[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Notices]
[Pages 77031-77033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9838]



[[Page 77031]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1382-N]


Medicare Program; Town Hall Meeting on the Fiscal Year 2008 
Applications for New Medical Services and Technologies and 
Informational Workshop on Payment for New Technologies Under the 
Inpatient Prospective Payment System (IPPS) and the Outpatient 
Prospective Payment System (OPPS), Processes for Diagnosis-Related 
Group (DRG) Assignment; and Requesting New International Classification 
of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) Codes Under 
the IPPS--February 22, 2007 (CMS-1382-N)

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

ACTION: Notice of meetings.

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SUMMARY: This notice announces a Town Hall Meeting to discuss fiscal 
year (FY) 2008 applications for add-on payments for new medical 
services and technologies under the Inpatient Prospective Payment 
System (IPPS). Interested parties are invited to this meeting to 
present their comments, recommendations, and data regarding whether the 
FY 2008 new medical services and technologies applications meet the 
substantial clinical improvement criteria. Additionally, we will hold 
an Informational Workshop for all interested parties on the application 
process and criteria for new medical services and technologies add-on 
payments under the IPPS, the transitional pass-through payment and new 
technology ambulatory payment classification (APC) assignment 
application processes under the Outpatient Prospective Payment System 
(OPPS) and the processes of Diagnosis-Related Group (DRG) assignment 
and requesting new ICD-9 codes under the IPPS.

DATES: Meeting and Informational Workshop Date: Both the Town Hall 
Meeting and Informational Workshop will be held on Thursday, February 
22, 2007. The Informational Workshop will begin at 9 a.m. e.s.t. The 
Town Hall Meeting will begin at 1:30 p.m. e.s.t.
    Registration Deadline for All Participants for the Town Hall 
Meeting and the Informational Workshop: All participants must register 
by February 15, 2007.
    Registration Deadline for Presenters of the Town Hall Meeting: All 
presenters for the Town Hall Meeting, whether attending in person or by 
phone, must register and submit their agenda item(s) by February 6, 
2007.
    Comment Deadline for the Town Hall Meeting: Written comments for 
discussion at the Town Hall Meeting must be received by February 6, 
2007. All other written comments on whether the service or technology 
represents a substantial clinical improvement must be received by March 
9, 2007 for consideration before publication of the FY 2008 IPPS 
proposed rule.
    Agenda Item(s) Deadline for the Town Hall Meeting: Agenda items for 
the Town Hall Meeting must be received by February 6, 2007.

ADDRESSES: Meeting Location: The Information Workshop and 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.
    Registration and Special Accommodations: Individuals wishing to 
participate or who need special accommodations or both must register by 
completing the on-line registration located at [email protected] or 
by contacting Tiffany Swygert (410) 786-4642 or Michael Treitel at 
(410) 786-4552. Registration information may also be mailed to the New 
Technology Team, Division of Acute Care, Center for Medicare 
Management, Centers for Medicare & Medicaid Services, Mail stop C4-08-
06, 7500 Security Boulevard, Baltimore, MD 21244-1850 or faxed to the 
New Technology Team at (410) 786-0169.
    Written Comments for the Town Hall Meeting: We will accept written 
questions or other statements, not to exceed three single-spaced, typed 
pages that are received by the date specified in the ``DATES'' section. 
Written comments may be sent electronically to [email protected] 
(please make the subject of the e-mail new technology comments); sent 
via mail to the New Technology Team, Division of Acute Care, Center for 
Medicare Management, Centers for Medicare & Medicaid Services, Mail 
stop C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850; or 
sent via fax to the New Technology Team at (410) 786-0169.
    Agenda Item(s) for the Town Hall Meeting: Agenda items for the Town 
Hall Meeting regarding whether a FY 2008 application meets the 
substantial clinical improvement criteria may be sent by mail, fax, or 
electronically. Agenda items must be received by the date specified in 
the ``DATES'' section. Agenda item(s) may be sent electronically to 
[email protected] (please make the subject of the e-mail new 
technology agenda item(s)); sent via mail to the attention of the New 
Technology Team, Division of Acute Care, Center for Medicare 
Management, Centers for Medicare & Medicaid Services, Mail stop C4-08-
06, 7500 Security Boulevard, Baltimore, MD 21244-1850; or faxed to the 
New Technology Team at (410) 786-0169.

