55850 Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 

Medicare & Medicaid Services, 7500 

Security Boulevard, Mailstop S1–05–06, 

Baltimore, MD 21244–1850 or contact 

Ms. Johnson via e-mail 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 by 

contacting Lynne Johnson at the address 

listed in the ADDRESSES section of this 

notice or by telephone at (410) 786– 

0090, by the date listed in the DATES

section of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Lynne Johnson, (410) 786–0090. Please 

refer to the CMS Advisory Committees’ 

Information Line (1–877–449–5659 tollfree)/(410–786–9379 local) or the 

Internet (http://www.cms.hhs.gov/ 

FACA/04_APME.asp) for additional 

information and updates on committee 

activities. Press inquiries are handled 

through the CMS Press Office at (202) 

690–6145. 

SUPPLEMENTARY INFORMATION: 

Section 9(a)(2) of the Federal 

Advisory Committee Act authorizes the 

Secretary of Health and Human Services 

(the Secretary) to establish an advisory 

panel if the Secretary determines that 

the panel is ‘‘in the public interest in 

connection with the performance of 

duties imposed * * * by law.’’ Such 

duties are imposed by section 1804 of 

the Social Security Act (the Act), 

requiring the Secretary to provide 

informational materials to Medicare 

beneficiaries about the Medicare 

program, and section 1851(d) of the Act, 

requiring the Secretary to provide for 

‘‘activities * * * to broadly disseminate 

information to [M]edicare beneficiaries 

* * * on the coverage options provided 

under [Medicare Advantage] in order to 

promote an active, informed selection 

among such options.’’ 

The Panel is also authorized by 

section 1114(f) of the Act (42 U.S.C. 

1311(f)) and section 222 of the Public 

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

Secretary signed the charter establishing 

this Panel on January 21, 1999 and 

approved the renewal of the charter on 

November 14, 2006. The establishment 

of the charter and the renewal of the 

charter were announced in the February 

17, 1999 Federal Register (64 FR 7899), 

and the March 23, 2007 Federal 

Register (72 FR 13796), respectively. 

The Panel advises and makes 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

opportunities to enhance the 

effectiveness of consumer education 

strategies concerning the Medicare 

program. The Secretary delegates 

authority to the Administrator. 

The goals of the Panel are as follows: 

• To provide recommendations on 

the development and implementation of 

a national Medicare education program 

that describes the options for selecting 

a health plan and prescription drug plan 

under Medicare. 

• To enhance the Federal 

government’s effectiveness in informing 

the Medicare consumer, including the 

appropriate use of public-private 

partnerships. 

• To provide recommendations on 

how to expand outreach to vulnerable 

and underserved communities, 

including racial and ethnic minorities, 

in the context of a national Medicare 

education program. 

• To assemble an information base of 

best practices for helping consumers 

evaluate health plan options and build 

a community infrastructure for 

information, counseling, and assistance. 

The current members of the Panel are: 

Gwendolyn T. Bronson, SHINE/SHIP 

Counselor, Massachusetts SHINE 

Program; Dr. Yanira Cruz, President and 

Chief Executive Officer, National 

Hispanic Council on Aging; Clayton 

Fong, President and Chief Executive 

Officer, National Asian Pacific Center 

on Aging; Nan Kirsten-Forte, Executive 

Vice President, Consumer Services, 

WebMD; Dr. Jessie C. Gruman, President 

and Chief Executive Officer, Center for 

the Advancement of Health; Dr. Frank 

B. McArdle, Manager, Hewitt Research 

Office, Hewitt Associates; Rebecca 

Snead, Executive Vice President and 

Chief Executive Officer, National 

Alliance of State Pharmacy 

Associations. Thirteen new members 

will be appointed to the panel and 

announced at the meeting. 

The agenda for the October 22, 2008, 

meeting will include the following: 

• Recap of the previous (June 26, 

2008) meeting. 

• Introduction of New Members. 

• Medicare Outreach and Education 

Strategies. 

• Public Comment. 

• Listening Session with CMS 

Leadership. 

• 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 Lynne 

Johnson 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 Ms. Johnson at the address 

listed in the ADDRESSES 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 Ms. 

Johnson 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: September 10, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E8–21910 Filed 9–25–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Statement of Organization, Functions, 

and Delegations of Authority 

Part F of the Statement of 

Organization, Functions, and 

Delegations of Authority for the 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services (CMS), (Federal 

Register, Vol. 73, No. 127, pp. 37463– 

37464, dated Tuesday, July 1, 2008) is 

amended to reflect an update to the 

functions for the Center for Medicare 

Management. 

Part F. is described below: 

• Section F. 20. (Functions) reads as 

follows: 

Center for Medicare Management 

(FAH) 

• Serves as the focal point for all 

Agency interactions with health care 

providers, intermediaries, carriers, and 

Medicare Administrative Contractors 

(MACs) for issues relating to Agency 

fee-for-service (FFS) policies and 

operations. 

• Responsible for policies related to 

scope of benefits and other statutory, 

regulatory and contractual provisions. 

