01 Civ. 685(GBD).
March 14, 2001.
MEMORANDUM OPINION ORDER
Plaintiff, Nickolas Zervos, moves for a preliminary injunction pursuant to Rule 65(a) of the Federal Rules of Civil Procedure requesting that defendants be enjoined from refusing to provide coverage, pre-certify, and pay for a cancer treatment, which consists of a single cycle of high-dose chemotherapy followed by an autologous blood stem cell transplant ("HDCT"). Plaintiff requests that this Court compel defendants to pay for HDCT rather than the conventional chemotherapy for which defendants now provide coverage. Defendants previously provided coverage for HDCT, until March 2000, when defendant Empire Healthchoice, Inc. ("Empire") concluded that HDCT was "experimental and investigational" and of unproven benefit to patients. They continue, however, to provide coverage for a conventional chemotherapy regimen.
Plaintiff's efforts to obtain whatever treatment might give him a chance to overcome a grave and potentially fatal disease is understandable and sympathetic. Unfortunately, a full and thorough consideration of the arguments and evidence proffered does not support the issuance of a preliminary injunction. Therefore, his application must be denied.
Plaintiff argues that this Court should grant a preliminary injunction on his behalf because he will be irreparably harmed through his substantial additional suffering and probable death without HDCT.
Plaintiff also argues that he will also be irreparably harmed because he is unable to bear the costs of HDCT without rendering his family destitute, and the hospital will not proceed without the health plan carrier's pre-certification, or in the absence of pre-certification, pre-payment in full. Defendants argue that an injury is not irreparable if it can be remedied by money damages. Borey v. Nat'l Union Fire Ins. Co., 934 F.2d 30, 34 (2d Cir. 1991). For the purposes of this motion, this Court accepts plaintiff's assertions that HDCT will be unavailable to him without insurance coverage.
He also alleges that he is likely to succeed on the merits of this action because of the arbitrary and capricious manner in which the defendants determined to deny coverage. He primarily argues that the health plan administrators who make decisions regarding the denial of benefits acted arbitrarily and capriciously in violation of his rights under the Employee Retirement Income Security Act of 1974 ("ERISA"), 29 U.S.C. § 1001 et seq, and therefore their judgment should be preempted by this Court.
Additionally, Plaintiff argues that defendant's denial of medical coverage for HDCT violates his rights under Title VII of the Civil Rights Act of 1964 ("Title VII"), 42 U.S.C. § 2000e et seq., and its companion state and local anti-discrimination statutes, New York State Executive Law § 296(1)(a) and New York City Administrative Code Title 8, § 8-107(1)(a) because defendants discriminated against plaintiff based on his gender. He alleges that defendants were willing to pay for HDCT for women suffering from metastatic breast cancer, but were unwilling to pay for HDCT for men. Plaintiff contends that there is no medical basis for defendants to draw a distinction between genders in the treatment of this disease.
Plaintiff finally argues that defendants also violated his rights under the Americans with Disabilities Act of 1990 ("ADA"), 42 U.S.C. § 12101 et seq., by discriminating against him in the provision of health care insurance on the basis of his disability. Plaintiff alleges that defendants have decided to improperly single out the management of metastatic breast cancer in male patients. Plaintiff again contends that there is no medical basis to distinguish between male and female breast cancer patients in the covered provision of this treatment.
Plaintiff was first diagnosed with metastatic breast cancer ("MBC") in March 2000. Initially, plaintiff received a radial mastectomy, followed by a conventional chemotherapy regimen prescribed by plaintiff's treating physician from April 2000 until October 2000. Defendant Empire provided coverage, pre-certified and paid for all procedures and services attendant with that regimen. Upon completing conventional chemotherapy, plaintiff's physician, Dr. Charles Hersdorffer, recommended HDCT, finding that plaintiff was a qualified and appropriate candidate for such treatment at that time, and expected plaintiff to be ready to commence HDCT in mid-November 2000. Plaintiff's physician prepared paperwork on plaintiff's behalf requesting coverage for HDCT, and transmitted the forms to Empire for approval. Declaration of Charles Hersdorffer, dated January 30, 2001("Hersdorffer Dec.") ¶ 7.
Under the terms and language of the Medical Plan, defendants provide coverage and benefits for procedures that are "Medically Necessary," which is defined as "care which, according to the Claims Administrator's criteria and in the Claims Administrator's judgment, is: consistent with the symptoms or diagnosis and treatment of the Covered Person's condition, Illness, ailment or Injury; in accordance with the standards of good medical practice; not solely for the Covered Person's convenience or that of the Covered Person's Physician or other provider; not primarily custodial; and the most appropriate supply or level of service which can safely be provided to the Covered Person."
Order to Show Cause, Exhibit F "NYNEX Medical Expense Plan" at 13. The Plan excludes coverage for procedures that are "Experimental/Investigational, " which is 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." Order to Show Cause, Exhibit F "NYNEX Medical Expense Plan" at 8 (emphasis added).
