Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
|
IN THE CASE OF | |
Randall L. Snook, M.D., |
DATE: April 6, 2001 |
- v - |
|
The
Inspector General
|
Docket No.C-01-088
Decision No. CR761 |
DECISION | |
I sustain the determination of the Inspector
General (I.G.) to exclude Randall L. Snook, M.D. (Petitioner) from participation
in the Medicare, Medicaid, and other state and federal health care programs
for a period of three years.(1) I find that
the I.G. is authorized to exclude Petitioner pursuant to section 1128(b)(3)
of the Social Security Act (Act), and that the three-year exclusion imposed
by the I.G. against Petitioner falls within a reasonable range.
I. Background By letter dated August 31, 2000, the I.G. notified Petitioner
that he was being excluded from participation in the Medicare, Medicaid,
and all federal health care programs for a period of three years. The
I.G. advised Petitioner that she is authorized to exclude him pursuant
to section 1128(b)(3) of the Act because of his conviction in the District
Court, Douglas County, State of Colorado, for a criminal offense related
to the unlawful manufacture, distribution, prescription, or dispensing
of a controlled substance. Petitioner filed a request for review of the
I.G.'s determination on October 27, 2000. I held a prehearing telephone conference on November 20,
2000. The parties appeared through counsel and agreed on a briefing schedule.
During the conference call, I advised the parties that any request for
an in-person hearing should be submitted at the end of the briefing period.
By letter dated February 20, 2001, Petitioner advised that an in-person
hearing was not required and the case could be decided based on the written
submissions. Attached to his Request for Hearing (P. Request), Petitioner
submitted documents marked Exhibits A through L. He attached documents
marked Exhibits M through Q to his Response Brief (P. Br.). Attached to
the I.G.'s Brief in Support of Exclusion (I.G. Br.) are Exhibits One through
Five. There being no objections, Petitioner's Exhibits A through Q (P.
Exs. A-Q) and I.G. Exhibits One through Five (I.G. Exs. 1-5) are admitted
into evidence. II. Applicable Law Section 1128(b)(3) of the Act allows the Secretary of
Health and Human Services (Secretary) to exclude from participation in
federal health care programs(2) an individual
who has been convicted under federal or state law of a misdemeanor criminal
offense "relating to the unlawful manufacture, distribution, prescription,
or dispensing of a controlled substance." The Secretary has delegated
to the I.G. the authority to impose the exclusion. 42 C.F.R. � 1001.401(a).
The regulations specify a benchmark exclusion period of three years, which
may be lengthened or shortened based on the presence of specific aggravating
or mitigating factors listed in the regulation. 42 C.F.R. � 1001.401(c)(1).
In reviewing the I.G.'s actions, I may not review the exercise of the
I.G.'s discretion to impose that exclusion. 42 C.F.R. � 1001.401(c)(5);
Tracey Gates, R.N., DAB No. 1768 (2001). Nor may I determine that
a different period of exclusion would be "better;" instead, my review
is limited to whether the period imposed by the I.G. is within a reasonable
range. Gerald A. Snider, M.D., DAB No. 1637 (1997). III. Findings of Fact and Conclusions of Law 1. Petitioner is a physician licensed to practice medicine
in the State of Colorado. P. Ex. J at 1. 2. Petitioner issued prescriptions for the drug, Phentermine,
to certain individuals who were not his patients. Id. 3. Phentermine is a non-amphetamine appetite suppressant
approved for the treatment of obesity. P. Ex. C at 1. 4. Petitioner understood that the Phentermine he prescribed
would ultimately be provided to Bill Romanowski, a professional football
player whom he had met socially. P. Ex. I at 1. 5. When he called in the prescriptions, Petitioner had
not examined and was not treating Bill Romanowski nor any of the individuals
in whose names he wrote the prescriptions. P. Ex. J at 1. 6. As a result of these actions, Petitioner and three
other individuals were indicted in the District Court of Douglas County,
Colorado, on one count of felony conspiracy. I.G. Ex. 1. 7. Subsequently, a misdemeanor count was added to the
indictment, alleging that between September 7, 1998 and August 21, 1999,
Petitioner unlawfully dispensed a Schedule V controlled substance. I.G.
