Kimberly Jones, DAB No. 3033 (2021)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Kimberly Jones (Petitioner) appeals a decision by an Administrative Law Judge (ALJ) upholding the determination of the Inspector General (I.G.) under section 1128(a)(4) of the Social Security Act (Act)1 to exclude her from participation in all federal health care programs for 15 years.  Kimberly Jones, DAB CR5758 (2020) (ALJ Decision).  Petitioner conceded before the ALJ that her 2019 felony conviction for illegally dispensing controlled substances provided a basis to exclude her under section 1128(a)(4) but argued that a 15-year exclusion – 10 years more than the five-year statutory minimum – was unreasonable.  The ALJ rejected that argument, concluding that a 15-year exclusion was not unreasonable in light of three aggravating factors identified by the I.G. and no mitigating factors.  As more fully explained below, we find the ALJ’s conclusion is supported by substantial evidence and consistent with applicable law and Board precedent.  We therefore affirm the ALJ’s decision. 

Legal Background

Section 1128(a) of the Act requires the Secretary of Health of Human Services to exclude from participation in federal health care programs individuals with certain types of criminal convictions.  Section 1128(a)(4) mandates exclusion of an individual who has been convicted of a felony offense “relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.”2  Exclusions imposed under

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section 1128(a) are referred to as “mandatory” exclusions.  The mandatory minimum period of an exclusion imposed under section 1128(a) is five years.  Act § 1128(c)(3)(B); 42 C.F.R. § 1001.102(a). 

The Secretary has delegated to the I.G. the authority to enforce section 1128’s exclusion provisions.  See 48 Fed. Reg. 21,662 (May 13, 1983).  The I.G. in turn has issued regulations, codified in 42 C.F.R. Parts 1001 and 1005, implementing the delegated exclusion authority.  See 57 Fed. Reg. 3298 (Jan. 29, 1992). 

Title 42 C.F.R. § 1001.102(b) authorizes the I.G. to impose a section 1128(a) exclusion longer than the mandatory minimum five years if one or more of the aggravating factors specified in paragraphs (b)(1) through (b)(9) of that section are present.  Three of those factors are relevant here: 

•     “The acts that resulted in the conviction, or similar acts, were committed over a period of one year or more” (section 1001.102(b)(2));
•     “The sentence imposed by the court included incarceration” (section 1001.102(b)(5)); and
•     “The individual or entity has been the subject of any other adverse action by any Federal, State or local government agency or board if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion” (section 1001.102(b)(9)).

When the I.G. determines that one or more aggravating factors justifies an exclusion longer than the mandatory minimum, the I.G. may consider certain mitigating factors as a basis for reducing the exclusion period to no less than five years.  See 42 C.F.R. § 1001.102(c).

Although a mandatory exclusion is based on a criminal conviction, the exclusion’s purpose is “not to punish the wrongdoer.”  Edwin L. Fuentes,DAB No. 2988, at 14 (2020).  Rather, its purpose is to protect federal health care programs and program beneficiaries from “untrustworthy providers.”  Id.; see also Rehab. Ctr. at Hollywood Hills, LLC, DAB No. 3001, at 15 (2020).

An excluded individual may request a hearing before an ALJ, but only on the issues of: (i) whether the I.G. had a basis for the exclusion; and (ii) whether an exclusion longer than the required minimum period is unreasonable in light of any applicable aggravating and mitigating factors.  42 C.F.R. §§ 1001.2007(a), 1005.2(a); Gracia L. Mayard,DAB No. 2767, at 8 (2017).  A party may appeal the ALJ’s decision to the Board.  Id. § 1005.21(a). 

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Case Background

In 2019, following a jury trial, Petitioner, a pharmacist, was convicted in a United States District Court of seven felony counts of illegally dispensing controlled substances and sentenced to a term of imprisonment for those offenses.  See I.G. Ex. 3, at 1-2; I.G. Ex. 5.  She was acquitted by the jury of 30 other counts, including a count alleging health care fraud.  I.G. Ex. 3, at 1; I.G. Ex. 5.

By letter dated April 30, 2020, the I.G. notified Petitioner that, based on her 2019 felony conviction, she was being excluded from all federal health care programs for 15 years pursuant to section 1128(a)(4) of the Act.  I.G. Ex. 1, at 1.  The I.G. stated in its exclusion notice that Petitioner was subject to a minimum five-year exclusion (pursuant to section 1128(c)(3)(B) of the Act) but that she was being excluded for ten additional years because of three aggravating factors, which the notice specified as follows: 

1.     The acts that resulted in the conviction, or similar acts, were committed over a period of one year or more.  The acts occurred from about October 2014 to about July 2017.

2.     The sentence imposed by the court included incarceration.  The court sentenced you to 78 months of incarceration.

3.     The individual or entity has been the subject of any other adverse action by any Federal, State, or local government agency or board if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion.  The Kentucky Board of Pharmacy suspended your license to practice as a pharmacist.

Id. at 1-2 (italics added). 

Petitioner requested a hearing to contest the exclusion.  During a pre-hearing conference with the ALJ, Petitioner acknowledged that the I.G. had a basis to exclude her under section 1128(a)(4), and indicated she was challenging only the length of the exclusion.  See July 21, 2020 Order Following Prehearing Conference and Setting Schedule for Prehearing Submissions.

