Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68931

Volume 69, Number 215, pages 64762–

64769. 

The notice is amended as follows: On 

page 64765, second column, Section 

IV.2, line 4, delete ‘‘Maximum number 

of pages: 25 pages’’ and replace with 

‘‘Maximum number of pages: 2 pages.’’

Dated: November 19, 2004. 

Alan A. Kotch, 

Acting Deputy Director, Procurement and 

Grants Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–26184 Filed 11–24–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5011–WN] 

Medicare and Medicaid Programs; 

Notice of Withdrawal of the Solicitation 

of Proposals for the Private, for-Profit 

Demonstration Project for the Program 

of All-Inclusive Care for the Elderly 

(PACE)

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Withdrawal notice.

SUMMARY: This document withdraws the 

‘‘Notice for the Solicitation of Proposals 

for the Private, For-Profit Demonstration 

Project for the Program of All-Inclusive 

Care for the Elderly (PACE)’’ published 

in the Federal Register on August 10, 

2001. That notice solicited proposals 

from private, for-profit organizations for 

a fully captitated joint Medicare and 

Medicaid demonstration. The goal of the 

solicitation notice was to determine 

whether the risk-based long-term care 

model employed by the nonprofit PACE 

could be replicated successfully by forprofit organization.

EFFECTIVE DATE: March 28, 2005.

FOR FURTHER INFORMATION CONTACT:

Michael Henesch, (410) 786–6685.

SUPPLEMENTARY INFORMATION:

I. Background 

Section 4804(a)(2) of the Balance 

Budget Act of 1997 (BBA) requires us to 

conduct a study to compare the costs, 

quality, and access to services provided 

by for-profit entities to those of 

nonprofit Program of All-Inclusive Care 

for the Elderly providers (PACE). 

Section 4801(h)(2)(A) of the BBA states 

that the terms and conditions for the forprofit PACE must be the same as those 

for PACE providers that are nonprofit, 

private organizations except that only 

10 waivers may be granted. 

On August 10, 2001, we published a 

notice in the Federal Register (66 FR 

42229). The notice solicited proposals 

from for-profit entities to demonstrate 

that they could successfully provide 

comprehensive coordinated care for the 

frail elderly under a prepaid fully 

capitated payment system. The 

solicitation notice specified that we 

would consider proposals only from forprofit organizations and the 

demonstration would operate for 3 

years. 

II. Provisions of the Notice 

This notice withdraws the solicitation 

notice that we published in the Federal 

Register on August 10, 2001. As 

specified in the solicitation notice, we 

would consider proposals only from forprofit organizations and the 

demonstration would operate for 3 

years. Before submitting a proposal, all 

interested applicants were to submit 

letters of intent. We indicated that 

proposals would be accepted until 10 

sites were awarded. Following the 

selection of 10 sites, organizations that 

had submitted letters of intent, but had 

not yet submitted proposals, would be 

notified that the limit of approved sites 

had been reached. 

Since the publication of the 

solicitation notice, we received only ten 

letters of intent. Of these 10 letters of 

intent, 8 were received in 2001 and 

early 2002, 1 was received in February 

2003, and 1 was received in August 

2003. Although we have provided 

information to numerous organizations 

including having discussions with the 

organizations that have submitted letters 

of intent, we have not received any 

proposals. We have also contacted the 

two most recent organizations that have 

submitted letters of intent to offer 

technical assistance and have 

ascertained that only one organization 

has considered submitting a proposal. In 

addition, we have been informed by the 

National PACE Association, that it has 

consulted with organizations that have 

not submitted letters of interest. 

Although the demonstration is 

mandated by the BBA, since CMS has 

not received any proposals that it could 

fund under the authority of the BBA, we 

are withdrawing our solicitation. 

