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# Sunrise Lee, DAB CR5906 (2021)

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

## Sunrise Lee,(OI File No. 1-13-40237-9),Petitioner,

## v.

## The Inspector General.

### Docket No. C-21-411Decision No. CR5906August 2, 2021

### AMENDED DECISION1

Petitioner, Sunrise Lee, was a regional sales manager and regional director for Insys Therapeutics, a pharmaceutical company that manufactured, marketed, and sold the powerful and highly addictive opioid, “Subsys,” which is a fentanyl spray.  To increase product sales, she and others (company executives) engaged in an elaborate scheme of bribery and fraud.  Eventually they were caught and indicted on charges that included conspiracy to commit racketeering, a felony.  After a lengthy jury trial, she was convicted, sentenced to a year and a day in prison, and ordered to pay five million dollars in restitution. 

Based on her conviction, the Inspector General (IG) has excluded Petitioner for 28 years from participating in Medicare, Medicaid, and all federal health care programs, as provided for in sections 1128(a)(1) and 1128(a)(3) of the Social Security Act (Act).  Petitioner appeals the exclusion.

For the reasons discussed below, I find that the IG properly excluded Petitioner and that the 28-year exclusion falls within a reasonable range.

Page 2

### Background

In a letter dated December 31, 2020, the IG notified Petitioner that she was excluded from participating in Medicare, Medicaid, and all federal health care programs for a period of 30 years because she had been convicted of a “criminal offense related to the delivery of an item or service under Medicare or a state healthcare program” and because she had been convicted of a “felony offense related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a healthcare item or service, or with respect to any act or omission in a healthcare program (other than Medicare or a state health care program) operated by, or financed, in whole or in part, by any federal, state, or local government agency.”  The letter explained that sections 1128(a)(1) and 1128(a)(3) of the Act authorize the exclusion.  IG Ex. 1.  Petitioner timely requested review. 

While her appeal was pending, the IG reduced the length of her exclusion to 28 years.  In a letter dated April 29, 2021, she advised Petitioner of the change.  IG Ex. 6. 

The IG initially submitted a written brief (IG Br.) and four exhibits (IG Exs. 1-4).  Petitioner responded by filing her own brief (P. Br.) and nine exhibits (P. Exs. 2-10).2  The IG filed a reply (IG reply) with two additional exhibits (IG Exs. 5-6).  I left the record open to allow Petitioner an opportunity to respond to the IG’s reply and supplemental exhibits.  *See* 42 C.F.R. § 1005.13(c).  Petitioner did not respond.3

The IG objects to six of Petitioner’s proposed exhibits: 
                            - P. Ex. 4 is a heavily altered copy of what appears to be the presentence investigation report, prepared to assist the criminal court in sentencing.  The IG argues that the document is irrelevant and incomplete. 

Page 3
                            - The document is incomplete (15 of 58 pages), and it has been heavily altered in other respects.  Major sections of the “offense level computation” have been deleted.  Comments have been added.  The document would not be admissible under the Federal Rules of Evidence.   See  Rules 106 (providing for production of the remainder of an incomplete writing), 902, and 1005, Fed. R. Evid. (requiring copies of official records to be correct and self-authenticating).  While I am not bound by the Federal Rules, I may apply them to exclude unreliable evidence.  42 C.F.R. § 1005.17(b).  I agree that the document has been so significantly altered as to be unreliable and decline to admit P. Ex. 4. 
                            - P. Ex. 6 is a copy of the brief submitted to the First Circuit in Petitioner’s appeal of her conviction.  The IG argues that it is irrelevant and immaterial.  I agree that the document represents a collateral attack on Petitioner’s criminal conviction and is therefore irrelevant.  As discussed below, the regulations preclude such attacks.  Because it is irrelevant, I decline to admit it.  42 C.F.R. § 1005.17(c).
                            - The IG objects to portions of P. Ex. 7 (pp. 10-36), which appear to be a training manual for the Insys sales team.  The IG argues that it is irrelevant.  I am not convinced that it is wholly irrelevant.  Read together with the indictment and conviction documents, it paints a more complete picture of the practices that were part of the criminal conspiracy, and seems to confirm a scheme that involved sales personnel (which would include Petitioner) with the program that Insys set up to defraud insurers.  I will therefore admit P. Ex. 7 in its entirety. 
                            - The IG objects to portions of P. Ex. 8 (pp. 1-17), communications Petitioner and her attorney had with Insys personnel at the time she was fired.  The IG argues that the documents are irrelevant and immaterial and, because they are heavily marked-up and redacted, they are not self-authenticating.  These documents relate to Petitioner’s purportedly wrongful termination from Insys, which, she argues, made her a victim and a whistleblower, who was entitled to protection, rather than criminal prosecution.  Again, she attacks the validity of her conviction, and the regulations preclude such collateral attacks, making irrelevant any evidence in support of that attack.   	On the other hand, some of these documents might be marginally relevant, although not in a way that helps Petitioner.  For example, her attorney represents that she was a top sales producer at the company, which, given the tactics employed to increase sales, seems to bolster the government’s case that she was actively involved in and profited from the conspiracy.

