Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of: Henry A. Peters, D.O., Petitioner,
- v. -
The Inspector General.
DATE: September 24, 1992
Docket No. C-92-074
Decision No. CR232
DECISION
This is a case arising from an action taken by the
Inspector General (I.G.) of the United States Department
of Health and Human Services (DHHS) against Henry A.
Peters, D.O. (Petitioner), pursuant to section 1156 of
the Social Security Act (Act). On February 6, 1992, the
I.G. notified Petitioner by letter (Notice) that he would
be excluded from participating in Medicare and all
federally financed State health care programs for a
period of one year. 1/ The I.G. informed Petitioner that
his exclusion was based on the recommendation of the
Sentinel Medical Review Organization, the peer review
organization of Indiana (PRO) and was authorized by
section 1156 of the Act. 2/ The I.G. advised Petitioner
that he had determined that Petitioner had, in two
instances "grossly and flagrantly" violated his
obligation under section 1156(b)(1)(B) to provide care
that meets professionally recognized standards of health
care in his treatment of one patient (Patient E.S. -- PRO
Case No. 309-07-7091B)). 3/ The I.G. asserted that
Petitioner had demonstrated an unwillingness and a lack
of ability "substantially to comply" with his obligations
under the Act. 4/ The I.G. alleged that Petitioner's
inability is further demonstrated by the problems
identified by the PRO in the care Petitioner provided in
two additional cases.
In the Notice, the I.G. informed Petitioner that he was
entitled to a hearing on the I.G.'s determination to
exclude him for one year. Under section 1156, the
exclusion would be in effect pending a decision by the
Administrative Law Judge (ALJ) on the merits. However,
because Petitioner practices in a county with a
population of less than 70,000, he was also entitled to a
hearing on the related issue of whether Petitioner posed
a "serious risk" to Medicare patients. 5/ As Petitioner
timely requested a hearing on both issues, the exclusion
did not take effect. 6/ See Order and Notice of
Prehearing Conference at 1, dated February 25, 1992.
I held the hearing in this case on May 4-8, 1992, in
Evansville, Indiana, on both the "serious risk" issue and
on the merits. The parties submitted post-hearing
briefs.
ISSUES
The issues in this case are:
1. Whether this case must be dismissed by reason of the
due process issues raised by Petitioner.
2. Whether Petitioner "grossly and flagrantly" violated
his obligations to provide health care which meets
professionally recognized standards.
3. Whether Petitioner demonstrated an "unwillingness or
lack of ability substantially to comply" with those
obligations.
4. Whether the one year exclusion imposed and directed
against Petitioner by the I.G. is reasonable.
5. Whether Petitioner presents a "serious risk" to
Medicare and Medicaid program beneficiaries and
recipients within the meaning of section 1156 of the Act.
SUMMARY OF THIS DECISION
I have considered the testimony and exhibits and the
parties' briefs and arguments. I conclude that the
evidence establishes that Petitioner "grossly and
flagrantly" violated his obligation to provide health
care which meets professionally recognized standards with
respect to one patient within the meaning of section 1156
of the Act. I conclude further that Petitioner has
demonstrated "a lack of ability substantially to comply"
with his obligation. Therefore, the I.G. had the
authority to exclude Petitioner under section 1156 of the
Act. Petitioner was not denied due process. I also
conclude that the remedial need for an exclusion, in this
case, will be satisfied by the one year exclusion
proposed by the I.G. Finally, with respect to the issue
of "serious risk," I find that Petitioner poses a
"serious risk" to beneficiaries and recipients of the
health care programs within the meaning of section 1156
of the Act and must be excluded during the pendency of
these proceedings.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
Having considered the entire record, the arguments, and
the submissions of the parties, and being advised fully,
I make the following Findings of Fact and Conclusions of
Law (FFCLs): 7/ 8/
Petitioner
1. Petitioner is a physician with a doctor of
osteopathy degree from Kansas City, Missouri, College of
Health Science. He has practiced medicine in Oakland
City, Indiana since 1956 and is on the staff of Wirth
Osteopathic Hospital in Oakland. Tr. 891-92.
2. Petitioner has been board certified in family
practice medicine by the American Osteopathic Association
for about 20 years. Tr. 892.
Procedural History
3. On August 19, 1988, the PRO notified Petitioner that
a potential quality issue had been identified in
reviewing the chart of Patient E.S., a patient of
Petitioner's. Tr. 50; I.G. Ex. 1.
4. On August 29, 1989, the PRO informed Petitioner
that, based on a third physician reviewer's review of the
chart of Patient E.S., the problem was a assigned a Level
II of severity (potential for adverse effects), and the
following interventions had been assigned: (1) notice
letter and (2) additional focused review of a minimum of
10 cases of patients with infection. 9/ Tr. 52; I.G. Ex.
1 at 6.
5. Subsequently, the PRO identified other cases as
potential quality of care issues, and on February 12,
1990, the PRO began sending Petitioner notices in these
other identified cases. I.G. Exs. 7 at 1, 9, 11, 13, 15,
17, 20, 22, 24, 26, 28, 30, 32, 34, 36.
6. By letter dated May 28, 1990, the PRO notified
Petitioner that the Quality Committee had determined that
the quality of care issue regarding his treatment of
Patient E.S. was a Level III issue (actual adverse
effect) and assigned additional interventions as part of
a Corrective Action Plan (CAP) which required Petitioner
to be reviewed 100 percent, to obtain 24 hours of
Continuing Medical Education (CME) on infectious diseases
within six months, and to submit documentation of the CME
credits to the PRO. Tr. 53-54; I.G. Ex. 1 at 8.
7. Petitioner responded to the PRO's letter described
in FFCL No. 6 by enclosing information on CMEs obtained
from 1979-1983. I.G. Ex. 1 at 9-21.
8. By letter dated August 1, 1990, the PRO notified
Petitioner that it had concluded that there was a
reasonable basis for determining that the case of Patient
E.S. represented a "gross and flagrant" violation (within
the meaning of section 1156 of the Act) and that he could
request a meeting with the Sanction Committee before a
final determination was made. Tr. 56, I.G. Ex. 1 at 22-
34.
9. The Sanction Committee sent two more requests to
Petitioner that he meet with the Committee. I.G. Ex. 1
at 51, 53.
10. Petitioner met with the Sanction Committee on
November 20, 1990, and by letter dated November 28, 1990,
the Committee affirmed the interventions. I.G. Exs. 2,
43 at 94.
11. At a meeting with Petitioner in September of 1991,
Dr. Peter Livingston, Medical Director of the PRO,
discussed additional quality of care issues, and asked
him to submit the required CME documentation. Petitioner
did not submit the documentation. Tr. 63-64.
12. On October 18, 1991, the PRO recommended to the I.G.
of DHHS that Petitioner be excluded for six months from
participating in Medicare and Medicaid based on its
conclusion that Petitioner had "grossly and flagrantly"
violated his obligation to provide health care that met
professionally recognized standards and that he had
demonstrated an unwillingness and inability to comply
with his obligation within the meaning of section 1156 of
the Act. I.G. Ex. 43 at 2.
13. By letter dated February 6, 1992, the I.G. notified
Petitioner that he was being excluded from participating
in Medicare and Medicaid for a period of one year. The
I.G. stated that in the case of patient E.S., Petitioner
had grossly and flagrantly violated his obligation to
provide health care of a quality that met professionally
recognized standards within the meaning of section 1156
of the Act. The I.G. also determined that Petitioner was
unwilling and unable substantially to comply with his
obligations. I.G. Ex. 3.
Due Process Issues
14. The regulations require the I.G. to determine
whether the PRO is following its procedures. 42 C.F.R.
1004.90(b)(1). 10/
15. In this case, there were some minor and harmless
errors made by the PRO in failing to follow its
procedures.
16. The PRO notice letters adequately addressed the
charges leveled against Petitioner for each review level.
17. The PRO reviewers must forward to the Quality Review
Committee those cases in which they have awarded 10 or
more points (in severity) to a physician within a three
month period. They may also forward other cases to the
Quality Review Committee, especially where interventions
have been assigned. Tr. 102-03
18. The PRO is not required to specify which CMEs a
physician should take to fulfill a CAP. See Tr. 55-56.
19. When reviewing a case, the PRO may increase or
decrease its assigned severity level. Tr. 41-42; see Tr.
179.
20. The PRO provided Petitioner with a written
explanation of why it increased the severity level of
Petitioner's case from Level II to Level III. I.G. Ex.
43 at 7-9.
21. At each level of review, Petitioner was provided
with an opportunity to respond to the PRO's charges
against him.
22. The PRO did follow its procedures (except for some
minor and harmless errors) and did not violate
Petitioner's due process rights.
23. The I.G.'s Notice, taken in its entirety, is
sufficient to apprise Petitioner of the action taken
against him by the I.G. and to afford him the opportunity
to respond. See I.G. Ex. 3.
24. The I.G. is not bound by the PRO's recommended
sanction but properly based its determination of
Petitioner's sanction on the factors set forth in 42
C.F.R. 1004.90(d).
25. As this is a de novo review, the I.G. may introduce
evidence not included in the Notice, but, because the
I.G. did not provide Petitioner with sufficient notice
with respect to the evidence submitted on the 15
additional cases, this evidence may only be used with
regard to the issues of the reasonableness of the length
of the exclusion, i.e., Petitioner's trustworthiness, and
whether he presents a "serious risk" to the program.
26. The I.G. did not violate Petitioner's due process
rights.
27. The regulations and their preamble provide for
consideration of differences of opinion among experts in
that the preamble states that there is no litmus test
with respect to the required standard of care. See 42
C.F.R. 1001.2 (1992); 57 Fed. Reg. 3301 (January 29,
1992).
28. I must assume that the Act and its implementing
regulations are constitutional and the determination of
an attack on the constitutionality of section 1156 of the
Act or its implementing regulations is outside my
jurisdiction. See Califano v. Sanders, 430 U.S. 99, 109
(1977).
29. I have the authority to interpret and apply federal
statutes and regulations. Francis Schaenboen, DAB CR97
(1990), aff'd DAB 1249 (1991).
"Gross and Flagrant"
30. Under Section 1156 of the Act, the Secretary may
exclude a physician from participating in Medicare and
Medicaid where the Secretary determines, based on a
recommendation by a PRO, that the physician has grossly
and flagrantly violated the obligation to provide health
care of a quality which meets professionally recognized
standards of care, within the meaning of section 1156 of
the Act, and has demonstrated an unwillingness or lack of
ability "substantially to comply" with the obligation to
provide that care. Sections 1156(a)(2) and (b)(1) of the
Act.
31. "Professionally recognized standards of care"
(within the meaning of section 1156 of the Act) are those
which professional peers of the individual or entity,
whose provision of care is an issue, recognize as
applying to those peers practicing or providing care
within a State. 42 C.F.R. 1001.2.
32. A "gross and flagrant violation" is defined as the
violation of an obligation to provide care 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 a high risk
situation. 42 C.F.R. 1004.1(b).
33. The I.G. proved that Petitioner committed a "gross
and flagrant" violation of his obligation to provide
health care in accordance with professionally recognized
standards of care.
Patient E.S.
34. Patient E.S. was a 72 year old woman who had been
hospitalized several times in the last few years of her
life with multiple chronic medical problems. Tr. 761-63;
I.G. Ex. 1 at 43.
35. Patient E.S., a Medicare beneficiary, was
hospitalized at Deaconess Hospital from March 5 to 22,
1988, where she was treated by Dr. William Houser and Dr.
Herman Rusche upon referral by Petitioner. Her admitting
symptoms were an elevated white blood count (WBC),
diarrhea, and abdominal distention.
36. During the hospitalization at Deaconess, Patient
E.S. was diagnosed as having pseudomembranous colitis and
was treated with Vancomycin and other drugs. Tr. 763-69;
I.G. Ex. 1.
37. On March 29, 1988, Patient E.S. was admitted to
Wirth Osteopathic Hospital by Petitioner with a
provisional diagnosis of septicemia, and the admitting
reports listed her complaints as including extreme
exhaustion, poor appetite, and white sores on the throat
and mouth. I.G. Ex. 6 at 8-9.
38. Petitioner's physical examination of Patient E.S.
included findings of poor skin texture, dehydration, and
markedly tender and distended abdomen with hyperactive
bowel sounds, and he noted her prior hospitalization for
"pseudomembranous ulcerated colitis." I.G. Ex. 6 at 25.
39. During the course of Patient E.S.'s last
hospitalization at Wirth, her WBC elevated daily from
12,000 on March 29 to 49,200 on April 4, 1988, the day
she died. See I.G. Exs. 1 at 10, 6 at 25-62.
40. After hospitalization, Petitioner ordered a blood
count, chemistries, and electrolyte and blood gas
studies, but blood cultures were not ordered until April
2 and 4, and a stool culture was not ordered until April
4. I.G. Exs. 1 at 10, 6 at 25-63.
41. During Patient's E.S.'s last hospitalization at
Wirth, Petitioner prescribed or continued the
prescription of numerous drugs, including Theophylline,
Levothyroxine, Berocca-Plus, Naprosyn, Spironolactone,
Brethine, Donnatal, Furosemide, Darvocet, Synthroid,
Prednisone, Lanoxin, Bicillin, Klotrix, ACTH, Septra,
Bactrin, insulin, Immodium, Lomotil, Solumedrol,
Gentamycin, Gentian Violet, and Morphine Sulphate. I.G.
Ex. 6.
42. Vancomycin was not ordered for Patient E.S. by
Petitioner until 11:30 p.m. April 1, 1988, and does not
show up on the nurses' record of medications until
"Hospital Day 4" (April 2). I.G. Ex. 6 at 30, 46.
43. On March 30, 1988, Dr. Terry Gehlhausen provided a
consultation on Patient E.S., and recommended that her
multiple medications be reduced and that more lab tests
be done. I.G. Ex. 6 at 6-7.
44. Patient E.S. died the evening of April 4, 1988, and
the final diagnosis was septicemia, respiratory failure,
and pseudomembranous ulcerative colitis. I.G. Ex. 6 at
61.
45. Petitioner failed to timely order tests to permit
diagnosis of the cause of the septicemia and determine
appropriate treatment or to test for pseudomembranous
colitis, and he ignored Dr. Gehlhausen's recommendations
for additional testing.
46. Petitioner prescribed Septra and Bicillin for
Patient E.S. without diagnosing the cause of her
septicemia and which drugs could also have caused or
exacerbated a relapse of her pseudomembranous colitis.
47. Petitioner prescribed ACTH, a steroid anti-
inflammatory, and two other cortisone drugs, Solumedrol
and Prednisone, without medical indication for Patient
E.S. and continued the ACTH even after Dr. Gehlhausen
questioned the necessity for repeating it.
48. Petitioner failed to continue to treat Patient E.S's
dehydration when he prescribed the diuretics Lasix and
Spironolactone and reduced her IV fluids, although she
had diarrhea on admittance which increased during her
hospitalization, and her intake and outtake rates
indicated that she was becoming more dehydrated.
49. Petitioner failed to evaluate or treat Patient
E.S.'s abdominal condition by failing to attempt to
determine its cause, although hospital records indicate
that she had abdominal problems, that her diarrhea
steadily increased during her hospitalization, and that
Petitioner was aware of her recent treatment for
pseudomembranous colitis.
50. Petitioner failed to timely restart Patient E.S. on
Vancomycin to treat the suspected pseudomembranous
colitis, although it is one of only two drugs useful for
this condition.
51. Petitioner administered several drugs which are
contraindicated for a someone in Patient E.S's condition
and which were potentially harmful to her, including
Septra, Bicillin, Lomotil, Immodium, ACTH, and Morphine
Sulphate.
52. Petitioner's failure to properly evaluate, test, and
treat Patient E.S. was a violation of professionally
recognized standards of care.
53. Petitioner's violation of professionally recognized
standards of care placed Patient E.S. unnecessarily in a
high risk situation and presented serious risk of
imminent danger.
54. Petitioner's conduct was a "gross and flagrant"
violation of his obligation under section 1156 of the Act
to provide health care of a quality which meets
professionally recognized standards of care.
Willingness and Ability to Comply
55. The evidence does not support a finding that
Petitioner timely or fully complied with the PRO's
assigned CAP of completing 24 credits of CME in
infectious diseases within six months and forwarding
proof to the PRO. See Tr. 64, 916-17; I.G. Ex. 1 at 9;
P. Ex. 1.
56. Petitioner has regularly attended medical seminars
in excess of that required to maintain his board
certification. P. Exs. 1 and 10.