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Following the pre-hearing conference, the parties submitted briefs and exhibits.3   The I.G.’s exhibits included judicial records – including a jury verdict form – evidencing Petitioner’s 2019 conviction and sentence.  I.G. Exs. 3, 5.  The I.G.’s exhibits also included a copy of an “Agreed Order of Suspension” issued by the Kentucky Board of Pharmacy (Kentucky Board), suspending Petitioner’s pharmacy license for a period not to exceed five years and one day.  I.G. Ex. 4, at 3.  The Kentucky Board’s order states that the “factual basis” for the suspension was Petitioner’s 2019 conviction for “knowingly and intentionally distributing and dispensing” controlled substances (including oxycodone and hydrocodone) “outside the scope of professional practice and not for legitimate medical purpose[s].”  Id. at 2.

In her brief to the ALJ, Petitioner again confirmed that the I.G. had a basis to exclude her under section 1128(a)(4) based on her felony conviction.  See Informal Br. of Pet. at 1.  She also conceded that the three aggravating factors described in the I.G.’s notice of exclusion existed in this case.  Id. at 2.  Petitioner argued, however, that a 15-year exclusion was “unreasonably long” in light of the aggravating factors and other circumstances relating to her criminal prosecution and life history.  Id. at 2, 4.4   She further argued that a 15-year exclusion was “not justified” because it exceeded exclusions imposed in other allegedly similar cases.  Id. at 2-3.  In support of the latter contention, Petitioner cited eight judicial, Board, or ALJ decisions, many of which, she claimed, reveal that the I.G. has “excluded medical professionals for less than 15 years despite [the] presence of the same three aggravating factors triggered by [her] conviction.”  Id.  

The ALJ’s Decision and Petitioner’s Notice of Appeal

The issue before the ALJ was whether the 15-year exclusion imposed by the I.G. based on the existence of three aggravating factors (and no mitigating factors) was unreasonable.  ALJ Decision at 3.  The ALJ made the following findings of fact and conclusions of law (which we quote verbatim):

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1.     Petitioner was a licensed pharmacist in the state of Kentucky.  

2.     Petitioner was charged in the United States District Court for the Eastern District of Kentucky (District Court) with 37 counts of criminal conduct.

3.     On February 7, 2019, a jury convicted Petitioner on seven of the 37 counts (Counts 5-6 and 31-35).

4.     Counts 5 and 6 and 31 through 35 all involve violations of 21 U.S.C. § 841(a)(1) (Dispensed Outside Scope of Professional Practice and not for a Legitimate Medical Purpose, Schedule II Controlled Substances).

5.     For Counts 5 and 6, the jury found beyond a reasonable doubt that, from February 13, 2014 and continuing through January 30, 2018, Petitioner knowingly and intentionally distributed and dispensed, outside the scope of professional practice and not for a legitimate medical purpose, Schedule II controlled substances Oxycodone and Oxymorphone.

6.     For Counts 31 through 35, the jury found beyond a reasonable doubt that, from October 31, 2014 and continuing through January 13, 2017, Petitioner knowingly and intentionally distributed and dispensed, outside the scope of professional practice and not for a legitimate medical purpose, Schedule II controlled substances Oxycodone and Hydrocodone. 

7.     On June 19, 2019, a judge of the District Court signed a Judgment in a Criminal Case in which he sentenced Petitioner to:  78 months of imprisonment for each of the seven counts, to run concurrently; three years of supervised release for each of the seven counts, to run concurrently; a fine of $5,000; and an assessment of $700.

8.     In September 2019, the Kentucky Board of Pharmacy suspended Petitioner’s license to practice pharmacy for a period of time not to exceed five years and one day.

9.     The pharmacist license suspension was based on the February 7, 2019 jury verdict that Petitioner was guilty of seven counts of knowingly and intentionally distributing and dispensing outside the scope of professional practice and not for legitimate medical

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    purpose, a Schedule II controlled substance (oxycodone and hydrocodone).

10.    Petitioner is subject to mandatory exclusion from participation in all federal health care programs under [the Act § 1128(a)(4)], and a 15-year length of exclusion is not unreasonable based on the existence of three aggravating factors (42 C.F.R. § 1001.102(b) (2), (5), (9)) and no mitigating factors.

ALJ Decision at 3-4 (citations and internal quotation marks omitted).

In support of his conclusion that the length of Petitioner’s exclusion was not unreasonable, the ALJ made a “qualitative assessment” of each of the three aggravating factors.  Id. at 5, 6.  Specifically, the ALJ found that Petitioner’s 78-month prison sentence (the aggravating factor in 42 C.F.R. § 1001.102(b)(5)) “weighs heavily in favor of a lengthy exclusion,” noting that a “prison sentence of as little as nine months is considered to be relatively substantial for exclusion purposes.”  Id. at 6 (citing Jason Hollady, M.D., DAB No. 1855, at 12 (2002)).  With respect to the acts resulting in Petitioner’s conviction occurring over a period of one year or more (the aggravating factor in 42 C.F.R. § 1001.102(b)(2)), the ALJ explained: 

[T]he length of Petitioner’s criminal conduct, lasting more than a year, provides strong support for the 15-year length of exclusion.  The jury specifically found that the Petitioner’s criminal conduct spanned four years, from February 2014 through January 2018.

Id. The ALJ further noted that Petitioner unlawfully dispensed opioids during this time and that her crimes “likely contributed to the national opioid crisis.”  Id.5   Finally, the ALJ concluded that the Kentucky Board’s decision to suspend Petitioner’s pharmacy license (the aggravating factor in 42 C.F.R. § 1001.102(b)(9)) further supports the 15-year exclusion and that her “lengthy” suspension shows Petitioner “betrayed the basic precepts of her profession and the public.”  Id. 

