Public Meeting on June 25, 2024 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2025, 26889-26892 [2024-08005]
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Federal Register / Vol. 89, No. 74 / Tuesday, April 16, 2024 / Notices
For Further Information Contact:
Laurel Garrison, M.P.H., Scientific
Review Officer, Office of Extramural
Programs, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
5555 Ridge Avenue, Cincinnati, Ohio
45213. Telephone: (513) 533–8324;
Email: LGarrison@cdc.gov.
The Director, Office of Strategic
Business Initiatives, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1819–N]
Public Meeting on June 25, 2024
Regarding New and Reconsidered
Clinical Diagnostic Laboratory Test
Codes for the Clinical Laboratory Fee
Schedule for Calendar Year 2025
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
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 2025.
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
public meeting is scheduled for
Tuesday, June 25, 2024 from 9:00 a.m.
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SUMMARY:
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to 5:00 p.m., Eastern Daylight Time
(E.D.T.).
Deadline for Submission of
Presentations and Written Comments:
All presenters for the CLFS Annual
Public Meeting must register and submit
their presentations electronically to our
CLFS dedicated email box, CLFS_
Annual_Public_Meeting@cms.hhs.gov,
by May 30, 2024 at 5:00 p.m., E.D.T. All
written comments (non-presenter
comments) must also be submitted
electronically to our CLFS dedicated
email box, CLFS_Annual_Public_
Meeting@cms.hhs.gov, by May 30, 2024,
at 5:00 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 30, 2024 at
5:00 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 2025 by early September 2024.
Deadline for Submission of Written
Comments Related to Proposed
Determinations: Comments in response
to the proposed determinations will be
due by early October 2024.
ADDRESSES: The CLFS Annual Public
Meeting will be held virtually and inperson 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, CLFS_
Annual_Public_Meeting@cms.hhs.gov
(the specific date for the publication of
these determinations and the deadline
for submitting comments regarding
these determinations will be published
on the CMS website).
FOR FURTHER INFORMATION CONTACT:
Rasheeda Arthur, (410) 786–3434.
The CLFS Policy Team and submit all
inquiries to the CLFS dedicated email
box, CLFS_Annual_Public_Meeting@
cms.hhs.gov with the subject entitled
‘‘CLFS Annual Public Meeting Inquiry.’’
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
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26889
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
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 clinical diagnostic laboratory
test (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) 2025
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
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CLFS Annual Public Meeting list of
codes can be found on the CMS website
at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. 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 § 414.508(a).
For a new CDLT that is assigned a new
or significantly revised code on or after
January 1, 2018, CMS assigns to the new
CDLT code the payment amount
established under § 414.507 of the
comparable existing CDLT. Payment for
the new CDLT code is made at the
payment amount established under
§ 414.507. (See § 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 MACspecific amounts. (See § 414.508(b)(2)).
Under section 1833(h)(8)(B)(iv) of the
Act and § 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
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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
§ 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 § 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 § 414.509.
Pertinent to this notice, those requesting
that we reconsider the basis for payment
or the payment amount as set forth in
§ 414.509(a) and (b), may present their
reconsideration requests at the
following year’s CLFS Annual Public
Meeting provided the requestor made
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
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reconsidered codes under the CLFS for
CY 2025. The public hybrid meeting
will be conducted virtually and will
occur on-site at the CMS Central
Building.
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
8:30 a.m. to 9:00 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
2025 CLFS. The Medicare Advisory
Panel on Clinical Diagnostic Laboratory
Tests (Advisory Panel on CDLTs) will
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 25 and 26, 2024.
The public meeting for the Advisory
Panel on CDLTs will focus on the
discussion of and recommendations for
test codes presented during the June 25,
2024 CLFS Annual Public Meeting. The
Panel meeting also will address any
other CY 2025 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 30, 2024. 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 should be
sent via email to our CLFS dedicated
email box, CLFS_Annual_Public_
Meeting@cms.hhs.gov. In addition,
individuals may also submit requests
after the CLFS Annual Public Meeting to
obtain electronic versions of the
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presentations. Requests for electronic
copies of the presentations after the
public meeting should be sent via email
to our CLFS dedicated email box, noted
above.
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 https://www.cms.gov/
medicare/payment/fee-schedules/
clinical-laboratory-fee-schedule-clfs/
annual-public-meetings, under the
‘‘Meeting Notice and Agenda’’ heading.
For reconsidered and new codes,
presenters should address all of the
following five items:
• Reconsidered or new code(s) with
the most current code descriptor.
• 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.
• Test costs.
• Charges.
• 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 above 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
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for public written comments on these
determinations on our website by early
September 2024. The CMS website is
https://www.cms.gov/medicare/
payment/fee-schedules/clinicallaboratory-fee-schedule-clfs/annualpublic-meetings. Interested parties may
submit written comments on the
proposed determinations for new and
reconsidered codes by early October
2024, electronically to our CLFS
dedicated email box, CLFS_Annual_
Public_Meeting@cms.hhs.gov (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 2025 and reconsidered codes will
be posted our website in November
2024, 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. 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 § 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,
2024 and ending May 30, 2024,
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 by sending an email to CMS’s
CLFS dedicated email box, CLFS_
Annual_Public_Meeting@cms.hhs.gov.
The subject of the email should state
‘‘Presenter or In-Person Attendee
Registration for CY 2024 CLFS Annual
Laboratory Meeting.’’ All of the
following information must be
submitted when registering:
• Speaker or In-Person Attendee
name.
• Organization or company name.
• Telephone numbers.
