United States Court of Appeals 

For the First Circuit 

No. 19-1621 

UNITED STATES, 

Appellee, 

v. 

CHRISTOPHER CLOUGH, 

Defendant, Appellant. 

APPEAL FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW HAMPSHIRE 

[Hon. Joseph Laplante, U.S. District Judge] 

Before 

Howard, Chief Judge, 

Lynch, and Thompson, Circuit Judges. 

 William E. Christie, Shaheen & Gordon, PA, for appellant. 

 Scott W. Murray, United States Attorney, with whom Seth R. 

Aframe, Assistant United States Attorney was on brief, for 

appellee. 

October 23, 2020 
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THOMPSON, Circuit Judge. In a pattern of drug company 

kickback schemes repeating through criminal prosecutions across 

the United States, a jury convicted Christopher Clough of violating 

federal laws by conspiring to receive, and of actually receiving, 

kickbacks from the pharmaceutical company Insys in exchange for 

prescribing its synthetic opioid Subsys.1 Clough was one of the 

country's top-five prescribers of Subsys, and some of his patients 

suffered the unfortunate consequences of that ranking, including 

opioid addiction. Insys repaid Clough's prescribing diligence by 

giving him a place in the company's speaker program -- a perk that 

paid him nearly $50,000, often to "educate" non-existent audiences 

about the miracles of Subsys. On appeal Clough claims the 

government introduced insufficient evidence to support his 

convictions and that the government had the burden to prove that 

his conduct fell outside of the Anti-Kickback Statute's personal 

services safe harbor provision. And compounding this error, says 

Clough, was the district court's failure to instruct the jury about 

that same safe harbor provision. Finding no merit in Clough's 

arguments, we affirm. 

1 Subsys is a transmucosal immediate release fentanyl 

("TIRF") drug that is delivered into the body by means of a spray 

under the tongue and that the FDA approved for terminal cancer 

patients who experience extreme "breakthrough pain" and who are 

otherwise already on round-the-clock opioids. The major risks 

associated with TIRF drugs include respiratory depression (slowed 

breathing), sedation, and addiction. 
- 3 - 

BACKGROUND

 Because Clough challenges the sufficiency of the 

evidence, "we will recite the facts in the light most compatible 

with the jury's verdict." United States v. Serunjogi, 767 F.3d 

132, 135 (1st Cir. 2014) (citing United States v. Polanco, 634 

F.3d 39, 40 (1st Cir. 2011)). We summarize the facts to begin, 

adding more later as needed for our legal discussions. 

Speaker for Hire 

 With disappointing profits following Subsys's initial 

release, Insys crafted a sham speaker program. This is how it 

worked. Company executives undertook to supercharge prescriptions 

of the expensive drug by finding "just one good doc[tor]" or 

physician assistant2 in areas across the country willing to push 

its pharmaceutical without constraint. The scheme was simple; the 

more prescriptions that medical providers wrote for higher doses 

(which brought in sinful profits to Insys), the more meetings got 

scheduled in which Insys would pay providers like Clough to tout 

the phenomenal benefits of Subsys to other medical prescribers.3 

2 For simplicity, we will collectively refer to doctors, 

nurse practitioners, physician assistants, and other medical 

providers as "medical providers" throughout the opinion. 

3 Indeed, Insys deployed this scheme across the nation. See 

Stacey A. Tovino, Fraud, Abuse, and Opioids, 67 U. Kan. L. Rev.

901, 909-914 (June 2019) (describing multiple convictions for 

violations of Anti-Kickback Statute of medical providers who 

participated in Insys's speaker program across the nation); see 

also United States v. Ruan, 966 F.3d 1101, 1146 (11th Cir. 2020) 
- 4 - 

All too often though, nobody showed up for these presentations. 

Yet, Insys still paid the speakers, thus "hook[ing]" them in the 

same way that Subsys threatened to hook patients. Clough concedes 

that the Insys speaker program was an illegal scheme designed to 

incentivize physicians and providers to prescribe Subsys. He just 

contends he kept free from the taint. 

 Natalie Levine,4 an Insys pharmaceutical representative 

who sold Subsys and who "pled guilty to a conspiracy with 

prescribers to [organize] sham speaker programs" with "kickbacks" 

for those prescribers, barely broke a sweat looping Clough, a 

licensed physician assistant, into the scheme. When the two met, 

Clough worked at PainCare, a pain management clinic located in 

Somersworth, New Hampshire.5 As it happened, in the summer of 

(affirming guilty verdict for two doctors who conspired to violate 

the Anti-Kickback Statute because defendants agreed to "sham" 

speaker program with Insys); United States v. Schlifstein, No. 18-

CR-217 (KMW), 2020 WL 2539123, at *1 (S.D.N.Y. May 19, 2020) 

(describing "sham" Insys speaker programs for doctors who pled 

guilty to violating Anti-Kickback Statute, which "operated as 

follows: Insys paid kickbacks to the defendants in the form of 

speaker fees for sham Speaker Programs, and, in exchange, the 

defendants prescribed Subsys to their patients"); United States v. 

Freedman, No. 18-CR-217 (KMW), 2019 WL 3296967, at *1 (S.D.N.Y. 

July 23, 2019) (same). 

