One of the major developments in genomics policy over the past five years has been the introduction of state mandates for biomarker test coverage, now active in about 20 states. Typically, these bills peg private insurance coverage to Medicare coverage and guideline endorsement. (Private insurance coverage is state regulated and generally includes large-employer self-insurance aka ERISA plans).
See background at American Cancer Society here. (Their map below). See a 2024 article in JAMA by Lin, Coffman, Phillips here. See a viewpoint from Avalon here. See a recent press release re: Mississippi from ACS here.
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Several of the circa 20 states have issued some guidance to insurers about the laws:
AZ: Regulatory Bulletin 2026-01_Coverage for Biomarker Testing.pdf
GA: https://oci.georgia.gov/press-releases/bulletins
OK: BULLETIN NO. 2025-06 - Oklahoma Insurance Department
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AI CORNER
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I asked Chat GPT to review the four guidance documents.
Below is a clean rewrite using bracketed state names only, no hotlinks, and minimal referencing so it is easy to paste into HTML.
Over the past five years, one of the most consequential developments in genomics policy has been the emergence of state biomarker coverage mandates, now active in roughly twenty states. These laws generally require private insurers to cover biomarker testing when supported by FDA labeling, Medicare coverage, or nationally recognized clinical guidelines. Increasingly, state insurance departments are issuing bulletins clarifying how insurers must implement those mandates.
Four recent bulletins—[ARIZONA], [GEORGIA], [LOUISIANA], and [OKLAHOMA]—illustrate how this second phase of enforcement is unfolding.
General Structure
All four states interpret similar statutory language. Coverage is required for biomarker testing used for diagnosis, treatment, appropriate management, or ongoing monitoring when clinical utility is demonstrated by medical and scientific evidence. The qualifying evidence categories typically include:
FDA-approved or cleared labeled indications
Tests indicated for FDA-approved drugs
FDA drug label warnings or precautions
CMS National Coverage Determinations (NCDs)
Medicare Administrative Contractor Local Coverage Determinations (LCDs)
Nationally recognized clinical practice guidelines
The similarities are striking. But the tone and regulatory posture differ meaningfully.
[ARIZONA]: Compliance Warning and Policy Correction
The [ARIZONA] bulletin reads as corrective. The Department observed, largely through appeals, that insurers were denying biomarker testing based on utilization review policies or “investigational” classifications that had not been updated after passage of the statute.
The key message in [ARIZONA] is straightforward:
Insurers may not rely on outdated internal guidelines.
Insurers may not impose additional criteria beyond the statute.
Denials must specifically address statutory elements of clinical utility.
Policies must explicitly reflect the biomarker law’s requirements.
Arizona’s approach is enforcement-driven. It signals that regulators are reviewing appeal records and expect documentation demonstrating why a denial complies with statutory clinical utility standards.
[GEORGIA]: Operational Guidance and Concrete Examples
The [GEORGIA] bulletin is the most operationally detailed. In addition to restating statutory requirements, the Commissioner includes a non-exhaustive table of example test categories that meet coverage thresholds, tied to Medicare and guideline sources.
Examples include:
Comprehensive Genomic Profiling (NCD 90.2 / NCCN)
Liquid biopsy in lung cancer (MolDx LCD)
Minimal Residual Disease testing (MolDx LCDs such as Signatera/Guardant)
Pharmacogenomics (DPYD, TPMT, CYP2C19)
Hereditary cancer panels (NCCN / LCD references)
MGMT promoter methylation for glioblastoma
This is unique among the four states. While not formal coverage determinations, the inclusion of specific MolDx-referenced examples strongly signals regulatory expectations. In effect, [GEORGIA] aligns commercial insurer obligations with Medicare oncology policy.
The bulletin also requires coverage to be provided in a manner that limits disruption in care, including avoiding multiple biopsies or redundant specimen collection.
[LOUISIANA]: Legal Clarification and “Least Restrictive” Standard
[LOUISIANA] offers the most analytically detailed interpretation of “clinical utility.” It explicitly clarifies several important points:
Clinical utility is demonstrated if any one statutory category of evidence is satisfied.
Insurers may not require multiple categories of evidence.
If more than one category applies, insurers must apply the least restrictive coverage criteria.
Insurers may not impose additional criteria beyond what is in the statute or referenced LCD/FDA labeling.
The “least restrictive” principle is especially important. For example, if FDA labeling is broader than a particular LCD, the insurer must follow the broader FDA-labeled indication.
