Opinion
01 Civ 685 (GBD)
October 22, 2001
MEMORANDUM OPINION ORDER
The plaintiff, Nickolas Zervos, challenges a denial of health care benefits under the Employee Retirement Income Security Act of 1974 ("ERISA"), 29 U.S.C. § 1001 et seq. Plaintiff previously moved for a preliminary injunction in this case. This Court denied that motion, Zervos v. Verizon N.Y., Inc., 2001 U.S. Dist. LEXIS 2552 (S.D.N.Y. 2001), and that decision was affirmed on appeal, Zervos v. Verizon N.Y., Inc., 252 F.3d 163 (2d Cir. 2001). Defendant thereafter moved for summary judgment upon the completion of expedited discovery. This Court granted summary judgment on plaintiffs ADA claim, but denied the motion to dismiss plaintiffs ERISA claim.
A bench trial was held before me on plaintiffs ERISA claim on October 1-5, 2001. Dr. Charles Hesdorffer, plaintiffs treating physician, and Dr. Roy B. Jones, an expert in bone marrow transplantation and high-dose chemotherapy in the treatment of breast cancer, testified on behalf of the plaintiff. The plaintiff also testified on his own behalf. Dr. Steven Wolinsky, director of medical policy for Empire Healthchoice, Inc., testified in court and by deposition. The following deposition testimony was also received by the court: Dr. Thomas R. Spitzer, who conducted the first Medical Care Ombudsmen Program review of plaintiffs case; Dr. Diana E. Lake, an oncologist from Memorial Sloan-Kettering who gave a presentation at the meeting of the Technology Assessment Committee where Empire decided to deny coverage for the high-dose chemotherapy treatment plaintiff is seeking; Dr. Peter Goldschmidt, a representative from the Medical Care Ombudsmen Program that conducts the external reviews; Dr. Raymond Weiss, who conducted the second Medical Care Ombudsmen Program review of plaintiffs case; Dr. Alan E. Sokolow, chief medical officer for Empire; Dr. Janice L. Gabrilove, chief of medical oncology and deputy director for clinical affairs for the Derald H. Ruttenberg Cancer Center at the Mount Sinai School of Medicine; and Dr. Robert Peter Gale, an oncologist from Cedars-Sinai Medical Center and St. Vincent's Medical Center.
Based upon the credible evidence adduced at trial, this Court makes the following findings of fact:
Findings of Fact
Plaintiff suffers from metastic breast cancer and is seeking declaratory and injunctive relief to obtain health insurance coverage for a cancer treatment, which consists of a single cycle of high-dose chemotherapy followed by an autologous blood stem cell transplant ("HDCT"). Defendant Empire provides coverage for conventional chemotherapy for breast cancer patients, but does not cover HDCT for that condition because it is deemed to be an experimental/investigational treatment for breast cancer. Plaintiff applied for coverage for this treatment in October 2000. This application was routinely denied pursuant to Empire policy. Empire sent plaintiff a letter dated October 18, 2000 stating that "Autologous Peripheral Stem Cell Harvest/Transplant is Experimental and Investigational in Breast Cancer Stage IV" as the reason for the denial of coverage. (Tr. at 125; Defs. Ex. 3.)
Under the benefit contract, experimental/investigational procedures are defined as "services or supplies which are not of proven benefit for the diagnosis or treatment of the Covered Person's condition or are not generally recognized by the medical community as effective or appropriate for that condition as determined by the Claims Administrator." (Tr. at 66; Defs. Ex. 1.)
Empire follows one of two procedures in designating a treatment as experimental/investigational. The director of medical policy, Dr. Steven Wolinsky, may make the decision individually as the claims administrator and report it to the Technology Assessment Committee ("TAC"). The TAC consists of a group of medical doctors, directors, and nurses from Empire, as well as physicians from major university medical centers in the New York area. (Tr. at 67.) Alternatively, Dr. Wolinsky may present the treatment to the TAC in order for the committee to make the decision. It is within the director's discretion as to which procedure is utilized. (Tr. at 66.) To determine whether a treatment is "of proven benefit," Empire reviews the medical literature and evaluates the net health effect, which means that efficacy is weighed against toxicity, and compared to other standard treatments. (Tr. at 68.) To determine whether a treatment is "generally recognized by the medical community as effective or appropriate," Empire reviews the opinions of major academic medical centers in the New York area, specialty society opinions, and opinions of organizations for cancer treatments and evaluates whether the majority of the people in this community are recommending the treatment. (Tr. at 69-70.) HDCT is not covered for breast cancer by Empire under both categories. (Tr. at 71.)
Prior to March 2000, based on the state of the then existing medical literature, Empire provided coverage for HDCT to any person with breast cancer for whom the treatment was recommended. In 1999, Empire began to reevaluate its policy regarding HDCT for breast cancer patients as a result of conflicting evidence and opinions within the medical community concerning its effectiveness. A TAC meeting was held in July 1999, and the committee decided at that time to continue to cover the treatment. (Tr. at 96.) In March 2000, the TAC convened once again to re-evaluate the efficacy of HDCT for breast cancer patients. At this meeting. evidence was presented that the Stadtmauer study printed in the New England Journal of Medicine concluded that the treatment was not more beneficial than conventional chemotherapy, and that there was increased acceptance of the study's results by the medical community. This was the first controlled phase 3 randomized study that compared results from a group of patients that received HDCT and a group of patients that received conventional chemotherapy. (Tr. at 72-74.) Evidence was also presented that the Bezwoda study, the primary study previously supporting the use of the treatment, was discredited due to the fraud committed by Dr. Bezwoda. The number of requests Empire received for the treatment had also decreased during 1998-2000. (Tr. at 73.) Additionally, there was a presentation from Dr. Diana E. Lake of Memorial Sloan-Kettering, describing the results of three other studies, which indicated that HDCT is not as beneficial as conventional chemotherapy for breast cancer patients. (Tr. at 96.) After a review of the current available medical literature, the TAC concluded that HDCT was not effective in improving breast cancer patients' chances of survival. Therefore, Empire decided to change its policy and thereafter deny all future applications by breast cancer patients based on the determination that HDCT was experimental/investigational. (Tr. at 99; Pl's. Ex. 63.)