The ALJ concluded that the 15-year exclusion imposed by the I.G. was not unreasonable based on the three aggravating factors and no mitigating factors.  Id. at 1, 4 (¶ 10 & n.1), 5-6.  Finally, the ALJ rejected Petitioner’s argument that a 15-year exclusion is excessive compared with exclusions imposed in other cases.  Id. at 6-7.

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Petitioner filed a timely appeal of the ALJ Decision, contending that it rests on erroneous factual findings and inadequate legal analysis. 

Standard of Review

The Board reviews a disputed issue of fact as to whether the ALJ “decision is supported by substantial evidence on the whole record.”  42 C.F.R. § 1005.21(h).  The Board reviews a disputed issue of law as to whether the ALJ decision “is erroneous.”  Id.  The term “substantial evidence” means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”  Richardson v. Perales, 402 U.S. 389, 401 (1971) (quoting Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938)).

Analysis

On appeal, Petitioner does not dispute that the I.G. was required to exclude her for a minimum of five years, that the three aggravating factors found by the I.G. exist in this case, and that there are no mitigating factors.  Petitioner, however, takes the position that the ALJ erred in sustaining her 15-year exclusion because:  (i) his finding that her criminal conduct occurred over a four-year period is not supported by substantial evidence; (ii) his analysis of the three aggravating factors was “flawed”; (iii) his assertion that Petitioner likely contributed to the national opioid crisis was improper and not supported by substantial evidence; and (iv) the length of the exclusion is unsupported by case law and excessive compared to other cases.  For the reasons explained below, we find there is substantial evidence supporting the ALJ’s determination that a 15-year exclusion period is reasonable based on the existence of three aggravating factors (and no mitigating factors) and that any errors in the ALJ’s analysis were harmless. 

I.        The ALJ’s determination that Petitioner’s 15-year exclusion is reasonable is supported by substantial evidence and comports with the law.

In analyzing the duration of an exclusion period longer than the five-year statutory minimum, the ALJ’s role is to evaluate whether the exclusion “falls within a reasonable range, given the aggravating and mitigating factors and the circumstances underlying them.”  Rosa Velia Serrano, DAB No. 2923, at 8 (2019) (internal quotation marks omitted); Edwin L. Fuentes, DAB No. 2988, at 8 (2020) (quoting Serrano); see also Craig Richard Wilder, M.D., DAB No. 2416, at 8 (2011) (“[T]he ALJ’s role is limited to considering whether the period of exclusion imposed by the I.G. was within a reasonable range, based on demonstrated criteria.”).  Such an evaluation “does not rest on the specific number of aggravating or mitigating factors or any rigid formula for weighing those factors, but rather on a case-specific determination of the weight to be accorded each factor based on a qualitative assessment of the circumstances surrounding the factors in that case.”  Sushil Aniruddh Sheth, M.D., DAB No. 2491, at 5 (2012).  “The I.G. has broad discretion in setting the length of an exclusion in a particular case, based

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on [the I.G.’s] vast experience implementing exclusions.”  Id. (internal quotations and citations omitted).  “An ALJ may not substitute his or her judgment for that of the I.G. or determine a ‘better’ exclusion period.”  Id. (citation omitted). 

In this case, the ALJ, in accordance with Board precedent, evaluated the reasonableness of Petitioner’s 15-year exclusion by weighing the three aggravating factors identified by the I.G. and the surrounding circumstances as support for its decision to lengthen Petitioner’s exclusion beyond the mandatory minimum.  ALJ Decision at 6.  To reiterate, those aggravating factors are:  (1) the acts resulting in Petitioner’s conviction occurred over a period of one year or more; (2) Petitioner’s sentence included incarceration (specifically, a prison term of 78 months); and (3) Petitioner was subjected to an “adverse action” by a state board – namely, the suspension of her pharmacy license by the Kentucky Board – “based on the same set of circumstances that serves as the basis for the imposition of the exclusion.”  See I.G. Ex. 1, at 2; 42 C.F.R. § 1001.102(b)(2), (5), (9).

While conceding that each of these aggravating factors “exist in this case,” Petitioner contends the ALJ’s analysis of each factor is, for various reasons, “insufficient” or flawed and not supported by substantial evidence.  Pet.’s Appeal Br. at 3.

A.       Petitioner’s sentence, which included 78 months of incarceration, weighs heavily in favor of a 15-year exclusion.

With respect to the aggravating factor in section 1001.102(b)(5) – that Petitioner’s sentence included incarceration – the ALJ found “Petitioner’s prison sentence weighs heavily in favor of a lengthy exclusion.”  ALJ Decision at 6.  Petitioner complains, however, that the ALJ failed to “consider the specific circumstances of [her] sentence,” and that these “circumstances were not put forward by the OIG . . . even though the OIG had the burden to justify the exclusion.”  Id. at 3-4.  Petitioner does not specify the “circumstances of [her] sentence” that the ALJ should have considered and did not.  Moreover, the I.G. did not fail to meet any applicable burden of proof.  Under the ALJ’s prehearing order, the I.G. had the burden to prove the “existence of any aggravating factors . . . that the IG may have relied on to lengthen the exclusion.”  Standard Prehearing Order ¶ 6.6   The I.G. satisfied that burden with respect to section 1001.102(b)(5) by presenting judicial records showing that Petitioner was sentenced to prison for 78 months in connection with her felony conviction – a fact Petitioner does not dispute.  Section 1001.102(b)(5) does not require proof of facts or circumstance other than that the sentence imposed by the court for a covered offense “included incarceration.”

