Position Statements

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to submit comments regarding the above-captioned proposed Local Coverage Determination (LCD).

…C21 member companies currently offer and/or are actively developing next generation sequencing (NGS)-based comprehensive genomic profiles (CGPs) for patients with advanced cancer. Given C21’s mission to facilitate the development and commercialization of innovative diagnostics, C21 has a keen interest in National Government Services’ consideration of the above-captioned proposed LCD.

C21 strongly supports the proposed LCD insofar as it would expand coverage for NGS-based CGPs offered as laboratory-developed tests (LDTs), as permitted under National Coverage Determination (NCD) 90.2.

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.

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the above-captioned proposed rule. In particular, C21 strongly supports the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway to facilitate beneficiary access to life saving technologies. C21 members are developing clinical laboratory tests that would be eligible for coverage under the MCIT pathway following FDA market authorization.

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the Medicare Physician Fee Schedule (MPFS) Proposed Rule for Calendar Year 2021.

C21 comprises many of the world’s most innovative diagnostic technology companies, clinical laboratories, physicians, venture capital companies, and patient advocacy groups. C21’s mission is to improve the quality of healthcare by encouraging research, development, and commercialization of innovative diagnostic technologies that will personalize patient care, improve patient outcomes, and substantially reduce healthcare costs. For fifteen years, C21 has worked with CMS on the development, promulgation, and implementation of policies intended to facilitate appropriate patient access to high-quality clinical laboratory tests.

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rule for Calendar Year 2021. We strongly support the existing laboratory date of service (DOS) policy at 42 CFR 414.510(b)(5) which has expanded beneficiary access to innovative diagnostic testing since implementation in 2018. Likewise, C21 strongly supports CMS’ proposal to update the laboratory DOS policy and packaging policy exclusion to include cancer-related protein-based multi-analyte assays with algorithmic analyses (MAAA) tests. We believe this revision will promote similar billing jurisdiction rules for tests that are unrelated to the primary hospital outpatient service. To best promote the consistent application of the laboratory DOS policy, we respectfully recommend two updates to the agency’s proposal: 1. Confirm that the laboratory DOS policy and packaging policy exclusion apply 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.