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LCD L39284: Prostate Cancer Detection with IsoPSA®

LCD L39284, Prostate Cancer Detection with IsoPSA®, is the Local Coverage Determination that CGS Administrators, LLC applies to claims from 2 states (KY, OH), effective 2025-11-06 and first in force 2022-11-20. The policy text runs 88 words, and its billing and coding article A59066 lists 1 ICD-10-CM codes that support medical necessity for 1 procedure codes. No other contractor publishes a policy with this title.

QuickIntell editorial content · Legacy registry date · Review not verified

Data effective
Data currency: Medicare Coverage Database LCD export release of September 24, 2026 (effective September 20, 2026). Next CMS release: weekly (Thursdays) for the MCD.
Contractor
CGS Administrators, LLC
States and territories
2
KY OH
Revision effective
2025-11-06
Original effective
2022-11-20
Policy text
88 words
Covered ICD-10 codes (articles)
1

Where this LCD applies

Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.

Contracts that apply LCD L39284
ContractContractorTypeStates
15102CGS Administrators, LLCMAC - Part BKY
15202CGS Administrators, LLCMAC - Part BOH
15101CGS Administrators, LLCMAC - Part AKY
15201CGS Administrators, LLCMAC - Part AOH

Billing and coding: diagnoses and procedure codes

Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A59066 (Billing and Coding: Prostate Cancer Detection with IsoPSA™) 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.

A59066: Billing and Coding: Prostate Cancer Detection with IsoPSA™ (Billing and Coding, effective 2025-11-06)

Covered ICD-10-CM codes
1
1 group
Non-covered ICD-10-CM codes
0
Procedure codes listed
1
Full article
cms.gov record
First 1 covered ICD-10-CM codes in A59066
ICD-10-CMDescription (FY2027)
R97.20—

Procedure codes: 0359U.

Coverage indications, limitations and medical necessity

The IsoPSA® test will be considered medically reasonable and necessary when all the following are met:

Testing of men 50 years of age and older who have a confirmed* moderately elevated PSA (greater than 4 and ≤ 25 ng/mL)

AND

No other relative contraindication for prostate biopsy including:

• Less than a 10-year life expectancy

*PSA elevation should be verified after a few weeks under standardized conditions (e.g., no ejaculation, manipulations, and urinary tract infections) in the same laboratory or other CLIA approved laboratory before considering a biopsy.

Summary of evidence (opening)

Background

Screening modalities for prostate cancer(PCA) include digital rectal exam (DRE) and prostate-specific antigen (PSA) test at a frequency of every twelve months for men ages fifty and over in effort to detect increased risk for adenocarcinoma of prostate. 1 PSA is a reliable immunocytochemical marker for adenocarcinoma of the prostate. However, screening and early treatment of prostate cancer have come under scrutiny due to concerns for over diagnosis of low-risk cancers. 2 Guidelines have been updated due to studies to refine the use of PSA, which remains the primary screening test. 1-3 Investigations into adjunctive testing may provide opportunities to avoid biopsies and reduce overdiagnosis. 2

IsoPSA® is a blood-based single parameter, structure-based assay for improved detection of high-grade prostate cancer. The test partitions isoforms of prostate-specific antigen with an aqueous two-phase reagent. 4 The test aims to improve specificity by testing specific changes in PSA that arise specifically in cancer cells and would not be affected by conditions such as prostate hyperplasia, inflammation, or age that reduce the specificity of the standard PSA assays. 4

Evidence Review

The contractor cites 10 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.

Dates, lineage and related policies

Original determination effective
2022-11-20
Current revision effective
2025-11-06
Last reviewed by the contractor
2025-10-31
MCD version
12

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.

Other related documents: A59242 (Response to Comments).

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 CGS Administrators, LLC hub lists every other active policy from the same contractor.

Frequently asked questions

What does LCD L39284 cover?

The IsoPSA® test will be considered medically reasonable and necessary when all the following are met: 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 L39284 apply to?

CGS Administrators, LLC applies it to Medicare claims in KY, OH. 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 L39284?

The companion billing and coding article A59066 lists 1 ICD-10-CM codes in 1 group that support medical necessity; 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 L39284?

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.

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.