Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices 57297 

the EMTALA TAG is to review 

regulations affecting hospital and 

physician responsibilities under 

EMTALA to individuals who come to a 

hospital seeking examination or 

treatment for medical conditions. 

FOR FURTHER INFORMATION CONTACT: 

Beverly J. Parker, (410) 786–5320. 

George Morey, (410) 786–4653. Press 

inquiries are handled through the CMS 

Press Office at (202) 690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 1866(a)(1)(I), 1866(a)(1)(N), 

and 1867 of the Social Security Act (the 

Act) impose specific obligations on 

Medicare-participating hospitals that 

offer emergency services. These 

obligations concern individuals who 

come to a hospital emergency 

department and request or have a 

request made on their behalf for 

examination or treatment for a medical 

condition. EMTALA applies to all these 

individuals, regardless of whether or not 

they are beneficiaries of any program 

under the Act. Section 1867 of the Act 

sets forth requirements for medical 

screening examinations for emergency 

medical conditions, as well as necessary 

stabilizing treatment or appropriate 

transfer. 

Regulations implementing the 

EMTALA legislation are set forth at 42 

CFR 489.20(l), (m), (q) and (r)(1), (r)(2), 

(r)(3), and 489.24. Section 945 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173), requires 

that the Secretary establish a Technical 

Advisory Group (TAG) for advice 

concerning issues related to EMTALA 

regulations and implementation. 

Section 945 of the MMA specifies that 

the EMTALA TAG—

• Shall review the EMTALA 

regulations; 

• May provide advice and 

recommendations to the Secretary 

concerning these regulations and their 

application to hospitals and physicians; 

• Shall solicit comments and 

recommendations from hospitals, 

physicians, and the public regarding 

implementation of such regulations; and 

• May disseminate information 

concerning the application of these 

regulations to hospitals, physicians, and 

the public. 

The EMTALA TAG, as chartered 

under the legal authority of section 945 

of the MMA, is also governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) (5 U.S.C. 

Appendix 2) for the selection of 

members and the conduct of all 

meetings. 

In the May 28, 2004 Federal Register 

(69 FR 30654), we specified the 

statutory requirements regarding the 

charter, general responsibilities, and 

structure of the EMTALA TAG. That 

notice also solicited nominations for 

members based on the statutory 

requirements for the EMTALA TAG. In 

the August 27, 2004 Federal Register 

(69 FR 52699), we solicited nominations 

again for members in two categories 

(patient representatives and a State 

survey agency representative) for which 

no nominations were received in 

response to the May 28, 2004 Federal 

Register notice. In the March 15, 2005 

Federal Register (70 FR 12691), we 

announced the inaugural meeting of the 

EMTALA TAG and the membership 

selection. That meeting was held on 

March 30 and 31, 2005. On May 18, 

2005 (70 FR 28541) we announced the 

second meeting of the EMTALA TAG 

with a purpose to hear public testimony 

and consider written responses from 

medical societies and other 

organizations on specific issues 

considered by the EMTALA TAG at its 

inaugural meeting. The second TAG 

meeting was held on June 15, 16, and 

17, 2005. 

On September 23, 2005, (70 FR 

55903), we announced the third meeting 

of the EMTALA TAG, for the purpose of 

enabling the EMTALA TAG to hear 

additional testimony and further 

consider written responses from 

medical societies and other 

organizations on specific issues 

considered by the TAG at previous 

meetings. The third TAG meeting is 

scheduled for October 26, 27, and 28, 

2005 

II. Selection of New EMTALA TAG 

Member 

In the March 15, 2005 Federal 

Register (70 FR 12691), we announced 

the EMTALA TAG membership. One of 

those original members, a hospital 

representative, has been unable to 

complete his term of service. To enable 

the TAG to continue to function as 

required by section 945 of the MMA and 

to ensure that the concerns of hospitals 

are appropriately considered during 

TAG deliberations, another member has 

been selected to serve as a hospital 

representative. The new member is Rory 

Jaffe, M.D., M.B.A., of the University of 

California/Davis Medical Center. Dr. 

Jaffe was selected from the original list 

of nominees for the EMTALA TAG. 

