Prior Authorization Required

Prior authorization is required for Medicare Advantage plans and is recommended for Commercial products. Participating providers must obtain authorization via the payer's online tool prior to ordering the service. Laboratories are not permitted to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician; only the ordering physician may be involved in authorization, appeals, or related administrative actions.

• Affected codes: 81539, 81551, 0113U, 0339U, and other listed CPT/PLA codes in this policy
• MA (Medicare Advantage): Prior authorization required
• Commercial: Prior authorization recommended

Documentation of Shared Decision Making and Medical Necessity

Document that a shared decision-making discussion occurred between the ordering provider and the beneficiary and that medical necessity for the biomarker test is supported in the medical record. This documentation must be provided to the performing laboratory at the time the test is ordered.

• Include clinical indication, relevant PSA values, DRE findings, prior biopsy status, and how results will affect management
• Documentation must be sent to the laboratory with the order

Unlisted CPT code use and authorization

When an Unlisted CPT code (for example 81479) is used because no specific CPT exists for the service, prior authorization is required to determine the service rendered and whether it is covered or medically necessary. Providers should obtain authorization before performing or billing services reported with Unlisted codes.

• Affected code: 81479 (Unlisted molecular pathology/prostate tests such as phi or Mitomics when no specific CPT exists)
• Prior authorization will be used to determine the actual service rendered and coverage status

Laboratory Authorization and Billing Risk

If a laboratory provides a service that has not been authorized, the service will be denied and the financial liability will rest with the participating laboratory. If a laboratory or third party is found to have participated in obtaining authorization on the ordering provider's behalf, BCBSRI may take severe actions up to and including termination from the provider network.

• Denial condition: Services without required authorization will be denied
• Risk: Participating laboratory may be financially liable and subject to network termination for improper authorization assistance

Specimen collection and pretest conditions

Specimen collection and pretest conditions must follow the test developer's instructions and CLIA/FDA/ laboratory accreditation requirements. PSA elevations should be confirmed under standardized conditions (for example: no ejaculation, no manipulations, no active urinary tract infection, and not within the window of medications that alter PSA) in the same laboratory prior to ordering certain biomarker tests.

• Provide specimen per test-specific instructions and CLIA requirements
• Confirm PSA under standardized conditions before testing when specified

One biomarker per clinical indication

For a given clinical indication (pre- or post-biopsy), only one molecular biomarker test may be performed unless a second test that meets all policy criteria is reasonable and necessary as an adjunct to the first test. Exceptions must meet the same validation, intended-use, and medical-necessity requirements described in this policy.

• Rule: One biomarker per clinical indication (pre-biopsy or post-biopsy)
• Exception: A second test is allowed only if it meets all policy criteria and is reasonable and necessary as an adjunct

Policy informational and member benefit precedence

Policy informational: Tests in this policy are subject to the medical necessity criteria herein; when an Unlisted CPT is filed, the Genetic Services policy medical necessity rules apply. Providers should consult related policies for coding and testing requirements.

• See Related Policies section for Genetic Services and coding guidance
• Unlisted CPT filings will be reviewed under Genetic Services medical necessity criteria

Member Financial Consent and Billing Precedence

Member financial consent: Laboratories may not bill members for services that required prior authorization but were not authorized when performed. Where applicable, members must be informed about potential financial liability and consent obtained when required by member benefit terms.

• Laboratory billing: Unauthorized services may not be billed to the member if the laboratory is a participating provider
• Obtain member financial consent consistent with member benefit terms when non-covered testing is considered