Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
Narinder Saini, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: July 23, 1992
Docket No. C-425
DECISION
On April 18, 1991, the Inspector General (I.G.) notified Petitioner that he
was being excluded from
participating in Medicare and State health care programs pursuant to section
1128(b)(4) of the Social
Security Act (Act). 1/ The I.G. advised Petitioner that he was basing his decision
to exclude him on a
decision by the Board of Medical Examiners of the State of Iowa to suspend Petitioner's
license to practice
medicine in Iowa. The I.G. further advised Petitioner that he had determined
to exclude Petitioner until
Petitioner obtained a valid license to practice medicine in Iowa.
On July 8, 1991, the I.G. notified Petitioner, that, in light of information
which Petitioner had supplied to
the I.G., the exclusion was being modified to a term of three years. The I.G.
told Petitioner that he was
modifying the term of the exclusion based on the fact that Petitioner had obtained
a license to practice
medicine in the State of Wisconsin.
Petitioner requested a hearing, and the case was assigned to me for a hearing
and a decision. I held a
hearing in Madison, Wisconsin, on March 10, 1992. With the parties' consent,
I received additional
testimony by telephone on March 27, 1992. The parties submitted posthearing
briefs and reply briefs.
I have carefully considered the evidence, the applicable law, and the parties'
arguments. I conclude that the
three-year exclusion imposed and directed by the I.G. is reasonable. I therefore
uphold the exclusion.
ISSUE
The issue in this case is whether the three-year exclusion which the I.G. imposed
and directed against
Petitioner is reasonable.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
1. Petitioner is a psychiatrist. Tr. at 34. 2/
2. Petitioner was employed as a staff psychiatrist at Mendota Mental Health
Institute, in Madison,
Wisconsin, from February 24, 1986 to September 26, 1986. He was employed again
at Mendota Mental
Health Institute as a forensic psychiatrist, beginning January 29, 1990, and
he is presently employed in that
capacity by Mendota Mental Health Institute. P. Ex. 18/4; Tr. at 34.
3. From September 29, 1986 until May, 1989, Petitioner was employed as Medical
Director and
psychiatrist at the Mental Health Center of Mid-Iowa, in Marshalltown, Iowa.
P. Ex. 18/4.
4. Petitioner also served as the Clinical Director in Psychiatry at Ellsworth
Hospital, in Iowa Falls, Iowa,
from November, 1987 to February, 1988. P. Ex. 18/4.
5. From May, 1989 until August, 1989, Petitioner was employed as a psychiatrist
at the Mental Health
Center of North Iowa, in Mason City, Iowa. P. Ex. 18/4.
6. On August 7, 1990, the Board of Medical Examiners of the State of Iowa (Iowa
Board of Medical
Examiners) issued an order directing that Petitioner's license to practice medicine
and surgery in Iowa be
indefinitely suspended. I.G. Ex. 29.
7. In ordering that Petitioner's license to practice medicine and surgery be
suspended, the Iowa Board of
Medical Examiners accepted the Findings of Fact, Conclusions of Law, and Proposed
Decision of a panel,
consisting of three members of the Iowa Board of Medical Examiners and a State
administrative law judge,
which had conducted an evidentiary hearing in Petitioner's case on May 31, 1990.
I.G. Ex. 28; I.G. Ex. 29.
8. The Iowa Board of Medical Examiners found that, while employed at the Mental
Health Center of
North Iowa, Petitioner had experienced a psychotic episode. I.G. Ex. 28/3; I.G.
Ex. 29.
9. The Iowa Board of Medical Examiners found Petitioner's mental condition
affected his practice of
medicine and compromised the care of his patients. I.G. Ex. 28/3; I.G. Ex. 29.
10. The Iowa Board of Medical Examiners found that, although Petitioner had
received treatment for his
mental condition, there remained the possibility that Petitioner could experience
an additional psychotic
episode in the future which would compromise the care of his patients. I.G.
Ex. 28/15; I.G. Ex. 29.
11. The Iowa Board of Medical Examiners found that Petitioner was unable to
practice medicine with
reasonable skill and safety as a result of a mental or physical condition. I.G.
Ex. 28/16; I.G. Ex. 29.
12. The Iowa Board of Medical Examiners found that Petitioner's practice of
psychiatry had been harmful
or detrimental to the public. I.G. Ex. 28/16; I.G. Ex. 29.
13. The Iowa Board of Medical Examiners suspended Petitioner's license to practice
medicine and surgery
in Iowa for reasons bearing on Petitioner's professional competence or performance.
Findings 6 - 12.
14. On February 21, 1991, the State of Wisconsin Medical Examining Board (Wisconsin
Medical
Examining Board) issued a decision and order concerning Petitioner's license
to practice medicine and
surgery in Wisconsin. P. Ex. 1.
15. The Wisconsin Medical Examining Board found that Petitioner suffered from
a bipolar mental
disorder (manic-depressive illness). P. Ex. 1/2.
16. The Wisconsin Medical Examining Board found that Petitioner's illness was
reasonably related to his
ability to practice medicine and surgery. P. Ex. 1/2.
17. The Wisconsin Medical Examining Board found that Petitioner's illness could
reasonably be
accommodated by placing appropriate conditions on Petitioner's license to practice
medicine and surgery in
Wisconsin. P. Ex. 1/2.
