United States of America et al v. St. Mark's Hospital et al

Filing 524

MEMORANDUM DECISION AND ORDER denying 384 Motion for Partial Summary Judgment; denying as moot 381 Motion to Take Judicial Notice. Signed by Judge Ted Stewart on 8/19/20 (alt) Modified on 8/19/2020: corrected name of judge (alt)

Case 2:16-cv-00304-TS-DAO Document 524 Filed 08/19/20 PageID.22270 Page 1 of 6

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF UTAH
UNITED STATES OF AMERICA, ex rel.
GERALD POLUKOFF, M.D.,
Plaintiff/Relator,
v.
ST. MARK’S HOSPITAL;
INTERMOUNTAIN HEALTHCARE,
INC.; INTERMOUNTAIN MEDICAL
CENTER; SHERMAN SORENSEN, M.D.;
and SORENSEN CARDIOVASCULAR
GROUP,
Defendants.

MEMORANDUM DECISION AND
ORDER DENYING RELATOR’S
AMENDED MOTION FOR PARTIAL
SUMMARY JUDGMENT AND DENYING
AS MOOT RELATOR’S MOTION TO
TAKE JUDICIAL NOTICE OF CERTAIN
ADJUDICATIVE FACTS AND
MATERIALS

Case No. 2:16-CV-304 TS
District Judge Ted Stewart

This matter is before the Court on Plaintiff/Relator Gerald Polukoff, M.D.’s (“Relator”)
Amended Motion for Partial Summary Judgment. 1 For the reasons discussed below, the Court
will deny the Motion. The Court will also deny as moot Relator’s Motion for the Court to Take
Judicial Notice of Certain Adjudicative Facts and Materials. 2
I. SUMMARY JUDGMENT STANDARD
Summary judgment is proper if the moving party can demonstrate that there is no genuine
issue of material fact and it is entitled to judgment as a matter of law. 3 In considering whether a
genuine dispute of material fact exists, the Court determines whether a reasonable jury could
return a verdict for the nonmoving party in the face of all the evidence presented. 4 “An issue of

1

Docket Nos. 382, 384. While Docket No. 384 is the operative amended Motion, the
relevant exhibits are attached to Docket No. 382.
2

Docket No. 381.

3

FED. R. CIV. P. 56(a).

4

See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986); Clifton v. Craig, 924
F.2d 182, 183 (10th Cir. 1991).

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fact is ‘material’ if under the substantive law it is essential to the proper disposition of the
claim.” 5 The Court is required to construe all facts and reasonable inferences in the light most
favorable to the nonmoving party. 6
“The movant bears the initial burden of making a prima facie demonstration of the
absence of a genuine issue of material fact.” 7 “Such a movant may make its prima facie
demonstration simply by pointing out to the court a lack of evidence for the nonmovant on an
essential element of the nonmovant’s claim.” 8 Once a movant has carried its initial burden, “the
burden shifts to the nonmovant to go beyond the pleadings and ‘set forth specific facts’ that
would be admissible in evidence in the event of trial from which a rational trier of fact could find
for the nonmovant.” 9
II. DISCUSSION
Relator’s Motion provides 74 statements of allegedly undisputed material facts. 10 Dr.
Sorensen and Sorensen Cardiovascular Group (collectively, “Defendants”) contest eight of these
and offer 44 additional material facts. 11 Relator makes evidentiary objections to seven document
exhibits Defendants submitted in opposition to the Motion and contests 22 of Defendants’

5

Adler v. Wal-Mart Stores, Inc., 144 F.3d 664, 670 (10th Cir. 1998).

6

See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986);
Wright v. Southwestern Bell Tel. Co., 925 F.2d 1288, 1292 (10th Cir. 1991).
7

Adler, 144 F.3d at 670–71.

8

Id. at 671; accord Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986).

9

Adler, 144 F.3d at 671 (quoting FED. R. CIV. P. 56(e)).

10

See Docket No. 384 ¶¶ 1–74.

11

See Docket No. 414, at 6–23.
2

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additional material facts. 12 As none of these objections affects the Court’s analysis, they need
not be addressed here.
This case is about whether Sherman Sorensen, M.D. (“Dr. Sorensen”) violated the False
Claims Act (“FCA”), 31 U.S.C. §§ 3729–32, by submitting legally false claims for
reimbursement under the Medicare Act from 2002 to 2011. 13 Dr. Sorensen is a board-certified
cardiologist experienced in a medical procedure called Patent Foramen Ovale (“PFO”) closure. 14
A PFO is a “tunnel-like opening between the two upper chambers of the heart” that usually
closes naturally after birth. 15 It is not uncommon, however, for it to remain open to a degree, and
for some, it may be medically advisable to eliminate the opening through a transcatheter PFO
closure. 16
The Medicare Act provides that items or services that are “not reasonable and necessary
for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed
body member” may not be reimbursed. 17 To define “reasonable and necessary,” the Medicare
Program Integrity Manual (“Medicare Manual”) provides that:
Contractors shall determine if evidence exist to consider an item or service to be
reasonable and necessary if the contractor determines that the service is:
• Safe and effective;
• Not experimental or investigational . . . ; and

12

See Docket No. 424, at 2–8.

