Prostate Specific Antigen (PSA)

POLICY NUMBER

L.2.04.419

DESCRIPTION

Prostate Specific Antigen (PSA) when used in conjunction with other prostate cancer tests, such as digital rectal examination, may assist in the shared decision-making process for diagnosing prostate cancer. PSA, a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post-treatment phase of prostate cancer and serves as a marker in following the progress of most prostate tumors once a diagnosis has been established. This test is also an aid in the management of prostate cancer patients and in detecting metastatic or persistent disease in patients following treatment.

The decision to initiate or continue PSA screening should reflect an understanding of the possible benefits and harms and respect the patient’s preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by the patient. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms.

POLICY

Prostate specific antigen may be considered medically necessary for the following:

1. To differentiate between benign and malignant prostate disease in men with at least one of the following signs or symptoms of lower urinary tract disease:

   1. Hematuria

   2. Slow urine stream

   3. Hesitancy

   4. Urgency

   5. Frequency

   6. Nocturia

   7. Incontinence

   8. Palpably abnormal prostate glands on physical examination

2. To differentiate between benign and malignant prostate disease in men with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder.

3. To follow the progress of prostate cancer once a diagnosis has been established, such as detecting metastatic or persistent disease in men who may require additional treatment.

4. To screen for malignant prostate disease in men with documented shared decision making. Discussion between provider and patient should begin at age 50 in men with average risk and at age 40 – 45 in men with high risk (see Policy Guidelines) of malignant prostate disease.

Prostate specific antigen is considered not medically necessary for all other indications.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Risk for development of malignant prostate disease is considered high if one or more of the following are present:

• Black race

• Men with family history of malignant prostate disease, particularly in relatives younger than 65

• Men who are known or likely to have the BRCA 1 or BRCA 2 mutations

PSA testing limitations:

1. When performed in men with symptoms of lower urinary tract disease, the test should be performed once per year unless there is a documented change in the man’s medical condition.

2. When performed as screening for malignant prostate disease, the test should be performed no more often than every two years.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

05/23/2016: New policy added. Approved by Medical Policy Advisory Committee. Effective 07/01/2016.

06/07/2016: Policy number L.2.04.419 added.

06/27/2016: Added Z08 to the Medically Necessary Codes table in the Code Reference section.

09/30/2016: Code Reference updated to add the following new ICD-10 diagnosis codes: D49.59, N42.30, N42.31, N42.32, N42.39, R31.21, R31.29, R39.191, R39.192, R39.198, R97.20, and R97.21. Revised code descriptions for the following ICD-10 diagnoses: N40.0 and N40.1.

12/30/2016: Code Reference section updated to add new 2017 CPT code 81539.

10/05/2017: Code Reference section updated to remove deleted ICD-10 diagnosis codes D49.5, N42.3, R31.2, R39.19, and R97.2.

01/18/2023: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted CPT code 0010M.

02/15/2024: Policy reviewed; no changes.

03/13/2025: Policy reviewed; no changes.

SOURCE(S)

1. Medical Policy Advisory Committee

2. Medicare National Coverage Determination for Prostate Specific Antigen

3. UptoDate (uptodate.com)

4. USPSTF

5. Urology Physician Advisory Committee

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Medically Necessary Codes

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