The need to keep abreast of regulatory 

provisions of the nonprofit PACE 

requires us to attend all PACE meetings, 

since the for-profit PACE demonstration 

would mirror nonprofit PACE policy. In 

the nearly 3 years since the 

implementation of the solicitation 

notice, the effort to maintain this level 

of activity has been extensive. With the 

enactment of the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (Pub. L. 108–173), we 

believe that our resources can better be 

utilized in addressing other workloads, 

including various studies, and other 

efforts related to the start-up of new 

programs and benefits. Furthermore, we 

believe it is unlikely that we will 

receive a proposal for a for-profit PACE 

demonstration. Therefore, we are 

withdrawing the August 10, 2001, 

solicitation notice. 

This notice is intended to withdraw 

the solicitation by March 28, 2005. This 

withdrawal notice provides an 

opportunity for organizations that 

remain interested to submit proposals 

until that time. 

III. 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.

Authority: Section 1894(h) and 1934(h) of 

the Social Security Act (42 U.S.C. 1395)

(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: September 10, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–25980 Filed 11–24–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2202–FN] 

Medicare and Medicaid Programs; 

Approval of Application for Deeming 

Authority for Ambulatory Surgical 

Centers by the American Association 

for Accreditation of Ambulatory 

Surgery Facilities, Inc.

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Final notice.

SUMMARY: This final notice announces 

the approval of an application from the 

American Association for Accreditation 

of Ambulatory Surgery Facilities, Inc., 

(AAAASF) for continued recognition as 

a national accrediting organization for 

ambulatory surgical centers (ASCs) that 

request participation in the Medicare or

68932 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 

Medicaid programs. Following an 

evaluation of the organizational and 

programmatic capabilities of AAAASF, 

we determined that AAAASF’s 

standards for ASCs meet or exceed the 

Medicare conditions for coverage. 

Therefore, ASCs accredited by AAAASF 

under the CMS-approved program will 

be deemed to have met the conditions 

for coverage under the Medicare 

program.

EFFECTIVE DATE: This final notice is 

effective November 26, 2004 through 

November 26, 2009.

FOR FURTHER INFORMATION CONTACT:

Milonda Mitchell, (410) 786–3511.

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Statutory Provisions and Regulations 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in an ambulatory surgical 

center (ASC), provided that the ASC 

meets certain requirements. Section 

1832(a)(2)(F)(i) of the Social Security 

Act (the Act) authorizes the Secretary to 

establish distinct criteria for a facility 

seeking designation as an ASC. Under 

this authority, the Secretary has set forth 

in regulations minimum requirements 

that an ASC must meet to participate in 

Medicare. The regulations at 42 CFR 

part 416 (Ambulatory Surgical Services) 

specify the conditions under which 

Medicare makes payments for covered 

services provided by an ASC. 

Applicable regulations concerning 

provider agreements are at part 489 

(Provider Agreements and Supplier 

Approval) and those pertaining to 

facility survey and certification are at 

part 488 (Survey Certification and 

Enforcement Procedures), subparts A 

(General Provisions) and B (Special 

Requirements). 

B. Verifying Medicare Conditions for 

Coverage (CfC) 

For an ASC to enter into a provider 

agreement, a State survey agency must 

certify that the ASC is in compliance 

with the conditions or standards set 

forth in part 416 of our regulations. 

Then, the ASC is subject to ongoing 

review by a State survey agency to 

determine whether it continues to meet 

the Medicare requirements. However, 

there is an alternative to State 

compliance surveys. Accreditation by a 

CMS-approved accreditation program 

can substitute for ongoing State review. 

Section 1865(b)(1) of the Act 

mandates that provider entities 

accredited by CMS-approved 

accrediting organizations including 

ASCs are deemed to be in compliance 

with Medicare conditions for coverage. 

Accreditation by an accreditation 

organization is voluntary and is not 

required of ASCs for participation in the 

Medicare program. 

II. Deeming Application Approval 

Process 

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

provides a statutory timetable to ensure 

that we conduct our review of deeming 

applications in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of a complete 

application to complete our survey 

activities and application review 

process. Within 60 days of receiving a 

completed application, we must publish 

a notice in the Federal Register that 

identifies the national accreditation 

body making the request, describes the 

nature of the request, and provides no 

less than a 30-day public comment 

period. 

