Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices 71571 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: October 18, 2011. 

Patrick Conway, 

CMS Chief Medical Officer and Director, 

Office of Clinical Standards and Quality, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2011–29782 Filed 11–17–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1431–N] 

Medicare Program; Town Hall Meeting 

on FY 2013 Applications for New 

Medical Services and Technology AddOn Payments Under the Hospital 

Inpatient Prospective Payment System 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a town 

hall meeting in accordance with to 

discuss fiscal year (FY) 2013 

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 2013 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criterion. 

DATES: Meeting Date: The town hall 

Meeting will be held on Tuesday, 

February 14, 2012. The town hall 

meeting will begin at 9 a.m. eastern 

standard time (e.s.t.) and check-in will 

begin at 8:30 a.m. e.s.t. 

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 Monday, January 23, 2012. 

Deadline for Registration of All Other 

Participants for the Town Hall Meeting 

and Submitting Requests for Special 

Accommodations: All other participants 

must register by Tuesday, January 24, 

2012. Requests for special 

accommodations must be received no 

later than 5 p.m., e.s.t. on Tuesday, 

January 31, 2012. 

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 23, 2012. 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 March 6, 2012, for 

consideration before publication of the 

FY 2013 IPPS proposed rule. 

ADDRESSES: Meeting Location: The town 

hall meeting will 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 

2013 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 email to newtech@cms.hhs.gov 

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, 

michael.treitel@cms.hhs.gov, or 

Celeste Beauregard, (410) 786–8102, 

celeste.beauregard@cms.hhs.gov. 

Alternatively, you may forward your 

requests via email to 

newtech@cms.hhs.gov 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 Hospital 

Inpatient Prospective Payment System 

(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 FY 2002 IPPS 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. 

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71572 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices 

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 2013. 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 2013 

IPPS proposed rule. 

II. Town Hall Meeting Format 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 

clinical improvement. This meeting will 

allow for a discussion of the substantial 

clinical improvement criteria on each of 

the FY 2013 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. 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. Conference Call Information 

For participants who cannot come to 

CMS for the Town Hall Meeting, an 

open toll-free phone line, (877) 267– 

1577, has been made available. The 

conference code is ‘‘0638.’’ 

III. Registration Instructions 

The Division of Acute Care of CMS is 

coordinating the meeting registration for 

the Town Hall Meeting. While there is 

no registration fee, individuals must 

register to attend the Town Hall Meeting 

on substantial clinical improvement. 

Registration may be completed online 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’’. 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 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 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 CMS complex no later than 

8:30 a.m. e.s.t. if you are attending the 

Town Hall Meeting so that you will be 

able to arrive promptly for the 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, setup, 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 3, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–29832 Filed 11–17–11; 8:45 am] 

BILLING CODE 4120–01–P 

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