CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

IsoPSA (Cleveland Diagnostics) — Coverage Criteria and Prior Authorization

Policy governs medical necessity and prior authorization requirements for the IsoPSA (Cleveland Diagnostics) blood test for detection of high-grade prostate cancer for Medicare Advantage and commercial products; affects ordering physicians and participating laboratories/providers.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyIsoPSA (Cleveland Diagnostics) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeCoverage addedauthorization clarified

Effective Date07/01/2025

Next Review Date07/05/2025

Key ActionObtain prior authorization via the online tool—authorization must be obtained by the ordering physician (laboratories may not obtain authorization).

SourceLink

POLICY UPDATE CHANGES

IsoPSA (Cleveland Diagnostics, Inc) - CPT Code 0359U is considered medically necessary when the medical criteria in the online authorization tool for participating providers is met.

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online tool for participating providers.

0359UCPT code added/covered for IsoPSA

07/01/2025Effective date for coverage and PA requirement

PA requiredMedicare Advantage Plans

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Coverage Criteria

Medical necessity (IsoPSA)

IsoPSA is considered medically necessary when the medical criteria in the online authorization tool for participating providers is met.

Medically necessary when: All medical criteria specified in the online authorization tool for participating providers are metsee online authorization tool

Tool determines patient-level clinical criteria for coverage

Some genetic and biomarker testing services may be not covered or may be contractually excluded for certain self‑funded groups. Benefits and specific exclusions vary by group or contract; details about which tests require prior authorization, are not medically necessary, or are excluded for a given group are maintained in the related Genetic Testing Services and Proprietary Laboratory Analyses policies and in the member’s Benefit Booklet.

Coverage for laboratory tests, including IsoPSA, is determined by the member’s specific group/contract benefits. Refer to the member’s Evidence of Coverage or Subscriber Agreement and the applicable Benefit Booklet to confirm whether a requested test is covered, requires prior authorization, or is excluded under the plan.

Coding

Covered CPT CodesCPTCovered

0359U

IsoPSA (Cleveland Diagnostics, Inc)

Benefits variation notice

Member benefits may vary by contractCoverage and laboratory test benefits differ across groups and contracts; members should consult their Evidence of Coverage or Subscriber Agreement for applicable laboratory test coverage and not medically necessary/not covered benefits.

Reference documentsEvidence of Coverage (EOC) or Subscriber Agreement governs member-specific coverage determinations.

ApplicabilityVariation notice applies to Medicare Advantage and Commercial Products as described in the policy.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products. Authorization must be obtained via the online authorization tool for participating providers for IsoPSA (Cleveland Diagnostics, Inc) — CPT Code 0359U.

IsoPSA (Cleveland Diagnostics, Inc) — CPT Code 0359U

Note

Authorization Must Be Obtained by Ordering Physician

Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity.

Background

IsoPSA is a blood‑based, structure‑based assay that partitions isoforms of prostate‑specific antigen (PSA) to improve detection specificity for high‑grade prostate cancer. The test is intended to help distinguish cancer‑related PSA changes from benign causes such as benign prostatic hyperplasia, inflammation, or age‑related PSA variation and may reduce unnecessary biopsies and overdiagnosis.

Definitions

IsoPSA definition

Assay typeIsoPSA is a blood-based single parameter, structure-based assay.

MethodPartitions isoforms of prostate-specific antigen using an aqueous two-phase reagent.

PurposeDetects changes in PSA specific to cancer cells to improve specificity for high-grade prostate cancer and reduce confounding from benign conditions such as hyperplasia, inflammation, or age-related changes.

Clinical roleAdjunctive test to PSA screening intended to help avoid unnecessary biopsies and reduce overdiagnosis.