Medicare Program; Town Hall Meeting on the Fiscal Year 2025 Applications for New Medical Services and Technologies Add-On Payments, 66850-66853 [2023-21186]
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
or more additional components in
certain of its stress testing scenarios the
Board will notify the company in
writing and include a basis for its
determination. Within 14 calendar days
of receipt of this notification the
company may request in writing that the
Board reconsider the requirement that
company include the additional
component(s) or additional scenario(s),
including an explanation as to why the
request for reconsideration should be
granted. The Board will respond in
writing within 14 calendar days of
receipt of the company’s request. This
request would be submitted via the
Federal Reserve’s IntraLinks system.
Recordkeeping Requirements
Section 238.144(c)(1) requires a
Category II SLHC, Category III SLHC, or
a SLHC with average total consolidated
assets of greater than $250 billion to
establish and maintain a system of
controls, oversight, and documentation,
including policies and procedures, that
are designed to ensure that its stress
testing processes are effective in
meeting the relevant requirements.
These policies and procedures must, at
a minimum, describe the covered
company’s stress testing practices and
methodologies, and processes for
validating and updating the company’s
stress test practices and methodologies
consistent with applicable laws and
regulations.
Frequency: Ongoing, annual, biannual, or event-generated.
Respondents: Foreign SLHCs with
average total consolidated assets of
greater than $250 billion and domestic
covered SLHCs with average total
consolidated assets of greater than $100
billion.
Total estimated number of
respondents: 1.
Total estimated change in burden: 31.
Total estimated annual burden hours:
14,430.1
Board of Governors of the Federal Reserve
System, September 22, 2023.
Erin M. Cayce,
Assistant Secretary of the Board.
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[FR Doc. 2023–21160 Filed 9–27–23; 8:45 am]
BILLING CODE 6210–01–P
1 More detailed information regarding this
collection, including more detailed burden
estimates, can be found in the OMB Supporting
Statement posted at https://www.federalreserve.gov/
apps/reportingforms/home/review. On the page
displayed at the link, you can find the OMB
Supporting Statement by referencing the collection
identifier, FR LL.
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FEDERAL RESERVE SYSTEM
Agency Information Collection
Activities: Announcement of Board
Approval Under Delegated Authority
and Submission to OMB
Board of Governors of the
Federal Reserve System.
SUMMARY: The Board of Governors of the
Federal Reserve System (Board) is
adopting a proposal to implement the
Ad Hoc Clearance for Board-Wide Use
(FR 3100; OMB No. 7100–NEW).
FOR FURTHER INFORMATION CONTACT:
Federal Reserve Board Clearance
Officer—Nuha Elmaghrabi—Office of
the Chief Data Officer, Board of
Governors of the Federal Reserve
System, nuha.elmaghrabi@frb.gov, (202)
452–3884.
Office of Management and Budget
(OMB) Desk Officer for the Federal
Reserve Board, Office of Information
and Regulatory Affairs, Office of
Management and Budget, New
Executive Office Building, Room 10235,
725 17th Street NW, Washington, DC
20503, or by fax to (202) 395–6974.
SUPPLEMENTARY INFORMATION: On June
15, 1984, OMB delegated to the Board
authority under the Paperwork
Reduction Act (PRA) to approve and
assign OMB control numbers to
collections of information conducted or
sponsored by the Board. Boardapproved collections of information are
incorporated into the official OMB
inventory of currently approved
collections of information. The OMB
inventory, as well as copies of the PRA
Submission, supporting statements
(which contain more detailed
information about the information
collections and burden estimates than
this notice), and approved collection of
information instrument(s) are available
at https://www.reginfo.gov/public/do/
PRAMain. These documents are also
available on the Federal Reserve Board’s
public website at https://
www.federalreserve.gov/apps/
reportingforms/home/review or may be
requested from the agency clearance
officer, whose name appears above.
AGENCY:
Final Approval Under OMB Delegated
Authority To Implement the Following
Information Collection Collection
Collection title: Ad Hoc Clearance for
Board-Wide Use.
Collection identifier: FR 3100.
