GAB Decision 252
February 8, 1982 Charles River Health Care Foundation; Docket No.
81-103 Garrett, Donald; Settle, Norval Teitz, Alexander
Introduction
The Charles River Health Care Foundation (CRHCF) appealed the Health
Care Financing Administration's (Agency) decision to terminate its
grant, No. 97-P-99602/1, after an extension of the grant to November 30,
1981. The determination provided that the grant be further extended, if
necessary, to permit this Board to make a final decision. In its appeal
letter, dated July 16, 1981, CRHCF requested a hearing pursuant to
Section 1152(d)(2) of the Social Security Act (Act). A hearing before
the Presiding Board Member was held on September 18, 1981. This
decision is based on the Record in this case, which includes the written
submissions of the parties and the evidence presented at the hearing (as
recorded in the transcript (Tr.) of the hearing). /1/ Based on the
analysis below, we uphold the Agency's decision to terminate CRHCF's
grant.
This decision is divided into three sections. The first provides
general background information on the Professional Standards Review
Organization (PSRO) program and the nationwide evaluation of PSROs which
led to this dispute. The second discusses the evaluation of CRHCF --
how it was conducted and what general objections CHRCF raised regarding
the evaluation and the criteria used in the evaluation. The third
section sets out the Board's findings and conclusions on whether CRHCF
should receive any additional points for the contested criteria. (2) I.
General Background
A. Information on the PSRO Program
The 1972 Amendments to the Social Security Act provide for the
creation of PSROs, administered and controlled by local physicians, and
designed to involve local practicing physicians in the review and
evaluation of health care services covered under Medicare, Medicaid, and
the Maternal and Child Health programs. (Title XI, Part B, of the Act.)
PSROs are responsible, in specifically designated geographic areas, for
assuring that the health care paid for under these programs is medically
necessary and consistent with professionally recognized standards of
care. The PSROs also review whether the health services are provided at
the level of care which is most economical, consistent with the
patient's medical care needs. The major focus of the PSRO program has
been on review of impatient hospital services. While PSROs are also
charged with review responsibilities in other care settings, budget
restrictions have limited the PSRO's ability to review outside the
hospital setting.
The PSROs are responsible for developing and operating a quality
assurance system based on peer review of the quality and efficiency of
services and continuing education. In hospitals, the peer review system
must include: concurrent review, which is review focusing on the
necessity and appropriateness of inpatient hospital services performed
while the patient is in the hospital; medical care evaluation studies,
which are assessments, performed retrospectively, of the quality or
nature of the utilization of health care services and assessments of the
PSRO's impact where corrective action is taken; and profile analysis,
which is the analysis of patient care data to identify and consider
patterns of health care services. (See, e.g., PSRO Program Manual,
Chapter VII, p. 1, March 15, 1974.)
The Act, and regulations governing the program, provide that a PSRO
is "conditionally designated" for a period of time, and that there
will
be an agreement between the Secretary and the PSRO "fully designating"
the PSRO after it has satisfactorily performed PSRO functions during its
trial period as a conditional PSRO. After a maximum of six years, a
conditional PSRO must be fully designated or it can no longer
participate in the program. (Section 1154(b) and (c) of the Act.) A
fully designated PSRO may be terminated only after an opportunity for a
hearing, upon a finding by the Secretary that the PSRO "is not
substantially complying with or effectively carrying out the provisions
of such agreement." (Section 1152(d) of the Act.) (3) B. The Nationwide
Evaluation of PSROs
The Agency has stated that it implemented a nationwide evaluation of
the performance of PSROs in response to proposals by the President, in
February and March, 1981, to phase out the PSRO program within three
years, and to reduce funding for fiscal year 1981. In June, 1981
Congress approved a recission of $28,701,000 from the PSRO program.
(Pub. L. No. 97-12, Title I, Chapter VIII: 94 Stat. 3166.) The Agency
maintained that the legislative history of the recission bill indicated
that the Agency was to accomplish the recission by terminating
ineffective PSROs. (Agency Response, pp. 3-4.)
The Agency stated that, in order to identify ineffective PSROs, it
developed evaluation criteria to measure performance, and asserted:
The criteria were based on program policies and priorities in effect
for at least 2 years prior to the evaluation and in particular, the
criteria used to convert PSROs from conditional to fully designated
status, policy issuances, and previous performance assessment protocols.
(Agency Response, p. 4.) The Agency further explained that the major
change from the criteria previously used to assess PSROs was the
increased emphasis on cost effectiveness examined in Part I of the
evaluation criteria, and the PSRO's impact on the utilization and
quality of health care services examined in Part III. (Id.) The
proposed criteria were sent to all PSROs for review and comment on March
20, 1981. After considering the comments received and implementing some
of the suggestions, the Agency distributed the final version of the
criteria to all PSROs on April 15, 1981. (Id. at pp. 4-5.) The
criteria were not promulgated as a regulation nor published in the
Federal Register.
The final version of the criteria was sent to the Agency's Regional
Offices to be completed for each PSRO, along with instructions for
conducting the evaluation. The evaluations were conducted by the
Agency's project officer for each PSRO. The instructions included the
following:
Performance described in the indicators must be sustained throughout
calendar year 1980 or the most recent grant period (period should cover
12 months). If another time period is to be considered, it is specified
in the instructions for that item within the criteria set. (4) Each
scoring level, positive or negative, must be reasonably verifiable by
previous site visit, reports, grant applications, PSRO reports,
correspondence or other relevant documentation. The Project Officer
should assure the completeness of documentation on each PSRO. PSROs may
be consulted for additional information.
The Central Office (CO) scoring methodology will be sent to each RO
(Regional Office) following CO receipt of the evalutions. After CO has
completed scoring ROs will be notified of the scores of each PSRO for
verification.
(Agency Response, Ex. 2.)
The Agency stated that in order to insure uniformity and objectivity,
the "Regional Offices were instructed that no consideration was to be
given to factors not included in the criteria," and representatives from
the Central Office staff were sent to the regions to review the
evaluations and determine the validity of the supporting documentation.
(Agency Response, p. 5.)
C. The Format of the Evaluation Criteria and the Scores Needed To
Pass
The evaluation was composed of criteria which measured three areas of
performance: Part I -- organization and program management; Part II --
performance of review: compliance and process; and Part III --
performance of review: impact/potential impact. Each criterion was
assigned a point value which the Agency awarded to a PSRO if it "met"
the criterion or, with some criteria, the points were awarded based on
the PSRO's level of performance, as described in the criteria. In order
to pass the evaluation, a PSRO needed a total score of 1105 (of the 2350
valuable points) and passing scores on two of the three parts.
Part I evaluated organization and management by examining the
following areas: commitment of the PSRO Board and committees;
administration and financial management; cost efficiency and relations
with the State. A PSRO needed 190 of the 300 available points to pass
this part. Part II examined performance of PSRO review based on
compliance with established review processes including the acute care
review process, special actions taken to address identified problems
such as the modification of a review system and adverse actions, medical
care evaluation studies, the adequacy of the PSRO's data system, and the
use of profiles. A PSRO needed 400 (5) of the 850 available points to
pass this part. Part III evaluated PSROs on the basis of their impact
and potential impact on utilization objectives and the quality of health
care. A PSRO needed 515 of 1200 available points to pass this part.
(See, Agency Response, p. 7.)
II. The Evaluation of CRHCF
A. Summary of the Scores Awarded CRHCF and How the Evaluation of
CRHCF Was Conducted
The Agency initially awarded CRHCF a base score of 860 points, 245
short of the 1105 needed to pass the evaluation. CRHCF did not pass any
of the parts; CRHCF's score of 150 for Part I was 40 short of the 190
needed to pass; CRHCF's score of 390 for Part II was 10 short of the
400 needed to pass; and the score of 320 on Part III was 195 short of
the 515 needed to pass.
At the hearing, however, the Agency conceded that CRHCF should
receive 100 additional points for Part II. See, Tr., p. 8.) These
additional points gave CRHCF a base score of 960 points, 145 short of
the 1105 needed to pass the evaluation. The points also enabled CRHCF
to pass Part II with 490 points.
B. The Submission of Documentation
From the beginning of its appeal, CRHCF stressed that the Agency
failed to obtain full documentation for scoring the PSRO in the national
evaluation. In its appeal letter, one reason CRHCF gave for requesting
a hearing was:
The Regional Office did not, with one exception, attempt to verify
the (CRHCF) scoring level . . . by further written documentation
provided by the PSRO as required by relevant HSQB guidelines. . . .
(CRHCF Appeal, p. 3.)
In his opening testimony, Dr. Lewis S. Pilcher, the Assistant
Director of CRHCF, referred to the Agency instruction:
The Project Officer should assure the completeness of documentation
of each PSRO.
(Tr., p. 18; See also, CRHCF Post-hearing Brief, p. 3.) (6) He also
referred to the Agency's interpretative answers to "General Questions,"
and particularly the following:
Q. Should PSROs provide documentation in writing before the RO
(Regional Office) marks the criteria set?
A. Yes. However, the RO should still forward the criteria set to CO
(Central Office of HSQB) within the timeframe. If the RO has not
received the written documentation from the PSRO, the question should
not be completed. When the documentation has been received, the RO
should call CO with the information to complete the question. The
documentation must be received by April 27 to be included.
(See, e.g., CHRCF Appeal, App. B., General Questions.)
(7) In its Post-hearing Brief CRHCF repeated its argument that the
project officer failed to obtain the necessary documentation for the
assessment:
The Regional Office has presented no documentation to indicate that
it sought any current documents, which were readily available at CRPSRO,
to use for completion of the assessment.
(CRHCF Post-hearing Brief, p. 2.)
It does not appear from the Record that the project officer did very
much to "assure the completeness of documentation." Dr. Pilcher
testified about the lack of communication between the Regional Office
and the PSRO as to furnishing documentation. (Tr., pp. 21-22.) In
response to questioning by a Board staff attorney, Ms. Annette Kasabian,
the Chief of the Regional PSRO branch, could not specifically identify
more than one telephone call from the project officer to the PSRO
inquiring about current documentation. (Tr., pp. 247-48.)
This contention by CRHCF could have been significant if CRHCF did not
have opportunities to submit further documentation after the April 27,
1981 deadline. In this case, however, the Agency encouraged CRHCF to
provide to the Board any documentation it could. In its Response of
August 27, 1981, after referring to the PSRO's notice of the April 27
cut-off date, the Agency added the following significant sentence:
Finally, the Grantee has the opportunity during this appeal to submit
any documentation that might support its claim for additional points.
(Agency Response, p. 19.)
