Notice2025-06756
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 21, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 75 (Monday, April 21, 2025)</title>
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[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Pages 16682-16685]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06756]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1837-N]
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
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: 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.
DATES:
Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting Date:
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.
Deadline for Submission of Presentations and Written Comments: 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, <a href="/cdn-cgi/l/email-protection#7c3f303a2f233d1212091d10232c091e10151f233119190815121b3c1f110f5214140f521b13"><span class="__cf_email__" data-cfemail="43000f05101c022d2d36222f1c1336212f2a201c0e2626372a2d2403202e306d2b2b306d242c">[email protected]</span></a>v, 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,
<a href="/cdn-cgi/l/email-protection#37747b71646876595942565b686742555b5e54687a5252435e595077545a44195f5f44195058"><span class="__cf_email__" data-cfemail="70333c36232f311e1e05111c2f2005121c19132f3d151504191e1730131d035e1818035e171f">[email protected]</span></a>v, 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.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than May
29, 2025 at 5 p.m. E.D.T.
Publication of Proposed Determinations: 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.
Deadline for Submission of Written Comments Related to Proposed
Determinations: Comments in response to the proposed determinations
will be due by early October 2025.
ADDRESSES: 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.
Where to Submit Written Comments: Interested parties should submit
all written comments on presentations and proposed determinations
electronically to our CLFS dedicated email box,
<a href="/cdn-cgi/l/email-protection#bbf8f7fde8e4fad5d5cedad7e4ebced9d7d2d8e4f6dedecfd2d5dcfbd8d6c895d3d3c895dcd4"><span class="__cf_email__" data-cfemail="286b646e7b776946465d494477785d4a44414b77654d4d5c41464f684b455b0640405b064f47">[email protected]</span></a>v (the specific date for the
publication of these determinations and the deadline for submitting
comments regarding
[[Page 16683]]
these determinations will be published on the CMS website).
FOR FURTHER INFORMATION CONTACT: The CLFS Policy Team and submit all
inquiries to the CLFS dedicated email box,
<a href="/cdn-cgi/l/email-protection#7d3e313b2e223c1313081c11222d081f11141e223018180914131a3d1e100e5315150e531a12"><span class="__cf_email__" data-cfemail="77343b31242836191902161b282702151b1e14283a1212031e191037141a04591f1f04591018">[email protected]</span></a>v, 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.
SUPPLEMENTARY INFORMATION:
I. Background
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 Federal
Register (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 Federal Register 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 <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/</a>. 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 Federal Register. 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 Sec. 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 Sec. 414.507 of the comparable existing CDLT.
Payment for the new CDLT code is made at the payment amount established
under Sec. 414.507. (See Sec. 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 Sec. 414.508(b)(2)).
Under section 1833(h)(8)(B)(iv) of the Act and Sec. 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 Sec. 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.
Section 216(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) added section 1834A to the Act. The statute
requires extensive revisions to the Medicare payment, coding, and
coverage requirements for CDLTs. Pertinent to this notice, section
1834A(c)(3) of the Act requires the Secretary to consider
recommendations from the expert outside advisory panel established
under section 1834A(f)(1) of the Act when determining payment using
crosswalking or gapfilling processes. In addition, section 1834A(c)(4)
of the Act requires the Secretary to make available to the public an
explanation of the payment rates for the new test codes, including an
explanation of how the gapfilling criteria and panel recommendations
are applied. These requirements are codified in Sec. 414.506(d) and
(e).
After the final determinations have been posted on the CMS website,
the public may request reconsideration of the basis and amount of
payment for a new CDLT as set forth in Sec. 414.509. Pertinent to this
notice, those requesting that we reconsider the basis for payment or
the payment amount as set forth in Sec. 414.509(a) and (b), may
present their reconsideration requests at the following year's CLFS
Annual Public Meeting provided the requestor made
[[Page 16684]]
the request to present at the CLFS Annual Public Meeting in the written
reconsideration request. For purposes of this notice, we refer to these
codes as the ``reconsidered codes.'' The public may comment on the
reconsideration requests. (See the CY 2008 Physician Fee Schedule final
rule with comment period published in the Federal Register on November
27, 2007 (72 FR 66275 through 66280) for more information on these
procedures.)
