Michael Drakeford v. Tuomey , 792 F.3d 364 ( 2015 )


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  •                                PUBLISHED
    UNITED STATES COURT OF APPEALS
    FOR THE FOURTH CIRCUIT
    No. 13-2219
    UNITED STATES ex rel. MICHAEL K. DRAKEFORD, M.D.,
    Plaintiff – Appellee,
    v.
    TUOMEY, d/b/a Tuomey Healthcare System, Inc.,
    Defendant – Appellant.
    −−−−−−−−−−−−−−−−−−−−−−−−−−−
    AMERICAN HOSPITAL    ASSOCIATION;    SOUTH   CAROLINA    HOSPITAL
    ASSOCIATION,
    Amici Supporting Appellant.
    Appeal from the United States District Court for the District of
    South Carolina, at Columbia.     Matthew J. Perry, Jr., Senior
    District Judge; Margaret B. Seymour, Senior District Judge.
    (3:05-cv-02858-MBS)
    Argued:   October 31, 2014                    Decided:    July 2, 2015
    Before DUNCAN, WYNN, and DIAZ, Circuit Judges.
    Affirmed by published opinion.    Judge Diaz wrote the majority
    opinion, in which Judge Duncan joined.       Judge Wynn wrote a
    separate opinion concurring in the judgment.
    ARGUED: Helgi C. Walker, GIBSON, DUNN & CRUTCHER, LLP,
    Washington, D.C., for Appellant. Tracy Lyle Hilmer, UNITED
    STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellee.
    ON BRIEF: James M. Griffin, Margaret N. Fox, A. Camden Lewis,
    LEWIS, BABCOCK & GRIFFIN, LLP, Columbia, South Carolina; Daniel
    M. Mulholland III, HORTY SPRINGER & MATTERN, Pittsburgh,
    Pennsylvania; E. Bart Daniel, Charleston, South Carolina, for
    Appellant.    Stuart F. Delery, Assistant Attorney General,
    Michael D. Granston, Michael S. Raab, Civil Division, UNITED
    STATES DEPARTMENT OF JUSTICE, Washington, D.C.; G. Norman Acker,
    III, Assistant United States Attorney, OFFICE OF THE UNITED
    STATES ATTORNEY, Raleigh, North Carolina, for Appellee. Melinda
    R. Hatton, Maureen D. Mudron, AMERICAN HOSPITAL ASSOCIATION,
    Washington, D.C.; Jessica L. Ellsworth, Amanda K. Rice, HOGAN
    LOVELLS US LLP, Washington, D.C., for Amici Curiae.
    2
    DIAZ, Circuit Judge:
    In a qui tam action in which the government intervened, a
    jury determined that Tuomey Healthcare System, Inc., did not
    violate     the   False     Claims   Act       (“FCA”),    31    U.S.C.     §§ 3729-33
    (2012). 1   The district court, however, vacated the jury’s verdict
    and granted the government a new trial after concluding that it
    had   erroneously      excluded      excerpts       of    a     Tuomey     executive’s
    deposition testimony.          The jury in the second trial found that
    Tuomey knowingly submitted 21,730 false claims to Medicare for
    reimbursement.       The district court then entered final judgment
    for   the   government      and   awarded       damages       and   civil    penalties
    totaling $237,454,195.
    Tuomey contends that the district court erred in granting
    the government’s motion for a new trial.                        Tuomey also lodges
    numerous other challenges to the judgment entered against it
    following the second trial.             It argues that it is entitled to
    judgment as a matter of law (or, in the alternative, yet another
    new   trial)      because    it   did   not      violate      the   FCA.      In   the
    alternative, Tuomey asks for a new trial because the district
    court failed to properly instruct the jury.                         Finally, Tuomey
    1Under the qui tam provisions of the FCA, a whistleblower
    (known as the relator) can file an action on behalf of the
    federal government for alleged fraud committed against the
    government. If the action is successful, the relator shares in
    the recovery.
    3
    asks   us     to    strike     the    damages      and    civil    penalties         award     as
    either improperly calculated or unconstitutional.
    We conclude that the district court correctly granted the
    government’s         motion     for    a    new     trial,       albeit       for   a    reason
    different than that relied upon by the district court.                                  We also
    reject      Tuomey’s    claims        of   error     following         the    second     trial.
    Accordingly, we affirm the district court’s judgment.
    I.
    A.
    Tuomey is a nonprofit hospital located in Sumter, South
    Carolina, a small, largely rural community that is a federally-
    designated         medically    underserved          area.        At    the    time     of     the
    events leading up to this lawsuit, most of the physicians that
    practiced at Tuomey were not directly employed by the hospital,
    but instead were members of independent specialty practices.
    Beginning       around    2000,       doctors       who    previously        performed
    outpatient surgery at Tuomey began doing so in their own offices
    or at off-site surgery centers.                    The loss of this revenue stream
    was a source of grave concern for Tuomey because it collected
    substantial facility fees from patients who underwent surgery at
    the    hospital’s      outpatient          center.        Tuomey       estimated        that   it
    stood to lose $8 to $12 million over a thirteen-year period from
    the    loss    of    fees    associated       with       gastrointestinal           procedures
    4
    alone.    To stem this loss, Tuomey sought to negotiate part-time
    employment contracts with a number of local physicians.
    In drafting the contracts, Tuomey was well aware of the
    constraints imposed by the Stark Law.                           While we discuss the
    provisions of that law in greater detail below, in broad terms,
    the   statute,         42   U.S.C.    § 1395nn,       prohibits      physicians             from
    making     referrals           to     entities        where        “[t]he            referring
    physician . . .          receives     aggregate       compensation        .      .    .    that
    varies    with,    or       takes   into       account,   the    volume     or       value   of
    referrals or other business generated by the referring physician
    for the entity furnishing” the designated health services.                                   42
    C.F.R. § 411.354(c)(2)(ii) (2014).                    Pursuant to the Stark Law,
    “[a] hospital may not submit for payment a Medicare claim for
    services rendered pursuant to a prohibited referral.”                                     United
    States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., 
    675 F.3d 394
    , 397–98 (4th Cir. 2012).
    Beginning in 2003, Tuomey sought the advice of its longtime
    counsel, Nexsen Pruet, on the Stark Law implications arising
    from the proposed employment contracts.                         Nexsen Pruet in turn
    engaged    Cejka        Consulting,        a     national   consulting           firm       that
    specialized       in    physician     compensation,         to    provide     an       opinion
    concerning the commercial reasonableness and fair market value
    of the contracts.            Tuomey also conferred with Richard Kusserow,
    a former Inspector General for the United States Department of
    5
    Health    and     Human    Services,         and   later,   with     Steve     Pratt,   an
    attorney at Hall Render, a prominent healthcare law firm.
    The       part-time         employment        contracts     had     substantially
    similar terms.            Each physician was paid an annual guaranteed
    base salary.           That salary was adjusted from year to year based
    on the amount the physician collected from all services rendered
    the previous year.             The bulk of the physicians’ compensation was
    earned    in     the    form    of     a   productivity     bonus,     which    paid    the
    physicians eighty percent of the amount of their collections for
    that year.        The physicians were also eligible for an incentive
    bonus of up to seven percent of their earned productivity bonus.
    In addition, Tuomey agreed to pay for the physicians’ medical
    malpractice       liability           insurance    as   well    as     their    practice
    group’s share of employment taxes.                      The physicians were also
    allowed     to    participate           in   Tuomey’s     health     insurance        plan.
    Finally, Tuomey agreed to absorb each practice group’s billing
    and collections costs.
    The contracts had ten-year terms, during which physicians
    could maintain their private practices, but were required to
    perform     outpatient          surgical      procedures       exclusively       at     the
    hospital.        Physicians could not own any interest in a facility
    located    in     Sumter       that    provided    ambulatory      surgery     services,
    save for a less-than-two-percent interest in a publicly traded
    company that provided such services.                    The physicians also agreed
    6
    not to perform outpatient surgical procedures within a thirty-
    mile radius of the hospital for two years after the expiration
    or termination of the contracts.
    Tuomey     ultimately      entered       into     part-time        employment
    contracts with nineteen physicians.               Tuomey, however, was unable
    to reach an agreement with Dr. Michael Drakeford, an orthopedic
    surgeon.          Drakeford     believed       that     the   proposed      contracts
    violated the Stark Law because the physicians were being paid in
    excess of their collections.          He contended that the compensation
    package     did    not   reflect    fair       market     value,     and    thus    the
    government would view it as an unlawful payment for the doctor’s
    facility-fee-generating referrals.
    To address Drakeford’s concerns, Tuomey suggested a joint
    venture as an alternative business arrangement, whereby “doctors
    would become investors . . . in . . . a management company that
    would provide day-to-day management of the outpatient surgery
    center,” J.A. 3268, and both Tuomey and its co-investors would
    “receive payments based on that management [structure].”                           J.A.
    2036.    Drakeford, however, declined that option.
    Unable to break the stalemate in their negotiations, in May
    2005, Tuomey and Drakeford sought the advice of Kevin McAnaney,
    an attorney in private practice with expertise in the Stark Law.
    McAnaney    had     formerly    served     as    the    Chief   of    the    Industry
    Guidance Branch of the United States Department of Health and
    7
    Human Services Office of Counsel to the Inspector General.                            In
    that position, McAnaney wrote a “substantial portion” of the
    regulations implementing the Stark Law.                  J.A. 2026.
    McAnaney advised the parties that the proposed employment
    contracts raised significant “red flags” under the Stark Law. 2
    J.A. 2054.         In particular, Tuomey would have serious difficulty
    persuading the government that the contracts did not compensate
    the     physicians     in   excess    of       fair    market     value.       Such   a
    contention, said McAnaney, would not pass the “red face test.”
    J.A.       2055.    McAnaney   also   warned          Tuomey    that   the    contracts
    presented “an easy case to prosecute” for the government.                          J.A.
    2078.
    Drakeford ultimately declined to enter into a contract with
    Tuomey.       He later sued the hospital under the qui tam provisions
    of    the    FCA,   alleging   that   because          the     part-time     employment
    contracts violated the Stark Law, Tuomey had knowingly submitted
    false claims for payment to Medicare.                     As was its right, the
    government intervened in the action and filed additional claims
    2According to McAnaney, the joint venture                          alternative
    raised separate concerns under the Anti-Kickback                         Statute, 42
    U.S.C. § 1320a-7b(b), which bars “the payment of                        remuneration
    for the purpose of inducing the purchase of health                      care covered
    by any federal health care insurance program.”                            Michael K.
    Loucks & Carol C. Lam, Prosecuting and Defending                         Health Care
    Fraud Cases 233 (2d ed. 2010).
    8
    seeking equitable relief for payments made under mistake of fact
    and unjust enrichment theories.
    B.
    At the first trial, Tuomey argued that McAnaney’s testimony
    and related opinions regarding the contracts should be excluded
    as   an    offer    to   compromise    or       settle   under    Federal   Rule    of
    Evidence 408 because McAnaney was mediating a dispute between
    Tuomey     and     Drakeford.      Alternatively,        Tuomey     contended    that
    because McAnaney was hired jointly by Tuomey and Drakeford, he
    owed a duty of loyalty to both clients that precluded him from
    testifying.         The district court sustained Tuomey’s objection,
    although it did not articulate the ground for its ruling.
    Tuomey also objected to the government’s attempt to admit
    excerpts from the deposition testimony of Gregg Martin, Tuomey’s
    Senior     Vice     President    and   Chief      Operating      Officer.    Tuomey
    argued that the deposition testimony should be excluded because
    it contained Martin’s recollections of a discussion he had with
    Tuomey’s     counsel     concerning    McAnaney’s        opinions    regarding     the
    employment contracts.            According to Tuomey, the testimony was
    merely a “back doorway to get in Mr. McAnaney’s opinions.”                       J.A.
    808.      The government countered that the deposition testimony was
    admissible to show Tuomey’s state of mind and intent to violate
    the Stark        Law.    The    district    court    again    sustained     Tuomey’s
    objection.
    9
    The jury returned a verdict finding that, while Tuomey had
    violated    the    Stark       Law,    it    had     not    violated        the    FCA.       The
    government    filed       a    post-verdict          motion       for      judgment      on   its
    equitable claims.         It also moved for judgment as a matter of law
    under Federal Rule of Civil Procedure 50 on the FCA claim, or
    alternatively       for   a     new    trial      under     Rule      59    because      of   the
    district court’s decision to exclude McAnaney’s testimony and
    opinions, as well as the Martin deposition excerpts.
    The     district         court    denied      the      government’s          motion      for
    judgment as a matter of law.                  But the court agreed that it had
    committed     “a     substantial            error”     by        excluding        the     Martin
    deposition    excerpts.              J.A.    1296.         It    therefore        granted     the
    government’s       motion      for    a     new   trial.         Notably,      the      district
    court’s decision was based solely on its error in excluding the
    Martin deposition excerpts.
    While the government asked for a new trial only on the
    knowledge element of the FCA claim, the district court granted a
    new trial as to the entirety of the claim.                            Notwithstanding the
    court’s decision to grant a new trial on the FCA claim, the
    district    court     entered         judgment       for        the   government        on    its
    equitable claims based on the jury’s finding of a Stark Law
    violation, and ordered Tuomey to pay damages in the amount of
    $44,888,651 plus pre- and post-judgment interest.
    10
    On appeal, we vacated the judgment, concluding that the
    jury’s finding of a Stark Law violation was a common factual
    issue necessary to the resolution of both the equitable claims
    and the FCA claim. 3         Yet, because the district court rendered the
    jury’s verdict finding a Stark Law violation a “legal nullity”
    when it granted the government’s motion for a new trial, we held
    that the court deprived Tuomey of its Seventh Amendment right to
    a   jury    trial    by    entering    judgment    on   the   equitable   claims.
    
