Letter to CMS Regarding Revisions to the Laboratory Date of Service Policy in the Hospital Outpatient Prospective Payment System (HOPPS) Final Rule for Calendar Year 2018
…Consistent with its modernization of the date of service regulations, C21 respectfully requests that CMS update its policy for packaging laboratory tests furnished in the outpatient setting, to ensure that all tests with a different pattern of clinical use that make them less tied to the primary outpatient service than the routine laboratory tests that the agency packages are treated equally for purposes of packaging and the new laboratory date of service exception – including all multianalyte assays with algorithmic analyses (MAAAs). In addition, we urge the agency to release the application for designation of a test as an Advanced Diagnostic Laboratory Test (ADLT) under Section 216 of the Protecting Access to Medicare Act (PAMA) of 2014, in order to ensure that this component of the new, market-based payment system is able to take effect in accordance with the regulatory schedule on January 1, 2018.