pylori due to fastidious growth requirements that make traditional culture methods impractical for routine diagnosis. Multiple methods have been developed to detect H. pylori has been demonstrated to serve as a cure for PUD and therefore, the laboratory diagnosis of this organism is a critical component of both primary diagnosis and monitoring PUD treatment. pylori, a urease-producing bacterial species, which has a relatively high prevalence among adults, has had extensive epidemiological evidence to support its association with PUD, along with other disorders such as gastric cancer. Until recently, the etiology of peptic ulcer disease (PUD) had been largely idiopathic, but the elucidation of H. pylori Diagnosis in the Clinical Laboratory pylori (2) outline Medicare's past and current approach to coverage (3) analyze relevant clinical literature and (4) delineate reasons for retaining Medicare's current policy of contractor discretion. This memorandum serves four purposes: (1) describe and provide history of laboratory diagnosis for the ulcer-related bacteria H. Subject: National Coverage Policy Request To: File: Fecal Antigen Assay for Diagnosis of Helicobactor Pylori (H. The flexibility of the national coverage process allows for the introduction of future scientific and clinical knowledge which can be properly harnessed at the appropriate time when a national policy on the spectrum of H. As any new markers emerge, there will be a continuous opportunity for Medicare contractors to compare HpSA against both existing and new techniques, such that a blend of performance and clinical utility considerations can result in more informed policy-making. Encouraging technology diffusion at a local level, driven by clinical expertise at contractor advisory committees, will create an opportunity for stool antigen testing to obtain an appropriate diagnostic foothold. pylori testing would detract from making a national coverage policy.Ĭontinued contractor discretion offers the most optimal solution for addressing the current coverage request from Meridian Diagnostics, Inc. The previously described need for enhanced clarity regarding the clinical utility of H. HCFA would be better served to defer consideration of such an expansive policy until greater maturation is achieved across multiple assay formats. pylori diagnostics (including genotypic approaches currently being researched - Megraud ). Such a 'snapshot' national coverage policy would fail to account for the dynamic changes which are occurring in the development of non-invasive H.

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