Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division
In the Case of:
Bernard J. Burke, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: May 17, 1996
Docket No. C-94-380
Decision No. 1576
FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION
Bernard J. Burke, M.D., Petitioner, appealed the decision
of Edward D. Steinman, Administrative Law Judge (ALJ),
upholding Petitioner's five-year exclusion under section
1156 of the Social Security Act (Act) from participation
in Medicare and certain state health care programs,
including Medicaid. 1/ Bernard J. Burke, M.D., DAB CR406
(1995) (ALJ Decision). Petitioner's exclusion was
initiated by the Inspector General (I.G.) upon
recommendation of the Island Peer Review Organization,
Inc. (IPRO), the peer review organization for the State
of New York.
IPRO recommended that Petitioner be excluded for five
years based on its determination that, in a substantial
number of cases, Petitioner failed substantially to
comply with the obligations imposed on him under section
1156(a) of the Act. Section 1156(a) requires, in part,
that a physician treating Medicare or Medicaid patients
provide only services which are of a quality which meets
professionally recognized standards of health care and
which are supported by necessary documentation. IPRO
identified 20 cases in which Petitioner allegedly failed
to meet professionally recognized standards in the
quality of care or to support that care with necessary
documentation. 2/ Of these 20 cases, the I.G. agreed
with IPRO's findings with regard to 14 and imposed the
recommended exclusion of five years.
Petitioner appealed the I.G.'s exclusion. In a hearing
before the ALJ, the I.G. presented evidence on 13 of the
14 cases. The ALJ concluded that Petitioner substan-
tially violated his obligation under section 1156(a) with
regard to 11 of the 13 cases. The ALJ concluded that the
five-year exclusion imposed by the I.G. was reasonable.
Petitioner appealed the ALJ Decision to the Board.
SUMMARY OF THE DECISION
The ALJ Decision upholding the exclusion was based on 309
findings of fact and conclusions of law (FFCLs).
Petitioner objected to a substantial number of the FFCLs,
including one or more with regard to each of the 11 cases
in which the ALJ found that Petitioner failed to meet a
professionally recognized standard of care or of
documentation. Petitioner also objected to a number of
statements throughout the discussion section of the ALJ
Decision. See generally Petitioner's Notice of Appeal
(P. N.A.) and Brief (P. Br.), dated February 12, 1996. 3/
Below, we review each of the 11 patients, the ALJ's
application of the section 1156 standards, and his
determination of the length of the exclusion. Our
discussion focuses primarily on those alleged errors of
fact or law raised by the Petitioner which are material
to the underlying conclusions drawn by the ALJ for each
patient. In an appendix, we list the changes we have
made to the ALJ's FFCLs as a result of this decision.
With regard to five of the 11 patients, we have
determined that the ALJ's conclusions that Petitioner
violated a professionally recognized standard of care or
failed to support his care with necessary documentation
are either unsupported by substantial evidence or are
erroneous. These patients are the following: 4/ Patient
031943, Patient 058705, Patient 060717, Patient 039069,
and Patient 034026. With regard to the remaining six
patients, we uphold the ALJ's FFCLs on these patients
because we have determined that the FFCLs are based on
substantial evidence on the whole record and are not
erroneous.
Since we are reversing the findings for five of the
patients, a reassessment of the application of section
1156 becomes necessary. Moreover, while Petitioner did
not specifically object to the FFCLs in the sections
discussing the substantiality of his violations, his
inability and unwillingness to comply, the remedial need
for an exclusion, or the serious risk issue, Petitioner
raised in his brief some objections to the ALJ's
discussion of these matters.
Based on our assessment of how section 1156(a) applies to
the facts presented here, we determine, as did the ALJ,
that Petitioner committed substantial violations of his
section 1156(a) responsibilities in a substantial number
of cases. We also determine that Petitioner demonstrated
an unwillingness or inability to comply with his
obligations and that Petitioner poses a serious risk to
patients in his community. However, upon a review of the
eight regulatory factors which apply in determining the
length of the exclusion, we reduce the length of the
exclusion to two years. The PRO recommendation of an
exclusion of five years was based on alleged violations
in 20 cases, and the I.G.'s imposition of a five-year
exclusion was based on alleged violations in 14 cases.
We conclude that a reduction in the length of the
exclusion is appropriate since these cases have now been
reduced to six.
While we reduce the exclusion to two years, some
exclusion is merited. The record reflects that
Petitioner had, in many cases, an intuitive sense of his
patients' needs and a genuine concern for their well-
being. However, Petitioner's poor documentation and
failure to pursue tests and treatments within
professionally recognized standards had potential
negative effects on his patients' present and future
care.
FACTUAL BACKGROUND
This summary of the facts is based on parts of the FFCLs
which we uphold and on the ALJ's discussion of those
FFCLs, and provides a background to our analysis. 5/ At
all times relevant to this matter, Petitioner was a
physician licensed to practice medicine in the State of
New York. Petitioner practiced general medicine in
Little Falls, New York, and had admitting privileges at
Little Falls Hospital. Transcript of Hearing before the
ALJ, February 14-16, 1995 (Tr.) at 183-84. On June 16,
1989, Empire State Medical, Scientific and Educational
Foundation, Inc. (ESMSEF), which was at that time under
contract with the federal government to be the peer
review organization (PRO) for the State of New York,
notified Petitioner that it had determined he had failed
to comply with his obligations under section 1156 of the
Act. I.G. Exhibit (Ex.) 7. Petitioner entered into a
corrective action plan (CAP) with ESMSEF in which ESMSEF
would review all of Petitioner's hospital admissions for
the previous three months, and Petitioner agreed to take
continuing medical education courses and improve the
quality of his documentation of medical charts. I.G. Ex.
8 at 144-47; I.G. Ex. 9.
Beginning December 1, 1989, IPRO was awarded the PRO
contract for New York and assumed responsibility for
monitoring Petitioner's CAP. I.G. Ex. 10. Petitioner
met with IPRO concerning the findings and the CAP and
exchanged correspondence with IPRO on several occasions.
See generally I.G. Ex. 31; P. Ex. 15. On January 13,
1994, IPRO notified Petitioner that it had determined
that he had failed to comply substantially with his
obligations under section 1156(a) of the Act in 20 cases
and that it recommended to the I.G. that Petitioner be
excluded from Medicare and Medicaid for five years. I.G.
Ex. 1 at 4-8. Petitioner submitted rebuttal information
to the I.G. I.G. Ex. 31. By letter dated May 3, 1994,
the I.G. excluded Petitioner on the grounds that
Petitioner failed to meet his obligations under section
1156(a) in 14 cases: he provided care that failed to
meet professionally recognized standards in 11 cases and
failed to provide appropriate evidence of medical
necessity and quality in three cases. The I.G. also
found that Petitioner demonstrated an unwillingness and
inability substantially to comply with the obligations
imposed by section 1156(a) of the Act. I.G. Notice to
Petitioner (May 3, 1994).
LEGAL BACKGROUND
I. Exclusion Provisions
Under section 1156(a) of the Act, a provider of care is
obligated, in part, to assure that items or services
which he or she provides to Medicare program benefi-
ciaries are "of a quality which meets professionally
recognized standards of health care" and are "supported
by evidence of medical necessity and quality in such form
and fashion and at such time as may reasonably be
required by a reviewing peer review organization in the
exercise of its duties and responsibilities." Section
1156(a)(2) and (3). The I.G., as delegated by the
Secretary of Health and Human Services, may exclude a
provider where, based on the recommendation of a PRO, the
provider has "failed in a substantial number of cases
substantially to comply with any obligation imposed on
him under subsection [1156] (a)." Section 1156(b)(1)(A).
The applicable regulations provide that a failure to
substantially comply in a substantial number of cases
means that --
a pattern of care has been provided that is
inappropriate, unnecessary, or does not meet
recognized professional standards of care, or is not
supported by the necessary documentation of care as
required by a PRO.
42 C.F.R. 1004.1(b).
Before a health care practitioner is excluded under the
statute, he or she must ordinarily be given an
opportunity to enter into and complete a CAP with the
PRO. Section 1156(b)(1). After completing a CAP, a
practitioner may be excluded only if he or she "has
demonstrated an unwillingness or lack of ability
substantially to comply" with his or her obligations
under the Act. Id. In determining a reasonable length
of an exclusion, the I.G. considers eight factors:
1) the recommendation of the PRO;
2) the type of offense;
3) the severity of the offense;
4) the previous sanction record of the practitioner
or other person;
5) the availability of alternative sources of
services in the community;
6) any prior problems the Medicare carrier or
intermediary has had with the practitioner or other
person;
7) whether the practitioner or other person is
unable or unwilling to comply substantially with the
obligations; and
8) any other matters relevant to the particular
case.
42 C.F.R. 1004.90(d) (1991). 6/
While a practitioner ordinarily is excluded shortly
following notice regarding the exclusion from the I.G.,
under certain circumstances an exclusion does not become
effective until after a decision on the merits. These
circumstances consist of when a provider practices in an
area with a shortage of health care providers or in a
county with a population of less than 70,000. However,
if there is a finding that a practitioner poses a
"serious risk" to his patients in continuing to practice,
the exclusion will take effect as soon as such
determination is made. Section 1156(b)(5) of the Act.
II. Standard of Review
The standard of review of an ALJ Decision on a disputed
issue of fact is whether the ALJ Decision is supported by
substantial evidence on the whole record. The standard
of review on a disputed issue of law is whether the
initial decision is erroneous. 42 C.F.R. 1005.21(h),
made applicable to section 1156 cases by 42 C.F.R.
1004.130. "Substantial evidence" means more than a mere
scintilla of evidence; it means such evidence as a
reasonable mind might accept as adequate to support a
conclusion. Universal Camera Corp. v. National Labor
Relations Board, 340 U.S. 474 (1951).
In reviewing a decision to determine if the findings are
based on substantial evidence, the reviewer does not
reweigh conflicting evidence. Dodson v. National
Transportation Safety Board, 644 F.2d 647, 650 (7th Cir.
1981). The reviewer does not try the case de novo, and
he or she may not displace the initial decision-maker's
choice between fairly conflicting views even if the
reviewer would justifiably have made a different choice
had the matter been before him or her anew. Universal
Camera at 488. However, the reviewer is not barred from
setting aside a finding if he or she cannot conscien-
tiously find that the finding, or the decision as a
whole, is supported by substantial evidence, when viewed
in the light that the record in its entirety furnishes,
including the body of evidence opposed to the decision-
maker's view. Universal Camera at 488.
ANALYSIS
I. The Individual Patients
Below we discuss the findings and conclusions of the ALJ
Decision with regard to the 11 patients concerning whom
the ALJ found violations of a professionally recognized
standard of care or of documentation, as well as the
material errors which Petitioner has alleged. At the
beginning of the discussion of each patient, we summarize
the material facts which are established by the record.
We discuss each of the patients in the order they were
discussed in the ALJ Decision regardless of whether we
are upholding or reversing the findings which pertain to
that patient. 7/
1. Patient 031409 (UPHELD)
The following facts are not in dispute (see generally
I.G. Ex. 16): Patient 031409 was a woman who was treated
by Petitioner in the emergency room of Little Falls
Hospital (the hospital) with complaints of shoulder and
back pain. She had been admitted and released from the
hospital with similar pain several days earlier. The
patient was diagnosed with heart-related problems and
diabetes. She was given oxygen, and her shoulder and
back pain subsided. Petitioner ordered a gallbladder
sonogram on the patient. According to Petitioner, the
sonogram was ordered because Petitioner was not
completely satisfied that angina was causing the
patient's pain and he was searching for another source of
the pain. I.G. Ex. 6 at 14. The sonogram showed
evidence of gallstones and possible gallbladder
inflammation. 8/ I.G. Ex. 16 at 59. The sonogram showed
no enlargement of the common bile ducts which, according
to Petitioner, would indicate gallstones were blocking
the ducts and could result in possible complications. P.
N.A. at 15; P. Br. at 6-7.
The I.G. alleged that Petitioner failed to meet a
professionally required standard of care in failing to
order five types of tests in response to the results of
the gallbladder sonogram. Additionally, the I.G. found
that Petitioner failed to meet a professionally required
standard of care by not discussing the results of the
gallbladder sonogram with a gastroenterologist with whom
he consulted about the case.
Petitioner objected to the following FFCLs: 9/
54. Professionally recognized standards of care for
a physician presented with a sonogram indicating
gallbladder disease would require the physician
promptly to order tests to determine the patient's
complete blood count (CBC), and levels of serum
amylase, alkaline phosphatase, bilirubin, and
transaminase (also referred to as SGOT).
60. Petitioner testified that he did not order the
blood tests for this patient because he concluded
that the sonogram results and his physical
examination of the patient, which did not reveal
local abdominal pain, led him to conclude that the
patient's gallbladder disease was chronic, rather
than acute, and was not likely the cause of her
pain.
62. Petitioner's failure to note in the medical
record his reasons for concluding that further
laboratory tests were unnecessary was not in accord
with professionally recognized standards of health
care.
69. There is no indication in the patient's medical
record that Petitioner relied on the test results
from the July 25, 1991 admission in determining not
to repeat the tests done during the July 29, 1991
admission.
77. It is more likely than not that the consulting
gastroenterologist was not aware of the results of
this patient's gallbladder sonogram when he dictated
his consultation report.
78. The fact that the consulting gastroenterologist
did not suggest a diagnosis of gallbladder disease
in his report did not relieve Petitioner of the duty
to obtain the required blood tests or, at a minimum,
to discuss the need for such tests with the gastro-
enterologist.
P. N.A. at 7-21; P. Br. at 1-12. 10/
Petitioner argued that several of the five tests which he
allegedly neglected to perform were done only three days
earlier and that it was not necessary to repeat those
tests or to perform the remaining tests since the patient
had no acute gallbladder symptoms. P. N.A. at 12-13.
Petitioner argued that his discharge diagnosis of this
patient as having thoracic pain secondary to
cholecystolithiasis (presence of gallstones and
thickening of the gallbladder wall), on which the ALJ
placed much reliance, was only an interim diagnosis. He
argued that this diagnosis was clarified in his July 31,
1991 progress note, which stated "sonogram -- gallstones
-- relation to pain and vomiting obscure," and that there
was no inconsistency in his diagnosis or treatment. P.
N.A. at 7, 13-14. With regard to the consultation with a
gastroenterologist, Petitioner argued that there was no
professionally recognized standard of care presented by
the expert witnesses with regard to what information he
should have discussed with the consultant. P. N.A. at
20.
We find that the ALJ's FFCLs with regard to this patient
are supported by substantial evidence and are not
erroneous. One of the I.G.'s medical experts explained
the purposes of each of the five tests at issue and
testified why it would have been necessary to perform
each test during this patient's admission to the
hospital. Tr. at 39-43. The expert testified that
reliance solely on a sonogram was inappropriate given
that one could not see part of the pancreas from a
sonogram, and that abnormalities in the laboratory tests
would usually show up before abnormal clinical findings.
Tr. at 43-44. The I.G.'s other medical expert testified
that professionally recognized standards of care for a
family practitioner in 1991 would have required
Petitioner to discuss the results of the sonogram with
the gastroenterologist with whom he consulted even if the
sonogram results were obtained after the initial
consultation. Tr. at 313. Thus, we find that there is
no merit to Petitioner's argument that the I.G. failed to
establish the professionally recognized standard of care.
The main problems with Petitioner's position on this case
are the inconsistencies between Petitioner's assertions,
on the one hand, and the tests he ordered and treatment
he gave, on the other. Petitioner initially examined the
patient upon admission to the hospital. I.G. Ex. 16 at
9. While Petitioner stated that this examination
indicated that the patient had no symptoms of a
gallbladder problem, Petitioner then ordered a
consultation with a gastroenterologist. Id. at 20-21.
