National Coverage Analysis (NCA) Tracking Sheet

Helicobactor Pylori Testing for Ulcers

CAG-00006N

Issue

Fecal antigen assay may be used to aid in the detection of Helicobactor pylori. Helicobactor pylori is a gram-negative rod that is uniquely adapted to survive in the highly acid gastric environment. H. pylori infection of the stomach and duodenum has been causally linked to the development of chronic active gastritis, peptic ulcer disease and gastric cancer.

National Coverage Determinations

Benefit Category

Diagnostic Laboratory Tests

Requestor Information

Requestor Name Requestor Letter
Meridian Diagnosics, Inc. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/19/1999
Expected NCA Completion Date
10/17/1999
Public Comment Period
08/19/1999 - 09/17/1999
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
10/18/1999

Contacts

Lead Analysts
Kate Tillman
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

August 5, 1999

Lab team meeting for completeness.

August 12, 1999

Letter sent to Meridian Diagnostics accepting request as "formal."

August 18, 1999

Meeting with Meridian Diagnosics. Review of clinical application and clinical performance of HpSA. Dr. Vakil attended by conference call. Meridian was referred to payment staff to address their financial concerns.

September 1, 1999

Meeting of lab team to discuss formulating the bibliography. Svati Patel is co-lead analyst for the application.

September 7, 1999

Meeting of lab team. H pylori is on schedule for literature review and decision of record. Regular meetings of the lab team will be scheduled to review the current literature and to decide if tech assessment or panel is necessary to decide issues.

October 18, 1999