18. The Wisconsin Medical Examining Board restricted Petitioner's license to
practice medicine and
surgery in Wisconsin, subject to conditions which included the following:
a. Petitioner is prohibited from practicing or attempting to practice medicine
or surgery in Wisconsin as
a sole practitioner;
b. Petitioner must remain in treatment with Ronald Diamond, M.D., his treating
psychiatrist, and follow
that physician's recommendations for diagnostic testing, evaluation and treatment;
c. Dr. Diamond or his successor must submit reports every 90 days to the Wisconsin
Medical
Examining Board, concerning Petitioner's treatment program and his progress
in that program;
d. Petitioner shall notify the Wisconsin Medical Examining Board prior to
commencing any practice of
medicine or surgery in Wisconsin and shall identify an individual satisfactory
to the Wisconsin Medical
Examining Board who will supervise Petitioner's practice and who will report
any conduct by Petitioner
which may impact upon patient health, safety or welfare, or Petitioner's ability
to practice medicine or
surgery with reasonable skill and safety to patients.
P. Ex. 1/3.
19. On March 6, 1992, the Wisconsin Medical Examining Board renewed that the
conditions which it had
imposed on Petitioner's license to practice medicine and surgery in Wisconsin.
P. Ex. 25.
20. In January, 1992, Petitioner received neuropsychological testing at the
University of Wisconsin
Hospital and Clinics in Madison, Wisconsin. I.G. Ex. 31.
21. Testing established that Petitioner had a continuing impairment on the
nonverbal aspects of the
Wechsler Adult Intelligence Scale, with a Performance IQ in the Borderline Range.
I.G. Ex. 31/2.
22. Petitioner demonstrated impairment of naming and visual attention. I.G. Ex. 31/2.
23. Petitioner demonstrated impairment in performing nonverbal abstraction
tasks which required
flexibility of thinking and ability to shift problem solving set. I.G. Ex. 31/2
- 3.
24. Petitioner demonstrated difficulty on a task requiring him to spontaneously
recall complex verbal
material. I.G. Ex. 31/3.
25. Petitioner continues to manifest mental impairments, consisting in part
of mild bilateral cerebral
impairment. I.G. Ex. 31/3.
26. Petitioner's present mental impairments affect his ability to perform nonverbal
abstraction tasks and to
engage in tasks which require flexibility of thinking. Findings 21 - 25.
27. Petitioner's present cerebral impairments might affect his ability to make
complicated decisions
concerning the management of patients in the context of his present work as
a psychiatrist. Findings 21 -
26; Tr. at 100.
28. Petitioner has suffered from mental illness, diagnosed as bipolar affective
disorder, in addition to his
cerebral impairments. Findings 8, 15; I.G. Ex. I.G. Ex. 20/3; P. Ex. 12/1; Tr.
at 36.
29. Petitioner's mental illness has been successfully treated with medication. P. Ex. 4/2; P. Ex. 7.
30. Recently, Petitioner has appeared at times to be withdrawn and to display
diminished energy, but he
has not displayed clinical signs of active mental illness. Tr. at 96.
31. A significant minority of individuals who suffer from bipolar affective
disorders experience
recurrences of symptoms, despite treatment, which can be disabling for a period
of time. P. Ex. 12/1.
32. There is no guarantee that Petitioner will not, at some future date, experience
a relapse of his bipolar
affective disorder. Findings 28, 31.
33. Petitioner presently practices psychiatry at Mendota Mental Health Institute
under the supervision of
another psychiatrist on the staff of that facility. Tr. at 93 - 94.
34. Petitioner's present duties include evaluating patients for mental competency
and providing treatment
for some of them. Tr. at 40 - 41.
35. Petitioner is seen by his supervisor on a daily basis and also meets with
his supervisor for one hour
each week to discuss his work. Tr. at 94.
36. Petitioner has performed his present duties at Mendota Mental Health Institute
in a satisfactory
manner. Tr. at 94 - 96.
37. Petitioner's current duties can be monitored closely because he works in
a closed environment with a
fixed number of patients, in close contact with his supervisor and with coworkers,
including other health
care professionals. Tr. at 103.
38. Petitioner is capable of competently performing his current duties as a
psychiatrist at Mendota Mental
Health Institute, provided that he continues to work in a closed environment,
in close contact with
coworkers, including other health care professionals, and under the close supervision
of another
psychiatrist. Tr. at 124 - 125.
39. Petitioner is not trustworthy to provide care to patients outside of the
setting of his current employment
at Mendota Mental Health Institute or a setting with an equivalent level of
supervision. Findings 25 - 37.
40. The Secretary of the Department of Health and Human services (Secretary)
delegated to the I.G. the
authority to determine, impose, and direct exclusions pursuant to section 1128
of the Act. 48 Fed. Reg.
21662 (May 13, 1983).
41. The I.G. had authority to impose and direct an exclusion against Petitioner.
Findings 13, 40; Social
Security Act, 1128(b)(4)(A).
42. On April 18, 1991, the I.G. advised Petitioner that he had determined to
exclude Petitioner from
participating in Medicare, and to direct that he be excluded from participating
in Medicaid until Petitioner
obtained a valid license to practice medicine from the State of Iowa. I.G. Ex.
1.
43. On July 8, 1991, the I.G. advised Petitioner that he had determined to
modify Petitioner's exclusion
from participating in Medicare and Medicaid to a term of three years. I.G. Ex.
3.
44. Regulations published on January 29, 1992 establish criteria to be employed
by the I.G. in determining
to impose and direct exclusions pursuant to sections 1128(a) and (b) of the
Act. 42 C.F.R. Part 1001; 57
Fed. Reg. 3298, 3330 - 3341 (January 29, 1992).
45. The regulations published on January 29, 1992 include criteria to be employed
by the I.G. in
determining to impose and direct exclusions pursuant to section 1128(b)(4) of
the Act. 42 C.F.R.
