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8
The Utilization and Quality Control
Peer Review Organization Program
Kathleen N. Lohr and Allison I. Walker
INTRODUCTION
In the early 1980s, the Utilization and Quality Control Peer Review Or-
ganization (PRO) program replaced the Professional Standards Review
Organization (PSRO) program as the Medicare peer review effort. As with
the PSROs, the purpose of the PROs is to ensure that services rendered
through Medicare are necessary, appropriate, and of high quality. PRO
activities extend well beyond those emphases into many aspects of the
Medicare program, including implementation of the Medicare diagnosis-
related groups (DRG) prospective payment system (PPS) for hospitals. PROs
serve different purposes for different parties, not all of whom have the same
interests or concerns In the words of one interested observer, " . . . PROs
are quickly becoming all things to all people . . . " (Webber, cited in GIG,
1988b). The program is important to the Office of Inspector General (OIG)
in the Department of Health and Human Services (DHHS), the Executive
Office of Management and Budget, the Medicare beneficiary community
(and consumer groups more generally), and providers of many sorts (espe-
cially local practicing physicians).
This chapter describes the development of the PRO program up until the
summer of 1989, with most emphasis being placed on the required activities
that reflect the considerable expansion and complexity of responsibility and
activity of the program. For more extended discussions of the early im-
plementation of the PRO program, see Lohr (1985) or Dans et al. (1985~.
Volume I, Chapter 6 is excerpted extensively from this chapter, although
the committee conclusions and recommendations in that chapter are not
given here.
343
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KATHLEEN N. LOHR AND AI BISON J. WALKER
PRO LEGISLATION AND REGULATIONS
Legislation
The role of Congress in the development of the PRO program should not
be underestimated. Several pieces of legislation successively broadened the
mandate of the program, often beyond the capacity of the Health Care
Financing Administration (HCFA) to implement them as expected; they
also attempted to turn the program toward a greater emphasis on quality of
care. The key act was the Tax Equity and Fiscal Responsibility Act (TEFRA)
of 1982 (more specifically, the Peer Review Improvement Act, Title I,
Subtitle C of TEFRA), which amended Part B of Title XI of the Social
Security Act. Other important legislation included the Social Security
Amendments of 1983; the Deficit Reduction Act of 1984 (DEFRA); the
Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985; the
Omnibus Budget Reconciliation Acts (OBRA) of 1986, 1987, and 1989;
and the Medicare and Medicaid Patient Program Protection Act of 1987.
TEFRA (P.L. 97-248) established the PRO program. It changed the
funding arrangement from a system of federal grants to a 2-year fixed-price
competitive contract, and it extended eligibility for the PRO program to for-
profit groups and to payer organizations such as insurers and fiscal interme-
diaries (FIB) if there is no other available entity. It also strengthened the
PROs' ability to sanction providers, thus improving the potential effective-
ness of the program. The original 195 PSRO areas were consolidated into
54 areas.
The Social Security Amendments of 1983 (P.L. 98-21) established
Medicare's PPS scheme for hospital payment, which increased the number
of required activities of the PROs as well as their visibility. The legislation
required each PPS hospital to contract with a PRO as a condition of partici-
pation in the Medicare program. PROs were assigned many mandatory
review tasks, mostly relating to monitoring the behavior of hospitals fol-
lowing PPS; the most obvious concern was increased unnecessary admis-
sions. Required activities of PROs were aimed chiefly at the necessity and
appropriateness of admissions and invasive procedures rather than inade-
quate or poor technical care.
As part of DEFRA (P.L. 98-369), PROs became the quality and utiliza-
tion monitors for the new reimbursement system established by the Social
Security Amendments of 1983. This act provided for the continued funding
of PSROs from the Medicare Trust Fund until PRO contracts could be
signed. It also extended the deadline for hospitals to sign a contract with a
PRO.
COBRA 1985 (P.L. 99-272) and OBRA 1986 (P.L. 99-509) considerably
expanded PRO responsibilities. COBRA mandated pre-admission and pre
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UTILIZATION QUME CONTROL PRO PROGRAM
345
procedure review of certain surgical procedures (based on studies of medi-
cal practice variations) and pre-procedure review of cases requiring surgical
assistants at cataract surgery. It also gave PROs authority to deny Medicare
payment to physicians and hospitals for substandard quality (which would
come to be known as "quality denials". This authority was expected to
complement, not compete with, the PROs' ability to sanction providers in
other ways. OBRA 1989 clarified the quality denial activity somewhat.
OBRA 1986 considerably extended PRO review responsibility beyond
the inpatient setting to include review of the following: ambulatory ser-
vices; services provided in hospital outpatient departments and ambulatory
surgical centers (ASCs); care rendered in skilled nursing facilities (SNFs);
care rendered by home health agencies (HHAs); inpatient and outpatient
care from Medicare risk-contract health maintenance organizations (HMOs)
and competitive medical plans (CMPs); and all written complaints from
Medicare beneficiaries. These activities were to be phased in over several
years.
OBRA 1987 (P.L. 100-203) extended contract cycles from 2 to 3 years
and allowed a contract extension (up to 2 years) for existing contracts to
achieve more efficient renewals. Accordingly, a contract renewal phase-in
schedule (generally referred to as the third Scope of Work) was developed
in which one-fourth of the PROs began the new contract cycle on October
1, 1988, and the remaining PROs on April l, 1989. OBRA 1987 made
numerous other changes in the PRO program, including a mandated mini-
mum level of on-site review of rural hospital care and greater emphasis on
education and other instructional activities for rural practitioners.
