Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56653 (Billing and Coding: 4Kscore Test Algorithm) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A56653: Billing and Coding: 4Kscore Test Algorithm (Billing and Coding, effective 2024-04-29)
- Covered ICD-10-CM codes
- 1
- 1 group
- Non-covered ICD-10-CM codes
- 1
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| R97.20 | — |
Procedure codes: 81539.
Coverage indications, limitations and medical necessity
Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.
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 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:
• 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
• Tests performed without evidence of shared decision making between the ordering provider and the beneficiary.
Summary of evidence (opening)
In response to 4Kscore data being criticized suggesting that patients were not part of the intended population or that the results of a specific PSA range were not cited, Vickers et al 42 reanalyzed data from a recent meta-analysis using a Gleason grade group (GGG) of greater than or equal to 2. The base model that was used consisted of age, total PSA and DRE (if available). Initially, 1,792 different analyses reflecting the most common age, PSA and DRE were performed. The results of these analyses did not vary substantially. An analysis across all possible subgroups of age, PSA, DRE and cohorts was then performed. Out of 180,224 analyses 159,847 had meaningful data. Clinical validity was assessed by calculating the net benefit for the panel and base model at threshold probabilities of 6%, 9%, 12% and 15%. While sometimes at low threshold probabilities, if the PSA or age range was restricted or unusual, the authors were unable to find any reasonable combination of age or PSA in contemporary cohorts for which the decision curve did not support clinical utility of the panel.
Limitations of this analysis include no validation of this format being noted and no clinical outcomes noted. Several terms and definitions such as “results did not vary importantly” and “net benefit” were not defined.
In their guidelines, the American Urological Association (AUA) 24 recognizes that the decision to undergo PSA screening in men ages 55 to 69 involves weighing the benefits of reducing the rate of metastatic prostate cancer and prevention of prostate cancer death against the known potential harms associated with screening and treatment. For this reason, the Panel strongly recommends shared decision-making for men 55 to 69 years of age that are considering PSA screening, and proceeding based on a man's values and preferences.
The Panel does not recommend routine PSA screening in men 70 years of age or older or for any man with less than a 10 to 15 year life expectancy.
The contractor cites 43 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2019-03-21
- Current revision effective
- 2019-12-30
- MCD version
- 16
The contractor lists 2 National Coverage Determinations as related: NCD 190.31 Prostate Specific Antigen, NCD 210.1 Prostate Cancer Screening Tests. Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Novitas Solutions, Inc. hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L37792 cover?
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… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L37792 apply to?
Novitas Solutions, Inc. applies it to Medicare claims in AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L37792?
The companion billing and coding article A56653 lists 1 ICD-10-CM codes in 1 group that support medical necessity and 1 that do not; the first 1 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L37792?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.