[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76315-76317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24022]


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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: [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) 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