$05:Exclusion Case
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of: Sunil R. Lahiri, M.D., Petitioner,
- v. -
The Inspector General.
DATE: December 12, 1994
Docket No. C-92-088
Decision No. CR348
DECISION
By letter dated February 10, 1992, the Inspector General (I.G.)
notified Petitioner that, effective March 1, 1992, Petitioner was
excluded, pursuant to section 1128(b)(6)(B) of the Social Security
Act (Act), from participation in Medicare and any State health care
program as defined by section 1128(h) of the Act. 1/ The I.G.
further informed Petitioner that his exclusion was for a 10-year
period. The I.G. stated that the basis for Petitioner's exclusion
was that Petitioner, in seven separate cases, furnished items or
services to patients which were substantially in excess of their
needs and of a quality which failed to meet professionally
recognized standards. 2/
For the reasons contained below, I find that the I.G. had the
authority to exclude Petitioner pursuant to section 1128(b)(6)(B)
of the Act. I further find that, pursuant to 42 C.F.R. 1005.4
and 42 C.F.R. 1005.20(b), I have the authority to increase the
period of exclusion beyond the 10 years advocated by the I.G.
Moreover, the record of this case demonstrates that an exclusion of
greater than 10 years is justified.
I find that, by his conduct, Petitioner has shown an extreme
disregard of his responsibilities as an oncologist and has shown a
shockingly callous indifference to the well-being of the seven
patients at issue here. Petitioner furnished items and services to
these patients that were substantially in excess of their needs and
of a quality which failed to meet professionally recognized
standards. In doing so, Petitioner jeopardized the patients'
health and well-being by failing to adequately diagnose, document,
and treat their conditions. He deprived many of these patients of
the opportunity to receive treatment that could abate or cure their
cancer, or at least minimize the suffering associated with advanced
stages of cancer. By having these patients endure numerous,
prolonged infusions of subtherapeutic dosages of chemotherapy, and
repeated blood tests and vitamin injections of marginal efficacy,
Petitioner severely inconvenienced these patients and caused a
significant deterioration of their quality of life at a time when
their life expectancy was very short. This record of unnecessary
and excessive treatment, when combined with Petitioner's refusal
and inability to follow Medicare billing practices, leads me to
conclude that Petitioner's eagerness to generate the maximum amount
of Medicare billings was a principal factor in his choice of
treatment for these patients. Moreover, I find that Petitioner's
treatment of these patients demonstrates that he lacks the basic
knowledge and understanding of the medical practices and procedures
necessary to properly treat and diagnose cancer patients. For
these reasons and the reasons I will detail in the following pages,
I find that Petitioner's conduct justifies that he be permanently
excluded from Medicare and federally funded State health care
programs
BACKGROUND
On March 31, 1992, Petitioner filed a request for hearing to
contest the I.G.'s determination to exclude him for 10 years. The
case was assigned to me. On July 28, 1992, after several
continuances of the initial prehearing conference, I conducted a
prehearing conference at which I established a schedule through
which this case would proceed to hearing on January 25, 1993, in
San Francisco, California. On December 1, 1992, Petitioner moved
for a continuance of the January 25 hearing based on a motion he
had filed in federal court to enjoin these proceedings. On
December 10, 1992, I issued a Ruling in which I refused to
speculate as to the outcome of Petitioner's motion in federal court
and accordingly denied Petitioner's motion for continuance. On
January 7, 1993, Petitioner moved to consolidate this case with
another exclusion case that the I.G. had brought against him
(Docket No. C-93-036) and he once again moved for a continuance of
the January 25 hearing. I continued the January 25 hearing to
enable the parties to submit pleadings to argue Petitioner's
motions for continuance and consolidation. 3/ After receiving all
of the parties' submissions, I conducted another prehearing
conference on February 19, 1993. At the conference, I denied
Petitioner's motions. 4/
The parties completed their final exchanges in preparation for the
hearing scheduled for April 26, 1993, when, on April 9, my office
received a notice from Petitioner's former counsel indicating that
he was no longer representing Petitioner. I conducted another
prehearing conference on April 12, at which time Petitioner
informed me that he had terminated the services of his attorney and
requested a stay of the hearing to enable him to obtain new
counsel. I granted Petitioner's request. 5/
On April 22, 1993, Indra Lahiri, Esq., entered his appearance on
behalf of Petitioner. On April 23, 1993, I conducted another
prehearing conference and gave Petitioner until April 30, 1993 to
either file additional submissions or notify me of his intent to go
forward on the documents and exhibits that had been submitted by
Petitioner's previous counsel. At the conference, Petitioner's new
counsel stated that he would go forward with this case on the
record as submitted by the previous counsel and agreed to a
schedule culminating in a two-week hearing to begin on August 2,
1993 in San Francisco, California. 6/
On April 29, 1993, Petitioner moved for a continuance or
bifurcation of the August 2 hearing. The stated reason for
Petitioner's motion was Petitioner's desire to attend a medical
continuing education seminar beginning on August 7, 1993. In my
Order of May 25, 1993, I denied Petitioner's motion, for the
reasons stated therein.
On July 26, 1993, Petitioner again moved for a continuance of the
August 2 hearing. Petitioner's counsel stated that Petitioner had
suffered a heart attack of such severity that he would be unable to
attend the August 2 hearing and further stated that it would be
three to six months before Petitioner could withstand the rigors of
a hearing. In an Order dated July 27, 1993, I directed Petitioner
to provide me with documentation supporting his oral representation
that he was unable to attend the August 2 hearing for medical
reasons. In a letter dated July 27, 1993, Petitioner supplied me
with documentation to support his position. Counsel for the I.G.
objected to Petitioner's request for a continuance, stating that
the documentation was inadequate to support his contentions
regarding the nature and severity of his medical condition.
I subsequently denied Petitioner's request for continuance because
I found the documentation submitted by Petitioner to be
insufficient to support his request for continuance. 7/ Because of
the delays necessitated by my ruling on this matter, I delayed the
start of the hearing to August 4, 1993. On August 3, 1993,
Petitioner's attorney informed me that Petitioner had instructed
him not to appear at the August 4 hearing.
I conducted a telephone conference on August 4, 1993, for the
purpose of clarifying the parties' positions regarding the
statement made by Petitioner's counsel that Petitioner had
instructed him not to appear at the scheduled hearing. At the
August 4 telephone conference, it was agreed by all parties that
Petitioner's counsel would appear on August 11, 1993 to litigate a
motion to dismiss in Docket No. C-93-036, as Petitioner's counsel
had agreed that Petitioner's presence and testimony were not
required to fully and fairly litigate that case. 8/ It was further
agreed by the parties that the hearing in this case would be
continued to November 15, on the condition that Petitioner make a
good faith showing by documenting his current physical condition,
the nature of his treatment, and a prognosis that would show that
he would be medically able to attend the November 15 hearing.
On August 23, in accordance with the instructions contained in my
August 11 Ruling, Petitioner submitted additional documentation of
his medical condition. However, in my Ruling of September 29,
1993, I noted that the additional documentation submitted by
Petitioner was inadequate to support his previous representations
regarding his medical condition and therefore insufficient to
support his request for continuance of the hearing to November 15.
Also in my September 29 Ruling, I gave Petitioner until October 8,
1993 to submit documentation sufficient to support his request for
continuance.
Petitioner failed to submit sufficient documentation in accordance
with my September 29 Ruling. Accordingly, in my Order of October
15, 1993, I required Petitioner, by October 25, to provide
additional specific information to support his request for
continuance of the hearing to November 15, 1993. In a letter dated
October 22, 1993, Petitioner submitted documentation that indicated
that he had received medical clearance to attend the November 15
hearing.
Accordingly, I conducted a hearing in this case on November 15 -
23, 1993 in San Francisco, California. From November 15 - 19, the
I.G. presented its case-in-chief against Petitioner. On November
22, 1993, Petitioner began to testify on his own behalf. Toward
the close of the day, it became apparent that Petitioner could not
complete his testimony by the end of the day and would have to
return on November 23 to do so. Petitioner's counsel requested a
recess for the purpose of allowing him to contact his other witness
and instruct him not to travel to San Francisco to testify on
November 23 because Petitioner would be testifying that entire day.
At the conclusion of the recess, Petitioner informed me that he
would be unable to testify on November 23 because he had
contemplated that he would need only one day to testify. Also,
Petitioner stated that his brother had passed away 10 days prior
and that he would be unable to testify for the remainder of the
week because he had to attend a religious service related to his
brother's death. Petitioner's counsel stated that he knew
Petitioner's brother had passed away, but was unaware until that
moment that Petitioner's presence would be required at a religious
service such that it would preclude Petitioner from completing his
testimony. Unfortunately, Petitioner's counsel, unaware of
Petitioner's situation, had instructed the witness not to attend
the hearing the following day.
To resolve the situation, I offered to allow Petitioner to continue
his testimony until late that evening, but counsel for the I.G. did
not wish to do so. Counsel for Petitioner offered to try to
correct the situation by contacting his witness and instructing him
to be present to testify on November 23. On November 23,
Petitioner's counsel informed me that he had been unsuccessful in
contacting his witness. With the agreement of all parties, I
continued the hearing to January 24 - 28, 1994 in San Francisco.
The parties agreed to complete all remaining testimony in this case
during that time. 9/
On December 15, 1993, the I.G. moved to truncate the hearing to
allow her to present rebuttal testimony 30 days after the January
24 - 28 completion of the case-in-chief. The I.G. moved also to
exclude several of Petitioner's exhibits, asserting that these
exhibits were not offered in accordance with my order governing the
final prehearing exchange of documents. The I.G. moved also to
compel Petitioner to document the reason why he failed to continue
his testimony on November 23.
In a letter dated December 29, 1993, Petitioner requested a
continuance of the hearing. In his motion, Petitioner contended
that a hearing was neither economical nor feasible, in view of the
adverse decision Petitioner had received in Sunil R. Lahiri, M.D.,
DAB CR296 (1993).
In my Ruling of January 10, 1994, I denied the motions for
truncation and continuance and gave detailed reasons for doing so.
I ruled also that the I.G.'s motion to exclude several of
Petitioner's exhibits was not ripe. The parties completed their
presentation of testimony on January 24 - 26, 1994. Upon review of
the parties' posthearing briefs, on June 17, 1994, I requested
supplemental briefing from the parties on: 1) whether I have
authority to increase the term of exclusion proposed by the I.G.
and 2) whether, assuming I have the authority, such an increase is
justified based on the record of this case. 10/
ISSUES
The issues in this case are whether:
1. The I.G. had the authority to exclude Petitioner pursuant
to section 1128(b)(6)(B) of the Act; that is, whether Petitioner
furnished or caused to be furnished items or services to these
patients substantially in excess of the needs of these patients or
of a quality which failed to meet professionally recognized
standards.
2. The term of exclusion of imposed and directed against
Petitioner by the I.G. is reasonable.
3. Pursuant to the remedial purposes of the Act and the
regulations at 42 C.F.R. 1001.701 and 42 C.F.R. 1005.20(b),
I have the authority to increase the term of exclusion to a period
greater than the 10-year period referenced in the Notice.
4. Assuming I have the authority to increase the term of
Petitioner's exclusion beyond the 10-year period referenced in the
Notice, whether an increase is justified based on the record before
me and, if so, for what period of time should Petitioner be
excluded.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
1. At all times relevant to this case, Petitioner was a physician
licensed to practice medicine in the State of California. Tr. at
1668, 1675. 11/
2. At all relevant times, Petitioner was practicing oncology in
Bakersfield, California. Tr. at 1668 - 1686.
3. Oncology is the study of the treatment of cancer and tumors.
See Tr. at 56 - 60.
4. An oncologist is a medical doctor who specializes in the
treatment of cancer and tumors. See Tr. at 56 - 60.
5. Medical oncology is the use of drugs to treat cancer. Tr. at
59.
6. Surgical oncology is the use of surgery to treat cancer. Tr. at
59.
7. Radiation oncology is the use of radiation therapy to treat
cancer. Tr. at 59.
8. As of April 10, 1993, Petitioner's license to practice medicine
in California was revoked, the revocation was stayed, and
Petitioner was placed on probation for seven years on the condition
that he a) voluntarily cease to practice oncology, b) complete a
course in ethics, and c) practice only while being monitored by
another physician, with that physician obligated to periodically
report to the California Medical Board. I.G. Ex. 10; Tr. at 1726
- 1732.
9. For purposes of this case, the term chemotherapy refers to the
administration of chemicals, either singly or in combination, to
patients for the purpose of treating cancer. Tr. at 72 - 73.
10. Chemotherapy drugs are generally administered via intravenous
injection, called the "bolus method." P. Ex. 17 at 5; Tr. at 528
- 530.
11. The bolus method is a method of administering chemotherapy
drugs to a patient in which the drugs are either injected directly
into the patient's vein, or injected into a bag of saline solution
(called a "slow IV (intravenous) push") that then flows into the
patient's vein, thus causing the chemotherapy to enter the
patient's bloodstream over a period of several minutes. Tr. at 187
- 188, 529 - 530.
12. The bolus method of injecting chemotherapy drugs has been the
standard procedure for administering chemotherapy drugs for the
last 30 years. Tr. at 187 - 188, 529 - 530; P. Ex. 17 at 5.
13. Infusion of chemotherapy drugs is generally performed via a
central venous line. P. Ex. 17 at 26 - 27.
14. A central venous line is an intravenous tube in a large central
vein, usually located in the chest area, through which chemotherapy
drugs are administered to the patient, usually over a 24 to 72 hour
period. Tr. at 2776 - 2777; see P. Ex. 17 at 26.
15. Under certain specific conditions, infusion of some
chemotherapy drugs over a 24 to 72 hour period can reduce the
toxicity of the chemotherapy drugs to the patient and
can increase the rate at which the cancer cells are killed. Tr. at
189, 1391; P. Ex. 17, 18, 19.
16. Some chemotherapeutic agents that are administered by bolus
injection can cause local toxicity (to the tissue surrounding the
area of the injection) if the drug leaks from the vein into the
surrounding tissue. Tr. at 76, 2769.
17. In instances where a patient has problems with local toxicity
resulting from leakage of the chemotherapeutic agent into the
surrounding tissue, the chemotherapeutic agent can be infused over
a period of up to one hour to eliminate such problems. Tr. at 76,
569 - 574, 1829 - 1830, 2769.
18. Petitioner failed to document that any of the seven patients at
issue were, at any time during which Petitioner administered
chemotherapy to them, ever suffering from local toxicity effects
such that they required one hour infusions for the purpose of
eliminating local toxicity. Tr. at 1812 - 2737; I.G. Ex. 3E, 3N,
3O, 3P, 3Q, 3R, 3S, 3T. 12/
19. Infusing chemotherapy drugs over a one to eight hour period
does not reduce or minimize toxicity to the patient (other than
local toxicity) or increase the rate at which the cancer cells are
killed. Tr. at 184 - 190, 241 - 242, 529, 1337 - 1338, 1390 -
1391, 1829 - 1830, 2769; see P. Ex. 17, 19.
20. There is no evidence of record that would allow me to conclude
that any of these seven patients had experienced local toxicity
such that one hour infusions were medically indicated to eliminate
local toxicity effects. I.G. Ex. 3N, 3O, 3P, 3Q, 3R, 3S, 3T; Tr.
at 1812 - 2737.
21. The dosages and administration of chemotherapy drugs, even when
administered in accordance with professionally recognized standards
and not substantially in excess of the patient's needs, must be
carefully controlled, as the chemicals used in chemotherapy
treatments are always toxic to the person to whom they are
administered. Tr. at 73 - 75, 769 - 772, 1345 - 1346.
22. The toxicity from chemotherapy drugs involves nausea, vomiting,
destruction of bone marrow cells, anemia, low white blood cell
counts, low platelet counts, and damage and impairment of function
to organs such as the heart, liver, and lungs. Tr. at 771 - 772;
P. Ex. 17, 19.
23. Anemia, low white blood cell counts, and low platelet counts
lead to weakness, bleeding, infection, and possible death. Tr. at
771 - 772.
24. Professionally recognized standards mandate that an oncologist
treating a patient create a document called a flow sheet for the
purpose of precisely documenting the types and amounts of
chemotherapy drugs he administers to the patient, the response the
patient's cancer is having to the treatment, and any adverse
effects or toxicity the patient may be encountering, as well as to
ensure continuity of care in the event the patient should have to
be treated by another physician or oncologist. Tr. at 102, 771 -
774, 1399 - 1400; see Tr. at 764 - 787, 966 - 1008, 1069 - 1071,
1083 - 1089.
25. Precise documentation in the patient's flow sheet is essential
to ensure that the patient avoids serious and potentially dangerous
risks from failure to adequately monitor and treat the patient's
cancer, from excessive toxicity from chemotherapy drugs, or from
failure to ensure continuity of care. Tr. at 102, 771 - 774, 1400;
I.G. Ex. 3E, (especially at 3 - 4); see Tr. at 764 - 787, 966 -
1008, 1069 - 1071, 1083 - 1089.
26. Professionally recognized standards mandate that an oncologist
treating a patient with chemotherapy list on the flow sheet the
doses of drugs that the patient actually receives. Tr. at 771 -
772, 2766; see Tr. at 764 - 787, 966 - 1008, 1069 - 1071, 1083 -
1089; Findings 24 - 25.
27. Petitioner is cognizant of the purposes and crucial importance
of keeping accurate medical records and accurately documenting in
the patient's flow sheet the amount and type of medication the
patient actually receives. Tr. at 1865 - 1866.
28. It is potentially hazardous to the health, life, and well-being
of the patient if an oncologist does not enter on the patient's
flow sheet the dosages of chemotherapy drugs that the patient
actually receives. Tr. at 764 - 787, 966 - 1008, 1069 - 1071, 1083
- 1089; Findings 24 - 26.
29. It is below professionally recognized standards for an
oncologist to fail to enter on a patient's flow sheet the doses of
chemotherapy the patient actually receives. Findings 24 - 28; Tr.
at 771 - 787, 2766.
30. Adriamycin is a drug used in chemotherapy that is toxic both to
the bone marrow and to the heart muscle. Tr. at 74.
31. Adriamycin causes cumulative damage to the heart muscle. Each
time it is used, more damage occurs from which the heart does not
recover. Tr. at 74.
32. The maximum safe dosage of Adriamycin is approximately 350 -
550 milligrams per square meter of the patient's body surface area.
Tr. at 74, 1334 - 1335.
33. Adriamycin is contraindicated in patients with heart problems.
Tr. at 1416.
34. Adriamycin can cause local toxicity if, during the injection,
it leaks out of the vein. Tr. at 74 - 76.
35. The local toxicity effects of Adriamycin are tissue necrosis,
ulcers, and abscesses. Tr. at 74.
36. Adriamycin must be administered carefully to minimize these
local toxicity effects, but these effects cannot be avoided
completely. See Tr. at 74.
37. Cytoxan is a drug used in chemotherapy that is toxic to the
bone marrow, the lining of the bladder, and the heart, and
potentially damaging to the lungs. Tr. at 75, 1340, 1490.
38. Cytoxan administered in combination with Adriamycin causes
additional toxicity to the heart muscle. Tr. at 1335.
39. Cytoxan received in doses that are customarily given to
patients receiving chemotherapy causes hair loss. Tr. at 75.
40. The combination of Cytoxan administered with 5FU (fluorouracil)
causes hair loss, nausea, vomiting, diarrhea, suppression of bone
marrow, and oral lacerations. Tr. at 348, 352.
41. Cytoxan administered at the rate of 500 milligrams per week
will cause death in an average patient within 6 weeks. Tr. at 96.
42. Vincristine is a drug that, when used in dosages that are
required for treating cancer patients via chemotherapy, is
extremely toxic to the nervous system, producing constipation,
numbness and tingling, and loss of reflexes, and, if administered
in high doses, paralysis. Tr. at 75.
43. Bleomycin is a drug that, when used in the dosages that are
required for treating cancer patients via chemotherapy, causes
irreversible lung damage. Tr. at 240, 1434, 2859.
44. BCNU is a drug that, when used in the dosages that are required
for treating cancer patients via chemotherapy, causes suppression
of bone marrow. Tr. at 1533.
45. Complete blood counts (CBCs) are tests that reveal the number
of the different blood cells in a patient's blood. See Tr. at 123
- 125.
46. Platelets are substances in the blood which allow the blood to
clot. See Tr. at 123 - 124.
47. Platelet counts are laboratory tests that reveal the number of
platelets in a patient's blood. See Tr. at 123 - 124.
48. CEA stands for "carcinogenic embryonic antigen." Tr. at 239 -
240, 294 - 295.
49. CEA is a substance that is produced when the body has certain
types of cancer and that, in certain instances, is useful in
monitoring the progression of the cancer. Tr. at 294 - 295.
50. A CEA test is a laboratory test that measures the amount of CEA
in a patient's blood. Findings 48, 49; Tr. at 294 - 295.
51. PAP stands for "prostatic acid phosphatase." Tr. at 337, 346.
52. A PAP test is a laboratory test that measures the level of
prostatic phosphatase in a patient's blood, and that, in certain
instances, can be used to monitor the progression of prostate
cancer. Tr. at 345 - 346.
53. Laurens Park White, M.D. (Dr. White) is a physician and surgeon
who is board certified in medical oncology and internal medicine.
Tr. at 55.
54. Dr. White has been board certified in internal medicine since
1961 and has been board certified in medical oncology since 1977.
Tr. at 60.
55. Dr. White has had 45 articles published in various medical
journals, most of these relating to the practice of medical
oncology. Tr. at 60 - 63.
56. Dr. White is a specialist in the treatment of melanoma. Tr. at
476.
57. Dr. White is an experienced practitioner and an expert in both
oncology and internal medicine. I.G. Ex. 6; Findings 53 - 56.
58. The standards of practice for medical oncology are the same
throughout the country. Tr. at 65, 763.
59. Dr. White is a credible, articulate, and knowledgeable
individual who, at all periods of time relevant to this case, is an
expert regarding professionally recognized standards for the
treatment of cancer patients. Findings 53 - 58; Tr. at 55 - 753,
2751 - 2918.
60. Dr. White's review of Petitioner's treatment of patients B.G.,
J.W., D.R., H.W, J.L., H.S., and R.N. is accurately summarized in
I.G. Ex. 8. Tr. at 68.
61. Klaus D. Hoffman, M.D. (Dr. Hoffman) has been in private
practice as an oncologist and hematologist since 1977. I.G. Ex. 4.
62. Dr. Hoffman served a fellowship in the medical oncology program
of Tufts University. I.G. Ex. 4.
63. Dr. Hoffman is board certified in both medical oncology and
internal medicine and is a member of the American Society of
Clinical oncology. I.G. Ex. 4.
64. Dr. Hoffman has been a consultant in medical oncology to
several hospitals and has authored six articles relating to
oncology studies or procedures. I.G. Ex. 4.
65. Dr. Hoffman is an expert in the areas of medical oncology and
internal medicine. Findings 61 - 64.
66. Dr. Hoffman is a credible, knowledgeable, and articulate
individual who, at all periods of time relevant to this case, is an
expert regarding
professionally recognized standards for the treatment of cancer
patients. Findings 61 - 65; Tr. at 760 - 957, 966 - 1081.
67. Dr. Hoffman's review of Petitioner's treatment of patients
B.G., J.W., D.R., H.W, J.L, H.S., and R.N. is accurately summarized
in I.G. Ex. 3E. Tr. at 763.
68. Nagendranath Bellare, M.D., F.A.C.P. (Dr. Bellare) has served
fellowships in both hematology and oncology at the Cook County
Hospital in Illinois. I.G. Ex. 5.
69. Dr. Bellare is board certified in internal medicine and
oncology and is a member of the American Society of Clinical
Oncology. I.G. Ex. 5.
70. Dr. Bellare is serving on the Board of Directors of the
American Cancer Society and has served on the Board of Directors of
the Central California Cancer Registry and is currently a junior
faculty member in the bone marrow transplantation department at the
M.D. Anderson Cancer Center in Texas. I.G. Ex. 5; Tr. at 1297.
71. Dr. Bellare is an expert in medical and clinical oncology and
internal medicine. Findings 68 - 70.
72. Dr. Bellare is a credible, knowledgeable and articulate
individual who, at all periods of time relevant to this case, is an
expert regarding professionally recognized standards for the
treatment of cancer patients. Findings 68 - 71; Tr. at 1297 -
1654.
73. Dr. Bellare's review of Petitioner's treatment of patients
B.G., J.W., D.R., H.W., H.S., and R.N. is accurately summarized in
I.G. Ex. 3E. Tr. at 1301 - 1302. 13/
74. Drs. White, Hoffman, and Bellare are all familiar with the
professionally recognized standards used by oncologists in the
treatment of cancer patients, which standards were at all times
relevant to Petitioner's treatment of the seven patients at issue
in this case. Findings 53 - 73.
75. At all times relevant to this case, all seven patients at issue
in this case were Medicare beneficiaries. I.G. Ex. 3C, 3E, 3N, 3O,
3P, 3Q, 3R, 3S, 3T.
Petitioner's treatment of patient B.G.
76. B.G. was a 74-year-old female retired farm worker who spoke
only Spanish. I.G. Ex. 3N.
77. B.G. was hospitalized by Petitioner in September 1983 for
sudden onset of rectal and vaginal bleeding. I.G. Ex. 3N at 26 -
28.
78. After her admission to the hospital, B.G. was examined under
general anesthesia by a Dr. Lin, a gynecologist. P. Ex. 10 at 1.
79. In his September 19, 1983 report, Dr. Lin noted that B.G.'s
uterus was normal in size and that he could feel no definite
adnexal mass. P. Ex. 10 at 1. 14/
80. On September 21, 1983, B.G. was discharged from the hospital
with a diagnosis of cervical cancer. I.G. Ex. 3N at 30.
81. Petitioner stated in the discharge summary that he planned to
treat B.G. with radiation therapy plus or minus systemic
chemotherapy and indicated he would do further work to determine
the stage of B.G.'s cancer. I.G. Ex. 3N at 30.
82. Cancer of the cervix can be divided into four stages. In stage
I, the cancer is confined to the cervix of the uterus and is
entirely removable by surgery; in stage II, the cancer has grown
outside of the uterus into the surrounding tissue, but does not
extend to the pelvic wall; stage II is frequently divided into
stage II(a) and II(b) depending upon the amount of growth of the
cancer; in stage III, the cancer has spread into the pelvis and in
stage IV, the cancer has spread throughout the patient's body to
involve other body systems (metastasized), such as the lymph nodes,
liver, and the lungs. Tr. at 72, 78 - 79; P. Ex. 1 at 12.
83. Chemotherapy is not an appropriate treatment for stage II(a) or
II(b) cancer of the cervix, because chemotherapy does not cure
cancer of the cervix, and cervical cancer at that stage can
potentially be cured by radiation treatment. Tr. at 85, 1306 -
1308.
84. The proper identification of the progression of cervical cancer
(staging) is vital to enable the oncologist to determine the most
effective treatment for the patient. Tr. at 1307 - 1310.
85. Petitioner diagnosed B.G. as having stage III cervical cancer.
P. Ex. 1.
86. Petitioner based his diagnosis that B.G. had stage III cervical
cancer on a pelvic ultrasound report, dated September 13, 1983.
Tr. at 1374, 1820; P. Ex. 1 at 1 - 4.
87. Ultrasound is not an accurate diagnostic tool in staging
cervical cancer. Tr. at 1376 - 1381.
88. Professionally recognized standards relevant to the treatment
of B.G. during the period of time in which Petitioner treated her
dictated that Petitioner determine the stage (progression) of
B.G.'s cervical cancer based on a combination of 1) a pelvic
examination given under general anesthesia and 2) an examination of
B.G. by a radiation oncologist. Tr. at 1378 - 1382; P. Ex. 1 at
12.
89. Staging cervical cancer based on ultrasound is below
professionally recognized standards. Tr. at 1376 - 1381; Findings
84 - 88.
90. Petitioner's diagnosis of B.G.'s cervical cancer as stage III
based on an ultrasound report was below professionally recognized
standards. Findings 84 - 89.
91. On September 19, 1983, Dr. Lin performed a pelvic examination
of B.G. and found no evidence of Stage III cancer. P. Ex. 10 at 1.
92. As of September 1983, B.G.'s cancer had spread out of the
cervix but had not attached to the pelvic wall. Tr. at 72, 766.
93. In September 1983, B.G.'s cancer was not stage III, but was
either stage II(a) or II(b). Tr. at 72, 766; I.G. Ex. 3E, 3N.
94. Petitioner incorrectly staged B.G.'s cervical cancer. Findings
82, 84 - 93.
95. Professionally recognized standards mandate that a patient with
stage II(a) or II(b) cervical cancer be treated with radiation
therapy or surgery. Tr. at 72, 768, 1307.
96. Dr. Lin believed that B.G. was not a candidate for surgery
because of her age. Tr. at 1309; I.G. Ex. 3N.
97. Professionally recognized standards dictated that, given that
B.G. was not a candidate for surgery, she be referred by Petitioner
to a radiation oncologist for radiation treatment. Tr. at 68 -
235, 764 - 787, 966 - 1008, 1069 - 1071, 1083 - 1089, 1302 - 1407.
98. Even assuming B.G. had stage III cancer, professionally
recognized standards dictated that Petitioner use radiation to
control the cancer locally, and to use chemotherapy only in
conjunction with radiation. Tr. at 1307, 1318 - 1319.
99. Petitioner documented that, from December 2, 1983 through
January 22, 1987, he treated B.G. for cervical cancer by
administering infusions of Adriamycin, Vincristine, and Cytoxan on
an almost weekly basis. I.G. Ex. 3N.
100. Petitioner treated B.G.'s cervical cancer solely with
chemotherapy. I.G. Ex. 3N.
101. Treating B.G. with chemotherapy had no chance of curing B.G.'s
cancer and had no chance of prolonging her life. Tr. at 72, 85 -
89, 1310, 1405 - 1406.
102. It is within professionally recognized standards to treat
cervical cancer with chemotherapy in only two instances: 1) where
the patient's cancer has metastasized (spread) to the lungs, liver,
and other organs and 2) where it is given in conjunction with
radiation therapy. Tr. at 1320 - 1329.
103. B.G. did not have metastatic cancer when she was first seen
and diagnosed by Petitioner in September 1983. Tr. at 1320 - 1329;
I.G. Ex. 3N at 9 - 10.
104. B.G. did not have metastatic cancer when she was started on
chemotherapy treatment by Petitioner in December 1983. Tr. at 1320
- 1329; I.G. Ex. 3N at 58; see Tr. at 68 - 235, 764 - 787, 966 -
1008, 1069 - 1071, 1083 - 1089.
105. It was below professionally recognized standards for
Petitioner to use only chemotherapy to treat B.G.'s cervical
cancer. Tr. at 1388; Findings 76 - 104.
106. Petitioner gave B.G. a course of treatment which had no chance
of curing her. Findings 76 - 105 (especially at 100 - 101).
ASEC During the course of Petitioner's treatment of B.G., B.G.'s
cervical cancer continued to grow and her condition continued to
worsen. Tr. at 770 - 771; I.G. Ex. 3N at 12 - 22.
108. It was below professionally recognized standards for
Petitioner, in the face of steady progression of B.G.'s cancer
which demonstrated the ineffectiveness of the chemotherapy
treatments he was providing to B.G., to simply add to the treatment
various drugs without discontinuing the administration of drugs
that had proven to be ineffective in treating her cancer. I.G. Ex.
3N at 12 - 22.
109. Petitioner documented in B.G.'s flow sheet that he gave her
approximately 4840 milligrams of Adriamycin. I.G. Ex. 3N.
110. On an average-sized patient with a 1.75 square meter body
surface area, 4840 milligrams of Adriamycin is approximately 2765
milligrams per square meter. Tr. at 1334 - 1335.
111. The maximum dosage of Adriamycin that can be withstood by a
normal-sized patient is 550 milligrams per square meter. Tr. at
1334 - 1341.
112. The dosage of Adriamycin that Petitioner documented that he
gave to B.G. would have killed B.G. Tr. at 1334 - 1341; Findings
109 - 111.
113. B.G.'s death was not related to or caused by the toxic side
effects and heart damage from Adriamycin. I.G. Ex. 3E, 3N; see Tr.
at 68 - 235, 764 - 787, 966 - 1008, 1069 - 1071, 1083 - 1089, 1302
- 1407.
114. Petitioner did not administer Adriamycin to B.G. in the
dosages that were documented on her flow sheet. I.G. Ex. 3E, 3N;
Tr. at 1340 - 1341, 2753, 2767; Findings 109 - 113.
115. Petitioner's failure to enter into B.G.'s flow sheet the
amount of Adriamycin that she actually received jeopardized B.G.'s
health and safety by failing to adequately ensure continuity of
care and failing to protect her from excess toxicity. I.G. Ex. 3E,
3N; Findings 24 - 29, 114.
