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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 the 4Kscore test will be considered medically reasonable and necessary when all the following 
are met: 
 
    1. When all of the components of the algorithm are present. 
   2. Testing of men 45 years of age and older, prior to an initial biopsy or following a negative biopsy, who 
have a confirmed* moderately elevated PSA (greater than 3 and less than 10 ng/mL; greater than or equal to 4 
and less than 10 ng/mL in men greater than 75 years of age) when BOTH of the following are present: 
        No other relative indication** for prostate biopsy including ANY of the following: (this may not be an all 
inclusive list) 
DRE suspicious for cancer should be encouraged to undergo biopsy 
Persistent and significant increase in PSA should be encouraged to undergo biopsy 
Positive multiparametric magnetic resonance imaging (MRI) (if done) 
Other major risk factor for prostate cancer including: (this may not be an all inclusive list) 
 
    Ethnicity at higher risk for prostate cancer 
    First-degree relative with prostate cancer 
    High-penetrance prostate cancer risk gene(s) per the National Comprehensive Cancer Network (NCCN) (if 
known) 
 
        No other relative contraindication** for prostate biopsy including ANY of the following: 
            Less than a 10 year life expectancy 
            Benign disease not ruled out. 
 
*PSA elevation should be verified after a few weeks under standardized conditions (e.g. no ejaculation, 
manipulations, and urinary tract infections, no medications such as 5a-reductase) in the same laboratory or 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 the 4Kscore test will be considered medically reasonable and necessary when all the following 
are met: 
 
    1. When all of the components of the algorithm are present. 
   2. Testing of men 45 years of age and older, prior to an initial biopsy or following a negative biopsy, who 
have a confirmed* moderately elevated PSA (greater than 3 and less than 10 ng/mL; greater than or equal to 4 
and less than 10 ng/mL in men greater than 75 years of age) when BOTH of the following are present: 
        No other relative indication** for prostate biopsy including ANY of the following: (this may not be an all 
inclusive list) 
DRE suspicious for cancer should be encouraged to undergo biopsy 
Persistent and significant increase in PSA should be encouraged to undergo biopsy 
Positive multiparametric magnetic resonance imaging (MRI) (if done) 
Other major risk factor for prostate cancer including: (this may not be an all inclusive list) 
 
    Ethnicity at higher risk for prostate cancer 
    First-degree relative with prostate cancer 
    High-penetrance prostate cancer risk gene(s) per the National Comprehensive Cancer Network (NCCN) (if 
known) 
 
        No other relative contraindication** for prostate biopsy including ANY of the following: 
            Less than a 10 year life expectancy 
            Benign disease not ruled out. 
 
*PSA elevation should be verified after a few weeks under standardized conditions (e.g. no ejaculation, 
manipulations, and urinary tract infections, no medications such as 5a-reductase) in the same laboratory orother Clinical Laboratory Improvement Amendments (CLIA) approved laboratory before considering a biopsy.  
 
**The relative indications and contraindications are not absolute. When it is determined that the 4Kscore test is 
medically reasonable and necessary in a beneficiary with one of the relative indications or contraindications for 
prostate biopsy the medical record must support the medical necessity for the test and there must be 
documented evidence of shared decision making between the patient and provider. This supporting 
documentation must be provided to the laboratory at the time of ordering the test. 
 
    3.  Presence of shared decision making between the ordering provider and the beneficiary concerning the 
4Kscore testing. 
 
Limitations: The following are considered to be not medically reasonable and necessary: 
 
    1. Any test that does not contain all of the following components: 
        4 Kallikreins proteins (tPSA, fPSA, iPSA and hK2) 
        Clinical information including age 
        DRE 
        Prior biopsy history 
    2. Tests performed without evidence of shared decision making between the ordering provider and the 
beneficiary. 
 
You can find this information in Medicare's Local Coverage Determination (LCD): 4Kscore Test Algorithm 
(L37792). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.