$05:Exclusion Case
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
L. John Flage, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: November 3, 1995
Docket No. C-95-064
Decision No. CR399
DECISION
This case is before me on Petitioner's January 30, 1995 request for
hearing to contest the determination of the Inspector General
(I.G.) of the Department of Health and Human Services (DHHS) to
exclude him from participation in Medicare and to direct his
exclusion from participation from Medicaid for a period of three
years. 1/ The parties have stipulated that there exists a basis
for the I.G. to impose and direct an exclusion pursuant to section
1156 of the Act. In this Decision, I conclude that the three-year
exclusion imposed and directed against Petitioner by the I.G. is
reasonable.
BACKGROUND
In a letter dated December 1, 1994, the I.G. notified Petitioner
that she had decided to adopt the August 11, 1994 recommendation of
the Iowa Foundation for Medical Care, the peer review organization
(PRO) for Iowa, to exclude Petitioner from participation in
Medicare and Medicaid for a period of three years.
The PRO's recommendation of August 11 was based on its
determination that Petitioner, in 10 cases, "substantially
violated" the obligations imposed upon him by section 1156 of the
Act: 1) to provide care of a quality which meets professionally
recognized standards of health care in a substantial number of
cases; and 2) to support the services or items he ordered or
provided with evidence of the medical necessity and quality as may
reasonably be required by the reviewing PRO. In addition, on the
basis of similar violations in certain other cases, the PRO found
that Petitioner had demonstrated an inability and unwillingness
substantially to comply with his obligations under section 1156(a)
of the Act.
In its August 11 letter, the PRO gave Petitioner 30 days to submit
to the I.G. any additional material Petitioner believed would
affect the PRO's recommendation to exclude him from Medicare and
Medicaid. Petitioner submitted no material.
In her December 1 letter, the I.G. informed Petitioner that she
agreed with the PRO's conclusion that Petitioner, in his treatment
of 10 patients, had "substantially violated" his obligations under
section 1156 of the Act. Further, the I.G. informed Petitioner
that she agreed with the PRO's conclusion that Petitioner had
demonstrated an inability and unwillingness substantially to comply
with the obligations imposed upon him by section 1156 of the Act.
2/
By letter dated January 30, 1995, Petitioner requested a hearing,
stating that he disagreed with each of the PRO findings relied on
by the I.G. in her December 1 letter. The case was subsequently
assigned to me for hearing and Decision. During the prehearing
conference I conducted in this case on February 28, 1995, I
established procedures by which this case was to proceed to an
in-person hearing in Des Moines, Iowa, on May 8, 1995.
On May 4, 1995, the parties informed me that they had agreed to
file a joint stipulation that would obviate the need for an
in-person hearing. I conducted a telephone conference on May 5,
1995, during which Petitioner reaffirmed that he was waiving his
right to an in-person hearing in this case and declared that he was
not disputing the I.G.'s authority to exclude him. Petitioner
informed me also that he wanted to proceed by submitting briefs and
documentary evidence. Accordingly, in my Order of May 11, 1995, I
established a schedule for the parties to submit briefs and
documentary evidence, including their joint stipulation.
In his brief (P. Br.), Petitioner requested permission to provide
oral argument as well. 3/ I granted Petitioner's request.
Accordingly, I heard the parties' oral argument in this case on
September 6, 1995.
STIPULATION
The parties have stipulated that Petitioner failed in a number of
cases substantially to comply with the obligations imposed on him
under section 1156(a) of the Act, as cited by the PRO in its August
11, 1994 letter and as restated by the I.G. in her December 1, 1994
letter. The parties further stipulated that the sole remaining
issue in this proceeding is the reasonableness of the three-year
exclusion imposed and directed by the I.G. against Petitioner. ALJ
Ex. 1. 4/
FINDINGS OF FACT AND CONCLUSIONS OF LAW
1. During all times relevant to this case, Petitioner was
practicing medicine as a physician in Independence and Buchanan
Counties in Iowa. P. Ex. 1.
2. During all times relevant to this case, the Iowa Foundation for
Medical Care (IFMC) was the PRO for Iowa. I.G. Ex. 3.
3. On April 17, 1992, the PRO issued Petitioner an initial
sanction notice advising him that he had violated his statutory
obligations under section 1156 of the Act in ten cases. I.G. Ex.
5.
4. After meeting with Petitioner on July 15, 1992, the PRO
outlined a corrective action plan (CAP) for Petitioner to follow
instead of recommending that Petitioner be sanctioned. I.G. Ex. 6
at 2 - 7.
5. In a response dated August 13, 1992, Petitioner accepted and
agreed to follow the PRO's recommended CAP. I.G. Ex. 6 at 1 - 7.
6. On November 12, 1993, the PRO issued a second sanction notice
to Petitioner which informed Petitioner that, subsequent to the
implementation of the CAP, Petitioner had continued to violate his
obligations under section 1156 of the Act. I.G. Ex. 5.