57. The I.G. has not met his burden of proof with regard
to whether Petitioner is unwilling substantially to
comply with his obligations under the Act.
58. Petitioner's treatment of Patient E.S. demonstrates
that he lacks the ability: 1) to evaluate or treat the
cause of infectious processes; 2) to understand the
proper use of steroids, 3) to prescribe the appropriate
and least harmful medications for a patient's conditions;
4) to timely order and evaluate laboratory data or to
perform diagnostic tests when indicated; and 5) to manage
fluid intake in a patient who requires hydration.
59. Petitioner lacks the ability "substantially to
comply" with his obligation to provide care that meets
professionally recognized standards.
Authority to Exclude
60. The I.G. has demonstrated by a preponderance of the
evidence that Petitioner has violated his obligation to
provide health care in accordance with professionally
recognized medical standards with regard to Patient E.S.
61. The I.G. had the authority to exclude Petitioner
from participating in Medicare and Medicaid pursuant to
section 1156 of the Act.
Length of Exclusion
62. Petitioner violated professionally recognized
standards of health care by prescribing antibiotics for
Patients D.R. and C.H. without first isolating the cause
of their elevated WBC or identifying the source of their
infections.
63. Petitioner violated professionally recognized
standards of health care by failing to identify the
source of low hemoglobin in Patients C.H. and B.B. and by
failing to diagnose the cause of positive stool for
occult blood test results in Patient V.E.
64. Petitioner violated professionally recognized
standards of health care by failing to order a
computerized axial tomography (CAT) scan of Patient
E.R.'s brain to diagnose the cause of her acute
neurological unresponsiveness.
65. Petitioner violated professionally recognized
standards of health care by failing to control blood
glucose levels in Patients D.R. and A.M., who were
suffering from diabetes.
66. Petitioner violated professionally recognized
standards of health care by failing to either diagnose or
definitively rule out a urinary tract infection in
Patient A.A.
67. Petitioner violated professionally recognized
standards of health care by failing to institute either
fluid restriction or sodium infusion to reverse falling
serum sodium levels in Patient C.H.
68. Petitioner violated professionally recognized
standards of health care by failing to address Patient
W.H.'s hypotension, either by treating it or,
alternatively, by indicating in her medical record that
the low blood pressure readings were inaccurate.
69. Petitioner lacks the ability to diagnose the causes
of patients' abnormal laboratory results and to address
these results adequately.
70. Petitioner violated professionally recognized
standards of health care by prescribing steroids for
Patients N.H., W.H., and T.R., who were suffering from
illnesses that contraindicated the use of steroids.
71. Petitioner violated professionally recognized
standards of health care by prescribing steroids for
Patient J.R. without medical justification.
72. Petitioner violated professionally recognized
standards of health care by failing to prescribe the
recognized steroid treatment for Patient T.P., who was
suffering from an illness that did require steroid
treatment.
73. Petitioner violated professionally recognized
standards of health care by prescribing IV Kefzol, an
antibiotic, via an inappropriate route of administration
in the case of Patient A.M., and at an inappropriately
high dosage in the case of Patient V.E.
74. Petitioner violated professionally recognized
standards of health care by discontinuing the drug
Tenormin, an antihypertensive, in a dangerous manner for
Patient W.H.
75. Petitioner violated professionally recognized
standards of health care by prescribing various
medications that were contraindicated in the cases of
Patients A.M. and J.R.
76. Petitioner lacks the ability to prescribe the
appropriate medications for patients' conditions.
77. The I.G. failed to prove that Petitioner violated
professionally recognized standards of health care in his
treatment of the cardiac conditions of Patients C.H. and
J.R.
78. Petitioner violated professionally recognized
standards of health care by failing to intervene timely
to order an immediate EKG when Patient T.P. experienced
severe chest pain, apparently as a result of an acute
heart attack.
79. Petitioner violated professionally recognized
standards of health care by discontinuing cardiac
monitoring of Patient E.G., at a time when abnormal test
results indicated that her cardiac condition was still
unstable.
80. Petitioner violated professionally recognized
standards of health care by failing to perform the
necessary and usual tests to evaluate the cause of test
results that indicated possible cardiac problems in
Patients B.B. and O.B.
81. Petitioner lacks the ability to evaluate and
intervene appropriately in patients suffering acute
cardiac changes.
82. Petitioner violated professionally recognized
standards of health care by failing to order sufficient
IV fluids for Patient T.R., whom Petitioner had diagnosed
as dehydrated.
83. Petitioner violated professionally recognized
standards of health care by failing to order fluid
restrictions in the cases of Patients V.E. and E.G., whom
he had diagnosed as suffering from congestive heart
failure.
84. Petitioner lacks the ability to manage fluid intake
in patients who require hydration or fluid restriction.
85. The purpose of section 1156 of the Act is remedial
and 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. S. Khalid Hussain, M.D., CR204 at 94
(1992); Evelyn Reyes, M.D., DAB CR131 at 37 (1991).
86. Petitioner has engaged in conduct that endangered
the health and safety of Medicare beneficiaries.
87. Petitioner has demonstrated by his "gross and
flagrant" violation that he is not trustworthy to treat
program beneficiaries and recipients.
88. The I.G. has proven that there is a remedial purpose
to exclude Petitioner for one year.
"Serious Risk"
89. The I.G. has proven that Petitioner represents a
"serious risk" within the meaning of section 1156 of the
Act and should be excluded during his administrative
appeals.
90. Petitioner's exclusion shall run prospectively from
twenty days from the date of this decision.
DISCUSSION
I. Petitioner Was Not Denied Due Process.
Petitioner has raised a number of due process and
constitutional arguments, several of which he asserts are
not within my jurisdiction to decide. 11/ Petitioner
argues that:
1) The Act is unconstitutional.
2) The regulations are unconstitutional.
3) The regulations are not within the Secretary's
authority.
4) The PRO involved is not made up of representative
licensed doctors of medicine and osteopathy engaged
in the practice of medicine or surgery in the area
and who are representatives of practicing physicians
in the area.
5) The regulations do not take into account
differences of opinion among physicians regarding
practice standards.
6) The regulations do not set out any criteria for
imposing sanctions.
P. Br. at 2.
Petitioner has raised additional procedural arguments
throughout his brief, the majority of which I shall
address in this part of the decision. While I do not
have the authority to rule on the constitutionality of
the Act and regulations, I do have the authority to
interpret and apply federal statutes and regulations.
Francis Schaenboen, R.Ph., DAB CR997 (1990), aff'd DAB
1249 (1991). In addition, where there is room to decide
how to apply the statute, I have a duty to apply it in a
manner that is constitutional and valid. Betsy Chua,
M.D., DAB CR76 (1990), aff'd DAB 1204 (1990).
A. The PRO Did Not Violate Petitioner's Due Process
Rights.
Congress has determined that federal exclusion actions
under section 1156 of the Act originate when a PRO
recommends sanctions to the I.G., and the I.G., in
reviewing the PRO's report and recommendation, makes
certain findings and decides to issue a Notice of
Sanction to a medical provider. In addition to these
findings, the regulations require the I.G. in its review
to determine whether: "The PRO is following its
procedures." 42 C.F.R. 1004.90(b)(1).
Petitioner argues that this case should be dismissed and
no exclusion imposed because he was denied due process,
alleging that the PRO failed to follow its procedures.
The federal regulations governing PRO sanctions provide
several layers of due process protection for a medical
provider who is the subject of a PRO review. The PRO,
which is composed of a cross-section of medical
practitioners in a particular state, must, upon
identifying potential violations, give the target
physician a written notice explaining the obligation
violated, the basis for the determination, the
recommended sanction, and the physician's appeal rights.
42 C.F.R. 1004.50. Here, at each step along the way,
Petitioner was reviewed by different medical
professionals, and Petitioner had the opportunity to, and
did, reply to these notices.
Petitioner alleges that the PRO committed numerous errors
and demonstrated inconsistencies in processing his
quality review. P. Ex. 14. Many of these alleged errors
are minor and appear to be more typographical and
harmless than intentional or harmful violations of due
process. For example, one early PRO document makes a
reference to Patient E.S., a female, by using the term
"his." Id. at 2. Subsequent documents use the correct
gender. Another of Petitioner's allegations regards
corrections (white overs) regarding Patient E.S.'s
medical condition which were made to some early
documents. P. Ex. 14. Petitioner was well aware of each
of these errors and called them to the PRO's attention in
his responsive letters. Other allegations appear
rhetorical, such as Petitioner's questions regarding how
the PRO determined that he had not stayed current in
medicine, how the I.G. concluded, based on the PRO's
recommendation, that Petitioner was unable to comply with
his obligations under the Act, or why if Petitioner poses
a "serious risk," was he honored by his community. Id.
at 92-98, 209. Still others allege bias on the part of
members of the PRO and employees of the of the DHHS. Id
at 201.
More important than any of the minor harmless errors of
which Petitioner has complained, is Petitioner's
assertion that the notice letters from the PRO did not
adequately address the charges made against him and that
these charges changed as the case moved through the
several review levels. It is true that the charges
increased as the PRO discovered more problems with
Petitioner's handling of Patient E.S. However, in each
instance, Petitioner was informed of the charges and of
his right to be heard, and, in each instance, he
responded to the charges. In addition to his written
responses, he had an opportunity to be heard before the
Sanction Committee at its administrative hearing. This
argument appears to stem more from Petitioner's
disagreement with the PRO reviewers not agreeing with his
explanations than from any lack of due process.
Petitioner also argues that the PRO breached its own
statute of limitations and asserts that the PRO was
required to decide his case within a three month time
frames. This allegation is based on the PRO's
procedures, in which points are given depending on the
level of the severity of the violation found by the PRO.
A Level I issue is assigned one point, a Level II issue
has five points, and a Level III issue has 25 points.
Tr. 37. Interventions are triggered if a physician
accumulates ten points during a three month period.
Petitioner's intervention was originally classified as a
Level II and subsequently increased by the PRO Quality
Committee to Level III. Dr. Livingston, the Director of
the PRO, testified that there are no statutes of
limitations as such. If a doctor doesn't accumulate 10
points within a three month period, a case is closed.
Tr. 38. Contrary to Petitioner's assertions, this does
not mean that the case must be decided in three months,
only that if 10 points are accumulated in this time, a
case must be referred to the Quality Committee. Tr. 102-
03. However, other cases may be referred to the Quality
Committee if it is felt to be appropriate. Also, all
cases, similar to Petitioner's, in which interventions
such as monitoring are imposed, are forwarded to the
Quality Committee. Id. Thus, there was no violation of
PRO rules because the case did not close after three
months, but, rather, it was found to be an appropriate
case to refer to the Quality Committee even though
Petitioner did not originally accumulate a total of 10
points within that time frame.
Petitioner next asserts that the PRO failed in its
mandate to improve health care because it did not respond
to his requests for more information on why he had failed
in his obligations. P. Br. at 11. This, he claims, is
in violation of the PRO's rules. It appears from a
review of the PRO's record that there was a significant
exchange of written materials between the PRO and
Petitioner, and that Petitioner refused to accept the
PRO's comments regarding his treatment of Patient E.S.
See I.G. Ex. 43. Also, the PRO did attempt to meet its
obligation to educate Petitioner by requiring him to take
24 hours of CME in infectious diseases. Contrary to
Petitioner's protestations, the PRO was not required to
specify which courses, of the many available to
physicians, Petitioner should take. See Tr. 55-56.
Lastly, Petitioner argues that the PRO Quality Committee
failed to explain why it raised the level of the
violation from II (five points) to III (25 points).
Dr. Livingston testified that the Quality Committee may
re-review a case and adjust the level of severity after
discussion among the entire Committee. Tr. 41-42; see
Tr. 179. There is nothing in the PRO procedures to
prevent it from either upgrading or downgrading an
intervention on review. That is the purpose of a review.
The Quality Committee voted unanimously for the increase
and for the additional assigned interventions.
Petitioner asserts that the refusal to respond to his
question regarding the upgrading by the Chairman of the
Committee is a denial of due process. However, the PRO
did provide Petitioner, in writing, with information
regarding its decision and the factors upon which it
relied in upgrading the level of severity, including the
Quality Committee's determination that "the patient was
not adequately evaluated or treated resulting in her
death." I.G. Ex. 43 at 7-9 (Sanction Committee Report).
The Sanction Committee also voted unanimously that the
case was a Level III case.
In summary, I find that the evidence of record shows some
very minor irregularities, primarily harmless errors and
corrections to the written record. Petitioner has failed
to establish that these harmless errors resulted in
significant defects in the PRO's procedures. To the
contrary, the testimony and documentary evidence relating
to these factors shows that the PRO did, as a whole,
follow its procedures, and that the procedures provided
and available to Petitioner by the PRO afforded him with
considerably more than the rudimentary requirements of
fair play and due process. See Howard Lifshutz, M.D.,
DHHS Appeals Council Docket No. 000-44-7020 at 5 (June 1,
1989). 12/
B. The I.G. Did Not Violate Petitioner's Due Process
Rights.
In addition to due process challenges to the PRO's
procedures, Petitioner asserts that the I.G. violated his
due process rights because the I.G.'s Notice did not
advise Petitioner adequately of the nature of the charges
against him. P. Br. at 8-16. Petitioner states that due
process requires that he be fully advised, and asserts
that the Notice identifies the charges as only:
"cultures and antibiotic therapy should have been done
sooner" and "the patient was not adequately evaluated or
treated." P. Br. at 8, citing I.G. Ex. 3 at 1. The
first statement, he maintains, is contrary to the actual
charges, while the second is too generic to permit a
defense. These statements, however, are summaries and
not the full extent of the basis identified by the I.G.
for the charges. The PRO's exclusion recommendation
letter to the I.G., which Petitioner received prior to
the I.G.'s Notice, contained a three page case synopsis
setting forth the factual basis for the "gross and
flagrant" finding. The I.G.'s Notice stated that the
decision to exclude was based on the PRO recommendation
and "incorporated [it] in this notice by specific
reference." I.G. Ex. 3 at 1. I conclude that the I.G.'s
Notice, taken in its entirety, is of "such a nature as
reasonably to convey the required information" and is
sufficient to "apprise interested parties of the pendency
of the action and afford them an opportunity to present
their objections." Mullane v. Central Hanover Tr. Co.,
339 U.S. 306, 314 (1949).
Petitioner contends also that the I.G. increased the
PRO's proposed six month exclusion to one year without
explanation. The key here is that the PRO merely
recommends sanctions, but the I.G. must base his
determination of an appropriate sanction upon the
factors set forth in 42 C.F.R. 1004.90(d). The PRO
recommendation is only one of the factors that the I.G.
must consider. The I.G.'s Notice sets forth the I.G's
analysis of the regulation's criteria. See I.G. Ex. 3
at 2-3. There is no requirement that the I.G. adopt the
PRO's recommendations at all -- let alone be bound to the
recommended period of exclusion. 13/
Finally, Petitioner claims that the I.G. may not
introduce evidence that Petitioner committed violations
in addition to those specifically set forth in the
Notice. He asserts that due process requires notice of
all charges and evidence to be used in arriving at the
sanction. Petitioner is correct that certain specific
matters alleged by the I.G. to support the "serious risk"
issues on the question of the authority of the I.G. to
exclude were not referenced in the Notice. However,
these specific matters listed by Petitioner were not
relied on by the I.G. in determining to impose the
exclusion or the reasonableness of its length. Each of
the allegations in the "gross and flagrant" portion of
the I.G.'s case is included in the charges as noticed.
With respect to the additional evidence the I.G. has
introduced, this is a de novo review, and I may consider
information and evidence not considered or relied on by
the I.G. in his initial determination so long as doing so
would not be unfair. Papendick v. Sullivan, No. 91-1902
at 6 n.4 (7th Cir. July 17, 1992); Olufemi Okonuren,
M.D., DAB 1319 at 14 (1992).
Petitioner has also challenged the I.G.'s introduction of
evidence regarding 15 additional cases which are, or
were, on review by the PRO. There were three cases cited
in the PRO recommendation and the I.G.'s Notice, although
only the case of Patient E.S. was specifically
identified. As discussed more fully in part III-B of
this decision, this mere reference, without other
information, to the other two cases was insufficient to
provide adequate notice on the issue of the I.G.'s
authority to exclude Petitioner. Also, there was no
notice provided Petitioner by the I.G. of his intent to
rely also on the additional 13 cases to establish
Petitioner's "lack of ability substantially to comply."