The Medicare and Medicaid Patient Program Protection Act of 1987
(P.L. 93-100) expanded both sanction and civil monetary penalty authorities
for those programs. It also required the reporting of disciplinary actions
made by state medical licensure boards to the Secretary of DHHS, with the
latter being responsible for disseminating information on these actions to
state boards and to other state and federal officials. It did not, however,
mandate that PRO s report their disciplinary actions to state boards.
Regulations
Apart from legislative acts, numerous regulations and other directives
govern the administration and operation of PROB. The Administrative Pro-
cedure Act (APA) requires that regulations be promulgated through notice
and comment rulemaking procedures. HCFA considers the APA procedures
to apply to some but not all of its directives and publishes in the Federal
Register those procedures for which it seeks public comment. As an alter-
native or adjunct to the rather cumbersome regulatory rulemaking mecha-
nism, HCFA also relies extensively on PRO Manual transmittals, contracts
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KATHLEEN N. LOHR ARID ALLISON J. WALKER
and contract modifications (and their Scopes of Work), and other, less for-
mal instructions.
Administration
HCFA's Health Standards and Quality Bureau (HSQB) administers the
PRO program. HSQB functions are carried out in both the Central Office
(CO) and in the 10 HCFA Regional Offices (ROs). CO staff establish
policies for the program, perform a great deal of data analysis, negotiate
PRO contracts (with help from RO staff), and set evaluation criteria. RO
staff have appreciable involvement in PRO activities. They transmit pro-
gram requirements to PROs, oversee implementation of those requirements,
evaluate, and generally provide oversight and technical assistance. Some of
HCFA's guidance for the PRO program is promulgated in this way; thus,
inconsistencies among the ROs in interpreting HCFA policies and guide-
lines can pose a considerable problem for the program (OIG, 1989~.
PRO ORGANIZATIONAL CHARACTERISTICS
In organizing the PRO program, one change from the earlier PSRO pro-
gram was to consolidate the many PSRO regions into 54 PROs (all the
states, the District of Columbia, Puerto Rico, the Virgin Islands, and a
combined area of American Samoa, Guam, and the Commonwealth of the
Marianas). In a legislative attempt to retain some semblance of "local peer
review," Congress specified that, to qualify as a PRO, a statewide organi-
zation must either demonstrate sponsorship by being composed of at least
10 percent of the physicians practicing in the area (physician-sponsored
organizations) or have at least one physician in every generally recognized
specialty in the area available for PRO review (physician-access organiza-
tions). Third-party payers can obtain PRO contracts if no other eligible
organization is available; at the time of this study only one such organiza-
tion had a PRO contract.
A ~ ~ ~it. ~.~. .
. . . .
~ row may not De a neaten care rac~l~ty or other entity subject to review.
This avoids financial conflicts of interest with providers that may be the
subject of review. The contractor must have at least one consumer repre-
sentative on its governing board and must operate with objectivity and
without apparent or real conflict of interest.
PRO CONTRACTS
Unlike their PSRO predecessors, PROs are financed by contracts, not
grants. In principle, contracts make the program more manageable centrally
and more consistent nationally, because the contracting agency can specify
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UTINZATION ED QUME CONTROL PRO PROGRAM
347
in great detail precisely what it expects its contractors to do and can then
evaluate them on how well they meet those contract specifications. PROs
carry out a very complex set of review and intervention tasks that are
specified in minute detail in their HCFA contracts. The contracting proce-
dure is based on a formal Request for Proposal (RFP), which includes a
"scope of work" (SOW) that becomes part of the contract between the
government and the PRO.
PROs began with 2-year contracts, and an effort was made to have all
PROs start more or less at the same time. This proved very difficult to
implement. (The first contracts became effective over a 5-month phase-in
period from July to November 1984 that corresponded to the implementa-
tion of Medicare's PPS.) Therefore, OBRA 1987 extended contract periods
to 3 years, to permit somewhat more stability in anticipated financing and
planning. Timing of PRO contract periods is now staggered so that HCFA
does not have to negotiate 54 contracts simultaneously.
Contracts can be renewed triennially or canceled and put up for competi-
tive bidding if the existing PRO is judged not to qualify for a noncompeti-
tive renewal. In some cases these contracts have been won by the original
PRO because no competition emerged or because the bidding process galva-
nized the existing PRO into a credible renewal effort.
PRO contracts may be terminated by either the PRO or the secretary of
DHHS. The secretary may terminate or choose not to renew a PRO contract
when officials determine that the PRO has not met or is not meeting its
obligations in a satisfactory manner. A complex set of procedures is speci-
fied by which termination or nonrenewal can be accomplished. The
secretary's decisions in this regard are not subject to judicial review, and
the secretary has the absolute right to terminate a contract (rightfully or
wrongfully) without the possibility of the decision being overturned later in
court.
In addition to contracts between the PRO and DHHS, PROs must main-
tain written agreements with hospitals and with FIs and carriers. In hospital
agreements, PROs must include their review plans, criteria, and procedures
(including frequency of reviews, documentation to be required of the hospi-
tal, and time and location of reviews). The review process must be consis-
tent with the requirements placed on PROs in their own contracts with
lICFA, and the PRO-hospital agreements must be coterminous with PRO-
HCFA contracts. The agreements may be revised as needed to conform
with changes in statutes, regulations, and HCFA policies and directives for
the PRO program, meaning that changes to the PRO program can directly
and materially affect the hospital industry.
PROs must also enter into agreements with the FIs serving providers in
their areas. These agreements specify procedures to coordinate review ac-
tivities of the respective organizations. PROs are responsible for establish
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KATHLEEN N. LOHR AND ALLISON J. WALKER
ing procedures to collect and process data in order to assure that they are
complete, accurate, and promptly reported. FIs must provide internally
consistent and prompt data each month so that PROs can conduct timely
reviews, and they are responsible for both the internal consistency and
promptness in delivery of the information that they are required to produce.