Page 4
                            - However, the evidence is not wholly reliable and probably too tangential to be relevant.  I therefore decline to admit P. Ex. 8 at 1-17.
                            - The IG objects to P. Ex. 9, portions of a psychological evaluation, prepared by an unidentified individual at the behest of Petitioner’s criminal defense attorney.  The document is so heavily redacted as to be meaningless.  Whole pages are missing; even the name of the examiner has been obliterated.  It would not be admissible under the Federal Rules, and I decline to admit it because I consider it unreliable.  42 C.F.R. § 1005.17(b).
                            - The IG objects to P. Ex. 10, correspondence among Petitioner and attorneys representing her and Insys in an Equal Employment Opportunity Commission matter.  I agree with the IG that the documents are irrelevant and decline to admit them. 

In the absence of any objections, I admit into evidence IG Exs. 1-6.  I also admit P. Exs. 2, 3, 5, 7, and 8 pp. 18-22.

I directed the parties to indicate whether an in-person hearing would be necessary.  *See, e.g.,* (blank copy) Informal Brief of Petitioner at 5 (e-file document #14a).  The parties agree that an in-person hearing is not necessary, and neither listed any witnesses.  IG Br. at 15; P. Br. at 8.  The case may therefore be decided based on the written record. 

### Discussion

***1. Petitioner must be excluded from program participation for a minimum of five years because she was convicted of a criminal offense related to the delivery of an item or service under Medicare and because she was convicted of a felony related to fraud.  Act §§ 1128(a)(1), 1128(a)(3).***4

Under section 1128(a)(1) of the Act, the Secretary of Health and Human Services must exclude an individual or entity that has been convicted under federal or state law of a criminal offense related to the delivery of an item or service under Medicare or a state health care program.  *See also* 42C.F.R. § 1001.101(a).

Under section 1128(a)(3) of the Act, the Secretary must exclude an individual who has been convicted under federal or state law of felony fraud, theft, embezzlement,

Page 5

breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a healthcare item or service.  42C.F.R. § 1001.101(c)(1).

The IG is required to exclude Petitioner if *either* basis is established.  *Edwin L. Fuentes*, DAB No. 2988 at 7 (2020).

**The scheme**.  Insys Therapeutics manufactured, marketed, and sold the powerful and highly addictive opioid, “Subsys,” which is liquid fentanyl.  IG Ex. 5 at 2.  Fentanyl is one of the most potent opioids available for human use; Subsys was FDA-approved to treat cancer patients who, despite receiving round-the-clock opioid therapy, experience persistent pain.  IG Ex. 5 at 2; P. Ex. 2 at 5.  Petitioner Lee held a variety of executive management positions at Insys, including Regional Sales Manager for the Mid-Atlantic Region, Regional Director for the Central Region, and Regional Director for the West Region.  IG Ex. 5 at 6. 

