Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Contracts (10th Statement of Work), 46814-46818 [2011-19650]
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Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices
even greater (75%). In the absence of an
effective vaccine, behavioral
interventions represent one of the few
methods for reducing high HIV
incidence among African American
MSM (AAMSM). Unfortunately, in the
third decade of the epidemic, very few
of the available HIV-prevention
interventions for African American
populations have been designed
specifically for MSM. In fact, until very
recently none of CDC’s evidence-based,
HIV-prevention interventions had been
specifically tested for efficacy in
reducing HIV transmission among MSM
of color. Given the conspicuous absence
of (1) Evidence-based HIV interventions
and (2) outcome evaluations of existing
AAMSM interventions, our
collaborative team intends to address a
glaring research gap by implementing a
best-practices model of comprehensive
program evaluation.
The purpose of this project is to test,
in a real world setting, the efficacy of an
HIV transmission prevention
intervention for reducing sexual risk
among African American men who have
sex with men in LAC. The project is a
3-session, group-level intervention that
will provide participants with the
information, motivation, and skills
necessary to reduce their risk of
transmitting or acquiring HIV. The
intervention will be evaluated using
baseline, 3 month and 6 month followup assessments. This project will also
conduct in-depth qualitative interviews
with 36 men in order to assess their
experiences with the intervention, elicit
recommendations for improving the
intervention, and to better understand
the factors that put African American
MSM at risk for HIV.
CDC is requesting a 3-year clearance
for data collection. The data collection
system involves screenings, limited
locator information, contact
information, a baseline questionnaire,
client satisfaction surveys, a 3-month
follow-up questionnaire, a 6-month
follow-up questionnaire, and case study
interviews. An estimated 700 men will
be screened for eligibility in order to
enroll 528 men. The baseline and follow
up questionnaires contain questions
about participants’ socio-demographic
information, health and healthcare,
sexual activity, substance use, and other
psychosocial issues. The duration of
each baseline, 3-month, and 6-month
questionnaires are estimated to be 60
minutes; the 36 Success Case Study
interviews 90 minutes; Outreach
Recruitment Assessment 5 minutes;
limited locator information form 5
minutes; participant contact information
form 10 minutes; each client satisfaction
survey 5 minutes. There is no cost to
participants other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number
responses per
espondent
Number of
respondents
Average burden
per respondent
(in hours)
Total annual
urden in hours
Type of respondent
Form name
AAMSM ................................
700
1
5/60
58
700
528
1
1
5/60
10/60
58
88
..................
..................
..................
..................
..................
Outreach Recruitment Assessment (screener).
Limited Locator Information ..........
Participant Contact Information
Form.
Baseline Questionnaire .................
Client Satisfaction Survey .............
3 month follow up Questionnaire ..
6 month follow up Questionnaire ..
Success Case Study Interview .....
528
224
420
400
36
1
3
1
1
1
1
5/60
1
1
1.5
528
56
420
400
54
Total ..............................
.......................................................
............................
............................
............................
1662
AAMSM ................................
Enrolled AAMSM ..................
Enrolled
Enrolled
Enrolled
Enrolled
Enrolled
AAMSM
AAMSM
AAMSM
AAMSM
AAMSM
Dated: July 27, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–19614 Filed 8–2–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
srobinson on DSK4SPTVN1PROD with NOTICES
Medicare Program; Evaluation Criteria
and Standards for Quality
Improvement Program Contracts
(10th Statement of Work)
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
16:24 Aug 02, 2011
Jkt 223001
In commenting, please refer
to file code CMS–3143–NC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (Fax)
transmission.
ADDRESSES:
This notice with comment
period describes the general criteria we
VerDate Mar<15>2010
Effective Date: August 1, 2011 to
July 31, 2014.
Comment Date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
September 2, 2011.
DATES:
[CMS–3143–NC]
SUMMARY:
intend to use to evaluate the
effectiveness and efficiency of Quality
Improvement Organizations (QIOs) that
will enter into contracts with CMS
under the 10th Statement of Work
(SOW) on August 1, 2011. The
evaluation of a QIOs’ performance
related to their SOW will be based on
evaluation criteria specified for the
aims, drivers, tasks, and subtasks set
forth in section J–10 of the QIOs’ 10th
SOW.
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You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address only: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3143–NC, P.O. Box 8010,
Baltimore, MD 21244–8010.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address only: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3143–NC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
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srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments only to the
following addresses prior to the close of
the comment period:
a. For delivery in Washington, DC:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Alfreda Staton, 410–786–4194.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from
8:30 a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
VerDate Mar<15>2010
16:24 Aug 02, 2011
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I. Background
Section 1153(h)(2) of the Social
Security Act (the Act) requires the
Secretary of the Department of Health
and Human Services to publish in the
Federal Register the general criteria and
standards that will be used to evaluate
the effective and efficient performance
of contract obligations by the Quality
Improvement Organizations (QIOs), and
to provide the opportunity for public
comment with respect to these criteria
and standards. This notice describes the
general criteria that will be used to
evaluate QIO performance under the
10th Statement of Work (SOW) contract
beginning August 1, 2011.
