Opinion ID: 2966702
Heading Depth: 3
Heading Rank: 1

Heading: any supply or drug used must have received final

Text: approval to market by the U.S. Food and Drug Administration; 2. there must be enough information in the peer reviewed medical and scientific literature to let the Company judge the safety and efficacy; 3. the available scientific evidence must show a good effect on health outcomes outside a research setting; and 4. the service or supply must be as safe and effective outside a research setting as current diagnostic or therapeutic options. A service or supply will be experimental or investigative if the Company decides that any one of the four criteria is not met. 7 (J.A. at 885.)3 Therefore, because the Plan gives more detail than the SPD but does not contradict its terms, there is no conflict between the Plan and the SPD. Circuit precedent supports this conclusion. In Hendricks, we considered an argument that the district court, in ruling on coverage for his treatment, improperly relied upon definitions of the terms `experimental' and `investigative' in the official plan document maintained in Central Reserve's files and did not rest its decision on the terms of the summary plan description circulated to employees. 39 F.3d at 511. There, as here, the summary plan description used only the words experimental or investigative, while the plan defined the exclusion in greater detail. After carefully reviewing the common understanding of the terms experimental or investigative, we upheld the view of the district court that the definitions of `experimental' and `investigative' given in the official plan document are not so different from common understandings of the terms that they can be thought to conflict with those understandings. Id. at 512. We think that the reasoning of Hendricks is equally applicable here. Because the additional considerations outlined in the Plan are not so different from common understandings of the terms, no conflict exists between the SPD and the Plan. As noted in Hendricks, when the summary plan description and the plan itself do not conflict, our cases provide no prohibition against review of the official plan itself for a fuller understanding of the plan's terms. Indeed, in those circumstances the plan is the controlling document for determining the scope of benefits provided. Id. We also find that no conflict arises from the Plan's grant of discretion to Blue Cross to determine whether a procedure is experimental or investigative. Although the SPD contains no such language, we find no conflict between the absence of discretionary language in the SPD and its presence in the Plan. Vesting the plan administrator with discretion in making coverage decisions simply does not conflict with the SPD's silence on the matter.4 See Atwood v. Newmont Gold Co., _________________________________________________________________ 3 These four factors are very similar to the five factors appended to Blue Cross's letter of August 2, 1994, denying coverage. 4 Moreover, even were we to conclude that the Plan's grant of discretionary authority conflicted with the SPD's silence, Mrs. Martin could 8 45 F.3d 1317, 1321 (9th Cir. 1995) (holding that even though the summary plan description did not include discretionary language, the grant of discretionary authority in the plan controlled); see also Jensen v. SIPCO, Inc., 38 F.3d 945, 952 (8th Cir. 1994) (explaining that the plan will control when the plan document is specific and the SPD is silent on a particular matter). Therefore, the Plan controls, and it vests the administrator of the plan with discretion in making coverage decisions. Because the magistrate judge erred in finding a conflict between the SPD and the Plan and in concluding that the SPD controlled, he also erred in choosing the standard under which to review Blue Cross's denial of benefits. In actions under ERISA challenging the denial of benefits, we apply the standard of review described in Firestone Tire & Rubber Co. v. Bruch, 489 U.S. 101 (1989). Under this standard, we must show deference to the denial of benefits by an administrator with discretionary powers to determine eligibility for benefits, and we will reverse the administrator's denial of benefits only upon a showing of abuse of discretion. See id. at 115; Doe v. Group Hosp. & Med. Servs., 3 F.3d 80, 85 (4th Cir. 1993). This standard is slightly modified, however, when the administrator labors under a conflict of interest. In our Circuit, when a fiduciary exercises discretion in interpreting a disputed term of the contract where one interpretation will further the financial interests of the fiduciary, we will not act as deferentially as would otherwise be appropriate. Rather, _________________________________________________________________ hardly argue that she relied on or was prejudiced by the SPD's failure to describe the appropriate standard for coverage decisions. As explained by the Ninth Circuit, The language of the SPD in this case amply informed [the beneficiary] that there was a danger that he would be ineligible for severance benefits if he resigned. The omission of plan language placing the determination in the discretion of[the employer] does not undermine this conclusion. Atwood v. Newmont Gold Co., 45 F.3d 1317, 1321 (9th Cir. 1995). Here, Mrs. Martin knew that the Blue Cross policy did not cover experimental or investigative procedures, and she cannot claim to have been prejudiced by the fact that she did not know how Blue Cross would determine whether, applied to her illness, the procedure was experimental or investigative. 