Ex. 2. 8. On April 7, 2000, Count 1 of the indictment was dismissed.
Petitioner pled guilty to Count 2 of the indictment, unlawful dispensing
of a Schedule V controlled substance, buprenorphine, in violation of Colorado
Revised Statute (Colo. Rev. Stat.) � 18-18-414(1)(c), a misdemeanor. I.G.
Exs. 3, 4. 9. The court's acceptance of Petitioner's misdemeanor
guilty plea constituted a conviction within the meaning of section 1128(b)(3)
of the Act. Act, section 1128(i)(3). 10. Petitioner's conviction under Colo. Rev. Stat. � 18-18-414(1)(c)
constitutes a conviction within the scope of section 1128(b)(3) of the
Act. Act, section 1128(i)(3). 11. The Court sentenced Petitioner to a term of 18 months
unsupervised probation, imposed a fine of $1,363, and 200 hours of public
service. I.G. Ex. 4. 12. With respect to his medical license, Petitioner was
placed on probation for five years, and required to take a remedial prescription-writing
course. Petitioner's Drug Enforcement Administration (DEA) registration
number, used for writing prescriptions, was suspended pending completion
of the PACE Physician Prescribing Course. P. Exs. J, K. 13. By letter dated August 31, 2000, the I.G. advised
Petitioner of his three-year exclusion from participation in the Medicare,
Medicaid, and all federal health care programs, as authorized by section
1128(b)(3) of the Act. I.G. Ex. 5 at 1. 14. The I.G. did not allege any of the aggravating factors
set forth in 42 C.F.R. � 1001.401(c)(2). 15. Petitioner established the existence of a mitigating factor pursuant to 42 C.F.R. � 1001.401(c)(3) - his cooperation with law enforcement led to convictions of his confederates. 42 C.F.R. � 1001.401(c)(3)(i)(A). 16. Petitioner's claim that he did not understand the seriousness of his actions is not credible. He knew or should have known that the drugs he prescribed could be misused, and that his actions were improper and illegal. 17. Petitioner has not established
that alternative sources for the type and kind of services he provides
to the community are not available. 19. Petitioner has not established that the existence
of any mitigating factor merits shortening of the exclusion period imposed
by the I.G. 20. The I.G. properly excluded Petitioner from participation in the Medicare and Medicaid programs for a period of three years, pursuant to section 1128(b)(3) of the Act. 21. The I.G.'s determination to exclude Petitioner for a period of three years is reasonable. IV. Issues The issues before me are: (1) whether a basis exists for the I.G.'s imposition of the permissive exclusion; and (2) whether the length of the exclusion is reasonable. 42 C.F.R. � 1001.2007(a)(1). So long as the amount of time chosen by the I.G. is within a reasonable range, based on demonstrated criteria, I have no authority to change it. JoAnn Fletcher Cash, DAB No. 1725 at 10 (2000) (citing 57 Fed. Reg. 3298, 3321 (1992)). V. FactsFor the most part, the critical facts of this case are
not in dispute. Petitioner is a physician licensed to practice medicine
in the State of Colorado. In the summer of 1998, he met socially professional
football player Bill Romanowski and his wife, Julie Romanowski. In September
1998, at Julie Romanowski's request, Petitioner issued prescriptions for
the drug Phentermine to certain individuals who were not his patients.
Phentermine is a controlled substance used as an appetite suppressant.
Petitioner understood that the drugs would ultimately be provided to Bill
Romanowski to bolster his performance during football practices and games.
At Julie Romanowski's request, Petitioner prescribed the drugs using the
names of Julie Romanowski and others, so that no one would know that Bill
Romanowski was the intended user. P. Request at 2. Some of the individuals
whose names were used were aware of the scheme to provide drugs to Mr.
Romanowski and agreed to such use of their names, but apparently one person
was not aware that her name was being used. When he called in these prescriptions,
Petitioner had not examined and was not treating Bill Romanowski or any
of the other individuals involved. Because of these actions, Petitioner and three other individuals
were indicted in the District Court of Douglas County, Colorado, on one
count of felony conspiracy. A misdemeanor count was later added to the
indictment, alleging that between September 7, 1998 and August 21, 1999,
Petitioner unlawfully dispensed a Schedule V controlled substance. On
April 7, 2000, Count 1 of the indictment was dismissed, and Petitioner
pled guilty to the misdemeanor count, unlawfully dispensing a Schedule
V controlled substance, buprenorphine, in violation of Colo. Rev. Stat.
