[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53732-53734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1722-N]


Medicare Program; Town Hall Meeting on the FY 2021 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 
section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to 
discuss fiscal year (FY) 2021 applications for add-on payments for new 
medical services and technologies under the hospital inpatient 
prospective payment system (IPPS). Interested parties are invited to 
this meeting to present their comments, recommendations, and data 
regarding whether the FY 2021 new medical services and technologies 
applications meet the substantial clinical improvement criterion.

DATES: Meeting Date: The Town Hall Meeting announced in this notice 
will be held on Monday, December 16, 2019 and Tuesday December 17, 2019 
(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 will begin at 8:30 a.m. e.s.t.
    Deadline for Registration for Participants (not Presenting) at the 
Town Hall Meeting: The deadline to register to attend the Town Hall 
Meeting is 5:00 p.m. e.s.t. on Monday, December 9, 2019.
    Deadline for Requesting Special Accommodations: The deadline to 
submit requests for special accommodations is 5 p.m. e.s.t. on Monday, 
November 25, 2019.
    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 18, 2019.
    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 p.m. e.s.t. on Monday, November 25, 2019.
    Deadline for Submission of Written Comments after the Town Hall 
Meeting for consideration in the FY 2021 IPPS 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 Friday, January 
3, 2020, for consideration in the FY 2021 IPPS proposed rule.

ADDRESSES: Meeting Location: The Town Hall Meeting will be held in the 
main Auditorium in the central building of the Centers for Medicare & 
Medicaid Services located at 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    In addition, we are providing two alternatives to attending the 
meeting in person--(1) there will be an open toll-free phone line to 
call into the Town Hall Meeting; or (2) participants may view and 
participate in the Town Hall Meeting via live stream technology or 
webinar. These options are discussed in section II.B. of this notice.
    Registration and Special Accommodations: Individuals wishing to 
participate in the meeting must register by following the on-line 
registration instructions located in section III of this notice or by 
contacting staff listed in the FOR FURTHER INFORMATION CONTACT section 
of this notice. Individuals who need special accommodations should 
contact staff listed in the FOR FURTHER INFORMATION CONTACT section of 
this notice.
    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 2021 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 Michael Treitel, (410) 786-4552, 
[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 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 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.)
    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

[[Page 53733]]

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 2021. 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 2021 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 2021 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 8, 2019 
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 
2021 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

    For participants who cannot attend the Town Hall Meeting in person, 
an open toll-free phone line will be made available. Continue to check 
our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html for updated dial-in number and 
instructions.
    Also, there will be an option to view and participate in the Town 
Hall Meeting via live streaming technology or webinar. Information on 
the option to

[[Page 53734]]

participate via live streaming technology or webinar will be provided 
through an upcoming listserv notice and 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 Acute Care 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 attend the Town Hall Meeting in person must register to attend.
    Registration may be completed on-line at the following web address: 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. Select the link at the bottom of the 
page ``Register to Attend the New Technology Town Hall Meeting''. After 
completing the registration, online registrants should print the 
confirmation page(s) and bring it with them to the meeting.
    If you are unable to register on-line, you may register by sending 
an email to [email protected]. Please include your name, address, 
telephone number, email address and fax number. If seating capacity has 
been reached, you will be notified that the meeting has reached 
capacity.

IV. Security, Building, and Parking Guidelines

    Because this meeting will be located on Federal property, for 
security reasons, any persons wishing to attend the meeting must 
register by the date specified in the DATES section of this notice. 
Please allow sufficient time to go through the security checkpoints. If 
you are attending the Town Hall Meeting in person, we suggest that you 
arrive at 7500 Security Boulevard no later than 8:30 a.m. e.s.t. so 
that you will be able to arrive promptly for the meeting.
    Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.

    Note:  The REAL ID Act established minimum security standards 
for license issuance and production and prohibits Federal agencies 
from accepting for certain purposes driver's licenses and 
identification cards from states not meeting the Act's minimum 
standards. We encourage the public to visit the DHS website at 
https://www.dhs.gov/real-id prior to the new technology town hall 
meeting for updated information.

     All Foreign National visitor requests must be submitted 12 
business days prior to the scheduled visitor to allow for processing.
     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means 
of all persons entering the building. We note that all items brought to 
CMS, whether personal or for the purpose of presentation or to support 
a presentation, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set-up, safety, or timely arrival of any personal belongings 
or items used for presentation or to support a presentation.

    Note: Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meeting in person. The public may not enter the building earlier 
than 45 minutes prior to the convening of the meeting.

    All visitors must be escorted in all areas other than the lower 
level lobby and cafeteria area and first floor auditorium and 
conference areas in the Central Building. Seating capacity is limited 
to the first 250 registrants.
    Effective June 1, 2018, Federal Protective Services (FPS) has 
implemented new security screening procedures at all CMS Baltimore 
locations to align with national screening standards. Please allow 
extra time to clear security prior to the beginning of the meeting. 
Employees, contractors and visitors must place all items in bins for 
screening, including the following:
     Any items in your pockets.
     Belts, hats, jackets & coats (not suit jackets or sport 
coats).
     Purses, laptop computers, and cell phones.
     Larger items (for example computer bags) can be placed 
directly onto the conveyer.
    In the event the metal detector beeps when you walk through a 
security guard will run a hand-held metal detector over you--
     If the metal detector does not alarm, you are cleared to 
enter;
     If the hand-held metal detector alarms, the guard will pat 
down the area of the body where the metal detector alarmed; or
     If footwear alarms, it will need to be removed and placed 
in a bin for x-ray screening.
    If you believe that you have a disability that will cause you to 
require reasonable accommodation to comply with the new process, please 
contact [email protected] as soon as possible.

    Dated: September 26, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-21750 Filed 10-4-19; 11:15 am]
BILLING CODE 4120-01-P