9 we will review the merits of the interpretation to determine whether it is consistent with an exercise of discretion by a fiduciary acting free of the interests that conflict with those of the beneficiaries. In short, the fiduciary decision will be entitled to some deference, but this deference will be lessened to the degree necessary to neutralize any untoward influence resulting from the conflict. Doe, 3 F.3d at 87; see also Bedrick v. Travelers Ins. Co., 93 F.3d 149, 152 (4th Cir. 1996) (Inasmuch as the law is highly suspect of `fiduciaries' having a personal interest in the subject of their trust, the `abuse of discretion' standard is not applied in as deferential a manner to plans where the insurer processes and pays claims and acts as plan administrator.). Therefore, the appropriate standard under which to review Blue Cross's denial of benefits to Mrs. Martin is not de novo, as used by the magistrate judge, but rather a modified abuse of discretion standard. In light of the magistrate judge's application of the wrong standard in reviewing Blue Cross's denial of benefits, remand would ordinarily be appropriate. In our view, however, remand is unnecessary because we conclude, as a matter of law, that the procedure at issue was experimental or investigative within the meaning of the Plan. We first note that we have twice considered the issue, in different contexts. In Hendricks, 39 F.3d at 509, we considered the identical procedure as administered to a patient with small cell lung cancer. The procedure at issue in Hendricks was a clinical trial, regulated by the Food and Drug Administration and the Department of Health and Human Services. Furthermore, Hendricks signed an informed consent form and was subject to a protocol. Finally, Hendricks was one of the first patients to undergo high-dose chemotherapy with stem cell rescue for his particular type of cancer. We concluded that although the components of the treatment proposed are fairly well known and data demonstrate that high-dose chemotherapy generally has a tendency to improve a patient's response to cancer, the data failed to demonstrate that small cell lung cancer would be more effectively treated with high-dose chemotherapy than with standard chemotherapy. 10 Id. at 514. Later, however, in Wilson v. CHAMPUS, 65 F.3d 361 (4th Cir. 1995), a case that did not cite Hendricks , we held that autologous bone marrow transplant with high-dose chemotherapy was not experimental or investigative when administered for breast cancer. We rejected the argument that published, Phase III clinical trial results are required before a benefit can be provided. Id. at 365. Instead, we reasoned that there is considerable evidence that Phase III clinical trials are not the critical aspect in determining whether a therapy has become `generally accepted' within the medical community. Id. This reasoning, coupled with our review of the medical literature, led us to conclude that high-dose chemotherapy with stem cell rescue was not experimental or investigative when used to treat breast cancer. Hendricks and Wilson make clear that an insurance policy may limit coverage depending on the type of cancer involved. Although both cases involved the same procedure, we reached different results for small cell lung cancer and for breast cancer. Here, we conclude that, at the time Mrs. Martin underwent the procedure, Blue Cross did not abuse its discretion in determining that autologous bone marrow transplant with high-dose chemotherapy for epithelial ovarian cancer was experimental or investigative. Blue Cross extensively reviewed the medical literature before denying Mrs. Martin's application for coverage. In April of 1994, the National Institutes of Health (NIH) produced a consensus statement on Ovarian Cancer: Screening, Treatment, and Followup. (J.A. at 1035.) The statement specifically noted that high-dose chemotherapy with hematopoietic growth factors or bone marrow transplantation is experimental, and its use should be limited to research settings. (J.A. at 1046.) Dr. John L. Colley, Blue Cross's expert witness, testified that when the coverage decision for Mrs. Martin was made, Blue Cross had seen the NIH statement. (J.A. at 568.) Further, as explained by Dr. Colley, [t]he independent, seventy (70) or so Blue [Cross/Blue Shield] plans across the country[formed an] association [that] has a technology assessment program[the Technology Evaluation Center] that looks at emerging technologies and . . . they have a . . . very