Medicare Program: Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, July 23-24, 2025

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <DEPDOC>[CMS-1841-N]</DEPDOC> <SUBJECT>Medicare Program: Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, July 23-24, 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 the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Wednesday, July 23, 2025, and Thursday, July 24, 2025. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> <E T="03">Meeting Date:</E> Wednesday, July 23, 2025, from 10:00 a.m. to 4:00 p.m. Eastern Daylight Time (E.D.T.) and Thursday, July 24, 2025, from 10:00 a.m. to 4:00 p.m. E.D.T. The Panel is also expected to participate virtually in the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting for Calendar Year (CY) 2026 on Friday, June 27, 2025 to gather information and question presenters. Notice of the CLFS Annual Public Meeting for CY 2026 is published elsewhere in this issue of the <E T="04">Federal Register</E> . <E T="03">Deadline for Meeting Registration, Presentation and Comments:</E> May 30, 2025, 5:00 p.m. E.D.T. <E T="03">Deadline for Requesting Special Accommodations:</E> May 30, 2025, 5:00 p.m. E.D.T. <E T="03">In-Person Attendance:</E> If attending the meeting in person at the CMS Headquarters, registration is required and must be completed by May 30, 2025. For more information on how to register as an in-person attendee, see the “Registration Instructions” (section IV. of this notice). <E T="03">Virtual Attendee Only:</E> The public may also view this meeting via webinar or listen-only via teleconference. If attending the meeting via webinar, or listen-only via teleconference, registration is not required for non-speakers. <E T="03">Webinar and Teleconference Meeting Information:</E> Teleconference dial-in instructions, and related webinar details will be posted on the meeting agenda, which will be available on the CMS website approximately 2 weeks prior to the meeting at <E T="03">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.</E> A preliminary agenda is described in section II. of this notice. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The Panel meeting will be held <E T="03">virtually</E> and <E T="03">in-person</E> at the campus of the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> The CLFS Policy Team via email, <E T="03">CDLTPanel@cms.hhs.gov;</E> 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> The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs) (the Panel) is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), enacted on April 1, 2014. The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics. The Panel will provide input and recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following: • The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use “crosswalking” or “gapfilling” processes to determine payment for a specific new test. • The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests. • Other aspects of the payment system under section 1834A of the Act. A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014 <E T="04">Federal Register</E> (79 FR 63919 through 63920). In the August 7, 2015 <E T="04">Federal Register</E> (80 FR 47491), we announced membership appointments to the Panel along with the first public meeting date for the Panel, which was held on August 26, 2015. Subsequent meetings of the Panel and membership appointments were also announced in the <E T="04">Federal Register</E> . <HD SOURCE="HD1">II. Agenda</HD> The Agenda for the July 23 and July 24, 2025, hybrid Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's charter: • Calendar Year (CY) 2026 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes, which will be posted on the CMS website at <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.</E> • Other CY 2026 CLFS issues designated in the Panel's charter and further described on our Agenda. A detailed Agenda will be posted approximately 2 weeks before the meeting, on the CMS website at <E T="03">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel.</E> The Panel will make recommendations to the Secretary and the Administrator of CMS regarding crosswalking and gapfilling for new and reconsidered laboratory tests discussed during the CLFS Annual Public Meeting for CY 2026. The Panel will also provide input on other CY 2026 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda. <HD SOURCE="HD1">III. Meeting Participation</HD> This meeting is open to the public. Stand-by speakers may participate in the meeting in-person via teleconference and webinar. A stand-by speaker is an individual who will speak on behalf of a company or organization if the Panel has any questions during the meeting about technical information described in the public comments or presentation previously submitted or presented by the organization or company at the recent CLFS Annual Public Meeting for CY 2026 on June 27, 2025. The public may also attend the hybrid meeting in-person or view and/or listen-only to the meeting via teleconference and webinar. Please note that CMS reserves the right to shift the meeting format from hybrid to virtual-only, if for some reason, a hybrid format is not possible. If there is a need to shift to a virtual-only format, we will alert the public as soon as possible and post updated information on the CMS website at <E T="03">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel.</E> <HD SOURCE="HD1">IV. Registration Instructions</HD> Beginning May 1, 2025 and ending May 30, 2025 at 5:00 p.m. E.D.T., registration may be completed by stand-by speakers and in-person attendees. Individuals who intend to view and/or listen to the meeting virtually do not need to register. Stand-by speakers and individuals who intend to attend the meeting at the CMS campus must register online at <E T="03">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel.</E> On this web page, under the heading “Meeting” there is a link entitled “Register for Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting.” Click this link and enter the required information. All of the following information must be submitted when registering: • Name. • Indicate if individual is registering as a “Stand-by speaker” or “In-Person Attendee.” • Organization or company name. • Email addresses that will be used by the speaker to connect to the virtual meeting. • Indicate if individual is a “Foreign National” visitor • New or Reconsidered Code(s) for which the company or organization individual is representing submitted a comment or presentation, if applicable. Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by the date specified in the <E T="02">DATES</E> section of this notice. Additionally, registration information must reflect individual-level content and not reflect an organization name. Also, we request organizations register all individuals at the same time. That is, one individual may register multiple individuals at the same time. Individuals who are not registered in advance will not be permitted to enter the building (see section VI. of this notice). After registering, a confirmation email will be sent upon receipt of the registration. The email will provide information to the attendee in preparation for the meeting. Registration is only required for stand-by speakers and members of the public attending the meeting at the CMS campus (address specified in the <E T="02">ADDRESSES</E> section of this notice). All regi ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━