Statement of Organization, Functions, and Delegations of Authority, 65197-65199 [2011-27169]
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Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Notices
statistical and research purposes related
to evaluating and studying the operation
and effectiveness of the Medicare
program.
2. ‘‘Medicare Drug Data Processing
System (DDPS),’’ System No. 09–70–
0553, last published at 73 FR 30943
(May 29, 2008). The primary purpose of
this system is to collect, maintain, and
process information on all Medicare
covered, and as many non-covered drug
events as possible, for people with
Medicare who have enrolled into a
Medicare Part D plan.
3. ‘‘Medicare Integrated Data
Repository (IDR),’’ System No. 09–70–
0571, published at 71 FR 74915
(December 13, 2006). The primary
purpose of this system is to establish an
enterprise resource that provides one
integrated view of all CMS data to
administer the Medicare and Medicaid
programs.
4. ‘‘Chronic Condition Data
Repository (CCDR),’’ System No. 09–70–
0573, published at 71 FR 54495
(September 15, 2006). The purpose of
this system is to collect and maintain a
person-level view of identifiable data to
establish a data repository to study
chronically ill Medicare beneficiaries.
This system utilizes data extraction
tools to support accessing data by
chronic conditions and processes
complex customized research data
requests related to chronic illnesses.
DATES: The Centers for Medicare &
Medicaid Services (CMS) invites
interested parties to submit written
comments on the proposed system until
November 16, 2011. As required by the
Privacy Act (5 U.S.C. 552a(r)), CMS on
October 17, 2011 sent a report of a new
system of records to the Committee on
Homeland Security and Governmental
Affairs of the Senate, the Committee on
Oversight and Government Reform of
the House of Representatives, and the
Office of Information and Regulatory
Affairs of the Office of Management and
Budget (OMB). The proposed action
described in this notice is effective on
November 26, 2011, unless CMS
receives comments which result in a
republication of the notice.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Division of Information Security &
Privacy Management, Enterprise
Architecture and Strategy Group, Office
of Information Services, CMS, Room
N1–24–08, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Comments received will be available for
review at this location, by appointment,
during regular business hours, Monday
through Friday from 9 a.m.–3 p.m.,
Eastern Time zone.
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FOR FURTHER INFORMATION CONTACT:
Chris Haffer, Ph.D., Program Manager,
Data Development and Services Group,
Center for Strategic Planning, Centers
for Medicare and Medicaid Services,
7500 Security Boulevard, Mail-stop:
C3–24–07, Baltimore, MD 21244–1850.
Office: 410–786–8764, Facsimile: (410)
786–5515, E-mail address:
chris.haffer@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
statute defines QEs as public or private
entities that are determined by the
Secretary to be qualified to use
Medicare claims data to make such
evaluations of provider/supplier
performance, and that agree to meet
specific requirements regarding the
transparency of their methods and their
use and protection of Medicare data.
The statute requires that Medicare
claims extracts be combined with other
claims data, although the statute is not
specific on what, or how much, other
claims data should be combined with
Medicare claims data. The statute
requires that the only use of such data
and the derived performance
information about providers and
suppliers be in reports in an aggregate
form, released and made available to the
public, after first making such reports
available to any identified provider or
supplier and affording an opportunity to
appeal and correct errors. The statute
also instructs the Secretary to take such
actions as she deems necessary to
protect the identity of individual
beneficiaries, and authorizes her to
establish additional requirements that
she may specify for QEs to meet, such
as ensuring the security of data. The
Medicare claims extracts are to be made
available to QEs at a fee equal to the cost
of making such data available (the fees
will be deposited into the Part B Trust
Fund).
Dated: October 12, 2011.
Michelle Snyder,
Deputy Chief Operating Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 2011–27149 Filed 10–19–11; 8:45 am]
BILLING CODE 4120–03–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 &
PO 00000
Frm 00040
Fmt 4703
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65197
Medicaid Services (CMS), (Federal
Register, Vol. 70, No. 249, pp. 77160–
77161, dated December 29, 2005; Vol.
