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April 2024
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CMS Transmittals

National Coverage Determination
Procedure Code: 8XXXX
Prostate Specific Antigen
CMS Policy Number: 190.31
Back to NCD List

Description: Prostate Specific Antigen (PSA), a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post-operative phase of prostate cancer. Three to 6 months after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent disease. Six months following introduction of antiandrogen therapy, PSA is reported of distinguishing patients with favorable response from those in whom limited response is anticipated.

PSA when used in conjunction with other prostate cancer tests, such as digital rectal examination, may assist in the decision-making process for diagnosing prostate cancer. PSA also, 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.

PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs & symptoms (e.g., hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia & incontinence) as well as with patients with palpably abnormal prostate glands on physician exam, and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder. PSA is also a marker used to follow the progress of prostate cancer once a diagnosis has been established, such as detecting metastatic or persistent disease in patients who may require additional treatment. PSA testing may also be useful in the differential diagnosis of men presenting with as yet undiagnosed disseminated metastatic disease.

Generally, for patients with lower urinary tract signs or symptoms, the test is performed only once per year unless there is a change in the patient’s medical condition.

Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.

Frequency Limitations: For patients with lower urinary tract signs or symptoms, total PSA is performed only once per year unless there is a change in the patient's medical condition. Medicare covers a screening total PSA test one each year for men over 50 years of age.

To review all requirements of this policy, please see: CMS NCD listing by Chapter

Covered ICD-10 Codes.

C61Malignant neoplasm of prostate
C67.5Malignant neoplasm of bladder neck
C77.4Sec and unsp malig neoplasm of inguinal and lower limb nodes
C77.5Secondary and unsp malignant neoplasm of intrapelv nodes
C77.8Sec and unsp malig neoplasm of nodes of multiple regions
C79.51Secondary malignant neoplasm of bone
C79.52Secondary malignant neoplasm of bone marrow
C79.82Secondary malignant neoplasm of genital organs
D07.5Carcinoma in situ of prostate
D40.0Neoplasm of uncertain behavior of prostate
.... and many more.

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