Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Notices 70783 

Proposed Project 

Colorectal Cancer Control Program 

Indirect/Non-Medical Cost Study— 

New—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Colorectal Cancer (CRC) is the second 

leading cause of cancer-related deaths in 

the United States, following lung 

cancer. Based on scientific evidence 

which indicates that regular screening 

with fecal occult blood testing (FOBT), 

fecal immunochemical testing (FIT), 

flexible sigmoidoscopy, and/or 

colonoscopy is effective in reducing 

CRC incidence and mortality, regular 

CRC screening is now recommended for 

average-risk persons. In 2009, by 

applying lessons learned from a fouryear e demonstration program, CDC 

designed and initiated the larger 

population-based Colorectal Cancer 

Control Program (CRCCP) at 29 sites 

with the goals of reducing health 

disparities in CRC screening, incidence 

and mortality. 

To date there has been no 

comprehensive assessment of all the 

costs associated with CRC screening, 

especially indirect and non-medical 

costs that may act as barriers to 

screening, incurred by the low-income 

population served by the CRCCP. CDC 

proposes to address this gap by 

collecting information from a subset of 

patients enrolled in the program. CDC 

plans to conduct the information 

collection in partnership with providers 

in five states (Alabama, Arizona, 

Colorado, New York, and Pennsylvania). 

Each provider site will administer the 

survey to patients who undergo 

screening by FIT or colonoscopy until it 

reaches a target number of responses. 

Targets for each site range between 75 

and 150 completed questionnaires, 

depending on the volume of patients 

screened. Patients who undergo fecal 

immunochemical testing will be asked 

to complete the FIT questionnaire, 

which is estimated to take about 10 

minutes. Patients who undergo 

colonoscopy will be asked to complete 

the Colonoscopy questionnaire, which 

includes additional questions about the 

preparation and recovery associated 

with this procedure. The estimated 

burden per response for the 

Colonoscopy questionnaire is 25 

minutes. Demographic information will 

be collected from all patients who 

participate in the study. Participation in 

the study is voluntary, but patients will 

be offered an incentive in the form of a 

gift card. Each participating provider 

will make patient navigators available to 

assist patients with coordinating the 

screening process and completing the 

questionnaires. Providers will be 

reimbursed for patient navigator time 

and administrative expense associated 

with data collection. 

This information collection will be 

used to produce estimates of the 

personal costs incurred by patients who 

undergo CRC screening by FIT or 

colonoscopy, and to improve 

understanding of these costs as potential 

barriers to participation. Study findings 

will be disseminated through reports, 

presentations, and publications. Results 

will also be used by participating sites, 

CDC, and other federal agencies to 

improve delivery of CRC screening 

services and to increase screening rates 

among low-income adults over 50 years 

of age who have no health insurance or 

inadequate health insurance for CRC 

screening. 

OMB approval is requested for one 

year. Each respondent will have the 

option of completing a hardcopy 

questionnaire (in English or Spanish) or 

an on-line questionnaire. No identifiable 

information will be collected by CDC or 

CDC’s data collection contractor. There 

are no costs to respondents other than 

their time. The total estimated 

annualized burden hours are 181. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hr) 

Patients Served by the Colorectal Cancer 

Control Program.

FIT Questionnaire ..................................... 300 1 10/60 

Colonoscopy Questionnaire ..................... 315 1 25/60 

Dated: November 19, 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. 2012–28727 Filed 11–26–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3265–FN] 

Medicare and Medicaid Programs; 

Approval of the Accreditation 

Association for Ambulatory Health 

Care (AAAHC) Application for 

Continuing CMS Approval of Its 

Ambulatory Surgical Center 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the 

Accreditation Association for 

Ambulatory Health Care (AAAHC) for 

continued recognition as a national 

accrediting organization for ambulatory 

surgical centers (ASCs) that wish to 

participate in the Medicare and/or 

Medicaid programs. 

DATES: Effective Date: This notice is 

effective December 20, 2012 through 

December 20, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636. 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) requires ASCs to meet 


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70784 Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Notices 

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 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 416. 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, CMS will 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 

standards for accreditation that meet or 

exceed Medicare requirements, a 

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 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by CMS. 

The Ambulatory Health Care’s 

(AAAHC) current term of approval for 

their ASC accreditation program expires 

on December 20, 2012. 

