On October 1, 2015, CMS published a Proposed Rule outlining extensive revisions to Medicare reimbursement for clinical diagnostic laboratory tests (CDLTs) that are paid based on the Medicare Clinical Laboratory Fee Schedule (CLFS). The Proposed Rule implements a portion of the Protecting Access to Medicare Act of 2014 (PAMA), which requires that CMS set CLFS payment rates based on the weighted median of private payor rates for CDLTs as reported by clinical laboratories to CMS. In order to set CLFS payment rates effective on January 1, 2017 using this new methodology, CMS proposes that clinical laboratories collect private payor payment data for the period from July 1, 2015 through December 31, 2015, and report this data to CMS by March 31, 2016. Thus, clinical laboratories must immediately take steps to interpret the provisions of the Proposed Rule, assess their CDLT revenues, and prepare to implement applicable data collection and reporting processes, without the benefit of final regulations to establish the parameters of these requirements. King & Spalding’s Reimbursement and Government Pricing Teams have published a client alert analyzing the Proposed Rule available by clicking here.