Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23007 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicare and 

Medicaid Programs: Conditions of 

Participation for Home Health Agencies 

(HHA); Use: Home health services are 

covered for the elderly and disabled 

under the Hospital Insurance (Part A) 

and Supplemental Medical Insurance 

(Part B) benefits of the Medicare 

program, and are described in section 

1861(m) of the Social Security Act (the 

Act) (42 U.S.C. 1395x). These services 

must be furnished by, or under 

arrangement with, an HHA that 

participates in the Medicare program, 

and be provided on a visiting basis in 

the beneficiary’s home. They may 

include the following: 

• Part-time or intermittent skilled 

nursing care furnished by or under the 

supervision of a registered nurse. 

• Physical therapy, speech-language 

pathology, or occupational therapy. 

• Medical social services under the 

direction of a physician. 

• Part-time or intermittent home 

health aide services. 

• Medical supplies (other than drugs 

and biologicals) and durable medical 

equipment. 

• Services of interns and residents if 

the HHA is owned by or affiliated with 

a hospital that has an approved medical 

education program. 

• Services at hospitals, SNFs, or 

rehabilitation centers when they involve 

equipment too cumbersome to bring to 

the home. 

Section 1861(o) of the Act (42 U.S.C. 

1395x) specifies certain requirements 

that a home health agency must meet to 

participate in the Medicare program. 

Existing regulations at 42 CFR 440.70(d) 

specify that HHAs participating in the 

Medicaid program must also meet the 

Medicare CoPs.) In particular, section 

1861(o)(6) of the Act requires that an 

HHA must meet the CoPs specified in 

section 1891(a) of the Act and such 

other CoPs as the Secretary finds 

necessary in the interest of the health 

and safety of its patients. Section 

1891(a) of the Act establishes specific 

requirements for HHAs in several areas, 

including patient rights, home health 

aide training and competency, and 

compliance with applicable Federal, 

State, and local laws. 

Under the authority of sections 

1861(o), 1871 and 1891 of the Act, the 

Secretary proposes to establish in 

regulations the requirements that an 

HHA must meet to participate in the 

Medicare program. These requirements 

would be set forth in 42 CFR part 484 

as Conditions of Participation for Home 

Health Agencies. The CoPs apply to an 

HHA as an entity as well as the services 

furnished to each individual under the 

care of the HHA, unless a condition is 

specifically limited to Medicare 

beneficiaries. 

Under section 1891(b) of the Act, the 

Secretary is responsible for assuring that 

the CoPs, and their enforcement, are 

adequate to protect the health and safety 

of individuals under the care of an HHA 

and to promote the effective and 

efficient use of Medicare funds. To 

implement this requirement, State 

survey agencies generally conduct 

surveys of HHAs to determine whether 

they are complying with the CoPs. 

This information collection request is 

associated with Home Health Agency 

Conditions of Participation (0938– 

AG81) which published October 9, 

2014. Form Number: CMS–10539 (OMB 

control number: 0938–NEW); 

Frequency: Annually; Affected Public: 

Business or other for-profits and not-forprofit institutions; Number of 

Respondents: 19,474; Total Annual 

Responses: 32,929,239; Total Annual 

Hours: 2,786,198. (For policy questions 

regarding this collection contact 

Danielle Shearer at 410–786–6617.) 

Dated: April 21, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–09592 Filed 4–23–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3320–N] 

Medicare Program; Meeting of the 

Medicare Evidence Development and 

Coverage Advisory Committee—July 

22, 2015 

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, July 22, 2015. This meeting 

will specifically focus on lower 

extremity peripheral artery disease. This 

meeting is open to the public in 

accordance with the Federal Advisory 

Committee Act (5 U.S.C. App. 2, section 

10(a)). 

DATES: Meeting Date: The public 

meeting will be held on Wednesday, 

July 22, 2015 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 

p.m., EDT, Monday, June 15, 2015. Once 

submitted, all comments are final. 

Deadlines for Speaker Registration 

and Presentation Materials: The 

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, June 15, 2015. 

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/upcomingevents.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 p.m. EDT, Wednesday, 

July 15, 2015. 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, July 3, 2015. 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
23008 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 

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, July 22, 2015, public 

meeting of the Committee. During this 

meeting, the Committee will discuss 

lower extremity peripheral artery 

disease. Background information about 

this topic, including panel materials, is 

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

medicare-coverage-database/indexes/

medcac-meetingsindex.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 Web site 

no later than 2 business days before the 

meeting. We encourage the participation 

of appropriate organizations with 

expertise in lower extremity peripheral 

artery disease. 

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 June 

22, 2015. 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 Web site 

prior to the meeting: http://

www.cms.gov/medicare-coveragedatabase/indexes/medcac-meetingsindex.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 

must 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/upcomingevents.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 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. 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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23009 

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: April 16, 2015. 