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Petitioner also contends that the ALJ cited “no other comparative authority” except Jason Hollady, M.D., DAB No. 1855 (2002), to support his finding that 78 months is a lengthy prison term warranting an exclusion substantially longer than the five-year statutory minimum.  Pet.’s Appeal Br. at 3.  The citation to Hollady was sufficient.  Hollady held that a nine-month prison term, even with work release, was “relatively substantial” and, together with a second aggravating factor, supported an eight-year exclusion.  DAB No. 1855, at 12.  One can reasonably deduce from that holding that Petitioner’s 78-month prison term merits an exclusion substantially longer than the statutory minimum.  Other Board decisions confirm that 78 months (six years and six months) is a lengthy period of incarceration to which an ALJ may assign substantial weight.  See, e.g., Hussein Awada, M.D., DAB No. 2788, at 12 (2017) (affirming a 23-year exclusion and agreeing with the ALJ that a seven-year sentence was a “‘very substantial period,’ meriting significant weight”); Spyros N. Panos, M.D., DAB No. 2709, at 12 (2016) (affirming a 25-year exclusion and finding that 54 months is “unquestionably a significant period” of incarceration); Eugene Goldman, M.D., DAB No. 2635, at 5 (2015) (affirming a 15-year exclusion and finding 51 months a “significant period” of incarceration).

B.       Petitioner’s criminal conduct, which Petitioner concedes continued for two-and-a-half years, weighs heavily in favor of a 15-year exclusion.

With respect to the aggravating factor in section 1001.102(b)(2) – that the acts resulting in the conviction were committed over a period of one year or more – the ALJ found that “the length of Petitioner’s criminal conduct, lasting more than a year, provides strong support for the 15-year length of exclusion.”  ALJ Decision at 6.  We agree with the ALJ’s conclusion, but do not agree with the ALJ’s assessment that the jury found Petitioner’s criminal conduct “spanned four years.”  Id.  Below we explain why.

The ALJ evidently made this determination based on the jury’s verdict form – in particular, the portion of the form which asked the jury to indicate whether or not Petitioner was guilty of counts one through thirty of the indictment.  Id. at 3 (“For Counts 5 and 6, the jury found beyond a reasonable doubt” that Petitioner had illegally dispensed controlled substances “from February 13, 2014 and continuing through January 30, 2018.” (citing I.G. Ex. 5)).  Regarding counts one through thirty, the jury was instructed as follows:  

In order to find the defendant Kimberly Jones, guilty of Counts 1-30, you must find beyond a reasonable doubt that, from on or about February 13, 2014 and continuing through January 30, 2018, in Whitley County, Kentucky, the Defendant did knowingly and intentionally distribute and dispense, outside the scope of professional practice and not for a legitimate medical purpose, Schedule II controlled substances Oxycodone and Oxymorphone.

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IG Ex. 5, at 1 (emphasis added).  The verdict form reflects that the jury found Petitioner guilty on counts five and six, but not guilty on any of the other counts between one and thirty.  Id. at 1-5. 

The ALJ apparently read the instructions for counts one through thirty to mean that a guilty verdict on any one of those counts required the jury to find that Petitioner had engaged in criminal conduct spanning the specified four-year period.  That conclusion is not supported by evidence in the administrative record.  Because the instructions addressed counts one through thirty collectively, the ALJ concluded that the criminal conduct charged in each count occurred for the entire four-year period, rather than at some time during the specified four-year period.

Petitioner submits that the jury’s verdict – findings of guilt on counts five and six but acquittal on the 28 other counts – does not establish that she engaged in criminal conduct from February 13, 2014 through January 30, 2018, and that the ALJ erred in making this determination.  See Pet.’s Appeal Br. at 2-3, 4.  “As the jury charge [for counts one through 30] is worded,” says Petitioner, “the jury would have had to find [her] guilty of all” thirty counts in order for the ALJ to find that the acts resulting in conviction occurred throughout that four-year period.  Id. at 3. 

The verdict form does not specify the date (or time period) of the conduct relating to each count.  See I.G. Ex. 5.  Consequently, one cannot determine, based solely on the verdict form, when or how long the criminal conduct associated with counts five and six occurred.7   Furthermore, the district court’s judgment of conviction indicates that the offenses found by the jury with respect to counts five and six “ended” on March 2, 2017, not on January 30, 2018.  I.G. Ex. 3, at 1.  Still further, the guilty verdicts on counts 31 through 35 support only a finding that Petitioner’s criminal conduct occurred over a period of approximately two-and-a-half years.  See I.G. Ex. 5, at 5 (finding criminal conduct occurring “from on or about October 31, 2014 and continuing through January 13, 2017”); I.G. Ex. 3, at 1 (counts 31-35 offenses ended July 13, 2017).8

The I.G. suggests that Petitioner should have submitted evidence to support her contention that the ALJ made an erroneous finding about the duration of her criminal conduct.  See I.G. Response Br. at 15.  However, Petitioner did not need to proffer new or additional evidence in this appeal.  She only needed to show that the ALJ’s finding is not supported by substantial evidence in the record before the ALJ.  Moreover, Petitioner had

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no reason during the ALJ proceeding to counter the suggestion that her criminal conduct spanned a four-year period because the I.G. never made such a suggestion in the notice of exclusion or in the ALJ proceedings.  See I.G. Ex. 1, at 2 (“acts occurred from about October 2014 to about July 2017”); I.G. Informal Br. at 4 (alleging that Petitioner was convicted for conduct occurring over “an almost three-year period”).

