Last Reviewed: January 19, 2021

Archived Date: May 02, 2021

Description

Conditions related to the prostate gland include, but are not limited to:

Benign prostatic hyperplasia (BPH): The prostate has become enlarged, narrowing the urethra, which causes prostatism and is noted by nocturia, hesitancy, slow stream, terminal dribbling and frequency of urination.
Prostatitis: The prostate has become inflamed due to infection or non-infectious inflammation causing pain in the bladder region, frequency of urination and blood in the urine.
Prostatic carcinoma: Carcinoma of the prostate is one of the most common malignancies in men. In its early stages, most men show no physical signs of malignancy.

Criteria

The surgical and minimally invasive treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) may be considered medically necessary when ALL of the following criteria are met:

ONE of the following procedures is utilized:
- Transurethral Resection of the Prostate (TURP); or
- Holmium laser ablation of the prostate [HoLAP]; or
- Holmium laser enucleation of the prostate [HoLEP]; or
- Holmium laser resection of the prostate [HoLRP]; or
- Photoselective laser vaporization (PVP) (for example Greenlight laser); or
- Transurethral electrovaporization of the prostate (TUEVP, TUVAP or TUEVAP); or
- Transurethral ultrasound-guided laser-induced prostatectomy (TULIP); or
- Transurethral microwave thermotherapy (TUMT); or
- Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy; or
- Open/laparoscopic prostatectomy; or
- Prostatic urethral lift (UroLift) when prostate volume is less than 80 grams; or
- Water vapor thermal therapy (e.g., Rezum) when prostate volume is less than 80 grams; or
- Transurethral incision of the prostate (TUIP); and
The individual has a diagnosis of lower urinary tract symptoms (LUTS) secondary to BPH (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) that interfere with activities of daily living; and
The individual has a peak urine flow rate (Qmax) less than 15 cc/sec on a voided volume that is greater than 125 cc; and
The individual has failed a trial of satisfactory voiding with medication (alpha blocker and/or alpha-reductase inhibitor) or intolerance to medication (alpha blocker and/or 5-alpha-reductase inhibitor).

The surgical and minimally invasive treatment of urinary outlet obstruction when using one of the procedures above may be considered medically necessary when the individual has a diagnosis or history of prostate cancer and meets ONE of the following criteria:

The individual is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required; or
The individual is clinically in remission as evidenced by a PSA less than 1.0 ng/mL.

A radical prostatectomy may be considered medically necessary for individuals with a diagnosis of localized prostate cancer.

The use of any of the procedures listed above for any other indication is considered not medically necessary.

Procedure Codes

52441	52442	52450	52601	52630	52640	52647
52648	52649	53850	53852	53854	55801	55810
55812	55815	55821	55831	55840	55842	55845
55866

Cryosurgical ablation of the prostate gland as treatment of clinically localized (organ confined) prostate cancer may be considered medically necessary when performed:

As initial treatment; or
As salvage treatment of disease that recurs following radiation therapy.

The use of cryosurgical ablation of the prostate gland for any other indication will be considered not medically necessary.

Procedure Codes

55873

55880

The use of any focal therapy modality treatment for individuals with localized prostate cancer is considered experimental/investigational (E/I) and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. Examples of focal Modalities include, but are not limited to, the following:

Laser ablation; or
High-intensity focused ultrasound (HIFU); or
Cryoablation; or
Radiofrequency ablation; or
Photodynamic therapy.

Procedure Codes

55899

The following procedures are considered experimental/investigational for the treatment of BPH and therefore noncovered. Scientific evidence does not support the use any of the procedures listed below:

Subtotal prostate cryoablation in the treatment of prostate cancer;
High-intensity focused ultrasound (HIFU) ablation for the treatment for BPH;
Placement of temporary prostatic stents for the treatment for BPH;
Prostatic arterial embolization;
Focal laser ablation (Visualase)

Procedure Codes

37243

53855

53880

53899

55873

55880

55899

Outpatient HCPCS (C Codes)

C9739

C9740

C9747

C9769

Diagnosis Codes

Covered diagnosis codes for procedure codes: 52441, 52442, 52450, 52601, 52630, 52640, 52647, 52648, 52649, 53850, 53852, 53854, 55801, 55810, 55812, 55815, 55821, 55831, 55840, 55842, 55845, 55866.

D29.1	D40.0	D49.59	N32.0	N32.89	N32.9	N39.41
N39.42	N39.43	N39.44	N39.45	N39.46	N40.0	N40.1
N40.2	N40.3	N41.0	N41.1	N41.2	N41.3	N41.4
N41.8	N41.9	N42.83	N42.89	N42.9

Covered diagnosis codes for procedure codes: 52441, 52442, 52601, 52630, 52640, 52647, 52648, 52649, 53850, 53852, 55873, 55880, 55866

C61

C79.82

D07.5

Z85.46

Covered diagnosis codes for procedure codes: 55810, 55812, 55815, 55840, 55842, 55845 and 55866

C61

C79.82

D07.5

D40.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-21-2020 Coding update: Added C9769 to Outpatient HCPCS (C Codes)

Internal Medical Policy Committee 1-19-2021 Coding update: Added 55880

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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