Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of: Anthony G. Corkill, M.D., Petitioner,
- v.-
The Inspector General.
DATE: October 14, 1993
Docket No. C-93-046
Decision No. CR289
DECISION
On January 20, 1993, the Inspector General (I.G.) advised Petitioner, Anthony
G. Corkill, M.D., that a
determina-tion had been made to exclude him from participating in Medicare and
State health care
programs for three years. 1/ The I.G. told Petitioner that the exclusion was
authorized by section 1156 of
the Social Security Act (Act). The I.G. based the determination to exclude Petitioner
on a recommendation
made by California Medical Review Incorporated (CMRI), the peer review organization
for the State of
California.
CMRI's recommendation that Petitioner be excluded derived from its findings
that, with respect to nine
Medicare beneficiaries, Petitioner had failed substantially to provide care
that was: economical and only
when, and to the extent, medically necessary; of a quality that meets professionally
recognized standards of
health care; and supported by appropriate evidence of medical necessity and
quality of services in a form
and fashion as may be required. CMRI's recommendation specified, for each of
the nine cases at issue, the
violations it had discerned.
The I.G. informed Petitioner that CMRI's conclusions had been accepted. The
I.G. incorporated CMRI's
findings in the notice to Petitioner. Additionally, the I.G. advised Petitioner
that the I.G. had determined
that Petitioner demonstrated either an unwillingness or an inability to comply
with his obligations under
section 1156 of the Act. The I.G. noted that CMRI had on more than one occasion
offered Petitioner the
opportunity to correct his deficiencies by entering into a corrective action
plan, and Petitioner had not
agreed to do so.
Petitioner requested a hearing and the case was assigned to me for a hearing
and a decision. Petitioner
moved that the exclusion be held in abeyance pending a ruling by me as to whether
he posed a serious risk
to the welfare of patients in certain rural communities in which he practiced.
On March 5, 1993, I ruled
that Petitioner was "located in" a rural area within the meaning of
section 1156(b)(5) of the Act and I
ordered that the exclusion be held in abeyance until I issued a ruling on the
issue of whether Petitioner
posed a serious risk to patients.
I held a hearing in San Francisco, California, from May 17 - 19, 1993. The
parties agreed that the hearing
should consolidate the taking of evidence as to the issues of serious risk,
the authority of the I.G. to exclude
Petitioner pursuant to section 1156 of the Act, and the reasonableness of the
exclusion which the I.G.
imposed against Petitioner. On July 1, 1993, I issued a ruling in which I found
that Petitioner posed a
serious risk to patients. I permitted the exclusion to be in effect pending
a final decision in this case. The
July 1st ruling did not address the ultimate issues of whether the I.G. had
authority to exclude Petitioner or
whether the exclusion imposed against Petitioner by the I.G. is reasonable.
With respect to those issues, I have considered carefully the applicable law,
the evidence adduced at the
hearing, and the arguments raised by the parties in their respective briefs
and reply briefs. 2/ I conclude
that the I.G. proved that authority exists under section 1156 of the Act to
exclude Petitioner from
participating in Medicare and Medicaid. I find that the three-year exclusion
imposed by the I.G. is
reasonable.
ISSUES
The issues in this case are whether:
1. The I.G. is authorized to exclude Petitioner pursuant to section 1156(b) of the Act.
2. The three-year exclusion which the I.G. imposed against Petitioner is reasonable.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
I. Petitioner's education, training, work experience, and licensure as a physician 3/
1. Petitioner is a physician. P. Ex. 1, p. 1 (citations to Petitioner's Exhibits are made as "P. Ex.").
2. Petitioner received his medical education at Cambridge University, in England. P. Ex. 1, p. 1.
3. Petitioner is licensed to practice medicine in the State of California. P. Ex. 1, p. 1.
4. Petitioner specializes in neurosurgery and maintains a practice in Redding,
California. Tr. at 321.
(citations to the Transcript are made as "Tr. at").
5. Petitioner devotes approximately 80 percent of his practice to spinal surgery. Tr. at 324 - 325.
II. Spinal conditions which may cause medical problems for individuals
6. Instability of a vertebral segment of the spine is an abnormal play or motion
within that segment. Tr. at
96.
7. Instability of a vertebral segment may be from front to back, from side to side, or rotational. Tr. at 96.
8. Instability may cause a patient to experience pain. Tr. at 197.
9. In some cases, instability may be corrected with surgery. Tr. at 197 - 199; see Tr. at 96 - 97.
10. Spondylolisthesis is an abnormal positioning of a portion of the spinal column. Tr. at 200.
11. Anterior spondylolisthesis (anterolisthesis) is the most common form of
spondylolisthesis, and is the
abnormal forward shifting of a vertebral body in relation to an adjacent vertebral
body. Tr. at 200.
12. The presence of spondylolisthesis indicates potential instability. Tr. at 108.
13. Spondylosis and spurring are overgrowths of bone within the spine. Tr. at 223.
14. The presence of spondylosis or spurring may indicate instability within the spine. Tr. at 223.
15. In the majority of cases, spondylosis or spurring exists without instability. Tr. at 223.
16. Spondylolysis is an interruption of the bony ring which surrounds the spinal canal. Tr. at 226.
17. Spondylolysis may be a congenital or an acquired condition. Tr. at 226.
18. Spondylolysis frequently is a cause of instability. Tr. at 226.
19. Scoliosis is a rotation of the spinal column. Tr. at 233.
20. The presence of scoliosis is an indication of possible instability. Tr. at 233.
21. Paget's disease is a metabolic bone disease where bone is replaced with
fibrovascular tissue and bone.
Tr. at 124.
22. The bone which develops as a consequence of Paget's disease is structurally
relatively poor bone. Tr.
at 124.
23. In some patients, Paget's disease produces relatively few symptoms, whereas
in others it may produce
significant symptoms. Tr. at 124.
24. In most individuals, the soft elements of the spinal column will degenerate
over time as a consequence
of accumulated stresses and the aging process. Tr. at 193 - 195.
25. Sixty percent of individuals over the age of 60 have demonstrable evidence
of degeneration in their
spines. Tr. at 194.
26. The vast majority of individuals with degenerative spinal disease live
normal lives or have minimal
symptoms not requiring surgical intervention. Tr. at 195.
27. Stenosis is a narrowing of the canals through which run the nerves which
emanate from the spine. Tr.
at 218.
III. Circumstances under which spinal surgery to correct instability may be indicated
28. Surgery to correct spinal instability is justified where there exists clinical
evidence of instability
coupled with intractable pain. Tr. at 196 - 198, 300.
29. Surgery to correct spinal instability is not normally justified where there
exists instability, but where
the patient does not complain of intractable pain. Tr. at 197 - 198.
30. Surgery to correct spinal instability is not justified where the patient
complains of intractable pain, but
where there is not sufficient evidence to establish the presence of instability.
Tr. at 198, 291, 300.
31. The presence in a patient of a condition or conditions which might consist
of spinal disease or which
might be a cause of instability is not normally sufficient to conclude that
instability exists in that patient's
spine. Tr. at 124 - 125, 214, 217 - 218, 223 - 224, 300 - 301, 358 - 360, 377,
379, 382, 386; see Tr. at 303
- 304.
32. In order to confirm the presence of instability, special studies, such
as x-rays taken while the patient is
bending, may have to be performed. Tr. at 292, 353 - 354.
33. It may be helpful to temporarily immobilize a patient's spine in order
to determine whether the
patient's pain is caused by instability. Tr. at 356 - 357.
34. There may exist conditions for which spinal surgery such as decompression
or laminectomy is
appropriate but for which surgery to correct instability is not appropriate.
Tr. at 129; see Tr. at 124 - 126.
35. Decompression is a surgical technique which is intended to relieve pressure
on a part of the spinal sac
or nerve root. Tr. at 119.
36. Laminectomy is a surgery performed to remove a part of the lamina, which
is the covering of the
spinal canal. Tr. at 126.
IV. Techniques of surgery performed to correct spinal instability
37. Surgery performed to correct instability of the spine generally consists
of an attempt to obtain bony
fusion of the unstable part of the spine. Tr. at 96 - 97, 198 - 199.
38. The objective of fusion surgery is to obtain permanent stabilization of
the unstable part of the spine.
Tr. at 199, 352.
39. Grafting of bone to abnormal segments of the spine is the only way to accomplish
a permanent fusion
of the spine. Tr. at 202.
40. In order to accomplish bony fusion, the surgeon must graft an adequate
quantity of bone to the site
which is intended to be fused. Tr. at 204 - 205.
41. Typically, in performing a fusion, the surgeon removes the outer layers
of bone from the site which is
intended to be fused and grafts to that site bone, which is harvested from the
patient's own body. Tr. at
101, 204 - 205.
42. Bone used as grafts in fusion surgery usually includes bone taken from
the patient's hip (iliac crest).
Tr. at 204 - 205.
43. Bone from a patient's iliac crest is used often for fusion grafts because
it may be needed to supply a
sufficient quantity of bone to promote fusion. Tr. at 204 - 206.
44. Bone from sources other than a patient's own body, such as from cadavers,
can be used to achieve a
fusion. Tr. at 101, 205.
45. Bone from a patient's iliac crest often is used for fusion grafts because
the patient's own bone is more
likely to promote fusion than is bone taken from another source, such as bone
taken from a cadaver. Tr. at
205.
46. Fusion surgery may be accompanied by attempts to stabilize the spine mechanically.
P. Exs. 11, 15,
16; Tr. at 96 - 97, 202.
47. The purpose of stabilizing the spine mechanically is to immobilize the
part of the spine that has had
fusion surgery during the period of time that fusion occurs. P. Exs. 11, 15,
16; Tr. at 96 - 97, 202.
48. Devices used to stabilize the spine include both external and internal fixation devices. Tr. at 202.
49. External fixation devices include braces to be worn by patients during
the period that fusion is
occurring. Tr. at 201 - 202.
50. Internal fixation devices include a variety of systems that are implanted
in patients at the time of fusion
surgery. P. Exs. 11, 15, 16.
51. Internal fixation devices consist generally of systems of rods or metal
plates that are held together with
hooks or screws. Tr. at 95 - 97, 204.
52. The Steffee system (sometimes referred to as Steffee plating) is an internal
fixation device consisting
of a system of metal plates that are fastened to the spine with screws (pedicle
screws) that are implanted in
the vertebrae. P. Ex. 16; Tr. at 97 - 98.
53. Permanent immobilization of the spine without a bony fusion cannot be obtained
by the implantation
of an internal fixation device. Tr. at 162 - 1634 203, 352, 389 - 390.
54. In the absence of a bony fusion, an internal fixation device will fail
inevitably, either as a result of
metal fatigue, or because of loosening of the screws which attach the device
to the patient's spine. Tr. at
126 - 127, 162 - 163, 203, 389 - 390.
55. Should an internal fixation device fail in the absence of a fusion, the
patient will be put at risk for
recurrence of pain, the need for additional spinal surgery, and damage to tissue
(including nerves and blood
vessels). Tr. at 116, 123 - 124, 126 - 127, 384.
56. The health of older patients may be placed at risk if they undergo additional
spinal surgery to correct
for failed internal fixation devices. Tr. at 384.
57. The risks which are attendant to surgery performed on older patients include
heart attacks and
pulmonary emboli. Tr. at 384.
58. Internal fixation devices should be used without attempts to attain fusion
only in cases where there is
no need to immobilize the spine for longer than six to twelve months. Tr. at
103, 175 - 176, 250 - 251; see
Tr. at 389 - 390.
59. An example of a situation where an internal fixation device may be used
to immobilize a patient's
spine without performing fusion surgery would be that of a patient with a terminal
illness who is not
expected to live for more than six to twelve months. Tr. at 250 - 251.
V. Professionally recognized standards of care which govern the performance
of spinal surgery utilizing
internal fixation devices and the documentation of spinal surgery
60. A professionally recognized standard of health care is a professionally
developed norm of care,
diagnosis, and treatment which is prevalent in a particular geographic area
or nationally. Social Security
Act, section 1154(a)(6)(A); 42 C.F.R. 1001.2.
61. A professionally recognized standard of health care in a particular medical
specialty is a consensus
among physicians who practice that specialty about how care should be provided
to patients. Tr. at 103 -
104, 209 - 210; Finding 60; see Tr. at 398.
62. A professionally recognized standard of health care which governs when
to perform spinal fusion
surgery requires that the decision to perform such surgery be based on evidence
of spinal instability
coupled with intractable pain. Tr. at 275, 280 - 282, 300.
63. A professionally recognized standard of health care which governs the use
of internal fixation devices
to immobilize patients' spines requires that such devices not be used in the
absence of attempts to obtain
bony fusion of the spine (except in those circumstances where there is no need
to immobilize the spine for
more than six to twelve months). Tr. at 102 - 103, 115 - 117, 120, 123 - 124,
126, 129.
