United States Ex Rel. Wilkins v. United Health Group, Inc.

PRECEDENTIAL

UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
______________

No. 10-2747
______________

UNITED STATES EX REL. CHARLES WILKINS;
DARYL WILLIS,

Appellants

v.

UNITED HEALTH GROUP, INCORPORATED;
AMERICHOICE;
AMERICHOICE OF NEW JERSEY, INC.
______________

On Appeal from the United States District Court
for the District of New Jersey
(D.C. Civ. No. 1-08-cv-03425)
Honorable Robert B. Kugler, District Judge
______________

Argued March 24, 2011

BEFORE: FUENTES, SMITH, and GREENBERG,
Circuit Judges
 (Filed: June 30, 2011)
______________

Ross Begelman, Esq. (argued)
Marc M. Orlow, Esq.
Begelman, Orlow & Melletz
411 Route 70 East, Suite 245
Cherry Hill, NJ 08034

Attorneys for appellants

Michael C. Theis, Esq. (argued)
Jaasi J. Munanka, Esq.
Hogan Lovells US
1200 Seventeenth Street, Suite 1500
Denver, CO 80202

William P. Deni, Jr., Esq.
Bruce A. Levy, Esq.
Ellen Lubensky, Esq.
Gibbons
One Gateway Center
Newark, NJ 07102-5310

Attorneys for appellees

Tony West , Esq.
Assistant Attorney General
Paul J. Fishman, Esq.
United States Attorney

2
Douglas N. Letter, Esq.
Teal Luthy Miller, Esq. (argued)
Attorneys, Appellate Staff
Civil Division, Room 7234
U.S. Department of Justice
950 Pennsylvania Ave., N.W.,
Washington, DC 20530-0001

Attorneys for amicus curiae United States

______________

OPINION OF THE COURT
______________

GREENBERG, Circuit Judge.

I. INTRODUCTION

This matter comes on before this Court on an appeal from
an order the District Court entered on May 13, 2010, granting
the motion of appellees United Health Group, AmeriChoice, and
AmeriChoice-New Jersey (collectively “appellees”) under
Federal Rule of Civil Procedure 12(b)(6) to dismiss Charles
Wilkins‟ and Daryl Willis‟ (collectively “appellants”) qui tam
action1 based on the False Claims Act (“FCA”), 31 U.S.C. §

1
Private individuals can bring qui tam actions on behalf of the
Government in exchange for their right to retain some portion of
any resulting damages award. See Schindler Elevator Corp. v.
U.S. ex rel. Kirk, 131 S.Ct. 1885, 1889 (2011); Vt. Agency of

3
3729, for failure to state a claim on which relief may be granted.
Appellants have alleged that appellees, through their
participation in federally funded health insurance programs,
certified that they were in compliance with all healthcare laws
and regulations even though they knowingly violated several
Medicare marketing regulations, resulting in their submission of
false claims for payment to the federal government. Appellants
further alleged that AmeriChoice-NJ violated the FCA by
illegally providing kickbacks in violation of the Medicare Anti-
Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b, to a New
Jersey medical clinic to induce the clinic to switch its patients to
AmeriChoice-NJ‟s Medicare and Medicaid programs.
Moreover, appellants have alleged that AmeriChoice-NJ agents
violated the AKS by enticing doctors to provide the names of
patients eligible for Medicare and Medicaid programs. Thus,
this action involves two distinct types of claims with which we
will deal separately.

In addition to involving two distinct types of claims, the
action implicates the two medical programs to which we already
have referred, Medicare, a federally subsidized health insurance
program for the elderly and certain disabled persons, see 42
U.S.C. § 1395c and d, and Medicaid, a cooperative federal-state
public assistance program pursuant to which the federal
government makes matching funds available to pay for certain
medical services furnished to needy individuals, see 42 U.S.C. §
1396. Some elderly poor are “dual eligible” under both

Natural Res. v. U.S. ex rel. Stevens, 529 U.S. 765, 769-70, 120
S.Ct. 1858, 1860-61 (2000).

4
programs.2 Though appellants mention both programs in their
complaint, this case is essentially a Medicare case arising, as the
District Court indicated at the outset of its opinion, “out of
alleged fraudulent claims to Medicare.” United States ex rel.
Wilkins v. United Health Group, Inc., Civ. No. 08-3425, 2010
U.S. Dist. LEXIS 47080, at *1 (D.N.J. May 13, 2010)
(“Wilkins”).

The District Court held that appellants‟ allegations failed
to state a plausible claim for relief under the FCA for two
reasons: (1) appellants failed to identify a single false claim that
appellees submitted to the Government, and (2) the marketing
regulations that appellants claimed appellees violated were not
relevant to the Government‟s decision to pay appellees‟
Medicare claims. In addition, the Court dismissed appellants‟
AKS claims because they did not include an allegation that
appellees certified that they were in compliance with the AKS or
that such compliance was a relevant consideration when the
Government processed their Medicare claims. Inasmuch as we
agree with the Court‟s disposition of appellants‟ Medicare
marketing regulations claims but disagree with its holding with
respect to appellants‟ AKS claims, we partially will affirm and

2
Appellants state in their brief that dual eligible individuals
receive their prescription drug coverage from Medicaid, but
amicus curiae United States seems to describe Medicaid‟s
responsibility more broadly with respect to dual eligible
individuals. We are not concerned, however, with the division
between Medicare and Medicaid of responsibility for benefits
for dual eligible individuals on this appeal and thus will not
address that point.

5
partially will reverse the Court‟s May 13, 2010 order and we
will remand the case to the District Court for further
proceedings.

II. FACTS AND PROCEDURAL HISTORY

In view of the procedural posture of this case, we set
forth the facts as appellants have alleged them, and decide the
appeal on the basis of those allegations and, in doing so, will
construe the complaint in the light most favorable to appellants.
See Lexington Nat. Ins. Corp. v. Ranger Ins. Co., 326 F.3d 416,
417 (3d Cir. 2003).

United Health provides access to health care services and
resources and AmeriChoice and AmeriChoice-NJ are United
Health subsidiaries offering Medicare Advantage (“MA”)
plans.3 Under MA plans, AmeriChoice and AmeriChoice-NJ
provide individuals enrolled in Medicare with health care

3
Medicare Advantage, otherwise known as Medicare “Part C,”
authorizes qualified individuals to opt out of traditional fee-for-
service coverage under Medicare Parts A and B and enroll in
privately-run managed care plans that provide coverage for both
inpatient and outpatient services. 42 U.S.C. §§ 1395w-21,
1395w-28. United Health also offers qualified individuals
coverage under Medicare Part D which is a voluntary
prescription drug benefit program. See 42 U.S.C. § 1395w-101
et seq.

6
services and submit claims to the Government for
reimbursement based on the number of patients enrolled in their
Medicare programs.4 Organizations which provide services
under Medicare do so pursuant to contracts with the Centers for
Medicare and Medicaid Services (“CMS”), a division of the
Department of Health and Human Services charged with
administering the Medicare and Medicaid programs. See 42
C.F.R. § 422.503(a). Each month, as participants offering MA
plans, appellees certify to CMS that they continue to comply
with all of the CMS MA guidelines including MA marketing
regulations and the AKS.