OMB control number: 7100–NEW.
Effective Date: October 30, 2023.
General description of collection:
Information under this ad hoc
information collection would be
collected from Board-regulated entities,
other stakeholders, and the public
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(collectively, respondents) through tobe-defined surveys, interviews, and
focus groups, and other similar
activities about a variety of financial
service-related topics and the Board’s
operations. The clearance would help
the Board understand respondents’
perspectives, experiences, and
expectations regarding the financial
system and Board operations and would
be used to inform the Board’s initiatives
to promote financial system stability,
supervise and regulate financial
institutions and financial activities, and
promote consumer protection and
community development.
Frequency: As needed.
Respondents: Individuals,
institutions, state and local
governments, and other persons of
interest to the Board.
Total estimated number of
respondents: 850.
Total estimated annual burden hours:
17,000.1
Current actions: On May 15, 2023, the
Board published an initial notice in the
Federal Register (88 FR 30972)
requesting public comment for 60 days
on the implementation of the FR 3100.
The comment period for this notice
expired on July 14, 2023. The Board did
not receive any comments. The
collection will be implemented as
proposed.
Board of Governors of the Federal Reserve
System, September 22, 2023.
Erin M. Cayce,
Assistant Secretary of the Board.
[FR Doc. 2023–21157 Filed 9–27–23; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1795–N]
Medicare Program; Town Hall Meeting
on the Fiscal Year 2025 Applications
for New Medical Services and
Technologies Add-On Payments
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
1 More detailed information regarding this
collection, including more detailed burden
estimates, can be found in the OMB Supporting
Statement posted at https://www.federalreserve.gov/
apps/reportingforms/home/review. On the page
displayed at the link, you can find the OMB
Supporting Statement by referencing the collection
identifier, FR 3100.
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
This notice announces a town
hall meeting in accordance with the
Social Security Act (the Act) to discuss
fiscal year (FY) 2025 applications for
add-on payments for new medical
services and technologies under the
hospital inpatient prospective payment
system (IPPS). Interested parties are
invited to this virtual meeting to present
their comments, recommendations, and
data regarding whether the FY 2025 new
medical services and technologies
applications meet the substantial
clinical improvement criterion.
DATES:
Meeting Dates: The New Technology
Town Hall meeting announced in this
notice will be held virtually on
Wednesday, December 13, 2023, and
Thursday, December 14, 2023 (the
number of new technology applications
submitted will determine if a second
day for the meeting is necessary; see the
SUPPLEMENTARY INFORMATION section for
details regarding the second day of the
meeting and the posting of the final
schedule). The New Technology Town
Hall meeting will begin each day at 9
a.m. eastern standard time (EST) and
check-in via online platform will begin
at 8:30 a.m. EST.
Deadline for Registration of Presenters
at the New Technology Town Hall
Meeting: The deadline to register to
present at the New Technology Town
Hall meeting is 5 p.m., EST on Monday,
November 6, 2023.
Deadline for Submission of Agenda
Item(s) or Written Comments for the
New Technology Town Hall Meeting:
Written comments and agenda items
(public comments to be delivered at the
New Technology Town Hall meeting)
for discussion at the New Technology
Town Hall meeting, including agenda
items by presenters (presentation slide
decks), must be received by 5 p.m. EST
on Monday, November 13, 2023.
Deadline for Requesting Special
Accommodations: The deadline to
submit requests for special
accommodations is 5 p.m., EST on
Monday, November 20, 2023.
Deadline for Submission of Written
Comments after the New Technology
Town Hall Meeting for Consideration in
the Fiscal Year (FY) 2025 Hospital
Inpatient Prospective Payment System/
Long Term Care PPS (IPPS/LTCH PPS)
Proposed Rule: Individuals may submit
written comments after the New
Technology Town Hall meeting, as
specified in the ADDRESSES section of
this notice, on whether the service or
technology represents a substantial
clinical improvement. These comments
must be received by 5 p.m. EST on
Monday, December 18, 2023, to ensure
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consideration in the FY 2025 IPPS/
LTCH PPS proposed rule.
