Coverage Policy Manual
Policy #: 1997177
Category: Laboratory
Initiated: November 1993
Last Review: January 2024
  Tumor Antigen, Prostate Specific Antigen (PSA)
Description:
Prostate specific antigen (PSA) is an organ-specific serine protease localized to prostatic epithelial cells, both normal and malignant, but it is not produced by any other cell in the body.  Levels are undetectable in women, and men without prostatic tissue, and are elevated in patients with benign and malignant prostatic disease.  Combined with physical examination of the prostate, it has been shown to be more effective in detecting carcinoma of the prostate than digital examination alone although some urologists feel that a digital rectal exam is still the exam of choice in detecting prostate cancer.
 
Problems exist with studies performed to prove the efficacy of PSA testing.  PSA has not been proven to be an accurate test for the detection or staging of prostate cancer.  The studies thus far performed do not prove that PSA is sufficiently accurate to prevent the need for biopsy nor to replace digital rectal examination as the diagnostic test of choice.  PSA as a screening test for prostate cancer has not yet been proven to improve health outcomes but studies addressing this question are underway.
Policy/
Coverage:
Effective June 2023
 
Screening tests are exclusions in most member benefit certificates of coverage except for coverage based on the Patient Protection and Affordable Care Act (PPACA) screening recommendations for non-grandfathered plans and those contracts with wellness benefits (which like PPACA, covers specific screening procedures).
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Measurement of PSA level meets primary coverage criteria for effectiveness and is covered in men:
 
    • In whom there is a known diagnosis of carcinoma of the prostate when the test is being done to obtain a baseline level;
    • With a known neoplasm of contiguous or overlapping sites of the bladder where the point of origin of the tumor cannot be determined;
    • With secondary and unspecified malignant neoplasms of lymph nodes (excludes Hodgkin's disease and non-Hodgkin's lymphoma) with:
        • Tumor of unknown origin involving inguinal region lymph nodes;
        • Tumor of unknown origin involving intrapelvic lymph nodes;
    • With known carcinoma in situ of prostate in which a baseline level is being obtained;
    • With a family history of prostate cancer within the patient's immediate family (father or siblings) or second generation relatives (paternal or maternal grandfather, paternal or maternal first-degree uncles);
    • Following an abnormal digital rectal exam when the result of the PSA test will determine if further studies will be done (e.g., A questionable area in the prostate is found; the PSA is normal; and therefore, no further evaluation is done). If the test result does not influence further testing (e.g., the digital rectal examination is questionably abnormal, PSA result is normal and the patient goes on to needle biopsy and/or transrectal ultrasound regardless of normal PSA) then the PSA is only additive and is not covered (see does not meet section below).
    • Repeat measurement of an indeterminate PSA level may be allowed when the result of the second evaluation will be used to determine the next phase of the patient’s treatment. (Additional tests may be allowed within one year of the initial evaluation.)
    • With known carcinoma of the prostate where follow-up measurement of PSA level is to be used to direct therapy;
    • Who are on prescription testosterone therapy:
        • At baseline (prior to therapy);
        • After initial 3 months of therapy; and
        • Then annually while on therapy.
    • For stage A/B tumor:  every three months for one year following diagnosis, then every six months for five years; then once every year;
    • For stage C disease:  every three months for one year following diagnosis, then every six months times five years; then once every year;
    • For stage D disease:  if no further therapy planned, then no more than every five months.  If the patient is on therapy, then every three months.
 
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts
Without Primary Coverage Criteria
 
If the measurement of PSA level does not influence further testing  (e.g., the digital rectal examination is questionably abnormal, the PSA is normal, and the patient goes on to needle biopsy and/or transrectal ultrasound regardless of normal PSA) then measurement of  PSA level is only additive and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For contracts without primary coverage criteria, if the measurement of  PSA level does not influence further testing  (e.g., the digital rectal examination is questionably abnormal; the PSA is normal; and the patient goes on to needle biopsy and/or transrectal ultrasound regardless of normal PSA) then the measurement of  PSA level is only additive and is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Measurement of PSA level for any circumstance or indication not described above as covered, does not meet member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, measurement of PSA level for any circumstance or indication not described above as covered is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to June 2023
 
There is a great deal of pressure on physicians to perform PSA for screening.  Screening tests are exclusions in most member benefit certificates of coverage except for coverage based on the Patient Protection and Affordable Care Act (PPACA) screening recommendations for non-grandfathered plans and those contracts with wellness benefits (which like PPACA, covers specific screening procedures).
 