He also ordered a gallbladder sonogram which, according
to Petitioner, was for the purpose of ruling out a
possible gallbladder problem as the source of the
patient's pain. I.G. Ex. 6 at 14; I.G. Ex. 16 at 10. 11/
While the consultant did not suggest further gallbladder
tests, the sonogram (which the gastroenterologist
presumably did not know about because he did not
reference it in his report) indicated the presence of
gallstones and possible gallbladder inflammation.
Petitioner stated that he did not order the five tests
which would have been useful to rule out acute
gallbladder disease because he believed from his clinical
examination that the patient had no symptoms of a
gallbladder condition. P. N.A. at 12. However, it is
not reasonable that Petitioner would order the
consultation and sonogram if there were no gallbladder
symptoms, and then simply assume that the gallbladder
condition was chronic rather than acute when the sonogram
indicated the possibility of either an acute or a chronic
gallbladder condition. 12/
Likewise, Petitioner's assertion that he did not believe
there was a gallbladder problem because he relied on the
opinion of the gastroenterologist is not credible or
reasonable. There is no evidence that the gastroenter-
ologist was even aware of the results of the sonogram,
which indicated there was a possibility of gallbladder
inflammation. I.G. Ex. 16 at 21, 59. Moreover,
Petitioner would not have stated in the discharge
summary, signed several weeks after the patient's
discharge, that his final diagnosis of the patient was
thoracic pain secondary to cholecystolithiasis if he, at
that time, did not believe the gallbladder was possibly
the source of the patient's pain. 13/ See I.G. Ex. 16 at
10. Thus, we do not find it reasonable that Petitioner
would not then have ordered the tests, particularly where
the medical expert testified that positive results in the
five tests would precede clinical symptoms of gallbladder
disease.
Petitioner stated that he did not again order the tests
which were done during the prior admission because the
patient had fewer gallbladder symptoms than during the
previous admission and the tests he previously performed
were negative. However, again this does not explain why
Petitioner ordered a consultation with a specialist and a
gallbladder sonogram during the later admission if he was
not concerned with the patient's gallbladder as a
possible source of her pain. Moreover, the ALJ could
have reasonably determined that Petitioner's assertion
that he relied on the previous tests is not credible; the
patient's record reflects that Petitioner was aware of
the prior hospitalization, but does not reflect that he
was aware of the tests which were performed during that
admission. See I.G. Ex. 16 at 9-13. The prior tests, in
any event, did not include all five of the required
tests.
Finally, Petitioner's own statements on this matter are
revealing. In a September 1993 hearing before IPRO,
Petitioner stated the following with regard to repeating
the tests which were performed before the admission in
question:
Being of an economical mind and of an old school, I
did not repeat her laboratory work, which is
reprehensible, but that's at the moment I thought
her laboratory work of two days previously was
adequate.
I.G. Ex. 3 at 71.
Thus, given the above factors, there was clearly a basis
for the ALJ to conclude that Petitioner failed to meet a
professionally recognized standard of care in failing to
order the five tests. We do not find it was unfairly
prejudicial to Petitioner that the ALJ apparently
confused certain aspects of this patient's July 29
admission to the hospital with her prior admission just a
few days earlier. P. Br. at 1-2. Likewise, we do not
find it unfairly prejudicial to Petitioner that the
I.G.'s medical expert did not clearly distinguish between
the terms "x-ray" and "sonogram" or between the terms
"infection" and "inflammation." P. N.A. at 8; P. Br. at
5; P. Reply Br. at 4. We agree with the ALJ that, given
the probable order in which the consultation and sonogram
occurred, Petitioner's failure to order the five tests
after the sonogram results were obtained was not
mitigated by the gastroenterologist's failure to suggest
these tests.
While Petitioner's medical expert did not agree with the
other medical experts that the five tests and consulta-
tion were necessary in this case, it is within the ALJ's
authority to weigh the evidence and judge the credibility
of each witness. See Tr. at 404-406. If the ALJ found
the I.G.'s medical experts to be more convincing on these
matters than Petitioner's expert, then we must abide by
that determination absent a compelling reason not to.
Based on the expert testimony and Petitioner's
inconsistencies and admission, there was substantial
evidence on the whole record to support the ALJ's
findings that Petitioner violated a professionally
recognized standard of care with regard to his treatment
of this patient. For the above reasons, we affirm and
adopt FFCLs 54, 60, 62, 69, and 77-78. We modify FFCL 51
as previously discussed.
2. Patient 031943 (REVERSED)
The following facts are not in dispute (see generally
I.G. Ex. 17): Patient 031943 was a woman admitted to the
hospital with a complaint of chest pressure. The woman
was found to be anemic and to have stool samples which
were dark and fully saturated with blood indicating that
some type of internal bleeding had occurred. The patient
had been diagnosed with a hiatus hernia three years
previously and had a history of stomach cancer in her
family. Two days after admission to the hospital, the
patient was given two units of blood in response to the
anemia. Five days after admission, stool samples
indicated that the patient's internal bleeding had
essentially stopped. Seven days after admission, a
consulting physician performed a colonoscopy on the
patient which diagnosed diverticulosis of the sigmoid
colon; however, the colonoscopist found that
diverticulosis would not likely have caused the extensive
internal bleeding which the patient had at the time of
admission. Tr. at 80. The patient was discharged
exactly one week after admission; Petitioner's final
diagnosis was anemia secondary to bleeding from a hiatus
hernia.
Petitioner and the medical experts agreed that darkened
stool samples usually indicate an upper-gastrointestinal
(GI) source of bleeding. Tr. at 80, 290, and 412. The
ALJ found that Petitioner's failure to perform either an
endoscopy or an upper GI series of x-rays in order to
locate the exact source of the upper-GI bleeding violated
professionally recognized standards of care. ALJ Dec. at
15 (FFCL 97).
Petitioner took exception specifically to the following
FFCLs:
92. Professionally recognized standards of care for
a patient with an unexplained upper GI bleed
requires that a physician perform either an
endoscopy or an upper GI series, provided that
neither is contraindicated for the patient.
94. An upper GI series involves the patient taking
a barium swallow followed by an x-ray. The upper GI
series is not as accurate as an endoscopy, but it is
a viable alternative for diagnosing the cause of an
upper GI bleed.
95. The patient did not have any contraindications
for either an endoscopy or an upper GI series.
97. Petitioner's failure to obtain an endoscopy or
an upper GI series to investigate an upper GI bleed
is a substantial violation of professionally
recognized standards of care.
98. Petitioner's failure to obtain an endoscopy or
an upper GI series exposed the patient to the
serious risk of having a gastric malignancy go
undetected and untreated. It exposed her also to
the serious risk of rebleeding.
P. N.A. at 21-25. 14/ Petitioner argued that there was
considerable medical controversy over the use of
endoscopy in patients who have a single incident of
upper-GI bleeding. P. N.A. at 24-25; P. Br. at 14-18;
Reply Br. at 8-13. Petitioner discussed an article and
accompanying editorial reviewing medical research which
examined patients who had single incidents of upper-GI
bleeding which stopped during treatment. The article
reported that the researchers found that there was no
greater risk to nor rate of undesirable outcome among the
patients on whom an endoscopy was performed and those who
did not receive an endoscopy. P. N.A. at 24-25; P. Br.
at 14-18. The article was published in the New England
Journal of Medicine (NEJM), and Petitioner argued
physicians should be able to rely on articles in such
sources as establishing standards of care, particularly
because the research was later recognized as making the
role of routine endoscopy controversial in the Manual of
Intensive Care Medicine, Little Brown, 1987. P. Br. at
19. Petitioner argued that the NEJM article clearly
indicates there is significant controversy over the
routine use of endoscopy in detecting the source of
upper-GI bleeding. (Indeed, Petitioner argued that the
accompanying editorial concluded that the findings of the
research "appear to resolve the controversy" in favor of
not routinely using endoscopy. P. Reply Br. at 12.)
Thus, Petitioner asserted, delaying an endoscopy for this
patient pending further observation did not violate a
professionally recognized standard of health care or
subject her to further health risks. P. Br. at 19.
With regard to the other test for detecting the source of
an upper GI-bleed, Petitioner argued that an upper-GI
series is not a particularly accurate test. Moreover,
Petitioner asserted, performing an upper-GI series would
preclude doing an endoscopy if the patient rebled within
a short period of time, at which time an endoscopy would
then be warranted. P. N.A. at 23. Petitioner asserted
that the barium used in the upper-GI series would remain
in the patient's esophagus and would prevent a clear
endoscopy picture for a short time following the upper-GI
series.
Petitioner stated he concluded that it was appropriate
care to manage this woman's condition medically without
performing either test where the bleeding had a plausible
source (the hiatus hernia diagnosed three years earlier)
and stopped during admission, and where he could follow-
up with an endoscopy if the bleeding continued. While
Petitioner did not argue that this patient had medical
contraindications for performing either the endoscopy or
the upper-GI series, he argued that this patient was shy,
did not like to be examined, and that she did not enjoy
the colonoscopy and would not want the endoscopy. P.
N.A. at 23; P. Br. at 12.
We find that the ALJ's conclusions with regard to
Petitioner's care of this patient were not based on
substantial evidence on the whole record. We recognize
that the I.G.'s medical experts, one of whom was a
gastroenterologist, testified that it was a violation of
professionally recognized standards of health care for a
practitioner not to perform an endoscopy or an upper-GI
series on a patient with an unexplained upper-GI bleed.
Tr. at 79-80; 297. However, this testimony is seriously
compromised by the fact that the experts either flatly
denied or were unaware of the controversy regarding the
use of endoscopy in patients with a single upper-GI
bleed. Tr. at 87-88; 295-297. The article which
unequivocally asserted such a controversy was published
in the NEJM. See, generally, P. Ex. 53. The article
stated the following:
We conclude that endoscopy should not be a routine
procedure in patients with upper-gastrointestinal-
tract bleeding that ceases during treatment.
Id. at 1. 15/ Moreover, Petitioner's expert witness
testified that the Manual of Intensive Care Medicine,
Little Brown, 1987, recognized the "considerable
controversy about the role of routine endoscopy in upper-
GI bleeding" in view of the NEJM study. Tr. at 417. The
fact that another well-accepted authoritative text,
Harrison's Principles of Internal Medicine, relied on by
the I.G., takes an opposing view (supporting the routine
use of endoscopy) is simply additional evidence that
there is no consensus on the matter among well-respected
sources. Moreover, this text was printed in 1994, a
period of time not at issue in this decision. The fact
that Petitioner did not refer to an article or manual in
documenting in the patient's medical records his decision
not to suggest an endoscopy is not determinative; to
suggest that a physician must cite to some written author-
ity for every medical decision he makes is unreasonable.
With regard to the second test which the ALJ found would
meet the professionally recognized standard of health
care in determining the source of an upper-GI bleed, both
Petitioner's and the I.G.'s medical experts agreed that
the upper-GI series was significantly less accurate than
an endoscopy. Tr. at 89, 291, and 420. One of the
I.G.'s medical experts testified that the upper-GI series
had its limits and was only good for uncovering "gross
abnormalities." Tr. at 291. Petitioner's expert
testified that "barium studies may identify mucosal
lesions but cannot confirm active bleeding from the
site." Tr. at 420. Because of the limitations of the
upper-GI series, we conclude that the ALJ's finding that
professionally recognized standards of care required this
test in the absence of an endoscopy was not based on
substantial evidence. We have already determined that
the I.G. did not establish that professionally recognized
standards would require an endoscopy. While we recognize
that one of Petitioner's medical experts testified that
professionally recognized standards of care required an
upper-GI series in the absence of an endoscopy, neither
of the I.G.'s experts testified as to why Petitioner
should have proceeded with a less efficacious test where
substantial controversy surrounded the routine use of the
more reliable test.
Petitioner also argued, and Petitioner's medical expert
testified, that performing an upper-GI series would
preclude a physician from getting an accurate result if
an endoscopy became necessary following an upper-GI
series. Tr. at 421-422; P. N.A. at 23. The I.G. did not
address this argument in her brief, and none of the
I.G.'s medical experts testified concerning whether an
upper-GI series would interfere with obtaining accurate
results from an endoscopy performed shortly after an
upper-GI series. Thus, the only argument and testimony
we have on this matter in the record is that of
Petitioner and his medical expert, who both concurred
that an upper-GI series would interfere with the accuracy
of a future endoscopy if the need for one became
imminent.
Accordingly, based on the foregoing, we conclude that the
ALJ's finding that professionally recognized standards of
health care required that either an endoscopy or an
upper-GI series be performed on a patient with these
symptoms was not based on substantial evidence on the
whole record. Also, contrary to what the I.G. argued, we
do not find Petitioner's statement -- that he does not
like practicing defensive medicine -- to undermine his
credibility where, as here, he is entitled to argue
alternative theories for his actions. Tr. at 348.
We agree with the ALJ, however, that there is no evidence
that this patient had contraindications for performing
either an endoscopy or an upper-GI series. We do not
accept Petitioner's explanation that he could not perform
an endoscopy because this was "a retiring, self-effacing,
shy type of maiden lady" and that "she didn't enjoy the
colonoscopy" and "wasn't about to enjoy the [endoscopy]."
Tr. at 346, 349. Even if this patient would have been
uncomfortable with the test and may have even flatly
refused it, these facts would not have excused Petitioner
from discussing and recommending the tests if they were
medically necessary.
For the above reasons, we affirm and adopt FFCLs 94 and
95. We modify the following FFCLs:
92. The I.G. did not establish that professionally
recognized standards of care for a patient with an
unexplained upper GI bleed which ceases bleeding
during treatment and does not resume require that a
physician perform either an endoscopy or an upper GI
series.
97. Petitioner's failure to obtain an endoscopy or
an upper GI series to investigate an upper GI bleed
in this patient, who stopped bleeding during
treatment and did not rebleed, did not violate
professionally recognized standards of care.
98. [deleted]
3. Patient 039837 (UPHELD)
The following facts are not in dispute (see generally
I.G. Ex. 18): Patient 039837 was an elderly woman who
was moved from the long-term, chronic care ward to the
active floor of the hospital. At the time of this
transfer, the patient had mottled skin, cold perspira-
tion, fever of 104 degrees, cough, diarrhea, and was
totally unresponsive. Petitioner took blood and sputum
cultures as well as a chest x-ray (the first x-ray). The
first x-ray indicated that the patient had a large amount
of fluid in her chest (pleural effusion) and, according
to Petitioner, was essentially suffocating. Petitioner
performed a thoracentesis on the patient's chest, which
involved inserting a needle into the chest cavity and
draining the fluid. The difficulty of this procedure was
exacerbated by the fact that the patient had no palpable
blood pressure and had to be propped up on her side.
Petitioner did not follow-up the procedure with another
chest x-ray until the following morning (the second x-
ray). The second x-ray indicated that the patient had
developed a partial pneumothorax (air in the chest
cavity) and the patient's right lung was partially
collapsed. Two days following the second x-ray and in
response to deterioration of the patient's observed
condition, Petitioner performed a third chest x-ray. The
third x-ray indicated that the patient's right chest
cavity had again filled with fluid. Petitioner then
inserted a chest tube which drained the fluid for several
days. Three days following this procedure and after
significant improvement in the patient's condition, the
patient died. 16/
The ALJ found that Petitioner failed to meet the
professionally recognized standard of health care by
failing to take the second x-ray immediately following
the first chest drainage and by failing to take a urine
culture when the patient was first transferred to the
active floor of the hospital in a septic state. ALJ Dec.
at 17 (FFCLs 113 and 117).