75, No. 56, pp. 14176—14178, dated
March 24, 2010; and Vol. 76, No. 144,
pp. 44933–44934, dated July 27, 2011)
are amended to: (1) Realign the survey
and certification function from the
Center for Medicaid, CHIP and Survey
& Certification to the Office of Clinical
Standards and Quality (OCSQ) and to
change the organizational title for the
Center for Medicaid, CHIP and Survey
& Certification to the Center for
Medicaid and CHIP Services (CMCS),
and (2) realign the governmental
relations function from the Office of
Legislation (OL) to CMCS. Part F,
Sections FC.10 (Organization) and FC.20
(Functions) is revised as follows:
• Section FC. 10 (Organization):
Office of the Administrator (FC)
Office of Equal Opportunity and Civil
Rights (FCA)
Office of Legislation (FCC)
Office of the Actuary (FCE)
Office of Strategic Operations and
Regulatory Affairs (FCF)
Office of Clinical Standards and Quality
(FCG)
Center for Medicare (FCH)
Center for Medicaid and CHIP Services
(FCJ)
Center for Strategic Planning (FCK)
Center for Program Integrity (FCL)
Chief Operating Officer (FCM)
Office of Minority Health (FCN)
Center for Medicare and Medicaid
Innovation (FCP)
Federal Coordinated Health Care Office
(FCQ)
Center for Consumer Information and
Insurance Oversight (FCR)
Office of Public Engagement (FCS)
Office of Communications (FCT)
• Section FC.20 (Functions):
Center for Medicaid and CHIP Services
(FCJ)
• Serves as CMS’ focal point for the
formulation, coordination, integration,
implementation, and evaluation of all
national program policies and
operations relating to the Medicaid and
Children’s Health Insurance Program
(CHIP).
• In partnership with States,
evaluates the success of State agencies
in carrying out their responsibilities for
effective State program administration
and beneficiary protection, and, as
necessary, assists States in correcting
problems and improving the quality of
their operations.
• Identifies and proposes
modifications to Medicaid and CHIP
program measures, regulations, laws
and policies to reflect changes or trends
E:\FR\FM\20OCN1.SGM
20OCN1
65198
Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
in the health care industry, program
objectives, and the needs of Medicaid
beneficiaries. Collaborates with OL on
the development and advancement of
new legislative initiatives and
improvements.
• Serves as CMS’ lead for
management, oversight, budget and
performance issues relating to Medicaid,
CHIP, and the related interactions with
the States.
• Coordinates with the Center for
Program Integrity on the identification
of program vulnerabilities and
implementation of strategies to
eliminate fraud, waste, and abuse.
• In conjunction with the Office of
Public Engagement, oversees all CMS
interactions and collaboration relating
to Medicaid and CHIP with
beneficiaries, States and territories and
key stakeholders (e.g., health facilities
and other health care providers, other
Federal government entities, local
governments) and communication and
dissemination of policies, guidance and
materials to same to understand their
perspectives, support their efforts, and
to drive best practices for beneficiaries,
in States and throughout the health care
industry.
• Develops and implements a
comprehensive strategic plan, objectives
and measures to carry out CMS’
Medicaid and CHIP mission and goals
and position the organization to meet
future challenges with the Medicaid and
CHIP programs.
Office of Clinical Standards and
Quality (FCG)
• Serves as the focal point for all
quality, clinical, medical science issues,
survey and certification, and policies for
CMS’ programs. Provides leadership
and coordination for the development
and implementation of a cohesive, CMSwide approach to measuring and
promoting quality and leads CMS’
priority-setting process for clinical
quality improvement. Coordinates
quality-related activities with outside
organizations. Monitors quality of
Medicare, Medicaid, and the Clinical
Laboratory and Improvement
Amendments (CLIA). Evaluates the
success of interventions.
