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In the Supreme Court of the United States Docket No. 21-1967 __________________________ UNITED STATES EX REL. KEEGAN MASON, Petitioner, v. SOUTH AMERICAN METROPOLITAN CLINICS, INC., Respondents. __________________________ On Writ of Certiorari to the United States Court of Appeals for the Fifteenth Circuit BRIEF FOR PETITIONER Team 3014 Attorneys for Petitioner

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Page 1: In the Supreme Court of the United States Docket No. 21

In the

Supreme Court of the United States

Docket No. 21-1967

__________________________

UNITED STATES EX REL. KEEGAN MASON,

Petitioner,

v.

SOUTH AMERICAN METROPOLITAN CLINICS, INC.,

Respondents.

__________________________

On Writ of Certiorari to the United States Court of Appeals for the Fifteenth Circuit

BRIEF FOR PETITIONER

Team 3014

Attorneys for Petitioner

Page 2: In the Supreme Court of the United States Docket No. 21

i

QUESTIONS PRESENTED

1. Whether 31 U.S.C. § 3730(b)(5) of the False Claims Act (“FCA”) establishes a rule of

subject matter jurisdiction where Congress does not establish a clear intent to

characterize it as jurisdictional in either the plain language or context of the statute.

2. Whether the certification of a medical opinion can be false under the False Claims

Act when a provider submits a claim for a procedure that is not reasonable or

necessary to receive reimbursement from Medicare, or whether the relator must

show the certification was objectively false beyond their own medical expertise as

demonstrated by further evidence.

Page 3: In the Supreme Court of the United States Docket No. 21

ii

TABLE OF CONTENTS

STATEMENT OF JURISDICTION ................................................................................................................. 1

OPINIONS BELOW .......................................................................................................................................... 1

RELEVANT PROVISIONS .............................................................................................................................. 1

STATEMENT OF THE CASE .......................................................................................................................... 3

STATEMENT OF THE FACTS ......................................................................................................................... 3

PROCEDURAL HISTORY ................................................................................................................................. 6

SUMMARY OF THE ARGUMENT ................................................................................................................. 7

STANDARD OF REVIEW .............................................................................................................................. 10

ARGUMENT ..................................................................................................................................................... 11

I. PETITIONER FILED A DISTINCT CLAIM THAT CANNOT BE BARRED BY THE FIRST-TO-FILE RULE................................................................................................................................................... 11

A. The Court Must Adopt the Identical Facts Test as Intended by the Legislature. ................. 11 B. Even if the Court Adopts the Material Elements Test, Petitioner’s Claim Does Not Trigger

the First-to-File Bar Because her Claim Arises from Entirely Different Facts than Cobb’s. ....... 13 C. No Matter Which Test Applies, Barring Petitioner’s Claim Under the First-to-File Rule

Runs Contrary to Congressional Intent and Public Policy. .................................................................. 21

II. THE DISMISSAL OF COBB’S COMPLAINT RENDERED IT INSUFFICIENT TO PRECLUDE PETITIONER’S CLAIM UNDER THE FIRST-TO-FILE BAR. ....................................... 24

A. By Failing to State a Claim, Cobb’s Action Lacked Legal Ability to Preclude Petitioner’s

Later Claim. .................................................................................................................................................... 24

III. EVEN IF THE FIRST-TO-FILE RULE APPLIES TO PETITIONER’S CLAIM, THE COURT RETAINS SUBJECT MATTER JURISDICTION OVER IT BECAUSE CONGRESS DID NOT CLEARLY STATE THAT THE RULE PRESENTS A COMPLETE JURISDICTIONAL BAR. 31

IV. CERTIFICATIONS OF MEDICAL OPINIONS CAN BE FALSE UNDER THE FEDERAL CLAIMS ACT; HOWEVER, EVEN UNDER A MORE STRINGENT APPLICATION OF FALSITY, PETITIONER MEETS THE STANDARD. ................................................................................................... 38

CONCLUSION ................................................................................................................................................. 51

Page 4: In the Supreme Court of the United States Docket No. 21

iii

TABLE OF AUTHORITIES

Cases

Anchor Prop. & Cas. Ins. Co. v. Trif, 46 Fla. L. Weekly D 267 at 24 (2021) ..........................41

Arbaugh v. Y & H Corp., 546 U.S. 500, 516, 126 S. Ct. 1235, 1245 (2006) ...................... 33, 35

Campbell v. Redding Med. Ctr., 421 F.3d 817, 824 (9th Cir. 2005) ........................... 22, 24, 25

Doyle v. Hasbro, Inc., 103 F.3d 186, 194 (1st Cir. 1996) ........................................................26

Ebeid v. Lungwitz, 616 F.3d 993 at 998 (9th Cir. 2010) .........................................................39

Foster v. United States, 303 U.S. 118, 120 (1938) ............................................................ 11, 32

Gonzalez v. Thaler, 565 U.S. 134, 144, 132 S. Ct. 641, 650 (2012) ........................................38

Henderson v. Shinseki, 562 U. S., at 428, 435 (2011) .............................................................36

Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter, 135 S. Ct. 1970, 191 L.

Ed. 2d 899 (2015) ....................................................................................................... 8, 27, 29

Omnicare, Inc. v. Laborers Dist. Council Contr. Indus. Pension Fund, 575 U.S. 175 at 185-

191 (U.S. 2015)............................................................................................................... 41, 42

Patsy v. Bd. of Regents, 457 U.S. 496, 536, 102 S. Ct. 2557, 2578 n.4 (1982)........................21

Sebelius v. Auburn Reg’l Med. Ctr., 568 U.S. 145, 153, 133 S. Ct. 817, 824 (2013) ...... passim

Smith v. Clark/Smoot/Russell, A JV, 796 F3d 424, 430 (4th Cir. 2015).................................29

U.S. ex rel. Conner v. Salina Reg'l Health Ctr., Inc., 543 F.3d 1211, 1217 (10th Cir. 2008). 47

U.S. ex rel. Druding v. Druding, 952 F.3d 89 (3d. Cir. 2020) ......................................... passim

U.S. ex rel. Swift-Freeman v. Bon Secours Baltimore Health Sys., 2008 U.S. Dist. LEXIS

132574 (D. Md. 2008) ...........................................................................................................39

U.S. v. Univ. of Phx., 461 F.3d 1166 at 1174 (9th Cir. 2006) ........................................... 10, 40

United States ex rel. Boise v. Cephalon, Inc., 159 F. Supp. 3d 550, 558 (E.D. Pa. 2016) .. 8, 27

United States ex rel. Gadbois v. PharMerica Corp. ................................................................28

United States ex rel. Hagood v. Sonoma Cty. Water Agency, 929 F.2d 1416, 1420 (9th Cir.

1991) ............................................................................................................................. 8, 9, 25

United States ex rel. Hampton v. Columbia/Hca Healthcare Corp., 355 U.S. App. D.C. 23,

318 F.3d 214, 217 (2003)......................................................................................................14

Page 5: In the Supreme Court of the United States Docket No. 21

iv

United States ex rel. Hayes v. Allstate Ins. Co., 853 F.3d 80, 86 (2d Cir. 2017) ...................34

United States ex rel. Lujan v. Hughes Aircraft Co. ................................................................25

United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 516 (6th Cir. 2009) ....... passim

United States ex rel. Springfield Term. Ry. Co. v. Quinn, 14 F.3d 645, 649 (D.C. Cir. 1994)

........................................................................................................................................ 12, 23

United States ex rel. St. John LaCorte v. SmithKline Beecham Clinical Labs., Inc., 149 F.3d

227, 232-33 (3d Cir. 1998) ....................................................................................... 11, 12, 14

United States ex rel. Taxpayers Against Fraud v. GE, 41 F.3d 1032, 1035 (6th Cir. 1994) .21

United States ex rel. Todd Heath v. AT&T, Inc., 416 U.S. App. D.C. 289, 297-98, 791 F.3d

112, 120-21 (2015) ................................................................................................................34

United States ex rel. Williams v. NEC Corp., 931 F.2d 1493, 1499-500 (11th Cir. 1991) .....35

United States ex rel. Wood v. Allergan, Inc., 246 F. Supp. 3d 772, 799 (S.D.N.Y. 2017) .....29,

30, 31

United States ex. Rel. Karvelas v. Melrose-Wakefield Hospital, 360 F.3d 220, 226-31 (1st

Cir. 2004) .............................................................................................................................26

United States v. AseraCare, Inc., 938 F.3d 1278 (11th Cir. 2019). ................................ passim

United States v. Care Alternatives, 952 F.3d 89, 96 (3d Cir. 2020), cert. denied, 141 S. Ct.

1371, 209 L. Ed. 2d 119 (2021). ...........................................................................................48

United States v. Kwai Fun Wong, 575 U.S. 402, 408-09, 135 S. Ct. 1625, 1631 (2015) ... 9, 32,

37

United States v. Mckesson Corp., 2021 U.S. Dist. LEXIS 28744 at 7 (N.D. Cal. 2021) ........39

United States v. Millenium Labs., Inc., 923 F.3d 240, 248 (1st Cir. 2019) ............................34

United States v. Sanofi-Aventis U.S. LLC (In re Plavix Mktg.), 974 F.3d 228, 232 (3d Cir.

2020) ............................................................................................................................... 34, 36

Universal Health Serv.s Inc., v. U.S. ex rel. Escobar, 136 S. Ct. 1989 at 1993 (U.S. 2016) ..40

Walburn v. Lockheed Martin Corp., 431 F.3d 966, 972 (6th Cir. 2005) ......................... passim

Winter ex rel. U.S. v. Gardens Reg’l Hosp. & Med. Ctr., Inc., 953 F.3d 1008 (9th Cir. 2020)

...................................................................................................................................... passim

Page 6: In the Supreme Court of the United States Docket No. 21

v

Statutes

28 U.S.C. § 1331 .................................................................................................................................... 1

31 U.S.C. § 3729 ............................................................................................................................ 46, 50

31 U.S.C. § 3729(a)(1) ............................................................................................................... 2, 11, 43

31 U.S.C. § 3730(b)(5) ................................................................................................................. passim

31 U.S.C. § 3730(e)(4) ............................................................................................................. 26, 28, 39

31 U.S.C. §§ 3729 - 3733 ...................................................................................................................... 1

Other Authorities

AMERICAN BAR ASSOCIATION, 10th National Institute on the Civil False Claims Act and Qui Tam Enforcement, B-9 (2014). ...................................................................................... 52, 58

Center for Medicare and Medicaid Services, Local Coverage Determination for Wound Care,

L37228, (2020), https://www.cms.gov/medicare-coverage-

database/view/lcd.aspx?LCDId=37228 ................................................................................19

Centers for Medicare & Medicaid Services, NHE Fact Sheet, https://www.cms.gov/Research-

Statistics-Data-and-Systems/Statistics-Trends-and-

Reports/NationalHealthExpendData/NHE-Fact-Sheet (Dec. 16, 2020, 4:15 PM). ............52

Centers for Medicare and Medicaid Services, Medicaid Facts and Figures, (January 30,

2020), https://www.cms.gov/newsroom/fact-sheets/medicaid-facts-and-figures. ................23

Daniel R. Levinson, “Medicare Payments for Surgical Debridement Services in 2004” Dep’t

of Health and Human Serv., May 2007, 1, available at https://oig.hhs.gov/oei/reports/oei-

02-05-00390.pdf ...................................................................................................................19

James B. Helmer, Jr., American Bar Association Administrative Law and Regulatory

Practice Section, The False Claims Act: Whistleblower Litigation, (2021) at 463, 464 ....34,

35, 45

Larry M. Eig, Statutory Interpretation: General Principles and Recent Trends, Cong. Rsch.

Serv.s (Sept. 24, 2014), https://sgp.fas.org/crs/misc/97-589.pdf. .........................................53

Legislative Intent (Statutory Intent), Bouvier Law Dictionary, (The Wolters Kluwer

Bouvier Law Dictionary Desk Edition, 2012) .....................................................................25

NCD for Hyperbaric Oxygen Therapy § 20.29 (12/18/2017) available

at https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=12&ver=3. .19,

20, 21

Page 7: In the Supreme Court of the United States Docket No. 21

vi

S. Rep. No. 110-507, pt. 1 (2008). ................................................................................ 48, 51, 53

S. Rep. No. 99-345,(1986), reprinted in 1986 U.S.C.C.A.N. 5266, 5290 ................. 7, 14, 25, 35

Scott Glass, Is the False Claims Act's First-to-File Rule Jurisdictional? 118 Columbia L.

Rev. 2361, 2373 ........................................................................................................ 37, 39, 43

Page 8: In the Supreme Court of the United States Docket No. 21

1

STATEMENT OF JURISDICTION

The United States District Court for the District of Lincoln had federal question

jurisdiction over this claim pursuant to 28 U.S.C. § 1331 because it arises under the federal

False Claims Act. See 28 U.S.C. § 1331 (2019) and 31 U.S.C. §§ 3729 - 3733. On appeal,

the United States Court of Appeals for the Fifteenth Circuit had jurisdiction under 28

U.S.C. § 1331 as well. See id. § 1331. This Court has federal question jurisdiction under 28

U.S.C. § 1331. See id. § 1331.

