63984 Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices 

Conditions of Participation (CoP) and 

Supporting Regulations; Use: The 

information collection requirements 

contained in this request are part of the 

requirements classified as the 

conditions of participation (CoPs) which 

are based on criteria prescribed in law 

and are standards designed to ensure 

that each facility has properly trained 

staff to provide the appropriate safe 

physical environment for patients. 

These particular standards reflect 

comparable standards developed by 

industry organizations such as the Joint 

Commission on Accreditation of 

Healthcare Organizations, and the 

Community Health Accreditation 

Program. We will use this information 

along with state agency surveyors, the 

regional home health intermediaries and 

home health agencies (HHAs) for the 

purpose of ensuring compliance with 

Medicare CoPs as well as ensuring the 

quality of care provided by HHA 

patients. Form Numbers: CMS–R–39 

(OCN: 0938–0365); Frequency: 

Occasionally; Affected Public: Private 

sector—Business or for-profits and Notfor-profit institutions, and State, Local 

or Tribal governments; Number of 

Respondents: 13,577; Total Annual 

Responses: 20,202,576; Total Annual 

Hours: 6,422,694. (For policy questions 

regarding this collection contact 

Danielle Shearer at 410–786–6617.) 

4. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Enrollment 

Assistance Program; Use: As required by 

the Affordable Care Act, we will 

implement a grant-based Navigator 

Program to provide support to targeted 

communities. However, there will also 

be a need for broader based enrollment 

assistance in population centers we 

identified in states with Federallyfacilitated Marketplaces (FFMs) to 

provide Health Insurance Marketplace 

enrollment assistance to populations not 

covered or targeted by the Navigator 

Program. The target populations are 

individual consumers and families 

eligible to enroll in Qualified Health 

Plans (QHPs) in population centers we 

identified. Without such access to inperson enrollment assistance, millions 

of individuals who will be eligible for 

health insurance coverage in the 

Marketplaces might not have access to 

the direct assistance required to make 

educated choices on available 

healthcare options and may therefore be 

unable to successfully enroll in the 

Marketplaces. To monitor program 

effectiveness, the Enrollment Assistance 

Program will provide weekly, monthly, 

quarterly and annual reports. The 60- 

day Federal Register notice was 

published on July 29, 2013 (78 FR 

45205). No comments were received. 

Form Number: CMS–10491 (OCN: 

0938–NEW); Frequency: Weekly, 

Monthly, Quarterly, Yearly; Affected 

Public: Private Sector; Number of 

Respondents: 11; Number of Responses: 

84; Total Annual Hours: 554. (For 

policy questions regarding this 

collection contact Jabaar Gray at 301– 

492–4255.) 

5. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Conditions for 

Coverage of Suppliers of End Stage 

Renal Disease (ESRD) Services and 

Supporting Regulations; Use: The 

information collection requirements 

described herein are part of the 

Medicare and Medicaid Programs; 

Conditions for Coverage for End-Stage 

Renal Disease Facilities. The 

requirements fall into two categories: 

Recordkeeping requirements and 

reporting requirements. With regard to 

the recordkeeping requirements, we use 

these conditions for coverage to certify 

health care facilities that want to 

participate in the Medicare or Medicaid 

programs. For the reporting 

requirements, the information is needed 

to assess and ensure proper distribution 

and effective utilization of ESRD 

treatment resources while maintaining 

or improving quality of care. The 

recordkeeping requirements imposed by 

this collection are no different than 

other conditions for coverage in that 

they reflect comparable standards 

developed by industry organizations 

such as the Renal Physicians 

Association, American Society of 

Transplant Surgeons, National Kidney 

Foundation, and the National 

Association of Patients on Hemodialysis 

and Transplantation. Form Number: 

CMS–R–52 (OCN: 0938–0386); 

Frequency: Annually; Affected Public: 

Private sector—Business or other forprofit; Number of Respondents: 6,464; 

Total Annual Responses: 139,110; Total 

Annual Hours: 523,454. (For policy 

questions regarding this collection 

contact Lauren Oviatt at 410–786–4683.) 

Dated: October 22, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–25171 Filed 10–24–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3286–PN] 

Medicare and Medicaid Programs: 

Application From the Joint 

Commission for Continued Approval of 

Its Home Health Agency (HHA) 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Joint Commission 

for continued recognition as a national 

accrediting organization for Home 

Health Agencies (HHAs) that wish to 

participate in the Medicare or Medicaid 

programs. Section 1865(b)(3)(A) of the 

Social Security Act (the Act) requires 

that within 60 days of receipt of an 

organization’s complete application, 

CMS publish a notice that identifies the 

national accrediting body making the 

request, describes the nature of the 

request, and provides at least a 30-day 

public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 24, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–3286–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways: 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.regulations.gov. Follow the 

‘‘submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3286– 

PN, P.O. Box 8016, Baltimore, MD 

21244–8010. 

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–3286–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices 63985 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments to the following 

addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636, 

Patricia Chmielewski, (410) 786–6899, 

or Monda Shaver, (410) 786–3410. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering issues and 

developing policies. Referencing the file 

code CMS–3286–PN and the specific 

‘‘issue identifier’’ that precedes the 

section on which you choose to 

comment will assist us in fully 

considering issues and developing 

policies. 

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 Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from an HHA provided certain 

requirements are met. Sections 1861(o) 

and 1891 of the Social Security Act (the 

Act), establish distinct criteria for 

facilities seeking designation as an 

HHA. 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 484 specify the minimum 

conditions that an HHA must meet to 

participate in the Medicare program. 