PROs are not permitted to collect or have collected for them any informa-
tion that duplicates information that FIs are responsible for, although the
PROs can negotiate to purchase data not currently collected by FIs.
These relationships among PROs, hospitals, and FIs emphasize commu-
nication and data sharing. PROs must determine the accuracy of informa-
tion that hospitals provide to their FIs, and PROs and FIs must establish a
system of data sharing that permits PROs to inform FIs of data lacunae and
inaccuracies and then obtain completed and corrected information. After
completing their various reviews, PROs must also report to both hospitals
and FIs any claims that require payment adjustments.
PRO SCOPES OF WORK
The SOW details the specific obligations of the PRO that will be incor-
porated into its contract. It defines the duties and functions of the Medicare
review for a specific contract cycle. The first SOW was used during the
first contract cycle (1984-1986~; the second during the 1986-1988 contract
cycle; and the third covers the present period. No new SOWs are contem-
plated. To reinforce the sense of stability and common expectations for the
program, all future changes will be made through a contract modification
process. All PROs will be expected to implement changes at the same time.
If HCFA considers the contract modification to be significant, the agency
will publish it in the Federal Register 30 days in advance of its intended
start date. In the event that the contract modification requires more fund-
ing, PROs and HCFA will have to agree on the additional level of support
before the PROs begin the work.
Although most PRO activities have remained fairly constant over the
three SOWs, some tasks have changed dramatically. For example, the first
SOW emphasized controlling inappropriate utilization, whereas the second
and third SOWs direct more attention to assuring quality. The second and
third SOWs remained fairly similar as a result of efforts to achieve consis-
tency with minimum disruption to ongoing review activities; much of the
second SOW remains in the third, but with variations in the size of sarnples.2
All three SOWs are described in the following sections, but the third SOW
is described in greater detail because it is the current guide for PRO work.
Table 8.1 outlines the main activities of the third SOW, and Table 8.2
compares the three SOWs on certain key review and other requirements.
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UTILIZATION AND QUALITY CONTROL PRO PROGRAM
TABLE 8.1 Elements of Required Peer Review Organization (PRO)
Activities for the Third Scope of Work
349
I. Prospective Payment System (PPS) Hospital Casesa
A. Random (the 3-percene sample)
B. Transfers
1. PPS to PPS hospitals
2. PPS to exempt psychiatric units
3. PPS to exempt swing beds
C. Readmissions in less than 31 days from discharge from a PPS
hospital with review of intervening care
1. PPS hospital readmission
a. Identifying all readmissions
b. Review a random 25-percent hospital-specific sample
2. Intervening care
a. Identify all cases in the 25-percent sample with care
rendered by skilled nursing facilities, home health agencies,
or hospital outpatient departments
b. Review a 20-percent sample of each hospital's intervening
care universe for quality of care (not medical necessity or
overuse of services), with HCFA's generic quality screens
D. Focused DRGs (100 percent review of DRGs 385-391, 472, 474,
475; 50 percent review of DRG 468; 25 percent review of DRG
462)b
E. Day and cost outliers (25 percent random samples)
F. Medicare code editor (12 principal diagnoses)C
G.
H.
I.
Hospital adjustments (any adjustments to higher weighted DRGs)
Noncovered admissions (with covered level of care later in stay)
PI and HCFA regional office referrals
II. Specialty Hospitals
A. Exempt units of PPS hospitals
B. Exempt hospitals
III. Ambulatory Surgery [Hospital Outpatient Areas and Ambulatory Surgical
Centers (ASCs)]
IV.
Intensified Review
V. Pre-admission and Pre-procedure reviews
A. Ten procedures
B. Assistants at cataract surgery
VI. Review of Freestanding Cardiac Catheterization Facilities
VII. Objectives (e.g., based on Generic Quality Screens)
VIII. Development and Use of Explicit Written Criteria
TABLE 8.1 continues
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350
TABLE 8.1 Continued
KATHLEEN N. LOHR AND AllISON J. WALKER
IX. Reconsideration and Review of DRG Changes and Preparing Appeals
Folders
X. Data
A. Reports submitted to HCFA on completed reviews
B. Profiling
1. Hospital statistics (by 14 variables)
2. Physician statistics (by 4 variables)
3. Other provider statistics (HHA, SNFs, ASCs)
4. Internal quality control (monitoring of review decisions)
XI. Beneficiary Communications
A. Important Message to Medicare Beneficiaries (from hospitals)
B. Hospital notices of noncoverage
C. Community outreach
1. Hotline
2. Written inquiries responses
3. Education programs, seminars, and workshops
4. Informational materials
5. Coordination with beneficiary groups
XII. Responsiveness to Inquiries and Complaints
XIII. Interaction with Physicians and Providers
A. Peer review
B. Opportunity for consultation
C. Education
D. Criteria development and dissemination
E. Communications
F. Confidentiality and disclosure guidelines
G. External relationships with concerned organizations
H. Management responsibilities
XIV. Sanctions
XV. Confidentiality and Disclosure of Information
XVI. Fraud and Abuse Review (of Cases referred by OIG or HCFA)
XVII. Anti-Dumping Review (of Cases referred by HCFA)
XVIII. Private Review
XIX. Civilian Health and Medical Programs of the Uniformed Services
(CHAMPUS)
XX. Other Requirements
A. Cooperation win HCFA
B. Cooperation win tile SuperPRO
C. Private review
D. Internal quality control
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UTILIZATION AND BUMS CONTROL PRO PROGRAM
351
aThe required review activities include: generic quality screens' discharge
review, admission review, invasive procedure review' DRG validation, coverage
review, and waiver of liability.
bThe DRG categories are as follows: 385, neonates, died or transferred; 386,
extreme immaturity, neonates; 387, prematurity with major problems; 388,
prematurity without major problems; 389, full-term neonate with major problems;
390, neonate with other significant problems; 391, normal newborn; 462, rehabili-
tation; 468, unrelated operating room procedures; 472, extensive burns; 474,
acheostomy; and 475, mecharucal ventilation through endo~acheal incubation.