Petitioner objected specifically to the following FFCLs:
113. Petitioner's failure to obtain a chest x-ray
immediately after the September 28, 1991
thoracentesis was a substantial violation of his
obligation to provide care in accordance with
professionally recognized standards of care.
115. Professionally recognized standards of care
require a urine culture be taken of a patient who is
in a septic state.
117. Petitioner's failure to obtain a culture of
this patient's urine was a substantial violation of
professionally recognized standards of care for a
septic patient.
P. N.A. at 25-29. 17/
A. Failure to take chest x-ray
Petitioner admitted that a chest x-ray was not taken
immediately following the thoracentesis, but rather was
taken at 10:45 a.m. the following day (approximately 18-
20 hours following the procedure). P. N.A. at 25.
Petitioner argued that it was better to do the x-ray the
following day because pneumothoraxes develop slowly and
would not necessarily be detected immediately following
the procedure. Petitioner argued that a clinical
examination of the patient following the procedure showed
no signs of life-threatening complications. Id.
Petitioner further argued that discovering the pneumo-
thorax immediately following the thoracentesis would not
have changed the course of this patient's health nor of
Petitioner's treatment of her since, even once the pneu-
mothorax was discovered, he reasonably determined not to
intervene until two days later when her lung again filled
with fluid and her clinical signs showed that her
condition had deteriorated. P. N.A. at 26; see also I.G.
Ex. 18 at 7. Petitioner stated that the patient was
regularly monitored and was breathing normally for the
two days following the thoracentesis. P. N.A. at 24.
Petitioner emphasized that his performing the thoracen-
tesis, even under extremely difficult conditions,
produced immediate clinical improvement in the patient.
P. N.A. at 25.
It is not disputed that Petitioner's performance of the
thoracentesis produced an immediate benefit to the
patient and possibly prolonged her life. 18/ It is also
not disputed that, under the facts of this case as it
occurred, performing a chest x-ray immediately following
the first thoracentesis might not have changed
Petitioner's treatment or the outcome of this patient's
illness. However, the ALJ's findings are not based on
these factors. One of the I.G.'s expert witnesses
testified that any time an instrument is inserted into a
chest cavity, it is a violation of "any and all concepts
of medical care" not to do a chest x-ray immediately
following the procedure. The expert explained that this
is done to determine whether all the fluid has been
removed, whether the lungs were inadvertently clipped,
and to ensure that other damage was not done. Tr. at 95-
96. The expert testified that pneumothoraxes can lead to
breathing difficulties, cardiac arrest, and even death in
an elderly patient. Id. Petitioner's own medical expert
was asked by the ALJ what the professionally recognized
standard of care would have been as to the need to do a
chest x-ray immediately following the thoracentesis, to
which he responded "[i]t should have been done sooner."
Tr. at 466.
Even if we assume that Petitioner is correct in his
assertion that pneumothoraxes can develop slowly and that
doing an x-ray the following day could have been
beneficial to the patient, Petitioner did not assert that
he was limited to performing a single x-ray and that he
could not have also performed one immediately following
the procedure as well as the next morning. Thus, we do
not find this to be a reasonable explanation for his
delay where, as here, there is testimony offered by
experts representing both Petitioner and the I.G. that
Petitioner's 18- to 20-hour delay in performing an x-ray
was a violation of professionally recognized standards
and where one expert testified that this delay subjected
the patient to possible complications related to her
ability to breathe.
Petitioner emphasized that he was regularly monitoring
the patient's clinical signs and that had she developed a
life-threatening pneumothorax, Petitioner would have
known. While the I.G. did not directly address this
matter in his brief, we find no testimony in the record
from any of the expert witnesses substantiating this
assertion or implying that monitoring clinical signs is
as accurate in diagnosing complications following a
pleural effusion as a chest x-ray.
For the above reasons, we determine that the ALJ's
findings with regard to Petitioner's duty to perform a
chest x-ray immediately following a pleural effusion are
supported by substantial evidence on the whole record.
B. Failure to do urine culture
Petitioner argued that the I.G. did not establish a
professionally recognized standard of health care with
regard to the necessity of performing a urine culture on
a patient in a septic state. P. N.A. at 28. Petitioner
argued that his medical expert testified that it would
have been difficult to catheterize this patient in order
to get a diagnostically useful urine sample given her
general condition. P. Br. at 24. Moreover, Petitioner
argued, his medical expert testified that a urine
culture, even if it could have been obtained, would not
have produced an accurate reading because the patient was
receiving antibiotics immediately upon transfer to acute
care. P. N.A. at 28. Finally, Petitioner asserted that
while he had previously stated that his failure to obtain
a urine culture was "an oversight," it was minor and
understandable given the emergency condition of the
patient's lungs.
We do not find Petitioner's position convincing. While
the I.G.'s medical experts did not testify as to a
professionally recognized standard of health care for
obtaining a urine culture at the hearing, there is
evidence that both of the initial PRO reviewers
considered a urine culture mandatory in a septic patient.
I.G. Ex. 18 at 2, 5. While Petitioner's medical expert,
an infectious disease expert, questioned whether the
condition of this particular patient met the definition
of septic, it is clear that Petitioner believed the
patient was septic when he admitted her to the active
floor of the hospital. I.G. Ex. 18 at 8; Tr. at 459 and
461-62. Under these conditions, there was substantial
evidence on which the ALJ could have determined that
professionally recognized standards of health care
required a urine culture under the circumstances
presented here.
While it may have been difficult to catheterize this
patient in order to obtain a urine sample, no one
testified that it was impossible. Many procedures are
difficult to perform or uncomfortable for patients, but
that does not justify failure to perform them where they
are required under professionally recognized standards of
health care and the patient has not refused to consent to
them. Moreover, there is no indication in the record
that the urine sample could not have been taken prior to
starting the patient on antibiotics had it occurred to
Petitioner to do so.
Petitioner admitted that it was an oversight not to have
done a urine culture. E.g., I.G. Ex. 18 at 5. We do not
find that this oversight was minor, particularly where
Petitioner observed the patient to be in a septic state
and near death. Thus, we find that the ALJ did not err
in concluding that Petitioner failed to meet a
professionally recognized standard of health care in not
obtaining a urine analysis of this patient.
For the above reasons as stated in both subsections (A)
and (B), we affirm and adopt FFCLs 113, 115, and 117.
4. Patient 058705 (REVERSED)
The following facts are not in dispute (see generally
I.G. Ex. 19): Patient 058705 was an elderly man who
entered the hospital after being found unconscious on the
floor of his apartment. At the time of his admission, he
had an impacted colon and a blister with breakdown of the
skin on his left buttock from pressure caused by lying on
the floor of his apartment for an extended period of
time. The record reflects that both Petitioner and the
nursing staff noted the ulcer on the patient's left
buttock. Beginning on the date of admission, the nursing
notes indicate that the nurses moved the patient from
side to side at regular intervals to relieve pressure on
the blister. The nursing notes further indicate that two
days later, the patient was ambulating regularly. The
nurses repeatedly applied A&D ointment to the ulcer,
changed the patient's linens when they were wet, and
monitored his eating.
Petitioner's progress notes indicate that he was
monitoring the status of the patient's ulcer at regular
intervals throughout the patient's stay, and that the
blister was slowly improving. However, the physicians
who testified regarding this matter conceded that healing
was delayed by the patient's colon problem, which
interfered with the ability to keep the area of the
blister dry. Tr. at 263, 580.
More than three weeks into the patient's stay, the
patient's medical record first reflects that Petitioner
gave a specific direction with regard to care of the
blister. At that time, he directed the nursing staff to
apply Neosporin to the skin area. Petitioner was found
by the ALJ to have failed to meet professionally
recognized standards of health care in failing to
initiate a written or oral plan of care throughout the
patient's stay to address the blister. ALJ Dec. at 20
(FFCLs 143 and 149).
Petitioner took exception to the following FFCLs:
143. Professionally recognized standards of care
require an attending physician to initiate a written
plan of care to address skin conditions caused by
prolonged pressure.
145. Petitioner admits, and I find, that this
patient's chart does not contain a written plan of
care to address the treatment of the patient's skin
condition.
146. Petitioner's failure to document a plan of care
to address this patient's skin condition is a
substantial violation of professionally recognized
standards of care.
149. Petitioner's failure to initiate a plan of care
orally to address this patient's skin condition is a
substantial violation of professionally recognized
standards of care.
P. N.A. at 29-32. 19/
Petitioner argued that the I.G.'s expert did not
establish a professionally recognized standard of health
care nor did he state that a plan of care had to be in
writing, but merely stated that a physician is to
"direct" the care. P. N.A. at 29-30. Petitioner
emphasized that this patient's lesion was very
superficial and that the ALJ found that the care which
was given was adequate. He argued that it made no
difference whether he "initiated" the care since the ALJ
found that Petitioner was aware of the care given by the
nurses, that he found it to be adequate until such time
as he added the direction to use Neosporin, and that the
care given by the nurses met professionally recognized
standards. P. N.A. at 29; P. Br. at 25-28. Petitioner
argued that if a physician always had to initiate a
patient's care, nurses could never initiate treatment
within their professional abilities prior to a patient
being seen by a physician. P. Br. at 27. Petitioner
alleged that the ALJ finding that he failed to document
that he initiated a plan of care orally was beyond the
scope of the charges, which Petitioner asserted were
limited to a failure to initiate care. P. N.A. at 32.
Moreover, Petitioner asserted, he initiated a plan of
care orally for treatment of the blister (a claim which
the ALJ did not find credible). 20/ Id.
We agree with Petitioner that the ALJ's finding that
Petitioner failed to document a plan of care and thus
violated professionally recognized standards went beyond
the charges made here. Thus, Petitioner had no adequate
notice. Moreover, the expert testimony which the ALJ
cited in support of his finding that professionally
recognized standards of care required Petitioner to
initiate a written plan of care does not support that
finding. The testimony states that a physician must
"direct" the care, not that he has to "initiate" it. Tr.
at 255, 272. Webster's Dictionary defines "initiate" to
mean "to bring into practice or use; to introduce by
first doing or using." Webster's New Universal
Unabridged Dictionary, 2nd ed. (Dorset & Baber 1983)
(Webster's) at 943. "Direct" is defined to mean "to
manage the affairs of; guide; conduct; regulate;
control." "Direct" also means "to give authoritative
instructions to; order; command." Id. at 516. If
Petitioner had to initiate the care of the blister, it is
clear that Petitioner would have had to have been the
first person to take action with regard to treating this
patient's blister. However, if Petitioner were merely
required to "direct" the care, he could do so by
managing, guiding, or regulating, as well as by ordering
or commanding.
We do not presume that the I.G.'s medical expert who
testified that a physician is to direct the care of a
patient meant to limit Petitioner to directing care only
by giving affirmative orders. The ALJ found that
Petitioner noted the patient's blister when he was first
admitted, that Petitioner's progress notes on several
occasions indicated that he was monitoring the progress
of the healing, and that Petitioner participated in the
treatment of the patient's blister. FFCLs 119, 123, 126,
131 and 150. Petitioner was clearly directing this
patient's care in that he was in control of the care this
patient received for his blister. While the I.G. argued
that Petitioner "admitted" in his testimony before the
ALJ that his instructions to the nursing staff were
inadequate, Petitioner later clarified that only the
written instructions were inadequate, but that the [oral]
instructions "were very adequate." Tr. at 489.
For the above reasons, we modify FFCLs 143, 145, 146, and
149 as follows:
143. Professionally recognized standards of care
require an attending physician to direct a plan of
care to address skin conditions caused by prolonged
pressure.
145. Petitioner directed care of this patient's skin
condition by noting the condition of the skin upon
admission, monitoring the progress of the skin's
healing throughout the patient's stay, and giving
specific directions to the nursing staff to apply
Neosporin.
146. The I.G. did not prove that Petitioner's
direction of care with regard to this patient's skin
condition did not meet professionally recognized
standards of care.
149. [deleted]
5. Patient 032141 (ALJ FINDINGS OF NO VIOLATION
UPHELD; NOT OBJECTED TO)
Patient 032141 was an elderly woman with multiple
consecutive admissions to the hospital. See, generally,
I.G. Ex. 20. The allegations with regard to this patient
were counted by the ALJ as two cases presumably because
the I.G. alleged violations with regard to two of the
admissions. However, because the ALJ found that
Petitioner did not violate any professionally recognized
standard of care or documentation requirement with regard
to this patient, Petitioner did not raise any objections
to the findings and thus we do not discuss this patient
any further. Accordingly, we affirm and adopt FFCLs 155-
181.
6. Patient 060460 (UPHELD)
The following facts are not in dispute (see generally
I.G. Ex. 22): Patient 060460 was an elderly man brought
by ambulance to the emergency room following a sudden
episode of weakness, slurred speech, and confusion.
Petitioner performed a CT-scan on the patient.
Petitioner diagnosed the patient with transient ischemic
attack (TIA), a brain dysfunction caused by limited blood
flow into the brain. TIA causes symptoms which last
between several minutes and several hours, but it results
in no permanent neurological damage. Petitioner and the
experts who testified agree that TIA is usually caused by
blockage (stenosis) of the carotid artery in the neck.
Blockage of the artery of 25% or more can lead to stroke
and coronary heart disease, as well as to additional
TIAs. Blockage is often treated conservatively with
aspirin or other anti-coagulants. If the blockage
exceeds 70%, at least some physicians recommend surgery
("carotid endarterectomy,") which involves entering the
artery and removing the blockage.
Diagnosis of the degree of blockage of the carotid artery
is done through a Doppler ultrasound, a non-invasive
procedure which is not completely accurate. An
angiogram, which involves shooting dye into the artery,
is a more accurate but more invasive test for determining
the degree of blockage; however, an angiogram carries
with it a one percent chance of causing a stroke. There
is no conclusive evidence in the record that Petitioner
ever discussed these tests or the possibility of surgery
with this patient. However, Petitioner ordered
conservative care for this patient's condition,
recommending that the patient take aspirin on a daily
basis upon discharge. The ALJ found Petitioner had
violated a professionally recognized standard of care in
failing to perform a Doppler ultrasound on this patient
and, if the ultrasound showed a significant degree of
blockage, in failing to perform an angiogram.
Petitioner objected specifically to the following FFCLs:
193. Professionally recognized standards of health
care in diagnosing carotid artery stenosis require a
physician to first assess the status of the carotid
arteries non-invasively, using a Doppler ultrasound.
195. The preferred method for accurately measuring
the degree of stenosis of a patient's carotid
arteries is direct cerebral angiography, an invasive
procedure that involves injecting dye into the
carotid arteries, and which itself involves
approximately one percent risk of stroke.
199. Petitioner failed to meet his obligation to
provide care in accordance with professionally
recognized standards by failing to order a Doppler
ultrasound for this patient.
204. Petitioner's failure to document that this
patient refused surgical treatment violated
Petitioner's obligation to provide care in
accordance with professionally recognized standards
of care.
206. Because Petitioner failed to obtain a Doppler
ultrasound of this patient's carotid arteries,
Petitioner could not meaningfully have advised the
patient of the risks and benefits of carotid
endarterectomy surgery.
207. Petitioner violated his obligation to provide
health care that meets professionally recognized
standards by ruling out surgery for this patient
without obtaining the results of a Doppler
ultrasound of the patient's carotid arteries.
