Medicare Program; Renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), 16412 [2015-07105]
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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
• Costs of federal inspections of
laboratories in the state to verify that
New York State’s laboratory licensure
program requirements are equivalent to
or more stringent than those in the CLIA
program, and that they are enforced in
an appropriate manner. The average
federal hourly rate is multiplied by the
total hours required to perform federal
validation surveys within the state.
• Costs incurred for federal surveys,
including investigations of complaints
that are substantiated. We will bill the
State of New York on a semiannual
basis.
• The State of New York’s
proportionate share of the costs
associated with establishing,
maintaining, and improving the CLIA
computer system, based on the portion
of those services from which the State
of New York received direct benefit or
which contributed to the CLIA program
in the state. Thus, the State of New York
is being charged for a portion of our
direct and indirect costs of
administering the CLIA program. Such
costs will be incurred by CMS, the
Centers for Disease Control and
Prevention (CDC), the Food and Drug
Administration (FDA) and contractors
working on behalf of these respective
agencies.
To estimate the State of New York’s
proportionate share of the general
overhead costs to develop and
implement CLIA, we determined the
ratio of laboratories in the state to the
total number of laboratories nationally.
Approximately 1.5 percent of the
registered laboratories are in the State of
New York. We determined that a
corresponding percentage of the
applicable CMS, CDC, FDA, and their
respective contractor costs should be
borne by the State of New York.
The State of New York has agreed to
pay the state’s pro rata share of the
anticipated overhead costs and costs of
actual validation (including complaint
investigation surveys). A final
reconciliation for all laboratories and all
expenses will be made. We will
reimburse the state for any overpayment
or bill it for any balance.
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II. Approval
In light of the foregoing, we grant
approval of the State of New York’s
laboratory licensure program, CLEP,
under subpart E. All laboratories located
within the State of New York that hold
valid CLEP permits are CLIA-exempt for
all specialties and subspecialties until
March 27, 2021.
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
Dated: March 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–07113 Filed 3–26–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3318–N]
Medicare Program; Renewal of the
Medicare Evidence Development &
Coverage Advisory Committee
(MEDCAC)
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
renewal of the Medicare Evidence
Development & Coverage Advisory
Committee (MEDCAC).
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, (410) 786–0309. Additional
information on the MEDCAC, including
a copy of the Charter, is available at
https://www.cms.gov/Regulations-andGuidance/Guidance/FACA/
MEDCAC.html. A copy of the charter
may also be obtained by submitting a
request to Maria Ellis via phone or via
email at Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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 MCAC
on November 24, 1998. The MCAC was
originally established to provide
independent guidance and expert
advice to CMS on specific clinical
topics. In 2007, the Charter was
renewed and the name MCAC was
modified to Medicare Evidence
Development and Coverage Advisory
Committee (MEDCAC) to more
accurately reflect the Committee’s role.
The MEDCAC is advisory, with the final
decision on all issues resting with CMS.
Under the current charter, the MEDCAC
advises the Secretary of the Department
of Health and Human Services (DHHS)
(the Secretary) and the Administrator of
the Centers for Medicare & Medicaid
Services (CMS) on the quality of
evidence on clinical topics under
review by CMS.
The MEDCAC consists of a pool of
100 appointed members who serve
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
overlapping 2-year terms. Members
shall be invited to serve for two terms
(up to 4 years total). Members are
selected from among authorities in
clinical and administrative medicine,
biologic and physical sciences, public
health administration, health care data
and information management and
analysis, the economics of health care,
medical ethics, and other related
professions, as well as advocates for
patients. Of the pool of 100 members, a
maximum of 94 members shall be atlarge standing members (this includes 6
members who shall be patient
advocates) and 6 shall be members
representing industry interests. The
Secretary or designee appoints a Chair
and Vice-Chair from among the pool of
at-large members.
II. Provisions of This Notice
This notice announces the renewal of
the MEDCAC charter by the Secretary,
effective November 24, 2014. The
MEDCAC charter is effective for 2 years.
Among other things, the new charter
states that the committee will hold four
to eight meetings over the life of the
committee. Formerly, the charter
allowed up to 16 meetings over the life
of the committee.