After the initial denial of coverage for Mr. Zervos, Dr. Wolinsky called and spoke with Dr. Charles Hesdorffer, plaintiffs treating physician. During this conversation, Dr. Wolinsky and Dr. Hesdorffer shared their interpretations of the medical literature on HDCT for breast cancer and discussed the clinical history of the case. Pursuant to Empire policy, Dr. Wolinsky presented Dr. Hesdorffer with the opportunity for an appeal by an external review process, which Dr. Hesdorffer accepted on Mr. Zervos' behalf. (Tr. at 123-24; Defs. Ex. 46A.)
Empire refers the external reviews to the Medical Care Ombudsmen Program ("MCOP"). There is a fee contract between MCOP and Empire for the reviews, but there is no other corporate affiliation between the two organizations. (Tr. at 104-05.) MCOP physician reviewers must be board certified, in practice for five years after qualification, cannot have conflicts of interest that would effect reviewer credibility, and cannot have "any sanctions against them by state licensing authorities or other entities that would call into question their judgment." (Goldschmidt Dep. at 25-26.) MCOP independently selects a consultant who is an expert on the patient's condition to review each case. In selecting a reviewer for a case, MCOP assesses the credentials of available reviewers, identifying their qualifications, experience, and the areas that they indicate they are willing to review, and matches those credentials to the characteristics of a particular case. (Goldschmidt Dep. at 28.) The MCOP reviewers do not determine coverage or interpret the benefit contract. Empire asks the reviewers for their expert opinion about the medical literature and "whether a treatment is generally recognized as effective or appropriate for a given patient." (Tr. at 626.) Empire then makes a coverage decision based on the reviewer's decision about whether a treatment is recognized as effective or appropriate for the given situation. (Tr. at 627.) Reviewers do not contact the patient's recommending physician when reviewing a case in order to "maintain an independent relationship" and to ensure that the "treatments [that] are recommended are supported by documentation and a patient's medical record." (Tr. at 42.) Despite the experimental/investigational determination, where the reviewer recommends that the patient receive the treatment, Empire will cover the treatment. (Sokolow Dep. at 62.)
Dr. Wolinsky referred Mr. Zervos' case to MCOP for an external review as requested by Dr. Hesdorffer. Empire sent MCOP the clinical information submitted by Dr. Hesdorffer. (Tr. at 126.) Dr. Wolinsky asked the MCOP reviewer to answer the following seven questions:
1. Does the technology have final approval from the appropriate government regulatory bodies? 2. Does the scientific evidence support a result of improvement in health outcome? 3. Does the technology improve the net health outcome? 4. Is the technology as beneficial as any of the established alternatives? 5. Is this improvement obtainable outside of the investigational setting? 6. Is this a well designed study for which the patient is a good candidate? 7. Is the recommended treatment plan the best treatment available for this patient at this time?
(Defs. Ex. 18; Defs. Ex. 21.) MCOP assigned the case to Dr. Thomas R. Spitzer, who is listed in the MCOP specialty database under bone marrow transplantation and has handled approximately 200 cases in his 10 years at MCOP. (Spitzer Dep. at 16.)
In his review, in response to question number three, Dr. Spitzer indicated that there is no convincing evidence that the treatment will improve Mr.Zervos' health outcome. (Spitzer Dep. at 20; Defs. Ex. 18.) Dr. Spitzer answered "Not applicable" to questions 1 and 5, "Unable to respond" to question 6, "No" with explanation to questions 2, 3, and 7, and "Yes" with explanation to question 4. After Dr. Spitzer completed his report, Dr. Wolinsky reviewed the report in his capacity as appeals coordinator, and based on the answers given by the MCOP reviewer, again denied coverage for Mr. Zervos. (Tr. at 126-127.) Empire sent Mr. Zervos a second denial letter dated October 24, 2000, which stated, "verification of our decision was obtained from an outside oncology consultant, an expert in the field of transplant." (Defs. Ex. 4.) This letter, quoting language from Dr. Spitzer's answer to question 7, stated that the appeal was denied because "'[t]here are no convincing data to show that high dose chemotherapy and Autologous Peripheral Stem Cell Transplant is superior to conventional chemotherapy alone for males with metastic breast cancer.' The Autologous Peripheral Stem Cell Harvest and Transplant remains denied as experimental and investigational." (Defs. Ex. 4.)
After litigation was initiated, Verizon requested that Empire refer Mr. Zervos' case for a second review on January 30, 2001. (Tr at 133.) Where ERISA applies, the employer sometimes requests a second review and Empire always complies with that request. (Tr. at 120.) MCOP assigned Mr. Zervos' case to Dr. Raymond Weiss for the second review. (Weiss Dep. at 22.) Empire invited Dr. Hesdorffer to submit additional literature in support of his position on the treatment, which would be considered during the second review. He supplied three articles, which were sent to Dr. Weiss. (Tr. at 134, 220.) In his review, Dr. Weiss answered "No" with explanation as to all seven questions. He indicated that the published evidence did not suggest that HDCT was more beneficial than conventional chemotherapy. (Tr. at 139; Def's. Ex. 21.) After Dr. Weiss completed his report, Dr. Wolinsky reviewed the report and again concluded that it supported the denial of coverage for HDCT for Mr. Zervos due to the experimental/investigational nature of the treatment. (Tr. at 137.) Empire then sent Mr. Zervos his third denial letter dated February 1, 2001, which stated that the denial had been affirmed based on a review of the medical literature and summarized some of the conclusions reported in the literature. (Def's. Ex. 5.)
