Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12325 

have a serious or immediate impact on 

patient care. 

G. Subpart R—Enforcement Procedures 

The COLA meets the requirements of 

subpart R to the extent that it applies to 

accreditation organizations. The COLA 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

COLA will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the COLA and report that action to 

us within 30 days. The COLA also 

provides an appeals process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the COLA’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The federal validation inspections of 

laboratories accredited by the COLA 

may be conducted on a representative 

sample basis or in response to 

substantial allegations of 

noncompliance (that is, complaint 

inspections). The outcome of those 

validation inspections, performed by 

CMS or our agents, or the state survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by the COLA remain in 

compliance with CLIA requirements. 

This federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the COLA, 

for cause, before the end of the effective 

date of approval. If we determine that 

the COLA has failed to adopt, maintain 

and enforce requirements that are equal 

to, or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which the COLA would be 

allowed to address any identified issues. 

Should the COLA be unable to address 

the identified issues within that 

timeframe, CMS may, in accordance 

with the applicable regulations, revoke 

COLA’s deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of the COLA’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the CLIA 

program, codified in 42 CFR part 493 

subpart E, are currently approved by 

OMB under OMB approval number 

0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

Authority: Section 353 of the Public 

Health Service Act (42 U.S.C. 263a). 

Dated: February 8, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–03927 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3280–PN] 

Medicare and Medicaid Programs; 

Application From the Center for 

Improvement in Healthcare Quality 

(CIHQ) for CMS-Approval of Its 

Hospital Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice with 

comment period acknowledges the 

receipt of an application from the Center 

for Improvement in Healthcare Quality 

(CIHQ) for recognition as a national 

accrediting organization for hospitals 

that 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 March 25, 2013. 

ADDRESSES: In commenting, refer to file 

code (CMS–3280–PN). Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (choose only one of the ways 

listed): 

1. Electronically. You may submit 

electronic comments on specific issues 

in 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–3280–PN, P.O. Box 8016, 

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–3280–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written ONLY to 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, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously 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: 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

Monda Shaver, (410) 786–3410. 


sroberts on DSK5SPTVN1PROD with NOTICES
12326 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 

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 a hospital provided certain 

requirements are met. Section 1861(e) of 

the Social Security Act (the Act), 

establishes criteria for facilities seeking 

designation as a hospital. Regulations 

concerning provider agreements are 

located at 42 CFR part 489 and those 

pertaining to activities relating to the 

survey and certification of facilities are 

located at 42 CFR part 488. The 

regulations at 42 CFR part 482, specify 

the conditions that a hospital must meet 

to participate in the Medicare programs, 

the scope of covered services, and the 

conditions for Medicare payment for 

hospitals. 

Generally, to enter into an agreement, 

a hospital must first be certified by a 

State survey agency as complying with 

the conditions or requirements set forth 

in part 482 of our regulations. 

Thereafter, the hospital is subject to 

regular surveys by a State survey agency 

to determine whether it continues to 

meet these requirements. 

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. 

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 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. We have 

210 days from the receipt of a 

completed application to publish a 

notice of approval or denial of the 

application. 

The purpose of this proposed notice 

is to inform the public of CIHQ’s request 

for approval of its hospital accreditation 

program. This notice also solicits public 

comment on whether CIHQ’s 

requirements meet or exceed Medicare’s 

conditions of participation for hospitals. 

III. Evaluation of Deeming Authority 

Request 

CIHQ submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

approval of its hospital accreditation 

program. This application was 

determined to be complete on January 4, 

2013. Under section 1865(a)(2) of the 

Act and our regulations at § 488.8 

(Federal review of accrediting 

organizations), our review and 

evaluation of CIHQ will be conducted in 

accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of CIHQ’s 

standards for a hospital as compared 

with CMS’ hospital conditions of 

participation. 

• CIHQ’s survey process to determine 

the following: 

++ CIHQ’s composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ CIHQ’s processes compared to 

those of State agencies, including survey 

frequency, and the ability to investigate 

and respond appropriately to 

complaints against accredited facilities. 

++ CIHQ’s processes and procedures 

for monitoring a hospital that is out of 

compliance with CIHQ’s program 

requirements. These monitoring 

procedures are used only when CIHQ 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the State survey agency 

monitors corrections as specified at 

§ 488.7(d). 

++ CIHQ’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ CIHQ’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 CIHQ’s staff and 

other resources, and its financial 

viability. 

++ CIHQ’s capacity to adequately 

fund required surveys. 

++ CIHQ’s policies with respect to 

whether surveys are announced or 

unannounced. 

++ CIHQ’s agreement to provide CMS 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as CMS 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. 

V. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices 12327 

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 

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: February 14, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–04093 Filed 2–21–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7027–N] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Meeting of 

the Advisory Panel on Outreach and 

Education (APOE), March 27, 2013 

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: Wednesday, 

March 27, 2013, 8:30 a.m. to 4:00 p.m. 

Eastern Daylight Time (EDT). 

Deadline for Meeting Registration, 

Presentations and Comments: 

Wednesday, March 13, 2013, 5:00 p.m., 

EDT. 

Deadline for Requesting Special 

Accommodations: Wednesday, March 

13, 2013, 5:00 p.m., EDT. 

ADDRESSES: Meeting Location: The 

Embassy Row Hotel, 2015 

Massachusetts Avenue NW., 

Washington, DC 20036. 

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/ 

APOEMAR2013MTG 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: 

• Developing and implementing 

education and outreach programs for 

individuals enrolled in, or eligible for, 

Medicare, Medicaid, and the Children’s 

Health Insurance Program (CHIP). 

• Enhancing the federal governments 

effectiveness in informing Medicare, 

Medicaid, and CHIP consumers, 

providers and stakeholders pursuant to 

education and outreach programs of 

issues regarding these and other health 

coverage programs, including the 

appropriate use of public-private 

partnerships to leverage the resources of 

the private sector in educating 

beneficiaries, providers and 

stakeholders. 

• Expanding outreach to vulnerable 

and underserved communities, 

including racial and ethnic minorities, 

in the context of Medicare, Medicaid, 

and CHIP education programs. 

• Assembling and sharing an 

information base of ‘‘best practices’’ for 

helping consumers evaluate health plan 

options. 

• Building and leveraging existing 

community infrastructures for 

information, counseling, and assistance. 

• Drawing the program link between 

outreach and education, promoting 

consumer understanding of health care 

coverage choices and facilitating 

consumer selection/enrollment, which 

in turn support the overarching goal of 

improved access to quality care, 

including prevention services, 

envisioned under health care reform. 

The current members of the Panel are: 

Samantha Artiga, Principal Policy 

Analyst, Kaiser Family Foundation; 

Joseph Baker, President, Medicare 

Rights Center; Philip Bergquist, 

Manager, Health Center Operations, 

CHIPRA Outreach & Enrollment Project 

and Director, Michigan Primary Care 

Association; Marjorie Cadogan, 

Executive Deputy Commissioner, 

Department of Social Services; Jonathan 

Dauphine, Senior Vice President, AARP; 


sroberts on DSK5SPTVN1PROD with NOTICES