Medicare Program; Quality Improvement Organization (QIO) Contracts: Solicitation of Proposals From In-State QIOs-Idaho, Maine, South Carolina, and Vermont, 72830-72831 [2010-28817]
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Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from July 1, 2010, through
September 30, 2010. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2010, THROUGH SEPTEMBER 30, 2010
PMA No.
Docket No.
Applicant
Trade name
P080027, FDA–2010–M–0402 ...............
OraSure Technologies, Inc ...................
P050034, FDA–2010–M–0361 ...............
Vision Care Ophthalmic Technologies,
Ltd.
Abbott Molecular, Inc ............................
ORAQUICK HCV RAPID ANTIBODY
TEST.
IMPLANTABLE MINIATURE TELESCOPE.
ABBOTT REALTIME HBV ASSAY .......
P080026, FDA–2010–M–0519 ...............
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Interested organizations should monitor
the Federal Business Opportunities Web
site for all information relating to the
RFP.
Dated: November 18, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
ADDRESSES:
[FR Doc. 2010–29731 Filed 11–24–10; 8:45 am]
BILLING CODE 4160–01–P
Proposals for the contracts
must be submitted to the Centers for
Medicare & Medicaid Services,
Acquisitions and Grants Groups,
OAGM, Attn.: Naomi Haney-Ceresa,
7500 Security Boulevard, Mail Stop C2–
21–15, Baltimore, Maryland 21244–
1850.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
Alfreda Staton, (410) 786–4194.
I. Background
[CMS–3229–N]
Medicare Program; Quality
Improvement Organization (QIO)
Contracts: Solicitation of Proposals
From In-State QIOs—Idaho, Maine,
South Carolina, and Vermont
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice fulfills the
Secretary’s obligation under section
1153(i) of the Social Security Act (the
Act) to provide at least 6 months’
advance notice of the expiration dates of
contracts with out-of-State Quality
Improvement Organizations (QIOs)
before renewing any of those QIOs’
contracts. It also specifies the period of
time in which in-State QIOs may submit
a proposal for those contracts.
DATES: Interested organizations may
submit a proposal to perform the QIO
work in any of the States listed in this
announcement. The request for proposal
(RFP) will be made available to all
interested organizations through the
Federal Business Opportunities (https://
www.fedbizopps.gov) Web site. CMS
anticipates that the RFP for the QIO
contracts will be released sometime
during the month of February 2011.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:32 Nov 24, 2010
Jkt 223001
The Peer Review Improvement Act of
1982 (title I, subtitle C of the Tax Equity
and Fiscal Responsibility Act of 1982
(TEFRA), Pub. L. 97–248) amended Part
B of title XI of the Act (the Act) by
establishing the Utilization and Quality
Control Peer Review Organization
program.
Utilization and Quality Control Peer
Review Organizations, now known as
Quality Improvement Organizations
(QIOs), currently review certain health
care services furnished under title XVIII
of the Social Security Act (the Act)
(Medicare) to determine whether those
services are reasonable, medically
necessary, provided in the appropriate
setting, and are of a quality that meets
professionally recognized standards.
QIO activities are a part of the Health
Care Quality Improvement Program
(HCQIP), a program that supports our
mission to ensure health care quality for
our beneficiaries. The HCQIP rests on
the belief that a plan’s, provider’s, or
practitioner’s own internal quality
management system is key to good
performance. The HCQIP is carried out
locally by the QIO in each State. Under
the HCQIP, QIOs provide critical tools
(for example, quality indicators and
information) for plans, providers, and
practitioners to improve the quality of
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Approval date
June 25, 2010.
July 1, 2010.
August 13, 2010.
care provided to Medicare beneficiaries.
The Congress created the QIO program
in part to redirect, simplify, and
enhance the cost-effectiveness and
efficiency of the peer review process.
In June 1984, we began awarding
contracts to QIOs. We currently
maintain 53 QIO contracts with
organizations that provide medical
review activities for the 50 States, the
District of Columbia, Puerto Rico, and
the Virgin Islands. The organizations
that are eligible to contract as QIOs have
satisfactorily demonstrated that they are
either physician-sponsored or
physician-access organizations in
accordance with section 1152 of the Act
and our regulations at 42 CFR 475.102
and 475.103. A physician-sponsored
organization is one that is both
composed of a substantial number of the
licensed doctors of medicine and
osteopathy practicing medicine or
surgery in the respective review area
and who are representative of the
physicians practicing in the review area.