In its Post-hearing Brief, CRHCF admitted that it filed this appeal
of the Agency's decision and "submitted extensive documentation of
verify the inqccuracy and deficiency of the RO Assessment." (CRHCF
Post-hearing Brief, p. 1.) In addition, early in the hearing the Agency
attorney asked Dr. Pilcher of CRHCF had submitted all the documentation
which it felt supported the PSRO's position. (See, Tr., p. 27.) After
some parrying, Dr. Pilcher stated that while CRHCF had not submitted all
the relevant documentation from its files, the PSRO felt the Board had
"adequate documentation" to support CRHCF's claim. (Id. at p. 28;
see
also, Tr., p. 29.)
The Presiding Board Member then made it clear that CRHCF would not be
deprived of the the opportunity to submit more documentation if it
wished to do so, but the Board could consider only whatever material was
in the Record of the case.
Mr. Teitz: . . .Have you had a chance to put in everything that you
ought to? . . . That doesn't mean that if during the course of the
hearing you feel that you have other documentation in your files, which
you think is relevant to this appeal, that you may not come forward and
offer it.
I just want to make it clear that we have no way of getting in the
record anything in this Appeal that is in your files and isn't presented
in some manner. We are not, as has been suggested, going to take an on
site review of your files.
(tr., pp. 29-30.)
It was thus made abundantly clear to CRHCF that it could submit to
the Board up until the end of the hearing any additional documentation
it felt would support its position but that it (and not the Board) would
have to decide what to offer. /2/ Only what was offered and admitted
would be considered by the Board. The Board has itself examined all (8)
the documentation submitted by CRHCF, whether or not the Agency
commented on it. The Board resolves the issue here in the same way it
decided the issue when presented in Idaho Professional Review
Organization, Decision No. 236, December 8, 1981. The Board stated
that:
As a practical matter the Board need not reach the issue of whether
certain criteria were improperly marked "not met" because the project
officer allegedly did not obtain documentation. The Board has accepted
and considered all relevant documentation which IPRO submitted in
support of the criteria, even if the project officer did not consider
the material in making her decision.
(Idaho Professional Review Organization at p. 9.)
C. Burden of Proof
CRHCF has not explicitly raised the issue of the burden of proof,
that is, the issue of which party has the ultimate responsibility for
proving that the PSRO did or did not meet the requirements of each
criterion. But CRHCF has in effect raised a burden issue in its
continued insistence that the burden of assembling the required
documentation is on the Agency. This argument has been dealt with in
Section II.B. above, where the Board recognized that the Agency was
supposed to ask the PSRO for documentation, but that the actual
production of the necessary documentation was in fact the responsibility
of the PSRO.
The burden of proof issue was considered by the Board in Idaho
Professional Review Organization, supra, and what we said there applies
here as well. The Agency bears a burden to support its determination
that the PSRO did not meet certain criteria. The Agency must show a
reasonable basis for its determination on the contested criteria in
order for the Board to uphold that determination. This does not mean,
however, that the PSRO has no corresponding obligation. As appellant,
it is incumbent on CRHCF to demonstrate where the Agency's evaluation
lacked a reasonable basis or to show either that CRHCF met the criteria
or performed at a certain level described in the criteria. (See, Idaho
Professional Review Organization at pp. 8-9.)
In the appeal CRHCF cannot say simply that it was the Agency's duty
to produce the documentation that would show that CRHCF passed the
evaluation. CRHCF must show either that the Agency's evaluation lacked
a reasonable basis, or that CRHCF met the requirements for the various
criteria.
(9) D. Sustained Performance
CRHCF objected to the Agency's interpretation of its instruction:
Performance described in the indicators must be sustained throughout
calendar year 1980 or the most recent grant period (period should cover
12 months) . . .
See, e.g., CRHCF Appeal, App. B, General Questions.)
CRHCF contended that 17 of 25 criteria which were marked "not met"
or
given a zero by the Regional Office "were included in this 'not
sustained through 1980' group." (CRHCF Appeal, p. 3; See also,
Enclosure #(7) The objection of CRHCF is based on the following language
in the General Questions (and answers) issued by the Agency:
Q. What time period does this cover -- presently or calendar year
1980? If the PSRO is doing it now, is it met?
A. The PSRO should have been focusing and modifying its review
system during calendar year 1980. If problems were addressed and
resolved, this criteria (sic) can be considered met. If the PSRO has
just begun focusing and modifying its review system within the last
quarter, this criteria (sic) would not be met.
(See, e.g., CRHCF Appeal, App. B, General Questions.)
CRHCF went on to say:
We would assume that HSQB intended this principle to apply to other
elements in the PSRO review system, and not just to the specific element
about which the question was asked.
(CRHCF Appeal, Enclosure #7.)
The Agency's explanation was given under the heading Page 13, II.B.
1., which is the location and numerical identification for the criterion
"Modification of Review System." The language of the answer is clearly
limited to this one specific criterion, which has to do with "focusing
and modifying its review system." CRHCF, however, "felt that . . .
it
should have been used by the Regional Office to mark many review
criteria as 'met'." (CRHCF Appeal, Enclosure 7.) The use of the plural
"criteria" in the instructions is confusing, but an examination of
the
language of the answer shows clearly that it applied only to this one
criterion, pertaining to modification of a review system. CRHCF has in
its Enclosure #7 inadvertently taken advantage of the use of the plural
noun (10) by quoting part of the answer as saying: "If problems were
addressed and resolved, the criteria can be considered met." (Id.)
(emphasis added.) Even though the phrasing is ungrammatical, the Agency
clearly inttended the statement to apply to only this one particular
criterion.
III. The Board's Assessment of Specific Criteria in Dispute
This portion of the decision sets out each criterion in dispute (in
the same order as it appears in the evaluation criteria), the arguments
of the parties regarding whether CRHCF should receive points for the
criterion, and the Board's findings.
Part I of the Evaluation Criteria: Organization and Program
Management
CRHCF received 150 of 300 possible points on this part; 190 points
were needed to pass. The Board concludes that CRHCF should receive an
additional 15 points for this part, but this is still insufficient to
meet the passing score of 190 points. CRHCF disputed the Agency's
scoring of the following criteria in this part:
Criteria Section A. Board and committee commitment Criterion I.A.4.
Board or Executive Committee participates in establishing objectives and
monitors PSRO progress toward achieving them.
The Agency did not award CRHCF the 15 points available for this
criterion because the Agency determined that CRHCF's Board of Directors
"did not participate . . . in establishing objectives for fiscal year
1981" and the CRHCF's Board "could not have monitored the PSRO's
progress in achieving compliance with the fiscal year 1981 objectives
during a meeting in fiscal year 1980." (Agency Response, pp. 8-9.)
Ms. Annette Kasabian, the Chief of the PSRO Regional Branch of the
Health Standards and Quality Bureau, testified that "we did not find
indication going through the Board minutes, of the PSRO or the Executive
Committee, that they had been involved in the development or monitoring
of impact objectives." (Tr., p. 149.) The Agency asserted that CRHCF's
documentation for this criterion was a copy of the minutes of a May 15,
1980 CRHCF Board of Director's meeting. The Agency contended that these
minutes reflect that on May 15, 1980 CRHCF's proposed impact objectives
for fiscal year 1981 were "brought to the attention of the Board."
(Id.
at p. 8.) The Agency contended that CRHCF submitted its grant
application containing the impact objectives for fiscal year 1981 to the
Regional Office on March 1, 1980, "more than two months (11)before
CRHCFhs Board's May 15 meeting." (Id.; see also, Agency Ex. 1.) The
Agency aruged, therefore, that CRHCF's Board could not have participated
in establishing objectives for 1981.
CRHCF contended that it initially submitted a copy of the minutes of
the May 15, 1980 Board meeting to indicate the Board's participation in
monitoring impact objectives.(Tr., p. 33.) CRHCF subsequently claimed
that the interpretation of the term "objectives" in this criterion
should not be limited to impact objectives. (CRHCF Post-hearing Brief,
p. 5; See also, Tr., p. 33.) CRHCF argued that the term "objectives"
included "broad general objectives, as well as the limited individual
'impact objectives' listed in any given grant proposal." (id.) Dr.
Richard C. Kerr, Executive Director of CRHCF, testified:
In addition to impact objectives, there are much more numerous and
more important objectives that our Board considers -- including the
whole gamut of PSRO activities.
(Tr., p. 33.) CRHCF submitted copies of minutes of five CRHCF Board
meetings held throughout 1980 as evidence of its Board's involvement.
(see, CRHCF Reply Brief.) The minutes showed discussion of "general
objectives," but not specifically of the impact objectives. Dr. Kerr
testified that these minutes "demonstrate that the Board takes an active
part in consideration of all the significant objectives and policies of
the PSRO." (Tr., p. 33.)
The Agency argued that the criterion is clearly referring to impact
objectives. (Agency Post-hearing Brief, p. 2.) The Agency asserted that
the general statutory objectives were established by Congress. Ms.
Kasabian testified that the Agency would not have imposed on the PSROs
in the national evaluation "a criteria (sic) that they establish
objectives that Congress has already established." (Tr., p. 150.)
CRHCF also contended that the Agency drew an incorrect distinction
between actions taken by its Board of Directors or executive Committee
and actions of delegated Board committees. (CRHCF Post-hearing Brief,
p. 5.) CRHCF argued that the actions of these delegated committees were
subject to the approval of the Board of Directors and that this was the
"generally accepted manner in which a Board of Directors is supposed to
function." (Id.)
Finding: CRHCF should not receive the points for the criterion.
The Board finds that the documentation submitted by CRHCF fails to
show that CRHCF's Board of Directors or Executive Committee participated
in establishing objectives and subsequently monitored the PSRO's
progress (12)toward meeting those objectives. The minutes of the May
15, 1980 CRHCF Board meeting make no reference to participation by the
Board in establishing impact objectives. In fact, on cross-examination,
Dr. Kerr conceded that CRHCF's Board did not participate in establishing
impact objectives at this May 15 meeting. (See, Tr., p. 45.) Dr. Kerr
also conceded that the only monitoring of impact objectives by the PSRO
is performed by the staff rather than members of the Board. (id. at pp.
48-49.)
We also find that the additional documentation submitted by CRHCF
fails to show that CRHCF's Board of Directors was involved in
establishing objectives. There is no indication in the minutes of the
five meetings that CRHCF's Board actually participated in establishing
objectives. Therefore, we find that CRHCF failed to meet this
criterion.
The Board is not persuaded by CRHCF's argument that actions of
delegated committees in establishing objectives were sufficient to meet
this criterion. The criterion requires that the PSRO's Board of
Directors or Executive Committee participate in the objective setting
process. CRHCF did now show that the Agency acted unreasonably in
requiring the participation of either of these two groups in this
process. Therefore, we find that CRHCF must, but did not, show that its
Board of Directors or Executive Committee actually participated in the
objective setting process in order to meet this criterion.
It is unnecessary for the Board to decide the question of whether
this criterion pertains solely to impact objectives because CRHCF has
presented no evidence that its Board of Directors or Executive Committee
participated in establishing objectives of any kind.
