P.R. Laws tit. 26, § 9984

2019-02-20 00:00:00+00
§ 9984. Standards of coverage

(a) A health plan that provides coverage for drugs shall provide for the dispensation of any drug covered, regardless of the disorder, injury, illness, condition, or disease for which they were prescribed, provided, that:

(1) The drug has been approved by the FDA for at least one indication, and

(2) the drug is recognized for treatment of the disorder, injury, illness, condition, or disease in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature.

(b) Coverage of a drug pursuant to this section shall also include medically necessary services associated with the administration of the drug.

(c) This section shall not be construed to require a health insurance organization or issuer to provide coverage for a drug when the FDA has determined its use to be contra-indicated for treatment of the current indication.

(d) The following drugs or services shall not be subject to coverage under subsection (a) of this section:

(1) Drugs that are used in research trials sponsored by their manufacturers or a government entity, or

(2) drugs or services furnished in a research trial, if the sponsor of the research trial furnishes the drugs or services without charge to any participant in the research trial.

History —Aug. 29, 2011, No. 194, added as § 52.040 on Aug. 23, 2012, No. 203, § 8, eff. 90 days after Aug. 23, 2012.