Discussion
When an employee challenges a denial of benefits under 29 U.S.C. § 1132 (a)(1)(B), a court must review the denial "under a de novo standard unless the benefit plan gives the administrator or fiduciary discretionary authority to determine eligibility for benefits or to construe the terms of the plan." Firestone Tire Rubber Co. v. Bruch, 489 U.S. 101, 115 (1989); Pagan v. Nynex Pension Plan, 52 F.3d 438, 441 (2d Cir. 1995). Where discretionary authority is provided, a court should review the denial under an arbitrary and capricious standard. Id. As previously noted by this Court, Empire's benefit plan explicitly vests the administrator with "discretionary authority to determine eligibility for benefits or to construe the terms of the plan." Zervos, 2001 U.S. Dist. LEXIS 2552, *25 However, plaintiff argues that a de novo standard should still apply. Under a de novo standard, "a court reviews the administrative record and the plan at issue to determine for itself whether the claimant should be granted or denied the requested relief."Elsroth v. Consolidated Edison Co., 10 F. Supp.2d 427, 434 (S.D.N.Y. 1998) (citing DeFelice v. American Int'l Life Assurance Co. of N.Y., 112 F.3d 61, 65 (2d Cir. 1997)).
Plaintiff argues that this Court should apply a de novo standard in this case, instead of an arbitrary and capricious standard, because of Empire's conflict of interest in denying coverage for HDCT for breast cancer patients. The Second Circuit has set forth an explicit test for determining which standard to apply in cases where there is an alleged conflict of interest.
[I]n cases where the plan administrator is shown to have a conflict of interest, the test for determining whether the administrator's interpretation of the plan is arbitrary and capricious is as follows: Two inquiries are pertinent. First, whether the determination made by the administrator is reasonable, in light of possible competing interpretations of the plan; second, whether the evidence shows that the administrator was in fact influenced by such conflict. If the court finds that the administrator was in fact influenced by the conflict of interest, the deference otherwise accorded the administrator's decision drops away and the court interprets the plan de novo.Sullivan v. LTV Aerospace Defense Co., 82 F.3d 1251, 1255-56 (2d Cir. 1996). Here, plaintiff has filed to demonstrate that a conflict of interest exists or that Empire was actually influenced by such a conflict of interest.
Plaintiff points to three factors to indicate a conflict of interest. Plaintiff first argues that Dr. Wolinsky has a personal bias against HDCT. Although Dr. Wolinsky testified that in July 1999, while Empire was still covering the treatment, he was already of the opinion that HDCT was investigational and should not be covered, plaintiff has proffered no evidence that Dr. Wolinsky's opinions were based on anything other than the medical literature. (Tr. at 90, 670-74.) [n fact, Dr. Wolinsky testified that prior to the studies presented at the May 1999 meeting of the American Society of Clinical Oncology ("ASCO"), he believed that the evidence indicated that the treatment was of benefit and not investigational. (Tr. at 92.) It was only alter these studies were released that he changed his opinion. An opinion based on medical evidence does not equate to a personal bias. Moreover, it was the TAC, not Dr. Wolinsky himself, that made the decision to change Empire's policy concerning coverage for HDCT after extensive review and evaluation of the current medical literature and evidence in March 2000.
The second argument that plaintiff advances to demonstrate a conflict of interest is that financial considerations influenced the denial of coverage for this treatment. Verizon is a self-insured plan, which means that they pay their own claims. Empire is the plan administrator. As such, it administers the benefit contract and manages the medical care for Verizon employees. (Tr at 65.) Plaintiff has proffered no evidence to contradict Empire's position that its coverage decisions are based on clinical evidence and not influenced by financial costs. (Tr at 103.) Plaintiffs evidence, from which this Court is supposed to infer a financial influence, is that breast cancer is prevalent among Empire insureds and that an actuary was present at the TAC meeting where the decision was made to deny coverage for HDCT for breast cancer. (Tr. at 571-72, 601-02.) Based on the testimony presented, this Court cannot draw that inference. Dr. Wolinsky acknowledged that the incidence of a disease among Empire insureds and the expense of a treatment are factors which influence whether an issue is submitted to the TAC, , but these factors do not influence coverage decisions. (Tr. at 679-81; see also Sokolow Dep. at 90, stating HDCT policy change "not cost driven at all.") Although an actuary was present at the March 2000 TAC meeting, she had no input on the decisions made. The purpose of her presence was merely to facilitate her awareness of any changes in coverage that would affect rate calculations. The actuaries at Empire requested that they be notified of coverage decisions for this very purpose. (Tr. at 692-93.) None of the evidence presented controverts this testimony.
The third argument that plaintiff advances to demonstrate a conflict of interest is that Empire provides coverage for HDCT for acute myeloid leukemia ("AML") in certain circumstances, although the medical literature is less favorable for this disease than for breast cancer. Plaintiff argues that this is motivated by the lower cost of AML claims. The evidence does not support this argument. Plaintiffs own expert, Dr. Roy B. Jones, testified that AML is a different disease than breast cancer. (Tr. at 436.) Breast cancer is a solid tumor, whereas AML is a blood-borne disease. Id. A treatment may be effective for treating one disease, but be less effective in treating another. (See Gabrilove Dep. at 91, 135-36, stating that HDCT and stem cell transplant is "standard of care" in certain situations for AML and "high dose chemotherapy with stem cell transplantation needs to be evaluated in the context of each disease . . . I don't think one can make statements across the board.") Dr. Jones acknowledged that there are final reports of phase 3 randomized studies showing a greater benefit to AML patients from HDCT and stem cell transplant compared to conventional chemotherapy, whereas no such reports exist for breast cancer. (Tr. at 437, 501-02.) Dr. Jones also agreed that this type of study is "the best data that one could obtain to evaluate the efficacy of high-dose chemotherapy compared to conventional chemotherapy." (Tr. at 502.) Moreover, there is no evidence that the cost of HDCT for AML is less than the cost of HDCT for breast cancer.