13

See Docket No. 289 ¶¶ 171–86; United States ex rel. Polukoff v. St. Mark’s Hosp., 895
F.3d 730, 741 (10th Cir. 2018) (“‘[F]alse or fraudulent’ includes both factually false and legally
false requests for payment. . . . [Relator] claims the PFO closures do not comply with Medicare’s
‘reasonable and necessary’ requirement, meaning Dr. Sorensen submitted legally false requests
for payment.”).
14

See Docket No. 414, at 9.

15

Docket No. 384 ¶¶ 27–28 (internal quotation marks and citations omitted).

16

Id. at ¶ 31; Docket No. 414, at 7–8.

17

42 U.S.C. § 1395y(a)(1)(A); see also Docket No. 384 ¶ 2.
3

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•

Appropriate, including the duration and frequency that is considered
appropriate for the item or service, in terms of whether it is:
o Furnished in accordance with accepted standards of medical practice
for the diagnosis or treatment of the patient’s condition or to
improve the function of a malformed body member;
o Furnished in a setting appropriate to the patient’s medical needs and
condition;
o Ordered and furnished by qualified personnel;
o One that meets, but does not exceed, the patient’s medical need; and
o At least as beneficial as an existing and available medically
appropriate alternative. 18

The Tenth Circuit has held “that a doctor’s certification to the government that a procedure is
‘reasonable and necessary’ is ‘false’ under the FCA if the procedure was not reasonable and
necessary under the government’s definition of that phrase [provided above].” 19
Relator seeks summary judgment on two issues. He claims there is no genuine issue of
material fact to challenge (1) that “PFO closures from 2002–2011 were not reasonable and
medically necessary as a matter of law,” 20 and (2) what constituted the “standard of care/medical
necessity of PFO/ASD closure in the medical community” during that timeframe. 21 Regarding
each issue and its subparts, either Relator fails to make a “prima facie demonstration of the
absence of a genuine issue of material fact,” 22 or Defendants successfully go beyond the
pleadings to set forth facts admissible at trial “from which a rational trier of fact could find for
[Defendants].” 23

18

Center for Medicare and Medicaid Services, Medicare Program Integrity Manual §
13.5.4 (Rev. 863, 02-12-19).
19

Polukoff, 895 F.3d at 743.

20

Docket No. 384, at 34.

21

Id. at 42.

22

Adler, 144 F.3d at 670.

23

Id. at 671 (quoting FED. R. CIV. P. 56(e)).
4

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1. PFO Closures Not Reasonable and Necessary
Relator argues universally that PFO closures from 2002–2011 were not medically
reasonable and necessary because they were: (a) investigational and experimental, (b) not
demonstrated as safe and effective, (c) not demonstrated as having benefit over other forms of
therapy, and (d) not a generally accepted medical practice. 24 Regarding (a) and (b), Defendants’
evidence shows a question of material fact exists. 25 Regarding (c), the relevant standard from
the Medicare Manual states that a reasonable and necessary service must be “[a]t least as
beneficial as an existing and available medically appropriate alternative.” 26 Relator argues that
randomized clinical trials did not establish the benefit of PFO closure until 2013, but he fails to
show such trials are the only way to establish that benefit. 27 Finally, regarding (d), Relator fails
to show that this language—from the 2014 Medicare Manual and applicable to contractors
making Local Coverage Determinations 28—applies to Dr. Sorensen. 29
2. Standard of Care/Medical Necessity of PFO/ASD Closures in Medical Community
Relator asserts that his evidence regarding the standard of care and medical necessity of
PFO/ASD closures in the medically community during the relevant period has not been
“meaningfully challenged.” 30 He argues: (a) transcatheter PFO closures are appropriate only in
patients with at least one cryptogenic stroke, (b) the diagnosis of cryptogenic stroke must be

24

Docket No. 384, at 34–35.

25

See e.g., Docket No. 414-3, at 290; Docket No. 382-1, at 179.

26

CMS, Medicare Program Integrity Manual § 13.5.4 (Rev. 863, 02-12-19).

27

Docket No. 384, at 42; see Docket No. 382-1, at 188, 194–95.

28

See Docket No. 382-2, at 22; Docket No. 384, at 40.
See CMS, Medicare Program Integrity Manual, Exhibits (Rev. 943, 02-21-20)
(providing definition for “contractor”).
29

30

Docket No. 384, at 42.
5

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made by a neurologist and cardiologist, and (c) this diagnosis requires comprehensive evaluation
to rule out other potential causes of stroke. 31 Defendants counter that PFO closure is warranted
in a broader range of patients, 32 and diagnosis by a neurologist is not always necessary. 33 This is
a material issue of fact that is “essential to the proper disposition of the claim,” 34 as it partially
determines whether Dr. Sorensen’s procedures met the appropriate standard of care. Both parties
provide support for their contradictory assertions, and partial summary judgment must be denied.
III. CONCLUSION
It is therefore
ORDERED that Relator’s Amended Motion for Partial Summary Judgment (Docket No.
384) is DENIED. It is further
ORDERED that Relator’s Motion for the Court to Take Judicial Notice of Certain
Adjudicative Facts and Materials (Docket No. 381) is DENIED as moot.
DATED this 19th day of August 2020.
BY THE COURT:

Ted Stewart
United States District Judge

31
32

Id. at 43; see, e.g., Docket No. 382-1, at 375, 426–27.
Docket No. 414, at 7–8; see e.g., Docket No. 414-2, at 20, 23–27.

33

See, e.g., Docket No. 414-2, at 306, 567.

34

Adler, 144 F.3d at 670.
6