Generally, to enter into an agreement, 

an HHA must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

part 484 of our regulations. Thereafter, 

the HHA is subject to regular surveys by 

a state survey agency to determine 

whether it continues to meet these 

requirements. There is an alternative, 

however, to surveys by state agencies. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by 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 meet the 

Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under part 488, subpart A, must provide 

us with reasonable assurance that the 

accrediting organization requires the 

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 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by us. 

The Joint Commission’s current term 

of approval for their HHA accreditation 

program expires March 31, 2014. 

II. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.8(a) 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 the Joint 

Commission’s request for continued 

approval of its HHA accreditation 

program. This notice also solicits public 

comment on whether the Joint 

Commission’s requirements meet or 

exceed the Medicare conditions of 

participation (CoPs) for HHAs. 

III. Evaluation of Deeming Authority 

Request 

The Joint Commission submitted all 

the necessary materials to enable us to 

make a determination concerning its 

request for continued approval of its 

HHA accreditation program. This 

application was determined to be 

complete on August 30, 2013. Under 

section 1865(a)(2) of the Act and our 

regulations at § 488.8 (Federal review of 

accrediting organizations), our review 

and evaluation of the Joint Commission 

will be conducted in accordance with, 

but not necessarily limited to, the 

following factors: 

• The equivalency of the Joint 

Commission’s standards for HHA’s as 

compared with CMS’ HHA CoPs. 

• The Joint Commission’s survey 

process to determine the following: 


emcdonald on DSK67QTVN1PROD with NOTICES
63986 Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of the Joint 

Commission’s processes to those of state 

agencies, including survey frequency, 

and the ability to investigate and 

respond appropriately to complaints 

against accredited facilities. 

++ The Joint Commission’s processes 

and procedures for monitoring an HHA 

found out of compliance with the Joint 

Commission’s program requirements. 

These monitoring procedures are used 

only when the Joint Commission 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.7(d). 

++ The Joint Commission’s capacity 

to report deficiencies to the surveyed 

facilities and respond to the facility’s 

plan of correction in a timely manner. 

++ The Joint Commission’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 the Joint 

Commission’s staff and other resources, 

and its financial viability. 

++ The Joint Commission’s capacity 

to adequately fund required surveys. 

++ The Joint Commission’s policies 

with respect to whether surveys are 

announced or unannounced, to assure 

that surveys are unannounced. 

++ The Joint Commission’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). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

V. 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. 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program; No. 93.773 Medicare— 

Hospital Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 27, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–25010 Filed 10–24–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3289–N] 

Medicare Program; Request for 

Nominations for Members for the 

Medicare Evidence Development & 

Coverage Advisory Committee 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

request for nominations for membership 

on the Medicare Evidence Development 

& Coverage Advisory Committee 

(MEDCAC). Among other duties, the 

MEDCAC provides advice and guidance 

to the Secretary of the Department of 

Health and Human Services (the 

Secretary) and the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) concerning the 

adequacy of scientific evidence 

available to CMS for ‘‘reasonable and 

necessary’’ determinations under 

Medicare. 

We are requesting nominations for 

both voting and nonvoting members to 

serve on the MEDCAC. Nominees are 

selected based upon their individual 

qualifications and not as representatives 

of professional associations or societies. 

We wish to ensure adequate 

representation of the interests of both 

women and men, members of all ethnic 

groups and physically challenged 

individuals. Therefore, we encourage 

nominations of qualified candidates 

who can represent these interests. 

The MEDCAC reviews and evaluates 

medical literature, technology 

assessments, and hears public testimony 

on the evidence available to address the 

impact of medical items and services on 

health outcomes of Medicare 

beneficiaries. 

DATES: Nominations must be received 

by Monday, December 9, 2013. 

ADDRESSES: You may mail nominations 

for membership to the following 

address: Centers for Medicare & 

Medicaid Services, Center for Clinical 

Standards and Quality, Attention: Maria 

Ellis, 7500 Security Boulevard, Mail 

Stop: S3–02–01, Baltimore, MD 21244. 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, Executive Secretary for the 

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 

The Secretary signed the initial 

charter for the Medicare Coverage 

Advisory Committee (MCAC) on 

November 24, 1998. A notice in the 

Federal Register (63 FR 68780) 

announcing establishment of the MCAC 

was published on December 14, 1998. 

The MCAC name was updated to more 

accurately reflect the purpose of the 

committee and on January 26, 2007, the 

Secretary published a notice in the 

Federal Register (72 FR 3853), 

announcing that the Committee’s name 

changed to the Medicare Evidence 

Development & Coverage Advisory 

Committee (MEDCAC). The charter for 

the committee was renewed by the 

Secretary on November 24, 2012. The 

current charter is effective for 2 years. 

The MEDCAC is governed by 

provisions of the Federal Advisory 

Committee Act, Public Law 92–463, as 

amended (5 U.S.C. App. 2), which sets 

forth standards for the formulation and 

use of advisory committees, and is 

authorized by section 222 of the Public 

Health Service Act as amended (42 

U.S.C. 217A). 

The MEDCAC consists of a pool of 

100 appointed members including: 94 

voting members of whom 6 are 

designated patient advocates, and 6 

nonvoting representatives of industry 

interests. Members generally are 

recognized authorities in clinical 

medicine including subspecialties, 

administrative medicine, public health, 

biological and physical sciences, 

epidemiology and biostatistics, clinical 

trial design, health care data 

management and analysis, patient 

advocacy, health care economics, 


emcdonald on DSK67QTVN1PROD with NOTICES