[Federal Register Volume 73, Number 140 (Monday, July 21, 2008)]
[Notices]
[Pages 42352-42355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3189-NC]
RIN 0938-AP36


Medicare Program; Evaluation Criteria and Standards for Quality 
Improvement Program Contracts (9th Scope 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 efficiency and effectiveness of the 
Quality Improvement Organizations (QIOs) who will enter into contract 
with CMS under the 9th SOW on August 1, 2008. The evaluation of the 
QIOs' performance related to their Statement of Work (SOW) will be 
based on evaluation criteria specified within the themes, tasks, and 
subtasks set forth in the QIO's 9th SOW.

DATES: Comment Date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on August 20, 2008.

ADDRESSES: In commenting, please refer to file code CMS-3189-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 specific 
issues in this regulation to http://www.regulations.gov. Follow the 
instructions for ``Comment or Submission'' and enter the filecode to 
find the document accepting comments.
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3189-NC, P.O. Box 8016, Baltimore, MD 21244-1850.
    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 (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-3189-NC, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to either of the following addresses.
    a. Room 445-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201. (Because access to the interior of 
the HHH 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. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend 
to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.
    Comments 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: Cynthia Pamon (410) 786-9167.

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 Act requires the Secretary to publish in 
the Federal Register the general criteria and standards that will be 
used to evaluate the efficient and effective performance of contract 
obligations by QIOs and to provide the opportunity for public comment 
with respect to such criteria and standards. This notice describes the 
general criteria that will be used to evaluate QIO performance under 
the 9th SOW contract beginning in August 2008.

II. Themes, Tasks, Subtasks Description

    Under the 9th SOW, QIOs are responsible for completing the 
requirements for the following themes: Beneficiary Protection, Patient 
Safety, Prevention and Care Transitions. (Detailed information for each 
theme may be found in Sections C.6. and C.7. Theme Requirements of the 
9th SOW posted at the www.fedbizopps.gov Web site. On the home page of 
the Web site, type ``QIO'' into ``Quick Search'' and click on ``GO'' to 
view the RFP under solicitation numbers ``9thSOWInStateQIOs-NAHC'' and 
``CMS-2007-QIO9thSOW-NAHC'').

Beneficiary Protection (See Section C.6.1. of the 9th Statement of 
Work)

    Beneficiary Protection activities will emphasize statutory and 
regulatory

[[Page 42353]]

mandated review activity and quality improvement. Primary case review 
categories include utilization review, quality of care review, review 
of beneficiary appeals of certain provider notices, and reviews of 
potential anti-dumping cases. Quality of care review includes the 
review of beneficiary complaints. In conducting reviews of beneficiary 
complaints, the QIO shall utilize a number of tools intended to address 
the beneficiary's concerns, including implementation of quality 
improvement activities (QIAs), surveying of beneficiary satisfaction 
with the complaint process, and, if appropriate, alternative dispute 
resolution mechanisms. The Tasks under this theme will focus on 
conducting activities to meet, in an efficient and effective manner, 
regulatory and statutory requirements, to enhance QIO collaboration 
with the Beneficiary Complaint Survey Contractor, Fiscal Intermediaries 
(FIs), Carriers, Medicare Administrative Contractors (MACs), State 
Survey Agencies (SSAs), the Office of Inspector General (OIG), and the 
Medicare Office of Hearings and Appeals and to clearly establish the 
link between case review and quality improvement through data analysis 
and improvement assistance.

Patient Safety (See Section C.6.2. of the 9th Statement of Work)

    QIO activities under the Patient Safety Theme will focus on six 
components: Improving inpatient surgical safety and heart failure 
(SCIP/HF), reducing rates of pressure ulcers (PrU-Nursing Homes and 
Hospitals), reducing rates of and use of physical restraints (PR), 
improving drug safety, reducing rates of healthcare associated 
Methicillin-resistant Staphylococcus aureus (MRSA) infections and 
activities aimed at nursing homes in need (NHIN). The requirements of 
the Patient Safety Theme are designed to address areas of patient harm 
for which there is evidence of how to improve safety by improving 
health care processes and systems.

