Adams v. Blue Cross/Blue Shield of Maryland, Inc.

• Decision Date: 27 February 1991
• Docket Number: Civ. A. No. MJG-90-1730,MJG-90-2736.
• Citation: 757 F. Supp. 661
• Parties: Alexandra ADAMS, Plaintiff, v. BLUE CROSS/BLUE SHIELD OF MARYLAND, INC., Defendant. Kelly Sue WHITTINGTON, Plaintiff, v. BLUE CROSS/BLUE SHIELD OF MARYLAND, INC., Defendant.
• Court: U.S. District Court — District of Maryland

757 F. Supp. 661

Alexandra ADAMS, Plaintiff, v. BLUE CROSS/BLUE SHIELD OF MARYLAND, INC., Defendant.

Kelly Sue WHITTINGTON, Plaintiff, v. BLUE CROSS/BLUE SHIELD OF MARYLAND, INC., Defendant.

Civ. A. Nos. MJG-90-1730, MJG-90-2736.

United States District Court, D. Maryland.

February 27, 1991.

Richard Carter, Douglas M. Coleman, Hudgins, Carter & Coleman, Alexandria, Va., for plaintiffs.

Peter H. Gunst, Robert B. Levin, Frank, Bernstein, Conaway & Goldman, Baltimore, Md., for defendant.

GARBIS, District Judge.

In 1990, Plaintiffs Alexandra Adams and Kelly Whittington were diagnosed as having advanced breast cancer, a potentially fatal disease. Both women were advised by their treating physicians that High Dose Chemotherapy with Autologous Bone Marrow Transplant (hereinafter "HDCTABMT") would be the best available care for them. Because the treatment is very expensive, costing approximately $100,000.00, Plaintiffs requested their insurance carrier Blue Cross-Blue Shield of Maryland (hereinafter "Blue Cross") to confirm in advance that it would pay for the treatment. However, Blue Cross denied coverage for both, relying upon a policy provision which excluded coverage for "experimental and investigative" treatments. While acknowledging that the policy would cover the use of HDCT-ABMT for several other diseases,¹ Blue Cross took the position that the treatment was "experimental" when used to treat breast cancer, and that Plaintiffs were not eligible for coverage. This Court is asked to decide whether under the benefit plan Blue Cross must pay for Plaintiffs' treatment.

Procedurally, Plaintiffs seek to obtain a declaratory judgment compelling Blue Cross-Blue Shield of Maryland to pay for their treatment. Because the health insurance plans under which Plaintiffs are covered are "employee welfare benefit plans," this case is governed by the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. § 1001 et seq. Accordingly, federal jurisdiction for this case is conferred by 28 U.S.C. § 1332.

SUMMARY OF DECISION

In view of the high degree of public interest in this case, the Court believes it appropriate, at the price of some repetition, to provide a summary of its decision, followed by a detailed discussion of the issues.

Essentially, Blue Cross contends that it can deny coverage for the Plaintiffs' HDCT-ABMT treatment because a policy provision in the Blue Cross benefit plan states that "the plan will not pay for services ... that are experimental or investigative in nature." The plan provision specifically defines the term "experimental or investigative" to mean "any treatment ... not generally acknowledged as accepted medical practice by the suitable medical specialty practicing in Maryland, as decided by us." Blue Cross argues that HDCT-ABMT is experimental under that definition and, accordingly, is not covered by the plan.

As discussed at length below, this Court has concluded that High Dose Chemotherapy with Autologous Bone Marrow Transplant is not an "experimental" treatment for Plaintiffs' breast cancer under the definition of "experimental" prescribed in the Blue Cross plan. This Court finds that at the time Blue Cross decided to deny coverage to Plaintiffs, the suitable medical specialty practicing in Maryland, i.e., Maryland oncologists, generally acknowledged HDCT-ABMT as accepted medical practice. The Court heard convincing trial testimony that in April and July of 1990, the dates on which the Blue Cross decisions were made for Alexandra Adams and Kelly Whittington, respectively, Maryland oncologists considered HDCT-ABMT to be accepted medical practice. The Court also heard testimony that Maryland oncologists regularly refer breast cancer patients to institutions which administer the treatment, such as Duke University Medical Center, Johns Hopkins Medical Center, and Georgetown University Medical Center. Experts testified that the treatment was at the relevant time being offered at many major medical centers across the country, and the Court finds this, too, to be persuasive evidence that the treatment was generally acknowledged as accepted medical practice.

