United States v. Angela Dee Isley , 369 F. App'x 80 ( 2010 )


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  •                                                                   [DO NOT PUBLISH]
    IN THE UNITED STATES COURT OF APPEALS
    FOR THE ELEVENTH CIRCUIT          FILED
    ______________________ U.S. COURT OF APPEALS
    ELEVENTH CIRCUIT
    No. 08-14534                        MARCH 10, 2010
    ______________________                     JOHN LEY
    CLERK
    D. C. Docket No. 05-00621-CR-01-CAP-1
    UNITED STATES OF AMERICA,
    Plaintiff-Appellee,
    versus
    ANGELA DEE ISLEY,
    Defendant-Appellant.
    ____________________
    Appeal from the United States District Court
    for the Northern District of Georgia
    ____________________
    (March 10, 2010)
    Before DUBINA and TJOFLAT, Circuit Judges, and BOWEN,* District Judge.
    PER CURIAM:
    A jury convicted Angela Dee Isley on fourteen counts relating to a scheme
    *
    Honorable Dudley H. Bowen, Jr., United States District Judge for the Southern District
    of Georgia, sitting by designation.
    to defraud the Medicare program, in violation of 
    18 U.S.C. § 1347
    ; thirty-five
    counts of honest services mail fraud, in violation of 
    18 U.S.C. §§ 1341
     and 1346;
    and three counts of money laundering, in violation of 
    18 U.S.C. § 1957
    . Isley
    appeals her convictions. For the reasons set forth below, we affirm the judgment
    of the district court.
    I. BACKGROUND
    A.       Facts and Pre-Trial Proceedings
    Angela Denise Isley was hired by Orthoscript, Inc., a durable medical
    equipment (“DME”) supply company1 located in Alpharetta, Georgia, to manage
    its billing operations, which included the supervision and instruction of other
    employees who prepared and submitted claims for payment to insurance
    companies and Medicare.2 Under the Medicare program, Orthoscript submitted its
    claims for reimbursement to a Medicare contractor known as a DME Regional
    Carrier (“DMERC”). In the southeast region (Region C),3 the DMERC was
    Palmetto Government Benefits Administrators (“Palmetto”), which processed and
    1
    Specifically, Orthoscript sold orthopedic supplies such as arm slings, wrist splints, and
    walking boots to patients through their physicians in the southeast region of the United States.
    Once a physician prescribed and dispensed the supplies, Orthoscript filed claims for payment to
    insurance companies and Medicare.
    2
    Isley was also a shareholder in the company.
    3
    There are three other regions in the United States.
    2
    adjudicated Medicare claims from Orthoscript and other DME suppliers in the
    region.
    The Medicare program used a coding system called the Healthcare Common
    Procedure Coding System (“HCPCS”), under which the DME items were assigned
    product codes. When Orthoscript submitted a claim form to request Medicare
    payment, it was required to accurately identify the actual products dispensed to the
    patient by using the proper product code. To help the suppliers, Palmetto
    published a Supplier Manual and other advisories, setting forth Medicare’s rules
    for submitting claims, and it employed nurse educators to answer coding questions.
    Additionally, another Medicare contractor, the Statistical Analysis DME Regional
    Carrier (“SADMERC”), operated a coding help line and website to assist suppliers
    to correctly code their products on Medicare claim forms.
    Isley was first indicted on December 29, 2005, along with the owner and
    CEO of Orthoscript, James Arch Nelson, on thirty-one counts of Medicare fraud;
    specifically, they were charged with knowingly and willfully assigning incorrect
    product codes to certain orthopedic supplies in order to generate higher payments
    from Medicare than were authorized.4 In other words, the Government charged
    that Isley and Nelson exectued a scheme to file Medicare claims and receive
    4
    Isley and Nelson were also indicted on six counts of fraud against the Federal
    Employee Health Benefit Program, a federally funded health care benefit program for federal
    employees.
    3
    payment for DME products that were not equivalent to the products actually
    supplied to the patients. This alleged scheme to defraud Medicare took place from
    January 1, 1999 to November 30, 2003.
    On February 9, 2006, Isley filed a Brady motion 5 requesting that the
    Government produce, for the relevant time period, all medical necessity reviews of
    claims submitted to Palmetto by Orthoscript and other Region C DME suppliers
    for the DME product codes at issue in the indictment. Palmetto, as the DMERC,
    would at times subject a benefits claim to a medical necessity review, asking the
    DME supplier for detailed information about its claim, including the
    manufacturer’s picture and description of the item, the manufacturer’s invoice, and
    the physician’s medical necessity letter and treatment notes. After this review, the
    DMERC would approve or deny payment. The DMERC’s approval of a claim
    after a medical necessity review is called an “MNA” (for Medical Necessity
    Approval).6 According to Isley, the MNAs for the product codes at issue in the
    indictment would show that the DMERC’s use of the codes was ambiguous,
    confusing, and misleading. This, in turn, would show Isley’s use of the codes to be
    5
    Brady v. Maryland, 
    373 U.S. 83
    , 
    83 S. Ct. 1194
    , 
    10 L.Ed.2d 215
     (1963), “places an
    affirmative duty upon the [government] to reveal any ‘material’ evidence in its possession that
    would tend to exculpate a defendant.” Breedlove v. Moore, 
    279 F.3d 952
    , 961 (11th Cir. 2002).
