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Decision: unknown

 
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 state that there is 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)]. 
a) 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. 
b) 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 greater 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).  
 
A. 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 beneficiary's 
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. 
Analytical validity, clinical validity (of novel analytes), and clinical utility will be assessed as part of a 
thorough and comprehensive technical assessment (TA) by the Molecular Diagnostic Services Program 
(MolDX). 
You can find this rule in the Local Coverage Determination (LCD) for 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.