Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In The Case of:
Evelyn Reyes, M.D.,
- v -
The Inspector General,
Respondent.
DATE: May 31, 1991
Docket No. C-302
DECISION
On August 31, 1990, the Inspector General (I.G.) notified Petitioner that he
was excluding her from
participating in Medicare and any state health care program for three years.
1/ The I.G. advised Petitioner
that his authority to impose and direct an exclusion was derived from section
1156 of the Social Security
Act (Act). He stated that his exclusion determination was based on a recommendation
by the Puerto Rico
Foundation for Medical Care, Inc., the peer review organization (P.R.O.) for
Puerto Rico. The I.G. further
notified Petitioner that she had grossly and flagrantly violated her obligation
under section 1156 to provide
care to patients that met professionally recognized standards of health care.
He concluded that, while
Petitioner had exhibited a willingness to comply with her obligations under
section 1156, she had
demonstrated an inability to substantially comply with such obligations. The
I.G. based his conclusions on
Petitioner's treatment of three patients which he identified, and to which I
shall refer hereafter as patients
95883, 39026, and 143127. 2/
The I.G. notified Petitioner that she was entitled to request a hearing before
an administrative law judge
concerning his exclusion determination. The I.G. also advised Petitioner that,
because her practice was
located in a county with a population of less than 70,000 or in a rural health
manpower shortage area, she
was also entitled to a preliminary hearing before an administrative law judge
to decide whether the
exclusion should be implemented pending a final decision on her hearing request.
He informed Petitioner
that the issue at the preliminary hearing would be whether Petitioner posed
a serious risk to the welfare and
safety of program beneficiaries and recipients.
Petitioner timely requested hearings, both as to the preliminary issue of serious
risk, and as to the issue of
the reasonableness of the I.G.'s exclusion determination. The case was assigned
to me for hearings on all
issues. Petitioner requested, and the I.G. did not object to, a consolidated
hearing on all issues. I held a
consolidated hearing in San Juan, Puerto Rico, from December 3 - 6, 1990.
At the completion of the hearing, the I.G. requested that I rule on the serious
risk issue prior to issuing my
decision in this case. On January 9, 1991, I issued a ruling on the issue of
serious risk. I concluded that the
I.G. had failed to prove that Petitioner would pose a serious risk to the safety
and welfare of beneficiaries
and recipients pending my decision in the case. Therefore, I declined to impose
an exclusion pending my
decision on the merits.
The parties subsequently filed briefs concerning the issues of whether there
existed a basis to exclude
Petitioner and the reasonableness of the exclusion imposed and directed by the
I.G. The parties also filed
proposed findings of fact and conclusions of law. I have carefully considered
the parties' submissions as
well as the record of this case. I conclude that the evidence establishes that
Petitioner has grossly and
flagrantly violated her obligation to provide care which meets professionally
recognized standards and has
demonstrated an inability to comply with such obligation. The I.G. therefore
had authority to exclude
Petitioner pursuant to section 1156 of the Act. Although there is a remedial
need for an exclusion in this
case, no remedial purpose would be served by excluding Petitioner for three
years. Therefore, the three-
year exclusion imposed and directed by the I.G. is unreasonable. I modify the
exclusion to an exclusion
for six months, running prospectively from June 20, 1991 (to allow for receipt
and implementation of my
decision).
ISSUES
The issues in this case are whether:
1. I may consider evidence that Petitioner committed violations in addition
to those which the
I.G. specifically identified in his August 31, 1990, notice letter;
2. Petitioner grossly and flagrantly violated her obligation to provide health
care which meets
professionally recognized standards and demonstrated an inability to comply
with her obligation; and
3. the exclusion imposed and directed against Petitioner by the I.G. satisfies
the remedial purpose
of the Act.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
1. Petitioner is a physician who is licensed to practice medicine in Puerto Rico. P. Ex. 1/1. 3/
2. Petitioner has three years of residency in internal medicine and is board
eligible in internal medicine. P.
Ex. 1/1, 5/1.
3. Petitioner served as a physician on the staff of Arecibo Regional Hospital
(Arecibo Hospital) in
Arecibo, Puerto Rico, from 1981 until October 1990. P. Ex. 8/1; Tr. at 885.
4. On April 8, 1987, patient 143127 was transferred to Arecibo Hospital from
another hospital, Manati
Hospital, intoxicated with the medications phenobarbitol, dilantin, and tegretol.
I.G. Ex. 64a/1, 39; 64b/39.
5. Patient 143127 was unconscious on his arrival at Arecibo Hospital. He was
in a deep sleep with normal
respiration. The pupils of his eyes were fixed with poor response to light.
I.G. Ex. 64a/5.
6. Patient 143127 was admitted to Arecibo Hospital under Petitioner's service
on April 8, 1987. I.G. Ex.
64a/1; Tr. at 625.
7. When a patient is admitted under a physician's service, that physician assumes
responsibility for the
management of the care of the patient. Tr. at 625, 851, 884, 897, 911; See I.G.
Ex. 22/13-14.
8. Patient 143127 died at Arecibo Hospital on April 12, 1987. I.G. Ex. 64a/1.
9. Petitioner first saw patient 143127 on April 9, 1987, at about 10:35 am. I.G. Ex. 64a/6.
10. The I.G. did not prove that, prior to April 9, 1987, Petitioner was aware
that patient 143127 had been
assigned to her service.
11. The medical condition of patient 143127 at the time of his arrival at Arecibo
Hospital was such that he
should have been intubated immediately. I.G. Ex. 22/3; Tr. at 630-631.
12. When a patient is intubated, a tube is placed in the patient's throat in
order to create an unobstructed
passageway to the patient's trachea. Tr. at 632.
13. A patient is normally intubated in order to assist that patient's breathing,
to prevent hypoxemia
(deficient oxygenation of the patient's blood), and to prevent inspiration of
stomach contents when gastric
lavage is performed. Tr. at 632.
14. Patient 143127 was not intubated from the time of his admission until after
Petitioner first saw the
patient on April 9, 1987. I.G. Ex. 64a/26; Tr. at 630-631; Finding 9.
15. It is standard medical procedure to treat a patient who is intoxicated
with medications aggressively
during the first 12 hours after that patient's admission. Tr. at 754-755.
16. Aggressive treatment of intoxicated patients should be done in conjunction
with monitoring measures
which include continued evaluation of vital signs (blood pressure, pulse, and
respiration) and urinary
output. Tr. at 754.
17. Monitoring measures were not followed with respect to patient 143127 between
his admission and
April 9, 1987. I.G. Ex. 47/7; Tr. at 755, 762; See I.G. Ex. 64a.
18. Patient 143127 should have been placed in the intensive care unit on his
admission to Arecibo Hospital
so that necessary monitoring could be performed. I.G. Ex. 22/3, 47/18; Tr. at
767-770.
19. If no beds were available in the intensive care unit, patient 143127 should
nevertheless have received
care equivalent to what he would have received in the intensive care unit. Tr.
at 769-770.
20. Between April 8 and April 9, 1987, patient 143127 was neither placed in
the intensive care unit nor did
he receive equivalent treatment at some other location in Arecibo Hospital.
See I.G. Ex. 64a.
21. Patient 143127 was first placed in the intensive care unit at Arecibo Hospital
on April 9, 1987, on
Petitioner's orders. I.G. Ex. 64a/24, 43, 64b/43.
22. Patient 143127 was observed at 8:30 a.m. on April 9, 1987, to be experiencing
convulsions of five
seconds' duration every minute. I.G. Ex. 64a/42, 64b/42.
23. On April 9, 1987, at 10:45 a.m., Petitioner requested a consultation with
a neurologist concerning
patient 143127. I.G. Ex. 64a/6.
24. A neurologist examined patient 143127 on April 9, 1987, at 11:30 a.m. I.G. Ex. 64a/6.
25. The neurologist concluded that the prognosis for patient 143127 was very poor. I.G. Ex. 64a/6.
26. The neurologist recommended that if patient 143127 developed seizures,
he should be given valium
intravenously. I.G. Ex. 64a/6. The neurologist advised against giving patient
143127 anticonvulsant
medications. Id.
27. The neurologist also recommended that if patient 143127 developed status
epilepticus he should be
given depakene. I.G. Ex. 64a/6.
28. The neurologist also recommended that supportive measures for patient 143127
be maintained. I.G.
Ex. 64a/6.
29. Status epilepticus is an emergency medical condition in which a patient
develops continuous motor
convulsions. Tr. at 781-782.
30. When a patient develops status epilepticus, he manifests a muscular movement
which is similar to
trembling, but with a loss of consciousness. Tr. at 782.
31. Status epilepticus is an emergency condition, because if it persists for
more than 30 minutes, it can
result in permanent brain damage. Tr. at 782-783.
32. Patient 143127 manifested continuous convulsions after Petitioner consulted
with the neurologist. I.G.
Ex. 64a/46-50, 64b/46-50; Tr. at 780-783.
33. Patient 143127 was treated for convulsions with valium and depakene, as
per the recommendations of
the consulting neurologist. I.G. Ex. 64a/6, /47-50, I.G. Ex. 64b/47-50.
34. Patient 143127 continued to experience convulsions even though he was treated
with valium and
depakene. Tr. at 783-784.
35. On April 8, 1987, at 10:00 p.m., tests were made of patient 143127 to determine
his blood levels of
dilantin, tegretol, and phenobarbitol. I.G. Ex. 64a/8.
36. Tests to determine the blood levels of dilantin, tegretol, and phenobarbitol
were not repeated on patient
143127 after April 8, 1987. I.G. Ex. 64a.
37. Continuous testing of blood levels of medication are necessary in an intoxicated
patient as an adjunct
to other monitoring procedures. I.G. Ex. 22/4-5; Tr. at 793.
38. In a patient with a history of a convulsive disorder, such as Patient 143127,
there is a danger that blood
levels of anticonvulsants might, if not monitored, become abnormal, resulting
in seizures and status
epilepticus. Tr. at 798.
