70446 Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3262–FN] 

Medicare and Medicaid Programs; 

Approval of the American Association 

for Accreditation of Ambulatory 

Surgery Facilities (AAAASF) for 

Continuing CMS Approval of Its 

Ambulatory Surgical Center 

Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve the American 

Association for Accreditation of 

Ambulatory Surgery Facilities 

(AAAASF) for continued recognition as 

a national accrediting organization for 

ambulatory surgical centers (ASCs) that 

wish to participate in the Medicare or 

Medicaid programs. 

DATES: Effective Date: This final notice 

is effective November 27, 2012 through 

November 27, 2018. 

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 

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 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 

42 CFR part 416. Thereafter, the ASC is 

subject to regular surveys by a State 

survey agency to determine whether it 

continues to meet these 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 accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will 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 meet 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 an 

accrediting organization to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by CMS. 

American Association for 

Accreditation of Ambulatory Surgery 

Facilities (AAAASFs) current term of 

approval for their ASC accreditation 

program expires November 27, 2012. 

II. Application Approval Process 

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

provides a statutory timetable to ensure 

that our review of applications for CMS 

approval of an accreditation program is 

conducted in a timely manner. The Act 

provides us with 210 days from receipt 

of a complete application, with any 

documentation necessary, to make the 

determination and to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

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 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On June 22, 2012, we published a 

proposed notice in the Federal Register 

(77 FR 37678) announcing AAAASF’s 

request for continued approval of its 

ASC accreditation program. In the 

proposed notice, we detailed our 

evaluation criteria. Under section 

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

regulations at § 488.4 and § 488.8, 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. 

• The comparison of AAAASF’s 

accreditation to CMS’s current Medicare 

ASC conditions for coverage. 

• A documentation review of 

AAAASF’s survey process to— 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and AAAASF’s ability 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 ASCs found to be out of 

compliance with AAAASF’s program 

requirements. The monitoring 

procedures are used only when 

AAAASF identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State 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 CMS with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

+ Determine the adequacy of staff and 

other resources. 

+ Confirm 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 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. 

In accordance with section 

1865(a)(3)(A) of the Act, the June 22, 

2012 proposed notice also solicited 

public comments regarding whether 

AAAASF’s requirements met or 

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Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices 70447 

exceeded the Medicare conditions for 

coverage for ASCs. We received no 

public comments in response to our 

proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between AAAASF’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared AAAASF’s ASC 

requirements and survey process with 

the Medicare conditions for coverage 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of AAAASF’s 

ASC application, which were conducted 

as described in section III of this final 

notice, yielded the following: 

• To meet the requirements at 

§ 416.41(b)(2), AAAASF revised its 

standards to ensure the ASC’s transfer 

agreement is with a local, Medicareparticipating hospital that meets the 

requirements for emergency services. 

• To meet the requirements at 

§ 416.44(a)(2), AAAASF revised its 

standards to address the requirement 

that ‘‘the ASC must have a separate 

recovery room and waiting area.’’ 

• AAAASF revised its crosswalk to 

ensure that all regulatory references are 

correct for the following citations: 

§ 416.42(a)(2), § 416.42(c)(2), 

§ 416.44(c)(3), § 416.50(c)(1), § 416.50(e), 

and § 416.50(g). 

• To meet the requirements at 

§ 488.4(a)(4), AAAASF modified its 

policies to ensure all personnel files are 

accurate and complete. 

• To meet the requirements at 

§ 488.4(a)(5), AAAASF modified its 

policies to improve the accuracy and 

consistency of data submissions to CMS. 

• To meet the requirements at 

§ 488.4(a)(6), AAAASF modified its 

policies to ensure all compliant 

investigations are conducted in 

accordance with the requirements in 

chapter Five of the SOM. 

• To meet the requirements at 

§ 488.6(a), AAAASF revised its policies 

and procedures to ensure deemed status 

survey files are complete and accurate. 

• To meet the requirements at 

§ 488.12, AAAASF modified its policies 

to ensure all pertinent survey 

information, including all surveys 

conducted, is included in the final 

accreditation decision letters. 

• To meet the medical record 

requirements at Appendix L of the 

SOM, AAAASF revised its policies to 

ensure surveyors review the required 

number of medical records during a 

survey. 

• To meet the requirements at Section 

2728 of the SOM, AAAASF modified its 

policies regarding timeframes for 

sending and receiving a plan of 

correction. 

• To meet the requirements at Section 

3012 of the SOM, AAAASF modified its 

policies to ensure follow-up, focused 

surveys for condition level 

noncompliance are conducted timely. 

• To meet the requirements at Section 

2700A of the SOM, AAAASF modified 

its policies to ensure all surveys are 

conducted unannounced. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that 

AAAASF’s requirements for ASCs meet 

or exceed our requirements. Therefore, 

we approve AAAASF as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective November 27, 2012 

through November 27, 2018. 

V. Collection of Information 

Requirements 

This document does not impose any 

information reporting, recordkeeping or 

third-party disclosure 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). 

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—ASC 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 20, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–28640 Filed 11–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1597–N] 

Medicare Program; Semi-Annual 

Meeting of the Advisory Panel on 

Hospital Outpatient Payment (HOP 

Panel)—March 11 and 12, 2013 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

first semi-annual meeting of the 

Advisory Panel on Hospital Outpatient 

Payment (HOP, the Panel), (the 

Ambulatory Payment Classification 

(APC) Panel) for 2013. The purpose of 

the Panel is to advise the Secretary of 

the Department of Health and Human 

Services (DHHS) (the Secretary) and the 

Administrator of the Centers for 

Medicare & Medicaid Services (CMS) 

(the Administrator) on the clinical 

integrity of the APC groups and their 

associated weights, and hospital 

outpatient therapeutic supervision 

issues. 

DATES: Meeting Date: The first semiannual meeting in 2013 is scheduled for 

the following dates and times. 

Note: The times listed in this notice are 

Eastern Daylight Time (EDT) and are 

approximate times; consequently, the 

meetings may last longer than the times 

listed in this notice, but will not begin before 

the posted times: 

• Monday, March 11, 2013, 1 p.m. to 5 

p.m. EDT 

• Tuesday, March 12, 2013, 9 a.m. to 5 

p.m. EDT 

Deadlines 

Deadline for Presentations and 

Comments 

The email copy of a presentation or 

comment and form CMS–20017 must be 

in the Designated Federal Official’s 

(DFO’s) email inbox 

(APCPanel@cms.hhs.gov) by 5 p.m. 

EDT, Friday, January 25, 2013. The 

hardcopy of the presentation must be 

received by the DFO on or before 

Friday, February 1, 2013. Presentations 

and comments that are not received by 

the due dates will be considered late 

and will not be included on the agenda. 

(See below for submission instructions 

for both hardcopy and electronic 

submissions.) 

Meeting Registration Timeframe: 

Monday, January 9, 2013 through 

Friday, February 22, 2013 at 5 p.m. EDT. 

Participants planning to attend this 

meeting in person must register online, 

during the above specified timeframe at: 

https://www.cms.gov/apps/events/

default.asp. On this Web page, double 

click the ‘‘Upcoming Events’’ hyperlink, 

and then double click the ‘‘HOP Panel’’ 

event title link and enter the required 

information. Include any requests for 

special accommodations. Note: 

Participants who do not plan to attend 

this meeting in person should not 

register. No registration is required for 

participants that plan to view the 

meeting via webcast. 

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