• Identifies and develops best
practices and techniques in quality
improvement; implementation of these
techniques will be overseen by
appropriate components. Develops and
collaborates on demonstration projects
to test and promote quality
measurement and improvement.
• Develops, tests, evaluates, adopts
and supports performance measurement
systems (i.e., quality measures) to
evaluate care provided to CMS
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Jkt 226001
beneficiaries except for demonstration
projects residing in other components.
• Assures that CMS’ quality-related
activities (survey and certification,
technical assistance, beneficiary
information, payment policies and
provider/plan incentives) are fully and
effectively integrated. Carries out the
Health Care Quality Improvement
Program for the Medicare, Medicaid,
and CLIA programs.
• Oversees the planning, policy,
coordination and implementation of the
survey, certification and enforcement
programs for all Medicare and Medicaid
providers and suppliers, and for
laboratories under the auspices of CLIA.
• Serves as CMS’ lead for
management, oversight, budget, and
performance issues relating to the
survey and certification program and
the related interactions with the States.
• Leads in the specification and
operational refinement of an integrated
CMS quality information system, which
includes tools for measuring the
coordination of care between health care
settings; analyzes data supplied by that
system to identify opportunities to
improve care and assess success of
improvement interventions.
• Develops requirements of
participation for providers and plans in
the Medicare, Medicaid, and CLIA
programs. Revises requirements based
on statutory change and input from
other components.
• Operates the Quality Improvement
Organization and End-Stage Renal
Disease Network program in
conjunction with Regional Offices,
providing policies and procedures,
contract design, program coordination,
and leadership in selected projects.
• Identifies, prioritizes and develops
content for clinical and health related
aspects of CMS’ Consumer Information
Strategy; collaborates with other
components to develop comparative
provider and plan performance
information for consumer choices.
• Prepares the scientific, clinical, and
procedural basis for coverage of new
and established technologies and
services and provides coverage
recommendations to the CMS
Administrator. Coordinates activities of
CMS’ Technology Advisory Committee
and maintains liaison with other
departmental components regarding the
safety and effectiveness of technologies
and services; prepares the scientific and
clinical basis for, and recommends
approaches to, quality-related medical
review activities of carriers and
payment policies.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Office of Legislation (FCC)
• Provides leadership and executive
direction within CMS for legislative
planning to address the
Administration’s agenda.
• Tracks, evaluates and develops
provisions of annual legislative
proposals for Medicare, Medicaid, CHIP,
private health insurance programs,
CLIA, Health Insurance Portability and
Accountability Act and related statutes
affecting health care financing, health
insurance, quality, and access in concert
with CMS components, the Department
and the Office of Management and
Budget.
• Advances the legislative policy
process through analysis, review and
development of health care initiatives
and issues.
• Develops the long-range legislative
plans for CMS in collaboration with the
CMS Centers, Offices, and the Chief
Operating Officer (COO).
• Participates with other CMS
components in the development of CMS
policy, including implementing
regulations and administrative actions.
• Manages pro-actively CMS’
response in times of heightened
congressional oversight of CMS in
collaboration with the Centers, Offices,
and COO. Manages, coordinates and
develops policies for responding to
congressional inquiries.
• Coordinates activities with the
Office of the Assistant Secretary for
Legislation (ASL) and serves as the
ASL’s principal contact point on
legislative and congressional relations.
• In collaboration with CMS Centers,
Offices, and the COO, provides
technical assistance, consultation and
information services to congressional
committees and individual members of
Congress on the Medicare, Medicaid,
CHIP, and private health insurance
programs, new CMS initiatives, and
pertinent legislation.
• In collaboration with the CMS
Centers, Offices, and COO, provides
technical, analytical, advisory, and
information services to CMS’
components, the Department, the White
House, OMB, other government
agencies, private organizations and the
general public on CMS legislation.
• Tracks and reports on legislation
relating to CMS programs and maintains
legislative reference library.
