[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 http://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 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

[[Page 26891]]

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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?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