ADDRESSES:
Meeting Location: The New
Technology Town Hall meeting will be
held virtually via live stream technology
or webinar and listen-only via toll-free
teleconference. Live stream or webinar
and teleconference dial-in information
will be provided through an upcoming
listserv/email notice and will appear on
the final meeting agenda, which will be
posted on the New Technology website
when available at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/newtech.
html. Continue to check the website for
updates.
Registration and Special
Accommodations: Individuals wishing
to present at the meeting must follow
the instructions located in section III. of
this notice. Individuals who need
special accommodations should send an
email to newtech@cms.hhs.gov.
Submission of Agenda Item(s) or
Written Comments for the New
Technology Town Hall Meeting: Each
presenter must submit an agenda item(s)
regarding whether a FY 2025
application meets the substantial
clinical improvement criterion. Written
comments, questions or other
statements must not exceed three singlespaced typed pages and may be sent via
email to newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Drew Kasper, (410) 786–8926,
drew.kasper@cms.hhs.gov and
newtech@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on the Add-On Payments
for New Medical Services and
Technologies Under the IPPS
Effective for discharges beginning on
or after October 1, 2001, section
1886(d)(5)(K)(i) of the Act requires the
Secretary to establish (after notice and
opportunity for public comment) a
mechanism to recognize the costs of
new services and technologies under the
hospital inpatient prospective payment
system (IPPS). In addition, section
1886(d)(5)(K)(vi) of the Act specifies
that a medical service or technology will
be considered ‘‘new’’ if it meets criteria
established by the Secretary (after notice
and opportunity for public comment).
For further discussion on the new
technology add-on payment criteria, we
refer readers to the new technology addon payment final rule (66 FR 46912,
September 7, 2001), as well as the FY
2012 IPPS/LTCH PPS final rule (76 FR
51572 through 51574), the FY 2020
IPPS/LTCH PPS final rule (84 FR 42288
through 42300), and the FY 2021 IPPS/
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LTCH PPS final rule (85 FR 58736
through 58742).
As finalized in the FY 2020 and FY
2021 IPPS/LTCH PPS final rules,
technologies which are eligible for the
alternative new technology pathway for
transformative new devices or the
alternative new technology pathway for
certain antimicrobials do not need to
meet the requirement under 42 CFR
412.87(b)(1) that the technology
represent an advance that substantially
improves, relative to technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.
These medical devices or products will
also be considered not substantially
similar to an existing technology for
purposes of new technology add-on
payment under the IPPS. See the FY
2020 IPPS/LTCH PPS final rule (84 FR
42292 through 42297) and the FY 2021
IPPS/LTCH PPS final rule (85 FR 58737
through 58739) for additional
information.
In the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42289 through 42292), we
codified in our regulations at § 412.87
the following aspects of how we
evaluate substantial clinical
improvement for purposes of new
technology add-on payments under the
IPPS to determine if a new technology
meets the substantial clinical
improvement requirement:
• The totality of the circumstances is
considered when making a
determination that a new medical
service or technology represents an
advance that substantially improves,
relative to services or technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.
• A determination that a new medical
service or technology represents an
advance that substantially improves,
relative to services or technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries
means—
++ The new medical service or
technology offers a treatment option for
a patient population unresponsive to, or
ineligible for, currently available
treatments;
++ The new medical service or
technology offers the ability to diagnose
a medical condition in a patient
population where that medical
condition is currently undetectable or
offers the ability to diagnose a medical
condition earlier in a patient population
than allowed by currently available
methods, and there must also be
evidence that use of the new medical
service or technology to make a
diagnosis affects the management of the
patient; or
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++ The use of the new medical
service or technology significantly
improves clinical outcomes relative to
services or technologies previously
available as demonstrated by one or
more of the following:
—A reduction in at least one clinically
significant adverse event, including a
reduction in mortality or a clinically
significant complication.
—A decreased rate of at least one
subsequent diagnostic or therapeutic
intervention (for example, due to
reduced rate of recurrence of the
disease process).
—A decreased number of future
hospitalizations or physician visits.
