Connecticut General Statutes|Sec. 38a-518b. Coverage for certain off-label drug prescriptions.

                                                

Sec. 38a-518b. Coverage for certain off-label drug prescriptions. (a)(1) Each group health insurance policy delivered, issued for delivery, renewed, amended or continued in this state, that provides coverage for prescription drugs approved by the federal Food and Drug Administration for treatment of certain types of cancer or disabling or life-threatening chronic diseases, shall not exclude coverage of any such drug on the basis that such drug has been prescribed for the treatment of a type of cancer or a disabling or life-threatening chronic disease for which the drug has not been approved by the federal Food and Drug Administration, provided the drug is recognized for treatment of the specific type of cancer or a disabling or life- threatening chronic disease for which the drug has been prescribed in one of the following established reference compendia or in peer-reviewed medical literature generally recognized by the relevant medical community: (A) The U.S. Pharmacopoeia Drug Information Guide for the Health Care Professional; (B) The American Medical Association's Drug Evaluations; or (C) The American Society of Health-System Pharmacists' American Hospital Formulary Service Drug Information. As used in this section, “peer-reviewed medical literature” means a published study in a journal or other publication in which original manuscripts have been critically reviewed for scientific accuracy, validity and reliability by unbiased international experts, and that has been determined by the International Committee of Medical Journal Editors to have met its Uniform Requirements for Manuscripts Submitted to Biomedical Journals. “Peer-reviewed medical literature” does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or any health insurer, health care center, hospital service corporation, medical service corporation or fraternal benefit society that delivers, issues for delivery, renews, amends or continues a health insurance policy in this state.


(2) The coverage required under subdivision (1) of this subsection shall include medically necessary services associated with the administration of such drug.


(3) A drug use covered under subdivision (1) of this subsection shall not be denied based on medical necessity except for reasons that are unrelated to the legal status of the drug use.


(b) Nothing in subsection (a) of this section shall be construed to require coverage for (1) any drug used in a research trial sponsored by a drug manufacturer or a government entity, (2) any drug or service furnished in a research trial if the research trial sponsor furnishes the drug or service to an insured participating in such trial without charge, or (3) any drug that the federal Food and Drug Administration has determined to be contraindicated for treatment of the specific type of cancer or a disabling or life-threatening chronic disease for which the drug has been prescribed.


(c) Except as specified, nothing in this section shall be construed to create, impair, limit or modify authority to provide reimbursement for drugs used in the treatment of any other disease or condition.


(P.A. 94-49, S. 1; P.A. 11-19, S. 40; 11-172, S. 16; June Sp. Sess. P.A. 15-5, S. 470.)


See Sec. 38a-492b for similar provisions re individual policies.


History: P.A. 11-19 amended Subsec. (a) to add “amended or continued” and make technical changes, effective January 1, 2012; P.A. 11-172 amended Subsec. (a) to add “amended or continued”, add provisions re disabling or life-threatening chronic disease and make technical changes, amended Subsec. (b) to add provision re disabling or life-threatening chronic disease and amended Subsec. (c) to add “Except as specified”, effective January 1, 2012; June Sp. Sess. P.A. 15-5 amended Subsec. (a) by designating existing provisions re coverage for off-label prescriptions as Subdiv. (1) and amending same to add provisions re peer-reviewed medical literature, and adding Subdivs. (2) and (3) re coverage for medically necessary services and denial of drug use for reasons unrelated to legal status of the drug use, and amended Subsec. (b) by deleting “experimental or investigational drugs or”, designating existing provision re drug that Food and Drug Administration has determined to be contraindicated as Subdiv. (3), and adding Subdivs. (1) and (2) re drug used in research trial sponsored by drug manufacturer or government entity and drug or service furnished in research trial if sponsor furnishes drug or service without charge, and made technical and conforming changes, effective January 1, 2016.

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