II. Provisions of the Notice With
Comment Period
Description
Under the 10th SOW, QIOs are
responsible for completing the
requirements for the following Aims:
Beneficiary and Family Centered Care;
Improve Individual Care—A Patient
Safety Aim with components focused on
Healthcare Associated Infections (HAIs),
Pressure Ulcers, Physical Restraints,
Nursing Home Systemic Improvement,
Adverse Drug Events, Quality Reporting
and Improvement; Integrate Care for
Populations and Communities—A Care
Transitions Aim; and Improve Health
for Populations and Communities—A
Prevention Aim. The ability to achieve
the goals for each Aim will be through
the following Drivers: Learning and
Action Networks, Technical Assistance,
and the Care Reinvention through
Innovation Spread (CRISP) Model.
(Detailed information for each Aim and
Driver may be found in sections C.6.
through C.10. of the 10th SOW posted
at the https://www.fedbizopps.gov Web
site.)
Beneficiary and Family Centered Care
(See Section C.6 of the 10th Statement
of Work)
The Beneficiary and Family Centered
Care Aim focuses on: QIO statutorily
mandated case review activities as well
as interventions to promote
responsiveness to beneficiary and
family needs; providing opportunities
for listening to and addressing
beneficiary and family concerns; and
providing resources for beneficiaries
and caregivers in decision making.
Beneficiary-generated concerns provide
an excellent opportunity to explore root
causes, develop alternative approaches
to improving care, and improve
beneficiary and family experiences with
the health care system. Beneficiary and
family engagement and activation efforts
are needed to produce the best possible
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outcomes of care. These QIO beneficiary
and family centered efforts align with
the National Quality Strategy, which
encourages patient and family
engagement.
Improve Individual Patient Care (Patient
Safety) Initiatives (See Section C.7 of the
10th Statement of Work)
The Patient Safety initiatives are
designed to help achieve the goals of
improving individual patient care by:
Reducing Healthcare-Associated
Infections (HAIs)—Central Line
Bloodstream Infections (CLABSI),
Catheter-Associated Urinary Tract
Infections (CAUTI), Clostridium
Difficile Infections (CDI) and SurgicalSite Infections (SSI); Reducing
Healthcare Acquired Conditions in
Nursing Homes—Pressure Ulcers and
Physical Restraints; Developing a
learning and action network to begin to
make forward progress toward a safer
system of care; reducing Adverse Drug
Events (ADEs) and medication-related
harm; and providing technical
assistance to hospitals to improve their
quality of care related to Medicare
programs such as the Hospital Inpatient
Quality Reporting (IQR) Program and
the Hospital Outpatient Quality
Reporting (OQR) Program to promote
quality improvement and transparency
for consumer decision making through
publicly reported quality data.
Integrate Care for Populations and
Communities (See Section C.8 of the
10th Statement of Work)
The QIO work must improve the
quality of care for Medicare
beneficiaries who transition among care
settings through a comprehensive
community effort. These efforts aim to
reduce readmissions following
hospitalization and to yield sustainable
and replicable strategies to achieve
high-value health care for sick and
disabled Medicare beneficiaries.
Improve Health for Populations and
Communities (See Section C.9 of the
10th Statement of Work)
The QIO must improve population
and community health through
prevention and early diagnosis by:
Improving flu immunizations of patients
ages 50 and older during the flu season;
improving pneumococcal immunization
of patients ages 65 and older; improving
appropriate low-dose aspirin therapy
use in patients with ischemic vascular
disease; improving blood pressure
control in patients with hypertension;
improving low-density lipoproteincholesterol (LDL–C) control among
adults with ischemic vascular disease;
improving tobacco cessation
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intervention among adult patients who
smoke (screening and cessation
counseling); improving colorectal
cancer screening in patients ages 50
through 75; improving breast cancer
screening in women ages 40 through 69;
improving participation in the
Physician Quality Reporting System
(PQRS); improving the use of Electronic
Health Records (EHRs) for care
management; and integrating health
information technology to achieve
meaningful use and improve care
coordination and prevention goals.
Drivers—Learning and Action Networks,
Technical Assistance, and Care
Reinvention Through Innovation Spread
(CRISP) Model (See Section C.10 of the
10th Statement of Work)
Learning and Action Networks are
mechanisms by which large scale
improvement around a given aim is
fostered, studied, adapted, and rapidly
spread regardless of the change
methodology, tools, or time-bounded
initiative that is used to achieve the aim.
Learning Action Networks collaborate
with the Regional Extension Centers
with respect to quality improvement
and health IT/data related issues.
Learning and Action Networks
consciously manage knowledge as a
valuable resource. They engage leaders
around an action based agenda. The
network creates opportunities for indepth learning and problem solving, it
accepts all offers of support seeking to
catalyze interested parties, and it is
transparent, flexible, interchangeable,
and purposeful.