[LOUISIANA] also emphasizes limiting disruption in care and avoiding multiple biopsies.
This is a strong constraint on payer discretion and significantly narrows the ability of insurers to rely on internal medical policies that are more restrictive than federal references.
[OKLAHOMA]: Structured Clarification Mirroring Louisiana
[OKLAHOMA] closely parallels the Louisiana framework, offering four structured clarifications:
Any one statutory category of evidence is sufficient.
Insurers may not require multiple evidence categories.
The least restrictive applicable criteria must govern.
Insurers may not apply additional or different standards beyond statute.
Like Louisiana and Georgia, Oklahoma also emphasizes that coverage must limit disruption in care, including avoiding repeated biopsies or biospecimen collection.
The Oklahoma bulletin reinforces that medical policies must explicitly state that the biomarker law governs and prevails over broader or conflicting policy language.
Key Themes Across the Four States
Across these four states, several themes emerge:
Clinical utility is legislatively defined. It is no longer solely a payer medical policy construct.
Medicare coverage (NCDs/LCDs) is effectively incorporated into state-regulated commercial insurance.
FDA labeling is an independent qualifying basis for coverage.
Insurers may not layer on additional criteria.
In Louisiana and Oklahoma, the least restrictive qualifying evidence standard must apply.
Disruption-of-care language supports comprehensive testing strategies over stepwise payer gatekeeping.
The convergence is notable. These states are not merely requiring coverage of biomarker testing in theory—they are actively policing how insurers interpret clinical utility.
Policy Implications
Taken together, these bulletins represent the second stage of biomarker mandate implementation.
The first stage was legislative enactment. The second stage is regulatory clarification and enforcement.
What we are seeing is a structural shift:
Private coverage in state-regulated markets is increasingly tethered to Medicare oncology policy.
Internal payer “investigational” designations cannot override statutory clinical utility standards.
FDA labeling and guideline inclusion now carry direct commercial coverage consequences.
[GEORGIA] goes furthest operationally by listing MolDx categories as compliant examples.
[LOUISIANA] and [OKLAHOMA] go furthest doctrinally by imposing the least restrictive standard.
[ARIZONA] goes furthest from an enforcement perspective by flagging appeals-based noncompliance.
For stakeholders in genomics, CGP, MRD, and pharmacogenomics, these bulletins signal that biomarker mandates are not symbolic. They are becoming real regulatory guardrails on commercial payer behavior.
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EXTRAS - SIDEBARS
ERISA Carve-Outs (Concise)
These state biomarker mandates apply to state-regulated commercial insurance plans. They generally do not apply to large employer self-funded plans governed by ERISA, which are federally regulated and largely exempt from state insurance mandates.
That means:
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Fully insured plans sold in the state must comply.
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State employee plans typically must comply (as specified in statute).
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Large employer self-funded ERISA plans are generally outside state jurisdiction.
In practice, this creates a two-tier landscape. Many mid-size and small employer plans are subject to the mandate, while some of the largest national employers operating self-funded plans may not be. However, ERISA plans often track commercial policy trends voluntarily, particularly when Medicare and major guideline bodies support coverage.
Pricing: What If Everything Is Covered at $1?
Coverage mandates do not regulate reimbursement rates.
In theory, a payer could comply with a biomarker mandate—approve coverage for CGP, MRD, PGx, etc.—and reimburse each test at a nominal amount, say $1. That would satisfy the coverage obligation while functionally undermining access.
Three practical constraints limit that scenario:
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Network Adequacy and Contracting Reality
Laboratories are not required to contract at unsustainable rates. If reimbursement is nominal, labs may decline network participation, forcing plans into out-of-network payment disputes or access complaints. -
Market Benchmarking
When statutes tether coverage to Medicare NCDs/LCDs or FDA labeling, commercial pricing pressure tends to reference Medicare’s CLFS rates as a de facto floor. While not legally binding, Medicare pricing creates a powerful anchor. -
Good Faith and Regulatory Oversight
State regulators can scrutinize reimbursement practices if they effectively nullify a mandated benefit. While statutes focus on coverage, persistent token pricing could trigger complaints or broader unfair practice scrutiny.
So coverage mandates solve one axis of access—eligibility—but not the second axis—payment adequacy.
In genomics policy terms:
Mandates address “yes/no.”
Pricing determines whether the answer is economically meaningful.
