Whitney v. Empire Blue Cross and Blue Shield, 93 Civ. 0299 (RWS).

• Decision Date: 19 March 1996
• Docket Number: No. 93 Civ. 0299 (RWS).,93 Civ. 0299 (RWS).
• Parties: Katherine WHITNEY, as Executrix of the Estate of Barbara Whitney, Plaintiff, v. EMPIRE BLUE CROSS AND BLUE SHIELD, Defendant.
• Court: U.S. District Court — Southern District of New York

920 F. Supp. 477

Katherine WHITNEY, as Executrix of the Estate of Barbara Whitney, Plaintiff, v. EMPIRE BLUE CROSS AND BLUE SHIELD, Defendant.

No. 93 Civ. 0299 (RWS).

United States District Court, S.D. New York.

March 19, 1996.

Mark Scherzer, New York City, for Plaintiff.

Jeffrey D. Chansler and Joyce Tichy, New York City, for Defendant.

OPINION

SWEET, District Judge.

This case presents the issue whether High Dose Chemotherapy ("HDC") followed by Autologous Bone Marrow Transplantation ("ABMT") is a covered treatment for advanced metastatic breast cancer under a Tradition Plus Hospitalization Policy (the "Policy") issued by defendant Empire Blue Cross & Blue Shield ("Empire") to plaintiff, decedent Barbara Whitney ("Whitney"). Empire rejected coverage of Whitney's treatment on the ground that HDC/ABMT for breast cancer was "experimental" or "investigational" under the terms of the Policy. After a trial before the Court and upon the findings and conclusions set forth below, judgment will be entered in Whitney's favor.

Parties

Plaintiff Whitney was a resident of Brooklyn, New York and was covered at all relevant times, through her death, under a Tradition Plus Hospitalization Policy issued by defendant Empire.

Defendant Empire is a hospital services corporation formed under Article 43 of New York's Insurance Law with offices in Manhattan.

Prior Proceedings

The complaint in this action was filed on January 19, 1993. Whitney died in July 1993 and her daughter, Katherine Whitney, was substituted as executrix of Whitney's estate, by order of the Court dated December 14, 1993.

Discovery proceeded through 1994. In order to accommodate the schedules of the five¹ physician experts, the trial was heard over the course of almost eight months: February 6, April 19 and 21, May 8, and September 13-14, 1995. The parties briefed the case extensively post-trial. Oral argument was heard three months after the final witness on December 12, 1995 and the trial was considered complete at that time.

Facts

Whitney was first diagnosed with breast cancer in 1982. At that time she had a bilateral radical mastectomy and achieved a complete remission. The cancer recurred in April 1992. She was categorized as a Stage IV metastatic breast cancer patient; the breast cancer had spread to her bone and lung. She was 55 years old at the time.

Whitney was treated with Tamoxifen without response. That treatment was discontinued in July 1992. Subsequently she underwent several rounds of Conventional Dose Chemotherapy ("CDC"): first, three cycles of Cytoxan, Methotrexate, and 5-Flouruoracil; then, twenty-one cycles of Mitoxantrone. Finally, in January 1993, she underwent a five-day continuous infusion of Velban. Whitney's cancer progressed. Whitney was experiencing bone pain, difficulty breathing and required oxygen. At this point, her treating oncologist, Dr. Margaret Lewin, recommended that she be enrolled in a treatment program consisting of High Dose Chemotherapy with autologous bone marrow transplant or stem cell support ("HDC/ABMT")².

Whitney was covered at all relevant times under a Tradition Plus Hospitalization Policy (the "Policy") issued by Empire. The Policy was a group policy issued to Whitney's employer. 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 Katherine 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

2. not generally recognized by the medical community as reflected in the published peer-reviewed medical literature as effective or appropriate for the particular diagnosis or treatment of the Covered Person's particular condition.

We will also not cover any technology or any hospitalization in connection with such technology if, in our sole discretion, such technology is obsolete or ineffective and is not used generally by the medical community for the particular diagnosis or treatment of the Covered Person's particular condition.

Governmental approval of a technology is not necessarily sufficient to render it of proven benefit or appropriate or effective for a particular diagnosis or treatment of the Covered Person's particular condition. We may apply the following five criteria in exercising our discretion and may in our discretion require that any or all of the criteria be met:

1. any medical device, drug or biological product must have received final approval to market by the United States Food and Drug Administration for the particular diagnosis or condition. Any other approval granted as an interim step in the FDA regulatory process, e.g., an Investigational Device Exemption or an Investigational New Drug Exemption, is not sufficient. Once FDA approval has been granted for a particular diagnosis or condition, use of the medical device, drug or biological product for another diagnosis or condition may require that any or all of the five criteria be met.

2. conclusive evidence from the published peer-reviewed medical literature must exist that the technology has a definite positive effect on health outcomes; such evidence must include well-designed investigations that have been reproduced by nonaffiliated authoritative sources, with measurable results, backed up by the positive endorsements of national medical bodies or panels regarding scientific efficacy and rationale.

3. demonstrated evidence as reflected in the published peer-reviewed medical literature must exist that over time the technology leads to improvement in health outcomes, i.e., the beneficial effects outweigh any harmful effects.

4. proof as reflected in the

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