MD Anderson v. HHS ( 2021 )


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  • Case: 19-60226     Document: 00515706891          Page: 1    Date Filed: 01/14/2021
    United States Court of Appeals
    for the Fifth Circuit
    United States Court of Appeals
    Fifth Circuit
    FILED
    January 14, 2021
    No. 19-60226                         Lyle W. Cayce
    Clerk
    University of Texas M.D. Anderson Cancer Center,
    Petitioner,
    versus
    United States Department of Health and Human
    Services,
    Respondent.
    On Petition for Review of a Final Agency Decision
    of the U.S. Department of Health and Human Services
    Before Wiener, Engelhardt, and Oldham, Circuit Judges.
    Andrew S. Oldham, Circuit Judge:
    Employees of the University of Texas M.D. Anderson Cancer Center
    (“M.D. Anderson” or “Petitioner”) lost patients’ data. In response, the
    United States Department of Health and Human Services (“HHS” or the
    “Government”) fined M.D. Anderson $4,348,000. After M.D. Anderson
    filed its petition for review, HHS conceded that it could not defend a fine in
    excess of $450,000. The Government’s decision was arbitrary, capricious,
    and contrary to law. We grant the petition for review and vacate the penalty.
    Case: 19-60226     Document: 00515706891           Page: 2   Date Filed: 01/14/2021
    No. 19-60226
    I.
    Three unfortunate events set the stage for this lawsuit. First, back in
    2012, an M.D. Anderson faculty member’s laptop was stolen. The laptop was
    not encrypted or password-protected but contained “electronic protected
    health information (ePHI) for 29,021 individuals.” Second, also in 2012, an
    M.D. Anderson trainee lost an unencrypted USB thumb drive during her
    evening commute. That thumb drive contained ePHI for over 2,000
    individuals. Finally, in 2013, a visiting researcher at M.D. Anderson
    misplaced another unencrypted USB thumb drive, this time containing ePHI
    for nearly 3,600 individuals.
    M.D. Anderson disclosed these incidents to HHS. Then HHS
    determined that M.D. Anderson had violated two federal regulations. HHS
    promulgated both of those regulations under the Health Insurance Portability
    and Accountability Act of 1996 (“HIPAA”) and the Health Information
    Technology for Economic and Clinical Health Act of 2009 (the “HITECH
    Act”). The first regulation requires entities covered by HIPAA and the
    HITECH Act to “[i]mplement a mechanism to encrypt” ePHI or adopt
    some other “reasonable and appropriate” method to limit access to patient
    data. 
    45 C.F.R. §§ 164.312
    (a)(2)(iv), 164.306(d) (the “Encryption Rule”).
    The second regulation prohibits the unpermitted disclosure of protected
    health information. 
    Id.
     § 164.502(a) (the “Disclosure Rule”).
    HHS also determined that M.D. Anderson had “reasonable cause” to
    know that it had violated the rules. 42 U.S.C. § 1320d-5(a)(1)(B) (setting out
    the “reasonable cause” culpability standard). So, in a purported exercise of
    its power under 42 U.S.C. § 1320d-5 (HIPAA’s enforcement provision),
    HHS assessed daily penalties of $1,348,000 for the Encryption Rule
    violations, $1,500,000 for the 2012 Disclosure Rule violations, and
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    $1,500,000 for the 2013 Disclosure Rule violations. In total, HHS imposed a
    civil monetary penalty (“CMP” or “penalty”) of $4,348,000.
    M.D. Anderson unsuccessfully worked its way through two levels of
    administrative appeals. Then it petitioned our court for review. See 42 U.S.C.
    § 1320a-7a(e) (authorizing judicial review). After M.D. Anderson filed its
    petition, the Government conceded that it could not defend its penalty and
    asked us to reduce it by a factor of 10 to $450,000.
    II.
    The principal argument in M.D. Anderson’s petition is that a state
    agency is not a “person” covered by HIPAA’s enforcement provision. See
    42 U.S.C. § 1320d-5. For the sake of today’s decision, we assume that M.D.
    Anderson is such a “person” and that the enforcement provision therefore
    applies. The petition for review nonetheless must be granted for an
    independent reason: the CMP violates the Administrative Procedure Act
    (“APA”).
    A.
    The APA directs us to “hold unlawful and set aside” agency actions
    that are “arbitrary, capricious, an abuse of discretion, or otherwise not in
    accordance with law.” 
    5 U.S.C. § 706
    (2); see Windsor Place v. U.S. Dep’t of
    Health & Hum. Servs., 
    649 F.3d 293
    , 297 (5th Cir. 2011) (per curiam). To that
    end, we must “insist that an agency examine the relevant data and articulate
    a satisfactory explanation for its action.” FCC v. Fox Television Stations, Inc.,
    
    556 U.S. 502
    , 513 (2009) (quotation omitted). Our review is “searching and
    careful,” Marsh v. Or. Nat. Res. Council, 
    490 U.S. 360
    , 378 (1989) (quotation
    omitted), and we only consider the reasoning “articulated by the agency
    itself,” Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 
    463 U.S. 29
    , 50 (1983). Post hoc rationalizations offered by the Government’s counsel
    are irrelevant. See 
    ibid.
