Notice2026-08513
Medicare Program; Meeting Announcement for the Public and the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests-September 2026
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Published
May 1, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces meeting dates for a Clinical Laboratory Fee Schedule (CLFS) public meeting that includes the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Tuesday, September 15, 2026 and Wednesday, September 16, 2026. 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 (CDLTs). During the meeting, the public will have an opportunity to present recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for CDLTs (crosswalking or gapfilling) for which CMS received no applicable information during the data reporting period from May 1, 2026 through July 31, 2026 to calculate Medicare payment rates. After the public provides this input, the Panel will provide its recommendations to the Secretary and the Administrator on payment recommendations for these CDLTs.
Full Text
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<title>Federal Register, Volume 91 Issue 84 (Friday, May 1, 2026)</title>
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[Federal Register Volume 91, Number 84 (Friday, May 1, 2026)]
[Notices]
[Pages 23418-23421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1863-N]
Medicare Program; Meeting Announcement for the Public and the
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests--
September 2026
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces meeting dates for a Clinical Laboratory
Fee Schedule (CLFS) public meeting that includes the Medicare Advisory
Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Tuesday,
September 15, 2026 and Wednesday, September 16, 2026. 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 (CDLTs). During the meeting, the public will have an opportunity
to present recommendations (including data on which recommendations are
based) on the appropriate basis for establishing payment amounts for
CDLTs (crosswalking or gapfilling) for which CMS received no applicable
information during the data reporting period from May 1, 2026 through
July 31, 2026 to calculate Medicare payment rates. After the public
provides this input, the Panel will provide its recommendations to the
Secretary and the Administrator on payment recommendations for these
CDLTs.
DATE:
Meeting Date: Tuesday, September 15, 2026 and Wednesday, September
16, 2026, from 10:00 a.m. to 4:00 p.m. Eastern Daylight Time (E.D.T.).
[[Page 23419]]
Deadline for Meeting Registration, Presentation and Comments:
August 21, 2026, 5:00 p.m. E.D.T. The public meeting will be conducted
virtually and will not occur on-site at the CMS Central Building. This
meeting is still open to the public. Registration is only required for
those interested in presenting public comments or speaking during the
meeting.
Deadline for Requesting Special Accommodations: August 21, 2026,
5:00 p.m. E.D.T.
Webinar and Teleconference Meeting Information: 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 <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a>. A preliminary
agenda is described in section III. of this notice.
ADDRESSES: This meeting for the public and the Panel will be held
virtually only and broadcasted from the campus of the Centers for
Medicare & Medicaid Services (CMS), Central Building, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: The CLFS Policy Team via email,
<a href="/cdn-cgi/l/email-protection#692a2d253d3908070c05290a041a4701011a470e061f"><span class="__cf_email__" data-cfemail="1152555d4541707f747d51727c623f7979623f767e67">[email protected]</span></a>; or Rasheeda Arthur, Ph.D. (410) 786-3434.
The CMS Press Office, for press inquiry, (202) 690-6145.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
(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 (CDLTs), 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:
<bullet> The establishment of payment rates under section 1834A of
the Act for new CDLTs, including whether to use ``crosswalking'' or
``gapfilling'' processes to determine payment for a specific new test.
<bullet> The factors used in determining coverage and payment
processes for new CDLTs.
<bullet> 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.
The Secretary approved rechartering of the Panel on April 24, 2025. The
new charter is effective through April 24, 2027 and may be found on the
CMS website at <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a>.
The Panel charter provides that Panel meetings will be held up to 4
times annually and the Panel Chair will serve for a period of 3 years,
which may be extended at the discretion of the Administrator or his or
her duly appointed designee. Additionally, the Panel Chair facilitates
the meeting and the Designated Federal Official (DFO) or DFO's designee
must be present at all meetings.
Section 1834A of the Act requires revisions to the payment
methodology for CDLTs paid under the Clinical Laboratory Fee Schedule
(CLFS). We implemented the requirements of section 1834A of the Act in
the CLFS final rule that appeared in the June 23, 2016 Federal Register
(81 FR 41036) entitled, ``Medicare Program; Medicare Clinical
Diagnostic Laboratory Tests (CDLT) Payment System.'' Under the CLFS
final rule, ``reporting entities'' must report to CMS during a ``data
reporting period'' ``applicable information'' collected during a ``data
collection period'' for their component ``applicable laboratories.'' In
general, the payment amount for a CDLT furnished on or after January 1,
2018, will be equal to the weighted median of private payor rates
determined for the test, based on the applicable information that is
collected during a data collection period and reported to us during a
data reporting period. Under section 1834A(a)(1) and (b) of the Act, as
enacted by PAMA, for CDLTs that are not advanced diagnostic laboratory
tests (ADLTs), the data collection period, data reporting period, and
payment rate update were to occur every 3 years.
