[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73091-73094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1342-N]


Medicare Program; Town Hall Meeting on the Fiscal Year 2012 
Applications for Add-on Payments for New Medical Services and 
Technologies Under the Hospital Inpatient Prospective Payment System 
and Informational Workshop on the Application Process and Criteria for 
Add-on Payments for New Medical Services and Technologies Under the 
Inpatient and Outpatient Prospective Payment Systems

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

ACTION: Notice of meeting.

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SUMMARY: This notice announces a Town Hall meeting in accordance with 
section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to 
discuss fiscal year (FY) 2012 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 comments, recommendations, and data 
regarding whether the FY 2012 new medical services and technologies 
applications meet the substantial clinical improvement criterion.
    Additionally, we will hold an Informational Workshop for all 
interested parties on the application process and criteria for add-on 
payments for new medical services and technologies under the IPPS and 
the application processes for the outpatient prospective payment system 
(OPPS) transitional pass-through payment for drugs, biological, and 
devices and new technology ambulatory payment classification (APC) 
group assignments for new services.

DATES: Meeting Date: Both the Town Hall Meeting and Informational 
Workshop announced in this notice will be held on Wednesday, February 
2, 2011. The Informational Workshop will begin at 9 a.m., and check-in 
will begin at 8:30 a.m. eastern standard time (e.s.t.). The Town Hall 
Meeting will begin at 1 p.m. e.s.t. and check-in will begin at 12:30 
p.m. e.s.t. Only one check-in is required to enter the building. 
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

[[Page 73092]]

procedures and check-in again for the Town Hall Meeting.
    Deadline for Registration of 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 January 
19, 2011.
    Deadline for Registration of All Other Participants for the Town 
Hall Meeting and the Informational Workshop and Submitting Requests for 
Special Accommodations: All other participants must register by January 
24, 2011. Requests for special accommodations must be received no later 
than 5 p.m., e.s.t. on January 24, 2011.
    Deadline for Submission of Agenda Item(s) or Written Comments for 
the Town Hall Meeting: Written comments and agenda items for discussion 
at the Town Hall Meeting must be received by January 19, 2011. In 
addition to materials submitted for discussion at the Town Hall 
Meeting, individuals may submit other written comments, as specified in 
the ADDRESSES section of this notice, on whether the service or 
technology represents a substantial clinical improvement. These 
comments must be received by February 16, 2011, for consideration 
before publication of the FY 2012 IPPS proposed rule.

ADDRESSES: Meeting Location: The Town Hall Meeting and Informational 
Workshop will both be held in the main Auditorium in the central 
building of the Centers for Medicare and Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    Registration and Special Accommodations: Individuals wishing to 
participate in the meeting must register by following the on-line 
registration instructions located in section III. of this notice or by 
contacting staff listed in the FOR FURTHER INFORMATION CONTACT section 
of this notice. Individuals who need special accommodations should 
contact staff listed in the FOR FURTHER INFORMATION CONTACT section of 
this notice. Registration information and special accommodation 
requests may also be mailed to the address listed in the ADDRESSES 
section of this notice.
    Submission of Agenda Item(s) or Written Comments for the Town Hall 
Meeting: Each presenter must submit an agenda item(s) regarding whether 
a FY 2012 application meets the substantial clinical improvement 
criterion. Agenda items, written comments, questions or other 
statements must not exceed three single-spaced typed pages and may be 
sent via e-mail to [email protected] or sent via regular mail to:
    Division of Acute Care, New Technology Team, Mailstop C4-08-06, 
Centers for Medicare and Medicaid Services, 7500 Security Boulevard, 
Baltimore Maryland 21244-1850, Attention: Michael Treitel or Celeste 
Beauregard.

FOR FURTHER INFORMATION CONTACT: Michael Treitel, (410) 786-4552, 
[email protected], or Celeste Beauregard, (410) 786-8102, 
[email protected]. Alternatively, you may forward your 
requests via e-mail to [email protected] or regular mail as specified 
in the ADDRESSES section of this notice.

SUPPLEMENTARY INFORMATION:

I. Background on the Add-On Payments for New Medical Services and 
Technologies Under the IPPS

    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 to acute care hospitals 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 requires 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 final rule (66 FR 46912, September 7, 2001) 
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 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).
    ++ 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) amended section 1886(d)(5)(K)(viii) of 
the Act to revise 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 before publication of a proposed rule.
     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 party may 
present comments, recommendations, and data to the clinical staff of 
CMS as to whether the service or technology represents a substantial 
improvement before publication of a proposed rule.
    The opinions and alternatives provided during this meeting will 
assist us as we evaluate the new medical services and technology 
applications for FY 2012. 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 2012 IPPS proposed rule.

