Clinical lab tests
This article was originally published in The Gray Sheet
Executive Summary
Final rule establishing national Medicare coverage policies for 23 clinical diagnostic laboratory tests, including prothrombin time and fecal occult blood tests, is published Nov. 23 in the Federal Register. The rule incorporates six changes to a March 2000 proposed rule, including removing "egregious overutilization" as an exception Medicare contractors may use to pursue frequency-based denial of claims, and removing a provision in the "reasons for denial" section limiting coverage of non-FDA-approved devices to category B IDEs. CMS notes that it will be modifying regulations on IDEs following the creation of a clinical trials coverage policy in September 2000. In addition, the effective date for provisions requiring computer system adjustments is changed to Nov. 25, 2002. All other provisions are effective Feb. 21, 2002...