� 18-18-414(1)(c). That statute renders unlawful:
Colo. Rev. Stat. � 18-18-414(1)(c). The Court sentenced Petitioner to a term of 18 months
unsupervised probation, 200 hours public service, and imposed a fine of
$1,363. With respect to his medical license, Petitioner was placed on
probation for five years, and required to take a remedial prescription-writing
course. The DEA suspended his prescription writing privileges pending
completion of the remedial program. VI. Discussion Here, the parties agree that Petitioner is a health care
practitioner convicted under state law of a misdemeanor relating to the
unlawful manufacture, distribution, prescription, or dispensing of a controlled
substance. Nevertheless, Petitioner suggests that the conviction should
not be dispositive of that issue because the misdemeanor count was added
solely to permit a plea bargaining arrangement, and, although he pleaded
guilty to unlawfully dispensing buprenorphine, he did not prescribe that
drug. He also argues that he did not "dispense" any drug and his actions
"clearly do not meet the definition of this unlawful act." P. Br. at 9.
This is not an appropriate forum for re-litigating Petitioner's criminal conviction. The regulations are explicit:
42 C.F.R. � 1001.2007(d).(3)
See also, JoAnn Fletcher Cash, DAB No. 1725 (2000);
Chander Kachoria, R Ph., DAB No. 1380 (1993) ("There is no reason
to 'unnecessarily encumber the exclusion process' with efforts to reexamine
the fairness of state convictions"). The parties also agree that this case presents none of
the aggravating factors set forth in 42 C.F.R. � 1001.401(c)(2).(4)
They dispute which mitigating factors apply, and whether those factors
render unreasonable the I.G.'s imposition of a three-year exclusion. The
only factors considered to be mitigating, and a basis for shortening the
period of exclusion, are:
42 C.F.R. � 1001.401(c)(3). "Petitioner has the burden
of proving any mitigating factor by a preponderance of the evidence, since
the mitigating factor is in the nature of an affirmative defense." Barry
D. Garfinkel, M.D., DAB No. 1572 at 8 (1996). Petitioner argues that his cooperation with law enforcement
officers brings him within the ambit of 42 C.F.R. � 1001.401(c)(3)(i),
and that alternative sources of the care he provides are not readily available.
He also argues that additional factors should be taken into account when
the determination regarding exclusion is made. I next consider each of
these propositions. A. Petitioner's cooperation with law enforcement. Petitioner asserts that his cooperation with law enforcement
officials led to the indictment of Bill Romanowski and the conviction,
through plea arrangements, of two others involved in the scheme. P. Br.
at 10-12. The regulation sets forth three circumstances in which an individual's cooperation with federal or state officials may be considered mitigating and a basis for shortening the period of exclusion:
42 C.F.R. � 1001.401(c)(3)(i).(5)
The I.G. concedes that Petitioner has established the
existence of a mitigating factor -- cooperation with law enforcement leading
to convictions -- but asserts that that factor alone does not provide
sufficient basis for canceling or reducing significantly the three-year
exclusion. I.G. Reply at 3. The regulation authorizes, but does not compel, shortening
the length of an exclusion below the three-year benchmark. Likewise, the
existence of a mitigating factor does not automatically entitle Petitioner
to a reduction of the benchmark period. See Nanette Neu, R.N.,
DAB CR429 (1996). Here, even factoring in the Petitioner's cooperation
with law enforcement, I conclude that, considering the totality of the
circumstances, the three-year exclusion falls within a reasonable range
of possible exclusion periods. First, I do not agree with Petitioner's characterization of his offenses:
P. Br. at 7-8. I consider that Petitioner committed a
crime and see no virtue in his actions. He claims that he did not intend
to breach the law, but he unquestionably intended to write bogus prescriptions
for individuals he had never met, at the request of others whom he barely
knew. That he knowingly acted on behalf of a well-known athlete, and was
well aware that the athlete wanted the drugs to improve his performance
without anyone knowing about it, renders disingenuous Petitioner's assertions
of ignorance to the illegality of the scheme. I do not find credible Petitioner's claim that "he had
no knowledge of alleged abuse of medication by athletes." P. Request at
2. Petitioner admits that he later learned the "allegation that
Phentermine may be used by athletes as a performance-enhancing drug through
stimulant-like side effects," Id. (emphasis added),
but he still seems to deny that this is possible. During the telephone
conference call, Petitioner objected to the characterization of Phentermine
as a performance-enhancing drug. Nevertheless, at a minimum, he admits
that taking the drug permitted Mr. Romanowski to play professional football
without experiencing problems associated with eating or not eating. P.