Wilkins and Willis began employment with United
Health Group and AmeriChoice in 2007, Willis as a general
manager for Medicare/Medicaid marketing and sales and
Wilkins as a sales representative. In April 2008, United Health
terminated Wilkins‟ employment in reaction to his complaints
concerning what he perceived were United Health‟s illegal
practices which are the basis for this action. Similarly, at some
point during 2008, United Health, after demoting Willis for his
conduct in making complaints to his supervisors about what he
perceived were United Health‟s illegal practices, went further

4
The Government pays MA plan participants a set amount of
money based on the plans‟ enrollees‟ risk factors and other
characteristics rather than paying them a fee for specific services
performed. See 42 C.F.R. §§ 422.300 et seq. CMS makes
advance monthly payments to participants calculated on the
number of enrollees, adjusted to reflect risk and variations in
rates within the plan‟s service area. See 42 C.F.R. §§ 422.304,
423.315.

7
and terminated his employment.

On July 10, 2008, appellants filed this qui tam action
under seal in the District Court alleging that appellees‟ sales
representatives violated the FCA by offering physicians illegal
kickbacks and violating MA marketing rules while accepting
payments from government funded health insurance programs.
Specifically, appellants alleged that: (1) United Health used
marketing flyers that CMS did not approve beforehand; (2) its
licensed sales agents engaged in marketing activities in the
waiting rooms of clinics and doctors‟ offices; (3) non-licensed
individuals engaged in marketing activities; (4) United Health
commonly used an excessive number of sales representatives at
presentations in an attempt to “overwhelm the public;” (5) sales
representatives asked persons to raise their hands at
presentations if they were eligible for both Medicare and
Medicaid; (6) marketing personnel chased people in
supermarkets to ask them whether they were dual eligible; (7)
United Health used brokers to engage in door-to-door
solicitation; (8) United Health sales agents gave out prizes at
Medicare presentations in excess of $15 in value contrary to
CMS guidelines; (9) AmeriChoice‟s sales representatives paid
$27,000 to a medical clinic, Reliance Medical Group, to switch
certain eligible beneficiaries to its Medicare and Medicaid plans;
(10) United Health‟s sales representatives offered payments to
physicians in exchange for the physicians providing appellees
with the names of potential new enrollees eligible for Medicare
and Medicaid; (11) United Health failed to maintain and

8
implement a compliance program.5 App. at 39-46.

After appellants filed this action the Government
investigated their claims, and, during the investigation, in
accordance with the FCA‟s requirements the case remained
under seal. On May 26, 2009, after the Government finished its
investigation, it notified the parties that it would not intervene in
the case. See 31 U.S.C. § 3730(b)(4)(B).6 On August 5, 2009,
appellants filed an amended complaint which pleaded an FCA
claim predicated on the allegations we discuss above and nine
claims based on violations of state law.7 Notwithstanding the
seeming specificity of appellants‟ complaint, they do not
identify any specific claim for payment that United Health made

5
Even though this last claim appears to be separate from
appellants‟ claims based on marketing violations and illegal
kickback payments, appellants do not make any separate
arguments based on appellees‟ failure to maintain a compliance
program.
6
The Government did not move to dismiss the action, as it could
have done under 31 U.S.C. § 3730(c)(2)(A).
7
The state law claims alleged that appellees‟ actions violated
state false claims act provisions of New Jersey, Florida, Indiana,
Michigan, Tennessee, Texas, and New York law. In addition,
Wilkins and Willis individually alleged that appellees violated
the New Jersey Conscientious Employee Protection Act, N.J.
Stat. Ann. § 34:19-1 et seq. (West 2000). These state law
allegations are not at issue in this appeal.

9
to the federal Government in violation of the FCA. The
complaint, however, does allege that CMS makes advanced
monthly payments to United Health for each enrollee in its plans
and that United Health certifies each month its “continued
compliance with all of the CMS [Medicare Advantage]
Guidelines and based on such certification, United Defendants
continues [sic] to receive the monthly capitation payment.” Am.
Compl. at 10.8 Thus appellants contend that appellees, by
submitting claims for payment to CMS while failing to comply
with the Medicare laws and regulations, including the AKS,
presented false claims to the Government in violation of the
FCA.

After the Government declined to intervene, appellees
moved to dismiss the complaint under Federal Rule of Civil
Procedure 12(b)(6) for failure to state a claim upon which relief
could be granted and Federal Rule of Civil Procedure 9(b) for
failure to plead fraud with particularity.9 The District Court
granted appellees‟ motion for failure to state a claim and
therefore did not address appellees‟ alternative argument for
dismissal that appellants failed to plead their claims with the

8
The parties have included the original complaint but not the
amended complaint in their joint appendix. We, however, have
examined both versions of the complaint, and have considered
both in our disposition of this appeal.
9
We have held that plaintiffs must plead FCA claims with
particularity in accordance with Rule 9(b). See U.S. ex rel.
LaCorte v. SmithKline Beecham Clinical Labs., 149 F.3d 227,
234 (3d Cir. 1998).

10
particularity that Rule 9(b) requires. The Court dismissed the
complaint because appellants did not identify “even a single
claim for payment to the Government.” Wilkins, 2010 U.S.
Dist. LEXIS 47080, at *13. Moreover, the Court held that
United Health‟s failure to comply with marketing guidelines and
regulations that were not relevant to the Government‟s decision
to issue payment could not be the basis for a recovery for an
FCA violation. The Court also rejected appellants‟ FCA claims
that they based on violations of the AKS, finding that appellants
failed to allege that United Health certified compliance with the
AKS and also failed to allege that the Government predicated its
funding decisions on such a certification. Finally, the Court
declined to exercise supplemental jurisdiction over appellants‟
state law claims and denied appellants‟ request for leave to
amend the complaint.

Appellants filed a timely notice of appeal from the
District Court‟s May 13, 2010 order, challenging the Court‟s
decision granting appellees‟ motion to dismiss and arguing that,
in any event, when the Court determined that it would dismiss
the complaint it should have done so without prejudice and/or
allowed appellants to amend their complaint. The Government,
though declining to intervene in the District Court and
expressing no opinion on the merits of appellants‟ claims, has
filed an amicus curiae brief urging us to reverse the District
Court‟s order to the extent that the Court concluded that an FCA
claim cannot survive if the plaintiff does not identify a specific
false claim that a defendant submitted for payment and that
appellants‟ kickback allegations did not state a claim for relief
under the FCA.

11
 III. JURISDICTION AND STANDARD OF REVIEW

The District Court had jurisdiction over appellants‟ FCA
claims under 31 U.S.C. § 3732(a) and 28 U.S.C. § 1331 and
supplemental jurisdiction over appellants‟ state law claims under
28 U.S.C. § 1367. We have jurisdiction to review the District
Court‟s final order under 28 U.S.C. § 1291.

We exercise plenary review of the District Court‟s order
granting appellees‟ motion to dismiss for failure to state a claim.
See Allen ex rel. Martin v. LaSalle Bank, N.A., 629 F.3d 364,
367 (3d Cir. 2011). As we have indicated, we accept all factual
allegations in the complaint as true, construe the complaint in
the light most favorable to appellants, and determine whether,
under any reasonable reading of the amended complaint,
appellants may be entitled to relief. Id. In this determination
“[t]he issue is not whether [appellants] will ultimately prevail
but whether [they are] entitled to offer evidence to support the
claims.” See Maio v. Aetna, Inc., 221 F.3d 472, 482 (3d Cir.
2000) (citations and internal quotation marks omitted). We
review the District Court‟s decisions to dismiss the complaint
with prejudice and deny appellants‟ request for leave to amend
their complaint for an abuse of discretion. See In re NAHC, Inc.
Sec. Litig., 306 F.3d 1314, 1332 (3d Cir. 2002); Lake v. Arnold,
232 F.3d 360, 373 (3d Cir. 2000).

