Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices 42019 

Disease (MIPCD) Demonstration; Use: 

Under section 4108(d)(1) of the 

Affordable Care Act, we are required to 

contract with an independent entity or 

organization to conduct an evaluation of 

the Medicaid Incentives for Prevention 

of Chronic Disease (MIPCD) 

demonstration. The contractor will 

conduct state site visits, two rounds of 

focus group discussions, interviews 

with key program stakeholders, and 

field a beneficiary satisfaction survey. 

Both the state site visits and interviews 

with key program stakeholders will 

entail one-on-one interviews; however 

each set will have a unique data 

collection form. Thus, each evaluation 

task listed above has a separate data 

collection form and this proposed 

information collection encompasses six 

data collection forms. 

The purpose of the evaluation and 

assessment includes determining the 

following: 

• The effect of such initiatives on the 

use of health care services by Medicaid 

beneficiaries participating in the 

program; 

• The extent to which special 

populations (including adults with 

disabilities, adults with chronic 

illnesses, and children with special 

health care needs) are able to participate 

in the program; 

• The level of satisfaction of 

Medicaid beneficiaries with respect to 

the accessibility and quality of health 

care services provided through the 

program; and 

• The administrative costs incurred 

by state agencies that are responsible for 

administration of the program. 

Subsequent to the initial OMB approval 

issued January 23, 2014, we have added 

two Administrative Cost forms to the 

information collection. The burden 

estimates for this information collection 

have been revised to account for the 

burden associated with the new forms. 

Form Number: CMS–10477 (OMB 

control number: 0938–1219); Frequency: 

Annually; Affected Public: Individuals 

and households, business or other forprofits and not-for-profit institutions, 

State, Local or Tribal Governments; 

Number of Respondents: 4,706; Total 

Annual Responses: 4,706; Total Annual 

Hours: 2,236. (For policy questions 

regarding this collection contact Jean 

Scott at 410–786–6327.) 

2. Type of Information Collection 

Request: Extension of currently 

approved collection; Title of 

Information Collection: Granting and 

Withdrawal of Deeming Authority to 

Private Nonprofit Accreditation 

Organizations and of State Exemption 

Under State Laboratory Programs and 

Supporting Regulations; Use: The 

information required is necessary to 

determine whether a private 

accreditation organization/State 

licensure program standards and 

accreditation/licensure process is at 

least equal to or more stringent than 

those of the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA). If an accreditation organization 

is approved, the laboratories that it 

accredits are ‘‘deemed’’ to meet the 

CLIA requirements based on this 

accreditation. Similarly, if a State 

licensure program is determined to have 

requirements that are equal to or more 

stringent than those of CLIA, its 

laboratories are considered to be exempt 

from CLIA certification and 

requirements. The information collected 

will be used by HHS to: Determine 

comparability/equivalency of the 

accreditation organization standards 

and policies or State licensure program 

standards and policies to those of the 

CLIA program; to ensure the continued 

comparability/equivalency of the 

standards; and to fulfill certain statutory 

reporting requirements. 

Form No.: CMS–R–185 (OMB control 

number: 0938–0686); Frequency: 

Occasionally; Affected Public: Private 

sector—business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 12; Total Annual 

Responses: 96; Total Annual Hours: 

384. (For policy questions regarding this 

collection contact Arlene Lopez at 410– 

786–6782.) 

3. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: State 

Plan Preprint for Medicaid Recovery 

Audit Contractors (RACs); Use: Under 

section 1902(a)(42)(B)(i) of the Social 

Security Act, States are required to 

establish programs to contract with one 

or more Medicaid Recovery Audit 

Contractors (RACs) for the purpose of 

identifying underpayments and 

recouping overpayments under the State 

plan and any waiver of the State plan 

with respect to all services for which 

payment is made to any entity under 

such plan or waiver. Further, the statute 

requires States to establish programs to 

contract with Medicaid RACs in a 

manner consistent with State law, and 

generally in the same manner as the 

Secretary contracts with Medicare 

RACs. State programs contracted with 

Medicaid RACs were not required to be 

fully operational until after December 

31, 2010. States may submit, to CMS, a 

State Plan Amendment (SPA) attesting 

that they will establish a Medicaid RAC 

program. States have broad discretion 

regarding the Medicaid RAC program 

design and the number of entities with 

which they elect to contract. Many 

States already have experience utilizing 

contingency-fee-based Third Party 

Liability recovery contractors. 

