Reimbursement Position Statements

On behalf of the Coalition for 21st Century Medicine, and in follow-up to the comments we presented during the public meeting held on July 31, 2017, we are pleased to submit these additional comments for your consideration as you finalize your CY2018 Clinical Laboratory Fee Schedule (CLFS) Preliminary Payment Determinations.

The Coalition comprises many of the world’s most innovative diagnostic technology companies, clinical laboratories, physicians, venture capital companies, and patient advocacy groups. Given the Coalition’s mission to facilitate development and commercialization of innovative diagnostics to inform important patient management decisions, we have a keen interest in the agency’s CLFS payment policies and determinations – especially those addressing coding and payment for: (1) Multianalyte Assays with Algorithmic Analyses (MAAA) and (2) Genomic Sequencing Procedures and other Molecular Multianalyte Assays.

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.

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.

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%.

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.