CDiabetes mellitus, without mention of complication; noninsulin dependent and
insulin dependent; obesity; impacted cerumen; benign hypertension; left bundle
branch hemiblock; other bundle bench hemiblock; positive SRL/VRL HL3;
elevated blood pressure reading without diagnosis of hypertension; other and
unspecified complications of medical care, not elsewhere specified; and cardiac
pacemaker (fitting and adjustment).
Carotid endarterectomy and cataract procedures are required. Eight of the
following 11 can also be selected: cholecystectomy, major joint replacement,
coronary artery bypass graft, percutaneous transluminal coronary angioplasty,
larninectomy, complex peripheral revascularization, hysterectomy, bunionectomy,
inguinal hernia repay, prostatectomy, and pacemaker insertion.
SOURCE: Attachment 33, HCFA, 1988.
FIRST PRO SCOPE OF WORK (1984-1986 CONTRACT CYCLE)
The first PRO contracts emphasized the detection of inappropriate utili-
zation and payments under the new Medicare hospital PPS after October
1983. Contract activities, which concentrated on inpatient hospital care,
included reducing unnecessary admissions, ensuring that payment rates
matched diagnostic and procedural information contained in the patient rec-
ords, and reviewing patients who were transferred or readmitted to an acute
care hospital within 7 days of discharge. In addition, HCFA negotiated five
generic "quality objectives" for each PRO: (1) reduce unnecessary hospital
readmissions resulting from substandard care provided during the prior
admissions; (2) assure the provision of medical services which, when not
performed, have significant potential for causing serious patient complica-
tions; (3) reduce the risk of mortality associated with selected procedures
and/or conditions requiring hospitalization (initially denoted "reduce avoid-
able deaths; (4) reduce unnecessary surgery or other invasive procedures;
and (5) reduce avoidable postoperative or other complications.
Corrective actions for physicians or hospitals included education and
consultation, intensified review, and denial of payment for inappropriate or
unnecessary admissions or readmissions. During the first SOW, PROs were
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KATHLEEN N. WHR AND AI1ISON J. WALKER
TABLE 8.2 Companson of the Three Scopes of Work (SOWs) with
Respect to Selected Utilization and Quality Control Peer Review
Organization (PRO) Activities (Ordered by Tasks Pertaining to the
Third SOW)a
I. Prospective Payment System Hospitals Cases
Random Samples
First SOW: 5-percent admission sample. DRG sample ranging from 3 to
100 percent based on hospital discharge size
Second SOW: 3-percent sample (includes 1- and 2-day stays)
Third SOW: Same as second SOW
Transfers
First SOW: From PPS to another hospital, exempt unit, or swing bed
Second SOW: Same as first SOW, but lower level of review
Third SOW: PPS to PPS, 50-percent sample; PPS to psychiatric, 10 percent;
and PPS to swing bed, 25 percent
Readmissions
First SOW: All related readmissions within 7 days of discharge
Second SOW: All related readmissions within 15 days of discharge
Third SOW: 25 percent of readmissions within 31 days of discharge
Intervening Care
First SOW: Not in scope of work
Second SOW: Not in scope of work
Third SOW: 20 percent of all cases receiving home health agency, hospital
outpatient, inpatient, or skilled nursing facility (SNF) care between
sampled hospital admissions less than 31 days apart
Focused DRGs
First SOW: Review of DRG numbers 462 and 46B
Second SOW: Review of DRG numbers 462, 468, and 088
Third SOW: Review of DRG numbers 462, 468, 385-391 472 and
474 475b .
Day and Cost Outliers
First SOW: Originally 100 percent; reduced to 50 percent during contact
period
Second SOW: 50 percent of day and cost outliers
Third SOW: 25 percent of day and cost outliers
Medicare Code Editor
First SOW: 100 percent of 9 diagnoses with code editor rejects
Second SOW: Same as first SOW
Third SOW: 100 percent of 12 diagnoses with code editor rejectsC
Hospital Adjustments
First SOW: 100 percent of all cases adjusted to a higher-weighted DRG
Second SOW: Same as first SOW
Third SOW: Same as second SOW
PI and HCFA Regional Office Referrals
First SOW: 100 percent review of cases referred by FI or HCFA regional
office for determination of medical necessity
Second SOW: Same as first SOW
Third SOW: Same as second SOW
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UTILIZATION kD QUME CONTROL PRO PROGRAM
353
II. Specialty Hospital Review
First SOW: Proposed by each PRO
Second SOW: 15 percent of all discharges
Third SOW: 15-percent random sample for PPS-exempt hospitals and units
III. Ambulatory Surgery
First SOW: Not in scope of work
Second SOW: Not in scope of work
Third SOW: 5-percent random sample of all cases
Intensified Review
First SOW: Trigger; 2.5 percent or 3 cases reviewed (whichever is greater).
Review increased to 100 percent or subsets.
Second SOW: Trigger; 5 percent or 6 cases reviewed (whichever is greater).