Criterion I.A.7. Board or Executive Committee evaluates performance
of Executive and Medical Directors at last once per year.
The Agency did not award CRHCF the 5 points available for this
criterion because the Agency determined:
The documents submitted by (CRHCF) in support of its claim . . . do
not contain any indication that the Board or Executive Committee
evaluated the performance of . . . the PSRO's Executive and Medical
Director during calendar year 1980.
(Agency response, p. 9.)
CRHCF contended that the criterion does not require a formal
evaluation. CRHCF argued that the performance of its Executive and
Medical Directors was evaluated constantly at each Board and Executive
Committee meeting in 1980. (CRHCF Appeal, App. A, #2.)
(13) CRHCF submitted the minutes of three Executive Committee
meetings as evidence that CRHCF evaluated the performance of the
Executive and Medical Directors in 1980. (Id.) Dr. Kerr testified that
these minutes "indicate that the staff was being evaluated because of
compliants from the West Suburban Hospital Association about the
Executive Director and two part-time Medical Directors in their
relationship with some of the members of the Charles River PSRO." (Tr.,
pp. 34-35.)
The Agency contended that the documentation submitted by CRHCF
involved the resolution of a complaint by a provider and that such a
general discussion "does not qualify as an evaluation of Dr. Kerr's
performance as (CRHCF's) Executive and Medical Director." (Agency
Post-hearing Brief, p. 3; See also, Tr., p. 154.)
Finding: CRHCF should not receive the points for this criterion.
The Board finds that the evidence submitted by CRHCF does not
indicate that the Executive and Medical Director's performances were
evaluated by CRHCF's Board or Executive Committee. CRHCF's evidence
included a general discussion of certain relationships between CRHCF's
"staff" and a particular physician group. The evidence showed that
the
discussion was limited to compliants filed by the physician group. We
agree with the Agency that "evaluation" implies a more general review
of
overall performance. There is no mention of individual evaluations,
particularly of the Executive and Medical Directors. Since CRHCF has
presented no evidence that its Executive and Medical Directors were
evaluated, we find that CRHCF did not meet this criterion.
Criteria Section B. Administrative and Financial Management
Criterion I.B.1. Financial and personnel management systems are clearly
documented.
The Agency did not award CRHCF the 5 points available for this
criterion because the Agency determined that CRHCF's personnel
management system was not clearly documented and its financial
management system was not sustained throughout 1980. (Agency Reponse,
pp. 9-10.)
1) Financial management system
The Agency contended that the Regional Office's April, 1980
evaluation revealed that CRHCF resolved some problems concerning its
financial management system, but that the changes resulted from the
Regional Office's insistence between February and April of 1980. (Id.
at p. 9.) The Agency argued, therefore, that CRHCF did not sustain its
financial management system throughout 1980.
(14) In addition, Ms. Kasabian testified that CRHCF did not have a
system for allocating costs between federally funded and private review
activities. (Tr., p. 156; See also, Agency Post-hearing Brief, p. 3.)
Ms. Kasabian stated that as a result there was "no assurance that the
Federal Government was in fact paying a proper amount of money on a
percentage basis for the activities of the organization." (id.)
Ms. Kasabian also testified that CRHCF did not maintain employee time
records, nor, if there were any, were they signed by the supervisors.
(id.) Ms. Kasabian stated that there is an outstanding audit finding on
this question. (Id.)
CRHCF contended that it scored 100% on the items relating to
financial management on the Regional Office's April, 1980 assessment.
(CRHCF Appeal, App. A, #3.) CRHCF submitted a copy of page 3 of the
Regional Office's April, 1980 assessment and alleged that this page
showed that CRHCF met 100% of the financial management items. (Id.)
2) Personnel Management System
The Agency contended that CRHCF's personnel management system was not
clearly documented. Ms. Kasabian testified that CRHCF did not have
written policies for "travel; incentives for good performance; annual
performance appraisals; a salary schedule; personnel policy manual;
personnel files; or position descriptions that people were assured met
the job function." (Tr., p. 156.)
CRHCF argued that its personnel policies are documented in the
"Charles River policy manuals and reports." (Tr., p. 36.) Dr. Kerr
testified that these manuals have been revised and updated and have been
"considered to be a part of each employee's contract." (Id.)
Dr. Kerr conceded that "(a) few items in the personnel section had
not been implemented." (Id.) Dr. Kerr stated for example, that CRHCF's
contract "did not authorize us to offer educational benefits, or
incentives for good performance." (Id.) With regard to recruitment
procedures, Dr. Kerr stated they seemed unnecessary for a PSRO of
CRHCF's size which never exceeded 13 employees. Dr. Kerr stated:
Merit promotion policy, salary schedules, and travel policy were all
outlined in detail in our original 1975 contract, approved by HEW in
May, 1975. Grievance procedures and annual performance appraisal
procedures were in a separate document offered to the
(15) Regional Office at the time of our February, 1980 assessment.
Employment policy was reviewed and approved, starting in 1975, by the
project officer and HCFA contracting officer.
(Id. at pp. 36-37.)
CRHCF also argued that it received full credit on the April, 1980
assessment for its personnel practices, specifically for the following
items: "personnel policy manual," "complete personnel files
maintained," and "position descriptions consistent with function."
(CRHCF Post-hearing Brief, p. 6.)
Finding: CRHCF should not receive the points for this criterion.
CRHCF has presented no documentation of its personnel and financial
management systems for 1980. With regard to its financial management
systems, CRHCF submitted a copy of the Agency's February, 1980 report.
Since Dr. Pilcher testified that this report involved 1979 data, it
cannot be used to document CRHCF Appeal, p. 3.) The Agency condeded
that, at its request, CRHCF had resolved some of its problems by April,
1980. Even if this is interpreted as an admission of satisfactory
performance after April, 1980, there is no evidence in the Record of
satisfactory performance prior to April. Therefore, there is not
indication that performance was sustained throughout that year.
With regard to the personnel management systems, Dr. Kerr made
mention of a policy manual that CRHCF maintains. However, no such
manual was entered in the Record and, therefore, can not be considered.
No other evidence was offered to rebut the numerous deficiencies cited
by Ms. Kasabian. We therefore find that CRHCF did not present
sufficient evidence to support its argument that it met this criterion.
Criterion I.B.4. Submitted reports, proposals, plans, etc. are
well-developed and accurate. Less than 10% require Regional Office to
request revision or greater depth.
The Agency did not award CRHCF the 15 points available for this
criterion because the Agency determined that 18% of the reports
submitted by CRHCF during calendar year 1980 needed revision. (Agency
Response, p. 10.) Ms. Kasabian testified that of the 33 submissions by
CRHCF in 1980, six needed revision. (Tr., p. 157.) She stated that this
included four HCFA 121 reports, CRHCFs 1980 grant application, and an
audit report. (Id.) The Agency submitted as evidence of the percentage
of reports which required revision a copy of the Regional Office's
evaluation of CRHCF's performancce under this criterion. (See, Agency
Response, Ex. 2A.)
(16) CRHCF argued that the four HCFA 121 reports considered by the
Agency for this criterion were estimates requested by the Regional
Office. When the actual data was submitted by the hospitals, CRHCF
supplied them to the Regional Office. (Tr., p. 38) CRHCF argued that it
was unfair to include these estimated reports in a group classified
"required revision." (Id.)
The Agency argued that in determining whether CRHCF's reports were
"well-developed and accurate," the Agency "justifiably considered
the
PSRO's inability to file complete HCFA 121s on a timely basis." (Agency
Post-hearing Brief, p. 4.) Ms. Kasabian explained that the HCFA 121
reports "are quarterly reports submitted by the PSRO showing how many
admissions they've reviewed." (Tr., p. 159.) She stated that there was
an ongoing problem of getting HCFA 121 reports on a timely basis from
CRHCF. Ms. Kasabian stated that CRHCF's responsibilities for obtaining
the requisite information from the hospitals were outlined in an April
16, 1980 letter to Dr. Ahearn. In the interim, CRHCF was requested to
submit quarterly estimated HCFA 121s until the actual information was
provided by the hospitals so the final HCFA 121s could be submitted.
Finding: CRHCF should receive the 15 points for this criterion.
The Board finds that it was unreasonable for the Agency to consider
the four estimated HCFA 121s in computing the percentage of the reports
requiring revision by CRHCF. The Agency conceded that it required CRHCF
to submit the estimated HCFA 121s and required CRHCF to later revise the
HCFA 121s when complete data were provided by the hospitals. We are
also not persuaded by the Agency's argument that the estimated HCFA 121s
should be counted because CRHCF was delinquent in submitting the final
HCFA 121s. The criterion speaks of submitted reports. While it may be
reasonable to evaluate a PSRO on its ability to gather data in a timely
manner, that is not the subject of this criterion and, therefore, it is
unreasonable in this context to penalize the PSRO for complying with the
Agency's demand.
Therefore, by the Agency's calculations we are left with two reports
which required revisions out of a total of 33. This is less than 10%
and, therefore, CRHCF "met" the criterion.
Criterion I.B.5. PSRO staff performance is reviewed by Board,
Executive Director or a direct supervisor at least once per year.
The Agency did not award CRHCF the 5 points available for this
criterion because the Agency determined:
(17) The documents submitted by the PSRO in support of its claim for
points under this criterion are very general in scope and do not contain
any indication that PSRO staff performance was reviewed.
(Agency Response, p. 10.)
CRHCF contended that the criterion did not require a "formal staff
review session at least once a year." (CRHCF Appeal, App. A, #5.) Dr.
Kerr testified that CRHCF's staff met once per week since 1975, and that
at the meetings "(the) activities of the PSRO were discussed and
criticized," therefore, providing for a "weekly review of the
performance of staff members." (Tr., p. 39.) Dr. Kerr stated that the
President and a Board member attended these weekly meetings. CRHCF
submitted minutes of the weekly meetings to document its claim. ($USee,
CRHCF Appeal, App. A., #5.)
Ms. Kasabian testified that she did not think that a staff meeting is
a "sufficient point or place for appraisal." (Tr., p. 155.) She stated:
(In) terms of an employee appraisal and discussion with that employee
of work strength and weaknesses, one would not generally expect that to
be done in the form of a group setting, and not done formally. And
perhaps even committed to writing for the employee's benefit.
(Id.)
Finding: CRHCF should not receive the points for this criterion.
The documentation submitted by CRHCF indicates that weekly staff
meetings were indeed held. (See, e.g., CRHCF Appeal, App. A, #5.)
However, there is no indication in the minutes of these meetings that
the performance of individual members was evaluated. Instead, it
appears that general business was discussed at these meetings. Dr.
Kerr testified that the job performance of individual employees was not
evaluated by name but that "we do have a report on what they have been
doing and so on." (Tr., p. 62.) These reports were not submitted into
evidence by CRHCF. Even so, Dr. Kerr conceded that no evaluation was
made of whether an employee's performance was satisfactory based on
these reports. (Id.) Without some evidence of an evaluation of staff
performance, the Board finds that CRHCF did not meet this criterion.