[[Page 73093]]

II. Town Hall Meeting and Informational Workshop Formats and Conference 
Calling Information

A. Format of the Town Hall Meeting

    As noted in section I. of this notice, we are required to 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 
concerning whether the service or technology represents a substantial 
improvement. This meeting will allow for a discussion of the 
substantial clinical improvement criteria on each of the FY 2012 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 presentations of 
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 would like to present must register and submit their 
agenda item(s) to the address specified in the ADDRESSES section of 
this notice by the date specified in the DATES section of this notice. 
Comments from participants will be heard after scheduled statements if 
time permits. Once the agenda is completed, it will be posted on the 
CMS IPPS Web site at http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
    In addition, written comments will also be accepted and presented 
at the meeting if they are received at the address specified in the 
ADDRESSES section of this notice by the date specified in the DATES 
section of this notice. Written comments may also be submitted after 
the meeting for our consideration. If the comments are to be considered 
before the publication of the proposed rule, the comments must be 
received at the address specified in the ADDRESSES section of this 
notice by the date specified in the DATES section of this notice.

B. Informational Workshop 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 diagnosis-related group (DRG) assignment 
and requesting new ICD-9-CM 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/.
    In addition, to facilitate the public's knowledge of the OPPS 
application processes for transitional pass-through status of drugs, 
biologicals, and devices and assignment of new services to new 
technology ambulatory payment classification (APC) groups, the 
Informational Workshop will also include information on several 
processes for applying for special payment under the OPPS. One topic 
concerns the process for applying for a new category of devices for 
pass-through payment and criteria for evaluation. 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/04_passthrough_payment.asp#TopOfPage.
    Furthermore, under section 1833(t)(6) of the Act interested parties 
may also apply for transitional pass-through payment for certain new 
drugs and biologicals. As background information, we have posted 
application and process background information on our Web site at 
http://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage.
    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 9897 through 59903). As background information, we 
have posted application and process background information on our Web 
site at http://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage. We plan to discuss all three of these OPPS 
application processes at the Informational Workshop that will be held 
on February 2, 2011.
    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.

C. Conference Call Information

    For participants who cannot come to CMS for the Informational 
Workshop or the Town Hall Meeting, an open toll-free phone line, (877) 
267-1577, has been made available. The conference code is ``0400.''

III. Registration Instructions

    The Division of Acute Care in CMS is coordinating the meeting 
registration for both the Town Hall Meeting and the Informational 
Workshop. 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).
    Registration may be completed on-line at the following Web address: 
http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage. 
Select the link at the bottom of the page ``Register to Attend the New 
Technology Town Hall Meeting'' or ``Register to Attend the New 
Technology Informational Workshop''. After completing the registration, 
on-line registrants should print the confirmation page(s) and bring it 
with them to the meeting(s).
    If you are unable to register on-line, you may register by sending 
an e-mail to the contacts listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice. Please include your name, address, telephone 
number, e-mail address and fax number. If seating capacity has been 
reached, you will be notified that the meeting has reached capacity.

IV. Security, Building, and Parking Guidelines

    Because these meetings will be located on Federal property, for 
security reasons, any persons wishing to attend these meetings must 
register by close of business by the date listed in the DATES section 
of this notice. Please allow sufficient time to go through the security 
checkpoints. It is suggested that you arrive at 7500 Security Boulevard 
no later than 8:30 a.m. e.s.t. if you are

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attending the Informational Workshop and no later than 12:30 p.m. 
e.s.t. if you are attending the Town Hall Meeting so that you will be 
able to arrive promptly at the appropriate meeting.
    Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
     Interior and exterior inspection of vehicles (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Passing through a metal detector and inspection of items 
brought into the building. We note that all items brought to CMS, 
whether personal or for the purpose of demonstration or to support a 
demonstration, are subject to inspection. We 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 demonstration.

    Note:  Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meetings. The public may not enter the building earlier than 45 
minutes prior to the convening of the meeting(s).

    All visitors must be escorted in areas other than the lower and 
first floor levels in the Central Building. Seating capacity is limited 
to the first 250 registrants.

    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: November 18, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-29989 Filed 11-26-10; 8:45 am]
BILLING CODE 4120-01-P