Review increased to 100 percent or subsets (two consecutive quarters)
Third SOW: Same as second SOW
Preadmission Review
First SOW: 5 procedures proposed by each PRO
Second SOW: Pacemaker plus 4 procedures proposed by the PRO
Third SOW: 100 percent of 10 procedures (cataract extraction, cartoid
endarterectomy plus 8 of 11 others specified by HCFA)&
Assistants at Cataract Surgery
First SOW: Not in scope of work
Second SOW: 100 percent review of cases for medical necessity of assistant
at surgery
Third SOW: Same as second SOW
VII. Objectives
First SOW: Three admission objectives arid five quality objectives. All
proposed and validated by the PRO. Very limited areas for focusing
. .
O Electives
Second SOW: Five objectives based on PRO data from first 90 days of
generic quality screen review. HCPA-identified mortality rate outliers
Third SOW: Objectives based on data from generic screens. May be
statewide, or focused by physician, DRG, provider, etc.
Hospital Notices of Noncoverage
First SOW: 100 percent where patient or physician disagrees; 100 percent
where patient is liable; 10-percent random sample
Second SOW: Same as first SOW
Third SOW: 100 percent where patient or physician disagrees; 100 percent
where patient is liable
Community Outreach
First SOW: Not in scope of work
Second SOW: Each PRO to propose its own program
Third SOW: Minimum requirements to be met
aRoman numerals refer to parts in Table 8.1.
bFor definitions, see Table 8.1.
CFor definitions, see Table 8.1.
Nor listing, see Table 8.1.
SOURCE: Adapted from unpublished HCFA documents.
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KATlILEE:N N. LOHR AND ALLISON J. WALKER
control the performance of those providers, except over the very long run
when a sufficient number of patients have had experience with those pro-
viders.
The question of accountability may be more complicated by legal prece-
dent and rulings concerning whether entities that employ physicians and
other professionals are held to different standards than those that only con-
tract with physicians (essentially the distinction between group and staff
models on the one hand and IPA-type models on the other). Some IPA
physicians hold that they should not be subject to review until such time as
all physicians who contract with Medicare (presumably meaning all FFS
physicians) are reviewed. This may be especially salient in the light of a
case (Harrell v. Total Health Care, Inc.~39 in which the court held that an
HMO as a corporate entity could be liable for the negligence of contracting
referral physicians.
Other Issues Relating to HMO-CMP Review
PROs differ dramatically in the proportions of quality problems they find
in HMOs; one accounting showed a range of 1.8 percent in one state to
upwards of 30 percent in three states (HCFA data cited by O'Kane, 1989~.
Although it may be the case that HMO quality differs as much as 15-fold
across the states, variations of that magnitude call into question more than
the true quality of the care being rendered, most especially the validity of
inferences drawn about comparisons of HMOs with each other and with the
FFS system. It also raises the issue of whether HMO s operating in several
or many states are subjected to the "same" review, because the PRO in each
state is responsible for the state-specific portion of the HMO risk-contract
care.
In the site visits for this study, multistate HMOs had different views on
this issue. At least one felt very strongly that it wished to deal with only a
single PRO because it was experiencing considerable, unexplainable vari-
ation in review from the different PROs in the different states in which it
operated. By contrast, at least one other plan found PRO review suffi-
ciently nontroublesome that differences across PROs were either not notice-
able or not a problem.
The question of valid comparisons is especially problematic for those
states with only a single risk contractor, because information about numbers
of cases reviewed and numbers and percentages of quality problems cannot
be protected from public disclosure. For an HMO with an "unblemished"
record, this obviously poses no problems, but for an HMO with a "poor"
record the risk to its competitive position (vis-a-vis other HMOs in the
state) could be considerable.
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UTILIZATION AND QUALITY CONTROLPRO PROGRAM
CONCLUDING REMARKS
429
This chapter has presented information on the current Medicare PRO
program. It is intended mainly as a reference document for Volume I,
Chapter 6, of the IOM study committee's report. The history of the pro-
gram for review of care rendered in both FFS and prepaid group practice
settings is recounted with emphasis on the most recent (third) SOW. Some
problems related uniquely to HMO and CMP review are described, in addi-
tion to current special projects and other activities of the PROs (or HSQB
and HCFA).
Among the issues discussed are the following: the usefulness of hospital
generic screens, the practical question of ensuring review by peers, the
limitations of the current sanctioning process and denials for substandard
care, the adequacy of public oversight and adminis~aiive procedures for the
program, and the lack of any systematic program evaluation to date. In
formulating its mission of a model quality assurance program, the IOM
study committee took many of these issues under advisement, intending that
its proposed program overcome some of the more troublesome drawbacks
(e.g., He adversarial "regulatory" aspects of the program and the lack of
public accountability) while building on the considerable expertise, skills,
and experience of the PRO community.
NOTES
1. The authors wish to acknowledge the perceptive and timely assistance of Alan
Kaplan, a Washington, D.C. attorney and consultant, at various stages of the prepa-
ration of this overview of the PRO program. Harvey Brook and John Spiegel of the
Health Standards and Quality Bureau were always responsive to questions and re-
quests for data, and we thank them and their staff for a detailed and helpful review
of this chapter. We also thank Andrew Smith and Maxwell Mehlman, authors of a
related background paper for this study, for important legal and regulatory informa-
tion on which this chapter in part relies. Finally, the commissioned paper on the
history of and current issues relating to PRO review of risk-contract prepaid group
practices, by Margaret O'Kane, was a valuable background document.
2. The GIG (1989) notes that HCPA appears not to have formally published the
rationales for the sampling methods imposed on PROB. They also contend that
HCFA apparently sets most of the specific requirements for review internally, usu-
ally without pilot-testing.
3. A "substantial violation in a substantial number of cases" is a pattern of care
that is inappropriate, unnecessary, does not meet recognized professional standards
of care, or is not supported by documentation required by the PRO.