Form Number: CMS–10343 (OMB 

control number: 0938–1126); Frequency: 

Once; Affected Public: State, Local, or 

Tribal Governments; Number of 

Respondents: 56; Total Annual 

Responses: 56; Total Annual Hours: 56. 

(For policy questions regarding this 

collection contact Yolanda Green at 

410–786–0798.) 

Dated: July 15, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–16960 Filed 7–17–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3287–FN] 

Medicare and Medicaid Programs; 

Initial Approval of The Compliance 

Team’s (TCT’s) Rural Health Clinic 

(RHC) Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve The 

Compliance Team (TCT) for initial 

recognition as a national accrediting 

organization for Rural Health Clinics 

(RHCs) that wish to participate in the 

Medicare or Medicaid programs. 

DATES: This final notice is effective July 

18, 2014 through July 18, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Valarie Lazerowich, (410) 786–4750, 

Cindy Melanson, (410) 786–0310, or 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a RHC provided certain 

requirements are met. Section 1861(aa) 

and 1905(l)(1) of the Social Security Act 

(the Act) establishes distinct criteria for 

facilities seeking designation as a RHC. 

The minimum requirements that a RHC 

must meet to participate in Medicare are 

set forth in regulation at 42 CFR part 

491, subpart A. The conditions for 

Medicare payment for RHCs are set forth 

at 42 CFR 405, subpart X. Regulations 


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42020 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices 

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. 

For an RHC to enter into a provider 

agreement with the Medicare program, 

the RHC must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

section 1861(aa) of the Act and 42 CFR 

part 491. Thereafter, the RHC is subject 

to regular surveys by a state survey 

agency to determine whether it 

continues to meet these requirements. 

However, there is an alternative to 

surveys by state agencies. Certification 

by a nationally recognized accreditation 

program can substitute for ongoing state 

review. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization (AO) 

that all applicable Medicare conditions 

are met or exceeded, we will 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 (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 have met 

the Medicare conditions. A national AO 

applying for approval of its 

accreditation program under part 488, 

subpart A, must provide us 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 § 488.4 and 

§ 488.8(d)(3). 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On February 24, 2014, we published 

a proposed notice in the Federal 

Register (79 FR 10162) announcing 

TCT’s request for approval of its RHC 

accreditation program. In the proposed 

notice, we detailed our evaluation 

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

Act and in our regulations at § 488.4 and 

§ 488.8, we conducted a review of TCT’s 

application in accordance with the 

criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

TCT’s: (1) Corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and, (5) survey review and decisionmaking process for accreditation. 

• The comparison of TCT’s 

accreditation requirements to our 

current Medicare RHC conditions for 

certification. 

• A documentation review of TCT’s 

survey process to determine the 

following: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and TCT’s ability to provide initial and 

continuing surveyor training. 

++ Compare TCT’s processes to those 

of state survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

++ Evaluate TCT’s procedures for 

monitoring RHCs out of compliance 

with TCT’s program requirements. The 

monitoring procedures are used only 

when TCT identifies non-compliance. If 

non-compliance is identified by the 

state survey agency through validation 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.7(d). 

++ Assess TCT’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ Establish TCT’s ability to provide 

us with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ Determine the adequacy of TCT’s 

staff and other resources. 

++ Confirm TCT’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm TCT’s policies with 

respect to whether surveys are 

announced or unannounced. 

++ Obtain TCT’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 February 

24, 2014 proposed notice also solicited 

public comments regarding whether 

TCT’s requirements met or exceeded the 

Medicare conditions for certification for 

RHCs. We received eight comments in 

response to our proposed notice. All of 

the comments received expressed 

unanimous support for TCT’s RHC 

accreditation program. 

IV. Provisions of the Final Notice 

A. Differences Between TCT’s Standards 

and Requirements for Accreditation and 

Medicare’s Conditions and Survey 

Requirements 

We compared TCT’s RHC 

requirements and survey process with 

the Medicare conditions for certification 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of TCT’s RHC 

application, which were conducted as 

described in section III of this final 

notice, yielded the following: 

• To meet the requirements at § 491.2, 

TCT revised its standards to include the 

definition of ‘‘Secretary’’ and ‘‘Rural 

Area.’’ 

