51464 Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Notices 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

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

on September 20, 2010. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer. Fax Number: (202) 395– 

6974. E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: August 13, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–20386 Filed 8–19–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2476–FN2] 

Medicare and Medicaid Programs; 

Approval of the American Association 

for Accreditation of Ambulatory 

Surgery Facilities for Continued 

Deeming Authority for Ambulatory 

Surgical Centers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS). 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve without 

condition the American Association for 

Accreditation of Ambulatory Surgery 

Facilities’ (AAAASF) request for 

continued recognition as a national 

accreditation program for ambulatory 

surgical centers (ASC) seeking to 

participate in the Medicare or Medicaid 

programs. 

DATES: Effective Date: This final notice 

is effective on November 27, 2009 

through November 27, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson (410) 786–0310. 

Patricia Chmielewski (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

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) establishes distinct criteria 

for a facility seeking designation as an 

ASC. Under this authority, the 

minimum requirements that an ASC 

must meet to participate in Medicare are 

set forth in regulations at 42 CFR part 

416, which determine the basis and 

scope of ASC covered services, and the 

conditions for Medicare payment for 

facility services. Regulations concerning 

provider agreements are at 42 CFR part 

489 and those pertaining to activities 

relating to the survey and certification 

of facilities are at 42 CFR part 488. 

Generally, to enter into an agreement, 

an ASC must first be certified by a State 

survey agency as complying with 

conditions or requirements set forth in 

part 416 of our regulations. Then, the 

ASC is subject to regular surveys by a 

State survey agency to determine 

whether it continues to meet those 

requirements. There is an alternative, 

however, 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 accreditation organization that 

all applicable Medicare conditions are 

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

provider entities to have met the 

requirements. Accreditation by an 

accreditation organization is voluntary 

and is not required for Medicare 

participation. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, a 

provider entity accredited by the 

national accrediting body’s approved 

program may be deemed to meet the 

Medicare conditions. A national 

accreditation organization applying for 

approval of deeming authority under 

part 488, subpart A, must provide us 

with reasonable assurance that the 

accreditation organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning re-approval 

of accrediting organizations are set forth 

at section § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accreditation organizations to reapply 

for continued approval of deeming 

authority every 6 years, or sooner as 

determined by CMS. The regulation at 

§ 488.8(f)(3)(i) provides CMS the 

authority to grant conditional approval 

of an accreditation organization’s 

deeming authority, with a probationary 

period of up to 180 days, if the 

accreditation organization has not 

adopted comparable standards during 

the reapplication process. 

We received a complete application 

from AAAASF for continued 

recognition as a national accreditation 

organization for ASCs on March 31, 

2009. In accordance with the 

requirements at § 488.4 and 

§ 488.8(d)(3), we published a proposed 

notice on June 26, 2009 (74 FR 30587) 

and a final notice on November 27, 2009 

(74 FR 62330). This final notice 

provides CMS’ final determination in 

response to the conditional approval 

with a 180-day probationary period 

granted to the American Association for 

Accreditation of Ambulatory Surgery 

Facilities on November 27, 2009. 

II. Deeming Applications Approval 

Process 

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

provides a statutory timetable to ensure 

that our review of deeming applications 

is conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of an 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 request, and 

provides no less than a 30-day public 

comment period. At the end of the 210- 

day period, we must publish an 

approval or denial of the application. In 

accordance with § 488.8(f)(2), if CMS 

determines following the deeming 

authority review that the organization 

has failed to adopt requirements 

comparable to CMS requirements, the 

accreditation organization may be given 

a conditional approval of its deeming 

authority for a probationary period of up 

to 180 days to adopt comparable 

requirements. Within 60 days after the 

end of this period, we must make a final 

determination as to whether or not the 

AAAASF’s accreditation program for 

ASCs is comparable to CMS 

requirements and issue an appropriate 

notice that includes our reasons for our 

determination. 

III. Provisions of the November 27, 

2009 Final Notice 

Our review of AAAASF’s renewal 

application for ASC deeming authority 

revealed that AAAASF had on-going, 

serious, widespread areas of noncompliance. Specifically, AAAASF’s 

inability to provide accurate and timely 

data on deemed providers; lack of 

complete and accurate deemed facility 

survey files; and, inadequate surveyor 

training and evaluation program. Due to 

the significant number of areas of 

noncompliance identified during the 

review of AAAASF’s renewal 

application for deeming authority, we 

conditionally approved AAAASF’s ASC 

accreditation program for 3 years with a 

180 day probationary period. Under 

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

regulations at § 488.4 and § 488.8, we 

conducted a comparability review of 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Notices 51465 

AAAASF’s ASC accreditation program 

to determine compliance with the 

Medicare requirements for ASCs at 42 

CFR part 416. 

IV. Provisions of the Final Notice 

A. Differences Between AAAASF’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

During the 180 day probationary 

period, we conducted a comparison of 

AAAASF’s accreditation requirements 

for ASCs to our current Medicare 

conditions for coverage (CfCs) as 

outlined in the State Operations Manual 

(SOM). We also conducted a corporate 

onsite visit and survey observation to 

validate proper application of the 

requirements. Our review and 

evaluations of AAAASF’s deeming 

application yielded the following: 

• AAAASF’s survey files were 

complete, accurate, and consistent with 

the requirements at § 488.6(a). 

