United States Ex Rel. Greenfield v. Medco Health Solutions, Inc.

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
________________
No. 17-1152
________________
UNITED STATES OF AMERICA, ex rel.
STEVE GREENFIELD,
Appellant
v.
MEDCO HEALTH SOLUTIONS, INC.;
ACCREDO HEALTH GROUP, INC.;
HEMOPHILIA HEALTH SERVICES, INC.
________________
On Appeal from the United States District Court
for the District of New Jersey
(D.C. Civil Action No. 1-12-cv-00522)
District Judge: Honorable Noel L. Hillman
________________
Argued September 27, 2017
Before: AMBRO and KRAUSE, Circuit Judges, and
CONTI, Chief District Judge
(Opinion filed: January 19, 2018)
Ross Begelman
Marc M. Orlow
Regina D. Poserina (Argued)
Begelman Orlow & Melletz
411 Route 70 East, Suite 245
Cherry Hill, NJ 08034
Counsel for Appellant
Paul E. Boehm
Enu Mainigi
Craig D. Singer (Argued)
Daniel M. Dockery
Williams & Connolly
725 12th Street, N.W.
Washington, DC 20005
Counsel for Appellees
Chad A. Readler
Acting Assistant Attorney General
William E. Fitzpatrick
Acting United States Attorney

Honorable Joy Flowers Conti, Chief Judge of the United
States District Court for the Western District of Pennsylvania,
sitting by designation.
2
Katherine T. Allen (Argued)
Michael S. Raab
Charles W. Scarborough
United States Department of Justice
Civil Division, Appellate Staff
950 Pennsylvania Avenue, N.W.
Washington, DC 20530
Counsel for Amicus Curiae in Support of Neither Party
United States of America
________________
OPINION OF THE COURT
________________
AMBRO, Circuit Judge
Accredo Health Group, Inc., a specialty pharmacy that
provides home care for patients with hemophilia (a rare
condition that prevents blood from clotting properly), made
donations to charities, two of which allegedly recommended
Accredo as an approved provider for hemophilia patients. This
raises whether the donations came with something expected in
return for the recommendations, which might trigger violations
of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and, if
so, whether Accredo’s healthcare reimbursement claims for
persons who may have received the charities’
recommendations run afoul of the False Claims Act, 31 U.S.C.
§ 3729(a)(1)(A)-(B). No federal agency, however, made a
claim against Accredo. In stepped Steve Greenfield, a private
citizen and a former area vice president of Accredo, who sued
it and affiliates Medco Health Solutions, Inc., and Hemophilia
Health Services, Inc. (for simplicity, all are referred to as
3
“Accredo”) for alleged violations of the two federal statutes.1
If Greenfield prevailed, he would get at least 25% of any civil
penalty or damages award.
The District Court, at the end of discovery, entered
summary judgment against Greenfield and for Accredo, and
the Government here has chosen not to intervene. It found that
Greenfield failed to provide evidence of even a single federal
claim for reimbursement by Accredo that was linked to the
alleged kickback scheme. As he disagrees, Greenfield appeals
to us.
I. BACKGROUND
Accredo delivers clotting medication (medically called
“clotting factor”) to patients at their homes and provides
nursing assistance that is tailored to hemophilia patients’
needs. Along with its pharmaceutical services, Accredo makes
donations to various charities, including two that are pertinent
to this appeal: Hemophilia Services, Inc. (“HSI”), and
Hemophilia Association of New Jersey (“HANJ,” and
collectively with HSI, “HSI/HANJ”). From 2007 to 2012,
1
The legalese term for this type of private-suit piggybacking
on federal statutes is a qui tam action. “Qui tam is short for the
Latin phrase qui tam pro domino rege quam pro se ipso in hac
parte sequitur, which means ‘who pursues this action on our
Lord the King's behalf as well as his own.’” Vt. Agency of Nat.
Res. v. United States ex rel. Stevens, 529 U.S. 765, 768 n.1
(2000). A private person, called a qui tam relator, brings an
action “‘for the person and for the United States Government’
against the alleged false claimant, ‘in the name of the
Government.’” Id. at 769 (quoting 31 U.S.C. § 3730(b)(1)).
4
Accredo’s donations to HSI/HANJ ranged from approximately
$200,000 to $550,000 on an annual basis.
