Opinion ID: 788187
Heading Depth: 2
Heading Rank: 2

Heading: Is provided in a clinically controlled research setting; and

Text: 5 C. Uses a specific research protocol that meets standards equivalent to those defined by the National Institutes of Health. 6 When Ortlieb became seriously ill, she initially received medical treatment in Lincoln, Nebraska, and later at the Mayo Clinic in Rochester, Minnesota. As her health continued to fail, she sought treatment at the Environmental Health Center (EHC) in Dallas, Texas, under the medical supervision of Dr. William J. Rea (Dr. Rea). Dr. Rea diagnosed Ortlieb with a myriad of illnesses, including toxic encephalopathy, malnutrition, malabsorption, irritable bowel syndrome, allergic food gastroenteritis, toxic effect petrochemicals and solvents, and fatigue. Dr. Rea prescribed Ortlieb various treatments, including TPN therapy, which she began in late October 1999. 7 The pharmacy supplying Ortlieb's TPN services submitted a coverage request to United HealthCare for TPN and TPN-related services. Based on an internal medical review conducted by Dr. Debra Esser (Dr. Esser), United HealthCare denied the coverage request finding that TPN, as it related to malnutrition, fell within the Plan's experimental, investigational, or unproven service exclusion. In December 1999, United HealthCare notified Ortlieb of its decision to deny coverage. 8 In February 2000, the pharmacy sought reconsideration of the coverage denial, and attached to its request a letter written by Dr. Rea describing Ortlieb's medical condition and Dr. Rea's course of treatment. Later, in March 2000, Ortlieb appealed the initial denial of coverage. United HealthCare hired Dr. Robert A. Beer (Dr. Beer), an outside consulting physician, to review Ortlieb's medical records and to recommend a benefit determination under the Plan. Dr. Beer recommended United HealthCare deny coverage, which it did. 9 Ortlieb appealed the second coverage denial. Her intermediate appeal was reviewed by United HealthCare's Consumer Affairs Committee (CAC), which included an internal physician member, Dr. Tim Mergens (Dr. Mergens). The CAC upheld the denial of coverage for TPN and related services. Ortlieb made a final appeal to the National Appeals Service Center (NASC). NASC is administered by Edina, an external review company. Edina, in turn, hired Dr. Arnold Flick (Dr. Flick), an independent, board-certified gastroenterologist to review Ortlieb's medical records. Dr. Flick concluded insufficient medical literature existed to support TPN treatment for any of Ortlieb's proven medical conditions. 10 Thereafter, Ortlieb contested the denial of coverage by filing her case in the district court. The district court reviewed the benefit determination using an arbitrary and capricious standard of review. In opposing United HealthCare's motion for summary judgment, Ortlieb submitted four technical documents discussing TPN, none of which were included in the administrative record. The district court declined to consider the new evidence. Based on the administrative record, the district court determined United HealthCare reasonably relied on the assessments of multiple doctors that TPN was an unproven therapy for Ortlieb's medical conditions. The district court rejected Ortlieb's argument that United HealthCare had failed to consider the life-threatening condition exception to the unproven service exclusion. The court granted summary judgment in favor of United HealthCare. Ortlieb now appeals.