Unhappy with its sales of Subsys, company executives set up an elaborate scheme of bribery, fraud, and the illicit distribution of the drug.  The conspirators targeted practitioners who prescribed or had the capacity to prescribe unusually high volumes of rapid-onset opioids and gave these practitioners bribes or kickbacks in exchange for their increasing the number of prescriptions and increasing the dosage and number of units for new and existing prescriptions.  IG Ex. 5 at 8; *see* P. Ex. 7 at 13-14, 16-17, 19, 21-24.

Among the elements of the scheme, the conspirators set up a sham speakers’ bureau, disguising, as honoraria, the bribes and kickbacks they paid to physicians and pharmacies that pushed their product.  IG Ex. 5 at 12; *see* P. Ex. 7 at 34-35.  Petitioner and her co-conspirators closely tracked the effect of their bribes and kickbacks, calculating what they characterized as their “return on investment” for each targeted practitioner receiving the bribes and kickbacks.  IG Ex. 5 at 14; *see* P. Ex. 2 at 10-12 (explaining that the more the practitioners prescribed, the more they were paid to speak).  They instructed Insys employees to make false and misleading representations and omissions to insurers (including the Medicare program) in order to secure reimbursement for the Subsys prescriptions.  IG Ex. 5 at 16; P. Ex. 2 at 15; *see* P. Ex. 2 at 36-37 (observing that “Defendant Lee worked to put systems and people in place in [physician offices] to maximize the number of prior [insurance] authorizations.”). 

Petitioner Lee was an active and willing participant in the scheme.  P. Ex. 2 at 62 (finding that Defendant Lee was “engaged in all facets of the conspiracy”).  When a company sales representative reported that a practitioner in Chicago ran a “very shady pill mill,” for example, Petitioner Lee responded by offering that practitioner bribes and kickbacks in exchange for his prescribing Subsys.  IG Ex. 5 at 11-12.

Page 6

**The conviction**.  On September 18, 2018, a federal grand jury issued a second superseding indictment, charging Petitioner (and other company executives) with felony conspiracy to commit racketeering, in violation of 18 U.S.C. § 1962(d).  IG Ex. 5; *see* IG Ex. 2 (first superseding indictment, dated October 24, 2017). 

On May 2, 2019, following a 53-day trial in the Federal District Court of Massachusetts, a jury convicted Petitioner Lee of conspiring to violate the Racketeer Influences and Corrupt Organizations (RICO) statute, 18 U.S.C. § 1962(d).  IG Ex. 3 at 1, 13.  The jury determined that the conspiracy included mail fraud (18 U.S.C. § 1341); honest services mail fraud (18 U.S.C. §§ 1341, 1346); wire fraud (18 U.S.C. § 1343); honest services wire fraud (18 U.S.C. §§ 1341, 1346); and distribution of a controlled substance (21 U.S.C. § 841(a)(1)).  P. Ex. 2 at 4.  In an order dated November 26, 2019, the Court vacated portions of the verdict, but agreed that the criminal enterprise included multiple acts of mail fraud (18 U.S.C. § 1341) and wire fraud (18 U.S.C. § 1343).  P. Ex. 2 at 85.

On January 22, 2020, the Court entered judgment against Petitioner Lee, and sentenced her to a year and a day in prison, followed by three years of supervised release.  IG Ex. 3 at 2-3.  The Court entered a money judgment against her (and in favor of the United States) in the amount of $1,170,274, which represented her gross proceeds from participating in the racketeering conspiracy, minus taxes.  IG Ex. 3 at 11, 53.  Against all of the defendants, the court awarded a whopping *$59,755,362.45* in restitution.  IG Ex. 3 at 35.  Of this, Petitioner Lee and three of her co-conspirators were jointly and severally liable for *$5,000,000*.  IG Ex. 3 at 52. 

Given the difficulties of assessing its exact losses, the Court “limited” the Medicare program’s restitution award to *$30,232,895*, which represented the prescriptions attributable to thirteen identified co-conspirator prescribers.  (The court acknowledged that the amount was probably more.)  The bulk of the remaining amount (more than $26 million) was awarded to private insurers, and the rest (more than $10,000) went to individuals.  IG Ex. 3 at 27-29, 33, 55. 