4. "Gross and flagrant violation" means a violation of an obligation (in one or
more cases) that represents an imminent danger to a Medicare beneficiary's health,
safety, or well-being, or that places a beneficiary at an unnecessarily high risk.
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KATH~FEW N LOHR AND ALLISON J. WALKER
5. More cases are shown as reviewed than as selected for review. This may be
an artifact of counting practices. For instance, transfer and readmission categories
in the reviewed classification actually involve two or more cases, and Medicare
code editor cases are reported under both pre-admission-prepayment and retrospec-
tive review (HCFA, 1989b).
6. Interpretative guidelines for generic screens include two features, exclusions
and explanatory notes. For example, exclusions for adequacy of discharge planning
include death, transfer to an acute short-term general hospital or swing bed status, or
patient left against medical advice. Explanatory notes for nosocomial infection are
another example. They state: "A screen failure is not necessarily a confirmed
problem. A screen failure occurs when more than one indicator of an infection is
identified more than 72 hours after admission. Indicators [are]: temperature eleva-
tion of 101 degrees Fahrenheit or greater (oral) (38.9 Centigrade); elevated white
blood cell and/or left shift; isolation of organism from body fluids or specimens;
appropriate radiographic imaging abnormalities; purulent draining; heat, redness,
focal tenderness and/or pain; pyuria, dysuria; and productive cough. When the case
has two or more indications of a nosocomial infection (i.e., a screen failure), you are
encouraged to refer to the CDC's [Centers for Disease Control] guidelines to deter-
mine whether there was a nosocomial infection. The presence of a nosocomial infec-
tion is always a confirmed quality problem. Treatment of the nosocomial infection
does not negate the confirmed quality problem."
7. Prior-authorization criteria vary by PROB. For cataracts, for instance, the
Delmarva PRO indications for the procedure require visual acuity of 20/50 or worse
in the affected eye for distance, or visual acuity of 20/40 or worse in the affected
eye for near vision. Three other criteria are also (ambiguously) stated: visual acuity
is interfering with the patient's lifestyle; cataracts are causing another ocular dis-
ease; arid cataracts are preventing treatment for another disease. (Another set of
specifications serve as indications for admission for the procedure.) The New York
PRO indications for the procedure require the patient to meet one specific criterion
(cataract removal will improve the patient's visual performance for daily activities,
employment, and/or recreation) and one of a number of others, including vision in
the operative eye less than 20/60, or the nonoperative eye is phakic and visual acuity
is less than 20/40.
8. This chapter refers in various places to practitioners and providers; the
distinction is a term of art for the PRO program in that practitioners would be used
to refer to physicians or other individual clinical caregivers, and providers to facili-
ties and institutions such as hospitals, SNFs, HHAs, as well as HMOs and CMPs.
9. Comments to study site visitors from PRO officials indicated that many
Severity Level I cases ultimately turn out not to be quality problems as defined,
because they are related to poor documentation. The "quality problem" is not
confirmed when He target physician or provider provides satisfactory additional
information.
10. HCFA prescribes the format and wording of these initial sanction notices
(apart from the specifics of the case at hand). Presumably for legal reasons, they are
very formal in tone and must contain the following information: (1) the obligations
involved; (2) description of the activity resulting in the violation; (3) the authority
and responsibility of the PRO to report violations of obligations; (4) a suggested
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UTILIZATION AND QUALlTYCOlITROLPRO PROGRAM
431
method and time period for correcting the problem (at the discretion of the PRO);
(5) an invitation to submit additional information or discuss the problem with the
PRO within 20 days of the notice; and (6) a summary of the information used by the
PRO in reaching a determination.
11. As part of a case (American Medical Association v. Bowen) settled 3 years
ago, the OIG committed itself to seek a regulatory alternative to the practice of
newspaper notices. It was intended to permit sar~;ctioned physicians to inform their
Medicare patients personally that Medicare would no longer pay for the physicians'
services (e.g., by mailing notices to individual patients).
12. Payment cannot be made to another party where services or items have been
ordered by an entity excluded by sanction when that order was necessary as a
precondition of payment. Payment may be- made for services provided up to 30 days
after the effective date of the exclusion (1) when the recipient of the services or
items is an inpatient in a hospital or SNF and was admitted before the effective date
or (2) when home health care services are delivered under a plan established before
the exclusion.
13. The relevant passages defying peer review include: ". . . whenever possible,
the contractor [i.e., the PRO] [shall] use physician reviewers who practice in a
setting similar to that in which the physician whose services are under review prac-
tices. In . . . initial review of psychiatric and physical rehabilitation services, the
contractor must arrange for review (to the extent possible) by a physician who is
trained in the appropriate discipline.... In addition, the contractor would be re-
quired to use board certified or board eligible physicians or dentists, in the appropri-
ate specialty, to make reconsideration determinations, wherever practicable.... The
contractor would consult with other health care practitioners (e.g., podiatrists) when
appropriate (e.g., when reviewing services rendered by that type of practitioner)"
(HCFA, 1988~. The qualifiers ("whenever possible," "to the extent possible,"
"wherever practicable") appear to give the opportunity to dilute the emphasis on
peer review, although HCFA argues that the term "whenever possible" is used for
cases where it is not administratively feasible for the PRO to use a specialist.
Examples of such situations include (1) when the specialist is located on the other
side of the state or (2) when the specialty is so unique that it is not possible to locate
a specialist reviewer in the field.
14. Consistently throughout this study, respondents at site visits confirmed the
observation that quality problems tend to affect all patients, not just the elderly.
