Hendricks v. Central Reserve Life Ins. Co.
| Citation | 39 F.3d 507 |
| Decision Date | 09 November 1994 |
| Docket Number | No. 94-1709,94-1709 |
| Parties | , 18 Employee Benefits Cas. 2249 David Allen HENDRICKS, Plaintiff-Appellant, v. CENTRAL RESERVE LIFE INSURANCE COMPANY, Defendant-Appellee. |
| Court | United States Courts of Appeals. United States Court of Appeals (4th Circuit) |
ARGUED: Robert Edward Hoskins, Foster & Foster, Greenville, SC, for appellant. Stephanie Holmes Burton, Gibbes & Clarkson, P.A., Greenville, SC, for appellee. ON BRIEF: Suzanne E. Coe, Law Offices of Suzanne E. Coe, Greenville, SC, for appellant. Frank H. Gibbes, III, Gibbes & Clarkson, P.A., Greenville, SC, for appellee.
Before NIEMEYER, MICHAEL, and MOTZ, Circuit Judges.
Affirmed by published opinion. Judge NIEMEYER wrote the opinion, in which Judge MICHAEL and Judge MOTZ joined.
This case, filed under the Employee Retirement Income Security Act ("ERISA"), 29 U.S.C. Sec. 1001 et seq., involves the denial of a claim for health care benefits for the treatment of cancer.
David A. Hendricks of Greenville County, South Carolina, was diagnosed with small cell lung cancer in November 1993. Small cell lung cancer is an aggressive carcinoma of the lung and is almost always fatal within three to six months if left untreated. Upon the recommendation of his doctor, Hendricks elected to participate in a clinical trial of a multiphase treatment, known as "high-dose chemotherapy with peripheral stem cell rescue," which his doctor believed was his best chance for survival.
As part of his employer's welfare benefit plan, Hendricks received health care coverage under a policy issued by Central Reserve Life Insurance Company. When Hendricks presented this proposed treatment to Central Reserve for preapproval, Central Reserve advised him that the terms of the policy did not cover the proposed treatment because it was "experimental/investigative."
Hendricks filed suit against Central Reserve under ERISA, seeking an injunction ordering Central Reserve to provide benefits for this cancer treatment. Following a bench trial, the district court made findings of fact and conclusions of law that the proposed treatment was not covered by the Central Reserve policy. From the judgment entered in favor of Central Reserve, Hendricks appealed.
Hendricks assigns three errors. First, he asserts that the district court should not have relied upon detailed definitions of the terms "experimental" and "investigative" contained in the official employee welfare benefit plan documents on file with Central Reserve, but instead should have relied upon generally accepted definitions of those terms, because the summary plan description provided to him did not contain any definitions of "experimental" or "investigative." Second, he asserts that the district court improperly ruled that the proposed cancer treatment at issue is "investigative" or "experimental" and that we should review the court's findings on this issue de novo. Finally, he argues that even if we were to find that some phases of the proposed treatment were excluded from coverage of the Central Reserve policy, coverage should nevertheless have been provided for other phases of the multiphase treatment under our holding in Doe v. Group Hospitalization & Medical Services, 3 F.3d 80 (4th Cir.1993).
For the reasons that follow, we affirm.
When David Hendricks, at age 41, was diagnosed with small cell lung cancer, he was given standard-dose chemotherapy in conjunction with localized radiation therapy, which proved effective and resulted in a complete response. Central Reserve provided benefits under its policy for this treatment. Dr. Jeffrey K. Giguere, Hendricks' treating physician, however, stated that notwithstanding the immediate success of the standard-dose chemotherapy in the treatment of this disease, two-year survivors are few, and only three to eight percent of the persons with the disease survive more than five years. Based on an April 1993 study relating to the results of high-dose chemotherapy, Dr. Giguere believed that Hendricks' survival potential could be improved with a multiphase treatment involving high-dose chemotherapy, combined with peripheral stem cell rescue. Dr. Giguere recommended that Hendricks partake in a clinical trial being conducted by Dr. Giguere's firm, Response Technologies, Inc.