Plaintiff has failed to prove that defendant Empire had a conflict of interest as administrator in its interpretation of the plan. Even if this Court were to infer such a conflict of interest on the basis of the evidence presented by plaintiff, plaintiff has offered no evidence that Empire was in fact influenced by such a conflict. Since plaintiff has not proven a conflict of interest and Empire's benefit plan vests the administrator with discretionary authority, the arbitrary and capricious standard applies in this case. Under the arbitrary and capricious standard, a court may not overturn a decision to deny benefits unless "there has been a clear error of judgment." Jordan v. Retirement Comm. of Rensselaer Polytechnic Inst., 46 F.3d 1264, 1271 (2d Cir. 1995) (citation omitted). Clear error exists where the decision was "without reason, unsupported by substantial evidence, or erroneous as a matter of law."Pagen 52 F.3d at 442 (citing Abnathya v. Hoffman-Larouche, Inc., 2 F.3d 40, 45 (3d Cir. 1993)). Substantial evidence is defined as "such evidence that a reasonable mind might accept as adequate to support the conclusion reached by the [decision-maker and] . . . requires more than a scintilla but less than a preponderance." Miller v. United Welfare Fund, 72 F.3d 1066, 1072 (2d Cir. 1995) (citation omitted). Under this standard, the scope of review is narrow and a court is "not free to substitute [its] own judgment for that of the [plan administrator] as if[it] were considering the issue of eligibility anew." Pagan, 52 F.3d at 442. In this case, there are three levels of the decision-making process which this Court must assess to determine if the denial of coverage to Mr. Zervos was arbitrary and capricious. First, this Court must analyze Empire's decision to change its policy from providing coverage to denying coverage for HDCT for breast cancer as experimental/investigational. Second, this Court must analyze the decision to deny coverage for Mr. Zervos specifically. Third, this Court must analyze Empire's appeal process. Each issue will be addressed in turn.
The Policy Change
Empire's decision to deny coverage for HDCT for breast cancer patients based on its finding that the treatment is experimental/investigational cannot be said to have been arbitrary and capricious. There is substantial evidence before this Court to indicate that it was reasonable for Empire to conclude that the treatment is "not of proven benefit for the diagnosis or treatment" of breast cancer and "not generally recognized by the medical community as effective or appropriate for that condition." (Def's. Ex. 1.) Empire defines "proven benefit" as positive net health effect, meaning that the efficacy of the treatment is not outweighed by its toxicity and that the effect compares favorably to other standard treatments. (Tr. at 68.) Empire defines the relevant medical community in this case as "the general community of academic oncologists." (Tr. at 71.)
Medically, a treatment cannot be said to be of proven benefit where its toxicity or side effects outweigh the benefits gained from the treatment. Moreover, a treatment cannot be said to be of proven benefit where it merely matches the benefits gained from other treatments, but exposes patients to greater harm and potential death. The testimony given by plaintiffs expert, Dr. Jones, supports this conclusion. Dr. Jones agrees that "even if a treatment has slightly greater efficacy than a standard treatment, but the mortality risks are major and the cost is major, cost meaning toxicity, that it may, because of those greater mortality and morbidity risks, be totally inappropriate to use outside of the clinical trial." (Tr. at 416.) Furthermore, , Dr. Jones believes there should be a "cost benefit analysis, " consisting of weighing side effects and costs against the amount of increased benefit, to determine whether a patient should receive a different treatment from the standard treatment. (Tr. at 416-17.) If the side effects of a treatment are substantially greater and the benefits are only slightly greater than the standard treatment, then it is appropriate to decide not to give that treatment. (Tr. at 418.)
To determine whether HDCT is generally recognized by the medical community, it is necessary to ascertain whether the physicians who treat breast cancer select this treatment from a range of treatments to administer to their patients. Plaintiff argues that the relevant community consists of those oncologists who perform stem cell transplants. This argument assumes its own conclusion. As stated by Dr. Spitzer, the first MCOP reviewer for Mr. Zervos' case, ethically, "[a] physician would have to believe that the treatment offered an advantage over conventional therapy" in order to recommend HDCT for a patient. (Tr. at 40.) of course HDCT is generally recognized as effective in the transplant community because, otherwise, those doctors would be breaching their duty to their patients by performing the treatment. In this case, it is logical to define the relevant medical community as the general community of academic oncologists. These are the doctors who treat breast cancer. Dr. Jones' expert testimony at trial was limited to his opinion that HDCT for metastic breast cancer was generally recognized as effective or appropriate by the transplant community for treatment of metastic disease, "particularly in the context of a well-designed clinical trial." (Tr. at 315.) It is only where it can be shown that HDCT is a treatment whose viability is recognized by the doctors who routinely diagnose and treat breast cancer that one can conclude that the treatment is generally recognized by the medical community.
Nowhere in the evidence presented by plaintiff is there any evidence that this treatment is generally recognized by the medical community of oncologists. Dr. Jones admits that following the 1999 ASCO meeting, the exposure of the Bezwoda fraud, and the release of the abstract of theStadtmauer study, many oncologists worldwide had a negative view of HDCT as a treatment for breast cancer. (Tr. p. 340, 344.) He also concedes that there was controversy in early 2000 among oncologists treating breast cancer regarding "whether relapse-free survival or overall survival [was] improved by high-dose chemotherapy treatment as opposed to standard chemotherapy for breast cancer" and that this controversy is still ongoing. (Tr. at 400-01.) At his deposition, Dr. Jones unequivocally acknowledged that among oncologists, his views on HDCT are in the minority. (Jones Dep. at 87.) At trial, he was initially willing to confirm his deposition testimony that his opinion is a minority opinion, although he stated that he could not quantify whether it was a "slim or large minority." (Tr. at 338-339.) However, later during the examination, he completely altered his position, stating that he is unsure whether his opinion is in the minority because it is a "close call." (Tr. at 404-405.)
