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[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]

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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.

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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 http://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: http://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 http://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

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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 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

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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, 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 
(http://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 (http://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.

(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
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