39. Progress notes were not made concerning the condition of patient 143127
between his admission on
April 8, 1987, and 12:08 a.m. on April 9, 1987. I.G. Ex. 64a.
40. It is important in the case of a hospitalized patient for practitioners
who treat that patient to make
detailed progress notes in order to assist other practitioners in treating the
patient, to document what
treatments were provided or why they were not provided, and to document the
consequences and
complications of treatments. Tr. at 801.
41. The I.G. did not prove that Petitioner failed to properly act to have patient
143127 intubated upon
admission on April 8, 1987. See Findings 6-7, 9-10, 11-14.
42. The I.G. did not prove that Petitioner failed to properly monitor the condition
of patient 143127 on
April 8, 1987. See Findings 6-7, 9-10, 15-17.
43. The I.G. did not prove that Petitioner failed to properly act to assure
that patient 143127 was placed in
the Arecibo Hospital intensive care unit or under equivalent care on April 8,
1987. See Findings 6-7, 9-10,
18-21.
44. The I.G. did not prove that Petitioner failed to follow the consulting
neurologist's recommendations for
treatment of patient 143127 for status epilepticus. See Findings 23-34.
45. The I.G. did not prove that Petitioner failed to properly assure that good
progress notes were made of
the condition of patient 143127 between April 8 and 9, 1987. See Findings 6-7,
9-10, 39-40.
46. The I.G. proved that, in contravention of accepted medical practice, Petitioner
failed to monitor the
level of anticonvulsant medications in the blood of patient 143127. Findings
35-38.
47. On June 5, 1988, at 10:35 a.m., patient 39026 arrived at the Arecibo Hospital
emergency room. I.G.
Ex. 63a/102.
48. Patient 39026 was admitted to Arecibo Hospital under Petitioner's service
on June 5, 1988, at 12:15
p.m. I.G. Ex. 63a/40.
49. Petitioner first examined patient 39026 on June 6, 1988, at 4:00 p.m. I.G. Ex. 63a/35.
50. The I.G. did not prove that, prior to the time she first examined patient
39026 on June 6, 1988,
Petitioner was aware that patient 39026 had been admitted under her service.
51. Patient 39026 died at Arecibo Hospital on June 11, 1988. I.G. Ex. 63a/2.
52. Patient 39026 first arrived at Arecibo Hospital on June 5, 1988, suffering
from intoxication from the
medications luminal (phenobarbitol) and dilantin. I.G. Ex. 63a/4; Tr. at 540-541.
53. Patient 39026 was conscious when he arrived at the Arecibo Hospital emergency
room. I.G. Ex.
63a/102.
54. At 1:32 p.m., on June 5, 1988, while still in the emergency room, and after
having been admitted to
Arecibo Hospital, patient 39026 suffered a cardiac arrest. I.G. Ex. 63a/104;
Finding 48.
55. Patient 39026 was resuscitated in the Arecibo Hospital emergency room. I.G. Ex. 63a/106.
56. Patient 39026 was transferred to the Arecibo Hospital intensive care unit
at 2:10 p.m. on June 5, 1988.
I.G. Ex. 63a/106.
57. On arrival at the intensive care unit, patient 39026 was in a coma. I.G. Ex. 63a/51, 63b/51.
58. In her initial examination of patient 39026 on June 6, 1988, Petitioner
found him to be in a deep coma.
I.G. Ex. 63a/35.
59. In her initial examination of patient 39026, Petitioner found that the
pupils of his eyes were dilated,
that his body temperature was 39 degrees centigrade, and that he was not breathing
spontaneously. I.G.
Ex. 63a/35.
60. Petitioner concluded that patient 39026 was neurologically dead. I.G. Ex. 63a/35.
61. Petitioner's treatment plan for patient 39026 included placement of a nasogastric
tube, breathing
assistance with a respirator, and intravenous fluids to force diuresis. I.G.
Ex. 63a/35.
62. In cases of drug intoxication, the clinical signs of neurologic death may
be mimicked by the effects of
the drugs. Tr. at 557-561.
63. In cases of drug intoxication, a diagnosis of neurologic death may not
be made properly without ruling
out the possibility that the signs of neurologic death are drug-induced. I.G.
Ex. 88; Tr. at 551-552, 557-
561.
64. Petitioner's conclusion that patient 39026 was neurologically dead was
contrary to professionally
recognized criteria for determining neurologic death. I.G. Ex. 88; Tr. at 551-552,
557-561; Findings 62,
63.
65. The professionally recognized characteristics of phenobarbitol intoxication
include drowsiness
progressing into coma, hypothermia (low body temperature), and hypotension (low
blood pressure). I.G.
Ex. 89/313; Tr.
at 561-562.
66. Patient 39026 manifested the professionally recognized characteristics
of phenobarbitol intoxication on
June 6, 1988, when he was first examined by Petitioner. I.G. Ex. 63a/35; Finding
65.
67. The professionally recognized treatment for phenobarbitol intoxication
includes monitoring of the
patient's fluid intake and output, as well as monitoring of the patient's arterial
blood gases. I.G. Ex.
90/316-319; Tr. at 562-565.
68. One reason for monitoring a patient's arterial blood gases is to assure
that the patient does not
experience hypoxemia (low levels of oxygen in the blood). Tr. at 564-565.
69. Another reason for monitoring a patient's arterial blood gases is to assure
that the patient does not
experience metabolic acidosis (an excess of acid in the blood). Tr. at 597-598.
70. The consequence of metabolic acidosis is cell impairment leading to cell
death, and inefficient delivery
of oxygen from the blood's hemoglobin to the body's cells. Tr. at 600.
71. In establishing a treatment plan for patient 39026, Petitioner did not
order that the patient's blood gases
be monitored for metabolic acidosis or hypoxemia, or that the patient be treated
for these conditions. See
I.G. Ex. 63a/35.
72. Arterial blood gas studies were made of patient 39026 on June 5, June 7,
and June 9, 1988. I.G. Ex.
63a/17-19.
73. The results of the arterial blood gas study performed on June 9, 1988,
indicated that patient 39026 was
experiencing metabolic acidosis. I.G. Ex. 63a/17; Tr. at 602.
74. The results of the arterial blood gas study performed on June 9, 1988,
indicated that patient 39026 was
experiencing hypoxemia. I.G. Ex. 63a/17; Tr. at 602.
75. Arterial blood gas studies were not repeated for patient 39026 after June 9, 1988. See I.G. Ex. 63a.
76. Given the results of the June 9, 1988, arterial blood gas studies, studies
should have been repeated after
June 9, 1988, to monitor patient 39026 for metabolic acidosis and hypoxemia.
Tr. at 603-604.
77. The I.G. did not prove that Petitioner failed to properly diagnose the
condition of patient 39026 or to
properly treat patient 39026 prior to her first examining the patient on June
6, 1988. See Findings 50-57.
78. The I.G. proved that, in concluding that patient 39026 was neurologically
dead and in failing to order
arterial blood gas studies after June 9, 1988, Petitioner failed to properly
identify and order the
professionally recognized course of treatment for patient 39026. Findings 62-76.
79. The I.G. proved that Petitioner failed to monitor the respiratory status
of patient 39026 in order to
prevent hypoxemia and metabolic acidosis. Findings 73-76.
80. On December 21, 1988, patient 95883 was admitted to Arecibo Hospital under
Petitioner's service.
I.G. Ex. 62a/2.
81. Patient 95883 died at Arecibo Hospital on January 6, 1989. I.G. Ex. 62a/2-3.
82. Petitioner first examined patient 95883 on December 22, 1988. I.G. Ex. 62a/135.
83. In her report of this examination, Petitioner noted that patient 95883
complained of nausea and "coffee
ground" vomiting while at Arecibo Hospital. I.G. Ex. 62a/135.
84. Complaints of nausea and "coffee ground" vomiting by a patient
are symptoms that the patient is
experiencing bleeding from the upper gastrointestinal (GI) tract. Tr. at 275.
85. Petitioner concluded from her initial examination of patient 95883 that
the patient was suffering from
uncompensated congestive heart failure, chronic obstructive pulmonary disease,
and diabetes mellitus. I.G.
Ex. 62a/135; Tr. at 134-135.
86. Petitioner expressed concern in her report of her initial examination of
patient 95883 that the patient
could be suffering intoxication from the drug aminophylline. I.G. Ex. 62a/135.
87. Nausea, vomiting, and upper GI bleeding are signs of intoxication from
aminophylline. I.G. Ex. 67; Tr.
at 275.
88. Aminophylline intoxication is a medically dangerous condition which may
cause a patient to die. I.G.
Ex. 67; Tr. at 280-281.
89. A patient who suffers from aminophylline intoxication may experience increased
gastric bleeding,
seizures, cardiovascular arrhythmias, congestive heart failure, apnea, and coma.
I.G. Ex. 67; Tr. at 280-
281.
90. The professionally recognized standard for treating a patient who is suspected
to be experiencing
aminophylline intoxication includes immediately discontinuing administration
of aminophylline to that
patient. I.G. Ex. 67; Tr. at 279-280.
91. Based on her conclusion that patient 95883 might be suffering from aminophylline
intoxication,
Petitioner initially ordered that administration of aminophylline to the patient
be reduced but not
discontinued. I.G. Ex. 62a/135, /160.
92. The I.G. proved that Petitioner's order that administration of aminophylline
to patient 95883 be
reduced but not discontinued contravened the professionally recognized standard
for treating a patient who
is suspected to be experiencing aminophylline intoxication. Finding 90.
93. On December 22, 1988, Petitioner ordered that tests be performed immediately
to determine the blood
level of aminophylline in patient 95883. I.G. Ex. 62a/160.
94. Blood tests were performed on patient 95883 on December 22, 1988, and the
results were provided on
December 23, 1988. I.G. Ex. 62a/18.
95. Results of the December 22, 1988 tests on patient 95883 established his
serum aminophylline level on
that date to be 35.9 mcg/ml, which exceeds the professionally recognized maximum
therapeutic serum
levels for aminophylline of 20 mcg/ml. I.G. Ex. 62a/18, 67.