It is expected that the QIO will
develop and facilitate sustainable
Learning and Action Networks within
their respective State, as well as
participate in CMS supported and
facilitated Learning and Action
Networks, which will function to
support QIO activities at the local level.
The QIO must develop a team(s)
(number and composition to be
determined by the QIO) that is
responsible for supporting and
facilitating the Learning and Action
Networks for their respective State. This
team is responsible for creating interest
and active participation in the Learning
and Action Networks from vested
parties within the State around a
specific aim(s).
The QIO must provide technical
assistance to providers, facilities, and
partners. The QIO must offer direct
assistance related to quality
improvement questions and needs to
support local providers in making
changes by connecting the requestor
with quality improvement knowledge,
providing follow-up available at the
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local and national level. The QIO must
rely on their own internal resources,
those of the community, those availed
by Federal agencies, and those of the
National Coordinating Centers. The QIO
must provide technical assistance to
individual providers, provider groups or
health care systems upon their request
as well as upon the direction of CMS.
In general, technical assistance is
more focused, limited, and directed
than activities of the Learning and
Action Networks although it could be a
component of these activities. Some
activities include the following:
• The QIO is expected to develop and
spread a sustainable infrastructure by
facilitating the adoption of change from
the QIO to a provider, provider group or
health care system.
• The QIO will ensure that each
initiative includes a sustainability plan
and the QIO will work to achieve
consensus among participants so that
the quality improvement efforts will
continue as the need continues.
• The QIO will identify pertinent data
resources available to support the local
provider community. This includes
claims data, data organized by other
contractors, data available from the
Centers for Disease Control, National
Institutes of Health, World Health
Organization, the Census Bureau, the
community information available
through the coordinating center, the
Center for Medicare and Medicaid
Innovation, and the Agency for
Healthcare Research and Quality. The
QIO must conduct data analysis and
develop meaningful data reports to be
used by the local provider community,
Learning and Action Networks and
breakthrough initiatives.
The Care Reinvention through
Innovation Spread (CRISP) Model is the
framework for supporting the
communications and outreach activities
required to complete all Aims of the
10th SOW successfully. The CRISP
Model is designed to minimize internal
fragmentation, siloing, and duplication
or conflict of messages across individual
QIOs and the QIO Program as a whole.
The Model is used through all activities
of the 10th SOW so that all QIO
operations are stakeholder-centric and
focus on at least one of the three phases
of communicating with stakeholders
about quality improvement work: (1)
Initiation and ‘‘will building’’; (2)
engagement and maintenance; and (3)
retention and sustainment throughout
the life of the QIO task. The goal of the
model is to give access to the right
information and services, in the right
form, at the right time, to the right
people in the right place. The model
does this by focusing the QIO’s energies
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such that each policy, action, and
decision is made with an educated and
strategic consideration of the impacts
they may have on stakeholders.
Under the CRISP Model, the QIO
must ensure that Innovation Spread
Advisors (ISAs) are identified for their
State or territory. This individual(s)
would bring knowledge to every QIO
Aim (or project) team within the
enterprise by: Helping the Aim teams
determine who the stakeholders are and
what they need; ensuring beneficiary
input; facilitating the appropriate
mechanisms for stakeholder
communication; and determining if
activities are successful. The ISA(s)
from each QIO must attend CMSsponsored training sessions and serve as
brand ambassadors with branding
responsibilities as indicated in section
C.10.3.
III. Evaluation of the Aims and Drivers
(See Section J–10 and Section C.5 of the
10th Statement of Work)
A qualitative and quantitative
evaluation will be conducted at the 18th
(intermediate evaluation) and 27th
months (final evaluation) of the contract
with monitoring and measuring for
improvement conducted throughout the
3 year contract cycle. The evaluations
will be based on the most recent data
available to us. The performance results
of the evaluation at both time periods
(that is, 18 months and 27 months) will
be used, in addition to ongoing
monitoring activities, to determine the
performance on the overall contract.
Using lean and rapid techniques, QIOs
will be monitored and measured for
improvement on an ongoing basis using
self-assessment and Contracting Officer
Technical Representative (COTR)
review. The COTR will complete
assessment and review of qualitative
and quantitative contract evaluation
objectives.
The following categories will serve as
the basis for the qualitative evaluation
of the Technical Assistance Drivers as
specified on Table 1 of section J–10 in
the 10th Statement of Work:
• Rapid Cycle Improvement in
Quality Improvement Activities and
Outputs.
• Customer Focus and Value of the
Quality Improvement Activities to
Beneficiaries, Participants and CMS.
• Ability To Prepare the Field To
Sustain the Improvements.
• Value Innovation.
• Commitment to
‘‘boundarilessness.’’
• Unconditional Teamwork.
The quantitative evaluation of the
QIOs will be based on the number of
commitments secured, participants
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engaged, and the results in achievement
of the goals as specified on Tables 2 and
3 in section J–10 of the 10th Statement
of Work.