    Drakeford, 675 F.3d at 405
    .               We remanded the case for a new
    trial as to all claims.
    While the case was on appeal, the presiding judge passed
    away.      At the second trial, the new presiding judge allowed the
    government      to        introduce     the     previously    excluded      Martin
    deposition testimony, and also allowed McAnaney to testify.                    The
    jury found that Tuomey violated both the Stark Law and the FCA.
    It further found that Tuomey had submitted 21,730 false claims
    to Medicare with a total value of $39,313,065.                      The district
    court     trebled    the    actual    damages     and   assessed   an   additional
    civil penalty, both actions required by the FCA.                        31 U.S.C.
    § 3729(a)(1).         From    the     resulting    judgment   of   $237,454,195,
    Tuomey appeals.
    3
    Tuomey also sought leave to pursue an interlocutory appeal
    of the district court’s order granting a new trial on the FCA
    claim. We denied that motion.
    11
    II.
    A.
    Tuomey’s       appeal    presents     these       issues:          First,      did     the
    district court err in granting the government’s motion for a new
    trial on the FCA claim?              If not, did the district court err in
    (1) denying Tuomey’s motion for judgment as a matter of law (or,
    in the alternative, for yet another new trial) following the
    second trial; and (2) awarding damages and penalties against
    Tuomey based on the jury’s finding of an FCA violation?                                        We
    address each issue in turn, but first provide a general overview
    of the Stark Law.
    B.
    The Stark Law is intended to prevent “overutilization of
    services     by    physicians       who   [stand]       to       profit      from    referring
    patients     to    facilities       or    entities          in    which      they    [have]     a
    financial interest.”            
    Drakeford, 675 F.3d at 397
    .                        The statute
    prohibits a physician from making a referral to an entity, such
    as    a   hospital,          with   which     he       or        she   has     a     financial
    relationship, for the furnishing of designated health services.
    42    U.S.C.      § 1395nn(a)(1).           If    the       physician        makes     such    a
    referral, the hospital may not submit a bill for reimbursement
    to Medicare.          
    Id. § 1395nn(a)(1)(B).
                   Similarly, the government
    may    not     make    any     payment    for      a    designated        health       service
    provided in violation of the Stark Law.                          
    Id. § 1395nn(g)(1).
              If
    12
    a person collects any payment for a service billed in violation
    of the Stark Law, “the person shall be liable to the individual
    for, and shall refund on a timely basis to the individual, any
    amounts so collected.”           
    Id. § 1395nn(g)(2).
    4
    Inpatient and outpatient hospital services are considered
    designated health services under the law.                   
    Id. § 1395nn(h)(6).
    A referral includes “the request by a physician for the item or
    service.”         
    Id. § 1395nn(h)(5)(A).
           A referral does not include
    “any designated health service personally performed or provided
    by the referring physician.”              42 C.F.R. § 411.351.          However,
    there is a referral when the hospital bills a “facility fee”
    (also known as a “facility component” or “technical component”)
    “in connection with the personally performed service.”                  Medicare
    and    Medicaid      Programs;    Physicians’    Referrals     to   Health   Care
    Entities With Which They Have Financial Relationships, 66 Fed.
    Reg.       856,   941   (Jan.    4,   2001);   see   also    Medicare   Program;
    Physicians’ Referrals to Health Care Entities With Which They
    Have Financial Relationships (Phase II), 69 Fed. Reg. 16054,
    16063 (Mar. 26, 2004).
    4
    Because the Stark Law does not create its own right of
    action, the government in this case sought relief under the FCA,
    which provides a right of action with respect to false claims
    submitted for Medicare reimbursement.   See 
    Drakeford, 675 F.3d at 396
    & n.2.
    13
    A financial relationship constitutes a prohibited “indirect
    compensation           arrangement,”        if     (1)     “there       exists     an       unbroken
    chain    of      any    number . . . of          persons          or    entities        that      have
    financial            relationships . . .              between          them,”      (2)        “[t]he
    referring physician . . . receives aggregate compensation . . .
    that varies with, or takes into account, the volume or value of
    referrals or other business generated by the referring physician
    for the entity furnishing” the designated health services, and
    (3) the entity has knowledge that the compensation so varies.
    42 C.F.R. § 411.354(c)(2); see also 
    Drakeford, 675 F.3d at 408
    (“[C]ompensation arrangements that take into account anticipated
    referrals . . . implicate the volume or value standard.”).                                        The
    statute,         however,           does     not         bar      indirect         compensation
    arrangements where: (1) the referring physician is compensated
    at fair market value for “services and items actually provided”;
    (2)   the     compensation           arrangement           is   “not     determined          in    any
    manner      that       takes      into      account         the    volume         or    value       of
    referrals”;          (3)    the   compensation           arrangement         is   “commercially
    reasonable”; and (4) the compensation arrangement does not run
    afoul    of       any       other     federal         or    state       law.           42    C.F.R.
    § 411.357(p); 
    Drakeford, 675 F.3d at 398
    .
    Once       a     relator      or     the   government            has   established          the
    elements of a Stark Law violation, it becomes the defendant’s
    burden      to       show    that     the    indirect           compensation           arrangement
    14
    exception shields it from liability.               See United States ex rel.
    Kosenske v. Carlisle HMA, Inc., 
    554 F.3d 88
    , 95 (3d Cir. 2009).
    C.
    We first address the district court’s decision to grant the
    government a new trial on the FCA claim.                 The government pressed
    two grounds in support of its motion.              First, it argued that the
    district court erred by excluding McAnaney’s testimony, along
    with    all    evidence   containing    the    views     he   expressed         to   the
    parties on the potential Stark Law liability surrounding the
    contracts.       Second,    the    government      argued     that    the   district
    court     erroneously     excluded     the    Martin      deposition        excerpts.
    While    the   district    court   granted     a   new    trial      on   the   latter
    ground, we instead affirm the district court on the basis of its
    more glaring error, the exclusion of McAnaney’s testimony and
    related evidence.
    1.
    We review a district court’s decision to grant a new trial
    for abuse of discretion.            Cline v. Wal-Mart Stores, Inc., 
    144 F.3d 294
    , 301 (4th Cir. 1998).               We apply the same standard to
    the district court’s decision to exclude evidence.                        Buckley v.
    Mukasey, 
    538 F.3d 306
    , 317 (4th Cir. 2008).                   “By definition, a
    district court abuses its discretion when it makes an error of
    law.”     RZS Holdings AVV v. PDVSA Petroleo S.A., 
    506 F.3d 350
    ,
    356 (4th Cir. 2007).         Even so, we may reverse a district court
    15
    only    if   its    evidentiary          error       affects    a    party’s      substantial
    rights.      
    Buckley, 538 F.3d at 317
    .                       And, of course, we may
    affirm a district court’s ruling on any ground apparent in the
    record.      Republican Party of N.C. v. Martin, 
    980 F.2d 943
    , 952
    (4th Cir. 1992).
    2.
    We believe that the district court abused its discretion in
    granting     a     new   trial      on    the    ground      that     it   had        improperly
    excluded the Martin deposition excerpts.                            Even if the district
    court    should      not     have    excluded         this     evidence      in       the    first
    instance,     an    evidentiary          error       is   harmless    when       it    does      not
    affect a party’s substantial rights--in this case, whether it
    can be said with a high probability that the error did not
    affect the judgment.             Taylor v. Va. Union Univ., 
    193 F.3d 219
    ,
    235 (4th Cir. 1999) (en banc), abrogated on other grounds by
    Desert Palace, Inc. v. Costa, 
    539 U.S. 90
    (2003); Daskarolis v.
    Firestone Tire & Rubber Co., 
    651 F.2d 937
    , 942 (4th Cir. 1981)
    (noting that even if the district court believed that it had
    excluded admissible evidence, the erroneous exclusion could not
    be   grounds       for   a   new    trial       because      it     did    not    affect         the
    substantial rights of the parties).                       The district court made no
    effort to assess the alleged error under this stringent harmless
    error    standard.           Furthermore,        because        the    exclusion            of   the
    Martin deposition testimony was, in fact, a harmless error, the
    16
    district court abused its discretion in granting a new trial on
    this ground.
    In its motion for a new trial, the government argued that
    Martin’s       testimony        was     necessary         evidence     supporting        the
    scienter element of its FCA claim.                   Specifically, the government
    contended       that       Martin,    Tuomey’s      agent,    received       and    ignored
    McAnaney’s       warnings       that    the     part-time         employment      contracts
    raised significant Stark Law compliance issues.                         Thus, says the
    government,          the    evidence     would       have     demonstrated         Tuomey’s
    reckless       disregard        of     the     legal      minefield     that       it    was
    traversing.          We think, however, that the probative value of this
    particular evidence is weak at best, and excluding it did not
    negatively affect the government’s substantial rights.
    The    deposition       excerpts       predominantly         focus    on    Martin’s
    recollection of a discussion he had with Tuomey’s lawyer, Tim
    Hewson.       Hewson recounted to Martin the details of a conference
    call       between    Hewson,    McAnaney,         and    Drakeford’s       lawyer,     Greg
    Smith. 5     Specifically, Hewson told Martin that McAnaney had Stark
    Law    compliance          concerns     with       both     the    proposed       part-time
    5
    Hewson was likely recounting the details of two separate
    conference calls.   The first call was between McAnaney, Smith,
    and Hewson and covered the part-time employment contracts. The
    following day, Steve Pratt joined those three for a second call
    focusing on the joint venture arrangement. When asked if he was
    aware that there were two separate conference calls, Martin
    responded that he did not “remember for sure.” J.A. 105.
    17
    employment contracts as well as the joint venture arrangement
    (which Martin referred to as the “under arrangement”).                                   However,
    Martin was unable to remember specifics about the conversation,
    and often confused McAnaney’s concerns with issues raised by
    Steve Pratt.
    Martin did vaguely recall that Hewson had told him that
    McAnaney said the proposed arrangements would raise “red flags”
    with    the   government.           J.A.    104-05.         Yet,    Martin          could       not
    remember      whether     McAnaney’s        warnings    were       particular             to    the
    part-time employment contracts, the joint venture arrangement,
    or   both.       Indeed,      in    Martin’s      recollection          it    was        hard    to
    “separate the two.”           J.A. 107.         To the extent that Martin could
    distinguish      the    two   proposed       arrangements,         he     recalled          being
    warned of greater problems with the joint venture arrangement.
    With respect to McAnaney’s concerns about the employment
    contracts,       Martin     had     a   vague     recollection          of        some    issues
    related    to    fair     market    value,      but   was    unable          to    offer       more
    detail.         Ultimately,        Martin    acknowledged          that       there       was    a
    “difference of opinion” between McAnaney and Hewson, but decided
    to trust Hewson’s opinion that the contracts posed no Stark Law
    concerns.       J.A. 111.
    That Martin’s deposition testimony was hazy is not at all
    surprising, given that he was being asked to recall--nearly four
    years    after    the     fact--the        substance    of    a     conversation               with
    18
    Tuomey’s lawyer, who himself was recalling an earlier conference
    call with McAnaney.           Standing alone, we fail to see how the
    government was substantially prejudiced by the district court’s
    decision   to    exclude    this   evidence.    Thus,     we   hold    that    the
    district court abused its discretion in relying on this ground
    to grant the government’s motion for a new trial.
    3.
    Nonetheless, we affirm the district court’s order granting
    a new trial on the alternative ground urged by the government--
    that it was prejudiced by the exclusion of McAnaney’s testimony
    and other related evidence of his warnings to Tuomey regarding
    the legal peril that the employment contracts posed. 6                  To make
    its case that Tuomey “knowingly” submitted false claims under
    the FCA, the government needed to show that Tuomey knew that
    there was a substantial risk that the contracts violated the
    Stark    Law,   and   was   nonetheless    deliberately    ignorant      of,   or
    recklessly      disregarded    that   risk.    In   our    view,      McAnaney’s
    6 Tuomey says that we may not affirm on this alternative
    ground because the government’s brief never asked us to do so.
    But this assertion splits the thinnest of hairs. While perhaps
    the government could have been more direct in its brief, it
    clearly alerted us (and Tuomey) that there was an alternate
    ground for affirming the district court. See Appellee’s Br. at
    82 (“[The] new trial ruling was correct not only because of the
    exclusion of Martin’s testimony, but also because the exclusion
    of McAnaney’s testimony and related evidence was clearly
    erroneous   and  affected   the   substantial  rights   of  the
    government.”).
    19
    testimony was a relevant, and indeed essential, component of the
    government’s evidence on that element, and Tuomey offered no
    good reason why the jury should not hear it.
    The district court has now presided over two trials in this
    case, with strikingly disparate results.                   In the first trial,
    the jury did not hear from McAnaney and found for Tuomey on the
    FCA claim.       When the case was retried, McAnaney was allowed to
    testify and the jury found for the government.                    Coincidence?         We
    think not.       Rather, we believe that these results bespeak the
    importance of what the jury in the first trial was not allowed
    to consider.
    And this is so even while acknowledging that McAnaney was a
    looming presence throughout the first trial.                     For example, the
    jury heard audio of a Tuomey board meeting, where a board member
    mentioned that McAnaney had voiced concerns with the part-time
    employment contracts.            Left unsaid, however, was the precise
    nature   of    those     concerns     or   the   weight    and   seriousness          that
    McAnaney      attached    to    them.      The   jury   also     knew    that    Hewson
    (Tuomey’s      counsel     at    Nexson    Pruet)    was    generally         aware    of
    McAnaney’s      views    on     the   employment    contracts,          but    that     he
    dismissed them as not credible because, in his view, Drakeford
    was deliberately seeking to cherry pick a legal opinion that
    would undermine the entire deal.
    20
    The jury was also aware that Drakeford 7 wrote to Tuomey’s
    board       summarizing        McAnaney’s       opinions.        The    district       court,
    however, excluded Drakeford’s letter, although it did allow the
    jury        to    consider     the   board’s     response      wherein      it    summarily
    rejected Drakeford’s unspecified objections.                           Finally, the jury
    heard that Tuomey refused to allow McAnaney to prepare a written
    opinion          discussing    his   concerns        regarding    the    contracts,       and
    subsequently           terminated       McAnaney’s       engagement       altogether       on
    September 2, 2005.
    While certainly not insubstantial, the sum of the evidence
    at the first trial regarding McAnaney was that Tuomey (1) was
    aware        that      McAnaney      had    unspecified          concerns        about   the
    employment contracts; (2) refused to allow McAnaney to relay his
    concerns in writing; and (3) later terminated McAnaney’s joint
    representation.            Yet, under the FCA, the government had to prove
    that Tuomey knew of, was deliberately ignorant of, or recklessly
    disregarded         the    falsity    of   its       claims   (i.e.     that     its   claims
    violated         the   Stark    Law).      We    think    that    McAnaney’s       specific
    warnings to Tuomey regarding the dangers posed by the contracts
    were critical to making this showing.
    McAnaney           warned     Tuomey      that      procuring        fair       market
    valuations, by itself, was not conclusive of the accuracy of the
    7   Drakeford was not called as a witness at either trial.
    21
    valuation.        He emphasized that it would be very hard to convince
    the     government         that     a        contract    that     paid      physicians
    “substantially       above    even      their      collections,    much     less   their
    collections minus expenses,” would constitute fair market value.
    J.A.   2053.        According     to    McAnaney,       compensation      arrangements
    under which the contracting physicians are paid in excess of
    their collections were “basically a red flag to the government.”
    
