Connecticut § 38a-542b Clinical trial criteria.

Connecticut Statutes

§ 38a-542b — Clinical trial criteria.

Connecticut·Title 38a Insurance·Ch. 700c Health Insurance

A clinical trial for the prevention of cancer shall be eligible for coverage only if it involves a therapeutic intervention, is a phase III clinical trial approved by one of the entities identified in this section, and is conducted at multiple institutions. In order to be eligible for coverage of routine patient care costs, as defined in section 38a-542d, a clinical trial shall be (1) conducted under the auspices of an independent peer-reviewed protocol that has been reviewed and approved by:

(A)One of the National Institutes of Health;

(B)a National Cancer Institute affiliated cooperative group;

(C)the federal Food and Drug Administration as part of an investigational new drug or device application or exemption; or (D) the federal Department of Defense or Veterans Affairs; or (2) quali

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A clinical trial for the prevention of cancer shall be eligible for coverage only if it involves a therapeutic intervention, is a phase III clinical trial approved by one of the entities identified in this section, and is conducted at multiple institutions. In order to be eligible for coverage of routine patient care costs, as defined in section 38a-542d, a clinical trial shall be (1) conducted under the auspices of an independent peer-reviewed protocol that has been reviewed and approved by: (A) One of the National Institutes of Health; (B) a National Cancer Institute affiliated cooperative group; (C) the federal Food and Drug Administration as part of an investigational new drug or device application or exemption; or (D) the federal Department of Defense or Veterans Affairs; or (2) qualified to receive Medicare coverage of its routine costs under the Medicare Clinical Trial Policy established under the September 19, 2000, Medicare National Coverage Determination, as amended from time to time. Nothing in sections 38a-542a to 38a-542g, inclusive, shall be construed to require coverage for any single institution clinical trial conducted solely under the approval of the institutional review board of an institution, or any trial that is no longer approved by an entity identified in subparagraph (A), (B), (C) or (D) of subdivision (1) of this section. See Sec. 38a-504b for similar provisions re individual policies.

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Legislative History

(P.A. 01-171, S. 2, 25; P.A. 11-19, S. 63; P.A. 11-172, S. 9.) History: P.A. 01-171 effective January 1, 2002; P.A. 11-19 added provision limiting eligibility of clinical trial for the prevention of cancer, effective January 1, 2012; P.A. 11-172 replaced references to cancer clinical trial with references to clinical trial, designated existing clinical trial criteria as Subdiv. (1) and amended same to insert “application or” re investigational new drug or device, added Subdiv. (2) re Medicare qualification, and made technical changes, effective January 1, 2012.