For several years, Empire provided coverage for HDCT to any individual, male or female, suffering from breast cancer and for whom HDCT was recommended. In 1999, Empire began to question and re-evaluate its policy with respect to HDCT as a result of conflicting evidence and opinions within the medical community as to its effectiveness. In March 2000, Empire's Technology Assessment Committee ("TAC") convened to discuss the efficacy of HDCT. After a review of the then existing available medical literature, Empire concluded that HDCT was not effective in improving breast cancer patients' chances of survival, and therefore decided to change its policy and thereafter deny all future applications by breast cancer patients based on the determination that HDCT was investigational. Declaration of Steven Wolinsky, M.D., dated February 13, 2001 ("Wolinsky Dec.") ¶ ¶ 18-20.
Although Empire now routinely rejects applications for HDCT, through its review process a patient may appeal that decision and still obtain the treatment if it is recommended by an independent outside medical expert. Appeals of decisions rendered by Empire are referred to the Medical Care Ombudsman Program ("MCOP"), a private organization, unaffiliated with Empire, that provides review of pre-certification by insurers. MCOP randomly selects reviewers on a rotating basis according the reviewer's specialty, clinical expertise and availability. MCOP provides these referrals for insurers "that seek review of patients to whom they have denied pre-certification, on the grounds that the proposed HDCT is `experimental/ investigational.'" See Elsroth v. Consolidated Edison Co. of New York, 10 F. Supp.2d 427, 430 n. 4 (S.D.N.Y. 1998). Once the reviewer is selected, he or she reviews the patient's records and opines as to "whether the proposed treatment is appropriate in light of current medical practice, `within the framework of the [plan's] provisions.'" Id. Empire's policy is to abide by whatever decision the external reviewer makes on an appeal. Wolinsky Dec. ¶ ¶ 22, 28-30.
Empire received plaintiff's request for coverage for HDCT on October 17, 2000. In accordance with its then existing policy, Dr. Steven Wolinsky, Director of Medical Policy of Empire, denied plaintiff's request on the basis that the requested HDCT was "Experimental" and "Investigational," because it was not of proven benefit for metastatic breast cancer, or generally recognized by the medical community as an effective treatment. Dr. Wolinsky then informed plaintiff's doctor, Dr. Charles Hersdorffer, of his denial of coverage, at which point Dr. Hersdorffer requested an external peer review of Dr. Wolinsky's decision. As per Empire's policy for review of its decisions, Dr. Wolinsky then referred this appeal to MCOP.
On October 20, 2000, MCOP selected Dr. Thomas R. Spitzer, Director of the Bone Marrow Transplant Program and Deputy Chief of the Hematology-Oncology Unit at Massachusetts General Hospital, to conduct the review of Empire's denial of coverage. Dr. Spitzer reviewed plaintiff's medical records, as well as the treatment plan proposed by plaintiff's physician. He concluded that in his opinion there was "no convincing medical evidence that high-dose chemotherapy and stem cell transplantation is more effective in treating patients with metastatic breast cancer than conventional therapy. [Moreover], the high-dose chemotherapy and stem cell transplant proposed for Mr. Zervos will not improve his health outcome over what is to be expected from conventional chemotherapy. Conventional chemotherapy is likely to be as effective in terms of overall survival for Mr. Zervos." Declaration of Thomas R. Spitzer, dated February 9, 2001 ("Spitzer Dec.") ¶ ¶ 5-6. Dr. Spitzer agreed with Empire's determination to deny plaintiff insurance coverage for HDCT.
Dr. Wolinsky then sent a letter to Mr. Zervos informing him that Empire's denial of coverage had been confirmed on appeal. In late January 2001, defendant Verizon New York, Inc., plaintiff's employer, requested that Empire send plaintiff's case out for a second external peer review. Empire agreed and again referred the appeal to MCOP, which randomly selected Dr. Raymond B. Weiss, a Clinical Professor of Medicine at the Lombardi Cancer Center of Georgetown University School of Medicine to independently review plaintiff's case for a second time. Wolinsky Dec. ¶¶ 33-35. Dr. Weiss's finding was that "there is no scientific evidence that high-dose chemotherapy and stem cell transplantation is more effective in treating patients with metastatic breast cancer than conventional therapy. There is no scientific evidence that indicates that overall survival is improved using high-dose chemotherapy and stem-cell transplantation. . . The best established treatment, for metastatic breast cancer, for men and women, is conventional chemotherapy." Declaration of Raymond B. Weiss, dated February 9, 2001 ("Weiss Dec.") ¶¶ 5-7. Moreover, Dr. Weiss found that "Mr. Zervos is even less likely than others to benefit from this treatment because he achieved only a partial response to conventional chemotherapy as of the last medical records available to me (October 2000)." Weiss Dec. ¶ 7. As did Dr. Spitzer before him, Dr. Weiss also agreed with Empire's determination to deny plaintiff insurance coverage for HDCT. Accordingly, Empire, consistent with the recommendations of the two external reviewers as well as its own internal policy to no longer provide coverage for HDCT, continued to deny coverage for this treatment to plaintiff. However, Empire agreed to provide coverage, and continues to pay for conventional chemotherapy treatments for plaintiff.