A physician-access organization is one
that has available to it, by arrangement
or otherwise, the services of a sufficient
number of licensed doctors of medicine
or osteopathy practicing medicine or
surgery in the review area to ensure
adequate peer review of the services
furnished by the various medical
specialties and subspecialties. In
addition, a QIO cannot be a health care
facility, health care facility association,
a health care facility affiliate, or in most
cases a payor organization. (The
regulations provide that, in the event
CMS determines no otherwise qualified
non-payor organization is available to
undertake a given QIO contract, CMS
may select a payor organization which
otherwise meets certain requirements to
be eligible to conduct Utilization and
Quality Control Peer Review as
specified in Part B of Title XI of the Act
and its implementing regulations.)
Section 1152(2) of the Act requires QIOs
to perform review functions in an
E:\FR\FM\26NON1.SGM
26NON1
Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
efficient and effective manner, and
perform reviews of quality of care in an
area of medical practice where actual
performance is measured against
objective criteria, which defines
acceptable and adequate practice. The
selected organization must have a
consumer representative on its
governing board.
The Omnibus Budget Reconciliation
Act of 1987 (Pub. L. 100–203) amended
section 1153 of the Act by adding
paragraph (i). This provision prohibits
CMS from renewing the contract of any
QIO that is not an in-State QIO without
first publishing in the Federal Register
a notice announcing when the contract
will expire. This notice must be
published no later than 6 months before
the date the contract expires and must
specify the period of time during which
an in-State organization may submit a
proposal for the QIO contract for that
State. If one or more qualified in-State
organizations submit a proposal for the
QIO contract within the specified period
of time, we cannot automatically renew
the current contract on a
noncompetitive basis, but must instead
provide for competition for the contract
in the same manner used for a new
contract under section 1153(b) of the
Act. An in-State QIO is defined under
section 1153(i)(3) of the Act as a QIO
that has its primary place of business in
the State in which review will be
conducted (or, be a subsidiary of a
parent corporation, whose headquarters
is located in that State).
There are currently 4 QIO contracts
with entities that do not meet the
statutory definition of an in-State QIO.
The areas affected for purposes of this
notice along with the respective contract
expiration dates are as follows:
Vermont—July 31, 2011
Maine—July 31, 2011
Idaho—July 31, 2011
South Carolina—July 31, 2011
II. Provisions of the Notice
This notice announces the scheduled
expiration dates of the current contracts
between CMS and the out-of-State QIOs
responsible for review in the areas
mentioned above.
Interested in-State organizations may
submit a proposal in competing to
become the QIO for these States. In
order to be eligible for contract award,
the organization must have its primary
place of business in the States in which
review will be conducted or be a
subsidiary of a parent corporation,
whose headquarters is located in that
State. In order to be eligible for contract
award, each interested organization
must further demonstrate that it meets
the following requirements:
VerDate Mar<15>2010
16:32 Nov 24, 2010
Jkt 223001
A. Be Either a Physician-Sponsored or a
Physician-Access Organization
1. Physician-Sponsored Organization
a. The organization must be composed
of a substantial number of the licensed
doctors of medicine and osteopathy
practicing medicine or surgery in the
review area, who are representative of
the physicians practicing in the review
area.
b. The organization must not be a
health care facility, health care facility
association, health care facility affiliate,
or payor organization. However, statutes
and regulations provide that, in the
event CMS determines no otherwise
qualified non-payor organization is
available to undertake a given QIO
contract, CMS may select a payor
organization which otherwise meets
requirements to be eligible to conduct
Utilization and Quality Control Peer
Review as specified in Part B of Title XI
of the Act and its implementing
regulations.
c. In order to meet the ‘‘substantial
number of doctors of medicine and
osteopathy’’ requirements as specified
above in paragraph A.1.a, an
organization must state and have
documentation in its files showing that
it is composed of at least 10 percent of
the licensed doctors of medicine and
osteopathy practicing medicine or
surgery in the review area. In order to
meet the representation requirements as
specified above in paragraph A.1.a, an
organization must state and have
documentation in its files demonstrating
that it is composed of at least 20 percent
of the licensed doctors of medicine and
osteopathy practicing medicine or
surgery in the review area.
Alternatively, if the organization does
not demonstrate that it is composed of
at least 20 percent of the licensed
doctors of medicine and osteopathy
practicing medicine or surgery in the
review area, the organization must
demonstrate in its proposal, through
letters of support from physicians or
physician organizations, or through
other means, that it is representative of
the area physicians.
2. Physician-Access Organization
a. The organization must have
available to it, by arrangement or
otherwise, the services of a sufficient
number of licensed doctors of medicine
or osteopathy practicing medicine or
surgery in the review area to ensure
adequate peer review of the services
furnished by the various medical
specialties and subspecialties.
b. The organization must not be a
health care facility, health care facility
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
72831
association, health care facility affiliate,
or payor organization.
c. An organization meets the
requirements specified above in
paragraph A.2.a., if it demonstrates that
it has available to it at least one
physician in every generally recognized
specialty and has an arrangement or
arrangements with physicians under
which the physicians would conduct
review for the organization.