4 Following the events described, Natalie Levine married 

Insys President and CEO Michael Babich. Throughout his briefing, 

Clough refers to Levine using her married name, Natalie Babich. 

However, to steer clear of any possible confusion, we will refer 

to her by her maiden name. 

5 In New Hampshire, a physician assistant can prescribe 

medication under the supervision of a practicing physician. 
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2013, Clough inherited from a departing physician a patient who 

needed a refill of his prescription for Subsys. Because Clough 

had never prescribed the drug, PainCare invited Levine to attend 

Clough's first appointment with the patient to teach Clough how to 

navigate the complicated process of prescribing Subsys6 and of 

getting a specialty pharmacy to fill and dispense it. Moments 

after Clough approved and completed the Subsys refill (and while 

the patient was still in the room), Levine asked Clough if he would 

like to participate in the Insys paid speaker program. Clough 

jumped at the opportunity, but, as he explained, he wanted "doctor 

money." 

Becoming an Insys Proselytizer to No One in Particular 

 Despite Clough's eagerness, Insys required medical 

providers to hand out multiple doses to multiple patients before 

approving the provider as a speaker. So, Clough went at it. 

Clough had already written a second prescription on the very same 

However, the supervising physician is not required to approve each 

prescription that the physician assistant writes, even for 

controlled substances such as fentanyl. 

6 Prescribing Subsys was an onerous task. First, as a schedule 

II-controlled substance, medical providers needed to work through 

a specialty pharmacy to deliver Subsys to patients. Second, 

insurance companies did not want to cover Subsys due to its high 

cost and because medical providers could alternatively prescribe 

much cheaper generic TIRF drugs. To overcome that boundary, Insys 

representatives helped medical providers and their staffs obtain 

a "prior authorization" from the insurance company by convincing 

the companies that the patient needed Subsys instead of other, 

cheaper drugs. 
- 6 - 

day, June 27, 2013, that he first voiced interest in becoming an 

Insys speaker. Once Levine informed him of Insys's prescription 

requirement, Clough accelerated his pace, writing thirty-two 

prescriptions in July, almost all for doses higher than the 

recommended starting amount. 

Clough's whole-hearted embrace of Subsys did not escape 

Insys's notice. During a phone call in early August with Alec 

Burlakoff, Insys's Vice President of Sales, Burlakoff claimed he 

"could literally feel" Clough's enthusiasm about prescribing 

Subsys "coming through the phone;" this, even though Clough had 

almost certainly not had any follow-up visits with patients to 

whom he had prescribed the drug only a few weeks prior. Weeks 

into doling out Subsys, Clough had yet to lead any speaker 

programs. So Burlakoff stepped in and ordered Insys to provide 

Clough with substantial speaker opportunities. Those executing 

Burlakoff's demand, including Levine's boss, Jeffrey Pearlman, 

testified that the directive from the higher ups indicated clearly 

that "Clough was on board with the speaker programs and [with] 

Insys's way of using him" to drum up prescriptions. Indeed, it 

was Insys's strategy to "throw[] it in [the providers'] face[s]" 

that they would get "X [speaker] programs for X dollars" in 

speaker's fees. 

 On August 16, 2013, Clough signed the standard "Speaker 

Agreement" provided by Insys to its participating medical 
- 7 - 

providers. That agreement contains an express clause disclaiming 

any whiff of a notion that Insys would induce Clough to write more 

prescriptions in exchange for providing him with more speaker 

opportunities at $1,000 a pop.7 Yet Insys sales representatives, 

including Levine, testified to a separate unwritten but clearly 

understood side deal -- "kind of just like a little contract, but 

not an actual piece of paper contract" -- by which Insys paid 

medical providers speakers' fees in exchange for prescriptions. 

The number of prescriptions was the "only factor" in how Insys 

allocated those events, and Levine stated that Clough knew as much. 

Once Clough put his signature on the Speaker Agreement, he upped 

his prescription ante, meting out Subsys to an increasing number 

of patients in increasing dosages, sometimes without ever 

informing his patients of the prescription or the substantial risks 

associated with the drug, let alone telling them about his 

financial interest in the success of Subsys.8 

7 According to the agreement, Clough's compensation for 

participating in the speaker's program "will not be based upon the 

volume or value of any business generated between speaker and INSYS 

with respect to INSYS products." 

8 The parties stipulated that the federal government, through 

Medicare, paid about $2.1 million for a portion of the Subsys 

prescriptions that Clough wrote. 
- 8 - 

Speaking to No One in Particular

 Between September 2013 and October 2014, Clough 

participated in approximately one Insys speaker program per week, 

earning himself about $49,303 in fees.9 If the event turned out 

to be a no-show, Clough's contract with Insys formally mandated 

that the program be cancelled resulting in no payment to the 

speaker. Informally though, Insys executives preferred for the 

events, all of which got booked in high-end restaurants, not to be 

cancelled so as to keep prescribers hooked on the money. For a 

majority of the dinners for which Insys paid Clough, Levine gave 

Clough notice in advance that no other providers had RSVP'd to 

attend. But none of the dinners were kiboshed. Instead, Clough 

provided Levine with the names of other medical providers, mostly 

his colleagues, and then forged their signatures on a sign-in 

sheet, which concealed the illegitimacy of the sham speaking 

engagement, and which gave cover to Insys to pay Clough without 

appearing to violate the Anti-Kickback Statute. Multiple medical 

providers with whom Clough had worked, including his ex-wife with 

whom he was going through a divorce at that time, testified that 

9 This does not include the value of the many dinners at 

fancy restaurants for which Insys paid. 
- 9 - 

they never attended events for which their names appeared on 

Clough's sign-in sheets. 

