Section 47K Off-label drug use; cancer treatment - Massachusetts Statutes

Section 47K. No individual policy of accident and sickness insurance issued pursuant to section one hundred and eight which provides coverage for prescription drugs, nor any group blanket policy of accident and sickness insurance issued pursuant to section one hundred and ten which provides coverage for prescription drugs, shall exclude coverage of any such drug used for the treatment of cancer on the grounds that the off-label use of the drug has not been approved by the United States Food and Drug Administration for that indication; provided, however, that such drug is recognized for treatment of such indication in one of the standard reference compendia, or in the medical literature, or by the commissioner under the provisions of section forty-seven L.

Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.

This section shall not be construed to alter existing law with regard to provisions limiting the coverage of drugs that have not been fully licensed or approved by the United States Food and Drug Administration nor shall this section create an exclusionary presumption or inference concerning other appropriate medically accepted indications.

This section shall not be construed to require coverage for any drug when the United States Food and Drug Administration has determined its use to be contraindicated for cancer.

This section shall not be construed to require coverage for experimental drugs not otherwise approved for any indication by the United States Food and Drug Administration.

For the purpose of this section, and section forty-seven L, the following words shall have the following meanings unless the context clearly requires otherwise:—

“Medical literature”, published scientific studies appearing in any peer-reviewed national professional journal.

“Off-label use”, a prescription drug used in the treatment of cancer which has been approved by the United States Food and Drug Administration and such drug is used for indications other than those approved by said Food and Drug Administration.

“Standard reference compendia”, (a) the United States Pharmacopoeia Drug Information; (b) the American Medical Association Drug Evaluations; or (c), the American Hospital Formulary Service Drug Information.