OPINIONS BELOW

The United States District Court for the District of Lincoln denied Respondent’s

motion to dismiss for lack of subject matter jurisdiction per Fed. R. Civ. P. 12(b)(1) but

granted Respondent’s motion to dismiss for failure to state a claim per Fed. R. Civ. P.

12(b)(6). R. at 19. On appeal, the United States Court of Appeals for the Fifteenth Circuit,

reviewing de novo, affirmed the District Court’s decision to dismiss Petitioner’s holding that

the District Court did not have subject matter jurisdiction to hear the case. Id. at 25. The

Court of Appeals further held that the District Court should not have reached the issue of

falsity under the False Claims Act because 31 U.S.C. § 3730(b)(5) denied the court subject

matter jurisdiction. Id. at 23, 25.

RELEVANT PROVISIONS

This case centers around provisions within the False Claims Act (“FCA”). 31 U.S.C.

§§ 3729 - 3733. In particular, the case concerns the interpretation of 31 U.S.C. §

3730(b)(5), commonly referred to as the “first-to-file” rule, which states that “no person

other than the Government may intervene or bring a related action based on the facts

underlying pending action.” Additionally relevant to this case is 31 U.S.C. § 3729(a)(1),

Page 9: In the Supreme Court of the United States Docket No. 21

2

which states in pertinent part that “any person who knowingly presents, or causes to be

presented, a false or fraudulent claim for payment” may be found liable for certain acts

under the FCA.

Page 10: In the Supreme Court of the United States Docket No. 21

3

STATEMENT OF THE CASE

STATEMENT OF THE FACTS Respondent, Southern American Metropolitan Clinics Inc., (“SAM Clinics”),

specializes in treating chronic wounds and operates fourteen centers within the State of

Lincoln, making it the largest “for-profit” provider of wound care services within the

state. R. at 2. In addition to treating patients with non-surgical interventions, SAM

Clinics also performs selective and surgical debridement and Hyperbaric Oxygen (“HBO”)

therapy. Id. at. 3. Under the Center for Medicare and Medicaid Services (“CMS”)

guidelines, selective and surgical debridement are reimbursable so long as at least one

condition specified by the guidelines is present. Id. In contrast, the CMS guidelines for

HBO therapy require that “[t]he use of HBO therapy is covered as adjunctive therapy only

after there is no measurable signs of healing for at least 30 days of treatment with standard

wound therapy and must be used in addition to standard wound care.” Id. at 6. HBO

therapy may also be paid for by Medicare and Medicaid; however, treatments will only be

reimbursed if the wound is classified as Wagner Grade III or higher, has not positively

responded to standard wound therapy, and is provided in conjunction with standard wound

care procedures. Id. at 3-6. In total, Medicare reimbursements account for seventy-five

percent of SAM Clinics’ overall revenue. Id. at 2.

Petitioner, Keegan Mason, is a Clinical Nurse Specialist (“CNS”) who began working

at SAM Clinics when she relocated to the State of Lincoln two years ago. Id. at 4. Due to

her previous work experience, Ms. Mason is familiar with the CMS requirements for

reimbursement and has both diagnosed and ordered HBO therapy in the past. Id. In her

current role at SAM Clinics, Ms. Mason is allowed to supervise HBO therapy but cannot

personally diagnose or order such treatments. Id. Additionally, she attends to patients at

Page 11: In the Supreme Court of the United States Docket No. 21

4

several SAM Clinic facilities within Lincoln, including Washington City and other nearby

satellite clinics. Id.

SAM Clinics started providing wound care services when it opened in 1967, but

experienced significant expansion within the past ten years. Id. at 2. In January of 2019,

SAM Clinics hired its current CEO, John O’Keefe. Id. at 4. Just a month later, in February

2019, Petitioner noticed an increase in the number of HBO therapy treatments performed

at the clinics she supervises. Id. Petitioner pleaded that this increase in treatments was

“questionable” since factors such as the patients’ underlying diagnoses, responses to

conventional treatments, and Wagner grades of the wounds did not support the use of HBO

therapy. Id. Petitioner noticed that most of these patients were covered by Medicare and

Medicaid and knew that these treatments were certified as “medically necessary” under

CMS guidelines and therefore eligible for reimbursement. Id. at 5. Petitioner grew

concerned after hearing discussions about clinic management “pushing” physicians to meet

a “quota system.” Id. She also witnessed a physician change a wound’s Wagner grade after

meeting with O’Keefe. Id. When Petitioner confided in another CNS about her

observation, the CNS told her that it “was best to just do what they were told.” Id. A few

months later, on September 24, 2019, Petitioner overheard a SAM Clinic physician, Dr.

William Drake, and O’Keefe discussing the number of HBO therapy treatments the

physician performed. Id. Petitioner specifically heard O’Keefe say, “Got to keep those

numbers up,” to which Dr. Drake laughed and responded with, “I’m good. Almost got that

Tesla down payment.” Id. During this conversation, O’Keefe further stated, “Yep, CMS

approves, you get that fancy new car, and the patients are happy. It’s a win-win-

win.” Id. Also around this time, in October 2019, a plastic surgeon at SAM Clinics, Dr.

Elizabeth Cobb, alleged that she was fired by O’Keefe after he pressured her to perform and

certify a medically unnecessary surgical debridement to which she refused. Id.

Page 12: In the Supreme Court of the United States Docket No. 21

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In addition to these occurrences, Petitioner pleaded that at least four specific

patients’ diagnoses did not meet the CMS standards or match her observations regarding

their conditions. Id. at 7. In the case of the first patient, a physician, who originally

classified a wound as Wagner grade II and ordered that treatment did not include HBO

therapy, upgraded the wound to Wagner grade III after speaking with O’Keefe. Id. In the

case of the second patient, the CMS medical certification for their HBO therapy treatments

stated that their diagnosis was chronic refractory osteomyelitis, even though the

osteomyelitis responded to conventional treatments. Id. In the case of the third patient,

the severity of their wound resulted in a recommendation of amputation; however, they

underwent several HBO therapy treatments before the actual

amputation. Id. Additionally, when Petitioner asked a physician why they treated the

patient with HBO therapy, the physician responded with “talk to O’Keefe about

it.” Id. Lastly, in the case of the fourth patient, their medical certification classified their

wound as Wagner grade III even though they did not have a record of osteitis, abscess, or

osteomyelitis, which are required for a grade III classification. Id. Following these

experiences, Petitioner filed a complaint alleging that SAM Clinics certified and submitted

Medicare claims that they knew were medically unnecessary based on patients’ charts and

CMS criteria. Id. at 6. The complaint also referenced an affidavit from a medical expert

who held that the treatments identified by Petitioner contradicted CMS’s guidelines. Id. at

7. Overall, Petitioner claims that these facts show that SAM Clinics is involved in a scheme

to defraud Medicare by having physicians certify unnecessary HBO therapy treatments in

exchange payments based on the number of procedures they perform. Id. at 8. Petitioner

filed a qui tam action against SAM Clinics pursuant to these incidents on November 22,

2019. Id. at 1.

Page 13: In the Supreme Court of the United States Docket No. 21

6

PROCEDURAL HISTORY

Petitioner filed this qui tam action under seal on November 22, 2019, alleging that

Respondent utilizes a sort of “quota system” that ignores the requirements of § 20.29 of the

National Coverage Determination for Hyperbaric Oxygen Therapy that HBO therapy be

medically necessary to receive reimbursement under Medicare and Medicaid. R. at 5 and

National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy § 20.29

(12/18/2017) available at https://www.cms.gov/medicare-coverage-

database/view/ncd.aspx?ncdid=12&ver=3. Prior to Petitioner’s initial filing, Dr. Elizabeth

Cobb filed a qui tam action on October 14, 2019, alleging that one of Respondent’s locations

fired her for refusing to perform a medically unnecessary surgery in violation of the

FCA. R. at 5. Cobb’s action was promptly dismissed on January 20, 2020, for failure to

comply with the basic pleading requirements under Rule 9(b). Id. at 6. Petitioner’s claim

was unsealed on January 24, 2020. Id. at 1. Promptly thereafter, Respondent sought to

dismiss the case under Fed. R. Civ. P. 12(b)(1) and 12(b)(6). Id. at 1. Judge Garrett

Andrew of the United States District Court for the District of Lincoln denied the motion to

dismiss for lack of subject matter jurisdiction; however, granted the motion to dismiss

under Rule 12(b)(6) for failure to state a claim upon which relief can be granted. Id. at

19. Petitioner appealed to the United States Court of Appeals for the Fifteenth Circuit. Id.

at 20. In a 2-1 decision, the Fifteenth Circuit affirmed the District Court’s decision to

dismiss the case but held that the case should have been dismissed for lack of subject

matter jurisdiction, rather than failure to state a claim. Id. at 23, 25.

Page 14: In the Supreme Court of the United States Docket No. 21

7

SUMMARY OF THE ARGUMENT

Petitioner requests this Court to reverse the Fifteenth Circuit’s judgement

dismissing the Petitioner’s claim for lack of subject matter jurisdiction because (1)

Petitioner’s claim is factually distinct from the earlier filed claim by Cobb, and (2) even if

the first-to-file rule does apply, Congress did not intend § 3730(b)(5) of the False Claims Act

to create an absolute jurisdictional bar. Furthermore, this Court should reverse the

District Court’s decision to dismiss Petitioner’s claim under Fed. R. Civ. P. 12(b)(6) because

the objective falsehood standard goes against Congress’ intention to encourage reports of “all

types of fraud, without qualification . . .” Winter ex rel. United States v. Gardens Reg'l Hosp. &

Med. Ctr., Inc., 953 F.3d 1108, 1119 (9th Cir. 2020). This Court has subject matter

jurisdiction over Petitioner’s claim and Petitioner has sufficiently demonstrated that she

meets the proper standard required by the FCA to demonstrate that Respondent’s medical

certifications were false.

First, § 3730(b)(5) of the FCA was intended only to bar claims that contain identical

facts to an earlier filed and still pending claim. S. Rep. No. 99-345,(1986), reprinted in 1986

U.S.C.C.A.N. 5266, 5290. Petitioner alleges facts concerning different patients, medical

procedures, and locations, along with far more detailed information stemming from her

personal experiences as a CNA at SAM Clinics. R. at 4-7. Although the Court should adopt

the identical facts test as intended by the legislature, even should it adopt a broader test,

Plaintiff’s claim remains factually distinct from Cobb’s. Some courts apply a material

elements test, which considers whether the two claims raise the same or significantly

similar allegations of fraud. United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503,

516 (6th Cir. 2009). Again, Petitioner’s claim is distinct from Cobb’s because she raises

allegations of fraud pertaining to different medical procedures, patients, and locations. R.

at 4-7. Not only does she raise factually different allegations, but she also alleges a form of

Page 15: In the Supreme Court of the United States Docket No. 21

8

coercion and pressure different than Cobb alleges. Id. Cobb’s action stems from a single

dispute of medical opinion regarding the medical necessity of a surgical debridement

procedure, whereas Petitioner’s action stems from a plethora of concerning events that put

the Government on notice of severe fraud. Id.

Second, even if Petitioner and Cobb allege similar acts of fraud, the fact that Cobb’s

action was dismissed for failure to state a claim prior to Petitioner’s claim being unsealed

should grant this Court jurisdiction over her claim. United States ex rel. Poteet v.

Medtronic, Inc., 552 F.3d 503, 516 (6th Cir. 2009) (“[I]n order to preclude later-filed qui tam

actions, the allegedly first-filed qui tam complaint must not itself be jurisdictionally or

otherwise barred.”); Walburn v. Lockheed Martin Corp., 431 F.3d 966, 972 (6th Cir. 2005)

(A legally infirm action cannot trigger the first-to-file bar.); United States ex rel. Boise v.

Cephalon, Inc., 159 F. Supp. 3d 550, 558 (E.D. Pa. 2016) (“[I]t would be unjust to require

relators to refile their claims even though their only procedural roadblock was

dismissed.”). Cobb’s claim was dismissed for failure to state a claim as required by Rule

9(b), and was therefore meritless from the start. R. at 2. A legally infirm claim should not

preclude later filed, and legally valid, claims under the first-to-file provision because such a

result is contrary to Congressional intent. United States ex rel. Hagood v. Sonoma Cty.

Water Agency, 929 F.2d 1416, 1420 (9th Cir. 1991). Furthermore, once an earlier filed

claim is no longer pending, as in no longer active, the first-to-file bar should not remain in

effect because the procedural roadblock has been removed. Kellogg Brown & Root Services,

Inc. v. United States ex rel. Carter, 135 S. Ct. 1970, 191 L. Ed. 2d 899 (2015). Under either

interpretation, since Cobb’s claim was dismissed for lack of merit, it can no longer bar

Petitioner’s claim under the first-to-file rule.