Moreover, Dr. Jones offered conflicting testimony as to the status of the treatment even among the transplant community. On direct examination, he testified that HDCT is generally recognized as effective in the transplant community. (Tr. at 315.) On cross-examination, however, he agreed that the effectiveness of HDCT as compared to conventional chemotherapy in treating breast cancer is controversial. (Tr. at 338.) None of this conflicting testimony leads to the conclusion that HDCT is generally recognized in the medical community. Furthermore, Dr. Hesdorffer, plaintiff's treating physician, testified that oncologists within Columbia Presbyterian "all agree [HDCT] needs to be evaluated in terms of where its role is . . . [it is] as controversial as the treatment for leukemia." (Tr. at 210.) Additionally, Dr. Hesdorffer attributes the decrease in patients receiving HDCT at Columbia Presbyterian to "the change in public perception" about the treatment's effectiveness for breast cancer patients. (Tr. at 183.) This testimony is consistent with the conclusion that the treatment is not generally recognized by the medical community as effective.
Empire determined that HDCT is experimental/investigational based on a review of the medical literature, primarily the negative results of the Stadtmauer study, the increasing acceptance of the validity of this study in the medical community, the discrediting of the Bezwoda study, and a presentation at the TAC meeting by Dr. Lake which summarized the available data. See supra at 4. When reviewing data, Empire considers a randomized study where patients are divided into a treatment group and a control group as "the most reliable form of medical evidence." (Tr. at 69.) Plaintiffs expert, Dr. Jones, agrees. (Tr. at 502.) The only two published final reports of phase 3 randomized studies for HDCT versus conventional chemotherapy for metastic breast cancer are the Stadtmauer study and the Bezwoda study. The Stadtmauer study concluded HDCT did not result in longer survival or increased time to progression of the disease versus conventional chemotherapy. (Defs. Ex. 7.) This study also reported increased negative side effects among HDCT patients. Id. Based on the data, the researchers did not recommend the treatment for metastic breast cancer patients. Id. A New England Journal of Medicine editorial reviewing the study stated, "[w]e should now acknowledge that, to a reasonable degree of probability, this form of treatment for women with metastic breast cancer has been proved to be ineffective and should be abandoned in favor of well-justified alternative experimental approaches." (Def's. Ex. 8.)
On the other side of the issue is the Bezwoda study, which showed increased survival rates for metastic breast cancer patients who received HDCT as compared to those who received conventional chemotherapy. (Tr. at 83.) Plaintiffs expert, Dr. Jones, acknowledged that the Bezwoda study is the only published final report of a randomized phase 3 clinical trial that demonstrated a benefit to HDCT over conventional chemotherapy for breast cancer patients. (Tr. at 498.) By February 2000, investigators had discovered fraud in Dr. Bezwoda's research and Empire became aware that the results of his study were no longer accepted in the medical community. (Tr. at 84-89; Def's. Ex. 9.) Even plaintiff's expert, Dr. Jones, testified that by March 2000, all of Dr. Bezwoda's work in the breast cancer area was totally unreliable and his studies discredited. (Tr. at 408.)
Dr. Diana E. Lake also gave a presentation at the March 2000 TAC meeting where Empire decided to deny coverage for HDCT. This presentation indicated that the treatment "had not demonstrated a benefit in terms of . . . overall survival." (Lake Dep. at 50-51, 67, 69.) Dr. Lake concluded that HDCT is not standard therapy for breast cancer, but should still be researched to improve the results. (Lake Dep. at 38-39; Defs. Ex. 16.)
Based on the evidence in the record, this Court concludes that Empire's decision to deny coverage for HDCT for breast cancer was not a clear error of judgment or without reason, unsupported by substantial evidence, or erroneous as a matter of law, Plaintiff's expert, Dr. Jones, agrees that the "Stadtmauer study is one of the most widely accepted studies in the medical community about the effectiveness of high-dose chemotherapy for breast cancer" and that it would be "appropriate for an insurance company, in determining whether to cover a procedure in a case such as this one, to rely upon the Stadtmauer study as one of a series of pieces of information for consideration." (Tr. at 352.) Dr. Jones also agrees that it would be appropriate for an insurance company to use the New England Journal of Medicine editorial and the fraud found in the Bezwoda study in making a coverage decision. (Tr. at 353, 390, 408-09.) Furthermore, he stated that, in cases such as this one, while it is appropriate for insurance companies to give some weight to trials from different stages of breast cancer other than the one for which coverage is sought, more weight should be given to phase 3 trials for metastic breast cancer. (Tr. at 391.) After reviewing the evidence presented at the TAC meeting, it was reasonable for Empire to decide that HDCT for breast cancer patients was not of proven benefit or generally recognized by the medical community as effective or appropriate for that condition.
Plaintiff has offered no convincing evidence that the treatment is of proven benefit or generally recognized by the medical community. Plaintiff's expert, Dr. Jones, agrees that there is no definitive information regarding whether HDCT is more effective or beneficial than conventional chemotherapy in treating breast cancer. (Tr. at 341-342, 394, 395, 398, 400.) While Dr. Jones testified that there are phase 2 studies which demonstrate a possible benefit of HDCT, he never stated that these studies are conclusive. (Tr. at 300-305.) Furthermore, as previously discussed, Dr. Jones acknowledged that phase 3 trials are the best evidence and that the Stadtmauer study showing no increased benefit for HDCT is widely accepted in the medical community, though he disagrees with its findings (Tr. at 305-307). He also readily admits that theBezwoda study showing increased benefit has been totally discredited. See supra at 15. Dr. Hesdorffer, plaintiff's treating physician, acknowledges that at his institution, Columbia Presbyterian, "the reality is [that physicians] still see a large number of patients who [do not] achieve the kind of benefit from the stem cell transplant [the physicians] would like." (Tr. at 186.) Additionally, Dr. Hesdorffer testified that Columbia Presbyterian recognizes conventional chemotherapy as the standard therapy for metastic breast cancer and views HDCT as a treatment that needs to be studied and investigated as to its effectiveness in treating breast cancer. (Tr. at 202, 213.)
