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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 there are two applications of molecular biomarkers to risk-stratify patients at increased risk 
for prostate cancer: 
 
   I. A non-invasive or minimally invasive test, the results of which are obtained to inform the decision to 
perform an initial biopsy (pre-biopsy). 
   II. A test performed to further refine risk when a biopsy has been performed but does not clearly indicate 
malignancy on histopathologic examination (post-biopsy). Such a test can potentially obviate the need for a 
repeat biopsy. 
 
This contractor provides limited coverage for molecular Deoxyribonucleic acid/ribonucleic acid (DNA/RNA) 
biomarker tests for the diagnosis of prostate cancer that help differentiate men who may or may not benefit 
from a prostate biopsy when ALL of the following conditions are met: 
 
   1. The patient must not have an established diagnosis of prostate cancer. 
   2. The beneficiary is a candidate for prostate biopsy or repeat prostate biopsy, according to a consensus 
guideline [(i.e., National Comprehensive Cancer Network (NCCN), American Society of Clinical 
Oncology(ASCO), American Urological Association (AUA)]. 
 
       1. For men less than or equal to 75 years of age - Prostate Specific Antigen (PSA) (or adjusted PSA in 
special populations, i.e., patients taking 5alpha-reductase inhibitors) OR repeat PSA are greater than 3 and less 
than 10ng/mL AND/OR Digital Rectal Exam (DRE) findings are very suspicious for cancer. 
       2. For men greater than 75 years of age - PSA (or adjusted PSA in special populations, i.e., patients taking 
5-alpha-reductase inhibitors) OR repeat PSA are greatert than or equal to 4 and less than 10ng/mL AND/OR 
DRE findings are very suspicious for cancer. 
 
EXCEPTION: a molecular biomarker test may be performed in men with PSA levels greater than 10 ng/mL 
who are being considered for repeat biopsy IF appropriate according to consensus guidelines AND according to 
the following: the specific biomarker test has been validated in men with PSA levels greater than 10 ng/mL 
AND a Multiparametric MRI (mpMRI) is negative, if performed.  
    3. The beneficiary has not had a prostate biopsy OR has had a previous negative or non-malignant but 
abnormal histopathology finding (i.e., atypical small acinar proliferation (ASAP) or high-grade prostatic 
intraepithelial neoplasia (HGPIN) on prostate biopsy). 
 
        Patients under consideration for a repeat biopsy have first undergone repeat PSA and/or DRE testing as 
recommended by consensus guidelines 
 
   4. The beneficiary would benefit from treatment of prostate cancer and patient management will be impacted 
by use of a biomarker in a manner already demonstrated in the peer-reviewed published literature to improve 
patient outcomes. 
   5. The medical record supports the medical necessity for the biomarker test. 
   6. Testing is performed according to the intended use of the test in the intended patient population for which 
the test was developed and validated. 
   7. Testing must be performed according to Clinical Laboratory Improvement Amendments (CLIA) and/or 
Food and Drug Administration (FDA) regulations in an accredited laboratory. 
   8. For a given clinical indication (pre-OR post-biopsy), only one molecular biomarker may be performed 
UNLESS a second test, meeting all the criteria established herein, is reasonable and necessary as an adjunct to 
the first test, according to criteria established in this policy. 
   9. If the test relies on an algorithm which may range in complexity from a threshold determination of a single 
numeric value to a complex mathematical or computational function, the algorithm must be validated in a 
cohort that is not a development cohort for the algorithm. 
   10. The analytes measured have demonstrated clinical validity and clinical utility (i.e., improved detection or 
discrimination of cancer or high-grade cancer or reduction in the need for biopsy) in the peer-reviewed 
published literature, establishing a clear and significant biological/molecular basis for stratifying patients and 
subsequently selecting (either positively or negatively) their clinical management decision within a clearly 
defined population. 
   11. The test is ordered by a physician specialist in the management of prostate cancer, such as a urologist or 
oncologist. An exception may be made in geographic locations where the specialist(s) cannot be reasonably 
reached by the beneficiary and the ordering provider is located closer to the beneficiarys place of residence 
than the nearest specialist. We would generally expect that beneficiaries for whom the test is ordered under this 
exception to be living in rural locations, islands, or some other location where access to care is limited. 
 
NOTE: If the patient is considered higher risk (due to relevant family or personal cancer history, relevant high-
risk genetic mutations, African ancestry, or other clinical parameters highly suspicious for cancer including a 
persistent and significant increase in PSA), a biopsy may still be warranted. These relative indications for 
biopsy should be taken into consideration as part of a shared decision-making process regarding whether to 
proceed with a biopsy. 
 
You can find this information in Medicare's Local Coverage Determination (LCD): MolDX: Molecular 
Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer (L39005). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.