CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

off_label_drug_coverage_policy

Defines Blue Cross & Blue Shield of Rhode Island coverage approach for off-label uses of prescription drugs as mandated by Rhode Island General Laws Chapter 27-55, including applicable definitions, exclusions, and administrative provisions; applies to BCBSRI members with variation by group contract and self-funded plans.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyoff_label_drug_coverage_policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateJul 12, 1994

Next Review Date

Key ActionPrescribing physician must submit documentation supporting the proposed off‑label use if requested by the insurer (statutory responsibility).

SourceLink

POLICY UPDATE CHANGES

Policy documents coverage under Rhode Island General Law Chapter 27-55 for off-label prescription drug uses; no internal medical criteria or prior authorization specified.

Cancer & disabling/life‑threatening chronic diseaseCovered Indications

3Statutory Exclusions

Std ref or ≥2 peer‑reviewed articlesEvidence Requirement

Coverage Summary

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This policy documents Blue Cross & Blue Shield of Rhode Island (BCBSRI) coverage for off‑label uses of prescription drugs as mandated by Rhode Island General Laws Chapter 27-55 and applies to off‑label treatment of cancer and disabling or life‑threatening chronic disease. Coverage and benefits may vary by group contract, and self‑funded groups may choose not to follow the state mandate. Effective date: 07/12/1994. Policy last reviewed/updated: 02/06/2018.

Key policy facts

Covered IndicationsStatutory coverage for cancer and disabling or life‑threatening chronic disease

Exclusions summary3 explicit statutory exclusions: not FDA‑approved, FDA‑contraindicated use, or experimental (not FDA‑approved for any indication)

Evidence requirementRecognition in a standard reference compendium (USP, AMA Drug Evaluations, AHFS) or ≥2 peer‑reviewed articles showing safety and effectiveness

Effective Date1994-07-12

Last Review2018-02-06

Statutory Coverage & Exclusions

Statutory Coverage Conditions (Section 27-55-2)

Covered when ALL of the following statutory conditions are met:

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Statutory Exclusions (Section 27-55-2)

Coverage is NOT required under this chapter when ANY of the following apply:

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Provider Actions & Administrative Requirements

Documentation Required

Physician documentation for off-label use

Prescribing physician must submit documentation supporting the proposed off‑label use if requested by the insurer (statutory responsibility).

Prior Authorization

Prior authorization applicability

No specific prior authorization requirement within this policy; benefits, preauthorization, and managed care review may still apply per contract/benefit booklet and employer group choices.

Denial Risk

Denial risk for non‑FDA approved drugs/experimental uses

Claims may be denied when the drug is not FDA‑approved, FDA‑contraindicated for the use, or experimental (not FDA‑approved for any indication).

Documentation Required

Standard reference or literature requirement

Off‑label use must be supported by recognition in a standard reference compendium (United States Pharmacopeia Drug Information; AMA Drug Evaluations; AHFS) or by at least two peer‑reviewed medical journal articles demonstrating safety and effectiveness, unless clear and convincing contradictory evidence exists.

Definitions & Background

Rhode Island General Laws 27-55 mandate coverage of off‑label uses of prescription drugs for the treatment of cancer and disabling or life‑threatening chronic disease when the off‑label use is recognized in one of the standard reference compendia or in the medical literature. The statute requires the prescribing physician to submit documentation supporting the proposed off‑label use if requested by the insurer, and coverage of a drug that serves as the primary treatment also includes medically necessary services associated with administration. The statute also establishes an advisory panel of seven medical experts to make recommendations to the director of the department of health when payment disputes are referred; disputes must be referred within 30 days of a coverage denial.

Drug: Any substance prescribed by a licensed health‑care provider acting within the scope of the provider's license intended for diagnosis, mitigation, treatment or prevention of disease that is taken by mouth, injected, applied to the skin, or otherwise assimilated by the body; the term includes only substances that are approved by the FDA for at least one indication.

Medical literature: Published scientific studies appearing in at least two (2) peer‑reviewed medical journal articles that present data supporting the proposed off‑label use as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer‑reviewed medical journal. Peer‑reviewed journals are those meeting the International Committee of Medical Journal Editors' uniform requirements and exclude publications or supplements substantially sponsored by a pharmaceutical manufacturer or any health insurer or health‑care center.

Standard reference compendia: The United States Pharmacopeia Drug Information; the American Medical Association Drug Evaluations; or the American Hospital Formulary Service Information.

Revision History

1994-07-12effective_date

Policy effective date (EFFECTIVE DATE: 07/12/1994).

2018-02-06last_reviewLatest

Policy last updated/reviewed (POLICY LAST UPDATED: 02/06/2018).

clarified (non-material)Latest

Policy documents coverage under Rhode Island General Law Chapter 27-55 for off-label prescription drug uses; no internal medical criteria or prior authorization specified. Note: benefits may vary by group and self-funded groups may opt out of state mandates (not marked as a material change).