37678 Federal Register / Vol. 77, No. 121 / Friday, June 22, 2012 / Notices 

Dated: June 15, 2012. 

Ron A. Otten, 

Director, Office of Scientific Integrity (OSI), 

Office of the Associate Director for Science 

(OADS), Office of the Director, Centers for 

Disease Control and Prevention. 

[FR Doc. 2012–15354 Filed 6–21–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry: Notice of 

Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Board 

of Scientific Counselors, National 

Center for Environmental Health/ 

Agency for Toxic Substances and 

Disease Registry, Department of Health 

and Human Services, has been renewed 

for a 2-year period through May 21, 

2014. 

For information, contact Vikas Kapil, 

Designated Federal Officer, Board of 

Scientific Counselors, National Center 

for Environmental Health/Agency for 

Toxic Substances and Disease Registry, 

Department of Health and Human 

Services, 4770 Buford Highway 

Mailstop F61, Chamblee, Georgia 30341, 

telephone 770/488–8316 or fax 770/ 

488–3385. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: June 13, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–14923 Filed 6–21–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3262–PN] 

Medicare and Medicaid Programs; 

Application From American 

Association for Accreditation of 

Ambulatory Surgery Facilities for 

Continued Approval of Its Ambulatory 

Surgery Facilities Accreditation 

Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: This proposed notice with 

comment period acknowledges the 

receipt of an application from the 

American Association for Accreditation 

of Ambulatory Surgery Facilities 

(AAAASF) for continued recognition as 

a national accrediting organization for 

ambulatory surgery centers (ASCs) wish 

to participate in the Medicare or 

Medicaid programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 23, 2012. 

ADDRESSES: In commenting, please refer 

to file code CMS–3262–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (Fax) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3262–PN, 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 express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3262–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 before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey 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.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

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. 

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: 

Georganne Kuberski, (410) 786–0799. 

Patricia Chmielewski, (410) 786–6899. 

Cindy Melanson, (410) 786–0310. 

SUPPLEMENTARY INFORMATION: 

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.regulations.gov. Follow the search 

instructions 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. 


wreier-aviles on DSK7SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 121 / Friday, June 22, 2012 / Notices 37679 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in an ambulatory surgery center 

(ASC) that meet certain requirements. 

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

Security Act (the Act) establishes 

distinct criteria for facilities seeking 

designation as an ASC. 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. The regulations at 42 CFR part 

416 specify the conditions that an ASC 

must meet in order to participate in the 

Medicare program, the scope of covered 

services, and the conditions for 

Medicare payment for ASCs. 

Generally, in order to enter into an 

agreement, an ASC must first be 

certified by a State survey agency as 

complying with the conditions or 

requirements set forth in part 416. 

Thereafter, the ASC is subject to regular 

surveys by a State survey agency to 

determine whether it continues to meet 

these requirements. However, ASC’s 

have an alternative to surveys by State 

agencies for participation in the 

Medicare program. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we would deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting 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 have met 

the Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under part 488, subpart A, must provide 

us with reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or as determined 

by CMS. 

American Association for 

Accreditation of Ambulatory Surgery 

Facilities (AAAASF’s) current term of 

approval for their ASC accreditation 

program expires November 27, 2012. 

II. Approval of Deeming Organizations 

Section 1865(a)(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 

accrediting 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 

requirements; and ability to provide 

CMS with the necessary data for 

validation. 

Section 1865(a)(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 accrediting 

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 the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of AAAASF’s 

request for continued approval of its 

ASC accreditation program. This notice 

also solicits public comment on whether 

AAAASF’s requirements meet or exceed 

the Medicare conditions for 

participation for ASCs. 

III. Evaluation of Deeming Authority 

Request 

AAAASF submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its ASC 

accreditation program. This application 

was determined to be complete on April 

27, 2012. Section 1865(a)(3)(A) of the 

Act, requires that within 60 days of 

receipt of an organization’s complete 

application to be a CMS-approved 

accrediting organization, 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. Under section 

1865(a)(2) of the Act and our regulations 

at § 488.8 (Federal review of accrediting 

organizations), our review and 

evaluation of AAAASF would be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of AAAASF’s 

standards for an ASC as compared with 

CMS’ conditions for coverage. 

• AAAASF’s 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 AAAASF’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

• AAAASF’s processes and 

procedures for monitoring an ASC 

found out of compliance with 

AAAASF’s program requirements. 

These monitoring procedures are used 

only when AAAASF identifies 

noncompliance. If noncompliance is 

identified through validation reviews or 

complaint surveys, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

• AAAASF’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

• AAAASF’s capacity to provide CMS 

with electronic data 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, to assure that surveys are 

unannounced. 

• AAAASF’s agreement to provide 

CMS 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 (44 

U.S.C. 35). 

V. Response to Public 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 


wreier-aviles on DSK7SPTVN1PROD with NOTICES
37680 Federal Register / Vol. 77, No. 121 / Friday, June 22, 2012 / Notices 

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. 

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. 

(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: June 12, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–15293 Filed 6–21–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3265–PN] 

Medicare and Medicaid Programs; 

Application From the Accreditation 

Association for Ambulatory Health 

Care for Continued Approval of Its 

Ambulatory Surgical Centers 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Accreditation 

Association for Ambulatory Health Care 

for continued recognition as a national 

accrediting organization for ambulatory 

surgical centers that participate in the 

Medicare or Medicaid programs. This 

notice also solicits public comment on 

whether AAAHC’s requirements meet or 

exceed the Medicare conditions for 

coverage. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 23, 2012. 

ADDRESSES: In commenting, please refer 

to file code CMS–3265–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

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–3265– 

PN, 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 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–3265–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 before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey 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.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

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. 

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: 

Lillian Williams (410) 786–8636. 

Patricia Chmielewski, (410) 786–6899. 

Cindy Melanson, (410) 786–0310. 

SUPPLEMENTARY INFORMATION: 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.regulations.gov. Follow the search 

instructions 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 an ambulatory surgical 

center (ASC) provided certain 

requirements are met. Section 

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

Act (the Act) requires ASCs to meet 

health, safety, and other standards 

specified by the Secretary. 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. The regulations at 42 CFR part 

416 specify the conditions that an ASC 

must meet in order to participate in the 

Medicare program, the scope of covered 

services and the conditions for Medicare 

payment for ASCs. 

Generally, to enter into an agreement, 

an ASC must first be certified by a State 

survey agency as complying with the 

conditions or requirements set forth in 

part 482. Thereafter, the ASC is subject 

to regular surveys by a State survey 

agency to determine whether it 

continues to meet these requirements. 

However, there is an alternative to 

surveys by state agencies. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we would deem those 

provider entities as having met the 

Medicare requirements. Accreditation 

by an accrediting organization is 

voluntary and is not required for 

Medicare participation. 

If an accrediting organization is 

recognized by the Secretary as having 


wreier-aviles on DSK7SPTVN1PROD with NOTICES