7. On April 20, 1994, the PRO met with Petitioner to discuss its
findings of additional violations subsequent to the implementation
of Petitioner's CAP. I.G. Ex. 10.
8. On August 11, 1994, the PRO issued a final sanction notice
which informed Petitioner that it had found that Petitioner had, in
specified cases, substantially failed to comply with his
obligations under the Act to assure that the services ordered or
provided by Petitioner were: a) of a quality that meets
professionally recognized standards of health care; and b)
supported by adequate evidence of medical necessity and quality.
ALJ Ex. 1; I.G. Ex. 3.
9. The PRO's August 11 letter informed Petitioner also that he had
demonstrated an unwillingness and inability to comply with his
obligations under the Act and that it was recommending to the I.G.
that Petitioner be excluded for three years. I.G. Ex. 3.
10. The I.G. largely accepted the PRO's findings regarding
Petitioner and adopted the PRO's recommendation that Petitioner be
excluded for three years from Medicare and Medicaid. I.G. Ex. 1.
11. The parties have stipulated that Petitioner violated his
obligations under section 1156 of the Act, as stated in the PRO's
August 11 letter and as cited also in the I.G.'s December 1, 1994
letter informing Petitioner of his exclusion from Medicare and
Medicaid. ALJ Ex. 1.
12. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of patient I. McG. (admission date March 2, 1991) by
failing to: a) repeat abnormal calcium and phosphorus tests; and
b) evaluate patient I. McG.'s drop in hemoglobin. ALJ Ex. 1; I.G.
Ex. 1, 2, 10 at 27 - 29.
13. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO by failing to provide
accurate information on patient I. McG's discharge summary. ALJ
Ex. 1; I.G. Ex. 1 - 3, 10 at 29 - 30.
14. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care by
failing to monitor arterial blood gases (ABGs) or oximetry for
patient M.S. (admission date June 11, 1991), who had dyspneic
chronic obstructive pulmonary disease (COPD). ALJ Ex. 1; I.G. Ex.
1, 2, 10 at 33 - 35.
15. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care: a)
by inappropriately ordering Valium and morphine for patient D.M.
(admitted on June 22, 1991 for neurological observation),
specifically by failing to specify a route for the morphine; and b)
by failing to obtain adequate information regarding D.M. on
admission. ALJ Ex. 1; I.G. Ex. 1 - 3, 10 at 36 - 38.
16. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of E.H. (admitted June 27, 1991) by failing to: a)
continue Cardizem during E.H.'s hospital stay; b) obtain ABGs to
evaluate E.H.'s dyspnea (labored breathing); and c) appropriately
manage E.H.'s fluid therapy. ALJ Ex. 1; I.G. Ex. 1 - 3, 10 at 38
- 40.
17. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of E.G. (admitted May 21, 1991) by failing to: a)
adequately evaluate the cause of E.G.'s hematuria (blood in her
urine); b) order appropriate laboratory tests on the fluid from
both of E.G.'s thoracenteses; c) adequately evaluate E.G.'s
abnormal ABGs, aggressively treat E.G.'s compromised oxygen status,
and specify the route and flow rate of the oxygen administration;
and d) appropriately manage E.G.'s intravenous fluid therapy. ALJ
Ex. 1; I.G. Ex. 1 - 3, 10 at 40 - 49.
18. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO by failing to: a)
provide an adequate and timely history and physical (H & P) of
patient E.G.; and b) complete E.G.'s discharge summary in a timely
manner. ALJ Ex. 1; I.G. Ex. 1 - 3, 10 at 49.
19. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of patient O.S. (admitted October 22, 1990) by failing to:
a) repeat the white blood count that was elevated; b) obtain blood
and sputum cultures before initiating treatment with a broad acting
third generation cephalosporin (Cefobid); c) treat O.S.'s pneumonia
with a long enough course of antibiotic therapy; d) order an ACE
inhibitor for a patient with cardiomegaly and CHF; and e)
appropriately manage O.S.'s intravenous fluid therapy. ALJ Ex. 1;
I.G. Ex. 1 - 3, 10 at 50 - 52.
20. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO by failing to: a)
provide an adequate and timely H & P; and b) complete patient
O.S.'s discharge summary in a timely manner. ALJ Ex. 1; I.G. Ex.
1 - 3, 10 at 52.
21. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of M.R. (admitted March 12, 1991): a) by failing to
adequately evaluate and appropriately treat patient M.R.'s
hyponatremia; b) by inappropriately writing an order for "home
meds" without specific knowledge of the drugs being ordered; c) by
failing to obtain blood cultures before initiating treatment with
a broad acting third generation cephalosporin (Cefobid); and d) by
failing to appropriately manage M.R.'s intravenous fluid therapy.
ALJ Ex. 1; I.G. Ex. 1 - 3, 10 at 53 - 67, 80 - 82.
22. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO by failing to complete
patient M.R.'s H & P in a timely manner. I.G. Ex. 1 - 3, 10 at 83.
23. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of patient R.E. (admitted March 19, 1991) by
inappropriately: a) ordering oral Lasix, 40 mg twice daily, for a
patient without continued signs of heart failure; b) writing an
order for "home meds" without specific knowledge of the drugs being
ordered; and c) writing an order on March 20 which stated "May use
Lanoxin but wait to see chest x-ray results." ALJ Ex. 1; I.G. Ex.
1 - 3, 10 at 85 - 89.
24. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO: a) by failing to
complete patient R.E.'s H & P in a timely manner; and b) by
inappropriately providing inaccurate information in R.E.'s
discharge summary. ALJ Ex. 1; I.G. Ex. 1 - 3, 10 at 89 - 91.
25. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of patient M.C. (admitted June 9, 1991) by failing to
adequately address the abnormal thyroid study, thus providing
inappropriate care to a patient with a history of hypothyroidism.
ALJ Ex. 1; I.G. Ex. 1 - 3, 10 at 91 - 94.
26. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO by failing to provide
accurate information in M.C.'s discharge summary. ALJ Ex. 1; I.G.
Ex. 1 - 3, 10 at 91 - 94.
27. Petitioner has stipulated that he substantially violated his
statutory obligation to provide health care of a quality and type
which meets professionally recognized standards of health care in
the case of patient I.C. (admitted July 17, 1991): a) by
inappropriately ordering Synthroid for a patient with normal
thyroid function studies; and b) by failing to discontinue or lower
the Lanoxin dosage in a patient with bradycardia. ALJ Ex. 1; I.G.
Ex. 1 - 3, 10 at 94 - 102.
28. Petitioner has stipulated that he substantially violated his
statutory obligation to provide appropriate evidence of medical
necessity and quality to the reviewing PRO by failing to provide a
complete and timely H & P within 48 hours of I.C.'s admission. ALJ
Ex. 1; I.G. Ex. 1 - 3, 10 at 94 - 102.
29. Prior to recommending Petitioner's exclusion, the PRO gave
Petitioner the opportunity to complete a CAP to remedy the quality
of care and medical documentation problems which the PRO had
identified in Petitioner's practice. I.G. Ex. 3, 4.
30. In 22 cases involving incidents which occurred after
Petitioner agreed to the terms of the CAP, he violated his
statutory obligations. I.G. Ex. 3, 4, 6; Finding 5.
31. Petitioner failed to comply substantially with the terms of
the CAP. I.G. Ex. 3, 4; Finding 30.
32. Petitioner has demonstrated an inability or unwillingness to
comply with the terms of his CAP. I.G. Ex. 3 at 21, 73 - 79, 96 -
97; I.G. Ex. 10 at 6 - 7; Findings 30, 31.
33. Petitioner has placed patients at risk by failing to order or
perform appropriate medical tests, or by failing to order repeat
testing or monitoring in situations where patients' test results
were abnormal. I.G. Ex. 1 - 3; 10 at 87; 12; 13; 15; 16; 17; 18;
20; and 21.
34. Petitioner has placed patients at risk by failing to
appropriately evaluate patients' medical conditions or by failing
to order appropriate medical treatment for patients. I.G. Ex. 1 -
3; 10 at 38; 14; 15; 16; 17; 18; 19; 20; and 21.
35. Petitioner has admitted that his treatment of 10 patients was
not in accordance with professionally recognized standards of
health care. I.G. Ex. 10 at 27 - 102; Finding 11.
36. Petitioner has admitted that, in the cases cited by the I.G.,
he did not provide appropriate evidence of medical necessity and
quality to the reviewing PRO . I.G. Ex. 10 at 27 - 102; Finding
11.
37. Petitioner's treatment of the 10 patients identified by the
I.G. shows that he failed substantially in his obligation to
provide care of a quality which meets professionally recognized
standards of health care. See Findings 12, 14 - 17, 19, 21, 23,
25, and 27; Act, section 1156(a)(2).
38. In a substantial number of cases, Petitioner failed to comply
substantially with the obligation imposed upon him by section
1156(a)(2) of the Act to provide care of a quality which meets
professionally recognized standards of health care. Finding 37.
39. In a substantial number of cases, Petitioner failed to comply
substantially with the obligation imposed upon him by section
1156(a)(3) of the Act to provide appropriate evidence of medical
necessity and quality to the reviewing PRO. Findings 13, 18, 20,
22, 24, and 28.
40. Through his treatment of the 10 patients cited by the I.G. as
the basis for Petitioner's exclusion, and through the violations he
committed while under a CAP, Petitioner has demonstrated that he is
unable or unwilling substantially to comply with professionally
recognized standards of health care. Findings 12, 14 - 17, 19, 21,
23, 25, 27, 30 - 32.
41. Section 1156 is a remedial, not a punitive statute. Act,
section 1156; Dr. Abdul Abassi, DAB CR390 at 3 (1995); Gary E.
Wolfe, D.O., DAB CR395 at 5 (1995).
