Section 47O HIV/AIDS treatment; insurance coverage for certain off-label use of prescription drugs - Massachusetts Statutes

Section 47O. No individual policy of accident and sickness insurance issued or renewed 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 for HIV/AIDS treatment on the grounds that the off-label use of the drug has not been approved by the federal food and drug administration for that indication, if 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 P of this chapter.

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 federal 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 federal food and drug administration has determined its use to be contraindicated.

This section shall not be construed to require coverage for experimental drugs not otherwise approved for any indication by the federal food and drug administration.

For the purpose of this section, and section forty-seven P, the following words shall have the following meanings:

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

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

“HIV/AIDS” means human immunodeficiency virus or acquired immunodeficiency syndrome.

“Off-label” means a drug that has not been specifically approved by the Federal food and drug administration for HIV/AIDS treatment but is a drug approved for other indications by the Federal food and drug administration.