Wilson v. OFFICE OF CIVILIAN HEALTH & MED. PROGRAM
| Citation | 866 F. Supp. 931 |
| Decision Date | 21 October 1994 |
| Docket Number | Civ. A. No. 4:94cv130. |
| Court | U.S. District Court — Eastern District of Virginia |
| Parties | Gail Ann WILSON, Plaintiff, v. The OFFICE OF the CIVILIAN HEALTH AND MEDICAL PROGRAM OF the UNIFORMED SERVICES (CHAMPUS), a SUBDIVISION OF the DEPARTMENT OF DEFENSE OF the UNITED STATES of America, and William Perry, in his official capacity as the Secretary of Defense for the United States, Defendants. |
Timothy Gerard Clancy, Cummings, Hatchett, Moschel & Patrick, Hampton, VA, Robert E. Hoskins, Foster & Foster, Greenville, SC, Suzanne E. Coe, Greenville, SC, for plaintiff.
Lawrence R. Leonard, Office of U.S. Atty., Norfolk, VA, for defendants.
This matter comes before the Court on Plaintiff's Motion for Declaratory and Injunctive Relief. Gail Ann Wilson ("the Plaintiff"), brings this action for a permanent injunction and declaration enjoining the Office of Civilian Health and Medical Program of the Uniformed Services, ("CHAMPUS") and William Perry, Secretary of Defense for the United States, (collectively the "Defendants") from denying Plaintiff payment for certain medical procedures. Defendants have moved for summary judgment. These claims are governed by ERISA, 29 U.S.C. § 1001 et seq. For the reasons stated below, Plaintiff's motion is GRANTED, making Defendant's motion for summary judgment moot.
Plaintiff is a forty-seven year old married female residing in Newport News, Virginia. The Plaintiff's husband, Jim Wilson, is retired Navy. As retired personnel, Mr. Wilson and his dependent wife maintain health benefits coverage with CHAMPUS, which is a subdivision of the Department of Defense of the United States Government.
In June 1994, Plaintiff was diagnosed with having Stage II breast cancer.1 Plaintiff's treating physician, Dr. Elizabeth Harden, M.D. told the Plaintiff that her cancer was very aggressive and she recommended high-dose chemotherapy ("HDC") with peripheral stem cell rescue ("PSCR"). Dr. Harden is a board certified oncologist with experience in administering HDC to patients with breast cancer and other types of cancer. According to Dr. Harden, Plaintiff was to begin treatment as soon as possible, that was by September 26, 1994. Dr. Harden also stated that if Plaintiff did not begin treatment as soon as was possible, her condition would likely deteriorate to the point that she may not be able to receive the treatment or that her health would suffer from the lack of timely care. Dr. Harden states that HDC/PSCR represents the Plaintiff's best opportunity for long-term survival and sustained remission.
HDC/PSCR as it is to be administered to Plaintiff includes several stages. Currently, the Plaintiff is in the middle of the treatment. The first stage consists of the administration of low doses of chemotherapeutic agents, and Plaintiff has already undergone this stage. During the second stage, Plaintiff will be administered moderate doses of standard chemotherapeutic agents. During this phase of treatment, Plaintiff's body will produce extra amounts of components of the blood known as stem cells, and immediately subsequent to the stage, Plaintiff will have the extra stem cells removed by a procedure known as leukapheresis. The stem cells will then be quickly frozen and stored in liquid nitrogen. Plaintiff is scheduled to complete this stage of treatment the week of October 16, 1994.
Subsequent to the leukapheresis stage, Plaintiff will receive high doses of standard chemotherapeutic agents. Following the administration of the chemotherapeutic agents, Plaintiff's cancer cells should have been killed along with the healthy white blood stem cells. After the infusion of the above chemotherapy, Plaintiff will have her previously collected stem cells reinfused into her system so that her body will begin to rebuild the depleted stem cell count. Subsequent to re-administration of the stem cells, Plaintiff will likely be hospitalized for a short period for observation. Plaintiff is scheduled to begin this stage of the treatment the week of October 31, 1994.
