Medicare Program; Renewal and Renaming of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MedCAC) and a Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 3853-3854 [E7-1113]
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<![CDATA[
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices
statement in understandable language of
the reasons for the denial and a
description of the reconsideration and
appeals processes. These notices fulfill
the regulatory requirement. Form
Number: CMS–10003 (OMB#: 0938–
0829); Frequency: Reporting: Yearly;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 454; Total
Annual Responses: 105,138; Total
Annual Hours: 26285.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: CMS
Application for Federal Qualification
(901A); CMS Medicare Agreement
Application (901D) and Supporting
Regulations in 42 CFR Section 417.143
and 422.6; Use: Prepaid health plans
must meet certain regulatory
requirements to be federally qualified
health maintenance organizations or to
enter into a contract with CMS to
provide health benefits to Medicare
beneficiaries. The application forms are
used by CMS to collect information
about a health plan to determine their
compliance with federal regulations.
Form Number: CMS–901A and D
(OMB#: 0938–0470); Frequency:
Reporting: Once; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 55; Total Annual
Responses: 55; Total Annual Hours:
2,200.
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare ESRD
Exceptions; Use: This information is
collected in accordance with section
2145 of the Omnibus Budget
Reconciliation Act of 1981 and section
623 of the Medicare Prescription Drug
Improvement and Modernization Act of
2003. End Stage Renal Disease (ESRD)
facilities can file for an exception to its
composite payment rate. CMS uses the
information submitted to determine
whether an ESRD facility qualifies for a
rate increase and the amount of the
increase. Form Number: CMS–9044
(OMB#: 0938–0296); Frequency:
Reporting: Occasionally; Affected
Public: Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 10; Total Annual
Responses: 10; Total Annual Hours:
400.
4. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Review of
National Coverage Determinations and
Local Coverage Determinations and
Supporting Regulations in 42 CFR
VerDate Aug<31>2005
17:19 Jan 25, 2007
Jkt 211001
426.400 and 42 CFR 426.500; Use:
Section 522 of the Benefits
Improvement and Protection Act (BIPA)
of 2000 requires the implementation of
a process for the appeal of National
Coverage Determinations (NCDs) and
Local Coverage Determinations (LCDs).
Sections 426.400 and 426.500, state that
an aggrieved party may initiate a review
of an LCD or NCD, respectively, by
filing a written complaint. These
sections also identify the information
required in the complaint to qualify as
an aggrieved party as defined in
§ 426.110, as well as the process and
information needed for an aggrieved
party to withdraw a complaint. The
required documentation includes a copy
of the written authorization to represent
the beneficiary, if the beneficiary has a
representative, and a copy of a written
statement from the treating physician
that the beneficiary needs a service that
is the subject of the LCD. Form Number:
CMS–10099 (OMB#: 0938–0911);
Frequency: Reporting—On occasion;
Affected Public: Individuals or
Households; Number of Respondents:
1,040; Total Annual Responses: 1,040;
Total Annual Hours: 4,160.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on March 27, 2007.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—C, Attention:
Bonnie L. Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: January 19, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–1124 Filed 1–25–07; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00075
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3853
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3169–N]
Medicare Program; Renewal and
Renaming of the Medicare Coverage
Advisory Committee (MCAC) to
Medicare Evidence Development
Coverage Advisory Committee
(MedCAC) and a Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
renewal and name change of the
Medicare Coverage Advisory Committee
(MCAC) to Medicare Evidence
Development Coverage Advisory
Committee (MedCAC). It also requests
nominations for consideration for
membership on the Medicare Evidence
Development & Coverage Advisory
Committee (MedCAC).
DATES: Nominations will be considered
if postmarked by March 12, 2007.
ADDRESSES: Nominations for
membership must be sent by mail, fax,
or e-mail, to one of the following
addresses: Centers for Medicare &
Medicaid Services, Office of Clinical
Standards and Quality, Mail Stop: C1–
09–06, 7500 Security Boulevard,
Baltimore, MD 21244, Attention:
Michelle Atkinson; via fax to (410) 786–
9286; or e-mail to
michelle.atkinson@cms.hhs.gov.