The MEDCAC functions on a
committee basis. The MEDCAC hears
public testimony; reviews medical
literature, technology assessments and
other relevant evidence; and advises
CMS on the strength and weaknesses of
that evidence. The MEDCAC also
advises CMS of any evidence gaps that
may exist and recommends the types of
evidence that should be developed to
fill those evidentiary gaps. The
Committee may be asked to develop
recommendations about specific issues
related to Medicare coverage, and/or to
review and comment upon proposed or
existing Medicare coverage policies. The
Committee may also be asked to
comment on pertinent aspects of
coverage proposals being considered
and other policies. The Committee
works from an agenda provided by a
designated Federal official, which lists
specific issues to be reviewed.
Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
Dated: March 20, 2015.
Patrick Conway,
Deputy Administrator for Innovation and
Quality and CMS Chief Medical Officer,
Centers for Medicare & Medicaid Services.
[FR Doc. 2015–07105 Filed 3–26–15; 8:45 am]
BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Page 16412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3318-N]
Medicare Program; Renewal of the Medicare Evidence Development &
Coverage Advisory Committee (MEDCAC)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the renewal of the Medicare Evidence
Development & Coverage Advisory Committee (MEDCAC).
FOR FURTHER INFORMATION CONTACT: Maria Ellis, (410) 786-0309.
Additional information on the MEDCAC, including a copy of the Charter,
is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEDCAC.html. A copy of the charter may also be obtained by
submitting a request to Maria Ellis via phone or via email at
Maria.Ellis@cms.hhs.gov.
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 MCAC on November 24, 1998. The MCAC was originally established to
provide independent guidance and expert advice to CMS on specific
clinical topics. In 2007, the Charter was renewed and the name MCAC was
modified to Medicare Evidence Development and Coverage Advisory
Committee (MEDCAC) to more accurately reflect the Committee's role. The
MEDCAC is advisory, with the final decision on all issues resting with
CMS. Under the current charter, the MEDCAC advises the Secretary of the
Department of Health and Human Services (DHHS) (the Secretary) and the
Administrator of the Centers for Medicare & Medicaid Services (CMS) on
the quality of evidence on clinical topics under review by CMS.
The MEDCAC consists of a pool of 100 appointed members who serve
overlapping 2-year terms. Members shall be invited to serve for two
terms (up to 4 years total). Members are selected from among
authorities in clinical and administrative medicine, biologic and
physical sciences, public health administration, health care data and
information management and analysis, the economics of health care,
medical ethics, and other related professions, as well as advocates for
patients. Of the pool of 100 members, a maximum of 94 members shall be
at-large standing members (this includes 6 members who shall be patient
advocates) and 6 shall be members representing industry interests. The
Secretary or designee appoints a Chair and Vice-Chair from among the
pool of at-large members.
II. Provisions of This Notice
This notice announces the renewal of the MEDCAC charter by the
Secretary, effective November 24, 2014. The MEDCAC charter is effective
for 2 years. Among other things, the new charter states that the
committee will hold four to eight meetings over the life of the
committee. Formerly, the charter allowed up to 16 meetings over the
life of the committee.
The MEDCAC functions on a committee basis. The MEDCAC hears public
testimony; reviews medical literature, technology assessments and other
relevant evidence; and advises CMS on the strength and weaknesses of
that evidence. The MEDCAC also advises CMS of any evidence gaps that
may exist and recommends the types of evidence that should be developed
to fill those evidentiary gaps. The Committee may be asked to develop
recommendations about specific issues related to Medicare coverage,
and/or to review and comment upon proposed or existing Medicare
coverage policies. The Committee may also be asked to comment on
pertinent aspects of coverage proposals being considered and other
policies. The Committee works from an agenda provided by a designated
Federal official, which lists specific issues to be reviewed.
Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).
Dated: March 20, 2015.
Patrick Conway,
Deputy Administrator for Innovation and Quality and CMS Chief Medical
Officer, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07105 Filed 3-26-15; 8:45 am]
BILLING CODE 4120-01-P