III. Provisions of the Proposed Notice 

On July 23, 2004, we published a 

proposed notice (69 FR 44027) in the 

Federal Register that announced the 

American Association for Accreditation 

of Ambulatory Surgery Facilities, Inc.’s 

(AAAASF’s) request for approval as a 

deeming organization for ASCs. In that 

notice, we detailed our evaluation 

criteria. Under section 1865(b)(2) of the 

Act and regulations at § 488.4, we 

conducted a review of AAAASF’s 

application in accordance with the 

criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

AAAASF’s (1) corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and (5) survey review and decisionmaking process for accreditation.

• A comparison of AAAASF’s ASC 

accreditation standards to our current 

Medicare conditions for coverage. 

• A documentation review of 

AAAASF’s survey processes to:

—Determine the composition of the 

survey team, surveyor qualifications, 

and the ability of AAAASF to provide 

continuing surveyor training. 

—Compare AAAASF’s processes to 

those of State survey agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

—Evaluate AAAASF’s procedures for 

monitoring providers or suppliers 

found to be out of compliance with 

AAAASF program requirements. The 

monitoring procedures are used only 

when the AAAASF identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the survey agency monitors 

corrections as specified at § 488.7(d). 

—Assess AAAASF’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

—Establish AAAASF’s ability to 

provide us with electronic data in 

ASCII-comparable code and reports 

necessary for effective validation and 

assessment of AAAASF’s survey 

process. 

—Determine the adequacy of staff and 

other resources. 

—Review AAAASF’s ability to provide 

adequate funding for performing 

required surveys. 

—Confirm AAAASF’s policies with 

respect to whether surveys are 

announced or unannounced. 

—Obtain AAAASF’s agreement to 

provide us with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey that we may require, 

including corrective action plans.

In accordance with section 

1865(b)(3)(A) of the Act, the proposed 

notice also solicited public comments 

regarding whether AAAASF’s 

requirements met or exceeded the 

Medicare conditions for coverage for 

ASCs. 

We did not receive public comments 

regarding AAAASF’s renewal 

application as a national accrediting 

organization for ASCs. 

IV. Provisions of the Final Notice 

A. Differences Between AAAASF and 

Medicare’s Conditions and Survey 

Requirements 

On March 18, 2004, we sent a letter 

to AAAASF stating that ‘‘AAAASF’s 

new and revised standards meet or 

exceed the Medicare CfCs for ASCs and 

therefore has approved the revisions 

forwarded to CMS on March 3, 2004.’’

We sent this letter in response to 

AAAASF’s September 2003 submission 

of new and revised standards. Although, 

we approved the new and revised 

standards on March 18, 2004, AAAASF 

indicated in a letter dated June 10, 2004 

that ‘‘it will not implement its new 

standards until October 1, 2004 and that 

the approved Medicare standards will 

be printed prior to August 1, 2004 and 

will be sent to all new applicants after 

that date.’’ Since AAAASF’s 

implementation of its new and revised 

standards occurred during the review of 

its renewal application, we are 

including in this final notice AAAASF’s 

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68933

comments and responses to our review 

of its crosswalk ‘‘Comparison of New 

AAAASF Standards and CMS 

Standards.’’ The purpose of this review 

was to ensure that AAAASF’s standards 

met or exceeded the Medicare CfCs for 

ASCs. The review yielded the following: 

• In order to meet the requirements of 

§ 416.41, AAAASF added to its standard 

that the governing body is legally 

responsible for the safe and effective 

operation of the ASCs. 

• We requested AAAASF to clarify its 

standard AAAASF number 4.020.11.0,

regarding its criteria for patient 

discharge. In addition, we 

recommended that AAAASF strike its 

reference to Post Anesthesia Care Unit 

(PACU) and insert ASC. AAAASF 

responded and revised its standards by 

requiring the physician to examine the 

patient immediately before discharge 

from the ASC. Lastly, AAAASF adopted 

our recommendation and removed 

PACU from its standards and inserted 

ASC. 

