On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the CY 2022 Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rule. C21 continues to strongly support both the existing laboratory date of service (DOS) exceptions policy at 42 CFR 414.510(b)(5) and outpatient packaging exclusion, which have expanded beneficiary access to innovative clinical laboratory testing. As a follow up to the agency’s inclusion of cancer-related protein-based multi-analyte assays with algorithmic analyses (MAAA) tests in the DOS policy and outpatient packaging exclusion in last year’s rulemaking, we are writing to ensure consistency in applying the DOS policy and outpatient packaging exclusion to tests with a pattern of clinical use that is not connected with the primary hospital outpatient service. As discussed below, we recommend that CMS make the following adjustments to its current application of these policies:
1. Apply the laboratory DOS policy and packaging policy exclusion to MAAA tests described by Proprietary Laboratory Analyses (PLA) codes; and
2. Make the laboratory DOS policy and packaging policy exclusion applicable to all MAAA tests if they are unrelated to the primary hospital outpatient service.