Erringer

A class of Medicare beneficiaries (“the Beneficiaries”), whose claims for coverage of their health care services were denied based on Local Coverage Determinations (“LCDs”), 1 challenge rules issued by the Secretary of Health and Human Services (the “Secretary”) which give criteria to contractors for adopting LCDs. The Beneficiaries contend that the criteria governing the LCDs are substantive rules required to be promulgated under either the notice and comment requirements of the Administrative Procedures Act (“APA”), 5 U.S.C.' § 553(b) and (c), or the promulgation requirements of the Medicare Act, 42 U.S.C. § 1395hh. The district court held that the unpublished criteria are not subject to the formal rulemaking requirements of the APA and the Medicare Act because they are interpretive rules.. We have jurisdiction under 28 U.S.C. § 1291 , and we affirm.

1. Factual and Procedural Background

A. The Medicare Act and LCDs

The Medicare Act creates a health insurance program providing benefits to eligible elderly and disabled individuals. Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395 -1395hhh. Parts A and B provide coverage for various items and services,, but exclude…