Thus, Petitioner was convicted of a criminal offense related to the delivery of an item – the drug fentanyl – under the Medicare program, which suffered roughly half of the losses attributed to the conspiracy.  IG Ex. 3 at 28-29, 33, 55. 

Petitioner’s felony conviction was also plainly related to fraud (as the Court noted, her RICO conviction included multiple acts of mail and wire fraud) in connection with the delivery of a healthcare item – the drug fentanyl.  She must therefore be excluded for a minimum period of five years under sections 1128(a)(1) and 1128(a)(3).

Page 7

Petitioner attacks the validity of her conviction, arguing that she had “no knowledge or intent nor any direct involvement with the crimes.”  She argues that her conviction was tainted because the jury was prejudiced by evidence of honest services mail fraud, honest services wire fraud, and distribution of a controlled substance, elements that the trial court subsequently vacated.  She also maintains that, given the constitutional issues in her case, her conviction would not survive her appeal.  P. Br. at 2, 3. 

Any challenge to the federal court’s findings are precluded by federal regulations: 

When the exclusion is based on the existence of a criminal conviction . . . by a Federal, State, or local court . . . where the facts were adjudicated and a final decision was made, the basis for the underlying conviction . . . is not reviewable and the individual or entity may not collaterally attack it, either on substantive or procedural grounds, in this appeal. 

42 C.F.R. § 1001.2007(d); *Marvin L. Gibbs, Jr., M.D.*, DAB No. 2279 at 8-10 (2009); *Roy Cosby Stark*, DAB No. 1746 (2000).  

Nor does her pending appeal affect the exclusion.  The Act mandates exclusion when a conviction has been entered against her “regardless of whether there is an appeal pending . . . .”  Act § 1128(i)(1).  I am bound by the statute and regulations and may not disregard them based on a constitutional claim.  *Zahid Imran, M.D.*, DAB No. 2680 at 11 (2016), and cases cited therein.

Petitioner also argues that she should not have been excluded based on her conviction.  P. Br. at 3.  Although she offers a long list of reasons (P. Br. at 3-4), at bottom, virtually all of them attack the validity of her conviction.  She also complains that the IG erroneously relied on the allegations from her indictment, which were not proven.  She does not specify which of the allegations were not proven.  P. Br. at 3.  In fact, the indictment includes one count, and she was convicted on that count, so the IG could justifiably rely on its contents. 

***2. Based on the aggravating factors and no mitigating factor, a 28-year exclusion falls within a reasonable range.***

An exclusion brought under either section 1128(a)(1) or 1128(a)(3) must be for a minimum period of five years.  Act § 1128(c)(3)(B); 42 C.F.R. §§ 1001.102(a).  I now consider whether the length of the exclusion, beyond five years, falls within a reasonable range.  *See Edward L. Fuentes*, DAB No. 2988 at 8-9; *Hussein Awada*, DAB No. 2788 at 5-6 (2017).

Page 8

Among the factors that may serve as a basis for lengthening the period of exclusion are the four that the IG relies on in this case:  1) the acts that resulted in the conviction, or similar acts, caused a government program or another entity financial losses of $50,000 or more; 2) the acts that resulted in the conviction, or similar acts, were committed over a period of one year or more; 3) the acts that resulted in the conviction had a significant adverse physical, mental, or financial impact on program beneficiaries or other individuals; and 4) the sentence imposed by the court included incarceration.  42 C.F.R. § 1001.102(b).  “Simply meeting the threshold for an aggravating factor is a clear indication of untrustworthiness.”  *Hussein Awada*, DAB No. 2788 at 10.  The presence of an aggravating factor or factors, not offset by any mitigating factor or factors, justifies lengthening the mandatory period of exclusion.