• In order to meet the requirements of 

§ 416.42(c), we recommended that 

AAAASF revise its standard, AAAASF 

standard 8.001.08.0, by requiring the 

ASCs to provide not only the patient’s 

legally responsible representative with 

post-operative instructions before 

discharge, but also the actual patient 

himself or herself with post-operative 

instructions before discharge. AAAASF 

adopted our recommendation by 

revising its standard, which now 

requires adequate written post-operative 

instructions (including procedures in 

emergency situations) to be given to the 

patient and, if applicable, the adult 

responsible for the patient’s care before 

discharge. 

• AAAASF standard 10.002.01.0

indicated that the facility must display 

‘‘a professional look.’’ We requested that 

AAAASF provide a definition/

clarification of ‘‘a professional look’’ to 

ensure that its standard was in 

accordance with § 416.44. As referenced 

in Comparison of New AAAASF 

Standards and CMS Standards, 

AAAASF defines a professional look as 

‘‘the facility being properly constructed, 

equipped, and maintained to protect the 

health and safety of patients.’’

• In order to meet the requirements of 

§ 416.44(a)(2), we recommended that 

AAAASF revise its standard 3.032.02.0,

by requiring the ASC to have a separate 

recovery and waiting area. AAAASF 

revised its standard by requiring ASCs’

recovery rooms in its Medicare ASCs to 

be distinctly separate and segregated 

from the waiting area. 

• We asked AAAASF to revise its 

standard 9.002.00.1, to comply with 

§ 416.44(c)(1), by requiring its operating 

rooms (ORs) to have an emergency call 

system present in the OR. AAAASF 

revised its standards accordingly. 

• To comply with § 416.44(c)(4), 

AAAASF revised its standard 

9.002.00.4, by requiring its facilities to 

use standard cardiac defibrillators 

versus an automated external 

defibrillators. 

• We asked AAAASF to revise its 

standard 9.002.00.9, which did not state 

that emergency medication must be 

readily available in the OR. The 

AAAASF standard failed to meet the 

requirements set forth in § 416.44(c)(9). 

AAAASF adopted our recommendation. 

• AAAASF standard 7.004.09.0 failed 

to meet our standard § 416.44(d), by not 

specifying who was responsible for the 

use of cardiopulmonary resuscitation 

equipment in the ASC. AAAASF 

revised its standard by requiring a 

physician, Certified Registered Nurse 

Anesthetist (CRNA) or registered nurse 

(RN) with Advanced Cardiac Life 

Support certification or who is 

otherwise qualified in resuscitation to 

be immediately available in the facility 

until all patients have been discharged 

from the ASC. 

• AAAASF standard 11.000.05.4

failed to reference granting privileges in 

accordance with recommendations from 

qualified medical personnel, as 

referenced at § 416.45(a). AAAASF 

revised its standard accordingly. 

• We requested that AAAASF revise 

its standard 11.000.01.2, which failed to 

state that medical staff would be 

accountable to the governing body. 

AAAASF revised it standard in 

accordance with our regulations at 

§ 416.45.

• AAAASF standard 4.001.01 did not 

require medical records to be complete 

and comprehensive in accordance with 

§ 416.47. AAAASF revised its standard 

by requiring medical records to be 

accurate, legible, documented, 

complete, comprehensive, and filed in a 

timely manner to ensure adequate 

patient care. 

• In order to meet the requirements of 

§ 416.47(b)(4), we recommended that 

AAAASF insert the phrase ‘‘except 

those exempted by the governing body’’, 

in its standard 4.020.05.0. AAAASF 

adopted our recommendation. The 

standard now is identical to 

§ 416.74(b)(4). 

• In order to meet the requirements of 

§ 416.47(b)(5), we recommended that 

AAAASF revise its standard 4.003.01.3, 

by requiring the medical record to 

include documentation of patient drug 

reactions. AAAASF adopted our 

recommendation. 