Therefore, I conclude that it would be unfair to consider
evidence on the 15 additional cases (including the two
not specifically identified in the Notice) which are not
related to the case of Patient E.S. on the issue of the
I.G.'s authority to exclude Petitioner (i.e. the issues
of "gross and flagrant" and "unwillingness or a lack of
ability substantially to comply"). Reyes at 22-23.
Accordingly, I find that the I.G.'s Notice did give
adequate notice of the charges with respect to Patient
E.S. Also, I conclude that the I.G. may introduce
evidence of the 15 additional cases (two of which were
included in the Notice) which are, or were, under
review by the PRO for the purpose of determining the
reasonableness of the length of the exclusion and
Petitioner's trustworthiness and on the issue of
"serious risk." See Id.
In summary, I find that the I.G.: 1) reasonably found
that the PRO had followed its procedures in Petitioner's
intervention; 2) adequately advised Petitioner in the
Notice of the nature of the charges and the rationale for
the one year exclusion; and 3) was permitted to introduce
evidence not specifically identified in the Notice only
for the purposes of determining the length of the
exclusion and the "serious risk" issue.
C. Petitioner's Additional Statutory And Regulatory
Challenges Either Do Not Require Dismissal Or Are Not
Within My Jurisdiction To Decide.
Petitioner argues that the PRO is not made up of
physicians that are similar in practice to Petitioner.
Petitioner also argues that the regulations do not take
into account differences of opinion among physicians
regarding practice standards. Here, I assume that
Petitioner is referring to 42 C.F.R. Parts 1000 et al.,
and, especially, Part 1004 which deals with the
imposition of sanctions on health care practitioners and
providers of health care services by a PRO. As discussed
more fully in part II of this decision, the interpre-
tation of the statutory requirement of standard of care
in the preamble to the regulations specifically notes
that, with respect to the standard of care, there is no
litmus test which can be applied to every case. In this
proceeding, Petitioner was able to introduce expert
testimony from practitioners of his choice regarding the
appropriate standard of care. Further, the question of
differences of opinion among experts is not unique to the
PRO procedures. In all cases which involve the testimony
of experts, it is the duty of the trier of fact to
evaluate that testimony. I have done so here, and in
doing so, have considered and weighed these differences
of opinion in reaching my decision.
Thus, the regulations do address Petitioner's concern
regarding consideration of differing medical opinions.
Petitioner has not been denied due process on this
account. 14/
Petitioner has also challenged the constitutionality
of both the Act and its implementing regulations.
Petitioner recognizes that these constitutional issues
are beyond my jurisdiction and raised them solely for the
purpose of preserving them for appeal. See, Califano v.
Sanders, 430 U.S. 99, 109 (1977) (J. Stewart concurring).
Thus, I shall not consider these arguments. 15/
II. Petitioner "Grossly And Flagrantly" Violated His
Obligation To Provide Professionally Recognized Standards
Of Health Care In The Case Of Patient E.S. Within the
Meaning of Section 1156 of the Act.
A. Obligations and "Gross And Flagrant" Violations of
Obligations Under The Act.
Section 1156(a)(2) of the Act imposes on physicians an
obligation to provide services "of a quality which meets
professionally recognized standards of health care."
Although section 1156 does not define the term
"professionally recognized standards of health care," the
regulations provide the following definition:
Statewide or national standards of care, whether in
writing or not, that professional peers of the
individual or entity whose provision of care is an
issue, recognize as applying to those peers
practicing or providing care within a State.
42 C.F.R. 1001.2 (1992).
The preamble to the above regulation also notes that the
definition:
does not provide a litmus test which can be easily
applied in every case. It would be very difficult
to formulate a wholly objective standard in the area
of medical practice, where a certain amount of
subjectivity in judgement is inevitable.
57 Fed. Reg. 3301 (January 29, 1992).
Relying on this preamble, a recent case noted that
unanimity of opinion among physicians as to the
acceptability of a given treatment is not the standard,
and that a physician does not violate his obligation to
provide health care that meets professionally recognized
standards if the physician pursues a course of treatment
that has substantial support as proper practice among his
or her professional peers. Hussain, at 43.
Petitioner's concerns about the need to consider
differences of opinion among physicians regarding
practice standards are, therefore, encompassed in this
definition. Also, the standard of care is not limited by
locality. It is, and has been, a state or national
standard. 57 Fed. Reg. at 3301; see also Papendick at 6-
7 (ALJ did not err in applying statewide standard of
professional care). However, this does not mean, as
Petitioner seems to imply, that board certified family
practitioners, such as Petitioner, are held to a lower
standard of care. For example, a board certified
neurosurgeon might be expected to know more about his or
her specialty than other physicians. This does not mean
that the standard of care would excuse a physician who
practiced medicine which had the potential to harm a
patient on the ground that he is a general practitioner.
Section 1156(b)(1)(B) authorizes the Secretary to
exclude, from participation in Medicare and Medicaid,
physicians who have been determined by a PRO to have
"grossly and flagrantly" violated their obligation in one
or more instances. 16/ To justify an exclusion, the
Secretary must further conclude that the practitioner has
demonstrated an "unwillingness or lack of ability
substantially to comply" with his or her obligation under
the Act. Id.
"Gross and flagrant violation" has also been defined by
regulation as stated in note 3, supra. The term means a
violation "which represents an imminent danger to the
health, safety or well-being of a Medicare beneficiary or
places the beneficiary unnecessarily in high-risk
situations." 42 C.F.R. 1004.1. One court has expanded
on this by stating that a "gross and flagrant violation"
involves "an especially dangerous deviation from medical
norms." Varandani v. Bowen, 824 F.2d 307, 312 (4th Cir.
1987). Another case held that 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 I.G. asserts that Petitioner "grossly and flagrantly"
violated his obligation to provide services which meet
professionally recognized standards of health care in one
case, that of Patient E.S. Thus, I must first consider
whether Petitioner violated his obligation to provide
care of the requisite quality and, if so, whether the
violation placed Patient E.S. in imminent danger or
unnecessarily in a high risk situation. See Hussain at
49-50.
B. Petitioner "Grossly And Flagrantly" Failed to Provide
Patient E.S. With Services Which Meet Professionally
Recognized Standards Of Health Care.
Patient E.S., a Medicare beneficiary, was a 72 year old
female. According to Petitioner, who had treated her for
about 20 years, she had multiple chronic medical
problems, including a pacemaker, respiratory problems
caused by smoking and several bouts with pneumonia, and
chronic bronchitis. Tr. 761-62, 897; P. Br. at 3. She
was hospitalized several times in both 1987 and 1988.
Id.
She had been in Wirth Osteopathic Hospital in Oakland
City, Indiana (Wirth) for pneumonia between February 2
and 17, 1988, and treated with antibiotics. She was
readmitted on February 29, 1988, released and readmitted
on March 1 because of severe diarrhea. I.G. Ex. 1 at 42,
46. On March 5, she was transferred by Petitioner from
Wirth to Deaconess Hospital in Evansville, Indiana
(Deaconess). There, she was treated by Dr. William
Houser, a board certified pulmonary specialist and Dr.
Herman Rusche, a board certified internist and
gastroenterologist. She was admitted with an elevated
white blood count (WBC), diarrhea, and abdominal
distention. Tr. 763. Her weight was about 87.4 pounds.
At one point her WBC was elevated to 77,000, indicating a
serious infection somewhere in the body. 17/ She was
treated for it with Cefatan, a cephalosporin antibiotic.
She also had a nasogastral tube and intravenous fluids.
Tr. 763. Dr. Rusche believed that she had ascites and
severe hypoproteinemia, cavitary chronic obstructive
lung disease, and possible clostridium difficile
pseudomembranous colitis. Tr. 763. Pseudomembranous
colitis is a condition characterized by diarrhea,
dehydration, and usually severe illness. Tr. 220. It is
caused when antibiotics are used and the normal bacteria
in the bowel are killed off, the result of which leaves
leaving the clostridium difficile organism to grow
unchecked. Tr. 779. Although a stool test was negative,
a flexible sigmoidoscopy indicated evidence of the
organism responsible for pseudomembranous colitis
(clostridium difficile). 18/ P. Ex. 8 at 4.
At Deaconess, the antibiotics were discontinued and she
was treated for the pseudomembranous colitis with
Vancomycin for 10 days (including four days after her
discharge). Apparently, her colitis responded to the
Vancomycin enough so that she was discharged from
Deaconess on March 22, 1988, by Drs. Houser and Rusche.
Tr. 768. One of her attending physicians testified,
however, that he believed there had been a good
possibility that she would die during that hospitali-
zation because of her poor general condition and
continuing problems. Tr. 764-66. At the time of
discharge, her medications included, in addition to the
Vancomycin, Atovent and Proventil inhalers, Brethine,
and Theodur for breathing, Zantac for stomach acid,
Synthroid, a supplement thyroid, Lanoxin, a cardiac
medication, Aldactone for swelling, multivitamins,
Klotrix, Lasix, a diarrhetic, potassium, and oxygen.
Tr. 769; P. Br. at 4-5; I.G. Ex. 1 at 50. 19/
On the morning of March 29, 1988, Patient E.S. was
readmitted to Wirth under Petitioner's care. I.G. Ex. 6
at 1-2. It is this last hospitalization in which the
issue of Petitioner's alleged "gross and flagrant"
treatment arises. However, because Patient E.S.'s
immediate prior hospitalizations and medical problems
are relevant and have been raised and discussed by the
parties, they have been summarized briefly above.
Patient E.S. was admitted to Wirth by Petitioner with a
provisional diagnosis of septicemia. 20/ The admitting
nurse noted Patient E.S.'s condition as fair, with
complaints of extreme tiredness, no appetite, and white
sores on her mouth and tongue. I.G. Ex. 6 at 8. The
nurse noted that Patient E.S. was alert and able to obey
commands but was very emaciated. The nurse report also
noted her hospitalization at Deaconess for "ulcerated
colitis." Id. at 9. Petitioner, in his physical
examination of Patient E.S., noted that her skin texture
was poor and she appeared dehydrated. Her heart rate was
100. He noted that her lower lung fields had marked
generalized consolidation consistent with the possibility
of pneumonia in both lungs. He also noted her abdomen
was markedly tender with distension and hyperactive bowel
sounds. I.G. Ex. 6 at 5. He noted, on her progress
report, that she had been treated at Deaconess for
"pseudo membranous ulcerated colitis" with "apparent
improvement." 21/ I.G. Ex. 6 at 25.
Petitioner saw the patient four times the day she was
admitted. Tr. 900. Petitioner stated that her
medications included Theophylline, Levothyroxine,
Berocca-Plus, Naprosyn, Spironolactone, Brethine,
Donnatal, Furosemide and Lanoxin. Tr. 900; I.G. Ex. 6 at
28. He also started her on intravenous (IV) fluids, and
began treating her with penicillin. Id. He ordered a
blood count, chemistries, and electrolyte and blood gas
studies. He did not order cultures. Her WBC was 12,000.
I.G. Ex. 1 at 10. After receiving the initial results,
he temporarily removed her from the Theophylline.
Tr. 900. A chest x-ray showed emphysema but no
pneumonia. I.G. Ex. 6 at 24.
On March 30, Petitioner noted that Patient E.S. was not
doing well and was "very fragile." Her WBC had increased
to 14,800, and there was an increased frequency of
stools. I.G. Ex. 6 at 25. She was started on injections
of Bicillin. By March 31, the WBC had increased to
20,500. Petitioner noted that she did not feel well, but
bowel functions were normal. The records indicate she
had four documented stools. He ordered an injection of
ACTH, a steroid, and changed her diet from regular to a
buttermilk and yogurt diet. I.G. Ex. 6 at 25. There was
also a consultation done with Dr. Terry Gehlhausen, and
his diagnosis was fever and diarrhea of unknown origins.
He recommended that her multiple medications be reduced.
His recommendation was to:
Significantly reduce the patients [sic] [Patient
E.S.] medications including Vicon C capsules,
Klotrix, Furosemide, Donnatal, Brethine,
Spironolactone, Naprosyn, Berocca Plus. Give
further consideration to the necessity of Lanoxin in
light of an apparent normal size heart and apparent
normal sinus rhythm. [C]onsider the absolute
necessity of Theophylline in light of her diarrhea
and lack of current dyspnea and shortness of breath.
Consider the necessity of Levothyroxine in light of
the patient's past known history and documented
thyroid function test.
He also recommended a thyroid function test if not done
recently, a current SMAC, and an electrocardiogram. He
questioned the necessity to repeat ACTH injections and
suggested consideration of lab tests on the sputum, a
urinalysis, and a flat plate of the abdomen if the pain
continued. I.G. Ex. 6 at 6-7. The hospital records show
that Petitioner did not order any of the tests and did
not discontinue the ACTH, Theophylline, Berocca Plus,
Brethine, Donnatal, Furosemide, or Lanoxin. See
generally, I.G. Ex. 6 at 10-55.
By April 1, Patient E.S.'s WBC was up to 22,700, and she
was having more frequent bowel movements -- 13 documented
stools in one day. Petitioner discontinued the Naprosyn
and Vancomycin was ordered late that evening. On April
2, her WBC increased to 40,600. She was having almost
constant bowel movements and complaining of abdominal
pain. Petitioner ordered blood cultures and
discontinued the Septra and Aldactone. He ordered
insulin, Immodium, ACTH, and Vancomycin. On April 3,
her WBC was 44,200, and she had three bowel movements.
Potassium was eliminated from the IV, and she was given
ACTH, a shot of Bicillin, Immodium, and Lomotil.
Petitioner noted that her condition was critical, her
abdomen distended, and she was in respiratory failure.
I.G. Ex. 6 at 25-32.
By April 4, her WBC was 49,200. She had almost constant
diarrhea and was in critical condition. Blood and stool
cultures were ordered but the results were not available
before her death that evening. Permission for an autopsy
was not obtained due to her husband's illness.
Petitioner listed the final diagnosis as septicemia,
respiratory failure, and pseudomembranous ulcerative
colitis. I.G. Ex. 6 at 31-32, 52, 57, 61.
The I.G. alleges that Petitioner "grossly and flagrantly"
violated his section 1156 obligation to provide care for
Patient E.S. that meets professionally recognized
standards of health care. The I.G. asserts that cultures
and antibiotic therapy should have been performed sooner,
and the patient was not adequately evaluated and treated.
In support of his determination to exclude, he introduced
four expert witnesses: 1) Peter H. Livingston, M.D.,
Medical Director of the PRO, Tr. 28; 2) Alan Arkush,
D.O., a general surgeon practicing in Indianapolis,
Tr. 211-13; 3) Jessie Cooperider, D.O., a general
practitioner in Tipton, Indiana, a small city in a county
of 16,000, with experience in geriatric care and medical
director of three nursing facilities, Tr. 460-62; and 4)
Donald Snider, M.D., a surgeon and general practitioner
in Vincennes, Indiana, a town of 20,000, Tr. 511-12.
Drs. Arkush, Cooperider, and Snider are also associated
with the PRO as members of the Quality Committee or
Physician Reviewers.
Petitioner asserts that, considering the circumstances of
Patient E.S.'s previous hospital admissions and the
difficulty in diagnosing and treating pseudomembranous
colitis, his treatment of Patient E.S. was within the
professional standards for family physicians. Further,
he contends that his treatment did not cause her harm
because nothing could have saved her life. Petitioner
called several witnesses to testify as to the quality
of his care with respect to Patient E.S. (and the 15
additional cases discussed later in this decision):
1) Herman F. Rusche, M.D., a board certified
gastroenterologist practicing in Evansville, Indiana, who
treated Patient E.S. at Deaconess, Tr. 649-50; 2) Bruce
Brink, D.O., a family practitioner in Princeton, Indiana,
12 miles from Oakland City, who occasionally shares
patients with Petitioner, Tr. 671-72, 682; 3) Terry
Gehlhausen, D.O., a board certified family practitioner
in Oakland City, Indiana, who fills in for Petitioner
when he is unavailable (and performed a consultation on
Patient E.S. during the last hospitalization), Tr. 706,
744; 4) Debra Pentz Wayne, D.O., a third year family
practice resident at Deaconess and friend of Petitioner,
Tr. 749-753; 5) William Charles Houser, M.D., board
certified in pulmonary disease, critical care, and
internal medicine, who practices in Evansville, Indiana,
and also treated Patient E.S. at Deaconess, Tr. 759-66;
6) Richard John Noveroske, M.D., a radiologist at Wirth.