Although we disagree that the record evidence established a four-year period of criminal conduct by Petitioner, we find the error harmless because there is no dispute that Petitioner’s unlawful conduct occurred over a period far exceeding one year and this more than satisfies the aggravating factor and supports the significant weight given to it.  See 42 C.F.R. § 1005.23 (“[The Board] will disregard any error or defect in the proceeding that does not affect the substantial rights of the parties.”).  Indeed, Petitioner conceded before the ALJ – and concedes in this appeal – that the acts resulting in her conviction spanned two-and-a-half years, more than twice the threshold necessary to satisfy the aggravating factor in section 1001.102(b)(2).  Pet.’s Appeal Br. at 6 (stating that “two-and-a-half year period” was “more accurate”).  The Board has held that an ALJ may “reasonably assign significant weight” to illegal conduct that occurred for even slightly longer than the one-year threshold, noting that “simply meeting the threshold . . . is a clear indication of untrustworthiness.”  Hussein Awada at 8-10 (upholding a 23-year exclusion based, in part, on illegal conduct spanning 14 months).  Indeed, the “duration of an individual’s criminal activities reflects the Secretary’s recognition that an individual whose lapse in integrity occurs over a period of one or more years poses a far greater threat to federal health care programs and beneficiaries than an individual whose lapse in integrity is short-lived.”  Id. at 8 (internal quotation marks omitted).   

Accordingly, we hold that the ALJ’s erroneous finding concerning the duration of Petitioner’s criminal conduct is harmless error, and that his decision to assign substantial weight to the aggravating factor in section 1001.102(b)(2) is amply supported by the undisputed fact that Petitioner’s criminal conduct spanned two-and-a-half years.  Cf. Angelo D. Calabrese, M.D., DAB No. 2744, at 4 n.4 (2016) (holding that an inaccurate statement by the ALJ that the I.G. had found the excluded individual’s acts to have occurred over a six-year period “has no effect on [the Board’s] decision” because the “period stated by the I.G. in its notice [of exclusion] is more than double the length of time required to support the aggravating factor”).

We note also that in evaluating the second aggravating factor, the ALJ appears to have considered Petitioner’s conduct in the context of the national opioid crisis.  ALJ Decision at 6 (“It is not unreasonable for the IG to assign a long period of exclusion . . . given that her crime likely contributed to the national opioid crisis.”).  One may reasonably assume that Petitioner’s crimes – unlawfully dispensing opioids over a period of more than two years outside the scope of professional practice and not for legitimate medical purposes – may have contributed in some way to the national crisis described in the Secretary’s public health emergency declarations.  However, the details of Petitioner’s criminal

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conduct were not made part of the record, and Petitioner’s role in contributing to the opioid crisis was not at issue before the ALJ.  The I.G., for example, did not allege in its pre-hearing brief (or in its notice of exclusion) that Petitioner’s criminal conduct contributed to the opioid crisis or that the length of Petitioner’s exclusion was reasonable based on these circumstances.9   If such circumstances were a basis for imposing a 15-year exclusion, Petitioner had a right to notice and an opportunity to address such arguments.  Apart from procedural due process concerns, the basis for the ALJ’s contention that Petitioner “likely contributed” to the opioid crisis is unclear.  Neither party, for example, proffered evidence from Petitioner’s criminal trial or sentencing showing a link between her crimes and the broader national crisis. 

We find the ALJ’s consideration of Petitioner’s presumed role in contributing to the national opioid crisis was improper but find the error harmless.  We see no indication that it materially affected the weight given to the second aggravating factor or any other applicable factor.  Regardless of whether Petitioner’s crimes may have contributed to the opioid crisis, the duration of Petitioner’s criminal conduct, as explained above, amply supports the second aggravating factor and provides strong support for the 15-year exclusion. 

C.       The suspension of Petitioner’s pharmacy license by the Kentucky Board further supports the 15-year exclusion.

Regarding the aggravating factor in section 1001.102(b)(9) – that Petitioner was subject to an adverse action by a state board based on the same set of circumstances that were the basis for her exclusion – the ALJ found that the suspension of Petitioner’s pharmacy license by the Kentucky Board further supports the 15-year exclusion.  ALJ Decision at 6.  Petitioner asserts that the ALJ “disregarded the fact that the Kentucky Board of Pharmacy only excluded [her] for a maximum time that is one-third of her exclusion in this case.”  Pet.’s Appeal Br. at 5.  We disagree with Petitioner’s contention that the suspension of her pharmacy license for up to five years and one day somehow weighs in her favor.  The suspension of a state professional license for any period of time is significant, and the ALJ correctly viewed the suspension in this case as “lengthy.”  ALJ Decision at 6.  There is also no legal requirement that the length of an exclusion match or track the suspension of an individual’s state professional license.

Moreover, the fact that the Kentucky Board chose to impose a license suspension “not to exceed” five years and one day in no way undercuts the ALJ’s stated reason for assigning weight to the license suspension as an aggravating factor.  According to the ALJ, the

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suspension indicates that Petitioner “betrayed the basic precepts of her profession and the public.”  ALJ Decision at 6.  We agree.  The ALJ’s finding is supported by the Agreed Order of Suspension, in which Petitioner stipulated that there was probable cause to believe that she had violated numerous standards of conduct governing the practice of pharmacy in Kentucky.  See I.G. Ex. 4, at 2 (“Stipulated Conclusions of Law,” citing, inter alia, Ky. Rev. Stat. §§ 315.121(1)(a) (authorizing action against a licensee for “unprofessional or unethical conduct”) and 315.121(2)(b)-(h), (j) (defining “unprofessional and unethical conduct”)). 