Patrick Conway, 

Acting Principal Deputy Administrator, 

Deputy Administrator for Innovation and 

Quality, CMS Chief Medical Officer, Centers 

for Medicare & Medicaid Services. 

[FR Doc. 2015–09607 Filed 4–23–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1639–N] 

Medicare Program: Renewal of the 

Advisory Panel on Hospital Outpatient 

Payment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

renewal of the Advisory Panel (the 

Panel) on Hospital Outpatient Payment 

(HOP) charter. The charter was 

approved on November 6, 2014 for a 2- 

year period effective through November 

6, 2016. This notice publicly announces 

the renewal of the HOP Panel for 

another 2-year period. The purpose of 

the Panel is to advise the Secretary of 

the Department of Health and Human 

Services (DHHS) and the Administrator 

of the Centers for Medicare & Medicaid 

Services (CMS) concerning the clinical 

integrity of the Ambulatory Payment 

Classification groups and their relative 

payment weights. The Panel also 

addresses and makes recommendations 

regarding supervision of hospital 

outpatient services. The advice 

provided by the Panel will be 

considered as we prepare the annual 

updates for the hospital outpatient 

prospective payment system. 

DATES: April 24, 2015. 

ADDRESSES: Web site: For additional 

information on the Panel meeting dates, 

agenda topics, copy of the charter, and 

updates to the Panel’s activities, we 

refer readers to our Web site at the 

following address: https://

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

PanelonAmbulatoryPayment

ClassificationGroups.html. 

FOR FURTHER INFORMATION CONTACT: 

Designated Federal Official (DFO): Carol 

Schwartz, DFO, 7500 Security 

Boulevard, Mail Stop: C4–04–25, 

Woodlawn, MD 21244–1850. Phone: 

(410) 786–3985. Email: APCPanel@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary of the Department of 

Health and Human Services (the 

Secretary) is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act) (42 U.S.C. 1395l(t)(9)(A)) and 

is allowed by section 222 of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

217(a)) to consult with an expert outside 

advisory panel on the clinical integrity 

of the Ambulatory Payment 

Classification (APC) groups and relative 

payment weights, which are major 

elements of the Medicare Hospital 

Outpatient Prospective Payment System 

(OPPS), and the appropriate supervision 

level for hospital outpatient services. 

The Panel is governed by the provisions 

of the 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 

advisory panels. 

The Panel Charter provides that the 

Panel shall meet up to 3 times annually. 

We consider the technical advice 

provided by the Panel as we prepare the 

proposed and final rules to update the 

OPPS for the following calendar year. 

II. Renewal of the Hospital Outpatient 

Payment (HOP) Panel 

The Panel was originally chartered on 

November 21, 2000 and the Panel 

requires a recharter every 2 years. This 

notice announces the renewal of the 

HOP Panel charter, which was approved 

on November 6, 2014 for a 2-year period 

effective through November 6, 2016. 

The charter will terminate on November 

6, 2016, unless renewed by appropriate 

action. CMS intends to recharter the 

Panel for another 2-year period prior to 

the expiration of the current charter. 

Pursuant to the renewed charter, the 

Panel will advise the Secretary and CMS 

concerning optimal strategies for the 

following: 

• Addressing whether procedures 

within an APC group are similar both 

clinically and in terms of resource use. 

• Reconfiguring APCs (for example, 

splitting of APCs, moving Healthcare 

Common Procedures Coding System 

(HCPCS) codes from one APC to 

another, and moving HCPCS codes from 

new technology APCs to clinical APCs). 

• Evaluating APC group weights. 

• Reviewing packaging the cost of 

items and services, including drugs and 

devices into procedures and services; 

including the methodology for 

packaging and the impact of packaging 

the cost of those items and services on 

APC group structure and payment. 

• Removing procedures from the 

inpatient list for payment under the 

OPPS payment system. 

• Using claims and cost report data 

for CMS’ determination of APC group 

costs. 

• Addressing other technical issues 

concerning APC group structure. 

• Evaluating the required level of 

supervision for hospital outpatient 

services. 

III. Copies of the Charter 

To obtain a copy of the Panel’s 

Charter, we refer readers to the CMS 

Web site at: http://www.cms.gov/

Regulations-andGuidance/Guidance/

FACA/AdvisoryPanelonAmbulatory

PaymentClassificationGroups.html. 

Also, a copy of the Panel’s Charter can 

be received by submitting a request to 

the contact listed in the FOR FURTHER

INFORMATION section of this notice. 

IV. 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). 

Dated: April 13, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–09609 Filed 4–23–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3315–PN] 

Medicare and Medicaid Programs; 

Application by the American 

Association of Diabetes Educators for 

Continued Deeming Authority for 

Diabetes Self-Management Training 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

announces the receipt of an application 

from the American Association of 

Diabetes Educators for continued 

recognition as a national accreditation 


tkelley on DSK3SPTVN1PROD with NOTICES