Authority: Section 945 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 23, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 05–19484 Filed 9–29–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3144–NC; 0938–ZA49] 

Medicare Program; Calendar Year 2005 

Review of the Appropriateness of 

Payment Amounts for New Technology 

Intraocular Lenses (NTIOLs) Furnished 

by Ambulatory Surgical Centers 

(ASCs) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with public comment 

period. 

SUMMARY: In this notice with public 

comment period, we announce the 

requests we have received from entities 

seeking review of the appropriateness of 

the Medicare payment amount for new 

technology lenses furnished by 

ambulatory surgical centers (ASCs). 

Interested parties submitted these 

requests for review in response to our 

May 27, 2005 Federal Register notice 

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).’’ We received 

one timely application for review by the 

June 27, 2005 due date listed in that 

Federal Register notice. In this notice 

with comment period, we summarize 

the timely application received and 

solicit public comments on the one 

intraocular lens (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 

October 31, 2005. 

ADDRESSES: In commenting, please refer 

to file code CMS–3144–NC. 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 notice to http:// 

57298 Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices 

www.cms.hhs.gov/regulations/ 

ecomments (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, Attn: CAPT Michael 

Lyman, CMS–3144–NC, Mail Stop 

C1–09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

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–

3144–NC, 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 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: 

Michael Lyman, (410) 786–6938. 

SUPPLEMENTARY INFORMATION: 

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)(1) of SSAA 1994 

required us to develop and implement 

a process under which interested parties 

may request, with respect to 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 (§ 416.185); defined the terms 

relevant to the process (§ 416.180); and 

established an initial flat rate payment 

adjustment of $50 for IOLs that we 

determined were NTIOLs 

(§ 416.185(f)(1)). As provided in section 

416.200, the payment adjustment 

applies for a 5-year period that begins 

when we recognize a payment 

adjustment for the first NTIOL. Any 

subsequent IOLs with the same 

characteristics as the first IOL 

recognized for a payment adjustment 

will receive the same payment 

adjustment for the remainder of the 5- 

year period established by the first 

recognized NTIOL (§ 416.200(b)). In 

accordance with the payment review 

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

July 16, 2002, we have authority to 

modify the $50 adjustment amount 

through proposed and final rulemaking 

in connection with ambulatory surgical 

center services. To date however, we 

have made no changes to the payment 

amount and have opted not to change 

the adjustment for calendar year 2005 

(CY 2005). 

We will classify an IOL as an NTIOL 

if the lens meets the definition of a 

‘‘new technology IOL’’ in 42 CFR 

416.180, which incorporates section 

141(b)(2) of SSAA 1994. Under that 

section, a ‘‘new technology IOL’’ is 

defined as ‘‘an IOL that CMS determines 

has been approved by the FDA for use 

in labeling and advertising the IOL’s 

claims of specific clinical advantages 

and superiority over existing IOLs with 

regard to reduced risk of intraoperative 

or postoperative complication or 

trauma, accelerated postoperative 

recovery, reduced induced astigmatism, 

improved postoperative visual acuity, 

more stable postoperative vision, or 

other comparable clinical advantages.’’

The process we use for evaluating 

requests for NTIOL designation and 

reviewing the appropriateness of the 

payment amount for an NTIOL 

furnished by ASCs is described in our 

regulations at 42 CFR part 416, subpart 

F and in the February 27, 2004 Federal 

Register notice. This process includes: 

(1) Publishing a public notice in the 

Federal Register identifying 

requirements and the deadline for 

submitting a request; (2) Processing 

requests to review the appropriateness 

of the payment amount for an IOL; (3) 

Compiling a list of the requests we 

receive that identify the IOL 

manufacturer, IOL model number under 

review, name of the requester, and a 

summary of the request for review of the 

appropriateness of the IOL payment 

amount; (4) Publishing an annual public 

notice in the Federal Register that lists 

the requests and provides for a 30-day 

public comment period; (5) Reviewing 

the information submitted with the 

applicant’s request for review, and 

requesting confirmation from the FDA 

about labeling applications that have 

been approved on the IOL model under 

review. We also request the FDA’s 

recommendations as to whether or not 

the IOL model submitted represents a 

new class of technology that sets it apart 

from other IOLs. Using a baseline of the 

date of the last determination of a new 

class of IOLs, the FDA states an opinion 

based on proof of superiority over 

existing lenses of the same type of 

material or over lenses providing 

specific clinical advantages and proof of 

superiority over existing IOLs as 

described in the preceding paragraph; 

