known and accepted by the oncology profession throughout the United States. See Farley, No. 90-761-C-7 at 16 (E.D. Mo. Oct. 17, 1991) [Benefit Trust's Trial Brief, Ex. 8].
21. To determine whether Fuja's proposed treatment -- HDC/ABMT for metastatic breast cancer -- is generally known and accepted, the court has considered the testimony of the experts for both parties. Fuja's expert testimony reveals that HDC/ABMT for metastatic breast cancer is generally known and accepted by the oncology profession. See Fuja's Trial Ex. 1 at P 13; Fuja's Trial Ex. 2 at P 10. In addition, the weight of legal authority, albeit not controlling, sides with Fuja. See, e.g., Nesseim v. Mail Handlers Benefit Plan, 792 F. Supp. 674, 675, P 7 (D.S.D. 1992); Kulakowski v. Rochester Hosp. Serv. Corp., 779 F. Supp. 710, 716 (W.D.N.Y. 1991); Adams v. Blue Cross-Blue Shield, 757 F. Supp. 661, 672 (D. Md. 1991); Pirozzi v. Blue Cross-Blue Shield, 741 F. Supp. 586, 591-94 (E.D. Va. 1990).
22. Benefit Trust counters Fuja's expert testimony with the testimony of its expert, Dr. John Gradishar. Dr. Gradishar's testimony is not as persuasive as Dr. Williams' for two reasons: (1) Dr. Gradishar's treatment, research, and publication experience in the field of breast cancer pales in comparison to Dr. Williams' -- indeed, it is not clear that Dr. Gradishar has any experience with breast cancer treatment or research; (2) more importantly, Dr. Gradishar defines "generally accepted principles of medical practice" as treatment "not yet accepted as standard medical practice." Benefit Trust's Trial Ex. 2 at P 4. Dr. Gradishar does not use the "generally known and accepted" standard that the Farley court employed.
23. Benefit Trust also points to Farley itself to support the contention that HDC/ABMT as treatment for metastatic breast cancer is not "given in accordance with generally accepted principles of medical practice." Benefit Trust's Trial Br. at 21. That contention is meritless. The Farley court explicitly found that HDC/ABMT was not "given in accordance with generally accepted principles of medical practice" for the treatment of malignant melanoma with brain and lung tumors. Farley, No. 90-761-C-7 at 16-17 (E.D. Mo. Oct. 17, 1991) [Benefit Trust's Trial Brief, Ex. 8]. The Farley court did not discuss HDC/ABMT as it relates to metastatic breast cancer.
24. Similarly unpersuasive on this point is Benefit Trust's invocation of Calkins v. Mutual of Omaha, No. CI 91-4181 (Fla. Cir. Court May 5, 1992) and Harris v. Mutual of Omaha, No. IP 92-1089-C (S.D. Ind. Aug. 26, 1992) [Benefit Trust's Trial Brief, Exs. 10, 5]. Although the Calkins patient, like Fuja, suffered from stage IV metastatic breast cancer and received treatment by Dr. Williams at the University of Chicago Hospitals, the Calkins court construed provisions of an insurance policy that limited coverage to treatments considered "standard" within community practice. Id. at 2. Importantly, the Calkins court concluded that HDC/ABMT was not "standard" treatment for breast cancer. Id. at 4. While that may be true, Benefit Trust's insurance policy does not limit coverage only to "standard" treatments.
25. Harris also is inapposite. Harris arose in a wholly different procedural posture. In Harris the court reviewed an administrative agency's decision to deny coverage under the terms of Mutual of Omaha's insurance policy under an arbitrary and capricious standard. Harris, No. IP 92-1089-C at 22 [Benefit Trust's Trial Brief, Ex. 5]. Benefit Trust's denial, unlike Mutual of Omaha's, is reviewed de novo. In addition, the Harris case involved construction of a far more crabbed "experimental or investigational" provision than is present in Fuja's case. Id. at 6.
26. Fuja has submitted persuasive evidence showing that HDC/ABMT for metastatic breast cancer is generally known and accepted by the oncology profession. Accordingly, she has satisfied the burden of showing that the treatment is "given in accordance with generally accepted principles of medical practice in the U.S." She thus satisfies the second of five criteria used to adjudge whether a treatment is "medically necessary" under the terms of the Benefit Trust insurance contract.