Accredo contributed funds to HSI, which in turn
provided grants to HANJ. HSI’s grants served two purposes—
an insurance program for patients who are not eligible for
Medicare or Medicaid, and support for outpatient hemophilia
treatment centers. Accredo believed its donations went to
HANJ’s insurance program, but was aware that HANJ also
funded treatment centers.
HANJ purportedly recognized Accredo’s contributions
by identifying it as an HSI-approved provider or HSI-approved
vendor on its website. It stated HSI-approved vendors
“maintain the highest quality of care while providing [a]
continuity of services and constantly supporting the
community in numerous ways.” It also directed users to
“[r]emember to work with our HSI [approved] providers” and
included hyperlinks to the approved providers’ websites.
HANJ also provided treatment centers with lists identifying
specialty pharmacies that were designated as HSI-approved
providers. Accredo was noted in one list as one of four HSI-
approved vendors that “continually contribute to this
community.”
Although Accredo donated approximately $363,000 to
HSI/HANJ in 2010, it informed both charities that it planned
to reduce its annual donation to $175,000 in the following year.
In response, HSI sent a letter to its members informing them of
Accredo’s reduced pledge and encouraging them to request
that Accredo restore funding. HSI’s letter focused on the
possible shortfalls to HANJ’s private insurance program; in
HSI’s view, Accredo’s funding cuts would “place[] the
Insurance Program in jeopardy of being ‘phased out’ and
ceasing to exist in the foreseeable future.” HSI also forwarded
a copy of the letter to treatment centers, stating that “[t]he
5
attached [letter] is self explanatory. [Hemophilia Health
Services]/Accredo has behaved despicably, while enjoying the
fruits of HANJ’s labor.”
As a result of HSI’s letter, Accredo received
approximately 75 letters from HSI members requesting an
increase in funding. It then asked Greenfield (as noted, an area
vice president for Accredo) to analyze the potential return on
investment if it were to increase its annual donation from
$175,000 to $350,000. It also requested him to project the
“likely business deterioration to [its New Jersey] market share”
if it opted not to increase funding. Greenfield’s analysis
indicated that, absent a funding increase to $350,000, “all new
and existing business [could be] at risk,” and Accredo could
expect to “lose 100% of the margin” associated with patients
who switched out of Accredo’s services. Based on this
analysis, Accredo restored its annual donation to $350,000 in
2012.
Greenfield thereafter filed a qui tam suit against
Accredo, alleging it violated the False Claims Act by falsely
certifying it complied with the Anti-Kickback Statute.2
Although the statutory scheme gave the Government the option
to intervene in the suit, it declined to do so. See 31 U.S.C.
§ 3730(b)(2).
The case proceeded to summary judgment, where the
parties’ cross-motions presented differing theories on whether
Greenfield had established a False Claims Act violation. He
argued Accredo violated the Act by paying kickbacks to
HSI/HANJ in the form of charitable contributions to induce
recommendations and referrals of Accredo by HSI/HANJ to its
2
Greenfield initially brought multiple claims against Accredo,
but his operative complaint alleges only False Claims Act
violations.
6
members. In Greenfield’s view, Accredo’s alleged kickback
scheme amounted to a False Claims Act violation because at
least some referrals or recommendations were directed to
Medicare beneficiaries and because Accredo falsely certified
compliance with the Anti-Kickback Statute while submitting
Medicare claims for payment.3 Accredo argued Greenfield
could not prove a violation of the False Claims Act, as there
was no evidence any federally insured patient purchased its
prescriptions because of its contributions to HSI/HANJ.
The District Court denied Greenfield’s motion for
summary judgment while granting that of Accredo. In the
Court’s view, his claim required him to (1) “establish that
defendants violated the [Anti-Kickback Statute] through [their]
alleged quid pro quo arrangement with HANJ/HSI” and (2)
“show that, as a result of defendants’ [Anti-Kickback Statute]
violation, defendants received payment from the federal
government” in violation of the False Claims Act. United
States ex rel. Greenfield v. Medco Health Sys., Inc., 223 F.