FOR FURTHER INFORMATION CONTACT: Tiffany Swygert, (410) 786-4642, 
[email protected]. Michael Treitel, (410) 786-4552, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Sections 1886(d)(5)(K) and (L) of 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 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 IPPS proposed (66 
FR 22693, May 4, 2001) and final rules (66 FR 46912, September 7, 2001) 
for a more detailed discussion.) In addition, we have further discussed 
our application of the criteria in the IPPS proposed and final rules 
for FYs 2003, 2004, 2005, 2006 and 2007. (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; 70 FR 47341, August 12, 2005; and 71 FR 
47994, August 18, 2006 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

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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:
    [Dagger] Reduced mortality rate with use of the device.
    [Dagger] Reduced rate of device-related complications.
    [Dagger] Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
    [Dagger] Decreased number of future hospitalizations or physician 
visits.
    [Dagger] More rapid beneficial resolution of the disease process 
treatment because of the use of the device.
    [Dagger] Decreased pain, bleeding, or other quantifiable symptoms.
    [Dagger] 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:
     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.
     Provide for a meeting at which organizations representing 
hospitals, physicians, manufacturers and any other interested parties 
may present comments, recommendations, and data to the clinical staff 
of CMS whether the service or technology represents a substantial 
improvement.
    The opinions and alternatives provided during this meeting will 
assist us as we evaluate the new medical services and technology 
applications for FY 2008. In addition, they will help us to evaluate 
our policy on the IPPS new technology add-on payment process.
    We note that for applications for add-on payments for new 
technologies for FY 2008, we initially set a deadline of October 15, 
2006 for an applicant to submit a formal request, including a full 
description of the clinical applications of the medical service, 
evidence that the new medical service or technology represents a 
substantial clinical improvement, and a significant sample of data 
demonstrating that the medical service or technology meets the high-
cost threshold. As announced on our Web site, http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp, we extended the 
October 15, 2006 deadline to December 30, 2006. Applicants must also 
submit a complete database demonstrating that the medical service or 
technology meets the high-cost threshold by December 30, 2006.

II. Informational Workshop and Town Hall Meeting Format

    In addition to, the statutorily-required Town Hall Meeting on 
whether an IPPS new technology application meets the substantial 
clinical improvement criteria, we will be holding an Informational 
Workshop on applying for special payment for new medical services and 
technologies under the IPPS and OPPS. Specifically, for new technology 
add-on payments under the IPPS, we will discuss each criterion in 
detail along with other information that will be helpful in guiding an 
applicant through the new technology add-on payment process. We will 
also discuss the processes of DRG assignment and requesting new ICD-9 
codes under the IPPS. (Information on DRGs can be found on the IPPS Web 
site at http://www.cms.hhs.gov/AcuteInpatientPPS/01_overview.asp#TopOfPage and information on ICD-9-CM coding can be found 
on our Web site at http://www.cms.hhs.gov/ICD9ProviderDiagnosticCodes/02_newrevisedcodes.asp.)
    In addition, to facilitate the public's knowledge of OPPS new 
technology application processes, the Informational Workshop will also 
include information on several processes for applying for special 
payment under the OPPS. One topic concerns the process and criteria for 
applying for a new category of devices for pass-through payment. 
Interested parties may apply for a new device category, in accordance 
with section 1833(t)(6) of the Act. As background information, we have 
posted application and process background information on our Web site 
at http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/catapp.pdf. 
Furthermore, under section 1833(t)(6) of the Act interested parties may 
also apply for transitional pass-through payment for certain new drugs, 
biological or radiopharmaceutical agents. As background information, we 
have posted application and process background information on our Web 
site, http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/drugapplication.pdf. Finally, we provide the opportunity for the public 
to apply for new services to be placed in new technology APC groups in 
the OPPS, in accordance with our criteria and discussion in our 
November 30, 2001 final rule (66 FR 59897). We plan to discuss all 
three of these OPPS application processes at the Informational Workshop 
that will be held on February 22, 2007.
    The Informational Workshop is open to all interested parties 
including organizations representing hospitals, physicians and 
manufacturers. We encourage all interested parties to attend, 
especially those who are not familiar with these processes. Individuals 
who want to attend this Informational Workshop must register by the 
date specified in the ``DATES'' section of this notice. Registration 
information is available below.
    For participants who cannot come to CMS for the meeting, an open 
toll-free phone line, (888) 577-8990, has been made available. If you 
are calling in, the operator will ask you for the conference code. The 
conference code is ``New Tech.''
    We are required to provide for a Town 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 whether the service or technology for 
which an application has been submitted for new technology add-on 
treatment under the IPPS represents a substantial improvement. This 
meeting will allow for a discussion of the substantial clinical 
improvement criteria to each of the FY 2008 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/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
    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 to 15 minutes and will be 
based on the number of registered presenters. Presenters will be