    Id. He noted
    that similar cases had previously been prosecuted
    before, although all of them ultimately settled.
    McAnaney also pointed out that the ten-year term of the
    contracts,     combined      with      the    thirty-mile,      two-year    noncompete
    provision would reinforce the government’s view that Tuomey was
    “paying [the physicians] above fair market value for referrals.”
    J.A. 2055.         He concluded that the contracts did not pass the
    “red face test,” and warned that the government would find this
    “an easy case to prosecute.”             J.A. 2055, 2078.
    We   think    the    importance        of    McAnaney’s    testimony    to   the
    government’s case is self-evident.                    Indeed, it is difficult to
    imagine     any    more    probative     and       compelling    evidence    regarding
    Tuomey’s intent than the testimony of a lawyer hired by Tuomey,
    who was an undisputed subject matter expert on the intricacies
    of the Stark Law, and who warned Tuomey in graphic detail of the
    22
    thin legal ice on which it was treading with respect to the
    employment contracts. 8
    4.
    Tuomey urges, however, that McAnaney’s testimony and other
    evidence    containing       his   views       were    properly       excluded      under
    Federal Rule of Evidence 408.                 That rule, however, mandates the
    exclusion of evidence relating to offers to compromise or settle
    disputed    claims     if    the   evidence       is   being    offered       to   prove
    liability   on   the    claim.        Bituminous       Constr.,       Inc.   v.    Rucker
    Enters., Inc., 
    816 F.2d 965
    , 968 (4th Cir. 1987).                            We are not
    persuaded   that     McAnaney      was    retained      to    help     Drakeford     and
    Tuomey   compromise     or    settle      a    disputed      claim.      Rather,      the
    record   unambiguously        shows      that    Drakeford      and     Tuomey      hired
    McAnaney to advise them of the Stark Law risks posed by the
    employment contracts.          As a result, Rule 408 does not support
    the district court’s decision to exclude McAnaney’s testimony. 9
    8 We note that Tuomey waived the attorney-client privilege
    with respect to its communications with McAnaney when it
    asserted the advice-of-counsel defense. See Rhone-Poulenc Rorer
    Inc. v. Home Indem. Co., 
    32 F.3d 851
    , 863 (3d Cir. 1994) (“A
    defendant   may . . .  waive   [attorney-client]  privilege  by
    asserting reliance on the advice of counsel as an affirmative
    defense.”).
    9 In any event, as our concurring colleague ably explains,
    even assuming that McAnaney’s testimony would ordinarily be
    excludable under Rule 408, Tuomey nonetheless opened the door to
    its admission by raising the advice-of-counsel defense.
    23
    See ICAP, Inc. v. Global Digital Satellite Sys., Inc., 
    225 F.3d 654
    , 
    2000 WL 1049854
    , at *3 (4th Cir. 2000) (unpublished table
    opinion)      (finding        Rule    408    inapplicable      where   the    parties’
    communications           involved       contract     negotiations      rather     than
    settlement negotiations).
    Nor      do    we    find       merit   in    Tuomey’s    objection     based   on
    McAnaney’s supposed duty of loyalty to his clients.                          At trial,
    Tuomey     never         suggested      which      evidentiary     rule      supported
    exclusion on this ground, although it now characterizes this
    argument as a claim for exclusion under Rule 403.                      That rule of
    course allows a district court to exclude relevant evidence, but
    only “if its probative value is substantially outweighed by a
    danger   of    one       or   more     of    the   following:    unfair      prejudice,
    confusing the issues, misleading the jury, undue delay, wasting
    time, or needlessly presenting cumulative evidence.”                           Fed. R.
    Evid. 403.         Left unsaid by Tuomey is precisely how the probative
    value    of    McAnaney’s        compelling        testimony     was   substantially
    outweighed by the countervailing factors set out in Rule 403.
    In sum, Tuomey has offered no good reason why the jury in
    the first trial was not allowed to hear from McAnaney.                          And we
    agree with the government that this evidence was critical to its
    ability to satisfy its burden to prove that Tuomey acted with
    the requisite intent under the FCA.                     We therefore affirm the
    district court’s order granting a new trial on the FCA claim.
    24
    III.
    We turn now to Tuomey’s challenges to the judgment entered
    following    the     second   trial.     Tuomey         asks    for     judgment      as    a
    matter of law because a reasonable jury could not have found
    that (1) the part-time employment contracts violated the Stark
    Law,    or     (2)     Tuomey     knowingly         submitted         false      claims.
    Alternatively,       Tuomey     asks   for    a    new    trial       because    of    the
    district court’s refusal to tender certain jury instructions.
    A.
    We review the district court’s denial of Tuomey’s motion
    for judgment as a matter of law de novo.                        Austin v. Paramount
    Parks, Inc., 
    195 F.3d 715
    , 727 (4th Cir. 1999).                          We “view all
    the evidence in the light most favorable to the prevailing party
    and draw all reasonable inferences in [its] favor.”                           Konkel v.
    Bob Evans Farms Inc., 
    165 F.3d 275
    , 279 (4th Cir. 1999).                                   We
    will reverse the district court if a reasonable jury could rule
    only in favor of the moving party.                 Dennis v. Columbia Colleton
    Med.   Ctr.,   Inc.,    
    290 F.3d 639
    ,       645    (4th    Cir.    2002)     (“[I]f
    reasonable minds could differ, we must affirm.”).
    1.
    Tuomey argues that it is entitled to judgment as a matter
    of law because the contracts between it and the physicians did
    not run afoul of the Stark Law.                    As we explain, however, a
    reasonable jury could find that Tuomey violated the Stark Law
    25
    when it paid aggregate compensation to physicians that varied
    with or took into account the volume or value of actual or
    anticipated referrals to Tuomey.
    To begin with, we note that the Stark Law’s “volume or
    value” standard can be implicated when aggregate compensation
    varies with the volume or value of referrals, or otherwise takes
    into   account   the       volume    or    value   of    referrals.        42     C.F.R.
    § 411.354(c)(2)(ii).          That is precisely what the district court
    directed   the      jury    in     the    second   trial    to   assess.          Tuomey
    insists,     however,       that     our    earlier      opinion     in    this     case
    foreclosed    the    jury’s      consideration      of     whether   the    contracts
    varied with the volume or value of referrals.                        Instead, says
    Tuomey, the only question that should have been put to the jury
    was “whether the contracts, on their face, took into account the
    value or volume of anticipated referrals.”                   
    Drakeford, 675 F.3d at 409
    .
    We disagree.        The district court properly understood that
    the jury was entitled to pass on the contracts as they were
    actually implemented by the parties.                    We said as much in our
    earlier opinion, where
    we emphasize[d] that our holding . . . [was] limited
    to the issues we specifically address[ed]. On remand,
    a jury must determine, in light of our holding,
    whether the aggregate compensation received by the
    physicians under the contracts varied with, or took
    into account, the volume or value of the facility
    component referrals.
    26
    
