29120 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 

• Section 491.12(c)(3)(i), to update its 

standard to include reference to RHC 

‘‘staff’’ and to delete reference to 

‘‘FQHC.’’ 

• Section 491.12(d)(1)(iv), to update 

surveyor guidance to include specific 

examples of acceptable methods for 

documenting the evaluation of the 

effectiveness of RHC staff training, and 

the demonstration of RHC staff 

knowledge and competency. 

• To clearly include frequency of 

monitoring on-going compliance as a 

required element for acceptable plan of 

corrections. 

• To clarify its Administrative Policy 

regarding removal and denial of 

accreditation. 

• To ensure each deficiency is cited 

at the appropriate level according to the 

scope and severity of the finding. 

• To ensure all provider-submitted 

plans of correction address all noncompliant practices identified on 

survey. 

• To address the inaccurate reporting 

of facility and survey data to CMS. 

• To provide evidence ensuring staff 

were educated on its policy related 

required personal file documents to be 

located on site at the RHC. 

• To provide evidence ensuring staff 

are educated on its policy related to 

deficiencies that are corrected onsite. 

• To identify patient medical records 

while protecting the patient’s identity 

during the survey event. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that TCT’s 

rural health clinic requirements meet or 

exceed our requirements, and its survey 

processes are comparable to ours. 

Therefore, we approve TCT as a national 

accreditation organization for hospitals 

that request participation in the 

Medicare program, effective July 18, 

2018 through July 18, 2024. 

VI. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Dated: June 11, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–13436 Filed 6–21–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3358–PN] 

Medicare and Medicaid Programs: 

Application From the American 

Association for Accreditation of 

Ambulatory Surgery Facilities, Inc. 

(AAAASF) for Continued Approval of 

its Ambulatory Surgical Center 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the American 

Association for Accreditation of 

Ambulatory Surgery Facilities, Inc. for 

continued recognition as a national 

accrediting organization for Ambulatory 

Surgical Centers 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 23, 2018. 

ADDRESSES: In commenting, refer to file 

code CMS–3358–PN. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on 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–3358–PN, P.O. Box 8010, 

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–3358–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT:

Erin McCoy, (410) 786–2337. 

Monda Shaver, (410) 786–3410. 

Marie Vasbinder, (410) 786–8665. 

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 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

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 

conditions that an ASC must meet in 

order 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 of our Medicare 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 a Centers for 

Medicare & Medicaid Services (CMS) 

approved national accrediting 

organization (AO) that all applicable 

Medicare conditions are met or 

exceeded, we may deem those provider 

entities as having met the requirements. 

Accreditation by an AO is voluntary and 

is not required for Medicare 

participation. 

If an AO is recognized by the 

Secretary of the Department of Health 

and Human Services as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program may be deemed to meet the 

Medicare conditions. An AO applying 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 29121 

for approval of its accreditation program 

under part 488, subpart A, must provide 

CMS with reasonable assurance that the 

AO requires the accredited provider 

entities to meet requirements that are at 

least as stringent as the Medicare 

conditions. Our regulations concerning 

the approval of AOs are set forth at 

§ 488.5. 

The American Association for 

Accreditation of Ambulatory Surgery 

Facilities, Inc.’s (AAAASF’s) current 

term of approval for its ASC program 

expires November 27, 2018. 

II. Provisions of the Proposed Notice 

A. Approval of Deeming Organizations 

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

regulations at § 488.5 require that our 

findings concerning review and 

approval of an AO’s requirements 

consider, among other factors, the 

applying AO’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 AAAASF’s 

request for continued CMS-approval of 

its ASC accreditation program. This 

notice also solicits public comment on 

whether AAAASF’s requirements meet 

or exceed the Medicare conditions for 

coverage (CfCs) for ASCs. 

B. Evaluation of Deeming Authority 

Request 

AAAASF submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued CMS-approval of its ASC 

accreditation program. This application 

was determined to be complete on May 

1, 2018. Under Section 1865(a)(2) of the 

Act and our regulations at § 488.5, our 

review and evaluation of AAAASF will 

be conducted in accordance with, but 

not necessarily limited to, the following 

factors: 

• The equivalency of AAAASF’s 

standards for ASCs as compared with 

Medicare’s CfCs for ASCs. 

• AAAASF’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 AAAASF’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ AAAASF’s processes and 

procedures for monitoring an ASC 

found out of compliance with 

AAAASF’s program requirements. 

These monitoring procedures are used 

only when AAAASF identifies 

noncompliance. If noncompliance is 

identified through validation reviews or 

complaint surveys, the State survey 

agency monitors corrections as specified 

at § 488.9(c)(1). 

++ AAAASF’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ AAAASF’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 AAAASF’s staff 

and other resources, and its financial 

viability. 

++ AAAASF’s capacity to adequately 

fund required surveys. 

++ AAAASF’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ 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 CMS may require (including 

corrective action plans). 

C. Notice Upon Completion of 

Evaluation 

Upon completion of our evaluation, 

including evaluation of public 

comments received as a result of this 

notice, we will publish a final notice in 

the Federal Register announcing the 

result of our evaluation. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

IV. 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: May 29, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–13435 Filed 6–21–18; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7050–N2] 

Medicare & Medicaid Programs, and 

Other Program Initiatives, and 

Priorities; Meeting of the Advisory 

Panel on Outreach and Education 

(APOE), June 20, 2018 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Cancellation of meeting. 

SUMMARY: On June 1, 2018, we 

published a Federal Register notice (83 

FR 25461) announcing a new meeting of 

the Advisory Panel on Outreach and 

Education (APOE) (the Panel), which 

was scheduled for Wednesday, June 20, 

2018. This notice announces the 

cancellation of the June 20, 2018 

meeting. 

FOR FURTHER INFORMATION CONTACT: 

Lynne Johnson, Acting Designated 

Federal Official, Office of 

Communications, CMS, 7500 Security 

Boulevard, Mail Stop S1–05–06, 

Baltimore, MD 21244, 410–786–0897, 

email Lynne.Johnson@cms.hhs.gov. 

Additional information about the APOE 

is available on the internet at: http://

www.cms.gov/Regulations-andGuidance/Guidance/FACA/APOE.html. 

Press inquiries are handled through the 

CMS Press Office at (202) 690–6145. 


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