Third, Petitioner’s claim may be heard by this Honorable Court because a claim

brought in violation of the first-to-file rule does not require courts to dismiss such a claim

Page 16: In the Supreme Court of the United States Docket No. 21

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for lack of subject matter jurisdiction. This is because Congress did not clearly state that §

3730(b)(5) is a jurisdictional rule and as a result, the Supreme Court instructs courts to

treat the statute as nonjurisdictional. Sebelius v. Auburn Reg’l Med. Ctr., 568 U.S. 145,

153, 133 S. Ct. 817, 824 (2013) (“We inquire whether Congress has “clearly state[d]” that

the rule is jurisdictional; absent such a clear statement, we have cautioned, “courts should

treat the restriction as nonjurisdictional in character.”) (citation omitted). Because

Congress does not explicitly state an intention to render § 3730(b)(5) jurisdictional from

either the plain language of the statute or its context, this Court must treat it as

nonjurisdictional. A nonjurisdictional interpretation of § 3730(b)(5) leaves courts with more

leeway in hearing qui tam actions, which better accomplishes the purposes of the False

Claims Act. See United States v. Kwai Fun Wong, 575 U.S. 402, 408-09, 135 S. Ct. 1625,

1631 (2015) (“[A] litigant’s failure to comply with [a [jurisdictional] bar deprives a court of

all authority to hear a case[.]”). This leeway is precisely what Congress intended when it

amended the False Claims Act in 1986 to “repeal overly restrictive court interpretations” of

its provisions thereby allowing the public greater access to bring suit for the public

good. United States ex rel. Hagood v. Sonoma Cty. Water Agency, 929 F.2d 1416, 1420 (9th

Cir. 1991). A nonjurisdictional interpretation of the first-to-file provision would allow the

Court to hear Petitioner’s claim and allow future plaintiffs to rely on the finality of court

decisions without fear that defendants will seek to dismiss an action for lack of subject

matter jurisdiction on appeal. Because there is no clear statement from Congress to

interpret § 3730(b)(5) as jurisdictional, the Court must treat it as

nonjurisdictional. Sebelius v. Auburn Reg’l Med. Ctr., 568 U.S. 145, 153, 133 S. Ct. 817,

824 (2013). As a result, this Court may exercise jurisdiction over Petitioner’s claim.

For the above mentioned reasons, the Court has jurisdiction over Petitioner’s

claim. The Court must then turn its attention to Petitioner’s allegations of fraud. Under

Page 17: In the Supreme Court of the United States Docket No. 21

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the FCA, civil liability is imposed on any person who “knowingly presents, or causes to be

presented, a false or fraudulent claim for payment or approval.” 31 U.S.C. §

3729(a)(1)(A). A provider’s certification violates the FCA if they make “(1) a false statement

or fraudulent course of conduct, (2) made with scienter, (3) that was material, causing (4)

the government to pay out money or forfeit moneys due.” U.S. v. Univ. of Phx., 461 F.3d

1166 at 1174 (9th Cir. 2006). The FCA has not provided a definition for the term “false,”

and courts are split over which standard of falsity applies to false medical certification

claims. United States v. AseraCare, Inc., 938 F.3d 1278, 1297 (11th Cir. 2019). There are two

standards the court will consider in determining falsity: the common law, which determines a mere

medical opinion is sufficient as proof, and the objective falsehood standard, which requires actual

evidence. The common law standard of falsity best aligns with Congress’s intentions and the

statutory language of the FCA as Congress intended to reach all fraud. Even if the Court

were to require objective falsity be proven, the petitioner has met this requirement by using

her own medical expertise and reviewing patient files in determining the HBO therapies

were unreasonable and unnecessary per her and other medical expert opinions.

STANDARD OF REVIEW

The proper standard of review courts must apply for motions to dismiss is de

novo. Walburn v. Lockheed Martin Corp., 431 F.3d 966, 969 (6th Cir. 2005) (reviewing

dismissal of FCA claims for lack of subject matter jurisdiction). On appeal, the Court must

also accept all pleaded facts as true on appeal. See, e.g., Mohamad v. Palestinian Auth.,

566 U.S. 449, 452, 132 S. Ct. 1702, 1705 (2012).

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ARGUMENT

I. PETITIONER FILED A DISTINCT CLAIM THAT CANNOT BE BARRED BY

THE FIRST-TO-FILE RULE.

If an action is properly brought under the qui tam provisions of the FCA, another

party may not file an action based on the same underlying facts of the first party’s action;

however, there is a jurisdictional split regarding the interpretation of a “related” action. 31

U.S.C. § 3730(b)(5). Courts apply two different tests that consider whether the two claims

(1) are based on identical facts and circumstances, or (2) allege the same material

facts. See, e.g., United States ex rel. St. John LaCorte v. SmithKline Beecham Clinical

Labs., Inc., 149 F.3d 227, 232-33 (3d Cir. 1998) (applying a material elements analysis);

United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 516 (6th Cir. 2009) (holding

that later claims are barred even when they contain different details if they are based on

the same material elements). The Court should hold that the applicable interpretation of

relatedness is whether the actions are based on identical facts and circumstances because

that interpretation reflects Congress’s intent in enacting the legislation. Petitioner’s claim

is based on entirely different facts and circumstances than those alleged by Cobb. Under

either the identical facts or material facts test, Petitioner’s claim is not sufficiently related

to Cobb’s to merit application of the first-to-file bar.

A. The Court Must Adopt the Identical Facts Test as Intended by the Legislature.

Petitioner’s claim is so distinct from Cobb’s that she cannot be barred by the first-to-

file rule no matter which analysis the Court adopts. Nevertheless, the Court should apply

the identical facts test because that is what the legislature intended by enacting this

amendment. Foster v. United States, 303 U.S. 118, 120 (1938) (“Courts should construe

laws in harmony with the legislative intent and seek to carry out legislative

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purpose”). When Congress first enacted this provision in 1986, its purpose was to serve as

“the golden mean between adequate incentives for whistleblowing insiders with genuinely

valuable information and discouragement of opportunistic plaintiffs who have no significant

information to contribute of their own.” United States ex rel. LaCorte v. SmithKline

Beecham Clinical Labs., 149 F.3d 227 (3d Cir. 1998) (quoting United States ex rel.

Springfield Term. Ry. Co. v. Quinn, 14 F.3d 645, 649 (D.C. Cir. 1994)). Speaking further on

its purpose, Congress notes that the first-to-file provision “is not meant to produce class

actions or multiple separate suits based on identical facts and circumstances.” S. Rep. No.

99-345, at 25 (1986), reprinted in 1986 U.S.C.C.A.N. 5266, 5290 (emphasis added). Rather,

in enacting § 3730(b)(5), Congress sought to prevent subsequent actions based on the

“identical facts and circumstances” stemming from the first filed action and that is the

standard that must apply. Id. Thus, the proper test is whether the claims contain identical

facts and circumstances, not whether they contain similar facts and circumstances.

In essence, the first-to-file jurisdictional bar serves the imperative function of

preventing duplicative claims filed after the due diligence of the original plaintiff. By

reserving jurisdiction for the first filed claim, individuals who learn of the alleged fraud as

a result of the earlier claim cannot capitalize on the whistleblower who acted promptly and

diligently. The purpose of the first-to-file provision is to bar duplicative claims, as in

identical claims. Id. Any expansion of its application is contrary to the legislature’s

purpose in enactment and harmful to potential plaintiffs. For example, the policy purpose

of the first-to-file rule would be undermined should a preceding claim allege a small,

isolated instance of potential fraud and consequently bar a later filed claim with specific,

detailed, allegations of widespread fraudulent practices against the same defendant, which

is precisely the issue here.

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Under the identical facts test, Petitioner cannot be barred by Cobb’s earlier filed

claim because they do not allege identical facts and circumstances. Petitioner alleges

fraudulent practices pertaining to HBO therapy, whereas Cobb alleges fraudulent practices

pertaining to surgical debridement. R. at 5. Petitioner further alleges that these practices

are widespread throughout SAM Clinics and points to several specific instances of

fraudulent behavior conducted by various agents of the clinics. Id. at 5-7. On the other

hand, Cobb alleges only one instance of potentially fraudulent activity without enough

details to place the Government on notice of a truly fraudulent scheme. Id. at 5. Moreover,

Cobb does not detail Respondent’s method of pressuring physicians into certifying medical

necessity. Rather, she focuses on a dispute in medical opinion. Id. Another doctor

promptly rendered the medical procedure to the client Cobb refused to aid, and she does not

describe continuous pressure to falsely certify medical procedures as necessary like

Petitioner does. Id. The facts and circumstances these two claims allege are not at all

identical; a claim with identical facts to Cobb’s would allege the same medical procedure,

clinic location, and consequential termination. Petitioner, on the other hand, details a

series of fraudulent behavior pertaining to a different medical procedure, with different

Medicare reimbursement requirements, at multiple clinic locations. Id. at 4-

7. Consequently, Petitioner’s claim should not be barred under the identical facts test.

B. Even if the Court Adopts the Material Elements Test, Petitioner’s Claim Does Not

Trigger the First-to-File Bar Because her Claim Arises from Entirely Different Facts

than Cobb’s.

Although the Court should honor the legislature’s intended application of the rule, if

the Court adopts a different standard, Petitioner’s claim still cannot be barred by the first-

to-file rule because it is substantially different from Cobb’s claim. As mentioned, some

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circuit courts stray from the identical facts test and instead apply a “material elements”

test. United States ex rel. LaCorte v. SmithKline Beecham Clinical Labs., 149 F.3d 227 (3d

Cir. 1998); United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 516 (6th Cir.

2009). Under the material elements test, courts consider whether the “later allegation

states all the essential facts[,]” or material facts, stemming from the prior claim regardless

“if that claim incorporates somewhat different details.” SmithKline Beecham Clinical

Labs., 149 F.3d 227, 232-33; see also United States ex rel. Hampton v. Columbia/Hca

Healthcare Corp., 355 U.S. App. D.C. 23, 318 F.3d 214, 217 (2003) (rejecting the identical

facts test for the material facts test). The Sixth Circuit further elaborates that the test

must consider whether the “subsequent complaint raises the same or a related claim based

in a significant measure on the core fact or general conduct” alleged in the prior

claim. United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 516 (emphasis

added). Regardless of which test applies, Petitioner’s claim arises from an entirely different

set of events and provides numerous allegations that are completely nonexistent in Cobb’s

claim. SmithKline Beecham Clinical Labs., Inc., 149 F.3d 227, 232. Moreover, the

essential facts alleged by Petitioner place the Government on notice of an entirely different

fraudulent scheme than Cobb’s claim. Id. (“once the government knows the essential facts

of a fraudulent scheme, it has enough information to discover related frauds”); see also

United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 516.

In a case that illustrates the application of the material elements test, United States

ex rel. Poteet v. Medtronic, Inc. (“Poteet”), the Sixth Circuit considered whether two

competing complaints “allege[d] the same essential facts regarding the fraud against the

government” by the defendant. 552 F.3d 503, 517. There, a former employee filed a

wrongful termination suit against Medtronic, Inc. (“Medtronic”) and Medtronic Sofamor

Danek USA, Inc. (“MSD”) alleging that the company fired him for refusing “to comply with

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his supervisors’ directives to pay illegal kickbacks and bribes to MSD physician customers

in exchange for their business.” Id. at 508. The employee’s initial complaint contained

specific allegations regarding the company’s practices to essentially bribe healthcare

providers “with extravagant travel arrangements, sham consulting agreements, and

company-sponsored "Think Tanks" to ensure their continued use of MSD

products.” Id. Nearly a year later, another former employee, John Doe, filed a qui tam

action alleging the same facts but naming ten physicians as additional

defendants. Id. Poteet filed a qui tam action more than two years after the initial

claim. Id. Like the earlier plaintiffs, Poteet filed his claim against Medtronic and MSD,

along with seventeen additional healthcare defendants, two of whom were named in an

earlier complaint. Id. Poteet similarly alleged that MSD “paid the defendant physicians

large amounts of money and provided them with lavish travel and recreational

opportunities” in exchange for their business and in violation of the FCA and the Anti-

Kickback statute. Id. at 509. In comparing Poteet’s claim to John Doe’s claim, the court

found that “[t]he only potentially significant differences between the two complaints is that,

with the exception of two overlapping physician defendants and Medtronic and MSD, the

complaints identify different physician defendants.” Id. at 517. Aside from the difference

in defendants, the claims both alleged the same essential facts that Medtronic and MSD

involved “providing monetary and in kind compensation to physicians” for their business

and filing “false or ineligible claims for Medicare and Medicaid

reimbursement.” Id. Despite the different defendants and time frames alleged within the

complaints, Doe’s claim effectively put the Government on notice of the essential facts

involving a potentially fraudulent scheme, thereby enabling it to “discover related

frauds.” Id. As a result, Poteet’s claim could not withstand the first-to-file bar.