Once Empire refused to pay for HDCT, plaintiff's physician recommended that he undergo radiation therapy in an effort to maintain the status quo while he attempted to convince defendants to reconsider their denial of coverage. The radiation treatments ended on January 18, 2001, and plaintiff became eligible to receive HDCT on or about the end of February. Plaintiff's physician has declared that, as a result of conventional chemotherapy treatment, plaintiff's cancer is currently in remission.
Plaintiff exhausted his administrative and contractual remedies under his health care plan (the "Plan"). He filed a charge of discrimination under Title VII and the ADA with the EEOC, and further requested that the EEOC issue an immediate right to sue letter. Thereafter, on January 29, 2001, plaintiff filed this action and brought this motion for a preliminary injunction requesting that this Court enjoin defendants from refusing to pre-certify and provide insurance coverage to plaintiff for HDCT. The Court heard argument on the motion on February 20, 2001.
Defendants argue that plaintiff created the exigent circumstances which he believes necessitate a preliminary injunction by waiting three months from the time he was initially denied coverage by defendants to bring this action. Defendants' Memorandum of Law In Opposition to Plaintiff's Motion For a Preliminary Injunction ("Def. Mem.") at 27. Plaintiff responds that he spent months after his denial soliciting the aid of breast cancer advocacy groups and the New York State Attorney General's Office, the latter of which attempted to persuade defendants to reconsider their position with regards to plaintiff. His delay in bringing the instant action was attributed to his desire to resolve this conflict without litigating with his employer. Reply Memorandum of Law In Support of Motion For Preliminary Injunction ("Pl. Reply Mem") at 18-19; Transcript, dated February 20, 2001 at 17-18. This Court is not considering the timing of when plaintiff brought this action as any factor in the determination as to whether or not to issue a preliminary injunction.
In this Circuit, a preliminary injunction may be granted if the moving party shows "1) absent injunctive relief, it will suffer irreparable harm, and 2) either a) that it is likely to succeed on the merits, or b) that there are sufficiently serious questions going to the merits to make them fair ground for litigation, and that the balance of hardships tips decidedly in favor of the moving party." Wright v. Giuliani, 230 F.3d 543 (2d Cir. 2000); see also Jackson Dairy, Inc. v. H.P. Hood Sons, Inc., 596 F.2d 70, 72 (2d Cir. 1979).
Plaintiff argues that since he is "claiming that he is entitled to coverage under the terms of a health or medical policy, which right has been abridged by a violation of the contractual obligation to provide such coverage, a preliminary injunction requested to afford the same is properly considered to be more prohibitory than mandatory in nature." Plaintiff's Memorandum of Law In Support of Motion For Preliminary Injunction ("Pl. Mem.") at 6 (citations omitted). However, defendants argue that "[t]he relief sought by Mr. Zervos is a `mandatory' preliminary injunction, in that it seeks to alter the status quo by commanding some positive act — i.e., payment by Empire." Def. Mem. at 17 (citations omitted). Defendants argue that this Court should apply a heightened standard given that if the preliminary injunction is granted, the plaintiff will receive all of the ultimate relief sought. Plaintiff does not contest that the standard that should be applied when a mandatory preliminary injunction is sought is that plaintiff must make a "strong" showing of irreparable injury, and a "substantial" likelihood of success on the merits. See Marro v. K-III Communications Corp., 943 F. Supp. 247, 249 (E.D.N.Y. 1996). In any event, this Court is not persuaded that Mr. Zervos can show either irreparable injury or a substantial likelihood of success on the merits under either standard.
I. Irreparable Harm
The evidence proffered by plaintiff does not demonstrate that he will suffer irreparable harm if defendants are not immediately compelled to provide coverage for HDCT. Plaintiff argues that the evidence put before this Court through the declarations of two experts and their accompanying exhibits demonstrate that plaintiff's health will be irreparably injured if he does not receive HDCT. He argues that HDCT is "the only treatment which offers him a reasonable prospect of long-term disease-free survival." Pl. Reply Mem. at 2.
