Connecticut General Statutes 38a-504d – Clinical trials: Routine patient care costs
(a) For purposes of sections 38a-504a to 38a-504g, inclusive, “routine patient care costs” means: (1) Medically necessary health care services that are incurred as a result of the treatment being provided to the insured person for purposes of the clinical trial that would otherwise be covered if such services were not rendered pursuant to a clinical trial. Such services shall include those rendered by a physician, diagnostic or laboratory tests, hospitalization or other services provided to the insured person during the course of treatment in the clinical trial for a condition, or one of its complications, that is consistent with the usual and customary standard of care and would be covered if the insured person were not enrolled in a clinical trial. Such hospitalization shall include treatment at an out-of-network facility if such treatment is not available in-network and not eligible for reimbursement by the sponsors of such clinical trial, and (2) costs incurred for drugs provided to the insured person, in accordance with section 38a-492b, provided such drugs have been approved for sale by the federal Food and Drug Administration.
Terms Used In Connecticut General Statutes 38a-504d
- Contract: A legal written agreement that becomes binding when signed.
- 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
- Policy: means any document, including attached endorsements and riders, purporting to be an enforceable contract, which memorializes in writing some or all of the terms of an insurance contract. 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.
(b) Routine patient care costs shall be subject to the terms, conditions, restrictions, exclusions and limitations of the contract or certificate of insurance between the insured person and the insurer or health plan, including limitations on out-of-network care, except that treatment at an out-of-network hospital as provided in subdivision (1) of subsection (a) of this section shall be made available by the out-of-network hospital and the insurer or health care center at no greater cost to the insured person than if such treatment was available in-network. The insurer or health care center may require that any routine tests or services required under the clinical trial protocol be performed by providers or institutions under contract with the insurer or health care center.
(c) Notwithstanding the provisions of subsection (a) of this section, routine patient care costs shall not include: (1) The cost of an investigational new drug or device that has not been approved for market for any indication by the federal Food and Drug Administration; (2) the cost of a non-health-care service that an insured person may be required to receive as a result of the treatment being provided for the purposes of the clinical trial; (3) facility, ancillary, professional services and drug costs that are paid for by grants or funding for the clinical trial; (4) costs of services that (A) are inconsistent with widely accepted and established regional or national standards of care for a particular diagnosis, or (B) are performed specifically to meet the requirements of the clinical trial; (5) costs that would not be covered under the insured person’s policy for noninvestigational treatments, including, but not limited to, items excluded from coverage under the insured person’s contract with the insurer or health plan; and (6) transportation, lodging, food or any other expenses associated with travel to or from a facility providing the clinical trial, for the insured person or any family member or companion.