Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 66271 

objectives for treatment of tuberculosis 

(TB), prevention of multi-drug 

resistance, and surveillance programs, 

CDC is requesting approval from the 

Office of Management and Budget to 

continue information collection from 

participants in the Model Performance 

Evaluation Program for Mycobacterium 

tuberculosis Susceptibility Testing. This 

revision request includes (a) 

modification of the Participant Biosafety 

Compliance Letter of Agreement to 

contain language to ensure that 

participants understand and comply 

with biosafety guidelines using quality 

management system practices; (b) 

modification of Instructions to 

Participants Letter to include detailed 

instructions for online data entry of DST 

results; (c) modification of MPEP 

Mycobacterium tuberculosis Results 

Worksheet to include fields for entering 

methods used for conventional and 

molecular DST; (d)addition of a MPEP 

Mycobacterium tuberculosis Minimum 

Inhibitory Concentration (MIC) Results 

form for laboratories performing this 

procedure to enter results manually and 

submit by email to TBMPEP@cdc.gov; 

and (e) reduction in request for burden 

hours from 156 hours to 129 hours due 

to fewer laboratories participating in the 

program compared to the previous 

submission request. 

While the overall number of cases of 

TB in the U.S. has decreased, rates still 

remain high among foreign-born 

persons, prisoners, homeless 

populations, and individuals infected 

with HIV in major metropolitan areas. 

To reach the goal of eliminating TB, the 

Model Performance Evaluation Program 

for Mycobacterium tuberculosis Drug 

Susceptibility Testing is used to monitor 

and evaluate performance and practices 

among national laboratories performing 

M. tuberculosis susceptibility testing. 

Participation in this program is one way 

laboratories can ensure high-quality 

laboratory testing, resulting in accurate 

and reliable testing results. 

Revision of this information 

collection provides CDC with an 

evaluation program to assess the ability 

of the laboratories to test for drug 

resistant M. tuberculosis strains, 

laboratories also have a self-assessment 

tool to aid in optimizing their skills in 

susceptibility testing. The information 

obtained from the laboratories on 

susceptibility practices and procedures 

is used to establish variables related to 

good performance, assessing training 

needs, and aid with the development of 

practice standards. 

Participants in this program include 

domestic clinical and public health 

laboratories. Data collection from 

laboratory participants occurs twice per 

year. The data collected in this program 

will include the susceptibility test 

results of primary and secondary drugs, 

drug concentrations, and test methods 

performed by laboratories on a set of 

performance evaluation (PE) samples. 

The PE samples are sent to participants 

twice a year. Participants also report 

demographic data such as laboratory 

type and the number of tests performed 

annually. 

There is no cost to respondents to 

participate other than their time. Total 

burden hours is 129. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Domestic Laboratories .................................... Participant Biosafety Compliance Letter of 

Agreement.

80 1 5/60 

MPEP Mycobacterium tuberculosis Results 

Worksheet.

80 2 30/60 

Online Survey Instrument .............................. 80 2 15/60 

Minimum Inhibitory Concentration (MIC) Results Form.4 2 15/60 

Jeffrey M. Zirger, 

Acting Lead, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of Science, Centers for Disease Control and 

Prevention. 

[FR Doc. 2018–27853 Filed 12–21–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4188–PN] 

Medicare Program; Request for 

Renewal of Deeming Authority of the 

Utilization Review Accreditation 

Commission (URAC) for Health 

Maintenance Organizations and 

Preferred Provider Organizations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

announces that CMS is considering 

granting approval of the Utilization 

Review Accreditation Commission’s 

(URAC) renewal application for 

Medicare Advantage ‘‘deeming 

authority’’ of Health Maintenance 

Organizations and Preferred Provider 

Organizations. This new 6-year term of 

approval would begin on the date of 

publication of the final notice. This 

notice also announces a 30-day period 

for the public to submit comments on 

CMS’ renewal of the application. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. January 25, 2019. 

ADDRESSES: In commenting, refer to file 

code CMS–4188–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–4188–PN, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

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–4188–PN, 


amozie on DSK3GDR082PROD with NOTICES1
66272 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

FOR FURTHER INFORMATION CONTACT: Greg 

McDonald, (410) 786–8941; or Nick 

Proy, (410) 786–8407. 

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 through a Medicare Advantage 

(MA) organization that contracts with 

CMS. The regulations specifying the 

Medicare requirements that must be met 

for a Medicare Advantage Organization 

(MAO) to enter into a contract with 

CMS are located at 42 CFR part 422. 

These regulations implement Part C of 

Title XVIII of the Social Security Act 

(the Act), which specifies the services 

that an MAO must provide and the 

requirements that the organization must 

meet to be an MA contractor. Other 

relevant sections of the Act are Parts A 

and B of Title XVIII and Part A of Title 

XI pertaining to the provision of 

services by Medicare certified providers 

and suppliers. Generally, for an entity to 

be an MA organization, the organization 

must be licensed by the state as a risk 

bearing organization, as set forth in 42 

CFR part 422. 