Supp. 3d 222, 227 (D.N.J. 2016). For purposes of its analysis,
the Court did not determine whether Greenfield established an
3
When billing Medicare for a federal claim, Accredo needed
to certify its compliance with the Anti-Kickback Statute on
CMS Form 855s, which states in relevant part “I understand
that payment of a claim by Medicare is conditioned upon the
claim and the underlying transaction complying with
[Medicare] laws, regulations, and program instructions
(including, but not limited to, the Federal [A]nti-[K]ickback
[S]tatute . . . ), and on the supplier’s compliance with all
applicable conditions of participation in Medicare.”
7
Anti-Kickback Statute violation.4 Instead, it focused its
analysis on the second prong of the inquiry and concluded that,
even if an Anti-Kickback Statute violation were assumed,
Greenfield did not show sufficient evidence of a False Claims
Act violation.
Although discovery revealed that Accredo submitted
claims for 24 federally insured patients during the relevant time
period, the Court concluded this evidence alone did not provide
“the link between defendants’ 24 federally insured customers
and defendants’ donations to HANJ/HSI.” Id. at 230. Instead,
it explained Greenfield must show that federally insured
patients were referred to Accredo as a result of its donations to
HSI/HANJ. “Absent some evidence . . . that those patients
chose Accredo because of its donations to HANJ/HSI,” the
Court reasoned, Greenfield could not carry his burden on his
claim. Id. Thus it entered summary judgment for Accredo.
Greenfield appeals, arguing the District Court erred in
requiring him to prove a direct link between the alleged
kickback scheme and each false claim. The Government
appears as an amicus curiae in support of neither party,
contending the Court erred to the extent it required Greenfield
to prove that patients chose Accredo because of HSI/HANJ’s
referrals and recommendations. In its view, all that needed to
be shown was a claim that sought reimbursement for medical
care that was provided in violation of the Anti-Kickback
Statute. In response, Accredo maintains, inter alia, that the
District Court correctly stated Greenfield’s burden in
establishing a False Claims Act breach.
4
Like the District Court, we express no view on whether
Accredo’s charitable contributions were illegal kickbacks
under the Anti-Kickback Statute.
8
II. STANDARD OF REVIEW
Our review of a district court’s grant of summary
judgment is de novo. See Thomas v. Cumberland County, 749
F.3d 217, 222 (3d Cir. 2014). Summary judgment is proper
when “there is no genuine dispute as to any material fact and
the movant is entitled to judgment as a matter of law.” Fed. R.
Civ. P. 56(a). A genuine dispute exists “if the evidence is such
that a reasonable jury could return a verdict for the non[-
]moving party.” Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 248 (1986). The non-moving party must “go beyond the
pleadings” and “designate specific facts” in the record
“showing that there is a genuine issue for trial.” Celotex Corp.
v. Catrett, 477 U.S. 317, 324 (1986) (internal quotation marks
omitted). “Only disputes over facts that might affect the
outcome of the suit under the governing law will properly
preclude the entry of summary judgment.” Anderson, 477 U.S.
at 248.
III. ANALYSIS
A. Must an HSI/HANJ Member Subjectively
Choose to Use Accredo Because of the Alleged
Kickback Scheme?
As noted, Greenfield contends the District Court erred
by requiring a direct “link” between the donations to
HSI/HANJ by Accredo and its 24 federally insured customers.
He argues Accredo violated the False Claims Act because it
certified compliance with the Anti-Kickback Statute while
paying HSI/HANJ via donations in exchange for
recommendations. Accordingly, he claims no need to identify
specific false claims related directly to the alleged kickback
scheme.
1. The False Claims Act
9
The False Claims Act imposes liability on any person
who “(A) knowingly presents, or causes to be presented, a false
or fraudulent claim for payment or approval; [or] (B)
knowingly makes, uses, or causes to be made or used, a false
record or statement material to a false or fraudulent claim.”5
31 U.S.C. § 3729(a)(1). A false or fraudulent claim may be
either factually false or legally false. “A claim is factually false
when the claimant misrepresents what goods or services . . . it
provided to the Government. . . .” United States ex rel. Wilkins
5
Although Congress amended the False Claims Act in 2009 by
enacting the Fraud Enforcement and Recovery Act (“FERA”),
it did not substantially alter the provisions of the pre-FERA
version of the False Claims Act, which imposed liability on
any person who—
(1) knowingly presents, or causes to be
presented, to an officer or employee of the
United States Government or a member of the
Armed Forces of the United States a false or
fraudulent claim for payment or approval; [or]
(2) knowingly makes, uses, or causes to be made
or used, a false record or statement to get a false
or fraudulent claim paid or approved by the
Government.
