[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Proposed Rules]
[Pages 71555-71557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28518]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 412
[CMS-1604-N]
Medicare Program; Town Hall Meeting on FY 2015 Applications for
New Medical Services and Technology 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
the Social Security Act (the Act) to discuss fiscal year (FY) 2015
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 2015 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 Wednesday, February 12, 2014. 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 requests for special accommodations must be
received no later than 5:00 p.m., e.s.t. on Tuesday, January 28, 2014.
Deadline for Registration of Presenters of the Town Hall Meeting:
The deadline to register to present at the Town Hall Meeting must be
received no later than 5:00 p.m., e.s.t. on Tuesday, January 21, 2014.
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 Tuesday, January 21, 2014. 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 Wednesday, March 5, 2014, for
consideration in the FY 2015 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 view and
participate in the Town Hall Meeting via live stream technology and/or
webinar. Information on 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 2015 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: Michael Treitel, (410) 786-4552,
[email protected], or Celeste Beauregard, (410) 786-8102,
[email protected] or Carol Schwartz, (410) 786-0576,
[email protected]. Alternatively, you may forward your
requests via email to [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 71556]]
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 alternatives provided during this meeting will
assist us as we evaluate the new medical services and technology
applications for FY 2015. 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 2015 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 on each of the FY 2015 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 [email protected] 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 [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
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, (877) 267-1577, has been made available.
The meeting number is ``999 396 992.''
Also, there will be an option to view and participate in the Town
Hall Meeting via live streaming technology and/or a webinar.
Information on the option to participate via live streaming technology
and/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.
Disclaimer: We cannot guarantee reliability for live streaming
technology and/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
[[Page 71557]]
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 [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 these meetings will be located on Federal property, for
security reasons, any persons wishing to attend these meetings 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.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support a
demonstration, 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 demonstration or to support a demonstration.
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(s).
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building. Seating capacity is limited
to the first 250 registrants.
Authority: Section 503 of Pub. L. 108-173.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: November 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-28518 Filed 11-27-13; 8:45 am]
BILLING CODE 4120-01-P