Trial with an Audience of 12 

Following an investigation into this scheme, Clough was 

charged with one count of conspiracy to accept kickbacks for 

prescribing drugs paid for by a federal health care program in 

violation of 18 U.S.C. § 371 and seven counts of accepting such 

kickbacks in violation of the Anti-Kickback Statute, 42 U.S.C. 

§ 1320a-7b(b). During the six-day trial that ensued, Clough 

properly moved for judgment of acquittal pursuant to Federal Rule 

of Criminal Procedure 29, arguing "that there's not enough 

[evidence] to proceed to the jury." The court reserved judgment 

allowing the case to go to a New Hampshire jury which found Clough 

guilty of all charges. Thereafter, the district court denied 

Clough's Rule 29 motion and imposed sentence.10 And here we are. 

DISCUSSION

 Before us Clough advances arguments which boil down to 

two overarching claims of error: (1) the government did not 

present sufficient evidence to prove that he participated in a 

conspiracy to receive kickbacks, or to prove that he accepted those 

kickbacks in exchange for prescribing Subsys; and (2) the district 

10 The district court sentenced Clough to forty-eight months 

imprisonment, followed by two years of supervised release, and 

ordered Clough to pay $700,000 in restitution for a serious crime 

akin to "drug trafficking." 
- 10 - 

court committed plain error by not (sua sponte) instructing the 

jury about a safe harbor provision within the Anti-Kickback 

Statute. Neither argument convinces. 

1. Sufficiency of the Evidence 

 Defendants who challenge the sufficiency of the evidence 

journey a road well-traveled. Because Clough moved for a judgment 

of acquittal at trial asserting the same arguments below as here, 

he, as lawyers say, preserved the argument for appeal, and we 

accordingly review his appeal as if we were the first court to 

examine the question (i.e. de novo). See United States v. AcevedoHernández, 898 F.3d 150, 161 (1st Cir. 2018). To answer Clough's 

sufficiency challenge, we look at the evidence in the light most 

favorable to the verdict. See id. From there, we determine 

whether any reasonable jury, using common sense inferences based 

on their life experiences and knowledge, "could find all the 

elements of the crime proven beyond a reasonable doubt." Id.; see 

United States v. Iwuala, 789 F.3d 1, 11 (1st Cir. 2015) (reviewing 

conviction for health care fraud). We will not "weigh the evidence 

or make credibility judgments; these tasks are solely within the 

jury's province." Serunjogi, 767 F.3d at 139 (quoting United 

States v. Hernández, 218 F.3d 58, 64 (1st Cir. 2000)). 

Importantly, both direct and circumstantial evidence, whether 

alone or in concert, can sustain a conviction. See Hernández, 218 
- 11 - 

F.3d at 64 (1st Cir. 2000) (quoting United States v. Ortiz, 966 

F.2d 707, 711 (1st Cir. 1992)). 

 This standard applies both to Clough's challenge to the 

conspiracy conviction and to the conviction of violating the AntiKickback Statute. We tackle each in turn. 

A. Agreeing to Violate the Agreement (Conspiracy) 

 To prove that Clough conspired "to defraud the United 

States, or any agency thereof," under 18 U.S.C. § 371, the 

prosecution must demonstrate beyond a reasonable doubt 

that: (1) there was an agreement to commit an unlawful act -- 

here violating the Anti-Kickback Statute -- between the defendant 

and at least one other party; (2) the defendant participated 

knowingly and voluntarily in the conspiracy with the intent to 

violate the Anti-Kickback Statute; and (3) the defendant or 

another conspirator committed an overt act in furtherance of the 

conspiracy to violate the Anti-Kickback Statute.11 See Acevedo11 The third element -- an overt act -- is not in dispute 

because Clough wisely does not contend that he or a coconspirator 

never acted overtly in furtherance of the conspiracy. See United 

States v. Acevedo-Hernández, 898 F.3d 150, 161 (1st Cir. 2018). 

Such an argument would fall flat on its face considering that 

Clough participated in the speaker program, prescribed Subsys, and 

even fraudulently claimed that prescribers had attended his talks. 

Although 18 U.S.C. § 371 by its language requires an overt act to 

prove a conspiracy, see 18 U.S.C. § 371 ("[i]f two or more persons 

conspire either to commit any offense against the United States, 

or to defraud the United States, or any agency thereof in any 

manner or for any purpose, and one or more of such persons do any 

act to effect the object of the conspiracy.") (emphasis added), 

not every conspiracy statute in the United States Code mandates 
- 12 - 

Hernández, 898 F.3d at 161; United States v. Nowlin, 640 F. App'x 

337, 343 (5th Cir. 2016) (reviewing sufficiency challenge of 

conviction for conspiracy to violate Anti-Kickback Statute 

pursuant to 18 U.S.C. § 371). To succeed, the government therefore 

needed to prove that Clough conspired with Insys to receive illegal 

remuneration (the kickback payments through the speaker's program) 

as an inducement and in exchange for his prescribing Subsys to his 

patients in violation of the Anti-Kickback Statute.12 See United 

States v. Gorski, 880 F.3d 27, 31-32 (1st Cir. 2018) (government 

must not only prove defendant intended to agree, but that defendant 

that the government prove this third element, see, e.g., 18 U.S.C. 