    6
    The majority of benefits claims were processed by the DMERC automatically, that is,
    without a medical necessity review. If a benefits claim was denied, a DME supplier could
    appeal. The review of claims on appeal, however, was not as detailed as a medical necessity
    review.
    4
    reasonable and indeed expressly sanctioned by the DMERC. According to Isley,
    the MNAs were necessary to show that she lacked the requisite mens rea to
    commit fraud and that she was entitled to the defense of entrapment-by-estoppel.
    The magistrate judge orally granted this motion for production of Brady
    material at a hearing in February 2006. This ruling was later reversed in part by
    written order upon the magistrate judge’s conclusion that MNA information
    pertaining to other DME suppliers was not exculpatory and therefore need not be
    produced to Isley. Isley appealed, and after oral argument, the district court
    affirmed this ruling by Order dated September 1, 2006.
    After the issuance of this ruling, Isley filed a Freedom of Information Act
    request to Palmetto, seeking its MNAs of all DME suppliers for all product codes
    in the indictment. Isley sent this same request to the DMERCs in the three other
    regions as well. When months passed without response, Isley filed an ex parte
    motion for the issuance of subpoenas duces tecum, through which she requested
    subpoenas issued to the four DMERCs for the production of MNA information as
    it related to the claims of all DME suppliers from January 1, 1999 to November 30,
    2003 for the product codes at issue in the indictment.
    While this motion was pending, the Government filed a superseding
    indictment on February 20, 2007. Nelson was not named in the superseding
    indictment; he had pled guilty on a lesser charge and agreed to testify against Isley.
    5
    The superseding indictment charged Isley with 14 counts of health care fraud
    against Medicare and did not contain some of the product codes at issue in the
    original indictment.7 These charges involved a time period from January 2001 to
    December 2003. The superseding indictment added 36 counts of honest services
    mail fraud,8 in which Isley was charged with using her position of control over the
    finances of Orthoscript to misappropriate Orthoscript funds. Specifically, Isley
    wrote checks drawn upon Orthoscript’s bank account to pay her personal expenses
    charged on her personal credit card.9 Finally, the superseding indictment added
    three counts of money laundering related to the funds she criminally derived from
    the healthcare fraud.
    With respect to Isley’s motion for the issuance of subpoenas duces tecum,
    the Government argued that Isley had not shown that she had personal knowledge
    during the relevant time period of how other DME suppliers were billing their
    products or that she reasonably relied upon the other companies’ MNAs. Further,
    Isley had not presented any evidence that she herself was confused about the
    7
    The superseding indictment did not contain charges of fraud against the Federal
    Employee Health Benefit Program either.
    8
    The Government dismissed Count Twenty during the trial.
    9
    The Government had previously announced its intention to present these same
    allegations as inextricably intertwined, or alternatively, as Rule 404(b) evidence. According to
    the Government, the evidence of her misappropriation established a motive for Isley to increase
    the payments made to Orthoscript from Medicare.
    6
    coding standards.10 Despite these protestations and an earlier ruling that such
    information was not exculpatory, the district court allowed the issuance of the
    subpoenas on March 6, 2007. The return date for the production of documents
    responsive to the subpoenas was April 30, 2007. On that date, the Government
    filed motions to quash the subpoenas. The matter came before the district court for
    oral argument on June 25, 2007.
    At oral argument, Isley argued that MNA information from all four regions
    was necessary because she relied upon the approvals to inform her decisions with
    respect to coding and because the evidence could be used to impeach government
    witnesses who testify that the coding she used was clearly wrong. The United
    States Attorney’s Office and the non-party governmental DMERC agencies argued
    that the evidence was irrelevant and non-exculpatory. The district court heard
    about certain confusion among the various agencies respecting where and in what
    form the records were housed, as well as how difficult and expensive the
    production of documents would be. In the end, the district court agreed with Isley
    that the evidence may be Brady material and placed the burden of producing the
    information upon the government.11 Consequently, the district court directed the
    10
    The Government made these same arguments in moving in limine to exclude evidence
    of other DME suppliers’ Medicare billing practices and experiences with Medicare claims
    reviews.
    11
    The district court stated:
    7
    Government to produce the MNA information of all providers for the relevant
    codes only from Region C as a “sample” to determine whether the evidence was
    exculpatory. Following this production, the court ruled that while the evidence
    may be “relevant to some of the defendant’s possible defenses,” the burden and
    cost of requiring the Government to produce the other regions’ MNAs outweighed
    Isley’s need for such cumulative information.
