Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 37121 

in 2014), including the appropriate use 

of public-private partnerships to 

leverage the resources of the private 

sector in educating beneficiaries, 

providers, and stakeholders. 

• Expanding outreach to vulnerable 

and underserved communities, 

including racial and ethnic minorities, 

in the context of Medicare, Medicaid, 

and CHIP education programs. 

• Assembling and sharing an 

information base of ‘‘best practices’’ for 

helping consumers evaluate health plan 

options. 

• Building and leveraging existing 

community infrastructures for 

information, counseling, and assistance. 

• Drawing the program link between 

outreach and education, promoting 

consumer understanding of health care 

coverage choices and facilitating 

consumer selection/enrollment, which 

in turn support the overarching goal of 

improved access to quality care, 

including prevention services, 

envisioned under health care reform. 

The current members of the Panel are: 

Samantha Artiga, Principal Policy 

Analyst, Kaiser Family Foundation; 

Joseph Baker, President, Medicare 

Rights Center; Marjorie Cadogan, 

Executive Deputy Commissioner, 

Department of Social Services; Jonathan 

Dauphine, Senior Vice President, AARP; 

Jason Dollarhide, Deputy Executive 

Director, Housing Authority of the 

Peoria Tribe of Indians of Oklahoma; 

Barbara Ferrer, Executive Director, 

Boston Public Health Commission; 

Shelby Gonzales, Senior Health 

Outreach Associate, Center on Budget & 

Policy Priorities; Richard Frank, 

Director, Whittingham Cancer Center; 

Jan Henning, Benefits Counseling & 

Special Projects Coordinator, North 

Central Texas Council of Governments’ 

Area Agency on Aging; Deeana Jang, 

Policy Director, Asian and Pacific 

Islander American Health Forum; 

Warren Jones, Executive Director, 

Mississippi Institute for Improvement of 

Geographic Minority Health; Madeline 

Lawson, President and Chief Executive 

Officer, Institute for the Advancement of 

Multicultural & Minority Medicine; 

John Lui, Executive Director, Stout 

Vocational Rehabilitation Institute; 

Sandy Markwood, Chief Executive 

Officer, National Association of Area 

Agencies on Aging; Miriam MobleySmith, Dean, Chicago State University, 

College of Pharmacy; Ana NatalePereira, Associate Professor of 

Medicine, University of Medicine & 

Dentistry of New Jersey; Megan Padden, 

Vice President, Sentara Health Plans; 

David W. Roberts, Vice-President, 

Healthcare Information and 

Management System Society; Julie 

Bode ̈n Schmidt, Associate Vice 

President, National Association of 

Community Health Centers; Winston 

Wong, Medical Director, Community 

Benefit Director, Kaiser Permanente and 

Donna Yee, Chief Executive Officer, 

Asian Community Center of Sacramento 

Valley. 

The agenda for the July 28, 2011 

meeting will include the following: 

• Welcome and Listening Session 

with CMS Leadership. 

• Swearing in of new members. 

• Recap of the previous (October 13, 

2010) meeting. 

• Medicare, Medicaid & CHIP 

Outreach & Education Strategies. 

• An opportunity for public 

comment. 

• Next steps. 

Individuals or organizations that wish to 

make a 5-minute oral presentation on an 

agenda topic should submit a written 

copy of the oral presentation to the DFO 

at the address listed in the ADDRESSES

section of this notice by the date listed 

in the DATES section of this notice. The 

number of oral presentations may be 

limited by the time available. 

Individuals not wishing to make a 

presentation may submit written 

comments to the DFO at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

Authority: Sec. 222 of the Public Health 

Service Act (42 U.S.C. 217a) and sec. 10(a) 

of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) 

and 41 CFR 102–3). 

(Catalog of Federal Domestic Assistance 

Program No. 93.733, Medicare—Hospital 

Insurance Program; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). 