1001.501; 57 Fed. Reg. 3332.
46. The Secretary did not intend that regulations contained in 42 C.F.R. Part
1001 and, in particular, 42
C.F.R. 1001.501, govern my decision in this case.
47. I do not have authority to decide whether any exclusion imposed and directed
by the I.G. must
reasonably accommodate an excluded party's medical impairments. See 29 U.S.C.
794(a).
48. I do not have authority to impose an exclusion which applies to some, but
not to all, services for which
Petitioner potentially could file Medicare or Medicaid reimbursement claims.
Social Security Act,
1862(e)(1). See Findings 38 - 39.
49. The Act's remedial purpose will be accomplished by excluding Petitioner for three years.
ANALYSIS
Petitioner is a psychiatrist. Finding 1. Prior to 1989, he had practiced successfully
in various settings.
Findings 2 - 4. However, in 1989, Petitioner experienced a psychotic episode
while serving as a
psychiatrist on the staff of the Mental Health Center of North Iowa in Mason
City, Iowa. Finding 8.
Petitioner's illness was manifested by a host of bizarre behaviors. Petitioner
experienced hallucinations,
both auditory and visual. I.G. Ex. 20. He fantasized that he was the victim
of a conspiracy involving other
physicians in his community. I.G. Ex. 11. He engaged in assaultive behavior
towards his wife. I.G. Ex.
20. His mental problems affected his practice of psychiatry and prompted complaints
from his coworkers.
I.G. Ex. 9; I.G. Ex. 13. Eventually, Petitioner was hospitalized for his mental
problems. I.G. Ex. 20. He
was treated with medication, his condition improved, and he was discharged.
Id. Petitioner was diagnosed
to be suffering from a bipolar affective disorder, which is amenable to treatment
with medication. Id.
The Iowa Board of Medical Examiners, responding to complaints concerning the
manner in which
Petitioner was practicing psychiatry, investigated the facts of Petitioner's
case and conducted a hearing.
Finding 7. On August 7, 1990, it issued an order based on the evidentiary record
of that hearing,
indefinitely suspending Petitioner's license to practice medicine and surgery
in Iowa. Findings 6, 7. It
concluded that Petitioner was suffering from a mental impairment which affected
Petitioner's practice of
medicine and compromised the care of his patients. Findings 11, 12. It also
expressed concern that
Petitioner's mental problems might recur at some future date. Finding 10.
The Wisconsin Board of Medical Examiners initiated a proceeding concerning
Petitioner's license to
practice medicine and surgery in Wisconsin, based on the action taken by the
Iowa Board of Medical
Examiners. In February, 1991, the Wisconsin Board of Medical Examiners issued
an order which
permitted Petitioner to continue to practice medicine in Wisconsin, but under
strict limitations. Finding 17.
These limitations included requirements that Petitioner remain under the regular
care of his treating
psychiatrist and that his psychiatrist report regularly concerning Petitioner's
mental status and his response
to treatment. Finding 18. The Wisconsin Board of Medical Examiners also required
Petitioner to notify it
of any practice arrangement which he intended to enter. Id. Finally, it required,
as a condition for
Petitioner practicing in Wisconsin, that he be supervised in his practice by
an individual satisfactory to the
Wisconsin Board of Medical Examiners. Id. The Wisconsin license restrictions
were renewed in March
1992. Finding 19.
Beginning in early 1990, Petitioner has practiced at the Mendota Mental Health
Institute in Madison,
Wisconsin. Finding 2. He practices under the close supervision of another psychiatrist.
Finding 33. His
practice consists of evaluating individuals for mental competence and treating
some of these individuals.
Finding 34. His job performance while at Mendota Mental Health Institute has
been satisfactory. Finding
36.
Petitioner is not at this time manifesting clinical signs of a bipolar affective
disorder. Findings 29, 30.
However, neuropsychological testing performed in January, 1992, establishes
that he continues to manifest
some deficits in his thinking. I.G. Ex. 31; Findings 21 - 25. These deficits,
which may be attributable to
some organic cause other than Petitioner's bipolar affective disorder, affect
Petitioner's ability to engage in
nonverbal abstraction and to perform tasks which require flexi-bility of thinking.
Findings 26 - 27. 3/
Petitioner's supervisor has also noted that Petitioner has recently manifested
some decreased energy.
Finding 30.
The parties do not dispute that Petitioner's license to practice medicine and
surgery in Iowa was suspended
for reasons relating to his professional competence and performance. They do
not disagree that the I.G.
had authority to impose and direct an exclusion against Petitioner pursuant
to section 1128(b)(4)(A) of the
Act. 4/ The parties disagree as to whether the three-year exclusion imposed
and directed against Petitioner
by the I.G. is reasonable.
1. Regulations published by the Secretary on January 29, 1992 are not applicable to this case.
A threshold issue in this case is whether regulations published by the Secretary
on January 29, 1992
establish criteria by which I must adjudicate the reasonableness of the exclusion
which the I.G. imposed
and directed against Petitioner. 57 Fed. Reg. 3298, 3330 -41 (to be codified
at 42 C.F.R. Part 1001). The
I.G. asserts that these new regulations, which contain a section establishing
criteria for the I.G. to employ
in determining to impose and direct exclusions pursuant to section 1128(b)(4)
of the Act, also apply at the
level of administrative hearings to establish mandatory criteria for adjudicating
the reasonableness of
exclusions imposed and directed pursuant to section 1128(b)(4). 57 Fed. Reg.
at 3332 (to be codified at 42
C.F.R. 1001.501). The I.G. asserts that the regulations in effect require that
I sustain the exclusion which
he imposed and directed against Petitioner without considering evidence offered
by Petitioner as to the
exclusion's reasonableness. According to the I.G., 42 C.F.R. 1001.501 directs
me to sustain any
exclusion, imposed and directed under section 1128(b)(4) of the Act, which is
coterminous with a State
license suspension or revocation. 5/
I conclude, as I have on several previous occasions, that these regulations
do not establish criteria which
govern administrative law judges' reviews of exclusion determinations. Furthermore,
it is now settled that
the regulations do not apply to I.G. determinations made prior to the regulations'
publication date.
a. Regulations contained in 42 C.F.R. Part 1001 do not establish criteria
for review of exclusion
determinations.
