Smith v. OFFICE OF CIV. HEALTH AND MED. PROGRAM, IP 94-1396 C.

• Decision Date: 29 September 1994
• Docket Number: No. IP 94-1396 C.,IP 94-1396 C.
• Citation: 884 F. Supp. 303
• Parties: Erin Colleen SMITH, Plaintiff, v. The OFFICE OF 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 of America, Defendants.
• Court: U.S. District Court — Southern District of Indiana

884 F. Supp. 303

Erin Colleen SMITH, Plaintiff, v. The OFFICE OF 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 of America, Defendants.

No. IP 94-1396 C.

United States District Court, S.D. Indiana, Indianapolis Division.

September 29, 1994.

COPYRIGHT MATERIAL OMITTED

Steven J. Cohen, David Becsey, Zeigler Carter Cohen & Koch, Indianapolis, IN, for plaintiff.

Gerald A. Coraz, Asst. U.S. Atty., Indianapolis, IN, for defendant.

MEMORANDUM ENTRY

BARKER, Chief Judge.

Plaintiff, Erin Colleen Smith, brings this action for declaratory and injunctive relief challenging the presumed denial by the Office of Civilian Health and Medical Program of the Uniformed Services ("CHAMPUS") of authorization for high-dose chemotherapy ("HDC") with peripheral stem cell rescue ("PSCR") as treatment for her breast cancer. Defendants CHAMPUS and William Perry, in his official capacity as the Secretary of Defense for the United States (collectively "CHAMPUS"), have moved for summary judgment.¹ For the reasons stated below, Defendants' motion is denied. Summary judgment in favor of Plaintiff is granted, making her motion for preliminary injunction moot.

I. BACKGROUND

Plaintiff is married to Danny Smith, an Air Force retiree. Plaintiff and her husband are entitled to health care benefit coverage with CHAMPUS. 32 C.F.R. § 199.3.

Plaintiff is forty years old. In November, 1993, Plaintiff was diagnosed with breast cancer. The cancer has spread to Plaintiff's lymph nodes. Her doctors have prescribed a treatment course that includes HDC with PSCR ("HDC-PSCR"). If the HDC-PSCR treatment does not begin by October 1, 1994, it is the opinion of Plaintiff's doctors that she will be forced to undergo a course of adjuvant (conventional dose palliative) chemotherapy which will significantly delay administration of the HDC-PSCR treatment, adversely affect Plaintiff's health so that HDC-PSCR treatment cannot be administered, and may render the HDC-PSCR treatment less beneficial. In short, Plaintiff's doctors believe that immediate treatment with HDC-PSCR is Plaintiff's best opportunity for sustained health and life.

Last summer Plaintiff made a claim for a pre-treatment coverage commitment from CHAMPUS. In a letter dated August 2, 1994, David S. Bogner, M.D., Medical Director of CHAMPUS, denied coverage to Plaintiff, reasoning that CHAMPUS does not cover experimental therapy and that "CHAMPUS must continue to consider ... HDC-PSCR therapy as investigational for the treatment of breast carcinoma." Plaintiff then requested an expedited review of CHAMPUS' denial of coverage. In a letter dated September 14, 1994, Bogner responded that despite the materials supplied to him by Plaintiff (including federal district court rulings granting injunctive relief for CHAMPUS patients seeking similar therapies, three affidavits of oncologists stating, inter alia, that the requested treatment is not experimental, and an article from the New England Journal of Medicine), CHAMPUS stood by its determination that coverage for HDC-PSCR would be denied as experimental. Plaintiff proceeded to file the instant action.

II. DISCUSSION

A. The Merits of the CHAMPUS determination

The proper standard for reviewing the CHAMPUS determination is the arbitrary and capricious standard. Wheeler v. Dynamic Engineering, Inc., 850 F.Supp. 459, 464 (E.D.Va.1994) (citing Woods Psychiatric Institute v. U.S., 925 F.2d 1454 (Fed.Cir. 1991).

In applying this standard, this "court must consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment.

Western & Southern Life Ins. Co. v. Smith, 859 F.2d 407 (6th Cir.1988) (citations omitted). An agency action is properly found to be arbitrary and capricious where:

the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to evidence before the agency, or is so implausible that it could not be ascribed to difference in view or the product of agency expertise.

Petry v. Block, 737 F.2d 1193, 1198 (D.C.Cir. 1984) (quoting Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Ins. Co., 463 U.S. 29, 43-45, 103 S.Ct. 2856, 2867, 77 L.Ed.2d 443 (1983)).