Plaintiff made a claim for a pre-treatment coverage commitment from the Defendant CHAMPUS which was denied on July 15, 1994. CHAMPUS denial was based on two grounds. First, CHAMPUS denied coverage stating that the treatment Plaintiff sought, the HDC/PSCR procedure, is analogous to the autologous bone marrow transplant procedure2 and is therefore excluded from coverage pursuant to the CHAMPUS policy manual. Second, CHAMPUS stated that the HDC/PSCR procedure is "experimental" and "investigational" under the terms of its plan and is, therefore, excluded.
On September 23, 1994 the Court granted Plaintiff's Motion for Preliminary Injunction. The matter now comes before this Court in Plaintiff's Motion for a Permanent Injunction and Declaratory Judgment.
The scope of review of the action against CHAMPUS is the arbitrary and capricious standard as established by the Administrative Procedures Act ("APA"). 5 U.S.C. § 706(2)(A). (YEAR). See also Woods Psychiatric Institute v. United States, 925 F.2d 1454 (Fed.Cir.1991). Generally, under the APA this Court must find the decision of the Department of Defense denying coverage for HDC/PSCR to be arbitrary, capricious, or not in accordance with the law. The Supreme Court has stated the appropriate standard for courts to apply in determining whether an action was arbitrary and capricious:
The scope of review under the "arbitrary and capricious" standard is narrow and a court is not to substitute its judgment for that of the agency. Nevertheless, the agency must examine the relevant data and articulate a satisfactory explanation for its action including a "rational connection between the facts found and the choice made." Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168, 83 S.Ct. 239, 246, 9 L.Ed.2d 207 (1962).
Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983). "Agency action is arbitrary and capricious if the agency relies on factors that Congress did not intend for it to consider, entirely ignores important aspects of the problem, explains its decision in a manner contrary to the evidence before it, or reaches a decision that is so implausible that it cannot be ascribed to a difference in view." Bedford County Memorial Hospital v. Health and Human Services, et. al., 769 F.2d 1017, 1022 (4th Cir.1985) quoting Motor Vehicle, 463 U.S. at 43, 103 S.Ct. at 2867.
The issue in this case is whether the Defendants acted arbitrarily and capriciously in determining that the treatment sought by Plaintiff was not a covered benefit under the CHAMPUS policy. For the following reasons, the Court finds that the Defendants did act in an arbitrary and capricious manner in denying Plaintiff coverage.
Defendant argues that CHAMPUS' denial of Plaintiff's claim for pre-certification arose from language in its policy manual that precludes coverage for "experimental and investigational procedures or treatment regiments." In order for the Court to determine whether or not it was arbitrary and capricious for the Agency to contend that HDC/PSCR qualifies as an experimental or investigational procedure under the CHAMPUS policy, the Court must first look to the specific language of the regulations.
The general exclusion for experimental or investigational procedures in the CHAMPUS policy is set forth in 32 C.F.R. § 199.4(g)(15):
Not in accordance with accepted standards, experimental or investigational. Services and supplies not provided in accordance with accepted professional medical standards; or related to essentially experimental or investigational procedures or treatment regimens.
The CHAMPUS policy manual, Chapter 8, Section 14.1, provides a non-exclusive list of 69 "investigational or experimental" procedures which do not qualify for benefits under the policy. Significantly, HDC/PSCR is not listed therein. The policy elsewhere defines "experimental" as:
medical care that essentially is investigatory or an unproven procedure or treatment regimen (usually performed under controlled medicolegal conditions) that does not meet the generally accepted standards of usual professional medical practice in the general medical community.
In support of its denial of medical coverage, CHAMPUS submits to the Court the following list of materials from the administrative record that the agency relied on in making the initial determination that HDC/PSCR was an investigatory procedure:
Further, Dr. David Bogner, Medical Director of CHAMPUS, stated in an affidavit that since the time these reports were initially prepared, the Office of CHAMPUS has performed a continuous review of the referred medical literature and has had numerous confirming discussions with the OHTA regarding their position.
The Court, however, finds that in...
To continue reading
Request your trial