The ‘‘Aims Tasks’’ the QIO will be
evaluated on are as follows:
C.6 Beneficiary and Family Centered
Care:
• Case Review;
• Patient and Family Engagement
Campaign.
C.7 Improving Individual Patient
Care:
• Reduction of Healthcare Associated
Infections (CLABSI, CAUTI, CDI, and
SSI);
• Reduction of Healthcare Acquired
Conditions in Nursing Homes (Pressure
Ulcers and the Use of Physical
Restraints);
• Reduction of Adverse Drug Events;
• Hospital Inpatient and Outpatient
Quality Reporting and Improvement.
C.8 Integrating Care for Populations
and Communities:
• Reduction of Hospital Readmissions
Through a Comprehensive Community
Effort by Improving the Quality of Care
for Medicare Beneficiaries Who
Transition Among Care Settings.
C.9 Improving Health for
Populations and Communities:
• Promotion of Immunizations,
Colorectal, and Breast Cancer
Screenings;
• Cardiovascular Health Campaign;
• Improving Participation in the
Physician Quality Reporting System
(PQRS);
• Improving the Use of Electronic
Health Records (EHRs) for Care
Management;
• Integrating Health Information
Technology to Improve Care
Coordination, Achieve Meaningful Use,
and Achieve Prevention Goals.
The ‘‘Driver Tasks’’ the QIO will be
evaluated on are as follows:
C.10.1 Supporting and Convening
Learning and Action Networks.
C.10.2 Technical Assistance;
C.10.3 Care Reinvention Through
Innovation Spread (CRISP) Model.
If a QIO is not tasked to work on a
specific area under an ‘‘Aim’’ and/or
‘‘Driver,’’ the QIO will not be evaluated
under that particular area. Any Special
Innovation Project that the QIO may
carry out will be evaluated separately
and will not be considered in the overall
evaluation criteria.
In addition to the qualitative and
quantitative evaluation in the 18th and
27th months of the contract, we will
conduct monitoring activities
throughout the course of the contract
and will act upon findings as necessary.
The performance results of the
evaluation at both time periods (that is,
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18 months and 27 months) will be used,
in addition to ongoing monitoring
activities, to determine the overall
performance on the contract.
18th Month Contract Evaluation
The 18th month contract evaluation
will determine if the QIO has met the
performance evaluation criteria as
specified in J–10 of this Statement of
Work. The achievement within each of
the ‘‘Aims’’ and ‘‘Drivers’’ will be
evaluated on an individual basis for
appropriate contract action. Though, in
general, evaluation of each ‘‘Aim’’ and/
or ‘‘Driver’’ will relate only to that area,
we reserve the right to take appropriate
contract action in the event of failure in
multiple ‘‘Aims’’ and/or ‘‘Drivers’’.
18th Month Evaluation Criteria:
• Pass: Criteria met for the ‘‘Aim’’
and/or ‘‘Driver’’ as specified in the
evaluation section of the ‘‘Aim’’ and/or
‘‘Driver.’’
• Fail: Criteria not met for the ‘‘Aim’’
and/or ‘‘Driver’’ as specified in the
evaluation section of the ‘‘Aim’’ and/or
‘‘Driver.’’
27th Month Contract Evaluation
The 27th month contract evaluation
will determine if the QIO has met the
performance evaluation criteria as
specified in each of the ‘‘Aims’’ and
‘‘Drivers’’ areas of the 10th SOW. The
achievement within the ‘‘Drivers’’ and
‘‘Aims’’ will be evaluated on an
individual basis for appropriate contract
action.
27th Month Evaluation Criteria:
• Pass: Criteria met for the ‘‘Aim’’
and/or ‘‘Driver’’ as specified in the
evaluation section of the ‘‘Aim’’ and/or
‘‘Driver.’’
• Fail: Criteria not met for the ‘‘Aim’’
and/or ‘‘Driver’’ as specified in the
evaluation section of the ‘‘Aim’’ and/or
‘‘Driver.’’
Overall Contract Evaluation
The results of the 18th and 27th
month evaluation periods, in addition to
ongoing monitoring activities, will be
used to determine how the contractor
performed on the overall contract.
If we choose, we may notify the QIO
of our intention not to renew the QIO
contract and inform the QIO of their
rights under the current statute.
Any failure at the 18th or 27th month
evaluation for any ‘‘Aim or Driver’’ may
result in that QIO receiving an adverse
past performance evaluation. Further,
failure may impact on the QIO’s ability
to continue similar work in or eligibility
for award of the 11th SOW.
The list of measures and performance
criteria for each QIO will be recorded on
the CMS Dashboard, which will be
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46817
available on QIOnet (https://
qionet.sdps.org), the standard
information system that supports the
QIO Program. We will also post these
measures on the publicly accessible
CMS Web site (https://www.cms.gov).