• Coordinates CMS’ participation in
congressional hearings, including
preparation of testimony and briefing
materials, and covers all other
congressional hearings on matters of
interest to CMS except Appropriations
Committee hearings specifically on the
appropriation budget.
E:\FR\FM\20OCN1.SGM
20OCN1
Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Notices
Authority: 44 U.S.C. 3101.
Dated: October 13, 2011.
Michelle Snyder,
Deputy Chief Operating Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 2011–27169 Filed 10–19–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0720]
International Conference on
Harmonisation; E2B(R3) Electronic
Transmission of Individual Case Safety
Reports; Draft Guidance on
Implementation; Data Elements and
Message Specification; Appendix on
Backwards and Forwards
Compatibility; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘E2B(R3) Electronic Transmission of
Individual Case Safety Reports (ICSRs):
Implementation Guide—Data Elements
and Message Specification’’ (the draft
E2B(R3) implementation guidance) and
an appendix to the draft guidance
entitled ‘‘ICSRs: Appendix to the
Implementation Guide—Backwards and
Forwards Compatibility’’ (the draft BFC
appendix). The draft E2B(R3)
implementation guidance and draft BFC
appendix were prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft E2B(R3) implementation
guidance is intended to revise the
standards for submission of ICSRs and
improve the inherent quality of the data,
enabling improved handling and
analysis of ICSR reports. The draft BFC
appendix describes the relationship
between data elements from the 2001
ICH E2B guidance and draft E2B(R3)
implementation guidance.
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 these draft
documents before it begins work on the
final versions of the documents, submit
either electronic or written comments
on the draft documents by January 18,
2011.
ADDRESSES: Submit written requests for
single copies of the draft documents to
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
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the Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002, or the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. Send one self-addressed
adhesive label to assist the office in
processing your requests. The draft
documents may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft documents.
Submit electronic comments on the
draft documents to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance:
Krishna K. Chary, Center for Drug
Evaluation and Research, Food and
Drug Administration, 8201 Corporate
Dr., suite 540, Landover, MD 20785,
240–487–7377, fax: 301–459–2285, email: krishna.Chary@fda.hhs.gov; or
Deborah F. Yaplee, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–3288, fax: 301–827–9434, email: deborah.yaplee@fda.hhs.gov.
Regarding the ICH:
Michelle Limoli, Office of International
Programs, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 3506,
Silver Spring, MD 20993, 301–796–
4600.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory Agencies.
The ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
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65199
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labor,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In June and July 2011, the ICH
Steering Committee agreed that a draft
guidance entitled ‘‘E2B(R3) Electronic
Transmission of Individual Case Safety
Reports (ICSRs): Implementation
Guide—Data Elements and Message
Specification’’ and a draft appendix
entitled ‘‘ICSRs: Appendix to the
Implementation Guide—Backwards and
Forwards Compatibility’’ should be
made available for public comment. The
documents are the product of the
E2B(R3) Expert Working Group of the
ICH. Comments about these documents
will be considered by FDA and the
E2B(R3) Expert Working Group.
The key intention of the draft E2B(R3)
implementation guidance is to revise
the standards for submission of ICSRs
and improve the inherent quality of the
data, enabling improved handling and
analysis of ICSRs. The draft E2B(R3)
implementation guidance provides
support for the implementation of
software tools for creating, editing,
sending, and receiving electronic ICSR
messages. The draft E2B(R3)
implementation guidance provides
instruction for how pharmaceutical
industries and regulatory authorities
should use Part 2 of the International
Organization for Standardization (ISO)
ICSR standard to construct messages for
exchanging pharmacovigilance
information among themselves in ICH
regions, and in other countries adopting
ICH guidelines. The draft BFC appendix
describes the relationship between data
E:\FR\FM\20OCN1.SGM
20OCN1
]]>Agencies
[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Notices]
[Pages 65197-65199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27169]
-----------------------------------------------------------------------
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. 70, No.