• To meet the requirements at 

§ 491.5(a)(3), TCT revised its standards 

to address the requirement that RHCs 

can be both permanent and mobile 

units. 

• To meet the requirements at 

§ 491.5(d)(1)(i), TCT revised its 

standards to ensure the requirements 

related to designation of a shortage area 

included the ratio of primary care 

physicians practicing within the area to 

the resident population. 

• To meet the requirements at 

§ 491.7(b)(2)–(3), TCT revised its 

crosswalk to include standards 

concerning the disclosure of the names 

and addresses of the person principally 

responsible for directing the operation 

of the clinic or center and the person 

responsible for medical direction. 

• To meet the requirements at 

§ 491.8(a)(1), TCT revised its standards 

to address the requirement to have one 

or more physicians and one or more 

physician’s assistants or nurse 

practitioners. 

• To meet the requirements at 

§ 491.8(b)(1)(iii), TCT revised its 

standards address the role of the 


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Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Notices 42021 

physician in providing medical orders 

and medical care services to patients of 

the clinic or center. 

• To meet the requirements at 

§ 491.9(b)(4), TCT revised its standards 

to address the requirement that patient 

care policies are reviewed at least 

annually, and as necessary by the clinic 

or center. 

• To meet the requirements at 

§ 491.9(c)(2), TCT revised its standards 

to ensure laboratory services are 

provided in accordance with the 

requirements at 42 CFR Part 493 and 

Section 353 of the Public Health Service 

Act. 

• To meet the requirements at 

§ 491.9(d)(1), TCT revised its standards 

to require the clinic or center have an 

agreement or arrangement with one or 

more providers or suppliers 

participating under Medicare or 

Medicaid to furnish other services to its 

patients. 

• TCT developed an action plan to 

ensure compliance with its own policies 

regarding RHCs receiving the correct 

accreditation date on their notice of 

survey results. 

• To meet the requirements at 

§ 488.4(a)(6), TCT revised its policies to 

ensure timeframes for investigation of 

complaints are comparable with the 

requirements in section 5075.9 of the 

State Operations Manual. 

• To meet the requirements at 

§ 489.13(b), TCT revised its policies to 

clarify that the effective date of the 

agreement or approval is determined by 

the CMS Regional Office and may not be 

earlier than the latest of the dates of 

which CMS determines that all 

applicable federal requirements are met. 

TCT revised all Clinic Advisor On-Site 

Worksheets to include a descriptive title 

for the requirement of each worksheet 

for increased clarity. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that TCT’s 

RHC accreditation program 

requirements meet or exceed our 

requirements. Therefore, we approve 

TCT as a national accreditation 

organization for RHCs that request 

participation in the Medicare program, 

effective July 18, 2014 through July 18, 

2018. 

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. 

Dated: July 8, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–16735 Filed 7–17–14; 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: Child Care Quarterly Case 

Record Report—ACF–801. 

OMB No.: 0970–0167. 

Description: Section 658K of the Child 

Care and Development Block Grant Act 

of 1990 (P.L. 101–508, 42 U.S.C. 9858) 

requires that States and Territories 

submit monthly case-level data on the 

children and families receiving direct 

services under the Child Care and 

Development Fund. The implementing 

regulations for the statutorily required 

reporting are at 45 CFR 98.70. Case-level 

reports, submitted quarterly or monthly 

(at grantee option), include monthly 

sample or full population case-level 

data. The data elements to be included 

in these reports are represented in the 

ACF–801. ACF uses disaggregate data to 

determine program and participant 

characteristics as well as costs and 

levels of child care services provided. 

This provides ACF with the information 

necessary to make reports to Congress, 

address national child care needs, offer 

technical assistance to grantees, meet 

performance measures, and conduct 

research. Consistent with the statute and 

regulations, ACF requests extension of 

the ACF–801 without changes. 

Respondents: States, the District of 

Columbia, and Territories including 

Puerto Rico, Guam, the Virgin Islands, 

American Samoa, and the Northern 

Marianna Islands. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

ACF–801 .......................................................................................................... 56 4 25 5,600 

Estimated Total Annual Burden 

Hours: 5,600. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 


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