It is also undisputed that the side effects of HDCT are significantly greater than for conventional chemotherapy. Dr. Jones acknowledges that there are greater side effects for HDCT compared to conventional chemotherapy including higher mortality rates and injury to the lungs, heart, liver, kidneys, and gastrointestinal tract. (Tr. at 422-24.) Dr. Hesdorffer acknowledges, and discussed with Mr. Zervos, other side effects of the treatment including nausea, vomiting, mouth sores, fever, higher morbidity and mortality rates than conventional chemotherapy, and toxic side effects to the heart, lungs, kidney, liver, and nervous system which may be irreversible and result in death. (Tr. at 193-95; see also Def's. Ex. 2.) Based on the lack of evidence demonstrating that this treatment offers an increased benefit and the undisputed evidence of the increased side effects, plaintiff has not demonstrated that this treatment is of proven benefit.
In reviewing defendants' decision to deny coverage of HDCT, this Court joins other courts in finding that the insurer did not act arbitrarily and capriciously in denying coverage to patients for HDCT for breast cancer. Defendants reasonably concluded that it is experimental/investigational, meaning that it is not of proven benefit for the treatment of plaintiff's condition and not generally recognized as effective or appropriate by the medical community for the treatment of his condition. See. e.g., Elsroth v. consolidated Edison Co. of N Y, Inc., 10 F. Supp.2d 427, 432 (S.D.N.Y. 1998) (finding that "[t]hree highly acclaimed oncologists, including the independent expert appointed by the Court, have determined that [plaintiff] will not benefit from the HDCT, and may in fact be harmed or even killed by it."); Peruzzi v. Summa Medical Plan, 137 F.3d 431, 435 (6th Cir. 1998) (finding that the insurance company's denial of coverage for high dose chemotherapy and bone transplantation was not arbitrary and capricious); Harris v. Mutual of Omaha Co., 992 F.2d 706, 713 (7th Cir. 1993) (finding that insurer's denial of coverage for high dosage chemotherapy with autologous bone marrow transplants under plan's exemption of coverage for experimental treatment was not arbitrary and capricious). As discussed above, this Court also finds that Empire's decision to change its policy to deny coverage for HDCT for breast cancer was not affected by a conflict of interest. See supra at 8-10. Plaintiff has not demonstrated that Dr. Wolinsky has an unreasonable personal bias against HDCT, that financial concerns influenced the policy change, or that the policy change is inconsistent with Empire's policy of providing coverage for AML. Id. Empire's decision to deny coverage for HDCT for breast cancer was based on substantial evidence and is not arbitrary and capricious.
The Appeals Process
A second level upon which Empire's decision to deny coverage for HDCT could be found to be arbitrary and capricious is the specific decision to deny coverage to Mr. Zervos after his appeal. Empire consistently applies its policy on HDCT in making the initial denial of coverage. (Tr. at 103.) Plaintiff has not pointed to any case where an insured has been granted coverage for HDCT for breast cancer upon their initial application under Empire's current policy. Mr. Zervos' initial denial was consistent with this policy. Furthermore, Dr. Jones testified that the medical literature suggests that patients will receive a greater benefit from HDCT if they have achieved a complete remission, rather than a partial remission, from conventional chemotherapy. (Tr. at 425-26.) Mr. Zervos has only achieved partial remission. Id. Thus, he is not among the "metastic breast cancer patients most likely to benefit from high-dose chemotherapy." Moreover, according to the Stadtmauer study "[a]mong patients who were older than 42 years, those who received conventional-dose chemotherapy appeared to have a survival advantage over those who received high-dose chemotherapy and underwent stem-cell transplantation." (Def's. Ex. 7.) Mr. Zervos is over 50 years old. (Tr. at 208; Def's Ex. 2; Def's Ex. 46A.)
Plaintiff points to Empire's granting of coverage to a female patient to indicate that Empire's denial of coverage for Mr. Zervos was arbitrary and capricious. That patient was also initially denied, but was later granted coverage based on the external reviewer's report. (Tr. at 642.) While some of the answers to the questions on her external review and Mr. Zervos' initial review are similar, there are two crucial differences. (Pl's. Ex. 47; Def's. Ex. 18.) The first difference is that the female patient had stage 2 breast cancer, while Mr. Zervos has stage 4 metastic breast cancer. Stage 2 breast cancer is a less advanced form of the disease than stage 4 metastic breast cancer. As described by Dr. Hesdorffer, metastic breast cancer means "that the disease has spread beyond the confines of the breast itself that it involves bone or liver or lung or brain . . . it implies a major issue with respect to prognosis and treatment for the patient." (Tr. at 154.) metastic breast cancer is an incurable condition and HDCT is not a cure. (Tr. at 187-188; see also Def's. Ex. 2, stating "[m]etastic breast cancer is essentially incurable.") Thus, the treatment may be appropriate for a less advanced stage of the disease, but inappropriate for a more advanced stage, particularly in light of the increased side effects.