Plaintiff's first expert, Dr. Roy Jones, director of the Bone Marrow Transplant Program at the University of Colorado Health Science Center asserts that HDCT "provides Mr. Zervos his best chance for long-term disease free survival and, moreover, is likely superior to any of the so-called conventional therapies available to him." Declaration of Dr. Roy B. Jones, dated February 9, 2001 ("Jones Dec.") ¶ 14. In support of that opinion, Dr. Jones points to a study which he co-authored in June 2000, Yogo Nieto, et al. "Status of High-Dose Chemotherapy for Breast Cancer: A Review"(the "Jones Study") Jones Dec., Exhibit B. Dr. Jones co-authored that review with 14 prominent researchers in the field of High Dose Chemotherapy for breast cancer who were affiliated with 9 highly recognized and regarded cancer research centers in the United States. In his declaration to this Court, Dr. Jones states "that review . . . reflects the opinion of its authors, myself included, that High Dose Chemotherapy continues to offer superior prospects and benefits to conventional chemotherapy, particularly for patients in Mr. Zervos' condition." Jones Dec. ¶ 5.
The Jones Study, however, is couched in language that is far less conclusive or compelling. A close examination of the study's findings do not support the definitive conclusions that he urges upon the Court in his declaration. His published study concludes that "[a]lthough results from phase 2 studies are encouraging, an answer to the important question of its relative merit over standard chemotherapy will come only from the mature results of randomized phase 3 studies, most of which are still underway, either in the accrual phase or with enrollment completed. . . . Such data will be forthcoming in the next few years." Jones Dec., Exhibit B at 489. (emphasis added). The Jones Study reports that although there were "promising results," there are also "detractors of HDCT." The research upon which the reported study was based demonstrated that "although the results from phase 2 trials of HDCT in MBC were encouraging, it became clear that the majority of MBC patients still relapsed after HDCT." Id. at 478. The opinion of the authors of this study, including plaintiff's expert, Dr. Jones, regarding the general acceptance of HDCT in the medical community was that "this ongoing controversy clearly underscores the need for mature data from prospective well-designed and adequately sized randomized phase 3 trials." Id. The study's ultimate conclusion regarding the question of "are current HDCT regimens better than standard-dose chemotherapy for MBC," was that "in summary, currently available results from randomized trials in MBC reported to date are contradictory." Id. at 481.
Plaintiff's second expert is his own doctor, Dr. Charles Hersdorffer, Director of the Bone Marrow Transplant Program, Division of Medical Oncology, at the College of Physicians and Surgeons of Columbia University. Dr. Hersdorffer states that he believes that HDCT "affords Mr. Zervos the best opportunity for long-term survival of his metastatic cancer. . . . The longer term survival prospect with the Treatment affords him the opportunity of, if not having a complete cure, of long-term survival until other, newer treatments are developed." Declaration of Charles Hersdorffer, dated January 30, 2001 ("Hersdorffer Dec.") ¶ 12. Additionally, plaintiff's physician concludes that "available studies on high dose Chemotherapy" strongly suggest that HDCT will produce a 15-25% increase in long-term survival over more "`conventional' modalities." Supplemental Declaration of Charles Hersdorffer, dated February 13, 2001 ("Hersdorffer Supp. Dec.") ¶ 4. Dr. Hersdorffer further asserts that "[b]ased on the available data, Mr. Zervos' life expectancy without the Treatment would be 18-24 months.
Based on the available data with the Treatment his life expectancy would be greater than 24 months."
Hersdorffer Supp. Dec. ¶ 9. There is no specific evidence in the record that supports these blanket assertions. Nor does Dr. Hersdorffer identify the "available studies" or "available data" upon which he bases his opinions. The only proffered study that suggests that HDCT might produce any increase in long-term survival over conventional therapy is the Jones study previously discussed. That study found that ". . . HDCT was used as immediate consolidation after dose-intense adriamycin-based induction chemotherapy, which was administered to maximally cyto-reduce the tumor before HDCT. Phase 2 trials testing this strategy . . . consistently showed a longer term disease free survival rate of 15% to 25%." Jones Dec., Exhibit B at 477-478. The study further noted that "[t]hese encouraging phase 2 data . . . generated great enthusiasm among physicians and patients for the use of HDCT. . . [and] resulted in an explosive growth in the number of breast cancer patients receiving HDCT, despite the lack of results of randomized studies demonstrating that this approach should be the standard of care." Id. at 478. (emphasis added). Therefore, plaintiff offers no clear indication that HDCT would be beneficial, or would be a superior method of treatment to that which he is currently receiving. The Jones study upon which plaintiff's experts heavily rely supports a conclusion that HDCT is not generally accepted by the medical community as the standard of care nor is it currently of proven benefit for the treatment of metastatic breast cancer.