Especially in hospitals and prepaid systems, it was noted that most quality problems
tended to be with "systems" that cut across units and patient age groups. Moreover,
facilities and groups with well-established internal quality assurance systems delib-
erately did not single out "the elderly" or "Medicare patients" for specific quality
assurance attention (except insofar as they needed to meet PRO demands for records
and similar requirements), believing that a more efficient and ultimately more suc-
cessful approach to quality improvement would involve the entire institution, its
entire staff, and its enure patient census.
15. Regulations define "confidential information" as information that explicitly
or implicitly identifies an individual patient, practitioner, or reviewer; sanction re-
ports and recommendations; quality review studies that identify patients, practitio-
ners, or institutions; and/or PRO deliberations. "Implicitly identifies" means data
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KATHLEEN N. LOHR AND ALLISON J. WALKER
sufficiently unique or numbers so small that identification of an
practitioner, or reviewer would be obvious.
16. Estimates for Medicare outlays are from the Committee on Ways and Means
(1989, Table 15, p. 152), where slightly different figures are given depending upon
whether the estimates are from the Congressional Budget Office (CBO) or from
HCFA (CBO estimates tend to be higher). The figures cited here are roughly
midway between the CBO and HCFA numbers. Estimates for PRO budgets are
from HCFA staff (lI. Brook, personal communication, 1989~.
17. Material for the Medicare risk-contract section is based in part on a paper
prepared for this study, "PRO Review of Medicare Health Maintenance Organiza-
tions and Competitive Medical Plans," by Margaret E. O'Kane, Director of Quality
Assurance, Group Health Association, Washington, D.C., May 1989.
18. The PRO-HMO Task Force had three representatives each from three organi-
zations, the Group Health Association of America, the American Medical Care Re-
view Association, and the American Medical Peer Review Association; the first two
are prepaid group practice trade organizations, and the latter is the PRO national
. .
association.
19. The 15 sentinel conditions for ambulatory care review were diabetic coma or
acidosis, ruptured appendix, stroke with hypertension, bleeding or perforated ulcer,
gangrene, breast cancer, cancer of cervix, drug overdose/toxicities, mar-union of
fracture of hip, cellulitis, bowel obstruction, bleeding secondary to anticoagulation,
hypokalemia, septicemia, and pulmonary emboli.
20. The "comparable review" language for risk contracts was interpreted to
mean that the number of cases reviewed must be at the same level as was occurring
under PPS in the FFS system; this in turn implied a substantial level of record
review. The legislation did not provide for pilot projects or staged implementation.
21. The 25 states for QRO review of HMO and CMP services were Alabama,
Arizona, California, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky,
Maryland, Massachusetts, Missouri, New Jersey, New Mexico, North Carolina, Penn-
sylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington,
West Virginia, and Wisconsin.
22. As of December 1989, Quality Quest is the QRO only for Missouri. The
Illinois PRO (Crescent Counties Medical Foundation) is the QRO for Illinois. The
QRO contract for Kansas had not yet been awarded.
23. Each month, the PRO (or the QRO) receives a copy of the "Monthly Report
of Medicare HMO/CMP Contracts and Applications." This list is reconciled against
a list of established risk-based HMOs and CMPs to identify new plans in the area.
For each new plan that requests "limited review," the PRO (QRO) performs an
initial analysis to determine whether this level is appropriate. Absent such a request,
the plan is automatically placed on basic review.
24. The SOW for QRO review is sufficiently similar to that for PROs that it is
not described more fully here.
25. An additional requirement for HMO and CMP review, 100 percent of hospi-
tal transfers, was eliminated in July 1989.
26. The 13 "sentinel" conditions for HMO and CMP review include: diabetic
complications (ketoacidosis, hyperosmolar coma, other coma, and hypoglycemic
coma); acute appendicitis with generalized peritonitis or peritoneal abscess; hy
individual patient,
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UTILlZATION^D QUME CONTROL PRO PROGRAM
433
pertensive problems (several categories, including occlusion and stenosis of precere-
bral arteries and transient cerebral ischemia); gastrointestinal (GI) catastrophes (acute,
chronic, or unspecified gastric ulcer with hemorrhage without obstruction; chronic
duodenal ulcer with hemorrhage without obstruction; unspecified intestinal obstruc-
tion); gangrene of the extremity; operations for breast malignancy (from other bi-
opsy through unilateral radical mastectomy); malignant neoplasm of the genitouri-
nary organ; adverse drug reactions (several categories, mainly poisoning by specific
pharmacologic agents); other cellulitis and abscess; malignant neoplasm of colon;
hypokalemia; septicemia; and pulmonary embolus. These are very similar to the 15
conditions proposed by the PRO-HMO Ad Hoc Committee; mar-union of fracture of
hip is missing and bowel obstruction was evidently subsumed under GI catastro-
phes. For limited review, one of the four conditions reviewed must be the hyperten-
sive problems. In addition, two of the four must be selected from among the
following conditions: diabetic complications, gangrene, adverse drug reactions,
other cellulitis and abscess, hypokalemia, septicemia, or pulmonary embolus.
27. In 1988, HCFA proposed an Effectiveness Initiative intended to bring the
resources of Medicare to bear on the question of what works in the practice of
medicine (Roper et al., 1988; IOM, 1989~. Information generated from that initia-
tive was expected to provide an expanded basis of knowledge for the development
of practice guidelines and similar work, even if HCFA was not directly involved in
that development. The UCDS was seen as an integral part of the initiative. At
HCFA's request, the IOM convened one workshop of clinicians to advise on appro-
priate clinical conditions most appropriate for priority attention in such research;
that study recommended five conditions: stable and unstable angina, acute myocar-
dial infarction (AMI), breast cancer, congestive heart failure, and hip fracture. HCFA
then asked the IOM to convene three "research strategies" workshops on breast
cancer, AMI, and hip fracture to advise on key patient management issues that
should be addressed first; these workshops were conducted between February and
July 1989 (IOM, 1990a-d).
