Internal prototype — noindexed, not linked from public navigation yet.

Md. Code, Insurance § 15-804

This is the official text of Md. Code, Insurance § 15-804, part of Maryland’s Code, Insurance — regulates insurance companies and the policies they sell.

Not legal advice. This page reproduces the official text of a government statute for reference only. Laws change, and how a statute applies depends on your specific facts. For advice about your situation, consult a licensed attorney in your state.

§15–804.

Official statutory text

(a) (1) In this section the following words have the meanings indicated.

(2) “Medical literature” means scientific studies published in a peer–reviewed national professional medical journal.

(3) “Off–label use” means the prescription of a drug for a treatment other than those treatments stated in the labeling approved by the federal Food and Drug Administration.

(4) “Standard reference compendia” means any authoritative compendia as recognized periodically by the federal Secretary of Health and Human Services or the Commissioner.

(b) This section does not:

(1) alter any law that limits the coverage of drugs that have not been approved by the federal Food and Drug Administration;

(2) require coverage of a drug if the federal Food and Drug Administration has determined use of the drug to be contraindicated; or

(3) require coverage of experimental drugs not approved for any indication by the federal Food and Drug Administration.

(c) (1) This subsection applies to each health insurance policy or contract that is delivered or issued for delivery in the State to an employer or individual on a group or individual basis, including a contract issued by a health maintenance organization.

(2) A policy or contract subject to this subsection that provides coverage for drugs may not exclude coverage of a drug for an off–label use of the drug if the drug is recognized for treatment in any of the standard reference compendia or in the medical literature.

(3) Coverage of a drug required by this subsection also includes medically necessary services associated with the administration of the drug.

(d) The Commissioner may direct a person, including a health maintenance organization, that issues a health insurance policy or contract to make payments required by this section.

Status: in_force · Read it on the official government site

Need a lawyer in Maryland?

Find a Maryland lawyer
About this page: Statute text is reproduced from official government publishers via the Open US Law dataset (Vaquill AI, snapshot v2026.08, CC BY 4.0). Primary legislative text like this is public domain under the government-edicts doctrine (Georgia v. Public.Resource.Org, 2020). We link every section back to its official source so you can verify it independently.