The second difference is that the female patient was seeking coverage for a phase 3 trial, while Mr. Zervos is seeking coverage for a phase 2 trial. As stated earlier, phase 3 evidence is recognized as the best evidence to determine efficacy. See supra at 14. The reviewer in the female patient's case also states in her report that "[p]articipation in a well-designed randomized phase 3 clinical trial represents one of the best treatment options available for patients." (Pl's. Ex. at 47.) Dr. Spitzer, Mr. Zervos' first reviewer, states that the study for which Mr. Zervos is seeking coverage is well-designed. (Def's. Ex. 18.) However, Dr. Jones acknowledged that the protocol that Mr. Zervos is seeking coverage for is not testing a new method, although he characterizes it as a well-designed clinical trial. (Tr. at 497.) Dr. Hesdorffer also agrees that the protocol that, Mr. Zervos is seeking coverage for is not "the kind of clinical trial that would test the efficacy of high-dose chemotherapy and stem cell transplant in the treatment of metastic breast cancer compared to conventional chemotherapy in the treatment of metastic breast cancer[.]" (Tr. at 190.) Dr. Weiss, the second reviewer of Mr. Zervos' case, makes even stronger statements that the study is not "well-designed" because it is a "catchall" study that is "not scientifically worthwhile, " "does not have any innovative feature," and is not a "high-quality randomized clinical trial." (Weiss Dep. at 44-45, 76, 197-98.) This evidence indicates that coverage for the treatment was provided for the female patient and denied for Mr. Zervos because of the quality of the clinical study. This Court cannot conclude that Empire acted arbitrarily and capriciously in providing coverage for one patient and denying coverage for another where there are seminal differences in the stage of the patients' disease and the quality of the studies for which they sought coverage.
The third and final level upon which Empire's decision to deny coverage for HDCT for Mr. Zervos could be found to be arbitrary and capricious is in the appeal process. See Zervos, 252 F.3d at 174-75. This is a separate inquiry from this Court's determination that the policy decision to deny coverage for HDCT due to the experimental/investigational nature of the treatment was not arbitrary and capricious. As previously indicated, this Court finds that Empire's initial policy decision and Mr. Zervos' denial pursuant to that policy was reasonable and rational based on the evidence. See supra at 11-20. However, the inquiry does not end there. It is at the appeal stage of the process that Empire's procedure is flawed.
[A]n insurer who denies benefits under a plan governed by ERISA must rely on the express language of the plan itself. It may not insert its own terms into the plan." Elsroth, 10 F. Supp. 2d at 436-37 (citing Velez v. Prudential Health Care Plan of N.Y., Inc., 943 F. Supp. 332, 341 (S.D.N.Y. 1996) ("a fiduciary . . . cannot disregard any policy requirement, nor can it implicitly incorporate into the policy any term that does not expressly appear"); Kekis v. Blue Cross and Blue Shield of Utica-Watertown Inc., 815 F. Supp. 571, 579 (N.D.N.Y. 1993) ("fiduciary who ignores terms of the policy and inserts its own terms acts arbitrarily and capriciously"); Dozsa v. Crum Forster Ins. Co., 716 F. Supp. 131, 139 (D.N.J. 1989) (fiduciary abused discretion where he "applied a different exclusion having different criteria from the Plan's exclusion")). See also Gallo v. Madera, 136 F.3d 326, 330 (2d Cr. 1998) ("Even when trustees of a pension plan are entitled to deference in interpreting the terms of the plan, deference cannot be so broad as to permit them to graft additional requirements onto unambiguous plan definitions.")
In examining the reports submitted by the external reviewers in Mr. Zervos' case and in the case of the female patient who was granted coverage, and comparing those reports to the contract language, it is clear to this Court that the reviews are inconsistent and do not constitute a direct and clear review of the experimental/investigational denial. Empire represented to Mr. Zervos that he was denied because HDCT is experimental and investigational. (Def's Ex. 3.) This is an appropriate exclusion, as defined in the contract. However, while this was the reason for the initial denial of coverage to Mr. Zervos, it is apparent that any final decision after appeal is not limited to this level of review. First of all, none of the questions posed to the reviewers are direct questions that elicit a clear and unequivocal response regarding whether the treatment is of proven benefit or generally recognized by the medical community as effective or appropriate for the condition. From the questions posed, the nature of the determination that the reviewers are being asked to make is unclear. Dr. Wolinsky's original affidavit to this Court declared that an appeal by a covered person from a denial of coverage, it is Empire's policy to abide by whatever decision the external reviewer makes." (Pl's. Ex. 63.) At trial, he later testified that this is "somewhat misleading" in that MCOP does not make the coverage decision or the decision whether the treatment is experimental/investigational. (Tr. at 625-26.) According to Dr. Wolinsky, the reviewers make a decision regarding the status of the treatment based on their review of the medical literature, whether a treatment is generally recognized as effective or appropriate, and a clinical determination as to whether the requested treatment would be the best treatment for the particular patient. (Tr. at 106-07, 626.) Most of the questions posed to the reviewers, however, do not directly elicit those opinions. For example, question two asks "Does the scientific evidence support a result of improvement in health outcome?". (Def's. Ex. 18; Def's. Ex. 21.) Question three asks "Does the technology improve the net health outcome?". Id. Question four asks "Is the technology as beneficial as any of the established alternatives?". Id. Question seven does ask "Is the recommended treatment plan the best treatment available for this patient at this time?". Id. According to Dr. Wolinsky's testimony, if the reviewer answers that the treatment is beneficial and the best treatment for the patient, then Empire would cover the treatment. (Tr. at 108; see also Sokolow Dep. at 62, stating "We subject any negative decision to external review and in the event that the external reviewer makes an affirmative decision, we agree to cover under those circumstances.") However, there is no requirement in the definition of experimental/investigational that a treatment be the "test treatment." None of these questions directly reflect a determination of whether the treatment is of proven benefit or generally recognized by the medical community as effective or appropriate for the condition, nor does any of the language or terms used in the questions posed to the reviewers relate to coverage language in the contract.