We will monitor the QIO’s
performance on the ‘‘Aims’’ and
‘‘Drivers’’ against established criteria on
at least a quarterly basis, and may take
appropriate contract action (for
example, providing warning for the
need for adjustment, instituting a formal
correction plan, terminating an activity,
or recommending early termination of a
contract because of failure to meet
contract timelines as specified in
sections C.6 through C.10.).
We reserve the right at any point,
prior to the notification of our intention
not to continue the option for an ‘‘Aim’’
and/or ‘‘Driver’’ and/or to renew the
contract, to revise measures or adjust
the expected minimum thresholds for
satisfactory performance or remove
criteria from an ‘‘Aim’’ and/or ‘‘Driver’’
evaluation protocol for any reason,
including, but not limited to, data
gathered based on experience with the
amount of improvement achieved
during the contract cycle or in pilot
projects currently in progress,
information gathered through evaluation
of the QIO Program overall, or any
unforeseen circumstances. Further, in
accordance with standard contract
procedures, we reserve the right at any
time to discontinue an ‘‘Aim’’ and/or
‘‘Driver’’ or any other part of this
contract regardless of QIO performance
on the ‘‘Aim’’ and/or ‘‘Driver’’.
IV. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VI. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, this notice was
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not reviewed by the Office of
Management and Budget.
Submit either electronic or
written comments on the collection of
information by October 3, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
DATES:
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: June 15, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–19650 Filed 7–29–11; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0554]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Veterinary Feed
Directive
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reporting and recordkeeping
requirements for distribution and use of
Veterinary Feed Directive (VFD) drugs
and animal feeds containing VFD drugs.
SUMMARY:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
SUPPLEMENTARY INFORMATION:
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Veterinary Feed Directive—21 CFR Part
558 (OMB Control Number 0910–
0363)—Extension
With the passage of the Animal Drug
Availability Act of 1996 (Pub. L. 104–
250), the Congress enacted legislation
establishing a new class of restricted
feed use drugs, VFD drugs, which may
be distributed without involving State
pharmacy laws. Although controls on
the distribution and use of VFD drugs
are similar to those for prescription
drugs regulated under section 503(f) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353(f)), the implementing
VFD regulation (21 CFR 558.6) is
tailored to the unique circumstances
relating to the distribution of medicated
feeds. The content of the VFD is spelled
out in the regulation. All distributors of
medicated feed containing VFD drugs
must notify FDA of their intent to
distribute, and records must be
maintained of the distribution of all
medicated feeds containing VFD drugs.
The VFD regulation ensures the
protection of public health while
enabling animal producers to obtain and
use needed drugs as efficiently and cost
effectively as possible.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
srobinson on DSK4SPTVN1PROD with NOTICES
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
558.6(a)(3) through (a)(5) ....................................................
558.6(d)(1)(i) through (d)(1)(iii) ............................................
558.6(d)(1)(iv) ......................................................................
558.6(d)(2) ...........................................................................
514.1(b)(9) ...........................................................................
15,000
300
20
1,000
1
25
1
1
5
1
375,000
300
20
5,000
1
.25
.25
.25
.25
3.00
93,750
75
5
1,250
3
Total ..............................................................................
........................
........................
........................
........................
95,083
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
18:48 Aug 02, 2011
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]]>Agencies
[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46814-46818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3143-NC]
Medicare Program; Evaluation Criteria and Standards for Quality
Improvement Program Contracts (10th Statement of Work)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: This notice with comment period describes the general criteria
we intend to use to evaluate the effectiveness and efficiency of
Quality Improvement Organizations (QIOs) that will enter into contracts
with CMS under the 10th Statement of Work (SOW) on August 1, 2011. The
evaluation of a QIOs' performance related to their SOW will be based on
evaluation criteria specified for the aims, drivers, tasks, and
subtasks set forth in section J-10 of the QIOs' 10th SOW.
DATES: Effective Date: August 1, 2011 to July 31, 2014.
Comment Date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on September 2, 2011.
ADDRESSES: In commenting, please refer to file code CMS-3143-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (Fax) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3143-NC, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3143-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[[Page 46815]]
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments only to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Alfreda Staton, 410-786-4194.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: https://www.regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
Section 1153(h)(2) of the Social Security Act (the Act) requires
the Secretary of the Department of Health and Human Services to publish
in the Federal Register the general criteria and standards that will be
used to evaluate the effective and efficient performance of contract
obligations by the Quality Improvement Organizations (QIOs), and to
provide the opportunity for public comment with respect to these
criteria and standards. This notice describes the general criteria that
will be used to evaluate QIO performance under the 10th Statement of
Work (SOW) contract beginning August 1, 2011.