As a method of assuring compliance 

with certain Medicare requirements, an 

MA organization may choose to become 

accredited by a CMS approved 

accrediting organization (AO). By virtue 

of its accreditation by a CMS-approved 

AO, the MA organization may be 

‘‘deemed’’ compliant in one or more 

requirements set forth in section 

1852(e)(4)(B) of the Act. For CMS to 

recognize an AO’s accreditation 

program as establishing an MA plan’s 

compliance with our requirements, the 

AO must prove to CMS that their 

standards are at least as stringent as 

Medicare requirements for MA 

organizations. MA organizations that are 

licensed as health maintenance 

organizations (HMOs) or preferred 

provider organizations (PPOs) and are 

accredited by an approved accrediting 

organization may receive, at their 

request, ‘‘deemed’’ status for CMS 

requirements for the deemable areas. At 

this time, recognition of accreditation 

does not include the Part D areas of 

review set out at 42 CFR 423.165(b). 

AOs that apply for MA deeming 

authority are generally recognized by 

the health care industry as entities that 

accredit HMOs and PPOs. As we specify 

at § 422.157(b)(2)(ii) the term for which 

an AO may be approved by CMS may 

not exceed 6 years. For continuing 

approval, the AO must apply to CMS to 

renew their ‘‘deeming authority’’ for a 

subsequent approval period. 

The Utilization Review Accreditation 

Commission (URAC) was approved as a 

CMS approved accreditation 

organization for MA deeming of HMOs 

on May 26, 2012, and that term lapsed 

on May 25, 2018 prior to our decision 

on its renewal application. On October 

13, 2017 URAC submitted its initial 

application to renew its deeming 

authority. On that same date, URAC 

submitted materials requested by CMS 

that included information intended to 

address the requirements set out at 

§ 422.158(a) through (b) that are 

prerequisites for receiving approval of 

its accreditation program from CMS. 

CMS subsequently requested that 

additional materials, including 

revisions, be submitted by URAC to 

satisfy these requirements. 

II. Provisions of the Proposed Notice 

The purpose of this notice is to notify 

the public of URAC’s request to renew 

its Medicare Advantage deeming 

authority for HMOs and PPOs. URAC 

submitted all the necessary materials 

(including its standards and monitoring 

protocol) to enable us to make a 

determination concerning its request for 

approval as an accreditation 

organization for CMS. This renewal 

application was determined to be 

complete on November 8, 2018. Under 

section 1852(e)(4) of the Act and 

§ 422.158 (federal review of accrediting 

organizations), our review and 

evaluation of URAC will be conducted 

as discussed below. 

A. Components of the Review Process 

The review of URAC’s renewal 

application for approval of MA deeming 

authority includes, but is not limited to, 

the following components: 

• The types of MA plans that it would 

review as part of its accreditation 

process. 

• A detailed comparison of the AO’s 

accreditation requirements and 

standards with the Medicare 

requirements (for example, a crosswalk) 

in the following 5 areas: Quality 

Improvement, Anti-Discrimination, 

Confidentiality and Accuracy of 

Enrollee Records, Information on 

Advance Directives, and Provider 

Participation Rules. 

• Detailed information about the 

organization’s survey process, 

including— 

++ Frequency of surveys and whether 

surveys are announced or unannounced. 

++ Copies of survey forms, and 

guidelines and instructions to 

surveyors. 

++ Descriptions of— 

—The survey review process and the 

accreditation status decision making 

process; 

—The procedures used to notify 

accredited MA organizations of 

deficiencies and to monitor the 

correction of those deficiencies; and 

—The procedures used to enforce 

compliance with accreditation 

requirements. 

• Detailed information about the 

individuals who perform surveys for the 

accreditation organization, including— 

++ The size and composition of 

accreditation survey teams for each type 

of plan reviewed as part of the 

accreditation process; 

++ The education and experience 

requirements surveyors must meet; 

++ The content and frequency of the 

in-service training provided to survey 

personnel; 

++ The evaluation systems used to 

monitor the performance of individual 

surveyors and survey teams; and 

++ The organization’s policies and 

practice for the participation, in surveys 

or in the accreditation decision process, 

by an individual who is professionally 

or financially affiliated with the entity 

being surveyed. 

• A description of the organization’s 

data management and analysis system 

for the surveys and accreditation 

decisions, including the kinds of 

reports, tables, and other displays 

generated by that system. 

• A description of the organization’s 

procedures for responding to and 

investigating complaints against 

accredited organizations, including 

policies and procedures regarding 

coordination of these activities with 

appropriate licensing bodies and 

ombudsmen programs. 

• A description of the organization’s 

policies and procedures for the 

withholding or removal of accreditation 

for failure to meet the accreditation 

organization’s standards or 

requirements, and other actions the 

organization takes in response to 

noncompliance with its standards and 

requirements. 

• A description of all types (for 

example, full, partial) and categories (for 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 66273 

1We note that the Citizen’s Advisory Panel on 

Medicare Education is also referred to as the 

Advisory Panel on Medicare Education (65 FR 

4617). The name was updated in the Second 

Amended Charter approved on July 24, 2000. 

example, provisional, conditional, 

temporary) of accreditation offered by 

the organization, the duration of each 

type and category of accreditation and a 

statement identifying the types and 

categories that would serve as a basis for 

accreditation if CMS approves the 

accreditation organization. 