Tr. 789-92; 7) Don V. Elsoff, M.D., a general internist
and Vice President of Medical Affairs at St. Mary's
Hospital in Evansville, Indiana, Tr. 795-97; and 8) Kevin
Young, M.D., a board certified cardiologist practicing in
Evansville, Indiana, who treated several of the 15
additional cases, Tr. 841.
The I.G's case is premised on several alleged actions or
failures to act on the part of Petitioner with respect to
his treatment of Patient E.S. I shall first discuss each
of the alleged actions and then consider whether, as a
whole, they support a finding that Petitioner's care of
Patient E.S. was "gross and flagrant" (that is, whether
it was in violation of his obligation to provide care of
the requisite quality and, if so, whether the violation
placed Patient E.S. in imminent danger or unnecessarily
in a high risk situation).
1. Petitioner Failed To Order Cultures At The Time Of
Admission.
Petitioner's original diagnosis, on admittance, was
septicemia. Tr. 476; I.G. Ex. 1 at 1. Septicemia refers
to a condition of having bacteria in the bloodstream and
an infection somewhere in the body. Tr. 230, 476.
Patient E.S.'s WBC was elevated on admission and rose
daily during her last hospital stay. Tr. 480-81. This
high WBC indicated septicemia which continued to worsen.
Tr. 252-54, 481. Drs. Arkush, Cooperider, Snider, and
Houser testified that the first step in treating
septicemia is to obtain cultures and sensitivities of the
blood, urine, stool, sputum, and any open wound to
diagnose the cause and determine the appropriate
treatment. Tr. 230-31, 476, 535-36, 771-72. Also, if a
lab is not notified to use special handling, test results
may be inaccurate if blood cultures are not obtained
before beginning antibiotic treatment as the antibiotics
may inhibit the growth on the cultures. Tr. 288, 478,
537.
Petitioner immediately started Patient E.S. on
antibiotics but did not order cultures of blood, urine,
stool, or sputum upon admission, even though he listed
septicemia as both his provisional and final diagnosis.
I.G. Ex. 6 at 1, 61. Blood cultures were not ordered
until April 2 and 4, and a stool culture was not done
until April 4. Tr. 287, 477-78, 536; I.G. Ex. 6 at 30-
32. None of them showed the presence of pseudomembranous
colitis. However, a review of the blood chart did not
show special handling to compensate for the antibiotics.
Tr. 537, 904. More importantly, Dr. Cooperider noted
that the prime test for pseudomembranous colitis is a
titer, not a stool culture. Tr. 479. Just weeks before,
the doctors at Deaconess required the results of a
flexible sigmoidoscopy to make the diagnosis for
pseudomembranous colitis.
Petitioner argues that he did not order cultures upon
admission because he had access to the tests and cultures
done while Patient E.S. was at Deaconess, and they were
negative. Tr. 902-03. Also, he notes that, as the
patient had already had extensive antibiotic therapy, any
results from blood culture tests would already have been
compromised. Lastly, he relies on Drs. Rusche and Houser
who commented that studies are not always the first step
and may not show anything in circumstances such as these.
Tr. 667-69, 772-73.
I do not find these reasons persuasive. As the I.G.
notes, reliance on tests taken during a previous hospital
stay, in this case between March 5 and 22, may be useful
for their history of the patient's illnesses, but are not
definitive in diagnosing the problems in the current
hospitalization. Also, Petitioner was aware that the
flexible sigmoid exam done at Deaconess did indicate the
presence of pseudomembranous colitis. In addition, the
fact that tests may not always give correct results does
not mean that they should not be done or that attempts to
determine the source of infection should not be made. As
noted, Petitioner did not order the first blood culture
until April 2.
Further, Petitioner ignored the March 31 recommendations
of Dr. Gehlhausen to obtain a sputum culture and an
urinalysis. Petitioner admitted on two occasions that,
on hindsight, he should have ordered cultures on the
first day and that it was "a good question" as to why he
didn't culture the sputum. Tr. 904; I.G. Ex. 2 at 21.
Even Dr. Elsoff, one of Petitioner's witnesses testified
that he "would have liked to have seen blood cultures
done a little earlier . . . ." Tr. 822. The failure to
follow up on the initial diagnosis of septicemia with
proper testing, especially in light of a recommendation
to do so, and Petitioner's admissions that he does not
know why he did not test, is a violation of the
professionally recognized standards of care. Further, by
treating Patient E.S. with several antibiotics for
several days before performing any tests to determine the
cause and, therefore, the appropriate treatment (and by
failing to request special handling), he unnecessarily
jeopardized the possibility that these tests would have
indicated anything useful.
2. Petitioner Began Empiric Treatment Of Sepsis Without
A Diagnosis.
As noted, Drs. Arkush, Cooperider, Snider, and Houser
testified that the cause of sepsis should be determined
before prescribing antibiotics. This was especially
crucial with this patient, because any antibiotic other
than Vancomycin or Flagyl could have caused a relapse of
her pseudomembranous colitis. Tr. 232-33. Patient E.S.
was treated at Deaconess for pseudomembranous colitis,
and Petitioner testified that he "was trying to avoid
causing a recurrence of the pseudomembranous colitis."
Tr. 899. Nevertheless, he prescribed both Septra and
Bicillin before ordering any tests. Tr. 235-37, 539.
Drs. Arkush, Cooperider, and Snider testified that
neither of these antibiotics were indicated and may have
been harmful because pseudomembranous colitis is a
possible adverse reaction to Septra, a broad spectrum
antibiotic, and Bicillin, a penicillin used for specific
pulmonary infections. Tr. 235-37, 482, 539. Drs. Arkush
and Cooperider testified that there was no indication for
them, and thus, it was inappropriate to prescribe these
antibiotics. To do so, they continued, was a violation
of the professionally recognized standards of care and
was potentially harmful to Patient E.S. Tr. 241-2; see
Tr. 474.
Petitioner's argument that he prescribed Septra and
Bicillin soon after admission because they were the least
likely to cause a relapse of pseudomembranous colitis is
difficult to reconcile with his argument that he was
aware of her previous treatment for this disease and her
symptoms on admission. Petitioner's explanation of why
he prescribed Bicillin and Septra is illuminating. He
told the Sanction Committee that he "hoped they would do
some good, and wouldn't cause a relapse of the colitis
problem." I.G. Ex. 2 at 12. Therefore, not only did he
fail to determine the cause of the sepsis before
prescribing the antibiotics, but he prescribed
antibiotics which could cause or exacerbate a relapse of
pseudomembranous colitis (while believing that they would
not). In making this finding, I note that Dr. Houser
testified that prescribing these drugs would not
necessarily worsen the disease once established, although
he acknowledged that it was possible. Tr. 782.
3. Petitioner Used ACTH And Solumedrol In A Septic
Patient.
Petitioner prescribed ACTH (adrenal-caricoltropic
hormone), an anti-inflammatory agent, throughout Patient
E.S.'s last hospitalization. ACTH is a steroid which
stimulates the adrenal cortex to produce cortisol. Tr.
484; I.G. Ex. 6 at 28-31. As Petitioner admits, there
was no medical indication for the use of this drug. He
explained to the PRO that in older patients, steroids
could give the adrenal glands a "a little boost. It
seems to work." I.G. Ex. 22 at 6. Dr. Gehlhausen, the
consulting physician, even questioned its continued use.
Dr. Arkush testified that he disagreed with Petitioner's
assertion that ACTH could be useful. He stated that ACTH
actually inhibits the body's ability to fight infection
and may promote infection. Tr. 257, 332. Drs. Arkush,
Cooperider, and Snider testified that prescribing ACTH
for Patient E.S. was not appropriate for this patient
and was a violation of the professionally recognized
standards of care. 22/ Tr. 258, 485, 540-41.
Petitioner also prescribed Solumedrol, another type of
cortisone, which is also an anti-inflammatory agent, and
which is contraindicated in treating sepsis. Tr. 281-82.
See I.G. Exs. 6 at 31, 40 at 11 (the PHYSICIANS' DESK
REFERENCE (Edward R. Barnhart 1987) (PDR)). The evidence
regarding the prescription of these drugs indicates that
Petitioner does not understand the effects of, or reasons
for steroid use.
4. Petitioner Failed To Treat Patient E.S.'s
Dehydration.
According to Petitioner's history and physical
examination charts of Patient E.S., she was dehydrated
upon admission. I.G. Ex. 6 at 4-5. Although Petitioner
started the patient on IV fluids, he decreased the IV
fluid rate by half on April 1, at a time when her fluid
intake and outtake indicated that she was becoming more
dehydrated. Tr. 244-446; I.G. Ex. 6 at 29. This, Drs.
Arkush, Cooperider, and Snider testified, failed to meet
the professionally recognized standards of care.
Tr. 246, 495, 534.
Further, Petitioner continued the prescription of
Lasix, a diuretic, upon admission, for a patient whose
dehydration was increasing. He also prescribed
Spironolactone, another diuretic, for this patient.
There is no rationale given for these prescriptions.
Drs. Snider and Cooperider stated that Lasix, which is
used to eliminate excess fluid from the body, was
inappropriate for Patient E.S. Tr. 496; 533-35. They
further testified that the use of these prescriptions by
Petitioner represented a failure to meet professionally
recognized standards of care. Id. 23/
5. Petitioner Failed To Evaluate Or Properly Treat the
Patient's Abdominal Condition.
The I.G. argues that Petitioner failed to diagnose or
properly treat Patient E.S's abdominal condition.
On admission, Petitioner noted that Patient E.S.'s
abdomen was markedly tender and distended, and bowel
sounds were hyperactive. I.G. Ex. 6 at 5. He told the
PRO that she "came back to the hospital very weak and
with diarrhea." I.G. Ex. 2 at 22. Petitioner stated
that he was aware of her recent history of treatment at
Deaconess and had access to the tests done there. His
physical examination report included "possible relapse of
pseudomembranous ulcerative colitis." Tr. 899; I.G. Ex.
6 at 5. Also, Patient E.S. had six stools on March 30.
Tr. 485; I.G. Ex. 6 at 37. Thus, Petitioner had ample
reason to be aware that there were abdominal problems and
their probable cause. Drs. Arkush, Cooperider, and
Houser testified that, had they been the admitting
physician, their preliminary diagnoses would have been a
reoccurrence of the pseudomembranous colitis. Tr. 230,
470, 658. Also, Drs. Arkush, Cooperider, Snider, and
Rusche testified that there were several diagnostic tests
which could be used to obtain a positive diagnosis of
this disease. Tr. 220-21, 487, 517-18, 659.
Petitioner asserts that he did not initially test or
treat her for pseudomembranous colitis because: 1) the
tests performed at Deaconess were negative; 2) she
"presumably had recovered;" and 3) she did not have
diarrhea until April 1. P. Br. at 17-19. However, the
evidence shows that Petitioner was aware of Patient
E.S.'s diarrhea and that it was one of her complaints on
admission. I.G. Ex. 6 at 58. Also, as noted above,
Petitioner ordered almost no cultures and performed no
diagnostic tests to confirm his preliminary diagnoses.
Further, if Petitioner had access to her Deaconess
hospital records, he should have known that treatment
continued for pseudomembranous colitis after she was
dismissed from Deaconess, so presumably she had not fully
recovered. 24/ Nor is there any evidence that Petitioner
made any attempt to contact or consult with either Dr.
Rusche or Dr. Houser, who treated Patient E.S. at
Deaconess, although he was aware of the prior
hospitalization. Tr. 899, 783-84, 905. Also, he did not
obtain a gastroenterology consultation, although he
admitted to the PRO Sanction Committee that one was
available. I.G. Ex. 2 at 32-33.
Based upon the cumulative evidence, Petitioner's
assertion that he did not suspect a relapse of
pseudomembranous colitis or that Patient E.S. did not
have symptoms indicating a relapse on admission is not
credible. 25/ One chapter of Cecil's Textbook of
Medicine, submitted by Petitioner, states that the
clinical manifestations of this disease are diarrhea,
abdominal tenderness, electrolyte imbalance and
dehydration. P. Ex. 14 at 52. According to Drs. Arkush,
Cooperider, Snider, Rusche, and Houser, the only
effective drugs are Vancomycin and Flagyl. Tr. 226, 467,
517, 661, 779. Petitioner's own witnesses, Drs. Houser
and Rusche testified that if they suspected
pseudomembranous colitis, they would have restarted
Vancomycin right away. Tr. 661, 770. Petitioner did not
order Vancomycin until 11:30 p.m. on April 1. Tr. 258-
59; I.G. Ex. 6 at 30. Drs. Houser and Rusche also stated
further that had the Vancomycin been restarted sooner, it
is possible that Patient E.S. might have responded to
treatment. Tr. 656, 770. Drs. Arkush, Cooperider, and
Snider agreed. Tr. 233, 470, 520. Petitioner's
witnesses, Drs. Houser and Elsoff, agreed also that it
would have been better if the Vancomycin had been started
sooner. Tr. 774, 822.
6. Petitioner Administered Potentially Harmful Drugs To
Patient E.S..
Instead of testing and treating Patient E.S. for
pseudomembranous colitis, Petitioner prescribed several
potentially harmful drugs for her. Drs. Arkush and
Cooperider testified that giving other antibiotics,
such as Septra and Bicillin, to a patient with
pseudomembranous colitis, without administering
Vancomycin, could worsen a patient's condition because
they could kill the friendly bacteria and allow the
clustrating difficile bacteria to take over. Tr. 232,
474, 781-82. Dr. Cooperider stated that these drugs are
not the appropriate choice for this patient, that they
were 20-30 years ago, but are "no longer drug of choice."
Tr. 482-83. Dr. Houser agreed, but noted that "once you
develop the problem, making it worse is really academic."
Tr. 782. Dr. Arkush testified that prescribing Septra
and Bicillin for this patient was a violation of
professionally recognized standards of care. Tr. 241-42.
Petitioner also prescribed Lomotil and Immodium,
antiperistaltic agents. Tr. 237, 489, I.G. Ex. 6 at 31.
Dr. Arkush noted that by slowing down the peristalsis
with Lomotil, the body keeps the bacteria inside rather
than defecating it out. Tr. 238. The PDR indicates that
both drugs are contraindicated and potentially harmful
for patients with pseudomembranous colitis. Tr. 239-40,
268-69; I.G. Ex. 40 at 5, 9. Drs. Arkush and Cooperider
testified that prescribing these drugs for Patient E.S.
did not meet professionally recognized standards of care
and possibly worsened her condition. Tr. 241, 491-92.
See Tr. 268-70, 527-28. Petitioner's witness, Dr.
Rusche, also admitted that Lomotil and Immodium
theoretically could be harmful to a patient with
pseudomembranous colitis. Tr. 665.
Petitioner argues that his prescription of these drugs is
not a violation of the standards of care because other
physicians also make that mistake. 26/ He urges, again,
that he should not be held to any standard other than
that of a family practitioner. However, I conclude that
other physicians' failings do not excuse Petitioner's.
Also, although Dr. Houser testified that at a recent
medical seminar, he heard that Lomotil may not cause harm
in patients with pseudomembranous colitis, there is no
other evidence to this effect.
Lastly, the record shows that Petitioner prescribed
Morphine Sulphate on April 2, 1988, to relieve pain.
Tr. 271; I.G. Ex. 6 at 30. There is some testimony and
evidence which indicates that Morphine is contraindicated
for patients with pseudomembranous colitis because it may
make diagnosis more difficult by masking the pain and
causing constipation by slowing the intestine down. Tr.
272, 274; I.G. Ex. 40 at 7. Further, Drs. Arkush and
Snider testified that the dose was too high in a patient
as small as Patient E.S., and that too high a dose can
cause respiratory depression and apnea. Tr. 272, 542.
The nursing notes indicate that Patient E.S. had periods
of apnea after taking the Morphine Sulphate. Tr. 276-77;
I.G. Ex. 6 at 49. Dr. Arkush stated that the use of
Morphine for this patient was not appropriate, aggravated
her condition, and violated professionally recognized
standards of care. Tr. 277.