Dated: June 16, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–15613 Filed 6–23–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1584–N] 

Medicare Program; Second SemiAnnual Meeting of the Advisory Panel 

on Ambulatory Payment Classification 

Groups—August 10, 2011 Through 

August 12, 2011 

AGENCY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

second semi-annual meeting of the 

Advisory Panel on Ambulatory Payment 

Classification (APC) Groups (the Panel) 

for 2011. The purpose of the Panel is to 

review the APC groups and their 

associated weights and to advise the 

Secretary of the Department of Health 

and Human Services (DHHS) (the 

Secretary) and the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) (the Administrator) 

concerning the clinical integrity of the 

APC groups and their associated 

weights. We will consider the Panel’s 

advice as we prepare the final rule that 

would update the hospital Outpatient 

Prospective Payment System (OPPS) for 

CY 2012. 

DATES: Meeting Dates: We are 

scheduling the second semi-annual 

meeting in 2011 for the following dates 

and times: 

• Wednesday, August 10, 2011, 

1 p.m. to 5 p.m. eastern standard time 

(e.s.t.) 1

• Thursday, August 11, 2011, 8 a.m. 

to 5 p.m. (e.s.t.) 1

• Friday, August 12, 2011, 8 a.m. to 

12 Noon (e.s.t.) 2

Note: 1The times listed in this notice are 

approximate times; consequently, the 

meetings may last longer than listed in this 

notice, but will not begin before the posted 

times. 2 If the Panel’s business concludes on 

Thursday, August, 11, 2011, there will be no 

meeting on Friday, August, 12, 2011. 

Deadlines 

Deadline for Hardcopy Comments 

and electronic format suggested agenda 

topics—5 p.m. (e.s.t.), Friday, July 15, 

2011. 

Deadline for Hardcopy Presentations, 

including the required electronic 

documents as discussed below—5 p.m. 

(e.s.t.), Friday, July 15, 2011. 

Deadline for Attendance 

Registration—5 p.m. (e.s.t.), Wednesday, 

July 27, 2011. 

Deadline for Special 

Accommodations—5 p.m. (e.s.t.), 

Wednesday, July 27, 2011. 

ADDRESSES: The meeting will be held in 

the Auditorium, the Centers for 

Medicare & Medicaid Services (CMS) 

Central Office, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Paula Smith, Designated Federal Officer 

(DFO), CMS, CMM, HAPG, DOC, 7500 

Security Boulevard, Mail Stop C4–05– 

17, Baltimore, MD 21244–1850. Phone: 

(410) 786–3985. 

Note: We recommend that you advise 

couriers of the following information: When 


srobinson on DSK4SPTVN1PROD with NOTICES
37122 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 

delivering hardcopies of presentations to 

CMS, if no one answers at the above phone 

number, please call (410) 786–4532 or (410) 

786–7267. 

The e-mail address for comments, 

presentations, and registration requests 

is APCPanel@cms.hhs.gov. 

News media representatives must 

contact our Public Affairs Office at (202) 

690–6145. 

Advisory Committees’ Information 

Lines: The phone numbers for the CMS 

Federal Advisory Committee Hotline are 

1–877–449–5659 (toll free) and (410) 

786–9379 (local). 

Web Sites: For additional information 

on the APC Panel and updates to the 

Panel’s activities, we refer readers to our 

Web site available at: http:// 

www.cms.hhs.gov/FACA/05_

AdvisoryPanelonAmbulatory

PaymentClassification

Groups.asp#TopOfPage. 

Note: There is an UNDERSCORE after 

FACA/05; there is no space between the 

underscore and the capital A. You may also 

search information about the APC Panel and 

its membership in the Federal Advisory 

Committee Act (FACA) database at the 

following URL: https://www.fido.gov/ 

facadatabase/public.asp. 

Submission of Materials to the 

Designated Federal Officer (DFO) 

We require electronic versions of the 

written comments and presentations, in 

addition to hardcopies. Because of 

staffing and resource limitations, we 

cannot accept written comments and 

presentations by FAX, nor can we print 

written comments and presentations 

received electronically for 

dissemination at the meeting. Only 

hardcopy comments and presentations 

can be reproduced for public 

dissemination. All hardcopy 

presentations must be accompanied by 

Form CMS–20017 (revised May 2011). 

The form is now available through the 

CMS Forms Web site. To download 

Form CMS–20017, visit the following 

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

cmsforms/downloads/cms20017.pdf. 

