4584 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices 

Annually; Affected Public: State, Local 

or Tribal Government; Number of 

Respondents: 56; Total Annual 

Responses: 56; Total Annual Hours: 

1,568. 

4. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Rehabilitation 

Unit Criteria Work Sheet and 

Rehabilitation Hospital Criteria Work 

Sheet and Supporting Regulations at 42 

CFR 488.26; Form Number: CMS–437A 

and CMS–437B (OMB#: 0938–NEW—

NOTE: These instruments are currently 

approved under 0938–0358 but are 

being carved out into a separate 

collection as they are updated more 

frequently.); Use: The rehabilitation 

hospital and rehabilitation unit criteria 

work sheets are necessary to verify that 

these facilities/units comply and remain 

in compliance with the exclusion 

criteria for the Medicare prospective 

payment system; Frequency: Annually; 

Affected Public: Business or other-forprofit, Not-for-profit institutions, and 

State, Local, or Tribal Government; 

Number of Respondents: 1227; Total 

Annual Responses: 1227; Total Annual 

Hours: 306.75. 

To obtain copies of the supporting 

statement and any related forms for 

these paperwork collections referenced 

above, access CMS Web site address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB Desk Officer at 

the address below, no later than 5 p.m. 

on February 27, 2006. OMB Human 

Resources and Housing Branch, 

Attention: Brenda Aguilar, CMS Desk 

Officer, New Executive Office Building, 

Room 10235, Washington, DC 20503. 

Dated: January 12, 2006. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 06–605 Filed 1–26–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10173] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Agency: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Individuals 

Authorized Access to the CMS 

Computer Services; Form Number: 

CMS–10173 (OMB#: 0938–NEW); Use: 

The Centers for Medicare and Medicaid 

Services (CMS) is requesting the Office 

of Management and Budget (OMB) 

approval of the Individuals Authorized 

to Customer Service Application for 

Access to CMS Computer Systems. CMS 

has planned to provide a centralized 

user provisioning and administration 

service that supports the creation, 

deletion, and lifecycle management of 

enterprise identities. This service 

creates accounts, supports Role Based 

Access Control (RBAC), the form flow 

approval process and enterprise identity 

audit and recertification, and provides 

business application integration points. 

An application integration point allows 

business application owners to use the 

form flow process of the user 

provisioning service to approve or deny 

requests for access to business 

applications. The primary purpose of 

this system is to implement a unified 

framework for managing user 

information and access rights, for those 

individuals who apply for and are 

granted access across multiple CMS 

systems and business contexts. 

Information in this system will also be 

used to: (1) Support regulatory and 

policy functions performed within the 

Agency or by a contractor or consultant; 

(2) support constituent requests made to 

a Congressional representative; and (3) 

to support litigation involving the 

Agency related to this system.; 

Frequency: Other—As required; 

Affected Public: Business or other-forprofit, Individuals or Households, Notfor-profit institutions, Federal 

government, and State, local, or tribal 

government; Number of Respondents: 

60,000,000; Total Annual Responses: 

60,000,000; Total Annual Hours: 

15,000,000. 

To obtain copies of the supporting 

statement and any related forms for 

these paperwork collections referenced 

above, access CMS Web Site address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB Desk Officer at 

the address below, no later than 5 p.m. 

on February 27, 2006. OMB Human 

Resources and Housing Branch, 

Attention: Carolyn Lovett, CMS Desk 

Officer, New Executive Office Building, 

Room 10235, Washington, DC 20503. 

Dated: January 18, 2006. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 06–717 Filed 1–26–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–2228–PN] 

Medicare and Medicaid Programs; 

Application by the TU ̈ V Healthcare 

Specialists for Deeming Authority for 

Hospitals 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the TU ̈ V Healthcare 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices 4585 

Specialists for deeming authority for 

hospitals that wish to participate in the 

Medicare and Medicaid programs. 

Section 1865(b)(3)(A) of the Social 

Security Act requires that within 60 

days of receipt of an organization’s 

complete application, we publish a 

notice that identifies the national 

accrediting body making the request, 

describes the nature of the request, and 

provides at least a 30-day public 

comment period. 

DATES: We will consider comments if 

we receive them at the appropriate 

address, as provided below, no later 

than 5 p.m. on February 27, 2006. 

ADDRESSES: In commenting, please refer 

to file code CMS–2228–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/regulations/ 

eRulemaking. Click on the link ‘‘Submit 

electronic comments on CMS 

regulations with an open comment 

period.) (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–2228–

PN, P.O. Box 8018, Baltimore, MD 

21244–8018. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–2228-PN, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call Yolanda Hayes at telephone 

number (410) 786–7195 in advance to 

schedule your arrival with one of our 

staff members. Room 445–G, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201; or 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Amber Wolfe, (410) 786–6773. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering issues and 

developing policies. You can assist us 

by referencing the file code CMS–2228–

PN. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://www.cms.hhs.gov/ 

regulations/eRulemaking. Click on the 

link ‘‘Electronic Comments on CMS 

Regulations’’ on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a hospital provided certain 

requirements are met. The regulations 

specifying the Medicare conditions of 

participation (CoPs) for hospitals are 

located in 42 CFR part 482. These 

conditions implement section 1861(e) of 

the Social Security Act (the Act), which 

specifies services covered as hospital 

care and the requirements that a 

hospital must meet in order to 

participate in the Medicare program. 

Regulations concerning provider 

agreements are at 42 CFR part 489, and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488. 

Generally, in order to enter into an 

agreement with CMS, a hospital must 

first be certified by a State survey 

agency as complying with the CoPs set 

forth in part 482 of our regulations. 

Thereafter, the hospital is subject to 

regular surveys by a State survey agency 

to determine whether it continues to 

meet these requirements. There is an 

alternative, however, to surveys by State 

agencies. 

