[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62339-62342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1513-N]


Medicare Program; Town Hall Meeting on the Fiscal Year 2011 
Applications for New Medical Services and Technologies Add-on Payments 
and Informational Workshop on the Application Process and Criteria for 
New Medical Services and Technologies Add-on Payments

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

ACTION: Notice of meeting.

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SUMMARY: This notice announces a Town Hall meeting to discuss fiscal 
year (FY) 2011 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 2011 new medical services and technologies applications meet the 
substantial clinical improvement criterion.
    Additionally, this notice announces an Informational Workshop for 
all interested parties on the application process and criteria for new 
medical services and technologies under the IPPS and on the outpatient 
prospective payment system (OPPS) transitional pass-through payment for 
drugs, biologicals, and devices and new technology Ambulatory Payment 
Classification (APC) assignment for new services application processes.

DATES: Meeting Date: The Town Hall meeting and the Informational 
Workshop announced in this notice will be held on Wednesday, February 
10, 2010. The Informational Workshop will begin at 9 a.m., and check-in 
will begin at 8:30 a.m. eastern daylight time (e.d.t.). The Town Hall 
meeting will begin at 1 p.m. e.d.t. and check-in will begin at 12:30 
p.m. e.d.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 procedures and check-in.
    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 
26, 2010.
    Deadline for Registration of All Other Participants for the Town 
Hall Meeting, Participants of the Informational Workshop, and 
Submitting Requests for Special Accommodations: All other participants 
for the Town Hall Meeting and participants of the Informational 
Workshop must register by February 2, 2010. Requests for special 
accommodations must be received no later than 5 p.m., e.d.t. on 
February 2, 2010.

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 & 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 2010 application meets the substantial clinical improvement 
criterion. Agenda items or written comments, questions, or other 
statements must not exceed three single-spaced typed pages and must be 
sent to: Division of Acute Care, New Technology Team, Mailstop C4-07-
08, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850, Attention: Michael Treitel.
    Agenda items or written comments may also be sent via e-mail to 
[email protected].

FOR FURTHER INFORMATION CONTACT: 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 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

[[Page 62340]]

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). (For a more detailed discussion, see 
the FY 2002 proposed and final rules (66 FR 22693, May 4, 2001) and the 
final rule (66 FR 46912, September 7, 2001) 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).
    ++ 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 our clinical staff 
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 2011. 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 2011 IPPS proposed rule.

II. Town Hall Meeting and Informational Workshop Format

A. Town Hall Meeting Format

    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 will allow for a discussion of the substantial 
clinical improvement criteria as it relates to each of the FY 2011 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.
    For presenters or participants unable to attend the CMS for the 
meeting, an open toll-free phone line, (800) 603-1774, is available. 
Persons who call in will be asked for the conference code by the 
conference operator. The conference code is ``New Tech.''
    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 CMS 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 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/
)
    To facilitate the public's knowledge of OPPS application processes 
for transitional pass-through status of

[[Page 62341]]

drugs, biologicals and devices and assignment of new services to New 
Technology Ambulatory Payment Classification (APCs), 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, 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/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 
59897). As background information, we have posted application and 
process background information on our Web site, 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 10, 2010.
    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 in section III. of this notice.
    For participants who cannot come to CMS for the meeting, an open 
toll-free phone line, (800) 603-1774, has been made available. If you 
are calling in, the operator will ask you for the conference code. The 
conference code is ``New Tech.''
    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 will allow for a discussion of the substantial 
clinical improvement criteria on each of the FY 2011 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.
    For presenters or participants unable to attend the CMS for the 
meeting, an open toll-free phone line, (800) 603-1774, is available. 
Persons who call in will be asked for the conference code by the 
conference operator. The conference code is ``New Tech.''
    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 CMS 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.
    For participants who cannot come to CMS for the meeting, an open 
toll-free phone line, (800) 603-1774, has been made available. If you 
are calling in, the operator will ask you for the conference code. The 
conference code is ``New Tech.''

III. Registration Instructions

    The Division of Acute Care in CMS is coordinating 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 links at the bottom of the page ``Register to Attend the New 
Technology Town Hall meeting'' and ``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).
    If you are unable to register on-line, you may register by sending 
an email to the contacts listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice. Please include your name, address, telephone 
number, email 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 on 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.d.t. if you are attending the Informational 
Workshop and no later than 12:30 p.m. 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

[[Page 62342]]

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 30 to 
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 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 12, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. E9-27971 Filed 11-25-09; 8:45 am]
BILLING CODE 4120-01-P