• In accordance with § 416.47(b)(8), 

AAAASF revised its standard 

8.000.04.0, to require the physician to 

include the discharge diagnosis in the 

patient’s medical record. 

• In accordance with § 416.48(a), 

AAAASF revised its standard 

8.001.06.0, to require a physician or RN 

to administer drugs to patients. 

In addition to conducting a review of 

AAAASF’s standards, we reviewed the 

materials contained in ‘‘AAAASF 

Medicare Resource Guide,’’ ‘‘AAAASF’s 

Policy and Procedures Manual,’’ and 

AAAASF’s ‘‘Introductory Letter and 

Informational Packet.’’ We compared 

this information with our State and 

Regional Operations Manual. This 

review yielded the following: 

• We asked AAAASF to clarify the 

name of its Medicare Program for ASCs, 

as the organization used the title 

‘‘Medicare Accreditation and Medicare 

Certification’’ interchangeably 

throughout its application materials. 

AAAASF advised us that the name of its 

program is ‘‘AAAASF Medicare 

Accreditation.’’ This program accredits 

Class B and Class C ASCs. 

• We requested AAAASF to provide 

a definition or criteria for Class B and 

Class C facilities. According to 

AAAASF, a Class B facility performs 

surgical procedures in the facility under 

local or topical anesthesia and/or under 

intravenous or parenteral sedation, 

regional anesthesia, analgesia or 

dissociative drugs (excluding Propofol) 

without the use of endotracheal or 

laryngeal mask intubation, or inhalation 

general anesthesia (including nitrous 

oxide). In addition, the Class B facility 

must meet every standard under 

AAAASF’s Class A facility 

requirements. AAAASF defines Class C 

facilities as facilities meeting the 

requirements under Class A and Class B. 

In addition, Class C facilities perform 

surgical procedures with intravenous 

Propofol, spinal or epidural anesthesia, 

endotracheal or laryngeal mask 

intubation or inhalation anesthesia 

(including nitrous oxide), spinal or 

epidural, which is administered by an 

anesthesiologist or a certified registered 

nurse anesthetist (CRNA). 

• We requested AAAASF to clarify its 

accreditation decisions, as its policies 

and procedures indicate that, ‘‘Offices 

can be approved or not approved for 

accreditation or they can be placed on 

provisional status.’’ AAAASF 

responded that Class B and Class C 

facilities are either granted or denied 

Medicare Accreditation. These facilities 

are required to fully comply with 

AAAASF’s Medicare standards and are 

prohibited from receiving provisional 

status. 

• We requested AAAASF to provide 

clarification regarding its accreditation 

68934 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 

cycle and its self-evaluation process. 

AAAASF responded that its Medicare 

accreditation is effective for 3 years 

(assuming that the facility remains in 

compliance with all AAAASF 

requirements for continued Medicare 

accreditation, which includes 

completion of a second and third year 

self-evaluation). The second and third 

year self-evaluation survey is conducted 

by the Facility Director and/or 

Registered Nurse (OR manager) annually 

to ensure continued compliance with all 

AAAASF requirements. AAAASF 

processes the evaluation and the facility 

is notified of any deficiencies. If the 

facility has any deficiencies, it is 

required to correct them within 30 days. 

AAAASF performs an onsite Medicare 

inspection at every consecutive 3-year 

cycle. 

• We asked AAAASF to state who is 

responsible for performing the Life 

Safety Code (LSC) survey for its 

Medicare ASCs. It responded that it has 

contracted with Fire and Life Safety 

Concepts, L.L.C. to conduct its 

unannounced LSC surveys. In addition, 

AAAASF clarified that it is not 

requiring its Medicare ASCs to obtain 

their own LSC inspections from a state 

fire marshal or hired qualified inspector 

to qualify for Medicare accreditation. 