I find that Petitioner's failure timely or adequately to
evaluate, test, and treat Patient E.S. was a violation of
professionally recognized standards of care. Although
his own diagnosis indicated the possibility of a relapse
of pseudomembranous colitis, he performed no diagnostic
tests for it, only belatedly ordered cultures, ignored
the suggestions of the consulting physician, Dr.
Gehlhausen, did not obtain a consultation from an
available gastroenterologist at the hospital, and failed
to contact her physicians at Deaconess regarding her
prior hospitalization.
Instead, he relied on results of tests from her prior
hospitalization and ordered numerous drugs in an
apparently reckless manner, including drugs which are
specifically contraindicated and potentially dangerous
for a patient in her condition and with her symptoms.
Petitioner's protestations that he should be judged under
the standards of a family practitioner are misplaced.
Petitioner had treated the patient for many years and
should have been more aware of her current condition.
As Petitioner made a preliminary diagnosis of
pseudomembranous colitis and had access to the Deaconess
physicians, his failure to adequately evaluate or treat
this patient cannot be excused by his status as a family
practitioner or the fact that he had not seen this
disease before. Family practitioners are able to obtain
advice and consultations -- or at least look up in
reference books -- diseases which they suspect or have
reasons to know their patients may have or are suffering
a relapse of. To find otherwise would be a disservice to
other family practitioners. As Drs. Cooperider and
Snider, who practice in small towns, noted, there is no
difference in the standards of care between rural areas
such as Oakland and other parts of Indiana with regard to
the treatment of patients with symptoms similar to those
of Patient E.S. Tr. 463, 514. Thus, the fault must be
Petitioner's failure to follow up on his own diagnosis.
If Petitioner was not informed on evaluation and
treatment of this disease, he could have asked for a
consultation. If he had any concerns over the efficacy
of the drugs he was prescribing, he could have consulted
a PDR. Petitioner's argument that all drugs in the PDR
have adverse effects has no relevance to whether the
drugs he prescribed were specifically contraindicated in
Patient E.S.'s condition.
Petitioner's arguments that he did not harm Patient E.S.
and that nothing could have saved her is not the standard
by which section 1156 cases are judged. 27/ The I.G. is
not required to show actual harm or that Petitioner's
actions were a direct cause of Patient E.S.'s death.
That is a malpractice standard which is not applicable
here. Hussain at 42; cf 57 Fed. Reg. 3301 (in defining
term: "professionally recognized standards of health
care" agency did not adopt traditional malpractice
standards). Rather, the I.G. meets his burden of proof
by showing that the treatment placed the patient in
imminent danger or unnecessarily in a high risk
situation.
I find that the I.G. did meet this burden of proof and
that Petitioner's failures placed this patient
unnecessarily in a high risk situation and presented
serious risk of imminent danger. It is not disputed that
Patient E.S. was an extremely ill individual with
multiple problems and who had spent quite a bit of time
in and out of the hospital during the last several months
of her life. Also, people with pseudomembranous colitis
appear to have a generally poor prognosis. However, a
poor prognosis and no hope for recovery are not
synonymous. Dr. Elsoff testified that the death rate on
relapses of older debilitated patients with this disease
can be as high as 30 percent. Tr. 822. Dr. Cooperider
placed survival at 50/50 when patients are well treated.
Tr. 492. Dr. Rusche also testified that people do die in
spite of being properly treated, but that he couldn't say
with any degree of certainty what would have happened had
treatment been started earlier. Tr. 655-56. But Dr.
Cooperider testified that "by the treatment that he
[Petitioner] provided, he virtually guaranteed that she
would not survive." Id. Again, the standard here is not
whether the treatment resulted in Patient E.S.'s death
but whether it placed her in an unnecessarily high risk
situation or presented serious risk of imminent danger.
The key word is risk. I find that: 1) failure over a
period of several days to test, evaluate, and treat this
patient timely and promptly with at least one of the
effective medications for a life-threatening disease; and
2) the prescription of antibiotics and other drugs which
are contraindicated for that disease or which could cause
a relapse, did unnecessarily place this already weakened
patient in imminent danger to her health and safety and
placed her unnecessarily in a high risk situation.
Consequently, I find that Petitioner's conduct was a
"gross and flagrant" violation of his obligation within
the meaning of section 1156 of the Act.
III. Petitioner Is Willing, But Has Demonstrated A "Lack
Of Ability Substantially To Comply" With His Obligations
Under Section 1156 Of The Act.
As stated earlier, section 1156 authorizes an exclusion
where a physician "grossly and flagrantly" failed to
provide a service to a Medicare beneficiary which meets
professionally recognized standards of health care and
that physician has demonstrated either an "unwillingness
or a lack of ability substantially to comply" with the
obligations placed on that physician by section 1156. In
addition, the I.G. does not have authority to exclude
unless the PRO first submits a "report and
recommendation" to the I.G. and the physician is given
"reasonable notice and opportunity for discussion" prior
to the issuance of a notice of exclusion by the I.G. 42
U.S.C. 1320c-5 (b)(1).
I have found that the I.G. proved that Petitioner
"grossly and flagrantly" violated his obligation in one
instance (the case of E.S.). I also find that the I.G.
proved that Petitioner demonstrated "a lack of ability
substantially to comply" in one instance (the case of
Patient E.S.). In addition, the I.G. introduced evidence
showing that Petitioner demonstrated "a lack of ability
substantially to comply" in 15 other instances. But, the
I.G. cannot rely on these 15 other cases to establish
authority to exclude because he failed to prove that the
PRO submitted a "report and recommendation" in any of the
15 cases and failed to prove that Petitioner was given
"notice and opportunity for discussion" prior to the
issuance of the Notice issued in this case. The I.G.'s
February 6, 1992, Notice in this case states that the
I.G.'s authority to exclude is based on the case of
Patient E.S. and "two additional cases." At the hearing,
the I.G. only proceeded to prove the statutory
requirements with regard to the case of Patient E.S., not
with regard to the "two additional cases." Thus, on the
question of whether the I.G. had the authority to exclude
Petitioner, I have not relied on the evidence of the 15
additional cases (including the two additional cases
mentioned in the Notice). I find that the I.G. did not
meet his burden of proof with respect to Petitioner's
willingness but that Petitioner lacks the ability
"substantially to comply." In summary, the I.G. has
proved that he had authority to exclude Petitioner, based
solely on the case of Patient E.S.
A. The I.G. Did Not Meet His Burden Of Proof With
Respect To Petitioner's "Unwillingness . . .
Substantially To Comply."
The I.G. alleges that Petitioner is unwilling
"substantially to comply" with his obligations. He
states that this determination was based on Petitioner's
alleged failure to provide documentation showing that he
completed the CAP imposed by the PRO within the
established time frames. The I.G. also alleges that
Petitioner is unwilling to recognize and modify
deficiencies in his medical practice. Petitioner denies
both these allegations.
After making a determination that Petitioner's violations
were a Level III of severity, the PRO Quality Committee
assigned Petitioner additional interventions, including
100 percent review of his practice and 24 hours of CME on
infectious diseases. The interventions were assigned by
letter dated May 25, 1990, and the CME was to be
completed within six months with documentation forwarded
to the Quality Committee. 28/ I.G. Ex. 1 at 8. By
letter dated May 3, 1990, Petitioner wrote to the then
Medical Director of the PRO stating that he had "acquired
a very adequate knowledge of infectious disease," and
attached certificates of seminars he had attended between
1976 and 1983. I.G. Ex. 43 at 76. Despite Dr.
Livingston meeting with Petitioner in September 1991 and
requesting the documentation, Petitioner did not submit
any proof of compliance until December 19, 1991, two
months after the PRO had forwarded the case to the I.G.
29/ Tr. 64. That documentation, which was sent to the
I.G., consisted of a printout from the American
Osteopathic Association (AOA) which shows that Petitioner
earned 26 hours of CME on November 25-29, 1990. A review
of that printout does not indicate how many of the hours
were for the study of infectious diseases. 30/
Petitioner does not dispute that the CMEs were taken
several days after the end of the six month period,
although within the 60 days subsequently allotted by the
Sanction Committee, and he has offered no proof that the
documentation was ever filed with the PRO. 31/ Tr. 54.
Thus, the evidence supports a finding that Petitioner did
not fully or timely comply with the CAP.
Petitioner asserts, however, that he has kept up to date
on medicine and has regularly attended medical seminars.
He has submitted certificates and brochures from some
past seminars. A printout from the AOA indicates that he
attended 206.5 hours of CME credits during a two year
time period in which he was required by the AOA to obtain
only 150 credits to keep his board certification. P. Ex.
1 at 8; see also P. Ex. 10. Also, Petitioner has taken
at least one recent seminar on infectious diseases and
others on cardiology issues -- two of the areas in which
the I.G. has charged that Petitioner demonstrated an
inability to comply with his obligations. P. Ex. 1 at 4.
I accept these as evidence of Petitioner's willingness,
because they are not related to whether Petitioner
completed his CAP, and, thus, fall outside the scope of
42 C.F.R. 1005.17(j). On that basis, I conclude that
Petitioner has regularly attended CME seminars and
lectures.
Petitioner also states that his knowledge of medicine is
supported by the fact that a University regularly sends
physician-students to him for training in family
practice. Tr. 893-94. Further, several of Petitioner's
witnesses testified that Petitioner is a knowledgeable
and caring physician, has an excellent reputation, is a
patient advocate, and is loved by his patients. See,
e.g., Tr. 657 (Dr. Rusche), Tr. 767 (Dr. Houser), Tr. 682
(Dr. Brink), Tr. 792 (Dr. Noveroske), Tr. 750 (Dr.
Wayne).
The I.G. also argues that Petitioner's refusal to
recognize quality of care issues in his handling of
Patient E.S. and the 15 additional cases indicates his
unwillingness to meet professionally recognized standards
of care. Petitioner responds that he did not fail in his
duty to these patients. As discussed previously in this
decision, the evidence regarding the 15 additional cases
will not be considered on this issue. However, I have
already determined that Petitioner's treatment of Patient
E.S., taken as a whole, was "gross and flagrant."
Petitioner's refusal to acknowledge that there were any
problems in his care of this patient and his delay in
responding to the CAP concerns me and indicates a certain
reluctance to recognize and correct the deficiencies in
his practice. Nevertheless, I find that, in spite of his
limitations, he is willing to comply with his obliga-
tions. In making this finding, I have not relied on any
of the allegations made by either the PRO or Petitioner
regarding several of his responses to PRO letters and
notices. It appears that Petitioner responded promptly
at the early review levels, but as the case progressed
there were some problems and miscommunications, and
Petitioner apparently became upset and his correspondence
became somewhat abusive because the PRO did not agree
with his responses or answer all of his questions as he
would have wished. However, as a whole, the record shows
that Petitioner does regularly attend seminars to update
his medical knowledge and that his reputation among his
peers is of a caring family practitioner. Therefore, I
find that the I.G. has not met his burden of proof on
this issue.
B. Petitioner Has Demonstrated "A Lack Of Ability
Substantially To Comply" With His Obligation To Provide
Treatment That Meets Professionally Recognized Standards
Of Health Care.
The I.G.'s Notice in this case states that Petitioner's
inability is demonstrated by his handling of the case of
Patient E.S., Petitioner's written responses to the
concerns identified by the PRO, and Petitioner's
responses during his November 20, 1990, meeting with the
PRO about the handling of Patient E.S.
The I.G. argues that Petitioner's treatment of Patient
E.S. evidences several examples of mismanagement, which,
in turn, betrays Petitioner's lack of knowledge in
certain basic areas of medical care.
Petitioner argues that his treatment of Patient E.S.
caused no harm. However, even accepting this assertion
as true, the lack of harm to a patient does not prove
that Petitioner's medical practices conformed to
professionally recognized standards, nor does it prove
that he is able to conform his practice to that standard.
Based on the evidence in the record, Petitioner's
responses to that evidence, and the arguments of the
parties, I find and conclude that Petitioner demonstrated
a "lack of ability substantially to comply" with his
obligation to provide care that meets "professionally
recognized standards" in the case of Patient E.S. This
finding and conclusion is based on the reasons set forth
in part II-B of this decision which analyzes the proof of
Petitioner's "gross and flagrant" violation.
Obviously, this is not to say that a finding of "gross
and flagrant" would always be sufficient, on its own, to
support a "lack of ability substantially to comply"
finding. However, in this case, based on the evidence
presented by the I.G. as to Patient E.S., I conclude that
Petitioner's treatment demonstrates that he lacks the
ability: 1) to evaluate or treat the cause of infectious
processes; 2) to understand the proper use of steroids;
3) to prescribe the appropriate and least harmful
medications for a patient's conditions; 4) to timely
order and evaluate laboratory data or to perform
diagnostic tests when indicated; and 5) to manage fluid
intake in a patient who requires hydration. In fact, the
I.G. proved that Petitioner's treatment of patient E.S.
was even inconsistent with Petitioner's own diagnosis.
Although Petitioner has expressed a willingness to comply
with his obligations under the Act, and has made an
effort to take frequent medical seminars, such willing-
ness is inadequate protection for program beneficiaries
and recipients when he lacks either the basic medical
knowledge to comply or to recognize his inability to
comply. Mere credentials do not demonstrate an ability
to comply. Also, as noted previously, I find troublesome
Petitioner's refusal to acknowledge that he made any
errors in judgement with respect to his treatment of
Patient E.S. See William Anderson, M.D., DHHS Appeals
Council Docket No. HIX-000-84-7011 at 30 (January 24,
1990). Finally, although Petitioner has introduced
evidence consisting of praise from current and former
patients, popularity is not relevant to the issues in
this case.
For the above reasons, I find that Petitioner is unable
to comply with his obligations under the Act. Petitioner
has exhibited serious errors in the diagnosis, assess-
ment, and treatment of Patient E.S., which, in turn,
indicate a lack of important, fundamental knowledge that
is essential in meeting his obligations under the Act.
Petitioner has demonstrated a willingness to learn and
has begun to take steps to improve his knowledge in areas
in which he has particular weaknesses.
IV. The One Year Exclusion Imposed And Directed Against
Petitioner Is Reasonable And Comports With The Remedial
Purposes Of The Act.
The I.G. is authorized by section 1156 of the Act to
impose and direct a sanction against Petitioner. The
I.G.'s authority originated with the PRO's recommenda-
tions and were based on the evidence which the PRO
provided which indicated that Petitioner committed a
"gross and flagrant" violation. After reviewing the
PRO's recommendation and supporting materials, the I.G.
determined to increase the PRO's proposed exclusion from
six months to one year.
Pursuant to 42 C.F.R. 1004.90(d), the I.G. considered
the following factors in arriving at the appropriate
proposed sanction:
(1) the recommendation of the PRO (the recommended
six month exclusion);
2) the type of offense ("gross and flagrant"
violation of obligations in two instances involving
one patient);
3) the severity of the offense (the two above
instances presented imminent danger to the health,
safety, or well-being of the beneficiary or placed
the beneficiary unnecessarily in a high-risk
situation);
4) the previous sanction record of the practitioner
(none known);
5) the availability of alternative sources of
services in the community (other physicians practice
in the area);
6) any prior problems the Medicare carrier or
intermediary has had with the practitioner (none
identified);
7) whether the practitioner is "unable or unwilling"
to comply substantially with the obligations
including whether, prior to the PRO's recommenda-
tion, the practitioner entered into a corrective
action plan (CAP) and, if so, whether he or she
successfully completed that plan (I.G. determined
that unwillingness was demonstrated by failure to
complete timely the CAP or to provide documentation
of completion and inability demonstrated by
responses to the PRO and by the PRO's identification
of problems of care in two additional cases); 32/
and
8) any other matters relevant to the particular case
(I.G. unaware of other relevant issues).
I.G. Ex. 3 at 1-2.