64. A professionally recognized standard of health care which governs the performance
of fusion surgery
requires that the surgeon graft sufficient quantity of bone to a patient's fusion
site to assure a reasonable
likelihood that the surgery will result in bony fusion. Tr. at 203 - 205, 216;
see Tr. at 225 - 226, 232.
65. A professionally recognized standard of health care which governs the manner
in which a surgeon
documents cases in which he or she performs spinal surgery requires that the
surgeon explain in writing his
or her diagnosis, medical work up of the patient, and the surgery he or she
performs, in sufficient detail so
that another surgeon or a third party reviewer can ascertain: (1) the condition
or conditions which led to the
conclusion that surgery should be performed; (2) whether the patient's condition
or conditions justified the
surgery that was performed; and (3) the surgery which was performed and the
manner in which it was
accomplished. Tr. at 111 - 113, 130 - 131, 208 - 209, 398; see Tr. at 214 -
215, 221 - 222, 227.
VI. CMRI's investigation of Petitioner's treatment of Medicare beneficiaries,
its recommendation to the
I.G. that Petitioner be excluded, and the I.G.'s acceptance of CMRI's recommendation
66. CMRI is a peer review organization within the meaning of section 1154 of
the Act. I.G. Ex. 10, p. 1;
Social Security Act, section 1154.
67. CMRI's duties as a peer review organization include reviewing the professional
activities of physicians
in California for the purpose of determining whether the quality of services
that physicians provide to
Medicare beneficiaries meets professionally recognized standards of health care.
Finding 66; Social
Security Act, section 1154(a)(1)(B).
68. A physician whose services are reviewed by a peer review organization is
obligated to provide the peer
review organization with evidence as to the medical necessity and quality of
the services that he or she has
provided in such form and fashion and at such time as may reasonably be required
by the peer review
organization. Social Security Act, section 1156(a)(3).
69. On July 8, 1991, CMRI issued to Petitioner an initial notice which advised
Petitioner that CMRI had
determined that Petitioner had committed substantial violations of his obligations
under section 1156 of the
Act, in a substantial number of cases. I.G. Ex. 10.
70. CMRI provided Petitioner with a summary of those instances in which it
had made initial findings that
Petitioner had failed to comply substantially with his obligations under section
1156(a) of the Act. I.G. Ex.
10, pp. 2 - 6, 20 - 62.
71. CMRI offered Petitioner the opportunity to participate in a corrective
action plan. I.G. Ex. 10, pp. 6 -
7.
72. CMRI provided Petitioner the opportunity to offer additional information
to CMRI and to participate
in a meeting with representatives of CMRI. I.G. Ex. 10, pp. 7 - 8.
73. Petitioner requested a meeting with representatives of CMRI, and CMRI scheduled
a meeting with
Petitioner, which was held on September 27, 1991. I.G. Ex. 12; I.G. Ex. 13.
74. On February 26, 1992, CMRI issued to Petitioner a second notice which advised
Petitioner that CMRI
had reviewed information supplied to it by Petitioner in response to the first
notice, and had determined
that such information was not a basis for CMRI to modify its initial determination
that Petitioner had failed
to comply substantially with his statutory obligations in a substantial number
of cases. I.G. Ex. 13, p. 1.
75. CMRI additionally advised Petitioner that it had determined to recommend
to the I.G. that the I.G.
impose sanctions against Petitioner. I.G. Ex. 13, p. 1.
76. CMRI advised Petitioner also that it had concluded that he had not agreed
to accept a corrective action
plan at the meeting held on September 27, 1991, and it offered again to enter
into a corrective action plan
with Petitioner. I.G. Ex. 13, pp. 4 - 5.
77. CMRI afforded Petitioner the opportunity to provide it with additional
information or to have an
additional meeting with CMRI representatives before CMRI made its recommendation
to the I.G. I.G. Ex.
13, pp. 1 - 2.
78. On March 30, 1992, CMRI notified Petitioner that he had not responded to
its February 26, 1992 offer
to enter into a corrective action plan. I.G. Ex. 14, p. 1.
79. CMRI provided Petitioner with a final offer to enter into a corrective
action plan as an alternative to its
recommending to the I.G. that sanctions be imposed against Petitioner. I.G.
Ex. 14, pp. 1 - 2.
80. Petitioner did not agree to accept the corrective action plan which CMRI
offered to him on March 30,
1992. Tr. at 610 - 611.
81. On September 22, 1992, CMRI notified Petitioner that it had determined
that he had failed to comply
substantially with his obligations under section 1156 of the Act in a substantial
number of cases and that it
had recommended to the I.G. that he be excluded from participating in Medicare
and Medicaid. I.G. Ex.
15, pp. 1 - 2.
82. CMRI advised Petitioner that, within 30 days from his receipt of the notice
letter dated September 22,
1992 (receipt was presumed to be five days from the notice date), he could submit
to the I.G. any
additional information that he had which would affect CMRI's recommendations.
I.G. Ex. 15, p. 4.
83. On October 26, 1992, Petitioner submitted additional information to the
I.G., which the I.G.
considered as part of the final exclusion determination in this case. I.G. Ex.
16, p. 2.
84. On November 12, 1992, Petitioner submitted additional information to the
I.G., which the I.G.
declined to consider because of its untimely submission. I.G. Ex. 16, p. 2.
85. On January 20, 1993, the I.G. advised Petitioner that the I.G. accepted
CMRI's determination that
Petitioner had substantially violated his obligations to provide health care
under section 1156 of the Act in
a substantial number of cases. I.G. Ex. 16, p. 1.
86. The I.G. concluded that Petitioner had, in a substantial number of cases,
failed to provide care that
was:
a. economical and only when, and to the extent, that it was medically necessary;
b. of a quality that met professionally recognized standards of health care; and
c. that was supported by evidence of medical necessity and quality in such
form and fashion as may
reasonably be required by a reviewing peer review organization.
I.G. Ex. 16, p. 1.
87. The I.G. concluded further that Petitioner was either unable or unwilling
to comply substantially with
his obligations under section 1156 of the Act. I.G. Ex. 16, p. 3.
88. The I.G. determined to exclude Petitioner from participating in Medicare
and Medicaid for three years.
I.G. Ex. 16, p. 1.
VII. Acts or omissions by Petitioner on which CMRI made its recommendation
to the I.G. that Petitioner
be excluded and which the I.G. accepted
A. Patient HS 4/
89. HS was hospitalized at Mercy Medical Center, in Redding, California, from
May 8, 1989 until May
16, 1989. I.G. Ex. 1, p.1.
90. HS is a Medicare beneficiary. I.G. Ex. 1, p.1.
91. HS was admitted to the hospital under Petitioner's care with a diagnosis
of degenerative
spondylolisthesis of the lower lumbar spine. I.G. Ex. 1, p.2.
92. During the course of HS' admission, Petitioner performed surgery on HS
consisting of decompression,
bilateral Steffee plating, and a spinal fusion. I.G. Ex. 1, p. 17.
93. Petitioner used bone obtained from HS' spine during decompression surgery
as bone grafts for fusion.
I.G. Ex. 1, p. 17; Tr. at 206 - 207.
94. CMRI concluded that Petitioner performed unnecessary pedicle fixation (internal
fixation) on HS, and
the I.G. accepted this conclusion. I.G. Ex. 15, p. 2; I.G. Ex. 16, p. 2.
95. The record of HS' hospitalization does not contain documentation which
establishes that HS
manifested instability which would justify the performance of fusion surgery
or the placement of an
internal fixation device. I.G. Ex. 1, pp. 1 - 2, 5 - 6, 17; Tr. at 197, 200
- 201, 352 - 353, 358 - 360.
96. Although the record of HS' hospitalization does not contain documentation
which would justify the
performance of fusion surgery or the placement of an internal fixation device,
it does not demonstrate that
such surgery was unnecessary. See Finding 95.
97. The I.G. did not prove that Petitioner performed unnecessary pedicle fixation on HS. Findings 89 - 96.
98. CMRI concluded that Petitioner substantially violated his obligation to
furnish care to HS which meets
professionally recognized standards of care by failing to supplement internal
fixation with an acceptable
method of fusion, and the I.G. accepted this conclusion. I.G. Ex. 15, p. 2;
I.G. Ex. 16, p. 2.
99. Petitioner's use of bone which was generated from HS' spine during decompression
as a basis for a
fusion was of inadequate quantity to provide reasonable assurances that HS'
spine would fuse. Tr. at 203 -
207, 361 - 362; see Finding 93.
100. Petitioner's use of an inadequate quantity of bone to attempt fusion of
HS' spine violated a
professionally recognized standard of health care. Findings 64, 99.
101. The I.G. proved that Petitioner substantially violated his obligation
to furnish care to HS which meets
professionally recognized standards of care by failing to supplement internal
fixation with an acceptable
method of fusion. Findings 89 - 93, 98 - 100.
102. CMRI concluded that Petitioner substantially violated his obligation to
provide it with such evidence
of the medical necessity and quality of care that he gave HS as CMRI might reasonably
require by failing
to document the record of HS' treatment with an adequate history and physical
examination, progress
notes, an operative note, and indications for the surgery he performed; the
I.G. accepted this conclusion.
I.G. Ex. 15, p. 2; I.G. Ex. 16, p. 2.
103. Petitioner failed to explain in the records he created of HS' hospitalization
and surgery the reasons
why he concluded HS required fusion surgery with internal fixation. Tr. at 197
- 201, 359 - 362; Finding
95; see I.G. Ex. 1, pp. 1 - 2, 4 - 5, 17.
104. The I.G. proved that Petitioner substantially violated his obligation
to provide CMRI with such
evidence of the medical necessity and quality of care that he gave HS as CMRI
might reasonably require.
Findings 102 - 103.
B. Patient TS
105. TS was hospitalized at Mercy Medical Center in Redding, California, from
May 31, 1989 until June 8,
1989. I.G. Ex. 2, p. 1.
106. TS is a Medicare beneficiary. I.G. Ex. 2, p. 1.
107. TS was admitted to the hospital under Petitioner's care with a diagnosis
of lumbar disc disease. I.G.
Ex. 2, p. 2.
108. During the course of TS' admission, Petitioner performed surgery on TS
consisting of lumbar
decompression, Steffee plating, and a spinal fusion. I.G. Ex. 2, p. 15 - 16.
109. CMRI concluded that Petitioner substantially violated his obligation to
TS to order or furnish care
which meets professionally recognized standards of health care by performing
metal stabilization under
circumstances where a laminectomy alone would have adequately addressed TS'
medical problems; the
I.G. accepted this conclusion. I.G. Ex. 15, p. 2; I.G. Ex. 16, p. 2.
110. The record of TS' hospitalization does not contain documentation that
establishes that TS manifested
instability which would justify the performance of fusion surgery or the placement
of an internal fixation
device. I.G. Ex. 2, pp. 2, 5 - 6, 15 - 16; Tr. at 214 - 215, 363 - 364.
111. Although the record of TS' hospitalization does not contain documentation
which would justify the
performance of fusion surgery or the placement of an internal fixation device,
it does not demonstrate that
such surgery was unnecessary. See Finding 110.
112. The I.G. did not prove that Petitioner performed metal stabilization on
TS under circumstances where
a laminectomy alone would have adequately addressed TS' medical problems. Findings
105 - 111.
113. CMRI concluded that Petitioner had substantially violated his obligation
to give CMRI such evidence
of the medical necessity and quality of care which he provided to TS as CMRI
might reasonably require by
failing to document in the record of TS' hospitalization the reasons for his
decision to perform pedicle
fixation; the I.G. accepted this conclusion. I.G. Ex. 15, p. 2; I.G. Ex. 16,
p. 2.
114. Petitioner failed to explain in the records he created of TS' hospitalization
and surgery the reasons for
his decision to perform pedicle fixation and fusion on TS. I.G. Ex. 2, pp. 2,
5 - 6, 15 - 16; Tr. at 214 - 215,
363 - 364; Finding 110.
115. The I.G. proved that Petitioner substantially violated his obligation
to provide CMRI with such
evidence of the medical necessity and quality of care that he gave TS as CMRI
might reasonably require.
Findings 113 - 114.
C. Patient IS
116. IS was hospitalized at Mercy Medical Center in Redding, California, from
June 7, 1990 until June 13,
1990. I.G. Ex. 3, p. 1.
117. The I.G. asserted, and Petitioner did not dispute, that IS is a Medicare
beneficiary. I.G. Ex. 16; see
Petitioner's hearing request, January 25, 1993.
118. IS is a Medicare beneficiary. Finding 117.
119. IS was admitted to the hospital under Petitioner's care with a diagnosis
of lumbar canal stenosis. I.G.