    B.      Trial of the Case
    The ten-day trial of the case began with jury selection on April 14, 2008.
    The Government explained Isley’s Medicare fraud as a scheme to seek
    reimbursement for expensive, custom-fabricated medical equipment (specifically,
    wrist braces and walking boots) when the cheaper, pre-fabricated items had
    actually been provided to patients. Pre-fabricated items are manufactured in bulk
    for off-the-shelf distribution without a specific patient in mind. Pre-fabricated
    items could be trimmed, molded, bent or otherwise modified for use by a specific
    patient; however, this makes the item custom-fitted not custom-fabricated.
    I’ll be frank with you. It’s absolutely inconceivable to me that the government’s
    allowing these Medicare provider contractors, whatever they are, to run without
    keeping any better records that can be searched than there are. Now, I’m not
    going to try to sort out whether the people here today are telling the truth, or the
    people behind them are giving them false information or not. It’s real simple for
    me. I can turn the thing right back on its head and say I think it’s Brady material,
    and the government can start sorting through the boxes, and get it here, and you
    can sort out who’s who, and who’s got what, and when they did it, and whether
    they turned over the boxes and not the electronic data or whatever.
    (Tr. of Hrg. on June 25, 2007, at 105, R. on App. 212.)
    8
    Custom-fabricated items are molded or created specifically for an individual
    patient. The indictment charges that on ten occasions (Counts One through Ten),
    Isley billed Medicare for wrist braces using the custom-fabricated code of either
    L3800 or L3907. It further charges that on four occasions (Counts Eleven through
    Fourteen), Isley billed Medicare for walking boots using the custom-fabricated
    code of L1960. With respect to all fourteen counts, the Government charged that
    Isley’s use of these codes was fraudulent because the actual products dispensed
    were pre-fabricated.
    At trial, Isley had at her disposal all of the documents relating to the MNAs
    from Region C for the product codes at issue in the indictment (L3800, L3907, and
    L1960) as well as the other product codes that were no longer at issue in the case.
    She did not, however, have any MNAs from the other three regions. Isley believed
    that, as evidenced by the MNAs, Medicare erroneously approved the use of
    custom-fabricated codes for pre-fabricated products. Isley had maintained
    throughout the pre-trial proceedings that the MNAs were relevant Brady material
    because she had relied upon them in making her own coding decisions. The
    evidence at trial, however, belied this assertion.
    Sandra Sosebee, who worked in the billing department at Orthoscript,
    testified that she informed Isley on numerous occasions that the use of product
    code L3907 for pre-fabricated wrist braces was incorrect. Isley explained that she
    9
    believed this custom-fabricated code could be used if a pre-fabricated wrist brace
    was bent or molded to fit the patient. This matter was often discussed at manager
    meetings, wherein Isley persisted with her belief that a bent or molded pre-
    fabricated item could be billed using a custom-fabricated code. When Sosebee
    expressed her concern that Medicare would not agree with this coding, Isley
    responded: “Well, Medicare is stupid. I will deal with them when they come in
    here.” Sosebee testified that Isley never told her that she could rely on a prior paid
    claim in making a coding decision.
    On April 12, 2004, Sosebee wrote to Isley, via e-mail, again questioning the
    use of certain wrist brace codes. Sosebee suggested that prior paid claims could
    inform the decision of what code should be used. In response, Isley wrote:
    I would be hesitant to make any assumptions as to what Medicare is
    telling us. We have concluded in the past that Medicare is not
    consistent with regards to what they try to relay to us. I would not
    make the leap that if Medicare made a payment that means it’s correct
    and if they didn’t make a payment it is incorrect.
    Another billing department employee of Orthoscript, Victoria Meguiar,
    similarly testified that Isley looked at the fee schedule and the rate of
    reimbursement in determining what code should be used. Further, while Meguiar
    showed Isley letters indicating that Orthoscript’s billing codes were incorrect,
    Isley, in turn, never showed Meguiar MNAs indicating that the billing codes were
    correct. Meguiar was convinced that Orthoscript was coding certain products
    10
    incorrectly, and she set about trying to prove to Isley, through phone calls to the
    DMERC, that Isley’s understanding of pre-fabricated versus custom-fabricated
    product codes was incorrect.12 In fact, on one occasion, Meguiar changed the
    billing codes for wrist splints to a pre-fabricated code, which lowered the
    reimbursement rate. Isley confronted Meguiar and instructed her not to change the
    codes again.
    Melissa Carnes, who also worked in the billing department of Orthoscript,
    testified that she was present during the meeting about custom-fabricated versus
    pre-fabricated billing codes when Isley stated that Medicare is “stupid.” Carnes
    further testified that no one else at Orthoscript shared Isley’s viewpoint on the use
    of a custom-fabricated code for pre-fabricated items that were simply bent or
    molded to fit a patient.13
    Additionally, Sosebee, Meguiar, and Carnes all testified that the only
    document to which Isley referred in their discussions of using the proper product
    code was the Medicare fee schedule, which gave the rate of reimbursement for
    each product code. In fact, Carnes stated that Isley told her Orthoscript could not
    afford to use the pre-fabricated codes that Carnes wanted to use for certain items.