Ex B. In other words, Mr. Romanowski played better when he took the drugs. Moreover, Petitioner's own literature establishes that,
while not as effective as amphetamines, Phentermine is in a class of drugs
that have sympathomimetic and stimulant properties. P. Ex. F. Indeed,
it is widely accepted that Phentermine is a non-amphetamine appetite suppressant,
but can produce the same adverse effects as amphetamine appetite suppressants.
Prolonged use may be habit-forming. It should be used "only for a few
weeks as an adjunct to diet under strict supervision of [a] doctor." See
Stern and Chilnick, The Pill Book (1992); P. Ex. F (In some jurisdictions,
licensing regulations allowed the drugs's use for only 12 to 16 weeks). Next, no evidence suggests that Mr. Romanowski needed
or took the drug for its approved purpose -- treatment of obesity -- and
the literature does not justify Petitioner's providing this drug to Mr.
Romanowski under the circumstances Petitioner describes. To the contrary,
the literature emphasizes that Phentermine is legitimately used to treat
obesity, must be carefully monitored, and "should be reserved for those
who are clinically at risk from being overweight," and then only as part
of a comprehensive weight-reducing program. See P. Ex. F at 1.
Nothing suggests that this drug should appropriately be prescribed to
enable a professional football player to skip meals without affecting
his performance, much less to enjoy its stimulant effect. Finally, the record offers no explanation as to why, if
the drugs were legitimately intended for just one person, Petitioner wrote
prescriptions for four other individuals. This fact suggests that
Mr. Romanowski was either taking a lot of the drug, was taking it over
too long a period, or that he was providing it to others; obvious concerns
that should have occurred to Petitioner. Since Petitioner wrote prescriptions
over a period of nearly a year (September 1998 to August 1999), a reasonable
inference is that he changed patient names to avoid suspicion. Even if
doing so was not his idea, being asked to do so should have raised questions
in the mind of any reasonable physician. Petitioner's actions were foolish, unprofessional, potentially
dangerous -- and illegal. His protestations of ignorance as to the import
of his actions stretch the bounds of credulity. I recognize that Petitioner's subsequent cooperation with
law enforcement officials, resulting in the convictions of two of his
confederates, could justify lowering the period of exclusion below the
benchmark three years. However, Petitioner's actions raise significant
questions about his trustworthiness, and eliminating the exclusion entirely
would not be reasonable. That the imposition of a slightly shorter exclusion
period might also be reasonable does not render the three-year exclusion
outside a reasonable range. In view of the totality of the situation, and in light of Petitioner's actions, I consider the three-year exclusion within a reasonable range.
Petitioner also argues that the period of exclusion should
be shortened because alternative sources of care are not readily available.
He asserts that he specializes in the treatment of geriatric patients
and that his exclusion leaves approximately 1000 geriatric patients in
the Denver Metropolitan area without a physician. The Board has spoken at considerable length on how this
factor should be assessed. Unlike other mitigating factors, this one does
not suggest that the offense on which the exclusion is based is less serious,
but instead recognizes that excluding a provider may carry risks that
must be balanced against the purpose of the exclusion. Garfinkel
at 8. The focus must be on the adverse effect of the exclusion on previously
available services. However, it is not sufficient that an exclusion might
reduce the number of available health care providers, since some reduction
is likely to result from any exclusion. To establish this mitigating factor,
a provider must prove significant adverse changes in the previously available
services to program patients. Id. Petitioner has not met that burden here. He asserts that in the South Denver area, where he practices, fewer than 50% of all primary care physicians are accepting new Medicare patients, and provides a report that shows that the vast majority of physicians (over 80%) in Arapaho County, Colorado, continue to see and accept new Medicare Part B patients. P. Ex. Q. However, although 92% of specialists reported accepting new Medicare patients, only 53% of primary care physicians accept new Medicare patients. The figures for Medicare HMO patients are slightly lower. According to the report, the primary reason given by physicians for not accepting patients was reimbursement, followed by paperwork concerns. No matter how you crunch these figures, they still establish
that a significant number of physicians in the Denver area continue to
see and accept new Medicare patients. Petitioner has thus not established
that alternative sources of care are not available.
