Motion for Judgment of Acquittal or, in the Alternative, for a New Trial (D. Md., Document 78)
Summary
Defendant Ron Elfenbein's Motion for Judgment of Acquittal or, in the Alternative, for a New Trial, filed August 18, 2023 as Document 78 in Crim. No. JKB-22-0146, District of Maryland. The motion states that on August 4, 2023, a jury convicted Dr. Elfenbein on all five counts of the Superseding Indictment charging health care fraud in violation of 18 U.S.C. § 1347. It argues the evidence was insufficient to show that CPT codes 99204 and 99214 were incorrect, and asks for a judgment of acquittal under Federal Rule of Criminal Procedure 29. In the alternative it seeks a new trial under Federal Rule of Criminal Procedure 33, citing the weight of the evidence, excluded defense evidence, a hearsay statement, and closed voir dire.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Cite this document
“Motion for Judgment of Acquittal or, in the Alternative, for a New Trial (D. Md., Document 78).”
Original at archive.org. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/court-filing-d-md-no-1-22-cr-00146-dkt-78-d-md-b62a742c42/
, SHA-256 1e8871ea6d99d53f0e42b3c70b55c8f0002d99f9505e4d50ffd50f356c4991ec.Full text
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 1 of 48
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND
(Northern Division)
UNITED STATES OF AMERICA
v. Crim. No. JKB-22-0146
RON ELFENBEIN,
Defendant.
DEFENDANT RON ELFENBEIN’S MOTION FOR JUDGMENT OF ACQUITTAL
OR, IN THE ALTERNATIVE, FOR A NEW TRIAL
Gregg L. Bernstein (Bar No. 01340)
Martin S. Himeles, Jr. (Bar No. 03430)
Samantha A. Miller (Bar No. 21374)
Zuckerman Spaeder LLP
100 East Pratt Street - Suite 2440
Baltimore, MD 21202-1031
Tel. No: (410) 332-0444
Fax No: (410) 659-0436
gbernstein@zuckerman.com
mhimeles@zuckerman.com
samiller@zuckerman.com
Counsel for Defendant Ron Elfenbein
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 2 of 48
TABLE OF CONTENTS
INTRODUCTION .......................................................................................................................... 1
BACKGROUND ............................................................................................................................ 1
ARGUMENT .................................................................................................................................. 7
I. THE COURT SHOULD GRANT THE MOTION AND ENTER A JUDGMENT OF
ACQUITTAL UNDER RULE 29. ................................................................................................. 7
A. The evidence was insufficient to establish that CPT codes 99204 and 99214 inaccurately
represented E/M services provided to patients seeking COVID-19 testing services. ................. 8
i. No expert testimony established that level 4 was incorrect. ............................................ 9
ii. None of the government’s fact witnesses provided a basis for the jury’s determination
that level 4 was incorrect. ...................................................................................................... 14
B. The jury had no reasonable basis to find that Counts 2–5 constituted executions of the
alleged scheme because there was insufficient evidence that the CPT codes that were utilized
were wrong. ............................................................................................................................... 18
i. Count 5: S.T., date of service 4/19/21 ............................................................................ 20
ii. Count 4: J.J., date of service 3/2/21 ............................................................................... 21
iii. Count 3: D.M., date of service 5/10/21 .......................................................................... 22
iv. Count 2: W.R., date of service 4/23/21 .......................................................................... 22
C. The jury had no reasonable basis to find that Count 1 constituted an execution of the
alleged scheme because there was no scheme—alleged or otherwise—to bill for visits that did
not occur. ................................................................................................................................... 27
II. IN THE ALTERNATIVE, THE COURT SHOULD GRANT A NEW TRIAL UNDER
RULE 33. ...................................................................................................................................... 29
A. The weight of the evidence does not support a finding of guilt......................................... 29
B. The Court’s exclusion of key non-hearsay evidence offered by the defense and admission
of highly prejudicial hearsay testimony offered by the government warrants a new trial. ....... 32
i. The Court improperly excluded contemporaneous evidence of Dr. Elfenbein’s state of
mind that went to the heart of his defense. ............................................................................ 32
ii. The Court erroneously allowed A.H. to testify to the hearsay statement of an unknown
individual who purportedly said, “this is how we bill.” ........................................................ 41
C. The Court should not have closed voir dire to the public. ................................................. 43
CONCLUSION ............................................................................................................................. 44
i
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 3 of 48
INTRODUCTION
On August 4, 2023, a jury convicted Dr. Ron Elfenbein on all five counts of the
Superseding Indictment charging him with health care fraud in violation of 18 U.S.C. § 1347.1 The
jury reasonably could have found that the regulatory scheme governing healthcare reimbursement
in this country is complicated and absurd. The jury also reasonably could have found that Dr.
Elfenbein’s urgent care centers were not well-run during 2020 and 2021 when the country was in
the midst of a pandemic. But these were not the questions before the jury. Instead, the jury was
tasked with determining whether Dr. Elfenbein devised and executed a scheme to submit claims
for reimbursement using Current Procedural Terminology (“CPT”) codes that were incorrect, and
that he knew were incorrect. As to these questions, the evidence was simply insufficient to convict.
The jury’s verdict was not supported by the evidence, taken in the light most favorable to
the government, and allowing it to stand would be an injustice and contrary to law. Pursuant to
Federal Rule of Criminal Procedure 29, the Court should enter a judgment of acquittal on all
counts. In the alternative, the Court should order a new trial pursuant to Federal Rule of Criminal
Procedure 33.
BACKGROUND
In 2016, Dr. Elfenbein opened an urgent care center in Gambrills, Maryland, Drs ERgent
Care (“DEC”), that provided “standard urgent care type services” such as “in-house laboratory, x-
ray, minor in-office procedures, and office visits.” See 8/1/23 Tr. 119:9–22; 7/20/23 Tr. 81:6–10.
Shortly before the onset of the COVID-19 pandemic, DEC merged with a larger urgent care
1
Due to a non-substantive error in the Superseding Indictment, the government filed an Amended
Superseding Indictment. (ECF No. 51). In this motion, we refer to the operative indictment simply
as the Superseding Indictment.
1
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 4 of 48
company, Centennial Medical Group, which had locations in Howard County, Maryland. See
8/1/23 Tr. 126:25–129:2; 7/20/23 Tr. 81:14–20; 7/24/23 Tr. 161:6–7. Dr. Elfenbein was Medical
Director of the resulting entity operating in Gambrills, First Call Medical Center (“FCMC”).2 See
7/24/23 Tr. 161:3–18.
In March 2020, “due to COVID, there was a near overnight demand for COVID testing”
and the volume of patients coming to DEC increased significantly. 7/20/23 Tr. 82:9–23. From mid-
March 2020 through the end of February 2022, the period covered by the alleged scheme, DEC
submitted thousands of claims for reimbursement to Medicare and other insurance companies.
These claims included evaluation and management (“E/M”) codes for office or other outpatient
visits in addition to reimbursement for COVID-19 tests. Id. at 80:11–13. Dr. Elfenbein told DEC
providers these office visits should be coded at levels 4 and 5 under the CPT Manual coding rubric,
and most were coded at level 4. GX 140.
The allegations in the Superseding Indictment, and the facts developed at trial, are
inextricably bound to the complex regulatory scheme that governed this CPT coding scheme for
Medicare and CareFirst Blue Cross Blue Shield in 2020 and 2021.3 Entering 2020, the CPT codes
and their definitions, as well as guidance concerning their application, were found in the 2020 CPT
2
Some witnesses at trial referred to Dr. Elfenbein’s urgent care company as Drs ERgent Care and
others referred to it as First Call. During the relevant period, claims were submitted under the DEC
name, see 7/20/23 Tr. 82:4–8, but the company did business as FCMC, see, e.g., 7/24/23 Tr. 13:23–
14:4, 188:9–11. In this motion, we refer to the entity as DEC.
3
The Superseding Indictment alleged a scheme involving claims submitted to other insurers as
well. However, the government presented no evidence regarding the CPT coding standards of these
other insurers. The Court thus effectively granted a judgment of acquittal with respect to the
allegations that Dr. Elfenbein defrauded any insurers other than CareFirst and Medicare. See
7/26/23 Tr. 67:25–68:25 (prohibiting the government from presenting the jury with summary
exhibits that treated as fraudulent claims submitted to insurers other than Medicare and CareFirst).
2
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 5 of 48
Manual. DX 3;4 see also 7/18/23 Tr. 92:9–19. The correct code for a particular service, however,
could not be determined from the Manual alone. For example, CPT code 99204 was defined as an
“[o]ffice or other outpatient visit for the evaluation and management of a new patient, which
requires these 3 components: A comprehensive history; A comprehensive examination; Medical
decision making of moderate complexity.” DX 3, p. 13. The terms “moderate” and
“comprehensive” were not defined, and as confirmed by the government’s own expert witness,
Stephen Quindoza, the CPT Manual alone was not enough to determine what level of complexity
to assign to an office visit:
Q. . . . [D]etermining the complexity of medical decision making,
that’s not just something that a coder or a provider determines
based on the words, what is low complexity, correct?
A. Correct.
Q. There is some guidance that’s in the code book, right?
A. Yes.
Q. And then there’s guidance in the 1995 documentation guidelines,
correct?
A. Yes.
Q. And there’s guidance in the 1997 documentation guidelines,
correct?
A. Yes, sir.
7/18/23 Tr. 191:10–22 (emphasis added); see also id. at 65:14–16; id. at 165:13–16. In this vein,
Mr. Quindoza acknowledged that “[t]here’s a lot” of additional guidance for providers regarding
coding, 7/18/23 Tr. 153:16–18, and that there were “gaps” in the CPT Manual, id. at 161:5–9, 20–
24. He further agreed that guidance designed to fill these gaps was, at times, inconsistent. Id.5
4
Excerpts of the 2020 and 2021 CPT Manuals are in evidence as GX 902 and 903, and DX 3 and
4. We cite to the Defendant’s exhibits because the pages of the exhibits are numbered.
5
DEC’s in-house coder and biller, Cathy Raymond, also acknowledged that the providers had to
contend not only with the CPT Manual to determine an appropriate code, but also with “the audit
3
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 6 of 48
With the arrival of the COVID-19 pandemic, the government promulgated additional
regulations regarding CPT code selection that addressed the extraordinary needs caused by this
novel, unprecedented public health emergency. A Department of Health and Human Services
Centers for Medicare & Medicaid (“CMS”) Interim Final Rule published on April 6, 2020 and
effective retroactively to March 1, 2020 explicitly encouraged the use of telehealth to minimize
the spread of disease:
In support of the imperative to contain and combat the virus in the
United States, this [interim final rule] will give health care workers
and hospitals additional flexibility to respond to the virus and
continue caring for patients while minimizing exposure. CDC
guidelines are clear that public exposure greatly increases the
overall risk to public health and they stress the importance of
containment and mitigation strategies to minimize public exposure
and the spread of COVID–19.
