Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27993 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the 

reapproval of accrediting organizations 

are set forth at § 488.5. The regulations 

at § 488.5(e)(2)(i) require accrediting 

organizations to reapply for continued 

deeming authority every 6 years or 

sooner as we determine. 

The Community Health Accreditation 

Partner’s (CHAP’s) term of approval for 

its hospice accreditation program 

expires November 20, 2018. 

II. 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 a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’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 CHAP’s 

request for continued CMS approval of 

its hospice accreditation program. This 

notice also solicits public comment on 

whether CHAP’s requirements meet or 

exceed the Medicare conditions for 

participation for hospices. 

III. Evaluation of Deeming Authority 

Request 

CHAP submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its hospice 

accreditation program. This application 

was determined to be complete on April 

24, 2018. Under section 1865(a)(2) of the 

Act and our regulations at § 488.5 

(Application and re-application 

procedures for national organizations), 

our review and evaluation of CHAP will 

be conducted in accordance with, but 

not necessarily limited to, the following 

factors: 

• The equivalency of CHAP’s 

standards for hospices as compared 

with CMS’ hospice conditions of 

participation. 

• CHAP’s survey process to 

determine the following: 

++ CHAP’s composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ CHAP’s processes compared to 

those of State agencies, including survey 

frequency, and the ability to investigate 

and respond appropriately to 

complaints against accredited facilities. 

++ CHAP’s processes and procedures 

for monitoring a hospice found out of 

compliance with CHAP’s program 

requirements. These monitoring 

procedures are used only when CHAP 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.9(c). 

++ CHAP’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ CHAP’s capacity to provide CMS 

with electronic data, and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ CHAP’s staff adequacy and other 

resources, and its financial viability. 

++ CHAP’s capacity to adequately 

fund required surveys. 

++ CHAP’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ CHAP’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). 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this proposed 

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. 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: May 29, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–12840 Filed 6–14–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3363–N] 

Medicare Program; Meeting of the 

Medicare Evidence Development and 

Coverage Advisory Committee— 

August 22, 2018 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces that a 

public meeting of the Medicare 

Evidence Development & Coverage 

Advisory Committee (MEDCAC) 

(‘‘Committee’’) will be held on 

Wednesday, August 22, 2018. This 

meeting will focus on the state of 

evidence on Chimeric Antigen Receptor 

(CAR) T-cell therapies that are approved 

by the Food and Drug Administration 

(FDA). We are seeking the MEDCAC’s 

recommendations regarding collection 

of patient reported outcomes (PRO) in 

cancer clinical studies. The MEDCAC 

will specifically focus on appraisal of 

evidence-based PRO assessments to 

provide information that impacts 

patients, their providers, and caregivers 

after a CAR T-cell therapy intervention 

for the patient’s cancer. This meeting is 

open to the public in accordance with 

the Federal Advisory Committee Act. 

DATES: 

Meeting Date: The public meeting will 

be held on Wednesday, August 22, 2018 

from 7:30 a.m. until 4:30 p.m., Eastern 

Daylight Time (EDT). 

Deadline for Submission of Written 

Comments: Written comments must be 

received at the address specified in the 

ADDRESSES section of this notice by 5:00 

p.m., EDT, Monday, July 16, 2018. Once 

submitted, all comments are final. 

Deadlines for Speaker Registration 

and Presentation Materials: The 


sradovich on DSK3GMQ082PROD with NOTICES
27994 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 

deadline to register to be a speaker and 

to submit PowerPoint presentation 

materials and writings that will be used 

in support of an oral presentation is 5:00 

p.m., EDT on Monday, July 16, 2018. 

Speakers may register by phone or via 

email by contacting the person listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice. Presentation 

materials must be received at the 

address specified in the ADDRESSES

section of this notice. 

Deadline for All Other Attendees 

Registration: Individuals may register 

online at http://www.cms.gov/apps/ 

events/upcoming

events.asp?strOrderBy=1&type=3 or by 

phone by contacting the person listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by 5:00 p.m. EDT, 

Wednesday, August 15, 2018. 

We will be broadcasting the meeting 

live via Webcast at http://www.cms.gov/ 

live/. 

Deadline for Submitting a Request for 

Special Accommodations: Persons 

attending the meeting who are hearing 

or visually impaired, or have a 

condition that requires special 

assistance or accommodations, are 

asked to contact the Executive Secretary 

as specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice no later than 5:00 p.m., EDT 

Friday, August 3, 2018. 

ADDRESSES: 

Meeting Location: The meeting will be 

held in the main auditorium of the 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244. 

