United States v. Clough

19-1621P

2020 | Cited 0 times | First Circuit | October 23, 2020

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

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.

1Subsys 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.

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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)

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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.

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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

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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.

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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.

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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."

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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. Acevedo-

Hernández, 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

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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 Anti-

Kickback 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 Acevedo-

11 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

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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.

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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

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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. Pérez- Meléndez, 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.

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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 palpable-

through-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

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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).

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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.

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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 Anti- Kickback Statute for a jury to convict the defendant of violating

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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.

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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 well-

settled 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

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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

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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.");

- 22 -

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 Anti-

Kickback 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

- 23 -

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 payment-

structure 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).

- 24 -

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

- 25 -

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

18To 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)).

- 26 -

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 plain-

error 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

- 27 -

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).

- 28 -

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 .

- 29 -

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.

- 30 -

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

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.

1Subsys 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.

- 2 -

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)

- 3 -

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.

- 4 -

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.

- 5 -

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

- 6 -

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.

- 7 -

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.

- 8 -

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."

- 9 -

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. Acevedo-

Hernández, 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

- 10 -

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 Anti-

Kickback 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 Acevedo-

11 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

- 11 -

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.

- 12 -

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

- 13 -

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. Pérez- Meléndez, 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.

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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 palpable-

through-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

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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).

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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.

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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 Anti- Kickback Statute for a jury to convict the defendant of violating

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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.

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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 well-

settled 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

- 20 -

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

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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.");

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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 Anti-

Kickback 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

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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 payment-

structure 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).

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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

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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

18To 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)).

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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 plain-

error 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

- 27 -

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).

- 28 -

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 .

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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.

- 30 -

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