The first data collection period occurred from January 1, 2016,
through June 30, 2016 and the first data reporting period occurred from
January 1, 2017, through March 31, 2017.\1\ The second data collection
period for CDLTs that are not ADLTs was originally scheduled to be
January 1, 2019, through June 30, 2019, and the next data reporting
period was originally scheduled to take place from January 1, 2020,
through March 31, 2020, with the next update to the Medicare payment
rates for those tests based on that reported applicable information
scheduled to take effect on January 1, 2021. However, beginning in
2019, Congress passed a series of legislation that delayed the next
data reporting period under the CLFS for CDLTs that are not ADLTs. Most
recently, section 6226 of the Consolidated Appropriations Act, 2026
established that the next data reporting period for such tests is May
1, 2026 through July 31, 2026 and based on a data collection period of
January 1, 2025 through June 30, 2025.
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\1\ On March 30, 2017, we announced a 60-day period of
enforcement discretion with respect to the initial data reporting
period. <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf</a>.
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Under our existing regulations at 42 CFR 414.507(f), payment for a
CDLT for which CMS receives no applicable information is based on the
crosswalking or gapfilling methods described in Sec. 414.508(b)(1) and
(2). Consistent with this process and to support transparency in
payment determinations, in early August 2026, CMS will post on the CMS
website at <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a> a list of
laboratory codes for which CMS received no applicable information to
calculate Medicare payment rates based on the weighted median of
private payor rates. During this meeting on September 15 and 16, 2026,
members of the public will have an opportunity to present
[[Page 23420]]
recommendations for the basis of payment--specifically crosswalking or
gapfilling--and respond to any questions from the Panel regarding those
recommendations. The Panel will consider this input and provide
recommendations to the Secretary of HHS and the Administrator of CMS
regarding the following questions regarding these codes:
<bullet> What method of payment should be used to set rates for
these test codes (crosswalking or gapfilling), as required by 42 CFR
414.507(f))?
<bullet> If crosswalking, specify the crosswalk code(s).
II. Format
This virtual meeting will be conducted in two parts. During Part I,
registered public participants may discuss and make recommendations
regarding the basis of payment (that is, crosswalking or gapfilling)
for CDLTs for which CMS received no applicable information to calculate
Medicare payment rates. During Part II, the Panel will ask questions of
the registered public participants and discuss the information
presented in Part I and make recommendations for the establishment of
payment rates for the test.
In Part I, due to time constraints, presentations must be brief,
lasting no longer than 5 minutes. Written presentations must be
electronically submitted to CMS on or before August 21, 2026.
Presentation slots will generally be assigned based upon chronological
order of receipt of presentation materials. In the event there is not
enough time for presentations by everyone who is interested in
presenting, we will only accept written presentations from those who
submitted written presentations within the submission window and were
unable to present due to time constraints. Presentations must be sent
via email to our CLFS dedicated email box, <a href="/cdn-cgi/l/email-protection#81c2c5cdd5d1e0efe4edc1e2ecf2afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="2764636b73774649424b67444a54094f4f5409404851">[email protected]</span></a>. In
addition, a video recording of the meeting will be provided (once
available) on the CMS website at <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a> after the meeting
has concluded.
Presenters should submit all presentations using a standard
PowerPoint template. In addition to the standard PowerPoint template
available, presenters may also provide the same information from the
PowerPoint presentation in a provided Excel worksheet template.
Submitting the same information that is requested for the PowerPoint
presentation in the Excel worksheet template will aid with triaging and
reviewing recommendation information during the meeting and after the
meeting, during the code review process. The standard PowerPoint
presentation and Excel worksheet templates are available on the CMS
website at <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.htmls">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.htmls</a> under the
``Meeting'' heading.
Presenters should address all of the following items (where
applicable):
<bullet> Code(s) with the most current code descriptor.
<bullet> A recommendation with rationale for one of the two bases
(crosswalking or gapfilling) for determining payment for the test code.
