Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division
In the Case of:
Robert Matesic, R.Ph., d/b/a Northway Pharmacy,
Petitioner,
- v. -
The Inspector General.
DATE: April 22, 1992
Docket No. C-270
Decision No. 1327
FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION
Petitioner, Robert Matesic, R.Ph., d/b/a Northway Pharmacy,
requested
review of an October 18, 1991 decision by Administrative Law Judge
(ALJ)
Charles E. Stratton. See Robert Matesic, R.Ph., d/b/a
Northway
Pharmacy, DAB CR158 (1991) (hereinafter ALJ Decision). In
that
decision, the ALJ affirmed the authority of the Inspector General
(I.G.)
to exclude Petitioner from participation in the Medicare program and
to
direct his exclusion from participation in state health care programs
1/
pursuant to section 1128(b)(3) of the Social Security Act
(Act).
However, the ALJ found that the five-year exclusion proposed by the
I.G.
was not reasonably necessary to satisfy the remedial purpose of
section
1128 and modified the exclusion to a term of three years.
On appeal to this Board, Petitioner argued that a three-year exclusion
was
excessive and that a one-year exclusion was reasonable under
the
circumstances. 2/ The I.G. did not contest the reduction of
the
exclusion to three years but argued that the Board should uphold the
ALJ
Decision.
Based on the following analysis, we uphold the ALJ Decision.
BACKGROUND
The I.G. notified Petitioner by letter dated May 21, 1990, that both
he
and Northway Pharmacy would be excluded from participation in
the
Medicare and Medicaid programs for a period of five years. The
I.G.
further advised Petitioner that his exclusion was due to his
conviction
in the Allegheny County Court of Common Pleas, Pittsburgh,
Pennsylvania,
of a criminal offense related to the unlawful manufacture,
distribution,
prescription, or dispensing of a controlled substance.
The I.G. based
the exclusion on section 1128(b)(3) of the Act, codified at 42
U.S.C.
.1320a-7 (1988). Section 1128(b)(3) authorizes the I.G. to
exclude from
participation in the Medicare and Medicaid programs individuals
who have
been convicted of criminal offenses "relating to the
unlawful
manufacture, distribution, prescription, or dispensing of a
controlled
substance."
Petitioner timely requested a hearing before an ALJ. The ALJ issued
a
decision reducing Petitioner's exclusion to three years.
Petitioner
appeals from that decision.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
The ALJ Decision was based on the following findings of fact
and
conclusions of law (FFCLs):
1. Petitioner, at all times relevant to this case, is a
pharmacist
licensed to practice pharmacy in Pennsylvania.
2. Beginning in 1969, Petitioner was the sole owner of and
sole
pharmacist at Northway Pharmacy, located in Etna, Pennsylvania.
3. During a routine inspection at Northway Pharmacy on December
11,
1985, an agent of the State Bureau of Narcotics Investigation
(BNI)
found numerous violations, which included Petitioner acquiring
Schedule
II drugs with an expired Drug Enforcement Administration (DEA)
number
and failing to submit monthly Bureau of Drug Control Form #6
(BDC-6
forms).
4. A BDC-6 form is a monthly report that is required to be filed
by
every pharmacist, listing all prescriptions filled for Schedule
II
controlled substances. This form is filed with the Attorney
General's
Office.
5. The BDC-6 form provides BNI with the following
information:
identifies the Schedule II drugs being prescribed; identifies
the
doctors prescribing Schedule II drugs; and identifies the patients
who
are being prescribed Schedule II drugs.
6. A criminal complaint was filed on July 14, 1987, after
subsequent
investigations at Petitioner's Pharmacy were conducted, revealing
that
Petitioner had failed to maintain a current DEA number and had failed
to
file BDC-6 forms during various periods of time.
7. At a preliminary hearing held on July 23, 1987, Petitioner's
counsel
attempted to offer the six BDC-6 forms to the assistant
district
attorney and a DEA agent, both of whom refused to accept delivery
or
take possession of the forms.
8. On September 11, 1987, a seven-count information was filed
against
Petitioner in the Court of Common Pleas, Allegheny County,
Pennsylvania.
9. Petitioner was charged in the information with one felony count
of
knowingly and intentionally acquiring Schedule II drugs
by
misrepresentation by using an expired DEA number, in violation of
35
P.S. section 780-113(a)(12).
10. Petitioner was also charged in the information with six
misdemeanor
counts of knowingly or intentionally refusing or failing to
provide BNI
with BDC-6 forms for the months of December 1986 through May
1987, in
violation of 35 P.S. section 780-113(a)(21).