In the instant case CHAMPUS justifies its decision on the following bases:

1. CHAMPUS policy precludes it from cost-sharing for experimental and investigational procedures or treatment regimens.

2. Based on studies conducted in 1988, CHAMPUS considers HDC-PSCR to be experimental/investigational. Nothing to date has justified to CHAMPUS a departure from this position.

3. HDC-PSCR is analogous to bone marrow transplantation, which is explicitly defined by CHAMPUS to be investigational.

4. Other third party payors such as Blue Cross and Blue Shield Association ("BC/BS") and Federal Employee Health Benefits Program ("FEHBP") do not cover HDC-PSCR.

5. Neither technology assessments, scientifically controlled studies or current medical literature have yet shown that high dose chemotherapy with PSCR for the treatment of breast cancer is safe, effective and superior to existing therapies. In order for CHAMPUS to adopt a new benefit, these elements must be demonstrated.

See Affidavit of Martha M. Maxey. Unless these reasons are arbitrary or capricious, the CHAMPUS decision must stand.

Many, if not all, of CHAMPUS' arguments have been raised in at least three prior cases involving CHAMPUS' denial of coverage for HDC-PSCR to patients with advanced breast cancer. See Wheeler, 850 F.Supp. 459; Gripkey v. Mail Handlers Benefit Plan, 1994 WL 276265, No. 3:94-378-0 (D.S.C. Feb. 14, 1994); Hawkins v. Mail Handlers Benefit Plan, 1994 WL 214262, No. 1:94CV6 (W.D.N.C. Jan. 28, 1994). In all of these cases, relief (declaratory and/or injunctive) was granted to the plaintiff.²

1. HDC-PSCR as Analogous to Bone Marrow Transplant Treatment

CHAMPUS explicitly precludes coverage for a non-exclusive list of over sixty "investigational or experimental" treatments. Although HDC-PSCR is not included in this list, bone marrow transplants are. CHAMPUS argues that HDC-PSCR is justifiably excluded from treatment either because it falls within the definition of bone marrow transplant or because the procedure, if not identical, is similar.

The evidence before the Court is clear that Plaintiff is not having a bone marrow transplant.

Rather, Plaintiff is having a ... PSCR. Although the two procedures are similar in that they both provide support for a patient receiving high dose chemotherapy, they ... are distinct procedures. In bone marrow transplantation, marrow is collected from a patient. However, the Plaintiff is not having her marrow collected. She will have white blood cells removed from her blood stream and reinfused after the administration of high dose chemotherapy.

Wheeler, 850 F.Supp. at 468. Therefore, the section cited by CHAMPUS excluding coverage for autologous bone marrow transplantation does not apply to Plaintiff's case. Id.

If anything, the fact that bone marrow transplants are explicitly excluded from coverage in certain cases while HDC-PSCR is not actually supports Plaintiff's argument for coverage. If the procedures are similar and have both been available for years and one is explicitly excluded, the natural conclusion is that the other (HDC-PSCR) was not intended to be excluded.

2. HDC-PSCR as Investigational Procedure

The general exclusion for experimental or investigational procedures under CHAMPUS coverage 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 defines "experimental" as follows:

Medical care that essentially is investigatory or an unproven procedure or treatment regimen ... that does not meet the generally accepted standards of usual professional medical practice in the community.

Plaintiff, as did the plaintiffs in Wheeler, Hawkins, and Gripkey, has presented CHAMPUS and this Court with the testimony, in affidavit form, of three oncologists who conclude that they are convinced to a reasonable degree of medical certainty that HDC-PSCR is a generally accepted treatment.

Rather than counter the testimony of Plaintiff's experts with other experts, CHAMPUS relies on old studies and argues that nothing has changed the acceptability of HDC-PSCR as a form of treatment. Recently many courts have been forced to wrestle with determinations on whether certain treatments are experimental. The one thing that these courts as well as the medical profession have been able to agree upon is that the status (i.e., whether experimental or generally accepted) of many medical treatments is constantly in a state of flux. See, e.g., Harris v. Mutual of Omaha Companies, 992 F.2d 706, 713 n. 4 (7th Cir.1993) (noting that courts had reached different outcomes on the issue of whether HDC-autologous bone marrow transplant is an experimental procedure). Given the perpetual changes in status of treatments, it is not enough for CHAMPUS to counter medical experts' testimony that HDC-PSCR is generally accepted by simply relying on dated studies and arguing that the treatment's status has not changed.

CHAMPUS also argues that Plaintiff's experts are not able to testify to the acceptance of HDC-PSCR outside of their geographic area. The curriculum vitae of Plaintiff's experts indicate that their medical expertise is national and not just regional. Furthermore, the fact that experts in Wheeler, Hawkins, and Gripkey reached the same conclusions...