[. . .]
The provisions of this [interim final rule] better enable and facilitate
physicians and other clinicians, to focus on caring for these
beneficiaries during this [public health emergency] for the COVID–
19 pandemic and minimize their own risks to COVID–19 exposure.
For example, by increasing access to telehealth and testing in a
patient’s home, and improving infection control, this [interim final
rule] will provide flexibilities for Medicare beneficiaries to be able
to receive medically necessary services without jeopardizing their
health or the health of those who are providing those services, in
turn minimizing public exposure and the overall risk to public
health. Moreover, changes to Medicare payment rules will confer
on practitioners and other healthcare providers the broadest
flexibility to use remote communications technology to avoid
exposure risks to themselves, their patients, and communities.
DX 218, p. 53 (emphasis added).
tools that Novitas [the Medicare Administrative Contractor for the region] had put out.” 7/24/23
Tr. 37:18–38:23.
4
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 7 of 48
Significantly, CMS recognized that examinations via telehealth are more limited than what
can be accomplished during in-person visits. To encourage use of telehealth for COVID-related
visits, CMS “revis[ed] [its] policy to specify that the office/outpatient E/M level selection for these
services when furnished via telehealth [could] be based on MDM or time,” and “remov[ed] any
requirements regarding documentation of history and/or physical exam in the medical record.” Id.,
p. 41. In other words, even if a provider elected to perform a history and/or physical exam, the
provider had no obligation to document those aspects of the visit in the patient’s chart. The April
2020 Interim Final Rule, then, operated as a retroactive telehealth exception that removed the
history and exam requirements in the 2020 CPT Manual.
In 2021 (the year of service for the patients identified in each of the five counts of the
Superseding Indictment), the CPT E/M coding guidelines underwent a significant change. For all
office visits, code selection was no longer based on a “three key factors model” (history, exam,
and medical decision making). See 7/24/23 Tr. 37:18–38:23; see also DX 3. Instead, providers
were to code visits based on “medical decision making (MDM) or time,” DX 4, p. 5 (emphasis in
original), as they had been doing for telehealth visits throughout the pandemic. The extent of the
history and examination were eliminated as factors in code selection even for in-person visits, and,
in fact, a history and examination were not required at all. “Office or other outpatient services
included a medically appropriate history and/or physical examination, when performed. . . . The
extent of history and physical examination is not an element in selection of the level of office or
other outpatient codes.” Id., p. 12 (emphasis added).
Under the new 2021 CPT guidelines, an office visit assigned CPT code 99204—and coded
based on medical decision making rather than time6—was one in which the provider employed
6
It is undisputed that the claims at issue in this case were not coded based on time.
5
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 8 of 48
“moderate complexity” medical decision making. Id., p. 19. “Moderate complexity” medical
decision making was not “just something that a coder or a provider determine[d] based on the
words.” See 7/18/23 Tr. 191:10–22. The CPT Manual included a medical decision making chart,
which broke down the levels of complexity into their component parts and quantified the
requirements for each level of medical decision making:
DX 4, p. 16; see also id., p. 17 (breakdown of complexity required for CPT codes 99205 and
99215).
At trial, the government established several undisputed facts: (1) when patients presented
to DEC seeking a COVID-19 test, they received a rapid test, a PCR test, and an office visit with a
6
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 9 of 48
healthcare provider;7 (2) the office visits typically involved roughly five minutes of face-to-face
time with a provider, whether in person or via telehealth; (3) Dr. Elfenbein instructed providers,
as a general matter, to bill these office visits at CPT level 4 if the patient was asymptomatic or
level 5 if the patients was symptomatic; and (4) the vast majority of DEC office visits in 2020 and
2021 were billed at level 4. What the government did not establish was that the E/M Level 4 and
5 code selections were incorrect under the applicable CPT Manual codes and guidance. The central
allegation in the Superseding Indictment was that the office visits did not meet the requirements
for these codes, and, accordingly, the claims for level 4 office visits on the same day as COVID
tests were false statements. Thus, absent evidence from which a jury could find beyond a
reasonable doubt that the codes were incorrect, there was no false or fraudulent statement to
support the alleged scheme to defraud.
ARGUMENT
I. THE COURT SHOULD GRANT THE MOTION AND ENTER A JUDGMENT OF
ACQUITTAL UNDER RULE 29.
Under Rule 29(a), “the court on the defendant’s motion must enter a judgment of acquittal
for any offense for which the evidence is insufficient to sustain a conviction.” The “critical inquiry”
in determining whether a Rule 29 motion should be granted “is whether the record evidence could
reasonably support a finding of guilt beyond a reasonable doubt.” Jackson v. Virginia, 443 U.S.
307, 318 (1979). “[I]f the evidence is so insufficient that no rational trier of fact could convict, the
court should enter a judgment of acquittal.” United States v. Rafiekian, 68 F.4th 177, 186 (4th Cir.
7
Patients sometimes received additional tests if the provider believed them necessary. See, e.g.,
7/26/23 Tr. 23:12–18, 57:3–8 (testimony of Kathleen Wrona). On infrequent occasions, patients
only received a rapid test. See 8/1/23 Tr. 183:4–14 (testimony of Dr. Elfenbein); 8/2/23 Tr. 169:11–
173:13 (testimony of Dr. Elfenbein); GX 938. The patients whose visits constituted counts in the
indictment, like most patients, received rapid and PCR tests.
7
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 10 of 48
2023). In making this determination, “the court views the evidence and inferences therefrom in the
light most favorable to the government.” Id. (internal quotation marks omitted). Under this
standard, there was insufficient evidence for the jury to convict Dr. Elfenbein.
A. The evidence was insufficient to establish that CPT codes 99204 and 99214
inaccurately represented E/M services provided to patients seeking COVID-19
testing services.
Health care fraud requires proof of the knowing and willful use of “false or fraudulent
pretenses, representations, or promises” to obtain the money or property of a health care benefit
program. United States v. Jones, 471 F.3d 478, 481(3d Cir. 2006); see also, e.g., United States v.
Memar, 906 F.3d 652, 656 (7th Cir. 2018); United States v. Medina, 485 F.3d 1291, 1298 (11th
Cir. 2007). The Superseding Indictment alleged a “scheme” in which Dr. Elfenbein “instructed
providers and other employees” to bill office visits occurring alongside COVID-19 tests “as
moderate complexity E/M Services” (“represented” by CPT codes 99204 and 99214) “even though
such encounters did not occur as represented.” Sup. Ind. ¶¶ 30(e), (f) (ECF No. 51). The sine qua
non of the alleged scheme was thus that the codes did not describe the services. Id. ¶ 29(a), 30(c)–
(d), (h); see Jury Instruction No. 39 (ECF No. 64). Evidence from which the jury could find that
the codes were wrong was therefore essential; without it, the jury could not convict. 8
8
Throughout the trial, the government suggested that no provider visit was medically necessary
for patients presenting to FCMC for COVID-19 testing. See, e.g., 7/18/23 Tr. 21:9–13 (government
opening); 7/25/23 Tr. 20:6–10 (questioning patient whether she wanted a test, or to see a doctor);
8/1/23 Tr. 47:17–48:13 (questions pertaining to CPT code 99211); 8/3/23 Tr. 89:12–90:9
(government closing). The government, however, presented no evidence to support this theory.
The only testimony regarding medical necessity was offered through the defense’s expert witness,
Dr. Hugh Hill. Dr. Hill’s unrefuted expert opinion was that patients presenting for COVID-19
testing should be seen by a healthcare provider. 7/31/23 Tr. 74:25–75:24 (“Physicians don’t just
dole out tests, nor nurse practitioners, nor providers. It’s just not what we do. We’re not dispensers
or access points for tests.”). Moreover, CMS and the CDC urged providers to meet with patients—
including asymptomatic patients—at the time they were tested, in the interest of the health of both
patients and the public. DX 233, p. 3 (7/30/2020 CMS and CDC joint press release). CMS also
announced that it would “use existing evaluation and management (E/M) payment codes to
8
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 11 of 48
The government, however, offered insufficient evidence to support the allegation that
codes 99204 and 99214 were, in fact, the wrong codes. The government offered no expert
testimony concerning the applicability of level 4 E/M codes to patient encounters at any of the
DEC locations. Instead, the government relied on the opinions of numerous fact witnesses, many
of whom disagreed on what the rules meant and what the codes should have been. The insufficient
evidence that the codes were wrong was fatal to the government’s case.9
i. No expert testimony established that level 4 was incorrect.
“Expert testimony is required when the subject matter is so particularly related to some
science or profession that it is beyond the ken of the average layman.” Adams v. NVR Homes, Inc.,
142 F. Supp. 2d 649, 654 (D. Md. 2001). The government’s case against Dr. Elfenbein hinged on
whether CPT codes 99204 and 99214 accurately described the services provided to patients at
DEC. “The ordinary juror is not expected to have knowledge regarding CPT codes.” Counts v.
Pollock, No. 3:18-CV-1072-J-39JBT, 2020 WL 5534444, at *3 (M.D. Fla. Aug. 21, 2020); see
also United States v. Diaz, No. 07-20398-CR, 2008 WL 906725, at *6 (S.D. Fla. Mar. 28, 2008)
(“Medicare billing codes . . . [are] beyond the knowledge of an ordinary juror.”). Given the
complex regulatory backdrop of this case, the government was required to provide the jury with
reimburse providers” for these office visits. Id. Indeed, CMS reinstated the requirement of a
provider’s order for all COVID tests except a patient’s first one to ensure that providers would
receive “the medical attention and oversight required to ensure that diagnosis and treatment is
applied consistent with CDC guidelines and other medical standards,” and instructed that these
services be billed using E/M codes “to ensure that physicians and other practitioners . . . are paid
for these services.” DX 220, p. 20 (9/2/20 Interim Final Rule). CMS’s interim final rule thus
established that an E/M visit at the time an asymptomatic patient was tested was always medically
necessary.
9
In this regard, if the evidence is insufficient to establish that the codes that were utilized were
wrong, it is of no moment whether DEC employees told Dr. Elfenbein that they were
uncomfortable with using these codes, or that he selected these codes in order to maximize
reimbursement, which addresses the separate question of Dr. Elfenbein’s motive and knowledge.
9
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 12 of 48
an expert opinion based upon which jurors could conclude that level 4 was not the correct code.
The government did not do so. Instead, the government argued that the applicability of CPT codes
was a matter of common sense, and then argued that the jury should adopt government counsel’s
own contention that the applicable code was level 1—unsupported by any expert or other
testimony. See 8/3/23 Tr. 89:12–90:9, 94:6–17. Without expert testimony that the level 4 CPT
codes selected for most patient encounters did not describe the services rendered, and therefore
were false representations, the government could not establish that the codes were wrong.