11. On January 19, 1989, after a jury trial, Petitioner was
convicted
of six counts of failing to file BDC-6 forms for the months of
December
1986 through May 1987. Petitioner was acquitted of the felony
charge.
12. Petitioner was sentenced to one to six months' incarceration
on
count 2; sentenced to 30 months' probation on counts 3 through 7;
fined
$5,000; and ordered to pay court costs. Probation was conditioned
on
Petitioner filing the required BDC-6 forms.
13. The trial judge sentenced Petitioner to jail because she
concluded
that incarceration was necessary since Petitioner was unwilling
to
conform to one of the main conditions of probation: that is,
that
Petitioner file the required forms.
14. Petitioner filed the BDC-6 forms on March 12, 1990 and has been
in
compliance with the filing requirements since that date.
15. By Consent Agreement dated September 17, 1990, the
Pennsylvania
State Board of Pharmacy suspended Petitioner's license to
practice
pharmacy and suspended his permit to operate a pharmacy for two
years
because he had no valid DEA registration in effect during the
following
time periods: November 1, 1972 to January 1, 1973; November 1, 1976
to
November 9, 1977; November 1, 1978 to October 16, 1979; and November
1,
1984 to August 18, 1986.
16. The State Board of Pharmacy found that Petitioner's failure to
file
the six BDC-6 forms was a record keeping violation.
17. The State Board of Pharmacy stayed Petitioner's suspension in
favor
of two years' probation, subject to certain conditions of
probation:
(1) Petitioner was to adhere to the State's laws governing the
practice
of pharmacy or the distribution of drugs; (2) Petitioner was to obey
the
rules and regulations of the State Board of Pharmacy; and (3)
Petitioner
and the Pharmacy were to each pay a $500 civil penalty fee.
18. Petitioner's failure to file the BDC-6 forms was motivated by
his
concern for the confidentiality of his patients' privacy and his
belief
that the Attorney General's office lacked authority to receive the
BDC-6
forms.
19. Petitioner did not profit from the conduct which resulted in
his
1989 conviction, nor did his conduct cause direct injury to
another
person.
20. Petitioner was convicted of a criminal offense relating to
the
unlawful manufacture, distribution, prescription, or dispensing of
a
controlled substance, within the meaning of sections 1128(i)
and
1128(b)(3) of the Act. Act, section 1128(i) and 1128(b)(3).
21. Petitioner admits and I conclude that: (1) he was
"convicted,"
within the meaning of section 1128(i) of the Act; and (2) the
criminal
offense was "related to the unlawful manufacture,
distribution,
prescription, or dispensing of a controlled substance," within
the
meaning of section 1128(b)(3) of the Act.
22. The Secretary 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).
23. On May 21, 1990, the I.G. excluded Petitioner from participating
in
Medicare and directed that he be excluded from participating
in
Medicaid, pursuant to section 1128(b)(3) of the Act.
24. The exclusion imposed and directed against Petitioner is for
five
years.
25. The exclusion provisions of section 1128 of the Act
establish
neither minimum nor maximum exclusion terms in those circumstances
where
the I.G. has discretion to impose and direct exclusions. Act,
section
1128(b)(1)-(14).
26. A remedial objective of section 1128 of the Act is to
protect
program beneficiaries and recipients by permitting the Secretary (or
his
delegate, the I.G.) to impose and direct exclusions from
participation
in Medicare and Medicaid of those individuals who demonstrate
by their
conduct that they cannot be trusted to provide items or services
to
program beneficiaries and recipients. Act, section 1128.
27. The I.G. has not shown that a five-year exclusion of
Petitioner
from participating in Medicare and Medicaid is reasonably
necessary to
satisfy the remedial purpose of section 1128 of the Act.
See FFCL 1-19.
28. The remedial purpose of section 1128 of the Act will be
satisfied
in this case by modifying the exclusion imposed and directed
against
Petitioner to a term of three years.
29. Petitioner was convicted of a serious criminal offense. FFCL
8-13;
see 42 C.F.R. 1001.125(b)(1).
30. Petitioner's unlawful conduct did not have a direct adverse
impact
on his patients or on program beneficiaries or recipients. FFCL
18-19;
see 42 C.F.R. 1001.125(b)(2).
31. Petitioner's unlawful conduct was not intended to cause harm
to
patients or to the integrity of the Medicare and Medicaid
programs.