P. N.A. at 32-39. 21/
In response to the ALJ's findings and conclusions,
Petitioner asserted that it was the local medical
practice in his community to manage stenosis of the
carotid arteries with conservative medical care rather
than surgery. P. N.A. at 37. Petitioner stated that
this patient was a "stubborn Ukrainian" who would not
have considered surgery and who, from the time of
admission to the hospital, did not want to undergo
examination and insisted that he "just wanted to go
home." P. N.A. at 35. Petitioner introduced two
articles which Petitioner argued indicate that there is
no consensus of opinion in the medical community as to
whether and under what circumstances carotid
endarterectomy should be performed even in patients where
the degree of stenosis exceeds 70%. P. Exs. 50, 51; P.
N.A. at 32-34. Petitioner argued that the study which
the ALJ relied on to find that carotid surgery was
superior to medical management alone where the degree of
stenosis exceeded 70% was only an interim study and, in
fact, showed that the surgery's benefit over medical
management alone was very slim. Id.
Based on these facts, Petitioner stated that he
determined this patient was not a candidate for surgery.
Petitioner argued that he was justified in not performing
a Doppler ultrasound or an angiogram on this patient
because he and the patient did not need to know the
degree of stenosis since surgery was not being considered
and conservative management of the problem (i.e., taking
aspirin or other anti-coagulants) would be the same
regardless of the degree of stenosis. P. N.A. at 38-39;
P. Br. at 28-30. Petitioner stated that it was arguably
unethical to perform tests which would not affect the
course of treatment and that it would result in an
overutilization of limited health care resources.
Moreover, Petitioner argued, he could have a rational
discussion with the patient regarding the risks and
benefits of surgery without knowing the degree of this
particular patient's stenosis because the Petitioner
could discuss various degrees of stenosis and how they
would affect the patient's options. P. Br. at 29.
Finally, Petitioner argued that there was no
professionally recognized standard of care presented with
regard to the use of ultrasound, nor did the exhibit
cited by the I.G. suggest that ultrasound was mandatory
in these instances. P. N.A. at 34-35. Moreover,
Petitioner stated, angiogram was not the preferred method
for accurately measuring the degree of stenosis due to
its risks, although Petitioner conceded that it was the
most accurate method. P. N.A. at 35. Petitioner argued
that the finding that his failing to document the
patient's refusal for surgery was a violation of a
professionally recognized standard of health care was
beyond the scope of the charges, which focused on his
failure to perform the ultrasound. P. N.A. at 36.
We find that the ALJ's findings concerning this case are
supported by substantial evidence on the whole record and
that his conclusions were not erroneous. First, we find
that the I.G. established the applicable professionally
recognized standard of health care. One of the I.G.'s
medical experts testified that professionally recognized
standards would clearly require a physician to perform
either a Doppler ultrasound or an angiogram on a patient
diagnosed with a TIA in order to ascertain the degree of
blockage and to know how to advise the patient and to
proceed with his care. Petitioner failed to do either of
the two tests. Thus, there was substantial evidence
based on the whole record on which the ALJ could have
determined that Petitioner's failure to do either of
these tests was a violation of professionally recognized
standards.
This is not to say that carotid endarterectomy should
have been recommended for this patient. In fact, it
would be impossible to know from the evidence in the
patient's medical record whether endarterectomy should be
recommended without the results of these tests. Thus, it
does not matter that there is no consensus in the medical
community as to what circumstances warrant performing
this surgery. Petitioner admitted that endarterectomy
should at least be considered where the degree of
stenosis is greater than 70%. P. N.A. at 35. This
undercuts his assertion that it was not important to know
the degree of carotid artery blockage in this patient.
Petitioner did not prove that he discussed the
possibility of surgery with this patient. The ALJ found
that Petitioner's assertions to the contrary were not
credible, and we find no error in this finding. 22/ The
fact that Petitioner observed this patient to be a
"stubborn Ukrainian" who was anxious to go home does not
excuse Petitioner from fully assessing the patient's
medical condition and advising him of all of his options,
absent an affirmative refusal by the patient to consent
to testing. The fact that Petitioner asserted he could
discuss all possible options with the patient on a
hypothetical basis without knowing his particular
condition is immaterial where there is no credible
evidence that Petitioner had such a discussion with the
patient.
Once again, the ALJ found that Petitioner declined to
discuss a procedure required under professionally
recognized standards of health care to a patient because
Petitioner assumed, based on the patient's character
(i.e., a stubborn Ukrainian), that the patient would not
consent to the procedure. That this patient may not have
considered surgery (at least at this point) is not the
crucial issue; even if the patient was not a candidate
for surgery, the I.G.'s medical expert testified that it
was important to do the tests and determine the degree of
blockage so that a physician would know how to advise a
patient and how to proceed with his care. 23/ Tr. at
120.
For the above reasons, we affirm and adopt FFCLs 193,
199, and 206-207. We reverse FFCL 204.
7. Patient 060717 (REVERSED)
The following facts are not in dispute (see generally
I.G. Ex. 23): Patient 060717 was a male heart patient
who was admitted to the hospital with shortness of
breath. While in the hospital, he was switched from
Capoten to Vasotec, both of which are medications used
for the treatment of hypertension and congestive heart
failure. Tr. at 245. During the patient's stay, his
dosage of Vasotec was increased from five milligrams
twice daily (BID) to eventually ten milligrams twice
daily. The ALJ found that the patient was discharged
with proper oral instructions to take five milligrams of
Vasotec twice daily on an outpatient basis. Such
instruction was consistent with Petitioner's final
progress notes for this patient.
A discharge summary for this patient was dated and signed
by Petitioner 21 days after discharge. The discharge
summary incorrectly stated that the patient was
discharged with a prescription for five milligrams of
Capoten to be taken twice daily. The ALJ found that
Petitioner's failure to accurately document his discharge
instructions in the discharge summary was a substantial
violation of his obligation to provide care which is
supported by the necessary documentation. ALJ Dec. at 27
(FFCL 222).
Petitioner objected specifically to the following FFCLs:
219. The I.G. gave Petitioner sufficient notice that
she was alleging that Petitioner inaccurately
documented his treatment of the patient on the
discharge summary, and that this documentation error
was a basis for the I.G.'s determination to exclude
Petitioner.
221. Petitioner admits that the discrepancy between
his December 9, 1991 progress notes and his December
30, 1991 discharge summary might be confusing to a
physician attempting to treat the patient if he was
readmitted to the hospital.
222. Petitioner's failure to accurately document his
discharge instructions on the December 30, 1991
discharge summary was a substantial violation of his
obligation to provide care which is supported by the
necessary documentation.
P. N.A. 40-42. 24/
Petitioner argued that the alleged failure to correctly
document in his discharge summary the medication given to
the patient was beyond the scope of the charges, which
alleged rather that Petitioner had discharged a patient
with instructions to take a higher dosage of medication
than should have been ordered. Because the ALJ did not
find that the oral instructions given to this patient
were for a higher dosage of medication, Petitioner argued
that the charges with regard to this patient should be
dismissed. P. N.A. at 40; P. Br. at 31. Petitioner
emphasized that the incorrect reference to Capoten in the
discharge summary was not read by the patient, who was
given proper instructions to take 5 mg. of Vasotec twice
daily upon discharge; thus, according to Petitioner, this
error had no bearing on patient care and was merely an
insubstantial documentation error which occurs frequently
with regard to patients' charts. P. Br. at 31; P. N.A.
at 41-42. Finally, Petitioner argued that his admission
that the error in the discharge summary might be
confusing to another physician attempting to treat the
patient was qualified by the fact that it would be
confusing only if the patient's record was the only
source of information about the particular patient.
Petitioner argued that Little Falls is a small community
where there is constant communication between physicians
regarding patients. P. N.A. at 41.
As an initial matter, we find that the alleged failure of
Petitioner to document the proper medication in this
patient's discharge summary was inadequately addressed in
the notice of the scope of the charges. On May 3, 1994,
the I.G. sent Petitioner a letter informing him that he
was being excluded for five years based on IPRO's finding
that in a substantial number of cases Petitioner failed
substantially to comply with obligations imposed under
section 1156 of the Act. See Notice from I.G. (May 3,
1994) (Notice). The letter informed Petitioner of his
right to appeal to an ALJ. Each of the cases on which
the I.G. was relying was discussed in the Notice. With
regard to this patient, the PRO findings were stated as
follows:
Potential adverse patient effect when patient
discharged with instructions to take a higher dosage
of medication.
Notice at 5. The I.G. analysis section then stated:
Dosage of cardiac medication was changed in progress
notes, but not on order sheet. Discharge
instructions reflect the higher dosage of
medication. The medical record shows discharge
summary with 5 mg Capoten BID, but do [sic] not show
any such medication being given during hospital
admission. The record does show Vasotec, 10 mg BID,
prior to discharge. Practitioner advised why he
lowered the dosage, which is not disputed by the
PRO.
Id. at 5. When the PRO was reviewing this case prior to
recommending exclusion by the I.G., the error in the
discharge summary was noted by both of the initial
reviewers, and Petitioner addressed the matter in his
response to the initial review. I.G. Ex. 23 at 1-6.
While we find that the error in the discharge summary was
mentioned throughout the proceedings before the PRO and
the ALJ, we agree with Petitioner that it was not clear
from the Notice that the alleged violations on which the
exclusion was based included this discharge summary
documentation error. The sole PRO finding contained in
the Notice is that the patient was discharged with
instructions to take a higher dosage of medication than
he should have been taking. Petitioner testified that
the patient was correctly discharged with instructions to
take five mg. BID rather than ten mg. BID of Vasotec, and
the ALJ found Petitioner's testimony credible. FFCL 217,
citing Tr. at 503-504, 506. The ALJ found that the I.G.
did not prove that the patient was discharged with
instructions to take the higher dosage of ten milligrams
of Vasotec twice daily. FFCL 218, citing I.G. Ex. 23.
Thus, the ALJ did not uphold the finding of the PRO.
While the analysis section of the notice referred to the
error in the discharge summary, it was not clear that
this was a charge on which the exclusion was based.
Thus, we find that Petitioner did not have proper notice
that the error in the discharge summary provided a
separate basis for the exclusion.
However, even if we found that Petitioner did have
sufficient notice that the error in the discharge summary
formed a basis for the exclusion, we do not find that
this error should contribute to the ALJ's finding that
Petitioner substantially violated his obligations under
section 1156(a) in a substantial number of cases. The
regulations define a "substantial violation in a
substantial number of cases" to mean a pattern of care
that is inappropriate, unnecessary, does not meet
professionally recognized standards of health care, or is
not supported by documentation as required by the PRO.
We do not find that this error fits into any pattern of
errors as charged in this proceeding. Most of the other
errors alleged in these cases involved failure either to
perform necessary tests or to provide adequate treatment;
failure to communicate with patients regarding informed
consent or treatment options; or failure to document
which tests were relied on or why a normally appropriate
test was not being done. This is the only case which
involved what amounts to an error in transcription. The
error is particularly understandable given that the
patient was taking both Capoten and Vasotec at different
times during the patient's hospital stay.
The ALJ conceded that the error in isolation might not be
significant, but concluded that the error took on
significance when considered in light of Petitioner's
CAP, in which he promised to be more careful in his
documentation, and in light of his record of failing to
adequately document patient records. ALJ Dec. at 80.
However, the record does not establish that Petitioner's
commitment in his CAP encompassed this type of error as
opposed to the other types of documentation errors
identified above. The I.G. did not establish that
Petitioner's documentation must be flawless -- free even
of unintentional errors. The ALJ did not find that an
error of this nature would cause a delay in treating the
patient, as the I.G. argued; the ALJ found only that it
would cause another physician to expend some effort to
clarify the discrepancy. I.G. Br. at 35; ALJ Dec. at 80.
Finally, with regard to whether the discharge summary
could be confusing to another physician taking over the
patient's care, we do not disturb the finding of the ALJ.
Petitioner argued here that his admission that the
summary could be confusing was qualified by the fact that
Little Falls is a small community where physicians
regularly share information about patients and that
therefore the patient's record would not be the sole
source of information about this patient's care. We do
not find Petitioner's position on this matter convincing.
Even if Little Falls is a very small geographical area
with a limited population and relatively few physicians,
it is not realistic to suggest that each physician would
retain detailed knowledge of another physician's patients
even if the physician regularly treating the patient
discussed the patient's care with the other physicians.
Moreover, documentation is necessary because a physician
could leave the practice of medicine, retire or die.
For the reasons stated above, we modify FFCLs 219 and 222
to read as follows:
219. The I.G. did not give Petitioner sufficient
notice that she was alleging that Petitioner
inaccurately documented his treatment of the patient
on the discharge summary, and that this
documentation error was a basis for the I.G.'s
determination to exclude Petitioner. Notice at 5.
222. Even if Petitioner had been given sufficient
notice that the I.G. was excluding Petitioner based
in part on the error in the discharge summary, the
I.G. did not prove that Petitioner's failure to
accurately document his discharge instructions on
the December 30, 1991 discharge summary was a
substantial violation of his obligation to provide
care and to support his care by the necessary
documentation.
We affirm and adopt FFCL 221.
8. Patient 030053 (UPHELD)
The following facts are not in dispute (see generally
I.G. Ex. 24): Patient 030053 was a diabetic patient
brought to the emergency room following an insulin-
induced coma. During transport to the hospital, the
patient's blood sugar level was 33 mg/dL and the
emergency medical technicians administered 50 percent
Dextrose to the patient in order to bring up his blood
sugar level. 25/ Upon arriving at the hospital, the
patient was alert and oriented and had a blood sugar
level of 180 mg/dL. In the emergency room, the patient
suffered another episode of abnormally low blood sugar
and was admitted to the hospital for observation.
At the time of his admission to the hospital, the
patient's blood sugar level was checked at the following
times with the following results:
4:30 p.m. 77 mg/dL
9:30 p.m. 26 mg/dL
9:45 p.m. 57 mg/dL
10:30 p.m. 108 mg/dL
At 10:15 p.m., the record reflects that Petitioner
telephoned the nursing staff and directed the nurses to
"change [this patient's] IV solution to Dextrose 10% --
run at rate to obtain blood sugar above 80 then slow IV
down to KVO [keep vein open] for the n[ight]." There is
no indication that the patient's blood sugar level was
monitored again until 6:30 a.m. the following morning,
when it was found to be 134 mg/dL.
The ALJ found that Petitioner failed to meet profession-
ally recognized standards of health care because he
failed to specify a rate for administering the IV
Dextrose to this patient and failed to specify regular
monitoring of the patient's blood sugar level throughout
the night.
Petitioner objected specifically to the following FFCLs:
237. Professionally recognized standards of health
care require that the attending physician specify a
rate for administering IV Dextrose to a hypoglycemic
patient.
238. Professionally recognized standards of health
care require the attending physician to establish a
plan of care for a hypoglycemic patient that would
specify regular monitoring of the patient's blood
sugar.
239. Petitioner's orders for this patient failed to
specify a rate of administration for IV Dextrose and
failed to specify regular monitoring of the
patient's blood sugar levels.
240. Even if Petitioner's order to administer 10
percent Dextrose at a KVO rate once blood sugar was
normal was sufficient, the fact that this patient's
blood sugar was not monitored between 10:30 p.m. on
December 27, 1991 and 6:30 a.m. the next morning
would represent care that failed to meet
professionally recognized standards.
241. Petitioner's failure to order a rate for
administering the IV Dextrose, and his failure to
order regular monitoring of the patient's blood
sugar, are substantial violations of his obligation
to provide care of a quality that meets
professionally recognized standards of health care.