    12
    Meguiar testified that Isley wanted proof in “black and white” that Orthoscript was
    billing incorrectly.
    13
    Of note, Isley conceded on cross-examination that she had no way of knowing whether
    a doctor actually bent or molded a product to fit a patient once it is taken out of its box.
    11
    Finally, James Arch Nelson testified that Orthoscript employees came to him
    when they became frustrated with Isley’s use of incorrect billing codes. He
    attended a meeting between Isley and the employees, during which Isley explained
    her position on the billing codes; Isley did not, however, refer to any MNAs to
    support her position. Nevertheless, Nelson “sided with” Isley on the coding issue
    even though it appeared to him that the other employees were right and that
    Orthoscript was coding pre-fabricated products incorrectly.
    During the course of the trial, Isley used the DMERC’s treatment of product
    codes not charged in the superseding indictment to demonstrate confusion in the
    industry. For instance, Orthoscript had coded certain walking boots with L2114
    and L2116 codes.14 Orthoscript had received several MNAs for its claims that used
    the L2114 and L2116 product codes; thus, Isley relied upon the MNAs in using
    these codes. Subsequently, however, Orthoscript received both approvals and
    denials for the same products coded with the L2114 and L2116 codes. The
    confusion in the use of these codes led to an industry-wide review by the DMERC
    of the L2114 and L2116 codes.
    Despite the confusion over the use of the L2114 and L2116 codes, witnesses
    aside from Isley testified that there was no industry confusion regarding
    14
    The use of the L2114 and L2116 product codes had been charged in the original
    indictment but were not included in the superseding indictment.
    12
    Medicare’s definitions for custom-fabricated versus pre-fabricated products. Cathy
    Plunkett, an experienced health care consultant, testified that the definitions were
    “clear.” Missy Carnes, Vicky Meguiar, and Sandra Sosebee testified that they
    were not confused by the definitions. Further, Isley herself testified that a DME
    supplier could not use a custom-fabricated code if the doctor provided a pre-
    fabricated item to a patient; Orthoscript supplied only pre-fabricated wrist splints
    and walking boots to doctors’ offices.
    Nevertheless, Isley maintained at trial that she relied upon the MNAs from
    Region C as well as the other regions in the country to inform her decision on how
    to code the products. The district court permitted Isley to testify about her futile
    efforts to obtain the MNAs from Regions A, B, and D; moreover, Isley testified
    that even though she did not get physical possession of the MNAs, Region A had
    reported the existence of approximately 2000 MNAs, Region B had reported 812
    MNAs, and Region D had reported between 1500 and 2500 MNAs.15
    On cross-examination, however, Isley admitted that, with respect to seven of
    the ten charges related to wrist braces, she could not have relied upon any MNAs
    15
    In considering the number of MNAs that existed in the other regions, it is important to
    note that Isley had requested six different DME product codes, only three of which were charged
    in the indictment. She requested and received the MNAs in Region C for the same six product
    codes. It became apparent at trial, however, that a great majority of the MNAs from Region C
    related to the uncharged product codes. Isley only speculates that the MNAs from the other
    regions would not have a proportionate share of irrelevant MNAs, that is, MNAs unrelated to the
    product codes charged in the indictment.
    13
    when filing Orthoscript’s claims because there were no MNAs for the relevant
    product codes during the time that she had submitted the claims. With respect to
    the later filed wrist brace claims, Isley admitted that she did not see any MNAs
    related to the same product code until she reviewed discovery material in the case
    in 2007. With respect to the walking boot code, L1960, Isley’s testimony of
    reliance was refuted by Special Agent Erica Wilker’s testimony on rebuttal that for
    the relevant time period, Region C did not perform a medical necessity review of
    Orthoscript’s claims using product code L1960.16
    In short, Isley attempted, through MNAs from Region C, to paint a picture
    of confusion and ambiguity on behalf of the DMERC in the way that it processed
    claims involving the subject DME product codes. Yet, the only confusion shown
    related to uncharged product codes. Moreover, Isley presented no evidence, other
    than her own testimony, that she relied upon any MNA in determining what codes
    to utilize. Rather, the evidence presented at trial, as outlined above, directly
    refuted her assertion of reliance.
    C.     Post-Trial Motion
    On May 2, 2008, Isley filed a motion for a new trial based upon an alleged
    16
    In reviewing the three documents that Isley claimed to be MNAs from Orthoscript for
    product code L1960, Wilker testified that one was not for code L1960, that one was an appeal
    rather than an MNA, and that there was no evidence that the third was received and reviewed by
    Palmetto.
