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 in Response to the Centers for Medicare & Medicaid Services Physician Fee Schedule Proposed Rule for Calendar Year 2018 (Implementation of Medicare Clinical Diagnostic Laboratory Tests Payment System)

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the CY 2018 Physician Fee Schedule Proposed Rule. We are writing in response to the Centers for Medicare & Medicaid Services’ (CMS’) solicitation of public input on the implementation of the new private payor-rate based Medicare Clinical Diagnostic Laboratory Tests Payment System promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). C21 appreciates the work that CMS has performed over the past year in implementing PAMA’s private payor rate-based Clinical Laboratory Fee Schedule (CLFS). We continue to support the implementation of PAMA on the schedule set out in the CLFS Final Rule, which sets an effective date of January 1, 2018 for the new market-based payment rates. Additionally, we respectfully request that CMS release the application for Advanced Diagnostic Laboratory Test (ADLT) status as soon as practicable to enable qualifying tests to be designated in advance of CY 2018.

Letter in Response to the Centers for Medicare & Medicaid Services Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2018

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to submit our comments in response to the Centers for Medicare & Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rule for Calendar Year 2018. In particular, we are writing in support of the agency’s effort to modernize its Date of Service (DOS) billing policies for separately payable molecular pathology and Advanced Diagnostic Laboratory Tests (ADLTs) under Section 1834A(d)(5) of the Social Security Act that are performed on specimens collected from hospital outpatients. We agree with CMS that the current policy, as applied to these innovative tests, can create barriers to patient access to critical diagnostics and to the development of precision medicine, and that it is at odds with the agency’s rationale for excluding these tests from laboratory packaging in the hospital outpatient setting.

Letter in Response to New Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2018

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.

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. ยง 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.