Carol Whitley received health insurance through Carolina Care Plan. She had serious heart problems and her physicians decided to implant a left ventricle assist device (LVAD). The LVAD had two functions for Whitley. It could allow her to live for a period of time until she became a suitable candidate for transplant (she needed to lose weight to get to that point) or it could serve as a permanent implant to extend her life. The first use is “bridge to transplant” while the second is “destination therapy.” The medical expenses for Whitley’s care were significant, about $370,000. Carolina Care Plan denied the Whitleys' claim stating that the LVAD treatment fell within an exclusion for experimental, investigational or unproven services. Specifically, the Plan relied on a published article, the Hayes Report, to determine that using the LVAD for destination therapy was unproven and experimental. Carol and her husband appealed the denial three times and each time Carolina Care Plan upheld its decision. The Whitleys then filed suit in the U.S. District Court for South Carolina to recover the benefits they felt were owed to them. You can read the decision issued last week by Judge Cameron McGowan Currie in the library of this website here and here. I’ve split the 67 page decision into two separate PDF documents. The court reversed the denial of benefits and ordered the Plan to pay Whitley’s medical expenses for a number of reasons. While the Plan argued that the LVAD treatment as destination therapy was experimental, the Hayes Report made it clear that use of the LVAD as a bridge to transplant was well-accepted in the medical field. The court was troubled by the Plan’s dogged focus on Whitley’s LVAD as only destination therapy. In fact, the medical records reflected it was being used as a bridge to a prospective future transplant and, if the conditions to allow for that transplant did not occur, as destination therapy for Whitley. Second, the court pointed out that the Plan failed to consider supplemental information to the Hayes Report. The Report was issued about twenty months before Whitley’s surgery. In the interim over 62 articles evaluating various aspects of LVAD were made available on the Hayes Report website and were provided as updates to the original Report. However, the Plan failed to consider whether this new information took use of the LVAD for destination therapy out of the experimental category. Next, the court was unhappy that the Plan went to the effort of obtaining two separate opinions from outside reviewers, both of which stated that Whitley’s LVAD was not experimental, and then labeled them irrelevant and unnecessary to the appeal process. The court held that rejection of these opinions without presenting any reason for that action was unreasonable. Fourth, the decision faults the Plan because the person who made the initial decision that the LVAD was not covered, the medical director for Carolina Care Plan, was also involved in the decision making process at the second and third level appeals. This violated both the terms of the Plan and the mandates of ERISA’s claims procedure regulation that require each level of appeal to reconsider the denial without the input of individuals involved in previous denials. Next, the court found problematic the Plan’s exclusive reliance on the Hayes Report to evaluate whether LVAD as destination therapy was experimental. The exclusion language in the Plan referred to the need to evaluate whether a procedure is experimental by looking at broader measures of acceptance within the medical field than simply the report of one third party. The court’s conclusion: "The Plan’s decision and decision-making process ignored Plan language and precluded the Whitleys from obtaining a full, fair and unbiased review. The court, therefore, finds that the Plan abused its discretion both in its ultimate decision and in the process used to reach that decision."