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Unlike the claims in Poteet, Petitioner alleges essential facts of a fraudulent scheme

not at all derivable from Cobb’s and is therefore not subject to the first-to-file

bar. Specifically, Petitioner’s claim alleges a fraudulent scheme involving: (1) a direct

violation of CMS guidelines regarding HBO therapy (2) spread across multiple clinic

locations (3) in which multiple agents of SAM Clinics both engaged in and promoted. R. at

4-7. Additionally, in contrast to Cobb’s claim, Petitioner’s claim does not arise from

termination for failure to provide a surgical debridement, rather it arises from her first-

hand experience overhearing inculpatory conversations between SAM Clinics agents and

witnessing questionable medical procedures performed on a multitude of patients at

various SAM Clinics. Id. These are not “somewhat different details” but completely

independent factual allegations of fraud arising from distinct events. SmithKline Beecham

Clinical Labs., Inc., 149 F.3d 227, 232-33. Thus, Petitioner’s claim must survive the first-

to-file rule regardless of the standard to which it is held.

1. The claims allege a violation of materially different CMS guidelines because

they involve different medical procedures.

A key distinction between the two claims are the medical procedures at focus. Cobb,

a plastic surgeon, refused to provide a potentially medically unnecessary surgical

debridement. R. at 5. Surgical debridement, as defined in the record, is “the removal of

unhealthy tissue from a wound in order to promote healing.” Id. at 3. On the contrary,

Petitioner, a CNS, alleges fraudulent reimbursement for HBO therapy, which is not within

the category of surgical debridement under CMS guidelines. Id.; see also NCD for

Hyperbaric Oxygen Therapy § 20.29 (12/18/2017) available

at https://www.cms.gov/medicare-coverage-

database/view/ncd.aspx?ncdid=12&ver=3. These are two completely different procedures

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with completely different guidelines for reimbursement under the National Coverage

Determination and Local Coverage Determination standards. Surgical and selective

debridement involves the “removal of dead or unhealthy tissue from a wound using a sharp

instrument, such as a curette or scalpel” and does not require the heightened requirement

assigned to HBO therapy. Daniel R. Levinson, “Medicare Payments for Surgical

Debridement Services in 2004” Dep’t of Health and Human Serv., May 2007, 1, available at

https://oig.hhs.gov/oei/reports/oei-02-05-00390.pdf (further finding that only 1% of

debridement procedures were medically unnecessary); see also Center for Medicare and

Medicaid Services, Local Coverage Determination for Wound Care, L37228, (2020),

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=37228

(debridement requires at least one condition as listed by LCD guidelines be present and

documented). In comparison, HBO therapy is an “adjunctive therapy” that may only be

provided “after there are no measurable signs of healing for at least 30 days of treatment

with standard wound therapy and must be used in addition to standard wound care.” NCD

for Hyperbaric Oxygen Therapy § 20.29 (12/18/2017) available

at https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=12&ver=3. This

heightened requirement for HBO therapy differentiates the two cases’ essential facts. The

inquiry pertaining to Respondent’s fraudulent behavior involves completely different

standards and evidence of fraudulent activity.

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2. Petitioner’s claim articulates allegations of a fraudulent scheme permeating

throughout SAM Clinics backed by several specific instances of fraudulent

activity, whereas Cobb merely alleges a single disputed medical opinion

involving one location.

Moreover, unlike Cobb’s insufficient allegations of fraud, Petitioner’s claim involves

various clinic locations involved in fraudulent activity on a wide scale. R. at 4-

7. Additionally, Petitioner provides specific instances of four different patients, rather than

relying on a single dispute between practitioners. Id. at 7. Petitioner details how

individuals with type I diabetes who typically do not meet the threshold for reimbursable

HBO therapy under the NCD were provided such therapy nonetheless. Id. at 7. She

further alleges that another patient, Patient B, received HBO therapy despite their wound

positively responding “after a short course of conventional treatment[,]” which is a flagrant

violation of the NCD requirements for reimbursement. Id. and NCD for Hyperbaric Oxygen

Therapy § 20.29 (12/18/2017) available at https://www.cms.gov/medicare-coverage-

database/view/ncd.aspx?ncdid=12&ver=3 (“Failure to respond to standard wound care

occurs when there are no measurable signs of healing for at least 30 consecutive

days”). She further details how a physician could not support the rationale for changing a

patient’s course of treatment or the medical basis for another patient’s Wagner grade. R. at

7. All of her allegations regarding Respondents' fraudulent behavior are compounded when

she details an incriminating conversation between O’Keefe and another physician, in which

they explicitly discuss how they “Got to keep those [Medicare reimbursement] numbers

up.” Id. at 5. Additionally, Petitioner took the initiative to discuss her concerns with

another staff member and CNA at SAM Clinics, “who suggested that it was best to just do

what they were told.” Id. These discussions, along with the many incidents of suspicious

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behavior that Petitioner reports, indicate that Petitioner’s claim arises out of entirely

different facts than Cobb’s.

Cobb’s claim arises out of an alleged wrongful termination for noncompliance with a

procedure Cobb did not wish to perform. Id. Her claim merely alleges that she was

“pressured [] to certify the medical necessity of [a surgical debridement].” Id. The District

Court of Lincoln overseeing Cobb’s case found that her claim did not sufficiently detail

fraudulent activity. Id. Rather, Cobb's claim centers around an allegedly wrongful

termination as a result of not performing a surgical debridement; unlike Petitioner’s claim,

Cobb’s claim arises out of a wrongful termination and is focused on the interactions leading

to termination. Id. Moreover, Petitioner alleges widespread fraud throughout SAM Clinics

involving HBO therapy. Her claim arises solely out of concerns for fraudulent activity

under the FCA and is supported by ample examples of patients and inculpatory

conversations directly acknowledging fraudulent behavior. Id. at 5, 7.

3. Cobb’s claim could not have possibly put the Government on notice of the

fraudulent scheme alleged by Petitioner.

Finally, Petitioner’s claim places the Government on notice of an entirely different

fraudulent scheme that cannot be derived from the essential facts alleged in Cobb’s

claim. When assessing whether a claim is precluded by an earlier filed claim, courts

consider whether the earlier claim contains “the essential facts of a fraudulent scheme” so

the Government has “enough information to discover related frauds[,]” like the one alleged

by the later claim. SmithKline Beecham Clinical Lab’ys. Inc., 149 F.3d 227, 234. “After all,

once the whistle has sounded, the government has little need for additional whistle-

blowers.” United States ex rel. Batiste v. SLM Corp., 740 F. Supp. 2d 98, 104 (D.D.C.

2010). Here, but for the combination of distinct and independent allegations within

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Petitioner’s claim, the Government would not be on notice of SAM Clinic’s fraudulent HBO

therapy scheme from the essential facts Cobb alleges; the whistle would never sound if not

for Petitioner’s diligent pleadings. Cobb’s claim places the Government on notice of an

employment dispute stemming from a single difference in medical opinion regarding

surgical debridement. She claims that O’Keefe fired her for refusal to provide a surgical

debridement to a patient. R. at 5. She refused to certify the medical necessity of the

procedure because she did not believe it was necessary; however, despite her medical

opinion, O’Keefe disagreed and found it medically necessary, along with the other doctor

who took her place and certified its necessity. Id. While the patient in question happened

to be on Medicare, as are another 71 million individuals in the United States, her claim

leaves the Government grasping at straws to connect this to an actual fraudulent scheme,

let alone one as pervasive as Petitioner’s claim alleges. Centers for Medicare and Medicaid

Services, Medicaid Facts and Figures, (January 30, 2020),

https://www.cms.gov/newsroom/fact-sheets/medicaid-facts-and-figures. This single

disagreement is simply not “enough information [for the Government] to discover related

frauds” like the one Petitioner brings forth. SmithKline Beecham Clinical Lab’ys. Inc., 149

F.3d 227, 234. Cobb merely alleges a dispute in medical opinion between an employee and

two of her colleagues regarding a surgical debridement; she does not allege a series of

detailed and alarming acts of fraudulently reimbursed HBO therapy permeating

throughout “the largest for-profit provider of wound care services in Lincoln[.]” R. at

2. Under this analysis, Petitioner’s claim should not be barred.

Thus, even if “the phrase ‘related action based on the facts underlying the pending

action’, clearly bars claims arising from events that are already the subject of existing

suits[,]” Petitioner’s claim is too far removed from the events alleged by Cobb to be barred

under § 3730(b)(5). SmithKline Beecham Clinical Labs., Inc., 149 F.3d 227,

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232. Petitioner’s allegations arise from (1) a series of direct violations involving CMS

guidelines for HBO therapy, as opposed to surgical debridement; (2) spread across multiple

clinic locations on several occasions, as opposed to an isolated event involving a dispute in

medical opinion for a single patient; (3) in which multiple agents of SAM Clinics were

heavily involved in and aware of. R. at 4-7. Petitioner is a “true whistleblower” in every

sense of the word; thus, under even the most stringent inquiry, Petitioner’s claim is not

barred by the first-to-file rule. Medtronic, Inc., 552 F.3d 503, 515-16 (“for a qui tam relator

to have standing to bring her claim, she "must be a true 'whistleblower'" and will be

"precluded from collecting a bounty . . . if someone else has filed the claim first."”) (quoting

United States ex rel. Taxpayers Against Fraud v. GE, 41 F.3d 1032, 1035 (6th Cir. 1994)).

C. No Matter Which Test Applies, Barring Petitioner’s Claim Under the First-to-File

Rule Runs Contrary to Congressional Intent and Public Policy.

Should the Court find that Petitioner’s claim is duplicative, the Court essentially

prevents diligent whistleblowers from coming forward with substantial and extensive

claims of fraud because someone placed the government on notice of a mere sliver of that

fraud. Such a result would be a disservice to both the government and other diligent

whistleblowers who wish to file a claim that is both distinct from the first claim and

involves a greater degree of fraud. Furthermore, “courts are guided by congressional intent

in determining whether application of the doctrine would be consistent with the statutory

scheme.” Patsy v. Bd. of Regents, 457 U.S. 496, 536, 102 S. Ct. 2557, 2578 n.4 (1982). With

the policy purpose of § 3730(b)(5) in mind, interpreting the statute as one that bars

Petitioner from filing a claim substantially different from Cobb’s because that would be

contrary to the statutory scheme within the FCA. Rather, the statute seeks to bar claims

that allege identical facts and circumstances. S. Rep. No. 99-345, at 25 (1986), reprinted in

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1986 U.S.C.C.A.N. 5266, 5290 (“the Committee wishes to clarify in the statute that private

enforcement under the civil False Claims Act is not meant to produce class actions or

multiple separate suits based on identical facts and circumstances”); see also Legislative

Intent (Statutory Intent), Bouvier Law Dictionary, (The Wolters Kluwer Bouvier Law

Dictionary Desk Edition, 2012) (“In ascertaining legislative intent, formal statements

prepared by the committees responsible for passage usually have great weight, as do

statements made at the time of the introduction of bills”). Should the Court follow the

Fourth and Seventh circuit’s approaches to the statute, the Court would in effect “create an

absolute bar [that] would permit opportunistic plaintiffs with no inside information to

displace actual insiders with knowledge of the fraud.” Campbell v. Redding Med. Ctr., 421

F.3d 817, 824 (9th Cir. 2005). This absolute bar runs the risk of defeating the False Claims

Act’s purpose of ensuring the Government is alerted “to the essential facts of a fraudulent

scheme” because diligent parties with information regarding serious fraud could be barred

by hasty plaintiffs who file a claim on similar facts before the diligent party has a chance to

seek counsel. Under this alarming interpretation of the first-to-file bar, opportunistic

plaintiffs with weak claims, like Cobb, can rush to file and bar subsequent parties who wish

to file more developed claims of fraud. Such a result would render plaintiffs unable to

pursue potentially strong claims of fraud committed against the Government because the

claim shares some essential facts alleged by the earlier, yet weaker, claim. It would also

benefit defendants by essentially granting them immunity from a more damaging claim

simply because it was filed after an insufficient claim based on similar facts. Such a result

is certainly not what Congress intended to create by enacting § 3730(b)(5) and the Court

must not run afoul with Congressional intent and public policy.

The acts of fraud alleged by the Petitioner in this case are distinctly different from

those of Cobb’s earlier action and must not be treated as a related action regardless of

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which standard applies. Unlike Cobb’s action, Petitioner alleges widespread fraudulent

activity throughout the State of Lincoln involving HBO therapy and the specific Medicare

and Medicaid reimbursement provisions pertaining to such therapy. R. at 6. Additionally,

Petitioner’s claim puts the government on sufficient notice of a fraudulent scheme

permeating throughout the SAM clinics of Lincoln. In the process, Petitioner also brings

forth genuinely valuable information that Ms. Cobb did not and could not have

alleged. SmithKline Beecham Clinical Labs., 149 F.3d 227 (quoting United States ex rel.