116. Petitioner's failure to document in B.G.'s flow sheet the
actual amount of Adriamycin he administered to B.G. is below
professionally recognized standards. I.G. Ex. 3E, 3N; Findings 24
- 29, 114 - 115.
117. Petitioner documented that he administered the drug
Vincristine to B.G. in the amount of 5 milligrams per week from
July 1985 through January 1987. I.G. Ex. 3N at 69 - 72.
118. The amount of Vincristine that Petitioner documented that he
gave to B.G. would have caused complete paralysis of her arms and
legs within several months' time. Tr. at 96, 2770.
119. B.G. did not experience complete paralysis of her arms and
limbs. I.G. Ex. 3E, 3N.
120. B.G. did not receive Vincristine in the amounts Petitioner
documented in her flow sheet. I.G. Ex. 3E, 3N; Findings 42, 117 -
119.
121. Petitioner's failure to enter into B.G.'s flow sheet the
amount of Vincristine that she actually received jeopardized B.G.'s
health and safety. Findings 24 - 29, 42, 117 - 120.
122. Petitioner's failure to enter into B.G.'s flow sheet the
amount of Vincristine that she actually received is below
professionally recognized standards. Findings 24 - 29, 117 - 121.
123. Vincristine is not a drug that is useful in the treatment of
cancer of the cervix. Tr. at 96, 2770 - 2775.
124. Petitioner offered no evidence that he administered
Vincristine to B.G. for any purpose other than to treat her
cervical cancer.
125. Petitioner's attempt to treat B.G.'s cervical cancer by using
the drug Vincristine was below professionally recognized standards
and substantially in excess of B.G.'s needs. Findings 85, 117 -
124.
126. Petitioner documented that, in the first six weeks of treating
B.G., he administered Cytoxan to B.G. in an amount sufficient to
kill her. I.G. Ex. 3E, 3N; Tr. at 96 - 97, 1340 - 1341; see
Finding 41.
127. B.G. did not die within the first six weeks of receiving
Cytoxan from Petitioner. I.G. Ex. 3E, 3N.
128. B.G. did not receive Cytoxan in nearly the amount Petitioner
documented that he administered to B.G. Tr. at 1340 - 1341;
Findings 126 - 127.
129. It was below professionally recognized standards for
Petitioner to enter into B.G.'s flow sheet that B.G. received an
amount of Cytoxan that she did not actually receive. Findings 24
- 29, 37 - 41, 128; I.G. Ex. 3E, 3N.
130. Petitioner's failure to enter into B.G.'s flow sheet the
amount of chemotherapy drugs actually received by B.G. jeopardized
B.G.'s health and safety. Findings 22 - 29, 115 - 116, 121 - 122,
128 - 129; I.G. Ex. 3E, 3N.
131. Petitioner's documentation in B.G.'s medical chart is below
professionally recognized standards for the following reasons: the
chart does not contain Petitioner's orders; the progress notes do
not state the reason Petitioner, at various times during treatment,
changed the dosages of chemotherapy he administered to B.G.; and
the progress notes do not state the method Petitioner used to
administer the chemotherapy drugs. I.G. Ex. 3N at 66 - 72; Tr. at
2766 - 2785; Findings 24 - 29.
132. Petitioner's failure to properly document in B.G.'s flow sheet
the amounts or method of administration of the drugs he
administered to B.G. is below professionally recognized standards.
Findings 24 - 29, 116, 122, 129, 130.
133. Petitioner's contention that B.G. was given the choice of
surgery or radiation is not documented in B.G.'s patient chart. P.
Ex. 1 at 4; I.G. Ex. 3N.
134. Petitioner did not document in B.G.'s chart whether he
explained to B.G. that, if she failed to have radiation treatment
for her cervical cancer, she would not be cured. Tr. at 108; I.G.
Ex. 3N.
135. Petitioner did not document in B.G.'s chart whether he
referred B.G. to a radiation oncologist or whether he suggested
even that she see a radiation oncologist. Tr. at 108; I.G. Ex. 3N.
136. Petitioner has not been, at any time relevant to this case, a
radiation oncologist.
137. Petitioner did not refer B.G. to a radiation oncologist. P.
Ex. 1; I.G. Ex. 3N.
138. Professionally recognized standards mandate that Petitioner
should have referred B.G. to a radiation oncologist for a
consultation. Tr. at 108 - 118, 1316; Findings 88 - 98, 100.
139. Professionally recognized standards mandate that a
gynecologist and a radiation oncologist jointly evaluate and stage
the tumor in every patient with cancer of the cervix. P. Ex. 1 at
11 - 12; Tr. at 1942; Findings 88 - 98, 100.
140. Petitioner's failure to refer B.G. to a radiation oncologist
was below professionally recognized standards. Tr. at 1316;
Findings 135 - 139.
141. Petitioner concedes that B.G.'s decision to refuse radiation
treatment was of sufficient importance that it should have been
documented in B.G.'s chart. Tr. at 1923.
142. Professionally recognized standards mandate that Petitioner
should have ensured that B.G.'s refusal of radiation treatments be
an informed refusal, in that all of the consequences were explained
fully to her, including the fact that refusing radiation therapy
would deprive her of her only chance to be cured. Tr. at 1309 -
1310.
143. Petitioner's failure to document in B.G.'s chart that he
informed her of the consequences of not receiving radiation
treatment was below professionally recognized standards. Tr. at
109.
144. Petitioner's failure to document that he informed B.G. of the
side effects of the chemotherapy drugs he planned to administer to
her was below professionally recognized standards. Tr. at 116 -
118; Findings 141 - 143.
145. Petitioner's failure to document the discussions he had with
B.G. and her caretaker regarding B.G.'s treatment options was below
professionally recognized standards. Tr. at 116 - 118, 1821 -
1822.
146. Petitioner believed that B.G. was mentally impaired and
thought she may have had Alzheimer's disease. Tr. at 1310 - 1311,
1820 - 1822, 1932.
147. Assuming Petitioner's belief that B.G. was mentally impaired
to be true, Petitioner could not have obtained an informed consent
from B.G. sufficient to have enabled Petitioner to administer
chemotherapy drugs to her. Tr. at 2757.
148. Assuming Petitioner's belief that B.G. was mentally impaired
to be true, Petitioner could not have obtained her informed refusal
of the potentially lifesaving option of radiation therapy. Tr. at
2763.
149. When treating a mentally impaired individual, professionally
recognized standards of care dictate that the treating doctor must
specify clearly in the patient's chart what the patient understood
and what the decision was that the patient made, or that the
patient was incapable of making a decision. Tr. at 2762.
150. Assuming B.G. had a degree of mental impairment that made her
incapable of making a decision about the course of her cancer
treatment, a court appointed conservator, guardian, or family
member should have made the decision for her. Tr. at 1310 - 1314,
2762.
151. Assuming that B.G.'s caretaker was able to make decisions on
B.G.'s behalf regarding treatment options for B.G.'s cervical
cancer, professionally recognized standards require that this
person be informed so that the caretaker is able to make an
informed consent or refusal of treatment on behalf of B.G. Tr. at
1312 - 1315; Findings 141 - 150.
152. There is no documentation or evidence of record to indicate
that B.G.'s caretaker was legally able to accept or refuse
treatment on behalf of B.G. P. Ex. 1; I.G. Ex. 3E, 3N; Tr. at 1822
- 1829, 2760 - 2764.
153. Petitioner failed to document that he explained to B.G. or her
caretaker that radiation treatment was potentially curative and
that chemotherapy was not potentially curative. I.G. Ex. 3E, 3N;
Tr. at 107 - 110, 2759 - 2763.
154. Petitioner's contention that B.G. (or anyone authorized to act
on B.G.'s behalf) refused radiation treatment is unsupported by the
evidence of record, not credible, and indicative of Petitioner's
lack of trustworthiness. P. Ex 1; I.G. Ex. 3E, 3N; Findings 141 -
142, 152 - 153.
155. It was below professionally recognized standards of care that
Petitioner failed to document that B.G., or any person authorized
to accept or refuse treatment on B.G.'s behalf, gave an informed
refusal of potentially curative or lifesaving radiation treatment.
Tr. at 1312 - 1315, 1820 - 1823; I.G. Ex. 3E, 3N; Findings 141 -
154.
156. It was below professionally recognized standards of care that
Petitioner failed to document that he explained to B.G. and that
she understood, or that he explained to anyone authorized to accept
or refuse treatment on her behalf, the side effects of the planned
chemotherapy treatment. Tr. at 1820 - 1823, 2760 - 2763; Findings
141 - 155; I.G. Ex. 3N.
157. Petitioner claimed that he was minimizing toxicity to B.G. in
accordance with the wishes of B.G.'s caretaker. Tr. at 1828 -
1829.
158. From December 2, 1983 through January 22, 1987, Petitioner
documented that he administered chemotherapy consisting of
Adriamycin, Vincristine, and Cytoxan to B.G. via infusion on an
almost weekly basis. I.G. Ex. 3N.
159. The effects of the amounts and types of drugs that Petitioner
documented he administered to B.G. during the course of
chemotherapy treatments would have caused toxicity and adverse side
effects such that B.G. would have died from the toxic side effects
of these drugs had she received them in the amounts Petitioner
documented she received. Tr. at 68 - 235, 764 - 787, 966 - 1008,
1069 - 1071, 1083 - 1089, 1302 - 1407; I.G. Ex. 3E, 3N.
160. Petitioner's statement that, in accordance with the wishes of
B.G.'s caretaker, he wanted to provide B.G. with chemotherapy that
would not make B.G. sick, is contradicted by the types and amounts
of chemotherapy drugs that Petitioner documented that he
administered to B.G. I.G. Ex. 3E, 3N; Findings 157 - 159.
161. Petitioner's statement that he wanted to provide B.G. with
chemotherapy that would not make B.G. sick is not credible and is
indicative of Petitioner's lack of trustworthiness. Findings 157
- 160.
162. In order for Petitioner to administer chemotherapy drugs in
such a way as to not make B.G. sick, Petitioner would have had to
administer the chemotherapy drugs at subtherapeutic doses.
Findings 21 - 25; Tr. at 1344 - 1345.
163. Administration of subtherapeutic doses of chemotherapy would
be ineffective in treating B.G.'s cancer and could have caused
B.G.'s cancer to become more resistant to treatment. Tr. at 1389;
see Tr. at 68 - 235, 764 - 787, 966 - 1008, 1069 - 1071, 1302 -
1407; Finding 162.
164. Petitioner's statement that he administered chemotherapy to
B.G. in such a manner so as to minimize toxicity to B.G. is
directly contradicted by the chemotherapy drugs Petitioner chose to
administer to B.G. (Adriamycin, Cytoxan, and Vincristine) are all
extremely toxic; and one to eight hour infusions of chemotherapy do
nothing to minimize the overall toxicity of the drugs Adriamycin,
Cytoxan, and Vincristine. I.G. Ex. 3E, 3N; Tr. at 68 - 235, 764 -
787, 966 - 1008, 1069 - 1071, 1083 - 1089, 1302 - 1407, (especially
at 1828 - 1829), 2751 - 2847.
165. Petitioner's statement that he administered chemotherapy to
B.G. in such a manner so as to minimize toxicity to B.G. is not
credible and is indicative of Petitioner's lack of trustworthiness.
Finding 164.
166. To the extent that Petitioner's statement that he was
minimizing toxicity to B.G. by administering chemotherapy drugs to
B.G. via one to eight hour infusion can be construed to mean that
Petitioner was reducing the local toxicity of these drugs,
Petitioner's statement, in theory, has some merit. Tr. at 1828 -
1829; Findings 10 - 20, 165.
167. There is no evidence from which I can conclude that B.G. had
exhibited any effects from local toxicity such that Petitioner was
administering chemotherapy to her to minimize local toxicity. I.G.
Ex. 3E, 3N.
168. There is no evidence from which I can conclude that, in
administering chemotherapy drugs to B.G. in the manner and amount
documented in B.G.'s flow sheet, Petitioner was attempting to
minimize local toxicity. I.G. Ex. 3E, 3N.
169. There is no evidence from which I can conclude that, at any
time during his treatment of B.G., Petitioner changed the method he
was using to administer chemotherapy drugs to B.G. in response to
concerns about local toxicity. I.G. Ex. 3E, 3N.
170. Petitioner's administration to B.G. of chemotherapy via one to
eight hour infusions was not done for the purpose of preventing or
alleviating local toxicity to B.G. I.G. Ex. 3E, 3N; Findings 164
- 169.
171. Even if Petitioner had been attempting to reduce local
toxicity by administering chemotherapy to B.G. over one to eight
hour infusions, any reduction of local toxicity that could in
theory have occurred is outweighed by the fact that a) the bolus
method, if administered properly, works sufficiently well to
minimize local toxicity; b) chemotherapy infusions over one to
eight hours do not reduce overall toxicity to the patient or
increase the rate at which cancer cells are killed; c) the doses of
chemotherapy Petitioner documented he administered to B.G. were
supralethal, in excess of an amount which would have caused B.G. to
die from the side effects of the chemotherapy alone. Tr. at 68 -
235, 764 - 787, 966 - 1008, 1069 - 1071, 1083 - 1089, 1302 - 1407,
(especially at 1822 - 1832), 2751 - 2847; I.G. Ex. 3E, 3N; Findings
30 - 42.
172. Radiation treatment of the type that would have been effective
in treating B.G.'s cancer would have lasted approximately six
weeks. Tr. at 1319, 1329 - 1333.
173. The chemotherapeutic drugs Petitioner documented he
administered to B.G. are not generally used to treat cervical
cancer, nor are they effective in treating cervical cancer. Tr. at
2771 - 2772.
174. Petitioner treated B.G. with over three years of ineffective
chemotherapy. I.G. Ex. 3N; Tr. at 1319.
175. Petitioner's administration of chemotherapy to B.G. via one
and eight hour infusions served no medical purpose. Tr. at 1829 -
1830; I.G. Ex. 3E, 3N; Findings 15 - 20, 170 - 171, 174.
176. Petitioner's treatment of B.G. with chemotherapy for over
three years was substantially in excess of B.G.'s needs. Findings
173 - 175.
177. Petitioner documented that B.G. made office visits for
treatment on approximately a weekly basis from December 2, 1983
through January 22, 1987. I.G. Ex. 3E, 3N.
178. Petitioner's treatment of B.G. with chemotherapy caused B.G.
to be inconvenienced and spend excessive amounts of time in
Petitioner's office. Tr. at 1343 - 1344.
179. Had Petitioner treated B.G. in accordance with professionally
recognized standards and administered radiation treatment to her,
her treatment would have lasted approximately six weeks. Tr. at
1343.
180. Petitioner's treatment of B.G. with chemotherapy caused B.G.
to be severely inconvenienced and led to a deterioration of B.G.'s
quality of life. I.G. Ex. 3N; Tr. at 1340 - 1344.
181. Petitioner's statement that both he and two other physicians
performed a pelvic exam upon B.G. is unsupported by the evidence of
record and is not credible. I.G. Ex. 3E, 3N; Tr. at 105 - 109,
1816.
182. CEA tests are not useful in the diagnosis and treatment of
cancer of the cervix. Tr. at 121 - 122, 785.
183. The CEA tests given to B.G. by Petitioner served no medical
purpose for the diagnosis and treatment of B.G.'s cervical cancer.
Tr. at 125 - 128; Finding 182; I.G. Ex. 3N.
184. It was below professionally recognized standards and
substantially in excess of B.G.'s needs for Petitioner to
administer CEA tests to B.G. Findings 182 - 183; I.G. Ex. 3N.
185. All of the chemotherapy treatments given by Petitioner to B.G.
were below professionally recognized standards of health care and
substantially in excess of B.G.'s needs. Findings 76 - 184; I.G.
Ex. 3E, 3N; Tr. at 68 - 235, 764 - 787, 966 - 1008, 1069 - 1071,
1083 - 1089, 1302 - 1407.
186. All of the blood tests given by Petitioner to monitor B.G.'s
chemotherapy treatments were substantially in excess of her needs.
Finding 185; I.G. Ex. 3E, 3N; Tr. at 68 - 235, 764 - 787, 966 -
1008, 1069 - 1071, 1083 - 1089, 1302 - 1407.
187. Petitioner provided to B.G. items or services that were
substantially in excess of her needs and of a quality which failed
to meet professionally recognized standards of health care. I.G.
Ex. 3N; Tr. at 126 - 129, 783 - 785, 1406 - 1407; Findings 76 -
186.
188. Petitioner's management of B.G.'s oncological care jeopardized
B.G.'s health, safety, and well-being. Findings 76 - 187.
Petitioner's testimony regarding his treatment of B.G. is
indicative of Petitioner's lack of credibility and lack of
trustworthiness.
189. Petitioner's testimony regarding the care and treatment he
provided to B.G. is evasive, self-contradictory, inaccurate, and
contradicted by the evidence of record. Tr. at 1812 - 2012;
Findings 76 - 188.
190. Petitioner's testimony that he provided B.G. with care and
treatment that was not substantially in excess of B.G.'s needs or
of a quality or type that was below professionally recognized
standards of health care is not credible. Findings 76 - 189.
191. Petitioner's testimony regarding the care and treatment he
provided to B.G. is indicative of Petitioner's lack of credibility
and lack of trustworthiness. Findings 76 - 190.
192. Petitioner's representation to this tribunal that the infusion
method of administering chemotherapy is a well-established method
of treating cancer patients does not take into account that
administration of chemotherapy via infusion is done over a period
of 24 to 72 hours, whereas Petitioner documented that he
administered chemotherapy to B.G. via infusions of one to eight
hours. Tr. at 1829, 1841; I.G. Ex. 3E, 3N; P. Ex. 1.
193. Petitioner's assertion that B.G. initially responded very well
to the treatment he administered to her is directly contradicted by
the evidence of record, is not credible, and is indicative of
Petitioner's lack of trustworthiness. Tr. at 68 - 235, 764 - 787,
966 - 1008, 1069 - 1071, 1083 - 1089, 1302 - 1407, (especially at
1845); I.G. Ex. 3E, 3N.
ODC The standard used by medical oncologists since 1980 is called
"disease free survival." Tr. at 1369.
195. Disease free survival refers to the amount of time a patient
is cancer free. Tr. at 1369 - 1371.
196. B.G. had no disease free survival. I.G. Ex. 3N; Tr. at 1369
- 1371.
197. Petitioner's contention that B.G. met the five-year survival
standard for cancer of the cervix because she survived with cancer
of the cervix from 1983 through 1988 is indicative of a lack of
understanding of the standard used by medical oncologists since
1980. Findings 194 - 196.
198. Petitioner's assertion that B.G. met the five-year survival
standard, is directly contradicted by the evidence of record and is
indicative of Petitioner's lack of credibility and lack of
trustworthiness. Tr. at 1846, 1865; Findings 194 - 197.
199. Petitioner's assertion that all of the treatment he
administered to B.G. is the "standard protocol" that was modified
to fit B.G.'s needs is directly contradicted by the following:
professionally recognized standards mandated that B.G. should have
received radiation treatment; the chemotherapy Petitioner
documented he administered to B.G. was an extremely toxic
combination of chemotherapeutic agents that was administered in
supralethal doses; and the amount of chemotherapy Petitioner
actually administered to B.G., if any, was not an amount that could
have controlled or reduced B.G.'s cancer. Tr. at 68 - 235, 764 -
787, 966 - 1008, 1069 - 1071, 1302 - 1407, (especially at 1849);
Findings 76 - 198.
200. Petitioner's attempts to explain and justify why he did not
enter into B.G.'s flow sheet the amount of chemotherapy drugs that
B.G. actually received are not credible and are indicative of his
lack of trustworthiness. Tr. at 1883 - 1884; I.G. Ex. 3N at 71 -
72; P. Ex. 1; Findings 24 - 29; see Tr. at 1812 - 2012.
PTO Petitioner's statement that he was not surprised that B.G. had
no significant changes in her blood count is indicative of a lack
of understanding of the serious side effects of the chemotherapy
drugs which Petitioner documented he administered to B.G. Tr. at
1898; I.G. Ex. 3N; Findings 19 - 23.
202. Petitioner's testimony that the chart contained in P. Ex. 1 at
27 (and P. Ex. 1 in general) shows the efficacy of the combination
of chemotherapeutic agents he administered to B.G. is entirely
contradicted by a complete reading of P. Ex. 1. Tr. at 1908 -
1915.
203. Petitioner gave evasive answers when informed that the chart
at P. Ex. 1 at 27 and P. Ex. 1 in general refers to response rates
of only single agent chemotherapy. Tr. at 1908 - 1915.
204. Petitioner's attempt to justify his administration of
combination chemotherapeutic agents to B.G., based on the
information contained in P. Ex. 1, is contradicted by the evidence
of record and the information contained in P. Ex. 1, and is
indicative of Petitioner's lack of credibility and lack of
trustworthiness. Tr. at 1908 - 1915; Findings 79 - 203.
205. Petitioner's assertions that the combination of chemotherapy
drugs he administered to B.G. is superior to single agent
chemotherapy and does not produce any overlapping toxicity is
directly contradicted by the evidence of record. Tr. at 1908 -
1915; I.G. Ex. 3N; P. Ex. 1; Findings 79 - 204.
206. When given the opportunity to do so, Petitioner was not able
to cite or produce any evidence which would support his choosing
the combination of chemotherapeutic drugs or the amounts of
chemotherapeutic drugs he documented he administered to B.G. Tr.
at 1908 - 1915; I.G. Ex. 3N; P. Ex. 1; Findings 79 - 205.
207. Petitioner specifically denies that the consulting
gynecologist recommended that B.G. have radiation therapy to treat
her cervical cancer, despite the presence in the medical records of
such a recommendation by the gynecologist. Tr. at 1928 - 1930;
I.G. Ex. 3N at 35.
208. Petitioner's denial that the consulting gynecologist
recommended that B.G. have radiation therapy to treat her cervical
cancer is not credible and is indicative of Petitioner's lack of
trustworthiness. Tr. at 1928 - 1930; I.G. Ex. 3N at 35.
209. A CT scan of B.G.'s pelvis performed on September 3, 1985
shows possible recurrence or extension of B.G.'s cancer. Tr. at
1948 - 50; I.G. Ex. 3N at 43.
210. Petitioner's statement that, in September 1985, he changed the
treatment he administered to B.G. is contradicted by the evidence
of record and by B.G.'s flow sheet. Tr. at 1950; I.G. Ex. 3E, 3N.
211. Petitioner's statement that, in September 1985, he changed the
treatment he administered to B.G. is not credible and is indicative
of Petitioner's lack of trustworthiness. Finding 210.
212. Petitioner acknowledges there is no basis for performing a CEA
test on B.G. on a weekly basis. Tr. at 1956.
213. Petitioner submitted claims to Medicare which indicated that
he performed a CEA test on B.G. virtually every week during the
period of time he was treating her. Tr. at 1956 - 1958; I.G. Ex.
3E, 3N, 7.
214. Petitioner's assertion that, for the most part, he performed
a CEA test on B.G. every two months is directly contradicted by the
evidence of record. Tr. at 1957; I.G. Ex. 3E, 3N; Finding 213.
215. Petitioner denies that he performed CEA tests on B.G. on
virtually a weekly basis during the entire time he was treating
her. Tr. at 1956.
216. Petitioner's assertion that it was a mistake that caused him
to submit claims to Medicare in which he indicated he performed a
CEA test on B.G. virtually every week during the time that he was
treating B.G. is not credible and is indicative of Petitioner's
severe lack of trustworthiness. Tr. at 1956 - 1958; Findings 76 -
215.
217. Petitioner's attempts to justify his treatment of B.G. as
being in accordance with professionally recognized standards of
health care and not substantially in excess of B.G.'s needs are
inconsistent, insufficient, self-contradictory, either unsupported
or contradicted by the evidence of record, and not credible. P.
Ex. 1; Tr. at 68 - 235, 764 - 787, 966 - 1008, 1069 - 1071, 1083 -
1089, 1302 - 1407, 1812 - 2012, 2751 - 2795; Findings 76 - 216.
Petitioner's treatment of Patient D.R.
218. D.R. was an 84-year-old farm laborer who was five feet tall
and weighed 100 pounds. I.G. Ex. 3O at 41, 52.
219. D.R. was first seen by Petitioner on October 23, 1985. I.G.
Ex. 3O at 401.
220. There are four types of lung cancer -- adenocarcinoma, large
cell carcinoma, squamous cell carcinoma, and small cell carcinoma
(also called oat cell carcinoma). Tr. at 525 - 527.
221. Adenocarcinoma, large cell carcinoma, and squamous cell
carcinoma cannot be treated effectively by chemotherapy for any
sustained period of time. Tr. at 525 - 527.
222. Small cell carcinoma can be treated effectively via
chemotherapy. Tr. at 525 - 527.
223. Immediately prior to seeing Petitioner, D.R. was diagnosed by
a Dr. Salazar as having inoperable non-small cell cancer of the
right lung. I.G. Ex. 3O at 35.
224. Non-small cell cancer is the same as large cell cancer. I.G.
Ex. 3O at 35; Tr. at 243, 256.
225. Dr. Salazar's diagnosis was based upon exploratory surgery and
a tissue biopsy and analysis. I.G. Ex. 3O at 35.
226. Petitioner treated D.R. from October 23, 1985 through April
20, 1987. I.G. Ex. 3O at 52.
227. Complete records of Petitioner's treatment of D.R. exist for
the year 1986 only. See I.G. Ex. 3O at 1 - 2.
228. Only Petitioner's treatment of D.R. during the year 1986 is at
issue in this case. Findings 226 - 227; I.G. Ex. 3E, 3O.
229. To the extent Petitioner's treatment of D.R. is based on a
diagnosis by Petitioner that occurred prior to 1986, such diagnosis
is relevant to my determination in this case.
230. Professionally recognized standards of health care dictated
that Petitioner, in 1986, administer palliative care to D.R., i.e.,
treat only his symptoms. Tr. at 801, 1413.
231. "Palliative care" is treatment that attempts to alleviate the
patient's pain and deal with any adverse symptoms, rather than
those that attack the underlying illness. Tr. at 520, 801.
232. D.R. was not a patient whose condition could be palliated with
chemotherapy treatments. Tr. at 1439 - 1440.
233. Petitioner's administration of chemotherapy to D.R. was not
palliative. Findings 231 - 232.
234. In 1986, Petitioner documented in D.R.'s chart that D.R. made
136 visits to Petitioner's office to obtain chemotherapy treatment.
I.G. Ex. 3O at 3 - 5.
235. The combination of drugs that Petitioner documented that he
administered to D.R. in 1986 was not effective in treating D.R.'s
lung cancer. Tr. at 235 - 328, 788 - 811, 1008 - 1020, 1071 -
1074, 1407 - 1464; I.G. Ex. 3E, 3O.
236. Each of the chemotherapy treatments administered by Petitioner
to D.R. in 1986 was medically unnecessary and ineffective in
treating D.R.'s illness. Tr. at 242 - 262, 797 - 803, 1410; I.G.
Ex. 3E, 3O; see Tr. at 235 - 328, 788 - 811, 1008 - 1020, 1071 -
1074, 1407 - 1464.
237. Petitioner continued to treat D.R. with an ineffective
combination of chemotherapy drugs even when it was apparent that
the drugs were having no effect on D.R.'s cancer. Tr. at 792 -
804; I.G. Ex. 3E, 3O; Findings 235 - 236.
238. Petitioner's assertion that he chose a regimen of treatment
for D.R. that was likely to be least toxic in a man who is 84 years
of age is entirely and overwhelmingly contradicted by the evidence
and testimony of record, is not credible, and is indicative of
Petitioner's lack of trustworthiness. I.G. Ex. 3E, 3O; Tr. at 235
- 328, (especially at 2096 - 2100); see Tr. at 235 - 328, 788 -
811, 1008 - 1020, 1407 - 1464; I.G. Ex. 3E, 3O.
239. Petitioner documented that he subjected D.R. to an inordinate
number of office visits (136) that was substantially in excess of
D.R.'s needs. I.G. Ex. 3E, 3O; Tr. at 1411 - 1412; Finding 234.
240. Petitioner's treatment of D.R. with chemotherapy significantly
decreased D.R.'s quality of life, with no tangible benefit. I.G.
Ex. 3O at 20, 24; Tr. at 1407 - 1464; Findings 234 - 239.
241. Petitioner documented that, in 1986, he administered the drugs
Adriamycin, Cytoxan, 5-FU, Bleomycin, Vincristine, and BCNU to D.R.
I.G. Ex. 3E, 3O.
242. In 1986, D.R. was receiving the drug Lanoxin, which is used in
treating heart disorders. Tr. at 1416; I.G. Ex. 3O.
243. D.R. had a heart disorder in 1986 during the time he was
receiving chemotherapy treatments from Petitioner. I.G. Ex. 3E,
3O; Tr. at 793 - 796.
244. The drug Adriamycin is cardiotoxic and is contraindicated in
patients with heart disorders. Tr. at 1416.
245. Given D.R.'s age and his preexisting heart disorder, it was
below professionally recognized standards of health care and
substantially in excess of D.R.'s needs for Petitioner to
administer the drug Adriamycin to D.R. in 1986. Findings 241 -
244.
246. The amount of Adriamycin which Petitioner documented he gave
to D.R. in 1986 was a lethal amount sufficient to cause death from
the toxic side effects of this drug. I.G. Ex. 3E, 3O at 8 - 31;
Tr. at 243 - 253.
247. D.R. did not die from the toxic side effects of Adriamycin.
I.G. Ex. 3E, 3O.
248. D.R. did not receive Adriamycin in the amount Petitioner
documented that he administered to him. I.G. Ex. 3E, 3O; Tr. at
243 - 244; Findings 246 - 247.
249. It was potentially dangerous and life-threatening to D.R. for
Petitioner to incorrectly document that D.R. received Adriamycin in
amounts which he did not actually receive. Findings 24 - 33, 246
- 248.
250. It was below professionally recognized standards of health
care for Petitioner to document in D.R.'s chart that D.R. was
receiving an amount of Adriamycin that he was not receiving.
Findings 24 - 33, 248 - 249.
251. Bleomycin is not effective in treating non-small cell lung
cancer. Tr. at 240, 2859.
252. Bleomycin produces irreversible lung damage. Tr. at 240,
2859.
253. Bleomycin has not been used in treating lung cancer since at
least 1982. Tr. at 240, 2859.
254. It was below professionally recognized standards and
substantially in excess of D.R.'s needs for Petitioner to
administer Bleomycin to D.R. in 1986 for the treatment of D.R.'s
non-small cell lung cancer. Findings 43, 251 - 253.
255. Cytoxan is not effective in treating non-small cell lung
cancer. Tr. at 243.
256. 5-FU is not effective in treating non-small cell lung cancer.
Tr. at 243.
257. Vincristine is not effective in treating non-small cell lung
cancer. Tr. at 243.
258. BCNU is not effective in treating non-small cell lung cancer.
Tr. at 243.
259. It was below professionally recognized standards of health
care and substantially in excess of D.R.'s needs for Petitioner to
administer the drugs Cytoxan, 5-FU, BCNU, and Vincristine to D.R.
in 1986. Findings 230 - 233, 235 - 237, 241 - 258.
260. In 1986, Vincristine was available in reusable vials of one,
two, and five milligrams. Tr. at 1410 - 1411, 2855 - 2856.
261. The maximum dosage of Vincristine which can safely be
administered to a normal sized patient at one time is two
milligrams. Tr. at 1410 - 1411, 2855 - 2856.
262. Petitioner documented that he administered five milligrams of
Vincristine to D.R. on each occasion that he gave the drug to D.R.
in 1986. I.G. Ex. 3E, 3O at 83, 194.
263. On each occasion Petitioner submitted a claim for
reimbursement for administering Vincristine to D.R., Petitioner
billed the Medicare program for five milligrams. I.G. Ex. 3O; Tr.
at 1410 - 1411, 2855 - 2856.
264. The blood counts that Petitioner documented he performed on
D.R. do not support that D.R. received the doses of Cytoxan,
Adriamycin, and Vincristine that are documented in the flow sheet.
I.G. Ex. 3O at 19.
265. The dosages of Cytoxan which Petitioner documented he gave to
D.R. in 1986 were a lethal dose sufficient to cause death from the
toxic side effects of this drug. I.G. Ex. 3O at 8 - 31; Tr. at 246
- 251.
266. There is no medical documentation that D.R. had suppression of
bone marrow that is exhibited by decreased blood cell counts. I.G.
Ex. 3O; Tr. at 246 - 247.
267. D.R. exhibited no significant abnormality in his blood cell
counts. I.G. Ex. 3O; Tr. at 246 - 247, 801 - 802.
26: D.R. did not die from the toxic side effects of Cytoxan. I.G.
Ex. 3O at 52; Tr. at 247 - 251, 308 - 309.
269. Petitioner, despite documenting he did so, did not administer
the drug Cytoxan to D.R. in any significant amount, if at all.
Findings 264 - 268; Tr. at 246 - 247.
