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. 


daltland on DSKBBV9HB2PROD with NOTICES
29122 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 

Dated: June 19, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–13503 Filed 6–20–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Decisions Related to the Development 

of a Clearinghouse of Evidence-Based 

Practices in Accordance With the 

Family First Prevention Services Act of 

2018 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families, HHS, solicits 

comments by July 22, 2018 on initial 

criteria and potential candidate 

programs and services for review in a 

Clearinghouse of evidence-based 

practices in accordance with the Family 

First Prevention Services Act of 2018. 

The Clearinghouse will identify 

promising, supported, and wellsupported practices for mental health 

and substance abuse prevention and 

treatment programs, in-home parent 

skill-based programs, and kinship 

navigator programs appropriate for 

children who are candidates for foster 

care pregnant or parenting foster youth, 

and the parents or kin caregivers of 

those children and youth. 

SUPPLEMENTARY INFORMATION: Invitation 

to Comment: HHS invites comments 

regarding this Notice. To ensure that 

your comments have maximum effect, 

please identify clearly the section of this 

Notice that your comment addresses. 

1.0 Background and Legislative 

Context 

The Family First Prevention Services 

Act (FFPSA) was signed into law as part 

of the Bipartisan Budget Act (H.R. 1892) 

on February 9, 2018. FFPSA enables 

States to use Federal funds available 

under parts B and E of title IV of the 

Social Security Act to provide enhanced 

support to children and families and 

prevent foster care placements through 

the provision of evidence-based mental 

health and substance abuse prevention 

and treatment services, in-home parent 

skill-based programs, and kinship 

navigator services. As described in the 

statutory language, these services and 

programs are intended ‘‘for children 

who are candidates for foster care or 

who are pregnant or parenting foster 

youth and the parents or kin caregivers 

of the children’’. 

FFPSA requires an independent 

systematic review of evidence to 

designate programs and services as 

‘‘promising,’’ ‘‘supported,’’ and ‘‘wellsupported’’ practices, defined as follows 

in section 471(e)(4)(C): 

• Promising Practice: ‘‘A practice shall be 

considered to be a ‘promising practice’ if the 

practice is superior to an appropriate 

comparison practice using conventional 

standards of statistical significance (in terms 

of demonstrated meaningful improvements 

in validated measures of important child and 

parent outcomes, such as mental health, 

substance abuse, and child safety and wellbeing), as established by the results or 

outcomes of at least one study that—(1) was 

rated by an independent systematic review 

for the quality of the study design and 

execution and determined to be welldesigned and well-executed; and (2) utilized 

some form of control (such as an untreated 

group, a placebo group, or a wait list study).’’ 

• Supported Practice: ‘‘A practice shall be 

considered to be a ‘supported practice’ if (I) 

the practice is superior to an appropriate 

comparison practice using conventional 

standards of statistical significance (in terms 

of demonstrated meaningful improvements 

in validated measures of important child and 

parent outcomes, such as mental health, 

substance abuse, and child safety and wellbeing), as established by the results or 

outcomes of at least one study that—(aa) was 

rated by an independent systematic review 

for the quality of the study design and 

execution and determined to be welldesigned and well-executed; and (bb) was a 

rigorous random-controlled trial (or, if not 

available, a study using a rigorous quasiexperimental research design); and (cc) was 

carried out in a usual care or practice setting 

and (II) the study described in sub-clause (I) 

established that the practice has a sustained 

effect (when compared to a control group) for 

at least 6 months beyond the end of 

treatment.’’ 

• Well-supported Practice: ‘‘A practice 

shall be considered to be a ‘well-supported 

practice’ if (I) the practice is superior to an 

appropriate comparison practice using 

conventional standards of statistical 

significance (in terms of demonstrated 

meaningful improvements in validated 

measures of important child and parent 

outcomes, such as mental health, substance 

abuse, and child safety and well-being), as 

established by the results or outcomes of at 

least two studies that—(aa) were rated by an 

independent systematic review for the 

quality of the study design and execution and 

determined to be well-designed and wellexecuted; and (bb) were rigorous randomcontrolled trials (or, if not available, studies 

using a rigorous quasi-experimental research 

design); and (cc) were carried out in a usual 

care or practice setting and (II) at least one 

of the studies described in sub-clause (I) 

established that the practice has a sustained 

effect (when compared to a control group) for 

at least 1 year beyond the end of treatment.’’ 

In accordance with FFPSA, practices 

must also meet the following 

requirements: 

• Book or manual: The practice has a 

book, manual, or other available writings that 

specify the components of the practice 

protocol and describe how to administer the 

practice. 

• No empirical risk of harm: There is no 

empirical basis suggesting that, compared to 

its likely benefits, the practice constitutes a 

risk of harm to those receiving it. 

• Weight of evidence supports benefits: If 

multiple outcome studies have been 

conducted, the overall weight of evidence 

supports the benefits of the practice. 

• Reliable and valid outcome measures: 

Outcome measures are reliable and valid, and 

are administrated consistently and accurately 

across all those receiving the practice. 

• No case data for severe or frequent risk 

of harm: There is no case data suggesting a 

risk of harm that was probably caused by the 

treatment and that was severe or frequent 

(section 471(e)(4)(C)(ii) of the Act). 

In order to meet these requirements, 

the Administration for Children and 

Families (ACF) in the Department of 

Health and Human Services (HHS) 

intends to establish and maintain a 

public Clearinghouse of practices, 

including culturally specific, or 

location- or population-based 

adaptations of practices, identified via a 

systematic review of evidence on 

relevant programs and services. In 

accordance with FFPSA and building 

from other federal evidence reviews, 

HHS is developing initial criteria that 

will be used to designate programs and 

services as promising, supported, and 

well-supported practices. HHS will also 

identify a preliminary list of candidate 

services and programs that will be 

considered for systematic review. 

This Notice (1) identifies and requests 

comment on potential initial criteria for 

(a) identifying eligible programs and 

services for review by the 

Clearinghouse, (b) prioritizing eligible 

programs and services for review, (c) 

identifying eligible studies aligned with 

prioritized programs and services, (d) 

prioritizing eligible studies for rating, (e) 

rating studies, and (f) rating programs 

and services as promising, supported, 

and well-supported practices. This 

Notice (2) requests comment on 

potential programs and services that 

may meet the aforementioned criteria 

and that should be considered as 

candidates for systematic review. After 

comments are received, HHS will revise 

and publish the initial criteria and a 

preliminary list of candidate programs 

and services to be considered for 

review; and begin to conduct reviews. 

This Notice is one step in ensuring that 

activities associated with the 

development of a Clearinghouse are 


daltland on DSKBBV9HB2PROD with NOTICES