65676 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

ACTION: Notice of charter renewal. 

SUMMARY: This gives notice that under 

the Federal Advisory Committee Act of 

October 6, 1972, that the Mine Safety 

and Health Research Advisory 

Committee (MSHRAC), Centers for 

Disease Control and Prevention, 

Department of Health and Human 

Services, has been renewed for a 2-year 

period through November 30, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey H. Welsh, Designated Federal 

Officer, CDC/Mine Safety and Health 

Research Advisory Committee 

(MSHRAC), CDC, HHS, 626 Cochrans 

Mill Road, Pittsburgh, PA 15236, 

Telephone 412–386–4040, juw5@

cdc.gov. 

The Chief Operating Officer, Centers 

for Disease Control and Prevention, has 

been delegated the authority to sign 

Federal Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–27720 Filed 12–20–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3362–FN] 

Medicare and Medicaid Programs: 

Approval of the Accreditation 

Association for Ambulatory Health 

Care, Inc. (AAAHC) Application for 

Continued Approval of Its Ambulatory 

Surgical Center Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the 

Accreditation Association for 

Ambulatory Health Care, Inc. for 

continued recognition as a national 

accrediting organization for ambulatory 

surgical centers that wish to participate 

in the Medicare or Medicaid programs. 

DATES: Applicable Date: December 20, 

2018 through December 20, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636, 

Monda Shaver, (410) 786–3410, or 

Renee Henry, (410) 786–7828. 

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. Sections 

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 as 

complying with the conditions set forth 

in part 416 and recommended to the 

Centers for Medicare & Medicaid 

Services (CMS) for participation by a 

state survey agency. Thereafter, the ASC 

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 CMS may substitute for 

both initial and ongoing state review. 

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

that, if the Secretary of the Department 

of Health and Human Services finds that 

accreditation of a provider entity by an 

approved national accrediting 

organization meets or exceeds all 

applicable Medicare conditions or 

requirements, we may deem the 

provider entity as having met those 

conditions or requirements. 

Accreditation by an accrediting 

organization is voluntary and is not 

required for Medicare participation. 

A national accrediting organization 

applying for approval of its Medicare 

accreditation program under part 488, 

subpart A, must provide CMS 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. 

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 July 26, 2018, we published a 

proposed notice entitled ‘‘Application 

from the Accreditation Association for 

Ambulatory Health Care, Inc. (AAAHC) 

for Continued Approval of its 

Ambulatory Surgical Center 

Accreditation Program’’ in the Federal 

Register (83 FR 35486) announcing 

AAAHC’s request for continued 

approval of its Medicare 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 § 488.5, we 

conducted a review of AAAHC’s 

Medicare ASC accreditation renewal 

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 ASC surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited ASCs; and, (5) survey review 

and decision-making process for 

accreditation. 

• The comparison of AAAHC’s 

Medicare ASC accreditation program 

standards to our current Medicare ASC 

conditions for coverage (CfCs). 

• 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 we require of state survey 

agencies, including periodic resurvey 

and the ability to investigate and 

respond appropriately to complaints 

against accredited ASCs. 

++ Evaluate AAAHC’s procedures for 

monitoring ASCs it has found to be out 

of compliance with AAAHC’s program 

requirements. (This pertains only to 

monitoring procedures when AAAHC 

identifies non-compliance. If 

noncompliance is identified by a state 

survey agency through a validation 

survey, the state survey agency monitors 

corrections as specified at § 488.9(c).) 

++ Assess AAAHC’s ability to report 

deficiencies to the surveyed ASC and 

respond to the ASCs plan of correction 

in a timely manner. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65677 

++ 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 

AAAHC’s staff and other resources. 

++ Confirm AAAHC’s ability to 

provide adequate funding for 

performing required surveys. 

++ Confirm AAAHC’s policies with 

respect to surveys being 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 July 26, 

2018 proposed notice also solicited 

public comments regarding whether 

AAAHC’s requirements met or exceeded 

the Medicare CfCs for ASCs. We 

received no 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 Conditions 

and Survey Requirements 

We compared AAAHC’s ASC 

accreditation program requirements and 

survey process with the Medicare CfCs 

at part 416, and the survey and 

certification process requirements of 

parts 488 and 489. Our review and 

evaluation of AAAHC’s ASC 

application, which were conducted as 

described in section III of this final 

notice, yielded the following areas 

where, as of the date of this notice, 

AAAHC has revised its standards and 

certification processes in order to meet 

the requirements at: 

• § 416.44(b)(1), to ensure its 

standards appropriately reference Life 

Safety Code requirements; 

• § 416.44(c), to ensure its standards 

appropriately reference Life Safety Code 

requirements; 

• § 416.44(c)(1)(iv), to ensure its 

standards appropriately reference Life 

Safety Code requirements; 

• § 488.5(a)(4)(ii), to ensure 

comparability of AAAHC’s survey 

process and surveyor guidance to those 

required for state survey agencies 

conducting federal Medicare surveys for 

the same provider or supplier type; 

• § 488.5(a)(4)(iv), to ensure all 

identified areas of non-compliance are 

clearly documented and cited 

appropriately in the final survey report. 

• § 488.5(a)(7) through (9), to ensure 

its surveyors are appropriately qualified, 

trained and maintain competence 

during extended periods of time without 

conducting a survey; 

• § 488.5(a)(11)(ii), to ensure accurate 

survey findings are reported to CMS; 

• § 488.5(a)(12), to ensure complaints 

are triaged appropriately and surveyed 

within the required timeframes; 

• § 488.18(a), to ensure that the 

findings are documented and written 

within the principles of documentation. 

• § 488.26(b), to ensure deficiencies 

are cited at the appropriate level based 

on manner and degree of findings; and 

• § 488.28(d), to ensure that its 

policies for correction of deficiencies in 

ASCs is comparable to CMS 

requirements, requiring that deficiencies 

normally must be corrected within 60 

days. 

• § 489.13(c), to ensure that all 

accreditation requirements have been 

met before granting accreditation and 

making a recommendation for 

participation or continued participation 

in the Medicare program comparable to 

CMS requirements, requiring that 

deficiencies normally must be corrected 

within 60 days. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we approve AAAHC as a 

national accreditation organization for 

ASCs that request participation in the 

Medicare program, effective December 

20, 2018 through December 20, 2024. 

V. 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: December 14, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–27592 Filed 12–20–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: Head Start Program Information 

Report. 

OMB No.: 0970–0427. 

Description: The Office of Head Start 

within the Administration for Children 

and Families, United States Department 

of Health and Human Services, is 

proposing to renew, with changes, 

authority to collect information using 

the Head Start Program Information 

Report (PIR), monthly enrollment, 

contacts, and center locations. All 

information is collected electronically 

through the Head Start Enterprise 

System (HSES). The PIR provides 

information about Head Start and Early 

Head Start services received by the 

children and families enrolled in Head 

Start programs. The information 

collected in the PIR is used to inform 

the public about these programs, to 

make periodic reports to Congress about 

the status of children in Head Start 

programs as required by the Head Start 

Act, and to assist the administration and 

training/technical assistance of Head 

Start programs. Other program data is 

used to track enrollment, contact the 

program, provide a locator for parents to 

find a nearby program, and for 

oversight. 

Respondents: Head Start and Early 

Head Start program grant recipients. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Head Start Program Information Report .......................................................... 3,449 1 4 13,796 

Grantee Monthly Enrollment Reporting ........................................................... 2,066 12 0.05 1,240 

Contacts, Center Locations ............................................................................. 3,449 1 0.25 862 


amozie on DSK3GDR082PROD with NOTICES1