[Federal Register: December 22, 2006 (Volume 71, Number 246)]
[Notices]
[Page 77031-77033]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de06-81]
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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 newtech@cms.hhs.gov 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 newtech@cms.hhs.gov
(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
newtech@cms.hhs.gov (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,
tiffany.swygert@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 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
[[Page 77032]]
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/[fxsp0
]AcuteInpatientPPS/[fxsp0]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/[fxsp0]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
[[Page 77033]]
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/[fxsp0]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