FFCL 18-19; see 42 C.F.R. 1001.125(b)(4).
32. The remedial considerations of section 1128 of the Act will
be
served in this case by a three-year exclusion.
ALJ Decision at 4-8 (citations to the record omitted).
PETITIONER'S EXCEPTIONS
Petitioner raised three exceptions:
1. The ALJ erred in applying the facts to the law in modifying
the
exclusion period to three years rather than one year.
2. The ALJ erred as a matter of law by admitting immaterial
and
irrelevant evidence which prejudiced Petitioner by adversely
impacting
his credibility and trustworthiness.
3. The ALJ abused his discretion by admitting immaterial and
irrelevant
evidence which prejudiced Petitioner by adversely impacting
his
credibility and trustworthiness.
Petitioner specifically objected to the following FFCLs as immaterial
and
irrelevant: 3, 6, 15, 17. Since Petitioner challenged the
ALJ's
ultimate conclusion about the reasonable length of the suspension,
we
infer that he has also objected to FFCLs 28 and 32 in which the
ALJ
found a three-year exclusion to be reasonable.
Neither the I.G. nor Petitioner objected to any other FFCLs.
We
therefore affirm and adopt the unchallenged FFCLs without
any
discussion.
DISCUSSION
We find no basis for disturbing the ALJ's judgment that a
three-year
exclusion period was reasonable and affirm and adopt FFCLs 3, 6,
15, 17,
28, and 32.
The ALJ made a de novo determination regarding the appropriate period
of
exclusion based on a hearing. During the hearing, he had
the
opportunity to observe the demeanor of Petitioner and other
witnesses
and to evaluate their credibility. In contrast, our role as
the forum
for the administrative appeal of the ALJ Decision is a limited
one. See
Joyce Faye Hughey, DAB 1221 (1990), and Carlos E. Zamora,
M.D., DAB 1104
(1989). As we noted in those decisions, our standard for
review of
disputed issues of fact is "whether the ALJ's decision is supported
by
substantial evidence" and on disputed legal issues is whether "the
ALJ's
decision was erroneous." 3/ Lakshmi N. Murty Achalla, M.D., DAB
1231 at
7 (1991). Thus, the Appellate Panel will affirm the ALJ
Decision unless
we conclude that it was erroneous or unsupported by
substantial
evidence. As explained below, we conclude that we must
uphold the ALJ's
Decision.
1. The ALJ did not err by modifying the exclusion period
to
three years rather than one year.
In support of his argument that a three-year exclusion was
unreasonable
under section 1128(b)(3), Petitioner made the following
points:
o Petitioner cited the ALJ's finding that, in order to
be
adjudged reasonable, an exclusion must satisfy the
remedial
objective of section 1128 of protecting programs
and
beneficiaries from untrustworthy providers.
o Petitioner cited the ALJ's statement that Congress
enacted
section 1128 of the Act to protect the Medicare and
Medicaid
programs from fraud and abuse and to protect the
beneficiaries
and recipients of those programs from impaired and
incompetent
practitioners and inappropriate or inadequate care.
S. Rep. No.
109, 100th Cong., 1st Sess. 27, reprinted in U.S. Code
Cong. &
Admin. News 682, 708; Greene v. Sullivan, 731 F. Supp. 835,
838
(E.D. Tenn. 1990).
o Petitioner noted that the ALJ had found that he was
well
motivated, that he did not profit from failing to file
the
forms, that his failure had no direct adverse impact
on
recipients, that his failure was not intended to cause harm
to
patients or programs, that he was not a high risk to
offend
again, and that his purpose was not to break the law but
to
protect the privacy rights of his patients and
community
physicians.
Petitioner then concluded that since the I.G. had not shown
Petitioner
committed any form of fraud or abuse, had not shown that he was
impaired
or incompetent, and had not shown that he had rendered inappropriate
or
inadequate care, the ALJ erred in excluding him for three years.
We disagree with Petitioner's conclusion that the ALJ erred in imposing
a
three-year exclusion. As the ALJ noted, a fundamental purpose
of
section 1128 is "protection," the prevention of harm. See Webster's
II
New Riverside University Dictionary 946 (1984). As a means
of
protecting the Medicare and Medicaid programs and their
beneficiaries
and recipients, Congress chose to mandate, and in other
instances to
permit, the exclusion of individuals or entities who could be
considered
harmful or untrustworthy. 4/ In section 1128(b), Congress
set forth
three types of convictions pursuant to which an individual may be
found
to pose a threat to the programs or beneficiaries: conviction of
an
offense related to fraud in connection with delivery of a health
care
item or service (section 1128(b)(1)); conviction of an offense
relating
to obstruction of an investigation (section 1128(b)(2)); and
conviction
of an offense relating to controlled substances (section
1128(b)(3)).
