Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Notices 44029

and respond to the facility’s plan of 

correction in a timely manner. 

—AAAASF’s 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 AAAASF’s staff and 

other resources, and its financial 

viability. 

—AAAASF’s capacity to adequately 

fund required surveys. 

—AAAASF’s policies with respect to 

whether surveys are announced or 

unannounced. 

—AAAASF’s agreement to provide us 

with a copy of the most current 

accreditation 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. 

V. Response to Comments and Notice 

Upon Completion of Evaluation 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Response to Comments and 

Notice Upon Completion of Evaluation’’

at the beginning of your comments.] 

Because of the large number of items 

of correspondence 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 

public comments we receive by the date 

and time specified in the DATES section 

of this preamble, and when we proceed 

with a final notice, we will respond to 

the public comments in the preamble to 

the document. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a final notice in the Federal 

Register announcing the result of our 

evaluation. 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget did not review 

this proposed notice. 

In accordance with Executive Order 

13132, we have determined that this 

proposed notice would not have a 

significant effect the rights of States, 

local, or tribal governments.

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: July 1, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare and 

Medicaid Services.

[FR Doc. 04–16431 Filed 7–22–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3112–NC2] 

RIN 0938–ZA49 

Medicare Program; Adjustment in 

Payment Amounts for New Technology 

Intraocular Lenses Furnished by 

Ambulatory Surgical Centers

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice with public comment 

period. 

SUMMARY: This notice with public 

comment period acknowledges receipt 

of materials submitted by entities 

requesting review of the appropriateness 

of the Medicare payment amount for 

new technology lenses furnished by 

Ambulatory Surgical Centers (ASCs). In 

response to the February 27, 2004 

Federal Register notice entitled 

‘‘Medicare Program; Calendar Year 2004 

Review of the Appropriateness of 

Payment Amounts for New Technology 

Intraocular Lenses (NTIOLs) Furnished 

by Ambulatory Surgical Centers’’ we 

received a total of three timely 

applications for review by the March 29, 

2004 public comment due date. Of the 

three received, one application was 

withdrawn by the requester. In this 

notice we summarize timely 

applications received and solicit public 

comments on the two intraocular lenses 

(IOL) under review.

DATES: To be assured consideration, 

comments regarding the intraocular 

lenses specified in this notice must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

August 23, 2004.

ADDRESSES: In commenting, please refer 

to file code CMS–3112–NC2. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments (attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word). 

2. By 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–3112–NC2, 

P.O. Box 8010, Baltimore, MD 21244–

8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. 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 telephone number (410) 786–

9994 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: Gay 

W. Burton, (410) 786–4564.

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome 

comments from the public on the 

appropriateness of the Medicare 

payment amount for new technology 

intraocular lenses furnished by an 

ambulatory surgical center (ASC) listed 

in section II of this notice. You can 

assist us by referencing the file code 

CMS–3112–NC2. 

Inspection of Public Comments: All 

public comments received before the 

close of the comment period are 

available for viewing by the public, 

including any personally identifiable or

44030 Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Notices 

confidential business information that is 

included in a comment. After the close 

of the comment period, we post all 

electronic comments received before the 

close of the comment period on our 

public web-site. Comments received 

timely will 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, please 

telephone (410) 786–9994.

This Federal Register document is 

available from the Federal Register

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. The Web-site address is: http://

www.gpoaccess.gov/fr/index.html. 

I. Regulatory Background 

On October 31, 1994, the Social 

Security Act Amendments of 1994 

(SSAA 1994) (Pub. L. 103–432) were 

enacted. Section 141(b) of SSAA 1994 

requires us to develop and implement a 

process under which interested parties 

may request, for a class of new 

technology intraocular lens (NTIOLs), a 

review of the appropriateness of the 

payment amount for intraocular lenses 

(IOLs) furnished by ASCs under section 

1833(i)(2)(A)(iii) of the Social Security 

Act (the Act). 

On June 16, 1999, we published a 

final rule in the Federal Register

entitled ‘‘Adjustment in Payment 

Amounts for New Technology 

Intraocular Lenses Furnished by 

Ambulatory Surgical Centers’’ (64 FR 

32198), which added subpart F to 42 

CFR part 416. The June 16, 1999 final 

rule established a process for adjusting 

payment amounts for NTIOLs furnished 

by ASCs; defined the terms relevant to 

the process; and established a flat rate 

payment adjustment of $50 for IOLs that 

we determine are NTIOLs. The payment 

adjustment applies for a 5-year period 

that begins when we recognize a 

payment adjustment for the first IOL in 

a new subset of an existing class of IOLs 

or a new class of technology, as 

explained below. Any subsequent IOLs 

with the same characteristics as the first 

IOL recognized for a payment 

adjustment will receive the adjustment 

for the remainder of the 5-year period 

established by the first recognized IOL. 

In accordance with the payment review 

process specified in § 416.185(f)(2), after 

July 16, 2002, the $50 adjustment 

amount can be modified through 

proposed and final rulemaking in 

connection with ambulatory surgical 

center services. To date however, we 

made no changes to the payment 

amount and have opted not to change 

the adjustment for calendar year 2004 

(CY 2004). 

