The opinion of the court was delivered by: GEORGE W. LINDBERG
On March 10, 1995, plaintiff Phyllis Grethe filed a complaint against defendant Trustmark Insurance Company ("Trustmark") seeking a mandatory injunction and declaratory relief. The complaint states that Ms. Grethe is currently undergoing treatment for life-threatening, inoperable breast cancer. Ms. Grethe seeks an order from this court mandatorily enjoining Trustmark to provide preauthorization coverage for Grethe for High-Dose Chemotherapy with Autologous Bone Marrow Transplant or Peripheral Stem Cell Rescue ("HDCT/ABMT or PSCR"). Ms. Grethe has now moved for a preliminary injunction ordering Trustmark to pay for HDCT/ABMT treatment. The court held a hearing on the motion on March 24, 1995.
Ms. Grethe is a 50 year old woman who was first diagnosed with breast cancer in 1992. DE 1 at 30.
She was at all relevant times a beneficiary under an employee welfare benefit plan established and maintained by her husband's employer under the Employment Retirement Income Security Act of 1974, as amended, ("ERISA"), 29 U.S.C §§ 1001 et seq. Defendant's Hearing Br at 2. Ms. Grethe underwent surgery and standard-dose chemotherapy and seemed to be doing fairly well until the Fall of 1994 when she learned that the cancer had matasticized into her pulmonary nodules. Her treating oncologist, Dr. Gershon Y. Locker, put her back on chemotherapy. DE 1 at 30. An x-ray taken in late December indicated that Ms. Grethe's cancer was beginning to respond favorably to the chemotherapy. Tr 54. An x-ray taken on February 27, 1995 showed that the cancer in her lungs has almost disappeared. Tr 39. However, despite Ms. Grethe's current favorable response to standard-dose chemotherapy, it is inevitable that the cancer will recur in several years if standard-dose chemotherapy is the only treatment. Tr 47. Therefore, Dr. Locker has prescribed a new course of treatment for Ms. Grethe involving high-dose chemotherapy supported by autologous bone marrow transplant or peripheral stem cell rescue ("the proposed treatment"). Tr 47.
In high-dose chemotherapy, the patient receives between four and eight times the standard dose of cancer-fighting drugs. Tr 48. The idea is that higher doses of a cancer-fighting drug that has proven effective in a patient may yield a long-term response or permanent cure. Tr 48. However, the higher dose also kills the patient's bone marrow cells, which produce the body's red and white blood cells, rendering the patient susceptible to life-threatening infection, bleeding, and anemia. Tr 48.
Autologous bone marrow transplant and peripheral stem cell rescue are two methods of countering the toxic effect of the highdose chemotherapy. In an autologous bone marrow transplant, some of the patient's own bone marrow is extracted (prior to the high-dose chemotherapy) and placed in frozen storage. After the high-dose chemotherapy is given, the stored marrow is given back to the patient for the purpose of causing the patient's bone marrow to regenerate. Tr 48-49; Plaintiff's Hearing Br at 8.
Peripheral stem cell rescue is a similar procedure that involves storing a quantity of that part of the patient's blood that actually populates the bone marrow. When it is reintroduced after the high-dose chemotherapy, the cells in this blood will repopulate the bone marrow and overcome the potentially life-threatening toxicity of the treatment. Tr 48.
Ms. Grethe consulted with various institutions about having HDCT/ABMT or PSCR. She chose the University of Colorado Hospital ("University Hospital") because it has the highest patient survival rate and the most experience with performing bone marrow transplants. DE 2, Letter from Ms. Grethe to Illinois Department of Insurance dated 2/10/95, at 1. The proposed treatment at University Hospital would be conducted under the auspious of an Institutional Review Board protocol. An Institutional Review Board ("IRB") is a federally-mandated body that is established to protect those human research subjects who are participating in a study. Tr 122. For an institution to conduct a medical study on humans, it must approve a research protocol, which is a written document that defines the objectives and the methodology proposed in the study. Tr 122. Before a patient may receive treatment under an IRB protocol, he or she must sign an informed consent, which is a document that explains (1) the risks of the proposed therapy, (2) any alternatives to the proposed therapy, and (3) that the therapy is part of a research study. Tr 122.
The protocol under which Ms. Grethe was proposed to be treated outlined the considerations which led the investigators to propose the treatment outlined in the protocol. The protocol then stated its major hypothesis:
These considerations lead to the hypothesis that high-dose chemotherapy with autologous bone marrow support may be capable of producing long term disease free survival in patients with minimal residual disease. We propose to determine if high dose chemotherapy with autologous bone marrow support can be safely and effectively used (1) in the metastatic disease setting after intensive ambulatory induction therapy and (2) in the high risk adjuvant disease setting.
DE 1 at 251. The protocol often speaks of the proposed regimen as a "study," DE 1 at 260, 265, 275, and makes frequent reference to the "principal investigator," DE 1 at 261, 262-63, 266, 271, 275. The informed consent that accompanies the protocol is titled: "Subject Consent Form for Participation in a Clinical Investigation Project." DE 1 at 280. The first sentence of the consent form states that "you are being asked to participate in a research study to define the effectiveness of a program of high-dose chemotherapy with autologous bone marrow support . . . for patients with breast cancer which is either metastatic or is at high risk for recurrence following the best available conventional treatment." DE 1 at 280. The consent form also suggests that the results of "this or associated studies" may be reported in medical meetings or medical literature. DE 1 at 287. Finally, just above the line where the patient must sign, the consent form states: "I have read the above and understand the discomforts, inconveniences, and risks of this study. . . ." DE 1 at 288.
The Certificate issued under the insurance contract contains a rider (the "Medically Necessary Rider"), which provides:
Benefits will be paid only for "Medically Necessary" care.
The term "Medically Necessary" as used above means: drugs, therapies or other treatments that are required and appropriate for care of the Sickness or Injury; that are given in accordance with generally accepted principles of medical practice in the U.S. at the time furnished; and that are reimbursed by Medicare; and that are not deemed to be experimental, educational, or investigational in nature by any appropriate technological assessment body established by any state or federal government; and that are not furnished in connection with medical or other research.
We or our pre-certification review organization shall decide whether services are "Medically Necessary."
In this case, the outside experts were Dr. Christopher Desch, Dr. William Vaughan, and Dr. Michael Clarke. In late 1994, these experts were sent the all the medical information (up to that time), including the protocol and the informed consent, and a set of questions to answer. The questions propounded to the experts were:
1. Are the drugs, therapies or treatments required and appropriate for the care of the sickness?
2. Are they given in accordance with generally accepted principles of medicine in the U.S. at the time furnished?
3. Are they deemed to be experimental, educational or investigational in nature by you or an appropriate technological assessment body established by any state or federal government?
4. Are they furnished in connection with medical or other research?
5. Is the consent form to be signed by the patient one that would indicate or imply that the therapy being performed is a ...