270. The maximum tolerable dose of Vincristine for D.R. to have
received is three milligrams per month. Tr. at 255.
271. Petitioner documented that, at one point, he administered 10
milligrams of Vincristine to D.R. in a one month period. I.G. Ex.
3O; Tr. at 255.
272. Had D.R. received 10 milligrams of Vincristine in one month,
he would have been paralyzed in his arms and legs. Tr. at 255.
273. D.R.'s arms and legs did not become paralyzed. I.G. Ex. 3E,
3O.
274. Petitioner did not administer Vincristine to D.R. in the
amount he claimed to have administered to D.R. Tr. at 255; I.G.
Ex. 3O; Findings 270 - 273.
275. D.R. did not exhibit any side effects from the drug Bleomycin.
I.G. Ex. 3O; Findings 266 - 267; Tr. at 253 - 255.
276. D.R. did not receive Bleomycin in the amount Petitioner
documented he administered to D.R. Tr. at 253 - 255; Finding 275.
277. It was below professionally recognized standards for
Petitioner to have documented in D.R.'s flow sheet that D.R.
received chemotherapy doses of Adriamycin, Bleomycin, Cytoxan, and
Vincristine in amounts that were different from the amounts of
these drugs that Petitioner actually administered to D.R. I.G. Ex.
3E, 3O; Findings 21 - 42, 248 - 250, 269, 274, 276 - 277; Tr. at
235 - 328, 788 - 811, 1008 - 1070, 1071 - 1074, 1407 - 1464.
278. X-ray reports of March 26, 1986 and June 6, 1986 showed an
increasing and growing tumor mass in D.R.'s chest. I.G. Ex. 3O at
77 - 78.
ECNT As of September 1986, Petitioner believed that D.R. was having
an "excellent response" to the chemotherapy treatment. I.G. Ex. 3O
at 340.
280. Over the course of 1986, D.R.'s cancer continued to grow in
size and severity. I.G. Ex. 3E, 3O; Tr. at 1418 - 1419, 1444;
Finding 278.
281. The combination, type, amounts and frequency of drugs that
Petitioner documented he administered to D.R. were below
professionally recognized standards, substantially in excess of
D.R.'s needs, and were not medically effective nor medically
appropriate in the treatment of D.R.'s cancer. Tr. at 235 - 328,
788 - 811, 1008 - 1020, 1071 - 1074, 1407 - 1464; Findings 218 -
280.
282. Petitioner continued to provide the same treatment to D.R. in
the face of progressively worsening symptoms and increasing tumor
mass. Tr. at 792 - 811, 1418 - 1419, 1444; I.G. Ex. 3E, 3O;
Findings 278 - 280.
283. Petitioner failed to change his treatment of D.R. when there
was overwhelming objective evidence that the treatment he was using
had failed to have any effect on D.R.'s cancer. Tr. at 1418 -
1419, 1444; I.G. Ex. 3E, 3O; Findings 278 - 282.
284. It was below professionally recognized standards of health
care for Petitioner to have continued the same course of treatment
with D.R. in the face of progressive disease. Tr. at 251 - 252,
266, 797 - 801, 1418 - 1419, 1444; I.G. Ex. 3E, 3O; Findings 278 -
283.
285. Petitioner believed D.R. was a good candidate for chemotherapy
treatment because D.R. was fully ambulatory and had an 80 percent
Karnofsky Performance Status Score. P. Ex. 2 at 24.
286. A Karnofsky Performance Status Score is not determinative of
whether D.R. was a good candidate for chemotherapy. Tr. at 2861.
287. Petitioner's reliance on D.R.'s Karnofsky Performance Status
Score in determining whether D.R. was a good candidate for
chemotherapy is below professionally recognized standards.
Findings 285 - 286.
288. D.R. was not a good candidate for chemotherapy, given his age,
the condition of his heart, and the fact that he had non-small cell
cancer, which is not curable by chemotherapy. Findings 218, 220 -
225, 230 - 233, 235, 242 - 245; Tr. at 235 - 328, 800 - 802, 1450,
2861; I.G. Ex. 3E, 3O.
289. It was below professionally recognized standards of health
care for Petitioner to have administered chemotherapy treatment to
D.R. in the manner he purports to have administered it; that is,
via one to eight hour infusions. I.G. Ex. 3E, 3O at 20, 24;
Findings 10 - 20; Tr. at 234 - 328, 800 - 802.
290. The amounts of the chemotherapeutic agents Cytoxan,
Adriamycin, 5-FU, Vincristine, Bleomycin and BCNU that Petitioner
documented he gave to D.R. during 1986 were below professionally
recognized standards of health care and substantially in excess of
D.R.'s needs. I.G. Ex. 3E, 3O; Tr. at 235 - 328, 788 - 811, 1008
- 1020, 1071 - 1074, 1407 - 1464; Findings 246 - 277.
291. Petitioner documented that he administered chemotherapy drugs
to D.R. during 1986 via one and eight hour infusions on
approximately a weekly or biweekly basis. I.G. Ex. 3E, 3O.
292. The chemotherapy infusions (one and eight hours) Petitioner
documented he administered to D.R. in 1986 contained Adriamycin,
Cytoxan, and 5 FU, with occasional Bleomycin, Vincristine, and, on
three occasions, BCNU. I.G. Ex. 3O at 3 - 5, 13, 18 - 20.
293. It was of no medical benefit to D.R. for Petitioner to have
administered any of the chemotherapy agents he administered to D.R.
via a one to eight hour infusion. Tr. at 234 - 328, 788 - 811,
1008 - 1020, 1071 - 1074, 1407 - 1464; I.G. Ex. 3E, 3O at 8 - 31;
Findings 10 - 20, 292.
294. Petitioner documented that he administered at least 20
multivitamin injections and vitamin B-12 injections to D.R. during
1986. I.G. Ex. 3O.
295. There is no documentation to support Petitioner's contention
that D.R.'s medical condition required the administration of any
multivitamin injections and vitamin B-12 injections. I.G. Ex. 3O;
Tr. at 802 - 803, 1426.
296. It was below professionally recognized standards for
Petitioner to administer multi-vitamin injections and vitamin B-12
injections to D.R. without documenting the underlying condition
that caused D.R. to require such injections. I.G. Ex. 3E, 3O at
25, 29; Tr. at 806.
297. All of the multivitamin injections and vitamin B-12 injections
that Petitioner documented he administered to D.R. in 1986 were
substantially in excess of D.R.'s needs. Findings 294 - 296.
298. Petitioner documented that he administered three
laryngoscopies to D.R. Tr. at 274 - 275; I.G. Ex. 3O.
299. A laryngoscope is a device that allows a doctor to look inside
the larynx. See Tr. at 274, 275, 326 - 328.
300. Petitioner documented that he used a laryngoscopy on more than
one occasion to diagnose that D.R. had oral candidiasis or
"thrush". I.G. Ex. 3E, 3O; Tr. at 326 - 327.
301. The diagnosis and treatment of oral candidiasis does not
require the use of a laryngoscopy. Tr. at 326 - 327, 803, 1453.
302. Petitioner's use of three laryngoscopies to diagnose and treat
D.R.'s oral candidiasis was substantially in excess of D.R.'s
needs. Findings 298 - 301.
303. Given D.R.'s condition in 1986, the professionally recognized
standard permitted an oncologist to attempt to treat D.R.'s cancer
with an approved experimental chemotherapy protocol. Tr. at 258 -
259, 801; Finding 230.
304. Petitioner did not administer to D.R. an approved or
legitimate experimental chemotherapy protocol. I.G. Ex. 3E, 3O;
see Tr. at 235 - 328, 788 - 811, 1008 - 1020, 1071 - 1074, 1407 -
1464, 2849 - 2863, 2918 - 2928, 2960 - 2961.
305. In some instances, a patient's symptoms may be palliated with
chemotherapy. Tr. at 1439 - 1440.
306. Given D.R.'s age and heart problems, Petitioner could not have
reasonably expected to palliate D.R.'s symptoms by administering
chemotherapy which included the cardiotoxic drug Adriamycin. I.G.
Ex. 3E, 3O; Tr. at 1434 - 1436; Findings 231 - 233, 245.
307. Given D.R.'s age and physical problems, Petitioner could not
have reasonably expected to palliate D.R.'s symptoms by
administering chemotherapy which included the drug Cytoxan
(especially in combination with Adriamycin). I.G. Ex. 3E, 3O; Tr.
at 235 - 328, 1407 - 1464, 2849 - 2863, 2918 - 2928; Findings 37 -
38, 230 - 233.
308. Given D.R.'s age, the fact that he had one lung removed and
the fact that he had chronic obstructive pulmonary disease,
Petitioner could not have reasonably expected to palliate D.R.'s
symptoms by administering chemotherapy which included the drug
Bleomycin, which produces irreversible lung damage. Tr. at 240;
Findings 230 - 233, 251 - 253.
309. Petitioner documented that he administered prehydration in
conjunction with his administration of chemotherapy drugs to D.R.
I.G. Ex. 3E, 3O.
310. None of the chemotherapy drugs administered by Petitioner to
D.R. required prehydration. Tr. at 1407 - 1464; I.G. Ex. 3E.
311. Petitioner's providing of prehydration to D.R. was
substantially in excess of D.R.'s needs. Tr. at 1413, 1451; I.G.
Ex. 3E, 3O; Findings 309 - 310.
312. D.R.'s CEA was within the normal range. Tr. at 239 - 240,
295, 2851 - 2853.
313. CEA studies are not a useful aid in the treatment of large
(non small) cell carcinoma, the type of cancer D.R. had. I.G. Ex.
3E; Tr. at 235 - 328; Findings 223 - 224.
314. None of the CEAs which Petitioner documented that he provided
to D.R. were medically necessary. Findings 312 - 313.
315. The CEAs which Petitioner documented he provided to D.R. in
1986 were substantially in excess of D.R.'s needs. Findings 312 -
314.
316. None of the CBCs which Petitioner documented that he provided
for D.R. in 1986 were medically necessary. I.G. Ex. 3E, 3O; Tr. at
806.
317. None of the venipunctures which Petitioner documented that he
provided for D.R. in 1986 were medically necessary. I.G. Ex. 3E,
3O; Tr. at 235 - 328, 806, 1407 - 1464, 2849 - 2863, 2918 - 2928.
318. None of the platelet counts which Petitioner documented that
he provided for D.R. in 1986 were medically necessary. I.G. Ex.
3E, 3O; Tr. at 235 - 328, 806, 1407 - 1464, 2849 - 2863, 2918 -
2928.
319. The CEAs, venipunctures, prehydration, and platelet counts
that Petitioner provided to D.R. in 1986 were below professionally
recognized standards of health care and substantially in excess of
D.R.'s needs. I.G. Ex. 3E, 3O; Findings 309 - 318.
320. Petitioner's failure to properly document the actual amounts
of chemotherapy drugs that he administered to D.R. jeopardized
D.R.'s health, safety, and well-being. Findings 21 - 26, 28, 29,
250, 264, 269, 276 - 277, 281, 283 - 284, 290, 293.
321. Petitioner furnished or caused to be furnished items or
services to D.R. that were substantially in excess of D.R.'s needs.
Findings 218 - 320; Tr. at 235 - 328, 788 - 811, 1008 - 1020, 1071
- 1074, 1407 - 1464, 2089 - 2283, 2849 - 2863, 2918 - 2928, 2960 -
2961.
322. Petitioner provided items or services to D.R. of a quality
which failed to meet professionally recognized standards of health
care. Findings 218 - 321; Tr. at 235 - 328, 788 - 811, 1008 -
1020, 1071 - 1074, 1407 - 1464, 2089 - 2283, 2849 - 2863, 2918 -
2928, 2960 - 2961.
323. Petitioner's management of D.R.'s case jeopardized D.R.'s
health, safety, and well-being. Findings 219 - 322.
324. Petitioner's attempts to justify his treatment of D.R. are
inconsistent, insufficient, and not credible. P. Ex. 2; Tr. at 235
- 328, 788 - 811, 1008 - 1020, 1071 - 1074, 1407 - 1464, 2089 -
2283, 2849 - 2863, 2918 - 2928, 2960 - 2961.
325. The exhibit Petitioner offered into evidence to support his
treatment of D.R. does not support or justify his treatment of D.R.
P. Ex. 2; Tr. at 2096 - 2099; I.G. Ex. 3E, 3O; see Tr. at 235 -
328, 788 - 811, 1008 - 1020, 1071 - 1074, 1407 - 1464, 2849 - 2863,
2918 - 2928, 2960 - 2961.
Petitioner's testimony regarding his treatment of D.R. is
indicative of Petitioner's lack of credibility and lack of
trustworthiness.
326. Petitioner's contentions that either he or his office staff
knew how much chemotherapy D.R. received, even though the
documentation does not reflect the amounts D.R. received, is not
credible and is indicative of Petitioner's lack of trustworthiness.
Tr. at 1764, 2117 - 2120; I.G. Ex. 3E, 3O; Findings 249 - 250, 254,
259 - 277.
327. Petitioner's statement that he gave D.R. the amounts of
chemotherapy drugs documented in D.R.'s flow sheet is contradicted
by the evidence, is not credible, and is indicative of Petitioner's
lack of trustworthiness. I.G. Ex. 3E, 3O; Tr. at 235 - 328, 788 -
811, 1008 - 1020, 1071 - 1074, 1407 - 1464, 2849 - 2863; Findings
218 - 326.
328. Petitioner's statement that, in the event another doctor would
have to treat D.R., someone on Petitioner's staff would be fully
able to inform the other doctor of the precise amounts of
chemotherapy D.R. received from Petitioner sufficient to ensure
continuity of care is not supported by the evidence of record, is
not credible, and is indicative of Petitioner's lack of
trustworthiness. Tr. at 2123 - 2125; I.G. Ex. 3E, 3O; Findings 326
- 327.
329. Petitioner's explanations as to why D.R.'s flow sheets reflect
that D.R. received a different amount of chemotherapy from that
which he claims to have actually administered to D.R. are
self-serving, unsupported by the evidence of record, and not
credible. Tr. at 2123 - 2130.
330. Petitioner's attempt to blame alleged inadequacies in the
Medicare code book for his having billed for an entire vial of a
chemotherapeutic agent, even if he administered a lesser amount to
D.R., is indicative of Petitioner's lack of trustworthiness. Tr.
at 2119 - 2121.
331. On at least three separate occasions, Petitioner submitted
reimbursement claims to CA (California) Blue Shield for purportedly
having administered Cytoxan to D.R. whereas in fact D.R. did not
receive Cytoxan on those three occasions. Tr. at 2131 - 2136.
332. Petitioner blames his office staff for the erroneous billings
on the three occasions where CA Blue Shield was billed for Cytoxan
and D.R. did not receive it. Tr. at 2131 - 2137.
333. Petitioner's assertion that professionally recognized
standards of health care do not mandate that an oncologist keep
accurate written records of the total dose of chemotherapy
administered to a patient is contradicted by Petitioner's own
testimony and the evidence of record and is indicative of
Petitioner's lack of credibility and lack of trustworthiness.
Findings 21 - 29; Tr. at 1315, 2137 - 2138.
334. Petitioner's evasive and inaccurate testimony regarding the
amount of Adriamycin he administered to D.R. is indicative of his
lack of credibility and lack of trustworthiness. Tr. at 2140 -
2141.
335. Petitioner did not administer Adriamycin to D.R. over a 24 to
72 hour period. I.G. Ex. 3O.
336. Petitioner did not administer Adriamycin to D.R. via the
infusion method. Tr. at 2142 - 2143; Findings 13 - 20, 334 - 335;
I.G. Ex. 3E, 3O.
337. Petitioner's assertion that D.R. could tolerate four to five
times the amount of Adriamycin (if Petitioner administered
Adriamycin to D.R. via the infusion method) is entirely
contradicted by the evidence of record and is indicative of
Petitioner's lack of trustworthiness and lack of credibility. Tr.
at 2142; I.G. Ex. 3E, 3O; Findings 30 - 33, 241 - 250, 306.
338. Petitioner's assertion that D.R. was an "ideal" candidate for
chemotherapy is directly contradicted by the evidence and is
indicative of Petitioner's lack of credibility and lack of
trustworthiness. I.G. Ex. 3E, 3O; Tr. at 2146; Findings 218 - 293.
339. Petitioner's contention that chemotherapy was the only
treatment of choice for D.R. is not supported by the evidence. Tr.
at 2146 - 2150; I.G. Ex. 3E, 3N; Findings 230 - 234, 338.
340. Petitioner's statement that D.R.'s blood counts did not remain
normal during the time he was receiving chemotherapy is directly
contradicted by the evidence. Tr. at 2154 - 2155; I.G. Ex. 3O; Tr.
at 246 - 247, 801 - 802; Findings 264 - 267.
341. Petitioner's denial that he administered the drug BCNU to D.R.
is contradicted by D.R.'s flow sheet which indicates that D.R.
received BCNU while under Petitioner's care in 1986. Tr. at 2117,
2156 - 2159; I.G. Ex. 3O at 121, 202.
342. Petitioner's attributing to office or clerical error the fact
that Medicare was billed for D.R. receiving BCNU is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2156 - 2159; Findings 258 - 259, 341.
343. Petitioner was unable to give any medical justification for
his administration of prehydration prior to giving D.R. Adriamycin,
Cytoxan, or Vincristine. Tr. at 2165.
344. Petitioner asserts that he knew how much Vincristine he
administered to D.R., even though he was unable to give that
information in his testimony or point to any documentation in the
medical charts to indicate what amount D.R. received. Tr. at 2173
- 2174.
345. Petitioner's assertion that he knew how much Vincristine he
was administering to D.R. is indicative of his lack of credibility
and lack of trustworthiness. Tr. at 2173 - 2174.
346. Petitioner was evasive when questioned as to why he did not
change D.R.'s treatment when confronted with successive chest
x-rays indicating D.R.'s cancer was progressing. Tr. at 2175 -
2180; I.G. Ex. 3O at 77 - 81.
347. Petitioner's lack of credibility and lack of trustworthiness
is evidenced by his assertion that the notes that accompany D.R.'s
chest x-rays (which mention increases in the size of D.R.'s tumor
mass) are merely subjective evaluations that cannot be taken at
face value. Tr. at 2175 - 2180; I.G. Ex. 3O at 77 - 81.
348. Petitioner's assertion that his treatment of D.R.'s cancer
with Cytoxan and Adriamycin helped D.R. is directly contradicted by
the evidence. I.G. Ex. 3E, 3O; Findings 235 - 250, 255, 259, 264
- 269, 278 - 293; Tr. at 235 - 328, 788 - 811, 1008 - 1020, 1071 -
1074, 1407 - 1464, (especially at 2182 - 2192), 2849 - 2863.
349. Petitioner admitted that he added Bleomycin to D.R.'s
chemotherapy regimen of Adriamycin and Cytoxan. Tr. at 2182 -
2192; I.G. Ex. 3O at 89.
350. Petitioner's admission that he administered Bleomycin to D.R.
is indicative of a lack of understanding and knowledge about the
effects of Bleomycin. Tr. at 1434 - 1435, 2182 - 2192; I.G. Ex.
3E, 3O at 89, 3O; Findings 251 - 254.
351. Petitioner's admission that he administered Bleomycin to D.R.
is indicative of Petitioner's willingness to provide treatment that
is medically inappropriate and ineffective. I.G. Ex. 3E, 3O; Tr.
at 2182 - 2192; Finding 350.
352. Petitioner's statement that P. Ex. 2 supports his treatment of
D.R. is directly contradicted by the evidence of record and is
indicative of Petitioner's lack of credibility and lack of
trustworthiness. P. Ex. 2; Tr. at 1437 - 1444, (especially at
2192).
353. Petitioner's assertion that D.R. did not exhibit weight loss
is directly contradicted by the evidence of record and is
indicative of Petitioner's lack of credibility and lack of
trustworthiness. Tr. at 2193 - 2195; I.G. Ex. 3O at 51.
Petitioner's treatment of Patient H.W.
354. H.W. was an 82-year-old male who was not complaining of any
pain and who was first seen by Petitioner in April of 1985 for
cancer of the prostate. P. Ex. 3; I.G. Ex. 3P at 482.
355. Petitioner provided treatment to H.W. as his patient from
April 23, 1985 through February 8, 1989. I.G. Ex. 3P at 3 - 4.
356. Petitioner documented that he administered approximately
weekly doses of chemotherapy to H.W. from April 23, 1985 through
February 8, 1989. I.G. Ex. 3P at 3 - 4.
357. The diagnosis that H.W. had cancer of the prostate was made by
a Dr. James Nelson on the basis of a biopsy. P. Ex. 3; I.G. Ex. 3P
at 482.
358. Paget's disease is a common disorder of middle-aged and
elderly people in which the normal process of bone formation is
disrupted, causing the affected bones to weaken, thicken, and
become deformed, and which is usually restricted to a limited area
of the skeleton. American Medical Association Encyclopedia of
Medicine, (Charles B. Claymann, M.D., med. ed., Random House,
1989); Tr. at 813 - 814. 15/
359. Paget's disease can be confused with the appearance of
prostate cancer after prostate cancer has metastasized to a
patient's bone. Tr. at 813 - 814.
360. Petitioner's office note of June 19, 1985 states a tentative
diagnosis that patient H.W. had Paget's disease and no metastasis
of his prostate cancer. I.G. Ex. 3P at 478.
361. Two bone scans of H.W. showed that he had Paget's disease and
indicated that H.W. did not have metastatic prostate cancer. I.G.
Ex. 3P at 178; Tr. at 1509; I.G. Ex. 19 at 5.
362. At the time he began receiving treatment from Petitioner, H.W.
did not exhibit any symptoms of metastatic prostate cancer. I.G.
Ex. 3P at 13, 15, 17 - 19.
363. At no time did Petitioner document that H.W. had any symptoms
of metastatic prostate cancer. I.G. Ex. 3P.
364. Petitioner claims that the appearance of a lung nodule on a
1988 x-ray justifies a finding that H.W. had metastatic prostate
cancer. Tr. at 2284 - 2367; I.G. Ex. 3P at 31.
365. The chemotherapy treatment Petitioner documented he
administered to H.W. from April 23, 1985 through February 8, 1987
amounts to a supralethal dose of Cytoxan and a near supralethal
dose of 5FU. I.G. Ex. 3P; Tr. at 328 - 428, 811 - 836, 1020 -
1035, 1071 - 1074, 1464 - 1524, 2284 - 2367.
366. Cytoxan causes suppression of bone marrow. Tr. at 339 - 340.
367. Cytoxan given over a period of three and a half years causes
leukemia in 5 to 10 percent of the patients receiving the Cytoxan.
Tr. at 352.
368. There is nothing in the record to support a finding that H.W.
had any suppression of his bone marrow. I.G. Ex. 3E, 3P; Tr. at
341 - 342.
ODC Administration of 5FU in therapeutic doses causes suppression
of blood cell counts. Tr. at 343.
370. H.W. did not exhibit any prolonged, suppressed blood cell
counts that would be associated with receiving therapeutic doses of
5FU. Tr. at 343 - 344, 812 - 814; I.G. Ex. 3E, 3P.
371. Petitioner was unable to state with any degree of specificity
how much Cytoxan or 5FU he administered to H.W. Tr. at 2348 -
2350; P. Ex. 3.
372. H.W. did not receive anywhere near the amounts of Cytoxan and
5FU that Petitioner claimed to have administered to him. Findings
365 - 371.
373. Even assuming H.W. had required chemotherapy to treat
metastatic prostate cancer, such treatment would not be performed
using Cytoxan, as this chemotherapy agent is ineffective in
treating metastatic cancer of the prostate. Tr. at 350 - 351.
374. It was not medically necessary for Petitioner to administer
Cytoxan and 5FU to H.W. Findings 354 - 373.
375. H.W. would have died had he received the doses of Cytoxan that
Petitioner documented he administered to H.W. I.G. Ex. 3E, 3P; Tr.
at 328 - 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464 - 1524,
2284 - 2367.
376. H.W. would have been near death and may have died had he
received the doses of 5FU that Petitioner documented he
administered to H.W. I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836,
1020 - 1035, 1071 - 1074, 1464 - 1524, 2284 - 2367.
377. Petitioner's assertion that the appearance of a lung nodule on
an x-ray in 1988 justifies the regimen of chemotherapy treatment he
administered to H.W. from April 1985 through February 1989 is not
credible and is inconsistent with Petitioner's own documentation
concluding that H.W. had no metastatic prostate cancer. I.G. Ex
3E, 3P; Tr. at 328 - 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464
- 1524, 2284 - 2367, 2863 - 2872; Findings 354 - 364.
378. Assuming Petitioner believed that H.W. had metastatic prostate
cancer in 1985, professionally recognized standards of health care
dictate that he should have obtained a biopsy from H.W. and should
not have relied on an x-ray as proof that H.W. had metastatic
disease. Tr. at 1500 - 1513.
379. Even assuming that H.W. had metastatic prostate cancer in
1985, professionally recognized standards of health care mandate
that Petitioner first attempt to treat the cancer with hormone
manipulation rather than administering chemotherapy as a first
course of action. Tr. at 814 - 815.
380. Petitioner's assertion that H.W. had metastatic prostate
cancer in April 1985 is directly contradicted by the evidence of
record. Tr. at 328 - 428, 811 - 836, 1020 - 1035, 1071 - 1074,
1464 - 1524, 2284 - 2367, I.G. Ex. 3E, 3P.
381. Because Petitioner's diagnosis was in conflict with the
radiology reports, it was incumbent upon Petitioner to do further
studies to show that H.W. had metastatic cancer before initiating
chemotherapy. Tr. at 1508 - 1509; I.G. Ex. 3E, 3P.
382. Petitioner failed to document that H.W. was having any adverse
symptoms from his prostate cancer. I.G. Ex. 3E, 3P; Tr. at 328 -
428, 823, 1464 - 1524.
383. During the time Petitioner treated H.W., H.W.'s prostate
cancer was confined to the prostate and had not spread. I.G. Ex.
3E, 3P; Tr. at 328 - 348, 811 - 836, 1464 - 1524.
384. Professionally recognized standards of health care dictate
that, in treating H.W. during the period of time which Petitioner
treated him, Petitioner should not have administered treatments to
him simply because he had prostate cancer that was contained within
the prostate, but simply should have monitored him and begun
treatment if his symptoms worsened, indicating the disease was
progressively worsening. Tr. at 823 - 824; see Tr. at 328 - 428,
1464 - 1524.
385. H.W.'s prostate cancer was not progressively worsening. Tr.
at 328 - 428, 811 - 836, 1464 - 1524; I.G. Ex. 3E, 3P.
386. During the time Petitioner treated H.W., H.W. was not
exhibiting symptoms related to his prostate cancer. Tr. at 335;
I.G. Ex. 3E, 3P; Findings 354 - 364, 382 - 385.
387. Professionally recognized standards of health care dictated
that, in treating a patient such as H.W., whose prostate cancer was
not progressive and had not spread outside of the prostate, the
oncologist do nothing as long as the cancer is not causing
symptoms. Tr. at 334 - 339, 824.
388. Even if H.W. had prostate cancer that had metastasized to the
bone, the professionally recognized standard of health care would
have been to treat it with hormone therapy and to treat any bone
pain that H.W. may have had with localized radiation. Tr. at 328
- 428, 811 - 836, 1020 - 1035, 1464 - 1524.
389. Professionally recognized standards of health care for H.W.'s
case dictated that, since H.W. had no symptoms and no sign of
progressive disease, Petitioner should have monitored H.W.
periodically, administering no treatment as long as H.W. had no
symptoms and no sign of progressive disease; performed an
orchiectomy on H.W.; or administered hormone therapy to H.W. Tr.
at 328 - 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464 - 1524.
390. An "orchiectomy" is a surgical procedure in which the
patient's testicles are removed. Tr. at 825.
391. Professionally recognized standards of health care dictated
that Petitioner was obligated to document in his treatment notes
that H.W. was offered the orchiectomy option and refused it before
choosing to treat him with chemotherapy. Tr. at 1485 - 1486.
392. Petitioner never documented in his notes that H.W. was offered
and refused an orchiectomy as a curative measure. I.G. Ex. 3E, 3P;
Tr. at 2295, 2320 - 2322.
393. Treating H.W.'s localized prostate cancer with hormone
therapy, localized radiation, or surgical removal of the prostate
would have been within professionally recognized standards. Tr. at
356 - 359.
394. Hormone therapy for prostate cancer involves removing the male
hormone upon which the cancer feeds. Tr. at 819 - 821.
395. Hormone therapy can be accomplished by removal of the
testicles, treatment with the hormone estrogen, or treatment with
a "hormone blocker" which is a substance that interferes with the
production or uptake of the male hormone. Tr. at 357, 819 - 821.
396. The hormone blockers ("leuprolide" and "flutamide")
which
would be treatment options today were not readily available during
the time Petitioner began treating H.W. Tr. at 363.
397. At the time during which Petitioner was treating H.W., H.W.
had a history of heart problems and hypertension. I.G. Ex. 3P at
14, 18; Tr. at 328 - 428, 1464 - 1524.
398. Estrogen treatment can aggravate heart problems. Tr. at 360,
825.
399. Estrogen could have been administered to treat H.W.'s cancer
as long as H.W. was carefully monitored. Tr. at 355 - 361, 829 -
831.
400. Removal of the prostate has many adverse side effects. Tr. at
358, 367 - 368.
401. Removal of the prostate would not be indicated in H.W.'s case
because of the risks associated with the operation and the
availability of other preferable
treatment options, such as hormone manipulation and radiation. Tr.
at 328 - 428, 811 - 836, 1020 - 1035, 1464 - 1524.
402. Prostate cancer does not respond reliably to chemotherapy.
Tr. at 819.
403. Prostatic Acid Phosphatase (PAP) is a component of total acid
phosphatase. Tr. at 1471 - 1472.
404. PAP cannot be higher than total acid phosphatase. Tr. at 1471
- 1472; Finding 403.
405. Neither the PAP nor the prostate specific antigen (PSA) test
results indicated that H.W.'s prostate cancer was growing. Tr. at
345 - 346, 818 - 819.
406. During the time in which H.W. was being treated by Petitioner,
H.W.'s prostate cancer was not spreading and had not spread outside
of the prostate. I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836,
1020 - 1035, 1071 - 1074, 1464 - 1524, 2284 - 2367, 2863 - 2872;
Findings 385, 387.
407. Petitioner's use of the PAP test to diagnose and monitor H.W.
was in accordance with professionally recognized standards. Tr. at
346.
408. The PAP results showed that the chemotherapy treatment that
Petitioner documented he administered had no effect on H.W.'s
cancer. Tr. at 346, 817 - 818.
409. Professionally recognized standards of health care dictate use
of chemotherapy to treat metastatic cancer of the prostate only in
patients who have received hormone treatment and who did not
respond to it and who have received and not responded to radiation
therapy. Tr. at 351.
410. Petitioner did not document that he explained the treatment
options to H.W., including radiation and hormone therapy. I.G. Ex.
3E, 3P.
411. It was below professionally recognized standards of health
care for Petitioner not to document that he explained the treatment
options to H.W. Tr. at 328 - 428, 811 - 836, 1020 - 1035, 1071 -
1074, 1464 - 1524.
412. It was below professionally recognized standards of health
care for Petitioner not to document that he considered using
hormone therapy and the reasons he rejected the available hormonal
therapy options. I.G. Ex. 3E, 3P; Tr. at 369 - 372.
413. It was below professionally recognized standards of health
care for Petitioner not to document that he considered using
radiation treatment and the reasons he rejected using it to treat
H.W.'s localized cancer. I.G. Ex. 3E, 3P; Tr. at 369 - 372.
414. Chemotherapy could not cure H.W.'s prostate cancer. Tr. at
367.
415. Even if chemotherapy were used to treat metastatic cancer in
a patient who had not responded to either hormone treatment or
radiation therapy, such chemotherapy is palliative only and not
curative. Tr. at 351.
416. Even when the correct dosages and types of drugs are used,
chemotherapy can be used to palliate pain only for short periods of
time, i.e., approximately 6 to 14 weeks. Tr. at 1486.
417. The chemotherapy treatment which Petitioner documented that he
administered to H.W. was not palliative. I.G. Ex. 3E, 3P; Tr. at
328 - 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464 - 1524, 2284
- 2367; Findings 356, 414 - 416.
418. The chemotherapy treatment which Petitioner documented that he
administered to H.W. was not effective in the treatment of H.W.'s
prostate cancer. I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836,
1020 - 1035, 1071 - 1074, 1464 - 1524, 2284 - 2367; Findings 354,
355, 373 - 374, 384, 388, 405, 408, 415 - 417.
419. It was below professionally recognized standards of health
care and substantially in excess of H.W.'s needs for Petitioner to
treat H.W. with chemotherapy using the frequency, amounts, and
types of drugs that he did. Findings 354 - 418; I.G. Ex. 3E, 3P;
Tr. at 328 - 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464 - 1524,
2284 - 2367.