Springfield Term. Ry. Co. v. Quinn, 14 F.3d 645, 649 (D.C. Cir. 1994)) (emphasizing that

the purpose of the first-to-file rule is to discourage “opportunistic plaintiffs who have no

significant information to contribute of their own.”). She alleges specific instances of

suspicious activity involving four patients, notes incriminating statements made by the

company’s CEO, and blows the whistle for extensive fraudulent activity involving Medicare

and Medicaid reimbursements. R. at 5-7. Cobb’s claim, on the other hand, does little more

than put the government on notice of a single dispute of opinion between a plastic surgeon

and her superior in one of the fourteen wound care centers run by SAM Clinics throughout

Lincoln. Id. at 5. As a result, Cobb fails to establish any allegations of fraud and is

critically distinct from Petitioner’s claim thereby rendering the first-to-file rule

inapplicable. The two claims should not be treated as one in the same as their allegations

place the Government on notice of entirely different acts of fraud. To hold otherwise is

contrary to both public policy and the core purpose of the first-to-file bar.

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II. THE DISMISSAL OF COBB’S COMPLAINT RENDERED IT INSUFFICIENT

TO PRECLUDE PETITIONER’S CLAIM UNDER THE FIRST-TO-FILE BAR.

A. By Failing to State a Claim, Cobb’s Action Lacked Legal Ability to

Preclude Petitioner’s Later Claim.

Even if the claims rely on substantially similar facts, “in order to preclude later-filed

qui tam actions, the allegedly first-filed qui tam complaint must not itself be

jurisdictionally or otherwise barred.” United States ex rel. Poteet v. Medtronic, Inc., 552

F.3d 503, 516 (emphasis added). On January 20, 2020, Cobb’s action was dismissed for

failure to state a claim with the specificity required under Fed. R. Civ. P. 9(b). R. at 5, 6;

Fed. R. Civ. P. 9(b) (2019). Mason’s complaint was unsealed four days after Cobb’s action

was dismissed. R. at 1 (“Mason’s complaint was unsealed on January 24,

2020[.]”). Because Cobb’s previously filed claim failed to comply with the essential

requirements of Fed. R. Civ. P. 9(b), her claim was “legally infirm from its inception[,]” and

cannot preempt Petitioner’s action. Walburn v. Lockheed Martin Corp., 431 F.3d 966, 972

(6th Cir. 2005).

In Campbell v. Redding Medical Center, the Ninth Circuit Court of Appeals

addressed whether a qui tam action in violation of 31 U.S.C. § 3730(e)(4) of the False

Claims Act still triggers a jurisdictional bar under § 3730(b)(5). 421 F.3d 817, 818 (9th Cir.

2005); See 31 U.S.C. § 3730(e)(4) (“The court shall dismiss an action … if substantially the

same allegations or transactions as alleged in the action or claim were publicly

disclosed”). The court held that a qui tam action with a jurisdictional flaw does not bar

claims filed while the action was still pending. Id. In its rationale, the court notes that

“Congress sought to provide incentives to qui tam whistleblowers to come forward, and we

believe that an overly broad interpretation of the first-to-file bar, allowing even sham

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complaints to preclude subsequent meritorious complaints in a public disclosure case,

would contravene this intention.” Id. at 821.

The Campbell court, however, needed to distinguish it’s holding from United States

ex rel. Lujan v. Hughes Aircraft Co., in which the Ninth Circuit held that § 3730(b)(5)

“establishes an exception-free, first-to-file bar.” 243 F.3d 1181, 1183 (9th Cir. 2001). On

first impression, the Lujan court addressed the first-to-file rule and whether a claim filed

while an earlier claim is still pending triggers the first-to-file bar when the claim is

dismissed years later. Id. at 1188. Although the Campbell court attempts to distinguish

the two cases by emphasizing that “jurisdictionally flawed” claims are different from

meritless claims, its reasoning falls flat. 421 F.3d 817, 822. Instead, the court’s holding

presents contradictory arguments as to why the Lujan holding is a valid interpretation of

the first-to-file bar. For example, the court stresses the Congressional intent of § 3730(b)(5)

to encourage whistleblowers to come forward and cites the purpose of the 1986 amendments

to the FCA that sought to “repeal overly restrictive court interpretations” of the first-to-file

rule. Id. at 823 (quoting United States ex rel. Hagood v. Sonoma Cty. Water Agency, 929

F.2d 1416, 1420 (9th Cir. 1991)). It further explains how interpreting the first-to-file rule

as an absolute jurisdictional bar would be contrary to Congressional intent by “reducing the

number of qui tam suits[.]” Id. at 824. These policy considerations are the very same

reasons a meritless claim should not bar diligent whistleblowers from moving forward with

their claims.

Notably, the Government in Campbell refuted the contention that “an absolute first-

to-file rule would permit displacement of real whistleblowers by sham complaints by stating

that such a situation would be prevented by” the pleading requirements of Rule

9(b). Id. The court merely brushes off this counterpoint by stating that the pleading

requirement is a separate inquiry from the original source requirement set forth under §

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3730(e)(4). Id. As a result, the court failed to consider the impact on claims filed while a

“sham complaint[]” awaits dismissal under Rule 9(b). Id. The Sixth Circuit did consider

the impact of meritless claims and held that a later filed qui tam action cannot be barred by

the first-to-file rule if the earlier action could not meet the requirements of Rule

9(b). Walburn v. Lockheed Martin Corp., 431 F.3d 966, 973. In coming to this conclusion,

the court stated that it could not “see how according preemptive effect to a fatally-broad

complaint furthers the policy of encouraging whistleblowers to notify the government of

potential frauds.” Id. at 973. The court applied the same policy rationale as Campbell, but

properly extended it to include claims that fail to state a claim. Id.

This Court should apply the same considerations as Campbell but expand it’s

interpretation of the first-to-file bar to include meritless claims as the Sixth Circuit did in

Walburn. If a claim is inadequate to withstand the basic requirements of its filing,

whistleblowers acting diligently and in good faith should not be barred under the first-to-

file rule once courts discover the claims inadequacy. Fed. R. Civ. P. 9(a) is in place to “give

notice to defendants of the plaintiff’s claim, to protect defendants whose reputation may be

harmed by meritless claims of fraud, to discourage ‘strike suits,’ and to prevent the filing of

suits that simply hope to uncover relevant information during discovery.” United States ex.

Rel. Karvelas v. Melrose-Wakefield Hospital, 360 F.3d 220, 226-31 (1st Cir. 2004) (quoting

Doyle v. Hasbro, Inc., 103 F.3d 186, 194 (1st Cir. 1996)).

Additionally, the purpose of the first-to-file rule is to ensure that individuals who

learn of the earlier action do not capitalize on their finding by filing a similar claim. If that

earlier action failed to plead with particularity, and therefore failed to state a claim, the

policy purpose of the first-to-file rule is still achieved when a second party who filed during

that time frame is not barred because the first claim could not have put the second plaintiff

on sufficient notice of fraudulent conduct. If the Court, however, chooses to enforce the

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first-to-file rule so that even a meritless claim can preclude a later filed claim while the first

awaits its inevitable dismissal, the purpose of the first-to-file is abandoned. Under such

circumstances, a diligent plaintiff would be barred from litigating a claim involving fraud

against the Government simply because a meritless claim made it to the finish line first.

Preventing true whistleblowers from litigating their claims because they

unknowingly brought the action while an insufficient claim had yet to be dismissed is a

grave injustice contrary to the legislative intent of § 3730(b)(5). Cobb’s claim was illegally

infirm from its inception and cannot bar Petitioner’s claim. Walburn v. Lockheed Martin

Corp., 431 F.3d 966, 972. To hold otherwise would thwart the true purpose of the first-to-

file rule and preclude diligent plaintiffs like Petitioner from litigating an otherwise valid

claim alleging fraud against the Government.

B. Once Cobb's Action Was No Longer Pending, the First-to-File Rule No

Longer Applied to Petitioner’s Claim.

The first-to-file provision is not intended to bar later filed claims where the prior

claim was dismissed. While some circuits interpret it to bar such claims, others agree that

“it would be unjust to require relators to refile their claims even though their only

procedural roadblock was dismissed.” United States ex rel. Boise v. Cephalon, Inc., 159 F.

Supp. 3d 550, 558 (E.D. Pa. 2016). Because Cobb’s action was dismissed and therefore no

longer pending, Petitioner’s claim has overcome the only procedural roadblock and must not

be precluded by the first-to-file rule.

In Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter (“Carter”), the

Supreme Court held that “an earlier suit bars a later suit while the earlier suit remains

undecided but ceases to bar that suit once it is dismissed[.]” 135 S. Ct. 1970, 191 L. Ed. 2d

899 (2015) (emphasis added). While the Carter decision clarified the meaning of a

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“pending” action under the first-to-file bar, it also left circuit courts to grapple with the

question of what to do when a preceding claim is dismissed, leaving only the later claim

against the defendant. With the guidance of Carter, the First Circuit interpreted the

meaning of pending under the first-to-file bar as it relates to that question. In United

States ex rel. Gadbois v. PharMerica Corp., the court considered whether a claim in

violation of the first-to-file rule can be cured by filing a supplemental complaint once the

related action originally giving rise to the rule is dismissed. 809 F.3d 1, 5 (1st Cir.

2015). The court held that “subject matter jurisdiction falls within the cluster of defects

that may be cured by a supplemental pleading under Rule 15(d).” Id. Thus, if the first-to-

file rule is construed as jurisdictional, the lack of subject matter jurisdiction can still be

cured once the jurisdictional block, as in the earlier claim, is no longer pending. Id. The

Gadbois court notes that the first-to-file rule serves to deter forum-shopping in cases of

diversity jurisdiction and manipulative abuse in cases of federal question

jurisdiction. Id. When “there are no allegations of manipulative abuse of the rule[,]” courts

should provide plaintiffs the opportunity for their case to be heard despite their original

violation of the rule as opposed to simply dismissing their action. Id. Although the court

ultimately decided to remand the case to the district court to determine whether to grant

the plaintiff’s motion to supplement, should this Court determine that Petitioner’s claim

can be cured, the factual and procedural elements of this case are sufficiently developed for

the Court to provide relief. Id. Otherwise, the alternative remedy is to remand Petitioner’s

claim to the District Court of Lincoln to determine whether to cure her qui tam

action. Nevertheless, this Court should adopt the First Circuit’s approach and allow

claimants in violation of the first-to-file rule the ability to cure their technical violation once

the earlier case triggering the rule is dismissed.

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To bar Petitioner’s claim for a mere technicality is contrary to the purpose of the

first-to-file provision and the False Claims Act as a whole. The False Claims Act serves the

fundamental purpose of protecting the Government from being the unwitting victim of

fraudulent actors by presenting the public with an opportunity to both put them on notice

of the fraudulent activity while also prosecuting the case. If the first-to-file provision

precludes potentially successful claims simply because the party lost the race to file to a

party whose claim could not withstand dismissal, the provision would hinder the ability to

prosecute fraudulent conduct against the Government. Although the circuit courts have yet

to adopt a cohesive approach to the issue of first-to-file violations, even courts that have yet

to adopt the First Circuit’s approach concede that the FCA was not drafted with an intent

to dismiss actions for mere procedural violations. See, e.g., Smith v. Clark/Smoot/Russell, A

JV, 796 F3d 424, 430 (4th Cir. 2015) (holding that a violation of the FCA’s seal provision

requirements “did not incurably frustrate” the purposes of the FCA and therefore should

not be dismissed). As the Supreme Court asked, “Why would Congress want the

abandonment of an earlier suit to bar a later potentially successful suit that might result in

a large recovery for the Government?” Kellogg Brown & Root Servs. v. United States ex rel.

Carter, 575 U.S. 650, 663, 135 S. Ct. 1970, 1979 (2015). Quite simply, “[t]he answer is that

it would not.” United States ex rel. Wood v. Allergan, Inc., 246 F. Supp. 3d 772, 799

(S.D.N.Y. 2017) (holding that the first-to-file provision does not bar later filed claims where

the prior claim was dismissed).

Additionally, the result of preclusion would essentially “produce the contrary result

of [the legislative purpose by] blocking any action to prosecute the [fraudulent] conduct in

question -- in essence, an effective loophole for any prospective defendant.” James B.

Helmer, Jr., American Bar Association Administrative Law and Regulatory Practice

Section, The False Claims Act: Whistleblower Litigation, (2021) at 463, 464. The Third

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Circuit addressed this contrary concern in United States ex rel. Wood v. Allergan, Inc.,

where it held that an absolute bar under the first-to-file rule “would not only frustrate

Congress’s goal of helping the Government fight fraud, but it would also provide a windfall

to defendants … a particularly perverse outcome, as nothing in the text or history of the

first-to-file rule suggests that it was intended to benefit FCA defendants as opposed to the

conscientious relator and, by extension, the Government.” 246 F. Supp. 3d 772, 798. In

fact, Congress intended to create provisions that provide more protections to the

Government and public, not potential defendants. S. Rep. No. 99-345, at 1 (1986), reprinted

in 1986 U.S.C.C.A.N. 5266, 5290 (“The purpose of S. 1562, the False Claims Reform Act, is

to enhance the Government's ability to recover losses sustained as a result of fraud against

the Government. … In the face of sophisticated and widespread fraud, the Committee

believes only a coordinated effort of both the Government and the citizenry will decrease

this wave of defrauding public funds. S. 1562 increases incentives, financial and otherwise,

for private individuals to bring suits on behalf of the Government.”). Moreover, defendants

would not be prejudiced by allowing a plaintiff to continue their litigation once an earlier

claim is dismissed because, even under the most strict interpretation of the first-to-file rule,

the later filed claim may still be brought if the plaintiff refiles the claim to comply with the

statute. The later filed party’s claim against the defendant does not disappear when the

earlier filed claim does; once the party refiles their claim, the defendant will be exposed to

that litigation again. By allowing plaintiffs like Petitioner to continue with their claim once

the earlier one is dismissed, despite their initial violation of § 3730(b)(5), the Court merely

alleviates parties of delayed decisions and ineffective procedural formalities while also

reducing court resources necessary for such claims.

