HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 
Medical Policy:
S-275-002
Topic:
Prostate Disease: Diagnosis, Staging, and Treatment
Section:
Surgery
Effective Date:
July 1, 2022
Issued Date:
July 1, 2022
Last Revision Date:
June 2022
Annual Review:
March 2022
 
 

Diagnosing and Staging of Prostate Cancer

Saturation biopsy, either initial or repeat, for a high-risk individual provides pathologists with an extensive selection of cells to test and can be used to help diagnose and stage prostate cancer when previous conventional prostate biopsies have been negative.

Treatment of Benign Prostate Hypertrophy or Prostate Cancer

A wide variety of minimally invasive therapies and surgery are available for diseases of the prostate and may include but are not limited to:

  • Cryoablation of the prostate; or
  • Cystourethroscopy with insertion of permanent adjustable transprostatic implant; 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 stents; or
  • Prostatic urethral lift (PUL); or
  • Radical prostatectomy; or
  • Simple prostatectomy; or
  • Transuretheral anterior prostate commissurotomy; or
  • Transurethral electrovaporization of the prostate (TUEVP, TUVAP or TUEVAP); or 
  • Transuretheral incision of the prostate (TUIP); or
  • Transurethral microwave thermotherapy (TUMT); or 
  • Transurethral resection of the prostate (TURP); or
  • Transuretheral waterjet ablation of the prostate; or
  • Transurethral ultrasound-guided laser-induced prostatectomy (TULIP); or
  • Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy; or
  • Water vapor thermal therapy when prostate volume is less than 80 grams.

Polyethylene glycol (PEG) hydrogel is a slowly resorbing hydrogel injected into Denonvillier's space to limit rectal toxicity before radiation therapy for prostate cancer.

Note: Oral pharmacological treatments and prostate specific antigen testing are not addressed in this policy.

Policy Position

Diagnosis and Staging: Prostate Cancer

Saturation biopsy of the prostate (taking 20 or more core tissue samples at one time) may be considered medically necessary for ANY of the following indications in individuals with two (2) prior extended transrectal prostate biopsies (up to 12 core tissue samples) negative for invasive cancer:

  • Individuals with an elevated prostate specific antigen (PSA) that is persistently rising; or
  • Individuals with histologic evidence of atypia on prior prostate biopsy; or
  • Individuals with histologic findings of high-grade prostatic intraepithelial neoplasia (PIN) on prior biopsy.

Saturation needle biopsy of the prostate 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.

0443T

55700

55706

 

 

 

 


Treatment of the Prostate: Benign Prostate Hypertrophy , Prostate Cancer

The surgical and minimally invasive treatment 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  of urinary outlet obstruction due to prostate cancer may be considered medically necessary when ONE the following criteria are met:

  • The individual has 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 has a diagnosis or history of prostate cancer and is clinically in remission as evidenced by a prostate specific antigen (PSA) less than 1.0 ng/mL.

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

0421T

0582T

0619T

52282

52441

52442

52450

52601

52630

52640

52647

52648

52649

53850

53852

53854

55821

55831

 

 

 


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

55801

55810

55812

55815

55840

55842

55845

55866

 

 

 

 

 

 


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 four (4) -12 weeks 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.

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 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.

55873

 

 

 

 

 

 


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):
    •  T1 – T2; 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.

55880

55899

 

 

 

 

 


Polyethylene-glycol Hydrogel (PEG)

PEG hydrogel may be considered medically necessary in individuals diagnosed with prostate cancer and are going to be treated with radiotherapy.

PEG hydrogel usage 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.

55874

 

 

 

 

 

 


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; or
  • Transperineal focal laser ablation.

0655T

0714T

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; or
  • Placement of temporary prostatic stents for the treatment for BPH; or
  • Prostatic arterial embolization; or
  • Focal laser ablation.

37243

53855

53899

55873

55880

55899

 


C2596

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
Related Policies

Refer to Medical Policy L-260, Prostate Specific Antigen, for additional information.


Professional Statements and Societal Positions Guidelines

National Comprehensive Cancer Network (NCCN) – 2022

Saturation Biopsy

Current NCCN Prostate Cancer guidelines (v.3.2022) do not mention saturation biopsy. The guideline mentions biopsy identified by risk group as follows:

 

Risk Group

Recommendation

Very Low Risk Group

Consider confirmatory mpMRI ± prostate biopsy if MRI not performed initially. All patients should undergo a confirmatory prostate biopsy within 1-2 years of their diagnostic biopsy.