Part II of the Evaluation Criteria: Performance of Review Operations
- Compliance and Process
CRHCF received 390 of 850 available points for this part; 400 points
are needed to pass. The Board concludes that CRHCF should receive, in
addition to the 100 points conceded by the Agency, an additional 45
points in this part. CRHCF disputed the Agency's scoring of the
following criteria:
(18) Criteria Section A. Acute Care Review. Indicators of acute
care review process are:
Criterion II.A.3. PSRO has recommended rebuttal or revocation of
waiver of liability for a class of cases or an institution as a whole
within the past 24 months.
Although this criterion was marked "not met" on the evaluation,
the
Agency subsequently conceded that CRHCF had met this criterion and would
be awarded 30 points. (See, Tr., p. 8.)
Criterion II.A.4. PSRO has "carved out" medically unnecessary days
during a certified stay in the past 24 months. ("Carved out" means
denied days within the total stay.)
The Agency did not award CRHCF the 20 points available for this
criterion because the Agency determined that the "charts filled out by
the PSRO do not contain any indication of carved out days." (Agency
Response, p. 10.) Ms. Kasabian defined carved out days as:
(Days) that are a portion of a total stay. . . . In a carved out
situation, the PSRO identifies that there are in fact some portion of an
otherwise medically necessary hospital stay, that is not medically
necessary.
(Tr., p. 164.)
CRHCF submitted three charts which CRHCF alleged indicates the total
number of "carved out" days for (a) Medicare patients in 1980, (b)
Medicaid patients in 1980, and (c) for both categories of patients for
1976 through 1980. (CRHCF Appeal, App. A, #7.) Dr. Kerr testified that
the charts included in specific columns "denied days." (Tr., p. 40.)
Dr.
Kerr stated that "(the) denied days are defined by the criterion given
above as 'carved out' days." (Id.)
The Agency maintained that CRHCF's charts do not indicate whether
CRHCF denied days within the total stay. (Agency Post-hearing Brief, p.
5.) Ms. Kasabian testified that CRHCF's chart identified a number of
medically unnecessary days, but without knowing when the days took place
it cannot be determined whether they were "carved out." (Tr., p. 165.)
She stated that this was because:
(Unnecessary) days can be totally non-medically necessary
confinement, or in the middle of the stay. And if they are in the
middle of a stay or part of an otherwise medically necessary stay, they
would be called carved out days.
($UId.)
(19) CRHCF contended that, as indicated on these charts, it "carved
out denied days of hospital stay from other medically unnecessary days."
(CRHCF Post-hearing Brief, p. 6.)
Finding: CRHCF should receive the 20 points for this criterion.
The Agency has not presented a reasonable basis to support its
determination that CRHCF has "not met" this criterion. The
documentation submitted by CRHCF indicates the number of denied days
which were included within the total number of medically unnecessary
days in 1980. The criterion defines "carved out" days as denied days
within the total stay. When questioned on cross-examination whether
this meant denied days carved out of the middle or ends of a hospital
stay or simply any denied days Ms. Kasabian responded, "any denied
days." (Tr., p. 228.) Since CRHCF has identified carved out days during
1980, defined in the criterion and by CRHCF as denied days, we find that
CRHCF "met" this criterion.
In finding for CRHCF on this criterion, we find unpersuasive the
Agency's argument that without knowing when these days were denied, it
cannot be determined whether the days were "carved out" or not. As
stated above, Ms. Kasabian testified that "denied days" in the context
of this criterion meant "any denied days." (Tr., p. 228.) In addition,
it was apparent from Ms. Kasabian's testimony that she was confused
about the content of CRHCF's chart and the exact meaning of some of the
statistics presented on the chart. (See, generally, Tr., pp. 231-234.)
Ms. Kasabian stated that she was not sure whether there is a difference
between unnecessary and denied days in this criterion, although it is
apparent that CRHCF distinguished between the two terms on its chart.
(Tr., pp. 233-234.) She testified further that she did not review these
charts in marking this criterion and stated, "I'm not in a position
right now to know what this (chart) is." (Id. at p. 234.) Despite this
confusion at the hearing, the Agency did not provide any explanation in
its post-hearing brief. The Board finds that Agency's lack of
understanding of the content of CRHCF's chart made it impossible for the
Agency to determine that CRHCF had not "carved out" days in 1980.
Criteria Section B. Special Actions to Address Identified Problems.
Subsection 1. Modification of Review System.
Criterion II.B.1(e). PSO is addressing identified problems through
education.
The Agency did not award CRHCF the 10 points available for this
criterion because the Agency determined that CRHCF's documentation does
not:
(Reflect) any educational effort to correct problems -- i.e., they do
not discuss what the problems are and how they can be corrected.
(Agency Response, p. 11.)
(20) Ms. Kasabian testified that the Agency expected that in order to
comply with this criterion the PSRO would:
(Discuss) with the people involved what the problem is, get their
input on possible means of resolution, and have it be an education
encounter that would impact on behaviour.
(Tr., p. 166.)
CRHCF submitted as evidence for this criterion 10 letters, dated
between April and December 1980. (CRHCF Appeal, App. A, #8.) Dr. Kerr
testified that these letters contain:
(Suggestions) about improving review, information about comparative
hospital and physician performance, notices of information pertaining to
review procedures, etc.
(Tr., p. 41.)
Dr. Kerr stated that "(these) are obviously of a continuing
educational nature, designed to improve and refine PSRO review." (Id.)
Finding: CRHCF should not receive the points for this criterion.
The Board finds that the Record does not indicate that CRHCF
addressed identified problems through education. The letters submitted
by CRHCF in support of its claim to have met this criterion do not show
that CRHCF conducted, or participated in, any educational activities or
programs. In fact, in discussing the contents of these letters CRHCF
contended that the letters "identified problems, and CRHCF has presented
no evidence of addressing problems through education, we find that CRHCF
did not meet this criterion.
Criterion II.B.1(f). PSRO is addressing identified problems by
performing preadmission review.
The Agency did not award CRHCF the 10 points available for this
criterion because the Agency determined that the documents submitted by
CRHCF "do not describe or constitute a pre-admission review system."
(Agency Response, p. 11.) Ms. Kasabian testified that a preadmission
review system involves:
(21) (Limiting) the circumstances under which a given practitioner
can admit a patient until there has been a review of the appropriateness
of the admission. . . . (The) PSRO would do a review of the
appropriateness of admission prior to the time the patient showed up at
the hospital to be admitted.
(Tr., pp. 166-167.)
CRHCF conceded that it did not perform preadmission review as a
matter of course. However, CRHCF asserted that when a physician problem
was identified it used preadmission review. (See, CRHCF Appeal, App. A,
#9.) In support of its claim, CRHCF submitted a letter informing a
hospital that it was placing a physician on preadmission review, with a
description of how the procedure would be implemented. (Id.)
Ms. Kasabian stated that CRHCF's documentation showed some concern
over the appropriateness of admission but "the review itself did not
take place prior to the admission." (Tr., p. 167.) (emphasis added.)
CRHCF contended that some of its documentation was overlooked. Dr.
Kerr testified that CRHCF's Intensive Review Program states:
PSRO physician advisor will certify Medicare or Medicaid coverage or
non-coverage for payment . . . prior to the patient being admitted to
the hospital.
(CRHCF Appeal, App. A, #9.) Dr. Kerr stated that "this procedure was
instituted for a practitioner, and carried on for several months." (Tr.,
p. 41.)
The Agency maintained that CRHCF's Intensive Review Program does not
qualify as a preadmission review system because:
(The) procedure fails to provide that the affected physician cannot
admit a patient to a hospital until the medical necessity of the
admission has been determined.
(Agency Post-hearing Brief, p. 6.)
Finding: CRHCF should receive the 10 points for this criterion.
The documents and testimony presented by CRHCF show that this type of
intensive review was implemented for a practitioner. The Agency did not
dispute this, but argued that the preadmission review, according to
CRHCF's program, took place after admission of the patient. (See,
Agency Post-hearing Brief, pp. 5-6; see also, Tr., pp. 166-167.)
(22) CRHCF's description of its Intensive Review Program states:
If the physician, hospital, or patient request, the PSRO Physician
advisor will certify Medicare or Medicaid coverage or non-coverage for
payment for hospital admission prior to the patient being admitted to
the hospital. . .
(CRHCF Appeal, App. A, #9.)
We find that CRHCF's program provided for Physician Advisor
preadmission review if such review was requested. In the example CRHCF
submitted, CRHCF specifically requested the hospital to place the
physician on review under this program. Accordingly, that physician was
subject to the Physician Advisor's certification of a patient's
admission prior to the patient being admitted. We find therefore that
this program satisfies the requirements of this criterion.
Subsection 2. Adverse Actions
Criterion II.B.2(b). Warning (letters) to (institutions) and/or
practitioner(s) issued on actions which could lead to potential
sanctions.
Although this criterion was marked as "not met" on the evaluation,
the Agency subsequently conceded that CRHCF had met this criterion and
would be awarded the 60 points. (See, Tr., p. 8.)
Criterion II.B.2.(f). PSRO has removed delegation from at least one
hospital under review or hospitals are non-delegated for concurrent
review.
The Agency did not award CRHCF the 30 points available for this
criterion because the Agency determined:
(The) documents filed by (CRHCF) under this criterion refer to events
which occurred prior to calendar year 1980 and, thus, are outside the
scope of this evaluation.
(Agency Response, p. 11.)
The PSRO statute and regulations provide that a PSRO may delegate, to
hospitals determined capable, any and all review functions required by
the program; that the PSRO is to monitor the hospitals to assure they
were properly performing the delegated functions; and that the PSRO is
to withdraw delegation in whole or in part if the hospitals do not
perform their obligations. (See, Section 1155 of the Act; see also, 42
CFR 466.30.)
(23) CRHCF contended that it documented the withdrawal of hospital
delegation of the responsibility for delivery Notices of Non-Coverage in
CRHCF's hospitals. (CRHCF Appeal, App. A, #11.) Dr. Kerr testified that
the withdrawal of delegation took place in the last three months of 1979
and "has continued since then, including all of 1980." (Tr., p. 42.)
CRHCF argued that the withdrawal was, therefore, within the assessment
period.
The Agency asserted that "a PSRO can delegate any or all of the
following review functions to a hospital: preadmission review,
concurrent review, alternative review, MCEs, or modified review."
(Agency Response, p. 11.) The Agency argued that the delivery of a
denial notice is not a "delegated function under the statute and
regulations." (Id.)
CRHCF contended that delivery of the denial notice is a "delegated
function." Dr. Kerr testified that partial delegation of review
authority is in accord with the PSRO's statutory authority to delegate
responsibility for alternative review activities or to perform modified
review. (Tr., p. 42.)