    Id. at 409
    n.26 (emphasis added).
    A reasonable jury could have found that Tuomey’s contracts
    in fact compensated the physicians in a manner that varied with
    the   volume    or      value    of    referrals.         There     are    two     different
    components of the physicians’ compensation that we believe so
    varied.      First,       each    year,       the   physicians      were        paid    a    base
    salary that was adjusted upward or downward depending on their
    collections from the prior year.                      In addition, the physicians
    received    the      bulk   of        their    compensation        in    the     form        of    a
    productivity bonus, pegged at eighty percent of the amount of
    their collections.
    As Tuomey concedes, “the aggregate compensation received by
    the    physicians        under        the     Contracts     was     based         solely          on
    collections       for    personally           performed    professional           services.”
    Appellant’s Br. at 42.                And as we noted in our earlier opinion,
    there are referrals here, “consisting of the facility component
    of    the   physicians’          personally         performed      services,           and    the
    resulting      facility         fee     billed      by    Tuomey        based     upon       that
    component.”        
    Drakeford, 675 F.3d at 407
    .                      In sum, the more
    procedures the physicians performed at the hospital, the more
    facility fees Tuomey collected, and the more compensation the
    physicians received in the form of increased base salaries and
    productivity bonuses.
    27
    The nature of this arrangement was confirmed by Tuomey’s
    former    Chief   Financial    Officer,     William    Paul      Johnson,      who
    admitted “that every time one of the 19 physicians . . . did a
    legitimate    procedure   on   a   Medicare      patient   at    the   hospital
    pursuant to the part-time agreement[,] the doctor [got] more
    money,” and “the hospital also got more money.”                 J.A. 2012.     We
    thus think it plain that a reasonable jury could find that the
    physicians’   compensation     varied     with   the   volume    or    value   of
    actual referrals.      The district court did not err in denying
    Tuomey’s motion for judgment as a matter of law on this ground. 10
    10 We are not persuaded by Tuomey’s reliance on commentary
    promulgated by the Centers for Medicare & Medicaid Services as
    it developed implementing regulations for the Stark Law. Tuomey
    points to a portion of the commentary wherein the agency states
    that the “fact that corresponding hospital services are billed
    would   not  invalidate   an   employed   physician’s   personally
    performed work, for which the physician may be paid a
    productivity   bonus   (subject   to   the   fair   market   value
    requirement).” 69 Fed. Reg. at 16089. But this statement deals
    only with a productivity bonus based on the fair market value of
    the work personally performed by a physician--it says nothing
    about the propriety of varying a physician’s base salary based
    on the volume or value of referrals.
    In any case, the commentary regarding productivity bonuses
    appears under a section of the regulations that specifically
    addresses comments related to the exception for bona fide
    employment relationships.    This exception covers circumstances
    where there is a meaningful administrative relationship between
    the physician and the hospital. The jury was instructed on this
    exception at trial, and rejected it.     Tuomey does not quarrel
    with that aspect of the jury’s verdict; rather it contends that
    the commentary applies irrespective of whether a bona fide
    employment relationship actually exists. Nothing in the statute
    or the regulations, however, supports this notion.
    28
    2.
    Tuomey next argues that the district court erred in not
    granting its motion for judgment as a matter of law because it
    did not knowingly violate the FCA.                      Specifically, Tuomey claims
    that because it reasonably relied on the advice of counsel, no
    reasonable jury could find that Tuomey possessed the requisite
    intent to violate the FCA.               Because the record here is replete
    with evidence indicating that Tuomey shopped for legal opinions
    approving of the employment contracts, while ignoring negative
    assessments, we disagree.
    The    FCA    imposes          civil     liability         on    any        person       who
    “knowingly    presents,         or    causes      to    be     presented,         a   false     or
    fraudulent    claim       for   payment      or    approval”          to    an     officer      or
    employee     of     the       United     States         Government.                31       U.S.C.
    § 3729(a)(1)(A),          (b)(2)(A)(i).                Under     the       Act,       the     term
    “knowingly” means that a person, with respect to information
    contained    in     a     claim,       (1)   “has        actual       knowledge         of     the
    information;” (2) “acts in deliberate ignorance of the truth or
    falsity of the information;” or (3) “acts in reckless disregard
    of the truth or falsity of the information.”                           
    Id. § 3729(b)(1).
    The   purpose      of   the     FCA’s    scienter         requirement         is      to     avoid
    punishing “honest mistakes or incorrect claims submitted through
    mere negligence.”          United States ex rel. Owens v. First Kuwaiti
    29
    Gen. Trading & Contracting Co., 
    612 F.3d 724
    , 728 (4th Cir.
    2010) (internal quotation marks omitted).
    The record evidence provides ample support for the jury’s
    verdict as to Tuomey’s intent.            Indeed, McAnaney’s testimony,
    summarized above, is alone sufficient to sweep aside Tuomey’s
    claim of error. 11      We agree with the district court’s conclusion
    that “a reasonable jury could have found that Tuomey possessed
    the   requisite      scienter     once    it    determined    to     disregard
    McAnaney’s remarks.”        J.A. 4055-56.        A reasonable jury could
    indeed be troubled by Tuomey’s seeming inaction in the face of
    McAnaney’s      warnings,   particularly       given   Tuomey’s     aggressive
    efforts    to   avoid   hearing   precisely    what    McAnaney    had   to   say
    regarding the contracts.
    Nonetheless, a defendant may avoid liability under the FCA
    if it can show that it acted in good faith on the advice of
    counsel.     Cf. United States v. Painter, 
    314 F.2d 939
    , 943 (4th
    Cir. 1963) (holding, in a case involving fraud, that “[i]f in
    good faith reliance upon legal advice given him by a lawyer to
    whom he has made full disclosure of the facts, one engages in a
    11
    We note also that the jury at the second trial considered
    the deposition testimony of Tuomey executive Gregg Martin.
    While this evidence is (for reasons we have explained) not
    overly compelling in isolation, it is not without some value in
    showing that Tuomey was aware that its proposed contracts raised
    Stark Law concerns.
    30
    course of conduct later found to be illegal, the trier of fact
    may   in    appropriate       circumstances          conclude    the    conduct     was
    innocent    because    ‘the     guilty       mind’    was     absent”).      However,
    “consultation with a lawyer confers no automatic immunity from
    the   legal      consequences    of     conscious       fraud.”        
    Id. at 943.
    Rather,     to     establish     the      advice-of-counsel            defense,    the
    defendant must show the “(a) full disclosure of all pertinent
    facts to [counsel], and (b) good faith reliance on [counsel’s]
    advice.”      United States v. Butler, 
    211 F.3d 826
    , 833 (4th Cir.
    2000) (internal quotation marks omitted).
    Tuomey      contends     that     it     provided       full     and   accurate
    information       regarding     the     proposed       employment      contracts    to
    Hewson, who in turn advised Tuomey that the contracts did not
    run afoul of the Stark Law.             But as the government aptly notes,
    “[i]n determining whether Tuomey reasonably relied on the advice
    of its counsel, the jury was entitled to consider all the advice
    given to it by any source.”            Appellee’s Br. at 53.
    In denying Tuomey’s post-trial motions, the district court
    noted--and we agree--that a reasonable jury could have concluded
    that Tuomey was, after September 2005, no longer acting in good
    faith reliance on the advice of its counsel when it refused to
    give full consideration to McAnaney’s negative assessment of the
    part-time         employment          contracts         and      terminated        his
    31
    representation. 12        Tuomey defends           its dismissal       of McAnaney’s
    warnings       by   claiming    that   his      opinion   was   tainted    by    undue
    influence exerted by Drakeford and his counsel.                        But there was
    evidence before the jury suggesting that Tuomey also tried to
    procure a favorable opinion from McAnaney.                       Indeed, Tuomey’s
    counsel admitted that he was trying “to steer McAnaney towards
    [Tuomey’s] desired outcome” and that Tuomey needed to “continue
    playing along and influence the outcome of the game as best we
    can.”        J.A. 4482.      Thus, a reasonable jury could conclude that
    Tuomey ignored McAnaney because it simply did not like what he
    had to say.
    Tuomey points to the fact that it retained Steve Pratt, a
    prominent       healthcare       lawyer,     and     Richard     Kusserow,      former
    Inspector General at the United States Department of Health and
    Human Services, as further evidence that it acted in good faith
    and   did     not   ignore     McAnaney’s    warnings.         Pratt   rendered   two
    12
    The government contended that Tuomey submitted 25,973
    total claims for payment to Medicare between fiscal years 2005
    and 2009. The government’s evidence on this point consisted of
    a summary chart detailing the number of claims filed by Tuomey
    in each fiscal year.       It appears, however, that the jury
    subtracted the 4,243 claims that Tuomey submitted in fiscal year
    2005 (running from October 1, 2004 to September 30, 2005) from
    the government’s number. From this, the district court surmised
    that the jury resolved to hold Tuomey responsible for those
    claims filed beginning in fiscal year 2006 (that is, on or after
    October 1, 2005) given that they were filed after Tuomey
    terminated McAnaney’s joint representation on September 2, 2005.
    We think this is an entirely reasonable view of the evidence.
    32
    opinions that generally approved of the employment contracts.
    But    he    did    so    without       being    told       of    McAnaney’s           unfavorable
    assessment, even though Tuomey had that information available to
    it at the time.            In addition, Pratt reviewed and relied on the
    view        of     Tuomey’s       fair-market-value               consultant            that     the
    employment         contracts      would     compensate           the   physicians         at   fair
    market value, but he did not consider how the consultant arrived
    at its opinion.             Nor did he know how much the doctors earned
    prior to entering into the contracts, or that the hospital stood
    to lose $1.5-2 million a year, not taking into account facility
    fees, by compensating the physicians above their collections.
    We    thus       think    it     entirely       reasonable         for   a     jury      to    look
    skeptically on Pratt’s favorable advice regarding the contracts.
    The same can be said of the Kusserow’s advice.                                  Kusserow--
    who was called by the government to rebut Tuomey’s advice-of-
    counsel          defense--advised          Tuomey       regarding            the       employment
    contracts         about    eighteen       months      before       the   parties         retained
    McAnaney.           As     was    the     case       with    Pratt,       he       received      no
    information regarding the fair market value of the employment
    contracts,         information      that     Kusserow        considered        vital       “to    be
    able to do a full Stark analysis of [the proposed contracts].”
    J.A.    1676.        And       although     Kusserow        did    say   in        a    letter   to
    Tuomey’s counsel that he did not believe the contracts presented
    “significant Stark issues,” J.A. 1675, he hedged considerably on
    33
    that view because of “potentially troubling issues related to
    the       productivity          and    [incentive            bonus    provisions         in    the
    contracts] that have not been fully addressed.”                              J.A. 1677.
    As     the     district      court     observed,           “the    jury       evidently
    rejected Tuomey’s advice of counsel defense” as of the date that
    Tuomey received McAnaney’s warnings, “grounded on the fact that
    the       jury    excluded       damages       from      [before      the     termination      of
    McAnaney’s engagement] in making its determination” of the civil
    penalty and damages.                 J.A. 4055.          Thus, while Kusserow’s advice
    was certainly relevant to Tuomey’s advice-of-counsel defense, a
    reasonable jury could have determined that McAnaney’s warnings
    (and Tuomey’s subsequent inaction) were far more probative on
    the issue.
    In sum, viewing the evidence in the light most favorable to
    the government, we have no cause to upset the jury’s reasoned
    verdict that Tuomey violated the FCA.
    B.
    Next,       Tuomey    raises    several        challenges         to    the    district
    court’s          jury    instructions.              We    review      a     district      court’s
    “decision         to     give   (or    not    give)      a    jury    instruction        and   the
    content          of     an   instruction . . .            for    abuse       of   discretion.”
    United States v. Russell, 
    971 F.2d 1098
    , 1107 (4th Cir. 1992).
    Our task is to determine “whether the instructions[,] construed
    as    a    whole,        and    in    light    of     the     whole       record,   adequately
    34
    informed the jury of the controlling legal principles without
    misleading       or     confusing      the   jury   to    the     prejudice      of    the
    objecting party.”             Spell v. McDaniel, 
    824 F.2d 1380
    , 1395 (4th
    Cir. 1987).           We will reverse the district court’s decision not
    to give a party’s proposed instruction “only when the requested
    instruction (1) was correct; (2) was not substantially covered
    by the court’s charge to the jury; and (3) dealt with some point
    in the trial so important, that failure to give the requested
    instruction seriously impaired that party’s ability to make its
    case.”         Noel    v.    Artson,   
    641 F.3d 580
    ,    586       (4th   Cir.     2011)
    (internal quotation marks omitted). 13
    1.
    First, Tuomey urges us to grant it a new trial because the
    district court failed to give jury instructions consistent with
    our analysis in the first appeal.                   Specifically, Tuomey claims
    that     the    district       court    ignored     our    admonition         that    “the
    question, which should properly be put to a jury, is whether the
    contracts, on their face, took into account the value or volume
    of     anticipated          referrals.”       
    Drakeford, 675 F.3d at 409
    .
    According to Tuomey, the district court’s failure to so instruct
    the jury erroneously permitted the jury to consider extrinsic
    13
    Because two of Tuomey’s challenges to the instructions
    address the proper calculation of damages, we address them
    separately infra at Sections IV.A.1, and IV.B.
    35
    evidence     of    intent     in    determining        whether      the    physicians’
    compensation took into account the volume or value of referrals.
    As the district court correctly determined, however, we did
    not mean to limit the government’s ability to present evidence
    as to Tuomey’s intent to violate the FCA.                     Rather, we sought to
    emphasize that the government could not rely on such evidence
    alone to show a violation.               See 
    id. at 409
    n.25 (“We agree with
    [United States ex rel. Villafane v. Solinger, 
    543 F. Supp. 2d 678
    , 693 (W.D. Ky. 2008)] that intent alone does not create a
    violation.        However,    that       does   not    aid    Tuomey      if   the   jury
    determines that the contracts took into account the volume or
    value of anticipated referrals.”).               Thus, the district court did
    not err in declining to give this instruction.
    2.
    Tuomey next argues that the district court erred in not
    separately instructing the jury on the knowledge element in the
    Stark Law regulations’ definition of an indirect compensation
    arrangement.       As Tuomey correctly notes, the Stark Law requires
    that “[t]he entity furnishing [designated health services must]
    ha[ve] actual knowledge of, or act[] in reckless disregard or
    deliberate        ignorance        of,    the    fact        that    the       referring
    physician . . .       receives       aggregate        compensation        that   varies
    with, or takes into account, the volume or value of referrals.”
    42 C.F.R. § 411.354(c)(2)(iii).
    36
    Here, however, the district court instructed the jury that
    Tuomey would have acted knowingly under the FCA if it “realized
    what it was doing and was aware of the nature of its conduct and
    did not act through ignorance, mistake or accident.”                    J.A. 3942–
    43.     Given that a jury found Tuomey possessed the requisite
    scienter under the FCA, it necessarily also found Tuomey knew
    that its contracts varied with or took into account referrals.
    Therefore, the district court’s error (if any) in not separately
    instructing the jury as to the knowledge component of the Stark
    Law was harmless.
    3.
    Third,   Tuomey    argues   that       the   district    court    erred   by
    refusing to charge the jury that claims based upon differences
    of    interpretation     of   disputed    legal     questions    are    not   false
    under the FCA.      For this proposition, it cites to our decision
    in United States ex rel. Wilson v. Kellogg Brown & Root, Inc.,
    
