Personalized Medicine Coalition submits comments to CMS on the Potential Revisions to the Laboratory DOS Policy

PMC recognizes the need for a change to CMS’ “laboratory date of service policy,” which requires hospitals to manage the complex billing processes for many laboratory tests performed within 14 days after a patient’s discharge from the hospital even if the test is performed at an outside laboratory. As PMC notes in the letter, the administrative challenges caused by this policy can lead to delayed diagnostic testing that can guide the most appropriate

treatment decisions for patients. To ensure that the final policy incentivizes the timely and appropriate deployment of all personalized medicine tests, the Coalition has recommended that CMS consider the broadest possible application of the proposed changes — inclusive of all molecular pathology tests as well as the “advanced diagnostic laboratory tests” and “multianalyte assays with algorithmic analysis” described by the agency. PMC also recommended that the final policy account for the fact that liquid-based tests are sometimes ordered before tissue samples are collected.