Connecticut General Statutes 38a-542c – Evidence and information re eligibility for clinical trial. No coverage required for otherwise reimbursable costs
In order to be eligible for coverage of routine patient care costs, as defined in section 38a-542d, the insurer, health care center or plan administrator may require that the person or entity seeking coverage for the clinical trial provide: (1) Evidence satisfactory to the insurer, health care center or plan administrator that the insured person receiving coverage meets all of the patient selection criteria for the clinical trial, including credible evidence in the form of clinical or pre-clinical data showing that the clinical trial is likely to have a benefit for the insured person that is commensurate with the risks of participation in the clinical trial to treat the person’s condition; (2) evidence that the appropriate informed consent has been received from the insured person; (3) copies of any medical records, protocols, test results or other clinical information used by the physician or institution seeking to enroll the insured person in the clinical trial; (4) a summary of the anticipated routine patient care costs in excess of the costs for standard treatment; (5) information from the physician or institution seeking to enroll the insured person in the clinical trial regarding those items, including any routine patient care costs, that are eligible for reimbursement by an entity other than the insurer or health care center, including the entity sponsoring the clinical trial; and (6) any additional information that may be reasonably required for the review of a request for coverage of the clinical trial. The health plan or insurer shall request any additional information about a clinical trial not later than five business days after receiving a request for coverage from an insured person or a physician seeking to enroll an insured person in a clinical trial. Nothing in sections 38a-542a to 38a-542g, inclusive, shall be construed to require the insurer or health care center to provide coverage for routine patient care costs that are eligible for reimbursement by an entity other than the insurer, including the entity sponsoring the clinical trial.
Terms Used In Connecticut General Statutes 38a-542c
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- 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
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.