B. Have at Least One Individual Who Is
a Representative of Consumers on Its
Governing Board
If one or more organizations meet the
above requirements in a QIO area and
submit proposals for the contracts in
accordance with this notice, we will
consider those organizations to be
potential sources for the 4 contracts
upon their expiration. These
organizations will be entitled to
participate in a full and open
competition for the QIO contract to
perform the QIO statement of work.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare-Supplementary Medical Insurance
Program)
Dated: October 28, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–28817 Filed 11–24–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—Ethics
Subcommittee (ES)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned subcommittee:
Time and Date: 2 p.m.—3:30 p.m. Eastern
Standard Time, January 4, 2011.
Place: Teleconference.
Status: Open to the public, limited only by
availability of telephone ports. The public is
welcome to participate during the public
comment period. A public comment period
is tentatively scheduled from 3 p.m.—3:15
p.m. To participate in the teleconference,
please dial 1–877–928–1204 and enter
conference code 4305992.
Purpose: The ES will provide counsel to
the ACD, CDC, regarding a broad range of
public health ethics questions and issues
arising from programs, scientists and
practitioners.
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72830-72831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28817]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3229-N]
Medicare Program; Quality Improvement Organization (QIO)
Contracts: Solicitation of Proposals From In-State QIOs--Idaho, Maine,
South Carolina, and Vermont
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice fulfills the Secretary's obligation under section
1153(i) of the Social Security Act (the Act) to provide at least 6
months' advance notice of the expiration dates of contracts with out-
of-State Quality Improvement Organizations (QIOs) before renewing any
of those QIOs' contracts. It also specifies the period of time in which
in-State QIOs may submit a proposal for those contracts.
DATES: Interested organizations may submit a proposal to perform the
QIO work in any of the States listed in this announcement. The request
for proposal (RFP) will be made available to all interested
organizations through the Federal Business Opportunities (https://www.fedbizopps.gov) Web site. CMS anticipates that the RFP for the QIO
contracts will be released sometime during the month of February 2011.
Interested organizations should monitor the Federal Business
Opportunities Web site for all information relating to the RFP.
ADDRESSES: Proposals for the contracts must be submitted to the Centers
for Medicare & Medicaid Services, Acquisitions and Grants Groups, OAGM,
Attn.: Naomi Haney-Ceresa, 7500 Security Boulevard, Mail Stop C2-21-15,
Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Alfreda Staton, (410) 786-4194.
SUPPLEMENTARY INFORMATION:
I. Background
The Peer Review Improvement Act of 1982 (title I, subtitle C of the
Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Pub. L. 97-
248) amended Part B of title XI of the Act (the Act) by establishing
the Utilization and Quality Control Peer Review Organization program.
Utilization and Quality Control Peer Review Organizations, now
known as Quality Improvement Organizations (QIOs), currently review
certain health care services furnished under title XVIII of the Social
Security Act (the Act) (Medicare) to determine whether those services
are reasonable, medically necessary, provided in the appropriate
setting, and are of a quality that meets professionally recognized
standards. QIO activities are a part of the Health Care Quality
Improvement Program (HCQIP), a program that supports our mission to
ensure health care quality for our beneficiaries. The HCQIP rests on
the belief that a plan's, provider's, or practitioner's own internal
quality management system is key to good performance. The HCQIP is
carried out locally by the QIO in each State. Under the HCQIP, QIOs
provide critical tools (for example, quality indicators and
information) for plans, providers, and practitioners to improve the
quality of care provided to Medicare beneficiaries. The Congress
created the QIO program in part to redirect, simplify, and enhance the
cost-effectiveness and efficiency of the peer review process.
In June 1984, we began awarding contracts to QIOs. We currently
maintain 53 QIO contracts with organizations that provide medical
review activities for the 50 States, the District of Columbia, Puerto
Rico, and the Virgin Islands. The organizations that are eligible to
contract as QIOs have satisfactorily demonstrated that they are either
physician-sponsored or physician-access organizations in accordance
with section 1152 of the Act and our regulations at 42 CFR 475.102 and
475.103. A physician-sponsored organization is one that is both
composed of a substantial number of the licensed doctors of medicine
and osteopathy practicing medicine or surgery in the respective review
area and who are representative of the physicians practicing in the
review area. A physician-access organization is one that has available
to it, by arrangement or otherwise, the services of a sufficient number
of licensed doctors of medicine or osteopathy practicing medicine or
surgery in the review area to ensure adequate peer review of the
services furnished by the various medical specialties and
subspecialties. In addition, a QIO cannot be a health care facility,
health care facility association, a health care facility affiliate, or
in most cases a payor organization. (The regulations provide that, in
the event CMS determines no otherwise qualified non-payor organization
is available to undertake a given QIO contract, CMS may select a payor
organization which otherwise meets certain requirements to be eligible
to conduct Utilization and Quality Control Peer Review as specified in
Part B of Title XI of the Act and its implementing regulations.)