Finding: CRHCF should not receive the points for this criterion.
The examples of actions CRHCF submitted to satisfy this criterion
occurred prior to calendar year 1980 and, therefore, are outside the
period of this evaluation. CRHCF removed delegation from the hospital
on October 16, 1979. (See, CRHCF Appeal, App. A, #11; See also, Tr.,
p. 42.) This is outside the period of the evaluation and, therefore, we
find that CRHCF did not meet the criterion.
Though CRHCF argued that its withdrawal of delegation continued
throughout 1980, Dr. Kerr conceded that once the delegation was
withdrawn it continued to be withdrawn until it is reinstated. (Tr.,
pp. 64-65.) Therefore there could only be one point in time when the
actual withdrawal took place; here it occurred in 1979, which is
outside the evaluation period.
Criteria Section C. Medical Care Evaluation (MCE) Studies/Quality
Review Studies (QRS)
Criterion II.C.1. QA plan includes a detailed procedure to assure
that topics are based on known or suspected problems important to
patient care outcomes, and contains a method to prioritize problem areas
in selecting study topics for a given year.
(24) The Agency did not award CRHCF the 20 points available for this
criterion because the Agency determined that CRHCF's "performance under
this criterion was clearly not sustained throughout calendar year 1980."
(Agency Response, p. 12.) Ms. Kasabian testified that CRHCF adopted its
procedure for assuring that studies were based on known and suspected
problems in August of 1980. (Tr., p. 171.) She stated that this was not
"sustained" performance throughout 1980.(Id.)
CRHCF submitted as evidence a copy of the relevant portion of its
Quality Assurance Plan. (CRHCF Appeal, App. A, #12.) Dr. Pilcher
testified that the "background of this criterion" was the development
of
a "problem oriented quality assurance plan in accordance with the
provisions of PSRO Transmittal 100 and Regional PSRO Bulletin No. 55."
(Tr., p. 79.) Dr. Pilcher stated that Transmittal 100 was not effective
until Novermber 20, 1980 and Bulletin 55 until December 29, 1980. CRHCF
argued that it complied with these directives and, therefore, should
receive the points under this criterion.
Ms. Kasabian testified that CRHCF had been cited in February, 1980
for having no means of being involved in the hospitals' study topic
selection. She stated that subsequently in August, 1980, CRHCF
developed a plan to conform with the draft instructions issued in
February. Ms. Kasabian maintained, however, that the regulations
"always required that studies be based upon known or suspected
problems." (Tr., p. 171.) The Agency argued, therefore, that CRHCF's
performance in August, 1980 was not "sustained" performance for purposes
of this evaluation. (Id.)
Finding: CRHCF should not receive the points for this criterion.
The Board finds that CRHCF's implementation of a Quality Review Plan
in August, 1980 did not constitute "sustained" performance as required
in the Instructions and, therefore, CRHCF did not met this criterion.
In finding against CRHCF, the Board was unpersuaded by Dr. Pilcher's
testimony that this criterion was a result of Transmittal 100 which did
not become effective until November 20, 1980. PSRO Transmittal 43,
dated January 25, 1977, included as a basic characteristic of an
effective MCE study:
(It) focuses upon known or suspected problem area impacting on the
quality of health care.
(Transmittal 43, p. 3.)
Criterion II.C.2. Studies demonstrate the use of written criteria,
thorough data analysis, peer review, and documentation.
(25) The Agency did not award CRHCF the 15 points available for this
criterion because the Agency determined:
The documents submitted by (CRHCF) fail to show that the PSRO had any
involvement in the studies conducted by delegated hospitals. . . .
Also, if the PSRO did not have a quality review plan until August, 1980,
it could not have been performing these functions prior to that time.
(Agency Response, p. 12.)
CRHCF contended that its MCE and QRS studies had written criteria
decided on by CRHCF's Quality Assurance Committee. (See, CRHCF Appeal,
App. A, #13.) CRHCF submitted examples of criteria used in one hospital
in three different studies. (Id.) CRHCF submitted additional
documentation which CRHCF claimed showed its committee's involvement in
topic selection and the use of written criteria. (See, CRHCF Supp.,
Criterion II.C.2.)
Ms. Kasabian testified that CRHCF was not involved in the hospitals'
study selection process and "was not assuring the appropriateness of the
criteria as well." (Tr., p. 172.) She stated that the quality assurance
plan that CRHCF finally developed and implemented in August, 1980 made
provisions for these items. (Id.)
Ms. Kasabian also testified that CRHCF's delegation agreement with
the hospitals did not contain a list of obligations placed on the
hospitals, specifically the obligation that MCE studies be based upon
known or suspected problems. (Tr., p. 173.) Ms. Kasabian stated that
the Agency placed a condition on CRHCF's 1980 grant requiring it to
revise its agreements with the hospitals.
Finding: CRHCF should receive the 15 points for this criterion.
The Agency has not stated a reasonable basis to support its
determination that CRHCF has "not met" this criterion. The Board finds
that the Agency's emphasis on CRHCF's lack of involvement in the studies
conducted by delegated hospitals is inappropriate. The criterion on its
face makes no mention of such a requirement. In addition, another
criterion - II.C.6. - dealt specifically with the monitoring of
delegated hospitals' MCE/QRS studies. /4/
(26) The Board cannot sustain the Agency's scoring of this criterion
based on the information in the Record. The criterion speaks of studies
and their contents. The Agency presented no evidence indicating what
deficiencies the Agency found in CRHCF's studies. Therefore, we find
that CRHCF "met" this criterion.
Criteria Section E. Profiles
Criterion II.E.2. PSRO routine reports provide for a systematic
comparison of institutions, practitioners, and diagnostic groups in
order to identify potential problems. The reports are case-mix adjusted
and prioritize possible utilization problems based on the potential for
reducing inappropriate use.
The Agency did not award CRHCF the 30 points available for this
criterion because the Agency determined that CRHCF's reports "are not
case-mix adjusted." (Agency Response, p. 12.) Ms. Kasabian defined
case-mix adjustment as a:
(Means) of adjusting incomparable things so that they can be compared
with each other as if they were comparable. That means adjusting for
age, secondary diagnoses. Those are two of the main ones.
(Tr., p. 173.)
CRHCF contended that its ranking reports from its data processor
compare length of stay be institution for diagnoses and procedures.
(See, CRHCF Appeal, App, A, #14.) CRHCF claimed that particular
utilization problems can be identified from these reports by "comparing
figures with comparable figures in other hospitals." (Id.)
CRHCF agreed that Ms. Kasabian's definition of case-mix adjusting is
correct, but argued that CRHCF's documentation shows that its reports
were case-mix adjusted. (See, CRHCF Post-hearing Brief, p. 8.) CRHCF
contended that its data reports were "manually adjusted for age
(Medicare, Medicaid age groups), deaths, stays of longer than 90th
percentile, and presence or absence of surgery." (id.) CRHCF argued that
this constituted case-mix adjusting.
Ms. Kasabian testified that CRHCF's documentation did not indicate
that its data is case-mix adjusted. She stated:
There is no indication of secondary diagnosis being reflected on the
data; there is no indication that age is a mixed issue.
(27) The only time age is mentioned is what the average age is of all
the people in a given cell for a given diagnosis.
(Tr., p. 175.)
Finding: CRHCF should not receive the points for this criterion.
CRHCF has presented no evidence which shows that its reports are
case-mix adjusted. CRHCF did not contest that case-mix requires the
adjusting of unlike data so that it can be used for comparison purposes.
CRHCF's documentation shows only the compilation of data, such as the
average age and average length of stay for a particular operation in a
particular hospital. There is no indication that the age of a patient
being operated on was adjusted so the results of that operation could be
compared to another patient's operation. Likewise, there is no
indication that secondary diagnoses were adjusted for comparison
purposes. Since, as CRHCF agreed, there are two of the main data items
used in case-mix adjusting and CRHCF has produced no documentation
showing that it adjusted for these two data items or any others, we find
that CRHCF did not meet this criterion.
Criterion II.E.4. PSRO collects at least twice a year, either
routinely or in special studies, additional data elements on its
hospital abstract to facilitate problem identification, objective
setting, and/or impact assessment.
Although this criterion was marked as "not met" on the evaluation,
the Agency subsequently conceded that CRHCF had met this criterion and
would be awarded 10 points. (See, Tr., p. 8.)
Criterion II.E.3. PSRO profiles at least once each quarter to verify
potential utilization problems and specify possible problems.
Criterion II.E.5. PSRO uses profiles to routinely monitor its
progress toward meeting its objectives and to document impact.
Criterion II.E.8. PSRO routinely generates physician profiles to
identify problem physicians for focusing in or other appropriate
interventions; the PSRO provides profiles to such physicians.
Criterion II.E.10. PSRO regularly uses profiles to identify quality
problems and/or to facilitate the implementation and analysis of quality
review studies.
(28) The Agency did not award CRHCF any of the 95 points available
for these criteria because the Agency determined that CRHCF "did not
sustain (the) activity throughout calendar year 1980." (Agency Response,
pp. 13-14.) Ms. Kasabian testified that CRHCF "was not on a regular
basis developing profiles." (Tr., p. 177.)
Ms. Kasabian testified that the Regional Office determined from its
on-site assessment of CRHCF in February, 1980 that "what the PSRO was
doing did not constitute profile analysis." (Tr., p. 177.) Ms. Kasabian
acknowledged that CRHCF was "manually manipulating the PSRO's data."
(Id.) She stated that the evidence submitted by CRHCF was graphs
prepared "based on the PSRO's results of on-site monitoring, and not
based upon information from the data system." (Id.) Ms. Kasabian stated
that a condition was placed on CRHCF's July 1, 1980 grant requiring
CRHCF to "utilize its data - the data from the computer system - to
develop profiles and analyze those and distribute those to hospitals."
Id. at p. 178.)
CRHCF contended that it issued profile reports on a quarterly basis,
thereby meeting the sustained performance requirement for these
criteria. CRHCF submitted as evidence copies of its quarterly profile
analysis HCFA 141 reports. (See, CRHCF Supp., App. C.) Dr. Pilcher
testified that one profile had been reported on form 141 for each of the
criteria during each quarter of 1980. (Tr., p. 99.)
Dr. Pilcher asserted that for criteria II.E.3. these HCFA 141 reports
"verified the utilization problems and specified potential problems as
required by the criterion." (Id. at p. 97.)
CRHCF asserted that for criterion II.E.5. the HCFA 141 reports
indicated "the use of specific profile information to determine progress
on an objective." (CRHCF Appeal, App. A, #17.) Ms. Kasabian testified
that, with regard to criterion II.E.5., "(we) found one profile in
September of that year, that the profile was based upon the objectives."
(Tr., p. 178.) Ms. Kasabian stated that it was, therefore, not sustained
throughout 1980. (Id.)
