[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78466-78468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28153]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1292-N]


Medicare Program; Town Hall Meeting on the Fiscal Year 2006 
Applications for New Medical Services and Technologies Add-on Payments 
Under the Hospital Inpatient Prospective Payment System Scheduled for 
February 23, 2005

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

ACTION: Notice of meeting.

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SUMMARY: This notice, in accordance with section 503 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), 
announces a Town Hall meeting to discuss fiscal year (FY) 2006 
applications for add-on payments for new medical services and 
technologies under the hospital inpatient prospective payment system 
(IPPS). Applicants, supporters, opponents, and other interested parties 
are invited to this meeting to present their comments, recommendations, 
and data regarding whether the FY 2006 new medical services and 
technologies applications meet the substantial clinical improvement 
criteria.

DATES: Meeting Date: The Town Hall meeting announced in this notice 
will be held on Wednesday, February 23, 2005 at 9 a.m. and check-in 
will begin at 8:30 a.m. EST.
    Registration Deadline for Presenters: All presenters, whether 
attending in person or by phone, must register and submit their agenda 
item(s) by February 15, 2005.
    Registration Deadline for All Other Participants: All other 
participants must register by February 17, 2005.
    Comment Deadline: Written comments for discussion at the meeting 
must be received by February 15, 2005. All other written comments for 
consideration before publication of the IPPS proposed rule must be 
received by March 15, 2005.

ADDRESSES: The Town Hall meeting will be held in the Auditorium in the 
central building of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    Agenda Items or Written Comments: Agenda items and written comments 
regarding whether a FY 2006 application meets the substantial clinical 
improvement criterion may be sent by mail, fax, or electronically.

[[Page 78467]]

Agenda items must be received by February 15, 2005. We will accept 
written questions or other statements, not to exceed three single-
spaced, typed pages that are received by March 15, 2005. Send written 
comments, questions, or other statements to--
    Division of Acute Care, Mail stop C4-07-05, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850. Attention: Meredith Walz or Michael Treitel, Fax: (410) 786-0169. 
E-mail: [email protected]

FOR FURTHER INFORMATION CONTACT: Meredith Walz, (410) 786-9421, 
[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) 
require the Secretary to establish a process of identifying and 
ensuring adequate payments for new medical services and technologies 
under Medicare. Effective for discharges beginning on or after October 
1, 2001, section 1886(d)(5)(K)(i) required 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 May 4, 2001 proposed rule (66 FR 22693) and the 
September 7, 2001 final rule (66 FR 46912) 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 symptom.
    ++ 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) revised the process for evaluating new 
medical services and technology applications by requiring the Secretary 
to do the following:
     Before publication of a proposed rule, 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.
     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.
     Before publication of a proposed rule, 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.
    The opinions and alternatives provided during this meeting will 
assist us as we evaluate the new medical services and technology 
applications for FY 2006. 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 2006 IPPS proposed rule.

II. Meeting Format

    This meeting will allow for a discussion of the substantial 
clinical improvement criteria for each of the FY 2006 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/providers/hipps/newtech.asp. In addition, we believe 
some of the issues raised in public comments during the FY 2005 
rulemaking cycle warrant further investigation to determine whether our 
definition of ``substantial clinical improvement'' should be revised 
(69 FR 49001 through 49006). We also believe that the definition of 
``substantial similarity'' may need to be revisited. (See the IPPS FY 
2005 final rule (69 FR 49011) and the September 7, 2001 (66 FR 46915) 
final rule). Although we do not expect to have a general discussion of 
these topics during the timeframe of the town hall meeting, we are 
inviting comment as part of this town hall meeting notice. So that we 
can consider these comments in development of our proposed rule, we 
will accept comments through the deadline for other written comments 
specified in the DATES section of this notice. We will also solicit 
comments during the rulemaking process.
    The majority of the meeting will be reserved for comments, 
recommendations, and data from registered presenters. The time for each 
presenter's comments will be approximately 10 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 want to be presenters must 
register and submit their agenda items by Tuesday, February 15, 2005. 
Once the agenda is completed, it will be posted on the IPPS Web site at 
http://www.cms.hhs.gov/providers/hipps/newtech.asp. Comments from 
participants will be heard (time permitting) after the completion of 
the presentations.
    For presenters or participants that cannot come to CMS for the 
meeting, an open toll-free phone line, (877) 357-7851, has been made 
available. If you are calling in, you will be prompted to enter the 
conference identification number, 2940111, or the name of the meeting. 
In addition, written comments will also be accepted and presented at 
the meeting if they are received by February 15, 2005. Written comments 
may also be submitted after the meeting. If the comments are to be 
considered before the publication of the proposed rule, the comments 
must be received by March 15, 2005.

[[Page 78468]]

III. Registration Instructions

    The Division of Acute Care is coordinating meeting registration. 
While there is no registration fee, individuals must register to 
attend. Individuals may present their comments either in person or by 
phone. These individuals must register and submit their agenda item(s) 
by February 15, 2005. All other participants must register by February 
17, 2005. All registrants will receive confirmation with instructions 
for arrival at the CMS complex (persons who register on-line will 
receive this confirmation upon completion of the registration process 
and should print the confirmation and bring it with them to the 
meeting). Because of limited meeting space and our desire to maintain 
an accurate count of registrants that plan to come to CMS, we prefer 
that these persons register on-line. In addition, we would prefer that 
registrants that plan to participate by phone, register by phone or 
fax.
    On-line Registration: Registration may be completed on-line at the 
following web address: http://www.cms.hhs.gov/providers/hipps/newtech.asp. Select the link ``Register to Attend the New Technology 
Town Hall Meeting'' and then select ``New Technology Town Hall 
Meeting'' from the drop down menu and follow the instructions. After 
completing registration, on-line registrants should print the 
confirmation page and bring it with them to the meeting.
    Registration by Phone or Fax: Registration may be completed by 
contacting Meredith Walz at (410) 786-9421 or Michael Treitel at (410) 
786-4552. Registration may also be completed by fax to the attention of 
Meredith Walz or Michael Treitel at (410) 786-0169. If registration is 
completed by phone or fax, please provide your name, address, telephone 
number, and, if available, e-mail address and fax number.

IV. Security Information

    Since this meeting will be held in a Federal government building, 
Federal security measures are applicable. In planning your arrival 
time, we recommend allowing additional time to clear security. In order 
to gain access to the building and grounds, participants must bring a 
government-issued photo identification and a copy of their confirmation 
of registration for the meeting. Access may be denied to persons 
without proper identification. For security reasons, no additional 
meeting registrations will be accepted after the close of the 
registration period.
    Security measures also include inspection of vehicles, inside and 
out, at the entrance to the grounds. In addition, all persons entering 
the building must pass through a metal detector. All items brought to 
CMS, whether personal or for the purpose of demonstration or to support 
a presentation, are subject to inspection. Laptops and other computer 
equipment must be registered with the security desk upon entry. CMS 
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 
presentation. Participants should e-mail presentations to CMS prior to 
the meeting to ensure that CMS has a back-up copy in the event of 
computer problems or lack of software or memory card compatibility. 
Please note that CMS headquarters is a smoke-free facility.


    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: December 16, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-28153 Filed 12-29-04; 8:45 am]
BILLING CODE 4120-01-P