249, pp. 77160-77161, dated December 29, 2005; Vol. 75, No. 56, pp.
14176--14178, dated March 24, 2010; and Vol. 76, No. 144, pp. 44933-
44934, dated July 27, 2011) are amended to: (1) Realign the survey and
certification function from the Center for Medicaid, CHIP and Survey &
Certification to the Office of Clinical Standards and Quality (OCSQ)
and to change the organizational title for the Center for Medicaid,
CHIP and Survey & Certification to the Center for Medicaid and CHIP
Services (CMCS), and (2) realign the governmental relations function
from the Office of Legislation (OL) to CMCS. Part F, Sections FC.10
(Organization) and FC.20 (Functions) is revised as follows:
Section FC. 10 (Organization):
Office of the Administrator (FC)
Office of Equal Opportunity and Civil Rights (FCA)
Office of Legislation (FCC)
Office of the Actuary (FCE)
Office of Strategic Operations and Regulatory Affairs (FCF)
Office of Clinical Standards and Quality (FCG)
Center for Medicare (FCH)
Center for Medicaid and CHIP Services (FCJ)
Center for Strategic Planning (FCK)
Center for Program Integrity (FCL)
Chief Operating Officer (FCM)
Office of Minority Health (FCN)
Center for Medicare and Medicaid Innovation (FCP)
Federal Coordinated Health Care Office (FCQ)
Center for Consumer Information and Insurance Oversight (FCR)
Office of Public Engagement (FCS)
Office of Communications (FCT)
Section FC.20 (Functions):
Center for Medicaid and CHIP Services (FCJ)
Serves as CMS' focal point for the formulation,
coordination, integration, implementation, and evaluation of all
national program policies and operations relating to the Medicaid and
Children's Health Insurance Program (CHIP).
In partnership with States, evaluates the success of State
agencies in carrying out their responsibilities for effective State
program administration and beneficiary protection, and, as necessary,
assists States in correcting problems and improving the quality of
their operations.
Identifies and proposes modifications to Medicaid and CHIP
program measures, regulations, laws and policies to reflect changes or
trends
[[Page 65198]]
in the health care industry, program objectives, and the needs of
Medicaid beneficiaries. Collaborates with OL on the development and
advancement of new legislative initiatives and improvements.
Serves as CMS' lead for management, oversight, budget and
performance issues relating to Medicaid, CHIP, and the related
interactions with the States.
Coordinates with the Center for Program Integrity on the
identification of program vulnerabilities and implementation of
strategies to eliminate fraud, waste, and abuse.
In conjunction with the Office of Public Engagement,
oversees all CMS interactions and collaboration relating to Medicaid
and CHIP with beneficiaries, States and territories and key
stakeholders (e.g., health facilities and other health care providers,
other Federal government entities, local governments) and communication
and dissemination of policies, guidance and materials to same to
understand their perspectives, support their efforts, and to drive best
practices for beneficiaries, in States and throughout the health care
industry.
Develops and implements a comprehensive strategic plan,
objectives and measures to carry out CMS' Medicaid and CHIP mission and
goals and position the organization to meet future challenges with the
Medicaid and CHIP programs.
Office of Clinical Standards and Quality (FCG)
Serves as the focal point for all quality, clinical,
medical science issues, survey and certification, and policies for CMS'
programs. Provides leadership and coordination for the development and
implementation of a cohesive, CMS-wide approach to measuring and
promoting quality and leads CMS' priority-setting process for clinical
quality improvement. Coordinates quality-related activities with
outside organizations. Monitors quality of Medicare, Medicaid, and the
Clinical Laboratory and Improvement Amendments (CLIA). Evaluates the
success of interventions.
Identifies and develops best practices and techniques in
quality improvement; implementation of these techniques will be
overseen by appropriate components. Develops and collaborates on
demonstration projects to test and promote quality measurement and
improvement.
Develops, tests, evaluates, adopts and supports
performance measurement systems (i.e., quality measures) to evaluate
care provided to CMS beneficiaries except for demonstration projects
residing in other components.
