[Federal Register: February 27, 2004 (Volume 69, Number 39)]
[Page 9324-9326]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe04-60]
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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, 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 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