The new regulations' criteria for determining exclusions under section 1128(b)(4)
do not govern my review
of the reasonableness of the exclusion imposed and directed against Petitioner.
The regulations contained
in Part 1001 of the new regulations, and 42 C.F.R. 1001.501 in particular, were
not intended by the
Secretary to establish criteria to govern hearings as to the reasonableness
of exclusion determinations.
Stephen J. Willig, M.D., DAB CR192 (1992) (Willig); Charles J. Barranco, M.D.,
DAB CR187 (1992)
(Barranco). See Sukumar Roy, M.D., DAB CR205 (1992) (Roy); Steven Herlich, DAB
CR197 (1992)
(Herlich); Aloysius Murcko, D.M.D., DAB CR189 (1992) (Murcko).
The cited decisions explain in detail why the new regulations do not establish
criteria to be used by
administrative law judges at hearings. It is not necessary for me to repeat
verbatim the analysis contained
in these decisions. It is sufficient to state that these decisions are grounded
on two conclusions. First, the
new regulations, if applied to establish criteria at the hearing level, would
serve to strip excluded parties of
rights guaranteed by Congress in sections 205(b) and 1128 of the Act. Second,
interpreting the new
regulations as inapplicable at the hearing level is fully consistent with their
plain language and moreover
avoids any possible conflict with congressional intent.
The first ground for concluding that the new regulations are inapplicable at
the hearing level is that their
application would strip excluded parties of rights guaranteed by sections 205(b)
and 1128 of the Act. The
rights which would be extinguished include the right to a de novo review of
an exclusion determination,
measured against the remedial criteria of the Act.
The legitimate remedial purpose for any exclusion imposed pursuant to section
1128 is to protect federally-
funded health care programs and their beneficiaries and recipients from parties
who are not trustworthy to
provide care. Robert Matesic, R. Ph., d/b/a/ Northway Pharmacy, DAB 1327 at
7 - 8 (1992) (Matesic);
Willig at 14 - 15; Hanlester Network, et al., DAB CR181 at 37 - 38 (1992) (Hanlester).
Exclusions which
do not comport with this remedial purpose may be punitive, and, therefore
unlawful. 6/ Section 205(b) of the Act guarantees parties excluded pursuant
to section 1128 and who
request hearings de novo hearings as to the reasonableness of the length of
the exclusions imposed against
them. The standard for evaluating the reasonableness of exclusions at such hearings
is the remedial criteria
implicit in section 1128. Bernardo G. Bilang, M.D., DAB CR141 at 9 (1991), aff'd
DAB 1295 (1992);
Eric Kranz, M.D., DAB CR148 at 7 - 8 (1991), aff'd DAB 1286 (1991); Hanlester
at 39 - 43. Thus, in
hearings as to the reasonableness of exclusions imposed pursuant to section
1128, the Act requires
administrative law judges to entertain any evidence which either party offers
which reasonably relates to
the excluded party's trustworthiness.
The new Part 1001 regulations, including 42 C.F.R. 1001.501, narrowly state
the criteria which the I.G.
may consider in deciding the length of any exclusion he determines to impose.
If these regulations were
held to constitute a standard by which to measure the reasonableness of exclusions,
they would bar
administra-tive law judges from considering evidence which relates to an excluded
party's trustworthiness.
For example, 42 C.F.R. 1001.501(b) all but mandates that exclusions imposed
pursuant to section
1128(b)(4) of the Act be coterminous with State license suspensions or revocations.
The regulation forbids
the I.G. from considering evidence which might establish that a party would
be trustworthy at a time other
than the date when a State licensing authority decides to restore a license
to that party. Application of the
new regulations to establish criteria for review of exclusions would prevent
excluded parties from
contesting the reasonableness of their exclusions, even if the exclusions are
punitive, when measured
against the Act's remedial criteria. They would, if applied as a standard for
review of exclusion
determinations, mandate outcomes which are contrary to congressional intent
and are, therefore, unlawful.
Second, although I have no authority to declare regulations to be ultra vires
the Act, I do have the duty to
interpret regulations in a manner which is consistent with legislative intent,
insofar as I can do so in a way
which does not contravene the Secretary's explicit directives. The new regulations
can be read unambigu-
ously in a way which does not create conflict with congressional intent, but
which provides excluded
parties with the continued right to de novo review of the reasonableness of
their exclusions. Herlich at 14;
Willig at 18 - 24; Barranco at 24 - 27.
The plain language and the context of these regulations demonstrate that they
establish criteria to be used
by the I.G. in making exclusion determinations. The regulations neither state
nor suggest that they
establish standards for review of exclusions' reasonableness by administrative
law judges. 7/ Furthermore,
as I held in Herlich and Willig, if the Part 1001 regulations were held to establish
criteria for review of
exclusions, they would render meaningless the new Part 1005 regulations, which
establish procedures
governing hearings for parties excluded under section 1128. I am not prepared
to find that the rights
established under Part 1005 are hollow.