Additionally, presenters must clearly 

explain the action that they are 

requesting CMS to take in the 

appropriate section of the form. They 

must also state their relationship to the 

organization that they are representing 

in the presentation. 

Note: Issues that are vague, or that are 

outside the scope of the APC Panel’s 

purpose, will not be considered for 

presentations and comments. There will be 

no exceptions to this rule. We appreciate 

your cooperation on this matter. 

In summary, presenters and/or 

commenters must do the following: 

• Send both electronic and hardcopy 

versions of their presentations and 

written comments by the prescribed 

deadlines. 

• Send electronic transmissions to the 

e-mail address below. 

• Mail (or send by courier) to the 

Designated Federal Officer (DFO) all 

hardcopies, accompanied by Form 

CMS–20017 (revised 01/07), if they are 

presenting, as specified in the FOR

FURTHER INFORMATION CONTACT section of 

this notice. 

• Commenters not presenting at the 

APC panel meeting are not required to 

send Form CMS–20017 with their 

written comments. 

• Do not send images of patients in 

any of the documents unless their faces 

have been covered. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary is required by section 

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

(the Act) to consult with an expert, 

outside advisory panel on the clinical 

integrity of the APC groups and weights 

established under the Medicare Hospital 

Outpatient Prospective Payment System 

(OPPS). 

The APC Panel meets up to three 

times annually. The Panel consists of up 

to 15 members, who are representatives 

of providers, and a Chair. 

Each Panel member must be 

employed full-time by a hospital, 

hospital system, or other Medicare 

provider subject to payment under the 

OPPS. The Secretary or Administrator 

selects the Panel membership based 

upon either self-nominations or 

nominations submitted by Medicare 

providers and other interested 

organizations. 

All members must have technical 

expertise to enable them to participate 

fully in the Panel’s work. The expertise 

encompasses hospital payment systems; 

hospital medical care delivery systems; 

provider billing systems; APC groups; 

Current Procedural Terminology (CPT) 

codes; and alpha-numeric Health Care 

Common Procedure Coding System 

(HCPCS) codes; and the use of, and 

payment for, drugs, medical devices, 

and other services in the outpatient 

setting, as well as other forms of 

relevant expertise. Details regarding 

membership requirements for the APC 

Panel are found on the FACA and CMS 

Web sites as listed above. 

The Panel presently consists of the 

following members: (Note: The asterisk 

[*] indicates the Panel members whose 

terms end on September 30, 2011.) 

• E. L. Hambrick, M.D., J.D., Chair, 

CMS Medical Officer. 

• Ruth L. Bush, M.D., M.P.H. 

• Kari S. Cornicelli, C.P.A., FHFMA. 

• Dawn L. Francis, M.D., M.H.S. 

• Kathleen Graham, R.N., M.S.H.A., 

C.P.H.Q., A.C.M. 

• Patrick A. Grusenmeyer, Sc.D., 

F.A.C.H.E.* 

• David Halsey, M.D. 

• Brian D. Kavanagh, M.D., M.P.H. 

• Judith T. Kelly, B.S.H.A., R.H.I.T., 

R.H.I.A., C.C.S. 

• Scott Manaker, M.D., PhD 

• John Marshall, CRA, RCC, RT. 

• Agatha L. Nolen, PhD, M.S., 

F.A.S.H.P.* 

• Randall A. Oyer, M.D. 

• Daniel Pothen, M.S., R.H.I.A., 

C.P.H.I.M.S., C.C.S.P, C.H.C. 

• Gregory Przybylski, M.D. 

• Neville B. Sarkari, M.D., FACP. 

II. Agenda 

The agenda for the August 2011 

meeting will provide for discussion and 

comment on the following topics as 

designated in the Panel’s Charter: 

• Addressing whether procedures 

within an APC group are similar both 

clinically and in terms of resource use. 

• 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. 

• Using claims and cost report data 

for CMS’ determination of APC group 

weights. 

• Addressing other technical issues 

concerning APC group structure. 

Note: The subject matter before the Panel 

will be limited to these and related topics. 