42. Petitioner's violations of his obligations under section 1156
of the Act are serious in nature. Findings 12 - 28, 33, 34.
43. Petitioner's repeated violations of his obligations under
sections 1156(a)(2) and (3) of the Act indicate inadequate medical
understanding or confusion regarding treatments which endanger the
health of patients. Findings 33, 34, 38 - 40.
44. Petitioner's repeated violations of his obligations under
section 1156(a)(2) and (3) of the Act indicate a lack of
thoroughness in his medical evaluations and treatment of patients
which endanger the patients' health. Findings 33, 34, 38 - 40.
45. Petitioner's stipulations and his arguments based on those
stipulations do not negate the seriousness of his violations or the
risks he currently pose to patients. Findings 36, 37, 43, 44.
46. Petitioner's stipulations and his arguments based on those
stipulations do not negate the consequences of Petitioner's
inability to evaluate, manage, or treat relatively basic medical
conditions. Findings 11 - 32, 36, 37.
47. Petitioner's stipulations and his arguments based on those
stipulations do not negate the consequences of Petitioner's failure
or inability to complete his CAP successfully. Findings 29 - 31,
37, 38.
48. Petitioner's arguments in this proceeding do not show that he
recognizes the seriousness of his violations or that he is willing
and able to comply with the requirements of section 1156 of the
Act. See P. Br. at 2.
49. One of the remedial purposes of section 1156 of the Act is to
protect the health of Medicare beneficiaries and Medicaid
recipients. S. Khalid Hussain, M.D., DAB CR204 (1992); Louis W.
DeInnocentes, Jr., M.D., DAB CR247 (1992).
50. A three-year period of exclusion will provide Petitioner with
adequate time to: a) improve his medical knowledge; b) prepare him
to treat patients in accordance with professionally recognized
standards of health care; and c) avoid creating undue risks of harm
for patients. See, e.g., Findings 33, 34, 46, 48.
51. A three-year period of exclusion will protect program
beneficiaries from being placed at risk by a provider who has
demonstrated deficiencies in complying with professionally
recognized standards of health care. See, e.g., Findings 48 - 50.
52. A three-year exclusion will provide Petitioner with adequate
time to acquire the training to improve the documentation of his
prescribed course of treatment, patients' medical history, and the
medical necessity and quality of the treatment he provides. See,
e.g., Findings 29, 40.
53. A three-year exclusion is necessary, appropriate, and
justified in this case. Findings 1 - 52.
DISCUSSION
Section 1156(a) of the Act provides as follows:
It shall be the obligation of any health care practitioner and
any other person . . . who provides health care services for which
payment may be made (in whole or in part) under this Act, to
assure, to the extent of his authority that services or items
ordered or provided by such practitioner or person to beneficiaries
and recipients under this Act --
(1) will be provided economically and only when, and to
the extent, medically necessary;
(2) will be of a quality which meets professionally
recognized standards of health care; and
(3) will be 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) of the Act provides:
(1) If after reasonable notice and opportunity for
discussion with the practitioner or person concerned, and, if
appropriate, after the practitioner or person has been given a
reasonable opportunity to enter into and complete a corrective
action plan (which may include remedial education) agreed to by the
organization, and has failed successfully to complete such plan,
any organization having a contract with the Secretary under this
part determines that such practitioner or person has --
(A) failed in a substantial number of cases
substantially to comply with any obligation imposed on him under
subsection(a), or
(B) grossly and flagrantly violated any such obligation
in one or more instances,
such organization shall submit a report and recommendations to
the Secretary. If the Secretary agrees with such determination,
and determines that such practitioner or person, in providing
health care services over which such an organization has review
responsibility and for which payment (in whole or in part) may be
made under this Act, has demonstrated an unwillingness or a lack of
ability substantially to comply with such obligations, the
Secretary (in addition to any other sanction provided under law)
may exclude (permanently or for such period as the Secretary may
prescribe) such practitioner or person from eligibility to provide
services under the Act on a reimbursable basis. In determining
whether 5/ 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.
An excluded individual has a right to a de novo hearing to contest
the decision of the Secretary or her delegate (the I.G.) to impose
and direct the exclusion. Act, sections 1156(b)(4) and 205(b)(1);
Louis W. DeInnocentes, Jr., M.D., DAB CR247 (1992). Only two
issues are subject to the de novo hearing: 1) whether there is a
basis for the imposition of the exclusion; and 2) whether the
length of the exclusion is unreasonable. 42 C.F.R.
1001.2007(a).
Petitioner has stipulated to the basis for his exclusion.
Petitioner stipulated that he violated his obligations under
section 1156 of the Act. ALJ Ex. 1. In so stipulating, Petitioner
has admitted that, in the 10 cases identified by the I.G., he
substantially violated his statutory obligation to provide care of
a quality which meets professionally recognized standards of health
care. Also, Petitioner has stipulated that, in seven cases, he
substantially violated his obligation to provide appropriate
evidence of medical necessity and quality to the PRO.