Moreover, in contrast to the proffered opinions of plaintiff's experts, there is ample evidence in the record to support Empire's contrary conclusion that HDCT is ineffective and potentially harmful to those who seek it. This includes the most widely-recognized study published by the New England Journal of Medicine in April 2000, Edward A. Stadtmauer, et al. "Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer," 342 New Eng. J. Med. 1069 (2000); Declaration of Robert Peter Gale, M.D., Ph.D. ., dated February 12, 2001 ("Gale Dec."), Exhibit C; Weiss Dec., Exhibit C; Spitzer Dec., Exhibit C. This randomized study compared high-dose chemotherapy plus hematopoietic stem-cell rescue with a prolonged course of monthly conventional-dose chemotherapy in women with metastatic breast cancer. The study noted that "women with metastatic breast cancer who have a complete or partial response to standard chemotherapy and then receive high-dose chemotherapy and undergo autologous stem-cell transplantation do not survive longer or have a longer time to progression of disease than women who receive maintenance therapy with conventional doses of cyclophosphamide, methtrexate and fluorouracil." Id. at 1074. Additionally, the authors of the study concluded that "the routine practice of administering several cycles of conventional induction therapy followed by a single course of high-dose chemotherapy and stem-cell rescue cannot be recommended for women with metastatic breast cancer." Id. at 1076. The study found that "[a]s compared with maintenance chemotherapy in conventional doses, high-dose chemotherapy plus autologous stem-cell transplantation soon after the induction of a complete or partial remission with conventional-dose chemotherapy does not improve survival in women with metastatic breast cancer." Id. at 1069.
Additionally, the only study to have previously concluded that there was some definite benefit to metastatic breast cancer sufferers who received HDCT, which was conducted in 1995 by Dr. Werner Bezwoda, was called into question by the medical community when Dr. Bezwoda was personally discredited after admitting to falsifying data and results in a related HDCT study. As a consequence, the results of the Bezwoda study are no longer relied upon by the majority of the medical community.
Dr. Jones in his declaration asserts that "at the University of Colorado, where we continue to offer high dose chemotherapy for breast cancer, many insurance carriers have continued to cover such treatment." Jones Dec. ¶ 15. However, defendants have also introduced evidence into the record that cancer centers such as Memorial Sloan-Kettering and the Mount Sinai Medical Center in New York City "no longer treat metastatic breast cancer patients with autologous stem cell transplant approaches as a standard modality." Declaration of Janice L. Gabrilove, M.D., dated February 13, 2001 ¶ 6.
Furthermore, the position statement of the American Society of Clinical Oncology on the safety and effectiveness of HDCT is that "[g]iven the lack of persuasive data demonstrating superior effectiveness of this very toxic therapy, the American Society of Clinical Oncology recommends that high dose chemotherapy followed by autologous bone marrow transplants for breast cancer should only be performed in the context of a high quality clinical trial." Gale Dec., Exhibit B (emphasis added).
Giving careful consideration to the evidence put into the record by both plaintiff and defendants, this Court concludes that the evidence is not persuasive that HDCT would provide superior results than standard-dose chemotherapy. The evidence presented by plaintiff as compared to that proffered by defendants does not support a conclusion that HDCT is of proven benefit for the treatment of metastatic breast cancer or is generally recognized by the medical community as effective or appropriate for that condition. HDCT continues to be controversial and unproven as to its benefits or effectiveness in relation to conventional therapies currently offered and accepted as the standard of care and treatment. Since plaintiff cannot demonstrate that HDCT will be more beneficial to him than continuation of conventional chemotherapy, he has not sustained his burden of proving to this Court that he will be irreparably harmed if this Court does not order defendants to pay for HDCT rather than conventional chemotherapy. See Elsroth v. Consolidated Edison Co. of New York, 10 F. Supp.2d 427, 432-33 (finding that the Court's failure to compel defendants to pay for HDCT would not result in irreparable harm since "the overwhelming evidence is that [plaintiff] will benefit no more from the proposed HDCT than from a continuation of the standard chemotherapy.")
II. Likelihood of Success on the Merits
Additionally, plaintiff not only fails to demonstrate irreparable harm, but he also fails to demonstrate a likelihood of success on the merits. Mr. Zervos is covered by a health and medical insurance policy provided by virtue of his employment, and is therefore a beneficiary of an employment benefit plan subject to ERISA. Plaintiff is accordingly permitted to challenge defendants' denial of coverage for HDCT pursuant to 29 U.S.C. § 1132 (a)(1)(B) which provides that a civil action may be brought by a participant or beneficiary "to recover benefits due to him under the terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future benefits under the terms of the plan[.]"
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."
Where discretionary authority is provided, a court should review the denial under an arbitrary and capricious standard. Firestone Tire and Rubber Co. v. Bruch, 489 U.S. 101, 115 (1989); Pagan v. Nynex Pension Plan, 52 F.3d 438, 441 (2d Cir. 1995). 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)). However, where the standard of review is arbitrary and capricious, a court may only overturn a decision to deny benefits if "there has been a clear error of judgment" Jordan v. Retirement Comm. of Rensselaer Polytechnic Inst., 46 F.3d 1264, 1270 (2d Cir. 1995), that is only if it was `without reason, unsupported by substantial evidence, or erroneous as a matter of law." Pagan, 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) (citations omitted). Moreover, the scope of review under this standard is narrow, and when the court is considering the issue, it 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 the instant case, both plaintiff and defendants agree that this Court should apply an arbitrary and capricious standard of review when evaluating defendants' denial of benefits. See Pl. Mem. at 9; Def. Mem. at 19. The provisions of the Plan clearly gives the administrator or fiduciary discretionary authority to determine eligibility for benefits or to construe the terms of the plan . See Order to Show Cause, Exhibit G, "Other Plan Provisions of Bell Atlantic North Associates' Plan" ¶ 8.1 Benefit Claim and Appeal Procedures.