As I observed in both Herlich and Willig, the Departmental Appeals Board, including
its administrative
law judges, is the Secretary's delegate for purposes of interpreting the Act
and its implementing
regulations. Decisions by the Board's appellate panels and administra-tive law
judges which interpret the
Act and set forth standards for administrative review of exclusion determinations
are therefore the
Secretary's final interpretation of the Act. Herlich at 15; Willig at 20. The
Secretary may publish
regulations which overrule his interpretations of the Act. However, as I held
in Herlich and Willig, that
would require an unambiguous statement of intent, particularly where the interpreta-tions
at issue hold that
Congress conferred specific rights on excluded parties.
Had the Secretary intended that the Part 1001 regulations establish criteria
which extinguished a party's
right to a de novo hearing, or the right to have the exclusion measured against
the Act's remedial criteria,
he would have said so explicitly. He could have published a regulation in either
Part 1001 or Part 1005 of
the new regulations which stated such an intent. By the same token, the Secretary
could have published a
comment to the regulations which plainly established the Part 1001 regulations
as criteria for deciding the
reasonableness of exclusions at the hearing level. It is significant that the
Secretary did none of the
foregoing, especially in light of the plain and unambiguous language of the
new regulations, and the
equally plain and unambiguous decisions by the Board's appellate panels which
establish the standard of
review for deciding whether exclusions are reasonable.
The I.G. makes two arguments concerning applicability of these regulations
which he did not forcefully
advocate in Willig and Herlich. First, he contends that a portion of the commentary
to the new regulations
proves that the Secretary intended that the regulations apply as a standard
for review of exclusion
determinations. Second, the I.G. seems to argue that the interpretation of the
regulations which he
advocates is an act of discretion which is immune from any review by an administrative
law judge. Neither
of these arguments persuades me that there is error in the administrative law
judges' analysis of these
regulations.
The new regulations are preceded by a lengthy commentary. 57 Fed. Reg. at 3298
- 3329. As I observed
in both Willig and Herlich, nowhere does this commentary state that the Part
1001 regulations are intended
to establish criteria which govern hearings as to exclusions' reasonableness.
Furthermore, as the
regulations themselves are plain and unambiguous, the commentary is of only
limited value in interpreting
them. It would not be appropriate to give a regulation a meaning, which would
contravene its plain
meaning, based on a commentary about that regulation.
The commentary relied on by the I.G. is contained in a section of "comments"
and "responses" pertaining
to Part 1001 of the new regulations entitled "Aggravating and Mitigating
Factors." 57 Fed. Reg at 3314.
The "comment" states:
Commenters stated that an ALJ should be free to consider any factors whatsoever
in determining
whether the length of an exclusion should be reduced, and that the mitigating
factors included in the
regulations should be examples rather than an exhaustive list.
Id.
The "response" to this "comment" is:
The legislative history directs the Secretary to consider any mitigating circumstances
in setting the
period of exclusion. The Secretary has the authority to determine what circumstances
are mitigating.
Moreover, these factors only relate to the length of the exclusion. The OIG
considers many factors in
deciding whether to impose an exclusion in the first place.
Id.
The comment and response do not state that the criteria to be employed by administrative
law judges to
decide as to exclusions' reasonableness must consist of the "aggravating"
and "mitigating" factors which
are set forth in the new regulations as criteria for determining the length
of exclusions imposed and
directed by the I.G. The comment and response suggest, first, that administrative
law judges are not "free"
to consider any factors whatsoever in deciding whether to reduce the length
of an exclusion. That
statement is entirely consistent with the authority delegated by the Secretary
to administrative law judges,
pursuant the Act, and pursuant to the Board's appellate panel decisions interpreting
the Act. Neither the
Act nor appellate panels have ever suggested that administrative law judges
are free to invent criteria by
which to adjudicate exclusions. Rather, the Act and the decisions of appellate
panels establish a standard
by which exclusions must be adjudicated. That standard is trustworthiness. Adjudications
which do not
comport with this standard are in error and are subject to reversal. Therefore,
the first conclusion which is
to be drawn from the comment and response is that it repeats the obvious truth
that administrative law
judges are not free to invent their own criteria by which to evaluate exclusions.
8/
Second, the comment and response make it plain that administrative law judges
are not free to identify
"mitigating" factors in addition to those specified by the regulations.
That is not a controversial statement.
Administrative law judges do not have authority to amend or enlarge regulations.
But the issue here is not
whether administrative law judges may amend or enlarge regulations, but whether
the regulations
contained in Part 1001 contain criteria to be employed by administrative law
judges in deciding whether
exclusions are reasonable. The comment and response are silent on this issue.
The I.G. contends that administrative law judges are obligated to follow the
Secretary's determinations as
to the meaning of the Act, citing Association of Administrative Law Judges v.
Heckler, 594 F. Supp. 1132
(D.D.C. 1984). That is certainly true. My decision that the new Part 1001 regulations
do not establish
criteria to be employed by administrative law judges in deciding whether exclusions
are reasonable does
not constitute a departure from the Secretary's past decisions as to what are
appropriate criteria for
administrative law judges to employ. It is entirely consistent with those decisions.