**Financial loss (42 C.F.R. § 1001.102(b)(1))**.  The sentencing court ordered Petitioner Lee and three of her cohorts to pay a total of *$5,000,000* in restitution, or *one hundred times* the threshold for aggravation.  Restitution has long been considered a reasonable measure of financial losses.  *Edwin L.**Fuentes*, DAB No. 2988 at 13; *Hussein Awada*, DAB No. 2788 at 7; *Juan de Leon, Jr*., DAB No. 2533 at 5 (2013); *Jason Hollady, M.D.*, DAB No. 1855 (2002); *see* IG Ex. 3 at 18, citing *United States v. Naphaeng*, 906 F. 3d 173, 179 (1st Cir. 2018) (holding that a defendant convicted of crimes involving fraud or deceit must make restitution commensurate with the victims’ actual losses); IG Ex. 3 at 27, 28 (limiting restitution and acknowledging that “if anything, the amount of restitution being awarded by the Court underestimates the amount that should be paid”). 

Financial losses of even one dollar over $50,000 would justify extending the length of the period of exclusion.  *Edwin L. Fuentes*, DAB No. 2988 at 13.  The Departmental Appeals Board has characterized amounts substantially greater than the statutory standard as an “exceptionally aggravating factor” that is entitled to significant weight.  *Jeremy Robinson*, DAB No. 1905 (2004); *Donald A. Burstein, PhD.*, DAB No. 1865 (2003).  I agree.  If even a small percentage of program participants were capable of this level of fraud, the Medicare program could not long survive.  I therefore consider the enormity of the program’s financial losses here a significant aggravating factor that compels a period of exclusion much longer than the five-year minimum. 

Petitioner asserts that she did not intend to cause financial losses to any government program (she does not mention the private insurers and individuals – which qualify as “other entities”).  She also points to the criminal court’s determination that neither she nor her co-conspirators were criminally responsible for physicians writing Subsys prescriptions, because the prosecution failed to show, beyond a reasonable doubt, that they agreed to or intended the conduct.  P. Br. at 5-6. 

Page 9

Petitioner’s intentions are irrelevant (although it’s hard to see how anyone would not recognize that obtaining increased profits through fraud would not cause financial losses to some entity).  Her felony conviction establishes that she actively participated in a scheme that defrauded the Medicare program and other entities, and the amount of the victims’ losses, attributable to her participation, totaled $5,000,000.

**Length of criminal conduct (42 C.F.R. § 1001.102(b)(2))**.  We consider the length of Petitioner’s participation in the criminal scheme in order to distinguish between those whose lapse in integrity is short-lived from those who display a lack of integrity over a longer period of time.  “Participation in, or even knowing but silent acquiescence in, a continuing fraudulent scheme that could be expected to cause repeated misrepresentations and repeated harm over a period of time evidences a continuing lack of integrity.”  *Burstein*, DAB No. 1865 at 8. 

Here, for more than 31⁄2 years, from May 2012 through December 2015, Petitioner’s cohorts conspired to bribe and defraud in order to maximize profits.  Although the IG initially considered that Petitioner participated in the scheme for this entire period, she subsequently determined that Petitioner participated in the scheme from September 2012 through March 2015, 21⁄2 years, and, based on this finding, reduced the period of exclusion from 30 years to 28 years.  IG Ex. 6; IG Reply at 3.

Nevertheless, the acts that resulted in Petitioner’s conviction and similar acts were committed over a period significantly longer than the one year necessary to constitute an aggravating factor, evidencing an ongoing lack of integrity, which the IG can reasonably view as a serious threat to program integrity, and which thus justifies significantly increasing the period of exclusion. 

**Significant adverse physical, mental, or financial impact on program beneficiaries or other individuals (42 C.F.R. § 1001.102(b)(3)).**  Based on the Court’s final judgment, Petitioner’s fraud unquestionably had a significant adverse impact on individuals.  The Court agreed that the scheme injured individuals as well as institutions.  IG Ex. 3 at 19.5 It ordered the defendants to pay $10,198 in restitution to six individual victims, their losses ranging from $965 to $3,041.23.  IG Ex. 3 at 33.  For institutional victims, this might not be considered a significant amount, but, for an individual, it is.  Thus, without even considering the impact the conspiracy had on individuals’ physical and mental well-being, the financial impact alone justifies increasing the length of the exclusion.

