Biomarker testing coverage for health benefit plans
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This bulletin explains the Kentucky Department of Insurance's interpretation and enforcement of KRS 304.17A-263 requiring health benefit plans to cover biomarker testing ordered by qualified providers for diagnosis, treatment, management, or monitoring when supported by medical and scientific evidence; it applies to insurers issuing health benefit plans in Kentucky.
No material clinical or coverage changes in this revision.
Coverage Criteria and Conditions
Statutory coverage criteria
Covered when ALL of the following are met:
See statutory examples for what qualifies as medical and scientific evidence.
The statute's list is illustrative, not exhaustive; other evidence may qualify.
Insurers may not impose additional or different coverage criteria beyond those established in KRS 304.17A-263. The statute requires coverage when a biomarker test is (1) ordered by a qualified health care provider practicing within the provider's scope of practice; (2) intended to diagnose, treat, perform appropriate management, or provide ongoing monitoring of an insured's disease or condition; and (3) supported by medical and scientific evidence. If a test meets one of the statutory evidentiary examples (e.g., CMS national coverage determinations) the insurer cannot demand extra documentation or impose further conditions in order to deny coverage.
The bulletin does not enumerate a separate list of “not medically necessary” situations. When an insurer denies a biomarker test, the denial must be provided in writing and include an explanation of the appropriate medical or scientific reason for denial that aligns with current standards of practice. Insurers must also provide a clear, readily accessible, and convenient exception and appeal process on their website for both providers and insureds.
When Biomarker Testing Is Covered
Provider Requirements and Insurer Restrictions
Prior authorization must comply with Kentucky law
Prior authorization requirements applied to biomarker testing must comply with existing Kentucky prior authorization statutes (including KRS 304.17A-607) and the Kentucky Insurance Code. Insurers must ensure any prior authorization processes for biomarker testing do not conflict with the Code and must provide the insured and prescribing practitioner access to a clear, readily accessible, and convenient exception request process on the insurer's website.
- Prior authorization requirements must comply with existing prior authorization statutes, including KRS 304.17A-607.
- Insurers must ensure prior authorization requirements for biomarker testing comply with all applicable prior authorization requirements in the Kentucky Insurance Code.
- Insureds and prescribing practitioners must have access to a clear, readily accessible, and convenient process to request an exception on the insurer's website if a test is denied.
Restrictions on imposing extra requirements
Insurers may not impose additional or different coverage criteria beyond the statutory evidentiary examples in KRS 304.17A-263(2)(a)-(g). If a test meets one of the listed standards (for example a CMS national coverage determination), the insurer cannot require extra documentation or impose extra criteria to justify coverage.
- Insurers do not have discretion to require additional or different coverage criteria beyond those listed in statute.
- If the provider or insured demonstrates a test meets a listed example (e.g., CMS NCD), the insurer cannot demand additional documentation to establish coverage.
- The statute's list is illustrative and not exhaustive; other evidence sufficing the standard also prevents imposition of extra criteria.
Evidence support for orders
The ordered biomarker test must be supported by medical and scientific evidence as described in KRS 304.17A-263; demonstrating any one of the statute's enumerated examples (FDA-labeled indications, drug indications, warnings/precautions, CMS NCDs, MAC LCDs, nationally recognized guidelines, consensus statements) satisfies the evidence requirement, and other medical and scientific evidence demonstrable by the provider or insured may also qualify.
- Test must be supported by medical and scientific evidence per KRS 304.17A-263.
- At least one of the statutory examples (a–g) qualifies as meeting the evidentiary standard; the list is not exhaustive.
- Provider or insured may demonstrate other medical and scientific evidence not enumerated in the statute to meet the standard.
Denial and appeal requirements
If an insurer denies a biomarker test, the insurer must post a clear, readily accessible, and convenient exception and appeal process on its website for both providers and insureds; prior authorization denials must be provided in writing and include an explanation of the appropriate medical or scientific reason for denial that aligns with current standards of practice.
- Insurer's website must offer a clear, readily accessible, and convenient exception and appeal process to providers and insureds for denied biomarker tests.
- Prior authorization denials of biomarker claims shall be in writing and include an explanation of the appropriate medical or scientific reason for denial aligning with current standards of practice.
Who May Order Biomarker Testing
Order test only by qualified provider within scope of practice
Biomarker testing must be ordered by a qualified health care provider practicing within the provider's scope of practice; coverage is conditioned on this ordering requirement being met.
- Ensure the ordering clinician is legally qualified and acting within their scope of practice when placing the test order.
Key Definitions
Policy Background and Statutory Context
KRS 304.17A-263 defines a biomarker as an objectively measured characteristic that indicates normal biologic processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, and the statute explicitly includes examples such as gene mutations and protein expression. Biomarker testing encompasses analysis of a patient's tissue, blood, or other biospecimen and includes single-analyte tests, multiplex panels, and whole genome sequencing when ordered and supported as required by the statute.
Limitations and Exclusions
The bulletin does not list specific tests or clinical indications as categorically not covered. Instead, it prohibits insurers from imposing coverage requirements beyond those in the statute; coverage determinations must be based on whether the ordered test satisfies the statutory conditions and is supported by medical and scientific evidence (including the statutory examples).
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