[Federal Register Volume 69, Number 39 (Friday, February 27, 2004)]
[Rules and Regulations]
[Pages 9324-9326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1268-N]


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

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

ACTION: Notice of meeting.

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[[Page 9325]]

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) 2005 
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 2005 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 Monday, March 15, 2004 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 March 8, 2004.
    Registration Deadline for All Other Participants: All other 
participants must register by March 10, 2004.
    Comment Deadline: Written comments for discussion at the meeting 
must be received by March 8, 2004. All other written comments for 
consideration before publication of the IPPS proposed rule must be 
received by March 26, 2004.

ADDRESSES: The Town Hall meeting will be held in the Multipurpose Room 
in the central building of the Centers for Medicare and Medicaid 
Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    Agenda Item(s) or Written Comments: Agenda item(s) and written 
comments regarding whether a FY 2005 application(s) meet the 
substantial clinical improvement criterion may be sent by mail, fax, or 
electronically. Agenda item(s) must be received by March 8, 2004. We 
will accept written questions or other statements, not to exceed three 
single-spaced, typed pages that are received by March 26, 2004. 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, Fax: (410) 786-0169, [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 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 noted that we require the requester to submit 
evidence that the technology meets one or more of these criteria.
    Section 503 of the 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.
     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 2005. 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 2005 IPPS proposed rule.

II. Meeting Format

    This meeting will allow a discussion of the substantial clinical 
improvement criteria for each of the FY 2005 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/default.asp. 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. Therefore, individuals who want to be presenters must 
register and submit their agenda item(s) by Monday, March 8, 2004. Once 
the agenda is completed, it will be posted on the IPPS Web site at 
http://www.cms.hhs.gov/providers/hipps/default.asp. Comments from all 
participants will be heard (time

[[Page 9326]]

permitting) after the completion of the presentations.
    For presenters or participants that cannot come to CMS for the 
meeting, an open phone line, 1-877 357-7851, has been made available. 
If you are calling in, you will be prompted to enter the conference 
identification number, 5601867, or the name of the meeting. In 
addition, written comments will also be accepted and presented at the 
meeting if they are received by March 8, 2004. 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 26, 2004.

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 March 8, 2004. All other participants must register by March 10, 
2004. All registrants will receive confirmation with instructions for 
arrival at the CMS complex. 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/default.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 your confirmation 
of registration for the meeting. Access may be denied to persons 
without proper identification.
    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. 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.

    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: February 23, 2004.
Dennis G. Smith,
Acting Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. 04-4334 Filed 2-26-04; 8:45 am]
BILLING CODE 4120-01-P