II. Application Approval Process 

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

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 a notice of 

approval or denial of the application. 

III. Provisions of the Proposed Notice 

On June 22, 2012, we published a 

proposed notice in the Federal Register 

(77 FR 37678) entitled, ‘‘Application 

from the Accreditation Association for 

Ambulatory Health Care for Continued 

Approval of Its Ambulatory Surgical 

Centers Accreditation Program’’ 

announcing the AAAHC’s request for 

continued approval of its ASC 

accreditation program. 

Under section 1865(a)(2) of the Act 

and in our regulations at § 488.4 and 

§ 488.8, we conducted a review of 

AAAHC’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 

AAAHC’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 AAAHC’s 

accreditation to CMS’s current Medicare 

ASC conditions for coverage. 

• A documentation review of 

AAAHC’s survey process to— 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and AAAHC’s ability to provide 

continuing surveyor training. 

+ Compare AAAHC’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 AAAHC’s procedures for 

monitoring ASC’s found to be out of 

compliance with AAAHC’s program 

requirements. The monitoring 

procedures are used only when AAAHC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

+ Assess AAAHC’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

+ Establish AAAHC’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 AAAHC’s ability to 

provide adequate funding for 

performing required surveys. 

+ Confirm AAAHC’s policies with 

respect to whether surveys are 

announced or unannounced. 

+ Obtain AAAHC’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 

AAAHC’s requirements met or 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 AAAHC’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared AAAHC’s ASC 

requirements and survey process with 

the Medicare conditions for certification 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of AAAHC’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(a), AAAHC revised its 

standards to address all contracts. 

• To meet the requirements at 

§ 416.41(c)(1), AAAHC revised its 

standards to address ‘‘the emergency 

care of patients.’’ 

• To meet the requirements at 

§ 416.44, AAAHC revised its standards 

to address the Life Safety Code (LSC) 

survey and created a policy to ensure all 

ASCs receive a complete and 

comprehensive LSC survey. 

• To meet the requirements at 

§ 416.47(a), AAAHC revised its 

standards to address the use of patients 

records. 

• To meet the requirements at 

§ 416.47(b), AAAHC revised its 

standards to address the requirement 

that every record must be accurate, 

legible, and promptly completed. 

• To meet the requirements at 

§ 416.50(b)(1)(ii), AAAHC revised its 

standards to ensure patients have the 

right to ‘‘voice grievances regarding 

treatment or care that is (or fails to be) 

provided.’’ 

• To meet the requirements at 

§ 488.4(a)(5), AAAHC modified its 

policies to improve the accuracy and 

consistency of data submissions to CMS. 

• To meet the requirements at 

§ 488.4(a)(6), AAAHC modified its 


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Federal Register / Vol. 77, No. 228 / Tuesday, November 27, 2012 / Notices 70785 

policies to ensure that all compliant 

investigations are conducted in 

accordance with the requirements in the 

SOM, chapter 5. 

• To meet the requirements at 

§ 488.28(a) and Section 2726 of the 

SOM, AAAHC amended its policies to 

require a Plan of Correction (PoC) for all 

deficiencies cited. 

• To meet the requirements at section 

2728A of the SOM, AAAHC modified its 

policies to include all of the required 

elements in an acceptable PoC. 

• To meet the requirements at 2728B 

of the SOM, AAAHC modified its 

policies regarding timeframes for 

requesting PoCs. 

• To meet the requirements at section 

2728B of the SOM, AAAHC modified its 

policies to ensure that accepted PoCs 

contain all elements specified in the 

SOM. 

• To meet the Medicare requirements 

at section 3012 of the SOM related to 

focused and follow-up surveys, AAAHC 

amended its policies to include the 45- 

day response timeframe. 

• To meet the requirements at 

Appendix L of the SOM— Sampling for 

Initial Surveys, Recertification Surveys, 

or Representative Sample Validation 

Surveys, AAAHC revised its policies to 

ensure surveyors review at least the 

required minimum number of medical 

records during a survey. 

• To meet the requirements at 

Appendix L of the SOM— Use of the 

Infection Control Tool, AAAHC revised 

its survey protocol to ensure 

consistency, completeness and proper 

implementation of the Infection Control 

Tool. 

