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                              Bryan Wade Lewis, DAB CR6162 (2022)
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Bryan Wade Lewis, DAB CR6162 (2022)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Bryan Wade Lewis,
(O.I. File No.: B-21-40115-9),
Petitioner,

v.

The Inspector General.
Docket No. C-22-486Decision No. CR6162September 28, 2022

        
              
    

      DECISION

Petitioner, Bryan Wade Lewis, a pharmacist, pleaded guilty to a felony count of tampering with consumer products, related to his diversion of hydromorphone1 meant for patient use.  Based on Petitioner’s conviction, the Inspector General (IG) excluded Petitioner from participating in Medicare, Medicaid, and other federal health care programs for five years under section 1128(a)(3) of the Social Security Act (Act).  For the reasons set forth below, I find that Petitioner was convicted of a felony criminal offense related to theft in connection with the delivery of a health care item or service.  The IG was therefore required to exclude him from participating in Medicare, Medicaid, and other federal health care programs for a minimum period of five years.  The duration of the exclusion is the minimum required by section 1128(c)(3)(B) of the Act; accordingly, it is reasonable as a matter of law.

I.    Background

On or about January 23, 2019, a federal grand jury in the Western District of Virginia indicted Petitioner with one count of tampering with a consumer product in violation of

Page 2

18 U.S.C. § 1365(a)(4).  IG Exhibit (Ex.) 3.  The grand jury charged that, between August of 2017 and January of 2018, Petitioner tampered with vials of hydromorphone at a pharmacy where he was employed as a pharmacist.  *Id.* The grand jury alleged that Petitioner extracted the hydromorphone from the vials and replaced it with saline.  *Id*.  On or about September 16, 2020, Petitioner entered into a plea agreement with the United States Attorney.  IG Ex. 2.  Pursuant to the plea agreement, Petitioner agreed to plead guilty to the sole count of the indictment.  *Id.*at 1-2.

In support of the plea agreement, Petitioner signed an agreed statement of facts in which he admitted that he told a fellow employee that he had placed a needle, alcohol pad, and bloody tissue in an employee bathroom at his workplace.  IG Ex. 4 at 1.  He further told the fellow employee that he had been engaging in such conduct for nine months.  *Id.*Finally, he told the fellow employee that there was a 50 ml vial of hydromorphone in the narcotics cabinet that did not contain any hydromorphone because it had been replaced with saline.  *Id.*

According to the agreed statement of facts, further investigation revealed a 50 ml vial of hydromorphone in the narcotics cabinet that had four punctures in the vial stopper.  *Id.*at 2.  When analyzed, the tampered vial contained only 0.018 mg/ml of hydromorphone, compared with 10.4 mg/ml of hydromorphone in an untampered vial.  *Id.*The tampered vial was stored with multiple other vials resembling it.  *Id.* Petitioner’s employer could have used the tampered vial to create a final product for its patients.  *Id.* Petitioner admitted that he acted with “reckless disregard for the risk that another person would be placed in danger of bodily injury because a patient who received the liquid in the tampered vial would suffer physical pain, and possibly infection or misdiagnosis.”  *Id.*

On or about January 28, 2021, Petitioner pleaded guilty to count 1 of the indictment in the United States District Court for the Western District of Virginia (federal district court).  IG Ex. 5 at 1.  The Chief Judge of the federal district court adjudicated Petitioner guilty of tampering with a consumer product and sentenced Petitioner to twelve months and one day of incarceration.  *Id.*at 1-2.  The court recommended that Petitioner receive drug and mental health counseling and treatment while in prison.  *Id.*at 2.

In a letter dated February 28, 2022, the IG notified Petitioner that he was excluded from participation in Medicare, Medicaid, and all federal health care programs under section 1128(a)(3) of the Act because of his felony conviction in the federal district court.  The letter explained that Petitioner was excluded because he was convicted “of a criminal offense related to fraud, theft, embezzlement . . . in connection with the delivery of a health care item or service . . . .”  IG Ex. 1 at 1.  The letter referred to Petitioner’s conviction for tampering with a consumer product under 18 U.S.C. § 1365(a)(4).  *Id*.  Petitioner timely requested a hearing (P. RFH).  Following a telephone prehearing conference with the parties, I issued an Order and Schedule for Filing Briefs and Documentary Evidence (Briefing Order).