31 U.S.C. § 3729(a)(1)-(2).
Because only § 3729(a)(1)(B) of FERA is retroactive to June
7, 2008, both the pre-FERA and FERA versions of the False
Claims Act apply in our case. See Fraud Enforcement and
Recovery Act of 2009, Pub. L. No. 111-21 § 4(f)(1), 123 Stat.
1617, 1625 (2009). The minor differences in the two versions
of the statute do not affect our analysis.
10
v. United Health Grp., Inc., 659 F.3d 295, 305 (3d Cir. 2011).
It is legally false when the claimant lies about its compliance
with a statutory, regulatory, or contractual requirement. See id.
Where, as here, a plaintiff contends a defendant’s claim
is legally false, he or she must also prove the defendant’s
misrepresentation about its compliance with a legal
requirement is “material to the Government’s payment
decision.” Universal Health Servs., Inc. v. United States ex rel.
Escobar, 136 S. Ct. 1989, 1996 (2016). “[P]roof of materiality
can include, but is not necessarily limited to, evidence that the
defendant knows that the Government consistently refuses to
pay claims in the mine run of cases based on noncompliance
with the particular statutory, regulatory, or contractual
requirement.” Id. at 2003.
2. The Anti-Kickback Statute
To repeat, Greenfield contends Accredo’s claims were
legally false because they were incorrectly certified as
compliant with the Anti-Kickback Statute. In pertinent part,
the Statute prohibits “knowingly and willfully” offering or
paying “any remuneration . . . to any person to induce such
person . . . to refer an individual to a person 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.” 42
U.S.C. § 1320a-7b(b)(2)(A). It also prohibits “knowingly and
willfully solicit[ing] or receiv[ing]” kickbacks “in return” for
such conduct. Id. § 1320a-7b(b)(1)(A).
Congress amended the Anti-Kickback Statute in 2010
to provide “a claim that includes items or services resulting
from a violation of [that Statute] constitutes a false or
fraudulent claim for purposes of [the False Claims Act].” Id.
§ 1320a-7b(g). Although the amendment is not retroactive, see
Wilkins, 659 F.3d at 312 n.19, plaintiffs may still bring a False
11
Claims Act case for claims submitted before 2010, as the
amendment “clarif[ied], [but did] not alter, existing law that
claims for payment made pursuant to illegal kickbacks are false
under the False Claims Act,” United States ex rel.
Westmoreland v. Amgen, Inc., 812 F. Supp. 2d 39, 52 (D. Mass.
2011); see also United States ex rel. Quinn v. Omnicare, Inc.,
382 F.3d 432, 439 (3d Cir. 2004) (False Claims Act case
premised on alleged Anti-Kickback Statute violations brought
before the Anti-Kickback Statute was amended in 2010).
3. Proving a False Claims Act Violation at
Summary Judgment
As noted, the District Court granted summary
judgment to Accredo because Greenfield did not link its claims
for reimbursement to the alleged kickback scheme. Indeed, its
holding went further than that, arguably requiring a causal
relationship — Greenfield must provide “some evidence” that
federal beneficiaries “chose Accredo because of its donations
to HANJ/HSI.” Greenfield, 223 F. Supp. 3d at 230. That
evidence, in the Court’s view, is “an essential element” of
Greenfield’s claim. Id.
Greenfield and the Government contend that proof of
subjective intent is not required. They assert Congress enacted
the False Claims Act and Anti-Kickback Statute to impose
liability independent of patients’ subjective medical decisions.
Accredo counters that the statutory scheme requires Greenfield
to prove that federal beneficiaries would not have used
Accredo’s services but for the alleged kickback violation. It
insists that this is the correct evidentiary burden, even if it
would require plaintiffs to delve into patients’ intent. At issue,
therefore, is what “link” is sufficient to connect an alleged
kickback scheme to a subsequent claim for reimbursement: a
direct causal link, no link at all, or something in between.
12
When interpreting a statute, “[o]ur task is to give
effect to the will of Congress, and where Congress’s will has
been expressed in language that has a reasonably plain
meaning, that language must ordinarily be regarded as
conclusive.” Byrd v. Shannon, 715 F.3d 117, 122 (3d Cir.
