Connecticut General Statutes 38a-504f – 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-504g may use the form or process established by such agreement.
Terms Used In Connecticut General Statutes 38a-504f
- Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
- Commissioner: means the Insurance Commissioner. See Connecticut General Statutes 38a-1
- Insurance: means any agreement to pay a sum of money, provide services or any other thing of value on the happening of a particular event or contingency or to provide indemnity for loss in respect to a specified subject by specified perils in return for a consideration. See Connecticut General Statutes 38a-1
- Insured: means a person to whom or for whose benefit an insurer makes a promise in an insurance policy. See Connecticut General Statutes 38a-1
- Person: means an individual, a corporation, a partnership, a limited liability company, an association, a joint stock company, a business trust, an unincorporated organization or other legal entity. See Connecticut General Statutes 38a-1
- State: means any state, district, or territory of the United States. See Connecticut General Statutes 38a-1
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
(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-504g 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-504c, 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.