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, 23386-23389 [2021-09260]
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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
nominations for members was
published in the October 27, 2014
Federal Register (79 FR 63919 through
63920). In the August 7, 2015 Federal
Register (80 FR 47491), we announced
membership appointments to the Panel
along with the first public meeting date
for the Panel, which was held on August
26, 2015. Subsequent meetings of the
Panel and membership appointments
were also announced in the Federal
Register.
II. Agenda
The Agenda for the July 28 and July
29, 2021 Panel meeting will provide for
discussion and comment on the
following topics as designated in the
Panel’s charter:
• Calendar Year (CY) 2022 Clinical
Laboratory Fee Schedule (CLFS) new
and reconsidered test codes, which will
be posted on the CMS website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
ClinicalLabFeeSched/Laboratory_
Public_Meetings.html.
• Other CY 2022 CLFS issues
designated in the Panel’s charter and
further described on our Agenda.
A detailed Agenda will be posted
approximately 2 weeks before the
meeting, on the CMS website at https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/
AdvisoryPanelonClinicalDiagnostic
LaboratoryTests.html. The Panel will
make recommendations to the Secretary
and the Administrator of CMS regarding
crosswalking and gapfilling for new and
reconsidered laboratory tests discussed
during the CLFS Annual Public Meeting
for CY 2022. The Panel will also provide
input on other CY 2022 CLFS issues that
are designated in the Panel’s charter and
specified on the meeting agenda.
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III. Meeting Participation
This meeting is open to the public.
Stand-by speakers may participate in
the meeting via teleconference and
webinar. A stand-by speaker is an
individual who will speak on behalf of
a company or organization if the Panel
has any questions during the meeting
about technical information described
in the public comments or presentation
previously submitted or presented by
the organization or company at the
recent Clinical Laboratory Fee Schedule
(CLFS) Annual Public Meeting for
Calendar Year (CY) 2022 on June 24,
2021. The public may also view or
listen-only to the meeting via
teleconference and webinar.
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IV. Registration Instructions for Standby Speakers
Beginning Monday, May 3, 2021 and
ending Wednesday, June 30, 2021 at
5:00 p.m. E.D.T., registration to serve as
a stand-by speaker may be completed by
sending an email to the following
resource box CDLTPanel@cms.hhs.gov.
The subject of the email should state
‘‘Stand-by Speaker Registration for
CDLT Panel Meeting.’’ In the email, all
of the following information must be
submitted when registering:
• Stand-by Speaker name.
• Organization or company name.
• Email addresses that will be used
by the speaker in order to connect to the
virtual meeting.
• New or Reconsidered Code(s) for
which the company or organization you
are representing submitted a comment
or 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. In addition,
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 speaker in
preparation for the meeting. Registration
is only required for stand-by speakers
and must be submitted by the deadline
specified in the DATES section of this
notice. We note that no registration is
required for participants who plan to
view the Panel meeting via webinar or
listen via teleconference.
VI. Panel Recommendations and
Discussions
The Panel’s recommendations will be
posted approximately 2 weeks after the
meeting on the CMS website at https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/
AdvisoryPanelonClinicalDiagnostic
LaboratoryTests.html.
VIII. 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
(CDLTPanel@cms.hhs.gov). The
deadline for submitting this request is
listed in the DATES section of this notice.
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IX. Copies of the Charter
The Secretary’s Charter for the
Medicare Advisory Panel on Clinical
Diagnostic Laboratory Tests is available
on the CMS website at https://cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelon
ClinicalDiagnosticLaboratoryTests.html
or you may obtain a copy of the charter
by submitting a request to the contact
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
X. 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. 2021–09261 Filed 4–30–21; 8:45 am]
BILLING CODE 4120–01–P
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
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
SUMMARY:
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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
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, CLFS_
Annual_Public_Meeting@cms.hhs.gov,
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, CLFS_Annual_Public_
Meeting@cms.hhs.gov, 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, 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).
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FOR FURTHER INFORMATION CONTACT:
Rasheeda Arthur, Ph.D., (410) 786–3434.
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
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
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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 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
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(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
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
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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, CLFS_Annual_Public_
Meeting@cms.hhs.gov. In addition,
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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-Feefor-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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. Interested parties
may submit written comments on the
preliminary determinations for new and
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reconsidered codes by early October
2021, 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 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 § 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, CLFS_Annual_Public_
Meeting@cms.hhs.gov. 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
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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 listenonly 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/
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 (CDLT_
Annual_Public_Meeting@cms.hhs.gov).
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]
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23389
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–Z–0025]
Withdrawal of Notice Regarding the
Food and Drug Administration Drug
Review Timeline Transparency;
Revocation of Statement of Policy
Food and Drug Administration
(FDA), Department of Health and
Human Services (HHS).
ACTION: Notice; withdrawal; statement of
policy; revocation.
AGENCY:
The Department of Health and
Human Services (Department or HHS)
and the Food and Drug Administration
(FDA or Agency) are issuing this notice
to withdraw the notice published in the
Federal Register of January 15, 2021,
announcing a Statement of Policy
indicating that FDA will publish certain
information regarding the timeline for
its review of drug product applications.
The Department and FDA are
withdrawing the notice and revoking
the Statement of Policy because, among
other things, the notice did not account
for all relevant considerations related to
information that is already publicly
available about FDA’s review of drug
applications.
SUMMARY:
The notice is withdrawn and the
Statement of Policy is revoked as of May
3, 2021.
FOR FURTHER INFORMATION CONTACT:
Jennifer Forde, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
348–3035.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 15, 2021 (86
FR 4083), HHS published a notice
entitled ‘‘FDA Drug Review Timeline
Transparency; Statement of Policy’’
(Statement of Policy). The Statement of
Policy described the Department’s
review of application timelines and
directed FDA to publish annually on its
website, for each approved new drug
application (NDA) and abbreviated new
drug application (ANDA) approved after
the date of the Federal Register notice:
‘‘(a) the date on which FDA ‘filed,’ in
the case of an NDA, or ‘received,’ in the
case of an ANDA, such application; (b)
the date on which FDA approved the
NDA or ANDA; (c) the total days
elapsed between the dates in (a) and (b);
and (d) the total days in excess of 180days the date of (c).’’ We did not find
any evidence that HHS consulted with,
otherwise involved, or even notified
DATES:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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
[[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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/?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 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 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
