Helicobactor Pylori Testing for Ulcers

CMS NCA document | source_status=Closed | review_type=New | public_comment_open=False | document_id=CAG-00006N

Retaining Current Contractor Discretion Given FDA-approval, coupled with documented effectiveness and comparability in peer-reviewed literature, there is not a basis for a national non-coverage policy. Therefore, it should be deemed "reasonable and necessary" to enable providers to both diagnose and monitor eradication of H. pylori for the indications (CDC [1997]) mentioned above. However, there are two critical factors that counterbalance the benefit of a national coverage policy specifically configured for HpSA: Such a "snapshot" national coverage policy would fail to account for the dynamic changes which are occurring in the development of non-invasive H. pylori diagnostics (including genotypic approaches currently being researched - Megraud [1997]). HCFA would be better served to defer consideration of such an expansive policy until greater maturation is achieved across multiple assay formats. The previously described need for enhanced clarity regarding the clinical utility of H. pylori testing would detract from making a national coverage policy. Continued contractor discretion offers the most optimal solution for addressing the current coverage request from Meridian Diagnostics, Inc. 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. 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. 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. pylori diagnostics becomes applicable.