Under section 1128(b), it is not necessary for the I.G. to establish
a
direct link between a conviction and an abuse of a federal program
or
beneficiary. Rather, the statute considers such providers to pose
a
threat by virtue of the fact that they have been convicted of one of
the
enumerated types of crimes. Petitioner admitted and the ALJ
concluded
that his conviction fell within sections 1128(b)(3) of the
Act. The
I.G. therefore had the discretion to exclude him as long as
the
exclusion and duration of the exclusion satisfy the remedial
objective
of section 1128 of protecting programs and beneficiaries
from
untrustworthy providers. In reviewing the I.G.'s exclusion, the
ALJ
must therefore weigh the seriousness of the offense and factors
which
demonstrate the provider's trustworthiness, i.e. the likelihood that
the
offense or some similar abuse will occur again.
In light of the offense for which Petitioner was convicted and
the
circumstances surrounding his conviction, we cannot say that the
ALJ
erred in finding that a three-year exclusion was reasonable.
o Petitioner was convicted of six misdemeanor counts of
failing
to file BDC-6 forms. FFCL 11. A BDC-6 form
identifies the
Schedule II drugs being prescribed; identifies the
doctors
prescribing Schedule II drugs; and identifies the patients
who
are being prescribed Schedule II drugs. FFCL 5.
o While Petitioner was charged with and convicted of failure
to
file six months of BDC-6 forms, the ALJ found that his
failure
encompassed a greater time period. FFCLs 3, 6. In
fact,
Petitioner did not controvert the Bureau of
Narcotics
Investigation (BNI) agent's testimony that the requirement
was
established in 1972 (Transcript of February 15, 1991
hearing
(Tr.) at 23) and that, to the best of his
information,
Petitioner had never filed a BDC-6 prior to the time
criminal
charges were brought to force his compliance. Tr.
21-22.
o Obtaining Petitioner's compliance with the requirements
of
the law proved to be a laborious process spanning almost
five
years and involving repeated visits to his pharmacy by
BNI
agents, correspondence, telephone calls, a criminal
prosecution,
and a sentence of incarceration. FFCLs 3, 11, 13;
see ALJ
Decision citing I.G. Exs. 2, 6-13, 16.
o Petitioner argued that the reason he did not file the
BDC-6
forms was that the BNI agents did not supply him with the
source
of their authority to require him to file such forms with
the
Attorney General. 5/ Tr. 131-137. However, BNI's
apparent
failure does not excuse Petitioner's behavior and does
not
answer several questions surrounding his conduct. For
example,
from 1972, when BDC-6 forms were required, until 1985, when
he
was cited, Petitioner had apparently ignored the law and
not
filed BDC-6 forms with any agent of the State. Tr.
21-23.
Further, even after the correct regulation had been produced
for
him in the course of his criminal trial, even after he
was
convicted in January 1989, and even after he was sentenced
to
jail in September 1989, Petitioner did not file his BDC-6
forms
until March 1990. FFCL 11-14. Finally, Petitioner
testified
that he did not try to ascertain from any other source, such
as
the Pennsylvania Pharmacy Board or a pharmacy school,
whether
BDC-6 forms were required. Tr. 172-173. This course
of conduct
is not consistent with the actions of a person who
is
conscientiously interested in following the law. Rather,
it
supports the ALJ's determination that Petitioner needs
a
significant period of time in which to demonstrate that he
can
be trusted to follow all requirements of dealing with
Schedule
II drugs rather than just those requirements he
finds
appropriate. See ALJ Decision at 16.
o Failure to file BDC-6 forms was not the only
regulatory
standard concerning Schedule II drugs with which
Petitioner
failed to comply. As he stipulated in his Consent
Agreement
with the Pennsylvania State Board of Pharmacy, Petitioner
also
failed to maintain a current DEA number for four
different
periods totalling almost four years. FFCL 15.
o Petitioner argued that BDC-6 forms and current
DEA
registration numbers were record keeping violations which
did
not go to his trustworthiness or threaten the federal
programs.