Petitioner also contends that the ALJ “assigns too much weight” to this factor because:

[t]he fact that the Appellant was convicted of a felony and thereby sentenced to a term of incarceration basically guaranteed that the Appellant was going to face disciplinary action by the state pharmacy board.  In other words, Factor 1 in this case [a sentence of incarceration] is basically a guarantee of Factor 3.  The decision to accord weight to the third factor beyond that already given to the first factor was arbitrary and unreasonable, and it was an incorrect decision not based upon substantial evidence.

Pet.’s Appeal Br. at 5.  Petitioner’s argument has no merit and would effectively nullify section 1001.102(b)(9) as an aggravating factor in any case involving an excluded individual sentenced to a period of incarceration.  The aggravating factor at section 1001.102(b)(9) is not dependent in any way on whether the excluded individual was incarcerated and cannot be ignored or minimized simply because the “other adverse action” (e.g., suspension of a professional license) was a natural result of the individual’s conviction and incarceration. 

Section 1001.102(b)(9) applies when the excluded individual “has been the subject of any other adverse action” that is “based on the same set of circumstances that serves as the basis for the imposition of the exclusion.”  The “basis for the imposition of the exclusion” is the individual’s conviction within the meaning of section 1128(a), and not the sentence imposed in connection with the conviction.  There is no requirement in section 1128(a) that the excluded individual has received a sentence of any kind.  Consequently, the existence of the aggravating factor in section 1001.102(b)(9) is not, as a matter of law, based on the existence of the aggravating factor in section 1001.102(b)(5) (imposition of a sentence including incarceration).  The ALJ committed no legal or factual error in assigning independent weight to the aggravating factor in section 1001.102(b)(9) as required by the regulations.  See, e.g., Narendra M. Patel, M.D., DAB No. 1736, at 29 (2000) (noting that the aggravating factor in section 1001.102(b)(9) contemplates that an “additional adverse action beyond the criminal conviction” may be “additional evidence

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of the seriousness” of the criminal offense supporting the exclusion), aff’d, 319 F.3d 1317 (11th Cir. 2003), cert. denied, 539 U.S. 959 (2003).10

Accordingly, based on the presence of three aggravating factors, all of which warrant significant weight, and the absence of any mitigating factor permitted by regulation, we find that the ALJ’s decision to sustain the 15-year exclusion imposed by the I.G. is supported by substantial evidence and comports with applicable law. 

II.      The ALJ properly rejected Petitioner’s claim that the length of her exclusion is excessive compared with exclusions imposed in other cases.

We next consider Petitioner’s contention that the ALJ wrongly rejected her claim that a 15-year exclusion exceeds exclusions imposed on other similarly situated health professionals. 

In reviewing whether the length of an exclusion exceeding the statutory minimum is unreasonable, the Board has held that “[c]omparisons with other cases are not controlling and of limited utility” because “aggravating and mitigating factors do not have specific values” and “must be evaluated based on the circumstances of a particular case . . . which can vary widely.”  Robert Hadley Gross, DAB No. 2807, at 6 (2017) (internal quotation marks omitted); Baldwin Ihenacho, DAB No. 2667, at 9 (2015) (internal quotation marks omitted); see also Sheth at 15 (“[T]he reasonableness of exclusion periods must be made on a case-by-case basis, and, similarities notwithstanding, the facts of each case are unique to that case.”).  While case comparisons can “inform whether an exclusion falls within a reasonable range,” they are unhelpful to the Board’s decision-making unless supported by analysis that accounts for the unique circumstances of each case and the relative seriousness of any applicable aggravating and mitigating factors.  Sheth at 6; Goldman at 11 (“For any cited exemplar to be meaningfully informative to [the Board’s] decision-making on the reasonableness question, a petitioner should do more than offer a brief parenthetical summary and aver that the exemplar is in extreme contrast to the circumstances of his case.”).

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In her brief to the ALJ, Petitioner cited judicial, Board, or ALJ decisions in eight other cases in which the I.G. lengthened the statutory minimum exclusion based wholly or partly on the aggravating factors applicable here.  Informal Br. of Pet. at 2-3.11   Petitioner noted that in six of the eight cited cases, the exclusion sustained was only ten years “despite the identical nature of the aggravating factors,” and that in a seventh case (Charles Okoye, M.D., DAB CR4495 (2015)), the physician “had four aggravating factors,” including the three that exist in her case, but received only a 13-year exclusion.  Id. at 3.  Petitioner asserted that the alleged “disparities” between her 15-year exclusion and the shorter exclusions imposed in the other cases are “inequitable and unjust.”  Id. 

As an initial matter, we reject Petitioner’s implicit contention that case comparisons such as this demonstrate the upper limit of what is reasonable in any particular case.  Apart from the case-specific nature of each determination, the adjudicator’s role in each case is limited to deciding whether a basis for the exclusion exists and, if so, whether the length of the exclusion (if longer than the statutory minimum) is reasonable.  See 42 C.F.R. § 1001.2007(a).  An adjudicator’s determination that the length of an exclusion falls within a reasonable range does not necessarily mean that a longer exclusion would not have been sustained had the I.G. sought to impose it.  In other words, a specific period of exclusion (e.g., ten years) sustained by an ALJ or the Board does not necessarily represent the upper limit of what may be considered reasonable and does not necessarily foreclose a longer period of exclusion in a similar case.

