[Federal Register Volume 62, Number 127 (Wednesday, July 2, 1997)]
[Notices]
[Pages 35824-35826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17234]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HSQ-207-NC]
RIN 0938-AG32
Medicare Program; Description of the Health Care Financing
Administration's Evaluation Methodology for the Peer Review
Organization 5th Scope of Work Contracts
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: General notice with comment period.
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SUMMARY: This notice describes how HCFA intends to evaluate the Peer
Review Organizations (PROs) for quality improvement activities, under
their 5th Scope of Work (SOW) contracts, for efficiency and
effectiveness in accordance with the Social Security Act. In accordance
with the provisions of the Government Performance and Results Act of
1993, the 5th SOW contracts with the PROs are performance-based
contracts.
DATES: This notice is effective on July 2, 1997. Written comments will
be considered if we receive them at the appropriate address, as
provided below, no later than 5 p.m. on September 2, 1997.
ADDRESSES: Mail written comments (an original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HSQ-207-NC, P.O. Box 26676,
Baltimore, MD 21207-0476.
If you prefer, you may deliver your written comments (an original
and 3 copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, S.W.,
Washington, DC 20201-0001.
or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HSQ-207-NC. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue, S.W., Washington
DC 20201-0001, on Monday through Friday of each week from 8:30 a.m. to
5 p.m. (phone: (202) 690-7890).
Comments may also be submitted electronically to the following e-
mail address: [email protected] E-mail comments must include the full
name and address of the sender and must be submitted to the referenced
address in order to be considered. All comments must be incorporated in
the e-mail message because we may not be able to access attachments.
Electronically submitted comments will also be available for public
inspection at the Independence Avenue address shown above.
FOR FURTHER INFORMATION CONTACT: Henry Koehler, (410) 786-6850.
SUPPLEMENTARY INFORMATION:
I. Background
A. Program Description
The Peer Review Improvement Act of 1982 (title I, subtitle C of the
Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Pub. L. 97-
248) amended part B of title XI of the Social Security Act (the Act),
establishing the PRO program. The PRO program was established in order
to redirect, simplify, and enhance the cost-effectiveness and
efficiency of the medical peer review process. Sections 1153 (b) and
(c) of the Act define the types of organizations eligible to become
PROs and establish certain limitations and priorities regarding PRO
contracting. In 42 CFR part 462, subpart C, of our regulations, we
describe the types of organizations eligible to become PROs. In
Sec. 462.101, we require they: (a) Be either a physician-sponsored
organization as described in Sec. 462.102, or a physician-access
organization as described in Sec. 462.103; and (b) demonstrate their
ability to perform the review requirements set forth in Sec. 462.104.
Under section 1153(h)(2) of the Act, the Secretary is required 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 PROs, and provide the opportunity for public
comment. This notice sets forth the criteria that will be used to
monitor PRO performance of quality improvement activities.
Section 1154 of the Act requires that PROs 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, as specified in their contract with the Secretary. The Secretary
enters into
[[Page 35825]]
contracts with PROs to perform the following two broad functions:
To promote quality health care services for Medicare
beneficiaries; and
To determine whether those services are reasonable,
medically necessary, furnished in the appropriate setting, and of a
quality that meets professionally recognized standards of health care.
These functions, which include quality improvement projects, are
central elements of the Health Care Quality Improvement Program
(HCQIP). PRO contracts are awarded for three years with starting dates
staggered into three approximately equal groups starting on April 1,
July 1, and October 1.
B. Development of Evaluation Standards
Using the conceptual groundwork of a 1990 Institute of Medicine
report (``Medicare: A strategy for quality assurance,'' Volumes 1 & 2,
Committee to Design a Strategy for Quality Review and Assurance in
Medicare, Division of Health Care Services, Institute of Medicine, KN
Lohr, editor, National Academy Press, Washington, DC, 1990), we
reinvented and modernized our quality assurance and improvement
activities under the HCQIP. We launched the HCQIP in April 1993,
reorienting the PRO program from a random sample case-by-case review to
a system designed to encourage providers to maintain and strengthen
their own internal quality management systems. The PROs monitor the
quality of care provided in both fee-for-service and managed care
settings using both a data-driven approach to monitor care and outcomes
and a cooperative approach of working with the health care community to
improve care.
The agency changed the focus of the PRO contracts in recognition
that the case review approach as the principal means of monitoring did
not give providers adequate information on systemic health care
delivery problems and methods for improving service delivery systems
and health outcomes. The HCQIP approach addresses these weaknesses,
combining providers' internal quality management systems, driven by
clinically-reliable data, with external monitoring and educational
support from the PROs. Central to the monitoring system is the
identification of patterns of care. The goal of these data analyses is
to identify treatment patterns for individuals and populations that are
consistent with current professional knowledge and that are likely to
improve outcomes. The PROs educate physicians about best practices and
assist hospitals and other institutional and noninstitutional providers
in developing internal quality monitoring systems that will lead to
quality improvement.
In our recently modified 5th Scope of Work contracts with the PROs,
we specified four objectives that PROs should maximize as they design
and implement quality improvement projects. The PROs are directed to
implement quality improvement projects that--
1. Result in measurable improvements;
2. Involve as many beneficiaries, providers and provider types as
possible;
3. Focus on important clinical topics; and
4. Build internal and external capacity to improve care.
C. Measuring PRO Performance
The most important activity for the PROs in their 5th Scope of Work
contracts is implementing quality improvement projects that lead to
measurable improvements in quality of care and health status. The
second objective, involving as many beneficiaries, providers, and
provider types as possible, will be accomplished as a result of PROs
implementing a broad portfolio of successful improvement projects. The
measurements for evaluating progress towards achieving objectives 3 and
4 will not be part of the evaluation strategy at this time. Due to the
complexity involved in developing measures for those objectives, we
will pilot test them before we make implementation decisions.