Ex. 3, p. 1.
120. IS was found also to be suffering from anterolisthesis of her spine. I.G. Ex. 3, pp. 91 - 92.
121. During the course of IS' hospitalization, Petitioner performed surgery
on IS which included
installation of Steffee plating. I.G. Ex. 3, p. 86; Tr. at 118.
122. Petitioner did not perform fusion surgery on IS. I.G. Ex. 3, p. 86; Tr. at 118 - 119.
123. CMRI concluded that Petitioner substantially violated his obligation to
furnish care to IS which meets
professionally recognized standards of health care by failing to utilize bone
graft stabilization (fusion),
thereby putting IS at risk for additional surgery; the I.G. accepted this conclusion.
I.G. Ex. 15, p. 3; I.G.
Ex. 16, p. 2.
124. Petitioner's failure to perform fusion surgery on IS in conjunction with
implantation of an internal
fixation device created a likelihood that the internal fixation device would
fail. Tr. at 116 - 117, 221 - 222,
370 - 371; Finding 54.
125. The risks to IS resulting from likely failure of the internal fixation
device could include damage to
nerves and blood vessels, and the possibility that additional surgery would
be required. Tr. at 116, 374;
Findings 55 - 57.
126. Petitioner did not prove that an attempt at fusion of IS' spine would
have been futile. See Tr. at 491 -
492.
127. The I.G. proved that Petitioner substantially violated his obligation
to provide care to IS that meets
professionally recognized standards of health care by implanting an internal
stabilization device in IS
without performing fusion surgery. I.G. Ex. 15, p. 3; Tr. at 221 - 222, 372;
Findings 63, 116 - 126.
D. Patient VK
128. VK was hospitalized at Mercy Medical Center in Redding, California, from
July 25, 1989, until
August 2, 1989. I.G. Ex. 4, pp. 1 - 2.
129. VK is a Medicare beneficiary. I.G. Ex. 4, p. 1.
130. VK was admitted to the hospital under Petitioner's care with diagnoses
which included adult onset
scoliosis, spinal canal stenosis, and lumbar spondylosis. I.G. Ex. 4, p. 2.
131. During the course of VK's hospitalization, Petitioner performed surgery
on her consisting of
laminectomy, installation of Steffee plating, and a bilateral lateral fusion
of VK's spine, utilizing a
composite graft of bone from the hospital's bone bank and VK's bone. I.G. Ex.
4, pp. 17 - 18.
132. CMRI concluded that Petitioner violated his obligation to order or furnish
only care to VK that is
medically necessary by performing a major operation (decompressive laminectomy
and metal plating)
without clinical justification; the I.G. accepted this conclusion. I.G. Ex.
15, p. 3; I.G. Ex. 16, p. 2.
133. The preoperative work up performed in VK's case by Petitioner established
the presence of conditions
which may have been a cause of spinal instability, but which did not necessarily
cause spinal instability.
Tr. at 223 - 224; see I.G. Ex. 4, pp. 2, 5, 17 - 18.
134. The record of VK's hospitalization does not contain evidence which would
establish that VK
manifested instability which required the surgery performed by Petitioner. Tr.
at 224, 227; see Tr. at 377.
135. The I.G. proved that Petitioner violated his obligation to order or furnish
care to VK that is medically
necessary by performing surgery on VK without adequate medical justification
for that surgery. Findings
128 - 134.
E. Patient PW-N
136. PW-N was hospitalized at Mercy Medical Center in Redding, California,
from August 28, 1989 until
September 7, 1989. I.G. Ex. 5, p. 1.
137. PW-N is a Medicare beneficiary. I.G. Ex. 5, p. 1.
138. PW-N was admitted to the hospital under Petitioner's care with diagnoses
that included instability of
the lumbar spine and lumbar spondylosis. I.G. Ex. 5, p. 2.
139. During the course of PW-N's hospitalization, Petitioner performed surgery
on her which included the
implantation of bilateral Steffee plating, bilateral lateral fusion, and excision
of a herniated nucleus
pulpolsis. I.G. Ex. 5, pp. 2, 35 - 36.
140. CMRI concluded that Petitioner substantially violated his obligation only
to order or furnish care to
PW-N that is medically necessary by unnecessarily performing a bilateral pedicle
fixation and bony fusion;
the I.G. accepted this conclusion. I.G. Ex. 15, p. 3; I.G. Ex. 16, p. 2.
141. The record of PW-N's hospitalization does not contain findings which are
sufficient to establish that
the implantation of Steffee plating and fusion surgery which Petitioner performed
was medically necessary.
Tr. at 229, 379.
142. Although the record of PW-N's hospitalization does not contain documentation
which would justify
the performance of fusion surgery or the placement of an internal fixation device,
it does not demonstrate
that such surgery was unnecessary. See Finding 141.
143. The I.G. did not prove that Petitioner performed unnecessary surgery on PW-N. Findings 136 - 142.
F. Patient JW
144. JW was hospitalized at Mercy Medical Center in Redding, California, from
January 12, 1990 until
January 19, 1990. I.G. Ex. 6, pp. 1, 4.
145. JW is a Medicare beneficiary. I.G. Ex. 6, p. 1.
146. JW was admitted to the hospital under Petitioner's care with a principal
diagnosis of lumbar disc
disease. I.G. Ex. 6, p. 6.
147. During the course of JW's hospitalization, Petitioner performed surgery
on her which included
implantation of bilateral Steffee plating, and lumbar decompression. I.G. Ex.
6, pp. 6, 72 - 73.
148. Petitioner did not perform fusion surgery on JW. I.G. Ex. 6, pp. 6, 72 - 73; Tr. at 118.
149. CMRI concluded that Petitioner substantially violated his obligation to
JW only to order or furnish
care that is medically necessary by unnecessarily performing pedicle fixation;
the I.G. accepted this
conclusion. I.G. Ex. 15, p. 3; I.G. Ex. 16, p. 2.
150. Based on the record of JW's hospitalization, it is possible that JW may
have had a condition which
necessitated fusion surgery to correct. Tr. at 233.
151. It is not possible to conclude from the record of JW's hospitalization
that fusion surgery was either
necessary or unnecessary. Finding 150; see Tr. at 119.
152. While fusion surgery may have been medically justified by JW's condition,
there existed no necessity
for implanting an internal fixation device without performing fusion surgery
also. Tr. at 120, 233 - 234;
Finding 148.
153. The I.G. proved that Petitioner substantially violated his obligation
to JW only to order or furnish care
that is medically necessary by unnecessarily performing pedicle fixation. Findings
144 - 152.
154. CMRI concluded that Petitioner substantially violated his obligation to
JW to furnish care which
meets professionally recognized standards of health care by failing to perform
a bony fusion as a necessary
adjunct to pedicle fixation; the I.G. accepted CMRI's conclusion. I.G. Ex. 15,
p. 3; I.G. Ex. 16, p. 2.
155. Petitioner's failure to perform a fusion on JW as an adjunct to the implantation
of an internal
stabilization device violated a professionally recognized standard of care.
Tr. at 120, 233 - 234, 380 - 381;
Finding 63.
156. Petitioner's failure to perform a fusion on JW as an adjunct to the implantation
of an internal
stabilization device placed JW at risk for complications arising from failure
of the device, including nerve
damage and pain, and for additional surgery. Tr. at 234 - 236.
157. Petitioner did not prove that JW's medical condition was so frail as to
render inappropriate the
performance of fusion surgery. See Tr. at 593.
158. The I.G. proved that Petitioner substantially violated his obligation
to JW to furnish care which meets
professionally recognized standards of health care by failing to perform a bony
fusion as an adjunct to the
implantation of an internal stabilization device. Findings 147 - 148, 154 -
157.
G. Patient EW
159. EW was hospitalized at Mercy Medical Center in Redding, California, from
February 6, 1990 until
February 13, 1990. I.G. Ex. 7, p. 1.
160. EW is a Medicare beneficiary. I.G. Ex. 7, p. 1.
161. EW was hospitalized under Petitioner's care with a diagnosis of lumbar disc disease. I.G. Ex. 7, p. 2.
162. During the course of EW's hospitalization, Petitioner performed surgery
on him which included
lumbar decompression and the implantation of Steffee plating. I.G. Ex. 7, pp.
2, 10 - 11.
163. Petitioner did not perform fusion surgery on EW. I.G. Ex. 7, pp. 2, 10 - 11; Tr. at 123.
164. CMRI concluded that Petitioner substantially violated his obligation to
EW to order or furnish only
care that is medically necessary by performing a spinal canal exploration and
internal fixation without
sufficient medical indications for such surgeries; the I.G. accepted this conclusion.
I.G. Ex. 15, p. 3; I.G.
Ex. 16, p. 2.
165. EW's medical history includes five previous spinal surgeries, and this
history created the possibility
that spinal fusion was necessary. Tr. at 122.
166. The record of EW's hospitalization does not contain evidence of instability
which would establish the
need for fusion surgery. Tr. at 123, 382.
167. In the absence of evidence of instability, the fact that EW had five previous
spinal surgeries is
insufficient to justify performing internal fixation and fusion. Findings 165,
166.
168. Petitioner did not prove that a history of five previous spinal surgeries
alone justified the performance
of internal fixation surgery on EW. See Tr. at 529.
169. The I.G. proved that Petitioner substantially violated his obligation
to EW only to order or furnish
care that is medically necessary by performing internal fixation without sufficient
medical indications for
such surgery. Findings 159 - 168.
170. CMRI concluded that Petitioner substantially violated his obligation to
EW to provide care which
meets professionally recognized standards of health care by performing metallic
fixation without associated
bone grafts (fusion surgery); the I.G. accepted this conclusion. I.G. Ex. 15,
p. 3; I.G. Ex. 16, p 2.
171. Petitioner's failure to perform fusion on EW as an adjunct to implantation
of Steffee plating put EW at
risk for future complications. Tr. at 123, 239 - 240, 384.
172. Petitioner's failure to perform fusion on EW as an adjunct to implantation
of Steffee plating violated a
professionally recognized standard of care. Tr. at 384; Finding 63.
173. Petitioner did not prove that implantation of Steffee plating in EW without
fusion surgery was an
added benefit to EW beyond that which EW obtained from decompression. See Tr.
at 595 - 596.
174. The I.G. proved that Petitioner substantially violated his obligation
to EW to provide care which
meets professionally recognized standards of health care by performing metallic
fixation without associated
bone grafts. Findings 162 - 163, 170 - 173.
H. Patient LH
175. LH was hospitalized at Mercy Medical Center in Redding, California, from
February 16, 1990 until
February 25, 1990. I.G. Ex. 8, pp. 1 - 2.
176. LH is a Medicare beneficiary. I.G. Ex. 8, p. 1.
177. LH was hospitalized under Petitioner's care with diagnoses of unstable
lumbar spine and Paget's
disease. I.G. Ex. 8, p. 2.
178. During the course of LH's hospitalization, Petitioner performed surgery
on her consisting of lumbar
laminectomy and the implantation of Steffee plating. I.G. Ex. 8, pp. 2, 10 -
11.
179. Petitioner did not perform fusion surgery on LH. I.G. Ex. 8, pp. 2, 10 - 11; Tr. at 125 - 126, 242.
180. LH was hospitalized again in January 1991, under the care of a physician
other than Petitioner. I.G.
Ex. 21.
181. Fusion surgery was performed on LH during the January 1991 hospitalization. I.G. Ex. 21.
182. CMRI concluded that Petitioner substantially violated his obligation to
LH to order care which meets
professionally recognized standards of health care by failing to perform a fusion
in conjunction with
installation of metal plating; the I.G. agreed with this conclusion. I.G. Ex.
15, p. 4; I.G. Ex. 16, p. 2.
183. By failing to perform a fusion on LH as an adjunct to the implantation
of Steffee plating, Petitioner
placed her at risk for complications, including the need for additional surgery.
Tr. at 126 - 127, 387; see
Findings 180 - 181.
184. Petitioner violated a professionally recognized standard of health care
by not performing a fusion on
LH as an adjunct to the implantation of Steffee plating. Tr. at 387; Finding
63.
185. Petitioner did not prove that fusion would have been futile in this case
due to LH's Paget's disease.
See Tr. at 598 - 600.
186. The I.G. proved that Petitioner substantially violated his obligation
to LH to order care which meets
professionally recognized standards of health care by failing to perform a fusion
in conjunction with the
implantation of Steffee plating. Findings 175 - 185.
I. Patient WB
187. WB was hospitalized at Mercy Medical Center in Redding, California, from
April 9, 1990 until April
15, 1990. I.G. Ex. 9, pp. 1 - 2.