    525 F.3d 370
    , 377 (4th Cir. 2008), in which we said as much.
    However, we also held there that for a claim to be “false” under
    the FCA, “the statement or conduct alleged must represent an
    objective falsehood.”         
    Id. at 376.
    When submitting its claims to the government, Tuomey was
    required to certify its compliance with the Stark Law.                           See
    United States ex rel. Thompson v. Columbia/HCA Healthcare Corp.,
    
    125 F.3d 899
    , 902 (5th Cir. 1997) (“[W]here the government has
    37
    conditioned payment of a claim upon a claimant’s certification
    of compliance with . . . a statute or regulation, a claimant
    submits    a    false    or    fraudulent     claim     when    he   or   she   falsely
    certifies compliance with that statute or regulation.”); United
    States ex rel. Pogue v. Diabetes Treatment Ctrs. of Am., 565 F.
    Supp.     2d   153,     158–59      (D.D.C.    2008).      Here,      Tuomey    either
    complied with the Stark Law or it didn’t.                      This is an objective
    inquiry.       And the jury found that Tuomey, in fact, violated the
    Stark Law.      As a result, Tuomey’s certification that it complied
    with the Stark Law was false.                 The subjective inquiry--whether
    Tuomey knew that its claims were in violation of the Stark Law--
    is   covered     under        the   knowledge    element. 14         Therefore,     the
    district court did not err in refusing to give this instruction.
    4.
    For their last jury instruction challenge, Tuomey contends
    that the district court erred by failing to instruct the jury
    that Tuomey was entitled to rely on legal advice even if it
    turned out to be wrong.              However, the district court instructed
    14In Wilson, there was no either/or proposition of the kind
    present here. Rather, in that case, the relators contended that
    the disputed statement was false because the defendant “agreed
    to [certain conditions] in the contract even though it knew it
    would not, and later did not, abide by those terms.”     
    Wilson, 525 F.3d at 377
    .   As we explained, the relators’ assertion did
    not rest on an objective falsehood, “but rather on Relators’
    subjective interpretation of [the defendant’s] contractual
    duties.” 
    Id. 38 the
    jury that knowledge does not include actions taken “through
    ignorance,         mistake       or    accident.”             J.A.    3943.         It       later
    emphasized         that    the   jury       could    not     conclude      that    Tuomey       had
    knowledge “from proof of mistake, negligence, carelessness or a
    belief in an inaccurate proposition.”                           
    Id. (emphasis added).
    Because the import of Tuomey’s proposed charge was covered by
    the district court’s instructions, we reject Tuomey’s claim of
    error.
    IV.
    Finally,          Tuomey       makes        several        challenges           to      the
    $237,454,195 judgment entered against it.                          First, it argues that
    the   district        court      improperly         calculated       the    civil       penalty.
    Next,        it   claims    that      the    district      court     used    the    incorrect
    measure of actual damages.                     Finally, it brings constitutional
    challenges to the award under the Fifth and Eighth Amendments.
    A       defendant     found      liable        under    the    FCA     must       pay    the
    government “a civil penalty of” not less than $5,500 and not
    more than $11,000 “plus 3 times the amount of damages which the
    Government         sustains        because      of     that     person.”           31        U.S.C.
    § 3729(a)(1); 28 C.F.R. § 85.3(a)(9). 15                       In this case, the jury
    15
    The FCA sets the civil penalty range at $5,000 to
    $10,000, but includes a provision that adjusts the range for
    inflation.
    39
    found that Tuomey had submitted 21,730 false claims, for which
    it awarded actual damages of $39,313,065, which the district
    court trebled.    The district court then added a civil penalty of
    $119,515,000 to that sum, which it calculated by multiplying the
    number of false claims by the $5,500 statutory minimum penalty.
    Ordinary, we review a court’s calculation of damages for
    clear   error.    Universal     Furniture      Int’l,       Inc.   v.   Collezione
    Europa USA, Inc., 
    618 F.3d 417
    , 427 (4th Cir. 2010).                      However,
    to the extent the claim is that the calculations are influenced
    by legal error, our review is de novo.                      
    Id. Likewise, the
    constitutionality of a damages award is a legal question that we
    review de novo.         See Cooper Indus., Inc. v. Leatherman Tool
    Grp., Inc., 
    532 U.S. 424
    , 436 (2001).
    A.
    1.
    According    to     Tuomey,   the       civil    penalty      assessed   was
    improperly inflated because the jury was permitted to take into
    account both inpatient and outpatient procedures performed by
    the contracting physicians.             Instead, relying on our earlier
    opinion   in   this    case,   Tuomey    claims      that    the   only   relevant
    claims “were those Tuomey ‘presented, or caused to be presented,
    to Medicare and Medicaid for payment of facility fees generated
    as a result of outpatient procedures performed pursuant to the
    40
    contracts.’”       Appellant’s         Br.      at    54   (alterations     omitted)
    (quoting 
    Drakeford, 675 F.3d at 399
    ).                  Tuomey is incorrect.
    It is true that the contracts solely addressed compensation
    for outpatient procedures.            That is, the physicians’ collections
    (which form the basis for both their base salaries and their
    productivity bonuses) do not account for the volume or value of
    inpatient procedures performed.                 Tuomey, however, takes out of
    context language from our earlier opinion recognizing this fact
    to suggest that we commanded that the relevant claims be limited
    to those seeking payment for outpatient procedures.                         We said
    nothing of the sort.
    If    a   physician      has     a   financial       relationship     with    a
    hospital, then the Stark Law prohibits the physician from making
    any referral to that hospital for the furnishing of designated
    health     services.        E.g.,    United     States     ex   rel.   Bartlett     v.
    Ashcroft, 
    39 F. Supp. 3d 656
    , 669 (W.D. Pa. 2014) (“Because a
    ‘compensation arrangement’ existed between Physician Defendants
    and   [the]     Hospital,      the     Stark     [Law]     prohibited     Physician
    Defendants from making any patient referrals to [the] Hospital
    for designated health services.” (emphasis added)).                       Inpatient
    hospital services are designated health services.                      42 U.S.C. §
    1395nn(h)(6).          And    a     referral         includes   “the   request     or
    establishment of a plan of care by a physician which includes
    the   provision        of    the     designated        health   service.”          
    Id. 41 §
    1395nn(h)(5).         Plainly, then, inpatient services constitute a
    prohibited       referral    for     the   furnishing     of    designated      health
    services, and the district court properly instructed the jury to
    factor them into the damages calculation.
    2.
    Tuomey also asserts that the jury’s damage award is flawed
    because the government failed to present sufficient evidence of
    referrals.        Specifically, Tuomey contends that the government
    did not identify the “referring physician,” and thus failed to
    prove     that    the   alleged      false      claims   came   about    through     a
    prohibited referral.
    The government’s proof on this point came in the form of
    summary evidence and testimony detailing the claims submitted by
    Tuomey.     We agree with the district court that the government’s
    evidence was sufficient to support the jury’s verdict.                         We note
    also, as did the district court, that “Tuomey was entitled to
    offer its own expert and its own alternate damages calculations,
    but elected not to do so.”            J.A. 4061.
    In    any    case,     Tuomey    offers     no   authority   to    support    its
    argument that the claims must explicitly identify the referring
    provider.        Conversely, several courts have accepted that the
    “‘attending/operating’          physician         identified      in    Form     UB-92
    42
    qualifies as a referring physician.” 16            United States v. Rogan,
    
    459 F. Supp. 2d 692
    , 713 (N.D. Ill. 2006); see also United
    States v. Halifax Hosp. Med. Ctr., No. 6:09-cv-1002-Orl-31TBS,
    
