The Centers for Medicare & Medicaid Services (CMS) is preparing to host a significant virtual meeting of its Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on September 15 and 16, 2026. This assembly is critical for shaping the future payment landscape for specific clinical diagnostic laboratory tests (CDLTs) under Medicare, particularly those for which CMS did not receive applicable information during the May 1 through July 31, 2026, data reporting period.
Legislative Foundation and Panel's Role
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests operates under the authority of section 1834A(f)(1) of the Social Security Act, a provision established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA). PAMA was enacted on April 1, 2014, with the aim of reforming how Medicare pays for laboratory tests. The Panel itself is governed by the Federal Advisory Committee Act (FACA), ensuring transparency and proper governance for its operations.
This expert outside advisory panel is composed of individuals with deep expertise in CDLTs, including molecular pathologists, researchers, and specialists in laboratory science or health economics. Its primary mandate is to provide input and recommendations to the Secretary of the Department of Health and Human Services (HHS) and the Administrator of CMS. These recommendations cover the establishment of payment rates for new CDLTs, particularly whether to use crosswalking or gapfilling methods, the factors influencing coverage and payment processes for these tests, and other aspects of the payment system under section 1834A of the Act.
Evolution of CLFS Payment Revisions
Section 1834A of the Act mandated revisions to the payment methodology for CDLTs paid under the Clinical Laboratory Fee Schedule (CLFS). These requirements were formally implemented through a final rule published in the June 23, 2016 Federal Register. This rule introduced a system where payment for a CDLT, furnished on or after January 1, 2018, would generally be based on the weighted median of private payor rates. This calculation relies on applicable information collected during a specified data collection period and reported to CMS during a subsequent data reporting period.
Initially, for CDLTs that are not advanced diagnostic laboratory tests (ADLTs), data collection and reporting were set to occur every three years. The first cycle involved data collection from January 1, 2016, through June 30, 2016, with reporting from January 1, 2017, through March 31, 2017. However, Congress has repeatedly delayed subsequent reporting periods. Most recently, section 6226 of the Consolidated Appropriations Act, 2026, stipulated that the next data reporting period for these tests would be from May 1, 2026, through July 31, 2026, based on a data collection period spanning January 1, 2025, through June 30, 2025.
Addressing Data Gaps through Crosswalking and Gapfilling
Under existing regulations (42 CFR 414.507(f)), if CMS receives no applicable information to calculate a Medicare payment rate for a CDLT based on the weighted median of private payor rates, the payment is determined using either crosswalking or gapfilling methods. Crosswalking involves assigning a payment rate by identifying an existing, comparable test and adopting its rate. Gapfilling, conversely, is used when a comparable test cannot be found, requiring a more complex process to establish a new rate based on various factors like resources, costs, and market prices.
In early August 2026, CMS will post a list of laboratory codes for which it received no applicable information to calculate Medicare payment rates. This list will be the focus of the September Panel meeting. Public participants will have the opportunity to present recommendations, supported by data, on the appropriate basis for establishing payment amounts for these specific CDLTs. This input is crucial as it directly informs the Panel's subsequent recommendations to the Secretary of HHS and the Administrator of CMS.
Meeting Structure and Public Participation
The virtual meeting is divided into two parts. During Part I, registered public participants can discuss and make recommendations on payment methodologies for the affected CDLTs. Presentations are limited to five minutes and must be submitted electronically to CMS by August 21, 2026. Presenters are expected to address specific items, including the code(s), a recommendation for crosswalking or gapfilling with a clear rationale, test costs, and charges, along with supporting data. Presentations that omit this information may be deemed incomplete, though CMS may request missing details post-meeting.
Part II will feature the Panel questioning public participants and deliberating on the information presented. The Panel will then formulate its recommendations to HHS and CMS regarding crosswalking or gapfilling for the codes discussed. These recommendations are central to the payment determination process.
Post-Meeting Process and Future Outlook
Following the September meeting, CMS intends to post its proposed determinations regarding the appropriate payment basis for each test code in late September 2026. These determinations will include explanations of the reasoning, the data used, and a request for public written comments. Interested parties will then have a window in October 2026 to submit their feedback on these proposed determinations.
This ongoing process underscores the complexity of establishing fair and accurate payment rates for clinical diagnostic laboratory tests within the Medicare program. The September 2026 meeting serves as a pivotal moment for stakeholders to influence these critical financial decisions, ensuring that payment rates accurately reflect the value and cost of these essential diagnostic tools, thereby impacting patient access and the sustainability of clinical laboratory services.