P. N.A. at 42-46. 26/
Petitioner argued that it was not always appropriate to
specify an IV rate where the rate might need to be varied
to achieve a desired outcome (i.e., a blood sugar level
between 80 and 120 mg/dL). P. N.A. at 45-46; P. Br. at
32-33. He stated that his medical expert had testified
that not specifying an initial rate was appropriate, and
that the I.G.'s medical expert only testified as to what
was customarily done rather than as to a professionally
recognized standard of health care. P. N.A. at 42-43.
Moreover, Petitioner argued, it was not necessary to
monitor the patient's blood glucose level throughout the
night where the nursing staff was monitoring the
patient's clinical symptoms, the patient had achieved an
appropriate glucose level before the nurses ceased
monitoring it for the night, and where the effects of the
insulin overdose could have been expected to have worn
off by the time of the last monitoring. P. N.A. at 44-
45; P. Reply Br. at 29.
We find that the I.G. expert's testimony established a
professionally recognized standard of health care or, at
the very least, that his position was that Petitioner's
treatment of this patient fell short of any
professionally recognized standard of care. The expert
was asked to explain the significance of providing a drip
rate for the Dextrose solution. He responded, in part,
that "you want to know how much glucose you're giving the
patient in order to re-establish a blood sugar parameter
between 80 and 120." Tr. at 137. He was then asked if
there were any risks to the person by not specifying the
rate for the dextrose to be run. To this he responded,
Oh, certainly. You don't know what you're doing.
You are operating in the blind. You want to know
how much glucose, based on weight, you're giving the
patient, because you do have to monitor the patient
when they leave the hospital, so you know what
you're dealing with . . . .
Tr. at 137-38. Likewise, with regard to monitoring the
glucose level, the I.G.'s expert was asked if he was
"aware of any accepted practices regarding monitoring
hypoglycemia in patients," to which he responded,
The accepted practice is to do blood sugars by
finger stick at regular intervals. Usually, it's
every hour on the hour, or every hour on the half-
hour, so you follow that and you say they've gotten
so much glucose during the past hour, and where you
stand when you stop it. You don't want to put them
into hyperglycemia. You want to level them off.
Tr. at 138. 27/ As to the overall care rendered by
Petitioner, the expert stated "[t]his represents a
failure by the physician to properly manage and treat a
diabetic." Tr. at 137.
The I.G.'s medical expert established that it was a
violation of professionally recognized standards of
health care not to have the initial drip rate determined
by a physician. The I.G.'s medical expert never stated,
as argued by Petitioner, that it met professionally
recognized standards of health care to let the nursing
staff determine the initial drip rate. The expert was
asked who would determine the drip rate if an order was
given (by a physician to a nurse) to administer 10%
Dextrose to obtain a blood sugar level above 80, to which
he replied, "Well, you give the order and the nurse
determines it." Tr. at 139. The fact that the nursing
staff may be qualified to adjust a drip rate as necessary
to achieve a desired result, as Petitioner argued, is not
what is at issue here. Moreover, it is unreasonable to
assume that the nursing staff could adjust the rate to
achieve a desirable outcome if regular blood glucose
monitoring was not being done.
We agree with Petitioner that the record reflects that
the nursing staff monitored the patient's alertness
throughout the night. I.G. Ex. 24 at 33 and 35.
However, the point is not whether the staff would have
responded appropriately if the patient again showed signs
of hypoglycemia or coma. Rather, the significant point
is that blood glucose monitoring at regular intervals
could prevent the patient from again going into a coma
because Dextrose levels could then be adjusted as
necessary based on the test results. We also do not find
that it was reasonable to discontinue monitoring at 10:30
p.m. because, according to Petitioner, the insulin
overdose had presumably worn off; the patient's blood
sugar had been as low as 26 mg/dL just one hour earlier.
I.G. Ex. 24 at 33.
While we recognize that Petitioner's expert testified
that Petitioner's care of this patient was appropriate,
again it is not our role to re-weigh conflicting evidence
in the record or to substitute our judgment on the
credibility of that evidence absent some persuasive
reason to do so. We do not find, as argued by
Petitioner, that the professionally recognized standards
presented by the I.G.'s experts are only those of IPRO
and not of the medical community. For these reasons, we
do not accept Petitioner's assertions that it was
appropriate to order 10% Dextrose to be administered
without specifying a drip rate, that the nursing staff's
monitoring of the patient's clinical symptoms was
sufficient, and that there was no further danger to the
patient in not doing blood glucose tests throughout the
night because the effects of the insulin had worn off.
For these reasons, we find that the ALJ's findings are
based on substantial evidence on the record and that his
conclusions are not erroneous. Thus, we affirm and adopt
FFCLs 237-241.
9. Patient 030344 (UPHELD)
The following facts are not in dispute (see generally
I.G. Ex. 25): Patient 030344 was in the hospital for ten
days with a heart-related problem, after which he was
discharged. The discharge instruction sheet, which was
prepared by a nurse in response to instructions given by
Petitioner in his final progress notes, indicated certain
medications which the patient was to take upon discharge.
Neither the progress notes nor the discharge instructions
discussed whether the patient was to take Coumadin upon
discharge. When the PRO reviewers questioned why this
patient was not prescribed Coumadin, Petitioner stated
that he prescribed it for the patient upon discharge.
The ALJ found that Petitioner substantially violated his
obligation to provide necessary documentation of care
when he did not write his intent to prescribe Coumadin
upon discharge of the patient from the hospital in his
discharge instructions.
Petitioner specifically objected to the following FFCL:
251. Petitioner's failure to document his intent to
prescribe Coumadin to this patient on discharge is a
substantial violation of his obligation to provide
necessary documentation of his care.
P. N.A. at 46-48. 28/
Petitioner argued before us that no professionally
recognized standard of care was presented with regard to
a physician's duty to document his intent to prescribe a
medication after discharge. He also asserted that
neglect to document his future intent, to the extent it
occurred, is a minor rather than a substantial violation
of any necessary standard of documentation. P. N.A. at
47-48.
In his post-hearing brief before the ALJ, Petitioner
stated --
This finding is not contested by Dr. Burke. We
concede the intent to commence coumadin treatment
with this patient on an outpatient basis should have
been noted in the discharge summary.
Petitioner's Post-Hearing Brief before the ALJ, at 56.
Thus, given Petitioner's concession of the legal
conclusion at issue in this case, we do not find it to be
material whether or not the I.G. established an exact
standard of documentation since Petitioner acknowledged
that this was the standard. 29/
As far as whether the violation was substantial or minor,
we note that the regulation defining "substantial
violation in a substantial number of cases" does not
require that each violation in itself must be
substantial, but only that each violation contribute
collectively to a pattern of care which is inappropriate,
unnecessary, does not meet professionally recognized
standards of health care, or is not supported by
necessary documentation of care as required by a PRO.
Thus, a substantial violation in a substantial number of
cases can be gleaned from a pattern of violations, some
of which may not in and of themselves be substantial.
For the above reasons, we believe that the ALJ's findings
with regard to this patient were based on substantial
evidence on the whole record and that his conclusions
were not erroneous. We modify FFCL 251 as follows:
251. Petitioner's failure to document his intent to
prescribe Coumadin to this patient on discharge is a
violation of his obligation to provide necessary
documentation of his care.
10. Patient 039069 (REVERSED)
The following facts are not in dispute (see generally
I.G. Ex. 26): Patient 039069 was a male heart patient
admitted to the hospital with complaints of vertigo and
nausea. Petitioner diagnosed the patient with arterio-
sclerosis with acute episodes of vertigo, mild organic
brain syndrome, and arteriosclerotic heart disease with
ongoing auricular fibrillation and cardiac prominence.
Petitioner did not order a complete blood count (CBC)
test on this patient at the time of admission, although
there is evidence in the record that one was performed on
this patient at some point prior to this admission. 30/
The ALJ found at the outset that a CBC was necessary at
admission; however, the charge at issue here did not
involve an alleged violation of a professionally
recognized standard of care relating to performing a CBC,
and the ALJ therefore did not find that Petitioner
violated a professionally recognized standard of care
with regard to performing a CBC. Rather, the ALJ found
that Petitioner substantially violated his obligation to
provide the necessary documentation of care by failing to
document that he did not perform a CBC on this patient at
the time the patient was admitted, in failing to explain
why a CBC was not performed on admission, and in failing
to document the results of the CBC performed prior to
admission. ALJ Dec. at 31 (FFCL 258).
Petitioner objected specifically to the following FFCLs:
256. A CBC was necessary at admission.
258. Petitioner's failure to document that he did
not perform a CBC on this patient at the time he was
admitted, his failure to explain why a CBC was not
performed on admission, and his failure to document
the results of the CBC performed prior to admission
is a substantial violation of his obligation to
provide the necessary documentation of care.
P. N.A. at 48-49. 31/
Petitioner argued that no professionally recognized
standard of health care was presented with regard to
whether the CBC was necessary upon admission. P. N.A. at
48. Moreover, Petitioner argued, no standard of
documentation was presented with regard to Petitioner's
failure to document that he was not performing a CBC upon
admission, his reasons for not performing a CBC, and the
results of the prior CBC. P. N.A. at 49; P. Br. at 34-
35.
At the ALJ hearing, neither party offered any testimony
with regard to Petitioner's treatment or documentation of
care of this patient. In the hearing before the PRO,
Petitioner admitted that it was an oversight not to have
done a CBC. I.G. Ex. 6 at 182-83. Given Petitioner's
admission that his failure to perform a CBC was an
oversight, Petitioner has effectively conceded that he
should have performed a CBC upon admission and that the
ALJ's finding on this matter was based on substantial
evidence on the whole record. The ALJ did not, however,
specifically find that Petitioner's failure to perform a
CBC upon admission was a violation of a professionally
recognized standard of care. Thus, whether the expert
witnesses established a precise professionally recognized
standard of health care on this matter is irrelevant.
However, with regard to Petitioner's alleged failure to
document his decision not to do a CBC or to reference the
prior CBC in the patient's record, we conclude that the
I.G. did not prove that Petitioner failed to meet a
necessary standard of documentation. In fact, the I.G.
did not address this point at all in her brief; rather,
she focused only on the issue of whether a CBC was
necessary during this admission. There was no evidence
of any documentation requirement presented to the ALJ.
Thus, we do not know what other reasonable physicians in
the community would have done with regard to documenting
a decision not to perform the test suggested here or to
rely on a previous test.
Nor was any documentation requirement or the alleged
failure to meet such requirement addressed during the PRO
proceedings. The charges in the PRO notice to Petitioner
did not include a documentation failure relating to the
CBC. See I.G. Ex. 2 at 7-8. The only testimony
concerning this patient in the proceedings before the PRO
concerned Petitioner's failure to order the CBC. Neither
Petitioner nor the expert witnesses appearing before the
PRO testified concerning a documentation requirement
relating to the CBC. 32/ Thus, there is no evidence in
this entire record that would support the conclusion that
Petitioner was required to document a test he failed to
perform as a result of an oversight on his part. Nor is
there evidence in the record that would establish that
Petitioner actually failed to comply with such a
documentation standard. In fact, we do not know from
where or when this charge first arose.
We note further that in considering the merits of the
PRO's recommended decision finding Petitioner to have
committed this violation, there was some internal
disagreement within the I.G.'s office as to whether it is
necessary for a physician to document a decision not to
perform a test which is arguably not required. See I.G.
Ex. 29 at 7.
Accordingly, while the ALJ could have reasonably inferred
that a CBC was required upon admission, the ALJ lacked
any basis in the record to find that Petitioner violated
a standard of documentation related to his oversight in
not performing the CBC. Absent some type of
documentation requirement established by substantial
evidence in the record and absent evidence that
Petitioner failed to comply with that requirement, we
cannot hold Petitioner responsible for a violation.
For the above reasons, we affirm and adopt FFCL 256. We
modify FFCL 258 to read as follows:
258. The I.G. did not prove that Petitioner's
failure to document that he did not perform a CBC on
this patient at the time the patient was admitted,
his failure to explain why a CBC was not performed
on admission, and his failure to document the
results of the CBC performed prior to admission is a
substantial violation of his obligation to provide
the necessary documentation of care.
11. Patient 037680 (UPHELD)
The following facts are not in dispute (see generally
I.G. Ex. 27): Patient 037680 was an elderly female
admitted to the hospital with intermittent hallucina-
tions. Although throughout her admission the patient
would often state that she knew her hallucinations were
not real, they were very disturbing to her. At the time
of admission, Petitioner diagnosed this patient with
organic brain syndrome with hallucinatory and delusional
state. Petitioner also found that the patient's right
knee was acutely inflamed.
Throughout the patient's hospital stay, she alternated
between periods of disorientation and lucidity. Two days
following admission, Petitioner performed an arthro-
centesis on the patient's right knee in response to the
inflammation. Arthrocentesis is an invasive procedure in
which a needle is inserted into the knee and fluid is
withdrawn. Approximately 45 minutes after the arthrocen-
tesis was performed, the patient began crying and stated
that she saw snakes coming out of a box of needles. The
patient stated that, although she knew the snakes were
not real, she could still see them. She reported seeing
snakes the following day also. During the course of her
stay and while being given insulin, her hallucinations
diminished and she was discharged 20 days following
admission. Following the arthrocentesis, Petitioner
wrote in his progress notes, "Tapped Rt [right] Knee --
Old Blood -- Hemarthrosis." 33/ The nurse's notes for
the procedure stated only that the right knee was
injected, that certain preparation of the knee was done,
and that the patient tolerated the procedure well. I.G.
Ex. 27 at 61. Petitioner discarded the fluid withdrawn
from the knee.
The ALJ found that Petitioner failed to meet the
professionally recognized standard of care by not getting
informed consent to do the arthrocentesis on the patient,
by not documenting the procedure he performed in
sufficient detail, and by discarding the fluid withdrawn
from the knee without sending it to a laboratory for
analysis.
Petitioner objected specifically to the following FFCLs:
271. Professionally recognized standards of health
care regarding the process for obtaining informed
consent require the physician to explain the purpose
of the procedure, how it will be performed, the
possible benefits of the procedure, and the possible
complications of the procedure. The patient should
be given the opportunity to ask questions of the
physician.
273. If the patient is incapable of understanding
information pertaining to the procedure, it should
be explained to an adult who is the closest relative
to the patient. Consent for performing the
procedure should be obtained from that individual.
278. Petitioner did not obtain informed consent from
this patient.
285. Professionally recognized standards of care
require a physician to write a procedure note for
invasive procedures, such as arthrocentesis,
performed at bedside. The procedure note should
contain a comprehensive description of the
indication for the procedure, the procedure itself,
and the results.
286. Petitioner's August 23, 1991 entry in the chart
documents that arthrocentesis was performed and that
old blood was obtained, but it does not describe the
procedure and the results in sufficient detail to
comport with professionally recognized standards of
care.
287. Petitioner substantially violated a
professionally recognized standard of health care by
failing to document adequately the procedure
performed on this patient.
288. Professionally recognized standards of care
require that fluid withdrawn from a knee in the
course of arthrocentesis should be sent for
laboratory analysis.
292. Petitioner's discarding the withdrawn fluid
without obtaining the necessary tests to make a
final diagnosis is a substantial violation of
professionally recognized standards of care.
P. N.A. at 49-59. 34/
A. Failure to Obtain Informed Consent
Petitioner argued that there might have been written
consent at the time of the procedure which later became
misplaced from the patient's record. P. Br. at 35, 36.
In the alternative, he argued that it was not his duty
but that of the nurses to obtain the written consent. P.
N.A. at 53-54; P. Br. at 35. He also argued that he
obtained oral consent, an assertion which the ALJ did not
find credible. P. Br. at 35-36.