§ 1349 (criminalizing "[a]ny person who attempts or conspires to 

commit any offense under this chapter"); 21 U.S.C. § 846 (no overt 

act requirement for conspiracy to possess drugs with the intent to 

distribute pursuant to 21 U.S.C. § 841(a)(1)). 

 12 The full text of the Anti-Kickback Statute, 42 U.S.C. 

§ 1320(a)-7b(b), reads: 

(b) Illegal remunerations 

(1) Whoever knowingly and willfully solicits or receives 

any remuneration (including any kickback, bribe, or 

rebate) directly or indirectly, overtly or covertly, in 

cash or in kind-- 

(A) in return for referring an individual to a person 

for the furnishing or arranging for the furnishing of 

any item or service for which payment may be made in 

whole or in part under a Federal health care program, or 

(B) in return for purchasing, leasing, ordering, or 

arranging for or recommending purchasing, leasing, or 

ordering any good, facility, service, or item for which 

payment may be made in whole or in part under a Federal 

health care program, 

shall be guilty of a felony and upon conviction thereof, 

shall be fined not more than $100,000 or imprisoned for 

not more than 10 years, or both. 
- 13 - 

willfully entered agreement with intent to violate underlying 

statute). 

 In general, the government may prove "a conspiracy . . . 

based on a tacit agreement shown from a[] . . . working 

relationship." United States v. Willson, 708 F.3d 47, 54 (1st 

Cir. 2013) (quoting United States v. Patrick, 248 F.3d 11, 20 (1st 

Cir. 2001)); see also United States v. Ríos-Ortiz, 708 F.3d 310, 

315-16 (1st Cir. 2013) ("A conspiratorial agreement . . . 'need 

not be express so long as its existence can plausibly be inferred 

from the defendants' words and actions . . . .'") (quoting United 

States v. Famania–Roche, 537 F.3d 71, 78 (1st Cir. 2008)). 

Further, as with any conviction, the government can prove that a 

defendant agreed to conspire based on circumstantial evidence. 

See United States v. McDonough, 727 F.3d 143, 156 (1st Cir. 2013) 

(quoting United States v. Rivera Calderón, 578 F.3d 78, 88 (1st 

Cir. 2009)). Moreover, in a case such as this, because a written 

contract disavowing kickbacks does not necessarily defeat the 

government's case, we must examine whether a rational jury, based 

on all evidence presented, could find that Clough had otherwise 

entered into a conspiracy with Insys to defraud the government 

notwithstanding his signature on the Speaker Agreement containing 

the disclaimer. See United States v. Tull-Abreu, 921 F.3d 294, 

305 (1st Cir. 2019) (holding that no direct testimony needed from 
- 14 - 

coconspirators to prove agreement to conspire to commit health 

care fraud). 

Clough struggles to speak over the volume of the 

government's case by arguing that the prosecution could not prove 

either of the first two elements of conspiracy: (1) the existence 

of an agreement; and (2) his knowing and voluntary participation 

with the intent to violate the Anti-Kickback Statute. Clough tries 

to shield himself by pointing to the formal Speaker Agreement and 

its explicit terms prohibiting Insys from tying speaker fees to 

Clough's prescribing habits.13 Because of those terms, Clough 

assiduously insists that he could not have willfully entered into 

a conspiracy with the intent to violate the Anti-Kickback Statute 

because he understood his relationship with Insys to be exactly as 

13 In this line of argument, Clough also maintains that 

because the government's case was based on circumstantial evidence 

(which it was), the government had the burden of proving that 

participation in the paid speaker program was an "obviously illegal 

activity" and that Clough was "ready to assist" in a criminal 

enterprise. That argument ends before Clough's presentation 

begins. That quoted standard is relevant to a charge of aiding 

and abetting, not conspiracy. See, e.g., United States v. PérezMeléndez, 599 F.3d 31, 42 (1st Cir. 2010) (holding that in 

circumstantial evidence cases, aiding and abetting liability 

requires proof "(1) that the vessel was engaged in obviously 

illegal activity and (2) that each defendant was ready to assist 

in the criminal enterprise") (quoting United States v. Guerrero, 

114 F.3d, 332, 342 (1st Cir. 1997)). The government did not charge 

Clough with aiding and abetting a conspiracy. See 18 U.S.C. § 2 

(general aiding and abetting statute). At trial, the government 

had no burden to address whether Clough participated in an 

"obviously illegal activity" or that he was ready to assist in a 

criminal enterprise. 
- 15 - 

the document describes, legal in every respect. Even if he had a 

"casual" understanding that Insys intended the speaker program to 

incent him to write prescriptions, Clough argues that the 

government provided insufficient direct evidence that he agreed to 

such a scheme. Dripping with incredulity, the government's brief 

hammers the wealth of circumstantial evidence that works against 

Clough's sophistry. So we turn to the evidence examined by the 

jury regarding Clough's conspiratorial decision-making, keeping in 

mind Clough's sufficiency challenge. 