Issues related to calculation of the OPPS 

conversion factor, charge compression, 

revisions to the cost report, pass-through 

payments, payment adjustments, or correct 

code usage are not within the scope of the 

Panel’s purpose. Therefore, these issues will 

not be considered for presentations or 

comments. There will be no exceptions to 

this rule. We appreciate your cooperation on 

this matter. 

The Panel may use data collected or 

developed by entities and organizations 

other than the Department of Health and 

Human Services (DHHS) and CMS in 

conducting its review. We recommend 

that organizations submit data for the 

Panel’s and CMS’ review. 

III. Written Comments and Suggested 

Agenda Topics 

Hardcopy and electronic written 

comments and suggested agenda topics 

should be sent to the DFO as specified 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 37123 

in the ADDRESSES section of this notice. 

The DFO must receive these items by 

5 p.m. (e.s.t.), Friday, July 15, 2011. We 

appreciate your cooperation on this 

matter. 

IV. Oral Presentations 

Individuals or organizations wishing 

to make 5-minute oral presentations 

must submit hardcopy and electronic 

versions of their presentations to the 

DFO by 5 p.m. (e.s.t.), Friday, July 15, 

2011. 

The number of oral presentations may 

be limited by the time available. Oral 

presentations cannot exceed 5 minutes 

in length for an individual or an 

organization. 

The Chair may further limit time 

allowed for presentations due to the 

number of oral presentations, if 

necessary. Presentation times listed in 

the public agenda are approximate and 

presenters should be prepared to 

present earlier and later than indicated. 

V. Presenter and Presentation 

Information 

All presenters must submit Form 

CMS–20017 (Revised 05/11) that is 

required for all oral presentations. The 

DFO must receive the following 

information from those wishing to make 

oral presentations: 

• The Form CMS–20017 (Revised 05/ 

11) with all pertinent information 

completed. 

• One hardcopy of presentation. 

• Electronic copy of presentation. 

• Personal registration information as 

described in the ‘‘Meeting Attendance’’ 

section below. 

• Those persons wishing to submit 

written comments only (and not make a 

5 minute oral presentation at the Panel 

meeting) must send hardcopy and 

electronic versions of their comments, 

but they are not required to submit the 

Form CMS–20017 (Revised 05/11). 

VI. Oral Comments 

In addition to formal oral 

presentations, there will be opportunity 

during the meeting for public oral 

comments, which will be limited to 1 

minute for each individual and a total 

of 3 minutes per organization. 

VII. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Attendance will be 

determined on a first-come, first-served 

basis. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must e-mail the DFO to 

register in advance no later than 5 p.m. 

(e.s.t.), Wednesday, July 27, 2011. A 

confirmation will be sent to the 

requester(s) by return e-mail. 

The following personal information 

must be e-mailed to the DFO by the date 

and time above: 

• Name(s) of attendee(s). 

• Title(s). 

• Organization including address(es). 

• E-mail address(es). 

• Telephone number(s). 

VIII. Security, Building, and Parking 

Guidelines 

The meeting is open to the public, but 

attendance is limited to the space 

available. Persons wishing to attend this 

meeting must register by contacting the 

DFO at the address listed in the 

ADDRESSES section of this notice or by 

telephone at the number listed in the 

FOR FURTHER INFORMATION CONTACT

section of this notice by the date 

specified in the DATES section of this 

notice. 

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 before 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 

brought 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 before the 

convening of the meeting. 

All visitors must be escorted in areas other 

than the lower and first floor levels in the 

Central Building. 

IX. Special Accommodations 

Individuals requiring sign-language 

interpretation or other special 

accommodations must send a request 

for these services to the DFO by 5 p.m. 

(e.s.t.), Wednesday, July 27, 2011. 

X. Panel Recommendations and 

Discussions 

The Panel’s recommendations at any 

APC Panel meeting generally are not 

final until they have been reviewed and 

approved by the Panel on the last day 

before the final adjournment. 

XI. 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. Chapter 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). 

Dated: June 15, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–15903 Filed 6–23–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0536] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on 

Pharmacogenomic Data Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on 

Pharmacogenomic Data Submissions’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 7, 2011 (76 


srobinson on DSK4SPTVN1PROD with NOTICES