Sunday, November 4, 2018

CPT 81229, 81313, 81539, 81541 - Oncology, cytogenomic - Prostate cancer

Code Description CPT

81229 Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities

81313 PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)

81479 Unlisted molecular pathology procedure

81539 Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum,

81541 Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a disease-specific mortality risk score (new code effective 1/1/18)

Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer


A biomarker is a chemical in the body. Certain biomarkers can show when something unusual is going on with certain bodily processes. One of the most commonly known and tested biomarkers is prostate specific antigen (PSA). Higher levels of PSA in the blood indicate a problem with the prostate. The difficulty is that the PSA test doesn’t tell us what kind of problem is affecting the prostate – whether it’s simply an enlarged prostate or cancer. If the PSA is high, the usual next step is a biopsy. A biopsy is taking small bits of tissue to see if cancer is present. Other biomarker tests have been developed in recent years with the hope of telling doctors which patients should have a biopsy and who can skip it. Published medical studies about these newer prostate biomarker tests are contradictory. That means some studies show the tests detect what they’re supposed to and other studies don’t. At this time, there is not enough medical evidence to show that newer prostate cancer biomarker tests are effective.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Test Investigational Genetic and protein biomarkers

The following genetic and protein biomarkers for the diagnosis of prostate cancer are considered investigational:
* Candidate gene panels
* Gene hypermethylation testing (eg, ConfirmMDx®)
* Kallikrein markers (eg, 4Kscore™ Test)
* Mitochondrial DNA mutation testing (eg, Prostate Core Mitomics Test™)
* PCA3 testing
* Prostate Health Index (phi)
* SelectMDx
* TMPRSS fusion genes

Single nucleotide polymorphisms testing Single nucleotide polymorphisms (SNPs) testing for cancer risk assessment of prostate cancer is considered investigational.

Note: Prolaris and Oncotype DX Prostate, gene expression analysis tests for prostate cancer management, are addressed in a separate medical policy (see Related Policies).


Related Information

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients. Genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Evidence Review


Various genetic and protein biomarkers are associated with prostate cancer. These tests have the potential for determining which men should undergo prostate biopsy or rebiopsy after a prior negative biopsy. This evidence review addresses these types of tests for cancer risk assessment. Testing to determine cancer aggressiveness after a tissue diagnosis of cancer is addressed in a related policy (see Related Policies).

Prostate Cancer

Prostate cancer is the second most common cancer in men with a predicted 161,360 cases and 26,700 deaths expected in the United States in 2017.

1 Prostate cancer is a complex, heterogeneous disease, ranging from microscopic tumors that are unlikely to be life-threatening to aggressive tumors which can metastasize, leading to morbidity or death. Early localized disease can usually be treated with surgery and radiotherapy, and active surveillance may be adopted in men whose cancer is unlikely to cause major health problems during their lifespan or for whom the treatment might be dangerous. In patients with inoperable or metastatic disease, treatment consists of hormonal therapy and possibly chemotherapy. The lifetime risk of being diagnosed with prostate cancer for men in the United States is approximately 16%, but the risk of dying of prostate cancer is 3%.2 African American men have the highest prostate cancer risk in the United States; the incidence of prostate cancer is about 60% higher and the mortality rate is more than 2 to 3 times greater than that of white men.3 Although the lifetime risk of being diagnosed with prostate cancer is 16%, autopsy results have suggested that about 30% of men age 55 and 60% of men age 80 who have died of other causes have incidental prostate cancer.

4 This indicates that many cases of prostate cancer are present but are unlikely to pose a threat during a man’s life expectancy. Grading

The most widely used grading scheme for prostate cancer is the Gleason system.5

It is an architectural grading system ranging from 1 (well differentiated) to 5 (poorly differentiated); the score is the sum of the primary and secondary patterns. A Gleason score of 6 is low-grade prostate cancer that usually grows slowly; 7 is an intermediate grade; 8 to 10 is high-grade cancer that grows more quickly. Ten-year survival stratified by Gleason score has been estimated from the Surveillance, Epidemiology, and End Results to be about 98% for scores 2 through 6, 92% for score 7 with primary pattern 3 and secondary pattern 4 (3+4), 77% for score 7 (4+3), and 70% for scores 8 to 10.6

Numerous genetic alterations associated with the development or progression of prostate cancer have been described. These molecular markers have been used to help decide which men should undergo prostate biopsy or rebiopsy after an initial negative biopsy.

Summary of Evidence

For individuals who are being considered for an initial prostate biopsy or a repeat biopsy who receive testing for genetic and protein biomarkers of prostate cancer, the evidence includes systematic reviews and meta-analyses and primarily observational studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, test validity, other test performance measures, resource utilization, hospitalizations, and quality of life. The evidence supporting clinical utility varies by test but has not been directly shown for any biomarker test. In general, the performance of biomarker testing for predicting biopsy referrals compared with clinical examination, including the ratio of free or unbound PSA to total PSA, is lacking. Procedures for referrals for biopsy based on clinical examination vary, making it difficult to quantify performance characteristics for this comparator. There is also considerable variability in biopsy referral practices based on clinical examination alone, and many of the biomarker tests do not have standardized cutoffs to recommend biopsy. Therefore, to determine whether the tests improve the net health outcome, prospective comparative data are needed on how test results are expected to be used vs how they are actually being used in practice. Many test validation populations have included men with positive digital rectal exam, PSA level outside of the gray zone (between 3 or 4 ng/mL and 10 ng/mL), or older men for whom the information from PSA test results are to be informative. African American men have a high burden of morbidity and mortality, but have not been well represented in these study populations. It is unclear how to monitor men with low biomarker risk scores who continue to have symptoms or high or rising PSA levels. Comparative studies of the many biomarkers are lacking, and it is unclear how to use the tests in practice, particularly when test results are contradictory. The evidence is insufficient to determine the effects of the technology on health outcomes.

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