Tr. 9, 198. However, as the BNI agent testified, BDC-6
forms
are used to identify potential abuses of Schedule II drugs
by
pharmacists, doctors, and patients. Tr. 23-24. They are
not a
meaningless paper exercise. FFCL 29.
o The significant nature of the violations is reflected by
the
fact that the Pennsylvania Board of Pharmacy
suspended
Petitioner's license to practice pharmacy and suspended
his
permit to operate a pharmacy for two years. FFCL 15.
The
suspension was based on his admission that he had operated
his
pharmacy without valid DEA registration off and on for
many
years and had failed to file BDC forms for six months. I.G.
Ex.
17.
o The Board of Pharmacy's two-year suspension was
stayed
pursuant to Petitioner's agreement to observe conditions of
a
two-year probation including adherence to State laws
governing
the practice of pharmacy or the distribution of drugs.
FFCL 17.
Therefore, the Board determined, and Petitioner agreed, that
a
two year period of probation was an appropriate length of
time
for Board oversight of Petitioner's adherence to
the
requirements of the law. Petitioner's contention here, that
a
one year federal exclusion is sufficient, is not consistent
with
the Board of Pharmacy's determination that two years
was
necessary.
Based on the foregoing factors, we conclude that substantial evidence
in
the record supports the ALJ, who observed Petitioner's demeanor
and
attitude towards continuing compliance with his "record
keeping"
responsibilities. Therefore, we conclude that the ALJ did not
err in
finding that a three-year exclusion was an appropriate length of time
in
which to determine and assure Petitioner's trustworthiness in
such
matters.
2. The ALJ did not err as a matter of law or abuse
his
discretion by admitting evidence which adversely
affected
Petitioner's credibility and trustworthiness.
Petitioner argued that the ALJ erred as a matter of law or abused
his
discretion by admitting immaterial and irrelevant evidence
which
prejudiced Petitioner by adversely impacting his credibility
and
trustworthiness. 6/ Specifically, Petitioner objected to the
admission
of the following evidence:
o Agent Eugene Beard's Initial Report (I.G. Exhibit 6)
pursuant
to which the ALJ concluded that during a routine inspection
at
Northway Pharmacy on December 11, 1985, an agent of the
State
Bureau of Narcotics Investigation (BNI) found
numerous
violations, which included Petitioner acquiring Schedule
II
drugs with an expired Drug Enforcement Administration
(DEA)
number.
o July 14, 1987 Criminal Complaint No. 0065604C prepared
by
Agent Iorio (I.G. Exhibit 14) pursuant to which the
ALJ
concluded that Petitioner had failed to maintain a current
DEA
number and had failed to file BDC-6 forms during various
periods
of time.
o Consent Agreement and Order of Commonwealth of
Pennsylvania
Pharmacy Board (I.G. Exhibit 17) pursuant to which the ALJ
found
that by Consent Agreement dated September 17, 1990,
the
Pennsylvania State Board of Pharmacy suspended
Petitioner's
license to practice pharmacy and suspended his permit to
operate
a pharmacy for two years because he had no valid
DEA
registration in effect during the following time
periods:
November 1, 1972 to January 1, 1973; November 1, 1976
to
November 9, 1977; November 1, 1978 to October 16, 1979;
and
November 1, 1984 to August 18, 1986.
o Consent Agreement (I.G. Exhibit 17) pursuant to which the
ALJ
found that the State Board of Pharmacy stayed
Petitioner's
suspension in favor of two years' probation, subject to
certain
conditions of probation: (1) Petitioner was to adhere to
the
State's laws governing the practice of pharmacy or
the
distribution of drugs; (2) Petitioner was to obey the rules
and
regulations of the State Board of Pharmacy; and (3)
Petitioner
and the Pharmacy were to each pay a $500 civil penalty
fee.
o Reports of various BNI agents (I.G. Exhibit 6-13) pursuant
to
which the ALJ found that during a routine inspection
of
Petitioner's pharmacy in 1985, he physically assaulted a
DEA
agent, and this eventually led to Petitioner's arrest
and
arraignment.
o A BNI agent's testimony that Petitioner was not
very
cooperative during an inspection of his pharmacy in 1987.
Tr.
25-28.
Petitioner argued that since his exclusion was based on section
1128(b)(3)
and he admitted the elements of that section, no further
evidence should have
been admitted about his conviction or other
problems concerning compliance
with regulatory standards. Petitioner
argued that the ALJ should only
have heard evidence which went to fraud
and abuse or inappropriate or
inadequate care.