IV. DISCUSSION

A. The Record on Appeal

12
 Before we discuss the merits of appellants‟ claims we
address a dispute between the parties concerning whether we
should consider certain exhibits that appellants have included in
the appendix. Though ordinarily the parties on an appeal do not
have a dispute over what documents should be in the record, in
this case we address this question because appellants have
included two documents in the joint appendix, without our
leave, that neither party filed in the District Court and that the
Court therefore did not consider, i.e., the February 13, 2008
testimony of Kerry Weems, Acting Administrator for CMS,
before the Senate Finance Committee on “Selling to Seniors:
The Need for Accountability and Oversight of Marketing by
Medicare Private Plans, Part 2” and a December 2009 report the
United States Government Accountability Office authored on
Medicare marketing. See addendum to app. at 1-58. Appellants
contend that we should consider these materials as they are a
matter of “public record” which “are inextricably intertwined
and connected to items that are part of the record . . . .”
Appellant‟s br. at 12-13.

Though we do not doubt the authenticity of these
documents, nevertheless we will not consider them because the
parties did not present them to the District Court and we do not
find any indication in the record that the Court considered them
on its own initiative. See Fed. R. App. P. 10(a) (stating that
record on appeal is composed of original papers and exhibits
filed in district court, transcript of proceedings, if any, and a
certified copy of docket entries prepared by district court clerk);
Fed. R. App. P. 30 (limiting contents of a party‟s appendix to
record before district court). While we recognize that there
might be “exceptional circumstances” which could justify our

13
consideration of these materials even though they were not
presented to the District Court, we discern no such
circumstances on the appeal. See Acumed LLC v. Advanced
Surgical Servs., Inc., 561 F.3d 199, 226 (3d Cir. 2009).

We recognize that appellants argue that we should take
judicial notice of the two documents as they are part of the
“public record.” Appellant‟s reply br. at 2. Although a court of
appeals may take judicial notice of a matter of public record not
presented to the district court when reviewing the disposition of
a motion to dismiss under Rule 12(b)(6), see, e.g., Papasan v.
Allain, 478 U.S. 265, 268 n.1, 106 S.Ct. 2932, 2935 n.1 (1986),
we think that ordinarily a court of appeals should not take
judicial notice of documents on an appeal which were available
before the district court decided the case but nevertheless were
not tendered to that court, the precise situation here.10 See Zell
v. Jacoby-Bender, Inc., 542 F.2d 34, 38 (7th Cir. 1976) (refusing
to take judicial notice of documents filed in companion case to
undermine trial court‟s findings where to do so would violate
rule that appellate court must consider only record before trial
court). Therefore, we will make our analysis by considering
only the record that the parties made in the District Court for
that Court‟s consideration of appellees‟ motion to dismiss.11

10
Weems testified before appellants filed this action and the
Accountability Office submitted the December 2009 report after
appellants filed the action but before the District Court decided
the case.
11
We add, however, that even if we expanded the record to

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B. The False Claims Act

1. FERA Amendments

At this early point in our discussion we consider a recent
amendment to the FCA. On May 20, 2009, Congress enacted
the Fraud Enforcement and Recovery Act of 2009 (FERA), Pub.
L. No. 111-21, 123 Stat. 1617 (2009), which amended the FCA
and re-designated 31 U.S.C. § 3729(a)(1) as 31 U.S.C. §
3729(a)(1)(A) and 31 U.S.C. § 3729(a)(2) as 31 U.S.C. §
3729(a)(1)(B). The pre-FERA version of the FCA, imposed
liability on:

[A]ny 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;

(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).

include the two documents our result on this appeal would not
be different.

15
 The FCA as FERA has amended it, now imposes liability
on:

[A]ny person who—

(A) knowingly presents, or causes to be presented,
a false or fraudulent claim for payment or
approval;

(B) knowingly makes, uses, or causes to be made
or used, a false record or statement material to a
false or fraudulent claim[.]

31 U.S.C. § 3729(a)(1).

The FCA defines “material” as “having a natural
tendency to influence, or be capable of influencing, the payment
or receipt of money or property.” 31 U.S.C. § 3729(b)(4). For
purposes of this case both versions of the FCA define a claim in
pertinent part as a “request or demand . . . for money or property
that . . . is presented to an officer, employee, or agent of the
United States . . . .” 31 U.S.C. § 3729(c) (pre-FERA); 31 U.S.C.
§ 3729(b)(2)(A)(i) (post-FERA). FERA contains a retroactivity
provision which applies only to section 3729(a)(1)(B), and
provides that that clause “take[s] effect as if enacted on June 7,
2008, and appl[ies] to all claims under [the FCA] that are
pending on or after that date.”12 Pub. L. No. 111-21 § 4(f)(1),

12
Congress adopted the term “material to,” as well as the
retroactivity provision, in response to the Supreme Court‟s June
9, 2008 decision in Allison Engine Co. v. U.S. ex rel. Sanders,

16
123 Stat. at 1625.

Though appellants filed their complaint on July 10, 2008,
and their amended complaint on August 5, 2009, they cited to
the pre-FERA version of the FCA in both their original and
amended complaints. Nevertheless, appellants argued in the
District Court that the addition of “material to” in section
3729(a)(1)(B) made it easier to state a claim under the FCA
inasmuch as, under the amended version of the FCA, a relator
only need show that compliance with the applicable regulations
which the defendant allegedly violated would have a tendency to
influence the Government‟s payment decision. The Court,
though assuming that the amendment applied in this case, held
that Congress‟ addition of a materiality requirement did not
change the meaning of the FCA. Appellants do not contend that
the Court erred in this conclusion but they do argue that the

553 U.S. 662, 128 S.Ct. 2123 (2008), which Congress viewed
the Court as having decided incorrectly. See S. Rep. No. 111-
10, at 11 (2009), reprinted in 2009 U.S.C.C.A.N. 430, 437-39
(“To correct the Allison Engine decision . . . in section
3729(a)(2) the words „to get‟ were removed striking the
language the Supreme Court found created an intent requirement
for false claims liability under that section. In place of this
language, the Committee inserted the words „material to‟ a false
or fraudulent claim.”). In Allison Engine, the Supreme Court
held that a plaintiff “must prove that the defendant intended that
the false record or statement be material to the Government‟s
decision to pay or approve the false claim.” 553 U.S. at 665,
128 S.Ct. at 2126.

