Medicare Program: Public Meeting Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2026-June 27, 2025

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <DEPDOC>[CMS-1837-N]</DEPDOC> <SUBJECT>Medicare Program: Public Meeting Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2026-June 27, 2025</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2026. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> <E T="03">Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting Date:</E> The meeting is scheduled for Friday, June 27, 2025, from 10 a.m. to 4 p.m. Eastern Daylight Time (E.D.T.). The meeting will have a hybrid format, occurring in-person at the Centers for Medicare & Medicaid Services (CMS) campus, Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850 and virtually online. <E T="03">Deadline for Submission of Presentations and Written Comments:</E> All presenters for the CLFS Annual Public Meeting must register using the registration link provided on the Annual Public Meeting CMS web page and submit their presentations electronically to our CLFS dedicated email box, <E T="03">CLFS_Annual_Public_Meeting@cms.hhs.gov,</E> by May 29, 2025 at 5 p.m. E.D.T. All written comments (non-presenter comments) must also be submitted electronically to our CLFS dedicated email box, <E T="03">CLFS_Annual_Public_Meeting@cms.hhs.gov,</E> by May 29, 2025, at 5 p.m. E.D.T. Any presentations or written comments received after that date and time will not be included in the meeting and will not be reviewed. <E T="03">Deadline for Submitting Requests for Special Accommodations:</E> Requests for special accommodations must be received no later than May 29, 2025 at 5 p.m. E.D.T. <E T="03">Publication of Proposed Determinations:</E> We intend to publish our proposed determinations for new test codes and our proposed determinations for reconsidered codes (as described later in section II., “Format” of this notice) for calendar year 2026 by early September 2025. <E T="03">Deadline for Submission of Written Comments Related to Proposed Determinations:</E> Comments in response to the proposed determinations will be due by early October 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The CLFS Annual Public Meeting will be held virtually and in-person at the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. <E T="03">Where to Submit Written Comments:</E> Interested parties should submit all written comments on presentations and proposed determinations electronically to our CLFS dedicated email box, <E T="03">CLFS_Annual_Public_Meeting@cms.hhs.gov</E> (the specific date for the publication of these determinations and the deadline for submitting comments regarding these determinations will be published on the CMS website). <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> The CLFS Policy Team and submit all inquiries to the CLFS dedicated email box, <E T="03">CLFS_Annual_Public_Meeting@cms.hhs.go</E> v <E T="03">,</E> with the subject entitled “CLFS Annual Public Meeting Inquiry” or Rasheeda Arthur, Ph.D. (410) 786-3434. The CMS Press Office, for press inquiries, (202) 690-6145. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) required the Secretary of the Department of Health and Human Services (the Secretary) to establish procedures for coding and payment determinations for new clinical diagnostic laboratory tests (CDLTs) under Part B of title XVIII of the Social Security Act (the Act) that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). The procedures and Clinical Laboratory Fee Schedule (CLFS) public meeting announced in this notice for new tests are in accordance with the procedures published on November 23, 2001 in the <E T="04">Federal Register</E> (66 FR 58743) to implement section 531(b) of BIPA. Section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the Secretary to establish by regulation procedures for determining the basis for, and amount of, payment for any CDLT for which a new or substantially revised Healthcare Common Procedure Coding System (HCPCS) code is assigned on or after January 1, 2005. A code is considered to be substantially revised if there is a substantive change to the definition of the test or procedure to which the code applies (for example, a new analyte or a new methodology for measuring an existing analyte-specific test). (See section 1833(h)(8)(E)(ii) of the Act and 42 CFR 414.502.) Section 1833(h)(8)(B) of the Act sets forth the process for determining the basis for, and the amount of, payment for new tests. Pertinent to this notice, sections 1833(h)(8)(B)(i) and (ii) of the Act require the Secretary to make available to the public a list that includes any such test for which establishment of a payment amount is being considered for a year and, on the same day that the list is made available, cause to have published in the <E T="04">Federal Register</E> notice of a meeting to receive comments and recommendations (including data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for the tests on such list. This list of codes for which the establishment of a payment amount under the CLFS is being considered for calendar year (CY) 2026 will be posted on the Centers for Medicare & Medicaid Services (CMS) website concurrent with the publication of this notice and may be updated prior to the CLFS Annual Public Meeting. The CLFS Annual Public Meeting list of codes can be found on the CMS website at <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/.</E> Section 1833(h)(8)(B)(iii) of the Act requires that we convene the public meeting not less than 30 days after publication of the notice in the <E T="04">Federal Register</E> . The CLFS requirements regarding public consultation are codified at 42 CFR 414.506. Two bases of payment are used to establish payment amounts for new CDLTs. The first basis, called “crosswalking,” is used when a new CDLT is determined to be comparable to an existing test, multiple existing test codes, or a portion of an existing test code. New CDLTs that were assigned new or substantially revised codes prior to January 1, 2018, are subject to provisions set forth under § 414.508(a). For a new CDLT that is assigned a new or significantly revised code on or after January 1, 2018, CMS assigns the new CDLT code the payment amount established under § 414.507 of the comparable existing CDLT. Payment for the new CDLT code is made at the payment amount established under § 414.507. (See § 414.508(b)(1)). The second basis, called “gapfilling,” is used when no comparable existing CDLT is available. When using this method, instructions are provided to each Medicare Administrative Contractor (MAC) to determine a payment amount for its Part B geographic area for use in the first year. In the first year, for a new CDLT that is assigned a new or substantially revised code on or after January 1, 2018, the MAC-specific amounts are established using the following sources of information, if available: (1) charges for the test and routine discounts to charges; (2) resources required to perform the test; (3) payment amounts determined by other payers; (4) charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant; and (5) other criteria CMS determines appropriate. In the second year, the test code is paid at the median of the MAC-specific amounts. (See § 414.508(b)(2)). Under section 1833(h)(8)(B)(iv) of the Act and § 414.506(d)(1) CMS, taking into account the comments and recommendations (and accompanying data) received at the CLFS Annual Public Meeting, develops and makes available to the public a list of proposed determinations with respect to the appropriate basis for establishing a payment amount for each code, an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments on the proposed determinations. Under section 1833(h)(8)(B)(v) of the Act and § 414.506(d)(2), taking into account the comments received on the proposed determinations during the public comment period, CMS then develops and makes available to the public a list of final determinations of payment amounts for tests along with the rationale for each determination, the data on which the determinations are based, and responses to comments and suggestions received from the public. 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