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    In conducting arbitrary-and-capricious review, we must ensure that
    the agency did not “entirely fail[] to consider an important aspect of the
    problem” that it seeks to address. 
    Id. at 43
    . And we must reject “an
    explanation for its decision that runs counter to the evidence before the
    agency, or is so implausible that it could not be ascribed to a difference in
    view or the product of agency expertise.” 
    Ibid.
     Put simply, we must set aside
    any action premised on reasoning that fails to account for “relevant factors”
    or evinces “a clear error of judgment.” Marsh, 
    490 U.S. at 378
     (quotation
    omitted).
    The Supreme Court also has “made clear, however, that a court is not
    to substitute its judgment for that of the agency and should uphold a decision
    of less than ideal clarity if the agency’s path may reasonably be discerned.”
    Fox, 
    556 U.S. at
    513–14 (quotation omitted). “Agencies . . . have expertise
    and experience in administering their statutes that no court can properly
    ignore.” Judulang v. Holder, 
    565 U.S. 42
    , 53 (2011). “Fundamentally, the
    argument about agency expertise is less about the expertise of agencies in
    interpreting language than it is about the wisdom of according agencies broad
    flexibility to administer statutory schemes.” Perez v. Mortg. Bankers Ass’n,
    
    575 U.S. 92
    , 129 (2015) (Thomas, J., concurring in the judgment).
    But in this case, HHS steadfastly refused to interpret the statutes at
    all. The administrative law judge (“ALJ”) began his opinion by emphasizing
    that he would “not address” any of M.D. Anderson’s constitutional or
    statutory arguments. The ALJ understood his authority to extend only to
    enforcing HHS’s regulations—not to interpreting HIPAA, the HITECH
    Act, any other statute, or any provision of the U.S. Constitution. As the ALJ
    put it: “My authority to hear and decide this case rests entirely on a
    delegation from the Secretary [of HHS]. Nothing in that delegation
    authorizes me to find that the Secretary’s regulations are ultra vires.”
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    The ALJ likewise refused to consider whether the multi-million-dollar
    CMP was arbitrary or capricious. In response to M.D. Anderson’s argument
    that the CMPs in “other instances of ePHI loss . . . were far more lenient than
    what [the agency] requested in this case,” the ALJ concluded: “I do not
    evaluate penalties based on a comparative standard. There is nothing in the
    regulations that suggests that I do so.”
    HHS’s Departmental Appeals Board agreed with the ALJ. It held that
    M.D. Anderson is “free to make its ultra vires argument to a court, but we
    may not invalidate a regulation.” And the Board likewise agreed with the ALJ
    that the agency has no power to review penalties for arbitrariness or
    capriciousness because “there is nothing in the regulations that suggests that
    the ALJ evaluate penalties based on a comparative standard.”
    Thus, with respect to M.D. Anderson’s APA arguments—whether
    the CMP is arbitrary, capricious, or otherwise inconsistent with Congress’s
    statutes—it is impossible for us to substitute our judgment for the agency’s.
    See Fox, 
    556 U.S. at
    513–14. That’s because the agency itself repeatedly
    insisted that it was not offering a judgment at all. In accordance with HHS’s
    steadfast insistence in the administrative record, our review of M.D.
    Anderson’s statutory arguments is de novo.
    Our review of M.D. Anderson’s regulatory arguments is also de novo.
    As the Supreme Court recently emphasized, “a court should not afford Auer
    deference unless the regulation is genuinely ambiguous.” Kisor v. Wilkie, 
    139 S. Ct. 2400
    , 2415 (2019). 1 HHS never suggests that its regulations are
    1
    The Supreme Court “has often deferred to agencies’ reasonable readings of
    genuinely ambiguous regulations.” 
    Id. at 2408
    . It “call[s] that practice Auer deference, or
    sometimes Seminole Rock deference, after two cases in which [the Court] employed it.”
    
    Ibid.
     (citing Auer v. Robbins, 
    519 U.S. 452
     (1997); Bowles v. Seminole Rock & Sand Co., 
    325 U.S. 410
     (1945)).
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    ambiguous, nor does it even cite Auer. Therefore, each HHS regulation “just
    means what it means—and the court must give it effect, as the court would
    any law.” 
    Ibid.
    B.
    The Government’s CMP order against M.D. Anderson was arbitrary,
    capricious, and otherwise unlawful. That’s for at least four independent
    reasons.
    1.
    Let’s start with the Encryption Rule. That Rule provides, in relevant
    part, that a HIPAA-covered entity must “[i]mplement a mechanism to
    encrypt and decrypt electronic protected health information.” 
    45 C.F.R. § 164.312
    (a)(2)(iv) (emphasis added). 2 It is undisputed that M.D. Anderson
    implemented “a mechanism.” For example, M.D. Anderson’s “Information
    Resources Acceptable Use Agreement and User Acknowledgement for
    Employees” specified: “If confidential or protected MDACC data is stored
    on portable computing devices, it must be encrypted and backed up to a
    network server for recovery in the event of a disaster or loss of information.”