    2013 WL 6017329
    , at *10-11 (M.D. Fla. Nov. 13, 2013) (finding
    that the fact that one of the physicians with whom the hospital
    has a financial relationship is identified as an “operating” or
    “attending” physician is sufficient evidence that the physician
    was   also     the   “referring    physician”     absent   evidence    to   the
    contrary).      Given the lack of support for Tuomey’s position, we
    conclude that the jury had sufficient evidence to identify the
    prohibited referrals.
    3.
    Tuomey    next    argues    that    the   district   court   erroneously
    assessed the penalty based on the 21,730 UB-92/04 forms Tuomey
    submitted      to    Medicare    for     reimbursement.     Instead,    Tuomey
    asserts that the number of false claims should be limited to
    four Medicare cost reports that it submitted. 17
    16Form UB-92 (later replaced by Form UB-04) is used by
    hospitals to submit a claim for reimbursement to Medicare.
    17Cost reports (CMS-2552) “are the final claim that a
    provider submits to the fiscal intermediary for items and
    services rendered to Medicare beneficiaries. . . . Medicare
    relies upon the hospital cost report to determine whether the
    provider is entitled to more reimbursement than already received
    through interim payments, or whether the provider has been
    overpaid and must reimburse Medicare.”     J.A. 68-69 (citing 42
    C.F.R. §§ 405.1803, 413.60, 413.64(f)(1)).
    43
    Tuomey provides no Stark Law case to support its argument.
    Rather,      it    cites     to    FCA     cases    where     the       UB-92/04     forms
    themselves were not fraudulent, but were submitted as part of an
    ongoing     fraudulent       scheme.        In     those    cases,       the    fraud    was
    consummated only when the cost report was submitted.                            See United
    States ex rel. Hockett v. Columbia/HCA Healthcare Corp., 498 F.
    Supp.   2d    25,    70-71    (D.D.C.       2007);    Visiting          Nurse    Ass’n   of
    Brooklyn v. Thompson, 
    378 F. Supp. 2d 75
    , 99 (E.D.N.Y. 2004).
    But    even    those    cases       suggest    that    a    UB-92/04       form    can
    constitute a discrete fraudulent claim under the FCA when the
    government        proves   that     the    forms     were,       in   fact,      false   or
    fraudulent.         See 
    Hockett, 498 F. Supp. 2d at 70-71
    ; Visiting
    Nurse 
    Ass’n, 378 F. Supp. 2d at 99
    .                         This occurs when “the
    provider knowingly asks the Government to pay amounts it does
    not owe.”         United States ex rel. Clausen v. Lab. Corp. of Am.,
    Inc., 
    290 F.3d 1301
    , 1311 (11th Cir. 2002).
    Here, each time Tuomey submitted to Medicare a UB-92/04
    form asking for reimbursement for a prohibited referral, it was
    knowingly asking the government to pay an amount that, by law,
    it could not pay.          Consequently, we find the district court did
    not   err    in     finding       that    each   UB-92/04        form    constituted       a
    separate claim.
    44
    B.
    Tuomey    also     challenges          the      district      court’s       measure    of
    actual damages.        It argues that the true measure is not the sum
    total of all claims the government paid (as the court instructed
    the jury), but rather the difference (if any) between the true
    value of the services provided by Tuomey and what the government
    actually     paid.       According          to    Tuomey,        since    “there     was     no
    evidence     that     the     Government          did      not     get     what    it      paid
    for[,] . . .     there       were      no    actual        damages      under     the    FCA.”
    Appellant’s Br. at 87.              Here again, Tuomey’s view of the law is
    incorrect.
    The    Stark     Law    prohibits         the    government         from    paying    any
    amount of money for claims submitted in violation of the law.
    42 U.S.C. § 1395nn(g)(1).                Compliance with the Stark Law is a
    condition    precedent        to    reimbursement           of    claims    submitted       to
    Medicare.      When Tuomey failed to satisfy that condition, the
    government owed it nothing.                  United States v. Rogan, 
    517 F.3d 449
    , 453 (7th Cir. 2008).
    The     Stark     Law       expresses        Congress’s       judgment       that      all
    services     provided       in     violation         of    that    law     are    medically
    unnecessary.         By reimbursing Tuomey for services that it was
    legally    prohibited        from      paying,       the    government      has     suffered
    injury    equivalent     to      the    full     amount      of   the     payments.        Cf.
    United States v. Mackby (Mackby II), 
    339 F.3d 1013
    , 1018-19 (9th
    45
    Cir. 2003) (finding that the fact that the defendant actually
    rendered        the        service   billed     did       not    negate       the     government’s
    injury,         as     “[d]amages       under       the     FCA       flow     from    the    false
    statement”).               In this case, the damage from the false statement
    came from the payment to an entity that was not entitled to any
    payment         at    all.       Accordingly,         we    reject          Tuomey’s     claim     of
    error. 18
    C.
    Finally, Tuomey argues that the district court’s award of
    $237,454,195,              consisting     of   damages          and    a    civil     penalty,     is
    unconstitutional under the Excessive Fines Clause of the Eighth
    Amendment and the Due Process Clause of the Fifth Amendment.
    While      the       award     is    substantial,          we    cannot       say     that    it   is
    unconstitutional.
    “The           Excessive       Fines     Clause       of        the     Eighth    Amendment
    prohibits            the     government      from     imposing          excessive       fines      as
    punishment.”               Korangy v. FDA, 
    498 F.3d 272
    , 277 (4th Cir. 2007).
    “Civil fines serving remedial purposes do not fall within the
    reach      of    the        Eighth   Amendment.”            
    Id. But where
        “a   civil
    sanction ‘can only be explained as serving in part to punish,"
    18For the same reason, we also reject Tuomey’s contention
    that the district court erred in failing to instruct the jury
    that the government had to prove that the services received were
    worth less than what the government paid.
    46
    then the fine is subject to the Eighth Amendment.”                        
    Id. (quoting Austin
    v. United States, 
    509 U.S. 602
    , 610 (1993)).                         In such a
    case, the fine “will be found constitutionally excessive only if
    it   is    ‘grossly      disproportional         to     the    gravity      of    [the]
    offense.’”    
    Id. (alteration in
    original) (quoting United States
    v.   Bajakajian,   
    524 U.S. 321
    ,    334,       (1998)).       We    have   said,
    however, that instances in which the penalty prescribed under
    the FCA is unconstitutionally excessive will be “infrequent.”
    United States ex rel. Bunk v. Gosselin World Wide Moving, N.V.,
    
    741 F.3d 390
    , 408 (4th Cir. 2013).
    By contrast, the Due Process Clause “imposes substantive
    limits beyond which penalties may not go.”                     TXO Prod. Corp. v.
    Alliance    Res.   Corp.,    
    509 U.S. 443
    ,     453-54    (1993)     (internal
    quotation marks omitted) (Fourteenth Amendment case); Morgan v.
    Woessner, 
    997 F.2d 1244
    , 1255 (9th Cir. 1993) (finding that the
    Supreme Court’s analysis under the Due Process Clause of the
    Fourteenth Amendment applies equally under the Fifth Amendment),
    cited with approval in EEOC v. Fed. Express Corp., 
    513 F.3d 360
    ,
    376 (4th Cir. 2008).        Like the Eighth Amendment, the Due Process
    Clause does not apply to compensatory damage awards.                          This is
    because    compensatory     damages       “redress       the     concrete    loss    the
    plaintiff has suffered by reason of the defendant’s wrongful
    conduct,”    and   the    assessment       of     the    plaintiff’s        injury    is
    “essentially a factual determination.”                   Cooper Indus., 
    532 U.S. 47
    at 432.      On the other hand, punitive damages are “essentially
    ‘private fines’ intended to punish the defendant and to deter
    future      wrongdoing.”          
    Id. Consequently, there
      must     be
    “procedural and substantive constitutional limitations on these
    awards.”      See State Farm Mut. Auto Ins. Co. v. Campbell, 
    538 U.S. 408
    , 416 (2003).              Thus, the Due Process Clause imposes
    limits on “grossly excessive” monetary penalties that go beyond
    what   is    necessary     to    vindicate      the    government’s     “legitimate
    interests in punishment and deterrence.”                   BMW of N. Am., Inc. v.
    Gore, 
    517 U.S. 559
    , 562 (1996).
    The “FCA imposes damages that are essentially punitive in
    nature.”      Vt. Agency of Natural Res. v. United States ex rel.
    Stevens, 
    529 U.S. 765
    , 784 (2000).                    But the Supreme Court has
    also noted that the treble damages provision of the statute has
    a compensatory aspect, in that they account for the fact that
    some   amount   of    money      beyond    actual     damages   is    “necessary     to
    compensate the Government completely for the costs, delays, and
    inconveniences occasioned by fraudulent claims.”                        Cook Cnty.,
    Ill.   v.    United   States      ex    rel.    Chandler,     
    538 U.S. 119
    ,    130
    (2003).      Additionally, the provision allows the government to
    recover some measure of the amount it must pay to compensate
    relators in qui tam actions.               Id.; see also 31 U.S.C. § 3730(d)
    (“If   the    Government        proceeds    with      an   action    brought   by    [a
    relator, the relator] shall . . . receive at least 15 percent
    48
    but not more than 25 percent of the proceeds of the action or
    settlement of the claim . . . .”).                    On the other hand, the civil
    penalty is completely punitive.                    United States v. Mackby (Mackby
    I), 
    261 F.3d 821
    , 830 (9th Cir. 2001).
    The Supreme Court has instructed courts to consider three
    guideposts when reviewing punitive damages awards under the Due
    Process       Clause:    “(1)     the    degree       of     reprehensibility       of   the
    defendant’s misconduct; (2) the disparity between the actual or
    potential       harm     suffered       by    the    plaintiff      and    the     punitive
    damages       award;    and    (3)    the     difference        between    the     punitive
    damages awarded by the jury and the civil penalties authorized
    or imposed in comparable cases.”                19    State 
    Farm, 538 U.S. at 418
    .
    There is no reason to believe that the Court’s “approach to
    punitive       damages        under     the    Fifth         Amendment     would     differ
    dramatically from analysis under the Excessive Fines Clause.”
    
    Rogan, 517 F.3d at 454
    .
    The degree of reprehensibility of the defendant’s conduct
    is “[p]erhaps the most important indicium of the reasonableness
    of   a    punitive      damages      award.”         
    Gore, 517 U.S. at 575
    .    Of
    19
    Because the FCA’s civil penalty and treble damages
    provisions are Congressional mandates, we believe this final
    factor is not instructive here. Indeed, to the extent that the
    district court exercised any discretion at all, it did so by
    imposing the statutory minimum civil penalty for each fraudulent
    claim.
    49
    course, in this case the damages and penalties assessed against
    Tuomey are congressionally prescribed.                   31 U.S.C. § 3729(a)(1).
    As we have previously stated, the Stark Law expresses Congress’s
    judgment    of     the   reprehensibility        of    the    conduct       at    issue    by
    deeming services provided in violation of the law worthless.
    And “[t]he fact . . . that Congress provided for treble damages
    and an automatic civil monetary penalty per false claim shows
    that    Congress       believed      that    making     a     false    claim       to     the
    government is a serious offense.”                Mackby 
    II, 339 F.3d at 1018
    ;
    cf.    Rogan,    
    517 F.3d 454
       (“[O]ne        would    think    that       a    fine
    expressly authorized by statute could be higher than a penalty
    selected ad hoc by a jury.”).
    In   addition,     the     Supreme     Court     has    directed          courts    to
    evaluate     the    degree      of    reprehensibility         of     the    defendant’s
    conduct by considering whether:
    the harm caused was physical as opposed to economic;
    the tortious conduct evinced an indifference or a
    reckless disregard of the health or safety of others;
    the target of the conduct had financial vulnerability;
    the conduct involved repeated actions or was an
    isolated incident; and the harm was the result of
    intentional malice, trickery, or deceit, or mere
    accident.
    State 
    Farm, 538 U.S. at 419
    .                 While Tuomey’s conduct in this
    case does not implicate the first three factors, we think the
    last two are relevant here.                 See Saunders v. Branch Banking &
    Trust Co. of Va., 
    526 F.3d 142
    , 153 (4th Cir. 2008) (finding
    50
    that    even     the    presence      of    a     single       State        Farm    factor     “can
    provide    justification            for    a     substantial            award       of     punitive
    damages”).
    Clearly,        Tuomey’s      conduct         “involved          repeated         actions,”
    State    
    Farm, 538 U.S. at 419
    ,       as   it   submitted           21,730     false
    claims.        Thus, while the penalty is certainly severe, it is
    meant     to     reflect      the    sheer        breadth         of        the    fraud     Tuomey
    perpetrated upon the federal government.                          
    Bunk, 741 F.3d at 407
    -
    08 (explaining that the court was comfortable assessing high
    civil    penalties       in   FCA    actions          involving         a    large       number   of
    claims).          As     we   have        said,       “[w]hen          an     enormous       public
    undertaking        spawns      a     fraud        of      comparable              breadth     [high
    penalties] help[] to ensure what we reiterate is the primary
    purpose of the FCA: making the government completely whole.”
    