Copies of the Charter: To obtain a
copy of the Secretary’s Charter for the
MedCAC submit a request to: Centers
for Medicare & Medicaid Service, Office
of Clinical Standards and Quality, Mail
Stop C1–09–06, 7500 Security
Boulevard, Baltimore, MD 21244,
Attention: Maria Ellis or via e-mail to
maria.ellis@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Michelle Atkinson, (410) 786–2881,
Nominations; Marie Ellis, (410) 786–
0309, Copies of the charter.
SUPPLEMENTARY INFORMATION:
I. Background
On December 14, 1998, we published
a notice in the Federal Register (63 FR
68780) announcing the establishment of
the Medicare Coverage Advisory
Committee (MCAC). The Secretary
signed the initial charter for the
Medicare Coverage Advisory Committee
on November 24, 1998. The MCAC
E:\FR\FM\26JAN1.SGM
26JAN1
3854
Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices
advised the Secretary of the Department
of Health and Human Services (DHHS)
and the Administrator of the Centers for
Medicare and Medicaid Services (CMS),
as requested by the Secretary, whether
medical items and services were
reasonable and necessary under Title
XVIII of the Social Security Act (the
Act).
The MCAC consisted of a pool of 100
appointed members. Members were
selected from among authorities in
clinical medicine of all specialties,
administrative medicine, public health,
biologic and physical sciences, health
care data and information management
and analysis, patient advocacy, the
economics of health care, medical
ethics, and other related professions
such as epidemiology and biostatistics,
and methodology of trial design. A
maximum of 88 members are standard
voting members, 12 are nonvoting
members, 6 of whom are representatives
of consumer interests, and 6 of whom
are representatives of industry interests.
II. Provisions of This Notice
sroberts on PROD1PC70 with NOTICES
A. Renewal of the Charter and the
Renaming of the Committee
This notice announces the signing of
the MedCAC charter renewal by the
Secretary on November 24, 2006. The
charter will terminate on November 24,
2008, unless renewed by the Secretary.
The new charter makes the following
changes:
• Redesignates the Committee from
the MCAC to Medicare Evidence
Development Coverage Advisory
Committee.
• Gives the MedCAC an explicit
responsibility to advise CMS as part of
its coverage with evidence development
(CED) activity. The CED initiative
involves the issuance of national
coverage determinations that include, a
condition of payment, requirements for
developing additional clinical data on a
particular medical technology.
• Formalizes the role of patient
advocates on the MedCAC role. By
establishing the patient advocate as a
permanent MedCAC role, CMS is
ensuring that beneficiary community is
represented on the panels. These
advocates will identify issues most
important to patients, communicate the
patient perspective, and vote on the
Committee’s recommendations with
patients’ general interests in mind.
To accompany the changes in the
MedCAC charter, we have issued a
guidance document entitled, ‘‘Factor
CMS Considers in Referring Topics to
the Medicare Evidence Development
and Coverage Advisory Committee.’’
This document is consistent with
VerDate Aug<31>2005
17:19 Jan 25, 2007
Jkt 211001
Section 731 of the Medicare
Prescription Drug Improvement, and
Modernization Act (MMA) of 2003, and
is in line with our goal of continuing to
develop a more open, transparent, and
understandable national coverage
process.
B. Request for Nominations
As of May 2007, there will be 28
terms of membership expiring, 2 of
which are nonvoting consumer
representatives, 1 of which is a
nonvoting industry representative and 6
voting patient advocates. Accordingly,
we are requesting nominations for both
voting and nonvoting members to serve
on the MedCAC. Members are invited to
serve for overlapping 4 year terms. A
member may serve after the expiration
of the member’s term until a successor
takes office. Any interested person may
nominate one or more qualified persons.
Self-nominations are also accepted. We
have a special interest in ensuring that
women, minority groups, and physically
challenged individuals are adequately
represented on the MedCAC. Therefore,
we encourage nominations of qualified
candidates from these groups. Nominees
are selected based upon their individual
qualifications and not as representatives
of professional associations or societies.
The MedCAC functions on a
committee basis. The committee reviews
and evaluates medical literature,
reviews technology assessments, and
examines data and information on the
effectiveness and appropriateness of
medical items and services that are
covered or eligible for coverage under
Medicare. The Committee works from
an agenda provided by the designated
Federal official that lists specific issues,
and develops technical advice to assist
us in determining reasonable and
necessary applications of medical
services and technology when we make
national coverage decisions for
Medicare.