Page 3

Pursuant to the Briefing Order, the IG submitted a brief and five proposed exhibits (IG Br.; IG Exs. 1-5).  Petitioner submitted a brief (P. Br.) and did not submit any proposed exhibits.  The IG submitted a reply brief.  Petitioner did not object to the IG’s proposed exhibits.  Therefore, in the absence of objection, I admit into evidence IG Exs. 1-5.

The parties agree that this case may be resolved without an in-person hearing.  IG Br. at 8; P. Br. at 6.2  I therefore decide this case based on the written record.  *See*Briefing Order § 9.

II.   Discussion

***A. The IG was required to exclude Petitioner from participating in Medicare, Medicaid, and all other federal health care programs pursuant to section 1128(a)(3) of the Act because he was convicted of a felony offense related to theft in connection with the delivery of a health care item or service.3***

The Act authorizes the Secretary of Health and Human Services (Secretary) to exclude from program participation any individual who has been convicted of an “offense consisting of a felony relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct” “in connection with the delivery of a health care item or service.”  Act § 1128(a)(3).  The Secretary has delegated this exclusion authority to the IG.  42 C.F.R. § 1001.101(c).  Accordingly, the IG must establish the following elements to support Petitioner’s exclusion pursuant to section 1128(a)(3):  (1) Petitioner must have been convicted of a felony after August 21, 1996;4 (2) the felony offense for which Petitioner was convicted must have been related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct; and (3) the offense must have been committed in connection with the delivery of a health care item or service.  *See*42 C.F.R. § 1001.101(c).  Here, the IG has established the required elements.

Page 4

***1. Petitioner was convicted of a felony offense after******August 21, 1996***

On January 28, 2021, the federal district court accepted Petitioner’s guilty plea and adjudicated him guilty.  IG Ex. 5.  Petitioner was convicted, as that term is defined in subsections 1128(i)(2) and (3) of the Act, of a felony offense5 occurring after August 21, 1996.  Petitioner does not dispute that he was convicted of tampering with a consumer product in violation of 18 U.S.C. § 1365(a)(4) and that his conviction occurred after August 21, 1996.  P. Br. at 4.

***2. The felony offense for which Petitioner was convicted was related to theft.***

Petitioner contends that his conviction is not within the scope of section 1128(a)(3) because it was not for an offense relating to theft.  P. Br. at 4-5; P. RFH at 2.  Petitioner argues that the crime of tampering with a consumer product itself is unrelated to theft and that its elements do not constitute theft.  P. Br. at 4.  Petitioner argues that the IG has failed to establish by a preponderance of the evidence that his conviction is related to theft, because the IG has not established the criminal elements of theft.  *Id*. at 4-5.

The IG argues that section 1128(a)(3) does not require that Petitioner’s conviction be for the specific offense of theft, but only that the conviction be *related to* theft – that is, have a nexus or common sense connection to theft.  IG Br.at 5-7.  I agree.  As the appellate decision in *Charice D. Curtis* held, “the plain language of section 1128(a)(3) encompasses felonies ‘relating to’ fraud and the other types of listed offenses, not just to felonies that constitute fraud or one of the other listed offenses.”  *Charice D. Curtis*, DAB No. 2430 at 4 (2011).  Similarly, the decision in *Summit S. Shah*, *M.D.* held, “[the] [administrative law judge] is free to look beyond the narrow constructs of a state’s criminal statutes” when determining if a petitioner was convicted of a felony related to fraud or theft.  *Summit S. Shah*, *M.D.*, DAB No. 2836 at 7 (2017).

