Medicare Program; Town Hall Meeting on the FY 2024 Applications for New Medical Services and Technologies Add-On Payments, 59793-59795 [2022-21399]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 190 / Monday, October 3, 2022 / Notices
I. Background
In FR Doc. 2022–19099 of September
6, 2022 (87 FR 54510), there was a
technical error that is identified and
corrected in this correcting document.
The provision in this correction
document is effective as if it had been
included in the document published
September 6, 2022. Accordingly, the
correction is effective through
September 26, 2026.
II. Summary of Errors
On page 54512, we inadvertently
listed the accrediting organization as
‘‘TJC’’. Therefore, we are replacing
‘‘TJC’s’’ with ‘‘DNV’s’’.
lotter on DSK11XQN23PROD with NOTICES1
Jkt 259001
[FR Doc. 2022–21344 Filed 9–28–22; 4:15 pm]
BILLING CODE 4120–01–P
Centers for Medicare & Medicaid
Services
IV. Correction of Errors
In FR Doc. 2022–19099 of September
6, 2022 (87 FR 54510), make the
following correction:
1. On page 54512, in the first column;
in the first partial paragraph, line 4,
correct ‘‘TJC’s’’ to read ‘‘DNV’s’’.
The Director, Office of Strategic
Operations and Regulatory Affairs of the
Centers for Medicare & Medicaid
Services (CMS), Kathleen Cantwell,
having reviewed and approved this
document on September 20, 2022,
authorizes Lynette Wilson, who is the
19:00 Sep 30, 2022
Dated: September 27, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). However,
we can waive this notice and comment
procedure if the Secretary finds, for
good cause, that the notice and
comment process is impracticable,
unnecessary, or contrary to the public
interest, and incorporates a statement of
the finding and the reasons therefore in
the notice.
We believe that this final notice
correction does not constitute a rule that
would be subject to the notice and
comment requirements. This document
corrects a technical and typographical
error in the final notice. This final
notice correction is intended to ensure
that the information in the final notice
is accurate.
We find that there is good cause to
waive such requirements as
unnecessary, as we are not altering our
decision to approve the application by
DNV for its continued hospital
accrediting program, but rather, we are
simply making a technical correction.
This final notice correction is intended
solely to ensure that the final notice
accurately reflects the correct
information.
VerDate Sep<11>2014
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
[CMS–1776–N]
Medicare Program; Town Hall Meeting
on the FY 2024 Applications for New
Medical Services and Technologies
Add-On Payments
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a town
hall meeting in accordance with the
Social Security Act (the Act) to discuss
fiscal year (FY) 2024 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 2024 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 14, 2022 and
Thursday, December 15, 2022 (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 Requesting Special
Accommodations: The deadline to
submit requests for special
accommodations is 5 p.m., EST on
Monday, November 21, 2022.
Deadline for Registration of Presenters
at the New Technology Town Hall
Meeting: The deadline to register to
present at the New Technology Town
SUMMARY:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
59793
Hall meeting is 5 p.m., EST on Monday,
November 21, 2022.
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 28, 2022.
Deadline for Submission of Written
Comments after the New Technology
Town Hall Meeting for Consideration in
the Fiscal Year (FY) 2024 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
Thursday, December 22, 2022, to ensure
consideration in the FY 2024 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 2024
application meets the substantial
clinical improvement criterion. Agenda
items, written comments, questions or
other statements must not exceed three
single-spaced 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.
E:\FR\FM\03OCN1.SGM
03OCN1
59794
Federal Register / Vol. 87, No. 190 / Monday, October 3, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
I. Background on the Add-On Payments
for New Medical Services and
Technologies Under the IPPS
Sections 1886(d)(5)(K) and (L) of the
Social Security Act (the Act) require the
Secretary to establish a process of
identifying and ensuring adequate
payments to acute care hospitals for
new medical services and technologies
under Medicare. 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). (See the fiscal year
(FY) 2002 IPPS proposed rule (66 FR
22693, May 4, 2001) and final rule (66
FR 46912, September 7, 2001) for a more
detailed discussion.)
As finalized in the FY 2020 IPPS/
LTCH PPS final rule, technologies
which are eligible for the alternative
new technology pathway for
transformative new devices or the
alternative new technology pathway for
Qualified Infectious Disease Products
(QIDPs) 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) for additional information.)
