80 FR 74774 - Medicare Program; Town Hall Meeting on the FY 2017 Applications for New Medical Services and Technologies Add-On Payments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 229 (November 30, 2015)

Page Range		74774-74776
FR Document		2015-30314

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) 2017 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 2017 new medical services and technologies applications meet the substantial clinical improvement criterion.

Federal Register, Volume 80 Issue 229 (Monday, November 30, 2015)

[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Notices]
[Pages 74774-74776]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-30314]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1634-N]

Medicare Program; Town Hall Meeting on the FY 2017 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) 2017 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 2017 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 Tuesday, February 16, 2016. The Town Hall Meeting will
begin 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 and Submitting Requests for Special Accommodations:
The deadline to register to attend the Town Hall Meeting and submit
requests for special accommodations is 5:00 p.m., e.s.t. on Tuesday,
February 2, 2016.
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, February 1, 2016.
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, February 1, 2016. In addition
to materials submitted for discussion at the Town Hall Meeting,
individuals may submit other 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, February 26, 2016, for consideration in the FY 2017 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 and
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

[[Page 74775]]

view and participate in the Town Hall Meeting via live stream
technology or webinar. Information on these options is 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 agenda item(s) regarding whether a
FY 2017 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:
Michael Treitel, (410) 786-4552, michael.treitel@cms.hhs.gov, or
Noel Manlove, (410) 786-5161, noel.manlove@cms.hhs.gov.
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.)
In the September 7, 2001 final rule (66 FR 46914), we noted that we
evaluated a request for special payment for a new medical service or
technology against the following criteria in order to determine if the
new technology meets the substantial clinical improvement requirement:
The device offers a treatment option for a patient
population unresponsive to, or ineligible for, currently available
treatments.
The device 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. There must also be evidence that use of the device
to make a diagnosis affects the management of the patient.
Use of the device significantly improves clinical outcomes
for a patient population as compared to currently available treatments.
Some examples of outcomes that are frequently evaluated in studies of
medical devices are the following:
++ Reduced mortality rate with use of the device.
++ Reduced rate of device-related complications.
++ Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
++ Decreased number of future hospitalizations or physician visits.
++ More rapid beneficial resolution of the disease process
treatment because of the use of the device.
++ Decreased pain, bleeding or other quantifiable symptoms.
++ Reduced recovery time.
In addition, we indicated that the requester is required to submit
evidence that the technology meets one or more of these criteria.
Section 503 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1886(d)(5)(K)(viii) of
the Act to revise the process for evaluating new medical services and
technology applications by requiring the Secretary to 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 2017. 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 2017 IPPS proposed rule.

II. Town Hall Meeting and Conference Calling/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 criteria for each of the FY 2017 new
medical services and technology add-on payment applications.
Information regarding the applications can be found on our Web site 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.
Presenters will be scheduled to speak in the order in which they
register and grouped by new technology applicant. Therefore,
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.
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

[[Page 74776]]

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

For participants who cannot attend the Town Hall Meeting in person,
an open toll-free phone line, (877) 267-1577, has been made available.
The Meeting Place meeting ID is 998-698-471.
Also, there will be an option to view and participate in the Town
Hall Meeting via live streaming technology or a webinar. Information on
the option to participate via live streaming technology or a webinar
will be provided through an upcoming listserv notice and posted on the
New Technology Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. Continue to check
the Web site 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, on-line registrants should print the
confirmation page(s) and bring it with them to the meeting(s).
If you are unable to register on-line, you may register by sending
an email to newtech@cms.hhs.gov. 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 this meeting must
register by the date specified in the DATES section of this notice.
Please allow sufficient time to go through the security checkpoints. It
is suggested that you arrive at 7500 Security Boulevard no later than
8:30 a.m. e.s.t. if you are attending the Town Hall Meeting in person
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. The Real ID Act of 2005 (Pub. L. 109-13), establishes
minimum standards for the issuance of state-issued driver's licenses
and identification (ID) cards. It prohibits Federal agencies from
accepting an official driver's license or ID card from a state unless
the Department of Homeland Security determines that the state is in
compliance with the Real ID Act. (For information regarding the states
or territories that are not in compliance with the Real ID Act see
http://www.dhs.gov/real-id-enforcement-brief.) If a state or territory
is listed on the http://www.dhs.gov/real-id-enforcement-brief
[hairsp]Web site as non-compliant, a photographic ID (such as a
driver's license) issued by one of those states or territories will not
be accepted as identification to enter Federal buildings. Visitors from
these states/territories will need to provide alternative proof of
identification (such as a passport) to gain entrance into Baltimore-
based CMS buildings.
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
into 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. 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.