We do not find Petitioner's position that he obtained
informed consent from this patient to be substantiated by
the record. 35/ It is unlikely that this patient entered
into a written consent for the procedure if it is not in
the patient's record. Petitioner did not offer a logical
explanation as to how a signed consent form was
misplaced, why it was not ultimately returned to the
patient's record, or where it could be now given
Petitioner has had extensive time throughout these
proceedings to locate the form. Even if it was
generally the nurse's responsibility to have the consent
form signed, Petitioner did not allege that he could
properly proceed without ascertaining that such form had
been signed or that oral consent was obtained. 36/ Other
charges in this proceeding address a general failure of
Petitioner to document matters which should be included
in a patient's record, and this failing is consistent
with that pattern.
We also conclude that the ALJ's finding that Petitioner
failed to obtain oral consent from the patient is
supported by substantial evidence. There is no
documentation of such consent in the patient's medical
record. The ALJ found that Petitioner's assertion that
he obtained oral consent was not credible, and we have no
basis here to question the ALJ's judgment of credibility.
We find it particularly revealing that Petitioner, when
asked by the PRO if he "explain[ed] the procedure in
detail to this patient," responded --
Not to this 85 year old lady, no. We told her what
we were going to do . . . . She's a very compliant
individual. I don't think she would have understood
a full explanation.
I.G. Ex. 3 at 52. The I.G.'s expert testified as to what
would have constituted informed consent for this type of
procedure and the extent to which information would have
had to have been disclosed to the patient to make that
consent valid. Tr. at 150-51; 300-301. Petitioner
presented no reliable evidence that he made such
disclosure to the patient or that the patient
affirmatively consented. Thus, there is substantial
evidence on the whole record in support of the ALJ's
findings concerning the lack of informed consent for this
procedure.
B. Failure to Sufficiently Document
The ALJ found that Petitioner failed to sufficiently
document in detail the procedure he performed on this
patient's knee. ALJ Dec. at 34 (FFCLs 285-287).
Petitioner responded that his notes, which essentially
stated that he tapped the right knee and that old blood
was withdrawn, coupled with the nurse's notes, which
stated the preparation of the knee which was done and
that the patient tolerated the procedure well, were
sufficient to meet his documentary obligations. P. N.A.
at 56-57. Petitioner further argued that he does not
vary his procedure for arthrocentesis, which procedure he
explained in detail in his response to the PRO reviewers.
P. Br. at 37; see also I.G. Ex. 27 at 4.
Again, we find the ALJ's findings on documentation are
supported by substantial evidence. One of the I.G.'s
experts testified that the required documentation in the
patient's progress notes would include the color of the
fluid obtained, what it looked like, and that it was sent
to the laboratory for analysis. Tr. at 152. This
physician later stated that the physician performing the
procedure should also note the anaesthesia which was
used, the size of the needle inserted, and that fluid was
obtained under sterile conditions. Tr. at 156. The
expert also testified that the physician would state how
much fluid was obtained from the knee. Tr. at 157. The
I.G.'s other expert testified that the procedure note
should --
include the indication for the procedure, the
procedure then should be specified. Whatever
preparation is made of the skin. If a local
anaesthetic is used, that should be documented. And
the procedure itself should be documented, the
technique used, and the physician should comment on
how the patient tolerated the procedure after it's
completed.
Tr. at 301-302. While the standards related by the two
I.G. experts were not identical, they overlap, and
Petitioner's brief progress note for this patient did not
come close to containing the details both experts agreed
should have been included. There is no evidence in the
record that the attending physician can be less detailed
in his documentation if the nurse's notes contain details
of the procedure. Nonetheless, even when Petitioner's
notes are considered along with the nurse's notes, we do
not find the documentation here was sufficient to meet
the overall standards established by the I.G.'s medical
experts.
The fact that Petitioner subsequently explained his
procedure for arthrocentesis in his response to the PRO
and stated that he rarely varied from that procedure is
irrelevant. If Petitioner did not adequately document
the procedure in the patient's medical record, another
physician later treating the patient would not have been
able to determine exactly what was done with regard to
this patient and why.
Thus, we find that the ALJ's conclusion that Petitioner
failed to meet a necessary standard of documentation with
regard to this patient is based on substantial evidence.
C. Failure to Send Fluid to Laboratory
There is no dispute that the fluid which Petitioner
removed from the patient's knee was not sent to a
laboratory for analysis. Petitioner argued that, while
normally a physician would send fluid withdrawn from a
patient to a laboratory for analysis, it is not necessary
to send "old blood" because you could not get accurate
diagnostic results where the blood has already broken
down. P. N.A. at 57-59. Petitioner's expert witness,
who is an infectious disease specialist, agreed that one
would not get accurate results from analyzing old blood.
Tr. at 558.
One of the I.G.'s medical experts testified that blood
samples withdrawn from a knee are "absolutely sent to the
laboratory in every case." He testified that a
laboratory would analyze the contents of the fluid for
blood, pus, or other substances, which would help in the
accuracy of the diagnosis. Tr. at 163. The ALJ pointed
out in his decision that Petitioner did not document in
the patient's record why he believed the removed
substance was old blood or was beyond accurate analysis.
Petitioner responded that any physician and most laymen
could recognize old blood.
While there is clearly conflicting testimony in the
record regarding whether analysis of this substance would
have yielded meaningful results, there is sufficient
evidence based on the whole record on which the ALJ could
have determined that Petitioner failed to meet a
professionally recognized standard of health care in
failing to send the substance to the laboratory.
Moreover, the I.G.'s medical expert testified that all
specimens must be sent to a laboratory under state law.
Tr. at 163. Petitioner did not address this assertion or
attempt to rebut it. Petitioner did not, for example,
establish why a requirement of state law would not
establish (at least) a minimum standard of health care
under these circumstances. Thus, we find that there was
substantial evidence on which the ALJ could determine
Petitioner failed to meet a professionally recognized
standard of health care in failing to send the withdrawn
fluid to the laboratory.
For the above reasons stated in subsections (A), (B), and
(C), we affirm and adopt FFCLs 271, 273, 278, 285-288,
and 292.
12. Patient 034026 (REVERSED)
The following facts are not in dispute (see generally
I.G. Ex. 28): Patient 034026 was an elderly woman
admitted to the hospital with evidence of renal colic,
who remained an inpatient for two days. A blood test
performed on the day of admission found an abnormally
high blood glucose level of 232 mg/dL. 37/ Another blood
glucose test was ordered by a consulting physician for
the day of discharge and that order was documented in the
patient's medical record. The results of this second
blood test were never recorded in the patient's record.
It is uncertain whether this second blood test was ever
done. The ALJ found that Petitioner substantially
violated his obligation to provide necessary
documentation of the quality of his care by failing to
document the results of the second blood test. 38/ ALJ
Dec. at 35 (FFCL 301).
Petitioner objected specifically to the following FFCLs:
299. Petitioner admitted that results of the follow-
up blood test should have been in the medical
record.
301. Petitioner's failure to document the follow-up
blood test result represents a substantial violation
of his obligation to provide necessary documentation
of the quality of his care.
P. N.A. at 61-62. 39/
Petitioner asserted that it was the fault of the hospital
staff rather than his fault that the second blood test
was not done. Petitioner stated that it is the hospital
laboratory staff and not the attending physician who
documents test results. P. N.A. at 62; P. Br. at 40.
Moreover, Petitioner asserted, a urinalysis performed
within minutes of the first blood glucose test indicated
that the 232 mg/dL level was not likely an accurate
result since the urine test showed no presence of glucose
and thus an additional blood test was not necessary. Id.
Finally, Petitioner argued, his failure to document the
second blood test was not a substantial violation of a
professionally recognized standard of care or of a
documentation requirement. P. N.A. at 61.
We find that the ALJ erred in concluding that Petitioner
violated a standard of documentation of his care in this
case. The record substantiates that the second blood
glucose test was ordered by a consulting physician rather
than by Petitioner. See I.G. Ex. 28 at 4, 21; I.G. Ex. 3
at 27; I.G. Ex. 6 at 185-86. Petitioner testified that
it was this consulting physician who discharged the
patient from the hospital. I.G. Ex. 3 at 27. There was
no testimony or evidence establishing a duty of
Petitioner to follow-up on a blood test which was ordered
by another physician or to ensure that the results of the
blood test were recorded in the patient's record before
the other physician discharged the patient. We have no
basis on which to either confirm or doubt Petitioner's
assertion that it was the hospital staff's duty to enter
the test results in the patient's chart given that the
record is completely devoid of any evidence of a follow-
up or documentation standard in this case.
Moreover, we do not interpret Petitioner's alleged
statement -- that the follow-up blood test results should
have been in the patient's record -- as an admission.
First, the sources cited by the ALJ do not support a
finding that Petitioner made such a statement. See ALJ
Dec. at 35 (FFCL 299), citing I.G. Ex. 28 at 4 and P. Br.
(before the ALJ) at 91. Moreover, even if Petitioner had
made such a statement, it would simply be a statement of
Petitioner's opinion as to what information should be
contained in a patient's record. It is not reasonable to
infer from such an assertion that Petitioner was taking
the position that it was his responsibility to record the
results of the test in the record or to ensure that
someone else did.
Thus, without substantial evidence on the whole record
that it was Petitioner's duty to ensure that a blood test
ordered by another physician, who likely discharged the
patient, was done and that the results were recorded in
the patient's chart, we have no basis on which to
conclude that Petitioner violated any documentation
requirement with regard to this patient.
Based on the above, we modify FFCLs 299 and 301 to read
as follows:
299. The I.G. did not prove, nor did Petitioner
admit, that it was Petitioner's duty to record the
results of the follow-up blood test in the patient's
medical record or to ensure that someone else did.
301. The I.G. did not prove that Petitioner's
failure to document the follow-up blood test or to
ensure that someone else did was a substantial
violation of his obligation to provide necessary
documentation of the quality of his care.
II. Section 1156 Standards
A. Substantial Violations in a Substantial Number
of Cases
With regard to the Petitioner's failure to meet the
standards of section 1156(a), the ALJ found and concluded
the following:
302. A provider commits a substantial violation of
his or her statutory obligations under section
1156(a) in a substantial number of cases where the
pattern of care he or she provides is inappropriate,
unnecessary, does not meet professionally recognized
standards of care, or is not supported by necessary
documentation of care as required by a PRO.
303. The I.G. proved that Petitioner engaged in a
pattern of care that is inappropriate, unnecessary,
did not meet professionally recognized standards of
care, or was not supported by necessary documenta-
tion as required by IPRO.
304. The I.G. proved that Petitioner substantially
violated his obligations under section 1156(a) in a
substantial number of cases.
ALJ Dec. at 36.
Petitioner argued in response that the violations found
by the ALJ were with regard to only 11 out of the
approximately 450-500 patients Petitioner admits to the
hospital each year. P. Br. at 41-42. The PRO did a
focused review of 100% of Petitioner's hospital
admissions within a three-month time frame, looking
through hundreds of Petitioner's patients' charts; thus,
according to Petitioner, only finding errors with regard
to 11 of those patients would indicate that Petitioner
did not commit a substantial number of violations.
Petitioner objected to the ALJ's determination that a
"substantial violation" is "any violation that is not
minor and trivial." P. Br. at 44. Petitioner argued
that his violations were, at most, merely minor
documentation errors. P. Br. at 42. Moreover,
Petitioner argued, there is no evidence that his conduct
resulted in any harm to any of his patients. P. Br. at
42.
We have determined that the ALJ's findings and conclu-
sions in FFCLs 302, 303 and 304 are based on substantial
evidence on the whole record and are not erroneous.
While we have concluded that the underlying findings of
the ALJ with regard to five of the 11 cases in which he
found Petitioner failed to meet his obligations under
section 1156(a) were either unsupported by substantial
evidence or were erroneous, these five cases involved
most of the less significant charges against Petitioner.
Thus, eliminating them from the charges does not change
the factual basis on which the ALJ could have concluded
that the I.G. proved that Petitioner substantially failed
to meet the professionally recognized standard of health
care or to support his care with the necessary
documentation in a substantial number of cases. Thus,
the ALJ's conclusion that Petitioner substantially
violated his obligations under section 1156(a) in a
substantial number of cases is not erroneous.
Moreover, we conclude that the ALJ did not err in
defining "substantial" to include any violation which is
not minor or trivial. Webster's offers several
definitions of the word "substantial:"
1) belonging to or having substance;
2) real; true; not seeming or imaginary;
3) with regard to essential elements; corporeal;
material;
4) having strong substance; strong; stout; solid;
5) having property or possessions; wealthy;
6) of considerable worth or value; vital;
important;
7) of considerable size or amount; large;
8) in philosophy, of, or having the nature of;
substance.
Webster's at 1817. Almost all of these definitions and
many of the synonyms offered for them -- such as
material, solid, important -- focus on the fact that
substantial can mean virtually anything more than
immaterial or unimportant. Thus, we do not find that the
ALJ erred when he concluded that a substantial violation
is any violation that is not minor or trivial.
Moreover, we note once again that the definition of "a
substantial violation . . . in a substantial number of
cases" in the applicable regulations contemplates "a
pattern of care" which is "inappropriate, unnecessary,
does not meet professionally recognized standards of
care, or is not supported by necessary documentation of
care as required by a PRO." Thus, each and every
violation need not, in itself, be substantial, but must
merely contribute to a pattern of care which when
considered collectively constitutes a substantial
failure.
Finally, we agree with the ALJ that Petitioner's argument
that his care did not cause any direct harm to any of his
patients is irrelevant. Since the purpose of section
1156 is to protect program patients from providers who
render substandard care, there is no requirement that
harm be found before a practitioner can be excluded under
section 1156 of the Act. We also find no merit to
Petitioner's argument that his errors were limited to
minor documentation violations since most of the
remaining violations do not involve documentation issues
and are significant.
For these reasons, we affirm and adopt FFCLs 302, 303 and
304.
B. Unwillingness or Inability to Comply
With regard to Petitioner's unwillingness or inability to
correct his deficiencies under the requirements of
section 1156(b), the ALJ concluded the following:
305. The I.G. proved that Petitioner has
demonstrated an unwillingness and lack of ability
substantially to comply with his obligation to
provide care in accordance with his obligation under
section 1156(a) of the Act.
ALJ Dec. at 36. Petitioner argued in response that his
willingness and ability have been demonstrated by his
efforts to improve his documentation and his increasing
referrals of patients for consultations. P. Br. at 44-
46.
The ALJ found that Petitioner was both unwilling and
unable to comply with the requirements of section 1156(a)
based on his failure to meet professionally recognized
standards of health care even after entering into and
completing a CAP with the PRO and despite being counseled
to correct his deficiencies. 40/ ALJ Dec. at 106. The
ALJ was particularly disturbed by certain remarks of
Petitioner which indicated that Petitioner promised to
change his practices, but only because of pressure to do
so from the PRO. ALJ Dec. at 107. The ALJ stated that
Petitioner's remarks suggested that Petitioner was not
persuaded that there were true deficiencies in his
medical care or documentation. Id. The ALJ's conclusion
was based, in part, on his judgment of Petitioner's
demeanor (i.e., credibility), and Petitioner has provided
no reason why we should not defer to the ALJ's judgment.
Based on the record in this case, we determine that the
ALJ's conclusion in FFCL 305 is not erroneous. It is
clear from the evidence that Petitioner's treatment of
the patients which forms the basis for this exclusion
occurred after Petitioner agreed to correct his
deficiencies and after he entered into and completed a
CAP in 1989. It is not necessary that we find that
Petitioner was both unwilling and unable to comply with
the requirements of section 1156(a); either an inability
or an unwillingness is sufficient. While we do not
speculate as to Petitioner's state of mind and attitude
with regard to correcting the deficiencies, we conclude
that Petitioner's failure to meet the standards of
section 1156(a) following an opportunity to correct and
following a CAP show that Petitioner was either unwilling
or unable to comply.
