[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Notices]
[Pages 44031-44034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16432]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3142-NC]


Medicare Program; Evaluation Criteria and Standards for Quality 
Improvement Program Contracts

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: This notice describes the evaluation criteria we intend to use 
to evaluate the Quality Improvement Organizations (QIOs) under their 
contracts with CMS, for efficiency and effectiveness in accordance with 
the Social Security Act. These evaluation criteria are based on the 
tasks and related subtasks set forth in the QIO's Scope of Work (SOW). 
The current 7th SOW includes Tasks 1 through 4, with subtasks included 
under all tasks, excluding Task 4. QIOs were awarded contracts for the 
7th SOW, or 7th Round, for three years, with staggered starting dates 
beginning August 2002, November 2002, and February 2003.

DATES: To be assured of consideration, comments must be received at one 
of the addresses provided below, no later than 5 p.m. on August 23, 
2004.

ADDRESSES: In commenting, please refer to file code CMS-3142-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments to http://www.cms.hhs.gov/regulations/ecomments or to www.regulations.gov 
(attachments should be in Microsoft Word, WordPerfect, or Excel; 
however, we prefer Microsoft Word).
    2. By 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-3142-
NC, P.O. Box 8016, Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. 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 one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-7195 in advance to schedule your arrival 
with one of our staff members.
    Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    (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.) 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: Maria Hammel, (410) 786-1775.

SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments 
from the public on all issues set forth in this notice with comment 
period to assist us in fully considering issues and developing 
policies. You can assist us by referencing the file code CMS-3142-NC 
and the specific ``issue identifier'' that precedes the section on 
which you choose to comment.
    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. After the close of the 
comment period, CMS posts all electronic comments received before the 
close of the comment period on its public website. Comments received 
timely will 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 (410) 786-7195.

I. Background

    [If you choose to comment on issues in this section, please include 
the caption ``BACKGROUND'' at the beginning of your comments.]
    The Peer Review Improvement Act of 1982 (Title I, Subtitle C of 
Pub. L. 97-

[[Page 44032]]

248) amended Part B of Title XI of the Social Security Act (the Act) to 
establish the Peer Review Organization (PRO) programs. The PRO program 
(now called the Quality Improvement Organization (QIO) program) was 
established to redirect, simplify and enhance the cost-effectiveness 
and efficiency of the medical peer review process. Sections 1152, 
1153(b) and 1153(c) of the Act define the types of organizations 
eligible to become QIOs, and establish certain limitations and 
priorities regarding QIO contracting.
    The Secretary enters into contracts with QIOs to perform three 
broad functions:
     Improve quality of care for beneficiaries by ensuring that 
beneficiary care meets professionally recognized standards of health 
care;
     Protect the integrity of the Medicare Trust Fund by 
ensuring that Medicare only pays for services and items that are 
reasonable and medically necessary and that are provided in the most 
economical setting;
     Protect beneficiaries by expeditiously addressing 
individual cases such as beneficiary quality of care complaints, 
contested hospital issued notices of noncoverage (HINNs), alleged 
Emergency Medical Treatment and Labor Act (EMTALA) violations (patient 
dumping), and other statutory responsibilities.
    Section 1154 of the Act requires that QIOs review those services 
furnished by physicians; other health care practitioners; and 
institutional and non-institutional providers of health care services, 
including health maintenance organizations and competitive medical 
plans. Section 109 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, Public Law 108-173, amended section 
1154(a)(1) of the Social Security Act to expand the scope of review of 
QIOs to include Medicare Advantage Organizations, and prescription drug 
sponsors. Section 109 of the MMA also created a new section 1154(a)(17) 
of the Act, which requires QIOs to offer to providers, practitioners, 
Medicare Advantage Plans and prescription drug sponsors quality 
improvement assistance pertaining to prescription drug therapy. Because 
these provisions of sections 1154(a)(1) and (a)(17) are new, we will 
not evaluate QIOs on these provisions in the current SOW.
    Section 1153(h)(2) of the Act requires the Secretary to publish in 
the Federal Register the general criteria and standards that would be 
used to evaluate the efficient and effective performance of contract 
obligations by QIOs and to provide the opportunity for public comment. 
The QIO contracts for the 7th SOW were awarded for 3 years with 
starting dates staggered into three approximately equal groups (rounds) 
starting August 2002, November 2002 and February 2003 respectively.