    14
    Brady violation in that the Government failed to produce the MNAs from Regions
    A, B, and D. In this motion, Isley again argues that these MNAs were material to
    her defense that she relied upon the DMERC’s regular approval of using the same
    DME product code for the same product as those criminalized in the indictment.
    The district court denied the motion, ruling as follows:
    Now, having the benefit of the evidence at trial, the court
    concludes that the only use the defendant could have made of the
    additional medical necessity approvals would be impeachment. This
    is so because the evidence established that the defendant did not rely
    on these medical necessity approvals to make her own coding
    decisions.
    (Order of August 8, 2008, at 2, R. on App. 280.) In considering whether the other
    regions’ MNAs should have been produced for impeachment purposes, the district
    court ruled that failure to produce cumulative impeachment evidence does not
    constitute a Brady violation.
    D.     Isley’s Appeal
    On August 8, 2008, Isley filed a timely notice of appeal, in which she asserts
    the following errors. First, she argues the district court abused its discretion in
    denying her motion for new trial based upon the alleged Brady violation. She next
    argues that the district court erred in failing to give an “entrapment-by-estoppel”
    instruction and in failing to give an “interpretive rules” instruction to the jury.
    Finally, Isley argues that the district court erred by admitting evidence that Isley
    15
    made contributions to the Atlanta Lesbian Center and that she had an affair.
    II. DISCUSSION
    A.     The Claimed Brady Violation
    In this case, Isley argues that the Government violated Brady v. Maryland,
    
    373 U.S. 83
    , 
    83 S. Ct. 1194
    , 
    10 L.Ed.2d 215
     (1963), by failing to provide the
    MNAs from Region A, B, and D. We review the district court’s denial of a motion
    for new trial based on a Brady violation for abuse of discretion. United States v.
    Vallejo, 
    297 F.3d 1154
    , 1163 (11th Cir. 2002). Under Brady, the Government
    violates the Due Process Clause if it suppresses evidence favorable to the accused
    when the evidence “is material either to guilt or to punishment.” Brady, 
    373 U.S. at 87
    , 
    83 S. Ct. at 1197
    . Evidence favorable to the accused includes impeachment
    evidence. United States v. Bagley, 
    473 U.S. 667
    , 676, 
    105 S. Ct. 3375
    , 3380, 
    87 L.Ed.2d 481
     (1985). To obtain a new trial based upon a Brady violation, a
    defendant must show:
    (1) the government possessed favorable evidence to the defendant; (2)
    the defendant does not possess the evidence and could not obtain the
    evidence with any reasonable diligence; (3) the prosecution
    suppressed the favorable evidence; and (4) had the evidence been
    disclosed to the defendant, there is a reasonable probability that the
    outcome would have been different.
    Vallejo, 
    297 F.3d at 1164
    .
    16
    We cannot say that the district court abused its discretion here because Isley
    cannot show that had she obtained the MNAs from other regions, the outcome of
    her trial would have been different. This is because the evidence failed to establish
    that she relied upon any MNA in making the coding decisions charged in the
    indictment. While she testified at trial that she told Orthoscript employees that the
    MNAs were her “trump card” with Medicare, the employees testified that she
    never mentioned MNAs in explaining her coding decisions. Further, the evidence
    showed that she could not have relied upon MNAs for most of the charged coding
    decisions because no pertinent MNAs existed at the time Medicare was billed.
    Isley also testified that she did not see the other relevant MNAs until she reviewed
    the discovery material years after she made the coding decision. Thus, even
    assuming that there exists MNAs relevant to the subject codes in the other regions
    at the time Isley made her coding decisions, the jury rejected the notion that she
    relied upon them.
    To the extent that Isley sought a new trial based upon the impeachment
    value of the MNAs from other regions, her argument similarly fails. Isley believed
    that the other MNAs would impeach the Government witnesses by demonstrating
    confusion and ambiguity in the application of the billing codes to the subject
    products. Even if she could show confusion in the industry, Isley did not
    demonstrate that any such confusion affected her decisions because she did not rely
    17
    upon the coding decisions in the industry.
    Moreover, the district court determination that this impeachment evidence
    was cumulative was not erroneous. At trial, Isley was able to show that some
    errors had occurred in the medical necessity review process. Indeed, a large
    portion of her defense focused on the confusing and misleading application of the
    L2114 and L2116 codes for walking boots. Isley was therefore able to show that
    the DMERC was not always consistent. However, evidence of this nature from
    other regions would be merely cumulative.
    In short, the MNAs from other regions are not material, i.e., if the MNAs
    had been admitted at trial in Isley’s favor, there is not a reasonable probability of a
    different outcome in this case. The district court therefore did not abuse its
    discretion in denying Isley’s motion for a new trial.17
    B.      Jury Instructions
    We review the district court’s refusal to give a requested jury instruction for
    an abuse of discretion. United States v. Moore, 
    525 F.3d 1033
    , 1046 (11 th Cir.