Thus, we affirm and adopt FFCL 305.
C. The Remedial Need for an Exclusion
With regard to the remedial need to impose an exclusion
in this matter, the ALJ found the following:
306. The remedial purpose of an exclusion imposed
pursuant to section 1156 of the Act is to protect
the welfare of program beneficiaries and recipients
from providers who are untrustworthy to provide care
of the requisite quality.
307. The I.G. proved that Petitioner is an
untrustworthy provider of care.
308. A five-year exclusion is reasonable in this
case.
ALJ Dec. at 36. We note that the ALJ did not
specifically review each of the eight factors which the
I.G. applied in order to determine the length of the
exclusion. See 42 C.F.R. 1004.90(d); Notice at 8-10.
The ALJ simply addressed the remedial purpose of section
1156 and the reasonableness of a five-year exclusion
based on the evidence.
We discuss the eight factors below and the I.G.'s
application of those factors to Petitioner. We find that
a five-year exclusion is no longer reasonable given the
substantial reduction in the number of charges on which
this proceeding was originally based. We determine that
a two-year exclusion is reasonable under the
circumstances.
1. The recommendation of the PRO
IPRO recommended that Petitioner be excluded for a period
of five years. IPRO's recommendation was based on a
finding of violations in meeting professionally
recognized standards of health care or documentation with
regard to 20 patients. The I.G. reviewed IPRO's
recommendations and determined she agreed with IPRO's
findings with respect to 14 of the cases. The I.G.
adopted that recommendation and excluded Petitioner for
five years. The I.G. presented evidence on 13 of those
cases to the ALJ. The ALJ agreed with the I.G. on 11 of
those cases and upheld the five-year exclusion. See ALJ
Dec. at 8-9 and 36 (FFCLs 36-42 and 302-309). We affirm
the ALJ's conclusions with regard to six of the cases.
Given that the PRO's recommendation was based originally
on alleged violations in 20 cases and the I.G.'s
exclusion was based on 14 cases which have now been
reduced to six, we find that such significant reduction
in the number of violations calls for a substantial
reduction in the length of the exclusion.
2. The type of offense
The I.G.'s Notice informed Petitioner that the alleged
violations in the 14 cases included 11 violations of the
obligation to provide care that meets professionally
recognized standards of health care, and three violations
of the obligation to provide appropriate evidence of
medical necessity and quality in such form and fashion as
may be required. Notice at 9. Now that the cases have
been narrowed down to six, we are left with five cases
which involve violations of the obligation to provide
care that meets professionally recognized standards of
health care and two violations of the obligation to
provide necessary documentation of care. 41/ Thus, we do
not find that the type of offenses or their proportion
have changed significantly throughout this proceeding.
3. The severity of the offense
The I.G.'s Notice noted the following areas of concern
with regard to Petitioner's violations:
failure to provide adequate diagnostic testing;
failure to obtain appropriate consultations;
lack of appropriate documentation necessary to
coordinate care and facilitate continuum of
care; and
failure to keep pace with current and accepted
treatment modalities and general medicine
practice.
Notice at 9. The deficiencies with regard to
Petitioner's care and documentation of care of the six
remaining patients which we have not stricken as a basis
for the exclusion are individually and collectively
serious. These cases involve such findings as --
failure to order the appropriate tests to
determine whether a patient's gallbladder
condition was acute or chronic and was
therefore the source of her pain (ALJ Dec. at
10-13, 42-47);
failure to immediately follow-up a particularly
difficult thoracentesis with a chest x-ray to
determine whether additional fluid remained in,
or air had been introduced into, a patient who
was near death at the time of her transfer to
the hospital (ALJ Dec. at 15-17, 53-58);
failure to follow-up a suspected episode of
transient ischemic attack (TIA) with a Doppler
ultrasound to determine the degree of carotid
artery blockage in a patient who may have been
prone to future TIAs, strokes, or coronary
heart disease (ALJ Dec. at 23-26, 73-76);
failure to specify the drip rate for
administering Dextrose to a diabetic patient
who was admitted following an overdose of
insulin, and failure to specify a rate of
monitoring the patient's blood glucose level
throughout the night following the episode (ALJ
Dec. at 28-29, 82-85);
failure to document Petitioner's intent to
prescribe Coumadin upon discharge to a heart
patient (ALJ Dec. at 30-31, 85-88); and
failure to obtain informed consent, to document
the procedure in detail, and to send the
specimen to the laboratory for further analysis
in the case of an intermittently lucid patient
on whom Petitioner performed an arthrocentesis
to reduce swelling of the knee (ALJ Dec. at 32-
35, 91-103).
Collectively, the findings with regard to these six
patients clearly provide a basis for the ALJ to have
concluded that Petitioner's violations were serious. The
severity of the offenses have not changed significantly
from those noted in the I.G.'s Notice; only their number
has been reduced.
4. The previous sanction record of Petitioner
There is nothing in the record before us to suggest that
Petitioner had previously been sanctioned.
5. The availability of alternative sources of
services in the community
The I.G. Notice concluded that --
An exclusion will have little effect on the
availability of medical services in the community in
which [Petitioner] practice[s], the Little Falls
area in Herkimer County.
Notice at 9. The ALJ did not address this matter in his
decision. However, there is insufficient evidence in the
record on which we would come to a different conclusion
than the I.G. Testimony in the record does suggest that
Petitioner serves a disproportionate share of the poorest
patients in the community and accepts only nominal
payment from many of them when they are unable to pay.
Testimony also indicates that Petitioner serves patients
whom other physicians have declined care of and who are
poorer and sicker than most patients. Tr. at 10; I.G.
Ex. 6 at 213-14. However, under the applicable criteria
for determining whether alternative sources of medical
services exist in a community, Petitioner, in order to
argue for an otherwise shorter length of exclusion, would
have had to provide evidence to show that, as a result of
his exclusion, program patients would not have reasonable
access to the types of services he provides based on such
factors as the number of program participants he treated
prior to the exclusion, his success in finding new
providers for them, the number of other physicians in the
community accepting treatment of program participants,
and his own waiting list of patients. See Barry D.
Garfinkel, M.D., DAB 1572, at 20 (April 23, 1996).
Petitioner did not provide such evidence; thus, we have
no basis on which to conclude that the I.G. erred in
finding that the record does not establish that
Petitioner's exclusion will cause a shortage of services
for program participants. 42/
6. Any prior problems the Medicare carrier
has had with Petitioner
There is nothing in the record before us to suggest that
the Medicare carrier had prior problems with Petitioner.
7. Whether the practitioner or other person
is unable or unwilling to comply
substantially with the obligations of
section 1156 of the Act or the corrective
action plan
As discussed above, we affirm the ALJ's conclusion that
Petitioner was either unwilling or unable to comply with
the requirements of section 1156(a).
8. Any other matters relevant to the
particular case
In the I.G.'s Notice to Petitioner, she stated that there
were no other matters relevant to this particular case.
Petitioner did not raise additional matters.
We conclude that based on the factors discussed in
subsections (C)(1-8) above, an exclusion of five years is
unreasonable. For these reasons, we affirm and adopt
FFCLs 306 and 307. We modify FFCL 308 as follows:
308. A two-year exclusion is reasonable in this
case.
D. Serious Risk Issue
With regard to whether Petitioner poses a serious risk to
his patients, the ALJ concluded that --
309. The I.G. proved that Petitioner is a serious
risk within the meaning of section 1156 of the Act.
ALJ Dec. at 36. Petitioner pointed out in response that
the I.G. did not request an immediate hearing and
decision on the serious risk issue and that Petitioner
continued to practice medicine from May 3, 1994 when the
I.G. sent its Notice excluding Petitioner until the time
of the ALJ Decision. Moreover, he stated that no proof
was offered that Petitioner posed a serious risk to
patients. P. Br. at 48. Thus, Petitioner argued, the
ALJ's findings were "almost entirely gratuitous." Id.
The issue of serious risk arises under section 1156 only
when a provider practices in a rural health professional
shortage area or in a county with a population of less
than 70,000. While normally an exclusion under section
1156 takes effect shortly following notice from the I.G.
and before there is an opportunity for a hearing before
the ALJ, in these two circumstances the exclusion does
not take effect until after there has been a decision on
the merits. Section 1156(b)(5) of the Act. However, if
the ALJ determines that a petitioner poses a serious risk
to patients, the exclusion takes effect as soon as the
ALJ determines that the petitioner poses a serious risk.
In this case, the I.G. found that Petitioner practices in
a county in which the population is less than 70,000,
thus making the provision discussed above applicable.
ALJ Dec. at 114, citing an August 31, 1994 letter from
the I.G. to Petitioner. In order to avoid the delays
which would occur in holding two separate hearings -- one
on the serious risk issue and one on the merits of the
exclusion -- the parties requested that the ALJ
consolidate the hearings. The ALJ did so. ALJ Dec. at
114. Thus, the ALJ ruled both on the serious risk issue
and the merits of the exclusion in the same decision. 43/
The ALJ based his conclusion that Petitioner posed a
"serious risk" on the fact that Petitioner demonstrated
both "a lack of judgment and of knowledge of appropriate
basic medical responses in the evaluation and care of
patients." ALJ Dec. at 115. The ALJ explained that his
decision on this issue was not based on any findings that
Petitioner actually harmed his patients, but rather that
Petitioner's treatment practices were seriously
deficient. He cited to several specific cases where
Petitioner failed to order specific tests to diagnose his
patients' conditions. ALJ Dec. at 115-16.
We find that the ALJ's conclusion that Petitioner poses a
serious risk to his community is not erroneous based on
the record. Each of the examples in the record in which
we find that the ALJ Decision is supported by substantial
evidence and which involves a failure to perform
appropriate diagnostic tests is serious. We agree that
Petitioner caused no actual harm to these patients.
Nonetheless, the term "risk" implies that only a
potential for serious harm must be shown rather than
actual harm.
For the above reasons, we affirm and adopt FFCL 309.
CONCLUSION
For the reasons stated above, we find that the ALJ did
not err in upholding Petitioner's exclusion under section
1156 the Act. However, we reduce the length of the
exclusion to two years. We affirm and adopt each FFCL in
the ALJ decision with the modifications noted above,
which are listed in the appendix to this decision.
_______________________________
Judith A. Ballard
________________________________
M. Terry Johnson
________________________________
Donald F. Garrett
Presiding Board Member
APPENDIX
The following modifications have been made to the ALJ's
FFCLs:
51. The sonogram of the patient's gallbladder
revealed evidence of cholelithiasis (gallstones)
with thickened gallbladder walls suggesting possible
cholecystitis (gallbladder inflammation).
92. The I.G. did not establish that professionally
recognized standards of care for a patient with an
unexplained upper GI bleed which ceases bleeding
during treatment and does not resume require that a
physician perform either an endoscopy or an upper GI
series.
97. Petitioner's failure to obtain an endoscopy or
an upper GI series to investigate an upper GI bleed
in this patient, who stopped bleeding during
treatment and did not rebleed, did not violate
professionally recognized standards of care.
98. [deleted]
143. Professionally recognized standards of care
require an attending physician to direct a plan of
care to address skin conditions caused by prolonged
pressure.
145. Petitioner directed care of this patient's skin
condition by noting the condition of the skin upon
admission, monitoring the progress of the skin's
healing throughout the patient's stay, and giving
specific directions to the nursing staff to apply
Neosporin.
146. The I.G. did not prove that Petitioner's
direction of care with regard to this patient's skin
condition did not meet professionally recognized
standards of care.
149. [deleted]
219. The I.G. did not give Petitioner sufficient
notice that she was alleging that Petitioner
inaccurately documented his treatment of the patient
on the discharge summary, and that this
documentation error was a basis for the I.G.'s
determination to exclude Petitioner. Notice at 5.
222. Even if Petitioner had been given sufficient
notice that the I.G. was excluding Petitioner based
in part on the error in the discharge summary, the
I.G. did not prove that Petitioner's failure to
accurately document his discharge instructions on
the December 30, 1991 discharge summary was a
substantial violation of his obligation to provide
care and to support his care by the necessary
documentation.
251. Petitioner's failure to document his intent to
prescribe Coumadin to this patient on discharge is a
violation of his obligation to provide necessary
documentation of his care.
258. The I.G. did not prove that Petitioner's
failure to document that he did not perform a CBC on
this patient at the time the patient was admitted,
his failure to explain why a CBC was not performed
on admission, and his failure to document the
results of the CBC performed prior to admission is a
substantial violation of his obligation to provide
the necessary documentation of care.
299. The I.G. did not prove, nor did Petitioner
admit, that it was Petitioner's duty to record the
results of the follow-up blood test in the patient's
medical record or to ensure that someone else did.
301. The I.G. did not prove that Petitioner's
failure to document the follow-up blood test or to
ensure that someone else did was a substantial
violation of his obligation to provide necessary
documentation of the quality of his care.
308. A two-year exclusion is reasonable in this
case.
1. Section 1156 authorizes the Secretary to exclude a
person from eligibility to provide services under the
Act. See also 42 C.F.R. 1004.110 and 1001.1901.
Unless the term indicates otherwise, we hereafter use the
term "Medicaid" to represent all state health care
programs from which Petitioner was excluded.
2. For purposes of this decision, each case constitutes
the hospital care and treatment of a single patient,
except with regard to two cases that both involve the
fifth patient we discuss. Those two cases represent the
care and treatment of that patient during two different
hospital stays.
3. Petitioner submitted both a Notice of Appeal, in
which he discussed his objections to the FFCLs, and an
Appeal Brief, in which he discussed his objections to the
discussion section of the ALJ Decision. Both were dated
February 12, 1996 and were submitted together.
4. As did the ALJ Decision, we are withholding the
names of the patients involved and are referring to them
by their medical record numbers in order to protect their
privacy.
5. This summary is provided for the convenience of the
reader and is not intended to modify or reverse any
findings or conclusions of the ALJ.
6. The actions which led to the charges which form the
basis of this proceeding occurred in 1991, and the I.G.
applied these eight criteria as in effect during 1991.
7. As a preliminary matter, we affirm and adopt each of
the FFCLs in the sections captioned "Petitioner's
professional background" (FFCLs 1-7), "Right to a
hearing" (FFCLs 43-45), and "The I.G.'s authority to
impose an exclusion" (FFCLs 46-47). Petitioner raised no
objections to these sections. We also affirm and adopt
each of the FFCLs in the section captioned "Procedural
history" (FFCLs 8-42). While Petitioner raised several
objections, the ALJ appears to have included these
findings solely in order to provide a historical
background for the matter. The ALJ did not rely on these
findings in determining that the exclusion was
reasonable.
8. Based on the sonogram report and on the testimony of
one of the I.G.'s medical experts, the ALJ found that the
sonogram "revealed evidence of cholelithiasis
(gallstones) with thickened gallbladder walls suggesting
cholecystitis (gallbladder infection)." FFCL 51.
Petitioner argued that the sonogram report stated only
that there was a possibility of cholecystitis and that
cholecystitis is not defined as an infection of the
gallbladder but rather as an inflammation. We find that
Petitioner's objections have merit and that in these
respects FFCL 51 was not based on substantial evidence on
the whole record. The testimony of the I.G.'s medical
expert, Dr. Kops, and Petitioner's expert witness, Dr.