96. Additional blood tests were performed on patient 95883 on December 27,
1988, and the results were
provided on December 28, 1988. I.G. Ex. 62a/30.
97. Results of the December 27, 1988 tests on patient 95883 established his
serum aminophylline level on
that date to be 53.0 mcg/ml, which exceeds the professionally recognized maximum
therapeutic serum
levels for aminophylline. I.G. Ex. 62a/30, 67.
98. Although the serum aminophylline levels in patient 95883 exceeded the professionally
recognized
maximum therapeutic level, aminophylline was administered to patient 95883 daily
between December 22
and 27, 1988. I.G. Ex. 62a/317; Tr. at 289, 486-489.
99. The professionally recognized standard for administration of aminophylline
requires that the serum
aminophylline level in a patient be monitored to assure that therapeutic levels
are achieved and not
exceeded. I.G. Ex. 67; See Tr. at 284, 296-298.
100. Petitioner did not order tests to monitor the serum aminophylline levels
in patient 95883, aside from
those which were ordered on December 22 and 27, 1988. See I.G. Ex. 62a.
101. Between December 22, and 27, 1988, Petitioner did not order that administration
of aminophylline to
patient 95883 be discontinued, despite the results of the test taken on December
22, which showed the
patient's serum aminophylline level to exceed the therapeutic level. See I.G.
Ex. 62a.
102. The I.G. proved that Petitioner failed to monitor the serum aminophylline
levels in patient 95883
between December 22 and December 27, 1988. Findings 99, 100.
103. On December 27, 1988, patient 95883 experienced tonic focal seizures. I.G. Ex. 62a/140, 62b/140.
104. On December 27, 1988, gastric lavage was performed on patient 95883, and
he produced abundant
coffee ground aspiration. I.G. Ex. 62a/140, 62b/140.
105. Petitioner did not order that administration of aminophylline to patient
95883 be discontinued on
December 27, 1988, despite his development of seizures and production of coffee
ground aspiration. See
I.G. Ex. 62a.
106. On December 28, 1988, another physician (Dr. Salgado) ordered that administration
of
aminophylline to patient 95883 be discontinued. I.G. Ex. 62a/169.
107. On the morning of January 3, 1989, another physician whose name is not
legible in the medical
record ordered that administration of aminophylline to patient 95883 be resumed.
I.G. Ex. 62a/174.
108. On the afternoon of January 3, 1989, Petitioner ordered that no aminophylline
be administered to
patient 95883. I.G. Ex. 62a/175.
109. Petitioner did not order tests for serum aminophylline level for patient
95883 between December 27,
1988, and January 3, 1989, nor were any such tests performed. I.G. Ex. 62a.
110. The I.G. proved that Petitioner failed to monitor the serum aminophylline
level of patient 95883
between December 27, 1988, and January 3, 1989.
111. By failing to monitor the serum aminophylline level of patient 95883 between
December 22, 1988
and January 3, 1989, Petitioner contravened professionally recognized standards
of care for a patient who
is suffering from aminophylline intoxication. Findings 93-110.
112. On December 22, 1988, after her initial examination of patient 95883,
Petitioner ordered that he be
administered the drug tagamet. I.G. Ex. 62a/135.
113. Tagamet (also known as cimetidine) is a medication used to decrease secretion
of gastric acid in
patients suffering from peptic ulcers, thereby promoting the healing of peptic
ulcers. Tr. at 282-284.
114. One consequence of concomitant administration of aminophylline and cimetidine
to a patient may be
an elevated serum aminophylline level in that patient. I.G. Ex. 67, Tr. at 285-286.
115. The interactions between aminophylline and tagament in patient 95883 resulted
in complications that
jeopardized this patient's health and may have contributed to his death. Tr.
at 298.
116. Petitioner failed to recognize the potentially life-threatening interactions
between tagamet and
aminophylline in patient 95883, as is demonstrated by her failure to monitor
the serum aminophylline level
in this patient. Tr. at 298-300; Findings 102, 110, 112-115.
117. Although patient 95883 was suffering from respiratory problems, Petitioner
did not consult with a
pneumologist or order that the patient be transferred to a facility at which
a pneumologist was available.
I.G. Ex. 62a.
118. A pneumologist is a practitioner who specializes in respiratory problems. Tr. at 300-301.
119. No pneumologist was available for consultation at Arecibo Hospital. Tr. at 301.
120. Although it may have been in the interests of patient 95883 to have not
accepted him for admission at
Arecibo Hospital, given the lack of access to a pneumologist at that facility,
the I.G. did not prove that
Petitioner was consulted or involved in the decision to admit this patient.
Tr. at 302; See Findings 80, 82.
121. On December 22, 1988, patient 95883 was examined by a cardiology consultant
(Dr. Salgado). I.G.
Ex. 62a/132.
122. The cardiology consultant concluded that patient 95883 was suffering from
decompensated
congestive heart failure and made recommendations as to the patient's treatment.
I.G. Ex. 62a/132.
123. The I.G. did not prove that Petitioner failed to follow the cardiology
consultant's recommendations
concerning the treatment of patient 95883. I.G. Ex. 62a.
124. The cardiology consultant also saw patient 95883 on December 23, 26, 28,
29, 30, and 31, 1988, and
on January 3 and 4, 1989. I.G. Ex. 62a.
125. The I.G. did not prove that Petitioner failed to provide cardiology follow
up for patient 95883. I.G.
Ex. 62a.
126. On December 6, 1989, the P.R.O. told Petitioner that it had found a reasonable
basis to determine that
Petitioner had grossly and flagrantly violated her obligations to provide care
to Medicare beneficiaries that
are of a quality that meets professionally recognized standards of care. I.G.
Ex. 43.
127. On January 9, 1990, the P.R.O. held an informal hearing in Petitioner's case. I.G. Ex. 47; Tr. at 195.
128. On January 24, 1990, Petitioner submitted a plan of action to the P.R.O. I.G. Ex. 48; Tr. at 197.
129. In her January 24, 1990 plan of action, Petitioner agreed to write daily
progress notes and orders for
hospitalized patients whom she treated. I.G. Ex. 48.
130. Petitioner agreed to discuss ongoing cases at Arecibo Hospital with interns
or "second call"
physicians who were assigned to these cases as a work team, and to document
the tasks assigned to the
work team. I.G. Ex. 48.
131. Petitioner agreed to document all measures taken with the Arecibo Hospital
Pharmacy, X-Ray
Department, and with laboratories. I.G. Ex. 48.
132. Petitioner agreed to document all patient transfers, out-of-hospital tests,
and requests from work team
members, along with all errors and omissions in the treatment of patients. I.G.
Ex. 48.
133. In a January 24, 1990 plan of action, Petitioner advised the P.R.O. that
a conference was being
organized at Arecibo Hospital to discuss the management of intoxication by dilantin
and luminal. I.G. Ex.
48.
134. The P.R.O. concluded that Petitioner's plan of action did not adequately
deal with the deficiencies
which the P.R.O identified in Petitioner's treatment of hospitalized patients.
Tr. at 201-203.
135. On May 29, 1990, the P.R.O. recommended to the I.G. that Petitioner be
excluded from participating
in Medicare and Medicaid. I.G. Ex. 52; See I.G. Ex. 51.
136. The P.R.O. based its recommendation on its conclusion that Petitioner
had grossly and flagrantly
violated her obligations under section 1156 of the Act. I.G. Ex. 52; See I.G.
Ex. 51.
137. On August 31, 1990, the I.G. notified Petitioner that he was excluding
her from participating in
Medicare and Medicaid for three years, pursuant to section 1156 of the Act.
I.G. Ex. 57.
138. Based on the P.R.O.'s recommendation, the I.G. concluded that Petitioner
had grossly and flagrantly
violated her obligations under section 1156 of the Act. I.G. Ex. 57.
139. The I.G. concluded that Petitioner had expressed a willingness to comply
with her obligations under
the Act, but had demonstrated an inability to substantially comply with her
obligations. I.G. Ex. 57.
140. Under section 1156 of the Act, the Secretary of the Department of Health
and Human Services may
exclude a physician from participating in Medicare and Medicaid where the Secretary
determines, based on
a recommendation by a P.R.O., that the physician has grossly and flagrantly
violated the obligation to
provide health care of a quality which meets professionally recognized standards
of care and has
demonstrated an inability or unwillingness to substantially comply with the
obligation to provide such care.
Social Security Act, section 1156(a)(2), (b)(1).
141. A "gross and flagrant violation" is defined by relevant regulation
to mean the violation of an
obligation to provide care in one or more instances which meets professionally
recognized standards which
presents an imminent danger to the health, safety, or well-being of a Medicare
beneficiary or places the
beneficiary unnecessarily in a high risk situation. 42 C.F.R. 1004.1(b).
142. Patients 143127, 39026, and 95883 were Medicare beneficiaries. ALJ Ex.
15; See I.G. Ex. 62a/2,
63a/2, 64a/1; Tr. at 60-63. 4/
143. The I.G. proved that, by failing to monitor the blood levels of medication
in patient 143127 on or
after April 9, 1987, Petitioner committed a violation of her obligation to provide
care to that patient in a
manner which presented an imminent danger to his health, safety, or well-being,
and unnecessarily placed
him in a high risk situation. Tr. at 800; Findings 37, 38, 46.
144. The I.G. proved that, by failing to monitor the arterial blood gases of
patient 39026 after June 9,
1988, in order to identify and treat hypoxemia and metabolic acidosis, Petitioner
committed a violation of
her obligation to provide care to that patient in a manner which presented an
imminent danger to his health,
safety, or well-being, and unnecessarily placed him in a high risk situation.
Findings 67-76.
145. The I.G. proved that, by failing to monitor the serum aminophylline level
in patient 95883, Petitioner
committed a violation of her obligation to provide care to that patient in a
manner which presented an
imminent danger to his health, safety, or well-being, and unnecessarily placed
him in a high risk situation.
Tr. at 283, 286; Findings 102, 107, 111.
