Medicare Program; Town Hall Meeting on the FY 2023 Applications for New Medical Services and Technologies Add-On Payments, 53056-53059 [2021-20811]
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
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Federal Communications Commission.
Marlene Dortch,
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[FR Doc. 2021–20800 Filed 9–23–21; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
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including the companies listed below.
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
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Comments regarding each of these
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A. Federal Reserve Bank of Richmond
(Adam M. Drimer, Assistant Vice
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PO 00000
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Richmond, Virginia 23219. Comments
can also be sent electronically to or
Comments.applications@rich.frb.org.
1. Southern Bancshares (N.C.), Inc.,
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B. Federal Reserve Bank of
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1. MidCountry Acquisition Corp.,
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Minnesota, and thereby indirectly
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Board of Governors of the Federal Reserve
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Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–20757 Filed 9–23–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1759–N]
Medicare Program; Town Hall Meeting
on the FY 2023 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) 2023
applications for add-on payments for
new medical services and technologies
under the hospital inpatient prospective
payment system (IPPS). The United
States is responding to an outbreak of
respiratory disease caused by the virus
‘‘SARS–CoV–2’’ and the disease it
causes ‘‘coronavirus disease 2019’’
(abbreviated ‘‘COVID–19’’). Due to the
COVID–19 pandemic, the Town Hall
Meeting will be held virtually rather
than as an in-person meeting. Interested
parties are invited to this meeting to
present their comments,
recommendations, and data regarding
whether the FY 2023 new medical
services and technologies applications
meet the substantial clinical
improvement criterion.
SUMMARY:
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
DATES:
Meeting dates: The Town Hall
Meeting announced in this notice will
be held virtually on Tuesday, December
14, 2021 and Wednesday, December 15,
2021 (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 preliminary
meeting agenda). The Town Hall
Meeting will begin each day at 9 a.m.
Eastern Standard Time (e.s.t.) and
check-in via online platform will begin
at 8:30 a.m. e.s.t.
Deadline for requesting special
accommodations: The deadline to
submit requests for special
accommodations is 5 p.m., e.s.t. on
Monday, November 22, 2021.
Deadline for registration of presenters
at the Town Hall Meeting: The deadline
to register to present at the Town Hall
Meeting is 5 p.m., e.s.t. on Monday,
November 22, 2021.
Deadline for submission of agenda
item(s) or written comments for the
Town Hall Meeting: Written comments
and agenda items (public comments to
be delivered at the Town Hall Meeting)
for discussion at the Town Hall
Meeting, including agenda items by
presenters (presentation slide decks),
must be received by 5 p.m. e.s.t. on
Monday, November 29, 2021.
Deadline for submission of written
comments after the Town Hall Meeting
for consideration in the Fiscal Year (FY)
2023 Hospital Inpatient Prospective
Payment System/Long Term Care PPS
(IPPS/LTCH PPS) proposed rule:
Individuals may submit written
comments after the 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. e.s.t. on
Monday, December 27, 2021, for
consideration in the FY 2023 IPPS/
LTCH PPS proposed rule.
ADDRESSES:
Meeting location: The 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 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.
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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 Town Hall
Meeting: Each presenter must submit an
agenda item(s) regarding whether a FY
2023 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:
Michelle Joshua, (410) 786–6050,
michelle.joshua@cms.hhs.gov or
newtech@cms.hhs.gov.
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 new and not substantially
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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 new and 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.
Under current policy, a new technology
must receive FDA marketing
authorization by July 1 to be considered
in the IPPS final rule in order to allow
complete review and consideration of
all the information to determine if the
technology meets the new technology
add-on payment criteria at the
beginning of the fiscal year (that is,
October 1st).
Under the previously described
policy, cases involving eligible
antimicrobial products could begin
receiving the new technology add-on
payment sooner, effective for discharges
the quarter after the date of FDA
marketing authorization provided that
the technology receives FDA marketing
authorization by July 1 of the particular
fiscal year for which the applicant
applied for new technology add-on
payments. (See 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 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
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
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
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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 2023. 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 2023
IPPS proposed rule.
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II. Town Hall Meeting Format and
Conference Call/Live Streaming
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 2023 new medical services and
technology add-on payment
applications. Information regarding the
applications can be found on our
website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/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 to 15 minutes 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. A preliminary agenda will be
posted on the CMS website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatient
PPS/newtech.html by November 22,
2021, 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 2023 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, Live Streaming, and
Webinar Information
As noted previously, the Town Hall
Meeting will be held virtually due to the
COVID–19 pandemic. There will be an
option to participate in the Town Hall
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
Meeting via live streaming technology
or webinar and a toll-free teleconference
phone line. Information on the option to
participate via live streaming
technology or webinar and a
teleconference dial-in will be provided
through an upcoming listserv 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-Feefor-Service-Payment/AcuteInpatient
PPS/newtech.html. Continue to check
the website for updates.
C. Disclaimer
We cannot guarantee reliability for
live streaming technology or a webinar.
III. Registration Instructions
The Division of New Technology in
CMS is coordinating the meeting
registration for the Town Hall Meeting
on substantial clinical improvement.
While there is no registration fee,
individuals planning to present at the
Town Hall Meeting must register to
present.
Registration for presenters may be
completed by sending an email to
newtech@cms.hhs.gov. Please include
your name, address, telephone number,
email address and fax number.
