[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73091-73094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29989]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1342-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2012
Applications for Add-on Payments for New Medical Services and
Technologies Under the Hospital Inpatient Prospective Payment System
and Informational Workshop on the Application Process and Criteria for
Add-on Payments for New Medical Services and Technologies Under the
Inpatient and Outpatient Prospective Payment Systems
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) 2012 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 2012 new medical services and technologies
applications meet the substantial clinical improvement criterion.
Additionally, we will hold an Informational Workshop for all
interested parties on the application process and criteria for add-on
payments for new medical services and technologies under the IPPS and
the application processes for the outpatient prospective payment system
(OPPS) transitional pass-through payment for drugs, biological, and
devices and new technology ambulatory payment classification (APC)
group assignments for new services.
DATES: Meeting Date: Both the Town Hall Meeting and Informational
Workshop announced in this notice will be held on Wednesday, February
2, 2011. The Informational Workshop will begin at 9 a.m., and check-in
will begin at 8:30 a.m. eastern standard time (e.s.t.). The Town Hall
Meeting will begin at 1 p.m. e.s.t. and check-in will begin at 12:30
p.m. e.s.t. Only one check-in is required to enter the building.
Participants attending the Informational Workshop will be able to
attend the Town Hall meeting without an additional check-in unless they
exit the building. In this case, a participant will need to repeat the
security
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procedures and check-in again for the Town Hall Meeting.
Deadline for Registration of Presenters of the Town Hall Meeting:
All presenters for the Town Hall Meeting, whether attending in person
or by phone, must register and submit their agenda item(s) by January
19, 2011.
Deadline for Registration of All Other Participants for the Town
Hall Meeting and the Informational Workshop and Submitting Requests for
Special Accommodations: All other participants must register by January
24, 2011. Requests for special accommodations must be received no later
than 5 p.m., e.s.t. on January 24, 2011.
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 must be received by January 19, 2011. In
addition to materials submitted for discussion at the Town Hall
Meeting, individuals may submit other written comments, 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 February 16, 2011, for consideration
before publication of the FY 2012 IPPS proposed rule.
ADDRESSES: Meeting Location: The Town Hall Meeting and Informational
Workshop will both be held in the main Auditorium in the central
building of the Centers for Medicare and Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244-1850.
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. Registration information and special accommodation
requests may also be mailed to the address listed in the ADDRESSES
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 2012 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 e-mail to [email protected] or sent via regular mail to:
Division of Acute Care, New Technology Team, Mailstop C4-08-06,
Centers for Medicare and Medicaid Services, 7500 Security Boulevard,
Baltimore Maryland 21244-1850, Attention: Michael Treitel or Celeste
Beauregard.
FOR FURTHER INFORMATION CONTACT: Michael Treitel, (410) 786-4552,
[email protected], or Celeste Beauregard, (410) 786-8102,
[email protected]. Alternatively, you may forward your
requests via e-mail to [email protected] or regular mail as specified
in the ADDRESSES section of this notice.
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 inpatient hospital 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 FY 2002 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
evaluate 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 2012. 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 2012 IPPS proposed rule.
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II. Town Hall Meeting and Informational Workshop Formats and Conference
Calling 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
improvement. This meeting will allow for a discussion of the
substantial clinical improvement criteria on each of the FY 2012 new
medical services and technology add-on payment applications.
Information regarding the applications can be found on our Web site at
http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
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) to the address specified in the ADDRESSES section of
this notice by the date specified in the DATES section of this notice.
Comments from participants will be heard after scheduled statements if
time permits. Once the agenda is completed, it will be posted on the
CMS IPPS Web site at http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
In addition, written comments will also be accepted and presented
at the meeting if they are received at the address specified in the
ADDRESSES section of this notice 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 at the address specified in the ADDRESSES section of this
notice by the date specified in the DATES section of this notice.
B. Informational Workshop Format
In addition to the statutorily-required Town Hall Meeting on
whether an IPPS new technology application meets the substantial
clinical improvement criteria, we will be holding an Informational
Workshop on applying for special payment for new medical services and
technologies under the IPPS and OPPS. Specifically, for new technology
add-on payments under the IPPS, we will discuss each criterion in
detail along with other information that will be helpful in guiding an
applicant through the new technology add-on payment process. We will
also discuss the processes of diagnosis-related group (DRG) assignment
and requesting new ICD-9-CM codes under the IPPS. (Information on DRGs
can be found on the IPPS Web site at http://www.cms.hhs.gov/AcuteInpatientPPS/01_overview.asp#TopOfPage and information on ICD-9-
CM coding can be found on our Web site at http://www.cms.hhs.gov/ICD9ProviderDiagnosticCodes/.
In addition, to facilitate the public's knowledge of the OPPS
application processes for transitional pass-through status of drugs,
biologicals, and devices and assignment of new services to new
technology ambulatory payment classification (APC) groups, the
Informational Workshop will also include information on several
processes for applying for special payment under the OPPS. One topic
concerns the process for applying for a new category of devices for
pass-through payment and criteria for evaluation. Interested parties
may apply for a new device category, in accordance with section
1833(t)(6) of the Act. As background information, we have posted
application and process background information on our Web site at
http://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage.
Furthermore, under section 1833(t)(6) of the Act interested parties
may also apply for transitional pass-through payment for certain new
drugs and biologicals. As background information, we have posted
application and process background information on our Web site at
http://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage.
Finally, we provide the opportunity for the public to apply for new
services to be placed in new technology APC groups in the OPPS, in
accordance with our criteria and discussion in our November 30, 2001
final rule (66 FR 9897 through 59903). As background information, we
have posted application and process background information on our Web
site at http://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage. We plan to discuss all three of these OPPS
application processes at the Informational Workshop that will be held
on February 2, 2011.
The Informational Workshop is open to all interested parties
including organizations representing hospitals, physicians, and
manufacturers. We encourage all interested parties to attend,
especially those who are not familiar with these processes. Individuals
who want to attend this Informational Workshop must register by the
date specified in the DATES section of this notice. Registration
information is available below.
C. Conference Call Information
For participants who cannot come to CMS for the Informational
Workshop or the Town Hall Meeting, an open toll-free phone line, (877)
267-1577, has been made available. The conference code is ``0400.''
III. Registration Instructions
The Division of Acute Care in CMS is coordinating the meeting
registration for both the Town Hall Meeting and the Informational
Workshop. While there is no registration fee, individuals must register
to attend the Town Hall Meeting on substantial clinical improvement and
for the Informational Workshop (two separate registrations).
Registration may be completed on-line at the following Web address:
http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
Select the link at the bottom of the page ``Register to Attend the New
Technology Town Hall Meeting'' or ``Register to Attend the New
Technology Informational Workshop''. 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 e-mail to the contacts listed in the FOR FURTHER INFORMATION CONTACT
section of this notice. Please include your name, address, telephone
number, e-mail 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 close of business by the date listed 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
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attending the Informational Workshop and no later than 12:30 p.m.
e.s.t. if you are attending the Town Hall Meeting so that you will be
able to arrive promptly at the appropriate 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
meetings. 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 18, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-29989 Filed 11-26-10; 8:45 am]
BILLING CODE 4120-01-P