    2008). The denial of a requested instruction is reversible error if (1) the requested
    17
    We note that it is inconceivable that a district court could determine prior to trial that
    evidence would be merely cumulative when the court has not seen or does not know the exact
    nature of the evidence. Nevertheless, the district court’s post-trial conclusion in this case that the
    MNAs from other regions were only cumulative impeachment evidence is not erroneous, as
    explained above. Thus, any error conceivably committed by the district court prior to trial does
    not warrant reversal of Isley’s conviction.
    18
    instruction correctly stated the law; (2) the actual charge to the jury did not
    substantially cover the proposed instruction; and (3) the failure to give the
    instruction substantially impaired the defendant’s ability to present an effective
    defense. United States v. Richardson, 
    532 F.3d 1279
    , 1289 (11 th Cir. 2008).
    Isley requested an entrapment-by-estoppel instruction. “Entrapment-by-
    estoppel is an affirmative defense that provides a narrow exception to the general
    rule that ignorance of the law is no defense.” United States v. Funches, 
    135 F.3d 1405
    , 1407 (11th Cir. 1998), quoted in United States v. Eaton, 
    179 F.3d 1328
    , 1332
    (11th Cir. 1999). Entrapment-by-estoppel applies “when a government official
    erroneously tells a defendant that conduct is legal and the defendant, believing the
    official, acts on the advice.” United States v. Billue, 
    994 F.2d 1562
    , 1568 (11 th Cir.
    1993). This defense is not available unless a defendant can show that she relied
    upon an official government communication before acting in a manner proscribed
    by law. United States v. Johnson, 
    139 F.3d 1359
    , 1365 (11 th Cir. 1998).
    Isley contends that an entrapment-by-estoppel defense is supported by her
    reliance upon the MNAs Palmetto sent to Orthoscript. That is, through the MNAs,
    Palmetto advised her that her coding choices were correct.
    We first note that Isley cannot point to a single statement or communication
    19
    to her personally upon which she relied to make her coding decisions.18 Rather,
    she suggests that approvals of prior claims equated to affirmative statements upon
    which she could rely in coding the fourteen subject claims of the indictment.19 To
    the extent that there were misstatements through the MNAs about which product
    codes were acceptable, unless these statements were made directly to Isley, her
    reliance upon them is misplaced. See Eaton, 
    179 F.3d at 1332
     (“For a statement to
    trigger an entrapment-by-estoppel defense, it must be made directly to the
    defendant, not to others.”)
    Moreover, the evidence at trial established that there was no confusion in the
    industry: pre-fabricated products could not be coded with custom-fabricated codes.
    Thus, even assuming Isley relied upon an erroneous MNA, such reliance would not
    be objectively reasonable.20 Thus, the district court did not abuse its discretion in
    refusing to give the entrapment-by-estoppel charge.
    18
    Isley only points to a single phone call she personally made to Roberta Riddle, a nurse
    educator with Palmetto, the DMERC. According to Isley, Riddle told her that she need only
    match the doctor’s diagnosis code to the HCPCS product code in order for the selected code to
    be proper. Other than the fact that Riddle and other employees privy to the telephone call deny
    that Riddle made such a statement, the cross-coder lists several possible HCPCS codes for every
    diagnosis code. A simple “match” is not possible. Moreover, Isley conceded that the cross-
    coder was but a factor in determining the proper product code. Accordingly, Riddle’s advice to
    use the cross-coder is not an affirmative statement supporting an entrapment-by-estoppel
    defense.
    19
    Isley refers to Orthoscript’s reliance upon the MNAs Palmetto issued to Orthoscript
    rather than any statement made to her personally upon which she relied.
    20
    As noted above, Isley did not show at trial that she relied upon any MNA in making
    her coding decisions.
    20
    Isley also requested the following “Interpretative Rules” charge:
    You have heard the testimony during the case of Palmetto’s
    interpretations of various HCPCS (Healthcare Common Procedure
    Coding System) product codes for wrist splints and walking boots.
    The rules and regulations that have been mentioned during this trial
    are what is known as “interpretative” rules and regulations. They
    were not promulgated pursuant to the notice-and-comment
    requirements of the Administrative Procedure Act. You are hereby
    instructed that “interpretative” rules and regulations lack the force and
    effect of law. As such, they are non-binding, and do not foreclose
    alternative courses of action by durable medical equipment (DME)
    providers.
    Isley refers to the supplier manual and advisories issued by the DMERC and
    SADMERC as the interpretative rules upon which the Government relied. Isley
    contends that she was prosecuted under definitions of custom-fabricated and pre-
    fabricated set forth in these documents; thus, the above charge was appropriate.
    The district court did not abuse its discretion in refusing to give this charge
    because Isley was not indicted for violating an interpretative Medicare rule.