With regard to criterion II.E.8., CRHCF alleged that physician
profiles were routinely developed. (Id. at App. A, #18.) CRHCF
submitted as evidence information concerning one such physician profile.
(Id.) In addition, CRHCF submitted copies of physician profile data that
were sent to hospitals:
(29) (Identifying) the particular physicians and their cases which
raised each hospital's length of stay data well above the (CRHCF)
average for patients with fracture of the femur.
(Id.)
With regard to criterion II.E.8., Ms. Kasabian testified that "(we)
found an indication that at one time a physician profile was compiled"
(Tr., p. 178.) She stated further that "(we) found no indication that it
was ever sent out." (Id.)
CRHCF contended that for criterion II.E.10 it used a profile to
determine the mortality rates in each hospital for acute myocardial
infarction. (CRHCF Appeal, App. A, #19.) CRHCF argued that its Quality
Review Committee "devised criteria for a study of these mortality
statistics" and that such a study was started in CRHCF's hospitals in
January, 1981. (Id.)
Finding: CRHCF should not receive the 95 points for these criteria.
There was much discussion at the hearing about whether CRHCF's
reports constituted "profiles." Section 1155(a)(4) of the Social
Security Act states that each PSRO:
(Shall) be responsible for the arranging for the maintenance of and
the regular review of profiles of care and services received and
provided with respect to patients . . .
(Section 1155(a)(4) of the Act.)
Neither the Social Security Act nor the implementing regulations at
42 CFR 446.19 define or provide for what must be included in the
profiles. The regulations do set out the requirements for profile
analysis which include a comparison of patterns of care by similar
providers; comparison of current patterns with previous patterns;
identification of patterns that deviate from established norms; and the
tracking of care provided to particular patients or by particular
practitioners. (42 CFR 466.19(b).)
PSRO Transmittal 61, dated January 23, 1978, issued for the stated
purpose of providing more detailed guidance to PSROs on profile
analysis, defines the term "profile" as:
(A) relatively generic one, meaning the presentation of aggregated
data in formats which display patterns of health care services over a
defined period of time.
(PSRO Transmittal 61, p. 4.)
(30) The Transmittal states further:
Although not every display of data can be classified as a profile,
there is considerable latitude for location innovation and variability
in developing profiles . . .
(Id.)
However, Transmittal 61 also provides that "it is not feasible to
implement fully the profile analysis component under a manual data
collection system." (Id.)
The evidence submitted by CRHCF to support its claim that it "met"
these criteria consisted of quarterly profile analysis reports recorded
on HCFA 1411 forms, various graphs, and tables of statistical data.
The Agency argued, through Ms. Kasabian's testimony, that CRHCF was
not preparing profiles. In so testifying, Ms. Kasabian addressed only
the graphs submitted by CRHCF. She stated that the deficiency of these
graphs was that:
In many cases these (graphs) were being prepared based on the PSRO's
results of on-site monitoring, and not based upon information from the
data system.
(Tr., p. 177.) The Agency did not provide any explanation why CRHCF's
other evidence did not constitute profiles.
With regard to the issue of what constitutes a "profile," the Board
finds that CRHCF's graphs and statistical tables can be considered
profiles.; however, CRHCF's HCFA 141 reports are not profiles. The
purpose of a profile is to present raw data from which certain
comparisons can be made. Data manually compiled can be the same as that
produced by computer, albeit a much more difficult task. The Agency has
not alleged that CRHCF's data was incomplete, but only that it was
manually produced. Absent any absolute requirement that profiles be
compiled from computer produced data, we find that CRHCF graphs and
tables can be considered profiles. Whether or not these profiles met
the requirements of the criteria will be discussed below.
The Board also finds that CRHCF's HCFA 141 reports are not by
themselves "profiles." These reports, titled "Profile Analysis
Activity
Report," are an analysis of the actual profiles themselves. The HCFA
141 reports do not present the aggregated data or identify patterns of
care, but provide summary information on profiles. Therefore, the Board
finds that these reports by themselves do not constitute profiles.
(31) Having concluded that some of CRHCF's evidence were profiles, we
now consider whether the profiles provided the information required by
the criteria. The Board concludes that CRHCF should not receive the 30
points for criterion II.E.3. because the evidence in the Record does not
show that CRHCF used profiles to verify potential utilization problems
at least once each quarter. CRHCF did submit profiles for three
quarters of 1980. (See, CRHCF Appeal, App. A, #15.) However, the
criterion requires that there be, at a minimum, profiles for each of the
four quarters in 1980. Since CRHCF did not present evidence of profiles
for each quarter of 1980, the Board finds that CRHCF failed to meet this
criterion.
The Board concludes that CRHCF should not receive the 25 points for
criterion II.E.5. The profiles submitted by CRHCF to support its claim
that it met this criterion are for the years 1978 and 1979 (See, CRHCF
Appeal, App. A, #17.) Since this is outside the period of the
evaluation, the Board finds that CRHCF failed to meet this criterion.
The Board concludes that CRHCF should not receive the 25 points for
criterion I.I.E.8. Of the two profiles submitted by CRHCF to support
its claim that it met this criterion, one is for 1979 and is therefore
outside the period of the evaluation, and the second is for 1980.
($USee, CRHCF Appeal, App. A, #18.) Since the criterion requires the
PSRO to "routinely" generate physician profiles and CRHCF submitted
only
one acceptable profile, we find that CRHCF failed to meet this
criterion.
The Board concludes that CRHCF should not receive the 15 points for
criterion II.E.10. CRHCF submitted as evidence one profile which looked
at mortality statistics. ($USee, CRHCF Appeal, App. A, #19.) This
profile, although devised in 1980, was not started until January, 1981.
($UId.) Since this is outside the period of the evaluation it cannot be
considered in marking this criterion. In any event, it would not be
sufficient to meet this criterion since the criterion requires the PSRO
to "regularly" use profiles. Therefore, we find that CRHCF failed
to
meet this criterion.
Part III of the Evaluation Criteria - Performance of Review -
Impact/Potential Impact
CRHCF received 320 of the 1200 available points in this section;
CRHCF needed 515 points in order to pass this section. The Board
concludes that CRHCF should not receive any additional points for this
part.CRHCF disputed the Agency's determination of points for the
following criteria:
(32) Criteria Section A: Management Objectives
In accordance with the Instructions (see, p. 3 of decision), Criteria
Section A rated a PSRO's objectives based on whether they met one of
five stated levels for calendar years 1979 and 1980, or the last and
current grant period, not to exceed 24 months. CRHCF was scored at a
level "3" for the last grant period of July 1, 1979 - June 30, 1980
and
at a level "4" for the current grant period of July 1, 1980 - June
30,
1981. (See, Tr., pp. 182-183, 194.) CRHCF contested only the last grant
period, 1979-80, maintaining that it should have received a level "4"
for those objectives. A PSRO scoring at a level "3" was awarded 20
points for the last grant period; a PSRO scoring at a level "4" was
awarded 50 points for that period.
Level "3" read as follows:
PSRO sets objectives which minimally met the criteria (in III.A.2.).
/5/ Experience shows that the PSRO has had to make extensive major
modifications (50 percent or greater of the objectives in either of the
2 grant cycles being evaluated) of the objectives during or at the end
of the grant cycle. Major modifications being changes in the
methodology or proposed outcome which might have been accounted for if
the objective had been adequately developed prior to submission.
Level "4" read as follows:
PSRO sets 4-8 objectives each grant period which meet the criteria
addressed in III.A.2., and reflect the activity and priorities of the
PSRO. The ojbective methodologies and measurements have been developed
so as to require only minimal modifications during the grant cycle
(Minimal modifications include refinement of data measurements, shifting
of timeframes by no more than 30 days, etc.).
The Agency contended that CRHCF was not entitled to a level "4"
for
its last grant period 1979-80 for two reasons. First, the Agency
claimed that CRHCF's objectives required major modifications. (Agency
Response, p. 14.) The Agency contended that CRHCF eliminated an entire
impact objective and that "seven other modifications of objective
methodologies (33) and measurements occurred during the initial stages
of the grant cycle." (Id.) Second, the Agency asserted that CRHCF's
objectives did not "reflect the activity and priorities of the PSRO"
as
required to meet a level "4". (Id. at p. 15.) The Agency argued that:
Although (CRHCF) was engaged in long term care review, it did not
submit any acceptable objectives to the regional office for this type of
review.
($UId.)
The Agency also maintained that CRHCF's objectives for grant year
1979-80 required major revisions to be acceptable. Ms. Kasabian
explained that for an impact objective to be acceptable it must:
(State) in quantifiable terms what the issue is, what the impact will
be and in what timeframe.
(Tr., p. 198.)
The Agency submitted as evidence a copy of CRHCF's impact objectives
for grant year 1979-80. (Agency Ex. B.) Ms. Kasabian testified that the
first two objectives were not acceptable because they did not have
timeframes. (Tr., p. 200.) She stated that the third and fourth
objectives were not impact objectives. ($UId. at pp. 200-201.) Ms.
Kasabian stated that the fifth objective - to reduce the average
percentage of disagreement between fiscal intermediaries and delegated
hospitals - was not an acceptable impact objective because:
(There) is no way to determine that a disagreement rate, high or low,
effects the quality or utilization.
($UId. at p. 202.) Similarly, for objective number six, Ms. Kasabian
stated that there was no way of measuring the "result in the impact and
utilization of quality of care." ($UId.) She stated that the seventh
objective did not identify a problem or say that CRHCF would correct it.
($UId.) Ms. Kasabian stated that based on these problems "the Regional
Office did not find that these were acceptable objectives as proposed by
(CRHCF)." ($UId.)
CRHCF contended that the Agency's claim, that CRHCF's objectives
required major modifications, lacked credibility. (CRHCF Post-hearing
Brief, p. 12.) CRHCF contended that the only modification made during
its 1979-80 grant cycle was to drop one of its objectives. CRHCF argued
that the objective was dropped because:
(34) (The) national change of coding for ICDA-9 data made our
baseline data not comparable with data collected during the grant cycle.
(CRHCF Appeal, App. A, #20.) CRHCF argued that this was a "minimal"
modification and therefore, the PSRO should have been scored at a level
"4".
CRHCF also contended that the four modifications the Agency referred
to (see, e.g., Agency Response, p, 14) "could only have occurred in the
grant cycle between July, 1980 and July, 1981, since that was the only
grant proposal in which the PSRO submitted seven impact objectives."
(CRHCF Post-hearing Brief, p. 12.) CRHCF argued, therefore, that the
Agency's evidence is not credible.
CRHCF also argued that is should not be penalized for not having long
term care objectives because a PSRO's long term care activities were not
a subject of this evaluation.
Finding: The Board concludes that while it does not have sufficient
information to award CRHCF a level "4" based on its objectives, the
Agency has not shown that its stated reason for marking this criterion
at level "3" is valid.
