[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Notices]
[Page 76315-76317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de05-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1329-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2007
Applications for New Medical Services and Technologies Add-On Payments
Under the Hospital Inpatient Prospective Payment System Scheduled for
February 16, 2006
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
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SUMMARY: This notice, in accordance with section 1886(d)(5)(K)(viii) of
the Social Security Act (the Act), announces a Town Hall meeting to
discuss fiscal year (FY) 2007 applications for add-on payments for new
medical services and technologies under the hospital inpatient
prospective payment system (IPPS). Interested parties are invited to
this meeting to present their individual comments, recommendations, and
data regarding whether the FY 2007 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 Thursday, February 16, 2006 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 8, 2006.
Registration Deadline for All Other Participants: All other
participants must register by February 13, 2006.
Comment Deadline: Written comments for discussion at the meeting
must be received by February 8, 2006. All other written comments for
consideration before publication of the hospital IPPS proposed rule
must be received by March 15, 2006.
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 Item(s) or Written Comments: Agenda items and written
comments regarding whether a FY 2007 application meets the substantial
clinical improvement criterion may be sent by mail, fax, or
electronically. Agenda items must be received by February 8, 2006. We
will accept written questions or other statements, not to exceed three
single-spaced, typed pages that are received by March 15, 2006. 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.
Email: newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Meredith Walz, (410) 786-9421,
meredith.walz@cms.hhs.gov. Michael Treitel, (410) 786-4552,
michael.treitel@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) of the Act 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 FY 2002 proposed rule (66 FR 22693, May 4, 2001) and
the FY 2002 final rule (66 FR 46912, September 7, 2001) for a more
detailed discussion.) In addition, we have further discussed our
application of the newness criteria in the hospital IPPS proposed and
final rules for FYs 2003, 2004, 2005, and 2006. (See 67 FR 31427, May
9, 2002; 67 FR 50009, August 1, 2002; 68 FR 27184, May 19, 2003; 68 FR
45385, August 1, 2003; 69 FR 28236, May 18, 2004; 69 FR 49000, August
11, 2004; 70 FR 23353, May 5, 2005; and 70 FR 47341, August 12, 2005
respectively).
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).
[[Page 76316]]
++ 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), Pub. L. 108-173, which added section
1886(d)(5)(K)(viii) to the Act, 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 individual 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 2007. In addition, they will help us to evaluate
our policy on the hospital IPPS new technology add-on payment process
before the publication of the FY 2007 hospital IPPS proposed rule.
II. Meeting Format
This meeting will allow for a discussion of the substantial
clinical improvement criteria to each of the FY 2007 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 are
interested in individual public comments on our application of the
concept of ``substantial similarity''. See the FY 2006 final rule (70
FR 47350-47352, August 12, 2005), for a detailed discussion of this
issue. Although we do not expect to have a general discussion of this
topic during the timeframe of the town hall meeting, we are inviting
individual comments as part of this town hall meeting notice. We will
accept comments on our application of the concept of ``substantially
similar'' by the deadline stated above so they may be considered in our
proposed rule. We will also solicit comments during the rulemaking
process.
The majority of the meeting will be reserved for individual
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 want to be presenters must register and submit their
agenda item(s) by Wednesday, February 8, 2006. Once the agenda is
completed, it will be posted on the hospital 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 who 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, 9386196, 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 8, 2006. 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, 2006.
III. Registration Instructions
The Division of Acute Care in CMS is coordinating the meeting
registration. While there is no registration fee, individuals must
register to attend. Individuals may present their comments either in
person or by phone at the town hall meeting. These individuals must
register and submit their agenda item(s) by February 8, 2006. All other
participants must register by February 13, 2006. 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 who plan to come to CMS, we prefer that these persons
register on-line. In addition, we would prefer that registrants who
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/events/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 the
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 staff
listed above prior to the meeting to ensure that CMS has a back-up copy
in the event of
[[Page 76317]]
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 1, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-24022 Filed 12-22-05; 8:45 am]
BILLING CODE 4120-01-P