    Id. Substantial penalties
    also serve as a powerful mechanism to
    dissuade such a massive course of fraudulent conduct.                                       See 
    id. at 408.
           And the government has “a strong interest in preventing
    fraud” because “[f]raudulent claims make the administration of
    Medicare more difficult, and widespread fraud would undermine
    public confidence in the system.”                     Mackby 
    II, 339 F.3d at 1019
    .
    Nor were Tuomey’s actions in this case the result of a
    “mere accident.”          State 
    Farm, 538 U.S. at 419
    .                        Rather, the jury
    determined       that     Tuomey     submitted            false    claims          for     Medicare
    reimbursement “knowingly,” that is, with actual knowledge, in
    51
    deliberate ignorance, or with reckless disregard that the claims
    violated the Stark Law.                Under the circumstances, we agree with
    the government that “strong medicine is required to cure the
    defendant’s disrespect for the law.”                          
    Gore, 517 U.S. at 577
    .
    Next, we consider the disparity between actual harm and the
    punitive damages award.                     Specifically, we compare the actual
    damages assessed against Tuomey to the civil penalty and the
    portion    of       treble      damages          that       can   be     considered      punitive.
    Here,     we    can        properly         regard          the    entire       civil     penalty,
    $119,515,000,         as     punitive.             On       the   other       hand,    the   actual
    damages of $39,313,065 are entirely compensatory.                                     As discussed
    above,    the       additional        sum    of       $78,626,130         resulting      from    the
    trebling       of    actual     damages          is     a    hybrid      of    compensatory      and
    punitive damages.
    Although the Supreme Court has not told us where to draw
    the line, see 
    Chandler, 538 U.S. at 131
    , we may safely assume
    that the portion of the trebled award allocated to the relator
    is   compensatory.              See   
    id. Assuming further
          that    Drakeford
    receives the minimum amount allotted by the statute--that is
    fifteen    percent         of   the    total          recovery--the           relator    would    be
    entitled       to        $11,793,920         of         the       trebled       award,       leaving
    $66,832,210         to     be   allocated          to       punitive      damages.        By    this
    calculation,         the    portion         of    damages         that    is    compensatory      is
    $51,106,985 and the $186,347,210 balance is punitive.
    52
    While the Court has been reluctant to fix a bright-line
    ratio that punitive damages cannot exceed for purposes of the
    Due Process Clause, it has suggested that “an award of more than
    four times the amount of compensatory damages might be close to
    the line of constitutional impropriety.”               State 
    Farm, 538 U.S. at 425
    .    Here, the ratio of punitive damages to compensatory
    damages is approximately 3.6-to-1, which falls just under the
    ratio the Court deems constitutionally suspect. 20               We therefore
    conclude   that   the   damages     award    is    constitutional   under     the
    Fifth and Eighth Amendments.
    V.
    Finally,     we   do   not   discount   the    concerns   raised    by   our
    concurring colleague regarding the result in this case.                       But
    having no found no cause to upset the jury’s verdict in this
    case and no constitutional error, it is for Congress to consider
    whether changes to the Stark Law’s reach are in order.
    AFFIRMED
    20 The government contends that the ratio between the
    penalty awarded and the actual damages (after accounting for the
    relator’s recovery) may be as low as 2-to-1 or even 1-to-1.
    This calculation, however, ignores the treble damages award, a
    portion of which we consider to be punitive.
    53
    WYNN, Circuit Judge, concurring:
    Because Tuomey opened the door to the admission of Kevin
    McAnaney’s testimony by asserting an advice of counsel defense,
    and because I cannot say, based on the record before me, that no
    rational jury could have determined that Tuomey violated both
    the Stark Law and the False Claims Act, I concur in the outcome
    today.
    But I write separately to emphasize the troubling picture
    this   case   paints:     An   impenetrably   complex   set   of   laws   and
    regulations that will result in a likely death sentence for a
    community hospital in an already medically underserved area.
    I.
    Regarding the issue of whether the district court correctly
    granted a new trial, we review such a decision for abuse of
    discretion.     Cline v. Wal-Mart Stores, Inc., 
    144 F.3d 294
    , 301
    (4th Cir. 1998).        Similarly, we “review a trial court’s rulings
    on the admissibility of evidence for abuse of discretion,” and
    we will overturn such a ruling only if it is “arbitrary and
    irrational.”    United States v. Cole, 
    631 F.3d 146
    , 153 (4th Cir.
    2011) (quotation marks and citation omitted).
    A.
    Judge Perry, who presided over the first trial, excluded
    McAnaney’s testimony pursuant to Evidence Rule 408, which can be
    used to exclude evidence of settlement negotiations.                   Under Rule
    408, “conduct or a statement made during compromise negotiations
    about [a disputed] claim” is generally inadmissible when used to
    “prove or disprove the validity or amount of a disputed claim.”
    Fed. R. Evid. 408(a).
    It is unclear to me that the district court abused its
    discretion    in   determining    that       McAnaney’s   testimony     could    be
    excluded under Rule 408.         In his deposition testimony, McAnaney
    described himself as “a tie breaker” who was jointly hired by
    Drakeford and Tuomey when they could not agree about whether the
    contracts    violated   the     Stark    Law—arguably     a   disputed     claim.
    J.A.     139-41.     Tuomey’s    and     Drakeford’s      dispute      about    the
    legality of the contracts reached impasse and ended in Drakeford
    acting as a relator of this qui tam action only three months
    later.       Had   Drakeford    and     Tuomey    been    able    to    reach    an
    agreement, Drakeford presumably would not have filed this suit,
    in   which   the   government,     having       intervened,      now   stands    in
    Drakeford’s shoes.
    Rule 408’s exclusionary provision applies where a “dispute
    or a difference of opinion exists,” not just “when discussions
    crystallize to the point of threatened litigation.”                    Affiliated
    Mfrs., Inc. v. Aluminum Co. of Am., 
    56 F.3d 521
    , 527 (3d Cir.
    1995).     When viewed thusly, it is hard to say that Judge Perry
    55
    acted either arbitrarily or irrationally in deeming McAnaney’s
    testimony excludable.
    Crucially,       however,      evidence     subject       to   exclusion       under
    Rule 408 is so excludable “only if the evidence is offered to
    prove    either       liability    for    or    invalidity       of   a   claim   or    its
    amount;” otherwise, it may come in.                     Bituminous Const., Inc. v.
    Rucker    Enterprises,        Inc.,    
    816 F.2d 965
    ,    968   (4th    Cir.    1987)
    (emphasis added); Fed. R. Evid. 408(b) (“The court may admit
    this    evidence       for    another     purpose.”).            Stated      differently,
    “[s]ince the rule excludes only when the purpose is proving the
    validity or invalidity of the claim or its amount, an offer for
    another purpose is not within the rule.”                       2-408 Weinstein’s Fed.
    Evid.     §     408.08       (quotation        marks     and     citation       omitted).
    Therefore, if the McAnaney evidence was admissible for a purpose
    beyond the validity or amount of a disputed claim, Rule 408
    would provide no basis for barring it wholesale from the first
    trial.
    B.
    The     government     argues,         among     other    things,      that    the
    McAnaney evidence went to the heart of an issue wholly beyond
    the     scope    of    Rule    408’s     limited        exclusionary      ambit—namely,
    Tuomey’s advice of counsel defense.                    With this, I must agree.
    As explained by a district court in this Circuit in the
    context of a False Claims Act fraud claim, “good faith reliance
    56
    on the advice of counsel may contradict any suggestion that a
    [defendant] ‘knowingly’ submitted a false claim.”           United States
    v. Newport News Shipbuilding, Inc., 
    276 F. Supp. 2d 539
    , 565
    (E.D.    Va.   2003).   “[I]f   a   [defendant]   seeks   the   advice    of
    counsel in good faith, provides full and accurate information,
    receives advice which can be reasonably relied upon, and, in
    turn, faithfully follows that advice, it cannot be said that the
    defendant ‘knowingly’ submitted false information or acted with
    deliberate ignorance or reckless disregard of its falsity, even
    if that advice turns out in fact to be false.”            
    Id. See also,
    e.g., United States v. Butler, 
    211 F.3d 826
    , 833 (4th Cir. 2000)
    (identifying the elements of the advice of counsel defense as
    “(a) full disclosure of all pertinent facts to [a lawyer], and
    (b) good faith reliance on the [lawyer]’s advice”).
    When a party raises an advice of counsel defense, however,
    all advice on the pertinent topic becomes fair game.             “It has .
    . . become established that if a party interjects the ‘advice of
    counsel’ as an essential element of a claim or defense,” then
    “all    advice   received   concerning   the   same   subject   matter”   is
    discoverable, not subject to protection by the attorney-client
    privilege, and, by logical extension, admissible at trial.                 1
    McCormick On Evid. § 93 (7th ed. 2013).           See also, e.g., In re
    EchoStar Commc’ns Corp., 
    448 F.3d 1294
    , 1299 (Fed. Cir. 2006)
    (“Once a party announces that it will rely on advice of counsel
    57
    .    .    .    the    attorney-client      privilege          is    waived.           The   widely
    applied standard for determining the scope . . . is that the
    waiver applies to all other communications relating to the same
    subject matter. . . . Thus, when EchoStar chose to rely on the
    advice         of    in-house     counsel,       it        waived       the    attorney-client
    privilege           with   regard   to     any    attorney-client                  communications
    relating to the same subject matter, including communications
    with counsel other than in-house counsel, which would include”
    the advice of outside counsel.) (quotation marks and citation
    omitted).
    Here, there can be no doubt that Tuomey pressed an advice
    of       counsel      defense.      Tuomey      argued        to    the       first    jury,     for
    example, that “[t]he lawyers were the ones running the show . .
    . . All Tuomey did was accept their recommendations and vote on
    them if they thought that it was something that would be good
    for      the    hospital.        Advice    of    counsel           is    a    very,    very      good
    defense.            It is one that the law recognizes, and it is one that
    . . . fits perfectly in this situation.”                                Trial I, Transcript
    for Mar. 25, 2010, at 1986.
    Further,      the    district    court       instructed            the     jury   on   the
    advice         of    counsel    defense,    making          clear       that    it    provided     a
    vehicle for absolving Tuomey of False Claims Act liability.                                      The
    court instructed, among other things, that “the defendant has
    asserted        an    affirmative    defense          of    advice       of    counsel      to   the
    58
    United    States’         allegation      that           it   acted    in     violation         of     the
    False Claims Act.               An affirmative defense is an argument that,
    if     true,      will     defeat       the     government’s               claim.”         Trial        I,
    Transcript for Mar. 26, 2010, at 2098-99.                              Regarding what Tuomey
    needed       to    show    to     succeed       with          that    defense,        Judge          Perry
    instructed that “in order for the defendant to prevail on its
    affirmative defense of advice of counsel, Tuomey must prove the
    following: One, that the advice was sought in good faith; two,
    that    Tuomey       provided       full       and        accurate         information          to     the
    attorney; three, the advice could be reasonably relied upon;
    and, four, Tuomey faithfully followed the attorney’s advice.”
    
