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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that the most current NCCN recommendations reflect the growing body of evidence supporting 
the use of prostate biomarkers to further identify, and risk stratify those patients at risk of high-grade prostate 
cancer requiring further management from those with low grade or indolent cancer who might not benefit from 
further intervention and who may be spared unnecessary biopsies and interventions. Such biomarkers are non-
invasive (typically blood- or urine- based) and may contribute to improved sensitivity and specificity of 
screening, surpassing the limitations of PSA testing. 
 
In the post-biopsy setting, there are biomarkers that improve specificity in patients who have had at least 1prior 
negative biopsy. Some of these are liquid biomarkers that overlap with those already discussed for use in 
biopsy-naive patients, while others are tissue-based and should only be performed on a biopsy specimen. Some 
utilize gene expression data while others evaluate epigenetic markers such as hypermethylation in select genes 
thought to be associated with aggressive disease. Progensa PCA3 is an mRNA expression assay that can be 
tested from post-DRE urine. In the post-biopsy setting, it has been shown to improve the specificity of prostate 
cancer detection and determine which patients should undergo a repeat biopsy. One multi-center study 
evaluating men with at least 1prior negative prostate biopsy reported that those with a score of <25 were more 
than 4 times as likely to have a negative repeat biopsy as men with a score of =25. ConfirmMDx is a multi-
gene test that uses prostate biopsy tissue to assess the methylation status of 3 biomarkers (GSTP1, RASSF1, 
APC) associated with prostate cancer. The performance of this assay in large, blinded clinical validation studies 
demonstrated a NPV of 90% for all prostate cancer and 96% for high-grade disease, considerably higher than 
that afforded by standard histopathology review. A field observation study conducted in 138 patients with 
negative biopsies found a repeat biopsy rate of 4.3%, significantly lower than the 40% repeat biopsy rate 
reported in the PLCO trial, for patients with an initial negative biopsy. 
 
 
 For patients who have not yet had a biopsy, the guidelines include the use of %fPSA to improve cancer 
detection, and PHI, SelectMDx, 4Kscore, and ExoDxTM Prostate (EPI) tests to further define the probability 
of higher-grade cancer. They also include %fPSA, PHI, 4Kscore, EPI, PCA3 and ConfirmMDx to improve 
specificity for patients thought to be at higher risk despite a prior negative biopsy. However, as there is 
variation in the number and quality of clinical validity and clinical utility studies published, it is not always 
clear which biomarker test may be optimal in a particular setting. 
 
You can find these rules in the Local Coverage Determination (LCD) MolDX: Molecular Biomarkers to Risk-
Stratify Patients at Increased Risk for Prostate Cancer L39042. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.