420. It was below professionally recognized standards of health
care for Petitioner to treat H.W.'s prostate cancer with
chemotherapy, given the stage of the disease and the lack of
documented symptoms, and without first trying effective means of
treatment such as hormonal therapy or radiation. Findings 354 -
419; I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836, 1020 - 1035,
1071 - 1074, 1464 - 1524, 2284 - 2367.
421. It was below professionally recognized standards of health
care and substantially in excess of H.W.'s needs for Petitioner to
treat H.W. for over three years of chemotherapy treatments.
Findings 354 - 420; I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836,
1020 - 1035, 1071 - 1074, 1464 - 1524, 2284 - 2367.
422. It was below professionally recognized standards of health
care and substantially in excess of H.W.'s needs for Petitioner to
treat H.W. with Cytoxan, a chemotherapeutic agent that is not
effective in treating metastatic prostate cancer. Findings 354 -
421; I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836, 1020 - 1035,
1071 - 1074, 1464 - 1524, 2284 - 2367.
423. It was below professionally recognized standards of health
care for Petitioner not to document H.W.'s symptoms and progress.
I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836, 1020 - 1035, 1071 -
1074, 1464 - 1524, 2284 - 2367.
424. It was below professionally recognized standards of health
care and substantially in excess of H.W.'s needs for Petitioner to
continue to administer chemotherapy from April 1985 through
February 1989 without documenting H.W.'s symptoms that the
treatment was designed to alleviate or without sufficiently
documenting any progress made by H.W. I.G. Ex. 3E, 3P; Tr. at 328
- 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464 - 1524, 2284 -
2367.
425. It was below professionally recognized standards of health
care for Petitioner not to enter in H.W.'s flow sheet the actual
and precise amounts of drugs that H.W. received. Findings 354 -
424; I.G. Ex. 3E, 3P; Tr. at 328 - 428, 811 - 836, 1020 - 1035,
1071 - 1074, 1464 - 1524, 2284 - 2367.
426. Petitioner jeopardized the health, safety, and well-being of
H.W. by not entering on H.W.'s flow sheets the actual amounts of
drugs that H.W. received. Findings 354 - 425.
427. Petitioner's outpatient notes on H.W. were vague, unclear,
and, in some cases even, not written by Petitioner. Tr. at 375 -
376; I.G. Ex. 3P at 365, 373, 375.
428. Petitioner's outpatient notes on H.W. were below
professionally recognized standards of health care. Finding 427;
Tr. at 375 - 376.
429. Petitioner administered chemotherapy to H.W. via one and eight
hour intravenous infusions. I.G. Ex. 3E, 3P.
430. It was substantially in excess of H.W.'s needs for Petitioner
to administer CBCs and platelet counts to H.W. Tr. at 1487; I.G.
Ex. 3E, 3P; Tr. at 325 - 428, 811 - 836, 1464 - 1524.
431. Petitioner's care of H.W. reflects a lack of understanding of
professionally recognized standards of health care in the treatment
and management of prostate cancer. Findings 354 - 430.
432. Petitioner's attempts to justify his treatment of H.W. are
inconsistent, inadequate, and not credible. P. Ex. 3; Tr. at 328
- 428, 811 - 836, 1020 - 1035, 1071 - 1074, 1464 - 1524, 2284 -
2367, 2863 - 2872; Findings 354 - 431.
Petitioner's testimony regarding his care and treatment of H.W. is
indicative of Petitioner's lack of credibility and lack of
trustworthiness.
433. Petitioner's testimony, that he believed that, when he first
examined H.W., H.W. had metastatic prostate cancer, is directly
contradicted by the evidence of record, is not credible, and is
indicative of Petitioner's lack of trustworthiness. Tr. at 2286;
I.G. Ex. 3P at 48; see I.G. Ex. 3P; Findings 354 - 364, 377 - 383.
434. Petitioner asserted that his plan for treating H.W. was based
on the following factors: H.W.'s refusal to have orchiectomy;
H.W.'s extremely high blood pressure and congestive heart failure
prevented him from administering hormone therapy; and H.W.'s only
remaining treatment option was chemotherapy. Tr. at 2287.
435. Petitioner assertion's that H.W. had incurable metastatic
cancer of the prostate when he first began treating H.W. in April
of 1985 is not credible and is indicative of Petitioner's lack of
credibility and lack of trustworthiness. Tr. at 2296; Findings 354
- 364, 377 - 383.
436. Petitioner conceded that there is nothing in the medical
records that shows that he conducted any type of physical
examination of H.W.'s prostate. Tr. at 2303.
437. Petitioner contends that the page in the medical records that
shows that he conducted a physical examination of H.W.'s prostate
is missing from the I.G.'s medical records. Tr. at 2303.
438. The I.G. gave Petitioner the opportunity to submit rebuttal
materials before the I.G. made a final determination to accept the
PRO's recommendation to exclude Petitioner. I.G. Ex. 3B, 3G, 3M;
I.G.'s February 10, 1992 letter to Petitioner.
439. Petitioner was given ample opportunity to submit all records
relevant to the treatment of the seven patients at issue in this
case. I.G.'s February 10, 1992 letter to Petitioner; Petitioner's
March 31, 1992 letter requesting hearings; see my numerous
prehearing orders and rulings in this case.
440. Petitioner did not submit any evidence that supports his
contention that he conducted a physical examination of H.W.'s
prostate. Tr. at 2302 - 2305; Findings 354 - 439.
441. Petitioner's contention that the page in the medical records
that shows he performed a physical examination of H.W.'s prostate
is missing is not corroborated by any evidence, is not credible,
and is indicative of Petitioner's lack of trustworthiness.
Findings 354 - 440.
442. Petitioner's statement that he did not document that H.W. had
refused orchiectomy because another doctor had informed Petitioner
of H.W.'s refusal is indicative of a lack of understanding of the
reasons for documenting a patient's condition. Tr. at 2320 - 2322.
443. Petitioner's assertion that chemotherapy causes nausea and
vomiting only when it is not given in proper doses is directly
contradicted by the evidence of record and Petitioner's own
testimony. Tr. at 2296, 2317 - 2318; Findings 21 - 28.
444. Petitioner's assertion that chemotherapy causes nausea and
vomiting only when it is not given in proper doses is indicative of
Petitioner's lack of credibility and lack of trustworthiness.
Finding 443.
445. Petitioner's attempts to blame computer error for erroneous
results of PAP tests he administered to H.W. are self-serving and
not credible. Tr. at 2334.
446. Petitioner's own testimony and other evidence of record
directly contradict Petitioner's assertion that the doses of
chemotherapy he administered to H.W. in 1988 and 1989 are those
that are contained in H.W.'s flow sheet. I.G. Ex. 3E, 3P; Tr. at
2343 - 2346.
447. Petitioner's assertion is not credible that, from 1984 until
1988, the doses of chemotherapy he administered to H.W. are not
contained in the flow sheet but are contained in the route slip.
Tr. at 2343 - 2346.
448. Petitioner gave evasive, self-serving answers in response to
questions about how much H.W. actually received of the chemotherapy
drugs listed in H.W.'s flow sheet. Tr. at 2343 - 2351.
449. Petitioner admitted that H.W.'s flow sheets do not accurately
reflect the amount of chemotherapy medication Petitioner
administered to H.W. Tr. at 2347; I.G. Ex. 3P at 83 - 84.
450. Petitioner's assertion that, despite inaccuracies in H.W.'s
flow sheet, he could keep track of the amount of chemotherapy he
was administering to H.W. because, at the time he was treating
H.W., he had only four or five patients who were receiving
chemotherapy, is unsupported by the evidence of record, is not
credible, and is indicative of Petitioner's lack of credibility and
lack of trustworthiness. Tr. at 2347 - 2349.
451. Petitioner's attempt to blame his nursing staff for
inaccuracies in H.W.'s flow sheet and for his inability to be able
to determine how much chemotherapy H.W. actually received are
indicative of Petitioner's lack of credibility and lack of
trustworthiness. Tr. at 2348 - 2351.
452. Petitioner's progress note, in which he stated that H.W. had
excellent performance and showed improvement, is directly
contradicted by the evidence of record and is indicative of
Petitioner's willingness to resort to distortion to justify his
treatment of patients. Tr. at 2352 - 2355; I.G. Ex. 3E, 3P
(especially 3P at 457).
453. Petitioner's progress note that H.W. had excellent performance
despite clear evidence to the contrary is indicative of his lack of
credibility and lack of trustworthiness. Findings 354 - 452.
454. Petitioner's assertion that there is no standard for
documentation in a patient's chart is directly contradicted by the
evidence of record and by Petitioner's own testimony in which he
noted several important reasons for a treating oncologist or other
physician to properly document a patient's chart to indicate
precisely the course of treatment that is being followed by the
treating physician. Tr. at 1315, 2361 - 2362; Findings 24 - 29.
Petitioner's treatment of Patient J.W.
455. J.W. first obtained treatment from Petitioner in 1979. I.G.
Ex. 3Q, 11, 12.
456. In 1979, J.W. was a 24-year-old male with a history of
malignant melanoma that had spread to his lymph nodes. I.G. Ex.
11, 12.
457. J.W. had the lymph nodes removed and subsequently developed
brain metastasis, which also was surgically removed in 1980. I.G.
Ex. 3Q, 11, 12.
458. J.W. was given several postoperative radiation treatments by
a Dr. Hittle in 1980, but did not complete his treatment. I.G. Ex.
11, 12; Tr. at 1528.
459. In May 1983, J.W. underwent an extensive workup at the
University of Texas' M.D. Anderson Hospital and Tumor Institute
(Anderson Hospital) located in Houston, Texas. I.G. Ex. 15; Tr. at
1544.
460. Anderson Hospital is an institution that is recognized as one
of this country's premier institutions in treating cancer. I.G.
Ex. 15; Tr. at 1544.
461. The May 1983 workup and subsequent biopsy by Anderson Hospital
found no cancer in J.W. I.G. Ex. 14, 15, 17.
462. On May 18, 1983, a Dr. Nicholas Papadopoulos reported no
evidence of measurable malignant melanoma below J.W.'s neck. I.G.
Ex. 15; Tr. at 1544.
463. Dr. Papadopoulos' May 18, 1983 evaluation did note the
presence of a soft tissue mass involving the roof of the mouth and
sinus area (nasopharynx) and stated that the mass was biopsied by
a Dr. Medina and showed no malignancy. I.G. Ex. 15.
464. Another follow-up report by Dr. Papadopoulos, dated June 24,
1983, noted that the mass in J.W.'s nasopharynx area persisted, and
that he was awaiting comment from a Dr. Medina at the Head and Neck
Clinic. I.G. Ex. 17 at 1 - 2.
465. Petitioner's treatment of J.W. from February 11, 1985 through
November 22, 1989 only is at issue in this case. I.G. Ex. 3Q.
466. J.W.'s condition prior to February 11, 1985 is relevant and
probative as to whether Petitioner furnished or caused to be
furnished items or services from February 11, 1985 through November
22, 1989 that were substantially in excess of J.W.'s needs or of a
quality which fails to meet professionally recognized standards of
health care. Findings 455 - 464.
467. The treatment and care Petitioner received from the Anderson
Hospital in 1983 is relevant to whether, from February 11, 1985
through November 22, 1989, Petitioner furnished or caused to be
furnished services to J.W. that were substantially in excess of
J.W.'s needs and of a quality which fails to meet professionally
recognized standards of health care. Findings 459 - 464.
468. A Magnetic Resonance Imaging (MRI) report dated March 26, 1986
states that the findings were consistent with the presence of a
recurrent tumor with surrounding edema. P. Ex. 4 at 12.
469. The March 26, 1986 MRI is not determinative that J.W. had a
recurrence of his cancer. Tr. at 1549.
470. Professionally recognized standards of health care dictate
that, in J.W.'s case, upon receiving information such as that
contained in the March 26, 1986 MRI, the oncologist take into
consideration J.R.'s previous negative biopsies, his clean bill of
health from the Anderson Hospital, and confirm or disprove the MRI
results with a biopsy. Tr. at 1549.
471. Petitioner did not perform or order a biopsy to confirm or
disprove the March 26, 1986 MRI results. I.G. Ex. 3E, 3Q.
472. An MRI report dated August 15, 1986 notes that any abnormality
observed is likely due to postsurgical change, but did not rule out
a possible recurrence of J.W.'s cancer. P. Ex. 4 at 13.
473. An MRI report dated January 20, 1987 found no evidence of any
active disease and specifically notes that the area in which the
abnormality which appears in the MRI is smaller than it was in the
August 18, 1986 MRI. P. Ex. 4 at 14.
474. The January 20, 1987 MRI report concludes that the abnormality
seen in the MRI is the result of normal postoperative changes. P.
Ex. 4 at 14.
475. The three MRI reports -- March 26, 1986; August 15, 1986; and
January 20, 1987 -- collectively establish that there was no
progression of J.W.'s brain cancer during that period of time. Tr.
at 1548, 1560 - 1561, 2875 - 2876; Findings 468 - 474.
476. Excepting the March 26, 1986 MRI, no other MRI report from
February 11, 1985 through November 22, 1989 notes any active
metastasis or presence of disease in J.W. I.G. Ex. 3E, 3Q
(especially at 12 - 22); Findings 468 - 475.
477. J.W. did not have cancer (or metastatic melanoma) subsequent
to his surgery in 1980. Tr. at 464, 514 - 515, 855 - 859; I.G. Ex.
3E, 3Q.
478. J.W. did not have cancer subsequent to his workup at the
Anderson Hospital in May and June of 1983. Findings 455 - 477; Tr.
at 428 - 515, 837 - 864, 1035 - 1049, 1071 - 1074, 1525 - 1563
(especially at 1531 - 1532), 2873 - 2874.
479. J.W. had epilepsy since the age of 12. I.G. Ex. 3Q.
480. Petitioner was aware of J.W.'s epilepsy. I.G. Ex. 3Q at 66;
Tr. at 2383.
481. Petitioner failed to take into account J.W.'s history of
epilepsy as a possible cause of J.W.'s seizures. Findings 479 -
480; Tr. at 433; I.G. Ex. 3Q at 66.
482. J.W.'s seizures were the result of his epilepsy and not the
result of any metastatic disease. Tr. at 428 - 515 (especially at
433), 837 - 864, 1035 - 1049, 1071 - 1074, 1464 - 1524, 2872 -
2879, 2931 - 2937; I.G. Ex. 3E, 3Q; Findings 477 - 481.
483. Petitioner has failed to show any persuasive evidence that
J.W. had any type of cancer subsequent to J.W.'s surgery in 1980.
I.G. Ex. 3E, 3Q; Tr. at 428 - 515, 837 - 864, 1035 - 1049, 1071 -
1074, 1464 - 1524, 2378 - 2469, 2872 - 2879, 2931 - 2937.
484. Petitioner concluded that J.W. had melanoma 16/ that had
metastasized to the brain upon first examining J.W. in 1979. P.
Ex. 4; Tr. at 2383 - 2385.
485. Petitioner remained convinced that J.W. had metastatic
melanoma such that, from February 11, 1985 through November 22,
1989, Petitioner administered chemotherapy to J.W. to treat him for
melanoma that had metastasized to the brain. Tr. at 2378 - 2469;
P. Ex. 4; I.G. Ex. 3E, 3Q.
486. Petitioner's conclusion that J.W. had melanoma that had
metastasized to the brain at any time subsequent to 1980 is
directly contradicted by the evidence of record. P. Ex. 4; Tr. at
428 - 515, 837 - 864, 1035 - 1049, 1071 - 1074, 1464 - 1524,
(especially 2378 - 2469), 2872 - 2879, 2931 - 2937; I.G. Ex. 3E,
3Q; Finding 485.
487. Chemotherapy treatments are unlikely to have any effect on a
cancer that has spread to the brain because of the difficulty of
getting therapeutic doses of chemotherapy through the barrier
between the brain and the bloodstream. Tr. at 2876.
488. The professionally recognized standard of health care for
treating J.W. from February 11, 1985 through November 22, 1989 was
to observe J.W. and treat him with antiepileptic medications. Tr.
at 855 - 859; I.G. Ex. 3E, 3Q.
489. Petitioner's treatment of J.W. with chemotherapy drugs from
February 11, 1985 through November 22, 1989 was below
professionally recognized standards of health care and
substantially in excess of J.W.'s needs. 17/ Findings 455 - 488;
Tr. at 428 - 515 (especially at 465), 837 - 864, 1035 - 1049, 1071
- 1074, 1464 - 1524.
490. Petitioner did not refer J.W. to a radiation oncologist
subsequent to February 11, 1985. I.G. Ex. 3E, 3Q.
CASE Petitioner documented that he administered BCNU to J.W. from
April 11, 1985 through July 6, 1989. I.G. Ex. 3E, 3Q.
492. The amount of BCNU that Petitioner documented that he gave to
J.W. is a lethal dose that would have killed J.W. had J.W. received
it. Tr. at 845, 1533.
493. J.W. did not die from the effects of BCNU. I.G. Ex. 3E, 3Q.
494. J.W. did not receive BCNU in the amounts indicated by
Petitioner's flow sheets. Finding 491 - 493.
495. It was below professionally recognized standards of health
care for Petitioner to document that he administered an amount of
BCNU to J.W. that J.W. did not receive. Findings 21 - 29, 494.
496. Petitioner's administration of BCNU to J.W. from April 11,
1985 through July 6, 1989 was below professionally recognized
standards of health care and substantially in excess of J.W.'s
needs, due to the following: J.W. did not have evidence of
metastatic melanoma in his brain at any time subsequent to 1983,
and Petitioner administered BCNU to J.W. at irregular and varied
intervals. Tr. at 428 - 515, 837 - 864, 1035 - 1049, 1071 - 1074,
1525 - 1563; I.G. Ex. 3E, 3Q; Findings 491 - 495.
497. Given the irregular intervals at which Petitioner administered
BCNU to J.W., Petitioner's administration of BCNU to J.W. from
April 11, 1985 through July 6, 1989 was below professionally
recognized standards of health care. Tr. at 428 - 515, 837 - 864,
1035 - 1049, 1071 - 1074, 1525 - 1563; I.G. Ex. 3E, 3Q.
498. Petitioner documented in J.W.'s chart that he administered the
drug Bleomycin to J.W. on multiple occasions between June 2, 1988
through March 2, 1989. I.G. Ex. 3E, 3Q (especially at 146 - 148).
499. The drug Bleomycin does not have any effect on melanoma. Tr.
at 449 - 451.
500. The drug Bleomycin has adverse side effects such as causing
lung damage. Finding 252.
501. It was harmful to J.W.'s health, safety, and well-being and of
no medical benefit to J.W. for Petitioner to administer Bleomycin
to J.W. in the amounts Petitioner documented he administered to
J.W. I.G. Ex. 3E, 3Q; Findings 498 - 500.
502. Petitioner's administration of Bleomycin to J.W. at sporadic
intervals -- June 2, 1988 through March 2, 1989 -- was below
professionally recognized standards of health care and
substantially in excess of J.W.'s needs. I.G. Ex. 3E, 3Q
(especially at 146 - 148); Tr. at 428 - 515 (especially at 450 -
451), 837 - 864, 1035 - 1049, 1071 - 1074, 1525 - 1563; Findings
498 - 501.
503. Petitioner documented in J.W.'s chart that he administered the
drug Vincristine to J.W. on multiple occasions from April 6, 1985
through September 7, 1989. I.G. Ex. 3E, 3Q; Tr. at 453 - 454.
504. Vincristine is not a drug that is useful or effective in the
treatment of metastatic melanoma. Tr. at 453 - 454.
505. Petitioner documented that he administered Vincristine to J.W.
in an amount that would have left J.W. unable to walk. Tr. at 448
- 449.
506. There is no documentation in J.W.'s chart that he suffered any
form of paralysis from Vincristine. I.G. Ex. 3E, 3Q.
507. Petitioner did not administer the drug Vincristine to J.W. in
the amounts he documented in J.W.'s flow sheet. Findings 503 -
506.
508. Petitioner administered Vincristine to J.W. in such a manner
that he jeopardized J.W.'s health, safety, and well-being.
Findings 24 - 29, 42, 507.
509. Petitioner's administration of Vincristine to J.W. at sporadic
intervals from April 11, 1985 through September 7, 1989 was below
professionally recognized standards of health care and
substantially in excess of J.W.'s needs. I.G. Ex. 3E, 3Q; Tr. at
428 - 515, 837 - 864, 1035 - 1049, 1071 - 1074, 1525 - 1563;
Findings 503 - 508.
510. Assuming Petitioner was convinced that the biopsies of J.W. at
the Anderson Hospital were incorrect, professionally recognized
standards of health care dictated that Petitioner order another
biopsy taken to confirm the presence of cancer. Tr. at 1546 -
1549.
511. Because Petitioner was aware of the information contained in
the three MRIs, J.W.'s medical history, and the negative biopsy
from the Anderson Hospital, it was below professionally recognized
standards of health care and substantially in excess of J.W.'s
needs for Petitioner to treat J.W. with chemotherapy without
performing a biopsy to confirm the presence of cancer. Tr. at 1546
- 1549; Findings 455 - 486, 510.
512. Petitioner's treatment of J.W. over a four-year period with
chemotherapy, from 1985 through 1989, was below professionally
recognized standards of health care and substantially in excess of
J.W.'s needs. Findings 455 - 511.
513. Even assuming J.W. did have cancer subsequent to his surgery
in 1980 at the Anderson Hospital, professionally recognized
standards of health care dictated that Petitioner should have
referred J.W. to a radiation oncologist for a consultation before
administering chemotherapy. Tr. at 857, 1561, 2876; Findings 455
- 511.
514. Petitioner's assertion that he did not refer J.W. to a
radiation oncologist because J.W. could not tolerate any more
radiation is not supported by the evidence of record and is not
credible. I.G. Ex. 3E, 3Q; Tr. at 2392.
515. Petitioner's failure to refer J.W. to a radiation oncologist
before administering chemotherapy to him in 1985 was below
professionally recognized standards of health care. Tr. at 2392.
516. Petitioner's misdiagnosis of J.W.'s condition and
administration of chemotherapy drugs to J.W. between April 11, 1985
and September 7, 1989 18/ subjected J.W. to serious and unnecessary
risks. I.G. Ex. 3Q; Findings 455 - 515.
517. Even assuming that Petitioner's decision to treat J.W. with
chemotherapy was in accordance with professionally recognized
standards of health care (which it was not), the dosages Petitioner
gave to J.W. as documented in the flow sheet were below
professionally recognized standards of health care and
substantially in excess of J.W.'s needs. Tr. at 1527; I.G. Ex. 3E,
3Q.
518. Petitioner documented in J.W.'s flow sheet that he gave J.W.
the drug DTIC in sporadic dosages of 150 milligrams. 19/ See,
e.g., I.G. Ex. 3Q at 145.
519. The appropriate method for administration of DTIC is to give
between 125 - 250 milligrams per square meter (body surface area)
for five consecutive days. Tr. at 1534.
520. J.W. was 6 feet 1 inch tall, and weighed 195 pounds, giving
him a body surface area in excess of one square meter. See I.G.
Ex. 3Q at 54.
521. Petitioner's administration of DTIC to J.W. was below
professionally recognized standards of health care, in that
Petitioner administered doses of DTIC in an erratic and sporadic
manner and that Petitioner administered DTIC to J.W. eight years
after the last evidence of tumor. I.G. Ex. 3E, 3Q; Tr. at 454;
Findings 518 - 520.
522. For purposes of this Decision, the term "protocol" means the
treatment of cancer patients with specified types and dosages of
chemotherapy drugs, administered at specific intervals. See Tr. at
1534 - 1535, 1554 - 1555; P. Ex. 4
523. Petitioner asserts that he administered chemotherapy drugs to
J.W. in accordance with the BOLD protocol. 20/ Tr. at 2378 - 2469;
P. Ex. 4.
524. The types of drugs Petitioner documented that he gave to J.W.
are not in accordance with the BOLD protocol. Tr. at 1534 - 1554.
525. The dosages of drugs Petitioner documented that he gave to
J.W. are not in accordance with the BOLD protocol. Tr. at 1534 -
1554.
526. The frequency of administration of the drugs Petitioner
documented that he gave to J.W. are not in accordance with the BOLD
protocol. Tr. at 1534 - 1554.
527. The method of administration of the drugs Petitioner
documented that he gave to J.W. are not in accordance with the BOLD
protocol. Tr. at 1534 - 1554.
528. The BOLD protocol is not effective against metastatic
melanoma, except in some patients with soft tissue or lung
metastasis. P. Ex. 4 at 17.
529. J.W. did not have either soft tissue or lung metastasis. I.G.
Ex. 3E, 3Q; Tr. at 1536.
530. Petitioner's contention that he administered the BOLD protocol
to J.W. is not credible. P. Ex. 4; Findings 522 - 529.
531. Petitioner's contention that he administered the BOLD protocol
to J.W. is an attempt to justify the medically inappropriate course
of treatment and administration of drugs that Petitioner gave to
J.W. Findings 522 - 530.
532. Petitioner documented that he ordered numerous CEA (carcino
embryonic antigen) tests for J.W. between February 1985 and
November 1989. I.G. Ex. 3Q; see Findings 48 - 50.
533. Malignant melanoma does not produce CEA. Tr. at 860.
534. CEA tests are useless in the diagnosis and treatment of
malignant melanoma. Finding 533; Tr. at 860.
535. Petitioner's ordering of CEA tests for J.W. from February 1985
to November 1989 was below professionally recognized standards of
health care and substantially in excess of J.W.'s needs. Tr. at
860; Findings 532 - 534.
CASE Petitioner documented that he ordered complete blood counts
(CBCs) and numerous platelet counts for J.W. from February 1985 to
November 1989. I.G. Ex. 3E, 3Q.
537. The CBCs and platelet counts ordered by Petitioner for J.W.
from February 1985 to November 1989 were not medically necessary.
Tr. at 1535, 1556; Finding 536.
538. The CBCs and platelet counts ordered by Petitioner from
February 1985 to November 1989 for J.W. were substantially in
excess of J.W.'s needs. Finding 537.
539. Petitioner's ordering of CBCs and platelet counts for J.W.
from February 1985 to November 1989 was below professionally
recognized standards of health care. Tr. at 1535, 1556; Findings
536 - 538.
540. None of the treatment administered by Petitioner subsequent to
J.W.'s surgery in 1983 had any bearing on the fact that J.W.'s
cancer stopped growing subsequent to that surgery, without any
recurrence. Tr. at 2932; see Tr. at 428 - 515, 837 - 864, 1035 -
1049, 1071 - 1074, 1525 - 1563; Findings 455 - 539; I.G. Ex. 3E,
3Q.
541. Petitioner jeopardized the health and well-being of J.W. by
incorrectly diagnosing and treating his epileptic symptoms as
metastatic melanoma. Tr. at 428 - 515, 837 - 864, 1035 - 1049,
1071- 1074, 1525 - 1563.
542. Petitioner furnished or caused to be furnished to J.W. items
and services that were substantially in excess of his needs and of
a quality which failed to meet professionally recognized standards
of health care. I.G. Ex. 3E, 3Q, 8; Tr. at 428 - 515, 837 - 864,
1035 - 1049,
1071 - 1074, 1525 - 1563, 2378 - 2469, 2863 - 2872; Findings 455 -
541.
543. Petitioner's attempts to justify his medical treatment of J.W.
are inconsistent, insufficient, and not credible. P. Ex. 4; Tr. at
428 - 515, 837 - 864, 1035 - 1049, 1071 - 1074, 1525 - 1563, 2378
- 2469, 2863 - 2872.
Petitioner's testimony regarding his care and treatment of J.W. is
indicative of Petitioner's lack of credibility and lack of
trustworthiness.
544. Petitioner's assertion that the MRI findings in 1986 and 1987
definitely showed that J.W. had metastatic melanoma in his brain is
directly contradicted by the evidence of record and is indicative
of Petitioner's lack of credibility and lack of trustworthiness.
Tr. at 2399, 2411; Findings 455 - 543.
545. Petitioner's claim that, as of June 2, 1988, he placed J.W. on
the BOLD regimen is entirely contradicted by the evidence of record
and is indicative of Petitioner's lack of credibility and lack of
trustworthiness. Tr. at 2400 - 2404; Findings 522 - 531.
546. Petitioner's assertion that persons who reviewed Petitioner's
treatment of J.W. marvelled at the fact that he had cured J.W. of
his metastatic melanoma is entirely contradicted by the evidence
and is indicative of Petitioner's willingness to misstate the
record, and is further indicative of Petitioner's lack of
credibility and lack of trustworthiness. Tr. at 2405; Findings 455
- 545.
547. Petitioner was unable to remember the name of the doctor to
whom he claims to have referred J.W. and was unable to point to a
chart or any documentation to support his assertion that he
referred J.W. to another doctor for further surgery. Tr. at 2378
- 2469.
548. Petitioner's assertion that he referred J.W. to another doctor
for further surgery is not supported by any evidence in the record
and is not credible. I.G. Ex. 3E, 3N; Tr. at 2412 - 2414.
549. Petitioner's assertion that he referred J.W. to another doctor
for further surgery is indicative of Petitioner's lack of
credibility and lack of trustworthiness. Finding 548.
550. Petitioner's assertion that there is no maximum safe dosage of
Vincristine as long as the patient exhibits no side effects is
directly contradicted by the evidence of record, is not credible,
and is indicative of Petitioner's willingness to resort to
distorting facts to justify his treatment of patients. Findings 21
- 28, 42; Tr. at 2420.
551. Petitioner gave self-contradictory, evasive testimony when
responding to questions regarding whether the entries in J.W.'s
flow sheet contained the actual doses of Vincristine Petitioner
administered to J.W. Tr. at 2418 - 2421; I.G. Ex. 3Q.
552. Petitioner was unable to read and interpret his own
documentation in J.W.'s flow sheet. Tr. at 2423 - 2424; I.G. Ex.
3Q at 142.
553. The customary dosage of Vincristine for adults is 1.4
milligrams per meter squared. I.G. Ex. 3V at 20.
554. Petitioner was unable to articulate any reason for him to have
administered Vincristine to J.W. in a dosage at variance with the
usual dosage. Findings 550 - 553; I.G. Ex. 3Q at 142; Tr. at 2423
- 2425.
555. Petitioner's assertion that he was following the BOLD protocol
in treating J.W. is contradicted by Petitioner's own testimony.
Findings 530 - 531; Tr. at 2424 - 2432.
556. Petitioner is unable to give any legitimate medical reason as
to why he altered the treatment called for in the BOLD protocol
when he administered chemotherapy to J.W. Tr. at 2425 - 2432.
557. Petitioner's assertion that he did not administer the drugs
CCNU, DTIC, or Vincristine in accordance with the BOLD protocol in
order to make allowances for J.W.'s chemotherapy-induced sickness
and inability to come in for treatment is not supported by the
evidence. I.G. Ex. 3E, 3Q; Tr. at 428 - 515, 837 - 864, 1035 -
1049, 1525 - 1563, 2425 - 2432.
558. Petitioner's assertion that he did not administer the drugs
CCNU, DTIC, or Vincristine in accordance with the BOLD protocol in
order to make allowances for J.W.'s chemotherapy-induced sickness
and inability to come to Petitioner's office for treatment is
directly contradicted by evidence indicating that Petitioner
administered these drugs to J.W. in doses that were more than what
was customarily given and thereby actually increased the chances of
J.W. having chemotherapy-induced sickness and side effects. Tr. at
2425 - 2432.
559. Petitioner's stated reasons for deviating from the BOLD
protocol in providing treatment to J.W. are not credible and are
indicative of Petitioner's lack of credibility and lack of
trustworthiness. Tr. at 2429; Findings 555 - 558.
560. Petitioner's evasive testimony when confronted with the fact
that his own exhibit shows that the BOLD protocol only has a modest
response rate in treating metastatic melanoma is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2433 - 2434; P. Ex. 4 at 20.
561. Petitioner's assertion that he was not using CEA as a
diagnostic test for J.W.'s malignant melanoma, but rather because
he was checking the accuracy of the CEA test for Abbott Labs, is
unsupported by any affirmative evidence, is contradicted by the
fact that Petitioner billed Medicare for the CEA tests he
administered to J.W., is not credible, and is indicative of
Petitioner's lack of trustworthiness. Tr. at 2108 - 2109, 2345 -
2346; I.G. Ex. 3E, 3Q.
562. Petitioner admitted that he did not always make complete
entries in J.W.'s charts. Tr. at 2438 - 2439.
563. Petitioner's failure to make complete entries in J.W.'s charts
is indicative of his inability to follow professionally recognized
standards of health care even when he is cognizant of such
standards. Findings 27, 562.
564. Petitioner's assertion that the type and amount of drugs he
administered to J.W. from February 11, 1985 through November 22,
1989, is a "proven" combination, is directly contradicted by the
evidence of record, is not credible, and is indicative of
Petitioner's lack of trustworthiness. Tr. at 2444; Findings 455 -
543, 553 - 560.