Prevention (See Section C.6.3. of the 9th Statement of Work)

    The Prevention Theme contains two cancer screening tasks (breast 
cancer and colorectal cancer (CRC)), two immunization tasks (influenza 
and pneumococcal) and Tasks on disparities related to diabetes self-
management and chronic kidney disease (CKD) prevention.

Sub-National Theme Requirements

Prevention: Disparities (Directed Sub-National Task, See Section C.7.1. 
of the 9th Statement of Work)

    Under this Theme, the QIO will work with practice sites and other 
organizations in its state/jurisdiction to improve diabetes measures 
within underserved populations. QIO Disparities work includes tasks 
related to Diabetes Self-Management Education. Diabetes Self-Management 
Education (DSME) is an approach that has been demonstrated to be 
effective in improving diabetes clinical outcomes and other related 
health dimensions. DSME is an intervention in itself for diabetes 
behavior and outcomes improvement. The QIO will facilitate training of 
appropriate personnel at organizational sites using evidence-based CMS-
approved DSME programs within the underserved population of the 
qualified physician practices. The QIO will establish a partnership 
with the primary care physician, certified diabetes educators and 
community health workers to facilitate the accessibility of DSME 
services to patients. This task is directed and will be limited to a 
sub-set of States with sufficient underserved Medicare diabetes 
populations, as determined by CMS. See section C.7.1 of the 9th SOW for 
the list of the 33 states eligible for this task.

Care Transitions (Optional Sub-National Theme, See Section C.7.2. of 
the 9th Statement of Work)

    The QIO work under the Care Transitions Theme aims to measurably 
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 hospitalizations and to 
yield sustainable and replicable strategies to achieve high-value 
health care for sick and disabled Medicare beneficiaries.

Prevention: Chronic Kidney Disease (Optional Sub-National Task, See 
Section C.7.3 of the 9th Statement of Work)

    The goal of this Task is to detect the incidence and decrease the 
progression of chronic kidney disease (CKD) and improve care among 
Medicare beneficiaries through provider adoption of timely and 
effective quality of care interventions; participation in quality 
incentive initiatives; beneficiary education; and key linkages and 
collaborations for system change at the state and local level.
    In addition to improving the quality of care for the elderly and 
frail-elderly, this Task aims to reduce the rate of Medicare 
entitlement by disability through the delay and prevention of ESRD.
    The focus areas for quality improvement in CKD include: Timely 
testing to detect the rate of kidney failure due to diabetes; slowing 
the progression of disease in individuals with diabetes through the use 
of ACE (angiotensin converting enzyme) inhibitors and/or an angiotensin 
receptor blocking (ARB) agent; and arteriovenous fistula (AV fistula) 
placement and maturation (as a first choice for arteriovenous access 
where medically appropriate) for individuals who elect, as a part of 
timely renal replacement therapy counseling, hemodialysis as their 
treatment option for kidney failure.

III. Measuring QIO Performance

    Overall Contract Evaluation (See Section C.5 of the 9th SOW posted 
at www.fedbizops.gov for more detailed overall contract evaluation 
criteria. On the www.fedbizopps.gov home page, type ``QIO'' into 
``Quick Search'' and click on ``GO'' to view the RFP under solicitation 
numbers ``9thSOWInStateQIOs-NAHC'' and ``CMS-2007-QIO9thSOW-NAHC'').
    Under the 9th SOW, the QIO's performance in undertaking activities 
to carry out the requirements of each of the Themes (Beneficiary 
Protection, Care Transitions, Patient Safety and Prevention) and 
components within those Themes will be used to determine the QIO's 
success or failure in meeting the overall evaluation criteria as 
specified below. The QIO shall be evaluated on the Themes and 
components under the Themes required under the contract. If a QIO is 
not tasked to work on a Theme or a specific component under the Theme, 
the QIO will not be evaluated under that particular Theme or component. 
Any Special Project (SP) that the QIO may carry out will be evaluated 
separately and will not be considered in the overall evaluation 
criteria.
    There will be two periods of evaluation under the 9th SOW. The 
first evaluation will focus on the QIO's work in three Theme areas 
(Care Transitions, Patient Safety, and Prevention) and will occur at 
the end of 18 months using the most recent data available to CMS. The 
second evaluation will examine the QIO's performance on Tasks within 
all Theme areas (Beneficiary Protection, Care Transitions, Patient 
Safety, and Prevention). The second evaluation will take place at the 
end of the 28th month

