On behalf of the Coalition for 21st Century Medicine, we appreciate the opportunity to submit our comments in response to the Centers for Medicare & Medicaid Services (CMS) Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2017. We are writing in support of CMS’ proposal to expand the laboratory test packaging policy exception to also include Advanced Diagnostic Laboratory Tests. We believe, however, that the exception should be further expanded to include all Multianalyte Assays with Algorithmic Analyses protein based tests which are also not routinely performed by hospitals and are generally less tied to the hospital primary service than more routine laboratory tests.
In addition, we are writing on a related policy matter that is impacted by the agency’s packaging policy proposal. Specifically, we are requesting that CMS update its “date of service” regulations at 42 C.F.R. § 414.510 so that hospitals are not required to bill for clinical diagnostic laboratory tests that are excluded from packaging and are performed by an independent laboratory.