Thus, the comment and response on which the I.G. relies must be read against
the regulations themselves,
which are not ambiguous, and which do not suggest the interpretation advocated
by the I.G. It also must be
read in light of the Secretary's interpretations of the Act, and his previous
instructions to administrative law
judges, which have not been overruled either expressly or impliedly by the new
regulations. This comment
and response must also be read in the context of other commentary to the new
regulations which makes it
plain that the new Part 1001 regulations are intended to establish criteria
whereby the I.G. would make
exclusion determinations. 57 Fed. Reg. at 3299. Finally, the language of the
comment and response do not
support the I.G.'s sweeping assertions as to the meaning of the new regulations.
The I.G. also appears to assert that his interpretation of the Part 1001 regulations
is an "exercise of
discretion" which is in and of itself not reviewable by an administrative
law judge. See I.G.'s Post-Hearing
Brief at 6. 9/ The I.G. relies on 57 Fed. Reg. at 3351 (to be codified at 42
C.F.R. 1005.4(c)(5)), as
support for this apparent contention.
The regulation in question provides that administrative law judges do not have authority to:
Review the exercise of discretion by the . . . [I.G.] to exclude an individual
or entity under section
1128(b) of the Act or determine the scope or effect of the exclusion.
The I.G. seems to contend that his interpretation and application of the new
Part 1001 regulations in an
exclusion case constitutes an "exercise of discretion" which is not
reviewable by an administrative law
judge.
Of course, if the phrase "exercise of discretion" were read as broadly
as is advocated by the I.G., then any
exercise of judgment by the I.G. or his agents would be immune from review by
an administrative law
judge. That interpretation would render utterly meaningless the hearing rights
conferred by Part 1005 of
the new regulations. It would also render meaningless the Part 1001 regulations
-- even under the I.G.'s
expansive interpretation of those regulations -- because every exclusion determination
by the I.G. could be
characterized as an immune "exercise of discretion." Thus, under the
I.G.'s apparent interpretation, I would
not have the authority in an exclusion case even to decide whether an exclusion
comported with the criteria
for I.G. exclusion determinations expressed in Part 1001 of the new regulations.
The regulation would have troublesome implications if my authority in an exclusion
hearing were limited
to appellate review of the I.G.'s determinations. If my authority consisted
of appellate -- rather than de
novo -- review authority, then, arguably, the new regulation could immunize
from review virtually all of
the I.G.'s actions taken in connection with exclusion determina-tions. However,
my authority is not
appellate. Section 205(b) of the Act plainly requires that I conduct a de novo
review of exclusions in cases
where exclusions are challenged. The hearings which I conduct under sections
205(b) and 1128 are not
reviews of the I.G.'s "exercise of discretion" or of his judgment
in deciding to impose exclusions. Rather,
they are de novo evaluations of exclusions in light of the Act's requirements.
In conducting such
evaluations, I necessarily must exercise the delegated authority to interpret
and apply the Act and
regulations. Such interpretations and applications are in no sense a review
of the I.G's determinations, but
are independent decisions as to the Act's and regulations' meaning. Therefore,
42 C.F.R. 1005.4(c)(5)
does not reserve to the I.G. nonreviewable authority to interpret and apply
the Act and regulations.
The I.G.'s arguments as to the meaning and applicability of the new regulations
to the hearing process
betray a fundamental misconception of the purpose of the hearing and the role
of administrative law
judges in hearing and deciding exclusion cases under section 1128(a) or (b)
of the Act. Under the I.G.'s
analysis, administrative law judges are appellate reviewers whose function is
limited to certifying whether
or not the I.G.'s exclusion determinations comply with the I.G.'s internal policies
or the regulatory criteria
which govern the I.G.'s exclusion determinations. Under the I.G.'s analysis,
I should affirm any exclusion
which was made in compliance with such policies or the regulatory criteria.
And, under that analysis, I
should reject any evidence which was not considered by the I.G. For that reason,
the I.G. persists in calling
as witnesses his special agents, for the purpose of certifying that exclusion
determinations were made in
compliance with policies and regulations.
I have repeatedly and forcefully ruled that this analysis is incorrect. The
purpose of the hearing in an
exclusion case is not appellate, it is de novo. Section 205(b) of the Act, as
consistently interpreted and
applied by the Board's appellate panels, requires me to provide excluded parties
with nothing less than a de
novo hearing, governed on the issue of reasonableness by statutory criteria
which mandate that I
independently decide excluded parties' trustworthiness to provide care. The
Act does not direct me to limit
the evidence received at hearings to that which was considered by the I.G. and
his agents in determining to
impose exclusions. There is nothing in the new regulations which can be read
rationally as a directive by
the Secretary to transform
statutorily-mandated de novo hearing process into an appellate review.
b. The Part 1001 regulations do not apply retroactively to pending cases.
In Roy, Herlich, Willig, Barranco, and Murcko, DAB administrative law judges
found that it was not the
Secretary's intent to retroactively apply the new regulations to unlawfully
strip parties of previously vested
rights. We concluded that to apply the Part 1001 regulations as is advocated
by the I.G. would strip
excluded parties of previously vested rights contrary to the Act's letter and
intent. Therefore, we found
that, assuming the Part 1001 regulations did establish criteria for review of
I.G. exclusion determinations,
they did not apply to those determinations that were made prior to January 29,
1992. An appellate panel of
the Departmental Appeals Board recently reached the same conclusion in Behrooz
Bassim, M.D., DAB
1333 at 5 - 9 (1992). Thus, even if my conclusion that the Part 1001 regulations
do not establish criteria
for review of exclusions by administrative law judges is incorrect, those regulations
would not govern
cases in which exclusion determinations were made prior to January 29, 1992.
10/ The exclusion
determination in this case was made on April 18, 1991. Therefore, the Part 1001
regulations cannot be
applied retroactively to establish a standard for adjudicating the reasonableness
of the exclusion in this
case.