Thus, the only issue is the length of time during which Petitioner
should be excluded from participation as a provider in the Medicare
and Medicaid programs. The I.G. adopted the recommendation of the
PRO and imposed a three-year exclusion, which began in late
December of 1994. I.G. Ex. 1 at 13. Petitioner contends that the
exclusion should be limited to the period of time that has already
elapsed since the exclusion began. P. Br. at 5. I have the
authority to review the record and to affirm, increase, or reduce
the I.G.'s determination that Petitioner should be excluded for
three years. 42 C.F.R. 1005.20(b).
The regulation relevant to the issue before me specifies the
consideration of certain information but does not formulate the
period of exclusion. 42 C.F.R. 1004.90. I am, however, guided
by the principles of logic and reason, as well as by the remedial
purpose of the Act. I have concluded that the three-year exclusion
imposed against Petitioner is reasonable for advancing the remedial
goals of the Act.
In determining the reasonableness of the exclusion period, I have
especially considered the evidence establishing the nature and
seriousness of Petitioner's violations. I have concluded from my
review of the evidence that Petitioner has serious and recurring
deficiencies in his willingness or ability to comply with the
requirements set by section 1156(a)(2) and (3) of the Act.
Findings 12 to 35. Many of these deficiencies relate to his
medical knowledge of the management and treatment of patients,
which are evidenced by his failure to 1) order appropriate tests
to evaluate the condition of his patients; 2) specify dosage and
route for medications; 3) timely obtain or timely report adequate
information upon the admission or discharge of his patients; 4)
properly monitor his patients' conditions; 5) order appropriate
medications for some of his patients; 6) continue to administer
medications for a sufficient length of time; and 7) consider or
take appropriate actions based on abnormal test results. At the
very minimum, Petitioner's acts and omissions deprived each of
these 10 patients of a level of care required by statute that was
conducive to properly diagnosing or improving their condition.
The evidence provided by the I.G. is replete with details showing
that the medical care Petitioner provided to 10 patients was, in
each instance, lacking in some basic element of diagnostic or
treatment knowledge which also placed the patient's health in
unnecessary jeopardy. As correctly pointed out in the I.G.'s Brief
(I.G. Br.), examples of such fundamental problems in the record
include Petitioner's failure to understand that he should not give
morphine and Valium to a patient who was admitted for neurological
observation; Petitioner's repeated failure to monitor ABGs in
patients who had conditions involving oxygen depletion;
Petitioner's failure to address an abnormal thyroid study and
provide appropriate care to a patient who had a history of
hypothyroidism; Petitioner's inappropriate ordering of oral Lasix
for a patient who had no continued signs of heart failure;
Petitioner's repeated and inadequate orders for "home meds" for
patients without specific knowledge of the drugs the patients
received; and Petitioner's repeated failure to properly manage
patients' intravenous fluid therapy.
Petitioner relies on the opinions of his professional colleagues
who believe that his violations under section 1156 of the Act are
not severe, do not evidence deficiencies in his clinical judgment,
were errors of omission as opposed to commission, and have not
adversely affected his patients' condition. P. Br. at 3 (referring
to letters to Petitioner's attorney from Drs. Sutherland and Myers
in P. Ex. 1 at 7 - 8). One physician's opinion cited by Petitioner
suggests also that Petitioner's recordkeeping problems do not
amount to improper patient care. P. Br. at 3 and P. Ex. 1 at 7.
I do not find Petitioner's arguments to be persuasive. Nor do I
find Petitioner's reliance on the letters from his colleagues to be
appropriate or well founded.
First of all, Petitioner has stipulated that he has "failed in a
number of cases substantially to comply with the obligations
imposed on him under section 1156(a) of the Act ...." ALJ Ex. 1.
Congress has already determined the importance of the obligations
specified under section 1156(a) by permitting the Secretary or her
delegate, the I.G., to impose an exclusion in the event these
obligations are substantially violated in a substantial number of
cases. Act, section 1156(b)(1). Even though Petitioner has not
specifically acknowledged that his multiple failings in the cases
cited by the I.G. establish his violations in a substantial number
of cases, this conclusion is self-evident from the evidence of
record and the parties' stipulation. See, e.g., Findings 12 - 28,
38, 39.
Petitioner's stipulation and my related conclusion cannot be
altered by physicians who formed contrary opinions or who disagree
with the importance Congress has attached to a physician's need to
fulfill obligations under section 1156(b) of the Act. For an
exclusion to be valid, Petitioner's violations of the statutory
standard do not have to result in actual harm to patients. Act,
section 1156. Nor does the practitioner need to make errors of
commission instead of errors of omission, as suggested by one of
Petitioner's colleagues. As noted above, the goal of an exclusion
is to protect program beneficiaries and recipients from possible
harm. Finding 49.
In this case, the I.G. has set the exclusion at three years due to
Petitioner's potential for harming patients; there is no allegation
that the substandard quality of care rendered by Petitioner
actually has harmed patients. I.G. Ex. 1 at 11. The I.G. is
authorized to preclude Petitioner from being a source of harm to
program beneficiaries and recipients.