Because of greatly heightened interest in effectiveness and outcomes research on
the part of Congress and DHHS, considerable attention was placed in mid-1989 on
exactly where in the department resources for this work should be placed. OBRA
1989 (P.L. 101-239) created the Agency for Health Care Policy and Research in the
Public Health Service to conduct such work, and relatively little would be done in
HCFA. Consequently, the fate of the Effectiveness Initiative as envisioned by
HCFA was unclear as of this writing, although it was expected that the PRO pilot
projects relating to practice guidelines could proceed independently and that the
UCDS might be a source of clinical data.
28. Figures cited in the text concerning the rates of quality problems found by
the SuperPRO are from the oral testimony of Christy Moynihan, Ph.D., of SysteMet-
rics, Inc., at the October 21, 1988, public hearing of the IOM Study to Design a
Strategy for Quality Review and Assurance in the Medicare Program.
29. PROs sometimes negotiate review objectives with HCFA on the basis of
their experience with generic screens, with the idea of specifying a target problem
reduction level. Discharge planning is the most popular screen on which such
objectives are based, and it plus hospital-based trauma are areas in which PROs are
most successful in reaching or exceeding their targets (GAO, 1988b). Discharge
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434
KATHLEE7VN. LOHR AND AIllSON J. WALKER
planning and falls (as part of hospital-based trauma) are the two screens for which
nurse reviewers need not refer cases to physician advisors.
30. In its cumulative data summary, HCFA (1989b) notes that"totals for all
reviews for the generic quality screen data should not be used to project national
rates of occurrence" of the various problems identified through the screens. The
reason is that national totals include problems detected through focused review,
which (if it is being conducted as intended) should detect more than the usual
number of quality problems. Hence, the total rates of occurrence, if projected to all
discharges without accounting for the higher rates among focused review, might
yield rates higher than are actually the case.
31. With respect to additional screens developed by the PROs, the Peer Review
Organization of Washington (PRO/W) reported that some of its specially developed
screens identify more [allures and/or confirmed problems than do the HCFA screens.
32 An ancillary proposal is that the OIG be given the authority of a "national
medical board" to protect beneficiaries. States have not been very effective in
exerting discipline over the medical profession, and some suggest that such a na-
tional system would permit uniformity and greater protection for Medicare benefici-
aries (Jost, 1989~.
33. The OIG had advised PROs in July 1987 not to recommend fines unless they
could demonstrate that they would be cost-effective. Apart from perhaps contradict-
ing legal requirements that PROs bring sanction recommendations against all pro-
viders that have violated their Medicare obligations, this advisory discouraged PROs
from recommending monetary penalties and decreased the number of sanction fil-
ings. This situation was to have been remedied by Spring of 1989 by a change in
policy from the OIG to the PROs (McIlrath, 1989; Vibbert, 1989a).
34. Smith and Mehlman (1989) provided the basis for much of the discussion in
this entire section.
35. The site visits for this study-took place during the time that the proposed rule
was published for public comment, and thus PROs were just beginning to analyze
how it would affect their local operations. A major problem mentioned to the site
visitors was that implementation of quality denials as planned, particularly the alleg-
edly harsh language required for the letters to beneficiaries, would seriously erode
the ability of PROs to attract the necessary specialist physician advisors who would
be expected to make the initial denial decisions. Moreover, PROs believe that the
relatively low rates they can pay physician advisors, often only between $55 and
$65 an hour, already markedly hampers their recruitment efforts, especially of cer-
tain kinds of specialists and subspecialists; implementation of the quality denials,
with the heavy reliance on specialists as described, was expected to exacerbate the
problem.
36. Early in the PRO program the American Hospital Association (AMA) charged
that HCFA's administrative practices violated the APA and requested that DHHS
promulgate comprehensive PRO regulations (i.e., in accordance with APA require-
ments). This request was not met, and the AHA filed a lawsuit (~American Hospital
Association v. Bowen) claiming that DHHS had failed to meet its statutory duties
under the APA. The district court for the District of Columbia agreed with AHA.
DHHS appealed the decision, and the court of appeals reversed the district court
ruling. The majority opinion held that the contracting process, the issuance of the
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UTIllZATION AND QUALlIYCONTROLPRO PROGRAM
435
SOWs, and Manual transmittals were all covered by exceptions to the APA (Smith
and Mehlman, 1989~.
37. Vibbert (1989c) reported that some legislative language may require that
DHHS make HMOs, not hospitals, responsible for assuring that PROs obtain the
inpatient discharge abstract information needed to draw the relevant review samples.
The rationale was that the current random analysis approach is ineffective and intru-
sive (a point with which HMOs might well agree); nevertheless, this option would
not appear, from the point of view of the HMO industry, to overcome that particular
problem.
38. The issue of reimbursing hospitals for costs incurred in photocopying medi-
cal records has been especially contentious since 1985. A court order in mid-1989
required that HCFA reimburse hospitals retroactively for costs incurred in photo-
copying; the American Hospital Association argues in favor of a $0.12 per page
reimbursement level. Recently hospitals gained class action status in a federal suit
involving photocopying costs (Vibbert, 1989g).
39. No. WD39809 (Mo. Ct. App. 19891. Lee Missouri Court of Appeals found
that the doctrine of "corporate negligence" is not limited to treatment settings be-
cause it is based on common law principles of negligence. Moreover, it determined
that the defendant (the HMO) had a duty of care to protect members from unreason-
able risk of harm by exposing them to unqualified or incompetent physicians (and
the HMO had not done so because it had failed to make any investigation of the
background of the physician in question).
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OCR for page 438
Representative terms from entire chapter:
generic screens
