Bill Text: CT SB00418 | 2015 | General Assembly | Comm Sub
Bill Title: An Act Concerning Off-label Prescription Drugs.
Spectrum: Committee Bill
Status: (Engrossed - Dead) 2015-05-29 - House Calendar Number 646 [SB00418 Detail]
Download: Connecticut-2015-SB00418-Comm_Sub.html
General Assembly |
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January Session, 2015 |
*_____SB00418APP___051215____* |
AN ACT CONCERNING OFF-LABEL PRESCRIPTION DRUGS.
Be it enacted by the Senate and House of Representatives in General Assembly convened:
Section 1. Section 38a-492b of the general statutes is repealed and the following is substituted in lieu thereof (Effective January 1, 2016):
(a) (1) Each individual health insurance policy delivered, issued for delivery, renewed, amended or continued in this state, that provides coverage for [prescribed] 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: [(1)] (A) The U.S. Pharmacopoeia Drug Information Guide for the Health Care Professional; [(USP DI); (2)] (B) The American Medical Association's Drug Evaluations; [(AMA DE); or (3)] or (C) The American Society of [Hospital] Health-System Pharmacists' American Hospital Formulary Service Drug Information. [(AHFS-DI).] 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 [experimental or investigational drugs or] 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 [which] that the federal Food and Drug Administration has determined to be contraindicated for treatment of the specific type of cancer or 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.
Sec. 2. Section 38a-518b of the general statutes is repealed and the following is substituted in lieu thereof (Effective January 1, 2016):
(a) (1) Each group health insurance policy delivered, issued for delivery, renewed, amended or continued in this state, that provides coverage for [prescribed] 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: [(1)] (A) The U.S. Pharmacopoeia Drug Information Guide for the Health Care Professional; [(USP DI); (2)] (B) The American Medical Association's Drug Evaluations; [(AMA DE); or (3)] or (C) The American Society of [Hospital] Health-System Pharmacists' American Hospital Formulary Service Drug Information. [(AHFS-DI).] 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 [experimental or investigational drugs or] 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 [which] 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.
This act shall take effect as follows and shall amend the following sections: | ||
Section 1 |
January 1, 2016 |
38a-492b |
Sec. 2 |
January 1, 2016 |
38a-518b |
APP |
Joint Favorable Subst. |