(6) Determining which lenses meet the 

criteria to qualify for the payment 

adjustment based on clinical data and 

evidence submitted for review, the 

FDA’s analysis, public comments on the 

lenses, and other available information; 

(7) Designating a type of material or a 

predominant characteristic of an NTIOL 

that sets it apart from other IOLs to 

establish a new class; (8) Publishing a 

notice in the Federal Register 

announcing the IOLs that we have 

determined are ‘‘new technology’’ IOLs. 

These NTIOLs qualify for a $50 payment 

adjustment or the amount announced 

through proposed and final rules in 

connection with ASC services; and (9) 

Adjusting payments effective 30 days 

after the publication of the final notice 

announcing our determinations 

described in paragraph (8) of this 

section. 

II. Applications for New Technology 

Intraocular Lens (NTIOLs) for Calendar 

Year 2005 

On May 27, 2005 we published the 

first notice in the Federal Register 

entitled ‘‘Medicare Program; Calendar 

Year 2005 Review of the 

Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices 57299 

Appropriateness of Payment Amounts 

for New Technology Intraocular Lenses 

(NTIOLs) Furnished by Ambulatory 

Surgical Centers (ASCs)’’ to solicit 

requests for review of applications for a 

payment adjustment with respect to a 

class of NTIOLs. 

We received one request for the $50 

payment adjustment by the June 27, 

2005 due date specified in the notice: 

Manufacturer and Requestor: 

Advanced Medical Optics (AMO); 1700 

E. St. Andrew Place; P.O. Box 25162; 

Santa Ana, California 92799–5162. 

Model Numbers: Tecnis Models 

Z9000, Z9001 and Z9003. 

Reason for Requesting Review: The 

requestor states that the Tecnis IOLs 

were designed to improve contrast 

sensitivity, reduce ocular spherical 

aberration, and improve the functional 

vision of cataract surgery patients with 

implanted IOLs. 

Tecnis Models Z9000 and Z9001 

were previously submitted for NTIOL 

designation in calendar year 2004 and 

were determined by CMS to be 

ineligible for NTIOL designation due to 

a lack of evidence that the design 

improvements provided a clinical 

benefit to patients. AMO has 

resubmitted its NTIOL request and 

provided additional information on the 

clinical relevance of increased contrast 

sensitivity. AMO provided FDAapproved product labeling claiming 

improved functional vision compared 

with another IOL. AMO also provided 

additional studies, a meta-analysis, and 

justification of the choice of comparator 

lens that were not included in the 

previous 2004 NTIOL application. 

Submitting Comments: We welcome 

comments from the public on the 

appropriateness of the Medicare 

payment amount for the Tecnis’ IOLs 

listed in this notice with public 

comment period. You can assist us by 

referencing the file code CMS–3144–NC. 

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 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 from 8:30 a.m. to 4 p.m. Please 

contact us by phone at (800) 743–3951 

to schedule an appointment to view 

public comments associated with this 

notice. 

Copies: You can view and photocopy 

this Federal Register document at most 

libraries designated as Federal 

Depository Libraries and at many other 

public and academic libraries 

throughout the country that receive the 

Federal Register. 

This Federal Register document is 

also 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.access.gpo.gov/fr/index.html. 

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 to that document. 

III. Regulatory Impact Statement 

We have examined the impact 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 small 

governmental jurisdictions. 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 

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: Sections 1832(a)(2)(F)(i) (42 

U.S.C. 1395k(a)(2)(F)(i)) and 1833(i)(2)(A)(iii) 

(42 U.S.C. 1395l(i)(2)(A)(iii)) of the Social 

Security Act, and Section 141(b) of the Social 

Security Act Amendments of 1994, Pub. L. 

103–432). 

(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: September 23, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 05–19483 Filed 9–29–05; 8:45 am] 

BILLING CODE 4120–01–P