Should the Court hold that a procedural violation of § 3730(b)(5) is substantial

enough to preclude the violating action, plaintiffs would be required to refile their action

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following its dismissal. Put bluntly, such a process “would be a pointless formality” with

harmful consequences to both the public and the Government. James B. Helmer, Jr.,

American Bar Association Administrative Law and Regulatory Practice Section, The False

Claims Act: Whistleblower Litigation, (2021) at 468. This requirement, effectively barring

plaintiffs from curing their violation, “would undermine, rather than advance the purposes

of the FCA.” United States ex rel. Wood v. Allergan, Inc., 246 F. Supp. 3d 772, 798. For

example, the court in Allergan, Inc., notes that preclusion for a slight procedural error

“would diminish the incentive for any relator with valuable information to file suit, as she

would have to discount the probability of laying exclusive claim to any spoils by the risk

that, unbeknownst to her, someone else had beaten her to the courthouse door.” Id.

When an earlier filed case is dismissed, the Court should hold that the later filed

case is no longer barred by the first-to-file rule because there is no longer any pending

action warranting its preclusion. To hold that dismissal is required is contrary to

congressional intent. Thus, even if the Court finds that Petitioner’s claim is related to

Cobb’s earlier filed claim, Cobb’s claim is no longer pending and should not preclude

Petitioner from continuing with her claim that SAM Clinics defrauded the Government.

III. EVEN IF THE FIRST-TO-FILE RULE APPLIES TO PETITIONER’S CLAIM,

THE COURT RETAINS SUBJECT MATTER JURISDICTION OVER IT

BECAUSE CONGRESS DID NOT CLEARLY STATE THAT THE RULE

PRESENTS A COMPLETE JURISDICTIONAL BAR.

Even if this Court finds that the first-to-file rule is applicable to Petitioner’s claim,

the Court still maintains subject matter jurisdiction over the claim because Congress did

not clearly state that § 3730(b)(5) is jurisdictional and consequently must be interpreted as

nonjurisdictional. This interpretation of § 3730(b)(5) permits the Court to hear Petitioner’s

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claim. A jurisdictional statute prohibits a court from hearing a claim that violates the

statute’s requirements; however, a nonjurisdictional statute does not immediately bar the

court from hearing a claim that is noncompliant with the statute. See United States v.

Kwai Fun Wong, 575 U.S. 402, 408-09, 135 S. Ct. 1625, 1631 (2015) (“[A] litigant’s failure to

comply with [a [jurisdictional] bar deprives a court of all authority to hear a case”). Section

3730(b)(5) states that “no person other than the Government may intervene or bring a

related action based on the facts underlying pending action.” Thus, if this statute is

jurisdictional and a party files a related action following another party who has already

filed their claim, the court is immediately deprived of subject matter jurisdiction and

cannot hear the later filed claim. On the other hand, if the statute is nonjurisdictional,

noncompliance with the provision does not lead to an immediate jurisdictional bar. Scott

Glass, Is the False Claims Act's First-to-File Rule Jurisdictional? 118 Columbia L. Rev.

2361, 2373. Congress did not intend the first-to-file rule to render courts powerless in

hearing claims with substantial potential to protect the Government from fraud simply

because a party unknowingly lost the race to file. This Court must honor the congressional

intent behind § 3730(b)(5) and hold that it is nonjurisdictional. Foster v. United States, 303

U.S. 118, 120 (1938) (“Courts should construe laws in harmony with the legislative intent

and seek to carry out legislative purpose”). Under this approach, the Court has subject

matter jurisdiction over Petitioner’s claim.

Courts determine whether a statute is jurisdictional based on the explicit language

within the rule and context surrounding its enactment. Absent a clear statement or

supporting context from Congress that a rule is jurisdictional, courts must proceed under a

nonjurisdictional framework. Sebelius v. Auburn Reg’l Med. Ctr., 568 U.S. 145, 153, 133 S.

Ct. 817, 824 (2013) (“We inquire whether Congress has “clearly state[d]” that the rule is

jurisdictional; absent such a clear statement, we have cautioned, “courts should treat the

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restriction as nonjurisdictional in character.”) (citation omitted) and Arbaugh v. Y & H

Corp., 546 U.S. 500, 516, 126 S. Ct. 1235, 1245 (2006) (“If the Legislature clearly states that

a threshold limitation on a statute’s scope shall count as jurisdictional, then courts and

litigants will be duly instructed and will not be left to wrestle with the issue. But when

Congress does not rank a statutory limitation on coverage as jurisdictional, courts should

treat the restriction as nonjurisdictional in character.”). In Sebelius v. Auburn Reg’l Med.

Ctr., the Supreme Court applied an analysis of the explicit language within a statute

governing time-limits for healthcare providers to appeal Medicare reimbursement

determinations. 568 U.S. 145, 153, 133 S. Ct. 817, 824 (2013). In a unanimous opinion, the

Court found that the “language Congress used [in the statute] hardly reveals a design to

preclude any regulatory extension” for appeals and lacked key terms normally included in

jurisdictional rules, including “shall” and “notice of appeal.” Id. The Court did not stop its

analysis there, instead it notes that “Congress [need not] incant magic words in order to

speak clearly” regarding their intent to classify a rule as jurisdictional; context may still

indicate how the provision should be construed. Id. One contextual factor is whether the

Court previously interpreted similar provisions as jurisdictional; however, the placement of

the provision “in a section of a statute that also contains jurisdictional provisions” is not

enough to deem the provision jurisdictional. Id. at 825.

Although the circuit courts are divided on whether Congress intended § 3730(b)(5) to

be jurisdictional, circuit courts that interpret the first-to-file provision as jurisdictional

analyzed the statute prior to the Sebelius decision and consequently do not adopt the

proper analytical approach set forth by the Supreme Court. Scott Glass, Is the False

Claims Act's First-to-File Rule Jurisdictional? 118 Columbia L. Rev. 2361, 2376-79. The

Sebelius decision provides that, absent a clear statement from Congress that the rule is

jurisdictional, courts must conclude it is nonjurisdictional. 568 U.S. 145, 153, 133 S. Ct.

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817, 824 (2013). Since the Sebelius decision, circuit courts are breaking away from their

previous interpretations of the first-to-file rule, instead holding that it is nonjurisdictional

because Congress did not clearly state that it is jurisdictional. See United States v.

Millenium Labs., Inc., 923 F.3d 240, 248 (1st Cir. 2019) (“On de novo review, and in light of

[the] precedent [derived from the Sebelius decision], we hold that the first-to-file rule … is

nonjurisdictional.”); United States ex rel. Hayes v. Allstate Ins. Co., 853 F.3d 80, 86 (2d Cir.

2017) (Holding under the clear statement analysis that “a district court does not lack

subject matter jurisdiction over an action that may be barred on the merits by the first-to-

file rule.”); United States ex rel. Todd Heath v. AT&T, Inc., 416 U.S. App. D.C. 289, 297-98,

791 F.3d 112, 120-21 (2015) (“Congress … knew how to reference "jurisdiction expressly" in

the False Claims Act if that [was] its purpose. But it did not do so in the first-to- file rule.”);

United States v. Sanofi-Aventis U.S. LLC (In re Plavix Mktg.), 974 F.3d 228, 232 (3d Cir.

2020) (Holding that the first-to-file rule is nonjurisdictional because, “[a]s the Supreme

Court has recently instructed, unless Congress states clearly that a rule is jurisdictional,

we will treat it as nonjurisdictional.”). This Court should apply the clear statement rule

dictated by the Supreme Court and join the First, Second, Third, and District of Columbia

circuit courts’ interpretation of § 3730(b)(5) as nonjurisdictional.

Under the framework of Sebelius, this Court should hold that the first-to-file rule is

nonjurisdictional because the language and context of § 3730(b)(5) lack any indication that

it is meant to be jurisdictional. The first-to-file rule, in pertinent part, states:

“When a person brings an action under this subsection, no person other than the

Government may intervene or bring a related action based on the facts underlying

the pending action.” § 3730(b)(5).

The provision does not contain any explicit language requiring courts to interpret it as

jurisdictional. As the District Court in this matter found, “the plain language of the first-

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to-file provision does not include jurisdictional language,” and without such language or

supporting context, the court must not interpret the rule as jurisdictional. R. at 13. This

finding adopts the Supreme Court’s holding in Sebelius v. Auburn Reg’l Med. Ctr., where

the Court specifically pointed to a statute’s lack of jurisdictional language like “shall.” 568

U.S. 145, 153, 133 S. Ct. 817, 824 (2013). Section 3730(b)(5) contains language dissimilar to

another provision within the FCA, specifically § 3730(e)(1), which explicitly states that “[n]o

court shall have jurisdiction over an action brought by a former or present member of the

armed forces against a member of the armed forces arising out of such person's

service[.]” 31 U.S.C. § 3730(e)(1) (emphasis added). Such language precisely indicates a

jurisdictional intent. Additionally, it is distinct from the FCA’s public disclosure bar within

§ 3730(e)(4), which states that a “court shall dismiss an action or claim under this section,

unless opposed by the Government, if substantially the same allegations or transactions as

alleged in the action or claim were publicly disclosed.” (2014) (emphasis added). Like §

3730(e)(1), the public disclosure bar explicitly incorporates jurisdictional language

suggesting that Congress clearly intended it to be a jurisdictional bar. United States ex rel.

Williams v. NEC Corp., 931 F.2d 1493, 1499-500 (11th Cir. 1991) (“The list of methods of

"public disclosure" is specific and is not qualified by words that would indicate that they are

only examples of the types of "public disclosure" to which the jurisdictional bar would

apply. Congress could easily have used "such as" or "for example" to indicate that its list

was not exhaustive. Because it did not, however, we will not give the statute a broader

effect than that which appears in its plain language.” The absence of jurisdictional

language within the first-to-file provision leaves courts left to “treat the restriction as

nonjurisdictional in character.” Arbaugh v. Y & H Corp., 546 U.S. 500, 516, 126 S. Ct. 1235,

1245 (2006).

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Although § 3730(b)(5) does not plainly state or indicate that the rule is

jurisdictional, the Sebelius Court holds that explicit language alone need not dictate

whether a rule is jurisdictional; context must be considered when the statute lacks

jurisdictional terminology. Id. But even when assessing the context surrounding §

3730(b)(5), it is evident that Congress did not intend to classify this provision as

jurisdictional. First, the Supreme Court has “repeatedly held that filing deadlines are not

ordinarily jurisdictional; indeed [it has] described them as “quintessential claim-processing

rules.” Sebelius v. Auburn Reg’l Med. Ctr., 568 U.S. 145, 153, 133 S. Ct. 817, 825 (2013)

(quoting Henderson v. Shinseki, 562 U. S., at 428, 435 (2011)). These quintessential claim-

processing rules are defined by the Supreme Court as those “which seek to promote the

orderly progress of litigation by requiring parties to take certain procedural steps at

specified times.” Henderson v. Shinseki, 562 U.S. 428, 429, (2011). The first-to-file rule is

simply that: a quintessential claim-processing rule that requires parties to file a claim at a

specified time (prior to a related claim’s filing) in order to “promote the orderly progress of

litigation[.]” Id.

Second, the first-to-file sits alongside “other run-of-the-mill procedural rules” as

opposed to the statute’s jurisdictional sections. While the placement of a statute alone may

not provide enough context to establish Congress’s intent to categorize it as jurisdictional or

not, the location of § 3730(b)(5) in relation to other rules further supports the notion that

this rule is nonjurisdictional. United States v. Sanofi-Aventis U.S. LLC (In re Plavix

Mktg.), 974 F.3d 228, 232 (3d Cir. 2020) (“If Congress had meant to make the first-to-file

bar jurisdictional, it would have logically placed the bar in one of two other sections that

mention jurisdiction and were added at the same time as it.”).