—A more rapid beneficial resolution of
the disease process treatment
including, but not limited to, a
reduced length of stay or recovery
time; an improvement in one or more
activities of daily living; an improved
quality of life; or, a demonstrated
greater medication adherence or
compliance.
++ The totality of the circumstances
otherwise demonstrates that the new
medical service or technology
substantially improves, relative to
technologies previously available, the
diagnosis or treatment of Medicare
beneficiaries.
• Evidence from the following
published or unpublished information
sources from within the United States or
elsewhere may be sufficient to establish
that a new medical service or
technology represents an advance that
substantially improves, relative to
services or technologies previously
available, the diagnosis or treatment of
Medicare beneficiaries: Clinical trials,
peer reviewed journal articles; study
results; meta-analyses; consensus
statements; white papers; patient
surveys; case studies; reports;
systematic literature reviews; letters
from major healthcare associations;
editorials and letters to the editor; and
public comments. Other appropriate
information sources may be considered.
• The medical condition diagnosed or
treated by the new medical service or
technology may have a low prevalence
among Medicare beneficiaries.
• The new medical service or
technology may represent an advance
that substantially improves, relative to
services or technologies previously
available, the diagnosis or treatment of
a subpopulation of patients with the
medical condition diagnosed or treated
by the new medical service or
technology.
Section 1886(d)(5)(K)(viii) of the Act
requires that as part of the process for
evaluating new medical services and
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technology applications, the Secretary
shall do the following:
• Provide for public input regarding
whether a new service or technology
represents an advance in medical
technology that substantially improves
the diagnosis or treatment of Medicare
beneficiaries before publication of a
proposed rule.
• Make public and periodically
update a list of all the services and
technologies for which an application is
pending.
• Accept comments,
recommendations, and data from the
public regarding whether the service or
technology represents a substantial
improvement.
• Provide for a meeting at which
organizations representing hospitals,
physicians, manufacturers, and any
other interested party may present
comments, recommendations, and data
to the clinical staff of CMS as to whether
the service or technology represents a
substantial improvement before
publication of a proposed rule.
The opinions and presentations
provided during this meeting will assist
us as we evaluate the new medical
services and technology applications for
FY 2025.
II. New Technology Town Hall Meeting
Format and Conference Call
Information
A. Format of the Town Hall Meeting
As noted in section I. of this notice,
we are required to provide for a meeting
at which organizations representing
hospitals, physicians, manufacturers,
and any other interested party may
present comments, recommendations,
and data to the clinical staff of CMS
concerning whether the service or
technology represents a substantial
clinical improvement. This meeting will
allow for a discussion of the substantial
clinical improvement criterion for the
FY 2025 applications for new
technology add-on payments.
Information regarding the applications
can be found on our website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/newtech.html.
The majority of the meeting will be
reserved for presentations of comments,
recommendations, and data from
registered presenters. The time for each
presenter’s comments will be
approximately 10 minutes, with
additional time reserved for questions,
and will be based on the number of
registered presenters. Individuals who
would like to present must register and
submit their agenda item(s) via email to
newtech@cms.hhs.gov by the dates
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specified in the DATES section of this
notice.
Depending on the number of
applications received, we will
determine if a second meeting day is
necessary. The final schedule for the
New Technology Town Hall meeting
will be posted on the CMS website at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/newtech.html by
November 20, 2023 to inform the public
of the number of days of the meeting.
In addition, written comments will
also be accepted and presented at the
meeting if they are received via email to
newtech@cms.hhs.gov by the date
specified in the DATES section of this
notice. Written comments may also be
submitted after the meeting for our
consideration. If the comments are to be
considered before the publication of the
FY 2025 IPPS/LTCH PPS proposed rule,
the comments must be received via
email to newtech@cms.hhs.gov by the
date specified in the DATES section of
this notice.
B. Conference Call and Webinar
Information
As noted previously, the New
Technology Town Hall meeting will be
held virtually. There will be an option
to participate in the New Technology
Town Hall Meeting via webinar and a
toll-free teleconference phone line.
