The opinion of the court was delivered by: NEAL P. MCCURN
MEMORANDUM-DECISION AND ORDER
Plaintiff commenced this suit on January 27, 1993, pursuant to section 502 of the Employee Retirement Income and Security Act of 1974 ("ERISA"), 29 U.S.C. § 1132 (1988 & West Supp. 1992). Plaintiff alleges that her health insurance provider, defendant Blue Cross and Blue Shield of Utica-Watertown, Inc. ("BC/BS"), has wrongfully denied her coverage to which she is entitled under her health insurance policy. Plaintiff seeks, inter alia, an injunction ordering defendant to provide her coverage for certain medical treatment. Defendant denies that plaintiff is entitled to the coverage she seeks. This court has jurisdiction pursuant to 29 U.S.C. § 1132(e)(1) and 28 U.S.C. § 1331 (1988).
Along with her complaint, plaintiff filed an application for a preliminary injunction ordering defendant to provide the relevant coverage immediately. This court conducted an evidentiary hearing on plaintiff's application and directed the parties to submit written arguments and affidavits supporting their respective positions. Having considered all of the relevant testimony, exhibits, and written submissions in light of the applicable laws, the court now issues the following findings of fact and conclusions of law pursuant to Fed. R. Civ. P. 65.
On May 26, 1992, plaintiff Michelene Kekis, a resident of Rome, New York, went to her local doctor's office for a routine mammogram. The mammogram revealed a suspicious mass in her right breast. A subsequent sonogram indicated that the mass was solid. Noting the strong possibility of a malignancy,
a surgeon at Rome Hospital excised the mass and submitted it to the laboratory for a biopsy. The biopsy revealed that Ms. Kekis had an infiltrating ductal carcinoma, more commonly known as breast cancer. See Kekis Aff. (1/25/93) P 3.
After learning of the diagnosis, Ms. Kekis met with various oncologists, each of whom told her that the excision likely provided only temporary relief and that the cancer would almost certainly reappear absent immediate further treatment. In fact, one of her doctors, Dr. Ellis Levine of the Roswell Cancer Institute, told her that she was at an especially high risk for recurrence because seventeen of her eighteen lymph nodes tested positive for cancer. See Levine Aff. (1/25/93) P 5. Dr. Levine further explained that the threat of a recurrence is so dangerous because a reappearing cancer is almost always metastatic. Metastatic cancer, or cancer which has spread to other parts of the body, is widely believed by the medical community to be incurable and fatal. Id. P 6; accord, Def. Mem. at 8. Thus, according to Dr. Levine, Ms. Kekis was (and still is) in immediate need of treatment.
The traditional treatment for the type of breast cancer from which Ms. Kekis suffers is chemotherapy. Levine Aff. P 4. Standard chemotherapy, however, is not considered a successful treatment for breast cancer of the degree suffered by Ms. Kekis. According to Dr. Levine, "despite adjuvant chemotherapy, the prognosis for patients who have extensive involvement of the axillary lymph nodes at the time of primary therapy remains poor." Levine Aff. P 5. Dr. Levine cites to data from various studies indicating that 55% to 87% of women in Ms. Kekis's position suffer a relapse within five years of the initial diagnosis, despite receiving standard chemotherapy treatment. See id. Dr. Levine's figures comport with those provided in other sources, which similarly discuss the bleak success rates of standard chemotherapy for women in Ms. Kekis's position. Cf., e.g., Bucci v. Blue Cross-Blue Shield, Inc., 764 F. Supp. 728, 730-31 (D. Conn. 1991) (citing studies); Adams v. Blue Cross/Blue Shield, Inc., 757 F. Supp. 661, 673-74 (D. Md. 1991) (same); see also DiPersio Aff. (1/25/93) P 12.; Pl. exh. "C" (article). In short, Ms. Kekis's oncologists are not optimistic about her chances of long term survival, even with standard chemotherapy. See Levine Aff. P 5; see also DiPersio Aff. P 10.
Given her "high risk" situation, Ms. Kekis's oncologists brought to her attention a relatively new adaptation to standard chemotherapy called High Dose Chemotherapy with Autologous Bone Marrow Transplantation ("HDC-ABMT"). In Pirozzi v. Blue Cross-Blue Shield of Virginia, one of many cases notably similar to the present case, the Eastern District of Virginia succinctly and accurately described the nature of HDC-ABMT, explaining:
HDC-ABMT is a procedure by which bone marrow is extracted from the patient's body, frozen, and stored while the patient receives large, near lethal doses of chemotherapy. In some cases the chemotherapy is administered in doses in excess of one thousand times the standard dose. This high does chemotherapy kills not only the cancer, but much of the patient's remaining bone marrow, as well. This secondary effect, untreated, could well be lethal to the patient. Thus, after the chemotherapy is completed, the patient's stored bone marrow is returned to the patient's body to replace the damaged bone marrow and thereby "rescue" the patient. A patient undergoing HDC-ABMT is hospitalized, often in intensive care, for approximately 10 days of the treatment and requires full-time medical attention.
741 F. Supp. 586, 587 (E.D. Va. 1990). Accord, e.g., Nesseim v. Mail Handler's Benefit Plan, 792 F. Supp. 674, 675 (D.S.D. 1992); Schnitker v. Blue Cross/Blue Shield, 787 F. Supp. 903, 904-05 (D. Neb. 1991); see also, e.g., Def. exh. "Z" at 51-52 (article describing HDC-ABMT). Preliminary testing has suggested that HDC-ABMT might be more effective than standard chemotherapy in fighting recurrences of breast cancer. E.g. Bucci, 764 F. Supp. at 730-31; White v. Caterpillar, Inc., 765 F. Supp. 1418, 1421 (W.D. Mo. 1991); DiPersio Aff. P 10 (citing studies). The efficacy of HDC-ABMT vis-a-vis standard chemotherapy is hardly settled, however, and is the subject of widespread controversy within the medical community. See, e.g., Gary Taylor, Cancer Treatment Focus of Suits, N.L.J., Jan. 25, 1993, at 3.
