Latest Review Date: February 2024

Category: Surgery                                                       ​​​​

POLICY:

I.   Saturation biopsy of the prostate may be considered medically necessary in patients with the following:

• At least TWO prior extended (12 – 14 core) transrectal prostate biopsies that are negative for invasive cancer; AND
• ONE or more of the following:
  • An elevated prostate specific antigen (PSA) that is persistently rising; OR
  • Histologic evidence of atypia on prior prostate biopsy; OR
  • Histologic findings of high-grade prostatic intraepithelial neoplasia (PIN) on prior biopsy.

II.  Saturation biopsy of the prostate is considered investigational for all other indications, including but not limited to surveillance of patients with prostate cancer, due to lack of clinical evidence demonstrating an impact on improved health outcomes.

DESCRIPTION OF PROCEDURE OR SERVICE:

Saturation biopsy of the prostate, in which more cores are obtained than by standard biopsy protocol, has been proposed in the diagnosis (for initial or repeat biopsy), staging, and management of patients with prostate cancer.

The diagnosis of prostate cancer is made by biopsy of the prostate gland. The approach to biopsy has changed over time. Earlier methods, usually involving 6 random, evenly distributed biopsies, showed high rates of missed cancers. At present, many practitioners use a 12- to 14-core “extended” biopsy strategy for patients undergoing initial biopsy. This extended biopsy is done in an office setting and allows for more extensive sampling of a wider zone which appears to increase the cancer detection rate.

Another approach to increase the number of biopsy tissue cores is “saturation” biopsy. In general, saturation biopsy is considered as more than 20 cores taken from the prostate, with improved sampling of the zones of the gland which may be under sampled in standard biopsy strategies and might lead to missed cancers. Saturation biopsy might be performed transrectally or transperineally. The transperineal approach is usually performed as a minimally invasive surgical procedure which makes use of a three-dimensional coordinate (stereotactic) template-guided system to locate the various biopsy targets under general anesthesia.

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:

POLICY HISTORY

Reviewed and posted July 1, 2021. 

​​​February 2022: Annual review completed. No change to policy intent.

March 2023: Update to Current Coding section to remove CPT code 55700. No change to policy intent.

February 2024: Annual review completed. 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.