    Rather, she was charged with defrauding the Medicare program in violation of 
    18 U.S.C. § 1347
    . Isley knew that using custom-fabricated codes for pre-fabricated
    products would cause Medicare to pay a higher rate for custom-fabricated
    products.21 This conduct of intentionally manipulating the Medicare program is
    21
    By way of example, the evidence relating to count four of the superseding indictment
    shows the following. Orthoscript was a stock and bill operation, which means that it would
    stock and charge physicians for a supply of DME products, and once a physician dispensed a
    product, Orthoscript would obtain the prescription form and bill Medicare for reimbursement.
    With respect to count four, Orthoscript supplied several wrist braces to a physician’s office at a
    21
    made criminal by the Medicare fraud statutes, not the interpretative rules and
    regulations. The interpretative rules to which Isley refers are relevant only
    because they inform the jury on the question of whether the claims to Medicare
    were false. In any event, the district court gave an “intent” instruction which
    substantially covered the proposed charge.22
    C.       Admission of Extrinsic Evidence
    On January 25, 2007, prior to the superseding indictment, the Government
    filed a Rule 404(b) notice of its intent to introduce evidence that Isley had used
    Orthoscript funds without permission to pay for unauthorized personal charges on
    her corporate American Express account, including a $20,000 charitable donation
    to the Atlanta Lesbian Center. The Government also included notice of its intent to
    introduce evidence that Isley used Orthoscript funds without permission to pay for
    charges on her personal Capital One credit card accounts. In response thereto,
    Isley filed a motion to suppress, arguing that the Government was attempting to
    inject her sexual orientation into the trial improperly.
    charge of $4.10 each. Yet, when one of these wrist braces was prescribed to Patient E.A.,
    Orthoscript submitted a claim to Medicare for $100. (See Gov’t Ex. 4A - 4G.)
    22
    The “intent” instruction given was as follows:
    A statement or claim is not knowingly and willfully false if it is the
    subject of a disputed legal question or if it represents a reasonable interpretation
    of applicable rules or regulations. In this regard, the government has the burden
    of proof beyond a reasonable doubt that Ms. Isley’s statements or claims were not
    a reasonable interpretation of any applicable codes, rules or regulations.
    22
    In the superseding indictment, the Government charged Isley with 36 counts
    of honest services mail fraud relating to her use of Orthoscript funds for the
    payment of charges on the personal Capital One accounts of Isley and her
    significant other, Tracy Hollis. The personal credit card charges against her
    corporate American Express card, such as the charitable contribution, were not
    charged in the superseding indictment. In denying Isley’s motion to suppress the
    unindicted credit card transactions, the district court ruled that the charitable
    donation evidence was admissible either as inextricably intertwined with the mail
    fraud counts or relevant 404(b) evidence.
    At trial, the Government called Hollis to testify about the two Capital One
    credits cards that were the subject of the mail fraud charges. During direct
    examination, the Government asked Hollis questions about her relationship with
    Isley:
    Q:     Approximately how long were you involved in a relationship with Ms.
    Isley?
    A:     About nine and a half years.
    ....
    Q:     And when did the relationship end?
    A:     In June of 2004.
    Q:     All right. I’m not going to go into it in great detail, just briefly, can
    you tell the jury the nature of how the relationship ended?
    23
    A:      [Isley] was having an affair.
    ....
    Q:      Would you describe [your subsequent contacts with Isley] to be
    hostile, or amicable, or how would you describe it?
    A:      It was painful, difficult, but civil.
    Isley did not object to this testimony.
    On appeal, Isley objects to Hollis’s testimony that Isley had an affair and to
    the admission of evidence that she made a $20,000 donation to the Atlanta Lesbian
    Center.23
    1.      Hollis Testimony
    Because Isley did not contemporaneously object to this testimony, we
    review its admission for plain error only. United States v. Munoz, 
    430 F.3d 1357
    ,
    1375 (11th Cir. 2005). Under the plain error review standard, a defendant must
    show (1) error, (2) that is plain and (3) that affects a defendant’s substantial rights.
    United States v. Williams, 
    527 F.3d 1235
    , 1240 (11th Cir. 2008). To affect her
    substantial rights, Isley must show the admission of this evidence affected the
    23
    During voir dire, defense counsel informed the venire that Isley is gay and asked
    whether any venire member had feelings one way or another about gay people that would affect
    their impartiality as jurors. On appeal, the Government argues that Isley cannot be prejudiced by
    the admission of the extrinsic evidence challenged here because she first injected her sexual
    orientation into the trial of the case. Because Isley knew during voir dire, however, that the
    district court was going to allow evidence of her donation to the Atlanta Lesbian Center, she was
    entitled to qualify the venire on the issue as a matter of trial strategy. Thus, any argument that
    Isley somehow waived her objection to this evidence during voir dire is without merit.
    24
    outcome of the proceedings. United States v. Parker, 
    277 Fed. Appx. 952
    , at *4
    (11th Cir. May 15, 2008).
