CMS is still rolling out policies and procedures to fully implement the major clinical laboratory payment reforms mandated by the Protecting Access to Medicare Act of 2014 (PAMA). As previously reported, the June 23, 2016 final PAMA rule established the framework for basing Medicare clinical laboratory fee schedule (CLFS) payment on private insurance payment amounts, with associated data reporting requirements. The rule also defined a subcategory of clinical diagnostic laboratory tests — Advanced Diagnostic Laboratory Tests (ADLT) – with separate reporting and payment policies, including payment at actual list charge for three quarters.
On March 23, 2018, CMS released the ADLT application and detailed guidance for laboratories on the process for requesting ADLT status, including the quarterly schedule for review of ADLT applications. In addition, CMS has posted a new application for requesting a HCPCS code for an ADLT or clinical diagnostic laboratory tests (CDLT) that is not an ADLT. Finally, CMS has released a form that a laboratory or manufacturer must use to notify CMS of any CDLT (that is not an ADLT) that has been cleared or approved by the Food and Drug Administration — whether it has already been assigned a unique HCPCS code or has not yet been assigned a unique HCPCS code.