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 21, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2021–20811 Filed 9–23–21; 8:45 am]
BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10531 and CMS–
10501]
Agency Information Collection
Activities: Submission for OMB
Review; 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
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 on the collection(s) of
information must be received by the
OMB desk officer by October 25, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at:
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUMMARY:
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53059
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Transcatheter
Valve Therapy (TVT) Registry; Use: The
data collection is required by the
Centers for Medicare & Medicaid
Services (CMS) National Coverage
Determination (NCD) entitled,
‘‘Transcatheter Edge-to-Edge Repair
(TEER) for Mitral Valve Regurgitation’’
and was previously entitled
‘‘Transcatheter Mitral Valve Repair
(TMVR)’’. Effective January 19, 2021,
CMS updated this NCD to expand
coverage to functional mitral
regurgitation (MR). Previously, coverage
was limited to degenerative MR. To
more precisely define the treatment
addressed in this NCD, we replaced the
term TMVR with TEER. The TEER
device is only covered when specific
conditions are met including that the
heart team and hospital are submitting
data in a prospective, national, audited
registry. The data includes patient,
practitioner and facility level variables
that predict outcomes such as all-cause
mortality and quality of life. In order to
remove the data collection requirement
under this coverage with evidence
development (CED) NCD or make any
other changes to the existing policy, we
must formally reopen and reconsider
the policy. We are continuing to review
and analyze the data collected since the
original NCD was effective in 2014 and
following the update in 2021.
The data collected and analyzed in
the TVT Registry will be used by CMS
to determine if TEER is reasonable and
necessary (e.g., improves health
outcomes) for Medicare beneficiaries
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53056-53059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20811]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1759-N]
Medicare Program; Town Hall Meeting on the FY 2023 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) 2023
applications for add-on payments for new medical services and
technologies under the hospital inpatient prospective payment system
(IPPS). The United States is responding to an outbreak of respiratory
disease caused by the virus ``SARS-CoV-2'' and the disease it causes
``coronavirus disease 2019'' (abbreviated ``COVID-19''). Due to the
COVID-19 pandemic, the Town Hall Meeting will be held virtually rather
than as an in-person meeting. Interested parties are invited to this
meeting to present their comments, recommendations, and data regarding
whether the FY 2023 new medical services and technologies applications
meet the substantial clinical improvement criterion.
[[Page 53057]]
DATES:
Meeting dates: The Town Hall Meeting announced in this notice will
be held virtually on Tuesday, December 14, 2021 and Wednesday, December
15, 2021 (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 preliminary meeting agenda). The
Town Hall Meeting will begin each day at 9 a.m. Eastern Standard Time
(e.s.t.) and check-in via online platform will begin at 8:30 a.m.
e.s.t.
Deadline for requesting special accommodations: The deadline to
submit requests for special accommodations is 5 p.m., e.s.t. on Monday,
November 22, 2021.
Deadline for registration of presenters at the Town Hall Meeting:
The deadline to register to present at the Town Hall Meeting is 5 p.m.,
e.s.t. on Monday, November 22, 2021.
Deadline for submission of agenda item(s) or written comments for
the Town Hall Meeting: Written comments and agenda items (public
comments to be delivered at the Town Hall Meeting) for discussion at
the Town Hall Meeting, including agenda items by presenters
(presentation slide decks), must be received by 5 p.m. e.s.t. on
Monday, November 29, 2021.
Deadline for submission of written comments after the Town Hall
Meeting for consideration in the Fiscal Year (FY) 2023 Hospital
Inpatient Prospective Payment System/Long Term Care PPS (IPPS/LTCH PPS)
proposed rule: Individuals may submit written comments after the 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. e.s.t. on
Monday, December 27, 2021, for consideration in the FY 2023 IPPS/LTCH
PPS proposed rule.
ADDRESSES:
Meeting location: The 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 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 Town Hall
Meeting: Each presenter must submit an agenda item(s) regarding whether
a FY 2023 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: Michelle Joshua, (410) 786-6050,
[email protected] or [email protected].
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 new and 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 new and 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. Under current policy, a new
technology must receive FDA marketing authorization by July 1 to be
considered in the IPPS final rule in order to allow complete review and
consideration of all the information to determine if the technology
meets the new technology add-on payment criteria at the beginning of
the fiscal year (that is, October 1st).
Under the previously described policy, cases involving eligible
antimicrobial products could begin receiving the new technology add-on
payment sooner, effective for discharges the quarter after the date of
FDA marketing authorization provided that the technology receives FDA
marketing authorization by July 1 of the particular fiscal year for
which the applicant applied for new technology add-on payments. (See
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 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
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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 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 2023. 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 2023 IPPS proposed rule.
II. Town Hall Meeting Format and Conference Call/Live Streaming
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 2023 new medical
services and technology add-on payment applications. 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 to 15
minutes 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. A preliminary agenda will be
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html by November 22,
2021, 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
2023 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, Live Streaming, and Webinar Information
As noted previously, the Town Hall Meeting will be held virtually
due to the COVID-19 pandemic. There will be an option to participate in
the Town Hall
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Meeting via live streaming technology or webinar and a toll-free
teleconference phone line. Information on the option to participate via
live streaming technology or webinar and a teleconference dial-in will
be provided through an upcoming listserv 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 live streaming technology or a
webinar.
III. Registration Instructions
The Division of New Technology in CMS is coordinating the meeting
registration for the Town Hall Meeting on substantial clinical
improvement. While there is no registration fee, individuals planning
to present at the Town Hall Meeting must register to present.
Registration for presenters may be completed by sending an email to
[email protected]. Please include your name, address, telephone
number, email address and fax number.
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 21, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-20811 Filed 9-23-21; 8:45 am]
BILLING CODE 4120-01-P