Here, the ALJ analyzed six of eight cases cited by Petitioner and found that each was insufficiently comparable or actually supported Petitioner’s 15-year exclusion.  ALJ Decision at 6-7.  The ALJ concluded that the asserted comparisons “do not aid Petitioner” and declined to reduce the 15-year exclusion on that ground.  Id. at 6.  Among other things, every one of the cases evaluated by the ALJ involved sentences of incarceration that were significantly less than Petitioner’s seventy-eight months.  See id. at 6-7.   

Petitioner contends that the ALJ’s evaluation was flawed because he erroneously assumed that the acts resulting in her conviction spanned four years “instead of a more accurate two-and-a half-year period.”  Pet.’s Appeal Br. at 6.  However, Petitioner does

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not present any case-specific analysis demonstrating how (if at all) the “more accurate” information about the duration of her criminal conduct undercuts the ALJ’s analysis.  Furthermore, at no point in the administrative appeal process has Petitioner presented a meaningful comparative analysis to support the proposition that a 15-year exclusion is unreasonable given the seriousness of the existing aggravating factors.  The comparisons she drew before the ALJ are based largely on the number of aggravating factors present in each case and omit any discussion of the relative weight of those factors.  Informal Br. of Pet. at 2-3.  Petitioner is no more expansive in her appeal brief, stating only that the excluded individuals in other cases “had the same three [aggravating] factors but received shorter exclusions.”  Pet.’s Appeal Br. at 6.  Such superficial comparisons are inadequate to show that her 15-year exclusion is unreasonable.  See Sheth at 5 (holding that a proper evaluation of an exclusion’s reasonableness “does not rest on the specific number of aggravating or mitigating factors or any rigid formula for weighing those factors, but rather on a case-specific determination of the weight to be accorded each factor based on a qualitative assessment of the circumstances surrounding the factors in that case”). 

Petitioner admitted to the ALJ that her comparative analysis reflected only a “cursory search of recent decisions.”  Informal Br. of Pet. at 2.  Indeed, that search overlooked Baldwin Ihenacho,DAB CR4002 (2015), aff’d, DAB No. 2667 (2015), in which the I.G. imposed a 15-year exclusion in circumstances that are more similar to Petitioner’s than those in any of the eight cases she cited.  In Ihenacho, the excluded individual, a pharmacy owner and operator, was convicted of illegally dispensing controlled substances and other crimes.  DAB CR4002, at 7.  The I.G. found (and there was no dispute about the existence of) three aggravating factors:  (1) the pharmacy owner received a prison sentence of 63 months (14 months less than Petitioner’s sentence); (2) the acts resulting in his conviction occurred over a period of two years and one month (five months less than the period to which Petitioner admits); and (3) a state pharmacy board temporarily suspended the pharmacy owner’s registration.  Id. at 8.  The administrative law judge concluded that the pharmacy owner’s 15-year exclusion was not unreasonable based on those three factors, id. at 1, 7-8, and that conclusion was not disturbed on appeal, see DAB No. 2667.  Because the 15-year exclusion in Ihenacho is based on the same aggravating factors in this case, and because each of the factors in Ihenacho carry at least as much weight as those in Petitioner’s case, Ihenacho strongly indicates that the I.G. did not depart from prior exclusion decisions in imposing a 15-year exclusion on Petitioner.

Other cases confirm that a 15-year exclusion is reasonable and consistent with prior I.G. determinations given the gravity of the aggravating factors (and no mitigating factors) in Petitioner’s case.  See, e.g., Stacy R. Gale, DAB No. 1941 (2004) (sustaining a 15-year exclusion based on three aggravating factors:  a sentence of 364 days of incarceration, financial loss to the government of $273,188, and acts resulting in the pharmacist’s conviction that occurred over a period of 13 months); Johnnie Lee Winfield, DAB CR1971 (2009) (sustaining a 15-year exclusion based on three aggravating factors:  a

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one-year sentence of incarceration; financial loss to the government of $458,237; and the fact that the acts resulting in his conviction occurred over a period of 18 months); Margie Ellen Hollingsworth, DAB CR2992 (2013) (sustaining a 15-year exclusion based on two aggravating factors:  a 46-month sentence of incarceration, and a financial loss to the government of $556,704.12); Joel Adrian Milliner, M.D., DAB CR4600 (2016) (sustaining a physician’s 15-year exclusion based on two aggravating factors:  a sentence of 66 month of incarceration, and two adverse actions – suspension of the physician’s medical license, and termination of participation in a state Medicaid program – based on the circumstances underlying the exclusion); see also James Brian Joyner, M.D., DAB CR5071 (2018) (concluding that a 13-year exclusion based on a 70-month prison term and no other aggravating and no mitigating factors was not unreasonable for a physician convicted of conspiracy to distribute controlled substances by writing illegal prescriptions), aff’d, DAB No. 2902 (2018). 

Petitioner asserts that the ALJ failed to consider two cases cited in her brief to the ALJ – namely:  Bret Ostrager, DAB CR4950 (2017); and Angelo D. Calabrese, M.D., DAB CR4657 (2016), aff’d, DAB No. 2744 (2016).  Pet.’s Appeal Br. at 6.  Neither case is sufficiently comparable to Petitioner’s case.  Both Ostrager and Calabrese involved 10-year exclusions, each based on the same three aggravating factors that exist in Petitioner’s case.  See Ostrager, DAB CR4950, at 1; Calabrese, DAB CR4657, at 6-7.  Although the duration of the unlawful conduct in Ostrager and Calabrese (two years and two months in Ostrager,and approximately two and one-half years in Calabrese)was the same or slightly less than the duration of Petitioner’s criminal conduct, the 37-month prison sentences in both cases are less than half of Petitioner’s sentence (78 months).  See Ostrager, DAB CR4950, at 1-2; Calabrese, DAB No. 2744, at 3, 4 n.4.

