§ 38a-542f — Clinical trials: Standardized forms. Time frame for coverage determinations. Appeals. Regulations.

(a)(1) For purposes of cancer clinical trials, the Insurance Department, in cooperation with the Connecticut Oncology Association, the American Cancer Society, the Connecticut Association of Health Plans and Anthem Blue Cross of Connecticut, shall develop a standardized form that all providers, hospitals and institutions shall submit to the insurer or health care center when seeking to enroll an insured person in a cancer clinical trial. An insurer or health care center shall not substitute any other approval request form for the form developed by the department, except that any insurer or health care center that has entered into an agreement to provide coverage for cancer clinical trials approved pursuant to section 38a-542g may use the form or process established by such agreement. (2) For purposes of clinical trials other than cancer clinical trials, the Insurance Department, in cooperation with at least one state nonprofit research or advocacy organization concerned with the subject of the clinical trial, at least one national nonprofit research or advocacy organization concerned with the subject of the clinical trial, the Connecticut Association of Health Plans and Anthem Blue Cross of Connecticut, shall develop a standardized form that all providers, hospitals and institutions shall submit to the insurer or health care center when seeking to enroll an insured person in a clinical trial. An insurer or health care center shall not substitute any other approval request form for the form developed by the department, except that any insurer or health care center that has entered into an agreement to provide coverage for clinical trials approved pursuant to section 38a-542g , may use the form or process established by such agreement. (b) Any insurer or health care center that receives the department form from a provider, hospital or institution seeking coverage for the routine patient care costs of an insured person in a clinical trial shall approve or deny coverage for such services not later than five business days after receiving such request and any other reasonable supporting materials requested by the insurer or health plan pursuant to section 38a-542c , except that an insurer or health care center that utilizes independent experts to review such requests shall respond not later than ten business days after receiving such request and supporting materials. (c) The insured, or the provider with the insured's written consent, may appeal any denial of coverage for medical necessity to an external, independent review pursuant to section 38a-591g . Such external review shall be conducted by a properly qualified review agent whom the department has determined does not have a conflict of interest regarding the clinical trial. (d) The Insurance Commissioner shall adopt regulations, in accordance with chapter 54, to implement the provisions of this section. See Sec. 38a-504f for similar provisions re individual policies.

Legislative History

(P.A. 01-171, S. 6, 25; P.A. 11-19, S. 66; 11-58, S. 84; 11-172, S. 13; P.A. 12-145, S. 21.) History: P.A. 01-171 effective January 1, 2002; P.A. 11-19 made technical changes in Subsec. (b), effective January 1, 2012; P.A. 11-58 replaced reference to Sec. 38a-478n with “section 38a-591g” in Subsec. (c), effective July 1, 2011; P.A. 11-172 amended Subsec. (a) by designating existing provisions as Subdiv. (1) and amending same to change “may not” to “shall not” and by adding Subdiv. (2) re standardized form for clinical trials other than cancer clinical trials, amended Subsec. (b) by replacing references to cancer clinical trial with references to clinical trial, deleting provision re time period for approval or denial of coverage for phase III clinical trials for prevention of cancer and by making technical changes, and amended Subsec. (c) by replacing reference to cancer clinical trial with reference to clinical trial, effective January 1, 2012; P.A. 12-145 amended Subsec. (a)(2) to replace reference to Sec. 38a-504g with reference to Sec. 38a-542g, effective June 15, 2012.