II. Format
We are following our usual process, including an annual public
meeting to determine the appropriate basis and payment amount for new
and reconsidered codes under the CLFS for CY 2026. The public hybrid
meeting will be conducted virtually and will occur on-site at the CMS
Central Building. 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 a virtual-only
format, we will alert the public as soon as possible and post updated
information on the CMS website at <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings/">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings/</a>.
This meeting is open to the public. Registration is only required
for those interested in presenting public comments during the meeting
or attending the meeting in-person at the CMS campus at the address
specified in the ADDRESSES section of this notice. If attending the
meeting in-person, on-site check-in for visitors will be held from 9:15
a.m. to 9:45 a.m. E.D.T., followed by opening remarks.
During this hybrid meeting, registered persons from the public may
discuss and make recommendations for specific new and reconsidered
codes for the CY 2026 CLFS. The Medicare Advisory Panel on CDLTs
(Advisory Panel on CDLTs) may participate in this CLFS Annual Public
Meeting by gathering information and asking questions to presenters,
and will hold its next public meeting, virtually and in-person, on July
23 and 24, 2025. The public meeting for the Advisory Panel on CDLTs
will focus on the discussion of and recommendations for test codes
presented during the June 27, 2025, CLFS Annual Public Meeting. The
Panel meeting also will address any other CY 2026 CLFS issues that are
designated in the Panel's charter and specified on the meeting agenda.
The announcement for the next meeting of the Advisory Panel on CDLTs is
included in a separate notice published elsewhere in this issue of the
Federal Register.
Due to time constraints, presentations must be brief, lasting no
longer than 10 minutes. Written presentations must be electronically
submitted to CMS on or before May 29, 2025. In addition, if presenting
in-person, presenters should make copies available for approximately 50
meeting participants, since CMS will not be providing additional copies
to the public. 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#581b141e0b071936362d393407082d3a34313b07153d3d2c31363f183b352b7630302b763f37"><span class="__cf_email__" data-cfemail="6f2c23293c302e01011a0e03303f1a0d03060c30220a0a1b0601082f0c021c4107071c410800">[email protected]</span></a>v. In addition, a video recording
of the meeting will be provided on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.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 into a provided Excel worksheet template.
Submitting the same information that is requested for the PowerPoint
presentation into 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/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings</a> under the ``Meeting
Notice and Agenda'' heading.
For reconsidered and new codes, presenters should address all of
the following five items:
<bullet> Reconsidered or new code(s) with the most current code
descriptor.
<bullet> Test purpose and method with a brief comment on how the
new test is different from other similar analyte or methodologies found
in tests already on the CLFS.
<bullet> Test costs.
<bullet> Charges.
<bullet> Recommendation with rationale for one of the two bases
(crosswalking or gapfilling) for determining payment for reconsidered
and new tests.
Additionally, presenters should provide the data on which their
recommendations are based. Presentations regarding reconsidered and new
test codes that do not address the previous five items for presenters
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.
Taking into account the comments and recommendations (and
accompanying data) received at the CLFS Annual Public Meeting, we
intend to post our proposed determinations with respect to the
appropriate basis for establishing a payment amount for each new test
code and our proposed determinations with respect to the reconsidered
codes 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 by early
September 2025. This website can be accessed at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/</a>. Interested parties may
submit written comments on the proposed determinations for new and
reconsidered codes by early October 2025, electronically to our CLFS
dedicated email box, <a href="/cdn-cgi/l/email-protection#7d3e313b2e223c1313081c11222d081f11141e223018180914131a3d1e100e5315150e531a12"><span class="__cf_email__" data-cfemail="c6858a80959987a8a8b3a7aa9996b3a4aaafa5998ba3a3b2afa8a186a5abb5e8aeaeb5e8a1a9">[email protected]</span></a>v (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 2026 and reconsidered codes will be posted on our website
in November 2025, along with the rationale for each determination, the
data on which the determinations were based, and responses to comments
and suggestions received from the public. The final determinations with
respect to reconsidered codes are not subject to further
reconsideration. With respect to the final determinations for new test
codes, the public may request reconsideration of the basis and amount
of payment as set forth in Sec. 414.509.