146. The I.G. proved that, by failing to recognize the potentially life-threatening
interactions between
tagamet and aminophylline in patient 95883, Petitioner committed a violation
of her obligation to provide
care to that patient in a manner which presented an imminent danger to his health,
safety, or well-being,
and unnecessarily placed him in a high risk situation. Tr. at 296-300; Findings
115, 116.
147. The I.G. proved that Petitioner committed gross and flagrant violations
of her obligation to provide
health care of a quality which meets professionally recognized standards of
care. Findings 142-145; Social
Security Act, section 1156(a); 42 C.F.R. 1004.1(b).
148. Although Petitioner has manifested a willingness to meet her obligation
to provide health care of a
quality which meets professionally recognized standards of care, she has not
demonstrated the ability to do
so. See I.G. Ex. 48; Tr. at 200-203.
149. The I.G. had authority to exclude Petitioner from participating in Medicare
and to direct that she be
excluded from participating in Medicaid. Findings 146, 147; Social Security
Act, section 1156(a).
150. The purpose of section 1156 of the Act is remedial.
151. Section 1156 of the Act is intended to enable the Secretary to protect
federally-funded health care
programs and their beneficiaries and recipients from health care providers who
have demonstrated by their
conduct that they are not trustworthy.
152. Petitioner has engaged in conduct that endangered the health and safety
of program beneficiaries.
Findings 85-92; 141-146.
153. Petitioner has manifested an inability to effectively treat hospitalized
patients for drug intoxication.
Findings 35-38, 46, 55-76, 78, 79, 82-92, 97-105, 110-116.
154. Petitioner has demonstrated a lack of knowledge of the potentially lethal
consequences of drug
intoxication in hospitalized patients, and the interactions of drugs in such
patients. Findings 35-38, 46, 55-
76, 78, 79, 82-92, 97-105, 110-116.
155. Petitioner's deficient treatment of patients occurred in several cases
over an extended period of time.
Findings 4, 8, 48, 51, 80, 81.
156. Petitioner has demonstrated by her treatment of patients that she is not
trustworthy to treat program
beneficiaries and recipients. Findings 151-154.
157. The I.G. excluded Petitioner from participating in Medicare, and directed
that she be excluded from
participating in Medicaid, for three years. I.G. Ex. 57.
158. The I.G. has not proven that there exists a remedial purpose to exclude Petitioner for three years.
159. The remedial purpose of section 1156 will be served by excluding Petitioner
from participating in
Medicare and Medicaid for six months, running prospectively from June 20, 1991.
ANALYSIS
1. The I.G. may not introduce evidence that Petitioner committed violations
in addition to
those which the I.G. specifically identified in his August 31, 1990 notice letter.
The August 31, 1990 notice letter which the I.G. sent to Petitioner advised
her that a determination had
been made to exclude her "pursuant to the authority set out" in section
1156 of the Act. The letter noticed
Petitioner that the material which formed the basis for the I.G.'s exclusion
determination previously had
been provided to Petitioner by the P.R.O. and was "incorporated in this
notice by specific reference." The
I.G. advised Petitioner that he agreed with the P.R.O. that Petitioner grossly
and flagrantly violated her
obligation under section 1156 of the Act to provide care that met professionally
recognized standards of
health care with respect to patients 95883, 39026, and 143127. The I.G. stated
that:
The cases reviewed by the PRO resulted in the following findings, with which the OIG agrees.
Medical Record No. 95883:
- failure to monitor aminophylline levels
- failure to recognize drug interactions which caused complications leading to death
- failure to provide pneumology services
- failure to provide adequate cardiology intervention, and
involvement in follow up
Medical Record No. 39026:
- failure to recognize limitations in managing the patient
- failure to monitor respiratory status
- failure to identify and treat metabolic acidosis and resultant hypoxemia
Medical Record No. 143127:
- failure to recognize medication half life in order to review treatment and
prevent status
epilepticus
Based on these findings, I have determined that you have committed 3 gross
and flagrant violations of
your quality of care obligations. (Emphasis added)
At the hearing, the I.G. offered evidence as to all of these allegations, in
order to establish that Petitioner
committed gross and flagrant violations of her obligation to provide health
care in accord with
professionally recognized standards of care. The I.G. also sought to introduce
evidence relevant to
additional allegations that Petitioner had not properly treated patient 143127.
These consisted of
allegations that Petitioner had failed to: immediately intubate the patient
on his admission to Arecibo
Hospital; monitor the status of the patient from admission on April 8, 1987
to April 9, 1987; immediately
admit the patient to the intensive care unit on his admission at Arecibo Hospital;
reconsult a neurologist on
April 9, 1987, after the patient experienced convulsions; and make appropriate
progress notes with respect
to the patient's status and treatment. 5/
The issue before me is whether I should permit the I.G. to assert these additional
allegations as evidence
that Petitioner committed gross and flagrant violations of her obligation to
provide health care in
accordance with professionally recognized standards of care. I conclude that
the I.G. is not entitled to
assert that these additional allegations prove that Petitioner committed gross
and flagrant violations because
he failed to provide Petitioner with adequate notice of these allegations. I
conclude further that it would
not be fair to Petitioner to permit the I.G. to amend his notice of violations
to include these additional
allegations.
Under section 1156, the I.G.'s authority to exclude a provider derives from
the recommendation he receives
from a P.R.O. The Act specifically requires a P.R.O. determination that a provider
has failed to meet or
has violated his obligations as defined in section 1156(a) as a prerequisite
to any exclusion determination
by the Secretary. Based on a P.R.O. recommendation, the Secretary (or his delegate,
the I.G.) may
determine to exclude the provider. Social Security Act, section 1156(b)(1).
The I.G.'s determination that a provider has failed to meet or has violated
his obligations may not be based
on factors beyond those which form the basis for a P.R.O.'s recommendation.
However, the I.G. may make
a determina-tion on narrower grounds than those cited by the P.R.O. The Act
contemplates that the I.G.
will exercise his discretion to evaluate and accept or reject as appropri-ate
a P.R.O.'s recommendation. It is
within the realm of reasonable possibility in any case that a P.R.O. may make
a recommendation to
exclude based on a variety of factors, that the I.G. may accept part of this
recommen-dation and not accept
the balance, and that the I.G. may determine to exclude the provider based on
that with which he agrees.
The I.G.'s notice to a provider excluded under section 1156 informs that provider
of the allegations which
the provider must prepare to rebut in any hearing concerning the exclusion.
The exclusion notice functions
as an administrative complaint. The regulations require that the notice to an
excluded provider specify "the
legal and factual basis for the determination." 42 C.F.R. 1004.100(c)(1).
Because the I.G.'s determination
to exclude may be based on narrower grounds than those recommended by the P.R.O.,
the exclusion letter
serves as notice to an excluded party in such a case that there are some P.R.O.
findings which he will not
be obliged to rebut at a hearing.
The regulations are silent as to whether the I.G. may amend his notice after
having issued it. In the absence
of any prohibition against amending the notice, it is reasonable that the I.G.
should have such opportunity,
providing that no prejudice is caused to the excluded party. Therefore, the
I.G. may be permitted to amend
an exclusion notice upon a showing of good cause and an absence of prejudice
to the excluded party.
The notice in this case did not specify the additional allegations of gross
and flagrant violations concerning
patient 143127 which the I.G. sought to prove at the hearing. The notice letter
specifically enumerated the
allegations concerning this patient and these did not include those additional
allegations asserted by the
I.G. at the hearing. Nor did the notice letter incorporate those allegations
in a way which would have
reasonably notified Petitioner that the I.G. was relying on them as a basis
for his determination. The I.G. in
effect stated to Petitioner that he was relying on some, but not all, of the
recommendations made to him by
the P.R.O. Petitioner could reasonably infer from the notice letter that the
allegations against which she
must defend were limited to those which were specifically enumerated in the
letter. Therefore, the I.G. was
not entitled to rely on these additional allegations as an element of his case
against Petitioner.
The I.G. argues that, even though the notice in this case did not specify all
of the I.G.'s allegations
concerning patient 143127, these allegations were incorporated in the notice
letter by virtue of the I.G.'s
reference to P.R.O. documents which did contain the allegations and which previously
had been sent to
Petitioner. I conclude that the letter did not provide the Petitioner with reasonable
notice that the I.G. was
relying on additional unstated allegations as a basis for determining that Petitioner
had committed gross
and flagrant violations of her duties to patient 143127.
The notice on its face limits the I.G.'s allegations concerning patient 143127
to those listed in the notice.
The portion of the notice which I have quoted above states that the determination
to exclude Petitioner was
based on specifically enumerated findings. A reasonable individual reading this
language would logically
conclude that these findings comprised the ambit of the I.G.'s determination
as to gross and flagrant
violation. Thus, even though the notice incorporated P.R.O. documents by reference,
the specific
allegations in the notice assert narrower grounds (for finding that Petitioner
committed gross and flagrant
violations) than those stated by the P.R.O.
It would have been unreasonable to permit the I.G. to amend his notice at the
hearing to include the
additional allegations against Petitioner. This case turned on complex medical
evidence and the opinions
of experts. Each party needed time prior to the hearing to evaluate his or her
respective affirmative
positions and to prepare to rebut the arguments of his or her adversary. Given
the complexity of this case,
it would be unfair to in effect mousetrap Petitioner by requiring her to defend
against charges of gross and
flagrant violations which were not specifically alleged by the I.G. prior to
the hearing in this case. 6/
2. Petitioner grossly and flagrantly violated her obligation to provide health
care which meets
professionally recognized standards and demonstrated an inability to comply
substantially with her
obligation.
At issue in this case is whether Petitioner committed gross and flagrant violations
of her statutory
obligation to provide health care to program beneficiaries or recipients and
demonstrated either an
unwillingness or inability to substantially comply with her obligation. I conclude
that the I.G. proved that
Petitioner committed such violations in each of the three cases in evidence.