Information on the option to participate
via webinar and a teleconference dial-in
will be provided through an upcoming
listserv/email notice and will appear on
the final meeting agenda, which will be
posted on the New Technology website
at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/newtech.html.
Continue to check the website for
updates.
C. Disclaimer
We cannot guarantee reliability for a
webinar.
III. Registration Instructions
The Division of New Technology in
CMS is coordinating the meeting
registration for the New Technology
Town Hall meeting on substantial
clinical improvement. While there is no
registration fee, individuals planning to
present at the New Technology Town
Hall meeting must register to present.
Registration for presenters may be
completed by sending an email to
newtech@cms.hhs.gov, by the date
specified in the DATES section of this
notice. Please include the name and
email address of the presenter(s), as well
as address, telephone number, and the
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Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices
name of the technology for which they
will be presenting.
Registration for attendees not
presenting at the meeting is not
required.
IV. Collection of Information
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. chapter 35).
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Chyana Woodyard, who is
the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–21186 Filed 9–27–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2030]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Food and Drug Administration
Approval To Market a New Drug
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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 of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with applications
for FDA approval to market a new drug
or generic drug.
DATES: Either electronic or written
comments on the collection of
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information must be submitted by
November 27, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 27, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–2030 for ‘‘Application for Food
and Drug Administration Approval to
Market a New Drug.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
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66853
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
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]]>Agencies
[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66850-66853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21186]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1795-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2025
Applications for New Medical Services and Technologies Add-On Payments
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
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[[Page 66851]]
SUMMARY: This notice announces a town hall meeting in accordance with
the Social Security Act (the Act) to discuss fiscal year (FY) 2025
applications for add-on payments for new medical services and
technologies under the hospital inpatient prospective payment system
(IPPS). Interested parties are invited to this virtual meeting to
present their comments, recommendations, and data regarding whether the
FY 2025 new medical services and technologies applications meet the
substantial clinical improvement criterion.
DATES:
Meeting Dates: The New Technology Town Hall meeting announced in
this notice will be held virtually on Wednesday, December 13, 2023, and
Thursday, December 14, 2023 (the number of new technology applications
submitted will determine if a second day for the meeting is necessary;
see the SUPPLEMENTARY INFORMATION section for details regarding the
second day of the meeting and the posting of the final schedule). The
New Technology Town Hall meeting will begin each day at 9 a.m. eastern
standard time (EST) and check-in via online platform will begin at 8:30
a.m. EST.
Deadline for Registration of Presenters at the New Technology Town
Hall Meeting: The deadline to register to present at the New Technology
Town Hall meeting is 5 p.m., EST on Monday, November 6, 2023.
Deadline for Submission of Agenda Item(s) or Written Comments for
the New Technology Town Hall Meeting: Written comments and agenda items
(public comments to be delivered at the New Technology Town Hall
meeting) for discussion at the New Technology Town Hall meeting,
including agenda items by presenters (presentation slide decks), must
be received by 5 p.m. EST on Monday, November 13, 2023.
Deadline for Requesting Special Accommodations: The deadline to
submit requests for special accommodations is 5 p.m., EST on Monday,
November 20, 2023.
Deadline for Submission of Written Comments after the New
Technology Town Hall Meeting for Consideration in the Fiscal Year (FY)
2025 Hospital Inpatient Prospective Payment System/Long Term Care PPS
(IPPS/LTCH PPS) Proposed Rule: Individuals may submit written comments
after the New Technology Town Hall meeting, as specified in the
ADDRESSES section of this notice, on whether the service or technology
represents a substantial clinical improvement. These comments must be
received by 5 p.m. EST on Monday, December 18, 2023, to ensure
consideration in the FY 2025 IPPS/LTCH PPS proposed rule.
ADDRESSES:
Meeting Location: The New Technology Town Hall meeting will be held
virtually via live stream technology or webinar and listen-only via
toll-free teleconference. Live stream or webinar and teleconference
dial-in information will be provided through an upcoming listserv/email
notice and will appear on the final meeting agenda, which will be
posted on the New Technology website when available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. Continue to check the website for
updates.