III. Registration Instructions
The Division of Ambulatory Services in the CMS Center for Medicare
is coordinating the CLFS Annual Public Meeting registration. Beginning
May 1,
[[Page 16685]]
2025 and ending May 29, 2025, registration may be completed by
presenters and in-person attendees. Individuals who intend to view and/
or listen to the meeting virtually do not need to register. Presenter
registration and individuals who intend to attend the meeting at the
CMS campus must register online at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/</a>. On this web page, under the
heading ``Meeting Notice, Registration, Agenda, & Other Important
Materials'' you will find a link entitled ``Register for CLFS Annual
Meeting.'' Click this link and enter the required information. All of
the following information must be submitted when registering:
<bullet> Name.
<bullet> Organization/Company name.
<bullet> Email addresses.
<bullet> Indicate if individual is a presenter.
<bullet> Indicate how individual is participating in the meeting
(that is, in-person or virtual).
<bullet> Indicate if individual is a ``Foreign National'' visitor.
When registering, individuals who want to make a presentation must
also specify which test codes they will be presenting comments. A
confirmation will be sent upon receipt of the registration. Individuals
must register by the date specified in the DATES section of this
notice.
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 the name of an organization. For example, an
organization cannot request to register a group of individuals without
specifying registration details for each individual being registered.
See section V. of this notice for further information.
After registering, a confirmation email will be sent upon receipt
of the registration. The email will provide information to the
presenter or in-person attendee in preparation for the meeting.
Registration is only required for individuals giving a presentation
during the meeting or attending the meeting at the CMS campus.
Presenters or in-person attendees must register by the deadline
specified in the DATES section of this notice.
If you are not presenting during the CLFS Annual Public Meeting or
cannot attend in person, you may view the meeting via webinar or
listen-only by teleconference. If you would like to listen to or view
the meeting, teleconference dial-in and webinar information will appear
on the final CLFS Annual Public Meeting agenda, which will be posted on
the CMS website when available at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/</a>.
IV. 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
(<a href="/cdn-cgi/l/email-protection#de9d9a928a819fb0b0abbfb2818eabbcb2b7bd8193bbbbaab7b0b99ebdb3adf0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="04474048505b456a6a7165685b547166686d675b496161706d6a63446769772a6c6c772a636b72">[email protected]</span></a>). The deadline for submitting
this request is listed in the DATES section of this notice.
V. Security, Building, and Parking Guidelines
This hybrid meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend allowing additional time to clear security.
We suggest that you arrive at the CMS campus and parking facilities
between 9 a.m. and 9:45 a.m. E.D.T., so that you will be able to arrive
promptly at the meeting by 10 a.m. E.D.T. Individuals who are not
registered in advance will not be permitted to enter the building and
will be unable to attend the meeting. We note that the public may not
enter the CMS building earlier than 9:15 a.m. E.D.T. (45 minutes before
the convening of the meeting).
Security measures include the following:
<bullet> Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel. Persons without proper identification may be denied access
to the building.
<bullet> Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
<bullet> Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support a
demonstration, are subject to inspection. We cannot assume
responsibility for coordinating the receipt, transfer, transport,
storage, set-up, safety, or timely arrival of any personal belongings
or items used for demonstration or to support a demonstration.
VI. 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 Acting Administrator of the Centers for Medicare & Medicaid
Services (CMS), Stephanie Carlton 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. 2025-06756 Filed 4-18-25; 8:45 am]
BILLING CODE 4120-01-P
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