I find logical the I.G.'s conclusion that Petitioner's failure to
use proper documentation or recordkeeping procedures also could
harm patients in that other physicians would not have adequate
information for properly treating the same patient. I.G. Ex. 1 at
11. Notwithstanding the belief of one of the physicians who
submitted a statement on behalf of Petitioner, there is no adequate
or logical basis for accepting that Petitioner was providing proper
patient care while Petitioner was unable or unwilling to document
the medical necessity or quality of his care. See P. Ex. 1 at 7.
Therefore, I do not find persuasive Petitioner's arguments that his
violations were not severe because most of them were documentation
problems which had no impact on patient care. See P. Br. at 3.
Moreover, Petitioner has not established the proper foundation for
the opinions of the doctors who wrote in support of reducing
Petitioner's exclusion. For example, Dr. Myers, whose opinion was
quoted by Petitioner (P. Br. at 3), specifically noted that he did
not know the details of the deficiencies that have resulted in
Petitioner's exclusion. P. Ex. 1 at 7; see also letters of other
physicians in P. Ex. 1 at 1 - 6. Dr. Sutherland, who did review
the PRO's recommendation and summarized his disagreement in a
letter also relied upon by Petitioner (P. Br. at 3), did not list
his experience or his qualifications for evaluating the
significance of deficiencies under section 1156(a) of the Act. P.
Ex. 1 at 8.
The letters from Petitioner's physician colleagues are also
conclusive in nature and lack the detailed analysis and attention
to facts seen in the PRO's reports and in the I.G.'s notice letter.
Although Dr. Sutherland, in his letter, does profess to have
knowledge concerning the PRO records, nothing in his letter
persuades me that he has knowledge of the cases of the 10 patients
whose treatment is at issue. Even were I to assume such knowledge
on the part of Dr. Sutherland, his one-page letter lacks the
detailed and fact intensive analysis of the PRO's reports. Also,
I note that Dr. Sutherland agrees that Petitioner was deficient in
his care of patients, as cited by the PRO. P. Ex. 1 at 8.
Accordingly, I have given no weight to any of the physicians'
opinions relied upon by Petitioner.
With regard to Petitioner's unwillingness or inability to comply
with his statutory obligation under the Act, I find relevant that,
although, since November of 1991, Petitioner has not had a
registration number for prescribing a controlled substance, he was
convicted of the offense of dispensing or prescribing a controlled
substance on the basis of a post-November 1991 incident. I.G. Ex.
1 at 12. This type of conduct evidences Petitioner's general
unwillingness to follow the requirements imposed by law.
I find relevant also that Petitioner argues that the violations
cited by the I.G. in her December 1994 letter, to which he
stipulated, were "deficiencies" only, and which were "the
exceptions and not the rule for his practice." P. Br. at 2. I
disagree. The cited violations form a pattern and are not
"exceptions" to Petitioner's practice. P. Br. at 2. For example,
there is proof of Petitioner's recurring failure to order
appropriate medication therapy as evidenced by the cases of: 1)
patient R.E., who was placed on Lasix during March 1991 without
continued signs of heart failure (Finding 23); 2) patient D.M.,
who was placed on Valium and morphine during June of 1991 despite
his having been admitted to the hospital for neurological
observation (Finding 15); and 3) patient O.G., who was not placed
on a long enough course of antibiotic therapy for his pneumonia
during his hospitalization in October 1992 (Finding 19).
In addition, there were recurring problems with Petitioner's
failure to use or to properly interpret laboratory tests, such as
in the cases of: 1) patient M.R., who was placed on a broad acting
third generation cephalosporin in March 1991 before a blood culture
had been obtained and evaluated (Finding 21); 2) patient E.G., for
whom there was no adequate evaluation of ABGs or aggressive
treatment of the patient's compromised oxygen status in May 1991
(Finding 17); 3) patient E.H., for whom no ABGs were ordered to
evaluate dyspnea in June of 1991 (Finding 16); 4) patient M.C., who
had a history of hypothyroidism and abnormal thyroid studies but
was not provided appropriate care in June 1991; and 5) patient
I.C., who was placed on Synthroid in July of 1991 despite normal
thyroid study results (Finding 27). There were also recurring
failures by Petitioner to provide timely reports of histories and
physicals of his patients which, as discussed above, impedes the
ability of other physicians to delivery effective treatment to
patients. See Findings 13, 18, 20, 22, 24, 26, and 28.