17
original complaint “clearly alleged a time period were [sic]
claims would be pending on June 7, 2008.” Appellants‟ br. at
16 n.17. Appellees argue that the majority of courts considering
the applicability of the retroactivity provision have determined
that the retroactivity provision does not apply to cases which
were pending on June 7, 2008.13 Appellees‟ br. at 9 n.6 (citing
Hopper v. Solvay Pharm., Inc, 588 F.3d 1318, 1327 n.3 (11th
Cir. 2009)).14

We need not decide whether the earlier or amended
version of the FCA is applicable because we conclude that
appellants‟ claims based on appellees‟ alleged violation of the
Medicare marketing regulations cannot survive appellees‟
motion to dismiss under either version of the statute. Moreover,
as we explain later, appellants‟ claims under the AKS fall only
under pre-FERA section 3729(a)(1), which was still in force at
the time that appellees submitted their claims for payment to the
Government and at the time that appellants filed this suit.
Therefore, we will decide this case under the pre-FERA version
of section 3729(a)(1).

13
This is a puzzling argument inasmuch as this case was not
pending on June 7, 2008.
14
At least one district court has held that FERA‟s retroactivity
provision violates the Ex Post Facto Clause of the United States
Constitution. See U.S. ex rel. Sanders v. Allison Engine Co.,
667 F. Supp. 2d 747, 756 (S.D. Ohio 2009). Clearly, we need
not consider that possibility.

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 2. Establishing a Claim Under the FCA

The primary purpose of the FCA “is to indemnify the
government-through its restitutionary penalty provisions-against
losses caused by a defendant‟s fraud.” Mikes v. Straus, 274
F.3d 687, 696 (2d Cir. 2001) (citing U.S. ex rel. Marcus v. Hess,
317 U.S. 537, 549, 551-52, 63 S.Ct. 379, 388 (1943)). A
plaintiff, in order to establish a prima facie FCA violation under
section 3729(a)(1), must prove that “(1) the defendant presented
or caused to be presented to an agent of the United States a
claim for payment; (2) the claim was false or fraudulent; and (3)
the defendant knew the claim was false or fraudulent.” U.S. ex
rel. Schmidt v. Zimmer, Inc., 386 F.3d 235, 242 (3d Cir. 2004)
(internal quotation marks omitted); Hutchins v. Wilentz,
Goldman & Spitzer, 253 F.3d 176, 182 (3d Cir. 2001). As we
have indicated, a private individual, otherwise known as a
relator, may bring a civil action in the name of the United States
to enforce this provision of the FCA and may share a percentage
of any recovery resulting from the suit. 31 U.S.C. § 3730(b) &
(d).

There are two categories of false claims under the FCA: a
factually false claim and a legally false claim. U.S. ex rel.
Conner v. Salina Reg‟l Health Ctr., Inc., 543 F.3d 1211, 1217
(10th Cir. 2008). A claim is factually false when the claimant
misrepresents what goods or services that it provided to the
Government and a claim is legally false when the claimant
knowingly falsely certifies that it has complied with a statute or
regulation the compliance with which is a condition for
Government payment. Id. A legally false FCA claim is based
on a “false certification” theory of liability. See Rodriguez v.

19
Our Lady of Lourdes Med. Ctr., 552 F.3d 297, 303 (3d Cir.
2008), overruled in part on other grounds by U.S. ex rel.
Eisenstein v. City of New York, 129 S.Ct. 2230 (2009). On this
appeal, we are concerned only with allegedly legally false claims
related to appellees‟ eligibility to receive payment, as appellants
do not contend that appellees did not deliver the services for
which they sought payment.

There is a further division of categories of claims as the
courts have recognized that there are two types of false
certifications, express and implied. See, e.g., Conner, 543 F.3d
at 1217. Under the “express false certification” theory, an entity
is liable under the FCA for falsely certifying that it is in
compliance with regulations which are prerequisites to
Government payment in connection with the claim for payment
of federal funds. Rodriguez, 552 F.3d at 303. There is a more
expansive version of the express false certification theory called
“implied false certification” liability which attaches when a
claimant seeks and makes a claim for payment from the
Government without disclosing that it violated regulations that
affected its eligibility for payment. Id. Thus, an implied false
certification theory of liability is premised “on the notion that
the act of submitting a claim for reimbursement itself implies
compliance with governing federal rules that are a precondition
to payment.” Mikes, 274 F.3d at 699; see also United States v.
Sci. Applications Int‟l Corp., 626 F.3d 1257, 1266 (D.C. Cir.
2010) (“Courts infer implied certifications from silence where
certification was a prerequisite to the government action
sought.” (internal quotation marks and citation omitted)).

The United States Court of Federal Claims seems to have

20
been the first court to recognize that there can be implied false
certification liability under the FCA. See Ab-Tech Constr., Inc.
v. United States, 31 Fed. Cl. 429 (Fed. Cl. 1994), aff‟d, 57 F.3d
1084 (Fed. Cir. 1995). In Ab-Tech the court held that Ab-
Tech‟s submission of payment vouchers to the Government
impliedly certified that Ab-Tech was continuing to adhere to the
eligibility requirements of a federal small business program in
which it was a participant. Id. at 433-34. Though the vouchers
did not contain any express misrepresentations, Ab-Tech‟s
failure to honor the requirements of the program rendered it
subject to false certification liability under the FCA. Id. at 434.

While we have held that there can be express false
certification liability under the FCA, see U.S. ex rel. Kosenske
v. Carlisle HMA, Inc., 554 F.3d 88, 94 (3d Cir. 2009), we have
not decided whether there can be implied false certification
liability under the FCA. See Rodriguez, 552 F.3d at 303-04.15
However, other courts of appeals have considered this
possibility and a majority of those courts, including those in the
Second, Sixth, Ninth, Tenth, Eleventh, and District of Columbia
Circuits have recognized that there can be implied false
certification liability under the FCA. See Mikes, 274 F.3d at
699-700; U.S. ex rel. Augustine v. Century Health Servs., Inc.,
289 F.3d 409, 415 (6th Cir. 2002); Ebeid ex rel. U.S. v.

15
In Rodriguez we stated that we have “yet to adopt in a
holding the false certification theory, either in its express or
implied version.” 552 F.3d at 303-04. But, as we have
indicated, we later recognized that there can be FCA liability
under an express false certification theory and therefore our
statement in Rodriguez is no longer true.

21
Lungwitz, 616 F.3d 993, 996-98 (9th Cir. 2010); Conner, 543
F.3d at 1217-18; McNutt ex rel. U.S. v. Haleyville Med.
Supplies, Inc., 423 F.3d 1256, 1259 (11th Cir. 2005); Sci.
Applications Int‟l Corp., 626 F.3d at 1266, 1269; but see U.S. ex
rel. Hutcheson v. Blackstone Med. Inc., ____ F.3d ____, 2011
WL 2150191, at *7 (1st Cir. June 1, 2011) (declining to employ
judicially created categories of express and implied false
certification); Harrison v. Westinghouse Savannah River Co.,
176 F.3d 776, 786 n.8 (4th Cir. 1999) (stating without
addressing validity of implied false certification theory under
FCA, that its precedent makes the theory “questionable”). We
now join with these many courts of appeals in holding that a
plaintiff may bring an FCA suit under an implied false
certification theory of liability.