27. Fuja also has shown that HDC/ABMT for breast cancer is "approved for reimbursement by the Health Care Financing Administration."
28. Benefit Trust argues that HDC/ABMT for metastatic breast cancer has not been approved for reimbursement by the Health Care Financing Administration as of June 1992, because the treatment did not appear on a list of procedures covered by Medicare. See Benefit Trust's Trial Ex. 1 at 35-30. It is not entirely clear, however, that absence from the Medicare coverage list means that the Health Care Financing Administration has not or will not, in fact, reimburse for the procedure.
29. The determinative query, of course, is the meaning of "approved for reimbursement." Benefit Trust obviously argues that "approved for reimbursement" means that the procedure should appear on the list of procedures covered by Medicare. Fuja contends that if the Health Care Financing Administration has provided or will provide reimbursement for HDC/ABMT in any instance, and in any manner, then the procedure has, in fact, been "approved for reimbursement."
30. Fuja has established that the Health Care Financing Administration reimburses, or would reimburse, for HDC/ABMT in breast cancer cases. See Fuja's Trial Exs. 4, 10. The Health Care Financing Administration, through its federal financial participation in the Illinois Medicaid Program, contributes 50 percent toward reimbursements made under Illinois Medicaid. Id. Illinois Medicaid pays for HDC/ABMT when performed by certified transplant centers, such as the University of Chicago Hospitals. Id. The Illinois Department of Public Aid has certified transplant centers, including the University of Chicago Hospitals, to perform HDC/ABMT for breast cancer. Fuja's Trial Ex. 4 at P 5.
31. Fuja also has shown, as required by the fourth criterion contained in the "medically necessary" provision, that HDC/ABMT for metastatic breast cancer has not been "deemed to be experimental, educational or investigational in nature by any appropriate technological assessment body established by an state or federal government." The determinative qualifier here is that the procedure must be deemed experimental, educational or investigational by a technological assessment body (established by any state or federal government).
32. The parties do not quarrel with the first two limitations: Benefit Trust admits that no technological assessment body has deemed the procedure experimental and Benefit Trust does not rebut Fuja's contention that no such body has deemed the procedure educational. See Fuja's Trial Ex. 14; Benefit Trust Trial Brief at 17-18. The battle centers upon whether a technological assessment body has deemed the procedure investigational.
33. Benefit Trust argues that the National Cancer Institute ("NCI") has deemed HDC/ABMT for breast cancer investigational.
To support its contention, Benefit Trust offers two bits of evidence: (1) the affidavit of Dr. Bruce Cheson; and (2) the affidavit of Dr. John Gradishar, who relies upon the inferential argument that NCI must have deemed the procedure investigational because NCI currently is assessing the efficacy of HDC/ABMT for breast cancer and NCI only assesses treatment procedures that are "under investigation." Benefit Trust's Trial Brief at 17-18; Benefit Trust's Trial Ex. 2 at PP 4, 6.
34. Benefit Trust's evidence is not persuasive. First, Dr. Cheson never stated that NCI had deemed the procedure "investigational." Dr. Cheson purposely did not use the term "investigational" because he considered the term "ambiguous and problematic when dealing with evolving technology." Fuja's Trial Ex. 15. In any event, Dr. Cheson is not a "technological assessment body." He expressly stated that his opinions did not represent the official policies and positions of NCI. Id.
35. Similarly, Dr. Gradishar is not a "technological assessment body." Although he states that it is his belief that HDC/ABMT for breast cancer has been deemed investigational by NCI, his personal belief does not suffice. He neither purports to speak for NCI, nor does he contend that his opinion represents the official, articulated policy of NCI. See Benefit Trust's Trial Ex. 2 at PP 4, 6.
36. The best evidence available -- and it is not perfect -- regarding whether NCI has deemed the procedure "investigational" are two bulletins issued by NCI. Fuja's Trial Exs. 11, 17. The bulletins, issued in January 1992 and November 1992, represent the official views of NCI and, as such, they are persuasive and indicative of NCI views regarding whether NCI has deemed HDC/ABMT for breast cancer "investigational." The bulletins each state:
NCI believes that the terms "investigational" or "experimental" cannot be simply or unambiguously used to define new cancer therapies.