Further evidence that Petitioner has remained unwilling or unable
to comply with his statutory obligation is found in Petitioner's
failure to live up to the terms of his CAP, and to take advantage
of the opportunity to remedy his recurring problems under the
statute. As correctly pointed out by the I.G. and the PRO, the
same types of deficiencies in his practice occurred again in 22
cases (each case consisting of multiple violations) after he had
agreed to comply with the terms of a CAP. I.G. Ex. 1 - 6;
Findings 30, 31. From November 1992 until December 1993,
Petitioner continued to exhibit significant problems, such as
failing to: 1) adequately evaluate patients; 2) address abnormal
test results; 3) order appropriate medication therapy; 4) order
appropriate IV therapy; e) provide adequate or appropriate medical
orders; and 5) provide timely and adequate documentation, such as
H & Ps and discharge summaries. I.G. Ex. 1 - 4. Even after the
PRO apprised him of these additional cases in a second sanction
notice, Petitioner did not respond. I.G. Ex. 3 at 73.
Petitioner contends that he has successfully completed the CAP. P.
Br. at 8. Indeed, during oral argument, counsel for the I.G.
admitted that Petitioner had completed the training elements of the
CAP. Transcript of September 6, 1995 oral argument at 23 (Tr. at
23).
However, while Petitioner has shown that he eventually fulfilled
the training requirements in the CAP, the record reflects that,
during the time the CAP was in effect, he continued to commit
numerous substantial violations of professionally recognized
standards of health care. Tr. at 23. The violations that occurred
during the period that the CAP was in effect, coupled with
Petitioner's established pattern of basic mistakes regarding his
treatment of the 10 patients at issue, are very persuasive proof
that he is unwilling or unable to comply with his statutory
obligations.
Therefore, the record reflects that Petitioner's completion of the
CAP courses and paperwork are not persuasive in light of
Petitioner's continued violations of the most basic and important
elements of the CAP regarding the proper care and treatment of
patients and proper and adequate documentation. Petitioner's
completion of the CAP coursework is meaningless in view of his
continued violations of his obligation under the Act during the CAP
period, and certainly does not provide any indication that at
present Petitioner is willing or able to comply with his
obligations under section 1156 of the Act.
I find equally unpersuasive Petitioner's additional arguments and
evidence to support reducing the length of his exclusion. Having
already addressed the letters from physicians, I will now discuss
the letters of support from some patient and hospital staff
members, as well as the petitions signed by local residents. It is
obvious from these submissions that Petitioner is a well-liked
physician in his community. P. Ex. 1.
However, as set out in the I.G.'s letter of December 1994,
Petitioner's exclusion does not bar him from practicing medicine.
The exclusion bars him only from receiving payments under the
Medicare and Medicaid programs, so as to protect those whose access
to medical care depends on such payments. I.G. Ex. 1. The I.G.
has no authority to preclude Petitioner from practicing medicine,
having hospital privileges, or treating patients who wish to be
treated by him. In fact, Petitioner's exclusion has no potential
impact whatsoever on persons who are not Medicare beneficiaries or
Medicaid recipients. Yet the letters of support for Petitioner and
the petitions signed by local residents fail to indicate an
understanding of these distinctions. Some letters ask for
reinstatement of Petitioner's hospital privileges. E.g., P. Ex. 1
at 34, 35, 40, 47. Others object to depriving Petitioner of the
privilege of practicing medicine. E.g., P. Ex. 1 at 124. The
Administrator of a local hospital, for example, notes a physician
shortage in the area even though the exclusion from participation
in the Medicare and Medicaid programs does not require Petitioner
to terminate his medical practice or leave the area. P. Ex. 1 at
9; I.G. Ex. 1.
More importantly, none of the letters from patients or petitions
signed by local residents indicates any knowledge of the nature or
extent of those violations committed by Petitioner. One
individual, for example, appears to assume that Petitioner has been
derelict in "the mounds of paperwork required by the government."
P. Ex. 1 at 38 (emphasis in original). Nor does the record show
that the writers of the letters or signatories of the petitions
have the qualifications to evaluate the appropriateness and quality
of services rendered by physicians.
The majority of the letters express patient loyalty, contain lay
opinions on the quality of medical care, do not show sufficient
knowledge of the underlying facts of this case, and are not
entitled to any weight. I find it significant that Petitioner has
declined the repeated opportunities afforded him by the PRO to
address the merits of all the violations alleged by the PRO. E.g.,
I.G. Ex. 3 at 73. Now, having been unwilling or unable to convince
his professional peers familiar with the specific cases that his
medical decisions and actions were within professionally recognized
standards, Petitioner relies upon the opinions of lay individuals
unfamiliar with the PRO's medical findings and the I.G.'s reasons
for excluding him. I do not find that this approach establishes
that a three year exclusion is unreasonable.
With respect to the physician shortage alleged by Petitioner and
his supporters, I conclude that the evidence relevant to this issue
is not sufficient for finding a three year exclusion unreasonable.
Petitioner does not contest the I.G.'s determination that other
physicians practice in the area (I.G. Ex. 1 at 11), and Petitioner
does not allege that his Medicare and Medicaid patients will be
rejected by other area doctors. In fact, the physicians who wrote
letters in Petitioner's support do not assert that they have full
patient loads or will reject Medicare and Medicaid patients. P.