1. Membership Criteria
Nominees for voting membership
must have expertise and experience in
one or more of the following fields:
clinical medicine of all specialties,
administrative medicine, public health,
patient advocacy, biologic and physical
sciences, health care data and
information management and analysis,
the economics of health care, medical
ethics, and other related professions
such as epidemiology and biostatistics,
and methodology of trial design.
2. Submission of Nominations
All nominations must be
accompanied by nomination letter and
curricula vitae. Nomination packages
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
must be sent to the address specified in
the ADDRESSES section this notice. The
nomination letter must include—(1) A
statement that the nominee is willing to
serve as a member of the MedCAC and
believes that he or she does not have a
conflict of interest that would preclude
his or her committee membership; and
(2) specify whether the nominee is
applying for a voting position, consumer
representative; industry representative
or patient advocate. The curricula vitae
must include the following: (1) Date of
birth; (2) place of birth; (3) social
security number; (4) title and current
position; (5) professional affiliation; (6)
home and business addresses; (7)
telephone and fax numbers; (8) e-mail
address; and (9) list of the nominee’s
areas of expertise. Potential candidates
will be asked to provide detailed
information concerning such matters as
financial holdings, consultancies, and
research grants or contracts in order to
permit evaluation of possible sources of
conflict of interest.
Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: January 11, 2007.
Barry M. Straube,
Chief Medical Officer, Director, Office of
Clinical Standards and Quality, Centers for
Medicare &Medicaid Services.
[FR Doc. E7–1113 Filed 1–25–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4126–FN]
Medicare and Medicaid Programs;
Reapproval of Deeming Authority of
the Accreditation Association for
Ambulatory Health Care, Inc. for
Medicare Advantage Health
Maintenance Organizations and Local
Preferred Provider Organizations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
SUMMARY: This notice announces our
decision to approve Medicare
Advantage Deeming Authority of the
Accreditation Association for
Ambulatory Health Care, Inc. for health
maintenance organizations and local
preferred provider organizations for a
term of 6 years.
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 72, Number 17 (Friday, January 26, 2007)]
[Notices]
[Pages 3853-3854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1113]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3169-N]
Medicare Program; Renewal and Renaming of the Medicare Coverage
Advisory Committee (MCAC) to Medicare Evidence Development Coverage
Advisory Committee (MedCAC) and a Request for Nominations for Members
for the Medicare Evidence Development & Coverage Advisory Committee
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the renewal and name change of the
Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence
Development Coverage Advisory Committee (MedCAC). It also requests
nominations for consideration for membership on the Medicare Evidence
Development & Coverage Advisory Committee (MedCAC).
DATES: Nominations will be considered if postmarked by March 12, 2007.
ADDRESSES: Nominations for membership must be sent by mail, fax, or e-
mail, to one of the following addresses: Centers for Medicare &
Medicaid Services, Office of Clinical Standards and Quality, Mail Stop:
C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244, Attention:
Michelle Atkinson; via fax to (410) 786-9286; or e-mail to
michelle.atkinson@cms.hhs.gov.
Copies of the Charter: To obtain a copy of the Secretary's Charter
for the MedCAC submit a request to: Centers for Medicare & Medicaid
Service, Office of Clinical Standards and Quality, Mail Stop C1-09-06,
7500 Security Boulevard, Baltimore, MD 21244, Attention: Maria Ellis or
via e-mail to maria.ellis@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, (410) 786-2881,
Nominations; Marie Ellis, (410) 786-0309, Copies of the charter.
SUPPLEMENTARY INFORMATION:
I. Background
On December 14, 1998, we published a notice in the Federal Register
(63 FR 68780) announcing the establishment of the Medicare Coverage
Advisory Committee (MCAC). The Secretary signed the initial charter for
the Medicare Coverage Advisory Committee on November 24, 1998. The MCAC
[[Page 3854]]
advised the Secretary of the Department of Health and Human Services
(DHHS) and the Administrator of the Centers for Medicare and Medicaid
Services (CMS), as requested by the Secretary, whether medical items
and services were reasonable and necessary under Title XVIII of the
Social Security Act (the Act).