Clinical trials or investigations are regulated by the Food and Drug Administration and the Department of Health and Human Services. When one is conducted, a protocol document is required to standardize the procedure. The protocol document outlines in detail the treatment planned and the manner in which data is to be collected for the investigation. The regulations require that the investigators advise each patient participating in a clinical trial of the nature of the treatment and the risks.
The objective of the clinical trial proposed by Dr. Giguere for the treatment of small cell lung cancer with high-dose chemotherapy was "[t]o determine the impact of [the treatment] on duration of complete response and overall survival in patients with limited stage small cell carcinoma of the lung in complete remission or near-complete remission following standard [chemotherapy]." In accordance with the regulations governing clinical investigations, Hendricks executed an informed consent form in January 1994 which advised him of the nature of the treatment and the risks. In the consent form, he agreed that the treatment is "being explored as a new treatment" and that:
Although it is hoped that this treatment and study will be of benefit or that it will help others, it cannot be said that it will help me directly. I may expect to benefit from this project to the extent that any treatment I receive helps to manage my condition. There is no assurance, however, that participating will result in any improvement. I may also receive personal satisfaction from the knowledge that my participation in this project has contributed to the advancement of science.
The protocol for the proposed treatment utilizing high-dose chemotherapy outlines a number of phases. The first is the "induction phase" which qualifies the patient for the proposed high-dose chemotherapy and consists of standard-dose chemotherapy to determine whether the patient responds positively. Only a patient's positive response to standard-dose chemotherapy could indicate any success with respect to high-dose chemotherapy. In the second phase, "mobilization," the dosage level of chemotherapy is raised in order to mobilize "stem cells" from the bone marrow into peripheral blood. Stem cells are generally found in the bone marrow, and they can develop into white blood cells, which are the body's mechanisms for fighting infection. Mobilization is done in preparation for leukapheresis, during which blood is taken out of the body and centrifuged to separate and "rescue" the stem cells, and the remainder of the blood is returned to the body. The stem cells are maintained in a cold environment so that they remain viable for later return to the bloodstream after high-dose chemotherapy.
The next phase, the actual high-dose chemotherapy, is a radical attack on the lung cancer itself. Mobilization and leukapheresis are necessary precursors to high-dose chemotherapy since the high level of chemotherapy kills not only the cancer but also the body's white blood cells, leaving the body largely defenseless against infections. Following the high-dose chemotherapy, the preserved stem cells are reinfused into the bloodstream with the hope that they will grow into healthy white blood cells.
The final phase consists of a two-week hospitalization period, during which the patient is monitored for inevitable infections while the stem cells are growing into white blood cells.
In December 1993, Hendricks' doctors wrote Central Reserve for preauthorization of this proposed multiphase high-dose chemotherapy treatment and a determination of benefits under the policy issued by it. In February 1994, Central Reserve wrote Hendricks' doctors and advised them that the proposed treatment is considered "experimental/investigational" and that the Central Reserve policy expressly excluded coverage for treatments that are experimental or investigational in nature. After further urging from Hendricks' doctors and his attorney, Central Reserve conducted a second administrative review of the denial of Hendricks' request for preapproval and concluded by reaffirming its decision to deny coverage for the proposed procedure. Central Reserve observed that "[b]oth the protocol and the informed-consent form signed by Mr. Hendricks state that he is going to be treated as a patient in a research study" and that "the treatment may not benefit him." The letter from Central Reserve concluded:
It appears that the primary focus of the studies is to determine whether High-Dose Chemotherapy will make patients live longer. Importantly, the only randomized study which compared High-Dose therapy with standard therapy which you sent to us indicates that the researchers found no statistically significant difference in long-term survival for patients undergoing High-Dose Chemotherapy over those that received standard treatment. High-Dose Chemotherapy has simply not been proven to be a safe and effective treatment for small-cell lung cancer.
While the language of the Central Reserve policy provides benefits for radiation therapy and chemotherapy treatment, the policy excludes any charges:
For treatment or services experimental or investigational in nature....
Which are not necessary to the care or treatment of an illness....
For treatment or services which are not generally accepted medical practices in the United States for a given illness....
Hendricks filed suit in April 1994 and an expedited bench trial was held on May 2, 1994. After hearing all the evidence, the district court ruled:
The court finds that the evidence establishes that HDC/PSCR [high-dose chemotherapy...
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