We adopt the implied false certification theory for
liability for several reasons. First, the implied false certification
theory gives effect to Congress‟ expressly stated purpose that
the FCA should “reach all fraudulent attempts to cause the
Government to pay [out] sums of money or to deliver property
or services.” S. Rep. No. 99-345, at 9 (1986), reprinted in 1986
U.S.C.C.A.N. 5266, 5274; see also United States v. Neifert-
White Co., 390 U.S. 228, 232, 88 S.Ct. 959, 961 (1968) (“[T]he
[FCA] was intended to reach all types of fraud, without
qualification, that might result in financial loss to the
government.”). Moreover, our ruling is consistent with
Congress‟ stated intent inasmuch as under the implied false
certification theory of liability, even in the absence of a false
certification of compliance, the Government or qui tam
plaintiffs successfully may bring an action that holds a claimant
liable for submitting legally false claims to the Government:

22
 [A] false claim may take many forms, the most
common being a claim for goods or services not
provided, or provided in violation of contract
terms, specification, statute, or regulation . . . .
[Claims made to Medicare or Medicaid programs]
may be false even though the services are
provided as claimed if, for example, the claimant
is ineligible to participate in the program. . . .

S. Rep. No. 99-345, at 9, reprinted in 1986 U.S.C.C.A.N.
5266, 5274.

In addition, the language and the structure of the FCA
support the conclusion that a claim based on an implied false
certification “may constitute [an actionable] false or fraudulent
claim.” Shaw v. AAA Eng‟g & Drafting, Inc., 213 F.3d 519,
531 (10th Cir. 2000) (internal quotation marks omitted). “Under
§ 3729(a)(2), liability is premised on the presentation of a „false
record or statement to get a false or fraudulent claim paid or
approved.‟” Id. On the other hand, section 3729(a)(1) requires
only that a claimant present “a „false or fraudulent claim for
payment or approval‟ without the additional element of a „false
record or statement.‟” Id. Therefore, section 3729(a)(1), when
compared with section 3729(a)(2), indicates that a plaintiff can
bring a claim under the FCA even without evidence that a
claimant for Government funds made an express false statement
in order to obtain those funds. Id.

As several courts of appeals have held, however, the
implied certification theory of liability should not be applied
expansively, particularly when advanced on the basis of FCA

23
allegations arising from the Government‟s payment of claims
under federally funded health care programs. In particular, the
Court of Appeals for the Second Circuit in Mikes recognized
that the rationale behind Ab-Tech “does not fit comfortably into
the health care context because the [FCA] was not designed for
use as a blunt instrument to enforce compliance with all medical
regulations - but rather only those regulations that are a
precondition to payment . . . .” Mikes, 274 F.3d at 699.
Moreover, in Rodriguez, although we did not expressly adopt
the implied false certification theory, we stated that “[t]o state a
claim under [the implied false certification] theory it is
necessary to allege not only a receipt of federal funds and a
failure to comply with applicable regulations, but also that
payment of the federal funds was in some way conditioned on
compliance with those regulations.” 552 F.3d at 304. Thus,
under this theory a plaintiff must show that if the Government
had been aware of the defendant‟s violations of the Medicare
laws and regulations that are the bases of a plaintiff‟s FCA
claims, it would not have paid the defendant‟s claims. See
Conner, 543 F.3d at 1219-20 (“If the government would have
paid the claims despite knowing that the contractor has failed to
comply with certain regulations, then there is no false claim for
purposes of the FCA.”). Absent this requirement, the FCA
could turn “into „a blunt instrument to enforce compliance with
all . . . regulations‟ rather than „only those regulations that are a
precondition to payment.‟” Rodriguez, 552 F.3d at 304 (quoting
Mikes, 274 F.3d at 699). With these principles in mind, we now
will consider appellants‟ FCA allegations.

3. Violations of Medicare Marketing Regulations

24
 As we already have indicated, appellants contend that
United Health personnel engaged in marketing practices which
violated several Medicare marketing regulations, including: (1)
using marketing flyers and forms that CMS did not approve; (2)
engaging in marketing activities in the waiting rooms of clinics
and doctors‟ offices; (3) allowing non-licensed individuals to
engage in marketing activities; (4) using an excessive number of
sales representatives at presentations in an attempt to
“overwhelm the public;” (5) asking persons to raise their hands
at Medicare presentations if they were dual eligible for Medicare
and Medicaid; (6) chasing people in supermarkets to ask
whether they were dual eligible; (7) using agents to engage in
door-to-door solicitation; and (8) giving out prizes at Medicare
presentations in excess of $15 in value.

The District Court held that appellants‟ allegations that
United Health engaged in illegal marketing did not state a claim
for relief under either an express or implied false certification
theory. According to the Court, these allegations did not state a
claim under an express false certification theory inasmuch as
appellants failed to plead a single instance of United Health
submitting a false claim for payment to the Government:
“Without an allegation of a claim, Relators‟ False Claims Act
claim is like a battery without a touching, or a defamation
without a statement.” Wilkins, 2010 U.S. Dist. LEXIS 47080, at
*14. In support of its holding, the Court cited to our opinion in
Rodriguez, but appellants and amicus curiae contend that the
District Court mischaracterized the holding of Rodriguez, and

25
we agree.16

In Rodriguez, we based our holding affirming the district
court‟s Rule 12(b)(6) dismissal of the relators‟ FCA action on
their failure adequately to plead, under an implied false
certification theory, that the defendant violated a law or
regulation connected to the Government‟s decision to pay the
defendant‟s claims rather than on the relators‟ failure to identify
a specific claim for payment that the defendant submitted to the
Government. 552 F.3d at 304. It is true that to recover under
the FCA, 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.
U.S. ex rel. Quinn v. Omnicare Inc., 382 F.3d 432, 440 (3d Cir.
2004). Thus, in Quinn we held that the district court correctly
granted the defendant‟s Federal Rule of Civil Procedure 56(f)
motion for summary judgment based on the plaintiff‟s failure to
identify a single claim for payment to the Government arising
from defendant‟s alleged Medicare fraud. Id. But to our
knowledge we never have held that a plaintiff must identify a
specific claim for payment at the pleading stage of the case to
state a claim for relief. See Fowler v. UPMC Shadyside, 578
F.3d 203, 213 (3d Cir. 2009) (“It is axiomatic that the standards
for dismissing claims under Fed. R. Civ. P. 12(b)(6) and
granting judgment under . . . Fed. R. Civ. P. 56 are vastly
different.”).

16
The District Court also cited one of our not precedential
opinions but we will not discuss that case. See 3d Cir. Internal
Operating P. 5.7 (“The court by tradition does not cite to its not
precedential opinions as authority.”).

26
 In any event, as appellants correctly point out, the
question of whether a plaintiff, at the pleading stage, must
identify representative examples of specific false claims that a
defendant made to the Government in order to plead an FCA
claim properly is a requirement under the more particular
pleading standards of Rule 9(b). See Ebeid, 616 F.3d at 998-99
(listing cases and noting disagreement among courts of appeals).
But here, as we stated above, the District Court explicitly
declined to analyze appellants‟ claims under the pleading
requirements of Rule 9(b).

Nevertheless, we see no need to decide whether
appellants‟ marketing claims satisfied the pleading requirements
of Rule 9(b), because, despite our rejection of the District
Court‟s reasoning with respect to appellants‟ claim under an
express false certification theory, we will affirm its holding
dismissing appellants‟ claims predicated on the Medicare
marketing regulations on the same ground that the Court
provided for denying appellants‟ claims under an implied false
certification theory. Thus, we will affirm the District Court‟s
order rejecting appellants‟ claims predicated on the violation of
Medicare marketing regulations because appellants‟ allegations
that appellees violated the regulations do not state a plausible
claim for relief under the FCA inasmuch as the Government‟s
payments of appellees‟ Medicare claims were not conditioned
on their compliance with the marketing regulations.

