Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Notices 77031 

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. 

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 addon 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 DiagnosisRelated 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 


jlentini on PROD1PC65 with NOTICES
77032 Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Notices 

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) 

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 addon 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 highcost 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 passthrough 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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Notices 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 online. 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 online 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 checkin 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

AGENCY: Administration for Native 

Americans (ANA), HHS. 

ACTION: Notice of Public Comment on 

the Proposed Adoption of ANA Program 

Policies and Procedures; Correction 

SUMMARY: Pursuant to section 814 of the 

Native American Programs Act of 1974 

(the Act) 42 U.S.C. 2992b–1, ANA 

herein describes its proposed 

interpretive rules, statements of general 

policy and rules of agency procedure or 

practice in relation to the Social and 

Economic Development Strategies 

(hereinafter referred to as SEDS), Native 

Language Preservation and Maintenance 

(hereinafter referred to as Native 

Language), Environmental Regulatory 

Enhancement (hereinafter referred to as 

Environmental), Environmental 

Mitigation (hereinafter referred to as 

Mitigation), Improving the Well-Being 

of Children—Native American Health 

Marriage Initiative (hereinafter referred 

to as Healthy Marriage) programs and 

any Special Initiatives. Under the 

statute, ANA is required to provide 

members of the public an opportunity to 

comment on proposed changes in 

interpretive rules, statements of general 

policy and rules of agency procedure or 

practice and to give notice of the final 

adoption of such changes at least thirty 

(30) days before the changes become 

effective. This Notice also provides 

additional information about ANA’s 

plan for administering the programs. 

FOR FURTHER INFORMATION CONTACT: 

Sheila K. Cooper, Director of Program 

Operations, toll-free at (877) 922–9262. 

In the Federal Register Notice 

published on November 21, 2006 (Vol. 


jlentini on PROD1PC65 with NOTICES