[[Page 42354]]

of the contract term and will be based on the most recent data 
available to CMS. The performance results of the evaluation at both 
time periods (that is, at 18 months and at 28 months) will be used to 
determine the performance on the overall contract.
    The first contract evaluation will determine if the QIO has met the 
performance criteria in the Theme areas of Care Transitions, Patient 
Safety, and Prevention and in the components within those Themes. The 
Themes or components within the Theme as appropriate will be evaluated 
on an individual basis with the determination relative to only that 
area.
    The second contract evaluation will determine if the QIO has met 
the performance criteria in all Theme areas of Beneficiary Protection, 
Care Transitions, Patient Safety and Prevention, and in the components 
within those Themes. The performance on the Beneficiary Protection 
Theme will cover the 28-month contract period.
    The results of the first and second evaluations at the end of the 
18 and 28 month periods will be used to determine how the contractor 
performed on the overall contract in total.
18-Month Evaluation Criteria (by Theme or component of the Theme 
excluding Beneficiary Protection)
     Pass = Criteria met and CMS may elect the option to 
continue the work (and funding) of the Theme or component of the Theme 
where appropriate.
     Fail = Criteria not met and we may, among other remedies, 
elect NOT to continue the work (or funding) for the Theme or component 
of the Theme where appropriate for the contract duration.
28-Month Evaluation Criteria (by Theme or component of the Theme 
including Beneficiary Protection for the 28-month contract period)
     Pass = Criteria met for Theme or component of the Theme 
where appropriate.
     Fail = Criteria not met for Theme or component of the 
Theme where appropriate.
Overall Contract Performance
     Pass = Pass on all Themes and components within the Theme 
at both evaluation periods.
     Fail = Fail any Theme or component within the Theme in 
either evaluation period.

    If CMS chooses, we may notify the QIO of the intention not to renew 
the QIO contract, and inform the QIO of the QIO's rights under the then 
current statute.
    The specific evaluation criteria are described below for each Theme 
or component within a Theme as appropriate. In general, for areas of 
work that have been performed under the 8th SOW or other recent QIO SOW 
where historical data is available for analysis, the acceptable 
performance expectation is a specific target or tighter target range 
than for areas of work that have not been in previous SOWs and where 
the experience under a previous SOW demonstrated that there was a range 
for acceptable performance. For the purpose of determining scores for 
all Themes, components within a Theme, or measures within a Theme, all 
percentages will be rounded to two places (with the value at or above 
five in the thousands position (for example, .005, .015, etc. rounded 
up).
Beneficiary Protection
     Pass = 90% of Target
     Fail = <90%
Patient Safety: Surgical Care Improvement Project/Heart Failure (SCIP/
HF), Pressure Ulcers and Physical Restraints
     Pass = 70-100% of Target
     Fail = <70%
Patient Safety: Methicillin Resistant Staphylococcus Aureus (MRSA)
     Pass = 70-100% of Target
     Fail = <70%
Patient Safety: Drug Safety, Nursing Homes In Need (NHIN)
     Pass = 70-100% of Target
     Fail = <70%
Prevention: Cancer Screening, Mammograms, and Immunizations
     Pass = 100% of Target
     Fail = <100%
Prevention: Disparities
     Pass = 80% of Target
     Fail = <80%
Care Transitions
     Pass = 100%-80% of Target
     Fail = <80%
Prevention: Chronic Kidney Disease (CKD)
     Pass = 100%-80% of Target
     Fail = <80%

    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 our publicly 
accessible Web site (http://www.cms.gov).
    We will monitor the QIO's performance on Themes, components within 
the Themes and measures within Themes against established criteria on 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).
    CMS reserves the right at any point prior to the notification of 
our intention not to continue the option for a Theme and/or to renew 
the contract to adjust the expected minimum thresholds for satisfactory 
performance or remove criteria from a Theme or Theme component 
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 a 
Theme or a component of a Theme regardless of QIO performance on the 
Theme or component of the Theme.