As we stated above, to plead a claim upon which relief
could be granted under a false certification theory, either express
or implied, a plaintiff must show that compliance with the
regulation which the defendant allegedly violated was a

27
condition of payment from the Government. Rodriguez, 552
F.3d at 304; Mikes, 274 F.3d at 698. In determining whether
compliance with a regulation was a condition of payment from
the Government, courts have distinguished between regulations
which are conditions of participation in the Medicare programs
and conditions of Government payment of Medicare funds.
Conner, 543 F.3d at 1220; Mikes, 274 F.3d at 697 (“Since the
Act is restitutionary and aimed at retrieving ill-begotten funds, it
would be anomalous to find liability when the alleged
noncompliance would not have influenced the government‟s
decision to pay.”). The Court of Appeals for the Tenth Circuit
explained the difference between conditions of participation and
conditions of payment: “Conditions of participation . . . are
enforced through administrative mechanisms, and the ultimate
sanction for violation of such conditions is removal from the
government program,” while “[c]onditions of payment are those
which, if the government knew they were not being followed,
might cause it to actually refuse payment.” Conner, 543 F.3d at
1220.

Appellants assert that 42 C.F.R. § 423.509, pursuant to
which CMS may terminate a contract with a Medicare sponsor
that fails to comply with the applicable marketing guidelines,
demonstrates “[t]he relevancy and materiality of compliance”
with the marketing guidelines. Appellants‟ br. at 23. Indeed,
section 423.509 states that “CMS may at any time terminate a
contract if CMS determines that the Part D plan sponsor . . .
[s]ubstantially fails to comply with . . . [m]arketing requirements
in subpart V of this part.” 42 C.F.R. § 423.509(a)(8)(i); 42
C.F.R. § 422.510(a)(11) (same for MA organization). The same
regulation, however, provides that before CMS may issue a

28
notice of intent to terminate a Medicare contract it will provide a
plan sponsor “a reasonable opportunity of at least 30 calendar
days to develop and implement a corrective action plan to
correct the deficiencies.” 42 C.F.R. § 423.509(c)(1)(i); 42
C.F.R. § 422.510(c)(1)(i). The regulation further provides, in
section (c)(2)(iii), an exception for the 30-day correction period
if the termination is based on “credible evidence, [that the Plan
Sponsor] has committed or participated in false, fraudulent, or
abusive activities affecting the Medicare, Medicaid, or other
State or Federal health care programs, including submission of
false or fraudulent data.” 42 C.F.R. § 423.509(a)(4); 42 C.F.R. §
422.510(c)(2)(iii) (referring to 42 C.F.R. § 422.510(a)(4)). The
regulation also contains an exception to the requirement that a
sponsor be allowed a 30-day correction period where CMS‟s
delay in termination, or the financial difficulties of the Plan
Sponsor, pose an imminent and serious risk to the health of the
individuals enrolled in the sponsor‟s plan. 42 C.F.R. §
423.509(c)(2)(i)-(ii); 42 C.F.R. § 422.510(c)(2)(i)-(ii). Thus,
sections 423.509 and 422.510 clearly demonstrate that
compliance with the marketing regulations is a condition of
participation and not a condition of payment as the regulations
draw a line between the type of violations which are correctible
and, if corrected, will allow the sponsor to continue as a
Medicare program participant and the type of violations which
lead to immediate termination of a CMS contract.

Accordingly, the fundamental flaw in appellants‟
allegations is that the amended complaint does not cite to any
regulation demonstrating that a participant‟s compliance with
Medicare marketing regulations is a condition for its receipt of
payment from the Government. Nor do appellants cite

29
examples, in case law or otherwise, of the Government seeking
recovery of Medicare payments for services that a provider
actually performed on the basis that its lack of compliance with
marketing regulations rendered those services fraudulent.
Appellants offer no evidence beyond a CMS published
statement that the guidelines “were developed after careful
consideration by CMS of current industry practices, recent
advancements in communication technology, and how best to
protect the interests of Medicare beneficiaries.” Appellant‟s br.
at 21; app. at 210. This statement, however, does not indicate
that a participant‟s compliance with marketing regulations is a
condition for Government payment under the federal health care
programs. Moreover, we think that it is appropriate for us to
presume that the CMS surely develops all of its regulations after
careful consideration of these and other relevant factors no
matter what it determines should be the consequences of a
participant‟s non-compliance with the regulations.17

17
Similarly, appellants contend that Weems‟ statement, which
we have determined is not part of the record on which we will
decide this appeal, that “protecting people with Medicare from
deceptive or harmful practices is among our highest priorities at
CMS,” demonstrates the relevancy of the marketing guidelines
to the Government‟s decision to pay Medicare claims.
Appellant‟s br. at 21. However, even if we included that
statement in the materials that we consider in deciding this
appeal, we would regard the statement as demonstrating only
that CMS considers the marketing regulations to be very
important, but we would not regard the statement as indicating
what the consequence of non-compliance should be. After all,

30
 Further, considering that the Government has established
an administrative mechanism for managing and correcting
Medicare marketing violations which includes remedies for
violations other than the withholding of payment otherwise due,
it is clear that, although the Government considers substantial
compliance with the marketing regulations “a condition of
ongoing Medicare participation, it does not require perfect
compliance as an absolute condition for receiving Medicare
payments for services rendered.” Conner, 543 F.3d at 1221.
Furthermore, we think that anyone examining Medicare
regulations would conclude that they are so complicated that the
best intentioned plan participant could make errors in attempting
to comply with them. Moreover, it is ironical that if we allowed
appellants, though they are ostensibly acting on behalf of the
Government, to bring suit based on United Health‟s non-
compliance with marketing regulations, we would short-circuit
the very remedial process the Government has established to
address non-compliance with those regulations. “It would . . .
be curious to read the FCA, a statute intended to protect the
government‟s fiscal interests, to undermine the government‟s
own regulatory procedures.” Id. at 1222.

Finally, like the District Court in this case and the courts
of appeals in Conner and Mikes, we question the wisdom of
regarding every violation of a Medicare regulation as a basis for
a qui tam suit. Conner, 543 F.3d at 1221; Mikes, 274 F.3d at

as appellees aptly point out, “[p]resumably all regulations and
agency guidelines have some importance to the government
agency, or there would be no purpose for the agency to
promulgate them.” Appellees‟ br. at 24.

31
699-700. Federal agencies are unquestionably better suited than
federal courts to ensure compliance with Medicare marketing
regulations. In the circumstances, we believe that by permitting
qui tam plaintiffs to file suit based on the violation of
regulations which may be corrected through an administrative
process and which are not related directly to the Government‟s
payment of a claim, courts unwisely would shift the burden of
enforcing the Medicare regulations to themselves even though
the administration of the vast and complicated Medicare
program is best left to the administrators.18 In this regard, we
point out that if we adopted appellants‟ broad theory of FCA
liability, every time a plan participant‟s agent gave out a prize
worth over $15.00, or asked Medicare participants eligible for
Medicaid to raise their hands at a meeting, assuming that these
are improper marketing techniques, the agent‟s conduct could be
the basis for a federal court action. We do not think that this is
the purpose of 42 C.F.R. § 423.509, 42 C.F.R. § 422.510, the
marketing regulations, or the FCA.

