Appeal type: unknown
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 say that Medicare 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 
3. The beneficiary has not had a prostate biopsy OR has had a previous negative or non-malignant but 
abnormal histopathology finding 
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. 
4. The medical record supports the medical necessity for the biomarker test. 
5. Testing is performed according to the intended use of the test in the intended patient population for 
which the test was developed and validated. 
6. Testing must be performed according to Clinical Laboratory Improvement Amendments (CLIA) and/or 
Food and Drug Administration (FDA) regulations in an accredited laboratory. 
7. 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. 
8. 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. 
9. 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. 
10. 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. 
 
You can find this information in the 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. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.