Medicare Program; Town Hall Meeting on the FY 2022 Applications for New Medical Services and Technologies Add-On Payments, 65815-65817 [2020-22894]
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
information technology to minimize the
information collection burden.
DATES: Comments must be received by
December 15, 2020.
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
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llRoom C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
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This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10749 National Plan and
Provider Enumeration System
(NPPES) Supplemental Data
Collection
Under the 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
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18:59 Oct 15, 2020
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requires federal agencies to publish a
60-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.
65815
Dated: October 9, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–22892 Filed 10–15–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: National Plan
and Provider Enumeration System
(NPPES) Supplemental Data Collection;
Use: The adoption by the Secretary of
HHS of the standard unique health
identifier for health care providers is a
requirement of the Health Insurance
Portability and Accountability Act of
1996 (HIPAA). The unique identifier is
to be used on standard transactions and
may be used for other lawful purposes
in the health care system. The CMS
Final Rule published on January 23,
2004 adopts the National Provider
Identifier (NPI) as the standard unique
health identifier for health care
providers. Health care providers that are
covered entities under HIPAA must
apply for and use NPIs in standard
transactions. The law requires that data
collection standards for these measures
be used, to the extent that it is practical,
in all national population health
surveys. It applies to self-reported
optional information only. The law also
requires any data standards published
by HHS to comply with standards
created by the Office of Management
and Budget (OMB).
The web based optional data fields
can be seen in Appendix A1: Data
Collected for the Office of Minority and
Appendix A2: Data collected for the
21st Century Cures Act, interoperability.
The standards apply to population
health surveys sponsored by HHS,
where respondents either self-report
information or a knowledgeable person
responds for all members of a
household. HHS is implementing these
data standards in all new surveys. Form
Number: CMS–10749 (OMB control
number: 0938–NEW); Frequency:
Yearly; Affected Public: Private Sector,
Business or other for-profits, Not-forprofit institutions; Number of
Respondents: 999,291; Total Annual
Responses: 999,291; Total Annual
Hours: 169,880. (For policy questions
regarding this collection contact DaVona
Boyd at 410–786–7483.)
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Centers for Medicare & Medicaid
Services
[CMS–1742–N]
Medicare Program; Town Hall Meeting
on the FY 2022 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
section 1886(d)(5)(K)(viii) of the Social
Security Act (the Act) to discuss fiscal
year (FY) 2022 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 2022 new medical
services and technologies applications
meet the substantial clinical
improvement criterion.
DATES:
Meeting Date(s): The Town Hall
Meeting announced in this notice will
be held virtually on Tuesday, December
15, 2020 and Wednesday, December 16,
2020 (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 9:00 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
SUMMARY:
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65816
Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
accommodations is 5:00 p.m., e.s.t. on
Monday, November 23, 2020.
Deadline for Registration of Presenters
at the Town Hall Meeting: The deadline
to register to present at the Town Hall
Meeting is 5:00 p.m., e.s.t. on Monday,
November 23, 2020.
Deadline for Submission of Agenda
Item(s) or Written Comments for the
Town Hall Meeting: Written comments
and agenda items for discussion at the
Town Hall Meeting, including agenda
items by presenters, must be received by
5:00 p.m. e.s.t. on Monday, November
30, 2020.
Deadline for Submission of Written
Comments after the Town Hall Meeting
for consideration in the Fiscal Year (FY)
2022 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 5:00 p.m. e.s.t. on
Monday, December 28, 2020, for
consideration in the FY 2022 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.
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
2022 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
Cristina Nigro, (410) 786–7763,
cristina.nigro@cms.hhs.gov.
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18:59 Oct 15, 2020
Jkt 253001
Alternatively, you may forward your
requests via email to 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 and FY
2021 IPPS/Long-term Care Hospital
(LTCH) Prospective Payment System
(PPS) final rules, technologies which are
eligible for the alternative new
technology pathway for transformative
new devices or the alternative new
technology pathway for certain
antimicrobials do not need to meet the
requirement under 42 CFR 412.87(b)(1)
that the technology represent an
advance that substantially improves,
relative to technologies previously
available, the diagnosis or treatment of
Medicare beneficiaries. These medical
devices or products will also be
considered 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) and the FY 2021
IPPS/LTCH PPS final rule (85 FR 58733
through 58742) 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:
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• 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
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
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 2022. 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 2022
IPPS/LTCH PPS proposed rule.
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18:59 Oct 15, 2020
Jkt 253001
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 2022 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 23,
2020 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 2022 IPPS/LTCH PPS proposed rule,
the comments must be received via
email to newtech@cms.hhs.gov by the
date specified in the DATES section of
this notice.
B. Conference Call, 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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65817
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.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, 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: October 8, 2020.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2020–22894 Filed 10–14–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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Testing for Biotin Interference in In
Vitro Diagnostic Devices; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65815-65817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22894]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1742-N]
Medicare Program; Town Hall Meeting on the FY 2022 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
section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to
discuss fiscal year (FY) 2022 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 2022 new medical
services and technologies applications meet the substantial clinical
improvement criterion.
DATES:
Meeting Date(s): The Town Hall Meeting announced in this notice
will be held virtually on Tuesday, December 15, 2020 and Wednesday,
December 16, 2020 (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 9:00 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
[[Page 65816]]
accommodations is 5:00 p.m., e.s.t. on Monday, November 23, 2020.
Deadline for Registration of Presenters at the Town Hall Meeting:
The deadline to register to present at the Town Hall Meeting is 5:00
p.m., e.s.t. on Monday, November 23, 2020.
Deadline for Submission of Agenda Item(s) or Written Comments for
the Town Hall Meeting: Written comments and agenda items for discussion
at the Town Hall Meeting, including agenda items by presenters, must be
received by 5:00 p.m. e.s.t. on Monday, November 30, 2020.
Deadline for Submission of Written Comments after the Town Hall
Meeting for consideration in the Fiscal Year (FY) 2022 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 5:00 p.m. e.s.t. on
Monday, December 28, 2020, for consideration in the FY 2022 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 2022 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
Cristina Nigro, (410) 786-7763, [email protected].
Alternatively, you may forward your requests via email to
[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 and FY 2021 IPPS/Long-term Care
Hospital (LTCH) Prospective Payment System (PPS) final rules,
technologies which are eligible for the alternative new technology
pathway for transformative new devices or the alternative new
technology pathway for certain antimicrobials do not need to meet the
requirement under 42 CFR 412.87(b)(1) that the technology represent an
advance that substantially improves, relative to technologies
previously available, the diagnosis or treatment of Medicare
beneficiaries. These medical devices or products will also be
considered 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) and the FY
2021 IPPS/LTCH PPS final rule (85 FR 58733 through 58742) 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 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
[[Page 65817]]
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 2022. 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 2022 IPPS/LTCH PPS 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 2022 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 23, 2020
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
2022 IPPS/LTCH PPS proposed rule, the comments must be received via
email to [email protected] by the date specified in the DATES section
of this notice.
B. Conference Call, 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 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.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Seema Verma, 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: October 8, 2020.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2020-22894 Filed 10-14-20; 8:45 am]
BILLING CODE 4120-01-P