188. WB is a Medicare beneficiary. I.G. Ex. 9, p. 1.
189. WB was hospitalized under Petitioner's care with a diagnosis of lumbar
disc disease (although the
Discharge Summary recites that WB suffered from "cervical disc disease"
it is apparent from its context
that, in fact, the diagnosis was of lumbar disc disease). I.G. Ex. 9, p. 2.
190. During the course of WB's hospitalization, Petitioner performed surgery
on him consisting of lumbar
canal decompression and the implantation of Steffee plating. I.G. Ex. 9, pp.
2, 10 - 11.
191. Petitioner did not perform a fusion on WB. I.G. Ex. 9, pp. 2, 10 - 11; Tr. at 129.
192. CMRI concluded that Petitioner substantially violated his obligation to
WB to order or furnish only
care that is medically necessary by unnecessarily performing metallic fixation;
the I.G. accepted this
conclusion. I.G. Ex. 15, p. 4; I.G. Ex. 16, p. 2.
193. Although the record of WB's hospitalization established that he needed
decompression, the record
does not establish that WB needed fusion. Tr. at 128 - 129.
194. While it is possible that fusion surgery may have been medically justified
by WB's condition, there
existed no necessity for implanting an internal fixation device without performing
fusion surgery also. Tr.
at 129 - 130, 249 - 251, 389 - 390; Finding 190.
195. The I.G. proved that Petitioner substantially violated his obligation
to WB to order or furnish only
care that is medically necessary by unnecessarily performing metallic fixation
in the absence of fusion.
Findings 187 - 194.
196. CMRI concluded that Petitioner substantially violated his obligation to
WB to furnish care which
meets professionally recognized standards of health care by failing to supplement
the implantation of
metallic plating with a bone graft; the I.G. accepted this conclusion. I.G.
Ex. 15, p. 4; I.G. Ex. 16, p.2.
197. Petitioner's failure to perform a fusion on WB as an adjunct to implanting
Steffee plating put WB at
risk for complications in the future. Tr. at 249, 389 - 390.
198. Petitioner's failure to perform a fusion on WB as an adjunct to implanting
Steffee plating violated a
professionally recognized standard of care. Tr. at 129, 389; Finding 63.
199. Petitioner did not prove that implantation of Steffee plating in WB absent
a fusion was medically
justified. See Tr. at 542 - 547.
200. The I.G. proved that Petitioner substantially violated his obligation
to WB to furnish care which meets
professionally recognized standards of health care by failing to supplement
the implantation of metallic
plating with a bone graft. Findings 190 - 191; Tr. at 196 - 199.
201. CMRI concluded that Petitioner substantially violated his obligation to
provide evidence of medical
necessity and the quality of care of services which he provided to WB as CMRI
may reasonably require by
failing to provide it with adequate documentation to justify the implantation
of Steffee plating without
performing a fusion; the I.G. accepted this conclusion. I.G. Ex. 15, p. 4; I.G.
Ex. 16, p. 2.
202. Petitioner failed to explain in the records he prepared concerning WB's
hospitalization and surgery
why the implantation of Steffee plating in WB was medically necessary. Tr. at
129 - 131, 247.
203. The I.G. proved that Petitioner substantially violated his obligation
to provide to CMRI evidence of
the medical necessity and the quality of care of the services which he provided
to WB as CMRI may
reasonably require. Findings 201 - 202.
VIII. Additional acts or omissions by Petitioner which violate professionally recognized standards of care
A. Patient HS
204. A finding of spondylolisthesis in HS, even coupled with complaints by
HS of intractable pain, is not a
medically sufficient basis for performing fusion surgery (with or without implantation
of an internal
fixation device), absent findings of instability. Tr. at 197, 200 - 201, 352
- 353; Findings 95 - 96; see I.G.
Ex. 1, pp. 1, 5 - 6.
205. Petitioner did not develop evidence that demonstrated that HS suffered
from instability. Tr. at 201,
358 - 360; see I.G. Ex. 1, pp. 1, 5 - 6.
206. Petitioner's performance of fixation surgery on HS in the absence of evidence
establishing that HS
manifested instability violated a professionally recognized standard of health
care. Findings 62, 204 - 205;
see Tr. at 508.
B. Patient TS
207. A finding of stenosis and lumbar disc disease in TS, even coupled with
complaints by TS of
intractable pain, is not a medically sufficient basis for performing fusion
surgery (with or without
implantation of an internal fixation device), absent findings of instability.
Tr. at 214 - 215, 363 - 364;
Finding 110; see I.G. Ex. 2, pp. 2, 5 - 6.
208. Petitioner did not develop evidence that demonstrated that TS suffered
from instability. Tr. at 214 -
215, 363 - 364.
209. Petitioner's performance of fusion surgery on TS with implantation of
an internal fixation device, in
the absence of evidence establishing that TS manifested instability, violated
a professionally recognized
standard of health care. Findings 62, 207 - 208; see Tr. at 510.
C. Patient VK
210. In performing fusion surgery on VK, Petitioner utilized bone that he obtained
from VK's spine along
with cadaverous bone which he obtained from Mercy Medical Center's bone bank.
I.G. Ex. 4, pp. 17 - 18;
Tr. at 377 - 378.
211. It cannot be determined from the records which Petitioner prepared of
VK's hospitalization and
surgery whether he used adequate bone in the fusion surgery he performed on
VK to obtain fusion. Tr. at
225 - 226, 377 - 378; see I.G. Ex. 4, pp. 17 - 18.
212. Petitioner violated a professionally recognized standard of health care
by failing to document
adequately the quantity of bone which he used to attempt fusion in VK. Findings
65, 210 - 211.
D. Patient PW-N
213. Although PW-N was diagnosed by Petitioner to be suffering from lumbar
instability, the medical
evidence developed by Petitioner and documented by him fails to support that
conclusion. Tr. at 229, 379;
Finding 141; see I.G. Ex. 5, pp. 1, 5, 35 - 36.
214. Petitioner violated a professionally recognized standard of health care
by failing to document
adequately the necessity for performing fusion surgery on PW-N. Findings 65,
213.
E. Patient JW
215. Although JW was diagnosed by Petitioner to be suffering from dextroscoliosis
of the lumbar spine,
the medical evidence developed by Petitioner and documented by him does not
establish that JW suffered
from instability sufficient to justify fusion surgery or the implantation of
an internal fixation device. I.G.
Ex. 6, pp. 4 - 6; Tr. at 119, 223; Findings 150 - 151; see Tr. at 527.
216. Petitioner violated a professionally recognized standard of health care
by failing to document
adequately the necessity for implanting an internal fixation device in JW. Findings
65, 215.
IX. The I.G.'s authority to impose an exclusion against Petitioner based on
Petitioner's substantial violation
of his statutory obligations in a substantial number of cases and his unwillingness
to provide health care of
a quality which meets professionally recognized standards of care
217. A provider of care or practitioner is obligated to assure that items or
services which he or she provides
to Medicare beneficiaries and Medicaid recipients are:
a. provided economically and only when, and to the extent, medically necessary;
b. of a quality which meets professionally recognized standards of health care; and
c. supported by evidence of medical necessity and quality in such form and
fashion and at such time as
may reasonably be required by a reviewing peer review organization in the exercise
of its duties and
responsibilities.
Social Security Act, section 1156(a); Finding 68; see Findings 60 - 65.
218. The Secretary, or her delegate, the I.G., may exclude a provider or practitioner
from participating in
Medicare and Medicaid where, based on the recommendation of a peer review organization,
she or the I.G.
determines that the party has, in a substantial number of cases, substantially
violated his or her obligations
under section 1156(a) of the Act, and where that party is unable or unwilling
substantially to comply with
his or her statutory obligations. Social Security Act, section 1156(b)(1).
A. Petitioner's substantial violation of his statutory obligations in a substantial number of cases
219. A practitioner commits a substantial violation of his or her statutory
obligations under section 1156(a)
of the Act where the pattern of care he or she provides in a substantial number
of cases is inappropriate,
unnecessary, does not meet professionally recognized standards of care, or is
not supported by necessary
documentation of care as required by a peer review organization. 42 C.F.R. 1004.1(b).
220. Petitioner provided unnecessary and inappropriate care, or care which
failed to meet professionally
recognized standards of health care, or care which was not supported by necessary
documentation of care,
in nine cases of surgeries which he performed on Medicare beneficiaries. Findings
89 - 203.
221. The I.G. proved that Petitioner committed 13 violations of his statutory
obligations in nine cases of
surgeries which he performed on Medicare beneficiaries. Findings 101, 104, 115,
127, 135, 153, 158, 169,
174, 186, 195, 200, 203; Social Security Act, section 1156(a).
222. The violations of statutory obligations committed by Petitioner occurred
between May 8, 1989 and
June 13, 1990. Findings 89, 105, 116, 128, 136, 144, 159, 175, 187.
223. In a substantial number of cases, the I.G. proved that Petitioner engaged
in a pattern of care that is
inappropriate, unnecessary, did not meet professionally recognized standards
of health care, or was not
supported by necessary documentation as was required by CMRI. Findings 220.
224. In a substantial number of cases, the I.G. proved that Petitioner substantially
violated his obligations
under section 1156(a) of the Act. Findings 219 - 223; Social Security Act, sections
1156(a), (b)(1).
B. Petitioner's inability or unwillingness to demonstrate that he is complying
substantially with
his obligation to provide care in accordance with his obligations under section
1156(a) of the Act
225. Petitioner has refused to enter into a corrective action plan with CMRI
which would enable CMRI to
determine whether Petitioner is complying with his obligations under section
1156(a) of the Act. I.G. Ex.
14; Tr. at 610; Findings 71 - 80.
226. Petitioner has not provided CMRI with credible evidence that he is complying
with his obligations
under section 1156(a) of the Act. See Finding 225.
227. The I.G. proved that Petitioner is unable or unwilling to comply substantially
with his obligation to
provide care in accordance with his obligations under section 1156(a) of the
Act. Findings 225 - 227;
Social Security Act, sections 1156(a), (b)(1).
X. The remedial need for an exclusion
228. The remedial purpose of an exclusion imposed pursuant to section 1156
of the Act is to protect the
welfare of program beneficiaries and recipients from parties who are untrustworthy
to provide health care
of the requisite quality. Social Security Act, section 1156(b)(1).
229. Petitioner's repeated violations of his obligations under section 1156(a)
of the Act, and his additional
acts or omissions which violate professionally recognized standards of care,
constitute serious and repeated
violations of Petitioner's duty as a physician to provide health care of a quality
which meets accepted
medical standards. Findings 89 - 216; 42 C.F.R. 1004.90(d)(2), (3).
230. Petitioner's repeated violations of his obligations under section 1156(a)
of the Act, and his additional
acts or omissions which violate professionally recognized standards of health
care, establish an
unwillingness or inability by Petitioner to conform his practice to those standards
which are recognized
commonly by his peers as applying to the items or services which Petitioner
provides. Findings 60 - 65, 89
- 216; 42 C.F.R. 1004.90(d)(7).
231. Petitioner's assertions that he now performs fusion in all surgical cases
in which he implants fixation
devices and that he generally provides sufficient documentation of his surgeries
to satisfy the criteria of
reviewers is not credible in light of his refusal to enter into a corrective
action plan with CMRI. See
Findings 71 - 80.
232. Petitioner did not rebut evidence as to his untrustworthiness. See Finding 231.
233. The I.G. proved that Petitioner is an untrustworthy provider of care. Findings 229 - 231.
234. A three-year exclusion is reasonable in this case. Findings 228 - 233.
ANALYSIS
There are two principal issues in this case. The first issue is whether, based
on CMRI's determination and
recommendation to the I.G., the I.G. had authority to exclude Petitioner. The
second issue is whether the
three-year exclusion imposed and directed against Petitioner by the I.G. is
a reasonable remedy.
The I.G. proved by a preponderance of the evidence that authority exists to
exclude Petitioner. The
evidence in this case strongly supports CMRI's recommendations, as adopted by
the I.G., that Petitioner
engaged in a pattern of substantially inappropriate treatment of his patients,
in contravention of
professionally recognized standards of care, and in violation of his obligations
to his patients and to CMRI
under section 1156(a) of the Act. The credible evidence proves that Petitioner
performed spinal fixation
surgeries without documenting a sufficient medical basis for performing such
surgeries. Petitioner
performed these surgeries on elderly individuals where it appears, from the
evidence of record, that it is
possible that less drastic and less taxing measures might have sufficed. The
evidence proves further that
Petitioner implanted internal fixation devices in patients without attempting
to perform fusions on those
patients, a procedure which contravenes professionally recognized standards
of health care, is of dubious or
no medical benefit to patients, and puts patients at risk for future complications,
including additional
surgery.
Petitioner is either unwilling or unable to comply with his obligations under
section 1156(a) of the Act.