2013). Where a statute’s language is arguably not plain, we
consider statutory language “in the larger context or structure
of the statute in which it is found.” United States v. Tupone,
442 F.3d 145, 151 (3d Cir. 2006); see also Alli v. Decker, 650
F.3d 1007, 1012 (3d Cir. 2011) (same). Our effort to discern
Congress’s intent may resort to legislative history as an aid or
cross-check. See Universal Church v. Geltzer, 463 F.3d 218,
223 (2d Cir. 2006).
For convenience, we repeat that, under the Anti-
Kickback Statute, “a claim that includes items and services
resulting from a violation of [that Statute] constitutes a false or
fraudulent claim for purposes of [the False Claims Act].” 42
U.S.C. § 1320a-7b(g). The Statute does not define the term
“resulting from.” However, Black’s Law Dictionary defines
“result” as “a . . . logical . . . or legal consequence; to proceed
as an outcome or conclusion.” Black’s Law Dictionary (10th
ed. 2014).
In line with this definition, Accredo argues its
interpretation of “resulting from” is consistent with how the
Supreme Court has construed those words in other statutes,
most notably the Controlled Substances Act, 21 U.S.C. § 801
et seq. See Burrage v. United States, 134 S. Ct. 881, 887-88
(2014) (“‘Results from’ imposes, in other words, a requirement
of actual causality. . . . [T]his requires proof the harm would
not have occurred in the absence of—that is, but for—the
defendant’s conduct.” (internal quotation marks omitted)).
The Government responds that imposing but-for causation in
this context would lead to the incongruous result whereby “a
defendant could be convicted of criminal conduct under the
13
[Anti-Kickback Statute] for paying kickbacks to induce
medical referrals, but would be insulated from civil [False
Claims Act] liability for the exact same conduct, absent
additional proof that each medical decision was in fact
corrupted by the kickbacks.” Gov’t Amicus Br. at 22.
To determine if a particular reading of a statute
produces incongruous results, we ask whether that reading is
consistent with the drafters’ intentions. See United States v.
Zats, 298 F.3d 182, 187 (3d Cir. 2002). It appears the drafters
of the Anti-Kickback Statute intended “to strengthen the
capability of the Government to detect, prosecute, and punish
fraudulent activities under the [M]edicare and [M]edicaid
programs,” H.R. Rep. No. 95-393, at 1 (1977), because “fraud
and abuse among practitioners . . . is relatively difficult to
prove and correct,” id. at 47. “Since the medical needs of a
particular patient can be highly judgmental, it is difficult to
identify program abuse as a practical manner unless the
overutilization is grossly unreasonable.” Id. This counsels
requiring something less than proof that the underlying
medical care would not have been provided but for a kickback.
Similarly, Congress passed § 1320a-7b(g) in 2010 as
part of an overall effort to “strengthen[] whistleblower actions
based on medical care kickbacks” and “to ensure that all claims
resulting from illegal kickbacks are considered false claims for
the purpose of civil action[s] under the False Claims Act.” 155
Cong. Rec. S10852, S10853-54 (daily ed. Oct. 28, 2009) (Sen.
Kaufman) (emphasis added); see also United States ex rel.
Kester v. Novartis Pharm. Corp., 41 F. Supp. 3d 323, 332
(S.D.N.Y. 2014) (“There is no indication in either the law itself
or the legislative history that Congress intended to narrow the
scope of ‘falsity’ under the [False Claims Act] when it
amended the [Anti-Kickback Statute] to add Section 1320a–
7b(g).”). Although the legislative history of the provision does
not explain the term “resulting from,” the Congressional
14
Record indicates it was enacted to avert “legal challenges that
sometimes defeat legitimate enforcement efforts.” 155 Cong.
Rec. at S10853.
The False Claims Act’s legislative history echoes
these points. There Congress stated the “Act is intended to
reach all fraudulent attempts to cause the Government to pay
ou[t] sums of money or to deliver property or services,” and
“[a] false claim for reimbursement under Medicare, Medicaid,
or similar program . . . may be false even though the services
are provided as claimed.” S. Rep. No. 99-345, at 9 (1986)
(emphasis added). Thus the Anti-Kickback Statute and False
Claims Act were not drafted to cabin healthcare providers’
liability for certain types of false claims or for certain types of
illegal kickbacks. Instead, Congress intended both statutes to
reach a broad swath of “fraud and abuse” in the federal
healthcare system. H.R. Rep. No. 95-393 at 47 (1977).