In order to meet its burden, the government presented the testimony of only one expert,
Stephen Quindoza, who was qualified as an expert in “Medicare processes, rules, and regulations,”
and “procedural and diagnostic coding.” 7/18/23 Tr. 62:16–21. Mr. Quindoza did not offer “any
opinions concerning the medical necessity of a particular patient’s E/M visit,” 7/18/23 Tr. 126:12–
15. He offered no opinions “concerning the care of any patient or all patients received” at DEC.
Id. at 126:16–18. He offered no testimony concerning the correct CPT code for any office visit
during the two-year period of the alleged scheme. Instead, Mr. Quindoza’s testimony was intended
to establish the general rules governing CPT code selection. But even in this narrowly defined
scope, Mr. Quindoza failed to offer any testimony that supported the government’s theory. Indeed,
as the Court noted, rather than bolstering the government’s case, Mr. Quindoza’s testimony
undermined “the underlying sort of legal foundation for it all.” 7/19/23 Tr. 29:11–12.
While Mr. Quindoza’s testimony did not remotely assist the jury in determining whether
the correct codes were used for patients seen at DEC, including the five named patients in the
Superseding Indictment, his testimony regarding the substantive requirements for E/M code
selection did overwhelmingly illustrate both the complicated and confusing regulatory
environment and his lack of knowledge of the controlling rules. For example, he initially testified
10
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 13 of 48
that time was a relevant factor in determining the appropriate CPT code for E/M office visits in
both 2020 and 2021. 7/18/23 Tr. 95:18–21, 100:15–18. On cross-examination, however, Mr.
Quindoza retracted that testimony:
Q. Okay. So when you told the members of the jury earlier that
time is a factor in determining the level, that’s just not true, is it?
A. In determining the level?
Q. Yes, sir.
A. No, it’s not.
[. . .]
Q. . . . [I]t’s not a factor that a provider can rely on in selecting the
level, correct? Assuming no counseling or coordination of care.
A. Understand. Yes.
7/18/23 Tr. 205:6–25.10
On another issue of critical importance to this case—the role of the COVID-19 pandemic
in E/M code selection—Mr. Quindoza’s testimony was similarly contradictory. He initially
testified that the expansion of telemedicine during the COVID-19 pandemic had no impact on the
requirements for CPT code selection:
Q. . . . Did the requirements for telemedicine change with the
COVID pandemic?
A. Yes, sir, it did.
[. . .]
Q. And did these changes reduce any of the requirements for the
evaluation and management CPT codes?
10
Indeed, Mr. Quindoza’s testimony concerning the relevance of time in determining the level had
been based on the “typical” times in the code descriptions (which were established before the
pandemic). But in 2021—when all the substantive counts occurred—the CPT Manual eliminated
“typical” times for E/M office visit codes. DX 4, pp. 18–20. For all visits—not just telehealth—
providers were permitted to select a code based on medical decision making or time, at the
provider’s choice, and each code definition included a range that applied only “when using time
for code selection.” Id. If the provider chose to code based on medical decision making, time was
simply irrelevant.
11
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 14 of 48
A. No, sir.
Q. Did the changes reduce any of the things that a provider needed
to do to meet the requirements of those codes?
A. No.
7/18/23 Tr. 105:12–106:20. But he acknowledged on cross-examination that he had not read
CMS’s April 6, 2020 Interim Final Rule, or any of the other Interim Final Rules that CMS
published in the federal register during the pandemic, or even the transmittals from CMS to its
contractors. 7/19/23 Tr. 22:13–22, 32:11-33:20. He was, therefore, unaware that in the April 2020
Interim Final Rule, CMS “remove[d] any requirements regarding documentation of history and/or
physical exam in the medical record.” See 7/19/23 Tr. 15:3–6; DX 218, pp. 41, 53. Mr. Quindoza
admitted his mistake on the stand:
Q. . . . So the provisions in this interim final rule were effective
going back to March 1st of 2020, although they were published in
the Federal Register on April 6th, correct?
A. Yes, sir.
Q. All right. And that includes the provision that said, for
telemedicine, the rule that applied -- that was going to apply in 2021
to all visits, which is that the level is determined based on time or
medical decision making, the option of the provider, for
telemedicine that was effective as of March 1st of 2020. Is that true?
A. Yes, sir.
Q. Okay. All right. So your testimony on direct examination that
there were no changes to level selection or to the rules that relate to
the E/M codes in the requirements in 2020 was incorrect? Is that --
A. You are correct.
Q. I’m sorry?
A. You are correct.
7/19/23 Tr. 18:8–25.
Taken as a whole, Mr. Quindoza’s testimony established that the length of an office visit
did not affect the selection of the code for telemedicine and in-person office visits, and that CMS
12
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 15 of 48
eliminated the requirements of documentation of an examination and history for telemedicine
during the pandemic. More significantly, his testimony clearly established that even an expert
whose “job [it is] to know these sorts of changes,” see 7/19/23 Tr. 20:22–25, was unaware of the
changing guidance. Mr. Quindoza’s testimony certainly provided no basis on which the jury could
reasonably conclude that CPT codes 99204 and 99214 were inappropriately applied to the visits at
issue in this case. In this regard, the government’s reliance on time as well as examination and
history to establish the allegations in the Superseding Indictment was both incorrect and
misleading.
The only other expert who testified regarding CPT coding was the defense witness,
Michael Miscoe. Mr. Miscoe was qualified as an expert in medical coding, E/M coding, diagnostic
coding, and documentation of medical services in medical records. 7/31/23 Tr. 132:6–133:4.
Consistent with other government witnesses, Mr. Miscoe testified that the 2020 CPT Manual
included numerous undefined terms, the meaning of which could not be determined from review
of the Manual itself. Id. at 143:8–149:13. Mr. Miscoe’s uncontradicted expert opinion was that,
under the applicable coding guidance, COVID was an “undiagnosed new problem with an
uncertain prognosis,” a term with relevance in determining the complexity of medical decision
making that occurred during an office visit and the resulting E/M level. 7/31/23 Tr. 173:11–174:6;
DX 4, p. 16 (MDM Table).11
11
Mr. Miscoe testified that CMS’s guidance regarding the use of COVID diagnostic codes
instructed providers and coders not to use the new COVID screening code during the pandemic,
but instead, to assign to all COVID tests for which there was not a confirmed COVID diagnosis—
even encounters for preoperative testing, traveling, or to return to school—the code for “actual or
suspected exposure to COVID-19.” Id. at 173:11–174:6; DX 221, p. 7. The guidance instructed
that, “given the Public Health Emergency, . . . everybody was suspected to have COVID until it
was proven that they did not.” 7/31/23 Tr. 174:22–175:6. The government ignored this binding
guidance in repeatedly arguing during trial that the fact that patients came to DEC “simply” to be
tested for work or travel was evidence of a fraudulent scheme. See pp. 26–27 infra.
13
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 16 of 48
Moreover, unlike Mr. Quindoza, Mr. Miscoe offered expert testimony regarding the coding
of specific office visits that occurred at DEC: the five visits that were the subject of indictment
counts and a number of other visits that were part of the CareFirst audit. Mr. Miscoe’s
uncontradicted expert opinion was that the charts he reviewed supported the level 4 codes. 7/31/23
Tr. 200:18–25; 8/1/23 Tr. 3:19–7:18, 14:5–15.12
The jury was not required to credit Mr. Miscoe’s testimony simply because he was an
expert. But this case involved technical rules that experts spend years learning and applying, and
that rapidly changed during the pandemic. The government cannot supplant the testimony of an
expert concerning such rules by making up different rules out of whole cloth. Yet that is what the
government did. Government counsel’s own personal views as to whether E/M level 4 was the
appropriate code for these encounters cannot replace the uncontradicted testimony of the
defendant’s expert. Accordingly, the Court should grant the defendant’s motion and enter
judgment in his favor.
ii. None of the government’s fact witnesses provided a basis for the jury’s
determination that level 4 was incorrect.
Assuming that the jury could ignore the only expert who testified as to the proper method
of coding the visits at issue, the testimony of the government’s fact witnesses similarly failed to
establish a basis for the jury to find that 99204 and 99214 were the wrong codes. For example,
Cathy Raymond, DEC’s former biller and coder, acknowledged the “rapidly changing regulatory
environment” as she “considered multiple different code options to see which one actually
12
Mr. Miscoe’s testimony that patients who were tested each had an undiagnosed problem with
uncertain prognosis, which formed the basis for his conclusion that Level 4 was the appropriate
E/M code, was supported by the E/M worksheet created by Novitas, the Medicare Administrative
Contractor for Maryland.
14
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 17 of 48
accurately described the service and which one would be compliant. 7/20/23 Tr. 97:1–5. And
although Ms. Raymond testified that she raised concerns to Dr. Elfenbein that “the documentation
level that was there did not justify the high level office visits,” see 7/20/23 Tr. 84:18–19 (emphasis
added), she agreed that she was “okay” with billing COVID-related visits at level 4 and 5 “[i]f I
had the documentation to support it in the history and the exam.” 7/24/23 Tr. 45:16–18; see also
GX 602. Based on the level of documentation, she believed “the majority of patient encounters
that were billed” in 2020 should have been a level 3. See 7/24/23 Tr. 49:10–19. Significantly, at
no point did Ms. Raymond testify that the visits at issue did not involve moderate levels medical
decision making. Her disagreement with what she perceived as a “pattern of over coding” had
everything to do with documentation of the history and exam, and nothing to do with medical
decision making. See, e.g., 7/24/23 Tr. 48:17–49:4, 90:7–14. This critical point undermines her
testimony on code selection entirely.
Moreover, Ms. Raymond left DEC in 2020 and offered no testimony regarding its coding
practices in 2021, when all the patients named in the Superseding Indictment were seen. See
7/24/23 Tr. 42:19–21. Based on that fact alone, Ms. Raymond’s testimony provided no basis on
which the jury could reasonably conclude that CPT codes 99204 and 99214 were incorrect.
The government’s provider witnesses, Deborah Needle and Kathleen Wrona, offered even
less relevant testimony on this critical issue. Ms. Needle, who worked at DEC from 2019 to 2020,
testified that she had no coding experience and was “[n]ot really” familiar with E/M codes. 7/24/23
Tr. 134:2–7. She nevertheless testified that she “didn’t feel that an asymptomatic patient warranted
a level 4,” 7/24/23 Tr. 139:10–11 (emphasis added), a feeling not grounded in any rules or
regulations, see 7/24/23 Tr. 142:17–19. Ms. Needle “felt” that level 3 was the “more appropriate
level” for asymptomatic COVID patients, “but I had never lived through a pandemic before,” and
15
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 18 of 48
thus “accepted” Dr. Elfenbein’s instructions that level 4 was correct. See id. at 206:11–207:7. Ms.
Wrona, who worked at DEC in 2021, also had no experience with CPT codes. 7/26/24 Tr. 35:22–
23 (“I had never coded before”). She did not testify to any discomfort with coding at level 4.