II. Provisions of the Notice With Comment Period
Description
Under the 10th SOW, QIOs are responsible for completing the
requirements for the following Aims: Beneficiary and Family Centered
Care; Improve Individual Care--A Patient Safety Aim with components
focused on Healthcare Associated Infections (HAIs), Pressure Ulcers,
Physical Restraints, Nursing Home Systemic Improvement, Adverse Drug
Events, Quality Reporting and Improvement; Integrate Care for
Populations and Communities--A Care Transitions Aim; and Improve Health
for Populations and Communities--A Prevention Aim. The ability to
achieve the goals for each Aim will be through the following Drivers:
Learning and Action Networks, Technical Assistance, and the Care
Reinvention through Innovation Spread (CRISP) Model. (Detailed
information for each Aim and Driver may be found in sections C.6.
through C.10. of the 10th SOW posted at the https://www.fedbizopps.gov
Web site.)
Beneficiary and Family Centered Care (See Section C.6 of the 10th
Statement of Work)
The Beneficiary and Family Centered Care Aim focuses on: QIO
statutorily mandated case review activities as well as interventions to
promote responsiveness to beneficiary and family needs; providing
opportunities for listening to and addressing beneficiary and family
concerns; and providing resources for beneficiaries and caregivers in
decision making. Beneficiary-generated concerns provide an excellent
opportunity to explore root causes, develop alternative approaches to
improving care, and improve beneficiary and family experiences with the
health care system. Beneficiary and family engagement and activation
efforts are needed to produce the best possible outcomes of care. These
QIO beneficiary and family centered efforts align with the National
Quality Strategy, which encourages patient and family engagement.
Improve Individual Patient Care (Patient Safety) Initiatives (See
Section C.7 of the 10th Statement of Work)
The Patient Safety initiatives are designed to help achieve the
goals of improving individual patient care by: Reducing Healthcare-
Associated Infections (HAIs)--Central Line Bloodstream Infections
(CLABSI), Catheter-Associated Urinary Tract Infections (CAUTI),
Clostridium Difficile Infections (CDI) and Surgical-Site Infections
(SSI); Reducing Healthcare Acquired Conditions in Nursing Homes--
Pressure Ulcers and Physical Restraints; Developing a learning and
action network to begin to make forward progress toward a safer system
of care; reducing Adverse Drug Events (ADEs) and medication-related
harm; and providing technical assistance to hospitals to improve their
quality of care related to Medicare programs such as the Hospital
Inpatient Quality Reporting (IQR) Program and the Hospital Outpatient
Quality Reporting (OQR) Program to promote quality improvement and
transparency for consumer decision making through publicly reported
quality data.
Integrate Care for Populations and Communities (See Section C.8 of the
10th Statement of Work)
The QIO work must improve the quality of care for Medicare
beneficiaries who transition among care settings through a
comprehensive community effort. These efforts aim to reduce
readmissions following hospitalization and to yield sustainable and
replicable strategies to achieve high-value health care for sick and
disabled Medicare beneficiaries.
Improve Health for Populations and Communities (See Section C.9 of the
10th Statement of Work)
The QIO must improve population and community health through
prevention and early diagnosis by: Improving flu immunizations of
patients ages 50 and older during the flu season; improving
pneumococcal immunization of patients ages 65 and older; improving
appropriate low-dose aspirin therapy use in patients with ischemic
vascular disease; improving blood pressure control in patients with
hypertension; improving low-density lipoprotein-cholesterol (LDL-C)
control among adults with ischemic vascular disease; improving tobacco
cessation
[[Page 46816]]
intervention among adult patients who smoke (screening and cessation
counseling); improving colorectal cancer screening in patients ages 50
through 75; improving breast cancer screening in women ages 40 through
69; improving participation in the Physician Quality Reporting System
(PQRS); improving the use of Electronic Health Records (EHRs) for care
management; and integrating health information technology to achieve
meaningful use and improve care coordination and prevention goals.
Drivers--Learning and Action Networks, Technical Assistance, and Care
Reinvention Through Innovation Spread (CRISP) Model (See Section C.10
of the 10th Statement of Work)
Learning and Action Networks are mechanisms by which large scale
improvement around a given aim is fostered, studied, adapted, and
rapidly spread regardless of the change methodology, tools, or time-
bounded initiative that is used to achieve the aim. Learning Action
Networks collaborate with the Regional Extension Centers with respect
to quality improvement and health IT/data related issues. Learning and
Action Networks consciously manage knowledge as a valuable resource.
They engage leaders around an action based agenda. The network creates
opportunities for in-depth learning and problem solving, it accepts all
offers of support seeking to catalyze interested parties, and it is
transparent, flexible, interchangeable, and purposeful.
It is expected that the QIO will develop and facilitate sustainable
Learning and Action Networks within their respective State, as well as
participate in CMS supported and facilitated Learning and Action
Networks, which will function to support QIO activities at the local
level. The QIO must develop a team(s) (number and composition to be
determined by the QIO) that is responsible for supporting and
facilitating the Learning and Action Networks for their respective
State. This team is responsible for creating interest and active
participation in the Learning and Action Networks from vested parties
within the State around a specific aim(s).
