[Federal Register Volume 73, Number 230 (Friday, November 28, 2008)]
[Notices]
[Pages 72490-72492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1537-N]


Medicare Program; Town Hall Meeting on the Fiscal Year 2010 
Applications for New Medical Services and Technologies Add-on Payments 
Under the Hospital Inpatient Prospective Payment Systems, February 17, 
2009

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

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[[Page 72491]]

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) 2010 applications for add-on payments for new 
medical services and technologies under the hospital inpatient 
prospective payment systems. Interested parties are invited to this 
meeting to present their comments, recommendations, and data regarding 
whether the FY 2010 new medical services and technologies applications 
meet the substantial clinical improvement criterion.

DATES: Meeting Date: The Town Hall meeting will be held on Tuesday, 
February 17, 2009 at 1:30 p.m., e.s.t. and check-in will begin at 1 
p.m. e.s.t.
    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 February 
3, 2009.
    Deadline for Submission of Comments on the Town Hall Meeting: 
Written comments for discussion at the Town Hall meeting must be 
received by February 3, 2009. All other written comments on whether the 
service or technology represents a substantial clinical improvement 
must be received by March 9, 2009 for consideration before publication 
of the FY 2010 inpatient prospective payment systems proposed rule.
    Deadline for Registration of All Other Participants and Submitting 
Requests for Special Accommodations: All other participants must 
register by February 10, 2009. Requests for special accommodations must 
be received no later than 5 p.m., e.s.t. on February 10, 2009.

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, 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 for submission of 
agenda item(s) or written comments in the ADDRESSES section of this 
notice.
    Submission of Agenda Item(s) or Written Comments: Each presenter 
must submit an agenda item(s) regarding whether a FY 2010 application 
meets the substantial clinical improvement criterion. Agenda items or 
written comments, questions, or other statements must not exceed three 
single-spaced typed pages and must be sent via e-mail to 
[email protected] or sent via regular mail to the following address: 
Division of Acute Care, New Technology Team, Mailstop C4-07-08, Centers 
for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850, Attention: Tiffany Swygert or Michael Treitel.


FOR FURTHER INFORMATION CONTACT:
Tiffany Swygert, (410) 786-4642, [email protected].
Michael Treitel, (410) 786-4552, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 1886(d)(5)(K) and (L) of the Social Security Act (the Act) 
requires the Secretary to establish a process of identifying and 
ensuring adequate payments to acute inpatient 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 
systems (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 the 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 whether the service or technology represents a substantial 
improvement before publication of a proposed rule.

[[Page 72492]]

    The opinions and alternatives provided during this meeting will 
assist us as we evaluate the new medical services and technology 
applications for FY 2010. 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 2010 IPPS proposed rule.

II. Meeting Format

    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 2010 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.
    For presenters or participants unable to come to CMS for the 
meeting, an open toll-free phone line, (800) 619-2459, is available. 
Persons who call in will be asked for the conference code by the 
conference operator. The conference code is ``New Tech.''
    In addition, written comments will 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 CMS 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.

III. Registration Instructions

    The Division of Acute Care in CMS is coordinating the meeting 
registration for the Town Hall meeting. While there is no registration 
fee, individuals must register to attend the Town Hall meeting.
    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 ``New Technology Town Hall 
Meeting'' to complete the on-line registration. After completing the 
registration, on-line registrants should print the confirmation page 
and bring it with them to the meeting.
    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 this meeting will be located on Federal property, for 
security reasons, any persons wishing to attend this meeting 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 1 p.m., e.s.t. so that you will be able to arrive 
promptly at the meeting by 1:30 p.m., e.s.t.
    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. The public may not enter the building earlier than 45 
minutes prior to the convening of the meeting.

    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 Public Law 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 13, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. E8-28180 Filed 11-26-08; 8:45 am]
BILLING CODE 4120-01-P