II. Applications for New Technology 

Intraocular Lens (NTIOLs) for Calendar 

Year 2004 

On February 27, 2004, we published 

a notice in the Federal Register entitled 

‘‘Medicare Program; Calendar Year 2004 

Review of the Appropriateness of 

Payment Amounts for New Technology 

Intraocular Lenses (NTIOLs) Furnished 

by Ambulatory Surgical Centers (ASCs)’’

(69 FR 9322) to solicit requests for 

review of NTIOL applications. 

Three requests for review were 

submitted to us by the March 29, 2004 

public comment due date. Of the three 

timely applications submitted, one 

requester withdrew the application. We 

declined to accept an additional request 

for review, which was received after the 

March 29, 2004 comment due date, and 

lacked the required supporting 

documentation. We received the 

following timely review requests: 

1. Manufacturer: Alcon Laboratories, 

Inc. Model Numbers: ACRYSOF

Natural IOL; Models: SB30AL and 

SN60AT. 

Reason for Requesting Review: The 

manufacturer, Alcon Laboratories, Inc. 

indicates that the specified lenses are 

the first FDA-approved IOLs that filter 

light in a manner that approximates the 

human crystalline lens in the 400 to 475 

blue light wavelength range, thereby, 

mitigating the risk of blue lightmediated damage to the retina and may 

be considered as providing more stable 

postoperative vision. 

2. Manufacturer: Pharmacia & Upjohn 

Co. (A Subsidiary of Pfizer Inc.) Model 

Numbers: Tecnis, with Z-Sharp Optic 

Technology, Foldable Posterior 

Chamber IOL; Models Z9000 and Z9001. 

Reason for Requesting Review: The 

manufacturer, Pharmacia & Upjohn Co. 

indicates that these lenses are the first 

FDA-approved IOLs to use a modified 

prolate anterior optic surface in place of 

a conventional spherical optic. The 

manufacturer has also indicated that the 

Technis lens has demonstrated a 

significant reduction of ocular spherical 

aberration resulting in improved 

functional vision, particularly in low 

light conditions such as night driving, 

compared to conventional spherical 

optic IOLs. 

III. Collection of Information 

Requirements 

Because the requirements referenced 

in this notice will not affect 10 or more 

persons on an annual basis, this notice 

does not impose any information 

collection and record keeping 

requirements that are subject to review 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, 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 preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble of that document. 

V. Regulatory Impact Statement 

We have examined the impacts of this 

notice as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 16, 

1980, Pub. L. 96–354), section 1102(b) of 

the Act, the Unfunded Mandates Reform 

Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132.

Executive Order 12866, (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) directs agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). We 

have determined that this notice is not 

a major rule because it merely 

summarizes the timely applications 

received and solicits comments on IOLs 

under review. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and 

government agencies. Most hospitals 

and most other providers and suppliers 

are small entities, either by nonprofit 

status or by having revenues of $8.5 

million or less in any 1 year. We have 

determined that this notice will not 

affect small businesses. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a regulation may have 

a significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

Federal Register / Vol. 69, No. 141 / Friday, July 23, 2004 / Notices 44031

the provisions of section 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. We have 

determined that this notice does not 

have a significant impact on the 

operations of a substantial number of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in an expenditure 

in any 1 year by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. We have 

determined that this notice will not 

have a consequential effect on the 

governments mentioned or on the 

private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State, local, or 

tribal governments, preempts State law, 

or otherwise has Federalism 

implications. We have determined that 

this notice does not have an economic 

impact on State, local, or tribal 

governments. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget.

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh).

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program)

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—

Hospital Insurance; and Program No. 

93.774, Medicare—Supplementary 

Medical Insurance Program)

Dated: July 13, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–16659 Filed 7–22–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3142–NC] 

Medicare Program; Evaluation Criteria 

and Standards for Quality 

Improvement Program Contracts

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice with comment period.

SUMMARY: This notice describes the 

evaluation criteria we intend to use to 

evaluate the Quality Improvement 

Organizations (QIOs) under their 

contracts with CMS, for efficiency and 

effectiveness in accordance with the 

Social Security Act. These evaluation 

criteria are based on the tasks and 

related subtasks set forth in the QIO’s 

Scope of Work (SOW). The current 7th 

SOW includes Tasks 1 through 4, with 

subtasks included under all tasks, 

excluding Task 4. QIOs were awarded 

contracts for the 7th SOW, or 7th 

Round, for three years, with staggered 

starting dates beginning August 2002, 

November 2002, and February 2003.

DATES: To be assured of consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on August 23, 2004.

ADDRESSES: In commenting, please refer 

to file code CMS–3142–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments to http://

www.cms.hhs.gov/regulations/

ecomments or to www.regulations.gov

(attachments should be in Microsoft 

Word, WordPerfect, or Excel; however, 

we prefer Microsoft Word). 

2. By 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–3142–NC, 

P.O. Box 8016, Baltimore, MD 21244–

8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. 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 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:

Maria Hammel, (410) 786–1775.

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this notice with comment 

period to assist us in fully considering 

issues and developing policies. You can 

assist us by referencing the file code 

CMS–3142–NC and the specific ‘‘issue 

identifier’’ that precedes the section on 

which you choose to comment. 

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. After the close of the 

comment period, CMS posts all 

electronic comments received before the 

close of the comment period on its 

public website. Comments received 

timely will 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 (410) 

786–7195. 

I. Background 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘BACKGROUND’’ at the 

beginning of your comments.] 

The Peer Review Improvement Act of 

1982 (Title I, Subtitle C of Pub. L. 97–