II. Measuring QIO Performance

    [If you choose to comment on issues in this section, please include 
the caption ``MEASURING QIO PERFORMANCE'' at the beginning of your 
comments.]
    Under the 7th Round contracts, QIOs are responsible for completing 
tasks in the following 4 areas, with additional subtasks contained in 
the first three areas:
Task 1--Improving Beneficiary Safety and Health Through Clinical 
Quality Improvement
    a. Nursing Home
    b. Home Health
    c. Hospital
    d. Physician Office
    e. Underserved and Rural Beneficiaries
    f. Medicare+Choice Organizations (M+COs), now called Medicare 
Advantage Organizations (MAs)
Task 2--Improving Beneficiary Safety and Health Through Information and 
Communications
    a. Promoting the Use of Performance Data
    b. Transitioning to Hospital-Generated Data
    c. Other Mandated Communications Activities
Task 3--Improving Beneficiary Safety and Health Through Medicare 
Beneficiary Protection Activities
    a. Beneficiary Complaint Response Program
    b. Hospital Payment Monitoring Review Program
    c. All Other Beneficiary Protection Activities
Task 4--Improving Beneficiary Safety and Health Through Developmental 
Activities
    (Special Studies defined as work that CMS directs a QIO to perform 
or work that a QIO elects to perform with CMS approval which is not 
currently defined in the Tasks, but falls within the scope of the 
contract and section 1154 of the Act).
    Under this contract, to merit having its contract renewed non-
competitively, the QIO must meet the performance criteria (including a 
score of 1.0 or greater for Tasks 1a through 1e and 2b) on 10 of 12 
subtasks (9 of 11 for states with no MA plans) of Tasks 1 through 3 of 
the 7th SOW, provided that for both of the subtasks which do not meet 
the criteria, the QIO has: (1) Achieved a score of 0.6 or better on all 
quantitative subtasks, and (2) for the remaining subtasks only, in the 
judgment of the Project Officer, the QIO expended a reasonable effort 
to address these subtasks, developed and implemented an appropriate 
initial work plan, which was assessed during the contract period to 
determine if it was achieving results likely to lead to success in 
meeting contractual performance expectations, and had made appropriate 
adjustments to its work plan based on these results.
    To be considered successful (meeting the criteria outlined in the 
J-7 found at www.cms.hhs.gov/qio/2.asp), though not meriting a non-
competitive renewal, the QIO shall meet the performance criteria 
(including a score of 1.0 or greater for Tasks 1a through 1e and 2b) on 
9 of 12 subtasks (8 of 11 for states with no MA plans) of Tasks 1 
through 3 of the 7th Round Contract, provided that for the subtasks 
that do not meet the criteria, the QIO must: (1) Achieve a score of 0.6 
or better on all quantitative subtasks, (2) for the remaining subtasks 
only, in the judgment of the Project Officer, the QIO has expended a 
reasonable effort to address these subtasks, developed and implemented 
an appropriate initial work plan which was assessed during the contract 
period to determine if it was achieving results likely to lead to 
success in meeting contractual performance expectations, and had made 
appropriate adjustments to its work plan based on these results, and 
(3) failed to meet the criteria in no more than two subtasks of any one 
task. For Task 4, except as provided in Task 3b, all special studies 
approved under this task will be evaluated individually, based on 
study-specific evaluation criteria. The QIO's success or failure on a 
special study will not be factored into the evaluation of the QIO's 
work under Tasks 1-3.
    However, meeting the minimum performance standards does not 
guarantee a noncompetitive renewal of its contract. For example, an 
organization within a particular State meeting the definition of a QIO 
may express interest in competing for a contract currently held by a 
QIO from outside that state, pursuant to section 1153(i). In this case, 
we will compete the contract despite acceptable performance by the 
current QIO. We will make a final decision on renewal/non-renewal by 
the end of the 30th month of the 7th Round contract. We will issue a 
``Notice of Intent to Non-renew the QIO Contract'' letter to all

[[Page 44033]]