565. Petitioner is unable to provide any valid medical rationale
for administering the types and dosages of drugs he documented he
administered to J.W. from February 11, 1985 through November 22,
1989. Tr. at 2378 - 2469; Findings 455 - 564.
566. Petitioner is unable to provide any legitimate or credible
reason for departing from the BOLD protocol by modifying the types
and dosages of drugs he documented he administered to J.W.
subsequent to June 2, 1988. Findings 555 - 560; Tr. at 2444 -
2467.
567. Petitioner's testimony regarding his treatment of J.W. from
February 11, 1985 through November 2, 1989 demonstrates
Petitioner's lack of ability to practice oncology in accordance
with professionally recognized standards of health care and is
indicative of Petitioner's lack of trustworthiness. Tr. at 2378 -
2469; P. Ex. 4; I.G. Ex. 3E, 3N; Findings 455 - 566.
Petitioner's treatment of patient J.L.
568. J.L. was a 64-year-old man who had his left lung surgically
removed in February 1986 and who had inoperable, advanced squamous
cell cancer of the lung. I.G. Ex. 3R at 20 - 23; Tr. at 516, 518,
865.
569. Chemotherapy does not, to any significant degree, cure,
prevent the spread of, or prevent the growth of squamous cell
cancer. Tr. at 516 - 520, 869 - 870.
570. Petitioner first became involved in the treatment of J.L. on
March 12, 1986. I.G. Ex. 3R.
571. Petitioner's treatment of J.L. in 1986 only is at issue before
me in this case. I.G. Ex. 3R at 1; Tr. at 866.
572. On March 12, 1986, Petitioner started J.L. on a regimen of
chemotherapy consisting of Cytoxan, Methotrexate, and Adriamycin,
administered on virtually a weekly basis through December 19, 1986.
I.G. Ex. 3R at 2, 12 - 14.
573. On May 16, 1986, Petitioner administered 5FU to J.L. I.G. Ex.
3R at 2, 12 - 14.
574. On August 15, September 5, and October 3, 1986, Petitioner
administered doses of Bleomycin to J.L. I.G. Ex. 3R at 2, 12 - 14.
575. The standard of care for the treatment of J.L.'s squamous cell
cancer in 1986 was to administer localized radiation therapy to the
tumor that remained in J.L.'s chest. Tr. at 520, 867 - 869.
576. Chemotherapy does not predictably prolong survival in
patients, such as J.L., who have squamous cell lung cancer. Tr. at
515 - 575, 869 - 870.
577. In a letter dated October 15, 1986, another physician
recommended that Petitioner treat J.L. with localized radiation.
Tr. at 868; I.G. Ex. 3R at 48.
578. Professionally recognized standards of health care for the
treatment of patients, such as J.L., with squamous cell lung cancer
mandated that an oncologist who did not use radiation therapy had
to have documented his reasons for not doing so before he
administered chemotherapy. I.G. Ex. 3E, 3R; Tr. at 515 - 575, 864
- 889 (especially at 873 - 874), 1049 - 1056, 1077 - 1081.
579. Petitioner did not document his reasons for failing to
administer radiation therapy to J.L. I.G. Ex. 3E, 3R; P. Ex. 5.
580. It was below professionally recognized standards of health
care for Petitioner not to document his reasons for failing to
administer radiation therapy to J.L. before using chemotherapy to
treat J.L. Findings 578 - 579.
581. Professionally recognized standards of health care for the
treatment of J.L. mandated that, once Petitioner chose to
administer chemotherapy, he should have monitored the growth or
shrinkage of J.L.'s cancer to enable him to know whether the
treatment he was administering was effective or not effective. Tr.
at 864 - 889, 1049 - 1056, 1077 - 1081.
582. Petitioner failed to monitor the progression or decline of
J.L.'s cancer in 1986 sufficiently to enable him to know whether
J.L.'s cancer was growing or shrinking. I.G. Ex. 3E, 3R; Tr. at
864 - 889, 1049 - 1056, 1077 - 1081.
583. Petitioner's failure to monitor the progression or decline of
J.L.'s cancer in 1986 was below professionally recognized standards
of health care. Findings 581 - 582.
584. Professionally recognized standards of health care mandated
that Petitioner's administration of chemotherapy to J.L. be
discontinued or modified when it was not effective, such as is the
case in the face of progressive disease. Tr. at 871.
585. There is insufficient evidence to support the I.G.'s
contention that, in this case during 1986, Petitioner administered
to J.L. chemotherapy treatments in the face of progressive disease.
Tr. at 876.
586. Petitioner's decision to administer chemotherapy to J.L. in
1986, while somewhat at odds with what most oncologists would have
generally done, was within professionally recognized standards of
health care. Tr. at 869 - 870.
587. The drugs that were used by Petitioner to treat J.L. are
sometimes used in treating squamous cell cancer, provided that
these drugs are given in appropriate doses. I.G. Ex. 3E, 3R; Tr.
at 515 - 575, 864 - 889, 1049 - 1056, 1077 - 1081.
588. The drugs that Petitioner administered in 1986 to treat J.L.
are never useful in treating squamous cell cancer in the amounts
Petitioner documented that he administered to J.L. I.G. Ex. 3E,
3R; Tr. at 515 - 575, 864 - 889, 1049 - 1056, 1077 - 1081.
589. The doses of Adriamycin, Cytoxan, and Methotrexate that
Petitioner documented that he gave to J.L. in 1986 are supralethal
doses which would have killed J.L. I.G. Ex. 3E, 3R; Tr. at 515 -
575, 864 - 889 (especially at 876 - 881), 1049 - 1056, 1077 - 1081.
590. J.L. did not die from the effects of supralethal doses of
Adriamycin, Cytoxan, or Methotrexate that Petitioner documented
J.L. received in 1986. I.G. Ex. 3E, 3R.
591. Chemotherapy always has adverse effects on normal tissue when
it is given in doses that are sufficient to cause shrinkage in the
growth of lung cancer. Tr. at 876 - 877; Findings 21 - 23.
592. Had J.L. received amounts of Adriamycin, Cytoxan, or
Methotrexate in 1986 sufficient to cause shrinkage in J.L.'s
cancer, J.L. would have exhibited the adverse side effects in his
normal tissues. Tr. at 526 - 535, 876 - 883.
593. J.L.'s normal tissues exhibited no effects in 1986 from the
chemotherapy treatment he received from Petitioner. I.G. Ex. 3E,
3R; Tr. at 526 - 535, 876 - 877.
594. J.L. did not receive the doses of Adriamycin, Cytoxan, and
Methotrexate that Petitioner claims to have administered to him in
1986. Tr. at 526 - 535, 871, 876 - 882; Findings 592 - 593.
595. In 1986, J.L. received doses of Adriamycin, Cytoxan, and
Methotrexate which were insufficient to have any effect on either
J.L.'s cancer or his normal tissues. Tr. at 880 - 883; Findings
591 - 593.
596. Petitioner did not administer chemotherapy to J.L. in 1986 in
an amount that could cause shrinkage of his cancer. Tr. at 881 -
883; Finding 595.
597. Petitioner failed to administer chemotherapy to J.L. in 1986
in an amount that could have improved J.L.'s condition. Tr. at 881
- 883; Findings 591 - 596.
598. It was below professionally recognized standards of health
care for Petitioner not to have administered chemotherapy to J.L.
in 1986 in an amount that could have improved J.L.'s condition.
Findings 591 - 597.
599. It was below professionally recognized standards of health
care for Petitioner in 1986 to document in the flow sheet that J.L.
received an amount of chemotherapy drugs that he did not actually
receive. Tr. at 515 - 575, 876 - 882; Findings 24 - 29, 587 - 598.
600. Petitioner jeopardized J.L.'s health, safety, and well-being
in 1986 by documenting in J.L's flow sheet that J.L. had received
an amount of drugs that J.L. did not actually receive. Findings 21
- 29, 599.
601. In 1986, Petitioner jeopardized J.L.'s health, safety, and
well-being by subjecting J.L. to subtherapeutic doses of
chemotherapy that could actually increase the cancer's resistance
to future treatments. Tr. at 1389; see Finding 171.
602. On virtually every occasion on which Petitioner administered
chemotherapy to J.L. in 1986, he did so via infusions over a period
of one to eight hours. I.G. Ex. 3E, 3R.
603. Infusions of one and eight hours served no medical purpose in
the treatment of J.L. (at any time, including 1986). Tr. at 515 -
575, 880; I.G. Ex. 3E, 3R.
604. It was substantially in excess of J.L.'s needs and below
professionally recognized standards of health care for Petitioner
to have administered chemotherapy to J.L. in 1986 via one- and
eight-hour infusions. Findings 568 - 603; I.G. Ex. 3E, 3R; see Tr.
at 515 - 575, 864 - 889, 1049 - 1056, 1077 - 1081, 2879 - 2886.
605. Petitioner admits that he did not administer infusions to J.L.
of 24 hours or more despite billing Medicare for infusions 24 hours
or more. P. Ex. 17 at 25; Tr. at 2509.
606. Petitioner's statement that, because he administered
chemotherapy to J.L. via infusion, it was not critical to keep
track of the total amount of chemotherapy J.L. received in 1986 is
contradicted by the evidence, contradicted by Petitioner's own
testimony, is not credible, and is indicative of Petitioner's lack
of trustworthiness. Tr. at 2509 - 2512; Findings 21 - 29.
607. Petitioner's assertion that, by administering chemotherapy to
J.L. in 1986 via infusion, he caused J.L. to have a dramatic
reduction of cardiac toxicity, better response rate, and less side
effects, is directly contradicted by the evidence and is indicative
of Petitioner's lack of credibility and lack of trustworthiness.
Tr. at 2512; Findings 568 - 603.
608. Petitioner's assertion that an eight-hour infusion is an
accepted method of administering chemotherapy because Medicare has
a code for billing eight-hour infusions is directly contradicted by
the evidence, is not credible, and is indicative of Petitioner's
lack of trustworthiness. Tr. at 1170 - 1171, 2513; P. Ex. 19 at
11; Finding 912 (appearing subsequently in this section).
609. None of the CBCs, venipunctures, and platelet counts given by
Petitioner to J.L. in 1986 were medically necessary. Tr. at 541 -
543, 886 - 889; I.G. Ex. 3E, 3R.
610. All of the CBCs, venipunctures, and platelet counts given by
Petitioner to J.L. in 1986 were substantially in excess of J.L.'s
needs. I.G. Ex. 3E, 3R; Tr. at 515 - 575, 864 - 889, 1049 - 1056,
1077 - 1081; Finding 609.
611. A study cited by Petitioner to support his administration of
Adriamycin, Cytoxan, and Methotrexate to J.L. for the treatment of
J.L.'s squamous cell carcinoma is a study which relates to
adenocarcinoma and not squamous cell carcinoma. P. Ex. 5 at 9
(especially chart marked in the text as "Table 18-41").
612. J.L. had squamous cell carcinoma, which is not an
adenocarcinoma. Tr. at 2880 - 2883.
613. Petitioner did not treat J.L. using the same types and amounts
of chemotherapy referenced in the study he cited. P. Ex. 5; Tr. at
2880 - 2883.
614. Petitioner gave evasive answers when questioned about the
efficacy of chemotherapy and radiation in the treatment of squamous
cell cancer. Tr. at 2516 - 2517.
615. The test results cited by Petitioner to support his treatment
of J.L. do not in fact support the means Petitioner used to treat
J.L. in 1986. P. Ex. 5; I.G. Ex. 3E, 3R; Tr. at 889, 2880 - 2883;
Findings 611 - 614.
616. Petitioner's management of J.L.'s case in 1986 jeopardized the
health, safety, and well-being of J.L. Findings 568 - 615.
617. Petitioner provided to J.L. in 1986 items or services that
were substantially in excess of J.L.'s needs and below
professionally recognized standards of health care. I.G. Ex. 3E,
3R; P. Ex. 5; Tr. at 515 - 575, 864 - 889, 1049 - 1056, 1077 -
1081, 2470 - 2535, 2879 - 2886; Findings 568 - 615.
618. Petitioner's attempts to justify his treatment of J.L. in 1986
are inconsistent, inadequate, and not credible. I.G. Ex. 3E, 3R;
P. Ex. 5; Tr. at 515 - 575, 864 - 889, 1049 - 1056, 1077 - 1081,
2470 - 2523, 2879 - 2886; Findings 568 - 617.
Petitioner's testimony regarding his treatment of J.L. is
indicative of Petitioner's lack of credibility and lack of
trustworthiness.
619. Petitioner's assertion that his administration of chemotherapy
to J.L. from March 12, 1986 through December 12, 1986 caused J.L.
to have no evidence of measurable cancer such that Petitioner could
discontinue the treatment is directly contradicted by the evidence,
is not credible, and is indicative of Petitioner's lack of
trustworthiness. Tr. at 2473 - 2476; P. Ex. 5; I.G. Ex. 3E, 3R;
Tr. at 515 - 575, 864 - 889, 1049 - 1056, 1077 - 1081.
620. Petitioner's assertion that P. Ex. 5 supports the treatment he
documented that he provided to J.L. from March 12, 1986 through
December 12, 1986 is directly contradicted by the evidence, is not
credible, and is indicative of Petitioner's lack of
trustworthiness. P. Ex. 5; I.G. Ex. 3E, 3R; Tr. at 567, 889, 2474.
621. Petitioner's statement that there is significant evidence from
literature and seminars that support his use of infusional
chemotherapy is misleading in that infusional chemotherapy occurs
over a period of 24 to 72 hours, whereas Petitioner administered
infusions over a period of one to eight hours to J.L. Tr. at 2487
- 2488; I.G. Ex. 3E, 3R; Findings 11 - 20.
622. Petitioner's statement that there is significant evidence from
literature and seminars that support his use of infusional
chemotherapy is indicative of his willingness to use misleading
statements to justify his treatment of patients and is further
indicative of his lack of credibility and lack of trustworthiness.
Finding 621.
623. Petitioner admits that it is important for him to know the
precise quantities of chemotherapy drugs he administered to J.L. in
1986. Tr. at 2502 - 2512.
624. Petitioner's contradictory, evasive testimony in response to
questions asking him about how much chemotherapy he administered to
J.L. in 1986 is indicative of Petitioner's lack of credibility and
lack of trustworthiness. Tr. at 2502 - 2512.
625. Petitioner's evasive answers in response to questioning about
the efficacy of chemotherapy and radiation are indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2516 - 2517; I.G. Ex. 3R at 48.
Petitioner's treatment of patient H.S.
626. H.S. was an 80-year-old man with cardiac disease and chronic
obstructive pulmonary disease who was first seen by Petitioner on
April 30, 1985. I.G. Ex. 3S at 504, 559 - 560; Tr. at 578.
627. H.S. was treated by Petitioner from April 30, 1985 through
April 1988. I.G. Ex. 3S; Tr. at 890.
628. H.S. was diagnosed by another physician as having Kaposi's
sarcoma. Tr. at 578.
629. Kaposi's sarcoma is a disease that may be cancer-related which
causes an overgrowth of irregular, tumor-like cells. Tr. at 581 -
582.
630. Kaposi's sarcoma occurs in two forms. Tr. at 581 - 586.
631. One form of Kaposi's sarcoma is a slow growing, almost always
nonlethal form which occurs predominately in elderly people and
which causes localized skin lesions usually limited to the lower
extremities with no
involvement of the internal organs. Tr. at 581 - 586, 890 - 892,
1565.
632. The second form of Kaposi's sarcoma is a rapid growing form
that occurs in persons that have AIDS. This form tends to cause
lesions involving the head, neck, upper body, internal organs, and
parts of the body other than the skin. Tr. at 581 - 586, 890 -
892.
633. H.S. had non-AIDS related Kaposi's sarcoma. I.G. Ex. 3E, 3S;
Tr. at 581 - 586, 890 - 892, 1564 - 1566.
634. Localized radiation therapy is almost always effective in
treating non-AIDS related Kaposi's sarcoma. Tr. at 898 - 890,
1566.
635. Petitioner did not administer radiation therapy to H.S. I.G.
Ex. 3E, 3S.
636. Petitioner documented that he administered Adriamycin to H.S.
in an amount sufficient to cause severe suppression of H.S.'s blood
counts. Tr. at 905.
637. H.S. did not exhibit any suppression of his blood counts.
I.G. Ex. 3S.
638. Petitioner documented that he administered to H.S. an amount
of Adriamycin sufficient to kill H.S. Tr. at 903 - 905.
639. H.S. did not die from the effects caused by excessive amounts
of Adriamycin. I.G. Ex. 3S.
DC Petitioner did not administer Adriamycin to H.S. in amounts
approaching anywhere near the amounts in H.S.'s flow sheet.
Findings 636 - 639; Tr. at 894 - 909, 1563 - 1608.
641. It was below professionally recognized standards of health
care and jeopardized H.S.'s health, safety, and well-being for
Petitioner to document in H.S.'s flow sheet that he administered
Adriamycin to H.S. in an amount that H.S. did not receive. Tr. at
894; Findings 15 - 29, 640.
642. The drug Velban can be effective in treating Kaposi's sarcoma
when it is used in therapeutic doses. Tr. at 901.
643. Administration of even one dose of Velban in the amount
documented in H.S.'s flow sheet would cause a significant decrease
in H.S.'s white blood cell counts. I.G. Ex. 3S at 21.
644. H.S. did not exhibit any decrease in his white blood cell
count associated with receiving therapeutic doses of the drug
Velban. I.G. Ex. 3E, 3S; Tr. at 890 - 909, 1056 - 1064.
645. Petitioner's administration of Velban to H.S. did not improve
H.S.'s Kaposi's sarcoma. I.G. Ex. 3E, 3S; Tr. at 900 - 903.
646. Petitioner failed to administer the drug Velban to H.S. in
therapeutic doses or amounts that could alleviate H.S.'s Kaposi's
sarcoma. I.G. Ex. 3E, 3S; Tr. at 900 - 903; Findings 642 - 645.
647. It was below professionally recognized standards of health
care for Petitioner to administer the drug Velban in doses to that
could not alleviate H.S.'s Kaposi's sarcoma. I.G. Ex. 3E, 3S; Tr.
at 900 - 902; Finding 646.
648. Petitioner's administration of the drugs Adriamycin,
Bleomycin, and Velban to H.S. via one and eight hour infusions was
not medically necessary. I.G. Ex. 3S; Tr. at 906; Findings 10 -
20.
649. Petitioner's administration of the drugs Adriamycin,
Bleomycin, and Velban to H.S. via one and eight hour infusions was
below professionally recognized standards of health care and
substantially in excess of H.S.'s needs. Findings 10 - 20, 648.
650. Petitioner failed to document the progression of H.S.'s
Kaposi's sarcoma over time sufficient to enable him to assess
whether the treatment he was administering to H.S. was not
effective. I.G. Ex. 3E, 3S; P. Ex. 24/1, 24/2, 25/1, 25/2 21/; Tr.
at 890 - 909, 1056 - 1064, 1563 - 1608.
651. It was below professionally recognized standards of health
care for Petitioner not to document the progression of H.S.'s
Kaposi's sarcoma over time sufficient to enable him to assess
whether the treatment
he was administering to H.S. was not effective. I.G. Ex. 3E, 3S;
P. Ex. 24/1, 24/2, 25/1, 25/2; Tr. at 890 - 909, 1056 - 1064, 1563
- 1608.
652. It was below professionally recognized standards of health
care for Petitioner not to document in H.S.'s chart why he chose
not to administer radiation therapy to treat H.S.'s Kaposi's
sarcoma. Tr. at 890 - 909, 1056 - 1064, 1563 - 1608.
653. It was below professionally recognized standards of health
care for Petitioner not to document that H.S. refused radiation
treatment before proceeding with chemotherapy treatment. Tr. at
907; I.G. Ex. 3E, 3S.
654. Petitioner did not stop the administration of the chemotherapy
drugs he was administering to H.S. when there was evidence that
H.S.'s Kaposi's sarcoma was progressing. Tr. at 890 - 909, 1056 -
1064, 1563 - 1608.
655. It was below professionally recognized standards of health
care for Petitioner to continue to administer a combination of
chemotherapy drugs to H.S. in the face of evidence that these drugs
were not effective in alleviating H.S.'s condition. Tr. at 577 -
678, 890 - 909, 1056 - 1064, 1563 - 1608.
656. It was below professionally recognized standards of health
care for Petitioner not to change the treatment he was
administering to H.S. in the face of progressive disease. Tr. at
577 - 678, 890 - 909, 1056 - 1064, 1563 - 1608.
657. A June 21, 1985 chest x-ray of H.S. showed a pulmonary nodule.
I.G. Ex. 3E, 3S; Tr. at 897.
658. H.S.'s pulmonary nodule later disappeared. I.G. Ex. 3E, 3S;
Tr. at 897.
659. Petitioner stated that the June 21, 1985 chest x-ray of H.S.
showed that: the pulmonary nodule was evidence of metastatic
cancer; his treatment of H.S. with chemotherapy was justified; and
the treatment he administered to H.S. was beneficial. Tr. at 2536
- 2643, 2652 - 2655.
660. Petitioner's testimony that the June 21, 1985 chest x-ray of
H.S. showed that: the pulmonary nodule was evidence of metastatic
cancer; his treatment of H.S. with chemotherapy was justified; and
the treatment he administered to H.S. was beneficial -- is
contradicted by the evidence of record and is not credible. I.G.
Ex. 3E, 3S; Tr. at 577 - 678, 890 - 909, 1056 - 1064, 1563 - 1608,
2536 - 2643 (especially at 2539 - 2545), 2886 - 2897, 2945 - 2957.
661. It was below professionally recognized standards of health
care for Petitioner to use the June 21, 1985 chest x-ray of H.S. as
a basis to subject H.S. to lengthy chemotherapy treatments. I.G.
Ex. 3E, 3S; Tr. at 577 - 678, 890 - 909, 1056 - 1064, 1563 - 1608,
2536 - 2643, 2886 - 2897, 2945 - 2957; Findings 657 - 660.
662. Petitioner's statement that the lung nodule that appeared on
H.S.'s chest x-ray was malignant is contradicted by the evidence of
record. I.G. Ex. 3E, 3S; Tr. at 577 - 678, 890 - 909, 1056 - 1064,
1563 - 1608, 2536 - 2643 (especially at 2544), 2886 - 2897, 2945 -
2957; Findings 657 - 661.
663. CEA plays no role in the monitoring of Kaposi's sarcoma. Tr.
at 905.
664. CEA played no role as a screening test in H.S.'s case. Tr. at
1569 - 1571.
665. Petitioner stated that he performed CEA tests on H.S. because
he was concerned that H.S. would get a second malignancy or
lymphoma. P. Ex. 6.
666. The CEA tests administered by Petitioner to H.S. were not
medically indicated or medically necessary. I.G. Ex. 3E, 3S; Tr.
at 890 - 909, 1569 - 1571.
667. The CEA tests administered by Petitioner were substantially in
excess of H.S.'s needs. Findings 628, 633, 663 - 666.
668. There is no documentation in the record that supports that
H.S. had pernicious anemia (which would necessitate vitamin B-12
injections). Tr. at 890 - 909, 1563 - 1608; I.G. Ex. 3E, 3S.
669. The venipunctures, vitamin B-12 injections, and platelet
counts that Petitioner administered to H.S. were medically
unnecessary. I.G. Ex. 3E, 3S; Tr. at 906; see Tr. at 577 - 678,
890 - 909, 1563 - 1608.
670. The venipunctures, vitamin B-12 injections, and platelet
counts that Petitioner administered to H.S. were substantially in
excess of H.S.'s needs. Findings 668 - 669.
671. Petitioner performed tests of H.S.'s Digoxin levels that were
substantially in excess of H.S.'s needs. Tr. at 908.
672. H.S. had chronic obstructive pulmonary disease during the
period of time Petitioner was administering Bleomycin to him. I.G.
Ex. 3S; Tr. at 1572.
673. The drug Bleomycin causes severe lung damage. Tr. at 1572;
Findings 43, 252.
674. The drug Bleomycin was contraindicated in the treatment of
H.S. Tr. at 1572.
675. Petitioner's administration of Bleomycin to H.S. was below
professionally recognized standards of health care and
substantially in excess of H.S.'s needs. Tr. at 1572; Findings 671
- 674.
676. H.S. was admitted to the hospital on April 16, 1988 with a
diagnosis of pneumonia of both lungs. I.G. Ex. 3S at 28.
677. Petitioner administered chemotherapy treatment consisting of
Bleomycin to H.S. on April 15, 1988 and billed for an intermediate
office visit. I.G. Ex. 3S at 231; Tr. at 1575 - 1576.
678. In 1988, an intermediate office visit consisted of an
examination of more than one body system, including examination of
the patient's heart, lungs, abdomen, and talking to the patient to
see how the patient was feeling. Tr. at 1577.
679. Petitioner should have found that H.S. had pneumonia had he
properly performed an intermediate office visit of H.S. on April
15, 1988. Tr. at 1574 - 1575.
680. Petitioner did not document that he found anything medically
wrong with H.S. when he examined him on April 15, 1988. I.G. Ex.
3S; Tr. at 1574 - 1575.
681. Petitioner's failure to document that he found anything
medically wrong with H.S. on April 15, 1988 was below
professionally recognized standards of health care. Tr. at 1574 -
1575; I.G. Ex. 3E, 3S; Findings 677 - 680.
682. Petitioner's failure to document that, when he examined H.S.
on April 15, 1988, H.S. had pneumonia requiring treatment raises a
serious question of whether Petitioner actually saw or examined
H.S. on April 15, 1988. Findings 677 - 681.
683. H.S. died on April 19, 1988. I.G. Ex. 3S at 25.
684. Petitioner's diagnosis of H.S. as having Kaposi's sarcoma that
had metastasized to other parts of H.S.'s body is not supported by
the evidence. Tr. at 577 - 678, 890 - 909, 1056 - 1064, 1563 -
1608, (especially at 2536 - 2643); P. Ex. 6; I. G. Ex. 3S.
685. Petitioner's statement that H.S. had Kaposi's sarcoma that
had metastasized to other parts of H.S.'s body is not credible and
is indicative of Petitioner's lack of trustworthiness. Tr. at 2538
- 2540; Finding 684.
686. Petitioner's statement that H.S. had a "hybrid type" of
Kaposi's sarcoma is not supported by the evidence. Tr. at 577 -
678, 890 - 909, 1056 - 1064, 1563 - 1608, 2536 - 2643 (especially
at 2541 - 2542), 2652 - 2655.
687. Petitioner's statement that H.S. had a "hybrid type" of
Kaposi's sarcoma is not credible. Finding 686.
688. Petitioner's statement that there is no standard of care for
the treatment of patients with Kaposi's sarcoma is directly
contradicted by the evidence. Tr. at 577 - 678, 890 - 909, 1056 -
1064, 1563 - 1608, (especially at 2542 - 2544); I.G. Ex. 3E, 3S.
689. Petitioner's statement that there is no standard of care for
the treatment of patients with Kaposi's sarcoma is not credible.
Finding 688.
690. Petitioner asserted that H.S. was a unique patient such that
it was doubtful that there was a standard of care that would apply
to H.S.'s care and treatment. Tr. at 2543 - 2544.
691. Petitioner's testimony that H.S. was a unique patient such
that it was doubtful that there was a standard of care applicable
to H.S.'s care and treatment is directly contradicted by the
evidence of record. I.G. Ex. 3E, 3S; Tr. at 577- 678, 899 - 909,
1056 - 1064, 1563 - 1608, (especially at 2543 - 2544), 2886 - 2897.
692. Petitioner's testimony that H.S. was a unique patient such it
was doubtful that there was a standard of care that would apply to
H.S.'s care and treatment is not credible. Findings 690 - 691.
693. Petitioner's attempts to justify his treatment of H.S. as
being entirely within professionally recognized standards of health
care are inconsistent, inadequate, and not credible. P. Ex. 6; Tr.
at 577 - 678, 890 - 909, 1056 - 1064, 1563 - 1608, 2536 - 2643,
2652 - 2655, 2886 - 2897; Findings 626 - 692.
694. Petitioner's attempts to justify his treatment of H.S. as not
being substantially in excess of H.S.'s needs are inconsistent,
inadequate, and not credible. P. Ex. 6; Tr. at 577 - 678, 890 -
909, 1056 - 1064, 1563 - 1608, 2536 - 2643, 2652 - 2655, 2886 -
2897; Findings 626 - 692.
695. Petitioner's treatment of H.S. was below professionally
recognized standards of health care and substantially in excess of
H.S.'s needs. Findings 626 - 694.
Petitioner's testimony regarding his treatment of H.S. is
indicative of Petitioner's lack of credibility and lack of
trustworthiness.
696. Petitioner's assertion that H.S. had a hybrid type of Kaposi's
sarcoma is directly contradicted by the evidence and Petitioner's
own testimony and is indicative of Petitioner's lack of credibility
and lack of trustworthiness. I.G. Ex. 3E, 3S; Tr. at 2564.
697. Petitioner's assertion that H.S. had Kaposi's sarcoma on both
lower extremities is contradicted by Petitioner's own medical
records and charts and is indicative of Petitioner's lack of
credibility and lack of trustworthiness. I.G. Ex. 3E, 3S at 496,
559; P. Ex. 6; Tr. at 2566 - 2572.
698. Petitioner's assertion that the contraindications for
administering Adriamycin in an 80-year-old patient are no different
than the contraindications for administering it to anyone else is
contradicted by the evidence of record and is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2572 - 2573; see Tr. at 577 - 678, 890 - 909, 1056 - 1064, 1563
- 1608; I.G. Ex. 3E, 3S.
699. That Petitioner blames the lack of a Medicare code for the
fact that he billed for the full vial of drugs rather than the
amount he actually administered to H.S. is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2575.
700. Petitioner's assertion that either he was aware of the amounts
of chemotherapy he administered to H.S. because, during the time
H.S. was received chemotherapy from Petitioner, Petitioner was
treating only a small number of patients with chemotherapy is
directly contradicted by the following: a) the evidence; b)
Petitioner's admission that nothing in H.S.'s medical records
indicates the amount of chemotherapy H.S. was receiving; c)
Petitioner's inability to specify how many other patients were
receiving chemotherapy during the time H.S. was receiving it (1985
- 1987); and d) Petitioner's inability to state, even within a
general range, the amount of chemotherapy he administered to H.S.
I.G. Ex. 3E, 3S; Tr. at 577 - 678, 890 - 909, 1056 - 1064, 1563 -
1608, (especially at 2575 - 2577).
701. Petitioner's assertion that he was aware of the amounts of
chemotherapy he administered to H.S. is indicative of Petitioner's
lack of credibility and lack of trustworthiness. Finding 700.
702. Petitioner admits that the amounts of Velban and Bleomycin he
administered to H.S. were significantly less than the amounts
entered on H.S.'s medical charts. Tr. at 2578.
703. Petitioner's failure to enter into H.S.'s chart the amounts of
Velban and Bleomycin he administered to H.S. is indicative of
Petitioner's lack of credibility and trustworthiness. Findings 700
- 702.
704. That Petitioner administered Bleomycin to H.S. in the presence
of advanced chronic obstructive pulmonary disease is indicative of
Petitioner's lack of understanding and ability to treat patients in
accordance with professionally recognized standards of health care.
Tr. at 2580 - 2582; I.G. Ex. 3E, 3S at 35; Findings 43, 252.
705. Petitioner's assertion that H.S.'s metastasis disappeared as
a result of the chemotherapy treatments administered to H.S. by
Petitioner is directly contradicted by the fact H.S. did not have
metastasis. P. Ex. 6 at 6 - 7; Tr. at 577 - 678, 890 - 909, 1056
- 1064, 1563 - 1608, (especially at 2595 - 2598); I.G. Ex. 3E, 3S;
Findings 626 - 695.
706. Petitioner's assertion that H.S.'s metastasis disappeared as
a result of the chemotherapy treatments Petitioner administered to
H.S. is indicative of Petitioner's lack of credibility and lack of
trustworthiness. Findings 626 - 695, 705.
707. Petitioner admits that when his office submits a claim to
Medicare, Petitioner is the one who is responsible for the accuracy
of that claim. Tr. at 2600 - 2601.
708. Petitioner's attempt to deflect responsibility for submitting
claims to Medicare for performing CBCs and platelet counts that
were substantially in excess of H.S.'s needs is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2599 - 2601; Finding 707.
709. Petitioner's assertion that he performed CBCs and platelet
counts together when treating H.S. because the technology did not
exist to perform the tests separately is contradicted by the
evidence, is not credible, and is indicative of Petitioner's lack
of trustworthiness. I.G. Ex. 3E, 3S; Tr. at 577 - 678, 890 - 909,
1056 - 1064, 1563 - 1608, (especially at 2600 - 2601); Findings 669
- 670.
710. Petitioner is unable to provide a credible reason or
justification as to why he saw H.S. in his office 49 times (in 52
weeks) in 1986, 51 times (in 52 weeks) in 1987, and four times (in
one month) in January 1988. Tr. at 2605.