• AAAASF submitted documentation 

stating that ‘‘The Life Safety Code 

inspection is only performed during reinspection if we require compliance 

with a new version of the NFPA Life 

Safety Code.’’ We requested AAAASF to 

revise this statement, because a LSC 

survey is always required during reaccreditation by a deemed accreditation 

organization. In addition, we requested 

AAAASF to require its facilities to 

comply with the 2000 edition of the 

LSC. AAAASF responded that it will 

require its Medicare ASCs to obtain LSC 

surveys at the time of initial application, 

application renewal, or in instances 

which warrant a complaint survey 

involving physical environment. 

AAAASF provided us with copies of 

documentation that it sent to its 

Medicare ASCs, dated August 25, 2003, 

advising its facilities that effective 

September 11, 2003, all AAAASF 

Medicare approved ASCs are required to 

meet the NFPA 2000 LSC.

• We requested AAAASF to develop 

a comprehensive performance 

evaluation program for its Medicare 

inspectors. AAAASF responded by 

implementing a Medicare Inspector 

Examination Process. At the conclusion 

of each Medicare Inspector Training 

Workshop, an examination will be 

administered to assess the inspectors’

knowledge and application of 

AAAASF’s Medicare standards. In 

addition, we requested that the 

AAAASF inspectors accompany a field 

preceptor for an onsite Medicare facility 

inspection as part of the inspector 

training process. The field preceptor 

would complete a competency 

evaluation to assess the inspector’s 

knowledge of AAAASF’s survey 

process. Lastly, AAAASF now requires 

all of its Medicare ASCs to complete a 

facility evaluation form. It is a 

questionnaire completed by the 

surveyed facility and is designed to 

evaluate the inspector’s skills and 

knowledge as it relates to the 

application of AAAASF standards, the 

inspection process, and Medicare 

requirements. AAAASF states that these 

tools will facilitate the proper 

evaluation of its Medicare inspectors’

ability to apply AAAASF standards and 

survey processes, and will allow 

AAAASF to identify training needs for 

its inspectors. 

• We asked AAAASF to develop 

policies and procedures for monitoring 

complaints in its Medicare ASCs. 

AAAASF has a toll-free hotline that 

patients, patient family members, or 

guardians may use to advise AAAASF 

of any complaints they may have 

regarding its Medicare ASCs. Each 

Medicare ASC is required to post 

AAAASF complaint certificate in its 

facility. This certificate provides the 

contact information individuals need to 

advise AAAASF of any comments or 

questions regarding services provided at 

the facility. The AAAASF Investigative 

Committee reviews all complaints. 

AAAASF’s complaint categories are 

‘‘patient death,’’ ‘‘patient safety,’’ and 

‘‘clinical practices.’’ AAAASF’s 

complaint surveys are always 

unannounced. The AAAASF Medicare 

survey team is responsible for 

conducting the complaint surveys in 

accordance with AAAASF’s Medicare 

standards and with specific direction 

from the Investigative Committee chair. 

The survey team must investigate 

complaints involving patient death no 

later than 20 days after notifying the 

AAAASF office of the death. This 

allows the facility 10 days to respond to 

the request for information and allows 

AAAASF a maximum of 10 days to 

schedule the mandatory unannounced 

inspection. However, when 

investigating complaints involving 

patient safety or clinical practices, the 

survey team must complete its survey 

within 30 days after receipt of the initial 

complaint. This allows the facility 10 

days to respond to the request for 

information and allows AAAASF a 

maximum of 20 days to schedule the 

mandatory unannounced inspection. 

The Investigative Committee Chair is 

responsible for advising the 

complainant of the result of AAAASF’s 

investigation. The investigated facility 

will receive an outcome letter and a 

written investigation report. When 

applicable, the outcome letter will 

identify possible follow-up action (for 

instance, probation, suspension, or 

revocation of Medicare accreditation, 

follow-up visit, plan of correction, or no 

further action). Lastly, the outcome 

letter advises the facility of its rights to 

request a hearing in response to 

AAAASF’s recommendations. 