As such, the Government correctly observes that
Accredo’s reading of § 1320a-7b(g) is inconsistent with the
drafters’ intentions underlying both statutes. Per Accredo’s
reasoning, a plaintiff would have to prove a kickback actually
influenced a patient’s or medical professional’s judgment.
Such a requirement would hamper False Claims Act cases
under that provision even though Congress enacted it to
“strengthen[] whistleblower actions based on medical care
kickbacks,” 155 Cong. Rec. at S10853, and stated that
healthcare fraud “is relatively difficult to prove and correct,”
H.R. Rep. No. 95-393, at 47. Moreover, it would dilute the
False Claims Act’s requirements vis-à-vis the Anti-Kickback
Statute, as direct causation would be a precondition to bringing
a False Claims Act case but not an Anti-Kickback Statute
case.6 It follows that the broad statutory context of the False
6
Although Congress did not intend two different standards of
causation to apply in False Claims Act and Anti-Kickback
15
Claims Act and the Anti-Kickback Statute supports the
Government’s reading, as neither requires a plaintiff to show
that a kickback directly influenced a patient’s decision to use a
particular medical provider. Accordingly, Accredo’s
interpretation of § 1320a-7b(g) does not control the inquiry
here, as it would lead to results not intended by Congress.
Case law from our Court supports this conclusion. In
Wilkins, 659 F.3d at 314, we stated that a participant in a
federal healthcare program complies with the False Claims Act
by “refrain[ing] from offering or entering into payment
arrangements which violate the [Anti-Kickback Statute], while
making claims for payment to the Government under that
program.” Id. at 314. We observed that “[t]he Government
does not get what it bargained for when a defendant is paid . .
. for services tainted by a kickback.”7 Id. (internal quotation
marks omitted) (alteration in original).
Statute cases, it is worth repeating that the elements of the
statutes differ. Unlike the False Claims Act, the Anti-Kickback
Statute criminalizes a “knowing[] and willful[] offer” to pay a
kickback. 42 U.S.C. § 1320a-7b(b)(2). Thus an offer alone
may amount to a violation of the Anti-Kickback Statute, but is
not enough to prove a violation of the False Claims Act. See
id. § 1320a-7b(g) (“[A] claim that includes items or services
resulting from a violation of this section constitutes a false or
fraudulent claim for purposes of [the False Claims Act].”
(emphasis added)).
7
Other courts have gone further, expressly stating that
causation is not required in this context. For instance, in
United States ex rel. Hutcheson v. Blackstone Medical, Inc.,
647 F.3d 377, 393 (1st Cir. 2011), the First Circuit rejected the
defendant’s argument that the claims “were not false or
16
Our view is also consistent with the language in CMS
Form 855s, which requires providers to certify that “the claim
and the underlying transaction” (i.e., the medical care being
reimbursed) comply with the Anti-Kickback Statute. As is
apparent from its language, the Form directs the provider’s
attention to the medical care that is the subject of a claim. It
makes no mention of a patient’s reason(s) for selecting a
specific provider and does not require a provider to engage in
an intent-based inquiry before submitting a claim for
reimbursement.
The Government presented several hypotheticals to
illustrate this standard. For example, “if a medical service
provider pays kickbacks to a doctor to induce referrals and then
submits claims to Medicare for services it provided to patients
who were referred by that doctor, the claims are false because
the medical care was not provided in compliance with the
[Anti-Kickback Statute].” Gov’t Amicus Br. at 17. This
outcome is the same “regardless of whether the doctor would
have referred the patients absent the kickbacks . . . and
fraudulent because [they] were for services that would have
been provided in the absence of the alleged [Anti-Kickback
Statute] violations.” Instead, the Court concluded “the . . .
claims were ineligible for payment” because “the underlying
transaction violated the [Anti-Kickback Statute].” Id. (internal
quotation marks omitted). More recently, the Southern District
of New York rejected a defendant’s argument pressing the
same theory of causation Accredo now advances, reasoning
that “Congress gave absolutely no indication . . . it intended . .