QIOs that do not meet the minimum performance standards no later than 
the end of the 33rd month of the contract. The QIO will be considered 
to have met minimum performance standards if the QIO had demonstrated 
acceptable performance in each Task area as specified in Section III of 
this Notice, Standards for Minimum Performance.
    If the QIO has not met the criteria to merit a noncompetitive 
renewal, it shall be notified of CMS' intention not to renew its 
contract and will be informed of its right to request an opportunity to 
provide information pertinent to its performance under the contract to 
a CMS-wide panel. The panel will be made up of representatives from 
each of the 4 QIO Regional Offices and the Central Office. The QIO's 
Project Officer will not be eligible to represent the Regional Office 
on the panel when it reviews the work of his/her QIO. However, the 
Project Officer will be available to answer any questions the panel may 
have. The QIO will also be given the opportunity to provide additional 
information. The panel will have the right to create its own 
procedures, but must apply them consistently to all QIOs it reviews. At 
a minimum, the panel will use the criteria listed below for all Tasks:
     The degree of collaboration the QIO exhibited with the 
Quality Improvement Organization Support Centers (QIOSCs) and other 
QIOs, both by sharing the lessons and tools it developed and by 
adopting practices and tools developed by other QIOs;
     Whether the QIO was a new contractor in the 7th SOW;
     Whether specific identifiable circumstances uniquely 
interfered with the QIO's efforts;
     Evidence suggesting that the QIO has done exceptional work 
in one or more of the other Task areas; and
     Any other issues which the panel may deem relevant. Upon 
completion of its review, the panel will make a recommendation for a 
final disposition to the Director of CMS' Office of Clinical Standards 
and Quality (OCSQ).

III. Standards for Minimum Performance

    [If you choose to comment on issues in this section, please include 
the caption ``STANDARDS FOR MINIMUM PERFORMANCE'' at the beginning of 
your comments.]
General Criteria
    CMS will evaluate the QIO's performance on each sub-task by some 
combination of the following elements:
     Statewide improvement on the quality measure(s);
     Improvement on the quality of care measure(s) among a 
group of identified participants as defined within each subtask;
     Satisfaction among providers and practitioners regarding 
their interaction with the QIO.
    Satisfaction will be assessed using a survey, the purpose of which 
will be to:
     Measure satisfaction as one component of the QIO's 
evaluation.
     Identify opportunities where the QIO can improve 
satisfaction.
    Task 1 (including subtasks a through e) and subtask 2b will be 
evaluated quantitatively. Their success will be measured by assessing 
the QIO's relative improvement on each evaluation criterion. The term 
``improvement'' as used in the 7th Round Contract shall be defined 
mathematically to mean the relative reduction in the failure rate. The 
expected minimum improvement level will serve as the reference point 
for each calculated relative improvement.
    In a number of the Task 1 subtasks, statewide improvement will be 
averaged with the improvement among a set of identified participant 
providers. In these cases CMS has set a target percentage of identified 
participant providers, and the relative weights of the statewide 
improvement and of identified participants' improvement will combine to 
equal 80 percent and will be a function of the percentage of the target 
(up to 150 percent) that the QIO identifies as participants. Tasks 1f, 
2a, 2c and all of Task 3 will be evaluated by the Project Officer using 
qualitative measures based on information provided in reports developed 
from data provided by the QIOs on the QIO's status to date.

Task Specific Standards

Task 1--Improving Beneficiary Safety and Health Through Clinical 
Quality Improvement
    Task 1a--Nursing Home Quality Improvement--The QIO will be held 
accountable for improvement in the quality of care measure rates for 
all nursing homes in the state and for identified participant nursing 
homes. QIOs will be evaluated based on the following components: 
statewide improvement on the set of 3 to 5 publicly reported quality of 
care measures which the QIO has selected in consultation with 
stakeholders, improvement for the selected CMS nursing home publicly 
reported quality of care measures for identified participants, and 
nursing home satisfaction based on a survey of identified participating 
nursing homes. To view the weighting criteria for each component, go to 
www.cms.hhs.gov/qio/2.asp for a copy of the J-7.
    Task 1b--Home Health Quality Improvement--the QIO will be held 
accountable for improvement in the Outcome Based Quality Improvement 
(OBQI) quality of care measure rates for a set of home health agencies 
that are identified participants. The QIOs will be evaluated based on 
the following components: The extent to which the number of 
participating home health agencies, with significant improvement in a 
targeted outcome, equals or exceeds 30 percent of the total number of 
home health agencies in the state, and the identified participant 
satisfaction which will be measured by a survey of identified 
participant home health agencies using a composite measure of 
satisfaction that reflects the type of activities that QIOs are 
expected to have undertaken with these providers.
    Task 1c--Hospital Quality Improvement--QIOs will be evaluated on 
the following criteria: statewide improvement on the quality of care 
measures listed in the 7th Round Contract, and hospital satisfaction 
based on feedback from the hospitals in the state. To view the specific 
criteria, go to www.cms.hhs.gov/qio/2.asp for a copy of the J-7.
    Task 1d--Physician Office Quality Improvement--QIOs will be 
evaluated based on the following general criteria: statewide 
improvement of quality of care measures, improvement on diabetes and 
cancer screening quality of care measures for identified participant 
physicians, and physician satisfaction based on feedback from physician 
designees in the state who participated with the QIO. To view the 
specific criteria for this task, go to www.cms.hhs.gov/qio/2.asp for a 
copy of the J-7.
    Task 1e--Underserved and Rural Beneficiaries Quality Improvement--
The QIO's work on this task will be primarily evaluated on the success 
of the QIO's efforts to reduce disparity between the targeted 
underserved group and their geographically relevant non-underserved 
reference group from baseline to re-measurement. To be judged to have 
performed minimally successful on this task, the QIO must demonstrate 
disparity reduction. QIOs will also be evaluated on three factors that 
collectively demonstrate knowledge generated by the QIO about the 
underserved target group, the interventions planned upon the basis of 
that knowledge, the use of literature on effective interventions, and 
by demonstrating the effectiveness of their interventions through 
analyses