Id. So long as program patients have reasonable
access to alternative sources of comparable services, it is immaterial
that some patients, or some persons who refer patients, prefer the excluded
provider's services or will find other sources less convenient or desirable. Thus, Petitioner has not established that alternative sources of care are not available, and this factor may not mitigate the period of his exclusion.
Petitioner suggests that additional factors should be considered mitigating. First, Petitioner has no prior criminal record and no record of prior disciplinary actions. The Board answered this assertion in Garfinkel, rejecting the suggestion that the petitioner's not having been convicted of all the charges against him somehow diminished his culpability. The Board noted that in drafting the notice-and-comment regulations, the I.G. specifically rejected a proposal to consider as mitigating the absence of a prior record of convictions:
Garfinkel at 32, n.32, (citing 57 Fed. Reg.
at 3315). Second, Petitioner points out that his actions were unrelated
to any federal health care programs. The statute specifically mandates
the exclusion in cases such as this, even though the conviction is not
program-related. Act, section 1128(b)(3). Congress determined that this
category of convicted providers was inherently untrustworthy, and sought
to exclude them in order to protect federal and state health care programs. Finally, Petitioner notes that he was not prohibited from
the practice of medicine. This is not a mitigating factor. VII. Conclusion For the reasons set forth above, I conclude that the I.G. was authorized to exclude Petitioner pursuant to section 1128(b)(3) of the Act. I further find that the three-year exclusion period imposed was reasonable. |
|
JUDGE | |
Carolyn Cozad Hughes Administrative Law Judge
|
|
FOOTNOTES | |
1. "State health care programs" are defined in section 1128(h) of the Act, and include the Medicaid program (Title XIX), Maternal and Child Health Services Block Grant, and Block Grants to States for Social Service programs. 2. "Federal health care program" is defined in section 1128B(f) of the Act and includes any State health care program, as defined in section 1128(h) of the Act. 3. Moreover, that Petitioner pled guilty to charges that did not precisely correspond to his conduct in order to avoid more serious felony charges hardly furthers his case. 4. These aggravating factors include: (i) the acts were committed over a period of one year or more; (ii) the acts had significant adverse impact on program beneficiaries; (iii) the sentence imposed included incarceration; (iv) documented history of wrongdoing; and (v) other convictions or adverse actions. 5. Contrary to Petitioner's arguments
about the "plain language," I find this regulatory language ambiguous.
A superficial reading seems to require that cooperation with law enforcement
result in a program benefit. All three provisions refer to health care
programs, and, under any reasonable reading, subparts (B) and (C) mandate
a showing of program benefit. On the other hand, subpart (A) is ambiguous.
It could be read as requiring convictions related to Medicare, Medicaid,
or other health care program, or it could be read as simply requiring
convictions. The question is whether the adverb phrase "from Medicare,
Medicaid, and other health care programs," modifies both verbs, "convicted
or excluded," or only modifies the adjacent verb "excluded." Petitioner also argues that, inasmuch as his crime was not program-related, it would be "manifestly unjust" to so limit the mitigating circumstances. I do not see that result as unjust since the purpose of these exclusions is to protect the integrity of these health care programs, and a regulation designed to afford enforcement officials an additional tool in achieving that goal seems consistent with the legislative and regulatory purpose. Besides, many of the aggravating factors are also peculiar to program-related crimes, which inures to a petitioner's benefit. Nevertheless, after raising the argument during the prehearing conference, the I.G. seems to have abandoned it, and concedes that Petitioner has established the existence of a mitigating factor, so I do not consider the issue here. | |