• AAAASF’s data submissions are 

accurate, complete and timely in 

accordance with the requirements at 

§ 488.4(b). 

• AAAASF revised it accreditation 

decision letters to ensure they are 

accurate and contain all of the elements 

necessary for the Regional Office to 

render a decision regarding the deemed 

status of an accredited ASC. 

• AAAASF revised its policies to 

require its surveyors to use the surveyor 

tools thus ensuring accurate and 

complete survey files. 

• AAAASF developed surveyors tools 

to include a medical record review 

sheet, personnel review sheet, and 

policy review to assist surveyors with 

accurate, and complete documentation. 

• To meet the Medicare requirements 

related to unannounced surveys at 

2700A of the SOM, AAAASF modified 

its policies related to the survey 

window in which organizations could 

receive an accreditation survey for 

deemed status. 

• To meet the survey process 

requirements in Appendix L of the 

SOM, AAAASF developed a policy 

outlining the minimum number of 

medical records that must be reviewed 

during a certification survey. 

• To meet the requirements at SOM 

2200F, AAAASF revised its policies and 

procedures to ensure documentation of 

deficiencies contains a regulatory 

reference, a clear and detailed 

description of the deficient practice, and 

relevant finding. 

• To meet the requirements at 2728 of 

the SOM, AAAASF modified its policies 

regarding timeframes for sending and 

receiving a plan of correction (PoC) for 

life safety code surveys. 

• To ensure its surveyors were 

adequately trained, AAAASF developed 

a website where surveyors could access 

a resource library of training webinars, 

interpretative guidelines, principles of 

documentation, standards, surveyor 

handbook, survey forms and other 

materials to assist surveyors in the field. 

B. Term of Approval 

Based on the review and observations, 

we have determined that AAAASF’s 

accreditation program for ASCs meets or 

exceeds our requirements. Therefore, we 

approve, without condition, AAAASF 

as a national accreditation organization 

for ASCs that request participation in 

the Medicare program, effective 

November 27, 2009 through November 

27, 2012. Under § 488.4(f)(4), notice was 

given to AAAASF on November 27, 

2009 (74 FR 62330) and this final notice, 

although not required by our 

regulations, is being published as a 

public service for informational 

purposes. 

V. 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). 

(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: August 5, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–19888 Filed 8–19–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1572–N] 

Medicare Program; Announcement of 

Five New Members to the Advisory 

Panel on Ambulatory Payment 

Classification Groups 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces five 

new members selected to serve on the 

Advisory Panel on Ambulatory Payment 

Classification (APC) Groups (the Panel). 

The purpose of the Panel is to review 

the APC groups and their associated 

weights and to advise the Secretary of 

Department of Health and Human 

Services (the Secretary) and the 

Administrator of Centers for Medicare & 

Medicaid Services concerning the 

clinical integrity of the APC groups and 

their associated weights. We will 

consider the Panel’s advice as we 

prepare the annual updates of the 

hospital outpatient prospective payment 

system (OPPS). 

FOR FURTHER INFORMATION CONTACT: For 

inquiries about the Panel, contact the 

Designated Federal Official (DFO): Shirl 

Ackerman-Ross, (410) 786–4474. 

APC Panel E–Mail Address: The Email address for the Panel is as follows: 

CMS APCPanel@cms.hhs.gov (Note: 

There is no underscore in this e-mail 

address; there is a space between CMS 

and APCPanel.) 

News Media Contact: News media 

representatives must contact our Public 

Affairs Office at (202) 690–6145. 

CMS Advisory Committees Hotlines: 

The CMS Federal Advisory Committee 

Hotline is 1–877–449–5659 (toll free) 

and (410) 786–9379 (local) for 

additional Panel information. 

Web Sites: For additional information 

regarding the APC Panel membership, 

meetings, agendas, and updates to the 

Panel’s activities, search our Web site at 

the following Uniform Resource Locator 

(URL): http://www.cms.hhs.gov/FACA/ 

05_AdvisoryPanelonAmbulatory

PaymentClassificationGroups.asp#

TopOfPage. (Note: There is an 

underscore after FACA/05 (like this_); 

there is no space.) 

The public may also access the 

following URL for the Federal Advisory 

Committee Act Web site to obtain APC 

Panel information: https:// 

www.fido.gov/facadatabase/public.asp. 

A copy of the Panel’s Charter and other 

pertinent information are on both Web 

sites mentioned above. You may also email the Panel DFO at the above e-mail 

address for a copy of the Charter. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary of the Department of 

Health and Human Services (the 

Secretary) is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act) to consult with an expert 

outside advisory Panel regarding the 

clinical integrity of the Ambulatory 

Payment Classification (APC) groups 

and relative payment weights that are 


sroberts on DSKD5P82C1PROD with NOTICES