Petitioner refused to enter into corrective action plans which would assure
that he did not repeat his
improper conduct. He continues to deny that the procedures which he performed
contravened
professionally recognized standards of health care or jeopardized the welfare
of his patients, despite strong
evidence to the contrary.
The I.G. proved that the three-year exclusion which was imposed and directed
against Petitioner is
reasonable. Petitioner's pattern of inappropriate surgeries coupled with additional
violations by him of
professionally recognized standards of health care establishes Petitioner to
be an untrustworthy provider of
care. Petitioner's assurances that he is no longer engaging in inappropriate
medical practices are
unpersuasive, given his refusal to enter into a corrective action plan, his
unwillingness to accept that his
medical practices have been inappropriate, and his failure to present credible
evidence that his practice now
conforms to professionally recognized standards of health care. The exclusion
which the I.G. imposed
against Petitioner is justified to protect program beneficiaries and recipients
from the possibility that
Petitioner might fail to treat them properly.
1. The I.G. had authority to exclude Petitioner under section 1156(b)(1) of the Act.
The I.G. excluded Petitioner pursuant to section 1156(b)(1) of the Act. The
I.G.'s authority to impose an
exclusion under section 1156(b)(1) derives from a peer review organization's
determination and
recommendation that a party be excluded. In any hearing conducted under section
1156(b)(1), the judge
must resolve whether: (1) evidence adduced by the peer review organization and
relied upon by it in
making its recommendation to the I.G. supports its recommendation that a party
be excluded; and (2) the
peer review organization's recommendation is in accord with one of the statutory
grounds on which an
exclusion recommendation may be based.
Section 1156(a) of the Act defines three professional obligations of parties
who provide items or services
to program beneficiaries and recipients. These are that health care will be:
(1) provided economically and
only when, and to the extent, medically necessary; (2) of a quality which meets
professionally recognized
standards of health care; and (3) supported by evidence of medical necessity
and quality in such form and
fashion and at such time as may reasonably be required by a reviewing peer review
organization in the
exercise of its duties and responsibilities. Section 1156(b)(1) provides that
a peer review organization may
recommend that a party be excluded if it determines that the party has either
failed in a substantial number
of cases to comply substantially with any of these three obligations, or if
that party has grossly and
flagrantly violated any of these obligations in one or more instances. 5/
CMRI based its exclusion recommendation to the I.G. on its conclusion that
Petitioner had in a substantial
number of cases substantially violated his three statutory obligations under
section 1156(a)(1) of the Act.
The I.G. accepted CMRI's conclusion. The I.G. found also that Petitioner was
either unable or unwilling to
provide health care of a quality which meets professionally recognized standards
of health care. 6/
Section 1156(b)(4) of the Act provides that a party who is subject to an exclusion
determination pursuant
to section 1156(b)(1) is entitled to an administrative hearing. This section
expressly confers on excluded
parties those rights to a hearing which inure to parties under section 205(b)
of the Act. Section 205(b)
provides for a de novo hearing. Bernardo G. Bilang, M.D., DAB 1295 (1992); Eric
Kranz, M.D., DAB
1286 (1991). Thus, parties excluded pursuant to section 1156(b)(1) are entitled
to de novo hearings. Louis
W. DeInnocentes, Jr., M.D., DAB CR247 (1992).
My obligation in conducting a de novo hearing under sections 205(b) and 1156(b)(1)
on the issue of the
I.G.'s authority to exclude a party is to allow each party to the hearing the
opportunity to offer evidence
concerning the sufficiency of the facts on which a peer review organization's
recommendation and the
I.G.'s ultimate determination are based. 7/ Inasmuch as the I.G.'s authority
to exclude under section
1156(b)(1) derives from a determination and a recommendation made by a peer
review organization, I
must limit the evidence I receive on the issue of authority to exclude to evidence
which establishes whether
there exists a basis in fact for: (1) the peer review organization's determination
and recommendation to the
I.G.; and (2) the I.G.'s finding that the excluded party is unable or unwilling
to meet his or her statutory
obligation to provide care. DeInnocentes at 33. 8/
In hearing the issue of whether the I.G. has authority to exclude a party under
section 1156(b)(1), deriving
from a peer review organization's recommendation, I may not permit the I.G.
to offer evidence as to facts
which were not considered by the peer review organization in making its determination
and
recommendation, even if those facts might support the I.G.'s determination to
exclude a party. 9/ Also, I
must permit the excluded party the opportunity to challenge and to rebut the
factual basis for the peer
review organization's determination and recommendation. However, I may not allow
an excluded party to
offer evidence proving facts which exceed the scope of the peer review organization's
review,
determination, and recommendation. 10/
As I shall discuss infra, at Part 2 of this Analysis, the de novo hearing requirements
of section 205(b)
permit a broader evidentiary presentation in section 1156(b)(1) exclusion cases
on the issue of whether an
exclusion of a particular length is reasonable, than on the issue of whether
the I.G. has authority to exclude
a party. On the remedy issue, I may accept evidence from either party which
relates to an excluded party's
trustworthiness to provide care, even if that evidence exceeds the boundaries
of that which was considered
by the peer review organization in making its determination and recommendation
to the I.G.
My decision on the issue of whether the I.G. had authority to exclude Petitioner
is based on evidence which
relates to CMRI's findings that Petitioner substantially violated his statutory
obligations under section
1156(a) in a substantial number of cases. On this issue, I have not considered
evidence offered by the I.G.
concerning other instances in which Petitioner is alleged to have violated professionally
recognized
standards of health care. See Findings 204 - 216. Nor have I considered as relevant
to this issue evidence
offered by Petitioner concerning his practice of medicine subsequent to the
events upon which CMRI
based its recommendation to the I.G. However, I have considered such evidence
as relevant to the issue of
whether the three-year exclusion imposed by the I.G. is reasonable. On this
latter issue, I have also
considered evidence relating to CMRI's findings that Petitioner violated his
obligations under section
1156(a) of the Act. See Findings 89 - 203.
a. Petitioner did not prove that CMRI denied Petitioner due process in investigating
Petitioner's
conduct and in making its recommendations to the I.G.
Petitioner contends that CMRI denied him due process in investigating his conduct
and in making its
recommenda-tions to the I.G. He asserts that, consequently, CMRI's recommendation
to the I.G. was
defective, and the I.G. cannot rely on that recommendation as authority for
excluding Petitioner. This
contention subsumes two arguments. First, Petitioner asserts that CMRI was required
by the Act to publish
in writing the professionally recognized standards of care to which it held
Petitioner accountable. CMRI's
failure to publish such standards, according to Petitioner, was a denial of
due process which renders invalid
CMRI's entire review of Petitioner's items or services. Second, Petitioner argues
that he was entitled to
confront the medical reviewers whom CMRI employed to evaluate Petitioner's items
or services, prior to
CMRI making any recommenda-tions to the I.G. in his case, so that he could refute
their conclusions,
explain his practice, or establish that the reviewers were biased against him.
Petitioner contends that CMRI
denied him that right, thus denying him due process and invalidating its recommendations
to the I.G.
Neither the Act nor regulations require CMRI to publish or otherwise disseminate
to the medical
community the professionally recognized standards of health care to which it
holds providers accountable.
However, the record of this case proves that Petitioner received notice from
CMRI of those standards to
which he was held accountable. There is no right for parties under review by
peer review organizations to
confront the individuals who review their items or services. CMRI afforded Petitioner
that to which he
was entitled, which was to meet with a representative of CMRI. Furthermore,
Petitioner has not proven
that CMRI deprived him of the opportunity to present CMRI and its reviewers
with information which was
pertinent to his case and to CMRI's recommendations to the I.G.
The Act contains no requirement that peer review organizations codify and publish
the criteria which they
use to review providers' items or services. See Social Security Act, section
1154. Neither do regulations
governing the activities of peer review organizations. See 42 C.F.R. Part 1004.
The Act provides that, in discharging their duties, peer review organizations
must apply professionally
developed norms of care, diagnosis, and treatment, based upon typical patterns
of practice within the
geographic areas served by such organizations. Social Security Act, section
1154(a)(6)(A). On its face,
this section does not apply specifically to peer review organizations' discharge
of their duties under section
1156 of the Act. However, it does appear to establish a general obligation for
peer review organizations to
use professionally recognized standards of health care of either national recognition
or of a unique local
character in discharging their statutory duties. It is evident from this language
that a professionally
recognized standard of health care in a given medical specialty constitutes
a consensus among the
physicians practicing that specialty about how items or services should be provided.
Finding 61.
However, the statutory requirement that peer review organizations evaluate
physicians according to a
consensus of their peers as to how medicine should be practiced does not mean
that peer review
organizations must publish or disseminate every criterion for evaluation that
they use in every case.
Congress' directive to peer review organizations in section 1154(a)(6)(A) is
that they should use criteria for
evaluating physicians' practices which are so widely accepted in the community
of physicians that they
need not be published. Furthermore, given the diversity of medical practice
and the rapidity with which
technology changes in medicine, it probably would be impossible for peer review
organizations to publish
and disseminate such criteria.
The Act's requirements are mirrored in regulations adopted by the Secretary.
Regulations define
professionally recognized standards of health care to be:
Statewide or national standards of care, whether in writing or not, that professional
peers of the
individual or entity whose provision of care is an issue, recognize as applying
to those peers practicing or
providing care within a State.
42 C.F.R. 1001.2 (emphasis added). 11/
That is not to suggest that peer review organizations are under no duty to
advise individual providers
whose practices they review of the standards by which their practices are being
evaluated. A peer review
organization is required to give a provider whose items or services it reviews
written notice of its
determination of violations under section 1156(a) of the Act, which includes
a statement of any statutory
obligation the provider has been found to have violated, along with a basis
for the peer review
organization's finding of violation. Social Security Act, section 1154(a)(14);
42 C.F.R. 1004.40(b), (c),
1004.50(a). However, Petitioner has not demonstrated that CMRI failed to comply
with its duty to provide
him with such notice. In fact, the notices which CMRI sent to Petitioner articulate
in considerable detail
the specific deficiencies which CMRI found in Petitioner's items or services
and the standards which CMRI
considered Petitioner to have violated. I.G. Exs. 10, 13, 15.
The Act does not provide for a face-to-face meeting between a provider whose
items or services are being
reviewed and the persons who conduct the review on behalf of a peer review organization.
It provides only
that, before a peer review organization determines a violation of professionally
recognized standards of
health care, it must provide the affected provider with "reasonable notice
and opportunity for discussion."
Social Security Act, section 1154(a)(14).
Nor do regulations provide for a face-to-face meeting between a provider and
reviewers. Where a peer
review organization initially identifies what it believes to be a substantial
violation of statutory obligations
in a substantial number of cases, it must afford the provider under review the
option to submit more
information to the peer review organization, or to have a face-to-face meeting
with a "representative" of the
peer review organization. 42 C.F.R. 1004.40(c)(6). Where a peer review organization
determines that a
violation has occurred, it must afford the provider under review the opportunity
both to submit additional
information and to have a face-to-face meeting with the peer review organization.
42 C.F.R.
1004.50(b)(6). Neither of these regulations imposes on a peer review organization
the duty to have a
specific individual or individuals present at meetings between the peer review
organization and providers
whose items or services are under review. Rather, these regulations require
only that the peer review
organization designate a representative to meet with an affected provider. The
regulations give the peer
review organization the discretion to decide who will represent it.
CMRI discharged its duty under the Act and regulations to give Petitioner the
opportunity for face-to-face
discussions with a representative of CMRI. In its initial sanction notice to
Petitioner, CMRI advised him of
the opportunity to have a face-to-face meeting with a CMRI representative. I.G.
Ex. 10, pp. 1, 7 - 8;
Finding 72. 12/ CMRI afforded Petitioner the opportunity for a meeting with
a CMRI representative in the
notice it sent to him advising him of its determination that he had violated
his obligations under section
1156(a). I.G. Ex. 13, pp. 1 - 2; Finding 77. Petitioner met with a representative
of CMRI on at least one
occasion. Findings 73, 76.
Furthermore, Petitioner has not shown that, but for being deprived of the opportunity
to meet with the
individual or individuals who reviewed his items or services, he would have
presented CMRI with
information that would have changed the outcome of CMRI's review. He has argued
that he should have
been provided the opportunity to meet with a reviewing physician who had the
same specialty training and
expertise as does Petitioner. However, he has not explained why he could not
have furnished information
in writing in a form which CMRI could transmit to specialists who might have
been involved in reviewing
Petitioner's items or services. Furthermore, Petitioner has not demonstrated
that the representative of
CMRI who met with Petitioner was incapable of understanding Petitioner's explanations
for his items or
services.