¶ 8.1 states in pertinent part "The Claims Administrator and Appeals Administrator have the right, and the full discretion, and authority as fiduciaries, to:
* Interpret the Plan based on such Plan's provisions and applicable law, and make factual determinations about claims arising under such Plan;
* Determine whether a claimant is eligible for benefits;
* Decide the amount, form, and timing of benefits; and
* Resolve any other matter under the Plan that is raised by a Participant or a beneficiary, or that is identified by either the Claims Administrator or the Appeals Administrator.
The Claims Administrator has sole authority to exercise discretion in the resolution of claims under the Plan. The Appeals Fiduciary has sole authority to exercise discretion in the review and resolution of an appeal of a denied claim under the Plan. In case of an appeal, the Appeals Administrator's decision is final and binding on all parties to the full extent permitted under applicable law, unless the participant or a beneficiary later proves, to a court that has jurisdiction under ERISA to review the Appeals Administrator's decision, that the Appeals Administrator's decision was an abuse of fiduciary discretion."
Plaintiff alleges that defendants acted arbitrarily and capriciously in their decision to change their policy in March 2000 to deny coverage of HDCT because the decision is "without reason" and "unsupported by evidence." Pl. Reply Mem. at 14. Plaintiff argues that the medical literature does not support that decision. Additionally, plaintiff argues that defendant's review procedure is arbitrary and capricious because "they send it to outside consultants, and if the outside consultant says they should get the treatment, they get it . . . but if they send it to another outside person who says no, then that person doesn't get it. . . . [T]hat in and of itself bespeaks of an arbitrary and capricious implementation of the plan." Transcript, dated February 20, 2001 at 6-7. The defendants assert that their consideration of the developments in the medical and scientific literature convinced them that HDCT did not improve a patient's chance of survival, and they therefore decided to deny all future applications of HDCT as investigational.
1999, Empire began to reconsider its policy to provide coverage for HDCT because of developments in the medical literature that raised questions about the effectiveness of the treatment.
Declaration of Alan E. Sokolow, M.D., dated February 13, 2001 ("Sokolow Dec.") ¶ 17. In March 2000, Empire's TAC, which determines whether Empire should cover certain medical treatments, convened to determine whether Empire should continue to provide coverage for HDCT. The TAC reviewed the scientific data available to them, considered the fact that the results of Dr. Bezwoda's favorable study were discredited, and concluded that "[t]here is a 60%-70% 3 year survival rate no matter what the treatment." Sokolow Dec., Exhibit F. After considering all of the medical evidence of HDCT's unproven benefit, the TAC determined that "initial requests for these services would be denied on the bases that they are investigational and there is no proof in the literature that they are effective or that they are more effective or equally effective to standard treatment." Sokolow Dec., Exhibit F at 9.
The proffered evidence indicates that the treatment at issue falls within the Plan's definition of "Experimental/Investigational" treatment. Given that the evidence put in the record regarding this treatment can at best be characterized as conflicting, and that none of the evidence demonstrates that this treatment is generally accepted by the medical community, it was reasonable for defendants to categorize this treatment as experimental and investigational and deny coverage on that basis.
In reviewing defendants' decision to deny coverage of HDCT, this Court finds, as have many other Courts have found regarding the provision of HDCT, that defendants did not act arbitrarily and capriciously in declining to cover plaintiff's requested treatment. Defendants reasonably concluded that it is investigational and experimental, not of proven benefit for the treatment of plaintiff's condition, and not generally recognized as effective or appropriate by the medical community for his condition. See, e.g. Elsroth v. Consolidated Edison Co. of New York, 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). While this Court notes that there are varying conclusions over the years by the federal courts in their determinations as to whether or not this treatment is experimental or investigational, there is no evidence that any Court has found that HDCT is generally accepted in the medical community since the 1995 Bezwoda study was discredited, and the New England Journal Medicine concluded that HDCT was not recommended. Therefore, considering the definition of "Experimental/Investigational" under Empire's plan, and the evidence that Empire considered in determining to change its policy regarding coverage of HDCT, this Court finds that the evidence proffered supports a conclusion that defendants' decision was rational and considered, not arbitrary and capricious. Additionally, given that the lone study to have previously given credence to the effectiveness of HDCT was discredited in February 2000, the time frame in which Empire chose to reconsider its policy is also logical and reasonable, and not arbitrary and capricious.