711. Petitioner's inability to provide a credible reason or
justification as to why he saw H.S. in his office on almost a
weekly basis for over two years is indicative of Petitioner's lack
of credibility and lack of trustworthiness. Findings 710.
712. The day before H.S. was admitted to the hospital with
bilateral pneumonia, Petitioner documented that he administered
Bleomycin to H.S. Tr. at 2613 - 2616; I.G. Ex. 3S at 34 - 36.
713. Petitioner states that he was unaware that H.S. had even a
cough or a cold for several days prior to H.S.'s admission to the
hospital. Tr. at 2616 - 2618; I.G. Ex. 3S at 36.
714. The fact that Petitioner continued to treat H.S. with drugs
with high pulmonary toxicity and did not recognize that H.S. had
pneumonia is indicative of Petitioner's lack of understanding of
professionally recognized standards of health care, is indicative
of Petitioner's failure to properly treat H.S.'s condition, and is
evidence of Petitioner's inability to comply with professionally
recognized standards of health care. Findings 672 - 683, 713.
715. Petitioner's attempt to explain as a typographical error his
billing Medicare for Vincristine that, according to Petitioner's
flow sheets, was not received by H.S., is not credible and is
indicative of Petitioner's inability to follow proper Medicare
billing procedures. Tr. at 2629; I.G. Ex. 3S at 106.
716. Petitioner's failure to properly document that H.S. received
medication in the amounts and types Petitioner billed Medicare for
is indicative of Petitioner's lack of trustworthiness. Tr. at 2630
- 2641; I.G. Ex. 3S at 359; Findings 640 - 641, 646 - 647, 715.
717. The exhibit submitted by Petitioner as P. Ex. 6 to support his
treatment of H.S. is the result of a study involving patients whose
median age was 35 and who had AIDS-related Kaposi's sarcoma. P.
Ex. 6; Tr. at 2640.
718. Petitioner has offered nothing that is persuasive which would
support his treatment of H.S. as being in accordance with
professionally recognized standards and not substantially in excess
of H.S.'s needs. P. Ex. 6; I.G. Ex. 3E, 3S; Tr. at 577 - 678, 890
- 909, 1056 - 1064, 1563 - 1608.
719. That Petitioner would believe that P. Ex. 6 would support his
treatment of H.S. is indicative of Petitioner's lack of
understanding of proper treatment of patients with Kaposi's
sarcoma, Petitioner's inability to comply with professionally
recognized standards, and Petitioner's lack of credibility and
trustworthiness. Findings 626 - 718.
Petitioner's treatment of patient R.N.
720. The I.G. has based its action against Petitioner on his
treatment of R.N. in 1986 only. February 10, 1992 Notice Letter.
721. To the extent that Petitioner's treatment or diagnosis of R.N.
in years prior to or subsequent to 1986 is relevant to my
determination as to whether Petitioner provided care within
professionally recognized standards and substantially in excess of
R.N.'s needs during 1986, such treatment is relevant to my
determination here.
722. R.N. first was seen by Petitioner on December 28, 1983. I.G.
Ex. 3E, 3T at 24.
723. At the time he first was seen by Petitioner, R.N. was a 64-
year-old man with cancer of the prostate. I.G. Ex. 3E, 3T.
724. R.N.'s prostate cancer had been confirmed by biopsy. I.G. Ex.
3E, 3T; Tr. at 682.
725. A January 12, 1984 bone scan report revealed that R.N. had
metastatic, stage IV cancer. P. Ex. 7; Tr. at 912, 1612.
726. Petitioner diagnosed R.N. as having stage IV carcinoma of the
prostate. I.G. Ex. 3T at 24.
727. From the time Petitioner first saw R.N. on December 28, 1983,
R.N. had metastatic prostate cancer. Tr. at 912; I.G. Ex. 3E, 3T.
728. Stage IV carcinoma of the prostate is cancer of the prostate
that has spread beyond the prostate and metastasized to other body
and organ systems. I.G. Ex. 3E; Tr. at 696.
729. There was no treatment available which could have cured R.N.'s
cancer in 1986. Tr. at 1639.
730. The professionally recognized standard of health care in 1986
(and currently) was to palliate R.N.'s symptoms and attempt to get
R.N.'s disease into remission. Tr. at 1611.
731. Hormonal therapy was the treatment that stood the best chance
to get R.N.'s metastatic cancer into remission. Tr. at 679 - 752,
911 - 957, 1064 - 1068, 1608 - 1654.
732. Prostate cancer feeds on male hormone. Tr. at 918.
733. Hormone therapy for prostate cancer reduces the cancer by
introducing additional female hormone (estrogen) into the body,
which, in turn, effectively decreases the production of the male
hormone upon which the cancer feeds. Tr. at 917 - 918.
734. Hormone therapy for prostate cancer can also work by removal
of the site of production of the male hormone, the testicles,
through an orchiectomy. I.G. Ex. 3E, 3T at 13 - 28.
735. Petitioner administered Adriamycin and Cytoxan to R.N. via one
and eight hour infusions on an almost weekly basis throughout 1986.
I.G. Ex. 3E, 3T.
736. Petitioner administered 5FU to R.N. on 3/31, 6/23, 9/17, 9/24,
9/29, and 10/10 in 1986. I.G. Ex. 3E, 3T.
737. Petitioner administered 5FU to R.N. via one to eight hour
infusion on at least seven occasions in 1986. I.G. Ex. 3E, 3T.
738. Petitioner's administration in 1986 of Adriamycin and Cytoxan
5FU to R.N. via infusion was below professionally recognized
standards of health care and substantially in excess of R.N.'s
needs. Tr. at 679 - 752, 911 - 957, 1064 - 1068, 1608 - 1654, 2898
- 2907.
739. Petitioner administered Cisplatinum to R.N. via one to eight
hour infusion on 3/31, 6/23, 8/22, 9/15, 10/14, and 12/10 in 1986.
I.G. Ex. 3E, 3T at 3 - 4, 86.
740. Cisplatinum could have been an effective agent to treat R.N.'s
metastatic prostate cancer in 1986. Tr. at 947 - 948.
741. Professionally recognized standards of health care dictated
that Petitioner should have stopped administering Adriamycin and
Cytoxan before beginning the administration of Cisplatinum in 1986.
Tr. at 948.
742. It was below professionally recognized standards of health
care for Petitioner to fail to cease administering Adriamycin and
Cytoxan before administering Cisplatinum to R.N. in 1986. Tr. at
948.
743. Petitioner began administering 5FU to R.N. in July 1986. Tr.
at 949; I.G. Ex. 3E, 3T.
744. Professionally recognized standards of health care dictated
that Petitioner cease administering Adriamycin and Cytoxan to R.N.
before administering 5FU. Tr. at 949 - 951.
745. It was below professionally recognized standards of health
care for Petitioner to administer 5FU to R.N. in 1986 in
conjunction with a failed regime of Adriamycin and Cytoxan. Tr. at
948 - 951.
746. In early 1984, Petitioner began administering to R.N. three
milligrams of Estramustin also, which consists of the hormone
estrogen in combination with a chemotherapy agent. I.G. Ex. 3E,
3T; Tr. at 914.
747. Estramustine hydrochloride is known as Emcyt. I.G. Ex. 3T at
17.
748. Petitioner's administration of emcyt in three-milligram doses
to R.N. from early 1984 through November 1984 was within
professionally recognized standards of health care. I.G. Ex. 3E,
3T; Tr. at 940 - 941.
749. In November 1984, Petitioner ceased administering Emcyt and
switched to DES to treat R.N. I.G. Ex. 3E, 3T; Tr. at 940 - 942.
750. DES is a synthetic compound, similar to estrogen, that is used
in the treatment of prostate cancer via hormonal therapy. Tr. at
689, 916.
751. DES causes the body to decrease and potentially stop its
production of the male hormone. Tr. at 916.
752. R.N. had no previous history of heart disease such that
treatments involving the hormone estrogen were contraindicated.
Tr. at 918; I.G. Ex. 3E, 3T.
753. Petitioner administered DES to R.N. beginning in November 1984
through February 5, 1986. Tr. at 916, 944; I.G. Ex. 3E, 3T.
754. Petitioner did not administer DES to R.N. after February 1986.
Tr. at 944 - 947.
755. Petitioner did not administer any other type of hormone
therapy to R.N. after February 1986. Tr. at 944 - 947; Findings
753 - 754.
756. Bone scans in August 1984 and 1985 show marked improvement in
R.N.'s cancer. Tr. at 915; I.G. Ex. 3E, 3T.
757. A bone scan performed in March 1986 shows that R.N.'s cancer
was again growing. Tr. at 915; I.G. Ex. 3E.
758. A bone scan performed in June 1986 shows that R.N.'s cancer
had become worse in the period between the March 1986 and June 1986
bone scans. Tr. at 915 - 916; I.G. Ex. 3E, 3T.
759. R.N.'s condition continued to worsen from June 1986 through
the end of the year. I.G. Ex. 3E, 3T; Tr. at 915 - 916.
760. On April 2, 1987, R.N. died from the effects of metastatic
prostate cancer. Tr. at 916 - 917; I.G. Ex. 3E, 3T.
761. In 1986, the professionally recognized standard for the
treatment of R.N.'s metastatic prostate cancer was to use hormone
therapy rather than chemotherapy, unless hormone therapy had been
attempted and failed or unless there was some medical reason not to
administer hormone therapy. Tr. at 714 - 715, 916 - 919, 1608 -
1654.
7:\ In 1986, the professionally recognized standard for the
treatment of R.N.'s metastatic prostate cancer mandated that
Petitioner treat the cancer with hormone therapy involving some
form of estrogen, hormone blocker, or orchiectomy (removal of the
testicles), and to treat R.N.'s bone pain and any symptomology
caused by his metastatic cancer. Tr. at 684, 917 - 957, 1064 -
1654; I.G. Ex. 3E, 3T.
763. In 1986, the professionally recognized standard for the
treatment of R.N.'s metastatic prostate cancer mandated that, in
the event R.N.'s cancer continued to progress in the face of
treatment with one form of hormone therapy, successive hormonal
manipulations should be attempted using different drugs or
orchiectomy. I.G. Ex. 3E, 3T; Tr. at 679 - 752, 911 - 957, 1064 -
1068, 1608 - 1654, 2989 - 2907.
764. R.N. never exhibited symptoms that would be associated with
receiving the amounts of Adriamycin and Cytoxan that Petitioner
documented in R.N.'s flow sheet as having been administered to R.N.
by Petitioner during 1986. I.G. Ex. 3E, 3T; Tr. at 679 - 752, 911
- 957, 1064 - 1068, 1608 - 1654, 2898 - 2907.
765. R.N. would have died from the toxic effects of Adriamycin and
Cytoxan had he, in reality, received these two drugs in 1986 in the
amounts Petitioner documented he administered to R.N.
766. R.N. did not die from the toxic effects of Adriamycin and
Cytoxan. I.G. Ex. 3E, 3T; see Tr. at 679 - 752, 911 - 957, 1064 -
1068, 1608 - 1654.
767. In 1986, R.N. did not receive the drugs Adriamycin and Cytoxan
in the amounts that appear in R.N.'s flow sheet. Findings 764 -
766.
768. In 1986, it was below professionally recognized standards of
health care for Petitioner to record on R.N.'s flow sheet amounts
of Adriamycin and Cytoxan that R.N. did not receive. Tr. at 911 -
957 (especially at 949), 1064 - 1068, 1608 - 1654, 2898 - 2907;
Findings 24 - 29.
769. Petitioner jeopardized R.N.'s health, safety, and well-being
by failing to enter into R.N.'s flow sheet the precise amounts of
Adriamycin and Cytoxan that R.N. received during 1986. Findings 24
- 29, 768.
770. Petitioner did not document that Petitioner had discussed with
R.N. at any time, including 1986, the option of orchiectomy as a
possible treatment for R.N.'s cancer and that R.N. refused
orchiectomy as a treatment option. I.G. Ex. 3E, 3T.
771. In 1986, it was below professionally recognized standards for
Petitioner to administer chemotherapy treatments to R.N. without
first discussing with R.N. orchiectomy and other hormonal
manipulation treatments as an alternative and documenting that R.N.
refused treatment by hormonal manipulation. I.G. Ex. 3E, 3T; Tr.
at 911 - 957 (especially at 926), 1064 - 1068, 1608 - 1654.
772. Petitioner's treatment of R.N.'s prostate cancer with hormone
therapy via use of one-milligram doses of the drug DES was within
professionally recognized standards of health care for the period
of time from when Petitioner began to treat R.N. with DES until
there was objective evidence that the cancer had continued to grow
(the June 1986 bone scan). Tr. at 690 - 695, 918 - 957.
773. Once there was objective evidence that R.N.'s tumor had
continued to grow, professionally recognized standards of health
care dictated that Petitioner should have increased the dosage of
DES or other estrogen, or used another form of hormonal therapy,
such as orchiectomy, to achieve suppression of all male hormones.
Tr. at 919 - 957.
774. Only after all male hormones have been suppressed can an
oncologist determine whether prostate cancer remains dependent upon
male hormone or has the ability to grow independent of male
hormone. Tr. at 919 - 957.
775. Only after all male hormones have been suppressed can an
oncologist determine whether the prostate cancer is treatable with
hormone therapy. Tr. at 919 - 957, 1608 - 1654.
776. In most patients, one-milligram doses of DES have little
chance of suppressing all of the male hormones. Tr. at 919 - 957.
777. In 1986, professionally recognized standards of health care
dictate that, during the time when Petitioner was administering DES
to R.N., Petitioner should have administered a blood test to R.N.
to determine if he had achieved suppression of the male hormones.
Tr. at 919 - 957; I.G. Ex. 3E, 3T; Findings 773 - 776.
778. Petitioner did not administer a blood test to R.N. at any time
during 1986 that would have allowed Petitioner to determine that he
had achieved suppression of all of the male hormones. Tr. at 919
- 957; I.G. Ex. 3E, 3T.
779. In 1986, Petitioner did not administer a blood test to R.N.
that would have allowed Petitioner to determine whether treatment
of R.N.'s cancer via hormonal manipulation was effective. Tr. at
919 - 957; I.G. Ex. 3E, 3T; Findings 773 - 778.
780. Petitioner's failure to administer a blood test to R.N. in
1986 to determine the level of male hormones present in R.N. was
below professionally recognized standards of health care. Tr. at
919 - 957, 1608 - 1654; I.G. Ex. 3E, 3T.
781. Petitioner never showed nor demonstrated that R.N.'s cancer
was hormone-independent. Tr. at 919 - 957; I.G. Ex. 3E, 3T.
782. In 1986, it was below professionally recognized standards of
health care for Petitioner to administer chemotherapy to R.N.
without first proving that R.N.'s cancer was hormone-independent.
Tr. at 935 - 957; I.G. Ex. 3E, 3T; Findings 773 - 781.
783. R.N. developed thrombophlebitis in July 1986. I.G. Ex. 3E,
3T; P. Ex. 7; Tr. at 693 - 694.
784. Subsequent to finding that R.N. had developed thrombophlebitis
in July 1986, Petitioner stopped administering DES to R.N. and
instead administered Leupron. P. Ex. 7; Tr. at 694; I.G. Ex. 3T at
80 - 83.
785. Leupron would have the same general effect on R.N.'s cancer as
DES but with much less chance of aggravating R.N.'s
thrombophlebitis. Tr. at 694
786. Petitioner's discontinuation of DES and choosing to administer
Leupron in or around July 1986 was in accordance with
professionally recognized standards of
health care, in that Leupron would have much less chance of
aggravating R.N.'s thrombophlebitis. Tr. at 694, 1645.
787. Petitioner documented that in 1986, he administered weekly to
R.N. one and eight hour infusions of the chemotherapy drugs
Adriamycin and Cytoxan, with the drug Cisplatinum interspersed in
the mix at irregular, approximately monthly intervals. I.G. Ex.
3E, 3T.
788. Petitioner documented that he administered to R.N. in 1986 the
chemotherapy drug 5FU on the following dates: 9/17, 9/24, 9/29,
11/24, 12/10, 12/17 of 1986 (and on several occasions during 1987).
I.G. Ex. 3T at 82 - 83.
789. It is of no medical benefit to the patient to be given the
drugs Adriamycin or Cytoxan via infusion of one to eight hours.
Tr. at 724; Findings 10 - 20. 22/
790. On each occasion in 1986 that Petitioner administered the
drugs Adriamycin and Cytoxan to R.N., he did so via a one to eight
hour infusion. I.G. Ex. 3E, 3T.
791. It was below professionally recognized standards of health
care and substantially in excess of R.N.'s needs for Petitioner to
administer Adriamycin, Cytoxan, and 5FU to R.N. via a one to eight
hour infusion. I.G. Ex. 3T; Tr. at 724, 911 - 957, 1064 - 1068,
1608 - 1654; Findings 787 - 790.
792. It was within professionally recognized standards of health
care to administer the drug Cisplatinum by infusion. Tr. at 724.
793. The chemotherapy agents Cisplatinum and 5FU, in theory, can be
effective in treating metastatic prostate cancer. Tr. at 947 -
950.
794. In 1986, it was below professionally recognized standards of
health care for Petitioner to continue to administer Adriamycin and
Cytoxan to R.N. in the face of progressive metastatic disease.
Findings 756 - 760; I.G. Ex. 3E, 3T; Tr. at 947 - 950, 1621 - 1623.
795. In 1986, it was below professionally recognized standards of
health care for Petitioner to begin to administer Cisplatinum and
5FU to R.N. without first stopping the administration of Adriamycin
and Cytoxan, which had proven ineffective. I.G. Ex. 3E, 3T; Tr. at
947 - 950, 1621 - 1623.
796. Petitioner failed to document that he actually saw R.N. on
each of the 32 occasions in 1986 that he billed for an office
visit. 23/ I.G. Ex. 3T; Tr. at 724.
797. It was below professionally recognized standards of health
care for Petitioner to bill Medicare for an office visit where he
failed to document that he had actually seen R.N. Tr. at 727.
798. The 32 office visits that Petitioner provided to R.N. were
substantially in excess of R.N.'s needs. I.G. Ex. 3T; Tr. at 724.
799. Acid phosphatase tests need be performed only once every three
months to track the progression of a patient with prostate cancer.
Tr. at 721.
800. Acid phosphatase tests can be performed at more frequent
intervals for brief periods in the event the form of treatment the
patient is receiving is changed. Tr. at 721 - 722.
801. Petitioner's testing of acid phosphatase of R.N. every month
was substantially in excess of R.N.'s needs. Tr. at 722.
802. Petitioner's documentation of R.N.'s condition via his
outpatient notes does not meet professionally recognized standards
of health care. Tr. at 722 - 723.
803. There is no evidence in the record that would support
Petitioner's inference that he was treating R.N. for bladder
cancer. I.G. Ex. 3E, 3T; Tr. at 741.
804. There is no evidence in the record that would support a
finding that R.N.'s cancer at any time was or became resistant to
treatment by hormone manipulation. I.G. Ex. 3E, 3T.
805. Petitioner's assertion that R.N.'s cancer was resistant to
hormone treatment is not credible. Findings 720 - 804.
806. Petitioner mistakenly ascribed that it was the chemotherapy
treatments that he was administering to R.N. that had reduced
R.N.'s cancer when, in fact, it was the hormone treatment that had
reduced R.N.'s cancer. Tr. at 924.
807. CEA plays no role in following the course of or testing for
prostate cancer. Tr. at 718 - 719, 951.
808. In 1986, it was substantially in excess of R.N.'s needs for
Petitioner to administer CEA tests to R.N. Tr. at 718 - 719, 950
- 951.
809. The chemotherapy that Petitioner provided to R.N. in 1986 was
below professionally recognized standards of health care and
substantially in excess of R.N.'s needs, both in types of drugs
used and in the method of administration (one to eight hour
infusions). Findings 720 - 804.
810. All of the CBCs that Petitioner administered to R.N. in 1986
were unnecessary. Findings 768 - 769, 809; Tr. at 720 - 721, 952.
811. All of the CBCs that Petitioner administered to R.N. in 1986
were substantially in excess of R.N.'s needs. Finding 810.
812. All of the venipunctures that Petitioner administered to R.N.
in 1986 were medically unnecessary. Finding 809, 810; Tr. at 720
- 721, 952 - 953.
81: All of the venipunctures that Petitioner administered to R.N.
in 1986 were substantially in excess of R.N.'s needs. Findings
812; Tr. at 720 - 721, 952 - 953.
814. All of the platelet counts that Petitioner administered to
R.N. in 1986 were medically unnecessary. Findings 809; Tr. at 720
- 721, 952 - 953.
815. All of the platelet counts that Petitioner administered to
R.N. in 1986 were substantially in excess of R.N.'s needs. Finding
814; Tr. at 720 - 721, 952 - 953.
816. Petitioner's treatment of R.N. in 1986 was substantially in
excess of R.N.'s needs. Findings 720 - 815.
817. Petitioner's treatment of R.N. in 1986 was below
professionally recognized standards of health care. Findings 720
- 815.
818. Through his treatment of R.N. in 1986, Petitioner has
demonstrated that he was not familiar with the necessary concepts
and treatment options available to oncologists in 1986 to treat
metastatic prostate cancer. Findings 720 - 817.
819. Through his treatment of R.N. in 1986, Petitioner jeopardized
R.N.'s health, safety, and well-being. Findings 720 - 818.
820. Petitioner's attempts to justify his treatment of R.N. in 1986
as being entirely within professionally recognized standards,
health care are inconsistent, inadequate, and not credible. P. Ex.
7; Tr. at 2656 - 2737; Findings 720 - 819.
821. Petitioner's attempts to justify his treatment of R.N. in 1986
as not being substantially in excess of R.N.'s needs are
inconsistent, inadequate, and not credible. P. Ex. 7; Tr. at 2656
- 2737; Findings 720 - 820.
Petitioner's testimony regarding his treatment of R.N. is
indicative of his lack of credibility and lack of trustworthiness.
822. Petitioner's assertion that R.N.'s bone pain was well
controlled with Demerol is contradicted by the fact that Demerol is
not a very good agent for control of bone pain, and is indicative
of Petitioner's lack of credibility and lack of trustworthiness.
I.G. Ex. 3E, 3T at 16 - 18; Tr. at 2677.
823. Petitioner's self-contradictory testimony on the issue of
whether R.N.'s flow sheet reflects the doses of chemotherapy and
other medications Petitioner administered to R.N. is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2683 - 2685; I.G. Ex. 3T at 81 - 83.
824. Petitioner gave conflicting, evasive testimony when asked to
state the time period during which he had problems with the
Medicare billing codes. Tr. at 2683 - 2687.
825. Petitioner's conflicting, evasive testimony regarding the
period of time he alleges he had difficulty with the Medicare
billing codes is indicative of his lack of credibility and lack of
trustworthiness. Tr. at 2683 - 2687; Finding 824.
826. That Petitioner blames his nursing staff for the fact that
R.N.'s flow sheets do not reflect the amount of Adriamycin R.N.
actually received is indicative of Petitioner's unwillingness to
take responsibility for the care and treatment of R.N. Tr. at 2689
- 2690; I.G. Ex. 3T at 77.
827. That Petitioner blames his nursing staff for the fact that
R.N.'s flow sheets do not reflect the amount of Adriamycin R.N.
actually received is indicative of Petitioner's lack of credibility
and lack of trustworthiness. Finding 826.
828. Petitioner's assertion that side effects are not an integral
part of chemotherapy is directly contradicted by the evidence and
Petitioner's own testimony, is indicative of Petitioner's
willingness to distort the record and is further indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2693; Findings 21 - 29.
829. Petitioner's self-contradictory, conflicting testimony about
whether he read R.N.'s bone scan reports is indicative of
Petitioner's lack of credibility and lack of trustworthiness. Tr.
at 2700; see Findings 756 - 760.
830. Petitioner's inability to articulate any reason for his
erratic administration of Cisplatinum to R.N. in August and
September 1986 is indicative of: Petitioner's failure to treat R.N.
in accordance with professionally recognized standards of health
care; Petitioner's lack of credibility; and Petitioner's lack of
trustworthiness. Tr. at 2700 - 2702; I.G. Ex. 3E, 3T.
831. The exhibit submitted by Petitioner to support his treatment
of R.N. completely contradicts Petitioner's assertion as to the
validity of the chemotherapy treatment he administered to R.N. P.
Ex. 7 at 11; Tr. at 2705 - 2706.
832. The study cited by Petitioner is applicable to patients that
received orchiectomy, DES, and combination chemotherapy, all of
which R.N. did not receive. P. Ex. 7; Tr. at 2711 - 2712.
833. Petitioner's assertion that the study he submitted supports
that his treatment of R.N. gave R.N. a 63 percent increase in
five-year survival is directly contradicted by an accurate reading
of the study and is indicative of Petitioner's lack of credibility
and lack of trustworthiness. Tr. at 2705 - 2712; P. Ex. 7.
Petitioner's billing practices
834. At all times relevant to this case, Blue Shield of California
(CA Blue Shield) has been the Medicare carrier. Tr. at 1098.
835. At all times relevant to this case, CA Blue Shield has had the
responsibility of receiving and processing, which includes
reviewing and auditing, claims from beneficiaries throughout
northern California, except for the southern counties. Tr. at
1098.
836. Arthur J. Meharg is the director of Medicare administration
for CA Blue Shield. Tr. at 1099.
837. Mr. Meharg has worked with the Medicare program for 26 years.
Tr. at 1100.
838. As director of Medicare administration for CA Blue Shield, Mr.
Meharg is responsible for all prepayment and postpayment review of
medical claims submitted by CA Blue Shield providers. Tr. at 1100.
839. Mr. Meharg oversees the utilization and review branch of CA
Blue Shield. Tr. at 1101.
840. Utilization review examines a provider's entire practice for
a given period of time. Tr. at 1101.
841. Front-end review is a claim-by-claim review process, also
called "prepayment review." Tr. at 1101.
842. Prepayment review begins when Medicare claims are sorted by
computer according to a specific Medicare provider's number(s) and
the claims are reviewed by a nurse technician. Tr. at 1111 - 1114.
843. Nurse technicians reviewing Medicare claims have access to
physician advisors who have experience in the area of medical
specialty in which the claims are categorized. Tr. at 1111 - 1112.
844. A physician advisor becomes involved in the prepayment review
process only at the request of the nurse technician. Tr. at 1117,
1269 - 1271.
845. There is no requirement that a claim that a nurse technician
approves for payment be reviewed by a physician. However, a nurse
technician cannot deny a claim for reimbursement unless a physician
advisor is consulted and gives his or her approval to deny payment
of the claim. Tr. at 1156 - 1157, 1269 - 1271.
846. A physician advisor is not involved if a nurse technician
approves payment of a particular claim. Tr. at 1156 - 1157.
847. Some of Petitioner's claims on the seven patients at issue
here were denied in prepayment review. Tr. at 1271.
TL.R Prepayment review is a time consuming process that is very
expensive to the carrier. Tr. at 1111 - 1112.
849. In conducting prepayment review, the reviewer examines only
the individual claim that is submitted and accepts the provider's
diagnosis at face value -- the reviewer does not examine services
that may have been rendered to that patient at any time preceding
the date of that particular claim, nor does the reviewer examine
the medical records of the patient. Tr. at 1111 - 1112, 1195 -
1196.
850. In conducting prepayment review, the reviewer does not examine
the medical records of the patient who is being treated. Tr. at
1112 - 1113, 1195 - 1196.
851. Prepayment review does not examine the treatment of the
patient over a period of time. Tr. at 1112 - 1113, 1195 - 1196;
Findings 849 - 850.
852. Prepayment review is not conducive to examining the propriety
or course of treatment given by an oncologist to a patient over a
period of time. Tr. at 1195 - 1196; Findings 841 - 851.
853. On prepayment review (also called front-end review), the
claims are pulled by a computer and transferred to a nurse advisor
for review. Tr. at 1114.
854. The reviewer conducting prepayment review does not have
medical records to assist in the review process; he or she merely
checks that the diagnosis on the claim meets the service that the
physician billed for. Tr. at 1204.
855. Claims are generally denied on prepayment review either
because the service provided is not reimbursable or the service is
being provided in an excessive manner. Tr. at 1199 - 1200.
856. Prepayment review is not conducive to detecting services that
were not provided as claimed or that are not medically necessary.
Tr. at 1112 - 1113, 1195 - 1196; Findings 841 - 855.
857. Postpayment review (also called utilization review) is a
comprehensive review of a provider's treatment of patient(s) in
which the reviewer examines the medical records, patient charts,
and supporting documentation related to the treatment of patient(s)
over a period of time, e.g., six months to a year. Tr. at 1112 -
1113, 1195 - 1196, 1203 - 1205.
858. Postpayment review examines the medical records and other
documentation related to a provider's treatment of patient(s) and
compares it to the claims that were submitted in conjunction with
the provider's treatment of that particular patient to ensure: that
the provider's diagnosis and treatment of the patient (Medicare
beneficiary) was appropriate; that the provider billed his or her
services in accordance with Medicare requirements; and that the
provider was reimbursed in accordance with Medicare requirements.
Tr. at 1203 - 1204; Finding 857.
859. Encompassed in the postpayment review process is a
comprehensive review of the provider's medical records and his or
her diagnosis and treatment of patient(s) over a period of time,
e.g., six months to a year. Tr. at 1205.
860. The Medicare Carrier's Manual is designed as an instruction
for any provider who is billing the Medicare program. Tr. at 1264.
861. The Medicare Carrier's Manual is available upon request, via
purchase. Tr. at 1263.
862. HCFA policy, the Medicare Carrier's Manual, and the multiple
bulletins that are routinely sent to Medicare providers inform
providers that all services that are provided to the patient on a
particular date need to be stated on one claim form. Tr. at 1162
- 1163, 1257 - 1263.
863. In the event the services are too numerous to place on the
same claim form, Medicare directs providers to clip the claim forms
together. Tr. at 1163, 1223.
864. On numerous occasions, claims submitted by Petitioner did not
comport with the directives that all services provided on a
particular date be contained in one claim. Tr. at 1259 - 1264.
865. "Fragmenting" of claims occurs when a provider breaks a given
procedure code into subcomponents, causing the reimbursement that
provider receives to be greater than if the provider had used only
the single appropriate billing code. Tr. at 1102.
866. Fragmenting of claims can occur also where a provider sends
claims for reimbursement for services performed on the same day to
different claims processing centers. Tr. at 1103.
867. Submitting claims for reimbursement to different claims
processing centers enables the provider to avoid detection of
duplicative or excessive billing. I.G. Ex. 7; Tr. at 1103 - 1105;
see Tr. at 1158.
868. Petitioner's fragmenting of his claims hampered CA Blue
Shield's efforts to review Petitioner's care of patients and
monitor his billing practices over a period of time. Tr. at 1223
- 1226; Findings 864 - 867.
869. Petitioner would provide services to a patient during the
course of one or two days and then split the submission of his
claims for reimbursement such that CA Blue Shield would receive
Petitioner's claims on two separate occasions, spaced six months to
a year apart. Tr. at 1223 - 1226.
870. Petitioner exhibited a pattern of fragmenting his claims for
reimbursement in that, instead of submitting at one time all his
claims for reimbursement for services provided to a patient on a
particular day, he would submit several different forms and stagger
the times he submitted the forms. Tr. at 1158, 1177 - 1181, 1223
- 1226.
871. Beginning in 1986, CA Blue Shield allowed Petitioner to submit
claims electronically. Tr. at 1181.
872. At all times relevant to this case, as a condition of being
allowed to submit claims electronically, CA Blue Shield required
providers to sign an agreement to certify
that the services being rendered and billed for are true and
accurate. Tr. at 1197 - 1198.
873. Petitioner exhibited a pattern of fragmenting the claims he
submitted via the electronic claims submission process. Tr. at
1191.
874. Petitioner's pattern of fragmenting claims, both those that
were electronically submitted and those that were not, made it
difficult for CA Blue Shield to detect deficiencies related to his
treatment of patients and his billing practices. I.G. Ex. 7 at 2;
Tr. at 1103 - 1104, 1112 - 1113, 1119, 1158, 1177 - 1180, 1223 -
1226.
875. "Upcoding" is where providers attempt to bill a higher-level
service than was actually rendered or required, to increase
revenue. Tr. at 1102.
876. In 1979, CA Blue Shield placed Petitioner on prepayment review
of all of his Medicare claims. Tr. at 1106 - 1107, 1147.
877. In 1980, a Dr. Rosenbaum (a CA Blue Shield cancer specialist
and oncologist) met with Petitioner and, as a result of that
meeting, decided to reduce the prepayment review of all of
Petitioner's claims to a prepayment review of some of his claims.
Tr. at 1109 - 1110, 1147.
878. After meeting with Dr. Rosenbaum, Petitioner was placed on
partial prepayment review. Tr. at 1147.