In the present case, the evidence establishes that Petitioner’s conviction is “related to” theft within the meaning of section 1128(a)(3).  The common law definition of theft is “The wrongful taking and removing of another’s personal property with the intent of depriving the true owner of it.”  *Black’s Law Dictionary* (11th ed. 2019).6  Petitioner tampered with hydromorphone belonging to his employer by removing it from the vial and replacing it with saline.  IG Ex. 4 at 1-3.  Petitioner acknowledges this conduct, but argues that it does not relate to theft.  P. Br. at 5.  Petitioner dismisses as “inference and speculation” the conclusion that his employer permanently lost possession of the

Page 5

hydromorphone.  *Id.* Petitioner suggests that “one can . . . alter a consumer product sufficiently to qualify as tampering without . . . depriv[ing] another of their possessory interest sufficiently to relate to theft.”  *Id.*While Petitioner’s arguments might suffice to raise a reasonable doubt in a criminal proceeding, this is a civil administrative proceeding in which the burden of proof is a preponderance of the evidence.  42 C.F.R. §§ 1001.2007(c), 1005.15(d).  Nothing in the regulations prevents me from finding a fact is likely true based on inferences from the evidence of record.

Here, Petitioner does not affirmatively claim that he returned the hydromorphone to his employer.  Nor does Petitioner explain what became of the hydromorphone after he removed it from the vial.  Even if it is *possible* to infer, as Petitioner suggests, that his employer was not permanently deprived of the hydromorphone Petitioner removed from the vial, that scenario is not *likely*.  To the contrary, I find it more likely than not that Petitioner could not have returned the hydromorphone removed from the vial because he used it himself.  I base this conclusion on the fact that Petitioner admitted telling a fellow employee that he had put drug paraphernalia (a needle, alcohol pad, and bloody tissue) in a bathroom at their place of employment; that he had been doing so over a period of months; and that he knew there was a vial of hydromorphone in their employer’s narcotics cabinet from which the hydromorphone had been removed.  IG Ex. 4 at 1.  I find further support for this conclusion in the fact that Petitioner refused to present himself for a drug test as requested by his employer.  *Id.* Finally, this conclusion is reinforced by the fact that the federal district court recommended that Petitioner undergo drug treatment and counseling while in prison.  *See*IG Ex. 5 at 2.

Moreover, even if Petitioner did not divert the hydromorphone for his own use, Petitioner’s conduct was adverse to his employer’s property interest in the hydromorphone.  By removing the hydromorphone from the vial, Petitioner prevented his employer from using that vial for its intended purpose, i.e., dispensing hydromorphone to patients.  I find it very unlikely that, once removed from the vial, the hydromorphone would have been available to Petitioner’s employer for dispensing.  For all these reasons, I find that Petitioner’s conviction for tampering with a consumer product is factually related to theft.

***3. The felony offense for which Petitioner was convicted was committed in connection with the delivery of a health care item or service.***

In his hearing request, Petitioner argued that “18 U.S.C. §1365(a)(4) governs conduct wholly unrelated to the provision of health care.”  P. RFH at 2.  This may be intended to demonstrate that Petitioner’s conviction was not committed “in connection with the delivery of a health care item or service” within the meaning of section 1128(a)(3).  Petitioner did not elaborate further on this argument in his brief, choosing instead to focus on his contention that the conviction is unrelated to theft.  P. Br. at 3-5.

Page 6

Nevertheless, in this section of the decision, I explain why I conclude that there is a connection between Petitioner’s conviction and the delivery of health care items or services.

To determine whether a conviction is in connection with the delivery of a health care item or service, I must examine whether there is a “nexus or common sense connection” between the conviction and the basis for exclusion.  *Scott D. Augustine*, DAB No. 2043 at *3 (2006) (2006 WL 2751080).  In making that determination, I may consider “evidence as to the nature of an offense.”  *Berton Siegel, D.O.*, DAB No. 1467 at *4 (1994) (1994 WL 321798).  I may also consider extrinsic evidence to understand the basis for Petitioner’s conviction.  *Narendra M. Patel*, *M.D.*, DAB No. 1736 at *7 (2000) (2000 WL 1063716), *aff’d*, *Patel v. Thompson*, 319 F.3d 1317 (11th Cir. 2003).

