Federal & State Lawfederalstatelaw.com
Home/Federal/Federal Register/2025-17401
Notice2025-17401

Medicare Program; Town Hall Meeting on the Fiscal Year 2027 Applications for New Technology 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 10, 2025

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This notice announces a town hall meeting in accordance with section 1886(d)(5)(K)(viii)(III) of the Social Security Act (the Act) to discuss fiscal year (FY) 2027 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 2027 applications for new technology add- on payments meet the substantial clinical improvement criterion.

Full Text

<html>
<head>
<title>Federal Register, Volume 90 Issue 173 (Wednesday, September 10, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 173 (Wednesday, September 10, 2025)]
[Notices]
[Pages 43613-43615]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17401]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1840-N]


Medicare Program; Town Hall Meeting on the Fiscal Year 2027 
Applications for New Technology 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 
section 1886(d)(5)(K)(viii)(III) of the Social Security Act (the Act) 
to discuss fiscal year (FY) 2027 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 2027 applications for new technology add-
on payments 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 10, 2025, and 
Thursday, December 11, 2025 (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 9:00 a.m. Eastern Standard Time (EST) 
and online check-in 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 5:00 p.m. EST on Monday, November 3, 2025.
    Deadline for Submission of Agenda Item(s) or Written Remarks for 
the New Technology Town Hall Meeting: Written remarks and agenda items 
for discussion at the New Technology Town Hall meeting, including 
agenda items by presenters (presentation slide decks), must be received 
by 5:00 p.m. EST on Thursday, November 13, 2025.
    Deadline for Requesting Special Accommodations: The deadline to 
submit requests for special accommodations is 5:00 p.m. EST on 
Thursday, November 13, 2025.
    Deadline for Submission of Written Comments after the New 
Technology Town Hall Meeting for Consideration in the FY 2027 Inpatient 
Prospective Payment System/Long-Term Care Hospital 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 
5:00 p.m. EST on Monday, December 15, 2025, to ensure consideration in 
the FY 2027 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 to registered presenters, 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#9dd3c9dccdddfef0eeb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="2d63796c7d6d4e405e0345455e034a425b">[email&#160;protected]</span></a>.
    Submission of Agenda Item(s) or Written Remarks for the New 
Technology Town Hall Meeting: Each presenter must submit at least one 
agenda item for presentation regarding whether a FY 2027 application 
for new technology add-on payments meets the substantial clinical 
improvement criterion. Agenda items must be submitted via email, by the 
previously specified deadline, to: <a href="/cdn-cgi/l/email-protection#622c36233222010f114c0a0a114c050d14"><span class="__cf_email__" data-cfemail="440a100514042729376a2c2c376a232b32">[email&#160;protected]</span></a>.
    Submission of Written Comments for the New Technology Town Hall 
Meeting: Written comments must be submitted via email, by the 
previously specified deadline, to: <a href="/cdn-cgi/l/email-protection#e2acb6a3b2a2818f91cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="aee0faeffeeecdc3dd80c6c6dd80c9c1d8">[email&#160;protected]</span></a>. Comments should be 
limited to information or material regarding whether the application(s) 
for new technology add-on payments meet the substantial clinical 
improvement criterion. Information and studies previously submitted in 
the application do not need to be resubmitted in Town Hall comments, 
even if they are cited within the comment.

FOR FURTHER INFORMATION CONTACT: Drew Kasper, (410) 786-8926, 
<a href="/cdn-cgi/l/email-protection#33574156441d58524043564173505e401d5b5b401d545c45"><span class="__cf_email__" data-cfemail="e98d9b8c9ec782889a998c9ba98a849ac781819ac78e869f">[email&#160;protected]</span></a> and <a href="/cdn-cgi/l/email-protection#a6e8f2e7f6e6c5cbd588ceced588c1c9d0"><span class="__cf_email__" data-cfemail="0c42584d5c4c6f617f2264647f226b637a">[email&#160;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 
IPPS. For 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 that are eligible for the alternative pathway for certain 
transformative new devices or the alternative pathway for certain 
antimicrobial products 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. 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 
criterion:
    <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.

[[Page 43614]]

    <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 one of the following--
    ++ 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 
outcomes:

--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.
--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.
--A demonstrated greater medication adherence or compliance.

    ++ The totality of the information 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.
    The opinions and presentations provided during this meeting will 
assist us as we evaluate the substantial clinical improvement criterion 
for traditional pathway new technology add-on payment applications 
submitted for FY 2027.

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, which is evaluated for 
traditional pathway applications, for the FY 2027 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 from 
registered presenters. The time for each presentation will be 10 
minutes, with additional time reserved for questions from CMS and 
interested parties. Individuals who would like to present must register 
and submit their agenda item(s) via email to <a href="/cdn-cgi/l/email-protection#7b352f3a2b3b18160855131308551c140d"><span class="__cf_email__" data-cfemail="d49a80958494b7b9a7fabcbca7fab3bba2">[email&#160;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 date(s) 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, 2025 to inform the 
public of the number of days of the meeting.
    Written comments may be submitted after the meeting for our 
consideration. If the comments are to be considered before the 
publication of the FY 2027 IPPS/LTCH PPS proposed rule, the comments 
must be received via email to <a href="/cdn-cgi/l/email-protection#08465c4958486b657b2660607b266f677e"><span class="__cf_email__" data-cfemail="8bc5dfcadbcbe8e6f8a5e3e3f8a5ece4fd">[email&#160;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 registered presenters 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.

[[Page 43615]]

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#bbf5effaebfbd8d6c895d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="a7e9f3e6f7e7c4cad489cfcfd489c0c8d1">[email&#160;protected]</span></a>, by the date specified in the DATES section of this 
notice. Please include the name (with applicable title(s), as it should 
appear on the agenda) 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), Dr. Mehmet Oz, 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. 2025-17401 Filed 9-9-25; 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>
View on FederalRegister.gov →Plain-text source
Indexed from Federal Register on September 10, 2025.

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.