Evelyn Reyes, M.D., CR No. 131 (1991)

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.