During oral argument on February 20, 2001, this Court asked plaintiff if there were any cases that address plaintiff's requested HDCT and exactly the relief plaintiff is seeking. In response to that question, plaintiff submitted a letter brief to the Court. Plaintiff cited Velez v. Prudential Health Care Plan of New York, Inc., 943 F. Supp. 332 (S.D.N.Y. 1996); Marro v. K-III Communications Corp., 943 F. Supp. 247 (E.D.N.Y. 1996); Kekis v. Blue Cross Blue Shield of Utica-Watertown, Inc., 815 F. Supp. 571 (N.D.N.Y. 1993); Kulakowski v. Rochester Hospital Service Corp., 779 F. Supp. 710 (W.D.N.Y. 1991); Bucci v. Blue Cross-Blue Shield of Connecticut, Inc., 764 F. Supp. 728 (D.Conn. 1991); Scalamandre v. Oxford Health Plans (N.Y.), Inc., 823 F. Supp. 1050 (E.D.N.Y. 1993). Upon reviewing these cases, this Court finds that each of the situations confronted by the respective Courts is distinguishable from that in the instant case. Moreover, the decisions cited by plaintiff were rendered prior to the new developments in the medical literature which convince this Court that HDCT can no longer be defined as generally accepted in the medical community.
Plaintiff further claims that defendants' review procedure for making its final determinations regarding coverage is itself arbitrary and capricious. Since defendants made a reasonable determination to no longer provide coverage of HDCT, consistently following that policy to deny coverage in Mr. Zervos' case was reasonable, and not arbitrary and capricious. Moreover, Mr. Zervos' case was thereafter reviewed by two outside independent reviewers who had no stake — financial or otherwise — in the decision to either agree or disagree with Empire's initial determination. It is Empire's own policy to abide by whatever decision the outside reviewer makes with regard to any individual who appeals a denial of coverage. These MCOP physicians review the records of the patient, and make a determination about whether the treatment for which the patient applies would be beneficial to that individual patient. Therefore, while the general policy of Empire to deny coverage of HDCT was reasonably determined, individuals who might arguably benefit from the treatment have an opportunity to have an independent physician make an individual determination whether or not HDCT would be effective in their situation. This is a process which can only benefit the insured, since despite Empire's adverse decision, the outside reviewer may still make a determination that Empire should cover the treatment for the patient. In Mr. Zervos' case, he had the benefit of, not one, but two outside independent physicians to review the facts of his case, and neither concluded this treatment would be beneficial to him.
Plaintiff also argues that the manner in which individuals choose their insurance plans is arbitrary and capricious because "there is no way for the employee to know which of these plans would provide coverage and which wouldn't. It becomes even more of a lottery system." Transcript, dated February 20, 2001 at 12. Such an argument fails to allege a cognizable claim.
Plaintiff also argues that this process is arbitrary and capricious because if two people apply for HDCT, one may receive coverage for HDCT based on an outside reviewer's determination, and another may not. Plaintiff refers to this as the "`luck of the draw' in what amounts to a lottery that reeks of the very arbitrary and capricious decision-making that ERISA forbids." Pl. Reply Mem. at 4.
However, plaintiff mischaracterizes this process as arbitrary and capricious. The outside reviewers take into consideration all of the factors involved in each individual patient's case file before making a determination that coverage of HDCT should or should not be provided. The fact that some insured parties may receive HDCT and some may not, depending on the review of their individual case, is not a random lottery selection. It is no more arbitrary and capricious than the way cases are assigned to individual judges who must exercise discretion and judgment given the facts and evidence before them, even though no particular individual determination is ever consistently guaranteed. All reviewers are independent outside medical experts selected on a rotating basis according to the reviewer's specialty, clinical expertise and availability. The individual attention given to each insured during the external peer review is structured to be thoughtful and reasoned.
Plaintiff also argues that he can establish a substantial likelihood of success on the merits because he can show that defendants discriminated against him in violation of his rights under Title VII, 42 U.S.C. § 2000e-2(a)(1) which states "it shall be an unlawful employment practice for an employer — to fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment, because of such individual's race, color, religion, sex, or national origin. . ." Plaintiff alleges that defendants have violated his rights under Title VII by "arbitrarily deciding that, solely by virtue of Mr. Zervos' gender, he should not receive the life saving treatment recommended by his physician and that Empire has approved previously as medically efficacious in female insureds suffering from metastatic breast cancer . . .'" Pl. Mem. at 16. Plaintiff argues that defendants provided HDCT for women insureds in the past, but are unlawfully refusing to provide this treatment for Mr. Zervos simply because he is a man. Plaintiff also argues that the outside experts' statements regarding plaintiff's unsuitability for participation in clinical studies of breast cancer in women indicate that they intended to make distinctions based on gender in their denial of his application.