We define below the first two objectives concretely and
unambiguously and we will assess each PRO's progress in achieving the
objectives using explicit and quantifiable measures. We will feed back
to the PROs information about their success in achieving the contract
objectives. We will use this process to identify the successfully
performing PROs, to learn what characteristics are associated with
success, and to disseminate this information to the PRO community. We
will also use this feedback process to encourage average and poorly
performing PROs and to give them a mechanism by which they can gauge
the success of any remedial actions they might initiate.
We will use the data reported via the Standard Data Processing
System quality improvement project reporting system to evaluate each
PRO's progress in achieving objectives 1 and 2 of the 5th Scope of Work
contract. We reserve the right to ask for additional information and to
use alternate reporting channels should the data we require not be
present in the quality improvement project reporting system.
Specifically, to assess the PRO's ability to implement quality
improvement projects that result in measurable improvements, we will:
Monitor the achievement of key project steps for all
projects undertaken by the PRO. (These project steps include:
documenting the baseline opportunity to improve care, intervening
directly or in conjunction with appropriate health care providers to
improve care, and measuring the effect of these interventions.)
Monitor the number of projects the PRO reports as having
achieved some measurable improvement.
Assess the amount of improvement each project has
achieved.
With respect to objective 2, to assess the PRO's ability to
``implement quality improvement projects that involve as many
beneficiaries, providers and provider types as possible'', we will:
Determine the percentage of beneficiaries who might be
impacted by the project by measuring the number of beneficiaries in the
State who have the targeted clinical condition and measuring the number
of eligible beneficiaries who might be affected by the project.
Determine the percentage of acute care hospitals in each
State that actively collaborate with the PRO in one or more projects.
Measure the number of other providers and practitioners
who participate in the PROs' projects.
In addition to these performance measures, we may choose to use
other data sources, such as surveys or focus groups, in order to assess
and improve the validity of the evaluation process.
We will design a standard content and format for our evaluation
reports and will issue the reports at regularly scheduled intervals. In
addition, we will periodically issue special evaluation reports as new
issues become pertinent.
We plan to use this evaluation system as a basis for decisions
regarding future special PRO projects, awards, and competitive and
noncompetitive contract renewals. At the time that each of these
decisions is to be made, we will identify the pertinent criteria and
use the evaluation system to determine which PROs are eligible. In
addition, we will use the evaluation system to assure that the PROs'
5th Scope of Work performance does not deteriorate as their special
project activities are implemented.
As the end of the 5th Scope of Work contracts approaches, we will
use the
[[Page 35826]]
evaluation system to set a threshold for eligibility for noncompetitive
renewal of the PRO contract. We are issuing the following standards for
minimum performance to inform the PROs about what we consider to be a
minimum level of PRO performance during the 5th Scope of Work.
II. Standards For Minimum Performance
To be eligible for a noncompetitive renewal of its 6th round
contract, a PRO must meet, at a minimum, the performance standards
listed below by the end of its 18th contract month. However, meeting
these minimum performance standards does not guarantee a noncompetitive
renewal of its contract. We will make a final decision on renewal/
nonrenewal by the end of the 28th month of the 5th Scope of Work
contract.
We will issue a ``Notice of Intent to Non-renew the PRO Contract''
letter to all PROs that do not meet the minimum performance standards
by the end of their 18th contract month. A PRO will be considered to
have met the minimum performance standards if:
A. The PRO initiated quality improvement projects in at least the
five clinical topic areas to include acute myocardial infarction,
diabetes, prevention (flu vaccination, pneumonia vaccination, or
mammography), and two topic areas of a PRO's choice.
B. Each PRO quality improvement project is sufficiently broad
enough in scope to involve a specified percentage of beneficiaries in
the PRO's geographic area (a percentage of beneficiaries with the
condition or percentage for whom the prevention service is indicated)
as follows:
------------------------------------------------------------------------
Scope (Percentage
Topic Area of beneficiaries
involved)
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Acute Myocardial Infarction......................... 10
Diabetes............................................ 5
Prevention (flu vaccination, pneumonia vaccination,
or mammography).................................... 10
Topic of PRO's choice............................... 10
Topic of PRO's choice............................... 10
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C. The PRO demonstrates that a sufficient number of providers in
its contractually specified geographic area have actively attempted to
improve care through participation in the PRO's quality improvement
projects. Specifically, the PRO must have enlisted the participation
of:
At least 25 percent of all acute care hospitals; and
One of the following:
* In States with a high managed care penetration (defined to
include California, Florida, Oregon, Washington, Arizona,
Massachusetts, New York and Pennsylvania), at least one managed care
plan; or
* In all remaining states, at least 10 community-based
practitioners.
D. A PRO will demonstrate that at least one of the five prescribed
projects has achieved a measured improvement on one or more of the
targeted project indicators. In other words, the PRO must demonstrate
that the gap between the ``expected'' indicator level (for example, the
YEAR 2000 goal, practice guideline, clinical control trials
recommendation) and the ``actual'' level, as documented in the baseline
measurement, will have been lessened, as shown in the project's
evaluation (for example, remeasurement step).
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
III. Response to Comments
Although we are not able to acknowledge or respond to all items of
correspondence individually, we will consider all written comments that
we receive by the date and time specified in the DATES section of this
preamble.
Authority: Sections 1102 and 1881 of the Social Security Act (42
U.S.C. 1302 and 1395rr).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 29, 1997.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 97-17234 Filed 7-1-97; 8:45 am]
BILLING CODE 4120-03-P