• Based on program data, develops 

payment mechanisms, administrative 

mechanisms, and regulations to ensure 

that CMS is purchasing medically 

necessary items and services under 

Medicare FFS. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 55851 

• Develops, evaluates and maintains 

policies, regulations, and instructions 

that define the scope of benefits and 

payment amounts for: 

1. Hospitals for inpatient services 

under the inpatient prospective 

payment system and the long-term care 

hospital prospective payment system; 

2. Inpatient services in hospitals and 

units excluded from the prospective 

payment systems; 

3. Physicians and non-physician 

practitioners; 

4. Hospital outpatient departments, 

comprehensive outpatient rehabilitation 

facilities and ambulatory surgical 

centers; 

5. Clinical laboratory services; 

6. Ambulance services; 

7. Prescription drugs and blood, blood 

products and hemophilia clotting factor; 

and 

8. Telemedicine services, rural health 

clinics, and federally-qualified health 

centers. 

• Formulates CMS policy for 

development, analysis, and 

maintenance of new and revised 

medical codes and medical 

classification systems (including ICD–9– 

CM, Healthcare Common Procedure 

Coding System, Diagnosis Related 

Groups, and Ambulatory Payment 

Classifications) and develops common 

medical coding standards and policy. 

• Participates in the development and 

evaluation of proposed legislation 

pertaining to assigned subject areas. 

• Coordinates with the Office of 

Clinical Standards and Quality on 

coverage issues in assigned areas. 

• Develops, evaluates, and reviews 

regulations, manuals, program 

guidelines, and instructions required for 

the dissemination of program policies to 

program contractors and the health care 

field. 

• Identifies, studies and makes 

recommendations for modifying 

Medicare policies to reflect changes in 

beneficiary health care needs, program 

objectives, and the health care delivery 

system. 

• Develops, evaluates and maintains 

policies, regulations, and instructions 

that define the scope of benefits and 

payment amounts for skilled nursing 

facilities, home health agencies, 

hospice, durable medical equipment, 

orthotics, prosthetics and supplies. 

• Develops and evaluates national 

Medicare policies and principles for 

applying limitations to the costs of 

skilled nursing facilities and home 

health agencies. Develops criteria for 

exceptions to the cost limitations for 

skilled nursing facilities. Reviews and 

makes decisions on requests for such 

exceptions. 

• Analyzes payment data, develops, 

maintains and updates payments rates 

for End Stage Renal Disease services and 

Program of All-Inclusive Care for the 

Elderly sites. 

• Manages designation process for 

Medicare organ transplant centers, 

organ procurement organizations and 

for hospitals seeking out-of-service-area 

waivers. 

• Develops, issues and administers 

the specifications, requirements, 

methods, standards, policies, 

procedures and budget guidelines for 

Medicare claims processing related 

activities, including detailed definitions 

of the relative responsibilities of 

providers, contractors, CMS, other thirdparty payers and the beneficiaries of the 

Medicare program. 

• Develops and releases the coding 

and pricing databases and software for 

physician, laboratory, Skilled Nursing 

Facility, Home Health, Inpatient, 

Outpatient and supplier services in the 

Medicare claims processing standard 

systems. 

• Develops policies related to the 

integration of health care services, 

including policies on ownership and 

referral arrangements, business 

relationships and conflict of interest. 

• Serves as the CMS lead for 

management, oversight, budget and 

performance issues relating to Medicare 

carriers, fiscal intermediaries, and 

MACs. 

• Functions as CMS liaison for all 

Medicare carrier, fiscal intermediary, 

and MAC program issues and, in close 

collaboration with the regional offices 

and other CMS components, coordinates 

Agency-wide contractor activities. 

• Manages contractor instructions, 

workload, and change management 

process. 

• Manages and oversees Medicare 

contractor provider inquiry, outreach, 

and education activities including 

specifying Budget Performance 

Requirements, allocating and managing 

budget dollars across contractors, 

evaluating supplemental budget 

requests, issuing program instructions 

and participating in contractor 

performance evaluation activities. 

• In conjunction with the CMS 

program area experts, develops training 

programs and materials, and training 

tools to educate providers, physicians, 

suppliers and Medicare contractor 

provider education staff on new 

initiatives and changes to the Medicare 

program. 

• Develops national provider/ 

supplier education products and 

training tools for Medicare contractors 

as well as for provider education 

provided directly by CMS. 

• Supports communication between 

CMS and the provider/supplier 

community through facilitation of 

‘‘open door’’ and Participating 

Physician Advisory Committee 

meetings, other listening sessions and 

promotes awareness of Agency 

initiatives by sponsoring exhibit 

programs at industry conferences. 

• Develops system requirements and 

computer software for select portions of 

Medicare FFS claims processing 

systems. 

• Develops and implements Medicare 

FFS program requirements for provider 

billing and for claims processing 

systems. 

• Implements the Medicare Health 

Support Program. 

Dated: September 18, 2008. 

James W. Weber, 

Acting Director, Office of Operations 

Management, Centers for Medicare & 

Medicaid Services. 

[FR Doc. E8–22690 Filed 9–25–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0514] 

Draft Guidance for Industry on End-ofPhase 2A Meetings; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘End-of-Phase 2A 

Meetings.’’ This draft guidance provides 

information on end-of-phase 2A 

(EOP2A) meetings for sponsors of 

investigational new drug applications 

(INDs) who seek guidance on employing 

clinical trial simulation and quantitative 

modeling of prior knowledge (e.g., drug, 

disease, placebo) to design trials for 

better dose response estimation, dose 

selection, and other appropriate issues. 

This draft guidance is intended to 

further FDA initiatives directed at 

identifying opportunities to facilitate 

the development of innovative medical 

products and to improve the quality of 

drug applications through early 

meetings with sponsors. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 


jlentini on PROD1PC65 with NOTICES