Statement of Organization, Functions, and Delegations of Authority, 55850-55851 [E8-22690]
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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 (https://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.
jlentini on PROD1PC65 with NOTICES
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
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18:07 Sep 25, 2008
Jkt 214001
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
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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.
E:\FR\FM\26SEN1.SGM
26SEN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices
• 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.
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18:07 Sep 25, 2008
Jkt 214001
• 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.
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55851
• 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
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26SEN1
Agencies
[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Notices]
[Pages 55850-55851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22690]
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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.
[[Page 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 third-party 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