It was an "employee welfare benefit plan" subject to and governed by the Employee Retirement Income Security Act of 1974, as amended, 29 U.S.C.A. § 1001 ("ERISA") (1985).
On February 4, 1993, Whitney was evaluated at the Fred Hutchinson Cancer Research Center (the "Hutchinson Center") for enrollment in a High Dose Chemotherapy treatment program by Dr. William I. Bensinger ("Bensinger").
Whitney's prognosis at the time of her admission to the Hutchinson Center was that her life expectancy was "a matter of a month or so." There was general consensus among the experts that further CDC treatment was unlikely to have any significant effect. According to Empire's Medical Director, Marvin Blitz, M.D. ("Blitz"), the primary alternative to HDC treatment was "a hospice program" with "more pain medication" and "more oxygen," -- "acceptance of the inevitable."
On February 10 through 12, her stem cells were collected for later transplantation. On February 13 and 14, 1993, Whitney received intermediate dose chemotherapy as an "induction" treatment to improve her performance status, test her response, and assess her eligibility for the proposed HDC treatment. She experienced a "pretty good" response to the treatment and was referred for the HDC/ABMT procedure. A transfer note dated March 2, 1993 indicated that Protocol 779.0 involved at least a 10% mortality and an unknown degree of morbidity.
From March 4 through March 10, 1993, Whitney received her prescribed HDC treatment, consisting of the chemotherapeutic agents Busulfan, Melphalan, and Thiotepa. On March 12, 1993, Whitney received an autologous transplant of previously-collected peripheral stem cells. Both the IDC and HDC treatments were administered to Whitney pursuant to protocols approved by the Hutchinson Center's Investigative Review Board -- Trial 779.0.
Whitney was discharged on April 2, 1993, under the continuing care of the Hutchinson Center's outpatient department. On April 3, 1993, Whitney was discharged from the Hutchinson Center's outpatient department into the care of her oncologist, Dr. Lewin.
Whitney was described by Dr. Bensinger as having had a substantial response to the treatment, with "significant improvement in her symptomatology." This included that she was no longer bedridden, that she didn't require oxygen and that she was pain free for a number of months. Her MRI results from the end of May showed substantial improvement in the "areas of consolidation in the lung tissue and marked reduction in the amount of pleural fluid in the chest" compared with pre-treatment studies.
Whitney's daughter Katharine observed that her mother had absolutely benefitted from the treatment. The record shows disagreement between the experts as to exactly which treatment caused her improvement, but there was improvement in her symptoms and condition.
Despite signs of improvement, however, Whitney's cancer progressed and on July 16, 1993 she died.
On December 30, 1992, prior to Dr. Bensinger's commencement of HDC/PSCS treatment in February 1993, the Hutchinson Center sought pre-certification from Empire for the treatment. On December 31, 1992 Empire denied this request for coverage by notation on a pre-authorization form.
On January 15, 1993, Whitney, by her attorney, challenged Empire's determination and stated her intention to file a complaint to enforce her rights under the policy and to seek a preliminary injunction.
Empire's denial was confirmed by letter dated January 19, 1993. Empire refused coverage on the ground that HDC/ABMT "is considered to be experimental or investigational in the case of carcinoma of the breast." The letter neither discussed the particulars of Whitney's condition nor suggested that the treatment was established but medically unnecessary in Whitney's case. The Medical Director of Empire makes the final decision about what is exempt from coverage under the experimental exception.
Also on January 19, Whitney served a complaint on Empire. By stipulation and reservation of rights, also dated January 19, 1993, Empire paid the costs of Whitney's treatment.
The Experimental Exclusion, relied on by Empire to deny coverage, states, in relevant part:
Unless otherwise required by law . . . we will not cover any treatment . . . if, in our sole discretion, it is not medically necessary in that such technology is experimental or investigational. Experimental or investigational means that the technology is:
1. not of proven benefit for the particular diagnosis or treatment of the Covered Person's particular condition; or