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.

Supplemental Responses to Questions Raised by the Advisory Panel on Clinical Diagnostic Laboratory Tests at September 12, 2016 Meeting

On behalf of the Coalition for 21st Century Medicine (C21), we appreciated the opportunity to present our recommendations regarding the application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs) to the Advisory Panel on Clinical Diagnostic Laboratory Tests at its September 12, 2016 meeting. As a follow up to the Advisory Panel meeting, we would like to provide supplemental responses to several of the questions raised by the Panel. As CMS prepares the sub-regulatory guidance for the ADLT application and designation process, we believe it is important to implement the ADLT payment category in a way that promotes continued competition and innovation in precision medicine.

Comments in Response to the Centers for Medicare & Medicaid Services Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2017

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.

Letter to Andrew Slavitt (Acting Administrator, Centers for Medicare & Medicaid Services) Regarding 2016 Preliminary Gapfill Payment Determinations for New Genomic Sequencing Procedures Test Codes

On behalf of the Coalition for 21st Century Medicine (C21), we welcome the opportunity to provide input to the Advisory Panel on Clinical Diagnostic Laboratory Tests and the Centers for Medicare & Medicaid Services (CMS). In particular, we want to provide our recommendations on the application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs). As CMS works to develop the sub-regulatory guidance for the ADLT application and designation process, the Advisory Panel has a critical role in providing input on implementation of the new ADLT payment category.

Additionally, we urge the Advisory Panel to review and comment on the 2016 Preliminary Gapfill Payment Determinations for the Multianalyte Assays with Algorithmic Analyses (MAAA) and Genomic Sequencing Procedure (GSP) Current Procedural Terminology (CPT®) codes as recently submitted by the Medicare Administrator Contractors. The Advisory Panel previously considered these codes at the August and October 2015 Panel meetings. The Preliminary National Limitation Amounts (Preliminary NLAs), if finalized, would represent drastic reductions in payment rates for these innovative tests in the magnitude of approximately 30% to 90%.

Letter to Glenn McGuirk (Centers for Medicare & Medicaid Services, Center for Medicare) Regarding July 18, 2016 Advisory Panel on Clinical Diagnostic Laboratory Tests – ADLT Application and Designation Recommendations

On behalf of the Coalition for 21st Century Medicine (C21), we welcome the opportunity to provide input to the Advisory Panel on Clinical Diagnostic Laboratory Tests and the Centers for Medicare & Medicaid Services (CMS). In particular, we want to provide our recommendations on the application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs). As CMS works to develop the sub-regulatory guidance for the ADLT application and designation process, the Advisory Panel has a critical role in providing input on implementation of the new ADLT payment category.

Letter to Glenn McGuirk (Division of Ambulatory Services, Hospital and Ambulatory Payment Policy Group, Centers for Medicare & Medicaid Services) Regarding 2016 Preliminary Gapfill Payment Determinations for New MAAA CPT Codes

…The National Limitation Amounts must be adjusted in the 2016 Final Gapfill Payment Determinations to comply with the regulatory criteria for gapfill, to avoid substantial fluctuations in payment prior to and with the implementation of Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA 216), and to assure continued access to these advanced diagnostic tests, which the regional MACs where the laboratories are located have determined to be reasonable and necessary and valuable services for Medicare beneficiaries.