elaborate evaluation process for literature review and attendance at scientific meetings . . . . (J.A. at 560.) In 1994, the Technology Evaluation Center produced an eighteen-page assessment that review[ed] the available evidence to determine whether high-dose 11 chemotherapy with autologous stem cell support (HDC/AuSCS) improves survival for patients with epithelial ovarian cell cancer. (J.A. at 1056.) The assessment focuse[d] on evidence published since 1990, briefly review[ed] the earlier evidence, and synthesiz[ed] the prior conclusions with the new evidence. (J.A. at 1056.) After an extensive review of the available literature in the eighteen-page report, the Technology Evaluation Center concluded that high-dose chemotherapy with autologous stem cell support for the treatment of epithelial ovarian cancer does not meet the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. (J.A. at 1074.) Dr. Colley testified that Blue Cross relied on this assessment in denying coverage for Mrs. Martin's procedure, and Blue Cross specifically mentioned the assessment in its final denial of coverage to Mrs. Martin. Dr. Colley also testified that, when Mrs. Martin's application for coverage was denied, nothing had come to Blue Cross'[s] attention to cast doubt on the original understanding that [high-dose chemotherapy with autologous bone marrow transplant] was experimental [or] investigative for ovarian cancer. (J.A. at 568.) In fact, there is no testimony in the record that this treatment has yet become generally accepted or standard practice for treatment of epithelial ovarian cancer. Our conclusion that Blue Cross conducted an adequate review of the medical evidence and did not abuse its discretion in denying benefits is sufficient to dispose of Mrs. Martin's claim. But because the magistrate judge considered evidence beyond that which was before the administrator,5 and because neither party objected to the consider_________________________________________________________________ 5 In Sheppard & Enoch Pratt Hosp. v. Travelers Ins. Co., 32 F.3d 120, 125 (4th Cir 1994), we reaffirmed our view that, when the administrator is vested with discretion in making coverage decisions, an assessment of the reasonableness of the administrator's decision must be based on the facts known to it at the time. See also Berry v. Ciba-Geigy, 761 F.2d 1003 (4th Cir. 1985) (same, pre-Firestone). On the other hand, we have held that in conducting de novo review of an administrator's coverage decision, the reviewing court may consider evidence that was not before the administrator only when circumstances clearly establish that additional evidence is necessary to conduct an adequate de novo review of the benefit decision. Quesinberry v. Life Ins. Co. of N. Am., 987 F.2d 1017, 1025 (4th Cir. 1993) (en banc). Here, the magistrate judge incor- rectly assumed that review of Blue Cross's coverage denial was de novo and therefore considered evidence that was not before the administrator. 12 ation of such evidence, we note that the extrinsic evidence presented at the hearing does not undermine Blue Cross's denial of coverage. The Plan requires that, to avoid exclusion as experimental or investigative, the procedure meet four criteria, one of which is that it be as safe and effective outside a research setting as current diagnostic or therapeutic options. See supra p.11. Likewise, one of the five factors included in Blue Cross's final denial of coverage was that [t]he available scientific evidence must demonstrate a net beneficial effect on health outcomes. (J.A. at 25.) Dr. Wolff, Mrs. Martin's own expert witness, agreed with the statement that what's experimental is whether the therapy is better than standard alternatives for ovarian cancer. (J.A. at 489.) Therefore, although Dr. Wolff testified that application of Blue Cross's coverage factors otherwise indicated that the procedure was not experimental or investigative, and although his testimony was credited by the magistrate judge, he conceded that at least one of the factors precluded coverage because there was a lack of evidence to prove that this procedure was as safe . . . as current diagnostic or therapeutic options. The Plan makes clear that coverage will be denied if any one of the four criteria indicates that the procedure is experimental or investigative, and Dr. Wolff's concession cannot support Mrs. Martin's claim for benefits. Moreover, Dr. Wolff answered affirmatively when asked whether high-dose chemotherapy with autologous bone marrow transplant for ovarian cancer patients is experimental as you define the term experimental. (J.A. at 687.) Therefore, Dr. Wolff himself testified that, in the general sense of the term, Mrs. Martin's procedure was experimental or investigative. In other words, not only did Mrs. Martin's expert testify that at least one coverage factor indicated that the procedure was experimental or investigative, he also testified that he himself considered the procedure experimental or investigative. Finally, Mrs. Martin's procedure, like that in Hendricks, was part of a clinical trial, more specifically a Phase II clinical trial.6 In this _________________________________________________________________ 6 As we have previously explained,Phase III is the final stage of medical clinical trials. In Phase I, a new therapy is given to human beings for the first time . . . . In Phase II, the treatment is given to a larger group to determine whether the procedure is effective in treating a disease. Wilson v. CHAMPUS, 65 F.3d 361, 365 n.5 (4th Cir. 1995). 