law judge;" 42 U.S.C. § 1395ff(b)(3)(A) and (ii) "in any case in which a court determines that the record is incomplete or otherwise lacks adequate information to support the validity of the determination, [the court] shall remand the matter to the Secretary for additional proceedings to supplement the record . . . ." 42 U.S.C. § 1395(b)(3)(C).
At each of the various stages of the review process, the decision to deny coverage was based upon section 35-30 of the Medicare Coverage Issues Manual. Plaintiff, however, asserts that she is entitled to Medicare benefits because section 35-30 is "now several years old and the assumption that ABMT is not effective is not consistent with current technology and medical opinion." Complaint, at unnumbered 5, 6. Plaintiff devotes the bulk of her memorandum and exhibits to proving the efficacy of ABMT in treating CML.
Instead of defining which procedures would be covered by Medicare, Congress sketched Medicare benefits in broad strokes; however, it specifically precluded payment of those items and services that the Secretary found were not "reasonable and necessary." 42 U.S.C. §§ 1395ff(a), 1395y(a). The Medicare statute "unambiguously vests final authority in the Secretary, and no one else, to determine whether a service is reasonable and necessary, and thus whether reimbursement should be made." New York on behalf of Bodnar v. Secretary of Health and Human Services, 903 F.2d 122, 125 (2d Cir. 1990).
Unfortunately, even if this plaintiff can prove that she truly needs ABMT, only the Secretary can define what is medically necessary for the purposes of providing Medicare coverage. See 42 U.S.C. § 1395ff(a). ("The determination of whether an individual is entitled to benefits under [Medicare] part A or part B . . . shall be made by the Secretary in accordance with regulations prescribed by [her]"); see also Heckler v. Ringer, 466 U.S. 602, 617, 80 L. Ed. 2d 622, 104 S. Ct. 2013 (1984) ("The Secretary's decision as to whether a particular medical service is 'reasonable and necessary' and the means by which she implements her decision . . . are clearly discretionary.").
Moreover, "the provision permitting judicial review of the Secretary's Medicare determinations requires that such review be conducted in accord with the Administrative Procedure Act." Butler County Memorial Hosp. v. Heckler, 780 F.2d 352, 354 (3d Cir. 1985) (citing 42 U.S.C. § 1395oo(f)(1)). The Administrative Procedure Act requires that the court uphold agency decisions unless they are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . ." 5 U.S.C. § 706(2)(A).
The Secretary's decision to issue a national coverage determination excluding ABMT for treating CML was based upon a complex decision making process. As the Court of Appeals for the Third Circuit stated in Butler County Memorial Hospital, "legislators and judges are not medical specialists, and for that reason it is necessary that administrative agencies develop and apply medical expertise. . . . We must be cautious lest we disturb this appropriate allocation of governmental functions." 780 F.2d at 356. The Court finds that the comprehensive analysis performed at the direction of the Secretary, and the Secretary's continued reliance on this analysis, can not be said to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
The Court will defer substantially to the Secretary's considered judgment here. While the Court certainly sympathizes with plaintiff, it believes that the statements of the Court of Appeals for the Seventh Circuit are appropriate: "It may be unfortunate that Congress and [the Secretary] cannot provide funds for novel  procedures that may relieve pain and suffering. To be sure, adherents of the [ABMT] procedure may someday be able to demonstrate to the Secretary and to the general medical community that [AMBT for treatment of CML is medically necessary and appropriate.] Until then, however, [the Court] cannot sanction the provision of federal funds to support a  procedure that the Secretary, after appropriate analysis, is unable to establish as safe and effective." Wilkins v. Sullivan, 889 F.2d 135 (7th Cir. 1989).
An appropriate Order will follow.
AND NOW, this 28th day of August, 1996, it is hereby ORDERED THAT:
(1) The Motion for Summary Judgment of Plaintiff, Priscilla Bosko, ( Document No. 9) is DENIED ; and,
(2) The Motion for Summary Judgment of Defendant, Donna E. Shalala, Secretary of Health and Human Services ( Document No. 7) is GRANTED.
Donald J. Lee
United States District Judge