SUPPLEMENTARY INFORMATION:

I. Background

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 Federal Register (79 FR 63919 through 63920). In the August 7, 2015 Federal Register (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 Federal Register .

II. Agenda

The Agenda for the July 19 and July 20, 2023 Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's charter:

• Calendar Year (CY) 2024 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes, which will be posted on the CMS website athttps://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​ClinicalLabFeeSched/​Laboratory_​Public_​Meetings.html.
• Other CY 2024 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 https://www.cms.gov/​Regulat ions-and- Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. 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 2024. The Panel will also provide input on other CY 2024 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda.

III. Meeting Participation

This meeting is open to the public. Stand-by speakers may participate in the meeting 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 2023 on June 22, 2023. The public may also view or listen-only to the meeting via teleconference and webinar.

IV. Registration Instructions for Stand-by Speakers

Beginning May 1, 2023 and ending June 27, 2023 at 5:00 p.m. E.D.T., registration to serve as a stand-by speaker may be completed by sending an email to the following resource box CDLTPanel@cms.hhs.gov. The subject of the email should state “Stand-by Speaker Registration for CDLT Panel Meeting.” In the email, all of the ( printed page 23085) following information must be submitted when registering:

• Stand-by Speaker name.
• Organization or company name.
• Email addresses that will be used by the speaker in order to connect to the virtual meeting.
• New or Reconsidered Code (s) for which the company or organization you are representing submitted a comment or presentation.

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 DATES section of this notice. Additionally, registration information must reflect individual- level content and not reflect an organization entry. Also, each individual may only register one person at a time. That is, one individual may not register multiple individuals at the same time.

After registering, a confirmation email will be sent upon receipt of the registration. The email will provide information to the speaker in preparation for the meeting. Registration is only required for stand-by speakers and must be submitted by the deadline specified in the DATES section of this notice. Note: No registration is required for participants who plan to view the Panel meeting via webinar or listen via teleconference.

V. Panel Recommendations and Discussions

The Panel's recommendations will be posted approximately 2 weeks after the meeting on the CMS website at https://www.cms.gov/​Regulations -and- Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

VI. Special Accommodations

Individuals viewing or listening to the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should send an email to the resource box ( CDLTPanel@cms.hhs.gov). The deadline for submitting this request is listed in the DATES section of this notice.

VII. Copies of the Charter

The Secretary's Charter for the Medicare Advisory Panel on CDLT's is available on the CMS website at http://cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

VIII. Collection of Information Requirements

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Administrator of CMS, Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Evell J. Barco Holland, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .