[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23386-23389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1741-N]


Medicare Program; Public Meeting on June 24, 2021 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2022

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

[[Page 23387]]

payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar 
year (CY) 2022. 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: 
    CLFS Annual Public Meeting Date: The virtual meeting is scheduled 
for Thursday, June 24, 2021 from 9 a.m. to 5 p.m., 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 June 3, 2021 at 5 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 June 3, 2021, 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 June 
3, 2021 at 5 p.m. E.D.T.
    Publication of Proposed Determinations: We intend to publish our 
proposed determinations for new test codes and our preliminary 
determinations for reconsidered codes (as described later in section II 
``Format'' of this notice) for CY 2022 by early September 2021.
    Deadline for Submission of Written Comments Related to Proposed 
Determinations: Comments in response to the preliminary determinations 
will be due by early October 2021.

ADDRESSES: Due to the current COVID-19 public health emergency, the 
CLFS Annual Public Meeting will be held virtually and will not occur at 
the campus of 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 preliminary 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, Ph.D., (410) 786-
3434. 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) 2022 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 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

[[Page 23388]]

(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 2022. However, due to the 
COVID-19 public health emergency, the public meeting will be conducted 
virtually and will not occur on-site at the CMS Central Building.
    This meeting is still open to the public. Registration is only 
required for those interested in presenting public comments during the 
meeting. During the virtual meeting, registered persons from the public 
may discuss and make recommendations for specific new and reconsidered 
codes for the CY 2022 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 on July 28 and 29, 
2021. The public meeting for the Advisory Panel on CDLTs will focus on 
the discussion of and recommendations for test codes presented during 
the June 24, 2021 CLFS Annual Public Meeting. The Panel meeting also 
will address any other CY 2022 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 June 3, 2021. Presentation slots will 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 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 that is available on the CMS website, at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html, under the 
``Meeting Notice and Agenda'' heading.
    For reconsidered and new codes, presenters should address all of 
the following five items:
    (1) Reconsidered or new code(s) with the most current code 
descriptor.
    (2) 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.
    (3) Test costs.
    (4) Charges.
    (5) 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 preliminary 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 2021. This website can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. 
Interested parties may submit written comments on the preliminary 
determinations for new and

[[Page 23389]]

reconsidered codes by early October 2021, 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 2022 and reconsidered codes will be posted our website in 
November 2021, 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 3, 2021 and ending June 3, 2021, registration may be completed by 
presenters only. Individuals who intend to view and/or listen to the 
meeting do not need to register. Presenter registration may be 
completed by sending an email to our CLFS dedicated email box, 
[email protected]. The subject of the email should 
state ``Presenter Registration for CY 2021 CLFS Annual Laboratory 
Meeting.'' All of the following information must be submitted when 
registering:
     Speaker name.
     Organization or company name.
     Telephone numbers.
     Email address that will be used by the presenter in order 
to connect to the virtual meeting.
     New or Reconsidered Code (s) for which presentation is 
being submitted.
     Presentation.
    Registration details may not be revised once they are submitted. If 
registration details require changes, a new registration entry must be 
submitted by the date specified in the DATES section of this notice. 
Additionally, registration information must reflect individual-level 
content and not reflect an organization entry. Also, each individual 
may only register one person at a time. That is, one individual may not 
register multiple individuals at the same time.
    After registering, a confirmation email will be sent upon receipt 
of the registration. The email will provide information to the 
presenter in preparation for the meeting. Registration is only required 
for individuals giving a presentation during the meeting. Presenters 
must register by the deadline specified in the DATES section of this 
notice.
    If you are not presenting during the CLFS Annual Public Meeting, 
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 resource box 
([email protected]). The deadline for submitting 
this request is listed in the DATES section of this notice.

V. 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), Elizabeth Richter, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: April 28, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-09260 Filed 4-30-21; 8:45 am]
BILLING CODE 4120-01-P