Plaintiff also asserts that the outside reviewers who considered the particular facts of his case discriminated against him based on gender. Plaintiff points to Dr. Spitzer's initial review of his appeal which states "there are no convincing data to show that high dose chemotherapy and autologous stem cell transplantation is a superior approach to conventional chemotherapy for male patients with metastatic breast cancer." Spitzer Dec., Exhibit B. In Dr. Spitzer's declaration he states "I did not mean to imply by this statement that there is any difference between women and men regarding the efficacy of high-dose chemotherapy and stem cell transplantation in treating metastatic breast cancer." Spitzer Dec. ¶ 11.
There is no evidence in the record that discredits Dr. Spitzer's statement, nor is there any evidence that indicates he made his decision to affirm the denial of coverage based on plaintiff's gender. Plaintiff also points to Dr. Weiss' review of plaintiff's case in which he states that plaintiff would be ineligible for an HDCT study for which he sought approval because the title identifies it as a study for women. Weiss Dec., Exhibit B. Given that Dr. Weiss concluded in his declaration that "[t]he best established treatment for metastatic breast cancer, for men and women, is conventional chemotherapy," there is no indication that the denial of coverage of the proposed treatment for Mr. Zervos was based on plaintiff's gender. Weiss Dec. ¶ 6.
The evidence in the record reflects that, until March 2000, defendants provided coverage for HDCT for all patients regardless of gender. Defendants provided coverage for men and women alike, until Empire revised its policy and determined that all future applications for HDCT should be denied because the treatment was investigational and experimental. In fact, the evidence proffered was that only two male patients ever applied for HDCT treatment in the past, and both were granted coverage prior to the 2000 policy change. Wolinsky Dec. ¶ 15. After March 2000, Empire received four applications for coverage of HDCT from breast cancer patients, three women and the plaintiff. Empire initially denied coverage for all four applicants consistent with its policy. Each of the female patients appealed Empire's initial decision, and each of the appeals were referred to an outside expert for review by MCOP. Two of these women had their denials of coverage affirmed by independent reviewers. Only one applicant was granted coverage by an outside reviewer. The female who was approved for HDCT had stage II breast cancer, as opposed to plaintiff who suffers from stage IV metastatic breast cancer. That reviewer also noted that the particular patient was participating in a "`randomized phase III trial,' and that such randomized studies `are essential to determine the true value of [high dose chemotherapy and stem cell transplant] in the treatment of stage II breast cancer.'"
Wolinsky Dec. ¶¶ 21-24. The record before the Court does not support a conclusion that defendants made their determination to deny plaintiff coverage based on his gender. Therefore, plaintiff has not sustained his burden to demonstrate a likelihood of success on the merits that he was discriminated against based upon a violation of Title VII.
Plaintiff also cannot demonstrate a likelihood of success on his ADA claim. Under the ADA, 42 U.S.C. § 12112 (a) "[n]o covered entity shall discriminate against a qualified individual with a disability because of the disability of such individual in regard to job applications procedures, the hiring, advancement, or discharge of employees, employee compensation, job training, and other terms conditions and privileges of employment." Therefore, the behavior which is proscribed by the ADA is discrimination on the basis of disability. Plaintiff's claim of discrimination is based on the allegation that defendants made a determination improperly singling out the management of metastatic breast cancer in male patients from the same disease in female patients. Such an allegation, however, is not a disability-based claim, but again a gender-based claim. Therefore, such a claim would again be a potential violation of plaintiff's rights under Title VII, and not the ADA. See Saks v. Franklin Covey Co., 117 F. Supp.2d 318, 327 n. 7 (S.D.N.Y. 2000) (finding that if plaintiff's claim was that defendant was violating her rights under the ADA because men receive superior treatment for infertility than to do women, that claim would fall under different statutes [Title VII and the Pregnancy Discrimination Act, 42 U.S.C. § 2000e (k)]).
This Court is sympathetic to the plight of Mr. Zervos and his family in this difficult time, and understands his frustrating and diligent efforts in attempting to obtain insurance coverage for a treatment he hopes might provide a greater chance for long term survival for his disease of cancer. However, this Court is not convinced that the record indicates that HDCT would be beneficial to Mr. Zervos' health, nor is this Court convinced, given the evidence before it, that HDCT would prolong or save Mr. Zervos' life beyond that of conventional chemotherapy. The record before this Court indicates that Mr. Zervos is receiving what is generally accepted in the medical community as the best treatment available to an individual with his condition. Defendants continue to pay for the conventional chemotherapy treatment that plaintiff is receiving. Therefore, plaintiff has not sustained his burden to show that this Court should issue a preliminary injunction requiring defendants to pay for the additional experimental and investigational treatment of HDCT. Plaintiff's motion for a preliminary injunction, therefore, must be DENIED.