• To verify AAAHC’s continued 

compliance with the provisions of the 

LSC, CMS will conduct a follow-up 

survey observation within 1 year of the 

date of publication of this final notice. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that 

AAAHC’s requirements for ASCs meet 

or exceed our requirements. Therefore, 

we approve AAAHC as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective December 20, 2012 

through December 20, 2018. 

V. Collection of Information 

Requirements 

This document does not impose any 

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). 

(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. 2012–28728 Filed 11–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7026–N] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Meeting of 

the Advisory Panel on Outreach and 

Education (APOE), December 18, 2012 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

meeting of the Advisory Panel on 

Outreach and Education (APOE) (the 

Panel) in accordance with the Federal 

Advisory Committee Act. The Panel 

advises and makes recommendations to 

the Secretary of Health and Human 

Services and the Administrator of the 

Centers for Medicare & Medicaid 

Services on opportunities to enhance 

the effectiveness of consumer education 

strategies concerning Medicare, 

Medicaid and the Children’s Health 

Insurance Program (CHIP). This meeting 

is open to the public. 

DATES: Meeting Date: Tuesday, 

December 18, 2012, 8:30 a.m. to 4:00 

p.m. Eastern Standard Time (EST). 

Deadline for Meeting Registration, 

Presentations and Comments: Tuesday, 

December 4, 2012, 5:00 p.m., EST. 

Deadline for Requesting Special 

Accommodations: Tuesday, December 

4, 2012, 5:00 p.m., EST. 

ADDRESSES: Meeting Location: The 

Liaison Capitol Hill, 415 New Jersey 

Avenue NW., Washington, DC 20001. 

Presentations and Written Comments: 

Jennifer Kordonski, Designated Federal 

Official (DFO), Division of Forum and 

Conference Development, Office of 

Communications, Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Mailstop S1–13–05, 

Baltimore, MD 21244–1850 or contact 

Ms. Kordonski via email at 

Jennifer.Kordonski@cms.hhs.gov. 

Registration: The meeting is open to 

the public, but attendance is limited to 

the space available. Persons wishing to 

attend this meeting must register at the 

Web site http://events.SignUp4.com/ 

APOEDECMTG or by contacting the 

DFO at the address listed in the 

ADDRESSES section of this notice or by 

telephone at number listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice, by the date listed in the 

DATES section of this notice. Individuals 

requiring sign language interpretation or 

other special accommodations should 

contact the DFO at the address listed in 

the ADDRESSES section of this notice by 

the date listed in the DATES section of 

this notice. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Kordonski, (410) 786–1840. 

Additional information about the APOE 

is available on the Internet at http:// 

www.cms.gov/FACA/04_APOE.asp. 

Press inquiries are handled through the 

CMS Press Office at (202) 690–6145. 

SUPPLEMENTARY INFORMATION: In 

accordance with section 10(a) of the 

Federal Advisory Committee Act 

(FACA), this notice announces a 

meeting of the Advisory Panel on 

Outreach and Education (APOE) (the 

Panel). Section 9(a)(2) of the Federal 

Advisory Committee Act authorizes the 

Secretary of Health and Human Services 

(the Secretary) to establish an advisory 

panel if the Secretary determines that 

the panel is ‘‘in the public interest in 

connection with the performance of 

duties imposed * * * by law.’’ Such 

duties are imposed by section 1804 of 

the Social Security Act (the Act), 

requiring the Secretary to provide 

informational materials to Medicare 

beneficiaries about the Medicare 

program, and section 1851(d) of the Act, 

requiring the Secretary to provide for 

‘‘activities * * * to broadly disseminate 

information to [M]edicare beneficiaries 

* * * on the coverage options provided 

under [Medicare Advantage] in order to 

promote an active, informed selection 

among such options.’’ 

The Panel is also authorized by 

section 1114(f) of the Act (42 U.S.C. 

1314(f)) and section 222 of the Public 

Health Service Act (42 U.S.C. 217a). The 

Secretary signed the charter establishing 

this Panel on January 21, 1999 (64 FR 

7899, February 17, 1999) and approved 

the renewal of the charter on January 21, 

2011 (76 FR 11782, March 3, 2011). 

Pursuant to the amended charter, the 

Panel advises and makes 

recommendations to the Secretary of 

Health and Human Services and the 

Administrator of the Centers for 

Medicare & Medicaid Services (CMS) 

concerning optimal strategies for the 

following: 


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