In sum, inasmuch as compliance with the Medicare
marketing regulations is not a condition for Government
payment under the federal health insurance programs, the
District Court properly dismissed appellants‟ FCA claims based
on appellees‟ violations of those regulations for failure to state a
claim upon which relief could be granted.

4. The Anti-Kickback Statute

18
In reaching this conclusion we point out that administrators
sometimes address and resolve problems informally using
procedures that courts would not employ.

32
 The AKS, in relevant part, provides that

(2) whoever knowingly and willfully offers or
pays any remuneration (including any kickback,
bribe or rebate) directly or indirectly, overtly or
covertly, in cash or in kind to any person to
induce such person—

(A) to refer an individual to a person for
the furnishing or arranging for the
furnishing of any time or service for which
payment may be made in whole or in part
under a Federal health care program, or

(B) to purchase, lease, order, or arrange
for or recommend 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 upon conviction
thereof, shall be fined not more than $25,000 or
imprisoned for not more than five years, or both.

42 U.S.C. § 1320a-7b(b)(2).19

19
As part of the comprehensive health care legislation Congress
enacted in 2010, it amended the AKS to clarify that “a claim that
includes items or services resulting from a violation of this
section constitutes a false or fraudulent claim for purposes of

33
 As we stated above, a prima facie claim under the FCA
requires that the plaintiff show that “(1) the defendant presented
or caused to be presented to an agent of the United States a
claim for payment; (2) the claim was false or fraudulent; and (3)
the defendant knew the claim was false or fraudulent.” Schmidt,
386 F.3d at 242. We have held that “[f]alsely certifying
compliance with the . . . Anti-Kickback Act[] in connection with
a claim submitted to a federally funded insurance program is
actionable under the FCA.” Kosenske, 554 F.3d at 94. Further,
in Schmidt we stated that “[a] certificate of compliance with
federal health care law is a prerequisite to eligibility under the
Medicare program.” 386 F.3d at 243 (citing 42 C.F.R. §
413.24(f)(4)(iv)).

[the FCA].” Patient Protection and Affordable Care Act of 2010
(“PPACA”), Pub. L. No. 111-148 § 6402(f), 124 Stat. 119, 759
(to be codified at 42 U.S.C. § 1320a-7b(g)). But the PPACA
was not in effect at the time of the alleged violations at issue in
this case or at the time that appellants filed this action, and there
is no indication that Congress intended for the PPACA to apply
retroactively. See Graham County Soil & Water Conservation
Dist. v. U.S. ex rel. Wilson, 130 S.Ct. 1396, 1400 n.1 (2010)
(“The [PPACA] makes no mention of retroactivity, which would
be necessary for its application to pending cases given that it
eliminates petitioners‟ claimed defense to a qui tam suit.”).
Therefore we will not consider this amendment in our analysis
of appellants‟ AKS claims. In the circumstances, though we are
aware that there is an ongoing nationwide dispute with respect
to the constitutionality of the PPACA, we are not joining in that
controversy, at least not at this time.

34
 In dismissing appellants‟ AKS allegations, the District
Court stated that “[r]elators never once alleged that United
Health certified compliance with the [AKS], nor did they allege
that such compliance was relevant to the Government‟s funding
decisions (if indeed any were made, which Relators failed to
allege).” Wilkins, 2010 U.S. Dist. LEXIS 47080, at *18.
Appellants argue that “[a] certificate of compliance with federal
health care law is a prerequisite to eligibility under the Medicare
Program,” see appellant‟s br. at 41 (citing 42 C.F.R. §
413.24(f)(4)(iv)), and argue that they specifically referenced that
certificate of compliance in the amended complaint by referring
to the Medicare Managed Care Manual which states that a plan
sponsor ensures compliance with applicable federal laws,
including, specifically, the FCA and the AKS.

The Government, as amicus curiae, supports appellants‟
position by pointing out that Medicare regulations require MA
and Prescription Drug Plan (“PDP”) organizations to operate
under agreements with CMS which include a provision
requiring that the organization comply with the AKS. See 42
C.F.R. §§ 422.504(h) (“The MA organization agrees to comply
with—(1) Federal laws and regulations designed to prevent or
ameliorate fraud, waste, and abuse, including… [the AKS]”).
United Health responds that the District Court‟s holding was
correct inasmuch as “[n]owhere within the four corners of
Relators‟ Amended Complaint did the Relators allege the nexus
between compliance with the AKS and payment to a Medicare
Advantage plan contractor. . . .” Appellees‟ br. at 34.

The issue of whether appellants properly pleaded an FCA
claim based on United Health‟s express false certification of

35
compliance with the AKS presents a close question. Yet we
cannot ignore appellants‟ pleading in their amended complaint
that “[e]ach month . . . United Defendants certify to CMS its
continued compliance with all of the CMS MA Guidelines and
based on such certification, United Defendants continues [sic] to
receive the monthly capitation payments.” App. at 31.
Moreover, in the next section of the amended complaint,
appellants summarized the applicable Medicare regulations and
pleaded that an MA Organization may not provide “[a]ny
incentive that might have the effect of inducing enrollees to use
a particular provider, practitioner or supplier cannot [sic] violate
1128A(a)5 [sic] of the Social Security Act and the
corresponding regulations related to the federal anti-kickback
statute.” Id. at 32. Further, appellants alleged that
AmeriChoice paid $27,000 to the Reliance Medical Group to
induce the owners of the clinic to change dual eligible
beneficiaries from Horizon Blue and move them to
AmeriChoice, and that AmeriChoice agents enticed doctors into
receiving additional income if they provided agents with names
of the physicians‟ patients. Arguably, these allegations state a
claim for relief under an express false certification theory
inasmuch as appellants allege that appellees falsely certified
compliance with the AKS in order to receive monthly payments
from the Government.

But we need not decide whether the amended complaint
states a claim under an express false certification theory because
appellants‟ allegations in the amended complaint clearly state a
claim for relief under an implied false certification theory of
liability. Under an implied false certification theory, instead of
looking at the defendant‟s representations to the Government,

36
“the analysis focuses on the underlying contracts, statutes, or
regulations themselves to ascertain whether they make
compliance a prerequisite to the government‟s payment.”
Conner, 543 F.3d at 1218. Accordingly, we conclude that the
District Court‟s holding that because appellants failed to allege
in their complaint that United Health certified its compliance
with the AKS their AKS claim must fail is incorrect when we
analyze the amended complaint under an implied false
certification theory of liability. To plead a claim for relief under
an implied certification theory, appellants were required to
allege, as they did, that appellees submitted claims for payment
to the Government at a time that they knowingly violated a law,
rule, or regulation which was a condition for receiving payment
from the Government.