Submission of Presentations and 

Comments: Presentation materials and 

written comments that will be presented 

at the meeting must be submitted via 

email to MedCACpresentations@

cms.hhs.gov or by regular mail to the 

contact listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice by the date specified in the DATES

section of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, Executive Secretary for 

MEDCAC, Centers for Medicare & 

Medicaid Services, Center for Clinical 

Standards and Quality, Coverage and 

Analysis Group, S3–02–01, 7500 

Security Boulevard, Baltimore, MD 

21244 or contact Ms. Ellis by phone 

(410–786–0309) or via email at 

Maria.Ellis@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MEDCAC, formerly known as the 

Medicare Coverage Advisory Committee 

(MCAC), is advisory in nature, with all 

final coverage decisions resting with 

CMS. MEDCAC is used to supplement 

CMS’ internal expertise. Accordingly, 

the advice rendered by the MEDCAC is 

most useful when it results from a 

process of full scientific inquiry and 

thoughtful discussion, in an open 

forum, with careful framing of 

recommendations and clear 

identification of the basis of those 

recommendations. MEDCAC members 

are valued for their background, 

education, and expertise in a wide 

variety of scientific, clinical, and other 

related fields. (For more information on 

MCAC, see the MEDCAC Charter (http:// 

www.cms.gov/Regulations-andGuidance/Guidance/FACA/Downloads/ 

medcaccharter.pdf) and the CMS 

Guidance Document, Factors CMS 

Considers in Referring Topics to the 

MEDCAC (http://www.cms.gov/ 

medicare-coverage-database/details/ 

medicare-coverage-documentdetails.aspx?MCDId=10)). 

II. Meeting Topic and Format 

This notice announces the 

Wednesday, August 22, 2018, public 

meeting of the Committee. This meeting 

will focus on the state of evidence on 

CAR–T cell therapies that are approved 

by the FDA. We are seeking the 

MEDCAC’s recommendations regarding 

collection of PRO in cancer clinical 

studies. The MEDCAC will specifically 

focus on appraisal of evidence-based 

PRO assessments to provide information 

that impacts patients, their providers, 

and caregivers after a CAR T-cell 

therapy intervention for the patient’s 

cancer. Background information about 

this topic, including panel materials, is 

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

medicare-coverage-database/indexes/

medcac-meetings-index.aspx?bc=

BAAAAAAAAAAA&. We will no longer 

be providing paper copies of the 

handouts for the meeting. Electronic 

copies of all the meeting materials will 

be on the CMS website no later than 2 

business days before the meeting. We 

encourage the participation of 

organizations with expertise in the 

appraisal of the state of evidence for 

patient reported outcomes, development 

of patient reported health outcome 

measures, and use of patient reported 

health outcome assessments in cancer 

clinical trials. This meeting is open to 

the public. The Committee will hear 

oral presentations from the public for 

approximately 45 minutes. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

we may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by July 

23, 2018. Your comments should focus 

on issues specific to the list of topics 

that we have proposed to the 

Committee. The list of research topics to 

be discussed at the meeting will be 

available on the following website prior 

to the meeting: http://www.cms.gov/ 

medicare-coverage-database/indexes/

medcac-meetings-index.aspx?bc=

BAAAAAAAAAAA&. We require that 

you declare at the meeting whether you 

have any financial involvement with 

manufacturers (or their competitors) of 

any items or services being discussed. 

Speakers presenting at the MEDCAC 

meeting should include a full disclosure 

slide as their second slide in their 

presentation for financial interests (for 

example, type of financial association— 

consultant, research support, advisory 

board, and an indication of level, such 

as minor association <$10,000 or major 

association >$10,000) as well as 

intellectual conflicts of interest (for 

example, involvement in a federal or 

nonfederal advisory committee that has 

discussed the issue) that may pertain in 

any way to the subject of this meeting. 

If you are representing an organization, 

we require that you also disclose 

conflict of interest information for that 

organization. If you do not have a 

PowerPoint presentation, you will need 

to present the full disclosure 

information requested previously at the 

beginning of your statement to the 

Committee. 

The Committee will deliberate openly 

on the topics under consideration. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15-minute unscheduled open 

public session for any attendee to 

address issues specific to the topics 

under consideration. At the conclusion 

of the day, the members will vote and 

the Committee will make its 

recommendation(s) to CMS. 

III. Registration Instructions 

CMS’ Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

online at http://www.cms.gov/apps/ 

events/upcoming

events.asp?strOrderBy=1&type=3 or by 

phone by contacting the person listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by the deadline 

listed in the DATES section of this notice. 

