CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Off-Label Use of Prescription Drugs

Policy describing BCBSRI coverage requirements for off-label uses of prescription drugs as mandated by Rhode Island General Law Chapter 27-55; applies to BCBSRI members and notes potential variations by group contracts.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOff-Label Use of Prescription Drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 12, 1994

Next Review DateN/A

Key ActionPrescribing physician should submit documentation supporting the proposed off-label use if requested by the issuer.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

RI G.L. 27-55-2Governing statute cited

All membersMember applicability

Not requiredPrior authorization

Not applicableInternal criteria

Statutory Coverage Conditions

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Statutory coverage conditions: 1) Drug is used for treatment of cancer or a disabling or life‑threatening chronic disease; 2) Drug is FDA‑approved for at least one indication; 3) The proposed off‑label use is recognized for that indication in a standard reference compendium or in the medical literature; 4) The prescribing physician provides documentation supporting the proposed off‑label use if requested by the issuer.

Coverage subject to applicable benefit booklet/contract terms; self‑funded groups may choose not to follow state mandates.

No coverage is required for drugs that are not fully licensed or approved by the FDA, for uses the FDA has determined to be contraindicated, or for experimental drugs not approved for any indication by the FDA. This limitation reflects the statutory exclusions in Rhode Island G.L. 27-55-2 and applies specifically to the off-label coverage mandate for drugs used to treat cancer or disabling or life‑threatening chronic disease.

Provider Responsibilities and Authorization

Prior Authorization

Prior authorization is not required by this policy.

Note

Group-level Variations

Benefits may vary between groups or contracts. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable pharmacy/drug benefits and coverage. Self-funded groups may choose not to follow state mandates.

Documentation Required

Physician Documentation Responsibility

It is the responsibility of the prescribing physician to submit documentation supporting any proposed off‑label use when requested by the insurer.

Denial Risk

Statutory Denial Conditions

Coverage may be denied when: (1) the drug has not been fully licensed or approved by the U.S. Food and Drug Administration (FDA); (2) the FDA has determined the requested use to be contraindicated; or (3) the drug is experimental or not approved by the FDA for any indication. Nothing in this section limits application of contractual deductibles, copayments, or managed care review.

Key Definitions and References

Drug — statutory definition

Statutory definition'Drug' means any substance prescribed by a licensed health‑care provider acting within the scope of the provider's license intended for use in diagnosis, mitigation, treatment, or prevention of disease and taken by mouth, injected, applied to the skin, or otherwise assimilated by the body; includes only substances approved by the FDA for at least one indication.

Prescriber scopeMust be prescribed by a licensed health‑care provider acting within the scope of the provider's license.

Routes of administrationOral, intramuscular, transdermal, intravenous, topical, or otherwise assimilated by the body as specified in the statute.

FDA approval requirementIncludes only substances that are approved by the FDA for at least one indication.

Standard reference compendia

Accepted compendia (1)United States Pharmacopeia Drug Information.

Accepted compendia (2)American Medical Association drug evaluations.

Accepted compendia (3)American Hospital Formulary Service information.

Medical literature / Peer‑reviewed medical journals — statutory criteria

Medical literature requirement'Medical literature' means published scientific studies in at least two articles from major peer‑reviewed medical journals.

Peer‑review standard'Peer‑reviewed medical journals' are publications where original manuscripts are critically reviewed by unbiased independent experts and meet the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts.

ExclusionsDoes not include publications or supplements sponsored to a significant extent by a pharmaceutical manufacturer or any health insurer.

Policy Background

Rhode Island law (G.L. 27-55-2) requires that insurers not exclude coverage of a drug used to treat cancer or a disabling or life‑threatening chronic disease solely because the drug is not approved by the FDA for that specific indication, provided the off‑label use is recognized in a standard reference compendia or in the medical literature. The statute also states that the prescribing physician must provide documentation supporting the proposed off‑label use if requested by the insurer, and that coverage for a drug serving as the primary treatment includes medically necessary services associated with its administration.

Step Therapy and Benefit Variations

Group / Contract	Effect on Step Therapy / Coverage Sequencing
State‑mandated plans (fully insured)	Subject to Rhode Island statute; step‑therapy requirements must follow state coverage mandate for off‑label uses when applicable.
Self‑funded groups	May choose not to follow state mandates; benefits and step‑therapy sequencing can differ from the state‑mandated coverage — refer to the group’s benefit booklet or subscriber agreement.
All groups — member action	Refer to the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for specific pharmacy/drug benefit terms and step‑therapy requirements.