13 regard, the magistrate judge clearly erred in concluding that what was considered a clinical trial in November 1993 on the evidence before the district judge in Hendricks, was not a clinical trial accord- ing to the preponderance of the evidence in this case. (J.A. at 771.) In fact, it is uncontradicted in the record that Mrs. Martin's procedure was part of a Phase II clinical trial. In his deposition, Dr. Wolff explained that a Phase [II] study really tries to answer the question, in a specific disease situation how effective is the therapy intervention that you're trying. You have to also note that to go in Phase [II] studies means you're not taking standard therapy . . . . (J.A. at 496.) Although Wilson specifically rejected the argument that lack of a Phase III clinical trial renders a procedure experimental or investigative, Mrs. Martin's participation in a Phase II clinical trial strongly supports Blue Cross's conclusion that the procedure, when administered to Mrs. Martin, was experimental or investigative. Moreover, the required protocol for Mrs. Martin's procedure stated, THIS STUDY IS ENTIRELY RESEARCH, and, THIS STUDY IS AN INVESTIGATIONAL TREATMENT PROGRAM. (J.A. at 939.) Finally, Mrs. Martin signed an informed consent form before undergoing the procedure. In this consent form, it was noted that: Both of these drugs are used in standard therapy for various tumors either separately or in combination. Recently, there is some evidence that each of these agents may be more effective if given at doses much greater than normal. The use of the higher doses and the combination of these drugs at the higher doses is the investigational (research) part of this study. The combination of these drugs in high-doses have been used in only a few patients. Preliminary observations suggest that this therapy may be effective. It is the purpose of this study to determine the effectiveness and safety (side effects) of this high-dose therapy. It must be understood that compared to standard therapy the use of the therapy in this study will produce more serious side-effects and should be considered substantially more risky. (J.A. at 951 (emphasis added).) Therefore, Mrs. Martin knew before undergoing the procedure that it was considered experimental or investigative. 14 In short, Blue Cross did not abuse its discretion in denying benefits to Mrs. Martin because its decision was based on an extensive review of the available literature. Moreover, the extrinsic evidence considered by the magistrate judge supports Blue Cross's denial of cover- age. Dr. Wolff testified that at least one of Blue Cross's coverage factors indicated that the procedure was experimental or investigative and that he himself considered the procedure experimental or investigative. In addition, Mrs. Martin herself knew that the procedure was experimental or investigative because it was part of a Phase II clinical trial, was subject to a protocol, and required Mrs. Martin's informed consent. In light of this evidence, we cannot say that Blue Cross abused its discretion, even the more limited discretion afforded to a fiduciary acting under a possible conflict of interest, in concluding that the procedure here was experimental or investigative when used to treat epithelial ovarian cancer. Finally, we note that we are not at liberty to fragment the procedure into its component parts under the exclusion for experimental or investigative procedures. In Hendricks, we concluded that [t]o fragment the phases of treatment and consider each in light of the policy language produces an unrealistic and distorted analysis. 39 F.3d at 514. In doing so, we distinguished Doe v. Group Hosp. & Med. Servs., 3 F.3d 80 (4th Cir. 1993), which held that fragmentation of the treatment was permissible under an exclusion for autologous bone marrow transplants. In Hendricks, we reasoned that because the treatment which is experimental or investigative includes the highdose chemotherapy as well as the preparational and recovery phases of the treatment, the scope of the exclusion here is broader than the scope of the autologous bone marrow transplant exclusion considered in Doe. 39 F.3d at 515. Applying Hendricks, we hold that Mrs. Martin cannot recover the cost of any part of the procedure.7 _________________________________________________________________ 7 In light of our disposition of this issue, we need not decide whether reimbursement for the procedure was also prevented by the exclusion of autologous bone marrow transplants contained in both the Plan and the SPD. 15