Ms. Needle and Ms. Wrona did, however, testify about the types of medical decisions they
made when treating patients who came to DEC for COVID tests. Ms. Needle testified that she
made decisions about (1) whether a patient was symptomatic or asymptomatic; (2) whether a
patient might need to go to the hospital; (3) whether a patient needed medication; and (4) what
advice and recommendations to give to a patient. 7/24/23 Tr. 190:11–191:11. Ms. Wrona testified
that she made decisions about (1) whether to refer patients for monoclonal antibody treatments;
(2) whether a patient’s vital signs indicated an issue such as “happy hypoxia”; and (3) whether
tests other than COVID tests needed to be administered. 7/26/23 Tr. 17:25–19:12, 23:12–18. Ms.
Needle and Ms. Wrona offered no testimony about where this level of medical decision making
fell within the applicable CPT coding guidance.13
The only other government witness to testify about the E/M coding decisions at DEC was
Courtney Sinagra, a representative of CareFirst Blue Cross Blue Shield. Ms. Sinagra testified
regarding two CareFirst audits performed on a subset of DEC records, each of which had been
performed by auditors who were no longer employed at CareFirst. Her fact testimony also failed
to establish that CPT codes 99204 and 99214 were inappropriate as applied to office visits
occurring alongside COVID tests at DEC. She testified that in 2021, CareFirst conducted an audit
13
Every provider who testified—whether called by the government or the defense—described
significant, meaningful encounters with patients. Code selection was not based on the examination
or history in 2021, or in 2020 for telemedicine, but the providers’ testimony described physical
examinations when patients were seen in-person, and visual examinations when they were seen by
telemedicine. See, e.g., 7/24/2023 (Needle) Tr. 134:12–17 (“We were pulling blood pressure cuffs
out the door. We were taking all our equipment out the back door. We were seeing patients in their
car. We were climbing in the cars to see patients. It was -- it was -- it was chaos.”).
16
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 19 of 48
of 30 patient records. 7/25/23 Tr. 30:1–24. Ms. Sinagra admitted that the first audit was based on
review of medical records that were missing pages and were, in many cases, unintelligible due to
fax transmission errors. Id. at 30:25–33:2. Based on these incomplete records, CareFirst
determined that the charts—which were coded level 4—instead should have been coded level 3.
See 7/25/23 Tr. 112:23–113:21; 130:9–131:3. Ms. Sinagra also testified that in 2021, CareFirst
conducted a second audit of 89 patient charts. Id. at 34:18–21. This time, based on review of
records from roughly the same time period, CareFirst concluded that the charts should have been
coded at level 2. Id. at 54:23–56:7. When asked about this discrepancy in the audit findings, she
agreed that “auditors don’t necessarily make the same findings as to specific claims,” and that “a
one-level difference would not . . . necessarily be out of the ordinary.” Id. at 149:23-150:3. Ms.
Sinagra also agreed that, given the incomplete records on which the first audit was based, she did
not know whether the complete records supported level 4. Id. at 127:21–128:11. Finally, Ms.
Sinagra testified that COVID exposure could be considered “an undiagnosed problem of uncertain
prognosis,” a key factor in determining whether an office visit involved moderate levels of medical
decision making. Id. at 171:21–23.
Because the government did not offer Ms. Sinagra as an expert, the jury had no basis on
which to find that her testimony supported even the contradictory conclusions of CareFirst auditors
regarding the audited claims—either that the claims in the first audit coded as level 4 should have
been coded as level 3, or that the indistinguishable claims in the second audit should have been
coded as level 2. On direct examination, the government did not ask her any questions concerning
the reasons for CareFirst’s audit findings, and on cross-examination, the government successfully
objected to questions that would have tested her knowledge of the relevant regulatory changes and
the broader applicability of CareFirst’s audit findings because she was not testifying as an expert.
17
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 20 of 48
See 7/25/23 Tr. 77:16–78:18. Testimony of a witness insulated from cross-examination about
“policies and procedures and codes and guidance” that governed code selection during the
pandemic, id. at 78:10–13, who testified only to “what CareFirst did” in its audits, id. at 78:13–14,
could not provide a basis for a jury finding concerning the codes applicable to claims that were not
the subject of the CareFirst audit. Without such testimony, the jury could not reasonably find
beyond a reasonable doubt that the government proved that the codes selected were wrong—and
therefore could not find that the government proved the charged scheme to defraud.14
B. The jury had no reasonable basis to find that Counts 2–5 constituted executions
of the alleged scheme because there was insufficient evidence that the CPT codes
that were utilized were wrong.
Each of the five counts in the Superseding Indictment corresponds to a specific office visit
for a patient that the government contends was improperly coded at level 4. Even if the Court were
to find sufficient evidence to support a jury finding that there was a scheme to defraud, conviction
on any of the counts required proof that the code submitted was wrong—i.e., that the claim was
false or fraudulent. 8/3/23 Tr. 127:9–14 (instructing jury, “You may not find the defendant guilty
of a count in the Superseding Indictment unless you find the Government has proved beyond a
reasonable doubt that the claim charged in that count of the Superseding Indictment was false or
fraudulent as to a material fact or matter.”). With respect to each count, the evidence was plainly
insufficient to establish that level 4 was the wrong level for these visits.15 Accordingly, no
14
The defense also called two DEC providers to testify at trial. Both providers, Steven Carroll and
Suzana Silva, testified that they billed their COVID-related visits at a level 4 because they believed
level 4 accurately reflected the services they performed. See 7/31/23 Tr. 22:4–23:7; 8/1/23 Tr.
106:14–107:7. Ms. Silva was familiar with E/M coding and chose level 4 based on her own
experience with and understanding of the codes, not based on Dr. Elfenbein’s instructions.
15
This section deals specifically with Counts 2–5. Count 1 will be addressed separately in the next
section.
18
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 21 of 48
reasonable jury could have found beyond a reasonable doubt that the submissions of these level 4
claims constituted executions of the “scheme.”
The visits corresponding to all five counts occurred in 2021. Sup. Ind. ¶ 31. Accordingly,
E/M code selection was based either on the length of the visit or on the level of medical decision
making. DX 4, p. 14 (2021 CPT Manual). No history or physical examination was required, but
“when performed,” the “history and/or physical examination” were to be “medically appropriate .
. . as determined by the treating professional or other qualified health care professional reporting
the service.” Id., p. 12 (emphasis added). Further, all five counts also occurred via telehealth, so
there were no “requirements regarding documentation of history and/or physician exam in the
medical record.” DX 218, p. 41.
Given this backdrop, the jury could have found that the visits were improperly coded at
level 4 only if they determined that the rendering provider did not perform moderate complexity
medical decision making. But the jury was not permitted to make its own assessment about what
“moderate medical decision making” should mean—the jury was required to judge the visits
according to the applicable rules. See 7/18/23 Tr. 191:10–22 (testimony of Quindoza) (“Q. . . .
determining the complexity of medical decision making, that’s not just something that a coder or
a provider determines based on the words . . . correct? A. Correct.”). Stated another way, in order
to find that a false statement was made in the submission of the claim, the jury needed to find that
each patient’s provider did not consider the patient to have “1 undiagnosed new problem with
uncertain prognosis”; or did not order two unique tests or review one of those tests. See DX 4, p.
16 (MDM Table). There simply was not enough evidence for the jury reasonably to make those
findings with respect to the patient encounters that constituted these counts.
19
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 22 of 48
i. Count 5: S.T., date of service 4/19/21
S.T. testified that she and members of her family received multiple tests at the Earleigh
Heights location of DEC. 7/24/23 Tr. 97:23–98:4. S.T. was herself tested on April 19, 2021 due to
a COVID outbreak at her daughters’ daycare. Id. at 99:1–5. At the time of S.T.’s visit, she had an
unknown direct exposure to her COVID-positive daughter, which was revealed by her daughter’s
positive rapid test the same day. Id. at 120:7–25. S.T. received both a rapid test and a PCR test. Id.
at 102:22–25. She testified that she saw a provider via telehealth and that the visit was brief. S.T.
remembered a discussion about why she came to DEC and whether she had symptoms. Id. at
101:11–17. Notably, S.T. testified that she had trouble remembering the specifics of any particular
encounter, given that she visited DEC multiple times. 7/24/23 Tr. 101:18–20.
According to S.T.’s medical record, the provider she saw on April 19, 2023 was named
Alyssa Suchar. GX 408, p. 7. The government did not call Ms. Suchar to testify. Consequently,
S.T.’s medical record from April 19, 2021—which Ms. Suchar completed and signed the same
day—was the only evidence of the medical decision making that occurred during the visit. The
record indicates (1) that S.T.’s presenting problem was possible COVID exposure; (2) that she
received two COVID tests, one rapid and one PCR; and (3) that the results of S.T.’s rapid test were
reviewed on the same day as her visit. GX 408, pp. 7–8. On these points, S.T.’s testimony and the
medical record are consistent. Accordingly, based on the applicable coding guidance, S.T.’s
exposure to COVID-19 meant that she had an undiagnosed problem with uncertain prognosis.
Because she had two tests ordered and one result reviewed, her visit qualified as a level 4. Of
course, the defendant has no burden to prove what code should have applied; the government was
required to prove that it was not level 4. There was simply not enough evidence from which the
jury could conclude beyond a reasonable doubt that level 4 was the wrong code for this visit.
20
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 23 of 48
ii. Count 4: J.J., date of service 3/2/21
J.J. testified that she received a COVID test at Earleigh Heights “on or about” March 2,
2021 because she had been exposed at work and because she had symptoms. 7/25/23 Tr. 3:15–17,
8:2–9:2, 16:8–13. She testified that someone swabbed her nose, see id. at 10:2–4, 14:13–15, that
she saw a provider, and that the visit was short, see id. at 6:17–21, 9:24–10:4. J.J. testified that she
could not remember how she received her COVID results. Id. at 7:1, 19:17–25. She also agreed
that, due to the passage of time, “it’s possible there were things that happened at that visit that [she
didn’t] specifically remember.” See id. at 17:16–20.
According to J.J.’s medical record from March 2, 2021, she saw a provider named Nikita
Shah. GX 405, p. 7. The government did not call Ms. Shah to testify. As a result, J.J.’s medical
record from March 2, 2021—which Ms. Shah completed and signed that same day—was the only
evidence of the medical decision making that occurred during the visit. The record indicates (1)
that J.J.’s presenting problem was COVID exposure; (2) that she received two COVID tests, one
rapid and one PCR; and (3) that the results of J.J.’s rapid test were reviewed on the same day as
her visit. GX 405, pp. 7–8. J.J.’s limited recollection of her March 2, 2021 visit was not inconsistent
on these points. Her contemporaneous triage form, completed in her writing, reflects that she had
fatigue, nasal congestion, headaches, and sweats, and she suffered from asthma. GX 405, p. 10;
see also 7/25/23 Tr. 16:25–17:5. Based on the applicable coding guidance, J.J.’s presentation (with
symptoms) meant that she had an undiagnosed new problem with uncertain prognosis, and the two
tests ordered and one reviewed established decision making of moderate complexity. There was
simply not enough evidence for the jury to conclude beyond a reasonable doubt that level 4 was
the wrong code for this visit.