Still, many doctors, including Ms. Kekis's oncologists, are encouraged by the promising preliminary data from HDC-ABMT research. At the urging of some of her doctors as well as family and friends, in the summer of 1992 Ms. Kekis actively sought to enroll in a HDC-ABMT research protocol. See Kekis Aff. PP 5-7. She initially sought to enroll in Dr. Levine's study at Roswell but was told that the program was full and that she could not be accommodated until October, 1992. Id. P 7. She subsequently sought to enroll in a program offered by Strong Memorial Hospital at the University of Rochester ("Strong Memorial"). Id. P 8. Strong Memorial's program, like the program at Roswell, was being conducted pursuant to a research protocol, under which the hospital was investigating the effectiveness of HDC-ABMT compared to standard chemotherapy. Id.; DiPersio Aff. P 12. The director of the Strong Memorial program, Dr. John DiPersio, determined that Ms. Kekis was eligible for participation in the study and thus allowed her to enroll in his program. DiPersio Aff. P 9. Dr. DiPersio and Dr. Levine are hopeful that HDC-ABMT will provide Ms. Kekis with the good health and long life that would be so unlikely with standard chemotherapy.
Before finally permitting Ms. Kekis to receive HDC-ABMT, however, Strong Memorial required her to receive pre authorization for the treatment from her insurance carrier. This requirement is not unusual; many other hospitals performing this procedure similarly require that the patient's insurer guaranty complete coverage before treatment begins. See, e.g., Pirozzi, 741 F. Supp. at 588. This prerequisite to treatment undoubtedly stems in part from the fact that HDC-ABMT is an unusually expensive procedure. The entire procedure can cost as much as $ 150,000.00. See, e.g., Schnitker, 787 F. Supp. at 905. Standard chemotherapy, by contrast, costs significantly less.
Dr. DiPersio wrote a letter on plaintiff's behalf to BC/BS on August 19, 1992, requesting pre-authorization for the procedure. See DiPersio Aff. exh. "C" (letter requesting pre-authorization). The letter explained the procedure that would be applied, including the fact that her treatment was to be given as part of a research protocol, that the procedure would undoubtedly be very expensive, and that immediate treatment was necessary because the tumor had been excised more than eight weeks earlier and there had to date been no follow-up treatment to prevent recurrence. See id. Dr. DiPersio attached to his letter a copy of the protocol under which Ms. Kekis would be treated.
Upon receiving Dr. DiPersio's letter, BC/BS referred the matter to its Medical Director, Dr. Fel Davies, who in turn reviewed the letter and the attached protocol. Dr. Davies also considered a supplemental package of materials sent by Strong Memorial regarding Ms. Kekis's proposed treatment. The supplemental package contained, inter alia, Ms. Kekis's medical records, office notes of her primary oncologist, further descriptions of the study in which plaintiff sought to participate, and letters from other referring physicians relating to her condition and her need for HDC-ABMT. Dr. Davies discussed Ms. Kekis's request with colleagues in the insurance industry and consulted several published articles discussing HDC-ABMT. Upon considering all of this as well as substantial other information (to be discussed more thoroughly infra), Dr. Davies concluded that BC/BS should not provide coverage for Ms. Kekis's treatment. BC/BS agreed and adopted Dr. Davies's conclusion.
BC/BS's decision not to pre-authorize Ms. Kekis's participation in Strong Memorial's protocol was based upon its application of an exclusion clause contained in Ms. Kekis's policy. Specifically, BC/BS relied upon a clause in the contract which excludes from coverage services which are "experimental/investigative." This clause states:
In addition to certain exclusions and limitations already described in this rider, we will not pay under this rider when any of the following apply to you:
18. Experimental/Investigative Services. We will not pay for any service or procedure we do not recognize as accepted medical practice as we determine has no proven medical value.
Def. exh. "A" at 12-14. Since BC/BS viewed Ms. Kekis's proposed treatment as experimental and investigative in nature, it determined that such treatment was excluded by this clause from coverage under the policy.
According to BC/BS, a number of factors supported its invocation of the "Experimental/Investigative Services" exclusion. The most compelling reasons allegedly came from Ms. Kekis's own doctors, most notably Dr. DiPersio. In his letter requesting pre-authorization, Dr. DiPersio frequently referred to Strong Memorial's HDC-ABMT program as a "study" in which patients are "randomized," so that only half of the patients receive HDC-ABMT and the other half receive standard chemotherapy. DiPersio Aff. exh. "C".
In the attached protocol, Dr. DiPersio made further reference to the study and randomization process and additionally noted that the hospital "would find it difficult to do a transplant off-study as we simply do not know if this would be better or worse than conventional therapy." See id. (emphasis added). This letter and protocol immediately alerted Dr. Davies that Ms. Kekis's proposed treatment was likely experimental and investigative in nature.
The supplemental package that Strong Memorial sent to Dr. Davies for his consideration bolstered his initial impression. As mentioned above, the package included the office notes of Dr. Michael Spivey, Ms. Kekis's primary oncologist, in which Dr. Spivey described his conversations with Ms. Kekis and made special reference to his ...