I conclude further that the I.G.
proved that although Petitioner has shown a willingness to comply with her obligation,
she has failed to
demonstrate an ability to do so. I find, therefore, that the I.G. established
that he had authority to impose
and direct an exclusion against Petitioner under section 1156 of the Act.
a. Evidence as to gross and flagrant violations of the obligation to provide
care which
meets professionally recognized standards of care
Section 1156(b)(1)(B) authorizes the Secretary (or his delegate the I.G.) to
exclude a health care provider
where, based on the recommendation of a P.R.O., he determines that the provider
has grossly and
flagrantly violated his obligation to provide care of a quality which meets
professionally recognized
standards of care, and where he determines that the provider is either unwilling
or unable to comply with
that obligation. The Act does not define the term "grossly and flagrantly."
However, there is a regulatory
definition of the term at 42 C.F.R. 1004.1(b). The regulation defines a "gross
and flagrant violation" to
mean that:
a violation of an obligation has occurred in one or more instances which presents
an imminent danger to
the health, safety or well-being of a Medicare beneficiary or places the beneficiary
unnecessarily in high-
risk situations. 7/
A gross and flagrant violation of the obligation to provide care which meets
professionally recognized
standards must include an element of actual or potential harm to a patient.
The regulation defines a gross
and flagrant violation to be an especially dangerous deviation from medical
norms. Varandani v. Bowen,
924 F. 2d 307 (4th Cir. 1987). A gross and flagrant violation must be found
where "substandard medical
care unnecessarily places a patient in danger." Doyle v. Bowen, 660 F.
Supp. 1484, 1493 (D. Me. 1987).
The preponderance of the evidence establishes that, in each of the three cases
at issue, Petitioner committed
acts or omissions that contravened her obligation to provide care which meets
professionally recognized
standards of care. In each case, Petitioner's failure to meet her obligation
presented an imminent danger to
the Medicare beneficiary or unnecessarily placed that beneficiary in a high
risk situation. 8/
There are common elements to all three of the patient treatment episodes at
issue here. Each case involved
a patient hospitalized at Arecibo Hospital under Petitioner's service. In each
case, the patient was assigned
to Petitioner at least several hours prior to Petitioner actually seeing the
patient. In each case, the patient
was suffering from the effects of intoxication from medication. All three of
the patients ultimately died.
The I.G. has alleged, essentially, that Petitioner committed similar judgment
errors in each of the three
cases. The essence of the I.G.'s case is that Petitioner failed to properly
recognize the potential effects of
drug intoxication in each of the three cases, and consequently, failed to properly
treat or supervise the
treatment of the patients. The result, according to the I.G., was that in each
case the health and well-being
of the patient was imperiled.
Each of these cases involves complicated facts. It is apparent from the evidence
that serious judgment
errors were committed with respect to all three patients. It is at least arguable
that these errors resulted in
adverse consequences in each case, possibly leading to the patient's death.
In one way or another,
personnel at Arecibo Hospital failed to provide care to each of the patients
which was consistent with
professionally recognized standards of health care.
What is more difficult to discern is the extent to which the errors and omissions
that were committed with
respect to these patients legitimately can be attributed to Petitioner. Petitioner
was not the sole decision
maker in any of the three cases. Critical care decisions were made in these
cases prior to Petitioner actually
becoming involved in the diagnosis and treatment of the patients. Technically,
Petitioner bears
responsibility for all of the actions taken with respect to these patients after
their admission to Arecibo
Hospital, because the patients were admitted under her service. The reality
is, however, that with respect to
two of the three patients, patients 39026 and 143127, serious judgment errors
may have been made by staff
at Arecibo prior to Petitioner becoming involved in the diagnosis and treatment
of the patients. Petitioner
cannot reasonably be held responsible for these apparent errors by other staff
in view of the fact that they
were made prior to her seeing the patients.
Nevertheless, there is a core of truth to the I.G.'s allegations concerning
the manner in which Petitioner
diagnosed and treated the three patients. The evidence establishes that, in
each case, Petitioner failed to
diagnose or treat drug intoxication in accord with professionally accepted treatment
standards. Although
Petitioner is not responsible for the judgment errors that other providers may
have made in these cases, she
must bear responsibility for her own judgment errors. The evidence establishes
that Petitioner failed in
these cases to take charge and to manage effectively the treatment of the patients.
The consequence was
that the patients were to some extent set adrift in the hospital milieu, without
effective case management or
supervision. Petitioner's judgment errors with respect to these patients unnecessarily
placed all of them in
danger.
The I.G.'s evidence against Petitioner primarily consisted of the records of
the patients' treatment as well as
the testimony of expert physicians who had previously evaluated the treatment
records on behalf of the
P.R.O. (Drs. Gonzalez, Anduze, Arroyo, and de Jesus). Petitioner rebutted this
evidence with testimony
from physicians who had served with Petitioner on the staff of Arecibo Hospital
(Drs. Canavate, Salgado,
and Paez). In some respects, the case devolved into a contest of expert witnesses
who offered conflicting
opinions based on the treatment records. I have carefully reviewed the transcript
of testimony of each of
these witnesses. The testimony provided by the I.G.'s experts was more credible
than the testimony of
Petitioner's experts. The I.G.'s experts presented a more coherent and thorough
analysis of the medical
records than did Petitioner's experts. The I.G.'s experts' testimony was supported
by excerpts from learned
treatises, such as the Physician's Desk Reference. See, e.g., I.G. Ex. 67. Petitioner's
experts' testimony was
not similarly supported and, in fact, often conflicted with the opinions asserted
in learned treatises.
My conclusion that the I.G.'s experts were more credible than Petitioner's
experts reflects my determination
that the I.G.'s experts were unbiased witnesses, whereas Petitioner's experts
had an interest in defending
Petitioner's reputation. The I.G.'s experts were physicians who were employed
by the P.R.O. to evaluate
treatment records. None of them had a personal stake in the outcome of this
case, aside from vindication of
their professional opinions. The I.G.'s experts had not previously worked with
Petitioner, and their
interactions with Petitioner were limited to their involvement in this case.
By contrast, Petitioner's experts
had a substantial personal interest in the outcome of the case. All of Petitioner's
witnesses were colleagues
of Petitioner and were interested in seeing that she be exonerated of the I.G.'s
allegations. Petitioner's
experts also were individually involved in the diagnosis and treatment of the
patients whose care was at
issue in this case. To some extent, the allegations of improper treatment made
by the I.G. concerning these
patients related to diagnoses and treatment by Petitioner's experts. It was
apparent from the tone and
content of Petitioner's experts' testimony that these witnesses viewed their
testimony to be as much in their
own defense as that of Petitioner.
In light of these general conclusions, I turn to an analysis of the three treatment
episodes on which the I.G.
based his determination that Petitioner had grossly and flagrantly violated
her obligation to provide care
which meets professionally recognized standards of health care. They are discussed
here in date order.
i. Patient 143127
This patient first appeared at the Arecibo Hospital emergency room on the evening
of April 8, 1987, as a
transfer from another facility. The patient had a history of a seizure disorder.
He was admitted at Arecibo
Hospital in an unconscious state, having suffered an overdose of the medications
phenobarbitol, dilantin,
and tegretol. The patient did not regain consciousness prior to his death. Petitioner
first saw the patient on
the morning of April 9, 1987. The patient died on April 12, 1987.
The records of the patient's treatment prior to April 9 are sparse. Therefore,
it is not possible to determine
precisely what course of treatment was opted for by staff at Arecibo Hospital,
nor is it possible to
determine the reasons for the decisions that were made with respect to this
patient. However, even from
these records it is evident that staff at Arecibo Hospital made treatment errors
prior to Petitioner's first
seeing the patient. Although the patient was in a state that would normally
require immediate intubation
(placement of a breathing tube in his air passage), he was not ordered intubated
from the time of his
admission until 8:36 a.m. on April 9. The patient's condition on admission to
Arecibo Hospital was such
that he should have been immediately transferred to the intensive care unit
or provided with equivalent
treatment. The patient was not placed in the intensive care unit until Petitioner
ordered that he be
transferred to that facility on April 9.
When Petitioner first saw the patient on April 9, 1987, she determined that
a consultation with a
neurologist was in order. The neurologist concluded that the patient had a very
poor prognosis. She
recommended that, should the patient develop seizures, he should be treated
with intravenous
administration of valium. She further recommended that, if the patient developed
status epilepticus
(continuous motor seizures), the patient should be treated with depakene. She
recommended against
treatment with anticonvulsant medications, evidently because the patient had
overdosed on such
medications.
The patient did develop seizures of a continuous nature. Petitioner faithfully
followed the neurologist's
recommendations by administering both valium and depakene. The response was
poor.
The I.G. asserted that Petitioner committed an error in her treatment of this
patient in that she failed to
order appropriate blood tests to monitor the half-life of anticonvulsant medication
in the patient's blood.
The weight of the evidence supports this assertion. No blood tests were ordered
by Petitioner on April 9 or
thereafter. I am convinced from the testimony of the I.G.'s experts that, under
professionally recognized
standards of health care, Petitioner should have ordered the appropriate tests
and acted in accordance with
their results.
Petitioner should have ordered such tests be performed because the results
were necessary for her to
properly evaluate and treat the patient's status epilepticus. Findings 37-38.
The patient had a history of a
convulsive disorder and medications had been prescribed to control convulsions.
Although the patient had
overdosed on those medications, by April 9 and thereafter the levels of those
medications in the patient's
blood could have been below therapeutic levels. See Finding 38. Petitioner's
convulsions were not
adequately controlled by the medications recommended by the consulting neurologist.
Finding 34. The
continuing convulsions experienced by the patient constituted a life-threatening
condition. Finding 31.
That condition might have been ameliorated by proper administration of anticonvulsant
medications to the
patient, assuming that the level of such medications in the patient's blood
was determined to be below
therapeutic levels. Therefore, Petitioner's failure to order and evaluate the
appropriate tests in order to
determine whether to order that anticonvulsant medications be administered to
the patient presented an
imminent danger to the patient's health, safety, or well-being, or unnecessarily
placed him in a high risk
situation.
I am aware, in making this conclusion, that Petitioner became involved in treating
this patient only after
potentially grievous errors had already been committed by other staff at Arecibo
Hospital. I am not
holding Petitioner responsible for these errors, even though Petitioner may
be accountable for them under
prevailing medical ethics standards as the physician in charge of the case.