Finally, fundamental policy considerations further support the contention that the

first-to-file provision is nonjurisdictional. The key difference between a jurisdictional and

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nonjurisdictional provision is that, under a jurisdictional provision, courts must address

whether they have the power to hear the case sua sponte. Scott Glass, Is the False Claims

Act's First-to-File Rule Jurisdictional? 118 Columbia L. Rev. 2361, 2371. This duty to

review whether the court may hear a case sua sponte results in a burden on courts any time

a claim under the FCA is brought forth even though courts are less equipped to assess the

issue in comparison to the Government or defendant, both of whom are likely aware of

pending actions on similar or related matters. Additionally, under this framework, a

defendant may move to dismiss an FCA case at any time for lack of subject matter

jurisdiction. By keeping the door open for dismissal, “[t]ardy jurisdictional objections can

therefore result in a waste of adjudicatory resources and can disturbingly disarm

litigants.” Sebelius v. Auburn Reg'l Med. Ctr., 568 U.S. 145, 153, 133 S. Ct. 817, 824

(2013). Jurisdictions that do not derive an unspoken intention from Congress to

characterize the first-to-file rule as jurisdictional resolve these problems. Under a

nonjurisdictional interpretation of the rule, the defendant is responsible for challenging the

motion’s viability. The defendant would have twenty days from the time they are served to

motion to dismiss the case for lack of standing under § 3730(b)(5) if a related claim is

pending. The defendant would certainly be placed in a time crunch to raise this issue;

however, they are in the best position to determine whether the plaintiff is barred under

the rule because they have notice of any pending claims and the allegations they

contain. Preventing defendants from dismissing a qui tam action at any moment serves

two policy purposes: (1) reducing wasted court time and resources and (2) promoting

finality in court decisions.

Furthermore, given the “[h]arsh consequences” created by a jurisdictional rule, the

Supreme Court imposes “a high bar to establish that a statute of limitations is

jurisdictional.” United States v. Kwai Fun Wong, 575 U.S. 402, 409, (2015). The same

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rationale applied to jurisdictional statutes of limitations must apply to a rule that similarly

bars a plaintiff from litigating their clase because of the time in which they filed their

claim. The stakes are even higher when the jurisdictional bar also prevents the

Government from prosecuting potentially severe cases in which the named defendants

allegedly defrauded the Government. Congress enacted the FCA to equip the Government

and the people with the necessary tools to fight, prevent, and recover from fraudulent

activity against the Government. James B. Helmer, Jr., American Bar Association

Administrative Law and Regulatory Practice Section, The False Claims Act: Whistleblower

Litigation, (2021) at 13. Deeming § 3730(b)(5) as a jurisdictional rule curtails the

Government’s “chief weapon against fraud” and thwarts the intention of Congress’s

enactment. Id.; See also Gonzalez v. Thaler, 565 U.S. 134, 144, 132 S. Ct. 641, 650 (2012)

(Declining to classify a statute as jurisdictional because, inter alia, to do so “would thwart

Congress’ intent” in enacting the legislation.”).

To rule in favor of the Petitioner, the Court need only consider whether the

Petitioner has sufficiently stated a claim upon which relief may be granted. Given

Petitioner’s array of allegations of fraud and facts supporting Respondent’s wrongdoing, the

Court has subject matter jurisdiction to hear the case.

IV. CERTIFICATIONS OF MEDICAL OPINIONS CAN BE FALSE UNDER THE

FEDERAL CLAIMS ACT; HOWEVER, EVEN UNDER A MORE STRINGENT

APPLICATION OF FALSITY, PETITIONER MEETS THE STANDARD.

Under the FCA, civil liability is imposed on any person who “knowingly presents, or

causes to be presented, a false or fraudulent claim for payment or approval.” 31 U.S.C. §

3729(a)(1)(A). The Court should find that a medical opinion can be false under the FCA,

and that Petitioner has met the requisite standard to show such falsity by presenting

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evidence that Respondent certified HBO therapy treatments without believing they were

necessary. See generally Winter ex rel. U.S. v. Gardens Reg’l Hosp. & Med. Ctr., Inc., 953

F.3d 1008 (9th Cir. 2020); U.S. ex rel. Druding v. Druding, 952 F.3d 89 (3d. Cir. 2020); U.S.

ex rel. Polukoff v. St. Mark’s Hosp., 895 F.3d 730 (10th Cir. 2018).

To receive reimbursements from the Government through Medicare and Medicaid

programs, providers must comply with specific conditions, including that the reimbursable

services be certified by a physician as “medically necessary.” 42 U.S.C. § 1395f(a)(3). CMS

defines a “‘reasonable and necessary’ service as one that ‘meets, but does not exceed, the

patient's medical need,’ and is furnished ‘in accordance with accepted standards of medical

practice for the diagnosis or treatment of the patient's condition.’” Winter, 953 F.3d at

1113. If providers fail to comply with these conditions, but nevertheless certify that they

were met to receive government payments, they violate the FCA. See generally U.S. ex rel.

Swift-Freeman v. Bon Secours Baltimore Health Sys., 2008 U.S. Dist. LEXIS 132574 (D.

Md. 2008). Requests for government payment can be proven “false” either (1) factually,

when the facts within a claim are untrue, or (2) legally, when a claimant falsely certifies

that it has complied with a statute or regulation that is a condition for government

payments. Druding, 952 F.3d at 96. A claim may be legally false as a result of either an

express false certification or an implied false certification. United States v. Mckesson

Corp., 2021 U.S. Dist. LEXIS 28744 at 7 (N.D. Cal. 2021). For a certification to be false

under the express certification theory, a provider’s certification must falsely state

compliance with a law, rule, or regulation that is a prerequisite for reimbursement. Ebeid

v. Lungwitz, 616 F.3d 993 at 998 (9th Cir. 2010). In contrast, under the implied

certification theory, a provider is not required to make a certification, rather they are liable

if they violate submit payments requirements while knowingly violating the requirements

for payment. Mckesson Corp., 2021 U.S. Dist. LEXIS 28744. Although circuit courts are

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split regarding which certification theory should apply to cases involving false medical

certifications, the Supreme Court recently expanded the scope of potential liability by

holding that the implied certification theory is a valid theory of liability. Universal Health

Serv.s Inc., v. U.S. ex rel. Escobar, 136 S. Ct. 1989 at 1993 (U.S. 2016). The application of

this theory, however, is limited only to cases in which a provider “(1) made specific

representations about goods or services provided to the government; and (2) knowingly

violated a material statutory, regulatory, or contractual requirement.” Id. at 1995 . The

Supreme Court’s decision in Escobar sets a new precedent, which will likely result in an

increased application of the implied certification theory, even in courts that previously

rejected the theory. See generally Escobar, 136 S. Ct. 1989.

Regardless of which theory courts choose to apply, a provider’s certification violates

the FCA if they make “(1) a false statement or fraudulent course of conduct, (2) made with

scienter, (3) that was material, causing (4) the government to pay out money or forfeit

moneys due.” U.S. v. Univ. of Phx., 461 F.3d 1166 at 1174 (9th Cir. 2006). While the FCA

defines “knowing,” “claim,” “obligation,” and “material,” it does not provide a definition for

the term “false.” 31 U.S.C. § 3729. As a result of this ambiguity, courts have interpreted

“false” in different ways and have applied differing standards of falsehood to false

certification claims. See generally Winter , 953 F.3d 1008; Druding, 952 F.3d 89; Polukoff ,

895 F.3d 730. Some courts apply the common law test, while other courts require proof of

an “objective falsehood.” See generally Winter , 953 F.3d 1008; Druding, 952 F.3d 89;

Polukoff , 895 F.3d 730.

Since the objective falsity standard places a higher burden on plaintiffs who bring

forth accusations of fraud, and subsequently runs contrary to the fundamental purpose of

the FCA, this Court should find that the common law standard is the applicable standard

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for false certification claims and that, as a result, medical opinions can be false under the

FCA. See generally S. Rep. No. 110-507, pt. 1 (2008).

A. The Common Law Standard of Falsity Should Apply to False Certification Claims,

Medical Opinions Can be False Under the FCA, and Petitioner has Met this

Standard.

Under the common law test for falsity, courts presume that the FCA intended to

incorporate the common law definition of “false.” Winter, 953 F.3d 1108 at 1117. This

Court should hold that the common law test for falsity is the applicable standard for false

certification claims and that medical opinions can be false under the FCA because this

standard best aligns with policy considerations and it furthers the original purpose of the

FCA’s enactment. Id. Petitioner sufficiently establishes falsity under the common law test

because she presents evidence of a medical expert’s opinion that Respondent certified HBO

treatments in violation of CMS guidelines and that an agent of SAM Clinics adjusted a

patient’s wound’s Wagner grade without explanation. R. at 4-7. See generally Winter, 953

F.3d 1008; Druding, 952 F.3d 89; Polukoff , 895 F.3d 730.

The legal definition of a “false statement” is “[a]n untrue statement knowingly made

with the intent to mislead.” Anchor Prop. & Cas. Ins. Co. v. Trif, 46 Fla. L. Weekly D 267

at 24 (2021). Thus, under the common law standard, a provider’s opinion that the medical

procedure is necessary can be false if the provider does not actually hold the opinion, states

an opinion that contains a false fact, knows facts that would preclude the opinion, or does

not know facts that justify the opinion. Omnicare, Inc. v. Laborers Dist. Council Contr.

Indus. Pension Fund, 575 U.S. 175 at 185-191 (U.S. 2015). A number of circuit courts,

including the Ninth, Tenth, and Third Circuits, apply common law standards in cases

involving falsity and medical opinions. See generally Winter, 953 F.3d 1008; Druding, 952

F.3d 89; Polukoff , 895 F.3d 730. For example, the Third Circuit held that providers are

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liable under the FCA if they fail to comply with statutory or regulatory requirements.

Druding, 952 F.3d 89. In Druding v. Druding, the court invoked the common law standard

and held that a medical expert’s opinion could be used to show non-compliance with

regulatory requirements. See generally Druding, 952 F.3d 89. Additionally, in Druding,

the court held that the common law recognized that opinions can be false. Id. at 98.

Similarly, the Ninth Circuit, in Winter, held that “claims for unnecessary treatment are

false” and that “’[a] doctor’s clinical opinion must be judged under the same standard as any

other representation.’” Winter, 953 F.3d at 1113. The Ninth Circuit rationalizes it holding

by stating that “a ‘doctor, like anyone else, can express an opinion that he knows to be false,

or that he makes in reckless disregard of its truth or falsity.’” Id. In addition to the Third

and Ninth Circuits, the Tenth Circuit recognizes that medical opinions that a procedure is

necessary may be false, holding that “[i]t is possible for a medical judgment to be ‘false or

fraudulent’ as proscribed by the FCA.” Polukoff, 895 F.3d 730 at 742.

The Supreme Court, relying partially on common law principles, addressed the issue

of when medical opinions can be false in its case, Omnicare, Inc. v. Laborers Dist. Council

Constr. Indus. Pension Fund. See generally Omnicare, Inc., 575 U.S. 175 at 185-191.

There, the Supreme Court held that opinion statements can give rise to liability, (1) “if they

contain embedded statements of untrue facts,” (2) “if the speaker did not hold the belief she

professed,” or, (3) “if the supporting fact she supplied were untrue.” Id. at 176. The holding

in Omnicare, along with the circuit court holdings above, demonstrate that falsity can be

proven in several ways under the common law test for liability. See generally Omnicare,

Inc., 575 U.S. 175; Winter , 953 F.3d 1008; Druding, 952 F.3d 89; Polukoff , 895 F.3d 730.

Even circuit courts that require plaintiffs to show falsity with evidence of an “objective

falsehood,” like the Eleventh Circuit, agree that the common law provides useful guidance

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in determining whether an opinion may be actionable under the FCA. See generally United

States v. AseraCare, Inc., 938 F.3d 1278 (11th Cir. 2019).

The common law test is a useful guide for determining falsity and embodies

Congress’s intentions in enacting the FCA. See generally S. Rep. No. 110-507, pt. 1 (2008).

The FCA is the first whistleblower law enacted in the United States and was passed to

target fraud against the Government. Id. Since the purpose of the FCA is to “maximize

recovery of federal funds lost to fraud with the assistance of competent whistleblowers,”

Congress sought to provide ample opportunity for plaintiffs to present evidence of fraud

that could meaningfully assist the Government in protecting itself from fraud. AMERICAN

BAR ASSOCIATION, 10th National Institute on the Civil False Claims Act and Qui Tam

Enforcement, B-9 (2014). There is an especially high incentive for Congress to prevent

fraud related to Medicare and Medicaid reimbursements considering that, in 2019,

Medicare and Medicaid spending accounted for about 37 percent of all National Health

Expenditure. Centers for Medicare & Medicaid Services, NHE Fact Sheet,

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-

Reports/NationalHealthExpendData/NHE-Fact-Sheet (Dec. 16, 2020, 4:15 PM).

Considering this fact, the common law test for falsity is the most effective way to further

Congress’s objectives because it presents less of a challenge to petitioners who attempt to

bring forth evidence of fraud and it best supports the statutory language found within the

FCA. 31 U.S.C. § 3729. For example, under the common law test, plaintiffs need only show

a difference in medical opinion to support a finding of falsity. This requirement allows

plaintiffs to bring claims of fraud against the Government with greater ease than the far

more stringent requirement under the objective falsehood standard. AseraCare, Inc., 938

F.3d 1278.