The QIO must provide technical assistance to providers, facilities,
and partners. The QIO must offer direct assistance related to quality
improvement questions and needs to support local providers in making
changes by connecting the requestor with quality improvement knowledge,
providing follow-up available at the local and national level. The QIO
must rely on their own internal resources, those of the community,
those availed by Federal agencies, and those of the National
Coordinating Centers. The QIO must provide technical assistance to
individual providers, provider groups or health care systems upon their
request as well as upon the direction of CMS.
In general, technical assistance is more focused, limited, and
directed than activities of the Learning and Action Networks although
it could be a component of these activities. Some activities include
the following:
The QIO is expected to develop and spread a sustainable
infrastructure by facilitating the adoption of change from the QIO to a
provider, provider group or health care system.
The QIO will ensure that each initiative includes a
sustainability plan and the QIO will work to achieve consensus among
participants so that the quality improvement efforts will continue as
the need continues.
The QIO will identify pertinent data resources available
to support the local provider community. This includes claims data,
data organized by other contractors, data available from the Centers
for Disease Control, National Institutes of Health, World Health
Organization, the Census Bureau, the community information available
through the coordinating center, the Center for Medicare and Medicaid
Innovation, and the Agency for Healthcare Research and Quality. The QIO
must conduct data analysis and develop meaningful data reports to be
used by the local provider community, Learning and Action Networks and
breakthrough initiatives.
The Care Reinvention through Innovation Spread (CRISP) Model is the
framework for supporting the communications and outreach activities
required to complete all Aims of the 10th SOW successfully. The CRISP
Model is designed to minimize internal fragmentation, siloing, and
duplication or conflict of messages across individual QIOs and the QIO
Program as a whole. The Model is used through all activities of the
10th SOW so that all QIO operations are stakeholder-centric and focus
on at least one of the three phases of communicating with stakeholders
about quality improvement work: (1) Initiation and ``will building'';
(2) engagement and maintenance; and (3) retention and sustainment
throughout the life of the QIO task. The goal of the model is to give
access to the right information and services, in the right form, at the
right time, to the right people in the right place. The model does this
by focusing the QIO's energies such that each policy, action, and
decision is made with an educated and strategic consideration of the
impacts they may have on stakeholders.
Under the CRISP Model, the QIO must ensure that Innovation Spread
Advisors (ISAs) are identified for their State or territory. This
individual(s) would bring knowledge to every QIO Aim (or project) team
within the enterprise by: Helping the Aim teams determine who the
stakeholders are and what they need; ensuring beneficiary input;
facilitating the appropriate mechanisms for stakeholder communication;
and determining if activities are successful. The ISA(s) from each QIO
must attend CMS-sponsored training sessions and serve as brand
ambassadors with branding responsibilities as indicated in section
C.10.3.
III. Evaluation of the Aims and Drivers (See Section J-10 and Section
C.5 of the 10th Statement of Work)
A qualitative and quantitative evaluation will be conducted at the
18th (intermediate evaluation) and 27th months (final evaluation) of
the contract with monitoring and measuring for improvement conducted
throughout the 3 year contract cycle. The evaluations will be based on
the most recent data available to us. The performance results of the
evaluation at both time periods (that is, 18 months and 27 months) will
be used, in addition to ongoing monitoring activities, to determine the
performance on the overall contract. Using lean and rapid techniques,
QIOs will be monitored and measured for improvement on an ongoing basis
using self-assessment and Contracting Officer Technical Representative
(COTR) review. The COTR will complete assessment and review of
qualitative and quantitative contract evaluation objectives.
The following categories will serve as the basis for the
qualitative evaluation of the Technical Assistance Drivers as specified
on Table 1 of section J-10 in the 10th Statement of Work:
Rapid Cycle Improvement in Quality Improvement Activities
and Outputs.
Customer Focus and Value of the Quality Improvement
Activities to Beneficiaries, Participants and CMS.
Ability To Prepare the Field To Sustain the Improvements.
Value Innovation.
Commitment to ``boundarilessness.''
Unconditional Teamwork.
The quantitative evaluation of the QIOs will be based on the number
of commitments secured, participants
[[Page 46817]]
engaged, and the results in achievement of the goals as specified on
Tables 2 and 3 in section J-10 of the 10th Statement of Work.
The ``Aims Tasks'' the QIO will be evaluated on are as follows:
C.6 Beneficiary and Family Centered Care:
Case Review;
Patient and Family Engagement Campaign.
C.7 Improving Individual Patient Care:
Reduction of Healthcare Associated Infections (CLABSI,
CAUTI, CDI, and SSI);
Reduction of Healthcare Acquired Conditions in Nursing
Homes (Pressure Ulcers and the Use of Physical Restraints);
Reduction of Adverse Drug Events;
Hospital Inpatient and Outpatient Quality Reporting and
Improvement.
C.8 Integrating Care for Populations and Communities:
Reduction of Hospital Readmissions Through a Comprehensive
Community Effort by Improving the Quality of Care for Medicare
Beneficiaries Who Transition Among Care Settings.