While the above factors are those which, by regulation,
the I.G. must consider before imposing a sanction and are
not binding on me because this is a de novo hearing, they
are relevant in determining the reasonableness of the
length of the exclusion. Olufemi Okonuren, M.D., DAB
1319 at 14 (1992). I have already determined that the
I.G. has met his burden of proof with respect to the
"gross and flagrant" violation, the severity of the
offense, and Petitioner's inability "substantially to
comply." Also, as noted previously in part I-B, I have
determined to consider the evidence presented by the 15
additional cases on the issue of the reasonableness of
the exclusion and on the "serious risk" issue. Bernardo
G. Bilang, M.D., DAB 1295 at 6-9 (1992); See Robert
Matesic, R.Ph., DAB 1327 at 12 (1992). Therefore, the
above findings are augmented here by the additional cases
which I find establish patterns of inadequate medical
care in several areas. As discussed below, these
patterns include Petitioner's inability to adequately
evaluate and treat patients, specifically with regard to
the diagnosis of abnormal laboratory results, the
prescription of appropriate medications, evaluation and
intervention of patients suffering acute cardiac changes,
and the inability to manage fluid intake in patients
requiring hydration or fluid management.
A. Petitioner Lacks The Ability To Diagnose The Causes
Of Patients' Abnormal Laboratory Results And To Address
These Results Adequately.
The I.G. argues that Petitioner's treatment of the
additional patients reveals many instances in which he
failed properly to diagnose and treat conditions which
produced abnormal laboratory test results in the
patients. The I.G. alleges that, in several cases,
Petitioner either failed to diagnose the cause of an
infection or failed to recognize that an infection might
be present. In other cases, the I.G. argues that
Petitioner failed to identify the source of possible
internal bleeding. Finally, the I.G. points to several
instances in which Petitioner allegedly failed to
institute the appropriate treatment in the face of
abnormal test results.
The I.G. presented evidence that Petitioner failed to
isolate the cause of elevated WBC counts in the cases of
D.R. and C.H. As noted previously, an elevated WBC may
be a sign that the patient is suffering from an
infection. In both instances, Petitioner prescribed
antibiotics without first having identified the source of
infection. In the case of D.R., diagnostic tests, such
as urinalysis and ultrasound, were negative, Tr. 364-65;
in the case of C.H., Petitioner did not perform any
diagnostic tests before instituting antibiotic therapy.
Tr. 352-53; I.G. Br. at 40. The I.G.'s experts testified
that it was inappropriate to prescribe antibiotics as
"shotgun therapy" without knowing the source of
infection. Tr. 354. Petitioner argues that Patient D.R.
had other diagnostic tests prior to his admission to the
swing bed unit and that Patient C.H. was suffering from
infection and that his treatment was successful in
reducing her WBC and other symptoms, such as fever. P.R.
Br. at 8-9. Petitioner does not contend that he, in
fact, diagnosed the cause of the patients' infections. I
conclude that Petitioner's failure to isolate the source
of infection in Patients D.R. and C.H. prior to
instituting antibiotic therapy constituted treatment that
was not in accordance with professionally recognized
standards.
In addition to the cases in which Petitioner failed to
identify the source of patient infections, the I.G.
argues that, in several cases, Petitioner failed to
identify the cause of test results which suggested that
patients were experiencing blood loss. For example, the
I.G.'s expert, Dr. Arkush, testified that Patient C.H.
had a low hemoglobin count throughout her hospital stay.
Tr. 349-50. While Petitioner ordered a test of the
patient's stool for occult blood, he apparently
discharged the patient before obtaining the results of
the test. Tr. 351. The test result might have helped to
identify the source of the low hemoglobin. Tr. 350.
Another of the I.G.'s experts, Dr. Snider, was of the
opinion that Petitioner's failure to identify the cause
of C.H.'s low hemoglobin placed the patient unnecessarily
in a high risk situation. Tr. 558. Petitioner offered
no evidence to rebut the I.G.'s contentions.
Petitioner's treatment of Patient V.E. also presents
questions involving the results of the stool for occult
blood test. V.E.'s medical records showed two positive
stool for occult blood test results, indicating that
there was blood in the stool. I.G. Ex. 18 at 17, 59.
Dr. Snider testified that it would have been appropriate
to do further diagnostic tests, such as endoscopy of the
stomach and colon or X-ray of the stomach and colon, to
determine the source of the blood in the stool. Tr. 585.
Petitioner failed to order these diagnostic tests or to
make any evaluation of the cause. Id. Petitioner
offered no evidence to rebut these contentions.
The I.G. similarly alleges that in the case of Patient
B.B., Petitioner failed to perform the appropriate
diagnostic tests to determine the cause of the patient's
low hemoglobin count. The patient's chart reflects
Petitioner's belief that B.B.'s anemia might have been
due to gastrointestinal (GI) tract bleeding. I.G. Ex. 31
at 7. Dr. Snider testified that Petitioner failed to
order an endoscopy or X-ray of the stomach and duodenum,
which, in his opinion, was a violation of professionally
recognized standards of care. Tr. 608-11. Petitioner
argues that B.B. could not have tolerated these tests
because of her physical handicaps. P. Br. at 37-38.
However, Petitioner has not argued that he diagnosed the
cause of B.B.'s abnormal test results, nor has he shown
that he could not have performed other tests that might
have revealed the cause of those results. Therefore, I
conclude that by failing to identify the source of the
low hemoglobin results in Patients C.H. and B.B. and the
cause of the positive stool for occult blood test in
V.E., Petitioner failed to provide treatment in accord
with professionally recognized standards.
In the case of Patient E.R., the I.G. alleges that
Petitioner failed to order the appropriate diagnostic
test to determine the cause of the unresponsiveness for
which the patient was admitted. The I.G.'s expert, Dr.
Snider, testified that the required evaluation in the
case of a patient in an acute neurological state is a
computerized axial tomography (CAT) scan of the brain.
Tr. 602. Petitioner argues that the patient was
suffering from digitalis intoxication and not from a
cerebrovascular accident (CVA or stroke). P. R.Br. at 9.
Petitioner argues that the patient had suffered a CVA
some time previously to the admission at issue here. Id.
However, given a patient with a history of stroke
disease, it does not appear that Petitioner could be
certain of the cause of the patient's neurological
changes without using a CAT scan to rule out definitively
the presence of a stroke or subdural hematoma.
Therefore, I conclude that in failing to order a CAT scan
of E.R.'s brain, Petitioner failed to provide care that
meets professionally recognized standards.
In addition to cases in which Petitioner failed to
perform the appropriate tests or take other steps to
diagnose the cause of abnormal laboratory results or
other clinical symptoms, the I.G. alleges that in several
cases Petitioner failed to intervene with appropriate
treatments when presented with abnormal test results. In
the cases of Patients D.R. and A.M., who both suffered
from diabetes, the I.G. alleges that Petitioner failed to
address the patients' elevated blood glucose levels. The
I.G.'s expert, Dr. Arkush, testified that, as to both
patients, their blood glucose levels remained elevated
throughout their hospital stays. Tr. 358-59, 378. In
the case of D.R., Dr. Arkush opined that insufficient
insulin was prescribed. Tr. 369. In the case of A.M.,
he stated that the diet prescribed by Petitioner was
excessive to control blood sugar levels in a diabetic
patient. Tr. 380. Petitioner argues that Patient D.R.
was extremely noncompliant with his diet and other
measures to control his diabetes. P. Br. at 40-41.
However, if Petitioner was aware that this was the case,
presumably he should have been aware of the need to
prescribe additional insulin. As to Patient A.M.,
Petitioner did not present any evidence to rebut the
I.G.'s contention that the patient's blood sugar was not
adequately controlled. Therefore, I conclude that
Petitioner's failure to control the blood glucose levels
in these patients constitutes a failure to provide care
that meets professionally recognized standards.
In the case of Patient A.A., the I.G. alleges that
Petitioner failed to diagnose and treat a likely
infection. The I.G.'s expert opined that two urinalyses
both showed signs of a urinary tract infection because
bacteria were present in the urine. Yet Petitioner
failed to order a culture and sensitivity on the urine or
to institute antibiotic therapy. Petitioner argues that
A.A. had a weakness of the bladder known as a cystocele,
which could have caused her urine to be contaminated by
bacteria even if no infection was present. P. Br. at 35.
Petitioner's expert, Dr. Brink, testified that A.A. did
not have other signs of a urinary tract infection, such
as elevated temperature, chills, painful urination,
frequent urination, or elevated WBC. Tr. 677-78.
However, Petitioner's contention is not borne out by the
medical record, which indicates that A.A. was complaining
of frequent urination on admission. I.G. Ex. 25 at 1, 4.
As noted, Dr. Brink acknowledged that frequent urination
could be symptoms of a urinary tract infection.
Therefore, I conclude that Petitioner's failure to either
diagnose or definitively rule out a urinary tract
infection in Patient A.A. constitutes a failure to
provide care that meets professionally recognized
standards.
In the case of Patient C.H., the I.G. alleges that
Petitioner failed to intervene to correct the patient's
low sodium level. The patient's blood chemistry report
indicated that the patient had low serum sodium, which
continued to fall throughout her hospital stay. Tr. 342-
45, 549; I.G. Ex. 35. Dr. Snider testified that the
appropriate treatment in such a case was fluid
restriction or sodium infusion. Tr. 550. Yet,
Petitioner did not institute either of these treatments.
Petitioner did not offer any evidence to rebut the I.G.'s
contentions regarding his treatment of C.H.'s low serum
sodium level. I conclude that Petitioner's failure to
institute either fluid restriction or sodium infusion to
reverse C.H.'s falling sodium levels constitutes a
failure to provide care that meets professionally
recognized standards.
The I.G. alleges that Petitioner failed to meet
professionally recognized standards of care in his
treatment of Patient W.H. because he failed to address
the patient's low blood pressure (hypotension). The
I.G.'s expert, Dr. Arkush, testified that all but one of
five blood pressure readings taken during her hospital
admission indicated that the patient was hypotensive.
Tr. 422. Petitioner contends that the patient was not
hypotensive at all. P. Br. at 30. Petitioner's expert,
Dr. Young, testified that he had examined W.H. subsequent
to her hospitalization and found that blood pressure
readings in the patient's right arm were inaccurate due
to a blockage of the subclavian artery, but that blood
pressure readings in the left arm were normal. Tr. 843-
44. However, if Petitioner was aware that the patient's
low blood pressure readings were inaccurate, he failed to
document this in the patient's chart. Tr. 429, 875. The
I.G.'s expert, Dr. Arkush, testified that Petitioner's
failure to address the low blood pressure readings
anywhere in the chart was itself inappropriate care. Tr.
429. For this reason, I conclude that, even if Patient
W.H. was not in fact hypotensive, Petitioner's failure to
document the fact that her blood pressure readings were
inaccurate is not in accordance with professionally
recognized standards of health care.
The I.G. has proved, as to a number of cases, that
Petitioner failed to provide care that meets
professionally recognized standards. The I.G. has proved
a pattern of practice that indicates that Petitioner
lacks the ability to diagnose the cause of abnormal
laboratory test results and to intervene when indicated.
B. Petitioner Lacks The Ability To Prescribe Appropriate
Medications.
The I.G. argues that Petitioner often prescribes
medications that are inappropriate to treat patients'
conditions. The I.G. points to a number of cases in
which he alleges that Petitioner prescribed steroids
inappropriately. In other cases, the I.G. contends
that Petitioner failed to use IV antibiotics correctly.
Finally, the I.G. cites instances where he alleges that
medications were prescribed in a manner which placed the
patients at risk.
The I.G. contends that, in addition to Petitioner's
treatment of Patient E.S., his treatment of a number of
the additional patients supports a conclusion that
Petitioner does not understand the proper use of
steroids. In the case of Patient N.H., who was suffering
from a urinary tract infection, Petitioner prescribed the
steroid Depomedrol. Tr. 569-70; I.G. Ex. 14 at 20. The
I.G.'s expert, Dr. Snider, testified that Depomedrol
would inhibit the patient's resistance to infection. Tr.
570. Petitioner prescribed the steroid ACTH for Patient
W.H. I.G. Ex. 16 at 16. The I.G.'s expert, Dr. Arkush,
testified that ACTH was not appropriate because the
patient was suffering from fractures. According to Dr.
Arkush, the body needs an inflammatory response to such
an injury and the steroid would inhibit the inflammatory
response. Tr. 424. Petitioner prescribed Depomedrol
and ACTH for Patient T.R. Tr. 330; I.G. Ex. 23 at 21.
Dr. Arkush testified that Patient T.R.'s laboratory
reports indicated he may have suffered a heart attack.
Tr. 331. He testified that steroids are not appropriate
treatment for a heart attack patient because they cause
fluid retention, which may contribute to heart failure.
Id.
Petitioner argues that Patients W.H. and T.R. had
conditions for which steroids were appropriate treatment.
For example, he asserts that W.H. had a muscle strain and
T.R. was suffering from arthritis. P. R.Br. 10-11.
Taking these assertions as true, nevertheless, Petitioner
has failed to show that he could not have treated these
conditions with some other medication that would not have
posed the risks to these patients identified by the I.G.
The I.G. points to the cases of V.E., J.R., E.R., and
O.B., in which he alleges that Petitioner prescribed
steroids even though there was no indication for steroid
use in these patients. I.G. Br. at 43. Petitioner
contends, generally, that it is appropriate to treat
elderly patients with steroids to alleviate their
arthritis and to stimulate their adrenal glands. P. R.
Br. at 10. Dr. Arkush testified that using steroids to
boost adrenal glands is not efficacious. Tr. 332.
Petitioner contends that steroids were appropriately used
in Patient V.E. to treat progressive shortness of breath.
P. R.Br. at 11. In the case of E.R., Petitioner argues
that steroids were being used to treat cerebral edema.
P. R.Br. at 11; I.G. Ex. 26 at 3. As to Patient O.B.,
Petitioner argues that steroids were appropriate to
treat his severe pulmonary problems associated with
pneumoconiosis. P. R.Br. at 12. Petitioner did not
rebut the I.G.'s contention that there was no indication
for steroids in the case of J.R. Thus, accepting
Petitioner's justification for prescribing steroids for
Patients V.E., E.R., and O.B., it nevertheless appears
that he prescribed steroids for Patient J.R. without
medical justification.
In another case involving the use of steroids, the I.G.
alleges that steroids were indicated but that Petitioner
failed to prescribe the treatment of choice. Patient
T.P. was suffering from a condition known as idiopathic
thrombocytopenia purpura (ITP), which is a low platelet
count with bruising and bleeding effects. Tr. 390, 392,
394. Dr. Arkush testified that the standard treatment
for ITP is to give Prednisone, a type of steroid. Tr.
394. His testimony is supported by Conn's Therapy, a
recognized medical treatise, which also states that ITP
is treated with Prednisone. P. Ex. 9 at 3. Petitioner
prescribed ACTH and a Medrol Dose Pack for Patient T.P.,
rather than Prednisone. Tr. 394-95. Petitioner also
ordered 10 units of platelets for the patient. Tr. 391.
Dr. Arkush testified that this practice is reserved for
life-threatening bleeding. Tr. 393. He testified that,
in his opinion, Patient T.P. was not bleeding profusely
and did not suffer a life-threatening bleed. Tr. 391,
393.
Regarding the use of steroids, the I.G. has proved that
Petitioner's prescription practices failed to meet
professionally recognized standards in a number of cases.
Petitioner prescribed steroids in cases where the use of
steroids was contraindicated due to the nature of the
patients' illnesses. Petitioner failed to prescribe the
recognized steroid treatment in a case where steroids
were indicated. And, in at least one case, Petitioner
prescribed steroids where there was no medical indication
for their use.
The I.G. alleges also that Petitioner's use of other
medications does not conform to professionally recognized
standards. The I.G. identifies two cases involving the
administration of IV antibiotics. In the case of Patient
A.M., Petitioner prescribed the antibiotic Kefzol to be
administered intravenously. Tr. 374; I.G. Ex. 10. Dr.
Arkush testified that, in his opinion, the patient was
not suffering from an infection that would respond to
Kefzol, and that IV administration was not justified
because there was no evidence of an overwhelming
infection or that the patient was unable to tolerate oral
administration. Tr. 375-76. Petitioner also ordered IV
Kefzol for Patient V.E., who was suffering from renal
failure. I.G. Ex. 18 at 1, 37. Dr. Snider testified
that Petitioner prescribed an inappropriate dosage of
Kefzol, because he prescribed it at too high a rate,
given the patient's impaired kidney function. Tr. 578-
79. Petitioner argues as to Patient A.M. that it was
appropriate to prescribe Kefzol because a urinalysis
conducted in Petitioner's office prior to the patient's
admission indicated that the patient had a urinary tract
infection. P. Br. at 39. However, Petitioner did not
rebut the I.G.'s contention that IV administration was
not indicated for this patient. Nor did Petitioner offer
any evidence to rebut the I.G.'s contentions regarding
the dose of Kefzol prescribed for Patient V.E.
