4Kscore Test Algorithm

Jurisdiction: J9 MAC Part B. States: Florida, Puerto Rico, US Virgin Islands. Type: Active LCD

History/Background and/or General Information The 4Kscore test measures blood levels of four Kallikreins protein biomarkers (total prostate-specific antigen [tPSA], free PSA [fPSA], intact PSA [iPSA], and human Kallikrein-related peptidase 2 [hK2]) in addition to other clinical information, including age, digital rectal examination (DRE) and prior biopsy history. All of these components are placed into a proprietary algorithm to provide a percent risk for a high-grade Gleason score greater than or equal to 7 cancer on biopsy. 1 The 4Kscore test algorithm's goal is to refine patient selection for biopsies to reduce unnecessary biopsies in men being considered for biopsy of the prostate for potential cancer. The clinical features of this group of men are poorly defined. NOTE: If any of the above components and protein elements are not present in the test, the test is not a true 4Kscore test and will not be considered for payment. Covered Indications The 4Kscore test will be considered medically reasonable and necessary when all the following are met: When all of the components of the algorithm are present. 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 5α-reductase) in the same laboratory or other 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 not considered reasonable and necessary: Any test that does not contain all of the following components: 4 Kallikreins proteins (Total PSA [tPSA], Free PSA [fPSA], Intact PSA [iPSA] and human Kallikrein-2 [hK2]) Clinical information including age DRE Prior biopsy history Tests performed without evidence of shared decision making between the ordering provider and the beneficiary. As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual , Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.