My conclusion that Petitioner contravened professionally recognized standards
of health care by not
ordering and evaluating the appropriate tests takes into account the fact that
the consulting neurologist
recommended that no anticonvulsant medications be administered to the patient.
The neurologist made
that recommendation at a time when the patient was assumed to be suffering from
the effects of an
overdose of anticonvulsant medications. However, the level of those medications
in the patient's blood
would not have been a constant. See Finding 37. Furthermore, as no tests were
performed after April 8,
neither the neurologist nor Petitioner could have known the actual level of
anticonvulsant medications in
the patient's blood. See Findings 35, 36. The actual level of anticonvulsant
medications and the need to
adjust treatment accordingly could only be determined by ordering and interpreting
the appropriate tests.
ii. Patient 39026
This patient arrived at the Arecibo Hospital emergency room shortly after noon
on June 5, 1988, having
suffered an overdose of the medications phenobarbitol and dilantin. Although
the patient was conscious
and oriented on arrival, he suffered cardiac arrest while in the emergency room
and lapsed into
unconsciousness. He was resuscitated while in the emergency room and was transferred
to the Arecibo
Hospital intensive care unit. The patient never regained consciousness during
his stay at Arecibo Hospital.
He died on June 11, 1988.
Petitioner first saw and examined the patient on June 6, 1988. She concluded
that the patient was
neurologically dead. Finding 60. She ordered that the patient be intubated,
that his breathing be assisted
with a respirator, and that he be administered intravenous fluids to force diuresis.
The I.G. asserts that this
diagnosis and treatment plan contravened professionally recognized standards
of care for an individual in
the patient's condition as of the time Petitioner first examined the patient.
The I.G. further asserts that
Petitioner's judgment errors with respect to this patient unnecessarily placed
the patient in a high risk
situation and posed an imminent threat to his health and safety. I agree with
these contentions.
The weight of the evidence establishes that, as of June 6, Petitioner could
not legitimately conclude that the
patient was neurologically dead in light of the facts at hand. The I.G. offered
impressive and essentially
unrebutted evidence that the signs of neurological death can be mimicked in
patients who are suffering
from drug intoxication. Findings 62, 63. By prematurely concluding that the
patient was neurologically
dead, Petitioner effectively ruled out treatment measures that might have brought
the patient out of his
unconscious state, assuming that the state was in fact drug-induced and not
the consequence of
neurological death.
Petitioner asserted through the testimony of her witnesses that the probability
was high in this case that the
patient was neurologically dead. Essentially, they asserted that the patient's
state on June 6 was the
irreversible consequence of his cardiac arrest on the previous day and that
no measures by Petitioner would
have reversed that state. I do not disagree that, as a matter of probability,
Petitioner's witnesses may be
correct. But that does not serve to legitimize Petitioner's diagnosis and subsequent
treatment of the patient.
The point of the I.G.'s expert testimony, and the weight of the evidence, is
that there was a reasonable
possibility that the patient was not neurologically dead on June 6, and that
accepted medical practice
precluded a conclusion of neurological death at that time.
Petitioner's June 6 diagnosis of neurological death had potentially tragic
consequences for the patient. One
treatment measure that Petitioner could have opted for, had she concluded that
a reversible drug-induced
coma could not be ruled out, was to monitor the patient's arterial blood gases.
Findings 67-68. The
purpose of such monitoring, had Petitioner ordered it, would have been to facilitate
adjusting oxygen
administered to the patient to assure that the patient did not experience hypoxemia
(low levels of oxygen in
the blood). Another purpose would have been to facilitate administration of
medications to the patient to
assure that he did not experience metabolic acidosis, a condition which can
lead to cell impairment and
death. Finding 70. In fact, this patient did suffer from hypoxemia and acidosis.
Findings 73, 74. The
record does not establish that the patient's death was caused by hypoxemia or
acidosis, or that monitoring
of the patient's arterial blood gases would have enabled Petitioner to prevent
his death. However,
Petitioner should not have foregone monitoring until the patient's neurological
death was definitively
established, due to the potentially life-threatening consequences of hypoxemia
and acidosis.
My conclusion that Petitioner grossly and flagrantly violated her obligation
to this patient to provide care
which meets professionally recognized standards takes into account that the
patient's state on June 6, when
first seen by Petitioner, was the consequence of events that were beyond Petitioner's
capacity to control.
Finding 77. It is apparent, as with the case of patient 143127, that serious
errors may have been made by
other staff at Arecibo Hospital which could have gravely jeopardized the health
and safety of the patient. I
do not base my finding of gross and flagrant violations by Petitioner on errors
which may have been made
by other staff at Arecibo Hospital, nor do I find that Petitioner is responsible
for those possible errors.
My conclusion also takes into account the fact that physicians other than Petitioner
participated in the
treatment of this patient after Petitioner first saw the patient on June 6.
See I.G. Ex. 63a. There is nothing
in the medical record to suggest that other providers at Arecibo Hospital disagreed
with Petitioner's
diagnosis and treatment of the patient. That does not excuse Petitioner's errors
of judgment, however. As
the physician in charge of the patient's care, Petitioner was responsible for
the operative treatment decisions
for that patient, at least for the time ensuing after Petitioner first saw the
patient. See Finding 7.
iii. Patient 95883
This patient was admitted to Arecibo Hospital on the afternoon of December
21, 1988. He died at the
hospital on January 6, 1989.
Petitioner first saw the patient on December 22, 1988. She diagnosed the patient
to be suffering from
uncompensated congestive heart failure, chronic obstructive pulmonary disease,
and diabetes mellitus.
Finding 85. She also concluded that, based on the patient's history and his
complaints of nausea and
"coffee ground" vomiting (symptomatic of bleeding from the upper gastrointestinal
tract), the patient could
be suffering from intoxication from the drug aminophylline. Findings 83, 84,
86. Having reached this
conclusion, Petitioner ordered that administration of aminophylline to the patient
be reduced. Finding 91.
The I.G. contends that, while Petitioner's suspicion of aminophylline intoxication
was well-founded, her
treatment plan for the suspected intoxication contravened the professionally
recognized standard of
treatment for aminophylline intoxication. The I.G. further contends that Petitioner's
judgment error in
treating the patient caused imminent danger to his health, safety, or well-being,
or placed him
unnecessarily in a high-risk situation. The I.G. asserts, therefore, that Petitioner
grossly and flagrantly
violated her obligation to provide care.
I agree with the I.G.'s assertion. The I.G. proved that, in cases of suspected
aminophylline intoxication, the
professionally recognized standard of care is to immediately discontinue administration
of aminophylline.
Finding 90. Failure to do so poses a grave threat to the well-being of any patient
who may be suffering
from aminophylline intoxication, because intoxication from this drug may produce
potentially fatal effects,
including gastric bleeding, seizures, cardiovascular arrhythmias, congestive
heart failure, apnea, and coma.
Finding 89.
Petitioner asserted through her witnesses that she reduced rather than discontinued
administration of
aminophylline to the patient because the patient may have needed the medication
to deal with other
medical problems, including respiratory problems. Therefore, according to Petitioner,
her decision was a
rational approach to a complex medical problem. Although I am not challenging
Petitioner's good faith in
treating this patient, I am not persuaded from the evidence of record that ordering
anything other than
complete discontinuation of the drug constituted the professionally recognized
standard of treatment. I am
persuaded by the testimony of the I.G.'s expert, Dr. Gonzalez, and supporting
evidence (the I.G. offered an
excerpt from the Physician's Desk Reference), that the approach which Petitioner
should have followed
with this patient was to have discontinued administration of aminophylline.
Finding 90. The risk of harm
to the patient from aminophylline intoxication was so great that prescribing
a reduced dose, rather than
discontinuing the drug, was not a professionally acceptable course for the Petitioner
to have followed.
The I.G. asserted that Petitioner compounded her judgment error in treating
this patient's aminophylline
intoxication by failing to adequately monitor the patient's aminophylline blood
levels and to undertake
appropriate treatment based on the test results available to her. The evidence
sustains this assertion. Blood
tests for aminophylline levels were performed on the patient twice during his
stay at Arecibo Hospital, on
December 22 and 27, 1988. Findings 94, 96. The first test result, which was
available to Petitioner on
December 23, showed an aminophylline level of 35.9 mcg/ml, which exceeds the
professionally
recognized maximum therapeutic serum levels for aminophylline of 20 mcg/ml .
Finding 95.
Notwithstanding this first test result, Petitioner neither ordered aminophylline
discontinued, nor did she
order a follow-up blood test until December 27. The result of that test showed
the patient to have a serum
aminophylline level of 53.0 mcg/ml, higher than the previous test result, and
also above the maximum
therapeutic level for the drug.
It is apparent from this evidence that, despite her initial suspicion of aminophylline
intoxication, Petitioner
was not closely monitoring the patient for that problem. Had she done so, she
would have confirmed
intoxication no later than December 23, 1988. In fact, Petitioner did not order
that aminophylline be
discontinued to the patient, despite the fact that, on December 27, the patient
experienced seizures and
gastric lavage on that date produced abundant coffee ground aspiration. Findings
103, 104.
Administration of aminophylline to the patient was not ordered discontinued
until another physician issued
the order on December 28, 1988.
Two additional facets of Petitioner's treatment of this patient confirm her
failure to recognize and
appropriately treat the patient's aminophylline intoxication. First, notwithstanding
the patient's seizures on
December 27, Petitioner ordered no additional blood tests for aminophylline
levels after that date. Finding
111. Second, in her initial assessment of the patient on December 22, Petitioner
ordered that cimetidine
(tagamet) be administered to the patient. Tagamet is a medication used to suppress
secretion of gastric acid
and to promote the healing of gastric ulcers. Finding 113. It appears that Petitioner
prescribed this
medication to treat the patient's complaints of nausea and gastric bleeding.
However, tagamet is a drug
which can increase serum aminophylline levels in patients. Finding 114. In light
of her suspicion of
aminophylline intoxication, Petitioner should not have prescribed tagamet to
the patient.