    Id. Having put
    the advice it got from its lawyers squarely at
    issue,    Tuomey         should    not    have           been   permitted       to     cherry-pick
    which     advice      of     counsel          the        jury   was        permitted       to        hear.
    Instead, the jury should have been allowed to consider all the
    advice of all Tuomey’s counsel—including McAnaney.
    The     record      makes       clear        that,       whatever       else     McAnaney’s
    assessment         was,    it    was    also        advice      of    counsel.          McAnaney’s
    engagement letter to Tuomey and Drakeford, who had hired him
    jointly, stated that McAnaney, a lawyer, had been “retained” to
    “review      and    advise”       the    parties          “with      respect     to    a    proposed
    business relationship.”                 J.A. 145.             McAnaney committed to being
    guided       by    the     parties’       “instructions               in     carrying      out        the
    59
    representation” and reporting to the parties his “conclusions”
    and “any potential compliance issues.”                  
    Id. In other
    words,
    McAnaney was Tuomey’s counsel, and he advised Tuomey about the
    contracts at the heart of this case.
    The record makes similarly clear that Tuomey did not follow
    McAnaney’s advice.        McAnaney advised Tuomey that the proposed
    contracts raised significant “red flags” under the Stark Law.
    J.A. 2054.      McAnaney advised that Tuomey would have difficulty
    persuading the government that the contracts did not compensate
    the physicians in excess of fair market value.                         And McAnaney
    warned   Tuomey    that   the    contracts      presented     “an   easy      case   to
    prosecute” for the government.                J.A. 2078.       Rather than heed
    this advice and back away from the contracts, however, Tuomey
    told McAnaney not to put his conclusions in writing and ended
    his engagement.
    Allowing      McAnaney’s    testimony      into    evidence       to    show    the
    advice he gave in light of Tuomey’s advice of counsel defense
    would    have   been   outside     of    Rule   408’s    limited       exclusionary
    ambit.     In     other   words,    by    pressing      an    advice    of    counsel
    defense, Tuomey itself opened the door for McAnaney’s testimony
    to come in, even if it otherwise might have been excludable
    under Rule 408.        See Fed. R. Evid. 408(b).               Despite this, the
    district court barred McAnaney’s testimony wholesale.
    60
    In keeping McAnaney out of the first trial, the district
    court prevented the jury from getting the full picture of what
    advice Tuomey had gotten from counsel.                  Tuomey told the jury
    that “[t]he lawyers were the ones running the show . . . All
    Tuomey   did     was      accept    their      recommendations.”      Trial    I,
    Transcript for Mar. 25, 2010, at 1986.               But the government was
    effectively      prevented    from    showing     that    Tuomey    had    gotten
    conflicting recommendations from its different counsel, picked
    its preferred advice, and discarded the rest.                    It is hard to
    imagine that this constituted anything other than a prejudicial
    abuse of discretion.          Cf. Rodriguez-Garcia v. Municipality of
    Caguas, 
    495 F.3d 1
    (1st Cir. 2007) (reversing because erroneous
    Rule 408 ruling hamstrung plaintiff’s ability to show elements
    of claim).
    In sum, in allowing Tuomey to press its advice of counsel
    defense and giving the jury an advice of counsel instruction yet
    preventing the jury from hearing all the advice that Tuomey got,
    the   district    court    abused    its     discretion   and    prejudiced   the
    government.      This error alone was grave enough to warrant a new
    trial.       Accordingly,     I,     too,    conclude     that   Judge    Perry’s
    decision to grant a new trial must be upheld.
    61
    II.
    Moving beyond the district court’s decision to grant a new
    trial, I agree with the majority that the jury’s determination
    that Tuomey violated both the Stark Law and the False Claims Act
    must stand.   Our standard of review at this juncture is a highly
    deferential   one,       “accord[ing]          the        utmost    respect    to    jury
    verdicts” and “constraining” us to affirm so long as the record
    contains “sufficient evidence for a reasonable jury” to have
    returned the verdict it did.             Lack v. Wal-Mart Stores, Inc., 
    240 F.3d 255
    , 259 (4th Cir. 2001).                  After careful review of the
    record, I cannot conclude that no reasonable jury could have
    reached the verdict before us.
    Nevertheless,       I    am    troubled         by    the     picture    this   case
    paints:    An impenetrably complex set of laws and regulations
    that will result in a likely death sentence for a community
    hospital in an already medically underserved area.
    A.
    The   Stark   Law       is,   at   its    core,       a   prohibition     on    self-
    referrals, barring doctors from referring patients for certain
    services to entities in which the doctors (or their immediate
    family members) have a financial interest, unless an exception
    applies.    Patrick A. Sutton, The Stark Law in Retrospect, 20
    Annals Health L. 15, 25-26 (2011).                   Further, entities providing
    62
    the pertinent services are prohibited from billing Medicare or
    Medicaid pursuant to such a prohibited referral.                    
    Id. “The Stark
      Law   is    a    strict    liability    statute     so   it   is
    immaterial       whether     one       intended    to   violate      the    law;     an
    inadvertent violation can trigger liability.”                   Paula Tironi, The
    “Stark” Reality: Is the Federal Physician Self-Referral Law Bad
    for the Health Care Industry?, 19 Annals Health L. 235, 237-38
    (2010).       Individuals and entities that violate the Stark Law can
    be    subject    to    severe     monetary      penalties     and   exclusion      from
    federal health care programs.              
    Id. These “steep
    civil sanctions
    and program exclusions may be ruinous.                   Health care providers
    are    open     to    extensive     liability,      their     financial     security
    resting uneasily upon a combination of their attorneys’ wits
    [and] prosecutorial discretion.”                  Jo-Ellyn Sakowitz Klein, The
    Stark Laws: Conquering Physician Conflicts of Interest?, 87 Geo.
    L.J. 499, 503-04 (1998).
    Despite attempts to establish “bright line” rules so that
    physicians and healthcare entities could “ensure compliance and
    minimize . . . costs,” 66 Fed. Reg. 856, 860 (Jan. 4, 2001), the
    Stark Law has proved challenging to understand and comply with.
    Indeed, “[t]he Stark law is infamous among health care lawyers
    and their clients for being complicated, confusing and counter-
    intuitive; for producing results that defy common sense, and
    sometimes elevating form over substance.                    Ironically, the Stark
    63
    law was actually intended to simplify life by creating ‘bright
    lines’    between        what    would      be    permitted         and    what        would       be
    disallowed, and creating certainty by removing intent from the
    equation.”     Charles B. Oppenheim, The Stark Law: Comprehensive
    Analysis + Practical Guide 1 (AHLA 5th ed. 2014).                                Some of the
    invective     used       to     describe     the       Stark    law       even    borders          on
    lyrical: “ambiguous[,] arcane[,] and very vague;” and “heaps of
    words in barely decipherable bureaucratese.”                              Steven D. Wales,
    The   Stark    Law:        Boon      or     Boondoggle?         An    Analysis          of     the
    Prohibition on Physician Self-Referrals, 27 Law & Psychol. Rev.
    1, 22-23 (2003) (quotation marks and citations omitted).
    Given this complexity and the strict liability nature of
    the   statute,       a    Stark      Law    “compliance          program         can    help        a
    physician or [] entity prove good faith and obtain leniency in
    the event of a violation; however, the Stark Law’s complexity
    and   frequent     revisions         make    it    difficult         for    physicians         and
    entities to develop and implement such programs.”                             Tironi, supra
    at 238.     Against this problematic backdrop, the availability of
    an advice of counsel defense should perhaps be especially robust
    in Stark Law cases prosecuted under the False Claims Act.
    B.
    The False Claims Act discourages fraud against the federal
    government    by     imposing        liability         on    “any    person      who     .     .    .
    knowingly     presents,         or   causes       to    be     presented,        a     false       or
    64
    fraudulent    claim   for    payment    or        approval.”       31   U.S.C.     §
    3729(a)(1)(A) (emphasis added).             The False Claims Act is meant
    “to indemnify the government . . . against losses caused by a
    defendant’s fraud,” Mikes v. Straus, 
    274 F.3d 687
    , 696 (2d Cir.
    2001) (citing United States. ex rel. Marcus v. Hess, 
    317 U.S. 537
    , 549, 551–52 (1943)), as opposed to a defendant’s mistake.
    Accordingly,     a     defendant       may    skirt   False      Claims     Act
    liability    by   showing    good   faith     reliance     on   the     advice    of
    counsel.     As the majority opinion recognizes, in fraud cases,
    “‘[i]f in good faith reliance upon legal advice given him by a
    lawyer to whom he has made full disclosure of the facts, one
    engages in a course of conduct later found to be illegal,” the
    trier of fact may conclude that the conduct was innocent because
    “‘the guilty mind’ was absent.”             Ante at 30-31 (quoting United
    States v. Painter, 
    314 F.2d 939
    , 943 (4th Cir. 1963)).
    In the context of the Stark Law, it is easy to see how even
    diligent counsel could wind up giving clients incorrect advice.
    Between the law’s being amended to have a broader scope but then
    narrowed with various exceptions, along with the promulgation
    and amendment of copious associated rules and regulations, “the
    Stark Law bec[ame] a classic example of a moving target.                         For
    lawyers, who must depend on the predictability of the law when
    they give counsel to their clients, such unpredictability [i]s
    an unusually heavy burden.”         Wales, supra at 21.
    65
    In this case, there can be no doubt that Tuomey sought and
    followed    the     advice    of    its     long-time     counsel,       Nexsen      Pruet.
    Nexsen Pruet drafted and approved the contracts at the heart of
    this litigation.          Tuomey and Nexsen Pruet consulted with others,
    including    the      nation’s       largest      healthcare       law     firm      and    a
    national         consulting        firm     with     expertise           in     physician
    compensation.             Those     experts,       too,        signed    off      on       the
    arrangements       (though    the     parties      dispute       whether       Tuomey      had
    shared     all     pertinent        information       for       purposes        of     these
    additional assessments).
    Nevertheless, as the majority opinion notes, “a reasonable
    jury could have concluded that Tuomey was . . . no longer acting
    in good faith reliance on the advice of its counsel when it
    refused     to     give    full     consideration         to    McAnaney’s        negative
    assessment of the” contracts.               
    Id. at 32.
            As already explained,
    McAnaney, the former Chief of the Industry Guidance Branch at
    the Department of Health and Human Services’ Office of Counsel
    to the Inspector General, also served as Tuomey’s counsel.                                 And
    he   advised       Tuomey     that        the    proposed       arrangements         raised
    significant red flags and may well be unlawful.                                Had Tuomey
    followed    McAnaney’s        advice,       it   likely        would    have    faced       no
    lawsuit in which to raise an advice of counsel, or any other,
    defense.
    66
    III.
    This case is troubling.      It seems as if, even for well-
    intentioned health care providers, the Stark Law has become a
    booby trap rigged with strict liability and potentially ruinous
    exposure—especially   when   coupled   with   the   False   Claims   Act.
    Yet, the district court did not abuse its discretion when it
    granted a new trial and the jury did not act irrationally when
    it determined that Tuomey violated both the Stark Law and the
    False Claims Act.     Accordingly, I must concur in the outcome
    reached by the majority.
    67
    

Document Info

Docket Number: 13-2219

Citation Numbers: 792 F.3d 364

Filed Date: 7/2/2015

Precedential Status: Precedential

Modified Date: 1/12/2023

Authorities (46)

Rodriguez-Garcia v. Municipality of Caguas , 495 F.3d 1 ( 2007 )

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United States Ex Rel. Clausen v. Laboratory Corp. of ... , 290 F.3d 1301 ( 2002 )

Affiliated Manufacturers, Inc. v. Aluminum Company of ... , 56 F.3d 521 ( 1995 )

patricia-s-mikes-us-govt-ex-rel-patricia-s-mikes , 274 F.3d 687 ( 2001 )

Lynne S. Taylor, and Keisha Johnson v. Virginia Union ... , 193 F.3d 219 ( 1999 )

Buckley v. Mukasey , 538 F.3d 306 ( 2008 )

Noel v. Artson , 641 F.3d 580 ( 2011 )

United States Ex Rel. Wilson v. Kellogg Brown & Root, Inc. , 525 F.3d 370 ( 2008 )

Nicholas Daskarolis and Helen Daskarolis v. The Firestone ... , 651 F.2d 937 ( 1981 )

United States Ex Rel. Drakeford v. Tuomey Healthcare System,... , 675 F.3d 394 ( 2012 )

bituminous-construction-inc-v-rucker-enterprises-inc-and-jack-jones , 816 F.2d 965 ( 1987 )

joyce-k-dennis-v-columbia-colleton-medical-center-incorporated-and , 290 F.3d 639 ( 2002 )

Saunders v. Branch Banking and Trust Co. of VA , 526 F.3d 142 ( 2008 )

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stephanie-p-austin-v-paramount-parks-incorporated-dba-kings-dominion , 195 F.3d 715 ( 1999 )

christopher-lack-and-susan-willis-v-wal-mart-stores-incorporated-a , 240 F.3d 255 ( 2001 )

henry-z-spell-v-charles-d-mcdaniel-individually-and-as-patrolman-city , 824 F.2d 1380 ( 1987 )

United States v. Finley McAdoo Painter , 314 F.2d 939 ( 1963 )

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