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Advisory Panel on Clinical Diagnostic Laboratory Tests

Guidance for the Advisory Panel on Clinical Diagnostic Laboratory Tests.

Final

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: August 12, 2020

The Medicare Advisory Panel on Clinical Diagnostic Laboratory Services advises and reports to the Secretary of the Department of Health and Human Services (HHS) and the CMS Administrator.

We’re accepting nominations for the Panel. See “How do I nominate someone for the Panel?”.

Learn more about the Federal Advisory Committee Act (FACA).

What does the Panel advise on?

The Panel advises on and makes recommendations related to clinical diagnostic laboratory tests (CDLTs), including:

  • Application of market rates to establish Medicare payment rates
  • Evaluation and designation of tests as advanced diagnostic laboratory tests (ADLTs)
  • Whether to use crosswalking or gapfilling to determine payment for specific new tests
  • Factors used in determining coverage or payment processes for new CDLTs

CMS provides coordination, management, and operational services.

Who makes up the Panel?

The Panel is made up of 15 people (14 Representative members and a regular government employee) with expertise in issues related to CDLTs or health economics, including:

  • Molecular pathologists
  • Laboratory researchers
  • People with expertise in laboratory science or health economics with regard to issues related to the development, validation, performance, safety, and application of such tests

All members serve on a voluntary basis without compensation. They serve a term of up to 3 years. The Secretary of CMS Administrator’s designee appoint members. View current Panel members (PDF).

Two or more panel members can form subcommittees, if approved by the Secretary or designee. Learn more about subcommittees (PDF).

How do I nominate someone for the Panel?

We have vacancies and accept nominations on a continuous basis. To nominate someone:

Meetings

CMS-1824-N, Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, July 25-26, 2024

  • Agenda - CDLT Panel Meeting (July 25-26, 2024) (PDF)
  • **IMPORTANT NOTE: CMS complex is closed due to unforeseen building issues!

    Consistent with CMS’ approach of prioritizing the health and safety of our employees and visitors, the CMS complex at 7500 Security Boulevard is closed due to an unforeseen building issue. Because of this, the CDLT Panel Meeting scheduled for July 25-26, 2024, is being moved to a virtual-only format and will not have in-person attendance.

    Instructions for virtually connecting to the CDLT Panel Meeting may be found on the meeting agenda approximately 2-weeks prior to the meeting. 

    We thank you in advance for your cooperation and look forward to your virtual participation during the CDLT Panel Meeting.

  • Stand-by Speaker deadline: June 1, 2024

Meetings are held up to 4 times a year. CMS selects a Federal employee to service as the Designated Federal Officer (DFO) to attend each Panel meeting. See the DFO’s responsibilities (PDF).

To conduct panel business, a quorum is required. This exists when a majority of the currently appointed members are present at full Panel or subcommittee meetings or participating in conference calls.

Panel meetings are open to the public except if determined otherwise by the Secretary or other authorized official. We’ll publish a notice in the Federal Register announcing upcoming meetings.

See past Panel meeting agendas, Federal Register notices, and recordings.

Panel Recommendations
Other reports & documents

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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.