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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 the date 
specified in the ``DATES'' section. Once the agenda is completed, it 
will be posted on the IPPS Web site at http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage. 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, (888) 577-8990, has been made 
available. If you are calling in, the operator will ask you for the 
conference code. The conference code is ``New Tech.'' In addition, 
written comments will also be accepted and presented at the meeting if 
they are received by the date specified in the ``DATES'' section. 
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 the date specified in the 
``DATES'' section.

III. Registration Instructions

    The Division of Acute Care in CMS is coordinating the meeting 
registration for both the Informational Workshop and Town Hall Meeting. 
While there is no registration fee, individuals must register to attend 
the Town Hall Meeting on substantial clinical improvement and for the 
Informational Workshop (two separate registrations).
    Individuals may present their comments for the Town Hall Meeting 
either in person or by phone. These individuals must register and 
submit their agenda item(s) by the date specified in the ``DATES'' 
section. All other participants for the Town Hall Meeting must register 
by the date specified in the ``DATES'' section.
    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 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.

A. On-line Registration

    Registration may be completed on-line at the following Web address: 
http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage. Select the link ``Register to Attend the New 
Technology Town Hall Meeting'' and/or ``Register to attend the New 
Technology Informational Workshop.'' After completing the registration, 
on-line registrants should print the confirmation page and bring it 
with them to the meeting(s).

B. Registration by Phone, Fax or Mail

    Registration for both meetings may also be completed by contacting 
Tiffany Swygert at (410) 786-4642 or Michael Treitel at (410) 786-4552. 
Registration may also be completed by fax to the attention of the New 
Technology Team at (410) 786-0169. If registration is completed by 
phone fax or mail, please provide your name, address, and telephone 
number, meetings, which you are registering for Town Hall Meeting and/
or Informational Workshop and, if available, e-mail address and fax 
number. Please send mail in registration to address specified in the 
``ADDRESSES'' section.

IV. Security Information

    Because this meeting will be located on Federal property, for 
security reasons, any persons wishing to attend this Informational 
Workshop and Town Meeting must register by close of business on 
February 15, 2007. Individuals who have not registered in advance will 
not be allowed to enter the building to attend the meeting. Seating 
capacity is limited to the first 250 registrants.
    The on-site check-in for visitors will begin at 8:30 a.m. Please 
allow sufficient time to go through the security checkpoints. It is 
suggested that you arrive at central building by 8:30 a.m. so that you 
will have enough time to check-in before the session begins. 
Individuals that will only attend the Town Hall Meeting must check-in 
at 1 p.m. Security measures will include inspection of vehicles, inside 
and out, at the entrance to the grounds. In addition, all persons 
entering the building must check in by name, provide a government-
issued identification, and pass through a metal detector. All items 
brought to CMS, whether personal or for the purpose of demonstration or 
to support a presentation, including items such as laptops, cell 
phones, and palm pilots, are subject to physical inspection. 
Participants attending the Informational Workshop will be able to 
attend the Town Hall meeting without an additional check-in unless they 
exit the building. In this case, a participant will need to repeat the 
security check-in and procedures.

    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: November 30, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-9838 Filed 12-20-06; 8:45 am]
BILLING CODE 4120-01-P