21
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 24 of 48
iii. Count 3: D.M., date of service 5/10/21
D.M. testified that she received a COVID test at Earleigh Heights in May 2021. 7/20/23
Tr. 67:21–23. She testified that her nose was swabbed, that she saw a doctor on a screen, and that
the visit “wasn’t long.” Id. at 68:1–5, 69:19–21. D.M. remembered that she received two tests, but
little else. Id. at 69:11–18, 70:15–19. D.M. also initially testified that she needed a COVID test to
visit her mother-in-law, id. at 69:8–10, but later acknowledged that she completed paperwork
indicating that she had been exposed to COVID, id. at 73:25–74:7.
According to D.M.’s medical record from May 10, 2021, she saw a provider named Sunday
Laird. GX 404, p. 7. The government did not call Ms. Laird to testify. Consequently, D.M.’s
medical record from May 10, 2021—which Ms. Laird completed and signed that same day—was
the only evidence of the medical decision making that occurred during the visit. The record
indicates (1) that D.M.’s presenting problem was COVID exposure; (2) that she received two
COVID tests, one rapid and one PCR; and (3) that the results of D.M.’s rapid test were reviewed
on the same day as her visit. GX 404, pp. 7–8. D.M.’s limited recollection of her May 10, 2021
visit was not inconsistent on these points. Accordingly, based on the applicable coding guidance,
she too had an undiagnosed new problem with uncertain prognosis. At the very minimum, there
was simply not enough evidence from which the jury could conclude beyond a reasonable doubt
that level 4 was the wrong code for this visit.
iv. Count 2: W.R., date of service 4/23/21
The government did not call W.R. to testify at trial. Instead, his daughter S.T. testified as
to her memory of her father’s visit at DEC. S.T. testified that W.R. sought a COVID test because
he was exposed to S.T.’s COVID-positive daughter. 7/24/23 Tr. 107:15–24. S.T. testified that
W.R. saw a provider via telehealth at Earleigh Heights, that W.R. had a conversation with that
22
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 25 of 48
provider, and that the conversation was brief. Id. at 108:1–25. S.T. remembered little else about
her father’s visit. Id. at 109:5–7.
W.R.’s medical record indicates that he was seen by Kathleen Wrona, a physician assistant
whom the government did call to testify. See GX 407, p. 6. Ms. Wrona did not testify about the
decisions she made during W.R.’s visit specifically, see 7/25/23 Tr. 203:17–206:6; 7/26/23 Tr.
49:12–54:10, although she did testify about the types of decisions she made during COVID test-
related visits generally, see 7/26/23 Tr. 17:25–19:12, 23:12–18. Although W.R.’s medical
record—which indicated an in-person physical exam—differed from S.T.’s recollection that her
father had a telehealth visit, the existence or extent of a physical exam was irrelevant to code
selection in 2021. W.R.’s record indicates that he presented with exposure to COVID and received
two tests; on these points, the record is not inconsistent with S.T.’s testimony. Accordingly, based
on the applicable coding guidance, there was simply not enough evidence from which the jury
could conclude beyond a reasonable doubt that level 4 was the wrong code for W.R.’s visit.
In closing argument, the government pointed out that these four patients had brief
encounters (though the visits varied in duration, and the patients’ recollections were generally
limited); that some were asymptomatic; and that their physical examinations were insufficient. See
8/3/23 Tr. 24:6–11, 24:19–25:4, 27:2–7, 30:6–12. These arguments reflect the fundamental fallacy
in the government’s evidence and its prosecution theory. Both Mr. Miscoe and Mr. Quindoza
agreed that in 2021, if the level was based on medical decision making, the duration of the visit
was simply not relevant to code selection, nor was the extent of the examination—if any.
The 2021 CPT Manual makes both points abundantly clear. The level of medical decision
making was dictated by the medical decision making table. There is no question that for all four
patients, the amount of data to be reviewed and analyzed—the middle column in the chart—was
23
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 26 of 48
moderate, because two tests were ordered and one was reviewed. It is also undisputed that all four
patients were seen by a provider who performed some level of medical decision making. The only
relevant factor that remains is whether these patients—exposed to a disease that killed more than
1 million people in the United States alone and, in one case, symptomatic—had an “undiagnosed
new problem with an uncertain prognosis.” The only expert testimony on that point was Mr.
Miscoe’s, and he testified that under the governing coding rules and guidance, these patients did
in fact have an undiagnosed new problem with an uncertain prognosis. See 7/31/23 Tr. 173:23–
175:6 (“[T]he instructions were that regardless of the reason the patient was being tested, there
was a presumption that they had contact with or exposure . . . for that reason, it becomes classified
as an undiagnosed new problem. And due to the nature of COVID, it’s certainly a problem with
an uncertain prognosis.”).
The government’s arguments concerning these four counts lay bare the lawless approach
employed in this case. The government asked the jury to interpret “moderate level of medical
decision making” based on their understanding of those words—not based on the rules in the CPT
Manual. See 8/3/23 Tr. 92:18–20 (“[L]adies and gentlemen, you don’t need to be a Certified
Professional Coder to figure this out. Common sense says that the defendant’s justification cannot
be true.”). Counsel went so far as to argue that the applicable code was level 1, because it was
“symptom and exposure assessment and sample collection at mass testing sites.” 8/3/23 Tr. 90:10–
16. This contention illustrates what happens when complex binding rules are cast aside in favor of
counsel’s view of what the rules should be. In its May 8, 2020 Interim Final Rule, CMS made clear
that level 1 applied only when the patient does not interact with a provider at all, and clinical
staff—such as a medical assistant—does nothing more than use a swab to acquire a specimen for
testing. DX 219, p. 56 (“CPT code 99211 typically does not involve interaction with physician or
24
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 27 of 48
other qualified health care professional and the usual presenting problem(s) are minimal. Thus,
this CPT code typically is reported by a physician or practitioner when the patient only sees clinical
office staff for services like acquiring a routine specimen sample.”).
The evidence is undisputed that the patient encounters at DEC involved more than clinical
staff taking a swab. All of the providers who testified at trial described encounters in which they
reviewed patients’ histories; examined them visually in the case of telehealth visits and physically
if in person; determined whether to order additional or different tests than called for by the standing
order; and advised the patients concerning CDC guidelines for quarantining, symptoms that should
concern them, and whether to follow up with their primary care physicians or go to the emergency
room. See, e.g., 7/24/23 Tr. 137:10–14, 190:21–191:11; 7/26/23 Tr. 22:23–24:25; 7/31/23 Tr.
39:1–7; 8/1/23 Tr. 97:13–98:4, 100:8–101:20.
The government’s case amounted to a bait and switch. CMS urged providers to see patients
by telemedicine to reduce exposure risk and to see patients at the time they were tested. See DX
218, p. 5, 53; DX 233. CMS mandated that neither examination nor history would be factors in
level selection. DX 218, p. 41. Yet the government contended throughout the trial that the patient
visits were too brief and the examinations too limited for a level 4 visit. And the government
contended that although providers did exactly what CMS urged them to do, the providers’
encounters should be disregarded and the visits should be coded at level 1, as if nothing more
happened than a medical assistant acquiring a swab.
CMS recognized that the pandemic called for extraordinary measures, and it changed
coding rules to ensure that providers were financially incentivized to provide the care that was so
important in the midst of the pandemic. See DX 218, p. 1.16 Dr. Elfenbein responded. He is entitled
16
As the Court acknowledged:
25
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 28 of 48
to have his coding determinations judged based on the governing rules published in the CPT
Manual and modified by CMS. With the pandemic behind us, it is all too easy to rewrite the rules.
But Dr. Elfenbein did not have notice of the rules that government lawyers would later invent; his
conduct must be judged by the rules that existed at the time.
The same is true of diagnosis codes. CMS publishes the ICD-10 diagnosis codes, and it
requires both diagnosis and CPT codes on every claim. On that point the experts agreed. Mr.
Quindoza testified that every claim was required to include diagnosis as well as procedure codes,
and the diagnosis codes were important to CMS. 7/18/23 Tr. 106:25–107:14. To the government’s
chagrin, Mr. Miscoe testified that the two types of codes work hand in hand, and that CMS’s
guidance was to treat all patients tested for COVID as suspected of exposure to COVID. 7/31/23
Tr. 175:11–21; see also DX 221, pp. 6–7. The government offered no evidence that CMS did not
give the guidance to which Mr. Miscoe testified, and no witness testified that there was no such
guidance, or that it meant something else.
[I[f you’re operating in an environment where the Government has basically on an
emergency basis, because there’s a pandemic, knocked out a lot of the rules, and
even done it on a retroactive basis, it leaves the Government, it leaves you, it seems
to me, in a very precarious position. I mean, ultimately, it’s a system of laws, not
expectations of moral, honest conduct.
And it strikes me that at least on the surface that the Government made a decision
which I’m not necessarily in disagreement with. We were in a national emergency
here, huge crisis. We’ve got a highly regulated system by which we deliver health
care in the country. That, you know, we’re going to be like Gulliver here, tied down
by all of the Lilliputian rules so we can’t -- we can’t be nimble, we can’t move, we
can’t flex, we can’t react. And then somebody had the wisdom in the Government
to say, you know, the barn’s on fire, let all the horses out; otherwise, they’re all
going to die.
7/19/23 Tr. 28:5–21.
26
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 29 of 48
This testimony was devastating to the government, because if every patient tested for
COVID was diagnosed as possibly exposed to COVID, then every patient tested had an
undiagnosed problem of uncertain prognosis—unless their diagnosis was confirmed. So perhaps
it is not surprising that government counsel ridiculed Mr. Miscoe’s testimony on this point. See,
e.g., 8/3/23 Tr. 91:17–22. But whatever the government’s view, and whatever the merit of CMS’s
guidance, Mr. Miscoe was not the source of it. CMS issued the guidance and reinforced it in its
published update concerning ICD-10 codes related to COVID. In this respect as well, the
government substituted its own view for binding guidance from CMS because it found the CMS
guidance illogical, or at least unhelpful to its case. But the government was no more entitled to
rewrite the binding CMS rules than was Dr. Elfenbein—and the jury certainly was not permitted
to convict Dr. Elfenbein for following CMS guidance simply because that guidance might now
appear unreasonable.
C. The jury had no reasonable basis to find that Count 1 constituted an execution of
the alleged scheme because there was no scheme—alleged or otherwise—to bill
for visits that did not occur.
Count 1 of the indictment alleges that the submission of a level 4 claim for an E/M service
provided to A.H. on March 25, 2021 constituted an execution of the scheme. Sup. Ind. ¶ 31. Unlike
every other patient who testified at trial, A.H. testified that she did not receive a provider visit at
all. 7/19/23 Tr. 133:8–15. A.H.’s medical records, however, indicate that she had a visit with DEC
provider Sunday Laird. GX 403, p. 7. The government did not call Ms. Laird to testify and
presented the jury with no explanation as to why Ms. Laird would complete and sign a chart for
27
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 30 of 48
an office visit that did not occur. Nevertheless, assuming that A.H.’s recollection of her visit was
accurate, and she did not see Ms. Laird,17 level 4 would have been the wrong code.
