CurrentPremera BluecrossPolicy N/A

Right-to-Try Laws and Coverage of Services

Administrative guideline describing how Premera Blue Cross medical benefit plans treat member requests to use investigational products under state or federal Right-to-Try laws, and the related coverage implications for providers and members.

Policy Summary

PayerPremera Bluecross

PolicyRight-to-Try Laws and Coverage of Services

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr. 1, 2026

Next Review DateN/A

Key ActionObtain required informed consent and document patient eligibility when pursuing investigational products under Right-to-Try statutes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

WA, AKStates with specific discussion

41+States passed Right-to-Try

ExcludedContractual stance

AllowedEUA coverage

Apr 1 2026Last review

Coverage determinations and scope

Coverage Determinations

Coverage stance summary:

Contractual exclusion of investigational products: Investigational drugs, devices, and services that are not FDA-approved are contractually excluded from coverage.

Except as noted for EUA and emergency benefits for life‑threatening complications.

Situations where coverage may apply: Complications from investigational products may be covered if life‑threatening or emergent; EUA‑approved products may be temporarily covered for FDA‑specified indications and time periods.

Member contracts exclude coverage for investigational drugs, biological products, devices, and services that are not approved by the U.S. Food and Drug Administration (FDA). Related services provided to administer an investigational product are likewise contractually excluded as they are associated with a non‑covered drug, biological product, or device. Complications that arise from non‑covered investigational treatments are generally excluded from coverage as well, except when the complication is life‑threatening or emergent and covered under emergency benefits.

Although investigational products themselves are not covered, there are limited circumstances in which related care may be paid. Complications of investigational treatments may be covered if they meet criteria for emergency benefits (for example, when the complication is life‑threatening), and products authorized by the FDA under an Emergency Use Authorization (EUA) may be covered on a temporary basis for the FDA‑specified indication and time period.

Policy Summary

PayerPremera Bluecross

PolicyRight-to-Try Laws and Coverage of Services

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr. 1, 2026

Next Review DateN/A

Key ActionObtain required informed consent and document patient eligibility when pursuing investigational products under Right-to-Try statutes.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

What providers must do and denial risks

Prior Authorization

Authorization for investigational products — authorization policy and exceptions

Prior authorization may be required for use of investigational products where coverage is considered; however, most member contracts exclude investigational drugs, devices, and services. Check the member's contract and submit authorization requests with full clinical justification when applicable.

Verify member contract for investigational exclusions before initiating treatment.
If prior authorization is requested, provide detailed clinical rationale, trial phase/status, and any supporting literature.
Note: Emergency Use Authorizations (EUA) may be temporarily covered per FDA indication and timeframe.

Note

Consideration of approved treatments

Consideration of FDA‑approved treatment options is required by some state statutes before offering investigational products. Document that all FDA‑approved alternatives were discussed and considered with the patient.

Document discussion of all FDA‑approved treatment options and why they were not appropriate or acceptable.
Include evidence the patient is ineligible or unable to participate in a relevant clinical trial when applicable.

Documentation Required

Informed consent and eligibility documentation

Obtain and retain written informed consent and document eligibility per applicable state Right‑to‑Try or terminal‑illness statutes. Include specific elements required by state law and clinical justification for investigational use.

Written informed consent signed by the patient that meets state statutory requirements.
Documentation of terminal or serious life‑threatening condition and that investigational product has completed at least phase 1 where required (WA).
Record of manufacturer communication if product provision was requested and any written notices of immunity provided to the patient (AK).
Clinical notes showing consideration of FDA‑approved options and ineligibility for clinical trials when applicable.

Denial Risk

Denial triggers for investigational products

Coverage may be denied for investigational products for several reasons; providers should understand common denial triggers to reduce risk of claim denial.

Contractual exclusion: product not FDA‑approved for the indication or at all.
Lack of documented informed consent or missing state‑required eligibility documentation.
Failure to document that FDA‑approved alternatives were considered (where required by state law).
Complications of investigational product use may be excluded unless emergent life‑threatening complications meet emergency benefit criteria.
No evidence of prior authorization or insufficient clinical justification when authorization was required.

Key definitions

inv-09: Emergency Use Authorization — definition and relevance to coverage

DefinitionEmergency Use Authorization (EUA): FDA mechanism that allows unapproved medical products or unapproved uses of approved products to be used during a public health emergency to diagnose, treat, or prevent serious or life‑threatening diseases or conditions when no adequate, approved, and available alternatives exist.

When it appliesDuring declared public health emergencies when there are no adequate, approved, and available alternatives.

Relevance to coverageEUA products may be temporarily allowed for FDA‑specified indications and time periods despite general contractual exclusions for investigational products.

inv-10: Investigational Product — definition and typical development stage references

DefinitionInvestigational Product: A drug, biological product, or device that has successfully completed phase one and is currently in a subsequent phase of an FDA‑approved clinical trial assessing safety under 21 U.S.C. Sec. 355.

Typical development stageCompleted phase I and enrolled in later phases of FDA‑approved clinical trials.

Coverage implicationMember contracts exclude investigational products that lack final FDA approval; exceptions are limited (e.g., EUA or emergent complications).

inv-11: Serious or immediately life‑threatening — definition used for eligibility/context

DefinitionSerious or immediately life‑threatening disease or condition: a stage of disease in which there is a reasonable likelihood that death will occur within six months or in which a premature death is likely without early treatment (from WA RCW 69.77).

Timeframe referenceDeath reasonably likely within six months without treatment.

Use in policyDetermines eligibility/context for Right‑to‑Try access and for considering emergent coverage of complications under emergency benefits.

Policy background and scope

Right‑to‑Try laws allow eligible patients with serious, life‑threatening, or terminal illnesses to request access to investigational drugs, biologics, or devices that have completed at least phase one of FDA testing but lack final FDA approval. These statutes aim to provide an avenue for patients who are unable to participate in clinical trials to pursue investigational options and may include requirements such as documented informed consent and eligibility verification under state law.

From a benefits perspective, Premera treats requests under Right‑to‑Try consistent with member contract language: investigational products that do not have FDA approval are contractually excluded from coverage, complications from such non‑covered services are generally excluded except when life‑threatening or emergent, and FDA EUA‑authorized products may be considered for temporary coverage for the FDA‑specified indication and time period.

OpenPayer

Right-to-Try Laws and Coverage of Services

Coverage determinations and scope

Billing and coding references

What providers must do and denial risks

Key definitions

Facility and site considerations

Policy background and scope