CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Off-label prescription drug coverage (Rhode Island General Law Chapter 27-55)

Defines coverage requirements and limits for off-label uses of prescription drugs for treatment of cancer or disabling or life-threatening chronic disease per Rhode Island law; applies to BCBSRI members subject to benefit booklet and contract variations. Does not apply to drugs not FDA-approved, contraindicated uses, or experimental drugs.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOff-label prescription drug coverage (Rhode Island General Law Chapter 27-55)

Policy CodePolicy N/A

Change Typeclarified

Effective Date07/12/1994

Next Review Date

Key ActionPrescribing physician is responsible for submitting documentation supporting the proposed off-label use if requested by the issuer.

SourceLink

POLICY UPDATE CHANGES

Policy documents statutory coverage requirements under Rhode Island General Law Chapter 27-55 for off-label uses of prescription drugs.

1Primary Legal Source Cited (RI Chapter 27-55)

3Statutory Non‑coverage Categories

2Referenced Standard Reference Compendia (examples)

Coverage Summary

Scope: Defines coverage requirements and limits for off-label uses of prescription drugs for treatment of cancer or disabling or life‑threatening chronic disease per Rhode Island General Laws 27-55-2 and applies to Blue Cross & Blue Shield of Rhode Island (BCBSRI) members, subject to group/contract variations and benefit booklets. Effective date: 07/12/1994. Policy status: CURRENT (policy last updated 11/19/2019).

Statutory Exclusions (No Coverage Required)

Exclusions: Coverage is not 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. Coverage under this statute is limited to treatment of cancer or a disabling or life‑threatening chronic disease and must be recognized in one of the standard reference compendia or in the medical literature as defined by the law.

Provider Actions & Administrative Requirements

Documentation Required

Physician documentation may be requested

Prescribing physician is responsible for submitting documentation supporting the proposed off-label use if requested by the issuer.

Denial Risk

Coverage limited to specific clinical scope

Claims for off-label uses outside treatment of cancer or disabling or life‑threatening chronic disease, for unapproved/experimental drugs, or for FDA‑contraindicated uses may be denied.

Billing Rule

Benefits vary by contract

Benefits and coverage may vary between groups/contracts; refer to the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement; self-funded groups may opt out of state mandates.

Note

Dispute referral process

Parties may refer disputes about payment for an off-label use to the Rhode Island Department of Health director within 30 days of denial; an advisory panel will make recommendations regarding whether the particular off-label use is medically appropriate.

Definitions & Background

Background: Rhode Island General Laws 27-55-2 mandates coverage of off-label uses of prescription drugs for treatment of cancer or disabling or life‑threatening chronic disease when the off-label use is recognized in standard compendia or the medical literature. The statute establishes an advisory panel appointed by the director of the Department of Health to make recommendations when payment disputes are referred to the director; parties must refer disputes within 30 days of denial. This requirement is implemented for BCBSRI members, although benefits may vary by group/contract and self-funded groups may opt out of state mandates.

Term	Definition
Drug	Any substance prescribed by a licensed health-care provider intended for use in the diagnosis, mitigation, treatment or prevention of disease and taken by mouth, injected into muscle, the skin, a blood vessel or cavity of the body, applied to the skin, or otherwise assimilated by the body; includes only those substances that are approved by the FDA for at least one indication.
Medical literature	Published scientific studies in at least two articles from major peer-reviewed medical journals 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.
Standard reference compendia	Includes United States Pharmacopeia Drug Information, American Medical Association Drug Evaluations, and American Hospital Formulary Service information.

Revision History

1994-07-12effective_date

Policy effective date per document header.

2019-11-19last_reviewLatest

Policy last updated per document header.

clarification

Document collates Rhode Island General Law Chapter 27-55 statutory language and applies it to BCBSRI members; no clinical policy statement changes noted in header.