[[Page 44034]]

comparing the intervention group and a contrast group. To view the 
specific criteria for this task, go to www.cms.hhs.gov/qio/2.asp for a 
copy of the J-7.
    Task 1f--Medicare + Choice Organizations (M+COs) (now called 
Medicare Advantage Organizations (MAs) Quality Improvement--QIOs will 
be expected to have demonstrated appropriate activity to include MAs in 
Tasks 1a to 1e as determined by the Project Officer. CMS will survey 
MAs that have worked with the QIO using a composite measure of 
satisfaction that reflects the types of activities that QIOs are 
expected to have undertaken with these organizations. CMS will further 
use the results of the Medicare+Choice Quality Review Organizations 
(M+CQRO) or accreditation organization evaluation of the Quality 
Assessment and Performance Improvement (QAPI) projects to determine if 
expected improvement was demonstrated.
Task 2--Improving Beneficiary Safety and Health Through Information and 
Communications
    Task 2a--Promoting the Use of Performance Data--QIO success will be 
assessed on the timely completion and submission of a project work 
plan, timely completion and submission of all required reports and 
deliverables, and the extent to which the QIO uses information provided 
by CMS as well as any other feedback the QIO receives to refine its 
project activities to achieve the desired outcome.
    Task 2b--Transitioning to Hospital-Generated Data--The evaluation 
for this task will be based on the following. CMS will determine the 
completeness of the assessment survey information for each hospital. 
CMS will review hospital data submitted to the national repository via 
QualityNet Exchange to determine the proportion of hospitals within the 
State that have implemented a data abstraction system to abstract 
quality of care measures. CMS will review hospital satisfaction with 
the QIO data abstraction support. To view specific criteria for this 
task, go to www.cms.hhs.gov/qio/2.asp for a copy of the J-7.
    Task 2c--Other Mandated Communication Activities--QIO success on 
this task will be assessed on the following elements: The establishment 
and use of a Consumer Advisory Council to advise and provide guidance 
regarding consumer related activities, the QIO's success at broadening 
consumer representation on the QIO Board of Directors, the successful 
operation of a Beneficiary helpline, and the publication and 
distribution of an annual report.
Task 3--Improving Beneficiary Safety and Health Through Medicare 
Beneficiary Protection Activities
    Task 3a--Beneficiary Complaint Response Program--QIO success will 
be assessed by the timeliness of completed reviews, quality improvement 
activities as the result of beneficiary complaints, reliability of the 
review, and beneficiary satisfaction with the complaint process.
    Task 3b--Hospital Payment Monitoring Review Program--The QIO must 
complete reviews within the prescribed timeframes. The QIO must also 
meet one of the following criteria: With respect to the absolute 
payment error rate, the follow-up payment error rate must be no greater 
than 1.5 standard errors above the baseline error rate, or the QIO must 
have made acceptable progress in improving provider performance in 
relation to any and all projects approved or directed by CMS.
    Task 3c--Other Beneficiary Protection Activities--The QIO will be 
assessed on the timeliness of reviews for HINN/NODMAR, EMTALA review, 
other case review activities and post review activities.
    In accordance with the provisions of Executive Order 12866, this 
notice with comment period was not reviewed by the Office of Management 
and Budget.

    Authority: Section 1153 of the Social Security Act (42 U.S.C. 
1320c-2)

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


    Dated: May 4, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-16432 Filed 7-22-04; 8:45 am]
BILLING CODE 4120-01-P