Registration and Special Accommodations: Individuals wishing to
present at the meeting must follow the instructions located in section
III. of this notice. Individuals who need special accommodations should
send an email to [email protected].
Submission of Agenda Item(s) or Written Comments for the New
Technology Town Hall Meeting: Each presenter must submit an agenda
item(s) regarding whether a FY 2025 application meets the substantial
clinical improvement criterion. Written comments, questions or other
statements must not exceed three single-spaced typed pages and may be
sent via email to [email protected].
FOR FURTHER INFORMATION CONTACT: Drew Kasper, (410) 786-8926,
[email protected] and [email protected].
SUPPLEMENTARY INFORMATION:
I. Background on the Add-On Payments for New Medical Services and
Technologies Under the IPPS
Effective for discharges beginning on or after October 1, 2001,
section 1886(d)(5)(K)(i) of the Act requires the Secretary to establish
(after notice and opportunity for public comment) a mechanism to
recognize the costs of new services and technologies under the hospital
inpatient prospective payment system (IPPS). In addition, section
1886(d)(5)(K)(vi) of the Act specifies that a medical service or
technology will be considered ``new'' if it meets criteria established
by the Secretary (after notice and opportunity for public comment). For
further discussion on the new technology add-on payment criteria, we
refer readers to the new technology add-on payment final rule (66 FR
46912, September 7, 2001), as well as the FY 2012 IPPS/LTCH PPS final
rule (76 FR 51572 through 51574), the FY 2020 IPPS/LTCH PPS final rule
(84 FR 42288 through 42300), and the FY 2021 IPPS/LTCH PPS final rule
(85 FR 58736 through 58742).
As finalized in the FY 2020 and FY 2021 IPPS/LTCH PPS final rules,
technologies which are eligible for the alternative new technology
pathway for transformative new devices or the alternative new
technology pathway for certain antimicrobials do not need to meet the
requirement under 42 CFR 412.87(b)(1) that the technology represent an
advance that substantially improves, relative to technologies
previously available, the diagnosis or treatment of Medicare
beneficiaries. These medical devices or products will also be
considered not substantially similar to an existing technology for
purposes of new technology add-on payment under the IPPS. See the FY
2020 IPPS/LTCH PPS final rule (84 FR 42292 through 42297) and the FY
2021 IPPS/LTCH PPS final rule (85 FR 58737 through 58739) for
additional information.
In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42289 through
42292), we codified in our regulations at Sec. 412.87 the following
aspects of how we evaluate substantial clinical improvement for
purposes of new technology add-on payments under the IPPS to determine
if a new technology meets the substantial clinical improvement
requirement:
The totality of the circumstances is considered when
making a determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries.
A determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries means--
++ The new medical service or technology offers a treatment option
for a patient population unresponsive to, or ineligible for, currently
available treatments;
++ The new medical service or technology offers the ability to
diagnose a medical condition in a patient population where that medical
condition is currently undetectable or offers the ability to diagnose a
medical condition earlier in a patient population than allowed by
currently available methods, and there must also be evidence that use
of the new medical service or technology to make a diagnosis affects
the management of the patient; or
[[Page 66852]]
++ The use of the new medical service or technology significantly
improves clinical outcomes relative to services or technologies
previously available as demonstrated by one or more of the following:
--A reduction in at least one clinically significant adverse event,
including a reduction in mortality or a clinically significant
complication.
--A decreased rate of at least one subsequent diagnostic or therapeutic
intervention (for example, due to reduced rate of recurrence of the
disease process).
--A decreased number of future hospitalizations or physician visits.
--A more rapid beneficial resolution of the disease process treatment
including, but not limited to, a reduced length of stay or recovery
time; an improvement in one or more activities of daily living; an
improved quality of life; or, a demonstrated greater medication
adherence or compliance.
++ The totality of the circumstances otherwise demonstrates that
the new medical service or technology substantially improves, relative
to technologies previously available, the diagnosis or treatment of
Medicare beneficiaries.