The difference between a level "3" and level "4" is the
extent and
type of modifications made of the PSRO's objectives. Level "3" required
a finding that the PSRO made "extensive major modifications" of its
objectives during or at the end of the grant cycle. Major modifications
are defined as a change in the methodology or proposed outcome of the
objectives. The extent of the modifications is quantified as greater
than 50% in either of the two grant cycles. Level "4" speaks of "minimal
modifications." Minimal apparently refers to the quantity and quality of
the modifications. In terms of quantity, since level "3" required
50%
modifications, it can reasonably be inferred that "minimal" means
something less than 50%. With regard to quality, "minimal" is defined
as including, but is not limited to, the refinement of data measurement
and the shifting of timeframes by no more than 30 days. Level "4"
has
an additional requirment that the objectives "reflect the activity and
priorities of the PSRO."
The evidence presented by the Agency to support its claim that
CRHCF's objectives required major modifications were based on a
preliminary version of CRHCF's objectives. The evidence indicates that
the Agency required CRHCF to revise its objectives and that CRHCF did in
fact revise its objectives, to the apparent satisifaction of the Agency,
prior to (35) the beginning of the 1979-80 grant year. Since the
criterion level "3" requires the modifications to be made "during
or at
the end of the grant cycle," we find this evidence insufficient to
support the Agency's claim.
In additional, at least three of the modifications allegedly made by
CRHCF were the addition of timeframes. We note that by awarding CRHCF a
level "3" for this criterion, the Agency has conceded that the final
version of CRHCF's objectives had timeframes since one requirement of
level "3" is that the PSRO's objectives meet the criteria in level
"2"
which includes having timeframes.
The Board concludes, in addition, that the Agency's use of CRHCF's
failure to submit long term care objectives as a basis for not awarding
CRHCF a level "4" for this criterion is unreasonable. As stated in
the
Instructions, long term care objectives were not a proper subject for
this evaluation. Since the Agency determined that it would not include
long term care objectives as part of this evaluation, we find it
unreasonable for the Agency to rely on CRHCF's lack of long term care
objectives for not awarding CRHCF a level "4".
Although the Board has determined that the Agency did not state a
reasonable basis for awarding CRHCF a level "3", CRHCF has not provided
sufficient evidence to support a level "4". Level "4" requires
that the
PSRO's objectives "reflect the activities and priorities of the PSRO."
CRHCF presented no evidence showing that its objectives met this
requirement, and the Board cannot make such a determination based on the
information in the Record.
The Board would have remanded the issue of whether CRHCF met level
"4" to the Agency for a determination but for the fact that even with
a
level "4" score CRHCF would still fail to achieve sufficient points
to
pass this evaluation.
Section III.B.1.: Impact - Utilization (Objectives)
This criterion measured the impact on reducing hospital utilization
as reflected in the PSRO's objectives. The Agency awarded CRHCF 80
points out of a possible 375.
CRHCF contended that is should have received the full 375 points for
this criterion. CRHCF argued that, in scoring this criterion, the
Agency should not have limited itself to the review of the specific
impact objectives listed on CRHCF's 1980 grant proposal when in fact the
Agency's "Special Instructions" and "Additional Instructions"
for (36)
completing this criterion allowed for the scoring of broad general
objectives in addition to the specific impact objectives. (See, CRHCF
Appeal, p. 5) CRHCF further argued that its continuing objective to
determine and certify unnecessary and inappropriate hospital stay days
resulted in identifying 24,345 days of unnecessary hospital stay in 1979
and 30,692 days in 1980. (CRHCF Appeal, App. A, #21.) CRHCF submitted a
chart showing the breakdown of these unnecessary hospital days. (Id.)
CRHCF contended that these unnecessary days should have been considered
in scoring this criterion and that with this objective CHRCF should have
received the full 375 possible points.
The Agency asserted that the Regional Office was correct in
evaluating CRHCF against this criterion based upon CRHCF's stated
objectives in its grant proposal because the "Additional Instructions"
clearly stated that only agreed upon objectives were to be reviewed
under this criterion. (Agency Response, p. 16.)
The Instructions state:
(The) impact on utilization reported in this section must be measured
precisely in the way each objective was formulated . . . Objectives to
be counted are the last set of agreed upon objectives that the PSRO had
reflecting all modifications that may have been made over the course of
the grant period . . . Impact must be related to specifically stated
and agreed upon PSRO objectives. Impact related to other PSRO
activities will not receive credit in this section.
($USee, e.g., Agency Response, Ex. 7.)
The Agency argued that the rationale for this instruction was:
(If) a PSRO receives a grant based upon a proposal that it will
achieve a specific objective during the grant year, it should be
evaluated at the end of that period on the basis of whether it has met
its stated objective.
(Agency Response, p. 16.)
CRHCF contended that these instructions were contradicted by other
Agency instructions issued to aid the regions in conducting the
evaluations. (CRHCF Post-hearing Brief, p. 12.) CRHCF cited "Special
Instructions" contained on page 22 of the evaluation which stated:
(37) All developmental and process objectives in additional to
specific impact objectives may be considered if a measurable number of
days were saved as a result of this activity.
(See, e.g., CRHCF Appeal, App. A, #21.)
CRHCF also cited the following paragraph from the "Additional
Instructions":
If impact is calimed for a broad general objective, such as reducing
overall ALOS for all Medicare patients, impact cannot be claimed for any
other ALOS objectives dealing with Medicare stays.
(Id.)
The Agency contended that "broad" described the extent of the
objective itself and did not refer back to the original program
objectives required by statute. Ms. Kasabian testified that "broad
objective" meant:
(A) PSRO may choose, as an impact objective, to reduce the average
length of stay in its whole area. It could also choose . . . to reduce
the length of stay for a given diagnosis. By the word broad, the
instruction is addressing itself to an objective other than a diagnostic
specific one.
(Tr., p. 208.)
The Agency also argued that CRHCF "did not request or receive the
regional office's approval to pursue this objectie of its 1980 grant
year." (Agency Post-hearing Brief, p. 8)
CRHCF contended that Sections 5.1 through 5.5 of its 1980 Grant
Proposal included several objectives dealing with the identification of
medically unnecessary days. (CRHCF Post-hearing Brief, p. 11.) CRHCF
referred to objectives on pages 3, 5, 6, 7, and 9 of this document in
support of its argument. (See, e.g., Agency Response, Ex. 8.)
Finding: CRHCF should not receive any additional points for this
criterion.
The Agency's assertion that the Agency's evaluaton of CRHCF under
this criterion should be based upon CRHCF's stated objectives in its
1979 and 1980 grant proposals is reasonable. The "Addtional
Instructions" clearly state that "(impact) must be related to
specifically stated and agreed upon PSRO objectives." (See, e.g., Agency
Response, Ex. 7.) Contrary to CRHCF's assertions, this Instruction is
not (38) contradicted by other Agency instructions. The "Special
Instructions" cited by CRHCF concerning the use of developmental and
process objectives were contained in an earlier draft of the evaluation.
The revised impact section deleted these "Special Instructions." (See,
e.g., CRHCF Appeal, App. B., Revised Objectives.)
It is also clear that the reference to "Broard general" objevtives
in
the "Additional Instructions" is not a contradiction of other Agency
instructions, but, as the Agency contended, is defining the extent of
the individual stated objectives. It is clear from the "Additional
Instructions" that only those broad, general objectives specifically
stated on the grant proposal can be evaluated.
If impact for broad or general objectives was reported . . . report
impact as measured against the way in which the objective was stated.
(See, Agency Response, Ex. 7.)
To the extent CRHCF argued that this criterion should not be limited
to specifically stated impact objectives, we are not persuaded. The
Board will not substitute its judgment on program policy for reasonable
policy choices of the Agency charged with administering the program.
(See, e.g., Wisconsin Department of Health and Social Services, Decision
No. 116, August 16, 1980; New York Department of Social Services,
Decision No. 101, May 23, 1980; Family Health Care, Inc., Decision No.
147, January 29, 1981.) In those cases, the Board said that it will not
interfere with an Agency's exercise of its discretion if the Agency acts
in accord with the rules and regulations, and the discretion is
exercised in a reasonable manner. CRHCF did not show that the Agency
failed to follow rules or regulations or acted unreasonably in its
limiting the scoring of this criterion to specifically stated impact
objectives.
Therefore, only objectives listed by CRHCF as continuing through or
proposed for the 1980 grant year and approved by the Agency can be
considered in scoring this criterion. If these broad statutory
objectives were reduced to specific objectives and agreed to by the
Agency in the grant proposal, they can be considered in scoring this
criterion.
The Board finds, however, that only one of the numerous continuing
objectives cited by CRHCF in the March 26, 1979 memorandum (see, Agency
Response, Ex. 8.), which was incorporated as part of CRHCF's 1979-80
grant proposal, deals with the identification of medically (39)
unnecessary days and can be appropriately considered under this
criterion. The two objectives CRHCF referred to on page 3 of the March
26, 1979 memorandum were to develop criteria and to establish a
monitoring program. Neither of these objectives was specifically
designed to identify medically unnecessary days.
The objective CRHCF referred to in the seventh paragraph on page five
of the memorandum is listed for October, 1976. There is no indication
that this objective was continued through the grant years being
evaluated. Therefore, we find that this objective cannot be considerd
in scoring this criterion.
CRHCF also cited paragraphs one, five, and six on page seven of the
memorandum as continuing objectives that should be scored. We find that
none of the three objectivies can be considered for purposes of scoring
this criterion. One of the objectives is listed for May, 1978 and,
therefore, is clearly outside the timeframe of the evaluation. Another
of the objectives is to develop criteria. As we previously stated, the
development of criteria is not specifically designed to identify
medically unnecessary days and, therefore, will not be considered. The
memorandum stated that the third objective on this page was already
"attained by last two quarters of 1978." (See, e.g., Agency Response,
Ex. 8, p. 7.) Therefore, it is outside the period of the evaluation and
cannot be considered.
CRHCF cited an objective on page nine, paragraph seven of this
memorandum. This objective is listed for 1977-78 and, therefore, is
outside the period of the evaluation.
The last objective cited by CRHCF as a continuing objective, on page
six, paragraph four of this memorandum, was listed for January, 1977 and
"continuing through the present." This objective is:
To decrease inappropriate and unnecessary hospital admission or stay
for three categories of hospital utilization . . ., i.e., diagnostic
admissions, hospital services which could have been provided on an OPD
basis, and unnecessary hospital stay because of delay in nursing home or
home care placement.
Since this objective deals with identifying medically unnecessary
days and is within the timeframe of the evaluation, we find that it
should be evaluated in scoring this criterion.
(40) The Board finds, however, that the documentation submitted by
CRHCF does not correspond to this objective and, therefore, CRHCF has
failed to document its claim that any days were saved by the
accomplishment of this objective.
