off_label_drug_use_policy
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Defines BCBSRI coverage for off-label uses of prescription drugs per Rhode Island General Law Chapter 27-55, including required recognition by standard compendia or medical literature for cancer or disabling or life‑threatening chronic disease; exclusions for unapproved, contraindicated, or experimental drugs; and related dispute/advisory processes.
Policy documents coverage per Rhode Island General Law Chapter 27-55 and states service is covered for all BCBSRI members.
Coverage Summary
Rhode Island law (§27-55) mandates coverage of off-label uses of prescription drugs for the treatment of cancer or a disabling or life‑threatening chronic disease when the drug is recognized for that indication in one of the standard reference compendia or in the medical literature. The law also requires that the prescribing physician submit documentation supporting the proposed off‑label use if requested by the insurer. Scope: BCBSRI implements this statute to define coverage for off‑label uses of prescription drugs for the specified conditions, including recognition requirements by compendia or medical literature, exclusions for unapproved/contraindicated/experimental drugs, and processes for advisory review and dispute referral.
Medical Necessity Criteria
Coverage for off-label drug use (Section 27-55-2)
Covered when ALL of the following are met:
ALL of the following
- Drug is used for treatment of cancer or a disabling or life-threatening chronic disease.
- Drug is approved/licensed by the FDA for at least one indication (definition section).
ALL of the following
ONE of
- Recognized in one of the standard reference compendia (United States Pharmacopoeia drug information; American Medical Association drug evaluations; American Hospital Formulary Service drug information).
- Supported by medical literature (published scientific studies in at least two articles from major peer-reviewed medical journals presenting data supporting the proposed off-label use as generally safe and effective unless clear and convincing contradictory evidence exists).At least two peer-reviewed articles
- Prescribing physician must submit documentation supporting the proposed off-label use if requested by the insurer.
Exclusions (coverage NOT required if ANY apply)
- Drug has not been fully licensed or approved by the FDA.
- Use of the drug has been determined by the FDA to be contraindicated.
- Drug is experimental and not approved for any indication by the FDA.
Associated services
Coverage includes associated services when drug coverage is required:
ALL of the following
- Coverage of a drug that serves as the primary treatment required by this chapter also includes medically necessary services associated with administration of the drug.
Definitions & Evidence
Drug: Any substance prescribed by a licensed health‑care provider intended for use in the diagnosis, mitigation, treatment or prevention of disease that is taken orally, 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 in at least two (2) articles from major peer‑reviewed medical journals that present data supporting the proposed off‑label use as generally safe and effective unless clear and convincing contradictory evidence is presented in a major peer‑reviewed medical journal.
Standard reference compendia: The statute defines this as one of: (i) United States Pharmacopoeia drug information, (ii) American Medical Association drug evaluations, or (iii) American Hospital Formulary Service drug information.
Rhode Island General Laws establish the off‑label coverage requirement (Section 27-55-2) and set out associated provisions. The statute mandates coverage for off‑label uses for cancer or disabling or life‑threatening chronic disease when recognized in a standard compendium or the medical literature, requires physician documentation on request, and includes coverage for medically necessary services associated with administration when the drug is the primary treatment.
The law (Section 27-55-3) requires the director of the Department of Health to appoint an advisory panel of seven medical experts to make recommendations on medical appropriateness when a dispute about payment for a particular off‑label use is referred to the director. Parties seeking review of a denial must refer the dispute in writing to the director within thirty (30) days of the denial.
The statute also specifies exclusions where coverage is not required: drugs not fully licensed or approved by the FDA, uses the FDA has determined to be contraindicated, and experimental drugs not approved for any indication.
Provider Actions
Physician documentation for off-label use
Prescribing physicians must submit documentation supporting the proposed off-label use when requested by the insurer. The documentation should reference one of the specified standard reference compendia (United States Pharmacopoeia drug information; American Medical Association drug evaluations; American Hospital Formulary Service drug information) or provide medical literature consisting of at least two articles from major peer‑reviewed medical journals that present data supporting the proposed off‑label use as generally safe and effective.
- Reference a standard compendium OR at least two peer‑reviewed journal articles.
- Peer‑reviewed articles must meet the statute's definition (major peer‑reviewed medical journals).
Denial conditions (exclusions that may lead to claim denial)
Claims may be denied (no coverage required) if any of the following apply: the drug has not been fully licensed or approved by the FDA; the FDA has determined the use to be contraindicated; or the drug is experimental and not approved for any indication by the FDA.
- Not FDA‑approved for any indication (fully licensed/approved).
- FDA‑determined contraindicated use.
- Experimental drug not approved for any indication.
Dispute referral to state health director
If coverage is denied, parties may refer the dispute in writing to the Director of the Rhode Island Department of Health within 30 days of the denial. The Director may convene an advisory panel of seven medical experts to make recommendations on whether the particular off‑label use is medically appropriate.
- Written referral to the Director must be submitted within 30 days of the denial.
- An advisory panel of seven licensed Rhode Island physicians may be convened to advise on medical appropriateness.
Coding
| No codes listed |
Revision History
Provider Updates listed through November 2021; no clinical policy changes indicated in document.
Policy last updated (document last reviewed).
Policy effective date per document header.
Rhode Island statutory provisions (Sections 27-55-1 and 27-55-2) cited in the policy marked effective January 1, 2017, defining coverage requirements and definitions for off-label drug use.
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