The I.G. also alleged, as further evidence of gross and flagrant violations,
that Petitioner improperly failed
to consult with a pneumologist (a specialist in respiratory problems). He additionally
contended that
Petitioner failed to provide adequate follow up consultation with a cardiology
consultant whom she
consulted concerning patient 95883. I do not find that these allegations are
supported by the evidence.
Petitioner did not have access to the services of a pneumologist. The I.G.
did not prove that, given the
patient's condition, the patient could safely be transferred to a facility where
a pneumologist's services were
available. Given this, it would be unreasonable to hold Petitioner accountable
for her failure to consult
with a pneumologist. As far as Petitioner's interaction with a cardiologist
is concerned, the record shows
that a cardiology consultant saw the patient on several occasions and was actively
involved in treatment
recommendations. Findings 121-124.
b. Evidence as to Petitioner's inability to comply substantially with her obligation
The I.G. contends that Petitioner has expressed a willingness to comply with
her obligation to provide
health care of a quality which meets professionally recognized standards. However,
according to the I.G.,
Petitioner has not demonstrated an ability to comply with her obligation. The
preponderance of the
evidence supports this contention. Petitioner's inability to comply with her
obligation is established by her
pattern of gross and flagrant violations, coupled with her consistent failure
to rectify those violations,
despite having been counseled to do so by the P.R.O. The evidence establishes
a pattern of judgment
errors by Petitioner. Petitioner has on more than one occasion promised to correct
these errors. However,
she has offered no evidence that she has taken steps to rectify her deficiencies.
The P.R.O. met with Petitioner on at least two occasions to discuss Petitioner's
diagnosis and treatment of
the three patients. During these sessions, P.R.O. representatives expounded
at length on the diagnosis and
treatment deficiencies they observed. Petitioner promised to correct these deficiencies.
Petitioner provided two correction plans to the P.R.O. She submitted her first
plan in November, 1988.
I.G. Ex. 17. She made her most recent submission on January 24, 1990. Finding
128. In her most recent
plan, Petitioner promised to: write daily progress notes and orders for hospitalized
patients whom she
treated, document her interactions with other physicians at Arecibo Hospital,
document her interactions
with hospital support facilities such as the hospital's x-ray department, and
document patient transfers and
tests. Findings 129-132. She also advised the P.R.O. that a conference was being
organized at Arecibo
Hospital to discuss the management of intoxication by dilantin and luminal.
Finding 133.
Petitioner's 1990 correction plan demonstrates a recognition by Petitioner
of what she needs to do to cure
her practice deficiencies. Had she actually implemented this plan, then, arguably,
there might not be a
basis to exclude her. However, the record of this case is devoid of evidence
to show that Petitioner has
done more than promise to take corrective steps. Petitioner offered no evidence,
either to the P.R.O, or at
the hearing in this case, that she had taken concrete steps to rectify the problems
identified by the P.R.O.
The three cases on which the P.R.O. based its recommendation that Petitioner
had grossly and flagrantly
violated her obligation to provide care had occurred over a two year period.
Perhaps the most disturbing
finding that emanates from Petitioner's involvement in the three cases at issue
is that Petitioner has
consistently failed to recognize and treat the consequences of intoxication
with prescription drugs. I find it
reasonable to conclude from the evidence that Petitioner manifests some deficiencies
in her ability to
diagnose and to properly treat such conditions. Petitioner's promises in 1988
and 1990 to rectify her
deficiencies are not persuasive evidence that she is capable of rectifying her
deficiencies, in light of the fact
that these deficiencies had been consistently manifested over a protracted period
during which they were
not corrected by Petitioner. The I.G. points out, correctly, that the deficiencies
were originally brought to
Petitioner's attention prior to her submitting her November 1988 correction
plan. Despite twice promising
the P.R.O. that she would rectify her deficiencies, Petitioner has failed to
provide any evidence that she has
taken the necessary steps to accomplish the desired end.
3. The exclusion imposed and directed against Petitioner by the I.G. fails
to satisfy the remedial
purpose of the Act.
Petitioner's right to a hearing in this case is established by section 1156(b)(4)
of the Act. That section
provides that Petitioner is entitled to a hearing to the same extent as is provided
in section 205(b) of the
Act. Section 205(b) provides for a de novo hearing. Based on the evidence adduced
at the hearing, the
finder of fact may affirm, reverse, or modify the appealed determination.
I have the authority under this statutory framework to make findings and conclusions
both as to the issue of
liability under section 1156 and as to the reasonableness of the remedy imposed
against a petitioner by the
I.G. If I conclude that the I.G.'s remedy is unreasonable, I have the authority
to modify it.
The I.G. was authorized by section 1156 to impose and direct a remedy against
Petitioner. The I.G.'s
authority results from the P.R.O.'s recommendations based on evidence which
proves that Petitioner
committed gross and flagrant violations of her obligation to provide care which
met professionally
recognized standards of health care and demonstrated an inability to meet her
obligation. However, I do
not find that the remedy imposed and directed against Petitioner by the I.G.,
a three-year exclusion from
participation in Medicare and Medicaid, reasonably satisfies the Act's remedial
purposes. I conclude that,
while the evidence establishes the need for an exclusion, no remedial purpose
will be satisfied by imposing
and directing an exclusion of three years against Petitioner. I modify the exclusion
to permit Petitioner to
apply for reinstatement after six months. Petitioner's eligibility to apply
for reinstatement after six months
does not constitute an entitlement to be reinstated. If Petitioner does not
satisfy the I.G. that she has
rectified her deficiencies, then the I.G. is not required to reinstate Petitioner.
Section 1156 is a civil remedies statute. As with other civil remedies sections
of the Act (see sections 1128
and 1128A), the purpose of section 1156 is to enable the Secretary to protect
federally-funded health care
programs and their beneficiaries and recipients from individuals and entities
who have proven by their
misconduct that they are untrustworthy. Exclusions are intended to protect against
future misconduct by
providers. See Hanlester Network, et al., Melvin L. Huntsinger, M.D., and Ned
Welsh, DAB Civ. Rem. C-
186 - C-192, C-208, and C-213 at 93 (1991); Berney R. Keszler, M.D., et al.,
DAB Civ. Rem. C-167 at 32
(1990).
Federally-funded health care programs are no more obligated to continue to
deal with untrustworthy
providers than any purchaser of goods or services would be obligated to deal
with an untrustworthy
supplier. The exclusion remedy allows the Secretary to suspend his contractual
relationship with those
providers of items or services who are untrustworthy. The remedy enables the
Secretary to assure that
federally-funded health care programs will not continue to be harmed by untrustworthy
providers of items
or services. See Hanlester at 93; Keszler at 32-33. The exclusion remedy is
therefore closely analogous to
the civil remedy of termination or suspension of a contract to forestall future
damages from a continuing
breach of that contract.
Exclusion may have the ancillary benefit of deterring providers of items or
services from engaging in the
same or similar misconduct as that engaged in by excluded providers. See Hanlester
at 93; Keszler at 33.
However, the primary purpose of an exclusion is the remedial purpose of protecting
the trust funds and
beneficiaries and recipients of those funds. Deterrence cannot be a primary
purpose for imposing an
exclusion. Where deterrence becomes the primary purpose, section 1156 no longer
accomplishes the civil
remedies objectives intended by Congress. Punishment, rather than remedy, becomes
the end.
[A] civil sanction that cannot fairly be said solely to serve a remedial purpose
but rather can be
explained only as also serving either retributive or deterrent purposes, is
punishment, as we have come to
understand the term.
United States v. Halper, 490 U.S. 435, 448 (1989).
Therefore, in order to be adjudged reasonable under section 1156, an exclusion
must satisfy the remedial
objective of protecting federally-funded health care programs and their beneficiaries
and recipients from
untrustworthy providers of items or services. An exclusion which satisfies this
purpose may also have the
ancillary benefit of deterring wrongdoing; however, that ancillary benefit will
not sustain an exclusion
where the exclusion does not reasonably serve the Act's remedial objective.
9/
The weight of the evidence establishes that an exclusion is reasonable in this
case. Petitioner has
committed a series of potentially life-threatening judgment errors involving
the diagnosis and treatment of
patients entrusted to her care. The character of Petitioner's mistakes demonstrates
a disturbing pattern of
bad judgment. Petitioner manifests deficiencies in her ability to diagnose and
treat hospitalized patients
who are possibly suffering from drug intoxication. These deficiencies are compounded
by evidence which
shows that Petitioner failed to order or supervise monitoring and testing necessary
to properly treat
intoxicated patients. The pattern of similar errors manifested by Petitioner's
handling of the three cases at
issue here infers a likelihood that, barring some remedial action by Petitioner,
she will repeat her errors in
the future. I conclude that, based on the evidence before me, Petitioner is
an untrustworthy provider. An
exclusion is needed to protect program beneficiaries and recipients from future
judgment errors by
Petitioner which could adversely affect their health and well-being.
However, I am not persuaded that the three-year exclusion imposed and directed
by the I.G. is reasonable.
An exclusion of three years does not bear any reasonable relationship to the
remedial need established by
the evidence in this case.
Petitioner's deficiencies are not the consequence of bad faith or dishonesty.
There is no evidence in this
case to show that Petitioner is anything other than a dedicated and caring practitioner.
See P. Ex. 14-20.
Her deficiencies are deficiencies in judgment and, perhaps, training. She possesses
the power to cure her
deficiencies, either through education or simply by improving her management
and treatment of patients.
There is no evidence in this case that would show that such self-improvement
requires a lengthy period of
time. In light of that, a three-year exclusion is excessive.
My assessment of Petitioner's deficiencies also reflects my judgment that,
at least with respect to patients
143127 and 39026, Petitioner's judgment errors appear to have been only an aspect
of a series of errors
which may have led to the demise of the patients. In both of those cases, Petitioner
became responsible for
the care of the patients after serious damage to those patients' well-being
had already been done.
Furthermore, my examination of the record of treatment of all three patients
convinces me that Petitioner
conscientiously sought to provide care to the patients. In each case, she consulted
with specialists and
ordered care which she intended to benefit the patient.
