[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 44031-44034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-74]
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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.
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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 http://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
http://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 http://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 http://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 http://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 http://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