. to limit the [False Claims Act’s] reach where kickbacks were
concerned” and that “any claim connected in any way to an
[Anti-Kickback Statute] violation [is] ineligible for
reimbursement” under § 1320a-7b(g). Kester, 41 F. Supp. 3d
at 332, 335.
17
regardless of whether the patients would have chosen the
service provider absent the referral.” Id.
Consistent with this standard, Greenfield does not
need to prove HSI/HANJ’s referrals actually caused their
members to use a particular healthcare provider. A “link” is
required, but it is less than espoused by Accredo: For a False
Claims Act violation, Greenfield must prove that at least one
of Accredo’s claims sought reimbursement for medical care
that was provided in violation of the Anti-Kickback Statute (as
a kickback renders a subsequent claim ineligible for payment).8
How this plays out is where we turn.
B. Assuming There Was an Anti-Kickback
Statute Violation, What Must Greenfield
Provide to Prevail at Summary Judgment for
a False Claims Act Violation?
Even under our reading of the statute, Greenfield
contends the District Court erred by requiring him to show an
actual claim linked to Accredo’s alleged kickback scheme. He
argues this is too stringent a requirement. In his view, a
temporal connection is sufficient to prove a False Claims Act
violation at summary judgment. Because Accredo’s
contributions to HSI, its forwarding those monies to HANJ,
8
Even if Greenfield proves that one of Accredo’s claims
sought reimbursement for medical care that was provided in
breach of the Statute, he must also satisfy the False Claims
Act’s materiality requirement, as falsity and materiality are
distinct requirements in this context. See Escobar, 136 S. Ct.
at 2002 (“[A] misrepresentation about compliance with a
statutory, regulatory, or contractual requirement must be
material to the Government’s payment decision in order to be
actionable under the False Claims Act.”).
18
HSI/HANJ recommending Accredo as an approved provider to
their members, and Accredo filing reimbursement claims for
24 federally insured patients all took place in close proximity
between 2007 and 2012, Greenfield contends Accredo
necessarily violated the False Claims Act because all of its 24
claims incorrectly certified that it did not pay any illegal
kickbacks.
We disagree. A plaintiff cannot “merely . . . describe
a private scheme in detail but then . . . allege . . . that claims
requesting illegal payments must have been submitted, were
likely submitted[,] or should have been submitted to the
Government.” United States ex rel. Clausen v. Lab. Corp. of
Am., 290 F.3d 1301, 1311 (11th Cir. 2002).9 Instead, he must
provide “evidence of the actual submission of a false claim” to
prevail at summary judgment. Quinn, 382 F.3d at 439.
Consistent with these principles, we rejected a similar
argument in Quinn, where the plaintiff argued the defendant
violated the False Claims Act by reselling unused, returned
medications that were already paid by Medicaid (i.e., “recycled
medications”) and then submitting a second Medicaid claim
for the medication’s full value. See id. According to the
relator, “false claims must have been submitted” because the
defendant admitted that “approximately 60 percent of its
business is Medicaid and that it accepts returned medications
for recycling.” Id. at 440. We held that argument insufficient
9
Although the Eleventh Circuit stated the above in the context
of Federal Rule of Civil Procedure 9(b)’s pleading
requirements, its statement also is apt during summary
judgment because a non-movant’s “evidentiary burden . . . in a
summary judgment motion is significantly greater than in
a motion to dismiss.” Reese v. Anderson, 926 F.2d 494, 498
(5th Cir. 1991).
19
to survive summary judgment because the relator did not show
“a single claim that [the defendant] actually submitted to
Medicaid which covered a [recycled] medication for which
[the defendant] had previously submitted a claim.” Id. With
this failure “to link [the defendant’s] recycling and crediting
practices to the actual submission of a false claim,” there was
no genuine “issue of material fact to be decided by a jury.” Id.;
see also Wilkins, 659 F.3d at 308 (“It is true that to recover
under the [False Claims Act] we have recognized
that ultimately a plaintiff must come forward with at least a
‘single false [or fraudulent] claim’ that the defendants
submitted to the Government for payment.” (quoting Quinn,
382 F.3d at 440) (emphasis omitted)).
Our sister circuits have applied the same analysis,
holding that plaintiffs must provide evidence of at least one
false claim to prevail on summary judgment. For example, in
United States ex rel. Booker v. Pfizer, Inc., 847 F.3d 52, 58 (1st
Cir. 2017), the First Circuit held that “aggregate [information]
reflecting the amount of money expended by Medicaid” on off-
label prescriptions was “insufficient on its own to support a[]
[False Claims Act] claim” because it did not show “an actual
false claim made to the [G]overnment.” Likewise, the Seventh
Circuit concluded a plaintiff failed to carry his burden during
summary judgment because he failed to provide any claim
associated with the defendant’s alleged Medicare fraud.