C.9 Improving Health for Populations and Communities:
Promotion of Immunizations, Colorectal, and Breast Cancer
Screenings;
Cardiovascular Health Campaign;
Improving Participation in the Physician Quality Reporting
System (PQRS);
Improving the Use of Electronic Health Records (EHRs) for
Care Management;
Integrating Health Information Technology to Improve Care
Coordination, Achieve Meaningful Use, and Achieve Prevention Goals.
The ``Driver Tasks'' the QIO will be evaluated on are as follows:
C.10.1 Supporting and Convening Learning and Action Networks.
C.10.2 Technical Assistance;
C.10.3 Care Reinvention Through Innovation Spread (CRISP) Model.
If a QIO is not tasked to work on a specific area under an ``Aim''
and/or ``Driver,'' the QIO will not be evaluated under that particular
area. Any Special Innovation Project that the QIO may carry out will be
evaluated separately and will not be considered in the overall
evaluation criteria.
In addition to the qualitative and quantitative evaluation in the
18th and 27th months of the contract, we will conduct monitoring
activities throughout the course of the contract and will act upon
findings as necessary. The performance results of the evaluation at
both time periods (that is, 18 months and 27 months) will be used, in
addition to ongoing monitoring activities, to determine the overall
performance on the contract.
18th Month Contract Evaluation
The 18th month contract evaluation will determine if the QIO has
met the performance evaluation criteria as specified in J-10 of this
Statement of Work. The achievement within each of the ``Aims'' and
``Drivers'' will be evaluated on an individual basis for appropriate
contract action. Though, in general, evaluation of each ``Aim'' and/or
``Driver'' will relate only to that area, we reserve the right to take
appropriate contract action in the event of failure in multiple
``Aims'' and/or ``Drivers''.
18th Month Evaluation Criteria:
Pass: Criteria met for the ``Aim'' and/or ``Driver'' as
specified in the evaluation section of the ``Aim'' and/or ``Driver.''
Fail: Criteria not met for the ``Aim'' and/or ``Driver''
as specified in the evaluation section of the ``Aim'' and/or
``Driver.''
27th Month Contract Evaluation
The 27th month contract evaluation will determine if the QIO has
met the performance evaluation criteria as specified in each of the
``Aims'' and ``Drivers'' areas of the 10th SOW. The achievement within
the ``Drivers'' and ``Aims'' will be evaluated on an individual basis
for appropriate contract action.
27th Month Evaluation Criteria:
Pass: Criteria met for the ``Aim'' and/or ``Driver'' as
specified in the evaluation section of the ``Aim'' and/or ``Driver.''
Fail: Criteria not met for the ``Aim'' and/or ``Driver''
as specified in the evaluation section of the ``Aim'' and/or
``Driver.''
Overall Contract Evaluation
The results of the 18th and 27th month evaluation periods, in
addition to ongoing monitoring activities, will be used to determine
how the contractor performed on the overall contract.
If we choose, we may notify the QIO of our intention not to renew
the QIO contract and inform the QIO of their rights under the current
statute.
Any failure at the 18th or 27th month evaluation for any ``Aim or
Driver'' may result in that QIO receiving an adverse past performance
evaluation. Further, failure may impact on the QIO's ability to
continue similar work in or eligibility for award of the 11th SOW.
The list of measures and performance criteria for each QIO will be
recorded on the CMS Dashboard, which will be available on QIOnet
(https://qionet.sdps.org), the standard information system that supports
the QIO Program. We will also post these measures on the publicly
accessible CMS Web site (https://www.cms.gov).
We will monitor the QIO's performance on the ``Aims'' and
``Drivers'' against established criteria on at least a quarterly basis,
and may take appropriate contract action (for example, providing
warning for the need for adjustment, instituting a formal correction
plan, terminating an activity, or recommending early termination of a
contract because of failure to meet contract timelines as specified in
sections C.6 through C.10.).
We reserve the right at any point, prior to the notification of our
intention not to continue the option for an ``Aim'' and/or ``Driver''
and/or to renew the contract, to revise measures or adjust the expected
minimum thresholds for satisfactory performance or remove criteria from
an ``Aim'' and/or ``Driver'' evaluation protocol for any reason,
including, but not limited to, data gathered based on experience with
the amount of improvement achieved during the contract cycle or in
pilot projects currently in progress, information gathered through
evaluation of the QIO Program overall, or any unforeseen circumstances.
Further, in accordance with standard contract procedures, we reserve
the right at any time to discontinue an ``Aim'' and/or ``Driver'' or
any other part of this contract regardless of QIO performance on the
``Aim'' and/or ``Driver''.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VI. Regulatory Impact Statement
In accordance with the provisions of Executive Order 12866, this
notice was
[[Page 46818]]
not reviewed by the Office of Management and Budget.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: June 15, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-19650 Filed 7-29-11; 4:15 pm]
BILLING CODE 4120-01-P