Nicholas, confirm that cholecystitis means an
inflammation of the gallbladder that may or may not
involve an infection. Tr. at 311, 378. Moreover, the
sonogram report specifically states "possible"
cholecystitis. Thus, based on Petitioner's exceptions,
we modify FFCL 51 as follows:
51. The sonogram of the patient's gallbladder
revealed evidence of cholelithiasis (gallstones)
with thickened gallbladder walls suggesting possible
cholecystitis (gallbladder inflammation).
9. Throughout this decision, in citing to the ALJ's
FFCLs, we have deleted the ALJ's citations to the record.
10. Petitioner also objected to FFCLs 52, 53, 55, 56,
57, 58, 61, 63, 64, 66, 68, 70, 71, and 76. Id.
However, we find that FFCLs 63 and 66 were based solely
on judgments of credibility of witnesses or the proper
amount of weight to be given to pieces of conflicting
evidence, and we have determined they were based on
substantial evidence on the whole record. We therefore
affirm and adopt these FFCLs without further discussion.
We have determined that FFCLs 52, 53, 55, 56, 57, 58, 61,
64, 68, 70, 71, and 76 were not material to the
conclusions reached by the ALJ with regard to this
patient, or the objections were solely for clarification
because Petitioner found them to be misleading. Since
these FFCLs do not affect our underlying conclusions
concerning this patient, it is not necessary for us to
provide an extensive review of them. Any error, even if
established, would be harmless error. We therefore
summarily affirm and adopt them without further
discussion. Likewise, we affirm and adopt FFCLs 48-50,
59, 65, 67, 72-75, and 79, to which Petitioner did not
object.
11. It is not clear from the record whether the
consultation with the gastroenterologist or the
gallbladder sonogram occurred first, given that the
record reflects they were both done on the same day.
I.G. Ex. 16 at 21, 61. Because the gastroenterologist
did not comment on the sonogram results or even on the
fact that a sonogram was ordered, the ALJ found that the
sonogram was likely ordered after the consultation with
the gastroenterologist.
12. One possible explanation is that Petitioner made
this assumption because the sonogram did not indicate any
blockage of the common bile ducts. Petitioner, however,
did not establish that the absence of any blockage of the
common bile ducts, as indicated by a sonogram, would
absolutely rule out the possibility of acute cholecys-
titis or completely eliminate the efficacy of the five
tests which the I.G. expert testimony established were
necessary here. Moreover, the I.G.'s expert testified
that one could not see all of the necessary areas of the
pancreas from a sonogram and that other tests were
therefore necessary. Tr. at 44-45.
13. Petitioner argued that this opinion was only an
interim diagnosis, which was clarified by his progress
note of July 31, 1991, which stated "sonogram --
gallstones -- relation to pain and vomiting obscure." P.
N.A. at 7, 13. However, the discharge summary (which
indicated Petitioner's belief that the patient's pain was
related to her gallbladder) was written several weeks
after the progress note (which indicated Petitioner's
belief that the patient's pain was not gallbladder-
related). Thus, Petitioner's argument that he ultimately
concluded that the patient's pain was unrelated to her
gallbladder is not credible; at the very least, these two
entries show an inconsistency of diagnosis which would
weigh heavily in favor of performing the five tests in
order to resolve the inconsistency.
14. We affirm and adopt FFCLs 80-91, 93, and 96, to
which Petitioner did not object.
15. The ALJ nevertheless determined that Petitioner fit
within two of the exceptions identified in the NEJM
article to the general rule that an early endoscopy
should not be routinely performed: 1) where a patient
has had several prior episodes of bleeding; and 2) where
a malignancy is suspected. P. Ex. 53 at 5. Contrary to
what the ALJ found, the record does not establish that
this patient falls within the exceptions. The ALJ
reached this conclusion apparently based on his own
reading of the article, not on any expert testimony. The
ALJ ignored the fact that the article stated early
endoscopy should be performed where a patient has had
"several episodes of prior rebleeding," and incorrectly
found that this patient fell within this exception
because she had had one prior incident of bleeding
several years earlier. ALJ Dec. at 50, n. 13. Moreover,
the I.G. did not establish by evidence in the record that
Petitioner had a specific reason to suspect a malignancy.
The I.G. did not provide expert testimony that the
patient had any indications of an upper-GI malignancy or
that she was susceptible to stomach cancer because one
family member had previously had stomach cancer.
16. The I.G. did not suggest that Petitioner's care of
this patient contributed to her death.
17. Petitioner also objected to FFCLs 106 and 114. Id.
However, we find that FFCL 114 was based solely on the
ALJ's judgment of the proper amount of weight to be given
to pieces of conflicting evidence, and we have determined
it was based on substantial evidence on the whole record.
We therefore affirm and adopt it without further
discussion. Petitioner's objection to FFCL 106 was
solely for clarification because Petitioner found it to
be misleading. Since it does not affect our underlying
conclusions concerning this patient, it is not necessary
for us to provide an extensive review of it. Any error,
even if established, would be harmless error. We
therefore summarily affirm and adopt it without further
discussion. Likewise, we affirm and adopt FFCLs 99-105,
107-112, and 116, to which Petitioner did not object.
18. While one of the I.G.'s experts suggested that the
thoracentesis should not have been done, this exclusion
is not based in any part on such a charge. See Tr. at
98.
19. Petitioner also objected to FFCLs 136, 141, 142,
and 150. P. N.A. at 29-30. However, we have determined
that Petitioner's objection to these FFCLs was solely for
clarification of wording which Petitioner found to be
misleading. Since they do not affect our underlying
conclusions concerning this patient and since we are
reversing the underlying findings for this patient in any
event, it is not necessary for us to provide an extensive
review of them. We therefore summarily affirm and adopt
them without further discussion. Likewise, we affirm and
adopt FFCLs 118-135, 137-140, 144, 147-148, and 151-154,
to which Petitioner did not object.
20. Petitioner stated that he attached an affidavit of
the patient's attending nurse indicating that Petitioner
orally ordered care for this patient's blister. P. N.A.
at 31; P. Br. at 26. However, such affidavit was not
attached to the brief provided to the Board and,
according to the I.G., was not attached to the copy filed
with the I.G. either. I.G. Br. at 25.
21. Petitioner also objected to FFCLs 191, 194, 196,
202, 203, and 205. Id. However, we find that FFCLs 191,
194, 203, and 205 were based solely on judgments of
credibility of witnesses or the proper amount of weight
to be given to pieces of conflicting evidence, and we
have determined they were based on substantial evidence
on the whole record. We therefore affirm and adopt these
FFCLs without further discussion. We have determined
that FFCLs 196 and 202 were solely for clarification
because Petitioner found them to be misleading. Since
these FFCLs do not affect our underlying conclusions
concerning this patient, it is not necessary for us to
provide an extensive review of them. Any error, even if
established, would be harmless error. We therefore
summarily affirm and adopt them without further
discussion. Likewise, we affirm and adopt FFCLs 182-190,
192, 197-198, and 200-201, to which Petitioner did not
object.
22. The ALJ does appear to go beyond the scope of the
charges with regard to Petitioner's failure to document
any discussions with the patient, as Petitioner alleged.
However, we do not find a separate violation of a
professionally recognized standard of health care based
on a lack of documentation; the issue is whether there is
any documentation lending credence to Petitioner's
statement that he based his assertion that carotid artery
surgery was unacceptable to this patient on a discussion
with the patient.
23. Petitioner argued that the I.G.'s medical expert
stated, in the hearing before the PRO, that he agreed
with Petitioner's decision against surgery with regard to
this patient and that he implied that Petitioner's care
of the patient was fine. We do not interpret this
testimony to say that. The medical expert agreed only
that knowing someone else died from a similar procedure
could "switch your thinking" on the matter; the expert's
comment that "that's fine" was in direct reference to
Petitioner's assertion that Petitioner had reviewed some
articles on the surgery and had decided against it. I.G.
Ex. 6 at 149.
24. Petitioner also objected to FFCLs 211, 214, and
215. Id. at 39-40. However, we have determined that
Petitioner's objections to these FFCLs were solely for
clarification because Petitioner found them to be
misleading. Since they do not affect our underlying
conclusions concerning this patient and since we are
reversing the underlying findings for this patient in any
event, it is not necessary for us to provide an extensive
review of them. We therefore summarily affirm and adopt
them without further discussion. Likewise, we affirm and
adopt FFCLs 208-210, 212-213, 216-218, 220, and 223-227,
to which Petitioner did not object.
25. Normal blood sugar should range between 80 and 120
mg/dL. Tr. at 140.
26. Petitioner also objected to FFCL 230. Id. at 42.
However, we have determined that Petitioner's objection
to FFCL 230 was solely for clarification of wording which
Petitioner found to be misleading. Since it does not
affect our underlying conclusions concerning this
patient, it is not necessary for us to provide an
extensive review of it. Any error, even if established,
would be harmless error. We therefore summarily affirm
and adopt it without further discussion. Likewise, we
affirm and adopt FFCLs 228-229 and 231-236, to which
Petitioner did not object.
27. We do not find, as argued by Petitioner, that this
expert was limiting his testimony concerning this
frequent monitoring only to a patient who was, at the
time, in a coma. See P. Br. at 32; Tr. at 138.
28. Petitioner also objected to FFCLs 247 and 249. Id.
at 47. However, we have determined that Petitioner's
objection was solely for clarification because Petitioner
found the wording of these FFCLs to be misleading. Since
they do not affect our underlying conclusions concerning
this patient, it is not necessary for us to provide an
extensive review of them. Any error, even if
established, would be harmless error. We therefore
summarily affirm and adopt them without further
discussion. Likewise, we affirm and adopt FFCLs 242-246,
248, and 250, to which Petitioner did not object.
29. We have not considered any references in the I.G.
Brief to an alleged failure of Petitioner to properly
medicate this patient, since the I.G.'s charges related
solely to a failure to document.
30. The ALJ found that this patient had had a CBC done
approximately seven days earlier. FFCL 255, citing I.G.
Ex. 3 at 23. This was based on Petitioner's testimony
before the PRO that he thought that was approximately
when the previous CBC was done. However, Petitioner's
responses to the PRO reviewers indicate that he believed
that the prior CBC was done on August 6, 1991, more than
a month prior to this patient's admission. I.G. Ex. 26
at 4; see also I.G. Ex. 6 at 182. Since there is no
documentation of the prior test in the patient's medical
record as submitted here, we are unable to verify exactly
when the previous test was done.
31. We affirm and adopt FFCLs 252-255 and 257, to which
Petitioner did not object.
32. One expert, as part of a question, referred to
Petitioner's concession concerning his failure to perform
the CBC "as the CBC not being documented." I.G. Ex. 6 at
183. However, this testimony appears to refer to
Petitioner's concession regarding a professionally
recognized standard of care. No testimony was elicited
during the proceedings regarding a standard of
documentation concerning the performance of the CBC, and,
as we stated above, that issue was not even among the
charges against Petitioner.
33. "Hemarthrosis" means blood in the knee joint. Tr.
at 160 and 557.
34. Petitioner also objected to FFCLs 262, 263, 267,
268, 274, 276, 277, 279, 280, 281, 282, 289, 290, and
291. Id. However, we find that FFCLs 276, 277, 280, and
289 were based solely on judgments of credibility of
witnesses or the proper amount of weight to be given to
pieces of conflicting evidence, and we have determined
they were based on substantial evidence on the whole
record. We therefore affirm and adopt these FFCLs
without further discussion. We have determined that
FFCLs 262, 263, 267, 268, 274, 279, 281, 282, 290, and
291 were not material to the conclusions reached by the
ALJ with regard to this patient, or the objections were
solely for clarification because Petitioner found them to
be misleading. Since these FFCLs do not affect our
underlying conclusions concerning this patient, it is not
necessary for us to provide an extensive review of them.
Any error, even if established, would be harmless error.
We therefore summarily affirm and adopt them without
further discussion. Likewise, we affirm and adopt FFCLs
259-261, 264-266, 269-270, 272, 275, 281, and 283-284, to
which Petitioner did not object.
35. The ALJ questioned whether this patient was capable
of giving informed consent given her intermittent
hallucinations. He suggested that Petitioner should have
obtained consent from the patient's brother who lived
nearby. Petitioner responded that to do so would have
been unlawful. P. N.A. at 52-53. We do not need to
resolve the issue of whether the patient was capable of
consenting or whether it was unlawful for a family member
to consent because we find that no consent was given by
either the patient or any member of her family.
36. The I.G. objected to Petitioner offering the
affidavit of the attending nurse, Jean Guiney, R.N., into
evidence since it was not part of the record before the
ALJ. I.G. Br. at 51, citing F.P.C. v. Transcontinental
Gas Pipe Line, 423 U.S. 326, 331 (1976). The Board
ordinarily does not permit the introduction of evidence
into the record that could have been presented before the
ALJ but was not unless the party proffering the evidence
established good cause for its failure. See 42 C.F.R.
1005.21(f) (authorizes the Board to remand to ALJ where a
party proffers new and material evidence and where there
were reasonable grounds for failure to adduce the
evidence before the ALJ.) Petitioner here did not
establish good cause for failing to proffer evidence that
was available at the time of the hearing and highly
relevant to issues presented during the hearing.
Therefore, we decline to admit the affidavit into the
record. We note in any event that the affidavit strongly
undercuts Petitioner's position in several respects. The
affidavit does not establish that either oral or written
consent was received from this patient.
37. As stated previously, normal blood glucose levels
range between 80 and 120 mg/dL. Tr. at 140.
38. While the May 3, 1994 Notice to Petitioner alleged
(and the I.G. Brief discussed) a general failure to
properly evaluate or follow-up an abnormally elevated
glucose level, the ALJ made findings only with regard to
the more narrow issue of Petitioner's failure to document
the second blood test which was ordered. See Notice at
7. Thus, we limit our discussion to this more narrow
issue.
39. Petitioner also objected to FFCLs 295 and 298. Id.
at 60-61. However, we have determined that Petitioner's
objections to these FFCLs were solely for clarification
of wording which Petitioner found to be misleading.
Since they do not affect our underlying conclusions
concerning this patient and since we are reversing the
underlying findings for this patient in any event, it is
not necessary for us to provide an extensive review of
them. We therefore summarily affirm and adopt them
without further discussion. Likewise, we affirm and
adopt FFCLs 293-294, 296-297, and 300, to which
Petitioner did not object.
40. Petitioner objected to all references in the record
to allegations that his CAP was considered insufficient
by the PRO since such opinion was never communicated to
Petitioner prior to these proceedings. P. N.A. at 2-4.
We are not basing any part of our decision on such
allegations. Our decision is based solely on the
evidence indicating that Petitioner did complete the
required CAP but that his subsequent patient care failed
to meet the requirements of section 1156(a) in some
instances.
41. Patient 037680 (Patient 11) involves both failures
to meet professionally recognized standards of health
care and to adequately document the care.
42. While Garfinkel involved an exclusion under section
1128(b) of the Act rather than 1156(a), we nonetheless
find the principle at issue here is similar in both
sections. In both Garfinkel and this decision, the issue
is the reasonable length of an exclusion based, in part,
on consideration of whether alternative sources of health
care are available to program participants in the
community if a provider is excluded.
43. According to the ALJ, he addressed the "serious
risk" issue based on an uncertainty as to whether this
issue was moot. ALJ Dec. at 115. He stated that it was
unclear to him from the statute whether the exclusion
would take effect following his unfavorable decision on
the merits if the Petitioner appealed the ALJ Decision to
the Appellate Division of the Departmental Appeals Board.
Thus, the ALJ addressed the serious risk issue in order
to ensure that the exclusion took effect following his
decision rather than following a decision on further
appeal.