Dr. Wolinsky also testified that he may weigh the answers to the questions differently for each review. According to Dr. Wolinsky, question one has no applicability to this particular case. (Tr. at 629.) When Dr. Wolinsky examined the reviews in Mr. Zervos' case, the questions he weighed most heavily in the Weiss review were questions two, tree, four, and seven (Tr. at 137), but the questions he weighed most heavily in the Spitzer review were questions two, three, and seven (Tr. at 655-56). Dr. Wolinsky further testified that "question six really doesn't relate to the coverage decision," and a reviewer being unable to respond to that question does not impact his ability to make a coverage decision. (Tr. at 638.) These inconsistencies are the very practices prohibited by the arbitrary and capricious standard.
The questions currently posed to the reviewers are confusing and at times unintelligible to the medical experts. The confusing nature of the questions is illustrated by the different answers given by the reviewers. In response to question four, which asks "Is the technology as beneficial as any of the established alternatives?", Dr. Spitzer answers "Yes. High dose chemotherapy and autologous stem cell transplantation appears to be as effective as prolonged combination therapy for metastic breast cancer." (Defs. Ex. 18) (emphasis added). Dr. Weiss answers "There is no published evidence that indicates HDC/PBPCT for men with metastic breast cancer is any more beneficial than any other form of chemotherapy." (Defs. Ex. 21) (emphasis added). Dr. Wolinsky's explanation for this inconsistency is that Dr. Spitzer must have misunderstood the question. (Tr. at 656.) In response to question 5, which asks "Is this improvement obtainable outside of the investigational setting?", Dr. Spitzer answers "Not applicable" (Defs. Ex. 18), while Dr. Weiss answers "No" (Defs. Ex. 21). In response to question 7 regarding whether this is the best treatment available for the patient, both Dr. Spitzer and Dr. Weiss answer no. However, the reviewer of the female patient's case did indicate that it was the best treatment because it was a randomized phase 3 trial. (Pl's. Ex. 47.) Although desirable for medical research, it is unclear why a phase 3 trial would be the "best treatment." The phase of the trial has nothing to do with the proven effectiveness of the treatment, but only relates to the worth of the data collected. Moreover, whether HDCT would be "of proven benefit" to the patient rather than whether ills the "best treatment available" is a more relevant consideration under the contract language. Furthermore, the reviewer of the female patient's case was asked an additional question, which the Zervos reviewers were not. That patient was also initially denied under the experimental/investigational exclusion. (Tr. at 645.) However, the reviewer in that case answered no the additional question "Do you agree with the medical necessity denial . . .?" (Pl's. Ex. 47.) This is the clearest question directed to any of the reviewers regarding whether or not the patient should get the treatment, yet nothing similar was asked of Dr. Spitzer or Dr. Weiss in Mr. Zervos' case.
The decision to provide coverage pursuant to the MCOP review for the female patient was made by another Empire medical director in Dr. Wolinsky's absence. When questioned about his interpretation of the reviewer's recommendation, he testified "It's confusing . . . because the reviewer says in question 2 and 3 that ifs not known whether it will improve the outcome and the evidence does not support improvement in the outcome, but yet in 7 it says it's the best treatment available for the patient. . . In 4 it says beneficial as the alternative. So that seems contradictory to me.
Q. Part of the confusion is caused by question number 7, correct, the answer to question number 7? A. Well, the confusion in this case is caused by all of the answer being somewhat contradictory. . . Sure, 7 is part of it, the same as the answers to 2, 3, and 4 are part of the confusion." (Tr. at 64748.)
Empire has also demonstrated that it will provide coverage despite the experimental/investigational nature of the therapy under certain circumstances based on such a medical recommendation by MCOP, i.e. in a phase 3 clinical trial as indicated by the female patient who received coverage. However, this exception is not embodied in the language of the contract or addressed directly in the questions posed to the reviewers. None of the questions posed to the reviewers are direct questions regarding whether there is some other medical or research reason the patient should receive the treatment despite its experimental/investigational exclusion.
Empire abides by the recommendation of the MCOP reviewer even where the treatment is recommended despite its experimental/investigational determination. Empire has demonstrated that it will provide coverage despite the experimental/investigational determination in the context of a well-designed clinical trial. It is a reasonable, logical medically determined exception. However, it is an exception not provided for in the contract. All insureds are entitled to the same full consideration.
This Court finds that Empire's appeals process is arbitrary and capricious. However, based on the administrative record, this Court cannot find that the treatment is not experimental/investigational as defined in the contract or that there is some other medical or clinical reason that the patient should receive this treatment. This is still a medical determination to be made by a full and fair review by medical experts based on the current state of the medical literature and plaintiffs current medical condition and suitability for the proposed treatment. It is therefore inappropriate for this Court to order Empire to provide coverage to plaintiff for this treatment. Under the principles enunciated in Miller, 72 F.3d at 1071 ("if upon review a district court concludes that the Trustee's decision was arbitrary and capricious, it must remand to the Trustees with instructions to consider additional evidence unless no new evidence could produce a reasonable conclusion permitting denial of the claim or remand would otherwise be a "useless formality.'"), this Court remands this case to Empire for an immediate expedited review within 48 hours of plaintiffs submission of current relevant information to be considered. This Court orders that this review must be conducted by a new MCOP reviewer, and include direct questions that elicit a clear and unequivocal response regarding whether the treatment is of proven benefit or generally recognized by the medical community as effective or appropriate. The reviewer should also be clearly and directly asked whether there is any other medical or clinical reason that the patient should receive the treatment despite its experimental/investigational nature. The totality of the evidence presented does not convince this Court that a different determination is necessarily likely or appropriate. However, plaintiff is entitled to a full and fair review to determine his current suitability for this treatment under the proposed treatment protocol, and given the present state of his health.