On the first day Clough prescribed Subsys, he informed 

Levine that he wanted to join the speaker program, so long as he 

was paid "doctor money." When Levine soon thereafter told Clough 

that he could not participate without prescribing Subsys to 

multiple patients in multiple doses, Clough stepped up his 

prescription-writing prowess. In a matter of weeks, he had gone 

from having just learned about Subsys, and having only rarely 

prescribed other fast-acting fentanyl drugs in his career, to 

writing up copious Subsys scripts. He also expressed his palpablethrough-the-phone excitement about the drug to Insys executive 

Burlakoff in early August, likely before he had done any patient 

follow-up. By the time Clough signed the Speaker Agreement on 

August 16, 2013, he had prescribed Subsys around fifty times to 

his patients. A reasonable juror could infer that Clough's 

enthusiasm and prescribing practices came not from an infatuation 
- 16 - 

with the drug's efficacy as Clough argues, but from his knowledge 

that Insys would pay him through speaking events if he were to 

maintain or to accelerate his eye-popping Subsys prescribing pace. 

See, e.g., Iwuala, 789 F.3d at 11 (jury could find agreement to 

conspire to commit health care fraud from circumstantial 

evidence). 

Also, Clough's avarice, in the eyes of the jury, could 

well have demonstrated that he entered into a tacit agreement with 

Insys that went beyond the words of the Speaker Agreement. Levine 

testified that she and Clough had a "mutual understanding that if 

[he] write[s more] prescriptions [for Subsys], [he]'ll get more 

speaker programs." She described the understanding as more or 

less an oral agreement. At a dinner with Clough, Levine's boss 

made it clear that he "just need[ed] a few more patients and I can 

get you [(Clough)] a few more programs." Clough, according to 

Levine, responded in a way to make it clear that "he was fine with 

it; he was fine writing the drug." Clough's Insys business 

partners, as brought out during trial, certainly believed that 

they had a tacit agreement with Clough, and it was rational for a 

jury to find that Clough comprehended the true nature of his 

relationship to Insys. See Willson, 708 F.3d at 54; see also, 

Serunjogi, 767 F.3d at 139 (credibility determinations are for the 

trier of fact). 
- 17 - 

Further, Levine and Clough had a close working 

relationship; they spent many nights having dinner, either alone 

or with a group of Levine's friends, when no one would show up for 

Clough's nearly weekly speaking engagements (for which he still 

received pay despite doing no work other than prescribing Subsys). 

Levine also often travelled to Clough's office to help with the 

mountainous paperwork required to prescribe controlled substances 

like Subsys.14 Because of this regular business contact, a rational 

jury could find that Clough understood and tacitly agreed to 

Levine's "casually" conveyed message that Insys would pay Clough 

kickbacks through its speaker program so long as he prescribed 

Subsys in satisfactory quantities and doses (Insys would earn even 

more money when Clough prescribed higher doses). The jury had 

sufficient evidence, viewed in the light most favorable to the 

verdict, to conclude that the written speaker agreement was nothing 

but a smokescreen to hide Clough's conspiratorial conduct. See 

Willson, 708 F.3d at 54; Serunjogi, 767 F.3d at 139; United States 

v. Pfizer, 188 F. Supp. 3d 122, 134 (D. Mass. 2016) ("Formal 

14 Clough even had Levine complete certain applications to 

insurance companies that had denied coverage for Subsys to 

patients. The applications are supposed to be tailored to the 

individual patient, with the medical provider providing 

individualized reasons that they believe the previously denied 

medication was medically necessary for the patient. Rather than 

drafting those individualized applications himself, Clough 

provided a standard form to Levine to complete. The completed 

forms described a common collection of symptoms, often word for 

word, no matter what the patient actually suffered. 
- 18 - 

policies, of course, are only as good as their implementation; the 

very nature of a sham is that it pretends to be compliant when it 

is not."). 

 Turning to Clough's contention that the government 

provided insufficient evidence for a rational jury to find that he 

knowingly and voluntarily participated in the conspiracy with the 

intent to violate the Anti-Kickback Statute, we first sketch out 

the government's legal burden before applying law to facts. To 

prove Clough's intent, the government had to show that the 

defendant agreed to engage in the forbidden conduct, see United 

States v. Feola, 420 U.S. 671, 687 (1975), which here involved 

"knowingly and willfully" receiving illegal kickbacks in exchange 

for doling out prescriptions, see 42 U.S.C. § 1320a-7b(b)(2)(A). 

Without direct evidence, the government could prove "[a] 

defendant's knowing and [willful] participation" through 

"'inferences from acts committed by the defendant that furthered 

the conspiracy's purposes.'" Acevedo-Hernández, 898 F.3d at 162 

(quoting United States v. Castro-Davis, 612 F.3d 53, 60 (1st Cir. 

2010)). The already-described circumstantial evidence that Clough 

and Insys had an agreement to conspire also provides ample examples 

that Clough did so willingly and with the intent to violate the 

Anti-Kickback Statute so we need not repeat it here.15 But there 

15 A defendant need not have the intent to violate the AntiKickback Statute for a jury to convict the defendant of violating 
- 19 - 

is plenty more, some of which we highlight to explain why Clough's 

appeal cannot succeed. 

