Notice2021-20811
Medicare Program; Town Hall Meeting on the FY 2023 Applications for New Medical Services and Technologies Add-On Payments
Primary source
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Published
September 24, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces a Town Hall Meeting in accordance with the Social Security Act (the Act) to discuss fiscal year (FY) 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.
Full Text
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<title>Federal Register, Volume 86 Issue 183 (Friday, September 24, 2021)</title>
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[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53056-53059]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20811]
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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.
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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: <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a>.
Continue to check the website for updates.
Registration and special accommodations: Individuals wishing to
present at the meeting must follow the instructions located in section
III. of this notice. Individuals who need special accommodations should
send an email to <a href="/cdn-cgi/l/email-protection#3b555e4c4f5e58537b58564815535348155c544d"><span class="__cf_email__" data-cfemail="355b50424150565d755658461b5d5d461b525a43">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#630d06141706000b23000e104d0b0b104d040c15"><span class="__cf_email__" data-cfemail="f09e958784959398b0939d83de989883de979f86">[email protected]</span></a> .
FOR FURTHER INFORMATION CONTACT: Michelle Joshua, (410) 786-6050,
<a href="/cdn-cgi/l/email-protection#1d70747e75787171783377726e75687c5d7e706e3375756e337a726b"><span class="__cf_email__" data-cfemail="c8a5a1aba0ada4a4ade6a2a7bba0bda988aba5bbe6a0a0bbe6afa7be">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#dfb1baa8abbabcb79fbcb2acf1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="fa949f8d8e9f9992ba999789d4929289d49d958c">[email protected]</span></a>.
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:
<bullet> The totality of the circumstances is considered when
making a determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies
[[Page 53058]]
previously available, the diagnosis or treatment of Medicare
beneficiaries.
<bullet> A determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries means--
++ The new medical service or technology offers a treatment option
for a patient population unresponsive to, or ineligible for, currently
available treatments;
++ The new medical service or technology offers the ability to
diagnose a medical condition in a patient population where that medical
condition is currently undetectable or offers the ability to diagnose a
medical condition earlier in a patient population than allowed by
currently available methods, and there must also be evidence that use
of the new medical service or technology to make a diagnosis affects
the management of the patient; or
++ The use of the new medical service or technology significantly
improves clinical outcomes relative to services or technologies
previously available as demonstrated by one or more of the following:
--A reduction in at least one clinically significant adverse event,
including a reduction in mortality or a clinically significant
complication.
--A decreased rate of at least one subsequent diagnostic or therapeutic
intervention (for example, due to reduced rate of recurrence of the
disease process).
--A decreased number of future hospitalizations or physician visits.
--A more rapid beneficial resolution of the disease process treatment
including, but not limited to, a reduced length of stay or recovery
time; an improvement in one or more activities of daily living; an
improved quality of life; or, a demonstrated greater medication
adherence or compliance.
++ The totality of the circumstances otherwise demonstrates that
the new medical service or technology substantially improves, relative
to technologies previously available, the diagnosis or treatment of
Medicare beneficiaries.
<bullet> Evidence from the following published or unpublished
information sources from within the United States or elsewhere may be
sufficient to establish that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries: Clinical trials, peer reviewed journal
articles; study results; meta-analyses; consensus statements; white
papers; patient surveys; case studies; reports; systematic literature
reviews; letters from major healthcare associations; editorials and
letters to the editor; and public comments. Other appropriate
information sources may be considered.
<bullet> The medical condition diagnosed or treated by the new
medical service or technology may have a low prevalence among Medicare
beneficiaries.
<bullet> The new medical service or technology may represent an
advance that substantially improves, relative to services or
technologies previously available, the diagnosis or treatment of a
subpopulation of patients with the medical condition diagnosed or
treated by the new medical service or technology.
Section 1886(d)(5)(K)(viii) of the Act requires that as part of the
process for evaluating new medical services and technology
applications, the Secretary shall do the following:
<bullet> Provide for public input regarding whether a new service
or technology represents an advance in medical technology that
substantially improves the diagnosis or treatment of Medicare
beneficiaries before publication of a proposed rule.
<bullet> Make public and periodically update a list of all the
services and technologies for which an application is pending.
<bullet> Accept comments, recommendations, and data from the public
regarding whether the service or technology represents a substantial
improvement.
<bullet> Provide for a meeting at which organizations representing
hospitals, physicians, manufacturers and any other interested party may
present comments, recommendations, and data to the clinical staff of
CMS as to whether the service or technology represents a substantial
improvement before publication of a proposed rule.
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 <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a>.
The majority of the meeting will be reserved for presentations of
comments, recommendations, and data from registered presenters. The
time for each 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 <a href="/cdn-cgi/l/email-protection#d6b8b3a1a2b3b5be96b5bba5f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="c6a8a3b1b2a3a5ae86a5abb5e8aeaeb5e8a1a9b0">[email protected]</span></a> 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 <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a> by November 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 <a href="/cdn-cgi/l/email-protection#016f64767564626941626c722f6969722f666e77"><span class="__cf_email__" data-cfemail="254b40525140464d654648560b4d4d560b424a53">[email protected]</span></a> by
the date specified in the DATES section of this notice. Written
comments may also be submitted after the meeting for our consideration.
If the comments are to be considered before the publication of the FY
2023 IPPS proposed rule, the comments must be received via email to
<a href="/cdn-cgi/l/email-protection#761813010213151e36151b05581e1e0558111900"><span class="__cf_email__" data-cfemail="244a41535041474c644749570a4c4c570a434b52">[email protected]</span></a> 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
[[Page 53059]]
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: <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</a>. Continue to check the website
for updates.
C. Disclaimer
We cannot guarantee reliability for 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
<a href="/cdn-cgi/l/email-protection#d0beb5a7a4b5b3b890b3bda3feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="076962707362646f47646a74296f6f7429606871">[email protected]</span></a>. 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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