We find that this evidence was both material and relevant to the
issues
before the ALJ. As we have previously held, the ALJ may review
all
evidence on the reasonableness of an exclusion. See Joel Davids,
DAB
1283 (1991) at 7; Vincent Baratta, M.D., DAB 1172 (1990); Eric
Kranz,
M.D., DAB 1286 (1991). Since the reasonableness of an exclusion
turns
on the length of time necessary to establish that a provider is
not
likely to repeat the type of conduct which precipitated the
exclusion,
the ALJ must evaluate the myriad facts of each case. These
include the
nature of the offenses committed by the provider, the
circumstances
surrounding the offense, whether and when the provider sought
help to
correct the behavior which led to the offense, how far the provider
has
come toward rehabilitation, and any other factors relating to
the
provider's character and trustworthiness. See Joyce Faye Hughey,
supra.
In this case the ALJ considered Petitioner's failure to file
appropriate
forms on Schedule II drugs and his failure to maintain a
DEA
registration number pursuant to which he could order those drugs,
his
conviction, the circumstances leading up to the conviction, the
action
of the State licensing board in suspending Petitioner's license
for
failing to abide by regulatory requirements, and
Petitioner's
uncooperative behavior towards law enforcement officials.
All of this
evidence goes to the gravity of Petitioner's offense and the
likelihood
that this type of offense may occur in the future. It bears
directly on
Petitioner's trustworthiness to operate his pharmacy within
the
requirements of the law. Since it was his failure to operate
his
pharmacy within the requirements of the law that led to his
conviction
and the basis of his exclusion, all of this evidence is relevant
to the
question of the reasonableness of the term of his exclusion.
Therefore,
we conclude that the ALJ did not err in admitting this
evidence.
CONCLUSION
For the forgoing reasons, we affirm the three-year exclusion imposed
on
Petitioner.
Donald F. Garrett
Theodore J. Roumel U.S.
Public Health
Service
Cecilia Sparks Ford
Presiding Panel Member
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. The
term
"Medicaid" is used in this decision to represent all state health
care
programs from which the I.G. directed that Petitioner be excluded.
2. In his Reply to the Inspector General's Response,
Petitioner
informed the Board that the conviction on which this exclusion is
based
was remanded to the trial court for an evidentiary hearing
and
adjudication of allegations of ineffective assistance of
counsel.
Specifically, Petitioner alleged that his attorney failed to
raise
appropriate arguments in his criminal trial and failed to counsel
him
adequately about the possible consequences of his conduct.
Petitioner
attached the remand order of January 29, 1992. If the
conviction on
which this exclusion is based is reversed or vacated,
Petitioner is
entitled to reinstatement retroactive to the date of the
exclusion. See
42 C.F.R. .1001.136; 57 Fed. Reg. 3298, 3343 (1992) (to
be codified at
42 C.F.R. .1001.3005). However, this remand, as opposed
to a reversal,
does not affect this proceeding.
3. Effective January 29, 1992, the I.G. promulgated regulations
which
adopt this standard of review in appeals of ALJ exclusion decisions
to
the Board. 57 Fed. Reg. 3298, 3350-3354 (1992) (to be codified at
42
C.F.R. .1005.21(h)).
4. Section 1128(b) establishes the grounds for permissive
exclusions.
Under that section, the I.G. has discretion whether and for what
period
of time to propose an exclusion. Congress also defined two types
of
offenses which precipitate mandatory exclusions of five
years:
conviction of a program related crime (section 1128(a)(1))
and
conviction relating to patient abuse (section 1128(a)(2)).
5. The regulations BNI did supply to Petitioner stated that BDC-6
forms
were to be filed with the Secretary of Health rather than the
Attorney
General. Without specific authority to file with the Attorney
General,
Petitioner viewed such filing as a breach of duty to his customers
and
their physicians. At his criminal trial, the subsequent version of
the
regulation requiring filing with the Attorney General was introduced.
6. Prior to his hearing on February 4, 1991, Petitioner filed with
the
ALJ a Motion in Limine in which he sought an order excluding
certain
evidence as irrelevant, immaterial and unfairly prejudicial as
defined
by 28 U.S.C.S. Appendix, Federal Rules of Evidence 401, 402, 403 and
42
C.F.R. ..498.61 and 498.60(b)(i). Petitioner's Motion in
Limine,
Proposed Order of the Court, and Brief in Support of Petitioner's
Motion
in Limine. The evidence which Petitioner sought to exclude with
this
motion includes the evidence listed above and relied on by the ALJ
in
his decision. The ALJ denied the motion.
Tr.