The Coalition for 21st Century Medicine’s Reimbursement Workgroup is playing a lead role in crafting the future of coding, coverage, and payment for advanced diagnostics. Over the past year the Coalition has engaged directly with the Centers for Medicare & Medicaid Services (CMS) on the implementation of the Protecting Access to Medicare Act of 2014 (PAMA). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, of PAMA modernizes the Medicare payment system for clinical laboratory tests with the establishment of a market-based payment system. This will be the most significant modernization of the Clinical Laboratory Fee Schedule (CLFS) since the introduction of the CLFS in 1984. Additionally, the Coalition has been actively engaged with other critical stakeholders such as the American Medical Association CPT Editorial Panel on coding policy, and with the Medicare Administrative Contractors (MAC) on coverage policy and evidentiary requirements.

Letter to CMS Regarding Hospital Outpatient Prospective Payment System, Proposed Rule — Laboratory Date of Service and Packaging Policy

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.

Letter to CMS Regarding Medicare Coverage of Innovative Technology Proposed Rule

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.

Letter to CMS Regarding Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies for the Calendar Year 2021

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.

Letter to CMS Regarding the Laboratory Date of Service and Packaging Policy in the Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rule for the Calendar Year 2021

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.

Letter to Centers for Medicare & Medicaid Regarding Hospital Outpatient Prospective Payment System, Proposed Rule – Potential Changes to the Laboratory Date of Service Policy

On behalf of the Coalition for 21st Century Medicine, we appreciate the opportunity to comment on the Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2020. We are writing in strong support of maintaining the current laboratory date of service policy at 42 CFR 414.510(b)(5), which has dramatically improved beneficiary access to innovative molecular diagnostic tests to guide physicians in selecting appropriate care for complex diseases like cancer, cardiovascular disease, and rheumatoid arthritis.