Therefore, I conclude that in administering IV Kefzol to
Patients A.M. and V.E., Petitioner failed to provide care
that met professionally recognized standards.
The I.G. relies also on several cases in which he alleges
that Petitioner prescribed medications in a dangerous
manner or prescribed medications that were contra-
indicated. For example, Petitioner prescribed Tenormin,
an antihypertensive medication, for Patient W.H. I.G.
Ex. 16 at 16. As discussed previously, there was some
debate among the experts as to whether W.H. was
hypotensive during her hospital admission. Petitioner
contends that she was not. However, the I.G. argues
that, even if W.H. was not hypotensive, Petitioner
prescribed Tenormin in a dangerous manner. I.G. Br. at
53. Petitioner's expert, Dr. Young, testified that it
would be "very dangerous" to discontinue Tenormin
abruptly in a patient, such as W.H., who was suffering
from atherosclerotic heart disease and had a history of a
previous heart attack. Tr. 877. Yet, Petitioner
discontinued Tenormin on February 22, 1990, and did not
restart it until February 25th. Tr. 877-78; I.G. Ex. 16
at 14. I conclude that with respect to Patient W.H.
Petitioner did not manage the use of Tenormin in
accordance with professionally recognized standards.
In the cases of Patients A.M. and J.R., the I.G. argues
that Petitioner prescribed medications that were
contraindicated. As discussed previously, Patient A.M.
was suffering from diabetes and his blood glucose levels
were elevated. Tr. 378; I.G. Ex. 10 at 27. Petitioner
ordered hydrochlorothiazide (HCTZ), a diuretic, for
Patient A.M. Tr. 383. The I.G.'s expert testified that
the use of HCTZ was inappropriate because it can elevate
the blood sugar and make it more difficult to control
diabetes. Tr. 384. Petitioner also prescribed Normasol
M, an IV solution, for Patient A.M. Tr. 376; I.G. Ex. 10
at 27. Dr. Arkush testified that Normasol M is added to
an IV solution of dextrose 5 (sugar) and water. Tr. 377.
He testified that it was inappropriate to prescribe
Normasol M because it would aggravate the patient's
diabetes. Tr. 377. Petitioner did not present any
evidence to rebut these contentions. Therefore, I
conclude that Petitioner's prescription of HCTZ and
Normasol M for Patient A.M. did not conform to
professionally recognized standards of health care.
In the case of Patient J.R., Petitioner prescribed
Donnatal, a stomach sedative. I.G. Ex. 37 at 19. The
I.G.'s expert testified that J.R. presented the classic
symptoms of prostatism. Tr. 615. Dr. Snider opined that
prescription of Donnatal was inappropriate because that
medication is contraindicated in patients with
prostatism. Tr. 618. Petitioner argues that he
successfully treated the patient's stomach condition
without an adverse effect on his prostate condition. P.
R.Br. 13. Petitioner also argues that he could not treat
the patient's stomach problem without using a drug that
would have potential impact on the patient's other
problems. Id. However, the fact that administration of
Donnatal did not actually harm the patient does not
change the fact that the patient was placed at risk for
harm by the use of an inappropriate drug. Moreover,
Petitioner presented no evidence from which I could
conclude that there was no drug other than Donnatal which
would have been appropriate to treat the stomach
condition without aggravating the prostate condition.
Therefore, I conclude that by administering Donnatal to
Patient J.R., Petitioner failed to provide care that met
professionally recognized standards.
The I.G. has proved, in a number of cases, that
Petitioner prescribed steroids and other medications in
an inappropriate manner. The I.G. has proved a pattern
of prescription practices which evidences a lack of
knowledge of the effects of various medications on other
medical conditions from which patients may be suffering.
The I.G. has proved that Petitioner engaged in a pattern
of prescribing drugs in a manner that puts patients at
risk.
C. Petitioner Lacks The Ability To Evaluate And
Intervene Appropriately In Patients Suffering Acute
Cardiac Changes.
The I.G. argues that Petitioner's treatment of a number
of patients indicates that he lacks knowledge of
appropriate intervention in patients whose blood
chemistry or EKG test results suggest they may have
suffered a heart attack. Both the I.G.'s experts and the
Petitioner's expert testified that cardiac monitoring is
the standard treatment for patients who may have suffered
a heart attack. Tr. 327, 599, 887-88. Cardiac
monitoring involves placing electrodes on the patient to
constantly determine the behavior of the heart. Tr. 327,
552. Cardiac monitoring enables the physician to respond
immediately to an arrhythmia which could result in sudden
cardiac death. Tr. 327, 552, 599. The I.G. alleges that
Petitioner failed to use cardiac monitoring where
appropriate, and that he discontinued it inappropriately
in one instance where he did use it.
According to the I.G.'s experts, Patient C.H. had a
number of symptoms and diagnostic test results which
indicated that she might be suffering a heart attack.
For example, C.H. complained of nausea and vomiting on
admission. Tr. 340, 547; I.G. Ex. 35 at 7. Her blood
chemistry reports showed an elevated level of CPK enzyme,
which may indicate that the patient is suffering a heart
attack. Tr. 341-42; I.G. Ex. 35 at 10. Additionally,
the patient had two abnormal EKGs and her chest X-ray
showed an enlarged heart. Tr. 345-46; I.G. Ex. at 24.
The I.G.'s experts testified that Petitioner failed to
treat this patient in accordance with professionally
recognized standards because he failed to institute
cardiac monitoring. Tr. 353. Petitioner's expert, Dr.
Young, acknowledged that, if this had been his patient,
he might have monitored the patient. Tr. 889.
Petitioner argues that he did not place Patient C.H. on a
heart monitor because of the family's desire not to
pursue an "aggressive approach." P. Br. at 31; see I.G.
Ex. 35 at 3. Dr. Young testified that if the family had
requested that the patient not be resuscitated, there
would be no need for cardiac monitoring. Tr. 888-89.
However, Drs. Cooperider and Snider noted that Petitioner
had not adequately documented that the family had
requested that the patient not be placed on a monitor or
not be resuscitated. Tr. 458, 623-26. I agree that
Petitioner should have documented more clearly that the
patient's family requested that the patient not be
resuscitated. Nevertheless, it appears more likely than
not that Petitioner was acting in accordance with the
family's wishes in not performing cardiac monitoring on
Patient C.H. Therefore, I conclude that the I.G. has not
proved that Petitioner failed to treat Patient C.H. in
accordance with professionally recognized standards of
care.
The I.G. argues that Petitioner failed to provide
treatment to Patient T.R. that met professionally
recognized standards of care because Petitioner failed to
evaluate and treat the patient's cardiac condition. The
I.G.'s expert opined that Petitioner should have
instituted cardiac monitoring because the patient had two
EKGs that showed an anterior myocardial infarction, time
undetermined, and because his chest X-ray showed an
enlarged heart. Tr. 322-23, 337. According to Dr.
Arkush, these test results indicated that the patient may
have been admitted with a heart attack. Tr. 325. He
also testified that the patient was discharged with
bradycardia (low heart rate) and, thus, was not stable
for discharge. Tr. 335-36.
Petitioner relies on the expert testimony of Dr. Young, a
board-certified cardiologist, who opined that he could
not see any value to cardiac monitoring in this patient,
given his age and debilitated condition. Tr. 879. He
testified that, in his opinion, monitoring would not
reveal any information that would change the treatment
options for the patient. Id. He opined that the
patient's test results presented no evidence of an acute,
evolving heart attack. Tr. 852. The I.G. counters that
Petitioner is not a cardiologist and, so, probably would
not understand whether or not the abnormal test results
were evidence of a heart attack. I.G. R.Br. at 21-22.
However, this argument is speculative. I find the
testimony of Petitioner's expert more persuasive on this
point and therefore conclude that Petitioner did not fail
to provide care that met professionally recognized
standards by not performing cardiac monitoring on Patient
T.R.
The I.G. alleges that Petitioner failed to respond
appropriately when Patient T.P. suffered severe chest
pain during her hospital admission. The patient had an
EKG on admission to the hospital which showed an abnormal
result. Tr. 397, 402-403; I.G. Ex. 29 at 16. On the day
after admission, the patient complained of severe chest
pain. I.G. Ex. 29 at 35. Petitioner ordered
Nitroglycerin, Benadryl, and Lasix. Dr. Arkush testified
that Petitioner's orders were inappropriate because, in
his view, one would have to assume the patient was having
a heart attack at that point. Tr. 403. The I.G.'s
expert testified that the appropriate intervention would
have been an immediate EKG, treatment based on the result
of the EKG, and some type of cardiac monitoring. Id.
The patient was found dead in her bed later that day.
Tr. 404-05; I.G. Ex. 29 at 27.
Petitioner's expert, Dr. Young, also acknowledged that it
would have been reasonable to obtain an EKG at the time
the patient experienced chest pain. Tr. 863. However,
he opined that an EKG or cardiac monitoring would not
have altered the outcome for this patient. Id. That is,
in his view, the patient would likely have died anyway.
In this instance, both the I.G.'s expert and Petitioner's
expert agree that the appropriate intervention at the
time the patient began suffering chest pain was to at
least obtain an EKG, and perhaps institute cardiac
monitoring, as well. Petitioner did not do this. The
fact that the patient might well have died, even if he
had taken the appropriate steps, does not alter the fact
that, as to this patient, Petitioner failed to provide
care that met professionally recognized standards.
In the case of E.G., the I.G. alleges that Petitioner
discontinued cardiac monitoring at an inappropriate stage
of treatment. The patient's laboratory test results
showed an elevated CPK level, her chest X-ray showed an
enlarged heart, and she had two abnormal EKG reports.
Tr. 593-95; I.G. Ex. 21. Petitioner ordered a cardiac
monitor on May 11, 1990, and discontinued it on May 12.
Tr. 596; I.G. Ex. 21 at 38-39. The patient's CPK level
was elevated on the day the monitor was removed and on
the following day the CPK level was even higher. Id.
Dr. Snider testified that it was inappropriate to
discontinue the cardiac monitor when the patient's CPK
level was rising. Tr. 597.
Dr. Young, Petitioner's expert cardiologist, testified
that, in his opinion, it did not appear that Patient E.G.
suffered a heart attack during her admission. Tr. 854-
56. He stated that the enzyme results and the EKGs were
not indicative of an evolving myocardial infarction. Id.
Petitioner argues that, since the patient did not suffer
a heart attack, his decision to remove the heart monitor
was appropriate. I conclude that it was inappropriate
for Petitioner to discontinue cardiac monitoring in the
face of test results that suggested the patient's cardiac
condition may not have stabilized. Dr. Young testified
with the benefit of hindsight. At the time Petitioner
confronted the case, he could have been aware only that
the patient's CPK level had not yet returned to normal.
Therefore, I conclude that Petitioner's care of Patient
E.G. failed to meet professionally recognized standards.
The I.G. also alleges that, as to Patients B.B. and O.B.,
Petitioner failed to perform the necessary and usual
tests to evaluate their cardiac conditions, in the face
of abnormal test results. I.G. Br. at 63. Patient B.B.
had abnormal EKG, chest X-ray, and CPK results. Tr. 608-
09; I.G. Ex. 31 at 19-25. Patient O.B. had an elevated
CPK level. Tr. 612; I.G. Ex. 33 at 15. The I.G.'s
expert testified that Petitioner failed to evaluate these
patients properly because he failed to address possible
cardiac conditions. Tr. 614. Petitioner argues that
Patient B.B. was being treated for anemia, not cardiac
problems. P. R.Br. at 16. However, this does not
relieve Petitioner of the duty to address the patient's
cardiac condition if laboratory results suggest this is
necessary. As to Patient O.B., Petitioner argues that
his abnormal CPK level was caused by a drug,
Cephalosporin. P. Br. at 44; P. R.Br. at 16. However,
Petitioner has offered no evidence from which I could
find that elevated CPK is a known side effect of
Cephalosporin. For these reasons, I conclude that
Petitioner's failure to evaluate the cardiac condition
of Patients B.B. and O.B. was not in accord with
professionally recognized standards of care.
The I.G. did not prove that Petitioner failed to provide
care in accordance with professionally recognized
standards to Patients C.H. and T.R. Nevertheless, the
I.G. has proved that Petitioner's treatment of possible
cardiac problems in Patients T.P., E.G., B.B., and O.B.
did not meet professionally recognized standards of care.
I am particularly concerned by Petitioner's apparent
failure to recognize that Patient T.P. was suffering an
acute heart attack and to intervene appropriately.
D. Petitioner Lacks The Ability To Manage Fluid Intake
In Patients Who Require Hydration Or Fluid Restriction.
The I.G. argues that in three of the additional cases, as
well as in the case of E.S., Petitioner failed to treat
patients whose diagnosed conditions required fluid
management, either hydration or fluid restriction, in
accordance with professionally recognized standards. For
example, in the case of Patient T.R., both Petitioner's
admitting and final diagnoses included "acute
dehydration." I.G. Ex. 23 at 1. The I.G.'s expert, Dr.
Arkush, testified that the patient's clinical signs, such
as his pulse, temperature, and blood pressure, did not
support this diagnosis. Tr. 321. Nevertheless, assuming
Patient T.R. was dehydrated, Dr. Arkush testified that
Petitioner failed to treat the patient for dehydration.
Tr. 336. Petitioner ordered IV fluids for the patient at
the rate of 1000 ccs every 12 hours, then reduced the
rate to 1000 ccs every 24 hours. Tr. 323; I.G. Ex. 23 at
21. Dr. Arkush testified that the fluids prescribed by
Petitioner were insufficient to maintain even a normal-
sized person who was not dehydrated. Tr. 323.
Petitioner argues that his diagnosis of dehydration was
supported because the patient's digoxin level was 2.6.
P. R.Br. at 14; see I.G. Ex. 23 at 2. However Petitioner
has offered no explanation as to the meaning of this
result nor any evidence that such a result is indicative
of dehydration. Petitioner contends that he reduced the
rate of IV fluids when the patient's digoxin level
returned to normal and the patient became more alert.
P.R. Br. at 14. Petitioner did not rebut the I.G.'s
contention that the rate of IV fluids was insufficient to
treat a patient suffering from dehydration. For this
reason, I conclude that Petitioner failed to treat
Patient T.R. in accordance with professionally recognized
standards by failing to prescribe adequate fluids for the
treatment of dehydration.
The I.G. alleges that Petitioner not only lacks the
ability to treat dehydration appropriately, but that he
also is unable to treat patients who require fluid
restriction. The I.G. points to the cases of V.E. and
E.G. in this regard. As to both patients, Petitioner had
diagnosed congestive heart failure. I.G. Exs. 18 at 1,
21 at 1. The I.G.'s expert, Dr. Snider, testified that
the standard treatment for congestive heart failure would
include fluid restriction, diuretics, oxygen, and perhaps
digitalis. Tr. 576-77. Petitioner ordered 3000 ccs of
normal saline per day, rather than fluid restriction for
Patient V.E., which Dr. Snider testified was
inappropriate. Tr. 577-78. As to Patient E.G., in
addition to Petitioner's diagnosis of congestive heart
failure, a chest X-ray on admission revealed that the
patient had fluid in her left lung. Tr. 597; I.G. Ex. 21
at 25. Petitioner ordered IV fluids for the patient at
the rate of 2000 ccs per day. Tr. 597; I.G. Ex. 21 at
38. In Dr. Snider's opinion, the IV rate was not
appropriate, as the patient should have been managed with
fluid restriction. Id. Petitioner did not offer any
evidence to rebut the I.G.'s contentions regarding
Patients V.E. and E.G. Therefore, I conclude that
Petitioner failed to provide care that met professionally
recognized standards to Patients V.E. and E.G. because he
failed to order fluid restriction for those patients.
The I.G. has shown that Petitioner has failed to manage
properly the fluid intake of Patients T.R., V.E., and
E.G., in addition to the case of Patient E.S. I
conclude that the I.G. has shown a pattern of practice
by Petitioner that indicates he lacks the knowledge
necessary to manage the fluid intake of patients that
may be dehydrated or need fluid restriction.