Assures that CMS' quality-related activities (survey and
certification, technical assistance, beneficiary information, payment
policies and provider/plan incentives) are fully and effectively
integrated. Carries out the Health Care Quality Improvement Program for
the Medicare, Medicaid, and CLIA programs.
Oversees the planning, policy, coordination and
implementation of the survey, certification and enforcement programs
for all Medicare and Medicaid providers and suppliers, and for
laboratories under the auspices of CLIA.
Serves as CMS' lead for management, oversight, budget, and
performance issues relating to the survey and certification program and
the related interactions with the States.
Leads in the specification and operational refinement of
an integrated CMS quality information system, which includes tools for
measuring the coordination of care between health care settings;
analyzes data supplied by that system to identify opportunities to
improve care and assess success of improvement interventions.
Develops requirements of participation for providers and
plans in the Medicare, Medicaid, and CLIA programs. Revises
requirements based on statutory change and input from other components.
Operates the Quality Improvement Organization and End-
Stage Renal Disease Network program in conjunction with Regional
Offices, providing policies and procedures, contract design, program
coordination, and leadership in selected projects.
Identifies, prioritizes and develops content for clinical
and health related aspects of CMS' Consumer Information Strategy;
collaborates with other components to develop comparative provider and
plan performance information for consumer choices.
Prepares the scientific, clinical, and procedural basis
for coverage of new and established technologies and services and
provides coverage recommendations to the CMS Administrator. Coordinates
activities of CMS' Technology Advisory Committee and maintains liaison
with other departmental components regarding the safety and
effectiveness of technologies and services; prepares the scientific and
clinical basis for, and recommends approaches to, quality-related
medical review activities of carriers and payment policies.
Office of Legislation (FCC)
Provides leadership and executive direction within CMS for
legislative planning to address the Administration's agenda.
Tracks, evaluates and develops provisions of annual
legislative proposals for Medicare, Medicaid, CHIP, private health
insurance programs, CLIA, Health Insurance Portability and
Accountability Act and related statutes affecting health care
financing, health insurance, quality, and access in concert with CMS
components, the Department and the Office of Management and Budget.
Advances the legislative policy process through analysis,
review and development of health care initiatives and issues.
Develops the long-range legislative plans for CMS in
collaboration with the CMS Centers, Offices, and the Chief Operating
Officer (COO).
Participates with other CMS components in the development
of CMS policy, including implementing regulations and administrative
actions.
Manages pro-actively CMS' response in times of heightened
congressional oversight of CMS in collaboration with the Centers,
Offices, and COO. Manages, coordinates and develops policies for
responding to congressional inquiries.
Coordinates activities with the Office of the Assistant
Secretary for Legislation (ASL) and serves as the ASL's principal
contact point on legislative and congressional relations.
In collaboration with CMS Centers, Offices, and the COO,
provides technical assistance, consultation and information services to
congressional committees and individual members of Congress on the
Medicare, Medicaid, CHIP, and private health insurance programs, new
CMS initiatives, and pertinent legislation.
In collaboration with the CMS Centers, Offices, and COO,
provides technical, analytical, advisory, and information services to
CMS' components, the Department, the White House, OMB, other government
agencies, private organizations and the general public on CMS
legislation.
Tracks and reports on legislation relating to CMS programs
and maintains legislative reference library.
Coordinates CMS' participation in congressional hearings,
including preparation of testimony and briefing materials, and covers
all other congressional hearings on matters of interest to CMS except
Appropriations Committee hearings specifically on the appropriation
budget.
[[Page 65199]]
Authority: 44 U.S.C. 3101.
Dated: October 13, 2011.
Michelle Snyder,
Deputy Chief Operating Officer, Centers for Medicare & Medicaid
Services.
[FR Doc. 2011-27169 Filed 10-19-11; 8:45 am]
BILLING CODE 4120-01-P