As finalized in the FY 2021 IPPS/
LTCH final rule, we expanded our
alternative new technology add-on
payment pathway to include products
approved through FDA’s Limited
Population Pathway for Antibacterial
and Antifungal Drugs (LPAD pathway).
Under this policy, for applications
received for consideration of new
technology add-on payments for FY
2022 and subsequent fiscal years, if an
antimicrobial product is approved
through FDA’s LPAD pathway, it will be
considered not substantially similar to
an existing technology for purposes of
the new technology add-on payment
under the IPPS, and will not need to
meet the requirement that it represent
VerDate Sep<11>2014
19:00 Sep 30, 2022
Jkt 259001
an advance that substantially improves,
relative to technologies previously
available, the diagnosis or treatment of
Medicare beneficiaries.
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 in order 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
++ 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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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
E:\FR\FM\03OCN1.SGM
03OCN1
Federal Register / Vol. 87, No. 190 / Monday, October 3, 2022 / Notices
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 2024. In addition, they will help us
to evaluate our policy on the IPPS new
technology add-on payment process
before the publication of the FY 2024
IPPS proposed rule.
II. New Technology Town Hall Meeting
Format and Conference Call
Information
lotter on DSK11XQN23PROD with NOTICES1
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 2024 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 date
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 22, 2022 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
VerDate Sep<11>2014
19:00 Sep 30, 2022
Jkt 259001
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 2024 IPPS 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. Please include
the name and email address of the
presenter, 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,
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
59795
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: September 28, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2022–21399 Filed 9–30–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10595]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
December 2, 2022.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
SUMMARY:
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Notices]
[Pages 59793-59795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21399]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1776-N]
Medicare Program; Town Hall Meeting on the FY 2024 Applications
for New Medical Services and Technologies Add-On Payments
AGENCY: Centers for Medicare & Medicaid Services (CMS), 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) 2024
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 2024 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 14, 2022 and
Thursday, December 15, 2022 (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 Requesting Special Accommodations: The deadline to
submit requests for special accommodations is 5 p.m., EST on Monday,
November 21, 2022.
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 21, 2022.
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 28, 2022.
Deadline for Submission of Written Comments after the New
Technology Town Hall Meeting for Consideration in the Fiscal Year (FY)
2024 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 Thursday, December 22, 2022, to ensure
consideration in the FY 2024 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 2024 application meets the substantial
clinical improvement criterion. Agenda items, 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].
[[Page 59794]]
SUPPLEMENTARY INFORMATION:
I. Background on the Add-On Payments for New Medical Services and
Technologies Under the IPPS
Sections 1886(d)(5)(K) and (L) of the Social Security Act (the Act)
require the Secretary to establish a process of identifying and
ensuring adequate payments to acute care hospitals for new medical
services and technologies under Medicare. 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). (See the fiscal year (FY) 2002
IPPS proposed rule (66 FR 22693, May 4, 2001) and final rule (66 FR
46912, September 7, 2001) for a more detailed discussion.)
As finalized in the FY 2020 IPPS/LTCH PPS final rule, technologies
which are eligible for the alternative new technology pathway for
transformative new devices or the alternative new technology pathway
for Qualified Infectious Disease Products (QIDPs) 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) for
additional information.)
As finalized in the FY 2021 IPPS/LTCH final rule, we expanded our
alternative new technology add-on payment pathway to include products
approved through FDA's Limited Population Pathway for Antibacterial and
Antifungal Drugs (LPAD pathway). Under this policy, for applications
received for consideration of new technology add-on payments for FY
2022 and subsequent fiscal years, if an antimicrobial product is
approved through FDA's LPAD pathway, it will be considered not
substantially similar to an existing technology for purposes of the new
technology add-on payment under the IPPS, and will not need to meet the
requirement that it represent an advance that substantially improves,
relative to technologies previously available, the diagnosis or
treatment of Medicare beneficiaries.
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 in order 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
++ 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
[[Page 59795]]
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 2024. In addition, they will help us to evaluate
our policy on the IPPS new technology add-on payment process before the
publication of the FY 2024 IPPS proposed rule.
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 2024 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 date 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 22, 2022 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
2024 IPPS 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]. Please include the name and email address of the
presenter, 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 Lynette Wilson, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: September 28, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-21399 Filed 9-30-22; 8:45 am]
BILLING CODE 4120-01-P