Please provide your full name (as it 

appears on your state-issued driver’s 


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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27995 

license), address, organization, 

telephone number(s), fax number, and 

email address. You will receive a 

registration confirmation with 

instructions for your arrival at the CMS 

complex or you will be notified that the 

seating capacity has been reached. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a federal 

government building; therefore, federal 

security measures are applicable. The 

Real ID Act, enacted in 2005, establishes 

minimum standards for the issuance of 

state-issued driver’s licenses and 

identification (ID) cards. It prohibits 

Federal agencies from accepting an 

official driver’s license or ID card from 

a state unless the Department of 

Homeland Security determines that the 

state meets these standards. Beginning 

October 2015, photo IDs (such as a valid 

driver’s license) issued by a state or 

territory not in compliance with the 

Real ID Act will not be accepted as 

identification to enter Federal buildings. 

Visitors from these states/territories will 

need to provide alternative proof of 

identification (such as a valid passport) 

to gain entrance into CMS buildings. 

The current list of states from which a 

Federal agency may accept driver’s 

licenses for an official purpose is found 

at http://www.dhs.gov/real-idenforcement-brief. We recommend that 

confirmed registrants arrive reasonably 

early, but no earlier than 45 minutes 

prior to the start of the meeting, to allow 

additional time to clear security. 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Inspection, via metal detector or 

other applicable means, of all persons 

entering the building. We note that all 

items brought into CMS, whether 

personal or for the purpose of 

presentation or to support a 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

presentation or to support a 

presentation. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. 

All visitors must be escorted in areas other 

than the lower and first floor levels in the 

Central Building. 

V. Collection of Information 

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). 

Authority: 5 U.S.C. App. 2, section 10(a). 

Dated: June 4, 2018. 

Kate Goodrich, 

Director, Center for Clinical Standards and 

Quality, Chief Medical Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2018–12831 Filed 6–14–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

State Councils on Developmental 

Disabilities—Annual Program 

Performance Report (PPR) (OMB 

Control Number—0985–0033) 

AGENCY: Administration on Intellectual 

and Developmental Disabilities (AIDD), 

Administration for Community Living 

(ACL), U.S. Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living is announcing that 

the proposed collection of information 

listed above has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance as 

required under section 506(c)(2)(A) of 

the Paperwork Reduction Act of 1995. 

This 30-day notice collects comments 

on the information collection 

requirements related to the State 

Councils on Developmental 

Disabilities—Annual Program 

Performance Report (PPR) [Proposed 

Extension with Changes of a Currently 

Approved Collection (ICR Rev)]. 

DATES: Submit written comments on the 

collection of information by July 16, 

2018. 

ADDRESSES: Submit written comments 

on the collection of information by: 

(a) Email to: OIRA_submission@

omb.eop.gov, Attn: OMB Desk Officer 

for ACL; 

(b) fax to 202.395.5806, Attn: OMB 

Desk Officer for ACL; or 

(c) by mail to the Office of 

Information and Regulatory Affairs, 

OMB, New Executive Office Bldg., 725 

17th St. NW, Rm. 10235, Washington, 

DC 20503, Attn: OMB Desk Officer for 

ACL. 

FOR FURTHER INFORMATION CONTACT: Sara 

Newell-Perez at (202) 795–7413 or 

Sara.Newell-Perez@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, ACL 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. The proposed 

data collection represents a revision of 

a currently approved information 

collection (ICR-Rev). This collection is 

necessary for the proper performance 

and function of the agency. On an 

annual basis, Councils are required to 

submit a Program Performance Report 

(PPR) to describe the extent to which 

annual progress is being achieved on the 

5-year State plan goals. The PPR will be 

used by (1) the Council as a planning 

document to track progress made in 

meeting state plan goals; (2) the 

citizenry of the State as a mechanism for 

monitoring progress and activities on 

the plans of the Council; and (3) the 

Department as a stewardship tool for 

ensuring compliance with the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000 and for 

monitoring and providing technical 

assistance (e.g., during site visits), and 

support for management decision 

making. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice was published in the Federal 

Register on October 4, 2017 (Vol. 82, 

Number 191; pp. 46246–46247). Two 

comments were received. The first was 

a comment about ACL and policies 

around deinstitutionalization. The 

second comment requested that 

Councils have more transparency and 

make their PPRs available to the public 

via their websites. ACL appreciates and 

understands these comments. Although 

ACL recognizes that these comments 

might provide useful information for the 

program, it is not required to meet the 

statutory requirements for this program. 

No change is proposed. 

The proposed template may be found 

on the ACL website at https://

www.acl.gov/about-acl/public-input. 

Estimated Program Burden 

ACL estimates the burden of this 

collection of information as follows: The 


sradovich on DSK3GMQ082PROD with NOTICES