Disregarding the specific plan language, Blue Cross decided to deny Plaintiffs coverage based on its own independent evaluation of published scientific research results, completely ignoring the consensus of opinion of members of the Maryland oncological community. As is discussed at length below, Blue Cross's decision was both incorrect and unreasonable. The benefit plan does not allow Blue Cross to form its own independent evaluation of the treatment from scientific data, selectively dismissing the opinion of the very decision makers to which the plan requires Blue Cross to defer, i.e., medical oncologists practicing in Maryland.

Blue Cross also argued that the treatments were experimental based on the fact that the treatments at issue were to be given on research protocol at teaching hospitals. But the fact that treatment is provided at teaching centers "on protocol" does not alter the fact that at the relevant times Maryland oncologists generally acknowledged the treatment to be accepted medical practice. Of course, researchers maintain an interest in collecting further information about HDCT-ABMT. However, physicians refer their patients for HDCT-ABMT for the primary purpose of medical treatment, and under the plan definition it is of little consequence that the treatment also provides information to research investigators.

Indeed, physicians deliver many of today's accepted medical treatments at major teaching hospitals, whose practice it is to collect data on the patients they treat. The author Rose Kushner, a breast cancer victim who was for many years a source of comfort, information and inspiration to women with breast cancer, observed prior to her own death from the disease in 1990 that it is of no great moment that treatment given at teaching hospitals also provides the opportunity for data collection.

It is a personal decision whether or not to go to a research hospital. Such institutions do make certain demands on patients that non-research hospitals do not make. Physicians, nurses, psychologists, and social workers often interview and question patients. Members of the medical staff may want to examine their wounds ... As for being part of a "random sample," I may have been, for all I know. My operation may have been done using a new type of scalpel, while a sample of other women were cut by an older instrument. I honestly don't know. But what difference does it make?

Kushner, "Why Me?" at 25 (1977).

As discussed below, whether HDCT-ABMT treatment is experimental as defined by the Blue Cross plan does not turn on a determination by Blue Cross based upon its own evaluation of the scientific data. Nor does the question turn on whether the treatment is provided on an experimental protocol. Rather, it turns only upon whether at the relevant times medical oncologists practicing in Maryland generally acknowledge the treatment as accepted medical practice. This Court finds that they did at the pertinent time and that Blue Cross improperly denied insurance coverage to Mrs. Adams and Mrs. Whittington.

FACTS

THE TREATMENT AT ISSUE

Breast cancer is frequently treated with chemotherapy drugs which are designed to kill cancer cells. Administered in low doses, chemotherapy can be given to patients on an outpatient basis and is usually administered in several cycles of continuing treatment. However, the effectiveness of low-dose chemotherapy for more advanced forms of breast cancer is limited because the dosage frequently is not toxic enough to kill the more aggressive cancer cells.

Currently, doctors use a variety of dosages and drug mixtures, or "cocktails", in administering low-dose therapy (sometimes called "conventional chemotherapy"). To date, no standard dosages or preparative regimens exist for low-dose chemotherapy. Indeed, ongoing research continues to evaluate the effectiveness of different dosages and preparative regimens.

High Dose Chemotherapy with Autologous Bone Marrow Transplant is a procedure in which physicians administer relatively high doses of chemotherapy drugs in conjunction with a bone marrow "transplant." In addition to destroying cancer cells, high doses of chemotherapy also destroy the patient's bone marrow and blood cells, both of which play an essential role in immunity to disease and infection. Stripped of her bone marrow and certain blood cells, the patient is open to opportunistic infection and disease following treatment with high-dose chemotherapy. To counteract this potentially lethal side effect, a portion of the patient's bone marrow is harvested from the patient prior to her treatment with toxic chemotherapy drugs. After chemotherapy treatment is completed, the healthy marrow is then reinfused to "rescue" the patient. The marrow quickly multiplies to replace the marrow destroyed during high-dose chemotherapy.

THE BLUE CROSS HEALTH PLAN

Both Plaintiffs participated in a Blue Cross group health plan issued by their respective spouse's employer. The plan contains an exclusion provision which provides, in pertinent part, that "the plan will not pay for services and supplies ...

(3) that are experimental or investigative in nature or for the Covered Services related to them. The terms Experimental and Investigative mean the use of any treatment, procedure, facility, equipment, drug, device, or supply not generally acknowledged as accepted medical practice by the suitable medical specialty practicing in Maryland, as decided by us."

MRS. ADAMS

Plaintiff Alexandra Adams is a thirty-four year old, premenopausal mother of two children who was diagnosed in 1990 as having Stage II² or Stage III breast cancer. At the time Mrs. Adams' cancer was detected, it had spread to 18 of the 27 lymph nodes located in the region surrounding the breast. Her cancer was also described as "estrogen...