Ex. 1 at 1 - 8. Only one doctor has stated in his letter that
Petitioner's situation has created "somewhat of a hardship" for
other physicians. P. Ex. 1 at 7; P. Br., 4. However, at the time
this doctor wrote the letter, many patients of Petitioner's already
had changed doctors, and this doctor did not note that any Medicare
or Medicaid patient had failed or will fail to find a local
physician willing to treat him. Id.. Nor has any Medicare or
Medicaid beneficiary or recipient alleged that since Petitioner's
exclusion no doctor in the area has been willing to accept her or
him as a patient .
Moreover, I do not find that the appropriate method for relieving
the physician shortage situation alleged by many local residents
and Petitioner is to modify the exclusion period of a physician
whose treatment poses serious risks to patient health and who
cannot or will not conform the care he renders to professionally
recognized standards. It may be true that Petitioner's exclusion
causes the other doctors of the community to be "overworked," as
alleged by a hospital employee. P. Ex. 1 at 11. Placing
Petitioner back in the programs at this time may indeed lessen the
workload of other health care professionals in the community.
However, doing so will be a disservice to the health of program
patients who may be receiving treatment from Petitioner.
I am aware that Petitioner, at least in the proceedings before the
PRO and before me, has stipulated to the existence of his
violations under the Act. However, his willingness to enter into
the stipulation does not negate the seriousness of Petitioner's
violations, the risks he creates for patients, or his failure to
adequately remedy his deficiencies during the time period that the
CAP was in effect. To date, Petitioner continues to minimize the
potential harm he created for patients and shirk off the importance
of proper medical documentation, as seen by his reliance upon the
letters discussed above. People writing to support a reduction in
Petitioner's sanction period may have been given the incorrect
impression that the exclusions resulted from hypertechnical and
unnecessary paperwork requirements which Petitioner's busy schedule
as a good physician did not permit him to satisfy, or from his
failure to communicate with the government. E.g., P. Ex. 1 at 2,
13, 38.
The fact that others believe that Petitioner can and will work with
the local hospital's Continuing Quality Improvement (CQI) committee
to overcome his problems also does not establish that the exclusion
period should be decreased. Petitioner is being excluded due to
the numerous quality of care and documentation problems that have
resulted from his treatment of patients who were admitted to the
same hospital with the CQI committee. See, e.g., I.G. Ex. 12 - 34.
Petitioner's reliance on letters suggesting the usefulness of the
same hospital's CQI committee and his willingness to work with that
committee does not amount to a sincere recognition by Petitioner
that he has failed to meet his obligations under section 1156 of
the Act. Until he understands the nature and significance of his
past violations, it is unlikely that he will be able to comply
substantially with the statutory requirements.
Based on all of the foregoing considerations and the totality of
the evidence, I conclude that a three-year exclusion is reasonable
in order to protect the programs' beneficiaries and recipients. A
three-year exclusion will give Petitioner the opportunity to
understand the manner in which he has violated his statutory
obligations and the potentially harmful consequences to his
patients. A three year exclusion will also enable Petitioner to
obtain the necessary training and instruction which may persuade
him to change the types of practices noted by the I.G. and the PRO.
The three-year exclusion will provide Petitioner with sufficient
time to demonstrate that he can provide medical care to program
beneficiaries and recipients in a manner consistent with his
obligations under the Act and which will not create undue risk of
harm to them.
CONCLUSION
I uphold the three-year exclusion which the I.G. imposed and
directed against Petitioner.
_________________________
Mimi Hwang Leahy
Administrative Law Judge
Addressees:
Hugh Field, Esq. and Eric Johnson, Esq.
Beecher, Rathert, Roberts, Field,
Walker & Morris, P.C.
Court Square Building, Suite 300
620 Lafayette Street
P.O. Box 178
Waterloo, Iowa 50704
and
Nancy K. Born, Esq.
Assistant Regional Counsel
DHHS - Region VII
Room 535, 601 East 12th Street
Kansas City, Missouri 64106
1. Petitioner was excluded from participation as a provider in
Medicare and any State health care program as defined in section
1128(h) of the Social Security Act (Act). I use the term
"Medicaid" in this Decision to include all State health care
programs from which Petitioner was excluded.
2. In so doing, the I.G. indicated that she had not relied on
some or all of the PRO's findings in six of the cases which it
cited to support its conclusion that Petitioner is unwilling or
unable to comply with his obligations under section 1156 of the
Act. I.G. Exhibit 1 at page 10.
3. Petitioner indicated also a desire to file a reply brief. P.
Br. at 6. Both parties later waived the opportunity to file reply
briefs. Transcript of Oral Argument at 3.
4. I have received the parties' stipulation into evidence as
Administrative Law Judge Exhibit 1 (ALJ Ex. 1). Also, I have
received I.G. exhibits (I.G. Ex.) 1 through 34 and Petitioner's
exhibit (P. Ex. 1) into evidence.
5. In the Act, this appears as "whehter". I have changed it here
for the sake of clarity.