879. Petitioner remained on partial prepayment review until 1985,
when another oncologist, Dr. Bohannon, asked to review some claims
and recommended Petitioner again be placed on full prepayment
review. Tr. at 1109 - 1110, 1147.
880. In 1987, Petitioner was again placed on full prepayment review
of all of his claims. Tr. at 1118, 1147, 1159 - 1160.
881. Petitioner remained on full prepayment review through 1989.
Tr. at 1159 - 1160.
L.RP CA Blue Shield informed Petitioner in 1987 of the difficulties
they had found with his billing and treatment practices. I.G. Ex.
3F, 3G.
883. As early as August 14, 1987, Petitioner was informed that it
was not acceptable to bill for a drug in an amount that was not
actually administered to the patient. I.G. Ex. 3G, 3J.
884. As early as August 3, 1987, Petitioner was informed that the
medical records he keeps on each patient should reflect the amount
of medication each patient actually receives. I.G. Ex. 3F, 3J.
885. As early as August 14, 1987, Petitioner was informed of many
of the deficiencies regarding patient care and documentation of
services provided that eventually led to the instant action. I.G.
Ex. 3G, 3J.
886. In 1987, CA Blue Shield met with Petitioner and informed him
of specific deficiencies regarding his incorrect billing practices,
his inaccurate charting of medication administered to patients, his
inappropriate and excessive use of laboratory procedures, and his
excessive use of office visits. I.G. Ex. 3F, 3G, 3H, 3I, 3J; Tr.
at 1122 - 1123.
887. In August 1988, CA Blue Shield went to Petitioner's office to
review Petitioner's records of treating medical patients. Tr. at
1124 - 1126.
888. Petitioner's records were difficult for the CA Blue Shield
reviewers to decipher because Petitioner's records: were organized
based on the type of service that was provided rather than
according to the treatment given to an individual patient; often
did not contain sufficient documentation to support Petitioner's
claim for services on a particular date; contained few notations in
the patients' charts; and had reports which did not contain
laboratory results at regular intervals in the charts, but instead
were bundled in one section of the chart. Tr. at 1124 - 1129.
889. Subsequent to August 1988, CA Blue Shield kept Petitioner on
prepayment review and began to review Petitioner's treatment of
patients via postpayment review. Tr. at 1130 - 1131.
890. Between 1985 and 1989, Petitioner had three Medicare provider
numbers. Tr. at 1142.
891. Petitioner was paid the following amounts by CA Blue Shield as
reimbursement for Medicare claims he submitted under provider
number ZZZ-9081: $53,943.19 in 1988 and $44,997.16 in 1989, for a
total of $98,940.35. Tr. at 1142 - 1143.
892. Petitioner was paid the following amounts by CA Blue Shield as
reimbursement for Medicare claims he submitted under provider
number 00-A-263360: 1985 -- $788,835.94; 1986 -- $906,764.28; 1987
-- $416,630.70; 1988 -- $564,514.04; 1989 -- $534,538.60; for a
total of $3,211,283.56. Tr. at 1142 - 1143.
893. Petitioner was paid the following amounts by CA Blue Shield as
reimbursement for Medicare claims he submitted under provider
number 00-A-263361: 1985 -- $185.20; 1986 -- $537.43; 1987 --
$712.89; for a total of $1,435.60. Tr. at 1142 - 1143.
894. From 1985 through 1989, Petitioner received $3,311,659.51 in
reimbursement from CA Blue Shield. Tr at 1143 - 1144.
895. From 1985 through 1989, Petitioner submitted claims for
reimbursement to CA Blue Shield for over twice the amount he
actually received in reimbursement. Tr. at 1144.
896. Petitioner has been a Medicare provider at least since 1979.
Tr. at 1139.
897. Since 1979, CA Blue Shield sent Petitioner Medicare bulletins
that discuss the appropriate ways to bill Medicare for services.
Tr. at 1139 - 1140.
898. As of 1979, Medicare had placed Petitioner on notice that the
manner in which he was billing for his Medicare services was not
correct. Tr. at 1147; Findings 896 - 897.
.RPT Petitioner admitted that it was his practice to bill for the
vial size of a drug when he would administer only a portion of that
vial to a patient and would discard the unused portion even though
it was reusable. Tr. at 1128; I.G. Ex. 3G, 3H, 3I, 3J.
900. Petitioner was instructed on numerous occasions to bill for
the amount of drug that he actually administered to the patient.
Tr. at 1128, 1152; I.G. Ex. 3G, 3H, 3I, 3J.
901. Petitioner's assertion that at least two Blue Shield personnel
directed him to submit claims to Medicare for chemotherapy in the
manner in which he did is contradicted by the evidence of record.
Tr. at 2235, 2240 - 2242; I.G. Ex. 3H; P. Ex. 14.
902. During 1987 and on several subsequent occasions, Petitioner
requested that, if Blue Shield would tell him how to bill
correctly, he would follow their instructions. Tr. at 1152.
903. During 1987 and on several subsequent occasions, Petitioner
was specifically instructed by Blue Shield on how to bill
correctly. Tr. at 1152 - 1153; Findings 882 - 886; 902.
904. Blue Shield officials instructed Petitioner to follow the
instructions that were published in the Medicare bulletins. Tr. at
1153.
905. In a letter dated September 3, 1987, Petitioner acknowledged
that he understood he should bill Medicare for only the dosages of
chemotherapy he administered to the patient, and further indicated
that he would enter onto the patient's flow sheets only the amount
of chemotherapy that was actually received by the patient. I.G.
Ex. 3J.
906. Petitioner, despite repeated assertions that he would do so,
never complied with the instructions given to him by CA Blue Shield
on how to bill correctly for his services. Tr. at 1152; I.G. Ex.
3E, 3F, 3G, 3H, 3I, (especially 3J), 3K, 3L, 3M, 3N, 3O, 3P, 3Q,
3R, 3S, 3T; Findings 834 - 905.
907. Petitioner's assertion that he was willing to comply with
Medicare billing practices if only Medicare would give him
instructions is contradicted by the evidence of record, is not
credible, and is indicative of
Petitioner's lack of trustworthiness. Findings 1 - 906; Tr. at
2247 - 2248; I.G. Ex. 3E, 3F, 3G, 3H, 3I, (especially 3J), 3K, 3L,
3M, 3N, 3O, 3P, 3Q, 3R, 3S, 3T.
908. Petitioner blames his office and nursing staff for his
problems with Medicare billing. Tr. at 2214 - 2224.
909. A June 12, 1987 letter from Medicare to Petitioner is not
relevant to the issue of whether Petitioner violated section 1156
of the Act in his treatment of any of the seven patients on which
evidence was presented in this case. P. Ex. 14.
910. Petitioner's repeated assertion that CA Blue Shield instructed
him to bill for the vial amount of a drug, rather than the actual
amount he administered, is contradicted by the evidence of record,
is not credible, and is indicative of Petitioner's lack of
trustworthiness. I.G. Ex. 3G, 3H, 3I, (especially 3J); Findings
834 - 909; Tr. at 1765 - 1767, 1786 - 1788, 1793 - 1794, 1806
-1807, 2261 - 2281, 2869 - 2870; I.G. Ex. 3H; see Tr. at 1812 -
2737.
911. That, in 1980, CA Blue Shield's removal of Petitioner from
full prepayment review and his placement on partial prepayment
review was not the result of Petitioner's cooperation or compliance
with CA Blue Shield's billing instructions or procedures. Tr. at
1154.
912. The existence of a code for a particular service, e.g., eight
hour infusion, does not mean that service is an allowable service
that will be paid by the Medicare carrier. Tr. at 1170 - 1171.
913. Prepayment review does not assess a physician's treatment of
patients over time and does not question the diagnosis made by the
physician. Tr. at 1177 - 1180, 1195 - 1196; Findings 841 - 856.
914. CA Blue Shield's prepayment review of Petitioner's records did
not assess Petitioner's treatment of patients over time and it was
assumed that Petitioner's diagnoses were correct. Tr. at 1177 -
1180, 1195 - 1196; Findings 841 - 856, 911 - 913.
915. CA Blue Shield's prepayment review of Petitioner from 1980
through 1985 examined Petitioner's billing for laboratory and
oncology services only and did not examine Petitioner's billing for
office visits. Tr. at 1177.
916. Prepayment review was not adequate to detect most of the
problems with Petitioner's billings and treatment of patients. Tr.
at 1158, 1177 - 1182, 1195 - 1196; Findings 841 - 856, 913 - 914.
917. Only a more thorough review, e.g., a postpayment review, was
able to determine that Petitioner did not have supporting
documentation in his records to corroborate his billings or justify
his treatment of the patients at issue here. Tr. at 1158, 1177 -
1182, 1195 - 1196.
918. CA Blue Shield conducted a study in which it reviewed the
claims submitted by Petitioner for the treatment of 50 Medicare
beneficiaries and found that CA Blue Shield had paid, and
Petitioner had received, $340,466.36 in overpayments. Tr. at 1185
- 1187.
919. Petitioner was informed that he had received overpayments from
CA Blue Shield in the amount of $340,466.36, plus interest. Tr. at
1185 - 1187; I.G. Ex. 7.
920. CA Blue Shield is entitled to question the propriety of a
claim, even if that claim is paid after a prepayment review. Tr.
at 1192 - 1193.
921. The fact that CA Blue Shield may pay a claim after prepayment
review is not a tacit approval by CA Blue Shield of Petitioner's
billing for Medicare services or treatment of patients. Tr. at
1192 - 1193.
922. Petitioner never was informed that CA Blue Shield, in paying
for a claim Petitioner had submitted through prepayment review, was
endorsing that Petitioner had provided items or services in
accordance with professionally recognized standards of health care,
that were not substantially in excess of patients' needs, or that
Petitioner actually had provided services as claimed. Tr. at 1194.
923. It was not until 1988 that CA Blue Shield began conducting
postpayment review of Petitioner's billing and treatment practices.
Tr. at 1195.
924. Ms. Doris Schell has been a special investigator for the
utilization review department of CA Blue Shield for five years.
Tr. at 1202.
925. Utilization review is the same thing as postpayment review.
Tr. at 1203 - 1204.
926. Ms. Schell performed a comprehensive medical review and audit
of Petitioner's medical billing practice, covering Medicare
payments made to Petitioner from January 1985 through September
1989, involving 121 patients. Tr. at 1208 - 1211.
927. Ms. Schell's review of the medical records of 121 of
Petitioner's patients did not reveal a single instance where
Petitioner had placed written orders in the patients' charts. Tr.
at 1218.
928. Ms. Shell's review of Petitioner's practice during the period
1985 through 1989 found that: Petitioner had overutilized
chemotherapy, office visits, diagnostic tests, and laboratory
tests; the diagnoses that were written on Petitioner's claim forms
were often not substantiated in the medical records; Petitioner had
submitted claims for reimbursement for office visits where there
was no documentation in the patient's chart that would support that
Petitioner examined the patient on that particular day; and
Petitioner had submitted (and had been reimbursed for) claims for
visiting his patients
in the hospital, where, on the day the visit was supposed to have
occurred, the patient was discharged from the hospital. Tr. at
1220 - 1221.
929. From January 1, 1985 through September 30, 1989, Petitioner
was overpaid the following amounts with regard to his treatment of
the seven patients at issue in this case:
a. Approximately $34,000 for his treatment of D.R.;
b. Approximately $35,000 in overpayment for his medical
treatment of B.G.;
c. Approximately $14,000 in conjunction with his treatment of
J.L.;
d. Approximately $27,000 in conjunction with his treatment of
R.N.;
e. Approximately $20,000 in conjunction with his treatment of
H.S.;
f. Approximately $21,500 in conjunction with his treatment of
J.W.;
g. Approximately $20,500 in conjunction with his treatment of
H.W.
Tr. at 1228 - 1235.
930. In instances where CA Blue Shield denied payment, Petitioner
was informed specifically about what the reviewers had found and
why payment was denied. Tr. at 1266 - 1267.
931. In instances where the denial of payment was based on medical
records or reports, a copy of the document the reviewers used to
determine overpayment was included in the correspondence that was
sent to Petitioner. Tr. at 1266 - 1267.
932. Some of Petitioner's claims on these seven patients at issue
were denied in prepayment review. Tr. at 1271.
933. CA Blue Shield offers a procedure called a "fair hearing"
whereby a provider can challenge CA Blue Shield's disallowances of
reimbursement. Tr. at 1283 - 1284.
934. Petitioner wrote to CA Blue Shield and requested a "fair
hearing." Tr. at 1284 - 1285.
935. Pursuant to Petitioner's request, CA Blue Shield scheduled two
"fair hearings" to address Petitioner's disallowances. Tr. at 1283
- 1284.
936. Petitioner did not show up at either of the scheduled "fair
hearings." Tr. at 1283 - 1284.
I have the authority to increase the term of Petitioner's exclusion
beyond the 10 years originally proposed by the I.G.
937. An exclusion issued pursuant to section 1128(b)(6)(B) of the
Act will be for a period of three years unless certain specified
aggravating factors are present. 42 C.F.R.
1001.701(d)(paraphrase).
938. An exclusion pursuant to section 1128(b)(6)(B) for a period of
at least three years is justified in this case. Findings 1 - 936.
939. Only the following factors may be considered aggravating and
a basis for lengthening the term of Petitioner's exclusion:
a. The violations were serious in nature and occurred over a
period of one year or more;
b. The violations had a significant adverse physical, mental
or financial impact on program beneficiaries or other individuals;
c. The individual or entity has a prior criminal, civil or
administrative sanction record; or
d. The violation resulted in financial loss to Medicare or
the State health care programs of $1500 or more.
42 C.F.R. 1001.701(d)(2)(i) - (iv).
940. Only the following factors may be considered mitigating and a
basis for reducing the period of Petitioner's exclusion:
a. There were few violations and they occurred over a short
period of time; or
b. Alternative sources of the type of health care items or
services furnished by the individual or entity are not available.
42 C.F.R. 1001.701(3)(i) and (ii).
941. The aggravating factor at 42 C.F.R. 1001.701(d)(2)(i) is
present in this case. Findings 1 - 936.
942. The aggravating factor at 42 C.F.R. 1001.701(d)(2)(ii) is
present in this case. Findings 1 - 936.
943. The aggravating factor at 42 C.F.R. 1001.701(d)(2)(iii) is
present in this case. Findings 1 - 936.
944. The aggravating factor at 42 C.F.R. 1001.701(d)(2)(iv) is
present in this case. Findings 1 - 936.
945. The mitigating factor at 42 C.F.R. 1001.701(d)(3)(i) is not
present in this case. Tr. at 1812 - 2737; Findings 1 - 936; I.G.
Ex. 1 - 19; P. Ex. 1 - 25/2
946. Petitioner has not alleged the mitigating factor that appears
at 42 C.F.R. 1001.701(d)(3)(ii). P. Ex. 1 - 25/2; Findings 1 -
945.
947. The mitigating factor at 42 C.F.R. 1001.701(d)(3)(ii) is
not present in this case. P. Ex. 1 - 25/2; I.G. Ex. 1 - 19; Tr. at
1 - 2994; Findings 1 - 946.
948. The existence of four aggravating factors and the absence of
any mitigating factors supports that Petitioner should be excluded
for a term of greater than three years. Findings 937 - 947.
949. I have the authority to increase the term of Petitioner's
exclusion beyond the length imposed or proposed by the I.G.
Sections 205(b) and 1128(b)(6)(B) of the Act; 42 C.F.R.
1005.20(b).
Petitioner should be permanently excluded from Medicare and State
Health Care Programs.
950. Petitioner understands that a patient's flow sheet should
accurately reflect what drugs Petitioner actually administered to
the patient and the amounts the patient actually received. Tr. at
1865 - 1866; I.G. Ex. 3J; Finding 27.
951. Petitioner failed to record properly on each of these seven
patients' flow sheets the amount of chemotherapy that the patient
actually received, instead entering into their charts the amount of
chemotherapy for which he billed Medicare. Tr. at 2118 - 2124,
2135 - 2138, 2575.
952. With regard to all seven of these patients, Petitioner
provided care below professionally recognized standards of health
care by failing to record on each patient's flow sheet the precise
amount and type of chemotherapy each patient received. Findings 1
- 937, (especially at 116, 122, 129, 132, 200 - 201, 248 - 250,
269, 274, 276, 290, 320, 322, 324 - 325, 327, 329, 342, 345, 372,
425 - 426, 432, 446 - 449, 489, 494, 507, 594 - 595, 599, 617 -
618, 641, 693 - 695, 700, 767 - 768, 820 - 821, 826 - 827).
953. Petitioner jeopardized the health, safety, and well-being of
each of these seven patients by failing to record on each patient's
flow sheet the precise amount and type of chemotherapy each patient
received -- especially the following: Adriamycin, Cytoxan, and
Vincristine to B.G and D.R., Cytoxan to H.W.; Vincristine to J.W.;
Adriamycin, Cytoxan, and Methotrexate to J.L.; Adriamycin and
Velban to H.S.; Adriamycin and Cytoxan to R.N. Tr. at 254; I.G.
Ex. 3O at 8 - 31; Findings 1 - 833, (especially at 21 - 44, 188,
323, 426, 497, 508, 521, 525, 542, 551, 600, 616, 641, 769, 819).
954. Petitioner's statement that he was instructed by the Medi-Cal
carrier (CA Blue Shield) to record on the patient's flow sheet the
amount of chemotherapy drugs he billed for rather than the amount
he administered to the patient is not supported by any affirmative
evidence, is directly contradicted by testimony from a
representative of CA Blue Shield, and is contrary to Petitioner's
own statement. I.G. Ex. 3J; Findings 876, 882 - 886, 896 - 910.
955. Petitioner's statement that he was instructed by CA Blue
Shield to record on the patient's flow sheet the amount of
chemotherapy drugs he billed for rather than the amount he
administered to the patient is not credible and is a self-serving
attempt to mitigate the inappropriate and substandard care he
provided. Finding 954.
956. Petitioner has demonstrated a disturbing tendency to blame
Medicare (CA Blue Shield), his nursing staff, and doctors who
filled in for him while he was away from the office for
discrepancies in billing and omissions and errors in his treatment
of these seven patients. Tr. at 1886, 2120 - 2121, 2135 - 2138,
2155 - 2160, 2712 - 2715, 2723; Findings 189 - 217, 326 - 353, 433
- 454, 544 - 567, 619 - 625, 696 - 719, 822 - 833, 905 - 910.
957. Petitioner has demonstrated through his testimony and
practices a disturbing lack of knowledge regarding the medically
appropriate treatment of these seven cancer patients. Tr. at 1812
- 2737; Findings 1 - 936.
958. Petitioner has demonstrated through his treatment of these
seven patients that he is unable or unwilling to adequately
document his diagnoses and treatment of these seven patients in
accordance with professionally recognized standards of health care.
Findings 1 - 936.
959. In treating the seven patients at issue in this case,
Petitioner has not practiced oncology in accordance with
professionally recognized standards. Findings 1 - 936.
960. Petitioner has demonstrated a disturbing tendency to
administer chemotherapy in one to eight hour infusions in the
absence of any supporting medical reason for doing so. Findings 1
- 936.
961. Petitioner has demonstrated an unfamiliarity with the concepts
and principles needed to treat these seven cancer patients in
accordance with professionally recognized standards of health care.
24/ Findings 1 - 936.
962. Petitioner has demonstrated a disturbing tendency to offer
weak, unsupported, post hoc rationalizations to explain his
treatment of these seven patients. Tr. at 1812 - 2737; Findings 1
- 936, (especially at 189 - 217, 326 - 353, 433 - 454, 523 - 531,
544 - 567, 619 - 625, 696 - 719, 822 - 833, 905 - 910).
963. Petitioner has demonstrated a disturbing tendency to testify
that he administered chemotherapy to patients in accordance with a
recognized protocol, when, in fact, the protocol he claims to have
used as his basis for treating the patient is dissimilar in many
important and relevant aspects to the treatment the patient
actually received. Findings 1 - 936 (especially at 238, 303, 304,
338, 377, 380, 523 - 531, 622).
964. Petitioner has demonstrated a disturbing tendency to continue
with a course of treatment in the face of objective evidence that
it is not reducing or having any discernible effect upon the
patient's illness (or, having any effect on the patient at all).
Findings 1 - 936.
965. Petitioner has demonstrated a disturbing tendency to
administer CEA tests that are not medically necessary. Findings 1
- 936 (especially at 48 - 50, 182 - 184, 212 - 214, 312 - 315, 319,
532 - 535, 561, 663 - 667, 807 - 808).
966. Petitioner has demonstrated a disturbing tendency to
administer CBCs, platelet counts and venipunctures that are not
medically necessary. Findings 1 - 936 (especially at 45 - 47, 316
- 317, 430, 536 - 539, 609 - 610, 708 - 709, 810 - 816).
967. Petitioner has demonstrated a disturbing tendency to
administer vitamin B-12 injections that are not medically necessary
and therefore substantially in excess of his patients' needs.
Findings 1 - 936 (especially at 294 - 297, 668 - 670).
968. Petitioner has demonstrated a disturbing tendency to provide
his patients with office visits that are substantially in excess of
their needs. Findings 176 - 180, 239 - 240, 798, 886.
969. Petitioner has demonstrated a disturbing tendency to
administer laboratory tests and procedures, complete and partial
blood counts and platelet counts, venipunctures, and CEA tests that
are substantially in excess of patients' needs. Findings 965 -
966.
970. Petitioner has demonstrated a disturbing tendency to be unable
or unwilling to articulate and follow a medically logical, coherent
plan, or rationale, in accordance with professionally recognized
standards of health care, for the treatment of these seven cancer
patients. Findings 1 - 936.
971. Petitioner has demonstrated a disturbing tendency to fail to
make a diagnosis and plan of treatment that is appropriately
supported with medical documentation. Findings 1 - 936.
972. Through his treatment of these seven patients, Petitioner has
demonstrated an inability or unwillingness to treat patients in
accordance with professionally recognized standards of health care.
Findings 1 - 971.
973. Petitioner has demonstrated a disturbing tendency to
potentially endanger the health and safety of his patients through
his failure to provide care in accordance with professionally
recognized standards of health care. Findings 1 - 972.
974. Petitioner is not a credible witness. Findings 1 - 973.
975. Petitioner is not a trustworthy individual. Findings 1 - 974.
976. Petitioner has provided care that is substantially in excess
of patients' needs and below professionally recognized standards of
health care over a period of more than six years. Findings 1 - 936
(especially at 77, 465). 25/
977. Petitioner has demonstrated an egregious pattern of
noncompliance with professionally recognized standards of health
care such that he has subjected these seven patients to risks.
Findings 1 - 976.
978. Petitioner has demonstrated an egregious pattern of
noncompliance with professionally recognized standards of health
care such that he has disregarded these seven patients' health,
safety, well-being, and quality of life. Findings 1 - 977.
979. Petitioner has demonstrated an egregious pattern of providing
care that is substantially in excess of the needs of these seven
patients such that he has subjected them to risks. Findings 1 -
976.
980. Petitioner has demonstrated an egregious pattern of providing
care that is substantially in excess of the needs of these seven
patients such that he has disregarded the patients' health,
well-being, and quality of life. Findings 1 - 977.
981. Petitioner believes that he was underpaid by Medicare and that
Medicare payments "are a joke." Tr. at 1993.
982. Petitioner has demonstrated a contempt for the Medicare system
that has been reflected in his treatment of these seven patients.
Findings 1 - 981.
983. Petitioner was advised by CA Blue Shield specifically to bill
for the closest amount of cumulative vial sizes (e.g., when 25
milliliters of a drug were used, to bill for three 10 milliliter
vials) and Medicare specifically advised him not to bill for one
dose and throw the remainder of the drug away. Tr. at 1886, 2927
- 2928; I.G. Ex. 3H, 3J.
984. Petitioner has demonstrated a willingness to blame Medicare
for his having billed Medicare for an entire vial of chemotherapy
drug although the chemotherapy drugs administered by Petitioner,
with the exception of Bleomycin, came in reusable vials and the
billing codes were adequate for this purpose. Tr. at 2575, 2855 -
2857, 2867 - 2870, 2895 - 2896, 2927 - 2928; I.G. Ex. 3E, 3F, 3G,
3H, 3I, 3J; Findings 1 - 936 (especially at 326 - 330, 447 - 451,
565, 624, 834 - 936).
985. Petitioner's contention that his infusion treatments of these
seven patients was justified on the basis that administration of
chemotherapy via a one to eight hour infusion minimized local
toxicity to them and increased the kill rate of cancer cells is
completely refuted by the following factors:
a. Petitioner never documented that any of these seven
patients had any side effects from local toxicity;
b. Petitioner's administration of chemotherapy via a one to
eight hour infusion was not medically appropriate or justified in
the treatment regimen of B.G., D.R., H.W., J.W., J.L., H.S., and
R.N (with the exception of Cisplatinum to R.N.);
c. Petitioner should have used the bolus method which, if
administered properly or via a saline, works sufficiently well to
minimize local toxicity;
d. Petitioner should have known that chemotherapy infusions
over one to eight hours do not reduce the more important overall
toxicity to the patient nor do such infusions cause any increase in
the rate at which cancer cells are killed;
e. Although on many occasions Petitioner recorded that he
administered supralethal doses of drugs to these seven patients, in
many instances Petitioner administered doses, if any, of
chemotherapy drugs -- Adriamycin, Cytoxan, and Vincristine to B.G
and D.R., Cytoxan to H.W.; Vincristine to J.W.; Adriamycin,
Cytoxan, and Methotrexate to J.L.; Adriamycin and Velban to H.S.;
Adriamycin and Cytoxan to R.N. -- which were insufficient to have
any curative effect on the patient's cancer.
f. The dosage of chemotherapy Petitioner in fact administered
to each of these seven patients had no chance of curing or
reasonably treating their cancers (with the exception of J.W., who
had no cancer) because the treatments failed to have the side
effects associated with therapeutic dosages, and could have
actually have caused their cancers to become more resistant to
treatment; and
g. The frequency with which Petitioner administered these
chemotherapeutic agents is directly antithetic to reducing
toxicity.
Tr. at 68 - 752, 764 - 957, 966 - 1074, 1077 - 1081, 1083 - 1089,
1302 - 1654, (especially 1822 - 1832), 2751 - 2847; I.G. Ex. 3E,
3N, 3O, 3P, 3Q, 3R, 3S, 3T; Findings 1 - 833.
986. Petitioner has demonstrated a willingness to give testimony
that is not credible and that is directly contradicted by the
evidence. Findings 1 - 936 (especially at 189 - 217, 326 - 353,
433 - 454, 523 - 531, 544 - 567, 619 - 625, 696 - 719, 822 - 833,
905 - 910).
987. Petitioner has demonstrated a willingness to misstate the
record in attempts to justify his treatment of these seven
patients. Findings 1 - 936.
988. Petitioner has demonstrated that he is untrustworthy such
that, if given the opportunity, he will provide substandard and
excessive care to beneficiaries and recipients of federally funded
health care programs. Findings 1 - 987.
989. Petitioner has demonstrated that he believes his treatment of
these seven patients was within professionally recognized standards
of health care and not substantially in excess of their needs.
Findings 1 - 988.
990. Petitioner has demonstrated contempt for the Medicare program,
for persons responsible for administering and policing it, and for
this administrative process. Tr. at 1960 - 2070, 2100 - 2104, 2643
- 2651; Findings 1 - 989.
991. Petitioner has demonstrated a continuing and egregious pattern
of violations including his: willingness to jeopardize the health,
safety, and well-being of patients by providing inadequate and
ineffective diagnoses and care that was severely below
professionally recognized standards or substantially in excess of
patients' needs; failure to understand or recognize the reasons the
care he administered was not in accordance with professionally
recognized standards of health care or substantially in excess of
patients' needs; lack of remorse for his actions; willingness to
give evasive and unsupported testimony that borders upon
fabrication; willingness to blame others for his own actions; and
willingness to submit fragmented claims and engage in improper
billing practices such that it is extremely unlikely that
Petitioner at any time in the future could be entrusted to treat
Medicare beneficiaries or recipients of State health care programs.
Findings 1 - 990.
992. To allow Petitioner to ever again be a provider participating
in Medicare and State health care programs in light of this record
would place beneficiaries and recipients in unnecessary risk of
harm to their health, safety, and well-being. Findings 1 - 991.
993. To allow Petitioner to ever again be a provider participating
in Medicare and State health care programs in light of this record
would place the programs at severe risk of abuse or misuse from
Petitioner's activities. Findings 1 - 992.
994. Exclusions issued pursuant to section 1128(b)(6)(B) are
remedial in nature.
995. A remedial exclusion in this case encompasses a permanent
exclusion, as Petitioner has demonstrated: an egregious pattern of
violations that jeopardized the health, safety, and well-being of
these seven patients; a willingness to make hollow excuses for his
conduct; a failure, in many instances, to recognize the seriousness
of his conduct; a failure, in many instances, to recognize the
potential and actual harm and risk in which he placed these seven
program recipients; a lack of remorse for his conduct and actions
in the treatment of these seven patients; nothing in the record
from which I can conclude with any degree of certainty or
probability that Petitioner will, at any point in the future,
change his conduct to conform with professionally recognized
standards of health care; and, finally, a willingness to continue
with the same pattern of conduct, even while being subject to
prepayment and postpayment review. Findings 1 - 994.
996. Petitioner should be excluded permanently from being a
provider in the Medicare and State health care programs. Findings
1 - 995; section 1128(b)(6)(B) of the Act.
DISCUSSION
Due to the gravity, volume, complexity, and duration of the harm
Petitioner caused the seven Medicare patients (whose extensive
patient records are set forth in this record) and the programs, I
have chosen to make extensive findings of fact and conclusions of
law. It is only after Petitioner's conduct is scrutinized in its
entirety that its ramifications to his patients and the programs
become clear. Moreover, such scrutiny justifies the extraordinary
sanction of a permanent exclusion. No other remedy will adequately
protect the health and welfare of program recipients and
beneficiaries and the financial integrity of the programs.
For purposes of brevity, I will not repeat in this Discussion the
circumstances of Petitioner's conduct and its effect of patients
and the programs, but rather will summarize my findings and provide
record citation support for them. The record amply supports that
the I.G. has authority to exclude Petitioner and that the only
exclusion which will adequately protect the program is to ban
Petitioner permanently from being a program provider. Findings 1
- 996.
Section 1128(b)(6)(B) of the Act provides that the Secretary of
Health and Human Services (Secretary) and her lawful delegate, the
I.G., have the authority to exclude from participation in Medicare
and State health care programs any individual or entity that the
Secretary (or the I.G.) determines to have:
furnished or caused to be furnished items or services to
patients (whether or not eligible for benefits under title XVIII or
under a State health care program) substantially in excess of the
needs of such patients or of a quality which fails to meet
professionally recognized standards of health care.
In this case, the record is replete with instances of Petitioner
having both furnished or causing to be furnished items or services
substantially in excess of patients' needs. Findings 1 - 833. The
record is replete also with Petitioner furnishing items or services
to patients of a quality which fails to meet professionally
recognized standards of health care. Findings 1 - 833.
Accordingly, there is no question that the I.G. had the authority
to exclude Petitioner in this case. Findings 1 - 833.
The regulations at 42 C.F.R. 1001.701 provide that "an exclusion
imposed in accordance with section 1128(b)(6)(B) of the Act will be
for a period of three years, unless specific aggravating or
mitigating factors form a basis for lengthening or shortening the
period." The record of this case contains persuasive,
overwhelming, and unrefuted evidence of the presence and
seriousness of all four aggravating factors specified in the
regulations. Findings 939 - 944. The record is devoid of any
evidence of either of the mitigating factors. Findings 945 - 947.
Accordingly, the I.G. had the authority to exclude Petitioner for
more than three years. Finding 948.
The I.G. chose to exclude Petitioner for a term of 10 years.
However, this case, from the outset, has been governed by section
205(b) of the Act and regulations at 42 C.F.R. 1005.20(b).
Section 205(b) of the Act provides that hearings regarding provider
exclusions from Medicare and State health care programs be
conducted de novo. The regulations at 42 C.F.R. 1005.20(b)
explicitly provide that I may "affirm, increase, or reduce the
penalties, assessment or exclusion imposed by the I.G. or reverse
the imposition of the exclusion." The only constraint on my
authority is imposed by 42 C.F.R. 1005.4(c)(6), which does not
allow me to reduce an exclusion to zero. Accordingly, from the
outset of Petitioner's request for hearing, the parties have been
on notice of and subject to provisions that provide for my
authority to determine an appropriate term of exclusion for
Petitioner, which includes significantly reducing the term of
exclusion to something other than zero or to increase it to any
term that fits the remedial purposes of the act. 26/
During the hearing, I reminded the parties of my authority to
affirm, increase or reduce the 10-year term of exclusion imposed by
the I.G. Additionally, after the hearing, I provided the parties
with the opportunity to brief the issue of my authority to impose
a term of exclusion that is greater than the 10 years imposed by
the I.G. I gave the parties the opportunity also to brief the
issue of whether, assuming I have the authority to increase the
term of exclusion, the record of this case provides adequate
justification for my doing so.