The MCAC consisted of a pool of 100 appointed members. Members were
selected from among authorities in clinical medicine of all
specialties, administrative medicine, public health, biologic and
physical sciences, health care data and information management and
analysis, patient advocacy, the economics of health care, medical
ethics, and other related professions such as epidemiology and
biostatistics, and methodology of trial design. A maximum of 88 members
are standard voting members, 12 are nonvoting members, 6 of whom are
representatives of consumer interests, and 6 of whom are
representatives of industry interests.
II. Provisions of This Notice
A. Renewal of the Charter and the Renaming of the Committee
This notice announces the signing of the MedCAC charter renewal by
the Secretary on November 24, 2006. The charter will terminate on
November 24, 2008, unless renewed by the Secretary. The new charter
makes the following changes:
Redesignates the Committee from the MCAC to Medicare
Evidence Development Coverage Advisory Committee.
Gives the MedCAC an explicit responsibility to advise CMS
as part of its coverage with evidence development (CED) activity. The
CED initiative involves the issuance of national coverage
determinations that include, a condition of payment, requirements for
developing additional clinical data on a particular medical technology.
Formalizes the role of patient advocates on the MedCAC
role. By establishing the patient advocate as a permanent MedCAC role,
CMS is ensuring that beneficiary community is represented on the
panels. These advocates will identify issues most important to
patients, communicate the patient perspective, and vote on the
Committee's recommendations with patients' general interests in mind.
To accompany the changes in the MedCAC charter, we have issued a
guidance document entitled, ``Factor CMS Considers in Referring Topics
to the Medicare Evidence Development and Coverage Advisory Committee.''
This document is consistent with Section 731 of the Medicare
Prescription Drug Improvement, and Modernization Act (MMA) of 2003, and
is in line with our goal of continuing to develop a more open,
transparent, and understandable national coverage process.
B. Request for Nominations
As of May 2007, there will be 28 terms of membership expiring, 2 of
which are nonvoting consumer representatives, 1 of which is a nonvoting
industry representative and 6 voting patient advocates. Accordingly, we
are requesting nominations for both voting and nonvoting members to
serve on the MedCAC. Members are invited to serve for overlapping 4
year terms. A member may serve after the expiration of the member's
term until a successor takes office. Any interested person may nominate
one or more qualified persons. Self-nominations are also accepted. We
have a special interest in ensuring that women, minority groups, and
physically challenged individuals are adequately represented on the
MedCAC. Therefore, we encourage nominations of qualified candidates
from these groups. Nominees are selected based upon their individual
qualifications and not as representatives of professional associations
or societies.
The MedCAC functions on a committee basis. The committee reviews
and evaluates medical literature, reviews technology assessments, and
examines data and information on the effectiveness and appropriateness
of medical items and services that are covered or eligible for coverage
under Medicare. The Committee works from an agenda provided by the
designated Federal official that lists specific issues, and develops
technical advice to assist us in determining reasonable and necessary
applications of medical services and technology when we make national
coverage decisions for Medicare.
1. Membership Criteria
Nominees for voting membership must have expertise and experience
in one or more of the following fields: clinical medicine of all
specialties, administrative medicine, public health, patient advocacy,
biologic and physical sciences, health care data and information
management and analysis, the economics of health care, medical ethics,
and other related professions such as epidemiology and biostatistics,
and methodology of trial design.
2. Submission of Nominations
All nominations must be accompanied by nomination letter and
curricula vitae. Nomination packages must be sent to the address
specified in the ADDRESSES section this notice. The nomination letter
must include--(1) A statement that the nominee is willing to serve as a
member of the MedCAC and believes that he or she does not have a
conflict of interest that would preclude his or her committee
membership; and (2) specify whether the nominee is applying for a
voting position, consumer representative; industry representative or
patient advocate. The curricula vitae must include the following: (1)
Date of birth; (2) place of birth; (3) social security number; (4)
title and current position; (5) professional affiliation; (6) home and
business addresses; (7) telephone and fax numbers; (8) e-mail address;
and (9) list of the nominee's areas of expertise. Potential candidates
will be asked to provide detailed information concerning such matters
as financial holdings, consultancies, and research grants or contracts
in order to permit evaluation of possible sources of conflict of
interest.
Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: January 11, 2007.
Barry M. Straube,
Chief Medical Officer, Director, Office of Clinical Standards and
Quality, Centers for Medicare &Medicaid Services.
[FR Doc. E7-1113 Filed 1-25-07; 8:45 am]
BILLING CODE 4120-03-P