The government, however, did not charge Dr. Elfenbein with a scheme to bill for visits that
did not occur. The alleged scheme related to the level, not the existence, of the visit. There was
not a shred of evidence that Dr. Elfenbein instructed providers to bill for visits that did not occur.
The only evidence on this point was that Dr. Elfenbein took steps to ensure that there was no E/M
claim if a patient was not seen by a provider. See DX 51 (instructing providers to ensure that
records were not created until after the provider had made contact with the patient, because
“[d]oing so beforehand generates too much a possibility of accidental fraudulent billing and too
much work on the back end to delete all the encounters that are filed out.”).18 If Ms. Laird
submitted a claim for a visit she did not perform, there is no evidence whatsoever that this
submission would have been anything other than a mistake—and it was certainly not consistent
with Dr. Elfenbein’s instructions.
If A.H. was seen by a provider, the only evidence concerning the visit is the medical record.
It reflects that she was 71, had diabetes, high blood pressure, and asthma, and that she reported a
sore throat. GX403, pp. 7, 19; see 7/26/23 Tr. 12:7–13:23; 7/31/23 Tr. 87:6–25. She received a
17
It is equally (if not more) likely that A.H.’s recollection of events was faulty. She was adamant
that her vitals were not taken at Earleigh Heights, despite the fact that handwritten vital signs
appear in her record. See 7/19/23 Tr. 130:9–131:18; GX 403, p. 23. A.H. was also confident in her
recollection that when she called the phone number listed on her Explanation of Benefits, she
spoke to someone at DEC and complained about the charge to Medicare. Id. at 119:12–120:21.
The only phone number for DEC listed on A.H.’s Explanation of Benefits, however, was a fax
number. Compare GX 414 with GX 401, p.1. But we assume that, taking the evidence in the light
most favorable to the government, the jury could have found that A.H. did not see a provider.
18
As discussed infra, the Court erroneously excluded an email that would have established that
Dr. Elfenbein explicitly instructed providers not to bill a provider visit when only a swab was
taken. See DX 60.
28
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 31 of 48
rapid test, for which the result was reviewed on the same day, and a PCR test. As with the other
four counts, the evidence was not sufficient for the jury to find that the code for A.H.’s visit was
incorrect except if she did not see the provider, in which case there is no evidence that her claim
constituted an execution of the alleged scheme or was consistent with Dr. Elfenbein’s instructions.
The Court should enter a judgment of acquittal on all five counts.
II. IN THE ALTERNATIVE, THE COURT SHOULD GRANT A NEW TRIAL
UNDER RULE 33.
Under Federal Rule of Criminal Procedure 33(a), the Court may order a new trial “if the
interest of justice so requires.” “The ‘ultimate test’ of whether a new trial is warranted is ‘whether
letting a guilty verdict stand would be a manifest injustice.’” United States v. Rafiekian, 68 F.4th
177, 190 (4th Cir. 2023) (quoting United States v. Ferguson, 246 F.3d 129, 134 (2d Cir. 2001)).
Allowing the jury’s verdict to stand would be a manifest injustice. At minimum, for the reasons
explained below, the Court should grant a new trial.
A. The weight of the evidence does not support a finding of guilt.
“[A] new trial based on the weight of the evidence is warranted ‘[w]hen the evidence
weighs so heavily against the verdict that it would be unjust to enter judgment.’” United States v.
Rafiekian, 68 F.4th 177, 186 (4th Cir. 2023) (quoting United States v. Arrington, 757 F.2d 1484,
1485 (4th Cir. 1985)). In determining whether to order a new trial pursuant to Rule 33, the court
“conducts its own assessment of the evidence, unconstrained by any requirement to construe the
evidence in the government’s favor.” Id.
For all the reasons discussed above, the evidence was insufficient to convict. But even if
the Court concludes otherwise when construing the evidence in the light most favorable to the
government, a new trial is nevertheless warranted under Rule 33 because the evidence
preponderates strongly against the verdict. Throughout the trial, the government urged the jury to
29
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 32 of 48
draw nefarious conclusions from evidence that was irrelevant to the determination whether CPT
codes 99204 and 99214 were appropriate—the only basis for its allegation that false statements
were made in furtherance of a scheme to defraud.
For example, arguing that Dr. Elfenbein knew that patients were only there to be tested
adds nothing to the determination of the degree of medical decision making necessary for a
particular code. This is especially true given that the only medical expert who testified, Dr. Hill,
stated that providers needed to conduct some level of examination and assessment and not just
administer a test. See 7/31/23 Tr. 74:25–75:24. And CMS reinstated its requirement of an order
for every test after a patient’s first one in order to ensure that patients saw providers when tested,
E/M visits for which the providers were entitled to be paid even if they did nothing more than
counsel patients. See DX 220, pp. 19–20.
Also, with respect to the level of decision-making that occurred, the government suggested
repeatedly throughout the trial, and argued to the jury in closing argument, that little to no work or
medical decision making was performed during the office visits occurring at DEC. 8/3/23 Tr. 20:8–
13. These assertions ran contrary the testimony of every DEC provider who testified at trial,
including the two providers called by the government. See, e.g., 7/24/23 Tr. 138:11 (Deb Needle:
“we were trying to see patients and save lives.”).
Additionally, in closing argument, the government improperly urged the jury to disregard
the complexities of the CPT coding guidance and instead rely on their “common sense” judgment
about what “moderate complexity” should mean. See 8/3/23 Tr. 18–23. At the same time, the
government essentially admitted that the correct code for COVID-related visits was unknowable:
So you may be asking yourself, what question [sic] should have been
billed in this cases, and the good news for you is you don’t have to
figure that out. You don't have to decide if it’s a 3 or a 2 or a 1. The
30
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 33 of 48
only thing you have to decide is . . . that these visits, including our
five count beneficiaries, were not a level 4.
8/3/23 Tr. 28:6–9. It is inconceivable that a jury could be asked to decide that a false statement
was made in furtherance of a scheme to defraud based on the level of E/M services in a claim for
reimbursement when asked to simply intuit what would be correct, untethered from the controlling
rules.
Perhaps the most common arguments made by the government throughout the trial were
that the number of patients tested and seen by providers was too many for a meaningful E/M visit,
and that the five minute duration of the average visit was too short for a level 4 visit. See, e.g.,
7/18/23 Tr. 20:20–21:8, 22:15, 23:12, 26:8–12; 7/20/23 Tr. 69:19–23; 7/24/23 Tr. 101:21–25,
103:19–21, 108:17–25. The government may believe that the duration of visits should be relevant
to the level of medical decision making, or that a level 4 visit should be longer than five minutes.
But the rules established by the CPT Editorial Panel have no minimum—and in 2021 (and 2020
for telehealth visits), not even a typical duration. The government—and the jury—simply are not
free to disregard the coding rules in this respect any more than in any other respect. Of course, if
no encounter occurred at all, there was no basis to bill an E/M visit (other than a level 1 visit if the
clinical staff took a swab). But the indictment did not allege that there was no E/M visit, the
providers did not testify that they billed visits that did not occur, and Dr. Elfenbein instructed
providers to ensure that they did not even inadvertently bill visits that did not occur.19
19
The government emphasized that on the busiest days during the worst surges, providers saw
more than 150 patients in a day. According to the providers and the medical assistant in charge of
Earleigh Heights, providers worked 12-hour shifts that could stretch to 14 hours. See 7/31/23 Tr.
16:13–20, 53:2–9, 53:21–25. Dr. Hill testified that he has treated patients in 20 seconds, but agreed
that he wouldn’t want to. 7/31/23 Tr. 114:25–115:4. He testified that he could not do an entire
physical exam and history in one minute, id. 115:5–6, but the E/M level was not based on and did
not require a history or physical, except for in-person visits in 2020.
31
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 34 of 48
The irony in this case is that the government, which ordinarily seeks strict enforcement of
rules, wants nothing to do with them here. The government never attempted to apply the CPT rules
and CMS binding rules and guidance concerning their application during the pandemic. Indeed, at
the outset of the case, the government believed that time was a factor in code selection in 2020 and
2021; that the rules for telemedicine code selection were never changed during the pandemic; that
the examination was a factor in code selection for telemedicine, even in 2021; and that selecting
the applicable code was as simple as construing words like “moderate” and straightforward.” By
the end of the trial, each of these misunderstandings of the rules had been conclusively refuted—
but the government continued to argue that the jury should disregard the rules and decide the case
based on their own assessment of “moderate complexity.” Dr. Elfenbein was convicted of health
care fraud based on standards devised by government lawyers in 2023, without regard to the rules
in place during 2020 through 2022. Even if the Court believes that the evidence was sufficient to
permit the jury to find Dr. Elfenbein guilty, it would be “unjust to enter judgment” based on a
government theory of prosecution that was untethered from the controlling code selection rules.
At a minimum, the Court should grant Dr. Elfenbein a new trial.
B. The Court’s exclusion of key non-hearsay evidence offered by the defense and
admission of highly prejudicial hearsay testimony offered by the government
warrants a new trial.
i. The Court improperly excluded contemporaneous evidence of Dr.
Elfenbein’s state of mind that went to the heart of his defense.
At trial, the defense offered a number of emails as contemporaneous evidence of Dr.
Elfenbein’s state of mind. “[E]mail [is] a medium of communication that seems particularly prone
to candid, perhaps too-candid, statements of the declarant’s state of mind, feelings, emotions, and
motives.” Lorraine v. Markel Am. Ins. Co., 241 F.R.D. 534, 570 (D. Md. 2007) (Grimm, M. J.).
Accordingly, even where emails contain hearsay statements, a hearsay exception may permit their
32
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 35 of 48
admission. One exception to the hearsay rule in Federal Rule of Evidence 803(3) “permits the
statement of the declarant’s state of mind, sensation, mental, emotional, or physical condition, as
well as statements of motive, intent, plan or design,” and may be “used to prove a wide variety of
matters,” including “motive [and] lack of intent to defraud.” Id. Moreover, statements in emails
not offered for their truth, but instead as evidence of the declarant’s state of mind, are not hearsay
in the first instance. See United States v. Martin, 657 F. App’x 193, 199–200 (4th Cir. 2016) (citing
cases). The emails offered by the defense were admissible for both reasons.
