[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]


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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.

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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: http://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 http://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 http://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: http://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