Low Risk Group

Consider confirmatory mpMRI ± prostate biopsy and/or molecular tumor analysis if MRI not performed initially to establish candidacy for active surveillance. All patients should undergo a confirmatory prostate biopsy within 1-2 years of their diagnostic biopsy.

Intermediate Risk Group

Consider confirmatory mpMRI ± prostate biopsy and/or molecular tumor analysis if MRI not performed initially for those considering active surveillance. All patients should undergo a confirmatory prostate biopsy within 1-2 years of their diagnostic biopsy.

Active Surveillance

Consider confirmatory mpMRI ± prostate biopsy and/or molecular tumor analysis if MRI not performed initially. All patients should undergo a confirmatory prostate biopsy within 1-2 years of their diagnostic biopsy.

 

Cryosurgery/HIFU

Current NCCN Prostate guidelines (v.3.2022) recommends only cryosurgery and high-intensity focused ultrasound as local therapy options for RT recurrence in the absence of metastatic disease.

 

Polyethylene-glycol Hydrogel (PEG)

Current NCCN Prostate guidelines (v.3.2022) state, "Overall, the panel believes that biocompatible and biodegradable perirectal spacer materials may be implanted between the prostate and rectum in patients undergoing external radiotherapy with organ-confined prostate cancer in order to displace the rectum from high radiation dose regions."

American Urological Association (AUA) - 2021

The AUA guidelines (2021) address surgical interventions for BPH/LUTS as follows:

·         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.

·         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.

Procedure/Patient Population

Recommendation

Laser Enucleation

Holmium laser enucleation of the prostate (HoLEP) or thulium laser enucleation of the prostate (ThuLEP) should be considered as an option, depending on the clinician’s expertise with these techniques, as prostate size-independent options for the treatment of LUTS/BPH.

Medically Complicated Patients

HoLEP, PVP, and ThuLEP should be considered as treatment options in patients who are at higher risk of bleeding.

PUL

 

PUL should be considered as a treatment option for patients with LUTS/BPH provided prostate volume 30-80cc and verified absence of an obstructive middle lobe.

PUL may be offered as a treatment option to eligible patients who desire preservation of erectile and ejaculatory function

PVP

PVP should be offered as an option using 120W or 180W platforms for the treatment of LUTS/BPH.

Robotic Waterjet Treatment

Robotic waterjet treatment (RWT) may be offered as a treatment option to patients with LUTS/BPH provided prostate volume 30-80cc.

Simple Prostatectomy

 

Open, laparoscopic, or robotic assisted prostatectomy should be considered as treatment options by clinicians, depending on their expertise with these techniques, only in patients with large to very large prostates.

TURP

TURP should be offered as a treatment option for patients with LUTS/BPH.

TUIP

 

·         TUIP should be offered as an option for patients with prostates ≤30cc for the surgical treatment of LUTS/BPH.

 

TUMT

 

TUMT may be offered as a treatment option to patients with LUTS/BPH.

 

TUNA

 

TUNA is not recommended for the treatment of LUTS/BPH.

 

TUVP

Bipolar TUVP may be offered as an option to patients for the treatment of LUTS/BPH.

WVTT

 

WVTT should be considered as a treatment option for patients with LUTS/BPH provided prostate volume 30-80cc.

WVTT may be offered as a treatment option to eligible patients who desire preservation of erectile and ejaculatory function.


Covered diagnosis codes for procedure codes: 0421T, 0582T, 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: 0582T, 52441, 52442, 52601, 52630, 52640, 52647, 52648, 52649, 53850, 53852, 55866, 55873, and 55880

 

C61

C79.82

D07.5

 

 

 

 

 

Covered diagnosis codes for procedure codes: 0443T, 55700, 55706, 55810, 55812, 55815, 55840, 55842, 55845, 55866, and 55874

 

C61

C79.82

D07.5

D40.0

 

 

 

Covered diagnosis codes for procedure code: 0619T

N40.0

N40.1

 

 

 

 

 


Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Diagnosis, staging, and treatment of the prostate is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.