Harris v. Mutual of Omaha Companies, s. 92-3301
| Citation | 992 F.2d 706 |
| Decision Date | 29 April 1993 |
| Docket Number | Nos. 92-3301,92-3384,s. 92-3301 |
| Parties | , 16 Employee Benefits Cas. 2081 Judith HARRIS, Plaintiff-Appellant, Cross-Appellee, v. MUTUAL OF OMAHA COMPANIES and Rural Carrier Benefit Plan, Defendants-Appellees, Cross-Appellants. |
| Court | United States Courts of Appeals. United States Court of Appeals (7th Circuit) |
W. Scott Montross (argued), Townsend, Hovde & Montross, Indianapolis, IN, David W. Stone, IV, Stone Law Office & Legal Research, Anderson, IN, for plaintiff-appellant, cross-appellee.
Ariane Schallwig Johnson, Locke, Reynolds, Boyd & Weisell, Indianapolis, IN, Thomas E. Johnson (argued), Steven D. Davidson, Baird, Holm, McEachen, Pedersen, Hamann & Strasheim, Omaha, NE, for defendants-appellees, cross-appellants.
Before CUMMINGS and RIPPLE, Circuit Judges, and TIMBERS, Senior Circuit Judge. *
This is an appeal from a district court denial of preliminary injunction and declaratory judgment to a federal employee claiming health insurance coverage for a particular type of cancer treatment. The Office of Personnel Management (OPM), the agency charged with administering the Federal Employees Health Benefits Act (FEHBA), had determined that the employee's specific health insurance contract did not cover the treatment. For the reasons that follow, we affirm the judgment of the district court.
Judith Harris has been diagnosed as having advanced stage breast cancer. Her treating physician recommended that she undergo High Dosage Chemotherapy with Autologous Bone Marrow Transplants (HDC-ABMT) and referred her to Dr. Broun, an oncologist at Indiana University Medical Center. HDC-ABMT involves the use of extremely high doses of chemotherapy. During conventional chemotherapy, such high doses would result in the loss of bone marrow which produces necessary red blood cells and, consequently, would be lethal. The risk of toxicity is reduced in HDC-ABMT by removing a portion of the patient's own ("autologous") Ms. Harris is a federal postal worker insured by the Rural Carrier Benefit Plan ("RCBP" or "the Plan"), a health insurance policy that is underwritten by the defendant, Mutual of Omaha (Mutual). As a federal employee, Ms. Harris has the opportunity once a year to switch health care policies during an "open season." During open season, employees receive a comparison chart that summarizes the general differences in coverage offered by the various policies. Ms. Harris switched policies most recently at the beginning of 1992, after she had been diagnosed with breast cancer. She selected the Rural Carrier Benefit Plan because it covered the costs of cancer treatment.
bone marrow and by reinjecting those cells after the completion of chemotherapy. According to Dr. Broun, without HDC-ABMT Ms. Harris has very little chance of surviving for five years; with the procedure, she has a greater than sixty-five percent chance of survival beyond five years. The HDC-ABMT treatment costs between $100,000 and $150,000 per patient, and Indiana University requires pre-secured financing or pre-certification from a prospective patient's insurance company that the treatment costs will be reimbursed
The RCBP is detailed in a twenty-four page brochure which notes on the front page: "This brochure is the official statement of benefits available to FEHB members and is the sole document you should rely upon." On page 9 of the policy, under the heading "General Exclusions," the policy states:
Benefits are not provided for services and supplies ... [t]hat are investigational or experimental or are mainly for research purposes.
Plaintiff's Ex. 1 at 9. On page 5 of the policy under the heading "Definitions" the policy states:
A drug, device or medical treatment or procedure is experimental or investigational:
....
(2) if Reliable Evidence shows that the drug, device or medical treatment or procedure is the subject of on-going phase I, II, or III clinical trials or under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis; or
(3) if Reliable Evidence shows that the consensus of opinion among experts regarding the drug, device or medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy or its efficacy as compared with the standard means of treatment or diagnosis.
