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BOSKO v. SHALALA

August 28, 1996

PRISCILLA BOSKO, Plaintiff,
v.
DONNA E. SHALALA, Secretary of Health and Human Services, Defendant.



The opinion of the court was delivered by: LEE

 August 28, 1996

 I. INTRODUCTION

 Plaintiff, Priscilla Bosko ("Plaintiff"), brings this action pursuant 42 U.S.C. § 405(g) of the Social Security Act ("Act"). Plaintiff seeks review of the final determination of the Secretary of Health and Human Services ("Secretary"), denying Plaintiff's application for Medicare benefits under Title XVIII of the Act for a proposed autologous bone marrow transplant *fn1" ("ABMT") for her condition of chronic myelogenous leukemia, also known as chronic granulocytic leukemia.

 In August, 1989, the Secretary of Health and Human Services issued a formal ruling, section 35-30 of the Medicare Coverage Issues Manual, stating that "insufficient data exist to establish definite conclusions regarding the efficacy" of ABMT for chronic myelogenous leukemia ("CML") and, thus, ABMT is not considered "reasonable and necessary" within the meaning of the Medicare law and "is not covered under Medicare" for the treatment of CML. 54 Fed. Reg. 34555, 34567 (emphasis added). Plaintiff contends that section 35-30 is not currently supported by substantial medical evidence and, therefore, the Secretary's decision, relying upon section 35-30, is not based on substantial evidence and should be reversed.

 The parties have filed cross-motions for summary judgment pursuant to Federal Rule of Civil Procedure 56. (See Documents Nos. 7 and 9.) For the reasons stated, plaintiff's motion for summary judgment will be denied and defendant's motion for summary judgment will be granted.

 II. BACKGROUND

 Medicare, established in 1965 under Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395 through 1395, is a federally subsidized health insurance program administered by the Secretary and consists of two parts, Part A and Part B. See 42 U.S.C. § 1395 through 1395ccc. Part A is a mandatory hospital insurance program financed through employment taxes. Part B is a voluntary supplemental medical insurance program financed through monthly fees charged to those opting for the service.

 Part A, the portion at issue here, provides limited medical coverage for persons who are disabled or are under the Social Security Retirement Program. 42 U.S.C. § 1395. It provides insurance for the cost of hospital and related post-hospital services, but precludes reimbursement for any "items or services . . . which are not reasonable and necessary for the diagnosis or treatment of illness or injury." 42 U.S.C. § 1395y(a)(1). Since 1977, the Medicare policy has explicitly excluded from coverage services which are "experimental" or "investigational." *fn2" See Part A Intermediary Letter, No. 77-4, January 1977.

 Part A is administered by the Secretary through "intermediaries," insurance companies under contract with the Secretary who both review beneficiary claims and determine the amounts to be paid for the medical services. 42 U.S.C. § 1395h. An individual dissatisfied with the decision of an intermediary is entitled to an administrative hearing before the Secretary and to judicial review. 42 U.S.C. § 1395ff(b)(1).

 The Health Care Financing Administration ("HCFA"), which runs Medicare, issues a "national coverage decision" to indicate to intermediaries whether a particular technology is covered. HCFA's analysis involves searching the medical literature, meeting with interested parties, consulting its own panel of physicians, and seeking input from other agencies. HCFA will then make a coverage decision and invite public comment. 54 Fed. Reg. 4302, 4308 (January 30, 1989).

 "At any time after publication of a Medicare coverage instruction, interested parties may request reconsideration and submit evidence demonstrating that a reassessment of that coverage decision is warranted." Id. Additionally, reevaluation of a service might occur when the publication of new clinical studies in medical literature indicate that those findings are not consistent with the existing Medicare coverage policy. Id.

 In August, 1989, the Secretary, through the HCFA, issued a national coverage decision, section 35-30(c)(2), instructing that ABMT for treatment of CML was a noncovered condition and no payment was to be made for Medicare claims arising out of this procedure. It concluded that the procedure, when used for CML, "is not considered reasonable and necessary" within the meaning of the Medicare Act. 54 Fed. Reg. 34555, 34567.

 Section 35-30(c)(2) states, in pertinent part:

 
2. Noncovered Conditions. - Insufficient data exist to establish definite conclusions regarding the efficacy of autologous bone marrow ...

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