Petitioner contends also that, by not being permitted a face-to-face meeting
with the individuals who
reviewed his items or services, he was unable to determine whether such individuals
were biased against
him. Therefore, according to Petitioner, he was unable to exercise his right
to have reviewers disqualified
for bias. Petitioner has not cited any requirement in the Act or in regulations
that a peer review
organization furnish a provider whose items and services are under review with
the names of reviewers, or
offer a face-to-face meeting between the provider and the reviewers, so that
the provider may ascertain
possible bias and challenge the review on that ground. Indeed, regulations which
govern reviews by a peer
review organization prohibit the organization from disclosing the names of individuals
who conduct
reviews. 42 C.F.R. 476.139(b).
Although CMRI did not offer Petitioner a face-to-face meeting with the individuals
who reviewed his items
or services, it offered to provide Petitioner with the names of the members
of its Monitoring Committee
and its Board of Directors. I.G. Ex. 11, p. 2. These are the individuals who
bear responsibility for making
determinations concerning possible violations of statutory obligations by providers
and recommending
exclusions to the I.G. CMRI invited Petitioner to advise it whether he considered
any of these individuals
to be biased against him. There is nothing of record to suggest that Petitioner
ever asserted that any of
CMRI's Monitoring Committee or Board of Directors members were biased.
Finally, the experts whom the I.G. called as witnesses at the hearing acknowledged
that they had been
involved in the review of Petitioner's items or services. Tr. at 140 - 142,
252 - 255, 391. Petitioner was
provided the opportunity to cross-examine each of these experts and to establish
either bias or lack of
knowledge through cross-examination and impeachment. There was no evidence of
bias adduced at the
hearing, and Petitioner has not asserted that any of the experts were biased
against him. As I discuss at Part
1 c. of this Analysis, these experts are knowledgeable and dispassionate witnesses.
b. The I.G. is not estopped from excluding Petitioner.
In his request for a hearing, Petitioner contended that the I.G. was without
authority to exclude him
because an administrative law judge had found the items or services at issue
in this case to be reasonable.
Petitioner was alluding to an administrative law judge decision dated June 25,
1992, in which the
administrative law judge found that certain surgical items or services provided
by Petitioner, including,
apparently, many of the items or services at issue here, were medically necessary
and appropriate covered
care reimbursable under Part B of the Medicare program. P. Ex. 32.
This decision was vacated subsequently by the Appeals Council of the Social
Security Administration's
Office of Hearings and Appeals, which dismissed the request for hearing on which
the administrative law
judge's decision was premised. I.G. Ex. 20. The Appeals Council found that Petitioner
had no right to a
hearing before an administrative law judge, because he had not exhausted his
administrative remedies
within the Department of Health and Human Services prior to requesting a hearing.
Id. The order of the
Appeals Council became the Secretary's final administrative action in the case.
Therefore, the Secretary's
final administrative action in that case was to nullify the findings made by
the administrative law judge and
to vacate his decision. That administrative law judge's decision does not estop
the I.G. from imposing an
exclusion in this case. 13/
Petitioner has now filed a suit in the United States District Court for the
Eastern District of California in
which, among other things, he requests the court to vacate the Appeals Council's
dismissal of the
administrative law judge's decision under Part B of the Medicare program. P.
Ex. 37. Petitioner has not
averred that the District Court has issued any orders or decisions in that case
which reverse the Appeals
Council.
c. Petitioner committed substantial violations of his obligation to provide
care in compliance with
section 1156(a) of the Act in a substantial number of cases.
The I.G. proved that Petitioner engaged in a pattern of acts or omissions which
contravened his obligations
under section 1156(a) of the Act. The I.G. thus proved that Petitioner substantially
violated his obligations
under section 1156(a) in a substantial number of cases. 42 C.F.R. 1004.1(b).
At issue in this case are nine surgeries that Petitioner performed on Medicare
beneficiaries between May 8,
1989 and June 13, 1990. I.G. Exs. 1 - 9. CMRI determined that in these nine
cases Petitioner committed
18 violations of his obligations under section 1156(a)(1) of the Act. 14/ I
find that the I.G. proved that
Petitioner committed 13 violations of his obligations under section 1156(a),
and that these violations
comprise a pattern of care which violates statutory obligations. Findings 221,
223.
Each of the cases at issue involve common features. All nine of the beneficiaries
in question had
documented medical problems involving their lower spines. In each of the nine
cases, Petitioner performed
surgery consisting of implanting an internal fixation device (Steffee plating)
in the patient's spine, in order
to immobilize a portion of the spine. In five of the nine cases, Petitioner
implanted a fixation device
without attempting to attain bony fusion of the patient's spine. Findings 89
- 203.
The I.G. offered expert opinion testimony about these surgeries which was credible
and which strongly
supported CMRI's recommendations and the I.G.'s determinations. Drs. Patrick,
Nockels, and Conley
concurred that there were professionally recognized standards of health care
which governed the surgeries
performed by Petitioner, and which were utilized by CMRI in recommending that
Petitioner be excluded.
They agreed, first, that spinal fusion surgery is justified only in those cases
where there exists medically
demonstrated instability of the spine coupled with complaints of intractable
pain that reasonably could be
found to be caused by the instability. Finding 62. Second, they agreed that,
in performing fusion surgery,
an adequate quantity of bone must be grafted to the fusion site by the surgeon,
or the fusion attempt would
fail. Finding 64. Third, they concurred in finding that the implantation of
internal fixation devices, such as
Steffee plating, in patients without a concurrent attempt at fusion is justified
in only the most extraordinary
cases. Finding 63. That is so because the stresses imposed on patients' spines,
coupled with wear and tear
on the fixation devices, will cause such devices to fail inevitably. Failure
of fixation devices can put
patients at risk for future surgery and for complications, including nerve and
blood vessel damage. Finally,
the experts concurred that surgeons must document adequately the work that they
do so that other
providers and reviewers can understand their work and the reasons for it having
been performed. Finding
65.
Drs. Patrick, Nockels, and Conley offered testimony which was based on the
record adduced by CMRI and
which supported CMRI's conclusions that Petitioner had violated his obligations
under section 1156(a)(1)
of the Act. Based on these experts' testimony, and on the exhibits offered by
the I.G. and reviewed by
CMRI, I make the following findings. First, Petitioner performed surgeries which
were not medically
necessary, by implanting internal fixation devices in patients where medical
evidence developed by
Petitioner either did not justify surgery to stabilize the patients' spines,
or did not justify implantation of
fixation devices without concurrent fusion surgery. Findings 135, 153, 169,
195; Social Security Act,
section 1156(a)(1). Second, Petitioner performed surgeries which contravened
professionally recognized
standards of care, either by failing to utilize an adequate quantity of bone
in attempting to perform spinal
fusion, or by implanting internal fixation devices in patients without even
attempting to perform spinal
fusion. Findings 100, 127, 158, 174, 186, 200; Social Security Act, section
1156(a)(2). Finally, Petitioner
violated his obligation to provide CMRI with such information as CMRI might
reasonably require, by
failing to document adequately the reasons for performing surgeries on some
patients, or the surgeries he
actually performed. Findings 104, 115, 203. Social Security Act, section 1156(a)(3).
In three instances, CMRI determined, and the I.G. found, violations which I
conclude were not proven by a
preponderance of the evidence. Each of these alleged violations involved determinations
that Petitioner
had performed unnecessary spinal surgery on Medicare beneficiaries. In each
case, I find that the record of
the patient's hospital stay is unclear as to whether the surgery Petitioner
performed was necessary.
Findings 96 - 97, 111 - 112, 142 - 143. However, the evidence in these cases
establishes also that
Petitioner did not provide adequate medical justification, in accord with professionally
recognized
standards of health care, for the surgeries he performed. Had CMRI made the
determination that Petitioner
performed these surgeries without justification, instead of determining that
the surgeries were unnecessary,
then I would have concluded that Petitioner had violated his obligation in these
three cases to provide items
or services in accordance with professionally recognized standards of health
care. See Social Security Act,
section 1156(a)(2).
Petitioner attacks the testimony of the I.G.'s experts by asserting it to be
"conclusory" and without
foundation. I disagree with this assertion. These experts based their testimony
on the exhibits introduced
by the I.G., consisting of the treatment records of the nine Medicare beneficiaries
whose surgeries are at
issue, and on the professionally recognized standards of health care which they
identified. They identified
clearly and unequivocally the professionally recognized standards of health
care and the acts or omissions
by Petitioner on which they based their conclusions. Petitioner offered no evidence,
aside from his own
testimony, to support his argument that the standards identified by the experts
are not professionally
recognized standards of health care. The I.G.'s experts' opinions were supported
to some extent by the
expert opinions on which Petitioner relied. I.G. Ex. 13, pp. 47 - 48; P. Ex.
13, p. 11; P. Ex. 31, p. 2; Tr. at
519 - 521. Petitioner offered no treatment records as evidence which had been
reviewed by CMRI and
which would establish that the items or services he provided comported with
professionally recognized
standards of health care.
Petitioner relied on Dr. Byrd's opinion for the conclusion that implantation
of internal fixation devices was
justified in at least eight of the nine cases. However, Dr. Byrd's opinion is
of no relevance to the issue of
the I.G.'s authority to exclude Petitioner because it is based on facts which
were never presented by
Petitioner to CMRI or to the I.G. See n. 10, supra. Petitioner has not asserted
that he was precluded from
presenting these facts either to CMRI or to the I.G.
Petitioner asserts that fixation alone or fixation accompanied by fusion was
justified in some of these cases
because the patients manifested degenerative spinal conditions which in and
of themselves justified such
surgeries, without further proof of instability. Petitioner contends, specifically,
that instability, and, hence,
the need for fusion surgery, can be inferred from the presence of certain medical
conditions in patients,
such as spinal stenosis, without further proof of instability (such as motion
studies of the patients' spines).
Tr. at 412 - 414, 483 - 485. He therefore disputes the conclusion of the I.G.'s
experts that the presence of
degenerative conditions, such as stenosis, absent additional proof of instability,
is not a sufficient basis for
performing fixation and fusion.
The weight of the evidence does not support this contention by Petitioner.
I conclude that the opinions
expressed by Drs. Patrick, Nockels, and Conley are more authoritative than that
expressed by Petitioner.
These three physicians are extremely well-qualified and dispassionate experts.
By contrast, Petitioner's
assertion was motivated by his self-interest. Furthermore, Petitioner did not
support his assertion with
credible, dispassionate expert testimony that rebutted the opinions expressed
by the I.G.'s experts. Indeed,
one of the treatises that Petitioner cites to support his contention (that the
presence of stenosis, by itself,
justifies performance of fusion surgery) appears to support the opposite conclusion.
See P. Ex. 13, p. 11;
Tr. at 424. 15/
Petitioner argues that the advanced age and frailty of the patients justifies
his performing fixation surgeries
without concurrent fusion attempts. This contention is without support and is
contradicted by the opinions
of all of the experts who testified in this case, including Petitioner's expert,
Dr. Byrd. Tr. at 519 - 521. Dr.
Steffee, the physician whose fixation system Petitioner utilized, advised CMRI
that his system was not
intended to be used without concurrent fusion surgery. I.G. Ex. 13, pp. 47 -
48. He stated:
The plates were designed to help obtain a fusion. Considering the continuous
lumbar motion taking
place and forces at the lower end of the lumbar spine which are so great, there
is no hardware in existence
that would tolerate the stress and strain put on the screws without breaking.
As you know a broken screw
is an attorney's delight, and therefore I would say there is zero indication
for the use of plates and screws
without also doing a fusion operation.
Id. Dr. Steffee later advised Petitioner that, in over 1200 surgeries, he had
performed "one or two" cases of
stabilization without concurrent fusion. P. Ex. 31, p. 2. The one case he specifically
recalled consisted of
an 89-year-old individual who was not expected to survive long enough to obtain
a solid fusion. Id.
Petitioner made no showing that any of the nine cases at issue was equivalent,
medically, to the one case
cited by Dr. Steffee.
Petitioner did not offer affirmative proof to counter the opinions of the I.G.'s
experts as to the adequacy of
the documentation he provided for the surgeries at issue, aside from asserting
that, in his opinion, the
documenta-tion was adequate. I find that this testimony by Petitioner is outweighed
by the testimony
offered by Drs. Patrick, Nockels, and Conley. Petitioner did offer an exhibit
to prove that, generally, his
documentation of his items and services is of good professional quality. P.
Ex. 33. The exhibit is a
liability and risk assess-ment performed by the Medical Insurance Exchange of
California on 85 hospital
records of patients who were hospitalized under Petitioner's care at Mercy Medical
Center in Redding,
California, and who were discharged between January 1990 and the end of June
1991. Id. at 5. This
exhibit is, at best, of questionable relevance to the issue of the I.G.'s authority
to exclude Petitioner.