• We asked AAAASF to present 

documentation regarding its retention of 

facility files. AAAASF responded by 

submitting its policies and procedures 

for Record Retention and Maintenance. 

The policies and procedures state that 

facility records are maintained in both 

hard copy and database format. The 

hard copy file includes initial 

accreditation application records, 

surgeon credentials, Medicare 

accreditation onsite evaluations/

outcomes and correspondence. 

AAAASF indicated that it purges its 

records periodically, however, and 

maintains the last 3 years’ records for 

the facility including current 

credentials, correspondence, and 

evaluations. 

• We asked AAAASF to clarify its 

procedures for scheduling Medicare 

accreditation surveys. AAAASF 

responded by submitting its policy, 

‘‘Procedure for Securing a Medicare 

Inspector.’’

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we determined that AAAASF’s 

requirements for ASCs meet or exceed 

our requirements. Therefore, we 

recognize AAAASF as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective November 26, 2004 

through November 26, 2009.

V. 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 19, 

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

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

Executive Order 12866 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 

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68935

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). This final notice 

recognizes AAAASF as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

and Medicaid programs. There are 

neither significant costs nor savings for 

the program and administrative budgets 

of Medicare. Therefore, this notice is not 

a major rule as defined in Title 5, 

United States Code, section 804(2) and 

is not an economically significant rule 

under Executive Order 12866. 

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 $6 

million to $29 million in any 1 year. 

Individuals and States are not included 

in the definition of a small entity. For 

purposes of the RFA, States and 

individuals are not considered small 

entities. We are not preparing an 

analysis for the RFA because we have 

determined that this notice will not 

have a significant economic impact on 

a substantial number of small entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule 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 604 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 are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined 

that this notice will not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

In an effort to better assure the health, 

safety, and services of beneficiaries in 

ASCs already certified as well as 

provide relief to State budgets in this 

time of tight fiscal restraints, we deem 

ASCs accredited by AAAASF as 

meeting its Medicare requirements. 

Thus, we continue our focus on assuring 

the health and safety of services by 

providers and suppliers already 

certified for participation in a costeffective manner. 

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 expenditure in 

any 1 year by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. This 

notice will have no 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 and local 

governments, preempts State law, or 

otherwise has federalism implications. 

Since this notice does not impose any 

costs on State or local governments, the 

requirements of E.O. 13132 are not 

applicable. 

In accordance with the provisions of 

Executive Order 12866, this 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—Supplemental Medical Insurance 

Program)

Dated: October 22, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–25830 Filed 11–19–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1374–GNC] 

RIN: 0938–ZA50 

Medicare Program; Criteria and 

Standards For Evaluating Intermediary, 

Carrier, and Durable Medical 

Equipment, Prosthetics, Orthotics, and 

Supplies (DMEPOS) Regional Carrier 

Performance During Fiscal Year 2005

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), Health and 

Human Services (HHS).

ACTION: General notice with comment 

period. 

SUMMARY: This notice describes the 

criteria and standards to be used for 

evaluating the performance of fiscal 

intermediaries (FIs), carriers, and 

Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies 

(DMEPOS) regional carriers in the 

administration of the Medicare program 

beginning on the first day of the first 

month following publication of this 

notice in the Federal Register. The 

results of these evaluations are 

considered whenever we enter into, 

renew, or terminate an intermediary 

agreement, carrier contract, or DMEPOS 

regional carrier contract or take other 

contract actions, for example, assigning 

or reassigning providers or services to 

an intermediary or designating regional 

or national intermediaries. We are 

requesting public comment on these 

criteria and standards.

DATES: Effective Date: The criteria and 

standards are effective December 27, 

2004. 

Comment Date: Comments will be 

considered if we receive them at the 

appropriate address as provided below 

no later than 5 p.m. on December 27, 

2004.

ADDRESSES: In commenting, please refer 

to file code CMS–1374–GNC. 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 http://

www.regulations.gov (attachments must 

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–1374–GNC, 

P.O. Box 8013, Baltimore, MD 21244–

8013. 

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