I have no difficulty in concluding that there is a common sense connection between Petitioner’s offense and the delivery of health care items or services.  Petitioner was working for a pharmacy when he replaced hydromorphone belonging to the pharmacy with saline.  IG Ex. 4 at 1-2.  The hydromorphone that Petitioner removed was intended to be dispensed to patients.  It is well-settled that the necessary nexus exists where a pharmacist has taken drugs intended for patients for personal use.  *See Kevin J. Bowers*, DAB No. 2143 at 3-4 (2008), *aff’d, Bowers v. Inspector General of the Dep’t of Health & Human Servs.*, No. 1:08-CV-159, 2008 WL 5378338 (S.D. Ohio Dec. 19, 2008) (where a pharmacist interferes with the delivery of drugs, the crime was committed in connection with the delivery of a health care item); *see also* *Erik D. DeSimone, R.Ph.*, DAB No. 1932 at *3 (2004) (2004 WL 1764746) (“Petitioner’s theft of the drug while under the guise of performing his professional responsibilities [as a pharmacist] is clearly the requisite common sense ‘connection’ to health care delivery that section 1128(a)(3) requires.  Moreover, as the administrative law judge specifically found, his theft of this particular drug unquestionably had the effect of subverting the delivery by him and his employer of the very same drug to the general public.”).

Because Petitioner diverted hydromorphone that should have been available to patients, his crime was connected to the delivery of health care items or services.  In addition, Petitioner’s conduct placed patients at risk of harm.  In the agreed statement of facts, Petitioner admitted that, had the tampered vial been used to create products that were dispensed to patients, patients would be placed in danger of bodily injury.  IG Ex. 4 at 2.  Petitioner’s argument that he is only guilty of tampering with a consumer product minimizes the impact that his actions could have had on patients.  Even if Petitioner did not divert the hydromorphone for his own use, his criminal conduct interfered with its delivery to patients and placed patients at risk.

In summary, Petitioner’s position as a pharmacist gave him access to the hydromorphone he tampered with, which was meant to be dispensed to patients as a health care item or service.  By tampering with the vial, Petitioner exposed patients to the risk that they

Page 7

would be harmed if the contents of the tampered vial were dispensed.  Petitioner’s conviction is therefore “in connection with the delivery of a health care item or service” within the meaning of section 1128(a)(3) of the Act.

***B. Petitioner must be excluded for the statutory minimum period of five years under section 1128(c)(3)(B) of the Act.***

The Act requires that the period of exclusion for individuals convicted of offenses described in section 1128(a)(3) “shall not be less than five years.”  Act § 1128(c)(3)(B); *see also*42 C.F.R. § 1001.102.  Thus, I am required to uphold the length of Petitioner’s exclusion.  Once I have concluded that Petitioner is subject to exclusion pursuant to section 1128(a)(3), I may not reduce Petitioner’s exclusion to zero, nor may I direct the IG to reinstate Petitioner to program participation.  *See*42 C.F.R. § 1005.4(c)(6); *see also*42 C.F.R. § 1001.3002(f).

III.   Conclusion

For the reasons explained above, I conclude that Petitioner was convicted of a felony offense relating to theft and that his criminal conduct occurred in connection with the delivery of a health care item or service.  Therefore, the IG was required to exclude Petitioner pursuant to section 1128(a)(3) of the Act.  An exclusion pursuant to section 1128(a)(3) must be for a minimum period of five years; accordingly, the length of Petitioner’s exclusion is reasonable as a matter of law.

Endnotes

1 Hydromorphone is an opioid pain medication, also known by the brand name Dilaudid.

2 I cite to Petitioner’s brief using the PDF page numbers as they are displayed in the Departmental Appeals Board’s electronic filing system.

3 My findings of fact and conclusions of law are set out in bold italic type.

4 August 21, 1996 is the date of enactment of the Health Insurance Portability and Accountability Act of 1996.  110 Stat. 1936; *see also*42 C.F.R. § 1001.101(d).

5 Tampering with a consumer product is a felony offense because it carries a maximum prison term of ten years.  18 U.S.C. § 3559(a).

6 I cite to *Black’s Law Dictionary*as it appears in the Westlaw database.
  
          /s/
        Leslie A. Weyn

                      Administrative Law Judge Back to top
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