<bullet> Test costs.
<bullet> Charges.
Additionally, presenters should provide the data on which their
recommendations are based. Presentations that do not address the
previous four items (where applicable) may be considered incomplete and
may not be considered by CMS when making a determination. However, we
may request missing information following the meeting to prevent a
recommendation from being considered incomplete.
In Part II of the meeting, the Panel will make recommendations to
the Secretary and the Administrator of CMS regarding crosswalking and
gapfilling for the codes discussed during Part I, the CDLTs for which
CMS received no applicable information during the data reporting period
to calculate Medicare payment rates.
Taking into account the comments and recommendations (and
accompanying data) received at this meeting from the public and the
Panel, we intend to post our proposed determinations with respect to
the appropriate basis for establishing a payment amount for each test
code along with an explanation of the reasons for each determination,
the data on which the determinations are based, and a request for
public written comments on these determinations on our website in late
September 2026. This website can be accessed at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.htmls">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.htmls</a>. Interested parties may submit written
comments on the proposed determinations for codes in October 2026,
electronically to our CLFS dedicated email box,
<a href="/cdn-cgi/l/email-protection#2c6f606a7f736d4242594d40737c594e40454f736149495845424b6c4f415f0244445f024b435a"><span class="__cf_email__" data-cfemail="2a69666c79756b44445f4b46757a5f4846434975674f4f5e43444d6a49475904424259044d455c">[email protected]</span></a> (the specific date for the
publication of the determinations on the CMS website, as well as the
deadline for submitting comments regarding the determinations, will be
published on the CMS website). Final determinations for new test codes
to be included for payment on the CLFS for CY 2027, reconsidered codes,
and test codes that received no applicable information, will be posted
on our website in November 2026, along with the rationale for each
determination, the data on which the determinations were based, and
responses to comments and recommendations received from the public and
the Panel.
III. Agenda
The Agenda for the September 15 and 16, 2026, virtual-only meeting
with the public and the Panel will provide for discussion and comment
on the following topics:
<bullet> CY 2027 CDLT codes for which CMS received no applicable
information to calculate a Medicare payment rate, which will be posted
on the CMS website at <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel</a>.
<bullet> Other CY 2027 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 <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel</a>.
IV. Meeting Participation
This meeting is open to the public. Speakers may participate in the
meeting via teleconference and webinar. A speaker is an individual who
submitted a presentation or 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.
V. Registration Instructions
Beginning August 3, 2026 and ending August 21, 2026 at 5:00 p.m.
E.D.T., registration may be completed by presenters. Individuals who
intend to view and/or listen to the meeting virtually do not need to
register. Speakers must register online at <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel</a>. On this web page, under the heading ``Meeting''
there is a link entitled ``Register for September Medicare Advisory
Panel on Clinical Diagnostic
[[Page 23421]]
Laboratory Tests Meeting.'' Click this link and enter the required
information. All of the following information must be submitted when
registering:
<bullet> Name.
<bullet> Confirm Presentation.
<bullet> Organization or company name.
<bullet> Email addresses that will be used by the speaker to
connect to the virtual meeting.
<bullet> Code(s) for which the company or organization the
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 ``DATES'' 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 able to speak
during the meeting.
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
speakers. All registration 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 this meeting via webinar or
listen via teleconference.
VI. Panel Recommendations and Discussions
The Panel's recommendations will be posted approximately 2 weeks
after the meeting on the CMS website at <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a>.
VII. 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, must send an email to the resource box
(<a href="/cdn-cgi/l/email-protection#5e1d1a120a0e3f303b321e3d332d7036362d70393128"><span class="__cf_email__" data-cfemail="c88b8c849c98a9a6ada488aba5bbe6a0a0bbe6afa7be">[email protected]</span></a>). The deadline for submitting this request is
listed in the DATES section of this notice.
VIII. Copies of the Charter
The Secretary's Charter for the Medicare Advisory Panel on CDLTs is
available on the CMS website at <a href="http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a> 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.
IX. 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 the Centers for Medicare & Medicaid Services
(CMS), Mehmet Oz having reviewed and approved this document, authorizes
Vanessa Garcia, who is the Federal Register Liaison, to electronically
sign this document for purposes of publication in the Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2026-08513 Filed 4-30-26; 8:45 am]
BILLING CODE 4120-01-P
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