Page 10

With respect to having an adverse impact on individuals, Petitioner argues that, because she did not *intend* to harm individuals, this factor should not apply.  She points out that the Court reversed her conviction under the Controlled Substances Act and Honest Services Fraud Act because the prosecution did not establish the requisite intent, which is true, but irrelevant.  P. Br. at 6.  Specific intent may be required to establish criminal liability under the criminal statutes, but it is not required to establish an aggravating circumstance under the regulations that govern these proceedings.  The regulation requires only that the crime had the adverse impact.  *See Lyle Kai, R.Ph.*, DAB No. 1979 at 10 (2005) (expressing reluctance to read into the regulation requirements “that are not contained in the literal language”).

The criminal court determined that the conspiracy unquestionably had an adverse physical and mental impact on individuals: 

Here, the evidence presented at trial shows how Insys’ fixation on increasing the number and dosage of Subsys prescriptions[,] combined with prescribers’ interest in increased speaker payments, *ultimately harmed an untold number of patients*.

P. Ex. 2 at 21 (emphasis added).  *See also* IG Ex. 2 at 27 (noting that Petitioner and others routinely gave instructions to the company sales force that ignored the dangers of misuse, abuse, and addiction in favor of higher sales); P. Ex. 2 at 21 (finding that the evidence “could be readily understood as proving that defendants did not care whether patients needed the drug”); P. Ex. 2 at 33 (finding that the defendants agreed and specifically intended that a healthcare practitioner would prescribe Subsys outside the usual course of professional practice and without any legitimate medical purpose).  

**Incarceration (42 C.F.R. § 1001.102(b)(5))**.  The sentence imposed by the criminal court included incarceration.  The district court sentenced Petitioner to one year and a day in prison.  IG Ex. 3 at 3.  While any period of incarceration justifies increasing the period of exclusion, the Board has repeatedly held that longer periods of incarceration are relevant in determining whether a period of exclusion is reasonable.  *Eugene Goldman, M.D. a/k/a Yevgeniy Goldman, M.D.*, DAB No. 2635 at 6 (2015).  Generally, the longer the jail time, the longer the exclusion, because a lengthy sentence evidences a more serious offense.  *See Jeremy Robinson*, DAB No. 1905 (characterizing a nine-month incarceration as “relatively substantial.”); *Jason Hollady, M.D.*, DAB No. 1855 at 12 (characterizing a nine-month period of incarceration as “relatively substantial”); *Stacy Ann Battle, DDS.*, DAB No. 1843 (2002) (finding that four months in a halfway house, followed by

Page 11

four months home confinement justifies lengthening the period of exclusion); *Brenda Mills, M.D*., DAB CR1461, *aff’d* DAB No. 2061 (2007) (finding that six months home confinement justifies an increase in length of exclusion). 

**No mitigating factors**.  The regulations consider mitigating just three factors:  1) a petitioner was convicted of three or fewer misdemeanor offenses and the resulting financial loss to the program was less than $5,000; 2) the record in the criminal proceedings demonstrates that a petitioner had a mental, physical, or emotional condition that reduced his culpability; and 3) a petitioner’s cooperation with federal or state officials resulted in others being convicted or excluded, or additional cases being investigated, or a civil money penalty being imposed.  42 C.F.R. § 1001.102(c).  Characterizing the mitigating factor as “in the nature of an affirmative defense,” the Board has ruled that Petitioner has the burden of proving any mitigating factor by a preponderance of the evidence.  *Barry D. Garfinkel*, *M.D.*, DAB No. 1572 at 8 (1996).

Obviously, because Petitioner’s felony conviction involved program financial losses thousands of times greater than $5,000, the first factor does not apply here.  Petitioner does not claim to have cooperated with law enforcement, and, in fact, she did not cooperate with law enforcement. 