I have concluded that Petitioner failed to practice in
accordance with professionally recognized standards of
health care in numerous instances. I have further
concluded that these instances evidence patterns of
treatment which indicate that Petitioner lacks the
knowledge to conform his practice to professionally
recognized standards of care. Specifically, Petitioner
lacks the ability: 1) to diagnose the causes of patients'
abnormal laboratory results and to address these results
adequately; 2) to prescribe the appropriate medications
for patients' conditions; 3) to evaluate and intervene
appropriately in patients suffering acute cardiac
changes; and 4) to manage fluid intake in patients who
require hydration or fluid restriction.
Thus, the weight of the evidence confirms that a one-year
exclusion is reasonable in this case. Petitioner's
pattern of potentially life threatening judgement errors
involving the evaluation and treatment of patients is a
serious problem. These recurring patterns and
Petitioner's reliance on his status as a family
practitioner to excuse these errors is disturbing.
However, I do not find that these deficiencies are the
consequences of bad faith or of an uncaring physician.
Rather, they appear to be deficiencies in judgment,
knowledge of current medical procedures, and a failure to
consult when presented with unfamiliar medical issues.
Petitioner's practice includes a substantial number of
elderly patients. 33/ All deserve adequate medical care
based on current professional standards of practice. It
is also possible that Petitioner attempts to see too many
patients with severe and complicated problems to
adequately treat them all. Petitioner's failure to
comply timely or completely with the CME portions of his
CAP indicates to me that he did not believe there were
any deficiencies in his knowledge or that any changes in
his procedures were necessary.
In making the determination to impose the one year
exclusion, I must also consider the remedial nature of
the exclusion to ensure that its length is the minimum
time period needed for Petitioner to demonstrate that he
can be trusted to provide medical care to program
beneficiaries and recipients in a manner consistent with
his obligations. Hussain at 94; Reyes at 37-38. One
year is a relatively short exclusion. However, it will
balance the needs of the community in which Petitioner
works with the needs of the Medicare program to ensure
that Petitioner has reestablished his trustworthiness to
be a program provider. He will have the opportunity to
rectify his deficiencies, as established by the record.
At the end of this time, Petitioner may seek
reinstatement into the programs pursuant to 42 C.F.R.
1004.120. 34/
V. The I.G. Has Proven That Petitioner Represents A
"Serious Risk" To Medicare Beneficiaries And Should Be
Excluded During His Administrative Appeals.
The I.G.'s exclusion determination under section 1156 is
normally effective pending the outcome of an
administrative hearing. However, when, in cases such as
this one, the excluded provider is located in a rural
health manpower shortage area or in a county with a
population of under 70,000, the effectiveness of the
exclusion is stayed. The exclusion takes effect only
upon an adverse finding in the hearing or if there is a
preliminary finding that the provider will pose a
"serious risk" to program beneficiaries and recipients.
Section 1156(b)(5).
Petitioner requested both a preliminary hearing and one
on the underlying issue of the exclusion. The hearings
were consolidated, and the I.G. requested an expedited
decision of the "serious risk" issue. However, because
of the many issues involved in this proceeding, I wanted
a full briefing on them before reaching a decision.
Also, our procedures encourage prompt and timely
decisions, and two decisions in this instance would have
resulted in duplication and delays. Therefore, I have
consolidated the issues in this decision. 35/
"Serious risk," while not defined by statute or
regulation, has been interpreted in prior rulings as a
"propensity to unreasonably expose a patient to a hazard
or danger of serious harm." Louis W. DeInnocentes, Jr.,
Ruling on Issue of Serious Risk, at 5 (April 20, 1992);
Evelyn Reyes, M.D., Ruling on Serious Risk, at 5 (January
9, 1991) (Reyes I). To prove "serious risk," it is not
necessary that the I.G. prove repeated episodes of
patient endangerment. Exposure of a patient to a grave
hazard in any one case or less grave but serious errors
occurring with enough frequency to place beneficiaries
and recipients in danger of serious harm is sufficient.
DeInnocentes at 6; Reyes I at 5.
Based on the evidence and testimony of record and my
previous findings in this decision, I conclude that
program beneficiaries and recipients would be exposed to
a hazard or danger of serious harm through Petitioner's
current practice of medicine. This finding is based not
only on the violation found in the case of Patient E.S.
but also the 15 additional cases. These 16 cases
demonstrate a serious pattern of deficiencies in medical
judgment and knowledge. I emphasize that my conclusion
on "serious risk" is not based on -- nor do I make any
such findings regarding -- whether Petitioner cured any
of these patients or whether his treatment resulted,
where applicable, in their deaths. This conclusion is
based solely on finding that regardless of the prognosis
or poor condition of the patient, there were serious
deficiencies regarding their treatment. My principal
concern is the overall quality of care exhibited by
Petitioner.
In this case, the weight of the evidence is against
Petitioner. His care and treatment of the 16 patients
demonstrates a lack of knowledge of appropriate basic
medical responses to problems in both evaluation and
treatment of patients.
Finally, as no evidence has been introduced regarding
whether Petitioner's exclusion may adversely affect the
availability of medical resources in his community, I
conclude that it will not. Also, section 1156(b)(5) of
the Act contemplates that the existence of "serious risk"
to the programs outweighs the possibility of an
inadequate supply of medical resources.
Because Petitioner has not yet been excluded from
participation, the exclusion will run prospectively from
twenty days after the date of this decision, which will
allow time for receipt and implementation.
CONCLUSION
Based on the applicable law and the evidence, I conclude
that Petitioner "grossly and flagrantly" violated his
obligation within the meaning of section 1156 of the Act
to provide health care services of a quality that met
professionally recognized standards of health care in the
case of E.S. and demonstrated a "lack of ability
substantially to comply" with his obligation.
I conclude that the I.G. had the authority under section
1156 to impose an direct and exclusion against Petitioner
from participation in the Medicare and Medicaid programs
and that a one year exclusion is reasonable. I further
conclude that Petitioner represents a "serious risk" to
Medicare beneficiaries within the meaning of section 1156
of the Act and must be excluded during the course of
these proceedings.
So Ordered.
Charles E. Stratton
Administrative Law Judge
1. Federally financed State health care programs are
defined in section 1128(h) of the Act. There are three
types of federally financed programs, including Medicaid.
Hereinafter, I use the term "Medicaid" to refer to all
State health care programs from which the I.G. proposed
to exclude Petitioner.
2. Sentinel is the successor to the Indiana Medical
Review Organization, the PRO which began Petitioner's
Quality Review. The Secretary of DHHS contracts with
PROs to review the professional activities of physicians
to determine whether the physicians are providing
services which satisfy their obligations under section
1156 of the Act. If a PRO determines that a physician
has committed a "gross and flagrant" violation, the PRO
must submit a report and recommendation to the I.G.
3. "Gross and flagrant" is defined at 42 C.F.R.
1004.1 as a violation which represents "an imminent
danger to the health, safety or well-being of a Medicare
beneficiary or places the beneficiary unnecessarily in
high-risk situations."
4. Section 1156(a) of the Act imposes on health care
practitioners a number of duties, among them the duty to
provide care of a quality that meets professionally
recognized standards of health care. Section 1156(b)
authorizes the Secretary of the DHHS to exclude
practitioners who commit certain types of violations of
their statutory obligations. Section 1156(b)(1)(A)
authorizes exclusion of practitioners who substantially
violate their obligations in a substantial number of
cases. Section 1156(b)(1)(B) authorizes exclusion of
practitioners who "grossly and flagrantly" violate their
obligations on one or more occasions. In this case, the
I.G. alleged in his Notice that Petitioner's proposed
exclusion is authorized pursuant to the latter
subsection, 1156(b)(1)(B).
5. If the I.G. proves by a preponderance of the
evidence that Petitioner poses a "serious risk," within
the meaning of section 1156 of the Act, he must be
excluded during the pendency of these proceedings.
6. Section 1156(b)(5) of the Act requires that the
effective date of exclusion be stayed for physicians who
practice in a county with a population of less than
70,000 or in a rural manpower shortage area, until a
preliminary hearing can be held to determine whether the
physician poses a "serious risk" to Medicare
beneficiaries or Medicaid recipients. In the Notice,
Petitioner was advised that the issues at the preliminary
hearing would be whether Petitioner: 1) posed a serious
risk to persons entitled to participate in the health
care programs; and 2) should be allowed to continue to be
reimbursed for program items and services pending the
outcome of the hearing on the merits.
7. The record of this case will be cited as follows:
I.G.'s Exhibits I.G. Ex. (number) at (page)
Petitioner's Exhibits P. Ex. (number) at (page)
Transcript Tr. (page)
I.G.'s Brief I.G. Br. (page)
Petitioner's Brief P. Br. (page)
I.G.'s Reply Brief I.G. R.Br. (page)
Petitioner's Reply Brief P. R.Br. (page)
8. Some of my statements in the sections preceding
these formal findings and conclusions are also FFCLs. To
the extent that they are not repeated here, they were not
in controversy. Also, I have used headings in organizing
my FFCLs. These headings are not FFCLs and do not alter
the meanings of the FFCLs.
9. The record includes the use of both Arabic and Roman
numerals for the severity levels. For uniformity, I have
used Roman numerals throughout this decision.
10. Because the I.G.'s Notice to Petitioner is dated
February 6, 1992, I conclude that with respect to the
I.G.'s review, the new regulations published January 29,
1992, at 57 Fed. Reg. 3298 et al., are applicable to this
proceeding. See Behrooz Bassim, M.D., DAB 1333 at 9
(1992) (substantive provisions of the new regulations may
be applied to cases in which the I.G.'s Notice of Intent
to Exclude, Notice of Exclusion, or Notice of Proposal to
Exclude was dated on or after January 29, 1992).
However, with respect to the PRO proceedings, I have
relied on the regulations in effect at that time.
11. Petitioner notes in his brief that some of these
issues have been raised here only to preserve them on
appeal. P. Br. at 2; see Papendick v. Sullivan, No. 91-
1902 at 7 (7th Cir. July 17, 1992) (due process claims
must be raised at the administrative level to preserve
them).
12. In fact, contrary to Petitioner's assertions, the
record indicates that when it became apparent that the
PRO was not accepting Petitioner's explanation's
regarding his care of Patient E.S., he became somewhat
uncooperative. For example, he was sent several letters
with respect to his right to attend the administrative
hearing. He was also contacted several times regarding
his apparent refusal to complete, within the established
time frame, the Corrective Action Program assigned to him
by the PRO.
13. Just as the I.G. is not bound by the PRO's
recommendation, I am not bound by the I.G.'s
determination. Petitioner is entitled to, and has
received, a de novo review here. My analysis of the
reasonableness of the length of the proposed exclusion is
at part IV of this decision.
14. Petitioner has intimated that he may not have
received fair consideration from the PRO because he is a
doctor of osteopathy. I take note of the fact that
doctors of osteopathy took part in both the PRO
proceeding and these proceedings, and osteopaths
testified at the hearing both for Petitioner and the I.G.
15. Petitioner's assertion that the "regulations are
not within the Secretary's authority" is difficult to
address without more information regarding Petitioner's
arguments or to which regulations he is referring.
However, 42 C.F.R. Parts 1000-1007, which implement the
sanction and civil money penalty provisions of the Act
(including section 1156), were authorized by the same
legislation which established the Act. See 57 Fed. Reg.
3298 (January 29, 1992) for a list of the relevant
legislation.
16. See note 3, supra.
17. A normal WBC is 6,000 to 10,000. Tr. 763.
18. Although there was a report from Deaconess
indicating that there had been a positive stool culture
for pseudomembranous colitis, the doctor who wrote the
Deaconess discharge report testified that the report was
inaccurate and that the culture had been negative. A
stool culture is a different test than the sigmoidoscopy.
Tr. 776-77 See I.G. Ex. 1 at 49.
19. The record shows several spellings of these and
other medications. Throughout this decision, I have used
those spellings which appear most frequently.
20. Septicemia refers to the presence of bacteria in
the blood stream and an overwhelming infection somewhere
in the body. Tr. 230, 476.
21. Pseudomembranous colitis (or pseudomembranous
enterocolitis), for which Patient E.S. was treated at
Deaconess, is not the same disease as that listed by
Petitioner in his physical examination report and final
report -- pseudomembranous ulcerative colitis. They are
different conditions which require different diagnoses
and treatments. Tr. 516-18, 663. Also, some of the
early PRO reports mistakenly refer to the condition as
pseudomonas. However, by whatever name the parties used,
it appears that they meant to refer to the disease
pseudomembranous colitis. Also, as all parties agree
that the condition at issue is "pseudomembranous
colitis," that is the term I will use here. None of the
parties have argued that they have relied, to their
detriment, on the mistaken usage.
22. Dr. Arkush also stated that the prescription of
Prednisone, another anti-inflammatory, would exacerbate
the body's inability to fight the infection and its use
did not meet professionally recognized standards of care.
Tr. 271.
23. Drs. Snider and Cooperider also noted, that
although the admitting nurse noted that Patient E.S. had
lost fourteen pounds since her prior hospitalization,
Petitioner made no attempt to address the patient's
increased nutritional needs by using, for example, a
feeding tube. Tr. 493-94, 531 See I.G. Ex. 6 at 9.
24. The I. G. asserts that Petitioner's argument
regarding his access to the Deaconess tests should be
disregarded because the tests are not in the record. I
decline to do so because both parties have submitted
evidence and relied on testimony regarding several of
these tests.
25. Petitioner argues also that he relied on the
negative results of a Deaconess stool sample and that his
April 4 test also was negative. This does not explain
why he ignored the results of the flexible sigmoidoscopy,
or why the culture for the clostridium difficile bacteria
was not included in the testing.
26. Dr. Rusche testified that as a gastroenterologist,
he does not make that mistake, but he indicated that
other physicians do. Tr. 664.
27. Also, Petitioner's witnesses testified that they do
not think that Petitioner's treatment caused her any
harm. Tr. 766.
28. By letter dated November 28, 1990, the Sanction
Committee affirmed the previously assigned CME
requirement and gave Petitioner 60 days to comply. I.G.
Ex. 43 at 94.
29. The PRO did not forward the case to the I.G. until
October 13, 1991. The I.G. argues that this
documentation may not be considered by me because 42
C.F.R. 1005.17(j) does not permit me to consider
evidence of willingness and ability to enter into and
complete a CAP which pertains to matters occurring after
the PRO submits the case to the Secretary. As Petitioner
points out, the evidence does not concern matters which
occurred after the case was submitted. The CMEs, which
were the "matter," were taken on November 25-29, 1990,
well before the October 13, 1991, PRO submission.
Therefore, it is appropriate that I consider this
evidence with respect to whether the CMEs were taken.
Petitioner does not seriously dispute that he failed to
comply with respect to the timely filing of the
documentation with the PRO. Tr. 916-17.
30. 30 A brochure of the conference which was
submitted by Petitioner indicates that lectures included
the topics of sports medicine, consults in clinical
medicine, current procedural terminology, and a number of
lectures on infectious diseases -- treatments for viral
hepatitis and rhinitis, evaluation of fluoroquinoles in
infections, and several on HIV infections. P. Ex. 1 at
8.
31. Another AOA printout submitted here by Petitioner
shows that he earned seven more hours of CME during the
intervention period, but I am unable to determine all the
topics from the titles. See P. Ex. 1 at 8.
32. This subsection (7) was amended January 29, 1992.
57 Fed. Reg. 3350. I have already ruled that these new
regulations are applicable to this proceeding. Note 8
supra.
33. Dr. Wayne testified that when she was a student
under Petitioner, he would treat 12-14 people over the
age of 70 in a morning. Tr. 754.
34. This is the minimum period of the exclusion as
reinstatement is not automatic. The exclusion will
remain in effect until Petitioner applies and the I.G.
determines that the basis for the exclusion no longer
exists. This determination will be based on an
evaluation of whether Petitioner has corrected his
practice deficiencies, and, in doing so, the I.G. may
request advice from the PRO. 42 C.F.R. 1001.(a)(2)
and 1004.120.
35. Although there may be some question as to the
necessity of the "serious risk" finding at this stage,
the issue is not completely clear as to whether the
exclusion would take effect should Petitioner appeal this
decision. It is my understanding that the intent of the
statute is that the exclusion should take effect either
after a finding in a preliminary hearing or in a decision
on the merits. However, as there have been no rulings on
this issue, I have decided to address the serious risk
issue here.