Petitioner did not aver that he had provided the exhibit to CMRI. Assuming,
however, that the exhibit was
provided to CMRI, there is no evidence to show that Petitioner provided CMRI
with the underlying
medical records from which the study described in the exhibit was made. There
is no evidence to show
that any of the nine cases at issue were included in those records.
Petitioner argues that the I.G.'s experts based their opinions on incomplete
and inadequate documentation
of the surgeries which he performed. He contends that the I.G. ought to have
introduced into evidence
everything which CMRI reviewed concerning Petitioner's items or services. He
intimates, without
elaboration, that had the experts based their opinions on all of these materials,
their opinions might be
different.
Petitioner has not identified a single document in CMRI's records which he
contends would have affected
the opinions expressed by Drs. Patrick, Nockels, and Conley, or impeached these
experts' credibility.
Rather, he relies on his general contention that the experts should have been
shown more than they
reviewed and should have been questioned about these additional materials at
the hearing. At bottom,
Petitioner is contending merely that the experts might have changed their opinions,
or their opinions might
have been impeached, had the record contained some unspecified additional materials.
Petitioner had the
opportunity to cross-examine Drs. Patrick, Nockels, and Conley, and could have
questioned them about
any of the additional materials which ostensibly would have affected their opinions.
Petitioner did not
avail himself of that opportunity. Petitioner could have offered as exhibits
at the hearing any materials
which he provided to CMRI and which the I.G. did not present as part of the
I.G.'s case-in-chief. Petitioner
did not avail himself of that opportunity either. 16/
Petitioner contends also that the nine cases at issue represent only a small
fraction of the spinal surgery
cases he performed during the period at issue. He argues that it is not reasonable
to find a pattern of
inappropriate treatment from the nine cases, because they comprise only a small
sample of his total work
product. Notwithstanding this contention, the evidence supports a finding of
a pattern of violations. The
nine cases comprise surgeries performed over a brief period of time. The five
cases in which Petitioner
performed internal fixations without concurrent fusion surgery all occurred
between January and June,
1990. I.G. Ex. 3, 6 - 9. All of the cases involved similar surgeries. The violations
of statutory obligations
found by CMRI and the I.G. have common features.
Arguably, a pattern of inappropriate treatment would have been less evident
had these cases been evaluated
in the context of all of the surgeries performed by Petitioner during the time
period at issue. However, the
burden shifts to Petitioner to show that the conduct at issue did not constitute
a pattern of inappropriate
treatment, in light of the evidence presented by the I.G. Petitioner's assertion
that the cases at issue
comprise only a small part of his total practice does not rebut effectively
the evidence of a pattern of
misconduct which emerges from the nine cases. 17/
d. Petitioner is unable or unwilling to comply substantially with his obligation
to provide health
care of a quality which meets professionally recognized standards of health
care.
The I.G. determined that Petitioner was unable or unwilling to comply substantially
with his obligation to
provide health care of a quality which meets professionally recognized standards
of health care. The I.G.
made this determination in accordance with the Act, which as a prerequisite
to the imposition of an
exclusion against a party requires that the Secretary determine whether that
party is able or willing to
comply substantially with his obligation to provide health care as specified
by the Act. Social Security
Act, section 1156(b)(1). 18/
The I.G.'s determination is supported by the preponderance of the evidence.
It is supported by Petitioner's
unwillingness to enter into a corrective action plan with CMRI. It is supported
also by Petitioner's
continued failure to understand that his decisions to perform stabilization
and fusion surgery in some cases
do not comport with professionally recognized standards of health care.
The Act provides that the Secretary may infer that a provider is unable or
unwilling to comply substantially
with his obligation under the Act, based on the provider's unwillingness or
inability to enter into a
corrective action plan with a peer review organization. Social Security Act,
section 1156(b)(1). 19/ I infer
that Petitioner's refusal to enter into any corrective action plan with CMRI,
including the last plan which
CMRI offered to him, was motivated by his unwillingness to conform his surgical
practice with the
professionally recognized standards of health care which CMRI found him to have
contravened. I draw
this inference from the fact that the last plan which CMRI offered to Petitioner
was calculated reasonably
to address the deficiencies in Petitioner's practice. I draw it also from Petitioner's
failure to articulate a
cogent reason for his refusal to accept the plan.
Petitioner refused to accept any corrective action plan which CMRI offered
to him. Findings 76, 79 - 80.
Petitioner has offered no explanation for his refusal other than to state that
"I had no faith in their
corrective action plan and they never enunciated the terms in a manner that
we felt we could comply with."
Tr. at 610 - 611.
The final corrective action plan which CMRI offered to Petitioner would have
required Petitioner to:
document patient records sufficiently so that reviewers could determine the
need for surgeries which
Petitioner performed; perform internal fixations only with concurrent fusion
attempts; and provide CMRI
with a monthly list for six months of patients on whom Petitioner performed
surgeries consisting of spinal
fixation or decompression, so that CMRI could evaluate Petitioner's patient
care. I.G. Ex. 14, pp. 1 - 2.
This plan did not necessarily comprise CMRI's non-negotiable stance as to what
it would be willing to
accept from Petitioner. CMRI advised Petitioner that: "should you wish
to submit an alternate corrective
action plan you may do so; . . ." I.G. Ex. 14, p. 1.
Petitioner has not asserted that any of the requirements of this plan are unreasonable.
In fact, the terms that
CMRI sought to have Petitioner accept are calculated reasonably to address the
deficiencies which CMRI
observed in Petitioner's surgical practice. Petitioner has not provided any
explanation for his refusal to
execute the plan or to offer CMRI an acceptable alternative, beyond his assertion
that he had no faith in
CMRI. See Tr. at 610 - 611.
Petitioner contends that he is willing to comply with appropriate professionally
recognized standards of
health care. He asserts that he no longer performs internal fixations without
concurrent attempts at fusion.
He asserts also that he now documents his surgical procedures in a manner which
third-party reviewers
would find to be acceptable. These assertions do not rebut the inference of
unwillingness to comply which
I draw from his refusal to enter into any of the corrective action plans which
CMRI offered to him. The
corrective action plans would have required Petitioner to demonstrate that his
surgeries complied with
professionally recognized standards of health care. That stands in contrast
with his unsupported assertion
that he is doing so on his own. I find Petitioner's assertions of voluntary
compliance with professionally
recognized standards of health care to be not credible, in light of his refusal
to enter into a corrective action
plan.
I conclude also that Petitioner's refusal to accept that his surgeries did
not comply with professionally
recognized standards of care demonstrates that he is unable to comply with such
standards. Petitioner
continues to assert that the criteria he uses to judge when to perform fusion
surgery are acceptable
medically. In fact, as I discuss at Part 1 c. of this Analysis, Petitioner continues
to insist that fusion surgery
is appropriate in cases where there is not medically sufficient evidence of
instability causing intractable
pain. This contention is contrary to professionally recognized standards of
health care. Finding 62. The
inference which I draw from this is that Petitioner continues to be unable to
discern the appropriate case in
which to perform fusion. Petitioner continues also to insist that it was appropriate
medically for him to
have performed fixation surgeries in five cases, without concurrent attempts
at fusion. This contention is
contrary to the overwhelming weight of the evidence in this case.
2. The three-year exclusion which the I.G. imposed and directed against Petitioner is reasonable.
The final issue which I must resolve is whether the remedy which the I.G. imposed
and directed against
Petitioner -- a three-year exclusion from participating in federally funded
health care programs -- is
reasonable. That question is not answered automatically by my finding that the
I.G. had authority to
exclude Petitioner under section 1156(b)(1), because the Act does not direct
that an exclusion of any
particular duration is per se reasonable in a given case.
Section 1156 is a remedial statute. As with other sections of the Act which
authorize the imposition of an
exclusion as a remedy, the purpose of an exclusion under section 1156 is not
to punish a party for past
wrongful conduct, but to provide a remedy against possible wrongful conduct
by that party in the future.
DeInnocentes at 48; see Narinder Saini, M.D., DAB 1371, at 6 (1992). Evidence
of past wrongful conduct
by a party may serve as an important predictor of that party's propensity to
engage in wrongful conduct in
the future. For that reason, evidence about Petitioner's violations of his obligations
under section 1156(a)
is highly relevant to the question of whether the exclusion imposed by the I.G.
is reasonable. However, I
may not limit legitimately the evidence which I receive on the remedy issue
to that which was considered
by CMRI in making its determination that Petitioner had violated his statutory
obligations to provide care.
Because section 1156 is remedial, and because of the de novo nature of the hearing
which I conduct in a
section 1156 case, I must consider evidence offered either by the I.G. or by
Petitioner concerning his
propensity or lack of propensity to engage in wrongful conduct in the future.
Evidence which I received from the I.G. which relates to the issue of remedy
includes evidence concerning
the violations of statutory obligations on which CMRI based its recommendation
to the I.G. Findings 89 -
203. It includes evidence also concerning additional acts or omissions committed
by Petitioner in his
treatment of the nine Medicare beneficiaries whose cases are at issue here,
which violated professionally
recognized standards of health care. Findings 204 - 216. Evidence which I received
from Petitioner which
relates to the issue of remedy includes the testimony of Petitioner's expert,
Dr. Byrd, concerning the
appropriateness of the care which Petitioner provided to the nine Medicare beneficiaries.
It includes
Petitioner's testimony concerning the nature of his medical practice in the
time subsequent to the dates of
the nine cases at issue. It includes also evidence from Petitioner concerning
continuing medical education
and training which he has received since the dates of the nine cases at issue.
P. Ex. 34.
I am convinced from the weight of the evidence that the three-year exclusion
which the I.G. imposed and
directed against Petitioner is reasonable. Petitioner's treatment of the nine
Medicare beneficiaries whose
cases are at issue demonstrates a serious misunderstanding by him of the professionally
recognized
standards of health care which govern spinal surgery. His evaluation and treatment
of these beneficiaries
establishes a propensity to perform major surgeries in instances where there
is insubstantial evidence that
such surgeries are necessary and appropriate. Furthermore, he manifests a tendency
to perform surgeries
which his professional peers agree may endanger the welfare of his patients.
Petitioner refuses to concede that his judgments were incorrect, or that he
engaged in practices which
violated professionally recognized standards of health care. Most disturbing,
Petitioner refuses to
acknowledge that the standards which Drs. Patrick, Nockels, and Conley identified
as governing the
surgeries which Petitioner performs in fact exist or govern his surgeries. Thus,
Petitioner continues to
insist incorrectly that the presence of certain medical conditions alone, such
as spinal stenosis, justifies the
performance of fusion surgery without the need for additional evidence of instability.
Petitioner also
continues to contend against the weight of expert testimony that the performance
of internal fixation
without concurrent fusion surgery is appropriate in cases of elderly patients
who do not suffer from
terminal illness. From all of this, I infer the possibility that Petitioner
will continue in the future to engage
in conduct which violates professionally recognized standards of health care.
Petitioner did not rebut evidence which establishes his treatment of patients
to have been inappropriate, or
which shows that he continues to refuse to accept the judgments of experts concerning
the existence of, and
his adherence to, professionally recognized standards of health care. Petitioner
relied on Dr. Byrd's
opinions to prove that the surgeries Petitioner performed were appropriate medically.
I do not question Dr.
Byrd's professional qualifications or his expertise. However, his opinions were
presented without any
foundation, inasmuch as Petitioner did not offer as evidence any of the materials
which Dr. Byrd consulted
in offering his opinions. 20/ The I.G. had no opportunity to rebut these underlying
materials or to cross-
examine Dr. Byrd from them. I am not prepared to accept as credible Dr. Byrd's
opinions in the absence of
foundation evidence which could either support or refute those opinions.
Petitioner contends that the I.G.'s experts' opinions as to the potential for
harm to patients resulting from
the surgeries he performed is refuted by the allegedly excellent results the
patients obtained, including
relief from pain. The record in this case does not, in fact, demonstrate that
these patients all received the
benefits which Petitioner contends they received. In one instance, a patient
was hospitalized again and
underwent fusion surgery shortly after Petitioner installed a fixation device
in that patient's spine without a
concurrent attempt at fusion. Findings 177 - 181. However, the possibility that
some or even most of the
beneficiaries on whom Petitioner performed surgery may be satisfied with the
results of that surgery begs
the question of whether Petitioner's services were provided in accordance with
professionally recognized
standards of health care. What Drs. Patrick, Nockels, and Conley established
is that these surgeries did not
comport with professionally recognized standards of health care and that there
existed a serious potential
for harm to the beneficiaries.
Furthermore, in at least some cases, Petitioner performed fusion surgery without
evidence that would
justify the performance of such surgery. Findings 95, 110, 134, 141, 166, 193,
204 - 209, 213 - 216. The
fact that Petitioner's patients may have recovered from the surgery and even
experienced relief from their
symptoms does not refute evidence that equally good results might have been
obtained from less drastic
and risky surgery.