2. A three-year exclusion of Petitioner is reasonable.
The exclusion which the I.G. originally imposed against Petitioner would have
excluded him
coterminously with his Iowa license suspension. In July, 1991, the I.G. modified
that exclusion to a term
of three years. Therefore, what is now at issue is whether the three-year exclusion
imposed against
Petitioner by the I.G. is reasonable.
I conclude that a three-year exclusion is reasonable here. The evidence in
this case establishes that
Petitioner is suffering from medical conditions which affect his trustworthiness
to provide care. Findings
25 - 37, 39. Although Petitioner is not culpable for his medical problems, they
nonetheless render him less
than fully trustworthy to provide care. An exclusion is therefore necessary
to protect federally-funded
programs and their beneficiaries and recipients.
There is no evidence that Petitioner is presently manifesting clinical signs
of the bipolar affective disorder
which incapacitated him in 1989. Finding 30. That condition appears to have
been successfully treated
with medication. Finding 29. But the credible expert evidence of record in this
case is that in some
instances, the manifestations of bipolar affective disorder may recur, even
where a person has received
appropriate treatment with medication. Finding 31. Recurrences happen in thirty
percent or more of those
individuals who have a bipolar affective disorder. P. Ex. 12. There is no guarantee
that Petitioner's
disorder will not recur, notwithstanding the fact that he is presently not manifesting
clinical signs of the
condition. Finding 32. An exclusion can be justified in this case based on the
significant possibility that
Petitioner's bipolar affective disorder may recur, because, if that happened,
Petitioner's judgment could be
affected in a way which might endanger his patients.
However, there is a more compelling reason to exclude Petitioner. The medical
evidence of record in this
case establishes that Petitioner presently is suffering from diminished mental
functioning which affects his
ability to engage in tasks which require flexibility of thinking. Findings 20
- 27. His impairment may
affect his ability to make complex analyses and judgments relevant to his duties
as a psychiatrist. None of
the evidence, including the testimony of Petitioner's supervisor, who is a psychiatrist,
proves that Petitioner
is currently capable of performing the duties of a psychiatrist without restriction.
To the contrary, the
evidence shows that Petitioner is only trustworthy to perform such duties in
a highly controlled setting
under close supervision. Findings 37 - 39.
Petitioner bears no fault for his medical condition, and he appears to be functioning
reasonably well within
the constraints of his present work arrangement. However, the fact that Petitioner
may be functioning
successfully under close supervision does not support an argument that he should
not be excluded. To the
contrary, the need for close supervision of Petitioner is strong evidence that
he potentially could engage in
conduct that is harmful to beneficiaries and recipients of program funds. Petitioner's
impairments and his
need for close supervision are evidence of Petitioner's lack of trustworthiness
and are grounds to justify the
exclusion which was imposed in this case.
I cannot conclude that Petitioner is trustworthy to treat all program beneficiaries
and recipients. The three-
year exclusion which the I.G. imposed against Petitioner is necessary, if only
to protect program
beneficiaries and recipients from the dangers posed by Petitioner were he to
attempt to provide care outside
of his presently closely supervised and constricted working environment.
Petitioner argues that the current restrictions on his license to practice
medicine and surgery in Wisconsin
assure that he could not attempt to practice outside of his currently restricted
work environment. This is so,
according to Petitioner, because the restrictions require him to obtain permission
from the Wisconsin Board
of Medical Examiners prior to changing his practice arrangements. I agree with
Petitioner that this
restriction does serve as a restraint on any attempts by him to change his practice
arrangements. However,
there is no guarantee that Petitioner would not violate the terms of his license
restriction. The three-year
exclusion in this case is necessary to preclude the possibility that, during
that time, Petitioner might attempt
to seek reimbursement from Medicare or Medicaid for items or services furnished
to patients outside of his
current practice arrangement, in violation of the restrictions imposed by the
State of Wisconsin. Even
though such risk may be very slight, imposing an exclusion to protect program
beneficiaries and recipients
is a legitimate remedial purpose.
Petitioner asserts that whatever his trustworthiness may be to provide care
outside of his present work
environment, he is trustworthy within that environment. He argues from this
that the exclusion should at
least be modified to accommodate his present work arrangement. He also argues
that he is an "individual
with handicaps" within the meaning of the Rehabilitation Act of 1973, as
amended, 29 U.S.C. 794(a), and
its implementing regulations. He asserts that the Department is obligated to
modify his exclusion to
comply with the Rehabilitation Act's requirement that employers provide reasonable
accommodation to
individuals with handicaps.
I am without authority to order that the exclusion be modified to permit Petitioner
to claim reimbursement
for items or services which he provides to program beneficiaries and recipients
in his present work
arrangement. Sections 1128 and 1862(e)(1) of the Act require that an exclusion
apply equally to all
federally-funded health care programs. An exclusion cannot lawfully be tailored
to permit an excluded
party to claim reimbursement for particularized items or services. Walter J.
Mikolinski, Jr., DAB 1156
(1990). Thus, I cannot order that his exclusion be modified to allow him to
claim reimbursement for
program-related items or services which he may provide while employed at Mendota
Mental Health
Institute.
I am without authority to order that Petitioner's exclusion be modified to
accommodate his medical
condition, assuming that it is a handicapping condition under the Rehabilitation
Act of 1973. 11/ There is
nothing in the language or history of section 1128 which states or suggests
that Congress intended that
exclusions be modified to accommodate handicapping conditions. In the context
of section 1128 exclusion
hearings, I have not been delegated authority by the Secretary to consider issues
which might properly be
raised under the Rehabilitation Act of 1973.