Authority: Section 503 of Pub. L. 108-173.

Dated: November 12, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-30314 Filed 11-27-15; 8:45 am]
BILLING CODE 4120-01-P

74776 Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Notices

proposed rule, the comments must be suggested that you arrive at 7500 Authority: Section 503 of Pub. L. 108–173.
received via email to newtech@ Security Boulevard no later than 8:30 Dated: November 12, 2015.
cms.hhs.gov by the date specified in the a.m. e.s.t. if you are attending the Town Andrew M. Slavitt,
DATES section of this notice. Hall Meeting in person so that you will Acting Administrator, Centers for Medicare
be able to arrive promptly for the & Medicaid Services.
B. Conference Call, Live Streaming, and meeting.
Webinar Information Security measures include the
[FR Doc. 2015–30314 Filed 11–27–15; 8:45 am]
BILLING CODE 4120–01–P
For participants who cannot attend following:
the Town Hall Meeting in person, an • Presentation of government-issued
open toll-free phone line, (877) 267– photographic identification to the
Federal Protective Service or Guard DEPARTMENT OF HEALTH AND
1577, has been made available. The
Service personnel. The Real ID Act of HUMAN SERVICES
Meeting Place meeting ID is 998–698–
471. 2005 (Pub. L. 109–13), establishes Food and Drug Administration
Also, there will be an option to view minimum standards for the issuance of
and participate in the Town Hall state-issued driver’s licenses and [Docket No. FDA–2015–N–0001]
Meeting via live streaming technology identification (ID) cards. It prohibits
or a webinar. Information on the option Federal agencies from accepting an Psychopharmacologic Drugs Advisory
to participate via live streaming official driver’s license or ID card from Committee; Notice of Meeting
technology or a webinar will be a state unless the Department of AGENCY: Food and Drug Administration,
provided through an upcoming listserv Homeland Security determines that the HHS.
notice and posted on the New state is in compliance with the Real ID
Act. (For information regarding the ACTION: Notice.
Technology Web site at http://
www.cms.gov/Medicare/Medicare-Fee- states or territories that are not in This notice announces a forthcoming
for-Service-Payment/ compliance with the Real ID Act see meeting of a public advisory committee
AcuteInpatientPPS/newtech.html. http://www.dhs.gov/real-id- of the Food and Drug Administration
Continue to check the Web site for enforcement-brief.) If a state or territory (FDA). The meeting will be open to the
updates. is listed on the http://www.dhs.gov/real- public.
id-enforcement-brief Web site as non- Name of Committee:
C. Disclaimer compliant, a photographic ID (such as a Psychopharmacologic Drugs Advisory
We cannot guarantee reliability for driver’s license) issued by one of those Committee.
live streaming technology or a webinar. states or territories will not be accepted General Function of the Committee:
as identification to enter Federal
III. Registration Instructions To provide advice and
buildings. Visitors from these states/
recommendations to the Agency on
The Division of Acute Care in CMS is territories will need to provide
FDA’s regulatory issues.
coordinating the meeting registration for alternative proof of identification (such
the Town Hall Meeting on substantial as a passport) to gain entrance into Date and Time: The meeting will be
clinical improvement. While there is no Baltimore-based CMS buildings. held on February 3, 2016, from 8 a.m.
registration fee, individuals planning to • Inspection of vehicle’s interior and to 5 p.m.
attend the Town Hall Meeting in person exterior (this includes engine and trunk Location: FDA White Oak Campus,
must register to attend. inspection) at the entrance to the 10903 New Hampshire Ave., Bldg. 31
Registration may be completed on- grounds. Parking permits and Conference Center, the Great Room (rm.
line at the following Web address: instructions will be issued after the 1503), Silver Spring, MD 20993–0002.
http://www.cms.gov/Medicare/ vehicle inspection. Answers to commonly asked questions
Medicare-Fee-for-Service-Payment/ • Inspection, via metal detector or including information regarding special
AcuteInpatientPPS/newtech.html. other applicable means of all persons accommodations due to a disability,
Select the link at the bottom of the page entering the building. We note that all visitor parking, and transportation may
‘‘Register to Attend the New Technology items brought into CMS, whether be accessed at: http://www.fda.gov/
Town Hall Meeting’’. After completing personal or for the purpose of AdvisoryCommittees/
the registration, on-line registrants presentation or to support a AboutAdvisoryCommittees/
should print the confirmation page(s) presentation, are subject to inspection. ucm408555.htm.
and bring it with them to the meeting(s). We cannot assume responsibility for Contact Person: Kalyani Bhatt, Center
If you are unable to register on-line, coordinating the receipt, transfer, for Drug Evaluation and Research, Food
you may register by sending an email to transport, storage, set-up, safety, or and Drug Administration, 10903 New
newtech@cms.hhs.gov. Please include timely arrival of any personal Hampshire Ave., Bldg. 31, Rm. 2417,
your name, address, telephone number, belongings or items used for Silver Spring, MD 20993–0002, 301–
email address and fax number. If seating presentation or to support a 796–9001, FAX: 301–847–8533, PDAC@
capacity has been reached, you will be presentation. fda.hhs.gov, or FDA Advisory
notified that the meeting has reached Note: Individuals who are not registered in Committee Information Line, 1–800–
capacity. advance will not be permitted to enter the 741–8138 (301–443–0572 in the
building and will be unable to attend the Washington, DC area). A notice in the
IV. Security, Building, and Parking meeting. The public may not enter the Federal Register about last minute
Guidelines building earlier than 45 minutes prior to the modifications that impact a previously
jstallworth on DSK7TPTVN1PROD with NOTICES