Petitioner's completion of continuing medical education in spinal surgery does
not rebut the evidence
which establishes a need for an exclusion. I do not question the quality of
the courses which Petitioner
completed. See P. Ex. 34. However, notwithstanding his training, Petitioner
continues to espouse
practices which do not conform to professionally recognized standards of health
care. It does not appear
that the courses which Petitioner completed have affected Petitioner's assessment
of the criteria for
performing spinal fusion surgery and internal fixation.
Petitioner's assertions that he now complies with professionally recognized
standards of health care in the
performance of spinal surgery, and in his documentation of that surgery, are
not persuasive in view of his
refusal to acknowledge that he has contravened such standards in the past, or
to execute a corrective action
plan with CMRI. In effect, Petitioner is demanding that the Secretary trust
him to comply with
professionally recognized standards of health care, but at the same time is
refusing to acknowledge the
existence of these standards, or to offer any verifiable assurances that he
will comply with them. I do not
find that to be a reasonable position, in view of the record of Petitioner's
pattern of violations of his
obligations under the Act.
Furthermore, Petitioner did not offer convincing proof at the hearing that
he now is complying with
professionally recognized standards of health care. He had the opportunity to
present evidence
demonstrating that spinal fusion surgeries which he now performs are performed
only where the
professionally recognized criteria for performing such surgeries are met. He
offered no evidence which
would prove that.
Even if I were to find true Petitioner's assertion that he no longer implants
fixation devices in patients
absent concurrent attempts at fusion, that would not obviate the need for an
exclusion. While this asserted
change in Petitioner's surgical practice addresses one major deficiency identified
by CMRI, it does not
address other problems. CMRI's recommendation to the I.G. was based to a large
extent on Petitioner's
pattern of performing fusion surgeries in cases where the medical evidence did
not indicate a need for such
surgeries. Even if Petitioner is now attempting fusion in every case where he
implants a fixation device, he
may be continuing to implant fixation devices and to attempt fusions where fixation
devices and fusions
are not needed.
In deciding the issue of remedy, I have taken into consideration Petitioner's
education, training, and
experience as a surgeon. He is an individual who is well-trained and who has
had a successful professional
career. Findings 1 - 5. Petitioner's background suggests that he should be fully
aware of the professionally
recognized standards of health care which govern his specialty. That conclusion
makes it all the more
troubling that Petitioner refuses to acknowledge that they exist, or that he
should be bound by them. 21/
CONCLUSION
I conclude that the I.G. had authority to impose and direct an exclusion of
Petitioner pursuant to section
1156(b)(1) of the Act, based on the recommendation of CMRI. The three-year exclusion
which the I.G.
imposed and directed is reasonable.
__________________________
Steven T. Kessel
Administrative Law Judge
1. "State health care program" is defined by section 1128(h) of the
Social Security Act to cover three
types of federally financed health care programs, including Medicaid. Unless
the context indicates
otherwise, I use the term "Medicaid" hereafter to represent all State
health care programs from which
Petitioner was excluded.
2. On July 25, 1993, Petitioner moved to supplement the record with exhibits
not introduced into
evidence at the May 17 - 19 hearing. The I.G. opposed the motion. I denied it.
Ruling Denying
Petitioner's Motion to Supplement the Record, August 3, 1993.
3. As a convenience to the parties, I have divided my Findings of Fact and
Conclusions of Law
(Findings) into sections which are headed by descriptive captions. The captions
are not Findings, and they
are not intended to augment or substitute for my Findings in this case.
4. The names of each of the patients involved in this case are reported in
their hospital records, which are
in evidence. However, as a courtesy to these patients, and out of respect for
their privacy, I refer to each of
them by their initials.
5. The term "substantial violation in a substantial number of cases"
is defined by regulation to mean a
pattern of care that is inappropriate, unnecessary, does not meet professionally
recognized standards of
care, or is not supported by the necessary documentation of care as required
by a peer review organization.
42 C.F.R. 1004.1(b).
6. Section 1156(b)(1) provides that, in order to exclude a party based on a
recommendation by a peer
review organization, the Secretary must find that the party has demonstrated
either an inability or an
unwillingness to comply substantially with his or her obligations to provide
care consistent with the
requirements of section 1156(a).
7. In her opening statement at the hearing of this case, counsel for Petitioner
asserted that the de novo
hearing which I conducted should not be an adversary hearing, but, rather, should
be conducted according
to the procedures utilized in Social Security disability hearings. In such hearings,
the Secretary is not
represented by counsel and only the disability claimants and their representatives
generally appear
personally before administrative law judges in order to advocate the claimants'
entitlement to disability
benefits. See 20 C.F.R. 404.932. Petitioner has not repeated this argument in
his posthearing briefs and
may have abandoned it. I conducted the hearing in this case pursuant to regulations
published by the
Secretary which explicitly provide for hearings, including hearings in cases
of exclusions imposed pursuant
to section 1156(b)(1), in which both the Petitioner and the I.G., and their
respective representatives, may
appear. 42 C.F.R. 1005.2(a), (b). I note, furthermore, that section 205(b) of
the Act does not prescribe
the form that administrative hearings are to take. Therefore, the fact that
the Secretary may have opted to
conduct "non-adversary" hearings in Social Security disability cases
does not suggest that Congress
mandated that all hearings conducted pursuant to section 205(b) be "non-adversary"
in character.
8. Regulations which govern the process by which a peer review organization
makes an exclusion
recommendation, and the I.G. determines to accept or not accept such recommendation,
enable a provider
to present both the peer review organization and the I.G. with any facts relevant
to the items or services at
issue which should be considered by the peer review organization or the I.G.
42 C.F.R. 1004.40(c)(6),
1004.50(b)(6), 1004.60(b)(2).
9. At the hearing, the I.G. offered the opinions of three experts -- Kent Michael
Patrick, M.D. (Tr. at 94
- 176), Russ P. Nockels, M.D. (Tr. at 186 - 306), and Frances K. Conley, M.D.
(Tr. at 346 - 399) -- as to
whether there existed professionally recognized standards of health care which
governed Petitioner's
treatment of his patients, and as to whether Petitioner's acts or omissions
violated the standards of care
which they identified. Petitioner did not object to the testimony given by these
experts. The experts
confined their analysis of Petitioner's conduct to records which were reviewed
by CMRI. The experts did
not address facts which were not considered by CMRI, inasmuch as they confined
their opinions to
commenting on facts considered by CMRI in making its recommendation, and on
the appropriateness of
the criteria employed by CMRI in making its recommendation. Thus, the I.G.'s
use of experts on the
authority to exclude issue did not contravene the proscription against offering
facts on that issue which
exceed the scope of a peer review organization's review of a party's items or
services.
10. Petitioner introduced the written and live testimony of an expert, J. Abbott
Byrd, III, M.D., to prove
that the surgeries he performed were in accord with professionally recognized
standards of health care. P.
Ex. 35; Tr. at 497 - 522. In contrast to the testimony offered by Drs. Patrick,
Nockels, and Conley, Dr.
Byrd's testimony was based on facts that had not been reviewed by CMRI and,
therefore, not considered by
CMRI in making its recommendation to the I.G. Tr. at 504. I considered Dr. Byrd's
testimony to be
relevant to the preliminary issue of whether Petitioner posed a serious risk
to his patients, and relevant also
to the issue of whether the exclusion imposed by the I.G. is reasonable. In
my July 1, 1993 ruling as to
serious risk, I gave no weight to Dr. Byrd's testimony because Petitioner provided
no foundation for his
opinions. The materials on which Dr. Byrd based his opinions were not only not
provided by Petitioner to
CMRI, but were not offered by Petitioner as exhibits at the hearing which I
conducted. Petitioner did not
contend that he had been deprived of the opportunity to present these materials
to either CMRI or to the
I.G. See n.8, supra. However, while Dr. Byrd's testimony may be relevant to
the issues of serious risk and
remedy, I am precluded from considering it on the issue of the I.G.'s authority
to exclude Petitioner
because it is based on facts which were not before CMRI. See n.9, supra.
11. In his posthearing reply brief, Petitioner suggests that a codification
requirement might be in
regulations contained in 42 C.F.R. Part 466. These are regulations which govern
peer review
organizations' review of utilization and quality under sections 1154, 1866(a)(1)(F),
and 1886(f)(2) of the
Act, and which do not appear to have relevance to the functions exercised by
CMRI in reviewing
Petitioner's items or services for possible violations under section 1156(a)
of the Act. 42 C.F.R.
466.70(a). However, even if these regulations are of direct relevance, they
do not contain a requirement
that peer review organizations codify and publish all professionally recognized
standards of health care.
The regulations require that, for the conduct of a review, a peer review organization
must:
Establish written criteria based upon typical patterns of practice in the
PRO [peer review organization's]
area, or use national criteria where appropriate. . . .
42 C.F.R. 466.100(c)(1). This section gives the reviewing peer review organization
the option to use
national criteria for review or to establish its own special criteria for review.
It does not obligate a peer
review organization to codify and publish professionally recognized standards
of health care which are
recognized nationally.
12. CMRI advised Petitioner that "you may request that the physician(s)
at the . . . [peer review
organization] who determined that there is a reasonable basis for concluding
that you have violated one or
more obligations under the Medicare program appear at the meeting to discuss
the basis for the
determination, although CMRI does not have to grant that request." I.G.
Ex. 10, p. 8. CMRI thus
presented Petitioner with the opportunity to request something that was not
required either by the Act or
regulations. However, CMRI never waived its right to have a representative of
its choice present at the
meeting. Id.
13. It is not apparent that the I.G. would have been estopped by the administrative
law judge's decision
even had it remained in effect. The facts and legal issues in the Medicare Part
B reimbursement case do
not appear to be identical to those in this case.
14. On close review, it appears that CMRI determined that Petitioner had committed
16 violations, and
not 18 violations, as was alleged by the I.G. I.G. Ex. 15, pp. 2 - 4.
15. In discussing the appropriate surgery to perform on older individuals with
spinal stenosis, this text
provides:
A fusion procedure is generally not performed on the older patients in this
age group (usually about 60
to 70 years old), because decompression is already an extensive operation. The
motion segments in
question are usually rather immobile with significantly diminished disk heights
and osteophytes limiting
the danger of future instability.
P. Ex. 13, p. 11.
16. Subsequent to the hearing, and after Petitioner had rested his case, he
moved to supplement the
record by offering as evidence the entire record of materials reviewed and considered
by CMRI. I denied
that motion, because the offer was untimely, because Petitioner did not prove
any extraordinary
circumstances as required by regulation, because the I.G. would have been prejudiced
by my admitting the
materials into evidence, and because the hearing process would be disrupted
by my admitting the materials
into evidence. Ruling Denying Petitioner's Motion to Supplement the Record,
August 3, 1993. Petitioner
filed his initial posthearing brief on July 23, 1993 before I denied his motion.
Large portions of that brief
consist of arguments based on the materials which I refused to admit into evidence.
I cannot identify any
materials cited in that brief which Petitioner contends would have affected
the I.G.'s experts' opinions, had
they been shown them, or would have impeached these experts' credibility.
17. Furthermore, Petitioner did not prove that he had presented to CMRI evidence
about the surgeries he
performed, other than the nine surgeries at issue, which should have changed
CMRI's recommendation to
the I.G.
18. The Act does not require that the I.G. determine that a party is both unable
and unwilling to provide
health care of a quality which meets professionally recognized standards of
health care, as a prerequisite to
excluding that party. The Act's criteria for exclusion will be met if the I.G.
determines either that a party is
unable to provide health care of a quality which meets professionally recognized
standards of health care,
or that a party is unwilling to provide such health care. Social Security Act,
section 1156(b)(1).
19. This provision applies to peer review organization determinations made
after November 5, 1990. It
states:
In determining whether a practitioner or person has demonstrated an unwillingness
or lack of ability
substantially to comply with such obligations, the Secretary shall consider
the practitioner's or person's
willingness or lack of ability, during the period before the organization submits
its report and
recommendations, to enter into and successfully complete a corrective action
plan.
Social Security Act, section 1156(b)(1).
20. The materials consisted of x-ray films and other diagnostic studies which
Petitioner never provided
to either CMRI or to the I.G.
21. Subsequent to the hearing, my office received three letters from individuals
who are not parties to
this case, supporting Petitioner and urging that he not be excluded. I did not
admit these letters into
evidence and I did not consider them in deciding this case. I referred the letters
to Petitioner's counsel and
I provided her with the opportunity to move that they be admitted into evidence.
Had Petitioner moved to
admit the letters, I would have considered any opposition that the I.G. might
have offered, and I would
have decided whether to admit them. However, Petitioner never moved to admit
the letters into evidence.