CRHCF's documentation consisted of charts which identify a variety of
statistics related to the "days used" by federally subsidized patients.
The category of federal patients were further broken down between
Medicare and Medicaid patients. (See, CRHCF Appeal, App. A, #21.)
These statistics fail to provide the information which the objective
in question was aimed at providing. The documentation was for two broad
groups of federal patients, Medicare and Medicaid, whereas the objective
was aimed at three specific groups of patients which may or may not have
been subsumed within the two documented groups. It is not possible to
measure the impact of this objective from the documentation submitted by
CRHCF. Therefore, CRHCF is not entitled to any additional points for
this criterion.
Criteria Section C: Impact -- Quality
Section C rated a PSRO's documented impact on the quality of care. A
PSRO was awarded from 0 to 350 points, depending upon the Agency's
determination of which of four levels a PSRO had attained. CRHCF scored
a level "2"; PSROs scored at level "2" were awarded 50 points.
CRHCF
claimed it should have been scored a level "4"; PSROs scored at level
"4" were awarded 350 points.
Level C. 2. read as follows:
PSRO documented isolated quality impact, affecting only a few
physician or patient groups. Changes were small and insignificant.
PSRO may have had some influence in causing impact, but failed to make
any case that it was primarily responsible.
Level C. 3. read as follows:
PSRO documented quality impact. Documents showed that impact
encompassed a significant proportion of physicians or patients (10%-
25%) or at least one pattern of life threatening incidence was reduced;
(1) Change was clearly significant in that it improved the patient care
management or outcome of care for a selected category of patients by a
small percent of physicians; (2) Interventions by the PSRO seemed
largely responsible for the impact, though other factors or trends may
also have been significant; (3) Modified behavior patterns were clearly
documented.
(41) Level C. 4. read as follows:
PSRO produced documents claiming quality impact. Documents showed
that impact encompassed an exceptionally high proportion (greater than
25%) of physicians or (greater than 25%) of patients (1) change was
clearly significant in that it improved the patient care management or
outcome of care for a selected category of patients by a general percent
of physicians; (2) Interventions by the PSRO seemed largely responsible
for the impact; though other factors or trends may also have been
significant; (3) Modified behavior patterns were clearly documented;
or at least one pattern of life threatening incidence was eliminated.
PSRO fully demonstrated that its interventions were primarily
responsible for the impact.
The Agency stated that it scored CRHCF at a level "2" because "the
PSRO failed to produce any data showing that these alleged activities
resulted in quality impact." (Agency Response, p. 17.)
Ms. Kasabian stated further that CRHCF was scored at a level "2"
"(based) upon our knowledge." (Tr., p. 210.) She stated that "(if)
we
had to go strictly on documentation, the PSRO would have received a
(level) one." (Id.)
CRHCF claims that it should have received a level "4", and have
been
awarded 350 points. CRHCF contended that two of its objectives had an
impact on all federal patients and physicians in its hospitals in 1980.
(CRHCF Appeal, App. A, #22.)
CRHCF contended:
The postpayment monitoring objective resulted in motivating and
alerting all physicians treating Federal patients in our area hospitals
to the need for reviewing the appropriateness and quality of the medical
care being provided by them to their hospital patients.
(Id.)
CRHCF also contended that "since October, 1977, (CRHCF) has conducted
24 areawide MCE (Quality Review Studies) in its seven hospitals." (CRHCF
Appeal, App. A. #22.) CRHCF argued that eight of the MCE studies were
conducted during 1979 and 1980 and that the studies had an impact on 100
percent of the physicians and patients in those hospitals. (Id.) CRHCF
claimed that the impact of these MCE studies was measured by reaudits,
PHDDS data, profile analysis reports, and quarterly Audit (MCE)
Committee evaluations and reports. (Id.)
(42) CRHCF submitted as evidence in support of its claim four
areawide audits for each year, a sample listing of audits done at one
hospital, repeat audits, and a copy of CRHCF's Quality Review Plan.
(Id.)
CRHCF argued that this evidence supports its claim that it is
entitled to a level "4" for this criterion. Dr. Pilcher testified
that
the impact of these studies encompassed greater than 25% of the
physicians or patients because:
(It) is self-evident that the areawide MCE studies . . . encompassed
all patients . . . and their physicians in all of our seven hospitals.
(Tr., p. 121.)
Dr. Pilcher also stated that the studies improved patient care
management because:
Each MCE study increased and improved the knowledge of the physicians
in the category of patients studied in the MCE.
(Id.)
With regard to the requirement that the PSRO be largely responsible
for the impact, Dr. Pilcher contended that this is a "personal judgement
criteria"; however, he stated:
(The) members of the hospital staff . . . were sufficiently impressed
with helpful impact of the PSRO MCE program, so that they were eager to
continue it.
(Id. at p. 123.)
With regard to the requirement that modified behavior patterns be
clearly documented, Dr. Pilcher testified:
Effective action to correct patterns of behavior questioned by the
PSRO were instituted by hospitals involved in accordance with PSRO
recommended changes in practice patterns . . .
(Id. at pp. 123-124.)
Dr. Pilcher contended that it would be impossible to prove
statistically that CRHCF was primarily responsible for the impact in the
above mentioned areas. Dr. Pilcher stated, however, that since CRHCF
was assigned by (43) federal contract the duty to perform MCE studies in
the delegated hospitals during 1979 and 1980, "any impact resulting from
these areawide MCE studies would reasonably have to be credited to the
PSRO." (Id. at pp. 124-125.)
The Agency contended that postpayment monitoring procedures do not
usually impact on the quality care. (Agency Response, p. 17.) The
Agency further argued that even if CRHCF's postpayment monitoring
procedures could have an impact on the quality of care, CRHCF did not
document that the postpayment monitoring procedures in fact had that
impact.
The Agency also maintained that CRHCF "did not submit any data
showing that its MCE studies resulted in any actual quality impact."
(Agency Post-hearing Brief, p. 9.) Ms. Kasabian testified that it is
generally assumed that MCE studies will have some impact on the quality
of care. (Tr., p. 209.) However, she stated that it "is not a
quantifiable or measurable incident that a PSRO can claim impact on."
(Id.) She stated that what was necessary to show impact was not to list
MCE topics, but to show:
(What) your problem was -- how it was identified and quantified. And
if you did a follow-up study and the follow-up study showed improved
results which impacted on quality. . . . (One) could calculate the
percent of people affected by the quality issue and the quality
improvement.
(Tr., p. 210.)
CRHCF also claimed that it met the alternative provided for in level
"4", i.e., the PSRO document that it was primarily responsible for
"at
least one pattern of life threatening incidence (being) eliminated." Dr.
Pilcher testified to two examples of meeting this alternative
requirement. (See, Tr., p. 124.) The first example was the PSRO's
activities related to identifying early peptic ulcer bleeding by
requiring tests for acute bleeding on all ulcer patients. The second
was the requirement for admission of suspected acute myocardial
infarction patients to the cardiac intensive care unit for three to five
days. Dr. Pilcher stated:
These requirements were instituted by several hospitals after
receiving the findings of the MCE studies.
(Id.)
(44) Finding: CRHCF is not entitled to a higher score for this
criterion.
The Board finds that CRHCF has not shown that CRHCF's measure of
impact is greater than 10% or that at least one pattern of life
threatening incidence was reduced. Therefore, CRHCF is not entitled to
a score higher than a level "2".
The Board finds unpersuasive CRHCF's argument that because CRHCF
performed areawide MCE studies, it follows that CRHCF had an impact on
100 percent of the physicians and patients in that area. As Ms.
Kasabian pointed out, the MCE study could have shown that no problem
existed. (See, Tr., p. 210.) If that was the case, there would be no
need for PSRO intervention and no resulting impact.
The documentation submitted by CRHCF is skeletal at best. (See,
CRHCF Appeal, App. A, #21.) One document identifies areawide audits
performed in 1979 and 1980. The audits are identified by title or
subject only with no additional information.
Another set of documents identifies the audits performed at one
particular hospital. (Id.) Again, the audits are identified only by
their title or subject and contain no additional information whatsoever.
One example is an audit performed at Glover Hospital. The audit is
titled "Liver Scans" and was performed during the two month period
from
3/80 to 4/80.
The Board cannot determine from CRHCF's documention whether an actual
problem existed, whether the PSRO took steps to alleviate that problem,
and whether in fact the problem was reduced or eliminated thereby
resulting in measurable impact. Without this type of information the
Board finds that CRHCF failed to show that it deserved a higher score
for this criterion.
The Board also rejects CRHCF's claim that its postpayment monitoring
objective had an impact on all physicians treating federal patients.
CRHCF presented no evidence, either in the form of testimony or
documents, to substantiate its claim. Since CRHCF made no attempt to
prove claimed impact, the Board finds against CRHCF based on this
argument.
We also find that CRHCF failed to document the reduction of at least
one pattern of life threatening incidence. Dr. Pilcher identified two
examples which he alleged met this requirement of the criterion.
However, CRHCF presented no evidence showing that these two examples
were life threatening, whether a pattern was identified, and whether a
pattern was reduced. Since CRHCF presented no evidence to substantiate
its claim, we find that CRHCF failed to meet this part of the criterion.
(45) IV. Conclusion
Based on the foregoing analysis, the Board has determined that the
Record supports the Agency's determination to terminate CRHCF's grant.
CRHCF should have received a base score or 1020 points, 85 short of the
1105 points needed to pass the evaluation. In addition, CRHCF passed
only one of the three parts; Part II with 535 points. CRHCF should
have received 165 points for Part I which is 25 short of the 190 points
needed to pass that part; and CRHCF should have received (and did
receive) 320 points for Part III which is 195 short of the 515 points
needed to pass that part. /1/ Below, we refer to: CRHCF's "Letter of
Appeal and Enclosures," dated July 30, 1981, as CRHCF Appeal;
the "response of the Health Care Financing Administration," dated
August
27, 1981, as Agency Response; CRHCF's "Response to Grant Appeals Board
Request for Additional Arguments," dated August 8, 1981, as CRHCF Supp.;
CRHCF's September 10, 1981 submission as CRHCF Reply Brief; the
parties' post-hearing briefs dated October 28, 1981 (CRHCF) and October
29, 1981 (Agency), as CRHCF Post-hearing Brief and Agency Post-hearing
Brief. /2/ CRHCF did contact the Board after the hearing about
submitting additional material. The presiding Board Member informed the
PSRO, by letter dated October 6, 1981, that before he could rule on the
request he would have to know what the material was and why it had not
been offered earlier. CRHCF informed the Board, by letter dated October
15, 1981, that it did not wish to submit any additional documentation.
/4/ We note that the Agency determined that CRHCF met criterion II.C.6.
/3/ The criteria in III.A.2. were : objectives reflect significant
problems; have measurability; have sufficient or realistic
methodologies; have timeframes; and follow prescribed grant
application format.
OCTOBER 22, 1983