Advocacy: the voice of small business in government

As the Chief Counsel for the Office of Advocacy (Advocacy), I am writing you regarding the above-referenced proposed rule. Advocacy is concerned that the Centers for Medicare and Medicaid Services (CMS) has certified that the rule will not have a significant economic impact on a substantial number of small entities without providing a factual basis for the certification as is required by the Regulatory Flexibility Act. Advocacy is also concerned about the methodologies and assumptions underlying CMS' economic analysis and possible alternative approaches. For these reasons set out below, Advocacy believes that CMS should improve its small entity impact analysis as it drafts the Final Regulatory Flexibility Analysis to be contained in the final rule.