Petitioner maintains that her mental and emotional conditions reduced her culpability; however, she has not produced any reliable evidence of a mental or emotional condition that might have done so.  P. Br. at 7.  As discussed above, her proffered psychological report and presentencing evaluation are so heavily edited as to be unreliable and inadmissible.  Moreover, that Petitioner suffers from a mental disorder is, by itself, insufficient to establish a mitigating factor.  Petitioner must demonstrate that *the court determined that her mental and emotional disorders reduced her culpability*.  *Patel v. Shalala*, 17 F. Supp. 2d 662, 667 (W.D.Ky. 1998); *Spyros N. Panos*, DAB No. 2709 at 5, 10 (2016); *Christopher Switlyk*, DAB No. 2600 (2014).  Even if Petitioner had produced documentation establishing that she suffered from psychological problems at the time she committed her offenses, such documentation is “not evidence that the court determined Petitioner suffered from psychological problems that reduced [her] criminal culpability.”  *Switlya* at 6. 

Here, no evidence suggests that the court determined, explicitly or implicitly, that Petitioner’s culpability should be reduced. 

Thus, no mitigating factor offsets the significant aggravating factors present in this case.

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Based on the aggravating factors and the absence of mitigating factors, then, I must determine whether the exclusion period imposed by the IG falls within a reasonable range.  So long as that period falls within a reasonable range, my role is not to second-guess the IG’s judgment.  *Jeremy Robinson*, DAB No. 1905 at 5 (ALJ review must reflect the deference accorded to the IG by the Secretary).  A “‘reasonable range’ refers to a range of exclusion periods that is more limited than the full range authorized by the statute [i.e., from a minimum of five years to a maximum of permanent] and that is tied to the circumstances of the individual case.”  *Joseph M. Rukse, Jr. R. Ph.*, DAB No. 1851 at 11 (2002), *citing Gary Alan Katz, R.Ph*., DAB No.1842 at 8 n.4 (2002). 

The goal is to protect federal health care programs and beneficiaries from potential harm.  *Joann Fletcher Cash*, DAB No. 1725 (2000).  Given the nature of the aggravating factors here, a permanent exclusion would not have been out of line.  Petitioner caused enormous financial losses to the Medicare program and other entities; her criminal conduct lasted longer than the threshold for aggravation; she engaged in the criminal conspiracy without regard to the health and welfare of individuals, and an “untold number” of them were harmed; and she was sentenced to significant time in prison. 

Lengthy periods of exclusion are an appropriate means by which the IG can attempt to protect the integrity of the Medicare program, its beneficiaries, and others from the worst offenders.  The evidence here establishes the Petitioner Lee (and her cohorts) are among the worst offenders.

### Conclusion

I recognize that 28 years is a substantial period of exclusion and should be imposed on those posing a grave threat to program integrity and beneficiaries.  Petitioner Lee poses such a threat.  She and her co-conspirators engaged in a cunning and successful conspiracy that cost the Medicare program and others massive amounts of money over a significant period of time and endangered the health and well-being of beneficiaries and others.  Based on all of the circumstances discussed above, I find that a 28-year exclusion falls within a reasonable range.

Carolyn Cozad HughesAdministrative Law Judge

                                              1. This decision has been amended to correct a scrivener’s error in the case caption. 
                            - back to note 1
                                                  2. Petitioner marked her brief as P. Ex. 1.  In her exhibit list, she labeled the documents IG exhibits, instead of Petitioner’s exhibits.  I refer to her brief as P. Br. and to the exhibits by the numbers designated in the e-file listing.  (P. Exs. 2-10). 
                            - back to note 2
                                                  3. Because she is incarcerated and because mail deliveries have been delayed, I extended the period for reply by three weeks.  Ordinarily, her reply would have been due on or before May 25, 2021 (five days for receipt of the IG’s submissions, ten days to file her reply, and an additional five days for receipt by the Civil Remedies Division).  I closed the record on June 22. 
                            - back to note 3
                                                  4. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. 
                            - back to note 4
                                                  5. As with the institutional losses, however, the Court found individual losses difficult to quantify and, ultimately, limited restitution to the amounts that the defendants did not contest.  See IG Ex. 3 at 21-25. 
                            - back to note 5