The agency’s move has raised serious issues for lab groups, in particular, the new requirement that a cost estimate be included on the ABN and the short deadline currently envisioned for the transition which will require major systems changes and re-education and training of ordering physicians and staff. Lab groups want at least a one-year delay in implementation of the revised ABN from the date when instructions on its use are issued.

The American Clinical Laboratory Association has asked for a meeting with CMS officials to discuss these issues. ACLA has raised questions about the cost estimate requirement, saying it represents a substantial change in current law and policy, requiring at the least that CMS follow public notice and comment rulemaking under the Administrative Procedures Act.

The ABN is used to inform beneficiaries that Medicare may not cover a claim for a particular item or service and gives them the option of accepting the item/service and agreeing to be financially liable if the claim is denied, or declining the item/service and agreeing not to appeal to see if Medicare would pay.

For details on revised ABN implementation, see the April 28 issue of the National Intelligence Report.