IV. Standards for Minimum Contract Performance Within a Theme

Beneficiary Protection Contract Evaluation (See Sections C.5 and C.6.1. 
of the 9th SOW)

    CMS will evaluate, on a quarterly basis, achievement of minimum 
performance thresholds on timeliness of review activities, beneficiary 
satisfaction with the complaint process, beneficiary satisfaction 
generally and quality improvement activities. Additionally, CMS will 
evaluate system-wide change improvement activities and PPS inpatient 
hospital data reporting.

Patient Safety (See Sections C.5 and C.6.2. of the 9th SOW)

    CMS will evaluate achievement of minimum performance thresholds on 
specific clinical measures at the 18th and 28th month evaluation 
periods. CMS will evaluate improvements in the SCIP (surgical care 
improvement program) measures, MRSA (methicillin Resistant 
Staphylococcus Aureus) hospital measures, PrU (pressure ulcers) in 
hospitals and nursing homes and PR (physical restraints) in nursing 
homes, and prescription drug safety measures.

[[Page 42355]]

    CMS will also evaluate work and improvement with a small number of 
poorly performing nursing homes. CMS will evaluate the nursing homes' 
perception of the effectiveness of QIO technical assistance and on 
improvement in the quality measures.

Prevention (See Sections C.5 and C.6.3. of the 9th SOW)

    CMS will evaluate achievement of minimum performance thresholds on 
specific clinical measures at the 18th and 28th month evaluation 
periods. CMS will evaluate the work with a selected group of 
participating practices (PPs) in its state/jurisdiction with already 
implemented electronic health records (EHRs) to assess improvements in 
breast cancer and CRC screening rates and to improvements in 
immunization rates for influenza and pneumococcal pneumonia among 
Medicare beneficiaries.

Sub-National Theme Requirements Prevention: Disparities (Directed Sub-
National Task, See Sections C.5 and C.7.1. of the 9th SOW

    CMS will evaluate achievement of minimum performance thresholds on 
specific measures on a quarterly basis and at the 18th and 28th month 
evaluation periods. CMS will evaluate recruitment of targeted providers 
and enrollment of targeted patients. CMS will also evaluate 
improvements in the rates for hemoglobin A1c testing, eye exams, lipid 
testing and blood pressure control for diabetic patients.

Care Transitions, (Optional Sub-National Theme, See Sections C.5 and 
C.7.2. of the 9th SOW)

    CMS will evaluate achievement of minimum performance thresholds on 
specific clinical measures at the 18th and 28th month evaluation 
periods. CMS will evaluate patient care transitions that are: 
attributable to participating providers; related to implementation of 
interventions that address hospital/community system-wide processes; 
the potential subject of an implemented intervention that addresses 
acute myocardial infarction, congestive heart failure, and pneumonia; 
the potential subject of an implemented intervention that addresses 
specific reasons for readmission. CMS will also evaluate the percentage 
of implemented interventions that are measured and the percentage of 
patient care transitions to which implemented and measured 
interventions apply and show improvement. CMS will also evaluate 
patient satisfaction and patient readmission rates.

Prevention: Chronic Kidney Disease (Optional Sub-National Task, See 
Sections C.5 and C.7.3 of the 9th SOW)

    CMS will evaluate achievement of minimum performance thresholds on 
all clinical outcome measures at the 18th and 28th month evaluation 
periods. CMS will evaluate timely testing to reduce the rate of kidney 
failure due to diabetes, improvement in the use of ACE inhibitor and/or 
ARB agent, and improvement in the rate of AV fistula placement.

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.

Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program.

    Dated: April 25, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-16757 Filed 7-18-08; 8:45 am]
BILLING CODE 4120-01-P