Coverage for Participation in Approved Clinical Trials

THE GREAT SEAL OF THE STATE OF UTAH 1896 State of Utah GARY R. HERBERT Governor SPENCER J. COX Lieutenant Governor Insurance Department TODD E. KISER Insurance Commissioner ## Bulletin 2013-7 TO: All Health Benefit Plan Issuers in the State of Utah FROM: Todd E. Kiser, Utah Insurance Commissioner DATE: October 29, 2013 SUBJECT: Coverage for Participation in Approved Clinical Trials The purpose of this Bulletin is to remind health benefit plan issuers that effective January 1, 2014, the Affordable Care Act (ACA) requires non-grandfathered individual and group health plans to cover approved clinical trials. An approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or a life-threatening condition and is further defined in Section 2709 of the Public Health Service Act as added by the ACA. A health benefit plan issuer that offers an individual or group health benefit plan may not: - Deny participation by a qualified individual in an approved clinical trial; - Deny, limit, or impose additional conditions on the coverage of routine patient costs for items or services furnished in connection with participation in the trial; or - Discriminate against an individual on the basis of the individual's participation in an approved clinical trial. A network plan may require a qualified individual who wishes to participate in an approved clinical trial to participate in a trial that is offered through a health care provider who is part of the network plan if the provider is participating in the trial and the provider accepts the individual as a participant in the trial. basis of the individual's participation in an approved clinical trial. A network plan may require a qualified individual who wishes to participate in an approved clinical trial to participate in a trial that is offered through a health care provider who is part of the network plan if the provider is participating in the trial and the provider accepts the individual as a participant in the trial. Authority to require an insurer that issues, sells, renews, or offers health insurance coverage in this state to comply with the provisions of the ACA is granted to the commissioner by Subsection 31A-2-212(5)(b). If you have any questions related to this Bulletin, please contact Nancy Askerlund, Director, Health and Life Insurance, by phone at 801-537-9293 or email naskerlund@utah.gov. DATED this 29th day of October, 2013. Todd E. Kiser Insurance Commissioner State Office Building Suite 3110, Salt Lake City, UT 84114-6901 • (801) 538-3800 • Facsimile (801) 538-3829 • www.insurance.utah.gov