Section 1152(2) of the Act requires QIOs to perform review functions in
an
[[Page 72831]]
efficient and effective manner, and perform reviews of quality of care
in an area of medical practice where actual performance is measured
against objective criteria, which defines acceptable and adequate
practice. The selected organization must have a consumer representative
on its governing board.
The Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203)
amended section 1153 of the Act by adding paragraph (i). This provision
prohibits CMS from renewing the contract of any QIO that is not an in-
State QIO without first publishing in the Federal Register a notice
announcing when the contract will expire. This notice must be published
no later than 6 months before the date the contract expires and must
specify the period of time during which an in-State organization may
submit a proposal for the QIO contract for that State. If one or more
qualified in-State organizations submit a proposal for the QIO contract
within the specified period of time, we cannot automatically renew the
current contract on a noncompetitive basis, but must instead provide
for competition for the contract in the same manner used for a new
contract under section 1153(b) of the Act. An in-State QIO is defined
under section 1153(i)(3) of the Act as a QIO that has its primary place
of business in the State in which review will be conducted (or, be a
subsidiary of a parent corporation, whose headquarters is located in
that State).
There are currently 4 QIO contracts with entities that do not meet
the statutory definition of an in-State QIO. The areas affected for
purposes of this notice along with the respective contract expiration
dates are as follows:
Vermont--July 31, 2011
Maine--July 31, 2011
Idaho--July 31, 2011
South Carolina--July 31, 2011
II. Provisions of the Notice
This notice announces the scheduled expiration dates of the current
contracts between CMS and the out-of-State QIOs responsible for review
in the areas mentioned above.
Interested in-State organizations may submit a proposal in
competing to become the QIO for these States. In order to be eligible
for contract award, the organization must have its primary place of
business in the States in which review will be conducted or be a
subsidiary of a parent corporation, whose headquarters is located in
that State. In order to be eligible for contract award, each interested
organization must further demonstrate that it meets the following
requirements:
A. Be Either a Physician-Sponsored or a Physician-Access Organization
1. Physician-Sponsored Organization
a. The organization must be composed of a substantial number of the
licensed doctors of medicine and osteopathy practicing medicine or
surgery in the review area, who are representative of the physicians
practicing in the review area.
b. The organization must not be a health care facility, health care
facility association, health care facility affiliate, or payor
organization. However, statutes and regulations provide that, in the
event CMS determines no otherwise qualified non-payor organization is
available to undertake a given QIO contract, CMS may select a payor
organization which otherwise meets requirements to be eligible to
conduct Utilization and Quality Control Peer Review as specified in
Part B of Title XI of the Act and its implementing regulations.
c. In order to meet the ``substantial number of doctors of medicine
and osteopathy'' requirements as specified above in paragraph A.1.a, an
organization must state and have documentation in its files showing
that it is composed of at least 10 percent of the licensed doctors of
medicine and osteopathy practicing medicine or surgery in the review
area. In order to meet the representation requirements as specified
above in paragraph A.1.a, an organization must state and have
documentation in its files demonstrating that it is composed of at
least 20 percent of the licensed doctors of medicine and osteopathy
practicing medicine or surgery in the review area. Alternatively, if
the organization does not demonstrate that it is composed of at least
20 percent of the licensed doctors of medicine and osteopathy
practicing medicine or surgery in the review area, the organization
must demonstrate in its proposal, through letters of support from
physicians or physician organizations, or through other means, that it
is representative of the area physicians.
2. Physician-Access Organization
a. The organization must have available to it, by arrangement or
otherwise, the services of a sufficient number of licensed doctors of
medicine or osteopathy practicing medicine or surgery in the review
area to ensure adequate peer review of the services furnished by the
various medical specialties and subspecialties.
b. The organization must not be a health care facility, health care
facility association, health care facility affiliate, or payor
organization.
c. An organization meets the requirements specified above in
paragraph A.2.a., if it demonstrates that it has available to it at
least one physician in every generally recognized specialty and has an
arrangement or arrangements with physicians under which the physicians
would conduct review for the organization.
B. Have at Least One Individual Who Is a Representative of Consumers on
Its Governing Board
If one or more organizations meet the above requirements in a QIO
area and submit proposals for the contracts in accordance with this
notice, we will consider those organizations to be potential sources
for the 4 contracts upon their expiration. These organizations will be
entitled to participate in a full and open competition for the QIO
contract to perform the QIO statement of work.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance Program; and No. 93.774, Medicare-
Supplementary Medical Insurance Program)
Dated: October 28, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-28817 Filed 11-24-10; 8:45 am]
BILLING CODE 4120-01-P
