Notice2024-20791
Medicare Program; Town Hall Meeting on the Fiscal Year 2026 Applications for New Medical Services and Technologies Add-On Payments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 13, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces a town hall meeting in accordance with the Social Security Act (the Act) to discuss fiscal year (FY) 2026 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 2026 new medical services and technologies applications meet the substantial clinical improvement criterion.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 178 (Friday, September 13, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74962-74964]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1822-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2026
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.
-----------------------------------------------------------------------
SUMMARY: This notice announces a town hall meeting in accordance with
the Social Security Act (the Act) to discuss fiscal year (FY) 2026
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 2026 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 11, 2024, and
Thursday, December 12, 2024 (the number of presentations 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 4, 2024.
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 Tuesday, November 12, 2024.
Deadline for Requesting Special Accommodations: The deadline to
submit requests for special accommodations is 5 p.m., EST on Tuesday,
November 12, 2024.
Deadline for Submission of Written Comments after the New
Technology Town Hall Meeting for Consideration in the Fiscal Year (FY)
2026 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 16, 2024, to ensure
consideration in the FY 2026 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: <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a>. 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 <a href="/cdn-cgi/l/email-protection#fc92998b88999f94bc9f918fd294948fd29b938a"><span class="__cf_email__" data-cfemail="036d66747766606b43606e702d6b6b702d646c75">[email protected]</span></a>.
Submission of Agenda Item(s) or Written Comments for the New
Technology Town Hall Meeting: Each
[[Page 74963]]
presenter must submit at least one agenda item for presentation
regarding whether a FY 2026 application meets the substantial clinical
improvement criterion. Other items such as written comments, questions
or other statements must not exceed three single-spaced typed pages and
may be sent via email to <a href="/cdn-cgi/l/email-protection#4e202b393a2b2d260e2d233d6026263d60292138"><span class="__cf_email__" data-cfemail="325c57454657515a72515f411c5a5a411c555d44">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: Drew Kasper, (410) 786-8926,
<a href="/cdn-cgi/l/email-protection#a0c4d2c5d78ecbc1d3d0c5d2e0c3cdd38ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="caaeb8afbde4a1abb9baafb88aa9a7b9e4a2a2b9e4ada5bc">[email protected]</span></a> and <a href="/cdn-cgi/l/email-protection#cba5aebcbfaea8a38ba8a6b8e5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="6a040f1d1e0f09022a09071944020219440d051c">[email protected]</span></a>.
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:
<bullet> 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.
<bullet> 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
++ 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.
<bullet> 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.
<bullet> The medical condition diagnosed or treated by the new
medical service or technology may have a low prevalence among Medicare
beneficiaries.
<bullet> 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:
<bullet> 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.
<bullet> Make public and periodically update a list of all the
services and technologies for which an application is pending.
<bullet> Accept comments, recommendations, and data from the public
regarding whether the service or technology represents a substantial
improvement.
<bullet> 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.
[[Page 74964]]
The opinions and presentations provided during this meeting will
assist us as we evaluate the new medical services and technology
applications for FY 2026.
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 2026 applications
for new technology add-on payments. Information regarding the
applications can be found on our website at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a>.
The majority of the meeting will be reserved for presentations of
comments, recommendations, and data from registered presenters. The
time for each presentation will be approximately 10 minutes, with
additional time reserved for questions, and will be based on the number
of presentations. Individuals who would like to present must register
and submit their agenda item(s) via email to <a href="/cdn-cgi/l/email-protection#412f24363524222901222c326f2929326f262e37"><span class="__cf_email__" data-cfemail="375952404352545f77545a44195f5f4419505841">[email protected]</span></a> by the
dates specified in the DATES section of this notice.
Depending on the number of presentations, 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
<a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a> by November 25, 2024 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 <a href="/cdn-cgi/l/email-protection#5e303b292a3b3d361e3d332d7036362d70393128"><span class="__cf_email__" data-cfemail="8de3e8faf9e8eee5cdeee0fea3e5e5fea3eae2fb">[email protected]</span></a> 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
2026 IPPS/LTCH PPS proposed rule, the comments must be received via
email to <a href="/cdn-cgi/l/email-protection#96f8f3e1e2f3f5fed6f5fbe5b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="543a31232031373c143739277a3c3c277a333b22">[email protected]</span></a> 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 to registrants and will appear on the final meeting
agenda, which will be posted on the New Technology website at: <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a>. 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
<a href="/cdn-cgi/l/email-protection#2f414a585b4a4c476f4c425c0147475c01484059"><span class="__cf_email__" data-cfemail="244a41535041474c644749570a4c4c570a434b52">[email protected]</span></a>, 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 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. 2024-20791 Filed 9-12-24; 8:45 am]
BILLING CODE 4120-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 13, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.