United States ex rel. Crews v. NCS Healthcare of Ill., Inc., 460
F.3d 853, 857 (7th Cir. 2006); see United States v. Kitsap
Physicians Serv., 314 F.3d 995, 997 (9th Cir. 2002) (“It seems
to be a fairly obvious notion that a False Claims Act suit ought
to require a false claim. Yet, the plaintiff-appellant in this case
filed his action, proceeded to summary judgment, and
prosecuted this appeal without ever seeing or presenting to a
court a single false claim submitted by the defendants-
appellees. This flaw is fatal to a qui tam action under the False
Claims Act.”).
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It follows that Greenfield may not prevail on summary
judgment simply by demonstrating that Accredo submitted
federal claims while allegedly paying kickbacks. Nor may he
prevail by hypothesizing that at least some of HSI/HANJ’s
recommendations must have been directed to federal
beneficiaries because Accredo submitted claims for 24
federally insured patients during the relevant time period.
Instead, he must point to at least one claim that covered a
patient who was recommended or referred to Accredo by
HSI/HANJ.
He has not done so here. He fails to demonstrate that
any of Accredo’s 24 federally insured patients viewed
HSI/HANJ’s approved provider list or that HSI/HANJ referred
the federally insured patients to Accredo through some other
means. He even fails to establish that the 24 federally insured
patients were members of HSI/HANJ and thus recipients of
HSI/HANJ’s communications. The closest he comes is when
he asks us to assume that all 24 were members because
“[e]ssentially all hemophiliacs in New Jersey are HANJ
members.” Reply Br. at 5. But “it is impossible to rule out the
chance” that none of the 24 were HSI/HANJ members or that
none of the 24 members were exposed to an illegal referral or
recommendation. Quinn, 382 F.3d at 443. Thus the evidence
does not link Accredo’s alleged kickback scheme to any
particular claim.
Despite this evidentiary shortcoming, Greenfield
insists that the taint of a kickback renders every reimbursement
claim false. Because Accredo was violating the Anti-Kickback
Statute while submitting federal claims for reimbursement, he
argues, the alleged kickbacks need not have any connection to
the claims or the underlying medical care. Again we disagree.
A kickback does not morph into a false claim unless a
particular patient is exposed to an illegal recommendation or
referral and a provider submits a claim for reimbursement
21
pertaining to that patient. Even if we assume Accredo paid
illegal kickbacks, that is not enough to establish that the
underlying medical care to any of the 24 patients was
connected to a breach of the Anti-Kickback Statute; we must
have some record evidence that shows a link between the
alleged kickbacks and the medical care received by at least one
of Accredo’s 24 federally insured patients. Because Greenfield
provides no such evidence (not that any of the 24 received a
referral or recommendation to use Accredo’s services or even
that any of the 24 were members of HSI/HANJ), his case
cannot proceed to trial. Accordingly, the District Court
correctly entered summary judgment for Accredo.
IV. CONCLUSION
The Anti-Kickback Statute prohibits kickbacks
regardless of their effect on patients’ medical decisions.
Because any kickback violation is not eligible for
reimbursement, to certify otherwise violates the False Claims
Act. Yet there must be some connection between a kickback
and a subsequent reimbursement claim. It is not enough, as
Greenfield contends, to show temporal proximity between
Accredo’s alleged kickback plot and the submission of claims
for reimbursement. Likewise, it is too exacting to follow
Accredo’s approach, which requires a relator to prove that
federal beneficiaries would not have used the relevant services
absent the alleged kickback scheme. Instead, Greenfield must
show, at a minimum, that at least one of the 24 federally
insured patients for whom Accredo provided services and
submitted reimbursement claims was exposed to a referral or
recommendation of Accredo by HSI/HANJ in violation of the
Anti-Kickback Statute. Because he has failed to do so, we
affirm.
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