The government relied heavily on Dr. Elfenbein’s emails during its case-in-chief. In
opening statement, the government asserted repeatedly that “the defendant’s own words” would
establish that he “lie[d] for money” and was “[m]otivated by greed.” See 7/18/23 Tr. 20:8–10; id.
at 21:14–15; id. at 22:13–14. The government explicitly contended that Dr. Elfenbein’s emails
were evidence of his state of mind: “you’ll see e-mails in the defendant’s own words. Pay close
attention to these e-mails. The e-mails will show that Defendant Elfenbein . . . knew that these so-
called visits were simple and straightforward . . . because that is what he wrote.” Id. at 26:8–16
(emphasis added). Consistent with this position, the government introduced numerous emails from
Dr. Elfenbein throughout its case to show his state of mind. During the defense case, however, the
government objected on hearsay and relevance grounds to admission of Dr. Elfenbein’s emails,
even when they were evidence of his state of mind.
The Court excluded three emails the defense sought to introduce: DX 77, DX 60, and DX
66. All three were erroneously excluded.
DX 77:
The defense offered a December 18, 2021 email from Dr. Elfenbein to providers thanking
them “for all [their] hard work under extraordinary and incredibly difficult circumstances.” Dr.
33
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 36 of 48
Elfenbein wrote, “I know volumes are overwhelming, but please understand the WHY. The why
is all those people we are helping. . . . I COULD NOT BE PROUDER...” DX 77 (emphasis in
original). He further explained, “An individual we helped. An individual who is scared, has no
place else to go and might be ill. WE helped that person. Be it thru a test (which in and of itself
can help in so many ways), thru a lifesaving infusion, thru a ‘regular urgent care visit,’ a
vaccination, or anything else we do, WE were the solution to their problem. We allowed them to
travel, visit grandparents, volunteer, spend the holidays with family, reduced their risk of
dying/hospitalization, go back to work, go back to school, play sports, put on a play, etc....”
The defense did not offer DX 77 for the truth of any matters asserted therein. 8/1/23 Tr.
163:13–18. The point was not that the testing and related services provided at DEC had in fact
reduced the risk of dying or hospitalization; it was that Dr. Elfenbein’s motive was to help patients,
not to make money. The email was introduced to rebut the government’s contention that Dr.
Elfenbein was “[m]otivated by greed.” See 7/18/23 Tr. 20:8–10. The exclusion of an email that is
direct evidence of motive contrasts with the admission of the government’s summary exhibit that
showed the jury Dr. Elfenbein’s income from his tax returns, which the court found “minimally
probative of his motive and intent.” ECF No. 44, p. 2.; DX 77. See United States v. Safavian, 435
F. Supp. 2d 36, 45 (D.D.C. 2006) (ruling admissible emails that “might help to explain [the
defendant’s] motive and intent at the time he undertook certain actions”).
Nor was the Court’s proposed alternative to the admission of DX 77 sufficient. In excluding
DX 77, the Court stated:
Seems to me the proper way to examine this witness is to simply ask
him questions about what efforts he was making -- . . . That he was
working hard to keep his head above water and that circumstances
were demanding, taxing, at times overwhelming, and all of that
necessitated frequent coaching and encouragement and
cheerleading with the staff to keep the enterprise afloat and to keep
34
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 37 of 48
the medical service and care flowing to the community. All of that
can be explained by the witness who is right here, live, and in
person.
8/1/23 Tr. 163:19–164:7. Dr. Elfenbein’s testimony at trial does not negate the relevance and
admissibility of an email that would have served as crucial corroboration of Dr. Elfenbein’s
testimony about his state of mind at the time. See United States v. Ibisevic, 675 F.3d 342, 351 (4th
Cir. 2012) (finding reversible error where “the excluded testimony was the only evidence that
would have corroborated the defendant’s own testimony of assertedly innocent conduct”); Martin,
657 F. App’x at 201 (reversing conviction where testimony of the defendant was “not an adequate
substitute for the evidence that would have been heard by the jury had the [out-of-court statements
offered for a non-hearsay purpose] not been improperly excluded”).
The importance of such evidence is reinforced by the Court’s instruction to the jury that
state of mind may be inferred “from what one says or does: one’s words, one’s actions, and one’s
conduct, as of the time of the occurrence of certain events. The intent with which an act is done is
often more clearly and conclusively shown by the act itself or by a series of acts, than by words or
explanations of the act uttered long after its occurrence.” 8/3/23 Tr. 123:24–124:5. Admitting
contemporaneous emails that the government contended showed greed, but excluding other
contemporaneous emails offered by the defense that showed that Dr. Elfenbein’s motive was to
help people, left him in the impossible position of testifying to his motive without the ability to
offer his contemporaneous statements of his motive, which the Court instructed the jury were much
more important. Accordingly, exclusion of DX 77 was error.
35
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 38 of 48
DX 60:
The defense offered a February 11, 2021 email exchange between Dr. Elfenbein and
several employees.20 In Dr. Elfenbein’s first message in the thread, he asked questions and
provided instructions:
I see on Sweeny no results in chart…Laquelle, why no results?
Can we get the results loaded in like theyre supposed to be?”
If you look at Davis...It clearly states “Pt here for re-swab of
PCR only.”
It should be a nurse visit. Rhonda, can you fix that?
Laquelle responded that Mrs. Sweeney “ended up leaving the [testing] line for unknown reasons.
Only her evist appointment was canceled not her encounter, I apologize. It is canceled now.”
Regarding Mrs. Davis, Laquelle responded that “On the 28th she came back to get re-swabbed for
her PCR test only.”
In Dr. Elfenbein’s second message, he repeated and expanded on his earlier instructions:
“Andre, delete that encounter please. Please keep a log of who
you see to avoid things like this. Had you accidentally billed that
chart it would be fraudulent billing. Please know who you see-
maintain a list of chart in real time.”
“Laquelle, please be sure they are deleting people who leave.”
“Yes…Davis..like I said should be a nursing visit. Can you fix
that Rhonda? It SHOULD NOT be billed……. as of now there
is a[n] EM code of 99204… THAT CANNOT be billed like
that.”
20
The government objected only to emails from Dr. Elfenbein in this exchange, not emails to him.
See 8/2/23 Tr. 28:25–29:4) (“MR. PHELPS: And Your Honor, if it's any assistance, we'll limit
objections to hearsay statements by Dr. Elfenbein himself. THE COURT: Okay. Great. So I can
skip over the rest. The rest are all admissible.”)
36
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 39 of 48
The government objected to this email on the grounds that it was “irrelevant character
evidence.” 8/2/23 Tr. 34:6–8. The Court agreed, and prohibited the defense from responding in
full:
THE COURT: I get it. Mr. Bernstein, it does look like another
example of the defendant taking the opportunity to pull up exhibits
that show, “Look, generally, I complied with the law. It’s not exactly
in that COVID E/M coding context, but I give instructions to people
and I tell them, follow the law, don’t break the law.” Why isn’t this
just like the one we had before?
MR. BERNSTEIN: Well, only to the extent that he’s referencing the
99204 code, which –
THE COURT: No. Excluded. All right. Now, 65.
Id. at 34:16–25.
The Court’s ruling that DX 60 was irrelevant was plainly error. The government’s central
allegation against Dr. Elfenbein was that he instructed his providers to bill encounters related to
COVID-19 testing at CPT levels he knew were unsupported. DX 60 is evidence that directly
undercuts that theory. The email demonstrates that when Dr. Elfenbein became aware of a COVID-
19 encounter for a patient who came to DEC to be re-swabbed for a PCR test, which was
improperly coded at 99204, he instructed his staff to change it—and to take steps to avoid such
errors in the future. The email directly rebuts the government’s arguments that every time a patient
was tested, Dr. Elfenbein instructed providers and staff to code the visit at level 4.
Moreover, the email rebuts the government’s argument that Dr. Elfenbein knew that all or
most visits should be coded at level 1, because services were “provided by clinical staff to assess
symptoms and take specimens for COVID-19 laboratory testing for all patients.” DX 219, p. 56
(May 8, 2020 CMS Interim Final Rule). In this case, the patient had already been swabbed for a
PCR test, and apparently because of a problem with the swab, needed to come back to be re-
37
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 40 of 48
swabbed again for a PCR test. Had Dr. Elfenbein not instructed his staff to change the code, it
would have been a level 4 office visit on the same day as a test, and therefore part of the alleged
scheme. But Dr. Elfenbein recognized that it should not be coded as an E/M visit at all, but only a
nurse visit. Especially given that the code discussed in the email was 99204, DX 60 was clearly
relevant.
Similarly, the other problem addressed in the email is a chart in which there were no test
results. When Dr. Elfenbein asked questions, he learned that the patient had left the testing line,
but her encounter had not been deleted. Although the code is not specified, had Dr. Elfenbein not
intervened, it would have been erroneously billed as an encounter with a test—presumably a level
4 visit—and would have been part of the alleged scheme. Dr. Elfenbein instructed the provider to
delete the encounter, and to take steps to ensure that the error was not repeated by maintaining a
log of patients seen so that only their encounters were billed.
The central theme of the government’s case was that Dr. Elfenbein’s goal was to bill as
many as possible level 4 codes for office visits associated with tests. In the government’s closing
argument, counsel argued, “He wants to churn through the patients. That’s what he wanted.”
8/3/2023 Tr. 33:8–9. The government contended that Dr. Elfenbein did not reduce to level 3 visits
where only a rapid test was conducted, which was evidence of intent to defraud. Id. at 33:10–34:2.
Government counsel argued that whenever a patient showed up for a test, Dr. Elfenbein wanted to
bill a level 4 visit. But DX60 shows that when a patient was re-swabbed for a PCR test and
therefore did not need to see a provider, he was emphatic that no E/M code be billed. And when a
patient left the line and was not tested, he was emphatic that no claim should be billed. Instructing
staff and providers not to bill E/M codes that, if billed, would be part of the alleged scheme is clear
evidence of lack of intent to defraud. The Court was mistaken in reading the email as “not exactly
38
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 41 of 48
in that COVID E/M coding context, but I give instructions to people and I tell them, follow the
law, don’t break the law.” 8/2/23 Tr. 34:6–8 (emphasis added). DX 60 was precisely in the COVID
E/M coding context.
Moreover, DX 60 contained no hearsay statements, only questions and instructions.
“[S]tatements that are questions or imperative commands” are not hearsay “because they are not
offered to prove the truth of the assertions.” Lorraine v. Markel Am. Ins. Co., 241 F.R.D. 534,
566–66 (D. Md. 2007). To the extent Dr. Elfenbein’s questions and instructions were followed or
preceded by statements that could otherwise be classified as hearsay, they were nonetheless
admissible to establish context. Cf. United States v. Leake, 642 F.2d 715, 720 n.6 (4th Cir. 1981)
(“Leake’s testimony regarding his conversation with Graham would be meaningless unless both
sides of the conversation were recounted to the jury. Graham’s statements to Leake were
admissible, therefore, as necessary to explain the context in which Leake made the statements
revealing his state of mind.”). Even if DX 60 contained hearsay statements (it does not), it would
still be admissible under Rule 803(3). Lorraine, 241 F.R.D. at 570 (statements demonstrating a
“lack of intent to defraud” may be admissible as state-of-mind evidence).
DX 66:
Finally, the defense offered a March 13, 2021 email from Dr. Elfenbein to Jimmy Brothers.
