36522 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

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 as determined 

by CMS. Det Norske Veritas Healthcare’s 

(DNVHC) current term of approval for 

its CAH accreditation program expires 

December 23, 2014. 

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 us 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 DNVHC’s 

request for continued CMS approval of 

its CAH accreditation program. This 

notice also solicits public comment on 

whether DNVHC’s requirements meet or 

exceed the Medicare conditions of 

participation (CoPs) for CAHs. 

III. Evaluation of Deeming Authority 

Request 

DNVHC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its CAH 

accreditation program. This application 

was determined to be complete on May 

2, 2014. Under section 1865(a)(2) of the 

Act and our regulations at § 488.8 

(federal review of accrediting 

organizations), our review and 

evaluation of DNVHC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of DNVHC’s 

standards for CAHs as compared with 

CMS’ CAH CoPs. 

• DNVHC’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 DNVHC’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ DNVHC’s processes and 

procedures for monitoring a CAH found 

out of compliance with DNVHC’s 

program requirements. These 

monitoring procedures are used only 

when DNVHC identifies 

noncompliance. If noncompliance is 

identified through validation reviews or 

complaint surveys, the state survey 

agency monitors corrections as specified 

at § 488.7(d). 

++ DNVHC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ DNVHC’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 DNVHC’s staff 

and other resources, and its financial 

viability. 

++ DNVHC’s capacity to adequately 

fund required surveys. 

++ DNVHC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ DNVHC’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 (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 

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. 

Dated: June 18, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–15100 Filed 6–26–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3297–PN] 

Medicare and Medicaid Programs: 

Application From the Joint 

Commission for Continued Approval of 

Its Ambulatory Surgical Center 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Joint Commission 

for continued recognition as a national 

accrediting organization for ambulatory 

surgical centers (ASCs) 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 July 28, 2014. 

ADDRESSES: In commenting, please refer 

to file code CMS–3297–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways: 

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 (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3297– 

PN, P.O. Box 8016, Baltimore, MD 

21244–8010. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 36523 

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–3297–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 comments 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.) 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

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. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Monda Shaver, (410) 786–3410. Cindy 

Melanson, (410) 786–0310. Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering issues and 

developing policies. Referencing the file 

code CMS–3297–PN and the specific 

‘‘issue identifier’’ that precedes the 

section on which you choose to 

comment will assist us in fully 

considering issues and developing 

policies. 

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 from 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 minimum 

conditions that an ASC must meet to 

participate in the Medicare program. 

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 of our regulations. Thereafter, 

the ASC 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 of the 

Department of Health and Human 

Services (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 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or as determined 

by CMS. 

The Joint Commission’s current term 

of approval for their ASC accreditation 

program expires December 20, 2014. 

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 the Joint 

Commission’s request for continued 

approval of its ASC accreditation 

program. This notice also solicits public 

comment on whether the Joint 

Commission’s requirements meet or 

exceed the Medicare conditions for 

coverage (CfCs) for ASCs. 

III. Evaluation of Deeming Authority 

Request 

The Joint Commission 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 


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36524 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

complete on May 2, 2014. Under 

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

regulations at § 488.8 (Federal review of 

accrediting organizations), our review 

and evaluation of the Joint Commission 

will be conducted in accordance with, 

but not necessarily limited to, the 

following factors: 

• The equivalency of the Joint 

Commission’s standards for ASCs as 

compared with our ASC CfCs. 

• The Joint Commission’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 the Joint 

Commission’s processes to those of 

State agencies, including survey 

frequency, and the ability to investigate 

and respond appropriately to 

complaints against accredited facilities. 

++ The Joint Commission’s processes 

and procedures for monitoring an ASC 

found out of compliance with the Joint 

Commission’s program requirements. 

These monitoring procedures are used 

only when the Joint Commission 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the State survey agency 

monitors corrections as specified at 

§ 488.7(d). 

++ The Joint Commission’s capacity 

to report deficiencies to the surveyed 

facilities and respond to the facility’s 

plan of correction in a timely manner. 

++ The Joint Commission’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 the Joint 

Commission’s staff and other resources, 

and its financial viability. 

++ The Joint Commission’s capacity 

to adequately fund required surveys. 

++ The Joint Commission’s policies 

with respect to whether surveys are 

announced or unannounced, to assure 

that surveys are unannounced. 

++ The Joint Commission’s 

agreement to provide CMS with a copy 

of the most current accreditation survey 

together with any other information 

related to the survey that we may 

require (including corrective action 

plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, no 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). 

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 

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. 

Dated: June 18, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–15101 Filed 6–26–14; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3290–FN] 

Medicare and Medicaid Programs; 

Continued Approval of The Joint 

Commission’s (TJC’s) Hospital 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve The Joint 

Commission (TJC) for continued 

recognition as a national accrediting 

organization for hospitals that wish to 

participate in the Medicare or Medicaid 

programs. A hospital that participates in 

Medicaid must also meet the Medicare 

conditions of participation (CoPs) as 

required under section 1905(a) of the 

Social Security Act (‘‘Act’’) and 42 CFR 

482.1(a)(5). This approval is effective 

July 15, 2014 through July 15, 2020. 

DATES: This final notice is effective July 

15, 2014 through July 15, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Monda Shaver (410) 786–3410, Cindy 

Melanson, (410) 786–0310, or Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A healthcare provider may enter into 

an agreement with Medicare to 

participate in the program as a hospital 

provided certain requirements are met. 

Section 1861(e) of the Social Security 

Act (the Act) establishes criteria for 

providers seeking participation as a 

hospital. Regulations concerning 

Medicare provider agreements in 

general are at 42 CFR part 489 and those 

pertaining to the survey and 

certification for Medicare participation 

of providers and certain types of 

suppliers are at part 488. The 

regulations at part 482 specify the 

specific conditions that a provider must 

meet to participate in the Medicare 

program as a hospital. 

Generally, to enter into a Medicare 

hospital provider agreement, a facility 

must first be certified as complying with 

the conditions set forth in part 482 and 

recommended to us for participation by 

a state survey agency. Thereafter, the 

hospital is subject to periodic surveys 

by a state survey agency to determine 

whether it continues to meet these 

conditions. However, there is an 

alternative to certification surveys by 

state agencies. Accreditation by a 

nationally recognized Medicare 

accreditation program approved by us 

may substitute for both initial and 

ongoing state review. 

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

that, if the Secretary finds that 

accreditation of a provider entity by an 

approved national accrediting 

organization meets or exceeds all 

applicable Medicare conditions, we may 

treat the provider entity as having met 

those conditions, that is, we may 

‘‘deem’’ the provider entity to be in 

compliance. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

Part 488, subpart A, implements the 

provisions of section 1865 and requires 

that a national accrediting organization 

applying for approval of its Medicare 

accreditation program must provide us 

with reasonable assurance that the 

accrediting organization requires its 

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 Medicare 

accreditation program every 6 years or 

sooner as determined by us. TJC’s 

current term of approval as a recognized 


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