[Federal Register: December 30, 2004 (Volume 69, Number 250)]
[Notices]
[Page 78466-78468]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de04-84]
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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: newtech@cms.hhs.gov
FOR FURTHER INFORMATION CONTACT: Meredith Walz, (410) 786-9421,
mwalz@cms.hhs.gov; Michael Treitel, (410) 786-4552,
mtreitel@cms.hhs.gov.
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