Id. at 5. The term "reliable evidence" is used in the definition as a term of art and is defined thus:
Reliable evidence shall mean only published reports and articles in the authoritative medical and scientific literature; the written protocol or protocols used by the treating facility or the protocol(s) of another facility studying substantially the same drug, device or medical treatment or procedure; or the written informed consent used by the treating facility or by another facility studying substantially the same drug, device or medical treatment or procedure.
Id. (emphasis added). On page 15 of the policy under the heading "Additional Benefits" the policy states:
The Plan will pay, without dollar limitation, 100% of the reasonable and customary charges for any services and supplies normally covered by the Plan for the treatment of any illness diagnosed as cancer.
Id. at 15. Mutual does not dispute that 100 percent of the costs of "normal" cancer treatments are covered under the policy. In fact, Ms. Harris has received standard low dosage chemotherapy in the past year which the Mutual policy covered in full. Rather, Mutual argues that the specific form of cancer treatment Ms. Harris seeks is not covered under the Plan.
Because HDC-ABMT involves clinical trials using human subjects, it must be performed pursuant to a detailed written set of procedures known as a protocol. See National Cancer Institute Investigator's Handbook, Ex. D. The protocol sets forth the proposed treatment regimen and is presented to an Institutional Review Board for approval. The protocol for the treatment for which Ms. Harris is seeking insurance coverage is titled: "Phase II Trial of Standard Induction Therapy Followed by High-Dose Carboplatin/Cyclophosphamide with Standard Dose Etopside and Autologous Bone Marrow Rescue for Advanced Breast Cancer." The listed objectives of the Protocol are three-fold:
1. Establish response rate and duration of response in advanced breast cancer treated with [the Broun Treatment].
2. Determine toxicity associated with such a regimen in patients with high risk primary and advanced breast cancer.
3. Determine length of survival of these patients treated with such a regimen.
Ex. A § 1.0. The purpose of the Protocol "is to investigate the possibility of improving the duration of response and survival of patients with previously untreated breast cancer ... by administering [the Broun Treatment]." Id. § 2.0, at 3-4. Section 11.0 of the Protocol further states:
This is a phase I/II study designed to test the effectiveness of standard induction therapy followed by 2 rounds of high dose therapy with autologous bone marrow rescue in the treatment of advanced breast cancer. The primary endpoints of the study are response rate, response duration and survival. We would anticipate enrolling 18-20 patients over an 18-24 month period.
The Protocol was originally implemented by Dr. Broun and his colleagues in October 1990. It has been amended twice, but the provisions quoted above have remained unchanged. Indiana University has a Data Monitoring Committee that reviews and determines whether a protocol is effective or ineffective. To date, that committee has not certified whether the Protocol is effective. Mem.Op. at 13. Dr. Broun testified that, although the Protocol's plain language provides that the procedure is a Phase I/II trial, the Protocol is in fact outdated. He testified that the Protocol, which has now been used with forty-two patients, moved beyond Phase II after the first twenty patients had received treatment. Tr. of Aug. 21, 1992 at 67-72. Dr. Broun opined that, although the treatment was experimental three or four years ago, it is currently the standard treatment for advanced stage breast cancer.
Prior to receiving any HDC-ABMT treatments, Ms. Harris would have to sign an Informed Consent Statement. See Ex. B. The Informed Consent Statement she would receive tracks the Protocol closely and identifies the procedure as a "Phase II Trial." Defendant's Ex. 5. A copy of the consent statement Ms. Harris would need to sign is part of the administrative record and was before the agency prior to its final decision.
As part of the OPM record, Mutual introduced eighteen published articles and reports from sources that Dr. Broun asserted are authoritative in his field. The articles were published between November 1986 and July 1992. Each of the articles reached the conclusion that HDC-ABMT is currently in the developmental stage and requires more clinical research before it can be considered standard treatment for breast cancer. Additionally, each article indicated that HDC-ABMT
treatment was either a Phase II or Phase III procedure.
Ms. Harris submitted into the agency...
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