Evidence from the following published or unpublished
information sources from within the United States or elsewhere may be
sufficient to establish that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries: Clinical trials, peer reviewed journal
articles; study results; meta-analyses; consensus statements; white
papers; patient surveys; case studies; reports; systematic literature
reviews; letters from major healthcare associations; editorials and
letters to the editor; and public comments. Other appropriate
information sources may be considered.
The medical condition diagnosed or treated by the new
medical service or technology may have a low prevalence among Medicare
beneficiaries.
The new medical service or technology may represent an
advance that substantially improves, relative to services or
technologies previously available, the diagnosis or treatment of a
subpopulation of patients with the medical condition diagnosed or
treated by the new medical service or technology.
Section 1886(d)(5)(K)(viii) of the Act requires that as part of the
process for evaluating new medical services and technology
applications, the Secretary shall do the following:
Provide for public input regarding whether a new service
or technology represents an advance in medical technology that
substantially improves the diagnosis or treatment of Medicare
beneficiaries before publication of a proposed rule.
Make public and periodically update a list of all the
services and technologies for which an application is pending.
Accept comments, recommendations, and data from the public
regarding whether the service or technology represents a substantial
improvement.
Provide for a meeting at which organizations representing
hospitals, physicians, manufacturers, and any other interested party
may present comments, recommendations, and data to the clinical staff
of CMS as to whether the service or technology represents a substantial
improvement before publication of a proposed rule.
The opinions and presentations provided during this meeting will
assist us as we evaluate the new medical services and technology
applications for FY 2025.
II. New Technology Town Hall Meeting Format and Conference Call
Information
A. Format of the Town Hall Meeting
As noted in section I. of this notice, we are required to provide
for a meeting at which organizations representing hospitals,
physicians, manufacturers, and any other interested party may present
comments, recommendations, and data to the clinical staff of CMS
concerning whether the service or technology represents a substantial
clinical improvement. This meeting will allow for a discussion of the
substantial clinical improvement criterion for the FY 2025 applications
for new technology add-on payments. Information regarding the
applications can be found on our website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html.
The majority of the meeting will be reserved for presentations of
comments, recommendations, and data from registered presenters. The
time for each presenter's comments will be approximately 10 minutes,
with additional time reserved for questions, and will be based on the
number of registered presenters. Individuals who would like to present
must register and submit their agenda item(s) via email to
[email protected] by the dates specified in the DATES section of this
notice.
Depending on the number of applications received, we will determine
if a second meeting day is necessary. The final schedule for the New
Technology Town Hall meeting will be posted on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html by November 20, 2023 to inform the
public of the number of days of the meeting.
In addition, written comments will also be accepted and presented
at the meeting if they are received via email to [email protected] by
the date specified in the DATES section of this notice. Written
comments may also be submitted after the meeting for our consideration.
If the comments are to be considered before the publication of the FY
2025 IPPS/LTCH PPS proposed rule, the comments must be received via
email to [email protected] by the date specified in the DATES section
of this notice.
B. Conference Call and Webinar Information
As noted previously, the New Technology Town Hall meeting will be
held virtually. There will be an option to participate in the New
Technology Town Hall Meeting via webinar and a toll-free teleconference
phone line. Information on the option to participate via webinar and a
teleconference dial-in will be provided through an upcoming listserv/
email notice and will appear on the final meeting agenda, which will be
posted on the New Technology website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html.
Continue to check the website for updates.
C. Disclaimer
We cannot guarantee reliability for a webinar.
III. Registration Instructions
The Division of New Technology in CMS is coordinating the meeting
registration for the New Technology Town Hall meeting on substantial
clinical improvement. While there is no registration fee, individuals
planning to present at the New Technology Town Hall meeting must
register to present.
Registration for presenters may be completed by sending an email to
[email protected], by the date specified in the DATES section of this
notice. Please include the name and email address of the presenter(s),
as well as address, telephone number, and the
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name of the technology for which they will be presenting.
Registration for attendees not presenting at the meeting is not
required.
IV. Collection of Information
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. chapter 35).
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Chyana Woodyard, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-21186 Filed 9-27-23; 8:45 am]
BILLING CODE 4120-01-P