I must uphold an exclusion determination which I determine to be reasonable
in light of the evidence in
that case. An exclusion is "reasonable" if it is not extreme or excessive.
48 Fed. Reg. 3744 (1983). The
evidence in this case convinces me that the exclusion is reasonable because
Petitioner will not be
trustworthy to provide care to program beneficiaries and recipients for at least
three years. The evidence
establishes that there is a significant risk that Petitioner's bipolar affective
disorder may recur, even if
Petitioner complies with his medication regimen and remains under a psychiatrist's
care. Finding 31.
Moreover, neuropsychological testing of Petitioner, as recently as January 1992,
established that Petitioner
continues to manifest mental impairments which might affect his ability to practice
psychiatry. Findings
20, 21, 27. There is no evidence of record to suggest that either Petitioner's
bipolar affective disorder or his
cerebral impairments are likely to resolve within the near future. The I.G.
determined to exclude Petitioner
for three years, a period which is not extreme or excessive on the facts of
this case. Therefore, I conclude
that the three-year exclusion imposed and directed by the I.G. is reasonable,
and, accordingly, I uphold it.
CONCLUSION
For the foregoing reasons, I conclude that the three-year exclusion imposed
and directed against Petitioner
by the I.G. is reasonable. I therefore uphold the I.G.'s determination to impose
and direct a three-year
exclusion against Petitioner.
_________________________
Steven T. Kessel
Administrative Law Judge
1. "State health care program" is defined by section 1128(h) of the
Act to include any State Plan
approved under Title XIX of the Act (such as Medicaid). I use the term "Medicaid"
hereafter to represent
all State health care programs from which Petitioner was excluded.
2. I refer to the Inspector General's exhibits as "I.G. Ex. (number)/(page)."
I refer to Petitioner's exhibits
as "P. Ex. (number)/(page)." I refer to the Transcript as "Tr.
at (page)."
3. Petitioner testified that his performance on his most recent tests was adversely
affected by cultural
factors. Petitioner is a native of India, and he asserts that some of the tasks
he was asked to perform during
his testing involved concepts that he is not familiar with. Tr. at 56 - 57;
79 - 80. I conclude that
Petitioner's explanation for his performance on these tests does not credibly
account for the deficiencies
which he manifested. The tests were performed by a professor of neurology at
the University of Wisconsin
Hospital and Clinics. I.G. Ex. 31. The test report notes Petitioner's cultural
background and the fact that
English is Petitioner's second language. However, the report finds that Petitioner
manifests cerebral
impairments notwithstanding his background. I conclude that the tests performed
in January 1992
represent an accurate measure of Petitioner's performance at that time.
4. Section 1128(b)(4)(A) provides that the Secretary (or his delegate, the I.G.) may exclude a party:
whose license to provide health care has been revoked or suspended by any
State licensing authority, or
who otherwise lost such a license or the right to apply for or renew such a
license, for reasons bearing on . .
. [that party's] professional competence, professional performance, or financial
integrity . . . .
5. I note that, although the exclusion originally imposed and directed by the
I.G. is coterminous with the
license suspension ordered by the Iowa Board of Medical Examiners, that exclusion
was modified by the
I.G. to a term of three years. The I.G. has not explained how I am to evaluate
the reasonableness of this
modified exclusion under the new regulations, assuming that the new regulations
establish criteria which
govern reviews of exclusions by administrative law judges.
6. Civil remedy statutes cannot be applied constitutionally to produce punitive
results in the absence of
traditional constitutional guarantees such as the right to counsel, the right
to a trial by jury, or the right
against self-incrimination. Kennedy v. Mendoza-Martinez, 372 U.S. 144, 168 -
69 (1963).
7. The I.G. has contended in numerous cases, in addition to Roy, Herlich, Willig,
Barranco, and Murcko,
that the Part 1001 regulations establish criteria for review of exclusions by
administrative law judges. I
have routinely invited the I.G. and excluded parties to brief the issue of applicability.
The I.G. has filed
many briefs on this issue. The I.G. has never identified language in the regulations
which would even
arguably establish the Part 1001 regulations as criteria for review of the reasonableness
of exclusions.
8. The I.G. has the delegated authority to determine and impose exclusions.
DAB administrative law
judges and the Chair and members of the DAB have the delegated authority to
hear and decide cases in
which the reasonableness of exclusions is challenged. At the level of the administrative
hearing, the
administrative law judge is "the Secretary." An essential element
of the authority which has been delegated
to DAB administrative law judges and to the Chair and members of the DAB is
the authority to make
interpretations of the Act and regulations which are binding on all components
of the Department,
including the I.G. While administrative law judges may not be "free"
to invent criteria by which to
evaluate exclusions, they have the duty to interpret the Act and regulations
so as to identify the criteria
which must be applied to such evaluations.
9. This is not explicitly stated in the I.G.'s Post-Hearing Brief. I infer
that is the I.G.'s argument, given
the context of the I.G.'s citation to 42 C.F.R. 1005.4(c)(5).
10. In a recent hearing, counsel for the I.G. attempted to distinguish Bassim
as applying only to cases
where the hearing occurred prior to January 29, 1992. Under that analysis, the
new regulations would
apply to cases where the determination predated January 29, 1992, but where
the hearing took place after
January 29, 1992. I see no merit in this argument. Whatever substantive rights
inure to an excluded party
spring from the I.G.'s determination to exclude that party and not from the
hearing.
11. I make no findings as to whether or not Petitioner is an "individual
with handicaps" within the
meaning of the Rehabilitation Act of 1973.