Section 1865(b)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization that 

all applicable Medicare conditions are 

met or exceeded, we will ‘‘deem’’ those 

provider entities as having met the 

requirements. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accreditation organization applying for 

approval of deeming authority under 

part 488, subpart A must provide us 

with reasonable assurance that the 

accreditation organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare CoPs. 

Accreditation by an accreditation 

organization is voluntary and is not 

required for Medicare participation. 

The Joint Commission on 

Accreditation of Healthcare 

Organizations (JCAHO) and the 

American Osteopathic Association 

(AOA) are currently the only approved 

national accreditation organizations for 

hospitals. 

II. Approval of Deeming Organizations 

Section 1865(b)(2) of the Act and our 

regulations at § 488.8(a) require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accreditation organization’s 

requirements for accreditation; survey 

procedures; resources for conducting 

required surveys; capacity to furnish 

information for use in enforcement 

activities; monitoring procedures for 

provider entities found not in 

compliance with the conditions or 


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requirements; and ability to provide us 

with the necessary data for validation. 

Section 1865(b)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accreditation 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from our receipt of 

a completed application to publish 

approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of our 

consideration of the TU ̈ V Healthcare 

Specialists’ (TU ̈ VHS’) request to become 

a national accreditation organization for 

hospitals. This notice also solicits 

public comment on the ability of 

TU ̈ VHS requirements to meet or exceed 

the Medicare CoPs for hospitals. 

III. Evaluation of Deeming Authority 

Request 

On December 2, 2005, the TU ̈ V 

Healthcare Specialists (TU ̈ VHS) 

submitted all the necessary materials to 

enable us to make a determination 

concerning its request for approval as a 

deeming organization for hospitals. 

Under section 1865(b)(2) of the Act and 

our regulations at § 488.8 (Federal 

review of accreditation organizations), 

our review and evaluation of TU ̈ VHS 

will be conducted in accordance with, 

but not necessarily limited to, the 

following factors: 

• The equivalency of TU ̈ VHS’

standards for hospitals as compared 

with our comparable hospital CoPs. 

• TU ̈ VHS’ survey process to 

determine the following: 

—The composition of the survey team, 

surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

—The comparability of TU ̈ VHS’

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

—TU ̈ VHS’ processes and procedures for 

monitoring providers or suppliers 

found out of compliance with 

TU ̈ VHS’ program requirements. These 

monitoring procedures are used only 

when TU ̈ VHS identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the survey agency monitors 

corrections as specified at § 488.7(d). 

—TU ̈ VHS’ capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

—TU ̈ VHS’ capacity to provide us with 

electronic data in ASCII comparable 

code, and reports necessary for 

effective validation and assessment of 

the organization’s survey process. 

—The adequacy of TU ̈ VHS’ staff and 

other resources, and its financial 

viability. 

—TU ̈ VHS’ capacity to adequately fund 

required surveys. 

—TU ̈ VHS’ policies with respect to 

whether surveys are announced or 

unannounced. 

—TU ̈ VHS’ agreement to provide us with 

a copy of the most current ac 

creditation survey together with any 

other information related to the 

survey as we may require (including 

corrective action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

V. Response to Public Comments and 

Notice Upon Completion of Evaluation 

Because of the large number of 

comments we normally receive on 

Federal Register documents published 

for comment, we are not able to 

acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this proposed notice. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this proposed 

notice, we will publish a final notice in 

the Federal Register responding to the 

public comments and announcing the 

result of our evaluation. 

VI. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this proposed 

notice was not reviewed by the Office of 

Management and Budget. 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: January 20, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare and 

Medicaid Services. 

[FR Doc. 06–748 Filed 1–26–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–3144–FN] 

0938–ZA49 

Medicare Program; Approval of 

Adjustment in Payment Amounts for 

New Technology Intraocular Lenses 

Furnished by Ambulatory Surgical 

Centers 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: In this final notice we 

respond to public comments on our 

September 30, 2005 notice with 

comment period and announce our 

decision concerning an application 

submitted by Advanced Medical Optics 

(AMO) to adjust the Medicare payment 

amounts for certain intraocular lenses 

(IOLs) on the basis that they are new 

technology intraocular lenses (NTIOLs). 

This is the third of three statutorily 

required Federal Register documents. 

On May 27, 2005, we published a notice 

in the Federal Register entitled 

‘‘Medicare Program; Calendar Year 2005 

Review of the Appropriateness of 

Payment Amounts for New Technology 

Intraocular Lenses (NTIOLs) Furnished 

by Ambulatory Surgical Centers (ASCs)’’

(70 FR 30731) that solicited interested 

parties to submit requests for review of 

the appropriateness of the payment 

amount for an IOL furnished by an 

ambulatory surgical center. On 

September 30, 2005, we published a 

notice with comment period entitled 

‘‘Medicare Program; Calendar Year 2005 

Review of the Appropriateness of 

Payment Amounts for New Technology 

Intraocular Lenses (NTIOLs) Furnished 

by Ambulatory Surgical Centers (ASCs)’’

(70 FR 57297) acknowledging timely 

receipt of one application. In this final 

notice, we announce our decision to 

approve the NTIOL application 

submitted by Advanced Medical Optics 

(AMO) for Tecnis (model numbers 

Z9000, Z9001, and Z9003). 

EFFECTIVE DATE: This notice is effective 

on February 27, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Michael Lyman, (410) 786–6938. 

SUPPLEMENTARY INFORMATION:

I. Background 

On October 31, 1994, the Social 

Security Act Amendments of 1994 

(SSAA 1994) (Pub. L. 103–432) were 

enacted. Section 141(b)(1) of SSAA 1994 

required us to develop and implement 


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