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Furthermore, the common law test better reflects the statutory language of the FCA.

See generally S. Rep. NO. 110-507, pt. 1 (2008). Because Congress did not include any

requirements that petitioners prove an “objective falsity” in the FCA, this Court should not

derive such a requirement. Winter, 953 F.3d at 1113. When “the language of the statute is

plain and unambiguous, it must be applied according to its terms.” Larry M. Eig, Statutory

Interpretation: General Principles and Recent Trends, Cong. Rsch. Serv.s (Sept. 24, 2014),

https://sgp.fas.org/crs/misc/97-589.pdf. Since Congress did not define the term “false”

within the statutory language of the FCA, nor did they include a requirement that plaintiffs

must present evidence of an “objective falsehood,” this Court must apply the plain meaning

of the statute and hold that the FCA imposes a common law test for falsity. Larry M. Eig,

Statutory Interpretation: General Principles and Recent Trends, Cong. Rsch. Serv.s (Sept.

24, 2014), https://sgp.fas.org/crs/misc/97-589.pdf. Any concerns that the common law

standard could expose physicians to “open-ended liability,” is refuted by the notion that

policy concerns cannot supersede “the ‘clear statutory text’ of the FCA.” Winter, 953 F.3d

at 1117.

Petitioner meets the common law standard through presenting a compelling expert

medical opinion. R. at 7. For example, in Druding v. Druding, the court held that a

physician’s expert testimony challenging physicians’ certifications creates a triable issue

regarding falsity. Druding, 952 F.3d at 101. The court based this conclusion on the

plaintiff’s expert testimony which reported that, of the forty-seven Care Alternatives

patients examined, thirty-five percent were inappropriately certified for hospice care. Id. at

91. In addition to this, the plaintiff presented evidence that defendant admitted ineligible

patients for hospice care and encouraged its employees to alter their Medicare certifications

to state eligibility. Id. at 91-92. This evidence is similar here where Petitioner presents a

medical expert, who reviewed four cases in which Petitioner observed unqualified patients

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receiving HBO therapy treatments, and subsequently concluded that the four identified

treatments contradicted CMS guidelines. R. at 7. Based on the similarities of the evidence

presented in Druding to the evidence presented in this case, this Court should conclude

that Petitioner has presented sufficient evidence of falsity under the common law test. See

generally Druding, 952 F.3d 89.

In addition to presenting evidence that Respondent’s medical opinions were false,

Petitioner also introduced sufficient evidence that Respondent violated the FCA by showing

that SAM Clinics physicians falsely certified the medical necessity of HBO treatments. R.

at 6. For example, Petitioner introduced evidence to show that the HBO therapy

treatments certified by SAM Clinics did not satisfy the “reasonable and necessary”

requirement under CMS’s requirements. R. at 6-7. For example, in Polukoff, the court held

that a doctor’s certification for purposes of Medicare reimbursement is false under the FCA

if the procedure is not “reasonable or necessary” under the government’s definition.

Polukoff, 895 F.3d 730 at 743. The government definition of “reasonable and necessary” in

Polukoff included procedures that were “safe and effective, not experimental or

investigational, and appropriate…in terms of being furnished in accordance with accepted

standards of medical practice for the diagnosis or treatment of the patient’s condition”. Id.

at 735. By introducing evidence that the defendant performed unnecessary heart surgeries

yet signed and submitted CMS forms stating that he certified the services and that they

were medically indicated and necessary, the court found that the petitioner pled enough to

state a claim as a matter of law. Id. at 734-739. In the case before us, the applicable

definition of “reasonable and necessary” includes procedures that meet, but do not exceed,

the patient's medical need and are furnished in accordance with accepted standards of

medical practice for the diagnosis or treatment of the patient's condition. Winter, 953 F.3d

at 1113. By providing evidence that a SAM Clinic’s physician changed a wound’s Wagner

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grade from grade II to grade III, which made it eligible for Medicare reimbursement, and

that in four separate situations, patients who did not qualify for HBO therapy received

treatments, she presented evidence that the doctor’s certifications were false under the

FCA. R. at 7. Due to the presentation of this evidence, this Court should find that

Petitioner introduced sufficient evidence that SAM Clinics violated the FCA.

Moreover, Petitioner also provided evidence that SAM Clinics violated the FCA by

certifying the unnecessary use of these HBO treatments. R. at 4-7. For example, in

Winters, the court held that a relator had sufficiently stated a violation of the FCA when

she provided evidence that hospital management was falsely certifying the medical

necessity of inpatient hospital admissions. Winter, 953 F.3d at 1112. The court came to

this conclusion based on evidence that there was an unusually high increase in inpatient

hospitalizations after the defendant started managing the hospital, that admissions failed

to satisfy admission criteria, and that physicians were being pressured by hospital

management to admit patients and cause false claims to be submitted. Id. at 1113-20. The

evidence presented in Winter is similar to evidence presented by the Petitioner in this case,

including that the number of HBO therapy treatments increased significantly after O’Keefe

became SAM Clinics’ CEO, that at least four certified treatments contradicted CMS

criteria, and that O’Keefe told a physician to “keep those numbers up” when referencing the

HBO therapy treatments. R. at 5. Based on the similarities of evidence presented by the

relator in Winter and the Petitioner in this case, this Court should conclude that Petitioner

has shown sufficient evidence that SAM Clinics violated the FCA. Winter, 953 F.3d at

1108.

Overall, this Court should find that the common law test for falsity is the applicable

standard for false certification claims because this standard aligns with Congress’

intentions and policy consideration, as presented by the statutory language of the FCA, and

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it furthers the original purpose of the FCA’s enactment. Additionally, by applying the

common law standard to this case, the Court should find that a medical opinion can be false

under the FCA and that, by presenting evidence that SAM Clinics violated the FCA by

falsely certifying the medical necessity of HBO therapy treatments and introducing

corroborating expert testimony, Petitioner has met the standard to show falsity under the

common law test. Even if this Court chooses not to apply the common law standard of

falsity, Petitioner has still met the requirements under the “objective theory” of falsehood

standard.

B. A Realtor Should Not Be Required to Prove Objective Falsehood; However, If They

Must, The Petitioner Has Met This Standard.

Objective Falsehood requires a petitioner to show actual evidence that a provider’s

certification was “objectively false.” United States v. AseraCare, Inc., 938 F.3d 1278, 1297

(11th Cir. 2019). “In a run-of-the-mill ‘factually false’ case, proving falsehood is relatively

straightforward: A relator must generally show that the government payee has submitted

‘an incorrect description of goods or services provided or a request for reimbursement for

goods or services never provided.’” U.S. ex rel. Conner v. Salina Reg'l Health Ctr., Inc., 543

F.3d 1211, 1217 (10th Cir. 2008). A difference in reasonable medical opinions alone is not

sufficient to show that a judgment is false, and a relator is required to provide evidence of

something more than such. United States v. AseraCare, Inc., 938 F.3d 1278, 1297 (11th

Cir. 2019). The Eleventh Circuit determined objective falsehood can be shown in a number

of instances. For example, it is demonstrated where a petitioner either fails to familiarize

himself “with the patient's condition before asserting . . . [an] ill-formed clinical judgment”,

did not subjectively believe the medical opinion he was certifying, or stands alone in a

judgment no reasonable physician would have similarly concluded. United States v.

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AseraCare, Inc., 938 F.3d 1278, 1297 (11th Cir. 2019). “In each of these examples, the

clinical judgment on which the claim is based contains a flaw that can be demonstrated

through verifiable facts.” Id.

Courts have recently found the objective falsehood standard to be too strict and

discouraging of FCA reports of violation. This standard of falsity raises concern because it

allows providers to evade FCA liability by arguing that their judgments were

justifiable. Id. Furthermore, the objective falsehood theory makes it difficult for relators to

provide proof of fraud or falsity due to the high standard of evidence that must be

met. Id. This stringent standard contradicts the purpose of the FCA by limiting the

number of cases from which the government can recover federal funds that have been lost

to fraud. American Bar Association, 10th National Institute on the Civil False Claims Act

and Qui Tam Enforcement, B-9 (2014). The objective falsehood theory also runs contrary to

Congress’ intentions since, when the FCA was enacted, Congress “imposed no requirement

of proving ‘objective falsity’ within the statutory language of the FCA.” United States v.

AseraCare, Inc., 938 F.3d 1278, 1297 (11th Cir. 2019).

The Druding case, which also required the petitioner to prove objective falsity, was

reversed by United States v. Care Alternatives as the Third Circuit found its ruling to be

inconsistent with the application of the statute. In United States v. Care Alternatives, the

court found the district court's “objective” falsity standard conflates the elements of scienter

and falsity. United States v. Care Alternatives, 952 F.3d 89, 96 (3d Cir. 2020), cert. denied,

141 S. Ct. 1371, 209 L. Ed. 2d 119 (2021). They reasoned, “[the notion that] appellant[s]

[cannot] prove falsity because they did not [produce] [physical] evidence that any physician

lied . . . [is] “inconsistent with the text and application of the statute” Id. The court also

recognizes the policy reasons that “the FCA ‘was intended to reach all types of fraud,

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without qualifications, that might result in financial loss to the Government.” Id. at 97

(citing United States v. Neifert-White Co., 390 U.S. 228, 232, 88 S.Ct. 959, 19 L.Ed.2d 1061

(1968)).

Additionally, the Winter the court did not find themselves directly contradicting the

Eleventh Circuit decision in AseraCare for two reasons. First, the AseraCare court was

specifically asked whether a reasonable disagreement between physicians, without more

evidence, was sufficient to prove falsity at summary judgment. It is important to note that

the Eleventh Circuit “did not consider all subjective statements—including medical

opinions—to be incapable of falsity and identified circumstances in which a medical opinion

would be false.” Winter ex rel. United States v. Gardens Reg'l Hosp. & Med. Ctr., Inc., 953

F.3d 1108, 1119 (9th Cir. 2020). Second, the “objective falsehood” requirement did not

automatically apply to a physician’s certification of medical necessity. The Eleventh Circuit

explicitly distinguished Polukoff by reinforcing that “[CMS] is statutorily prohibited from

reimbursing providers for services ‘which are not reasonable and necessary . . .” United

States v. AseraCare, Inc., 938 F.3d 1278, 1295 (11th Cir. 2019). Congress intended to

prevent “all types of fraud, without qualification, that might result in financial loss to the

Government” and, as such, realtors ought to be subjected to a less stringent standard in

order to fulfill the purpose of the FCA. Therefore, this Court should find that the common

law theory is the more appropriate applicable standard for false certification

claims. Winter ex rel. United States v. Gardens Reg'l Hosp. & Med. Ctr., Inc., 953 F.3d

1108, 1119 (9th Cir. 2020).

Even if the Court chooses to require the objective falsehood theory, Petitioner has

met the standard to prove Respondent has violated the FCA with false certification

claims. In United States v. AseraCare, Inc., 938 F.3d 1278 (11th Cir. 2019), the

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Government gathered medical experts to determine the certification of patients being

terminally ill was false and, therefore, in violation of the FC; yet, they did not provide any

evidence of objective falsity as the Government’s experts—while they disagree—did

understand why the defendant reached his initial conclusion. The court held “a clinical

judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed

false, for purposes of the False Claims Act, when there is only a reasonable disagreement

between medical experts as to the accuracy of that conclusion, with no other evidence to

prove the falsity of the assessment.” United States v. AseraCare, Inc., 938 F.3d 1278, 1281

(11th Cir. 2019). The petitioner in United States v. AseraCare, Inc., had no other evidence

of the defendant’s wrongdoing but the expert testimony from other physicians—

contextualized by broad evidence of AseraCare’s improper business practices—who found

some patients “were not, as a medical fact, terminally ill at the time AseraCare collected

reimbursement for their hospice care.” United States v. AseraCare, Inc., 938 F.3d 1278,

1285 (11th Cir. 2019).

Here, Petitioner has a prior history and extensive knowledge regarding HBO

therapy prior to her transfer to SAM Clinics. Based on the unusual increase in HBO

therapy certifications and the conversations in reference to this, she gathered evidence of

factual falsity from four patient’s charts, all of whom did not have a reasonable or necessary

basis for such treatment. Unlike AseraCare, where the petitioner only had differing medical

opinions as evidence of fraud, here, Petitioner has physical documentation claiming these

procedures were necessary when it was clear, from a patient’s medical records, it was

not. These are not opinions, but verifiable facts—given a patient’s medical condition—that

can and are able to be determined. Should the Court apply the objective falsehood

standard, the reasonings of AseraCare should be followed where a medical certification is

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objectively false when no reasonable physician would have similarly concluded. AseraCare,

Inc., 938 F.3d at 1297 (11th Cir. 2019).

CONCLUSION

For the reasons set forth above, Petitioner respectfully requests that this Honorable

Court reverse the decision of the United States Court of Appeals for the Fifteenth Circuit.

Respectfully Submitted,

/s/_________________________

Team 3014

Counsel for the Petitioner

State of Lincoln