Like DX 60, it was largely an instructional email:
“Saw you made some changes to the billing and such in the
template. PLEASE DO NOT do that without speaking to me
first.”
“Cannot bill E&M level 5 AND critical care and this doesn’t
meet critical care designation. We also cannot bill for IV
hydration as we are not hydrating, we are infusing.”
“Please fix the coding on his chart to reflect above- remove
billing or the medicine/remove critical care and remove the IV
39
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 42 of 48
hydration. Then resubmit and let Kim Turner know NOT to bill
the first stuff you sent on him.”
The Court excluded DX 66 because of its “character quality.” 8/2/23 Tr. 37:15–16. As
explained above, however, Dr. Elfenbein’s instructions on proper coding levels, and his reactions
to the assignment of codes that do not reflect visits actually performed, are clearly relevant as to
his then state of mind and intent. Moreover, instructions are not hearsay, and even if DX 66 did
contain hearsay, it should have been admissible under Rule 803(3). Nor is it sufficient for the
government to argue that coding of infusions of monoclonal antibodies was not at issue. First, the
instruction rebutted the government’s contention that providers were instructed not to change
codes in templates to ensure that codes were not reduced to lower levels. It reflects that Dr.
Elfenbein’s concern about changing codes was not loss of revenue, but the use of codes
incorrectly—in this case, the use of a level 5 code only if it was supported. Second, the use of level
5 codes was part of the alleged scheme, and evidence that Dr. Elfenbein tried to ensure that those
codes were used correctly in COVID-19 care was central to the defense. This was not mere
evidence that Dr. Elfenbein complied with the law in other respects; it was evidence that he tried
to use the E/M codes at issue correctly.
The Court’s narrow view of permissible evidence of good faith and lack of motive and
fraudulent intent kept from the jury essential evidence of Dr. Elfenbein’s attempts to use E/M level
4 and 5 codes only when he believed they were supported, and that he was motivated by his desire
to provide essential treatment to patients. The case turned on two issues: Dr. Elfenbein’s intent,
and the codes billed for E/M visits. Given the absence of any evidence that the concerns of the
handful of employees who claimed to have been uncomfortable with level 4 E/M codes were
justified, and the codes were incorrect, the jury may well have been persuaded by the picture
painted by the government of Dr. Elfenbein as motivated only by money. The emails showing that
40
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 43 of 48
he stopped unjustifiable billing of level 4 and 5 E/M codes, including codes related to COVID
testing, and that his motive was to help patients, were essential to rebut the government’s
allegations. Their exclusion was error.
ii. The Court erroneously allowed A.H. to testify to the hearsay statement of
an unknown individual who purportedly said, “this is how we bill.”
During the testimony of A.H., the government elicited testimony regarding a conversation
she purportedly had with an employee of DEC. Specifically, A.H. testified that after she received
her Medicare Explanation of Benefits (“EOB”), she called the number listed for Drs ERgent Care
on the EOB to complain about the charge to Medicare for a service she claims she didn’t receive.
7/19/23 Tr. 115:14–22. Over defense objection, the Court permitted A.H. to testify that the person
she spoke with on the phone told her, “this is how we bill,” when A.H. told them she did not see a
provider. Id. at 119:11–120:21.
Where a party seeks to introduce a hearsay statement pursuant to the “agency” exception
contained in Federal Rule of Evidence 801(d)(2)(D), the “proponent of the evidence has the burden
to demonstrate that an individual qualifies as an ‘agent.’” Contracts Materials Processing, Inc. v.
Kataleuna GmbH Catalysts, 164 F. Supp. 2d 520, 530 (D. Md. 2001); see Rhodes v. Wells Fargo
Bank, N.A., Civil Action No. 3:10-cv-02347-L, 2013 WL 2090307 at *6 (N.D. Tex. May 14, 2013)
(finding that plaintiffs did not meet their burden of showing that “unidentified persons or persons
referred to only by first name in Rhodes's affidavit were agents or employees of Wells Fargo or
that the statements were made by agents or employees of Wells Fargo in the scope of their
employment or agency”).
Here the government did not meet its burden of showing that the unknown person on the
other end of the phone was an agent of Dr. Elfenbein. A.H. testified that the person who answered
gave a first name that A.H. did not remember, did not identify his or her position or mention the
41
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 44 of 48
name of the company, and did not confirm that A.H. was one of their patients. See 7/19/23 Tr.
119:14–120:13. She testified that the only reason she thought she was talking to somebody about
the bill she was disputing was because the phone number she called was on the Medicare
explanation of benefits. Id. at 120:10–13.
The Court should not have allowed A.H.’s testimony regarding the alleged phone call. The
supposed “admission” from the person on the other end—that, as a matter of course, DEC bills for
visits that did not happen—was both inflammatory and unsupported by the evidence. Before
finding that the government had met its burden to demonstrate that the person A.H. testified she
spoke to was an agent of Dr. Elfenbein, the Court should have required something more than
A.H.’s vague testimony. The only basis for her belief that she was talking to someone at DEC was
that the number she called was on the explanation of benefits—but the explanation of benefits also
listed a post office box in Belfast, Maine. GX 414, p. 3. Moreover, the phone call may not have
happened at all. The only phone number for Drs ERgent Care listed on A.H.’s EOB was a fax
number. Compare GX 414 with GX 401, p.1.
The Court permitted her testimony based on its finding that the business, “for purposes of
this proceeding and based on the evidence presented so far is effectively an alter ego of the
defendant.” 7/19/23 Tr. 122:9–15. But A.H. was the second witness at trial; only Mr. Quindoza
testified before her. There was no basis to find that Dr. Elfenbein and Drs ERgent Care were alter
egos. Moreover, subsequent testimony established that by the time Ms. Raymond left in October
2020—well before A.H.’s visit—the central billing office at Centennial Medical Group, headed
by Erin Sharp who did not report to Dr. Elfenbein was responsible for billing. 7/24/23 Tr. 58:11–
59:4. There was no reason to believe that calls concerning billing—assuming that A.H. reached a
42
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 45 of 48
person rather than a fax line—were handled by anyone at DEC rather than someone at the central
billing office.
The prejudice from this testimony was especially substantial because it had no relevance—
the scheme alleged in the indictment did not include billing for encounters that did not occur. It
also ascribed to Dr. Elfenbein an intent to bill for encounters that did not occur based on a
conversation with an unidentified person who may not even have worked for DEC. The admission
of this highly prejudicial testimony exacerbated the harm caused by the exclusion of three key
emails that negated the government’s evidence of Dr. Elfenbein’s intent and motive. A.H.’s
testimony should have been excluded, and the Court’s failure to do so, taken together with its
exclusion of three critical emails that were contemporaneous evidence of Dr. Elfenbein’s state of
mind, warrants a new trial.
C. The Court should not have closed voir dire to the public.
Criminal defendants have a Sixth Amendment right to a public trial. Presley v. Georgia,
558 U.S. 209, 212 (2010). “[A] violation of the right to a public trial is a structural error,” Weaver
v. Massachusetts, 582 U.S. 286, 296 (2017), and such errors may “require reversal because they
cause fundamental unfairness,” id. at 301. The Court closed the trial to the public during jury
selection. Because the infringement of Dr. Elfenbein’s right to a public trial “affect[ed] the
framework within which the trial proceeds,” id. at 925 (quoting Arizona v. Fulminante, 499 U.S.
279, 306, 309 (1991)), he is entitled to a new trial.
At the beginning of the individual questioning of jurors, the Court ordered members of the
public who were not direct participants in the trial to leave the courtroom. 7/17/23 Tr. 31:16–23.
Defense counsel stated that Dr. Elfenbein’s wife wished to stay in the courtroom. Id. at 32:9–10.
The Court responded as follows:
43
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 46 of 48
MR. BERNSTEIN: Dr. Elfenbein advises that his wife really wants
to be here.
THE COURT: All right. Well, if she's going to be here, then we
have to permit anybody to be here. So then by agreement of counsel
with the approval of the Court, because the Government says they
don't object. We have got one problem, though. We've instructed the
jurors, we've instructed the jurors that the normal practice would be
followed. I'm not sure how I'm going to undo that.
MR. BERNSTEIN: Your Honor --
THE COURT: I'm going to stick with the practice. So any -- no one
can be in the courtroom during the individual voir dire unless they
are a direct participant in the trial, so let's identify the persons who
wish to remain in the courtroom or who are not departing. I see
people picking up their things and departing so it looks like we are
not going to be identifying anybody.
Id. at 32:11–25. After the Court stated that it would follow this practice, government and defense
counsel agreed that it was acceptable. Id. at 33:5–9.
While “there are exceptions to th[e] general rule” that voir dire must be open to the public,
Presley, 558 U.S. at 213, exceptions are “rare,” and “trial courts are required to consider
alternatives to closure even when they are not offered by the parties.” Id. at 213–14. Because the
Court did not consider alternatives before closing the courtroom and simply chose to follow “its
normal practice,” Dr. Elfenbein is entitled to a new trial. The acquiescence by defense counsel,
after the Court had stated how it would proceed, does not cure this structural error.
CONCLUSION
For the reasons explained above, the Court should grant judgment of acquittal on all counts
or, at a minimum, grant a new trial.
44
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 47 of 48
August 18, 2023 Respectfully submitted,
Baltimore, MD
/s/ Gregg L. Bernstein
Gregg L. Bernstein (Bar No. 01340)
Martin S. Himeles, Jr. (Bar No. 03430)
Samantha A. Miller (Bar No. 21374)
ZUCKERMAN SPAEDER LLP
100 East Pratt Street - Suite 2440
Baltimore, MD 21202-1031
Tel. No: (410) 332-0444
Fax No: (410) 659-0436
gbernstein@zuckerman.com
mhimeles@zuckerman.com
samiller@zuckerman.com
Counsel for Defendant Ron Elfenbein
45
Case 1:22-cr-00146-JKB Document 78 Filed 08/18/23 Page 48 of 48
CERTIFICATE OF SERVICE
I certify that on this 18th day of August 2023, a copy of the foregoing Defendant Ron
Elfenbein’s Motion for Judgment of Acquittal or, in the Alternative, for a New Trial, was served
via CM-ECF to:
Matthew Phelps
Assistant United States Attorney
Office of the U.S. Attorney
36 S. Charles Street – 4th Floor
Baltimore, MD 21201
Matthew.Phelps@usdoj.gov
D. Keith Closer, Trial Attorney
U.S. Department of Justice
1400 New York Avenue, N.W. – 8th Floor
Washington, D.C. 20005
keith.clouser@usdoj.gov
/s/ Gregg L. Bernstein
Gregg L. Bernstein
46
File and source
- File
- 78.pdf
- Size
- 272,219 bytes
- SHA-256
- 1e8871ea6d99d53f0e42b3c70b55c8f0002d99f9505e4d50ffd50f356c4991ec
- Our copy
- 78.pdf
- Original
- archive.org