We reach our conclusion because appellants‟ amended
complaint meets the implied false certification standards for
liability as they alleged that appellees received payment from the
federal health insurance programs despite their knowing
violation of the AKS. Moreover, unlike the plaintiffs in
Rodriguez, 552 F.3d at 304, appellants alleged that compliance
with the AKS was an express condition of payment to which
appellees agreed when they entered into an agreement with
CMS. See app. at 31-32; 37-38 (stating that “Compliance with
CMS MA Guidelines . . . are express conditions of payment”
and stating that the AKS is part of the MA Guidelines). We
conclude that appellants, in stating a plausible claim for relief at
this stage of the proceedings for their complaint to survive a
Rule 12(b)(6) motion, need not allege a relationship between the
alleged AKS violations and the claims appellees submitted to

37
the Government.20 Rather, the complaint is sufficient to survive
a Rule 12(b)(6) motion to dismiss because appellants have
pleaded that appellees knowingly violated the AKS while
submitting claims for payment to the Government under the
federal health insurance program. See Ebeid, 616 F.3d at 998
(“Implied false certification occurs when an entity has
previously undertaken to expressly comply with a law, rule, or
regulation, and that obligation is implicated by submitting a
claim for payment even though a certification of compliance is
not required in the process of submitting the claim.”).

We disagree with the District Court to the extent that it
held that compliance with the AKS was not a condition for
payment from the Government under the federal health
insurance program. Compliance with the AKS is clearly a
condition of payment under Parts C and D of Medicare and
appellees do not refer us to any judicial precedent holding
otherwise. In fact, the precedents hold the opposite. See, e.g.,
Kosenske, 554 F.3d at 94 (“Falsely certifying compliance with
the Stark or Anti-Kickback Acts in connection with a claim
submitted to a federally funded insurance program is actionable
under the FCA.”); McNutt, 423 F.3d at 1259-60; Conner, 543
F.3d at 1223 n.8 (listing cases). Indeed, as both amicus curiae
and appellants point out, Medicare regulations specifically name
the AKS as a statute that is “designed to prevent or ameliorate
fraud, waste, and abuse.” 42 C.F.R. §§ 422.504(h), 423.505(h).

20
We emphasize again that we are not reviewing these claims
under the particularized pleading standards of Rule 9(b).

38
 We have not overlooked appellees‟ argument that our
holding will transform the FCA into a strict liability statute in
which “every participant in the Medicare program impliedly
certifies each time it submits a claim for payment to the program
that the claim does not arise from some payment arrangement
that—however attenuated, immaterial, and unknowing—could
be characterized as a violation of the AKS.” Appellees‟ br. at
36. Rather, we consider but reject this argument. First, the
AKS does not prohibit all payment arrangements related to
federal health care programs as the statute contains several safe
harbor provisions allowing such arrangements. See 42 U.S.C. §
1320a-7b(b)(3)(A)-(F). Further, contrary to appellees‟
argument, a defendant could not be held accountable for an
“unknowing” illegal payment arrangement inasmuch as the AKS
explicitly requires that for any payment to induce a person to
refer an individual for the furnishing of healthcare services to be
unlawful it must be made knowingly and willfully.

In order to avoid FCA liability under an implied
certification theory, participants making claims to the
Government under the federal health care programs have to
ensure that they are not violating the federal health care laws
which they agreed to follow when they entered into contracts
with CMS. As we made clear above, for purposes of the FCA,
this compliance does not require perfect adherence to
regulations which are not prerequisites to payment from the
Government. Compliance, however, does require a participant
in a federal health care program to refrain from offering or
entering into payment arrangements which violate the AKS,
while making claims for payment to the Government under that
program. We do not think this is an unreasonable requirement

39
to impose on federal health care contractors, for as Justice
Holmes once wrote: “Men must turn square corners when they
deal with the Government.” Rock Island, A. & L. R. Co. v.
United States, 254 U.S. 141, 143, 41 S.Ct. 55, 56 (1920). And
as the United States as amicus curiae points out, “[t]he
Government does not get what it bargained for when a
defendant is paid by CMS for services tainted by a kickback.”
Amicus curiae br. at 31. Therefore, we hold that appellants, by
alleging that appellees violated the AKS while submitting
claims for payment to a federal health insurance program, have
stated a plausible claim for relief under the FCA.

C. Amendment of the Complaint

Appellants argue that the District Court erred by
dismissing the case with prejudice. In this regard, they contend
that if the Court found the amended complaint to be deficient, it
should have dismissed the case without prejudice. Of course,
this argument now is partially moot as we are reversing the
District Court‟s order with respect to appellants‟ AKS claim.
But we nevertheless address the contention because the
argument remains germane with respect to the marketing claims.
On the merits, we are satisfied that appellants do not provide a
convincing argument that the District Court, to the extent that
we hold that it correctly dismissed the complaint, abused its
discretion by dismissing it with prejudice instead of without
prejudice, nor do they explain how if permitted to amend they
could cure the deficiencies that we have identified in their
complaint. In making this point we observe that when a district
court allows plaintiffs the opportunity to amend a complaint so
that they can survive a Rule 12(b)(6) motion, it is implicit in the

40
court‟s ruling that if the plaintiffs seek to amend the complaint
they will do so only in good faith and allege facts that they
believe they can prove.21 Accordingly, appellants‟ failure to
explain how they could have amended the complaint to cure its
deficiencies is a critical omission.

Appellants also argue that the District Court
misconstrued their statement in their reply to appellees‟ motion
to dismiss that “[i]n the event that the Court concludes that the
Complaint does not meet the standards of Rule 9(b), Relator
requests that he be provided the opportunity to amend the
Complaint . . . . ” Appellants‟ br. at 43. Appellants argue that
the amended complaint adequately pleaded the causes of action
and that “[t]he request was made only if, and subject to, the
Court concluding, after a review of United‟s [Motion to
Dismiss] and the Relator‟s [sic] opposition, that deficiencies
existed.” Id. at 44.

Whatever appellants‟ intentions were in asking the
District Court to permit them to amend their complaint, we
agree with that Court that the request, without an attached
amended complaint, was not the proper method for appellants to
seek to amend their complaint. See Fletcher-Harlee Corp. v.
Pote Concrete Contractors, Inc., 482 F.3d 247, 252 (3d Cir.

21
We are not suggesting that appellants have acted or would act
in bad faith and have made or would make allegations that they
did not believe. In fact, we do not doubt that appellants believe
that they can prove the allegations they already have made, and,
if permitted to amend their complaint again, would be able to
prove their new allegations.

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2007) (stating “that a failure to submit a draft amended
complaint is fatal to a request for leave to amend”). Therefore,
to the extent that appellants requested leave to amend their
complaint, the Court did not abuse its discretion by denying their
deficient request to amend nor did it abuse its discretion by not
granting them leave to amend sua sponte. Id. To the extent, if
any, that the Court misunderstood appellants‟ request to amend
their complaint, that circumstance has no bearing on this appeal.
Should appellants on the remand submit another request to
amend their complaint in any respect, it will be up to the District
Court to decide whether to grant them leave to amend their
complaint, and in making that determination to consider the
procedural appropriateness and substantive merits of the request.
See Fed. R. Civ. P. 15(a).

V. CONCLUSION

For the foregoing reasons, we will affirm the portion of
the District Court‟s May 13, 2010 order which dismissed
appellants‟ FCA allegations based on appellees‟ violation of
Medicare marketing regulations and will reverse the order
insofar as it grants appellees‟ motion to dismiss appellants‟
amended complaint based on its allegations that appellees
submitted false claims to the Government by violating the AKS.
We will remand the case to the District Court for further
proceedings consistent with this opinion. On remand, the
District Court should rule on appellees‟ Rule 9(b) contention
raised in their motion to dismiss with respect to the portion of
appellants‟ reinstated amended complaint. The parties shall bear
their own costs on this appeal.

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