We, therefore, hold that the ALJ did not err in rejecting Petitioner’s argument that her 15-year exclusion is unreasonable in comparison to exclusions imposed in other cases.

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Conclusion

The ALJ’s determination that the 15-year exclusion imposed by the I.G. is not unreasonable is supported by substantial evidence and consistent with applicable law.  Accordingly, we affirm the ALJ’s decision.

1. The current version of the Social Security Act can be found at http://www.socialsecurity.gov/OP_Home/ssact/ssact.htm.  Each section of the Act on that website contains a reference to the corresponding United States Code chapter and section.  Also, a cross-reference table for the Act and the United States Code can be found at https://www.ssa.gov/OP_Home/comp2/G-APP-H.html.
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2. Section 1128(a)(4) states that the offense must have occurred after August 21, 1996, the date of the enactment of the Health Insurance Portability and Accountability Act of 1996.  The felony offenses supporting Petitioner’s exclusion occurred after August 21, 1996.  See I.G. Ex. 3.
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3. When the I.G. filed its brief, Petitioner’s conviction was still on appeal to the United States Court of Appeals for the Sixth Circuit.  Informal Br. of I.G. at 1.  The Sixth Circuit subsequently affirmed Petitioner’s conviction on September 4, 2020.  United States v. Kimberly Jones, 825 F. App’x 335 (6th Cir. Sept. 4, 2020) (also available at https://www.opn.ca6.uscourts.gov/opinions.pdf/20a0521n-06.pdf).  Petitioner filed her brief to the ALJ on October 7, 2020.
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4. In her brief to the ALJ, Petitioner asserted that the mitigating factor defined in 42 C.F.R. § 1001.102(c)(1) was present because the acts resulting in her conviction caused a total loss to federal health care programs of less than $5,000.  Informal Br. of Pet.at 4-5.  As the ALJ noted in her decision, the mitigating factor in section 1001.102(c)(1) applies only when the excluded individual was convicted of three or fewer misdemeanors.  See ALJ Decision at 4 n.1.  Petitioner was convicted of felony offenses and, therefore, section 1001.102(c)(1) is inapplicable.  See id.  Petitioner does not challenge the ALJ’s conclusion regarding the absence of mitigating factors in this appeal.
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5. In support of his assertion that Petitioner “likely contributed” to the opioid crisis, the ALJ cited a public health emergency declaration, signed by the Secretary of Health and Human Services on October 7, 2020, stating that the Secretary was renewing a prior October 2017 determination under section 319 of the Public Health Service Act that “a public health emergency exists nationwide as a result of the consequences of the opioid crisis.”  ALJ Decision at 6 (citing https://www.phe.gov/emergency/news/healthactions/phe/Pages/opioid-8Oct20.aspx).
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6. With certain exceptions not relevant here, the I.G.’s regulations provide that “the ALJ will allocate the burden of proof as the ALJ deems appropriate.”  42 C.F.R. § 1005.15(c).  In this case, the ALJ allocated to the I.G. the burden of proving the “basis for exclusion” and the “existence” of any aggravating factor.  See Standing Prehearing Order ¶ 6.
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7. Neither Petitioner nor the I.G. included as part of the administrative record for this appeal the indictment or any other document which might specify the dates for the charged conduct.
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8. We note there is an unexplained discrepancy between the end date in the verdict form and the end date in the judgment of conviction concerning counts 31 through 35.  We need not resolve this discrepancy because Petitioner concedes the acts that resulted in her conviction occurred over a two-and-a-half-year period.
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9. We note that contributing to a national crisis is not one of the aggravating factors enumerated under 42 C.F.R. § 1001.102(b).  We further note that the aggravating factor under section 1001.102(b)(3), which is established if the acts that resulted in the conviction “had a significant adverse physical, mental or financial impact on one or more program beneficiaries or other individuals,” was not at issue in this case.
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10. When the exclusion in Patel was imposed, the aggravating factor presently defined in 42 C.F.R. § 1001.102(b)(9) was codified in section 1001.102(b)(8).  See DAB No. 1736, at 3 n.1.
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11. The eight decisions cited by Petitioner are:  Patel v. Shalala, 17 F. Supp. 2d 662 (W.D. Ky. 1998); Jennifer Franklin, M.D., DAB CR5512 (2020); James Dustin Chaney, D.O., DAB CR5063 (2018); James Josiah, DAB CR5514 (2020); Washington Bryan, II, M.D., DAB CR5188 (2018); Bret Ostrager, D.O., DAB CR4950 (2017); Angelo D. Calabrese, M.D., DAB CR4657 (2016), aff’d, DAB No. 2744 (2016); and Charles Okoye, M.D., DAB CR4495 (2015).  Six of the eight cases are unreviewed ALJ decisions, which were not appealed by either party, and which “are neither precedential nor binding on the Board or other ALJs . . . .”  See Fuentes at 15.  Moreover, the Board declined review in the Patel case and, in any event, that case is not precedential because it is from a federal judicial district different from where Petitioner’s appeal arises.  See William Garner, M.D., DAB No. 3026, at 11 (2020) (noting that district court decision from a different federal judicial district is not binding on the Board).
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