For one, Clough lied to an FBI investigator in 2016 about 

his interactions with Insys and about his prescribing habits for 

Subsys. When asked about Levine, Clough pretended not to be able 

to remember her name, despite their multiple business and social 

interactions -- he even took her to a World Series game at Fenway 

Park. Clough also falsely told the FBI investigator that he 

started most patients at the minimum dosage of Subsys (100 

micrograms) and that he never prescribed more than 400 or 500 

micrograms.16 The jury heard statistical evidence that put the 

truth to the lie. Another FBI investigator analyzed Clough's 

prescribing habits; he only prescribed 100 micrograms of Subsys 

once through his first 100 prescriptions, and he often prescribed 

the maximum of 1600 micrograms. The jury could have believed that 

Clough's memory failed him regarding Levine's name and his 

prescribing habits due to his rough emotional state at the time of 

the statute. It is enough that he knowingly and voluntarily 

accepts kickbacks. See 42 U.S.C. § 1320a-7b(b). 

16 The jury also heard evidence from which they could have 

inferred that Clough lied about why he stopped prescribing Subsys 

to his patients in 2014 when an insurance company investigated 

whether Clough's prescriptions, for which they paid, were 

legitimate. Clough claimed that he slowly stopped prescribing the 

medicine in early 2014 because he believed that its efficacy was 

diminishing, yet he continued to be a paid Insys speaker and to 

prescribe the drug through August 2014. 
- 20 - 

the interview, as he so testified. Or the jury could have inferred 

that Clough had fibbed to the FBI because he knew that his 

arrangement with Insys was conspiratorial and illegal. See United 

States v. Davis, 909 F.3d 9, 19 (1st Cir. 2019) ("It is a wellsettled principle that false exculpatory statements are evidence 

-- often strong evidence -- of guilt.") (internal citation and 

quotation marks omitted). 

As for other evidence submitted to prove that Clough 

knowingly and willingly participated in the kickback scheme, 

recall this. Levine "let [Clough] know" that Insys was "so happy 

that you've been writing a lot of their drug, so in return, we're 

going to give you some more speaker programs," and "I just need a 

few more patients and I can get you a few more programs." Remember 

too, the multiple no-show events wherein Levine testified that 

Clough forged the signatures of his co-workers to ensure Insys 

would pay him for speaker programs. The jury has the right to 

credit Levine's testimony which shows Clough was aware that the 

conspiracy involved kickbacks in exchange for prescriptions. See 

Serunjogi, 767 F.3d at 140. 

 The manner in which Clough treated his patients is 

additional evidence that he knowingly and voluntarily joined the 

conspiracy with the intent to violate the Anti-Kickback Statute. 

For several of them, Subsys endangered their health (if not their 

lives). Clough gave opioid-dependent patients high dosages of 
- 21 - 

this highly-addictive fentanyl drug, even when patients had no 

problems with their existing medicine regimen or when patients 

requested that Clough not change their existing prescriptions to 

include Subsys because they, in fact, worried about opioid 

addiction. Clough was apparently "fairly insistent" about his 

patients taking the drug, even going so far as to send Subsys 

prescriptions to two patients who did not know that he had 

prescribed it for them until it was delivered to their front doors. 

And he refused to change the Subsys prescription for patients who 

complained that the drug made them fall asleep at work or in 

public, telling one patient to stop "being a baby." Patients made 

Clough aware of other health problems resulting from their use of 

Subsys, but he did not lower their dosage or stop prescribing. 

Few, if any, of those patients had terminal cancer, which is the 

type of patient for whom Insys purportedly developed Subsys. Nor 

did Clough tell his patients about the drug's substantial risks. 

Continuing the abhorrent pattern, Clough withheld from them that 

he was a paid Insys speaker, which ethical rules required him to 

do so that his patients could decide whether Clough prescribed 

them medicine for their benefit or for his own. Finally, a clear 

pattern emerged showing a direct correlation between Clough's high 

dose prescription-writing and an increase in speaking engagements 

Clough received from Insys. All in all, a reasonable jury could 

have inferred from the totality of the evidence presented, and 
- 22 - 

from their own common sense, that Clough's aberrant behavior was 

not reminiscent of a physician assistant prescribing based on need, 

but rather of a drug pusher -- one who voluntarily furthered the 

conspiracy by knowingly and willfully enriching Insys at the 

expense of the U.S. Government in exchange for kickbacks through 

sham speaking engagements. See Acevedo-Hernández, 898 F.3d at 

162. 