• Email address that will be used by
the presenter to connect to the virtual
meeting.
• New or Reconsidered Code (s) for
which presentation is being submitted
(if applicable).
• Presentation (if applicable).
• Excel Worksheet (if applicable).
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26891
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 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 inperson 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 https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
ClinicalLabFeeSched/?
redirect=/ClinicalLabFeeSched/.
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 CMS resource box
(CDLT_Annual_Public_Meeting@
cms.hhs.gov). 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
8:00 a.m. and 8:45 a.m. E.D.T., so that
you will be able to arrive promptly at
the meeting by 9:00 a.m. E.D.T.
Individuals who are not registered in
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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 8:15 a.m. E.D.T. (45 minutes
before the convening of the meeting).
Security measures include the
following:
• 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.
• 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.
• 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, setup, 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 Administrator of CMS, Chiquita
Brooks-LaSure, 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.
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Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10573]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
June 17, 2024.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
SUMMARY:
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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10573 Reform of Requirements
for Long-Term Care Facilities
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Reform of
Requirements for Long-Term Care
Facilities; Use: The purpose of this
package is to request Office of
Management and Budget (OMB)
approval of the collection of information
requirements for the requirements of
participation for Long-Term Care (LTC)
facilities that must be met in order to
participate in the Medicare and
Medicaid Programs. LTC facilities
include skilled nursing facilities (SNFs)
as defined in section 1819(a) of the
Social Security Act in the Medicare
program and nursing facilities (NFs) as
defined in 1919(a) of the Act in the
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]]>Agencies
[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Notices]
[Pages 26889-26892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08005]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1819-N]
Public Meeting on June 25, 2024 Regarding New and Reconsidered
Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory
Fee Schedule for Calendar Year 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 2025. 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 public meeting is scheduled for Tuesday, June 25, 2024 from 9:00
a.m. to 5:00 p.m., Eastern Daylight Time (E.D.T.).
Deadline for Submission of Presentations and Written Comments: All
presenters for the CLFS Annual Public Meeting must register and submit
their presentations electronically to our CLFS dedicated email box,
[email protected], by May 30, 2024 at 5:00 p.m.,
E.D.T. All written comments (non-presenter comments) must also be
submitted electronically to our CLFS dedicated email box,
[email protected], by May 30, 2024, at 5:00 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
30, 2024 at 5:00 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 2025 by early
September 2024.
Deadline for Submission of Written Comments Related to Proposed
Determinations: Comments in response to the proposed determinations
will be due by early October 2024.
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,
[email protected] (the specific date for the
publication of these determinations and the deadline for submitting
comments regarding these determinations will be published on the CMS
website).
FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, (410) 786-3434.
The CLFS Policy Team and submit all inquiries to the CLFS dedicated
email box, [email protected] with the subject
entitled ``CLFS Annual Public Meeting Inquiry.''
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 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 clinical diagnostic
laboratory test (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) 2025 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
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CLFS Annual Public Meeting list of codes can be found on the CMS
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/?redirect=/ClinicalLabFeeSched/.
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 to 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 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 2025. The public hybrid
meeting will be conducted virtually and will occur on-site at the CMS
Central Building.
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 8:30
a.m. to 9:00 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 2025 CLFS. The Medicare Advisory Panel on Clinical
Diagnostic Laboratory Tests (Advisory Panel on CDLTs) will 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 25 and 26, 2024. The public meeting
for the Advisory Panel on CDLTs will focus on the discussion of and
recommendations for test codes presented during the June 25, 2024 CLFS
Annual Public Meeting. The Panel meeting also will address any other CY
2025 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 30, 2024. 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 should be sent via email to our CLFS dedicated email box,
[email protected]. In addition, individuals may
also submit requests after the CLFS Annual Public Meeting to obtain
electronic versions of the
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presentations. Requests for electronic copies of the presentations
after the public meeting should be sent via email to our CLFS dedicated
email box, noted above.
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 https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings, under the
``Meeting Notice and Agenda'' heading.
For reconsidered and new codes, presenters should address all of
the following five items:
Reconsidered or new code(s) with the most current code
descriptor.
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.
Test costs.
Charges.
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 above 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 2024. The CMS website is https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings. Interested parties may submit written comments on the
proposed determinations for new and reconsidered codes by early October
2024, electronically to our CLFS dedicated email box,
[email protected] (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 2025 and reconsidered
codes will be posted our website in November 2024, 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. 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, 2024 and ending May 30, 2024, 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 by sending an email to CMS's CLFS dedicated
email box, [email protected]. The subject of the
email should state ``Presenter or In-Person Attendee Registration for
CY 2024 CLFS Annual Laboratory Meeting.'' All of the following
information must be submitted when registering:
Speaker or In-Person Attendee name.
Organization or company name.
Telephone numbers.
Email address that will be used by the presenter to
connect to the virtual meeting.
New or Reconsidered Code (s) for which presentation is
being submitted (if applicable).
Presentation (if applicable).
Excel Worksheet (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 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 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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/?redirect=/ClinicalLabFeeSched/.
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 CMS resource
box ([email protected]). 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 8:00 a.m. and 8:45 a.m. E.D.T., so that you will be able to
arrive promptly at the meeting by 9:00 a.m. E.D.T. Individuals who are
not registered in
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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 8:15 a.m. E.D.T. (45 minutes before the convening
of the meeting).
Security measures include the following:
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.
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.
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 Administrator of CMS, Chiquita Brooks-LaSure, 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. 2024-08005 Filed 4-15-24; 8:45 am]
BILLING CODE 4120-01-P