Because this meeting will be located convening of the meeting. announced advisory committee meeting
on Federal property, for security All visitors must be escorted in all cannot always be published quickly
reasons, any persons wishing to attend areas other than the lower level lobby enough to provide timely notice.
this meeting must register by the date and cafeteria area and first floor Therefore, you should always check the
specified in the DATES section of this auditorium and conference areas in the Agency’s Web site at http://
notice. Please allow sufficient time to go Central Building. Seating capacity is www.fda.gov/AdvisoryCommittees/
through the security checkpoints. It is limited to the first 250 registrants. default.htm and scroll down to the

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Document Created: 2018-03-01 11:12:32
Document Modified: 2018-03-01 11:12:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of meeting.
Dates		Meeting Date: The Town Hall Meeting announced in this notice will be held on Tuesday, February 16, 2016. The Town Hall Meeting will begin at 9:00 a.m. Eastern Standard Time (e.s.t.) and check-in will begin at 8:30 a.m. e.s.t.
Contact		Michael Treitel, (410) 786-4552, [email protected], or Noel Manlove, (410) 786-5161, [email protected]
FR Citation		80 FR 74774

80 FR 74774 - Medicare Program; Town Hall Meeting on the FY 2017 Applications for New Medical Services and Technologies Add-On Payments

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 229 (November 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services