 Before addressing Clough's next appellate argument, we 

add one last coda. On top of the overwhelming evidence from which 

the jury could have inferred that Clough willfully participated in 

a conspiracy to defraud the U.S. Government, Clough also faces the 

uncharitable position of speaking to a skeptical judicial 

audience. See United States v. Mitrano, 658 F.3d 117, 120 (1st 

Cir. 2011) (defendants who challenge the sufficiency of the 

evidence typically face an uphill battle). Clough's claims that 

Insys took advantage of his gullibility and of his genuine belief 

in Subsys at a vulnerable time in his life, and that he had no 

intention to join a conspiracy, may be plausible, but those 

defenses did not convince at trial and they cannot overcome this 

crowd's reluctance to subvert the jury. See United States v. Seng 

Tan, 674 F.3d 103, 107 (1st Cir. 2012) ("[R]aising a plausible 

theory of innocence does the defendant no good, because the issue 

is not whether a jury rationally could have acquitted but whether 

it rationally could have found guilt beyond a reasonable doubt."); 
- 23 - 

see also United States v. Hill, 745 F. App'x 806, 814-815 (11th 

Cir. 2018) (circumstantial evidence overwhelmed claims that 

defendant was an unwilling pawn in marketing team's health care 

fraud conspiracy). 

After a thorough review of Clough's challenges, we 

uphold the conspiracy verdict, one which is clearly "supported by 

a plausible rendition of the record." Hernández, 218 F.3d at 64 

(quoting Ortiz, 966 F.2d at 711). 

B. The Actual Crime of Receiving Kickbacks 

 Clough also takes aim at the sufficiency of the evidence 

introduced in support of his substantive anti-kickback conviction, 

alleging as well, for the first time on appeal, that the government 

had the burden to prove that his conduct fell outside of the AntiKickback Statute's safe harbor provision. To remind, our 

sufficiency review is de novo and our view of the evidence is in 

the light most favorable to the verdict. See Acevedo-Hernández, 

898 F.3d at 161. In federal criminal law, the conspiracy to commit 

the crime and the actual crime are separate, and the government 

must prove both beyond a reasonable doubt. See Iwuala, 789 F.3d 

at 11-12 (separating analyses for both crimes). The same evidence, 

though, can support each conviction. See id. at 12. 

The Anti-Kickback Statute criminalizes any kickback 

knowingly and willingly offered, paid, solicited, or received in 

exchange for, among other behavior, prescribing a drug for which 
- 24 - 

a federal health care program has picked up the check. See 42 

U.S.C. § 1320a–7b(b)(2)(A); Guilfoile v. Shields, 913 F.3d 178, 

188-89 (1st Cir. 2019). The statute allows for the Department of 

Health and Human Services to promulgate a personal services safe 

harbor provision which provides that in personal services 

contracts, remuneration "does not include" payments made by a 

principal (here, Insys) to an agent (here, Clough) for certain 

services, such as speaking programs, so long as the arrangement 

does not compensate based on the number of prescriptions written 

by Clough for which "Medicare, Medicaid, or other Federal health 

care programs" pay.17 42 C.F.R. § 1001.952(d)(5). If a paymentstructure falls within this safe harbor provision, then the 

participant would not violate the Anti-Kickback Statute. See 

United States v. Vega, 813 F.3d 386, 397 (1st Cir. 2016). 

 In a vein similar to his sufficiency challenges, Clough 

first argues that the Speaker Agreement puts him snugly within the 

17 The relevant language in the safe harbor provision is as 

follows: 

'remuneration' does not include any payment made by a 

principal to an agent as compensation for the services 

of the agent, as long as . . . [t]he aggregate 

compensation paid to the agent . . . is not determined 

in a manner that takes into account the volume or value 

of any referrals or business otherwise generated between 

the parties for which payment may be made in whole or in 

part under Medicare, Medicaid or other Federal health 

care programs. 

 

42 C.F.R. § 1001.952(d)(5). 
- 25 - 

safe harbor provision, and that the Speaker Agreement prevented 

the government from proving beyond a reasonable doubt that Clough 

knowingly and willfully violated the Anti-Kickback Statute. Once 

more, taking the evidence in the light most favorable to the 

verdict, we assess whether a rational jury could have found that 

the government met its burden. See Serunjogi, 767 F.3d at 139. 

 As the government concedes, Clough's participation in a 

bona fide speaker program would have been lawful had it fallen 

within the parameters of the safe harbor provision. But, as with 

the conspiracy charge, and keeping in mind the detailed terrain 

discussed above, we find the government produced sufficient 

evidence, viewed in the light most favorable to the verdict, for 

a rational juror to conclude that an unwritten, "mutual 

understanding" of a kickback scheme actually governed the 

relationship between Clough and Insys. See Serunjogi, 767 F.3d at 

140 ("It suffices if the conclusions that the jury draws from the 

evidence, although not inevitable, are reasonable."). No matter 

the written terms of the agreement, the actual relationship between 

Insys and Clough (as the jury necessarily concluded) fell outside 

of the safe harbor provision because the payments from Insys to 

Clough were "determined in a manner that [took] into account the 

volume" of prescriptions that he wrote. 42 C.F.R. 

§ 1001.952(d)(5). See also Pfizer, 188 F. Supp. 3d at 134 ("If 

relators had adduced evidence that Pfizer's speaker series was 
- 26 - 

really meant to compensate doctors for prescribing Pfizer drugs, 

then the series would quickly fall out of the personal services 

safe harbor."). 

Clough next argues relatedly that the "[g]overnment had 

an obligation to address" the safe harbor provision with the jury 

because it introduced the Speaker Agreement. As he claims, "the 

[g]overnment presented no evidence regarding the Speaker 

Agreement's impact on the [Anti-Kickback Statute] violations or 

sought any determination as to whether Clough considered the 

written agreement, as opposed to these amorphous 'verbal 

contracts,' as controlling his relationship with Insys." 