There is no inherent right on the part of a physician to
participate as a provider in the Medicare system. Koppel v.
Heckler, 797 F.2d 858, 864 (10th Cir. 1986); Oberlander v. Perales,
740 F.2d 116, 120 (2d Cir. 1984). In keeping with this principle,
as this case amply illustrates, elderly or ill Medicare
beneficiaries and Medicaid recipients "often do not have the
physical, mental or financial resources to be effective advocates
on their own behalf in the event that they receive incompetent or
inadequate care." Martin Weissman, DAB CR116, at 37 (1991). My
responsibility is to weigh the need to protect program participants
from an untrustworthy provider, as Petitioner is shown to be on
this record, and to determine at what point in time Petitioner will
no longer pose a threat to the program to warrant his future
participation as a provider. The ultimate length of the exclusion
is to be remedial and not punitive. Greene v. Sullivan, 731 F.
Supp. 838 (E.D. Tenn. 1990); Manocchio v. Kusserow, 961 F.2d 1539
(11th Cir. 1992).
The remedial purpose of section 1128 of the Act, including section
1128(b)(6)(B), mandates that I evaluate the record in this case,
including the exclusion imposed against Petitioner, with an eye
toward the protection of Medicare beneficiaries and Medicaid
recipients from incompetent practitioners and from inappropriate or
inadequate care. Paul G. Klein, D.P.M., DAB CR317, at 10 (1994);
S. Rep. No. 109, 100th Cong., 1st Sess. 1 (1987), reprinted in 1987
U.S.C.C.A.N. 682; Teri L. Gregory, DAB CR336, at 16 (1994); Scott
Gladstone, M.D., DAB CR331, at 26 - 27 (1994); George Iturralde,
M.D., DAB CR218, at 9 (1992). An additional remedial purpose of
the Act is to protect federally-financed health care programs from
unscrupulous providers who, through their conduct, have
demonstrated that they pose a threat to the financial integrity of
these programs. David L. Gordon, M.D., DAB CR327, at 11, 13 - 14
(1994); Scott Gladstone, M.D., DAB CR331, at 26 - 27 (1994); George
Iturralde, M.D., DAB CR218, at 9 (1992). Even a slight threat to
beneficiaries and recipients will warrant a lengthy exclusion.
Myron R. Wilson, Jr., M.D., DAB CR146 (1991); Norman C. Barber,
D.D.S., DAB CR123 (1991); Thieu Lenh Nghiem, M.D., DAB CR248
(1992). Even though a permanent exclusion arguably will have an
adverse economic impact upon Petitioner, the need to provide
protection to program beneficiaries and recipients from an
untrustworthy provider is the paramount interest. Sam Williams,
Jr., M.D., DAB CR287, at 19 (1993). 27/
The regulations specify that the following factors be considered
aggravating and a basis for lengthening the period of exclusion for
more than three years: 1) the violations were serious in nature,
and occurred over a period of one year or more; 2) the violations
had a significant adverse physical, mental, or financial impact on
program beneficiaries or other individuals; 3) the individual or
entity has a prior criminal, civil, or administrative sanction
record; or 4) the violation resulted in financial loss to Medicare
or the State health care programs of $1500 or more. Petitioner has
not contended, nor does the record support, that any of the
mitigating factors at 42 C.F.R. 1001.701(d)(3)(i) and (ii) are
present. Findings 945 - 948.
In determining an appropriate term of exclusion in this case, I
must evaluate the exclusion de novo, in conjunction with the
regulatory criteria and in light of the remedial goals of the
statute. Sections 205(b) and 1128(b)(6)(B) of the Act; 42 C.F.R.
1001.701.
The number and severity of the aggravating factors that are present
in this case and the total lack of any mitigating factors
demonstrates that Petitioner is such an unscrupulous, untrustworthy
individual that he cannot possibly be considered anything but a
significant, serious, and continual threat to program beneficiaries
and recipients. Initially, the record demonstrates that Petitioner
has received prior administrative sanctions from the California
Board of Medical Quality Assurance (CBMQA). Finding 8. The record
further demonstrates that, from 1983 through 1989, well in excess
of the one year regulatory requirement, Petitioner engaged in
providing care to these seven patients that is substantially in
excess of their needs or of a quality which fails to meet
professionally recognized standards. Findings 1 - 833.
Petitioner's improper billing for these seven patients caused him
to receive approximately $172,000 in overpayments. Findings 834 -
936; Tr. at 1234 - 1235.
During much of this period, Petitioner was under the scrutiny of
the CBMQA or CA Blue Cross, where most of his treatment and
billings practices at issue here were subject to review. Despite
such action, Petitioner continued with treatment procedures and
billing practices that were grossly below professional standards of
practice. 28/ Moreover, even considering the wealth of expert
testimony presented in this case, Petitioner has yet to recognize
that his treatment of these seven patients was completely outside
of recognized bounds of propriety and safety. Findings 1 - 996.
The record amply demonstrates that Petitioner jeopardized the
health and safety of these seven patients and demonstrates that he
will, when given any opportunity to do so, subject program
recipients and beneficiaries to treatment and testing that is
medically inappropriate, ineffective, or unnecessary. Petitioner
has further demonstrated that he will 1) submit claims for
reimbursement that are not supported by documentation, and, when
questioned on his conduct, will attempt to blame others for his
mistakes; 2) rationalize that the absence of documentation to
support his purported treatment is due to allegedly missing patient
files; and 3) cite studies or treatises for support of his
treatment protocols which, upon review, support the opposite
conclusions. Moreover, Petitioner has demonstrated a highly
contemptuous attitude toward the Medicare program and those persons
responsible for policing the program, as well as the integrity of
this administrative process.
Most of the arguments and statements made by Petitioner in response
to the I.G.'s allegations were, at best, unsupported and, at worst,
deliberately misleading. Findings 76 - 833 (especially 165, 181,
189 - 217, 326 - 353, 433 - 454, 544 - 567, 619 - 625, 696 - 719,
822 - 833). Several of the more egregious examples of this type of
conduct involved Petitioner's insistence that he was instructed to
throw away a large portion of the chemotherapy drugs after only one
usage, despite the fact that these chemotherapy drugs were
available in multi-use vials. Notwithstanding the testimony of two
credible witnesses and the record as a whole, Petitioner constantly
maintained that he was explicitly informed by CA Blue Shield to
bill for an entire vial of chemotherapy drugs even though he
administered only a portion of the vial to the patient. Findings
834 - 936. Another example of this type of conduct is Petitioner's
tendency to blame his staff for both for billing discrepancies and
for Petitioner's own failure to accurately record critical
information in a patient's flow sheet. Findings 1 - 936
(especially 165, 181, 189 - 217, 326 - 353, 433 - 454, 544 - 567,
619 - 625, 696 - 719, 822 - 833).
Moreover, Petitioner has demonstrated that he has no remorse for
his actions, because he remains sincere in his belief that, in all
but the most minor instances, his treatment of these seven patients
was within professionally recognized standards and not
substantially in excess of their needs. 29/ Findings 189 - 217,
326 - 353, 433 - 454, 544 - 567, 619 - 625, 696 - 719, 822 - 833.
Petitioner takes this position despite overwhelming evidence to the
contrary. Findings 76 - 833. In steadfastly defending treatment
regimes that were so below professionally recognized standards as
to endanger his patients' health and degrade their quality of life,
and in attempting to justify services that he provided that were
substantially in excess of his patients' needs where the record
amply demonstrates that Petitioner provided excessive and
unnecessary services, Petitioner has demonstrated a disturbing
tendency to deny reality and trivialize the severity, seriousness,
and magnitude of his unlawful conduct. Findings 165, 181, 189 -
217, 326 - 353, 433 - 454, 544 - 567, 619 - 625, 696 - 719, 822 -
833. Through his testimony at the hearing, Petitioner has further
demonstrated that, when questioned about issues regarding his
inappropriate treatment of these seven patients, he misstated the
record and invented scenarios that were entirely unsupported.
Findings 189 - 217, 326 - 353, 433 - 454, 544 - 567, 619 - 625, 696
- 719, 827 - 833.
Review of Petitioner's educational background and work experience
leads to the conclusion that he should have the intellect to
understand the complexity of the issues presented by this case.
I.G. Ex. 3E; P. Ex. 1; Findings 1 - 2. When confronted with
overwhelming evidence that his treatment and billing practices were
grossly deficient, Petitioner steadfastly chose to maintain his
position and provided surprisingly weak rationalizations.
Particularly in light of evidence that he was repeatedly informed
and shown that such was the case, as well as Petitioner's failure
to accept any responsibility or blame for his conduct or its
consequences at any point in this proceeding, Petitioner's failure
to recognize that his treatment of patients was grossly below
professionally recognized standards strongly suggests that he can
never be trusted to be a program provider again.
Some of the most egregious examples of this conduct occurred when
Petitioner maintained that, despite the fact patients' flow charts
did not accurately reflect the amounts of various chemotherapy
drugs these seven patients actually received, his office could
nonetheless keep track of the amounts because only a few patients
were receiving chemotherapy. Findings 189 - 217, 326 - 353, 433 -
454, 544 - 567, 619 - 625, 696 - 719, 827 - 833. Petitioner did,
however, acknowledge that proper documentation in a patient's flow
sheet was important to assure continuity of care. Finding 27.
Petitioner's assertion that it is appropriate to stake the safety
and care of his patients on his ability to recall, without
documentation, the precise dosages of chemotherapy received by his
patients raises serious concern about his ability to safely treat
patients in the future. 30/ Such a statement also is a feeble
attempt by Petitioner to rationalize obvious and potentially
dangerous errors, as well as to diminish the impact of care that
was not rendered in accordance with professionally recognized
standards.
The fact that Petitioner is cognizant of the purpose for accurate
and precise documentation of the chemotherapy a patient receives
only serves to make his repeated lapse in documentation and
subsequent post hoc rationalizations more egregious. Findings 1 -
966.
Petitioner has exhibited an arrogant disdain for both the Medicare
review process and that of the peer review organization by
continuing to treat patients in ways that are below professionally
recognized standards and substantially in excess of patients'
needs, even while being subject to prepayment and postpayment
review. Findings 834 - 936. Petitioner has further shown his
disdain for Medicare and its regulations by submitting billings in
ways designed to minimize detection of his substandard and
excessive treatment of these seven patients. Findings 834 - 936.
At the hearing, Petitioner demonstrated a contempt for these
proceedings by testifying that his treatment of patients was
supported by medical research and then offering the researchers'
published studies as exhibits. Findings 189 - 217, 326 - 353, 433
- 454, 544 - 567, 619 - 625, 696 - 719, 827 - 833. Upon
examination, not only did the exhibits fail to support Petitioner's
contentions, the exhibits refuted the very principles Petitioner
asserted the studies conclusively proved. Findings 76 - 833. The
exhibits, when examined in their entirety, undermine Petitioner's
position and support the testimony given by the I.G.'s expert
witnesses that Petitioner's care was below professionally
recognized standards and substantially in excess of the needs of
these seven patients. Findings 76 - 833. In his zealous attempts
to justify his care of these patients, Petitioner undermined his
credibility as, while under oath, he attempted to twist the
meanings of the studies to justify his treatment of these seven
patients. Findings 189 - 217, 326 - 353, 433 - 454, 544 - 567, 619
- 625, 696 - 719, 822 - 833. Petitioner further demonstrated his
contempt for these proceedings by using every means at his disposal
to delay and prolong the ultimate resolution of this case.
Background at pages 3 - 6; Tr. at 1960 - 1977.
Most serious, Petitioner demonstrated a total disregard for the
health and well being of the seven patients. Findings 76 - 833.
Petitioner repeatedly and consistently administered unnecessary and
useless CEA and blood tests. Findings 76 - 833. In doing so,
Petitioner inflicted useless and unnecessary venipunctures. On
several occasions, Petitioner administered unnecessary and useless
vitamin injections. Findings 76 - 833.
Petitioner's disregard for the health and quality of life of his
patients, and Petitioner's willingness to jeopardize the health and
well-being of his patients, was amply shown by his failing to
document accurately the amounts and types of chemotherapy he
administered. Findings 76 - 833. It is illustrated also by
Petitioner's insistence on administering chemotherapy via infusion
which, in all but one instance, was useless as far as helping the
patient, but seems to have been instrumental in allowing him to
charge more for treatments. 31/ Despite Petitioner's statements to
the contrary, his administration of infusion treatments of one to
eight hours unnecessarily prolonged the amount of time his patients
spent in his office. Findings 76 - 833. Had Petitioner
administered chemotherapy in accordance with professionally
recognized standards and not substantially in excess of the
patients' needs, he would have administered virtually all of the
treatments by bolus, which would have been less time consuming and
caused the patients to spend less time in Petitioner's office.
Findings 76 - 833.
The seriousness of Petitioner's conduct is further demonstrated in
the decreased quality of life that his excessive and substandard
services caused these seven patients, as well as the adverse mental
and financial impact his conduct had on these seven patients.
Findings 1 - 936. Petitioner's provision of services in excess of
patients' needs resulted in many of these seven patients coming to
his office at an excessive frequency, such that it calls into
question whether some of these individuals were even examined or
treated by Petitioner on all of the occasions Petitioner claimed to
have examined or treated them. Findings 76 - 833. Petitioner's
records reflect that several of these seven patient were compelled
to make staggering numbers of office visits over the course of
their treatments, at probably great inconvenience. Findings 76 -
833. This is especially true where treatment within professionally
recognized standards would have resulted in fewer office visits.
Findings 76 - 833.
Petitioner consistently documented that he was administering
supralethal doses of chemotherapy to these patients, but the lack
of documented side effects and the fact that these individuals did
not die from the excessive doses Petitioner claimed to have
administered shows that Petitioner failed to administer the
chemotherapy in the amount claimed. Findings 76 - 833. Indeed,
the record reflects that, in many instances, when Petitioner
claimed to have provided supralethal doses of various chemotherapy
drugs, the patient actually received doses that were insufficient
to have any effect on the patient's cancer. Findings 76 - 833.
Petitioner's administration of doses of chemotherapy that were
insufficient to have any effect on the patient's cancer was below
professionally recognized standards and jeopardized the health,
safety, and well-being of these individuals. Findings 1 - 833.
Moreover, in administering ineffective treatments and unknown
doses, Petitioner robbed patients of any hope for cure of their
cancer or palliation of their symptoms. Findings 1 - 833. In
several instances, Petitioner administered prolonged, expensive
chemotherapy treatments when other more effective treatments were
available. Findings 1 - 833. In other instances, Petitioner
misdiagnosed patients' conditions, and insisted in providing
chemotherapy treatment to one patient who did not even have cancer.
Findings 1 - 833.
Finally, Petitioner has demonstrated that, in many instances, he
does not understand why his treatment was not in accordance with
professionally recognized standards or substantially in excess of
the patients' needs. Petitioner's treatment of these seven
patients, and the record as a whole, indicate that he is not able
to practice oncology in accordance with professionally recognized
standards. Findings 1 - 996. This fact is borne out by
Petitioner's censure from the CBMQA, which has banned Petitioner
from practicing oncology, and limited his practice of medicine
generally to situations where his treatment of patients is overseen
by another physician. Finding 8.
Petitioner has further demonstrated a complete lack of remorse for
his conduct and is unwilling to recognize or concede that his
treatment of these seven patients was inappropriate, excessive, or
not in accordance with professionally recognized standards.
Findings 1 - 936. Petitioner's lack of remorse is further
demonstrated by Petitioner's tendency to blame others for billing
errors or for the submission of claims to CA Blue Shield for drugs
that were not received by his patients. Findings 165, 181, 189 -
217, 326 - 353, 433 - 454, 544 - 567, 619 - 625, 696 - 719, 827 -
833, 834 - 936.
In providing care below professionally recognized standards or
substantially in excess of the needs of these seven patients,
Petitioner caused financial loss to the Medicare and State health
care programs in an amount well in excess of the $1500 regulatory
threshold. Findings 944. More important, the record demonstrates
that Petitioner used CA Blue Shield's review process, and CA Blue
Shield's failure to initially take a vigorous enforcement posture
against him, to extend the period of time over during which he
excessively and improperly billed for program services and thereby
threatened the financial integrity of the programs. Findings 834 -
936. Petitioner has displayed a willingness to attempt to secure
payment for improper or excessive billings even while he was on
notice of the problems associated with his practices and even while
he was being denied reimbursement for a substantial percentage of
his claims. Findings 834 - 936.
Petitioner contends that Medicare's continuing to authorize payment
of his treatment of these patients serves to legitimize the
treatment he provided. Petitioner asserts that CA Blue Shield, and
the I.G., are now precluded from challenging the treatment he
provided to these patients because CA Blue Shield initially
approved the claims he submitted for reimbursement for the
treatment he provided to these patients. Petitioner contends that,
in monitoring him for twelve years and continuing to reimburse him
for the vast majority of the claims he submitted, CA Blue Shield
ratified his treatment of these patients.
However, as the CA Blue Shield representative testified, that is
not the case. While, admittedly, it would have been preferable had
CA Blue Shield denied more of Petitioner's claims for excessive or
substandard services in the review process, the fact that CA Blue
Shield paid many of the claims submitted by Petitioner in no way
precludes them from challenging these claims at a later date. Nor
can Petitioner can point to any authority to establish that, once
a claim manages to survive the prepayment or postpayment review
process, it somehow becomes immune to any future challenges. As
the CA Blue Shield representatives testified, Petitioner fragmented
his claims in such a way as to elude detection of his excessive and
substandard services. Findings 834 - 936.
Petitioner places mistaken reliance on his having managed to emerge
unscathed from the review process for many years. He escaped
detection through a combination of his own manipulations and a lack
of vigorous enforcement by CA Blue Shield, and the mere fact of his
having escaped detection does not support that the treatment he
provided to these seven patients was in accordance with
professionally recognized standards and not in excess of these
patients' needs. Findings 834 - 936. Unfortunately, as CA Blue
Shield officials noted, routinely claims are questioned only after
the provider has received reimbursement. Findings 834 - 936.
Moreover, the peer review process which brought these problems to
litigation in this case is a more thorough, intensive review than
either the prepayment or postpayment review process. Findings 834
- 936.
Petitioner contends that the I.G.'s experts are not persuasive in
this case because they did not examine the patients in question and
because they did not agree unanimously on every aspect of what were
the professionally recognized standards regarding the treatment of
these seven patients. I take this argument also to mean that
Petitioner calls into question whether the I.G.'s experts were able
to agree on whether Petitioner provided services substantially in
excess of the needs of these seven patients.
While it is true that none of the I.G.'s experts examined any of
these seven patients, Petitioner has offered nothing that would
lead me to conclude that any of the testimony that was given by the
I.G.'s experts was flawed by their not having examined these
patients. All of the problems associated with Petitioner's care
and treatment of these patients are readily apparent from the
record presented by the I.G. There was no need for any of these
experts to have examined these patients to be able to discern the
substandard, excessive care that Petitioner provided.
Petitioner's assertion that the I.G.'s reliance upon the limited
paperwork hampered her experts' ability to render valid opinions is
undercut by the fact that most of the documentation regarding these
seven patients was from Petitioner's own files. Moreover,
Petitioner was given ample opportunity to submit any rebuttal
information he wished, including 1) when CA Blue Shield initially
questioned the claims; 2) when the PRO requested he submit all
rebuttal information; and 3) during the exchange of documents and
exhibits in this case. Yet, on all three occasions, Petitioner
offered nothing persuasive to support his contentions that the
treatment he administered to these seven patients was in accordance
with professionally recognized standards and not in excess of the
patients' needs.
Petitioner contends that the testimony of the I.G.'s experts must
be discounted because all three did not agree unanimously on what
treatments and procedures were within professionally recognized
standards. While I concede the experts were not unanimous in all
of their opinions, there was a consensus in all but the most
unimportant points. Findings 1 - 966. In the few areas where the
experts did not agree, I either did not use the testimony in those
areas to make adverse findings against Petitioner or made
affirmative Findings that the treatment provided by Petitioner was
in accordance with professionally recognized standards or not
substantially in excess of a patient's needs. 32/ See Findings
407, 585 - 588. However, in the overwhelming majority of the
testimony, there was almost total uniformity and consensus among
the experts such that, in weighing the evidence as a whole, I was
able to make the Findings and reach the conclusions as elaborated
earlier. Accordingly, Petitioner's contention that the expert
testimony in this case should be discounted because of a lack of
consensus is without merit.
CONCLUSION
The remedial purposes of the Act guide my Decision in this case.
Considering the extensive record before me, Petitioner has provided
little or nothing to indicate that he understands, recognizes, or
accepts that his treatment of these seven patients was not in
accordance with professionally recognized standards or
substantially in excess of their needs. Certainly, his competency
to treat oncology patients now and in the future has been seriously
questioned and his ability or willingness to attain such skills
remains in doubt. He has shown a total lack of remorse for his
conduct and contempt for the Medicare program and for this
proceeding. Of particular importance, Petitioner has demonstrated
an outrageous disregard for the welfare of these patients,
subjecting them to essentially worthless oncology treatment
protocols which neither cured their cancer nor provided palliative
measures. Equally of concern is that Petitioner has placed his
desire to maximize his Medicare billings over and above the proper
treatment of these patients, even going so far as to unmercifully
expose them to excessive office visits for unnecessary medical
procedures that robbed them of their dignity and quality of life.
There is nothing in the record that would allow me to conclude
that, at any time in the future, Petitioner has the capacity or
willingness to recognize the unlawfulness of his behavior and
modify his conduct such that he will no longer pose a tremendous
and overwhelming threat to both the health and well being of
program beneficiaries and recipients and the financial integrity of
Medicare and State health care programs.
I have carefully examined this record to discern any credible
evidence that at some point in the future Petitioner will no longer
pose a threat to program recipients and beneficiaries. None exists
in this record. I am mindful of the significance of the permanent
exclusion of this Petitioner. However, I cannot find any evidence
in this record to suggest that any shorter exclusion will
adequately protect the programs or be consistent with the remedial
purposes of the Act. Accordingly, I find that the I.G. has the
authority to direct and impose an exclusion against Petitioner, and
I further find that a permanent exclusion from participation as a
provider in the Medicare and State health care programs is
appropriate.
_________________________
Edward D. Steinman
Administrative Law Judge
1. The term "State health care program" as defined at 1128(h) of
the Act encompasses Medicaid and other federally funded health care
programs. All references to State health care programs throughout
this Decision are to that term as it appears in section 1128(h) of
the Act.
2. For purposes of this Decision, unless explicitly stated
otherwise, the term "professionally recognized standard(s)" refers
to professionally recognized standards of health care as that term
appears in section 1128(b)(6)(B). Additionally, all references to
professionally recognized standards as applied to a particular
patient pertain to the periods of time that Petitioner was treating
that patient. Other references to professionally recognized
standards pertain to Petitioner's treatment of any patient who was
subjected to the medical practices at issue in this case.
3. Also pending was the I.G.'s motion to dismiss Docket No.
C-93-036, based on Petitioner's failure to timely request a
hearing. I held in abeyance my ruling on this motion. Docket No.
C-93-036 was an exclusion case brought by the I.G. against
Petitioner based on an entirely separate set of facts and statutory
authority (section 1156 of the Act). Docket No. C-93-036 received
a separate hearing and decision which was entirely independent of
the instant case. Accordingly, I will not go into the details of
that case, as it is not relevant to the issues presented here. My
decision in Docket No. C-93-036 was issued as Sunil R. Lahiri,
M.D., DAB CR296 (1993).
4. My Order of March 4, 1993 details these events.
5. These events are described in more detail in my Order of
April 15, 1993.
6. My April 30, 1993 Order and Notice of Hearing describes the
events of the April 23 prehearing conference in detail.
7. In my Ruling of August 2, 1993, I detail my analysis and the
basis for denying Petitioner's request for continuance.
8. The events and the oral Ruling I made at the August 4
conference appear in written form in my Ruling dated August 11,
1993.
9. The events which caused the hearing to be resumed the week of
January 24, 1994 can be found in the transcript at pages 1959 -
1977, 2012 - 2030, 2035 - 2044.
10. As part of his posthearing activity, Petitioner moved for a
rehearing and for me to recuse myself. In a Ruling of October 7,
1994, I denied Petitioner's motion. In that Ruling, I identified
and rejected an I.G. exhibit as I.G. Ex. 18. This exhibit should
have been referred to as I.G. Ex. 20, and it has now been marked as
such.
11. I refer to the parties' exhibits, briefs, and the transcript
as follows:
I.G.'s Exhibit . . . . . . . . . . . . I.G. Ex. (number
at page)
Petitioner's Exhibit . . . . . . . . . P. Ex. (number at
page)
Transcript . . . . . . . . . . . . . . Tr. at (page)
Petitioner's 1st posthearing brief . . P. Br. at (page)
I.G.'s 1st posthearing brief . . . . . I.G. Br. at (page)
Petitioner's reply brief . . . . . . . P. R. Br. at
(page)
I.G.'s response brief . . . . . . . . I.G. R. Br. at
(page)
Petitioner's supplemental brief . . . P. Supp. Br. at
(page)
I.G.'s supplemental brief . . . . . . I.G. Supp. Br. at
(page)
12. Some of the I.G.'s exhibits are marked with numbers and
letters.
13. Dr. Bellare did not review Petitioner's care of patient J.L.
Tr. at 1301 - 1302.
14. This is noted in the chart as "no definite adnexal mass
palpable." P. Ex. 10 at 1. The term adnexal refers to a location
next to the cervix. In the context of this case, the term
"adnexal" is used to describe a cancerous mass located next to the
cervix that would be characterized as stage III cancer of the
cervix. Tr. at 1375.
15. For purposes of this Decision, I take judicial notice of the
aforementioned definition of Paget's disease, as it appears in the
American Medical Association Encyclopedia of Medicine.
16. The term melanoma refers to a specific type of cancer. I
use the terms "cancer" and "melanoma" interchangeably when
referring to J.W. because melanoma is the specific type of cancer
for which J.W. was receiving treatment from Petitioner. The
references to metastatic melanoma refer to the fact that Petitioner
believed J.W.'s melanoma had metastasized in J.W.'s brain.
17. The I.G. has placed no records into evidence that
demonstrate the types and amounts of chemotherapy Petitioner
administered to J.W. between 1979 (when Petitioner first examined
and diagnosed J.W.) and February 11, 1985. Admittedly, this date
is somewhat arbitrary and may seem abrupt to the reader. I take
this cutoff merely at face value, i.e., that the I.G. simply does
not have sufficient records to document Petitioner's care of J.W.
during this period. I do not infer from the absence of the records
to imply either that Petitioner's treatment of J.W. between 1979
and February 11, 1985 was or was not in accordance with
professionally recognized standards. Likewise, I do not infer from
the absence of data that Petitioner's treatment of J.W. between
1979 and February 11, 1985 either was or was not substantially in
excess of J.W.'s needs.
18. I.G. Ex. 3Q does not reflect that Petitioner administered
any chemotherapy to J.W. on February 11, 1985 or on November 22,
1988. Instead, the record reflects that Petitioner claimed to have
administered chemotherapy to J.W. starting on April 11, 1985
through September 7, 1988.
19. DTIC is the abbreviated name for the drug Dacarbazine, which
is used in the treatment of metastatic melanoma. I.G. Ex. 3Q at 1,
6; P. Ex. 4 at 17 - 20.
20. The BOLD protocol, or regimen, is the administration of the
chemotherapy drugs Bleomycin, Vincristine, Lomustine, and DTIC for
the treatment of metastatic melanoma. The drug Vincristine is also
called "Oncovin." The first letter of each of the drugs used in
the protocol spell the word BOLD, hence the name for the protocol.
The drugs used in the BOLD protocol are administered in very
specific amounts and on very specific intervals called cycles. P.
Ex. 4 at 17 - 20; I.G. Ex. 3Q at 17.
21. Instead of being numbered consecutively, these four
Petitioner's exhibits were marked as P. Ex. 24/1, 24/2, 25/1.
22. Adriamycin, infused over a 24-hour period, does exhibit
reduced cardiotoxicity. Tr. at 1338.
23. My review of the record reveals that Petitioner billed for
34 office visits for R.N. in 1986. However, since counsel for the
I.G. alleges that only 32 office visits occurred, I make this
lesser amount my Finding.
24. In making this Finding, I recognize that there exist several
instances in the record where Petitioner acted in accordance with
professionally recognized standards and, in doing so, demonstrated
some knowledge of appropriate treatment of patients. See Findings
407, 586, 740 - 741, 748. However, the evidence examined and
weighed in its entirety, overwhelmingly supports this Finding.
25. Petitioner's treatment of B.G. began in September 1983, and
his treatment of J.W. ended on November 22, 1989. Petitioner's
treatment of all other patients is interspersed throughout this
period.
26. By regulation, the Secretary limits the authority of an
administrative law judge to reduce an exclusion, but does not limit
a judge from increasing an exclusion. The regulatory silence on
the issue of the judge's authority to increase the exclusion is an
indication of the Secretary's acknowledgement that the Judge should
formulate the length of exclusion consistent with the remedial
purposes of the Act. The permanent exclusion that I have imposed
is a result of a careful analysis of the record which persuaded me
that a permanent exclusion was needed to protect program
participants and the program itself from the threat of a
continuation of Petitioner's conduct should he be reinstated into
the program. In my Findings and in my Discussion, I set forth in
more detail the extent of my analysis.
27. I note that in the case of Robert L. Alexander, M.D., DAB
CR244, at 14 (1992), Administrative Law Judge Charles Stratton
intimated that an exclusion should not be permanent because the
remedial purposes of the Act contemplate rehabilitation of the
excluded Petitioner. This general prohibition is premised on the
principle that an exclusion "may not be so extreme and
disproportionate that it bears no rational relation to the remedial
goals." Alexander at 24. While I concur with this principle, I do
not agree that valid circumstances can never exist to warrant a
permanent exclusion where rehabilitation is unlikely. This case is
unlike Alexander, where Judge Statton found compelling reasons in
the record to conclude that the Petitioner was undertaking steps to
remedy his misconduct, the risk of repetition of such conduct was
minimal, and the imposition of a 10-year exclusion was warranted
rather than the more lengthy exclusion imposed by the I.G. Here,
my findings of fact and conclusions of law establish the presence
of extreme and extensive evidence of Petitioner's violations of
section 1128(b)(6)(B). Consequently, I cannot find any compelling
basis in this record to impose anything less than a permanent
exclusion. Therefore, since Petitioner has demonstrated no remorse
or likelihood of rehabilitation, his conduct is so abhorrent and is
dangerous to the health, safety, and welfare of program recipients
and beneficiaries and presents a clear risk to the financial
integrity of such programs, a permanent exclusion is supportable as
the only remedy which will satisfy the remedial purposes of the
Act.
28. The three million dollars Petitioner was paid in the years
in question, utilizing more than one provider number, shows the
extent to which he used his oncology practice as a means to obtain
payment from the Medicare and Medicaid programs. Findings 890 -
892.
29. For instance, after repeated denials in both direct and
cross-examination, Petitioner finally admitted that he should have
documented B.G.'s refusal of potentially curative treatment.
Again, only after repeated questioning, Petitioner admitted also
that, in several instances, he should have documented the amount of
chemotherapy the patient actually received. However, examining the
record as a whole, it is apparent that, in the vast majority of
instances, Petitioner either denies that the treatment he provided
was in any way deficient, or blames his mistakes on his office
staff (for whom he is responsible) or on what he contends were
inadequate billing instructions by CA Blue Shield. Findings 1 -
966.
30. This is shown by testimony that, when given the opportunity
to state how much chemotherapy he administered to patients,
Petitioner could not recall and referred to the flow sheet.
Findings 334, 344 - 345, 700 - 701, 823; see Findings 326 - 329,
446 - 450, 551 - 552, 624, 716.
31. With one minor exception, the I.G.'s experts testified that
Petitioner's infusions of between one to eight hours served no
medical purpose except to allow Petitioner to bill Medicare more.
Findings 1 - 966; I.G. Ex. 3E; see Tr. at 68 - 752, 764 - 957, 966
- 1081, 1302 - 1654.
32. One such area of disagreement was where Dr. Hoffman stated
that he did not believe that Petitioner's attempt to treat patient
J.L. with chemotherapy was below professionally recognized
standards. Tr. at 870 - 872; Findings 585 - 588. Accordingly, I
made no findings that Petitioner's attempt to treat J.L. with
chemotherapy was below professionally recognized standards.
However, Dr. Hoffman did agree with the other I.G. experts in
stating that he did believe the types, amounts, method of
administration and duration of the chemotherapy that Petitioner
documented he provided to J.L. was below professionally recognized
standards and substantially in excess of J.L.'s needs. Findings
568 - 618. It is that criticism of Petitioner's treatment of J.L.
that is reflected in my Findings.