SUBJECT:

Randall L. Snook, M.D.,

Petitioner,

The Inspector General

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.

18. That Petitioner has no prior criminal record, no prior disciplinary actions against him, that his actions were unrelated to any federal health care programs, and that he was not prohibited from the practice of medicine are not mitigating factors, and do not form the basis for the shortening of the exclusion period.

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.

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)).

For 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:

[t]he dispensing of any schedule III, IV, or V controlled substance unless such controlled substance is dispensed from a pharmacy pursuant to a written, oral, mechanically produced, computer generated, electronically transmitted, or facsimile transmitted order or is dispensed by any practitioner in the course of his or her professional practice.

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:

[w]n the exclusion is based on the existence of a conviction . . . the basis for the underlying determination is not reviewable and the individual or entity may not collaterally attack the underlying determination, either on substantive or procedural grounds, in this appeal.

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:

i) [t]he individual's or entity's cooperation with Federal or State officials resulted in - A) Others being convicted or excluded from Medicare, Medicaid, and all other Federal health care programs, B) Additional cases being investigated or reports being issued by the appropriate law enforcement agency identifying program vulnerabilities or weaknesses, or C) The imposition of a civil money penalty against others; or

ii) Alternative sources of the type of health care items or services furnished by the individual or entity are not available.

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:

(A) The cooperation resulted in "others being convicted or excluded from Medicare, Medicaid, and all other health care programs;"

(B) The cooperation resulted in additional cases being investigated or reports being issued by the appropriate law enforcement agency identifying program vulnerabilities or weaknesses; or

(C) The cooperation resulted in the imposition of a civil money penalty against others.

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:

[t]he only arguable improper act by Dr. Snook is attempting to protect Mr. Romanowski's privacy by prescribing medications in the names of other individuals. Based on the media attention that this matter has received, the privacy concerns were well-founded.

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.

B. Alternative Sources of Care Not Readily Available.

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.

That Petitioner is beloved by many of his patients who are upset at the prospect of losing him is not the appropriate standard for mitigating his exclusion. The issue of comparability of services is a question directed to the objective qualifications and type of services offered by alternative sources and the practical access to those services by program patients. Garfinkel at 9.

To undertake an inquiry into the professional practices and abilities of all available alternative providers of the same type of services in every case in which the absence of alternative sources is alleged as a mitigating factor would unnecessarily prolong hearings and risk inconsistency. . . .

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.

C. Other Factors.

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:

[n]o one "deserves special credit (in the form of a reduced period of exclusion) for doing what is expected, that is, obeying the law."

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.

Carolyn Cozad Hughes

Administrative Law Judge

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.