PSA meets primary coverage criteria for effectiveness and is covered in men:
    • In whom there is a known diagnosis of carcinoma of the prostate when the test is being done to obtain a baseline level;
    • With a known neoplasm of contiguous or overlapping sites of the bladder where the point of origin of the tumor cannot be determined;
    • With secondary and unspecified malignant neoplasms of lymph nodes (excludes Hodgkin's disease and non-Hodgkin's lymphoma) with:
      • Tumor of unknown origin involving inguinal region lymph nodes;
      • Tumor of unknown origin involving intrapelvic lymph nodes;
    • With known carcinoma in situ of prostate in which a baseline level is being obtained;
    • With a family history of prostate cancer within the patient's immediate family (father or siblings) or second generation relatives (paternal or maternal grandfather, paternal or maternal first-degree uncles).
 
There are obviously situations where physicians, after doing a digital rectal examination, make a decision because of abnormal findings on the examination to obtain a PSA determination.  This test is covered when the result of the test is used in determining whether further studies will be done (e.g., a questionable area in the prostate is found; the PSA is normal; and therefore, no further evaluation is done).  If the test result does not influence further testing  e.g., the digital rectal examination is questionably abnormal; the PSA is normal; and the patient goes on to needle biopsy and/or transrectal ultrasound) then the PSA examination is only additive and would not be covered.
 
Occasionally, patients are seen with a PSA level that is indeterminate.  The physician may wish to repeat the examination in several months.  The utility of this is unproved at the present time, but if the result of the second evaluation is to be used in determining the next phase of the patient's treatment, the additional tests may be allowed within one year of the initial evaluation.
 
In patients with known carcinoma of the prostate where follow-up PSA determination is to be used to direct therapy, repeat PSA determination will be allowed:
    • For stage A/B tumor:  every three months for one year following diagnosis, then every six months for five years; then once every year;
    • For stage C disease:  every three months for one year following diagnosis, then every six months times five years; then once every year;
    • For stage D disease:  if no further therapy planned, then no more than every five months.  If the patient is on therapy, then every three months.
Rationale:
2013 Update
A search of the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search conducted through January 2018 did not reveal any new information that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2018. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
84153Prostate specific antigen (PSA); total
G0103Prostate cancer screening; prostate specific antigen test (psa)
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Carter BS, Bova GS, Beaty TH, et al.(1993) Hereditary prostate cancer: epidemiologic and clinical features. J Urol 1993; 150:797-802.

Catalona WJ, Partin AW, Slawin KM, et al.(1998) Use of the Percentage of Free Prostate-Specific Antigen to Enhance Differentiation of Prostate Cancer from Benign Prostatic Disease: A Prospective Multicenter Clinical Trial. JAMA 1998; 279:1542-1547.

Catalona WJ.(1993) Urology. JAMA 1993; 270:265-266.

Chodak GW.(1994) Screening for Prostate Cancer: The Debate Continues. JAMA 1994; 272:813-814.

Chybowski FM, Bergstralh EJ, Oesterling JE.(1992) The Effect of Digital Rectal Examination on the Serum Prostate Specific Antigen Concentration: Results of a Randomized Study. J Urology 1992; 148:83-86.

Collazos J, Genolla J, Ruibal A.(1993) Study of the tumor marker carbohydrate antigen 50 in liver cirrhosis. Pathogenetic considerations. Clin Nucl Med 1993;18:56-9.

Cooke RR, Nacey JN, Beeston RE, et al.(1993) Serum Tumor Markers for Prostatic Cancer. ACP J Club 1993; 88.

Cupp MR, Oesterling JE.(1993) Prostate-Specific Antigen, Digital Rectal Examination, and Transrectal Ultrasonography: Their Roles in Diagnosing Early Prostate Cancer. Mayo Clin Proc 1993; 68:297-306.

Dorr VJ, Williamson SK, Stephens RL.(1993) An Evaluation of Prostate Specific Antigen as a Screening Test for Prostate Cancer. Arch Int Med 1993; 153:2529-2537.

Garnick MB.(1993) Prostate cancer: screening, diagnosis, and management. Ann Int Med 1993; 118:804-818.

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Jacobsen SJ, Katusic SK, Bergstralh EJ, et al.(1995) Incidence of Prostate Cancer Diagnosis in the Eras Before and After Serum Prostate-Specific Antigen Testing. JAMA 1995; 274:1445-1449.

Krahn MD, Mahoney JE, Eckman MH, et al.(1994) Screening for Prostate Cancer: A Decision Analytic View. JAMA 1994; 272:773-780.

McNaughton Collins M, Ransohoff DF, Barry MJ.(1997) Early Detection of Prostate Cancer: Serendipity Strikes Again. JAMA 1997; 278:1516-1519.

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Oesterling JE, Jacobsen SJ, Chute CG, et al.(1993) Serum Prostate-Specific Antigen in a Community-Based Population of Healthy Men. JAMA 1993; 270:860-864.

Oesterling JE, Suman VJ, Zincke H, et al.(1993) PSA-Detected (Clinical Stage T1c or B0) Prostate Cancer: Pathologically Significant Tumors. Urol Clin N Am 1993; 20:687-693.

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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