• A list of all currently accredited MA 

organizations and the type, category, 

and expiration date of the accreditation 

held by each of them. 

• A list of all full and partial 

accreditation surveys scheduled to be 

performed by the accreditation 

organization. 

• The name and address of each 

person with an ownership or control 

interest in the accreditation 

organization. 

• CMS will also consider URAC’s 

past performance in the deeming 

program and results of recent deeming 

validation reviews, or look-behind 

audits conducted as part of continuing 

federal oversight of the deeming 

program under § 422.157(d). 

B. Notice Upon Completion of 

Evaluation 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a notice in the Federal 

Register announcing the result of our 

evaluation. Section 1852(e)(4)(C) of the 

Act provides a statutory timetable to 

ensure that our review of deeming 

applications is conducted in a timely 

manner. The Act provides us with 210 

calendar days after the date of receipt of 

an application to complete our survey 

activities and application review 

process. At the end of the 210-day 

period, we must publish an approval or 

denial of the application in the Federal 

Register. 

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. 3501 et seq.). 

IV. Response to 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. 

Dated: December 14, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–27802 Filed 12–21–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7052–N] 

Medicare & Medicaid Programs, and 

Other Program Initiatives, and 

Priorities; Meeting of the Advisory 

Panel on Outreach and Education 

(APOE), January 16, 2019 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the Advisory Panel on 

Outreach and Education (APOE) (the 

Panel) in accordance with the Federal 

Advisory Committee Act. The Panel 

advises and makes recommendations to 

the Secretary of the U.S. Department of 

Health and Human Services (HHS) and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

opportunities to enhance the 

effectiveness of consumer education 

strategies concerning CMS programs, 

initiatives, and priorities. This meeting 

is open to the public. 

DATES:

Meeting Date: Wednesday, January 16, 

2019 8:30 a.m. to 4:00 p.m. eastern 

standard time (e.s.t). 

Deadline for Meeting Registration, 

Presentations, Special Accommodations 

and Comments: Wednesday, January 2, 

2019, 5:00 p.m., e.s.t. 

ADDRESSES: Meeting Location: U.S. 

Department of Health & Human 

Services, Hubert H. Humphrey Building, 

200 Independence Avenue SW, Room 

705A, Conference Room, Washington, 

DC 20201. 

Presentations and Written Comments: 

Presentations and written comments 

should be submitted to: Lynne Johnson, 

Acting Designated Federal Official 

(DFO), Office of Communications, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Mailstop S1–05–06, Baltimore, MD 

21244–1850 or via email at 

Lynne.Johnson@cms.hhs.gov. 

Registration: The meeting is open to 

the public, but attendance is limited to 

the space available. Persons wishing to 

attend this meeting must register at the 

website https://www.regonline.com/ 

apoe2019jan16meeting or by contacting 

the Acting DFO listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice, by the date listed in the 

DATES section of this notice. Individuals 

requiring sign language interpretation or 

other special accommodations should 

contact the Acting DFO at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Lynne Johnson, Acting Designated 

Federal Official, Office of 

Communications, CMS, 7500 Security 

Boulevard, Mail Stop S1–05–06, 

Baltimore, MD 21244–1850, 410–786– 

0090, email Lynne.Johnson@

cms.hhs.gov. Additional information 

about the APOE is available on the 

internet at: http://www.cms.gov/ 

Regulations-and-guidance/Guidance/ 

FACA/APOE.html. Press inquiries are 

handled through the CMS Press Office 

at (202) 690–6145. 

SUPPLEMENTARY INFORMATION:

I. Background 

The Advisory Panel for Outreach and 

Education (APOE) (the Panel) is 

governed by the provisions of Federal 

Advisory Committee Act (FACA) (Pub. 

L. 92–463), as amended (5 U.S.C. 

Appendix 2), which sets forth standards 

for the formation and use of federal 

advisory committees. The Panel is 

authorized by section 1114(f) of the 

Social Security Act (42 U.S.C. 1314(f)) 

and section 222 of the Public Health 

Service Act (42 U.S.C. 217a). 

The Secretary of the U.S. Department 

of Health and Human Services (HHS) 

(the Secretary) signed the charter 

establishing the Citizen’s Advisory 

Panel on Medicare Education 1 (the 

predecessor to the APOE) on January 21, 

1999 (64 FR 7899, February 17, 1999) to 

advise and make recommendations to 

the Secretary and the Administrator of 

the Centers for Medicare & Medicaid 

Services (CMS) on the effective 

implementation of national Medicare 

education programs, including with 

respect to the Medicare+Choice (M+C) 

program added by the Balanced Budget 

Act of 1997 (Pub. L. 105–33). 

The Medicare Modernization Act of 

2003 (MMA) (Pub. L. 108–173) 

expanded the existing health plan 

options and benefits available under the 


amozie on DSK3GDR082PROD with NOTICES1