The history of this case establishes that the P.R.O. was anything but confident
in making its exclusion
recommendation to the I.G. In June 1989, the P.R.O. determined that Petitioner
was capable of adequately
treating patients in an office setting, but was unable to cope with the limited
facilities available to her at
Arecibo Hospital. I.G. Ex. 28a/2. It recommended that Petitioner be excluded
from participation in the
Medicare program for a minimum of one year. I.G. Ex. 28a/3, 28b/3. 10/. The
recommendation was
rejected by the I.G. because the I.G. concluded that the P.R.O. had not complied
with the procedural
requirements of 42 C.F.R. Part 1004. I.G. Ex. 31.
By letter dated July 14, 1989, the P.R.O. advised the I.G. that recommending
a remedy was difficult,
alluding in part to problems which Petitioner confronted with the facilities
at Arecibo Hospital. I.G. Ex.
33. On July 28, 1989, the P.R.O. recommended, unambiguously, that Petitioner
be excluded from
participating in the Medicare program for one year. See I.G. Ex. 37. Again,
the I.G. rejected this
recommendation for procedural reasons. I.G. Ex. 38. On May 21, 1990, after additional
proceedings, the
P.R.O. recommended to the I.G. that Petitioner be excluded for five years. I.G.
Ex. 51.
The P.R.O.'s hesitancy in recommending an exclusion in this case reflects its
conclusion that Petitioner's
deficiencies related to her ability to diagnose and treat hospitalized patients
and not to her overall
qualifications as a physician. See I.G. Ex. 40/1. It also reflects its conclusion
that Petitioner's deficiencies
were in some respects exacerbated by conditions prevailing at Arecibo Hospital.
I.G. Ex. 28a/2.
Given the foregoing, I can find no logical remedial basis for the three-year
exclusion imposed and directed
by the I.G. Three years would not appear to be needed for Petitioner to take
the steps necessary to cure the
deficiencies in diagnosing and treating patients identified by the P.R.O. and
established by the evidence in
this case. The P.R.O.'s deliberative processes suggest that three years is longer
than it originally felt was
necessary. Finally, the I.G. has offered no evidence to show why a three-year
exclusion would be needed
in this case to satisfy the Act's remedial purposes.
The Act's remedial purposes would be satisfied in this case by an exclusion
of six months, running
prospectively. During that period, Petitioner should be able to take all of
the steps she identified in her
1990 correction plan. The exclusion also allows Petitioner time to take remedial
education in the diagnosis
and treatment of patients suffering from drug intoxication. 11/
My decision to modify the exclusion to a term of six months also reflects the
fact that any exclusion
imposed and directed against a provider under section 1156 sets forth the minimum
period that the provider
will be excluded prior to becoming eligible for reinstatement by the I.G. Under
section 1156 and
applicable regulations, the I.G. is not required to automatically reinstate
an excluded provider at the end of
the exclusion period. At the completion of the exclusion, the excluded provider
may apply for
reinstatement. However, the exclusion remains in effect until the I.G. determines
that "the basis for the
exclusion no longer exists and there is reasonable assurance that the problems
will not recur . . . ." 42
C.F.R. 1004.120. Therefore, the I.G. may evaluate any application for reinstatement
by Petitioner to
determine whether Petitioner has corrected her practice deficiencies, prior
to determining whether or not to
reinstate Petitioner. In deciding whether to approve an application for reinstatement,
the I.G. may seek
advice from other sources, including the P.R.O. See 42 C.F.R. 1001.130(a)(2).
12/
Because I declined to effect an exclusion against Petitioner in my preliminary
ruling, Petitioner has not yet
been excluded from participation. The exclusion, as modified by me, will run
prospectively from June 20,
1991, which is 20 days from the date of this decision (to allow time for receipt
and implementation). 13/
CONCLUSION
Based on the applicable law and evidence, I conclude that Petitioner grossly
and flagrantly violated her
obligation under section 1156 of the Act to provide care which was of a quality
which met professionally
recognized standards of health care, and demonstrated a lack of ability to comply
substantially with her
obligation. I conclude that the I.G. had authority to impose and direct an exclusion
against Petitioner from
participating in the Medicare and Medicaid programs. I conclude that the three-year
exclusion imposed
and directed against Petitioner was not reasonable, but that a six-month exclusion
will serve the Act's
remedial purposes.
____________________________
Steven T. Kessel
Administrative Law Judge
1. "State health care program" is defined by section 1128(h) of the
Social Security Act to cover three types
of federally financed programs, including Medicaid. I use the term "Medicaid"
hereafter to represent all
state health care programs from which Petitioner was excluded.
2. Patients 95883 and 39026 are referred to in the I.G.'s submissions by these
designations and as patients
"095883" and "039036."
3. I refer to the exhibits and the transcript of the proceedings as follows:
Petitioner's Exhibit P. Ex. (number)/(page)
Inspector General's I.G. Ex. (number)/(page)
Exhibit
ALJ Exhibit ALJ Ex. (number)
Transcript Tr. at (page)
4. On April 23, 1991, I directed that a letter be sent to the parties advising
them that, although there did not
seem to be a disagreement as to whether patients 143127, 39026, and 95883 were
Medicare beneficiaries,
there did not appear to be proof that in fact, these patients were Medicare
beneficiaries. Counsel for the
I.G. responded with a letter dated May 6, 1991, advising me that she and counsel
for Petitioner concurred
that patients 143127, 39026, and 95883 were Medicare beneficiaries. I have identified
this May 6, 1991
letter as ALJ Ex. 15 and have admitted it into evidence.
5. I received this evidence over the objection of counsel for Petitioner. In
receiving the evidence, I
advised the parties that I might ultimately rule that the evidence was inadmissible
to prove that there
existed authority to exclude Petitioner. I also advised the parties that the
evidence might be admissible on
the issue of the reasonableness of the three-year exclusion imposed and directed
against Petitioner by the
I.G.
6. I have made findings of fact concerning the additional allegations which
the I.G. asserted at the hearing
concerning patient 143127. See Findings 11-21, 39-45. I have done so because
it is difficult to properly
assess Petitioner's role in treating this patient without considering her services
in the context of the patient's
entire stay at Arecibo Hospital. See Analysis, Part 2a, infra. I consider that
context to be especially
important in my evaluation of a reasonable remedy in this case. See Analysis,
Part 3, infra. My findings as
to the I.G.'s additional allegations concerning Petitioner's treatment of patient
143127 are favorable to
Petitioner.
7. At the time of enactment of the regulation, section 1156 applied only in
cases involving patients who
were beneficiaries under Title XVIII of the Act (Medicare). Effective September
1, 1987, P.L. 100-93
amended section 1156 to make it applicable to cases involving patients who were
beneficiaries or
recipients of federally-funded health care programs, including Medicaid. Although
the regulation was not
revised to conform to the statutory amendment, it is apparent from the language
and context of the
regulation that the policy of the Secretary is to apply the regulation equally
to all cases brought pursuant to
section 1156.
8. In my January 21, 1990 ruling, I found that Petitioner did not pose a serious
risk to beneficiaries and
recipients of federally-funded health care programs and I declined to exclude
her pending my decision in
this case. I noted then that the serious risk and gross and flagrant abuse standards
were not synonymous
and that I could ultimately conclude that Petitioner had committed gross and
flagrant abuses and sustain an
exclusion. I made no specific findings of fact or conclusions of law in that
ruling. To the extent that any
of my findings and conclusions in this decision differ in any material respect
from those in my ruling, that
is due to my having had the time to thoroughly review the record in this case
and to more carefully reflect
on the parties' arguments. The findings of fact that I reach in this decision
supersede any fact conclusions
that I made in my January 21 ruling.
9. Section 1156(b)(3) provides that, in lieu of an exclusion, the Secretary
may require a party found to
have provided or ordered medically improper or unnecessary items or services
to pay an amount not in
excess of the actual or estimated cost of the improper or unnecessary items
or services. The I.G. contends
that I have no authority to order this relief as a remedy in lieu of an exclusion.
I am inclined to disagree
with this contention, because under section 205(b), I am delegated with the
authority to act as "the
Secretary" in hearings and appeals, and because my delegated authority
includes authority to modify any
remedy imposed by the I.G. However, I am making no findings on that issue in
this case, because I do not
believe that substituting a mandatory payment for an exclusion would be a reasonable
remedy here. Any
exclusion imposed and directed against Petitioner must be premised on the conclusion
that she is an
untrustworthy provider of care. Requiring Petitioner to make a payment in lieu
of an exclusion would not
protect beneficiaries and recipients from future untrustworthy acts. Thus, while
a payment might serve as a
legitimate remedial alternative to an exclusion in some cases, it would not
so serve in this case.
10. It is somewhat unclear from this recommendation whether the P.R.O recommended
that Petitioner's
exclusion be limited to her claiming reimbursement for treatment of Medicare
beneficiaries in a hospital
setting. The I.G. seems to have interpreted the recommendation as being for
an exclusion limited to
claiming reimbursement for treatment of patients in a hospital setting. I.G.
Ex. 30.
11. My decision to impose a six-month exclusion in some respects reflects the
fact that nearly six months
has already elapsed from the date of the hearing in this case. Presumably, if
Petitioner has acted in good
faith, she has already taken many of the steps she promised to take in her 1990
corrective plan.
12. The authority to reinstate an excluded provider lies entirely with the
I.G. I have no authority to
enumerate conditions pursuant to which the I.G. must grant reinstatement.
13. The I.G.'s exclusion determination under section 1156 is effective pending
the outcome of an
administrative hearing except in those cases where the excluded provider is
located in a rural health
manpower shortage area or in a county with a population of under 70,000 and
where an administrative law
judge declines to make an interim finding that the provider will pose a serious
risk to program beneficiaries
and recipients. Social Security Act, section 1156(b)(5). In such cases, should
the administrative law judge
ultimately conclude that there exists a remedial need to exclude the provider,
then the exclusion will
become effective no earlier than the date of the administrative law judge's
decision.