    First, Isley claims that Hollis’s testimony was not needed because Special
    Agent Erica Wilker had already testified that the charges to the Capital One cards
    were personal in nature; thus, Hollis was called solely to emphasize Isley’s sexual
    orientation and to introduce evidence of her infidelity. To the contrary, Isley
    specifically argued during the opening statement that the Capital One credit cards
    were used for both personal and business expenses. Hollis, also an account holder,
    was the only person other than Isley who could testify that the indicted transactions
    were personal in nature. Prior to her testimony, the Government did not know
    whether Isley planned to dispute the personal nature of the charges. Accordingly,
    Hollis’s testimony was not unnecessary.
    Second, the Government properly impeached Hollis under Federal Rule of
    Evidence 607 by eliciting from her that she may have a bias against Isley because
    of their break-up. Thus, we find no error in the admission of this evidence.
    Nevertheless, Isley contends that if the testimony is admissible, its probative value
    is substantially outweighed by the danger of unfair prejudice. Even if we were to
    agree with Isley on this point, she is not entitled to a new trial because she has not
    shown that its admission changed the outcome of the trial. The evidence of Isley’s
    healthcare fraud and honest services mail fraud amply supports the convictions.
    25
    2.      Charitable Donation Evidence
    As an initial matter, we will review the admission of the evidence that Isley
    donated $20,000 to the Atlanta Lesbian Center for an abuse of discretion. United
    States v. Ramirez, 
    426 F.3d 1344
    , 1354 (11 th Cir. 2005). While the Government
    points out that Isley did not contemporaneously object to the donation evidence
    when it was admitted, Federal Rule of Evidence 103(a) provides that “[o]nce the
    court makes a definitive ruling on the record admitting or excluding evidence,
    either at or before trial, a party need not renew an objection or offer of proof to
    preserve a claim of error for appeal.”24 In this case, the district court definitively
    ruled prior to trial that the donation evidence would be admissible.
    Federal Rule of Evidence 404 prohibits evidence of other bad acts to prove
    the character of a person in order to show she acted in conformity therewith. This
    evidence is admissible, however, if it may show proof of “motive, opportunity,
    intent, preparation, plan . . . or absence of mistake.” Fed. R. Evid. 404(b).
    Evidence of other bad acts is not extrinsic to the charged offense under Rule
    404(b), however, “when it is (1) an uncharged offense which arose out of the same
    transaction or series of transactions as the charged offense, (2) necessary to
    complete the story of the crime, or (3) inextricably intertwined with the evidence
    24
    “When the ruling is definitive, a renewed objection . . . at the time the evidence is to
    be offered is more a formalism than a necessity.” Fed. R. Evid. 103, advisory committee's note to
    2000 Amendment.
    26
    regarding the charged offense.” United States v. Edouard, 
    485 F.3d 1324
    , 1344
    (11th Cir. 2007) (internal quotations and citations omitted).        Here, Isley does not
    contest that the donation evidence was either inextricably intertwined with the
    scheme to defraud Orthoscript through the unauthorized use of its funds or offered
    for a proper purpose under Rule 404(b). Rather, Isley contends that its probative
    value was limited and substantially outweighed by its potential for unfair
    prejudice. Regardless of whether the donation evidence falls inside or outside the
    scope of Rule 404(b), the evidence must still satisfy the requirements of Rule
    403.25 
    Id.
    The donation evidence was not the only evidence of unauthorized personal
    charges on the corporate American Express card. The Government also presented
    evidence that Isley used this credit card to pay for Christmas and birthday parties.
    There was also evidence that she took unauthorized salary increases throughout the
    relevant time period. All of these unauthorized expenditures occurred during the
    same time that Isley was paying her Capital One accounts with Orthoscript funds.
    It is probative of Isley’s intent and plan to defraud her employer and of her motive
    in defrauding Medicare. The charitable donation was simply part and parcel of
    such evidence. It was not unfairly singled out or emphasized by the prosecution.
    25
    Rule 403 provides: “Although relevant, evidence may be excluded if its probative
    value is substantially outweighed by the danger of unfair prejudice . . . .”
    27
    Moreover, the nature of the donation had to be revealed to show that it was
    personal and unauthorized, i.e., was not related to or did not further the business of
    Orthoscript. Finally, any prejudice arising from the fact that the charitable
    donation was made to the Atlanta Lesbian Center was mitigated by the defense’s
    qualification of the jury to ensure there was no bias against her sexual orientation.
    In short, the probative value of the charitable donation evidence was not
    substantially outweighed by the danger of unfair prejudicial. See Edouard, 
    485 F.3d at
    1344 n.8 (“Rule 403 is an extraordinary remedy, which should be used only
    sparingly, and the balance should be struck in favor of admissibility.” (quotation
    marks, citation, and brackets omitted)). The district court therefore did not abuse
    its discretion in its admission of the evidence.
    III. CONCLUSION
    For all of the foregoing reasons, Isley’s convictions are AFFIRMED.
    28