Notwithstanding our doubt about Clough's contention that the 

government had an affirmative burden to disprove that Clough's 

conduct fell within the Speaker Agreement terms -- an issue the 

First Circuit has never addressed -- we would at best review the 

argument for plain error since Clough never raised it below.18 

Given that the two circuits to have addressed the issue, albeit in 

unpublished cases, have suggested that the Anti-Kickback Statute's 

safe harbor provision is an affirmative defense, see United States 

18 To establish plain error, a "defendant must show (1) that 

an error occurred (2) which was clear or obvious and which not 

only (3) affected the defendant's substantial rights, but also (4) 

seriously impaired the fairness, integrity, or public reputation 

of judicial proceedings." United States v. Vega, 813 F.3d 386, 

396 (1st Cir. 2016) (quoting United States v. González–Vélez, 466 

F.3d 27, 35 (1st Cir. 2006)).
- 27 - 

v. Job, 387 F. App'x 445, 455-56 (5th Cir. 2010) (citing United 

States v. Norton, 17 F. App'x 98, 102 (4th Cir. 2001)), and that 

Clough cannot point to any federal-appellate case law supporting 

his position, he cannot show an error that was plain, see United 

States v. Romero, 906 F.3d 196, 207 (1st Cir. 2018) ("With no 

binding precedent on his side, [defendant] cannot succeed on plainerror review unless he shows" that theory "is compelled" by 

constitutional law, statute, regulation, or other legal mandate); 

United States v. Correa-Osorio, 784 F.3d 11, 21 & n.12 (1st Cir. 

2015); United States v. Marcano, 525 F.3d 72, 74 (1st Cir. 2008) 

(per curiam) ("plain error cannot be found . . . absent clear and 

binding precedent"); see also United States v. Whab, 355 F.3d 155, 

158 n.1 (2d Cir. 2004) (plain error impossible without Supreme 

Court or controlling precedent from the same circuit, no matter if 

other circuits are split on the issue). 

But even if the government has such an affirmative burden 

to prove Clough's conduct falls outside the scope of the safe 

harbor provision, it more than satisfied that burden. This is so 

because if the jury had believed that Clough received payments 

from Insys as part of a bona fide business relationship, they would 

have, as instructed by the judge, found Clough not guilty because 

he would have "accepted the remuneration from Insys for a reason 

other than his writing of prescriptions for Subsys and that this 
- 28 - 

other reason was his only reason for accepting remuneration." 

Clearly, the jury thought otherwise. 

 Without recourse to the safe harbor provision, the 

defendant has little left with which to sweep away the conviction, 

and we affirm. See Guilfoile, 913 F.3d at 188-89 (quoting the 

Anti-Kickback Statute); United States v. Nagelvoort, 856 F.3d 

1117, 1125-26 (7th Cir. 2017) (describing kickback scheme that 

fell outside safe harbor provision even though defendants 

concealed payments within seemingly legitimate contractual 

arrangements). 

2. Jury Instruction 

Clough takes a final (and related) stab at securing a 

new trial, aiming at what he claims was a misstep by the district 

court in articulating the jury instructions. For the first time, 

he argues that the omission of a jury instruction concerning the 

safe harbor provision of the Anti-Kickback Statute was error. 

Without such an instruction, he hypothesizes that the jury could 

not have considered whether the payments Clough received from Insys 

would have fallen outside of the definition of kickbacks. We need 

not linger over Clough's contentions because he waived this claim 

by failing to request such an instruction below. See United States 

v. Dávila–Nieves, 670 F.3d 1, 9 (1st Cir. 2012) ("We have 

considered the failure to request a jury instruction to waive the 

right to that instruction."). See also Fed. R. Crim. P. 30(d). 
- 29 - 

Even if we were to bypass waiver and review for plain 

error, see Fed. R. Crim. P. 52(b), Clough still would not prevail. 

We have been clear time and again that, "[w]here a defendant does 

not offer a particular instruction and does not rely on the theory 

of defense embodied in that instruction at trial, the district 

court's failure to offer an instruction on that theory sua sponte 

is not plain error." United States v. Alberico, 559 F.3d 24, 27 

(1st Cir. 2009) (quoting United States v. George, 448 F.3d 96, 100 

(1st Cir. 2006)). "[T]he plain error hurdle . . . nowhere looms 

larger than in the context of alleged instructional errors." 

United States v. González–Vélez, 466 F.3d 27, 35 (1st Cir. 2006) 

(quoting United States v. Paniagua–Ramos, 251 F.3d 242, 246 (1st 

Cir. 2001)). 

Clough neither offered an instruction related to the 

safe harbor provision nor relied upon a safe harbor theory at 

trial. The closest that he came was in his opening and closing 

when he mentioned the "contract" (Speaker Agreement) that he had 

with Insys; Clough, however, never connected the Speaker 

Agreement's language to the Anti-Kickback Statute's safe harbor 

provision. The district court did not plainly err when it issued 

no such instruction. See Alberico, 559 F.3d at 27. 
- 30 - 

CONCLUSION 

For the reasons set out above, none of Clough's arguments 

move the needle from where the jury left it. Thus, Clough's 

conviction is affirmed.