    M.D. Anderson furnished its employees an “IronKey” to encrypt and
    decrypt mobile devices and trained its employees on how to use it. M.D.
    Anderson also implemented a mechanism to encrypt emails. And M.D.
    Anderson implemented various other mechanisms for file-level encryption in
    2
    The parties agree that the Encryption Rule does not require all entities to adopt
    such “a mechanism.” Encryption is a so-called “addressable” requirement, which means
    that a covered entity can “address” it by explaining why it’s not “reasonable and
    appropriate” under that covered entity’s particular circumstances. See 
    45 C.F.R. § 164.306
    (d). It’s undisputed that M.D. Anderson thought an encryption mechanism was
    reasonable and appropriate, and that it attempted to adopt one that satisfied the Encryption
    Rule. Therefore, for purposes of this opinion, we ignore the “addressability” carveout to
    the Encryption Rule.
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    its ClinicStation software. Petitioner plainly implemented “a mechanism” to
    encrypt ePHI.
    The dispute in this case is whether M.D. Anderson should’ve done
    more—either to implement a different mechanism or to better implement its
    chosen mechanism. The Government adamantly argues yes. First, HHS
    argues that M.D. Anderson’s internal documents show that Petitioner
    wanted to strengthen its mechanisms for protecting ePHI. But it’s plainly
    irrational to say that M.D. Anderson’s desire to do more in the future means
    that in the past it “failed to encrypt patient data on portable media at all.”
    Red Br. 48 (emphasis by HHS).
    Second, the Government argues that the stolen laptop and the two lost
    USB drives were not encrypted at all. That appears undisputed. But that does
    not mean M.D. Anderson failed to implement “a mechanism” to encrypt
    ePHI. It means only that three employees failed to abide by the encryption
    mechanism, or that M.D. Anderson did not enforce that mechanism
    rigorously enough. And nothing in HHS’s regulation says that a covered
    entity’s failure to encrypt three devices means that it never implemented “a
    mechanism” to encrypt anything at all.
    For example, imagine that a covered entity has a million USB drives.
    It pays millions of dollars for military-grade encryption of those drives, with
    the expectation that they would be impervious to the most sophisticated
    computer hackers on earth. Then the covered entity puts ePHI on the drives.
    What happens if a new hacker nonetheless decrypts three of them? Or what
    if someone in the factory accidentally fails to encrypt three USB drives, and
    they get stolen? Under the Government’s theory, the covered entity violated
    the Encryption Rule because the decrypted or unencrypted devices prove res
    ipsa it could’ve done more. As the ALJ understood the Encryption Rule, it
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    “require[s] covered entities to assure that all systems containing ePHI be
    inaccessible to unauthorized users.” Period. Full stop. No exceptions. 3
    But that’s not the regulation HHS wrote. The regulation requires only
    “a mechanism” for encryption. It does not require a covered entity to
    warrant that its mechanism provides bulletproof protection of “all systems
    containing ePHI.” Nor does it require covered entities to warrant that all
    ePHI is always and everywhere “inaccessible to unauthorized users.” Nor
    does the regulation prohibit a covered entity from creating “a mechanism”
    by directing its employees to sign an Acceptable Use Agreement that requires
    encryption of portable devices. Nor does it say that providing employees an
    IronKey is insufficient to create a compliant mechanism. Nor does it say
    anything about how effective a mechanism must be, how universally it must
    be enforced, or how impervious to human error or hacker malfeasance it must
    be. The regulation simply says “a mechanism.” M.D. Anderson
    undisputedly had “a mechanism,” even if it could’ve or should’ve had a
    better one. So M.D. Anderson satisfied HHS’s regulatory requirement, even
    if the Government now wishes it had written a different one.
    3
    It’s no answer to say, as the Government does, that there’s a significant difference
    between M.D. Anderson and the hypothetical herculean covered entity that pays millions
    of dollars for military-grade encryption on some of its portable devices. As M.D. Anderson
    points out, there’s ample evidence in the administrative record that Petitioner spent
    considerable money and energy protecting ePHI and implementing improvements to its
    ePHI protections. And in all events, the Encryption Rule does not contain a Herculean-
    Efforts Exception that protects one covered entity and not another based on how hard they
    try to encrypt ePHI. As relevant here, see supra note 2, the Rule requires all covered entities
    to establish “a mechanism.” And a covered entity either satisfies that requirement by
    creating “a mechanism” (as M.D. Anderson argues) or it faces strict liability for creating
    no mechanism at all if three of its devices are unencrypted or decrypted (as HHS argues).
    As explained above, we agree with M.D. Anderson. If HHS wants to police just how
    herculean a covered entity must be in encrypting ePHI, the Government can propose a rule
    to that effect and attempt to square it with the statutes Congress enacted.
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    2.
    Next consider the Disclosure Rule. With exceptions not relevant here,
    that Rule prohibits a covered entity from “disclos[ing]” ePHI. 
    45 C.F.R. § 164.502
    (a). And the Rule defines “disclosure” to “mean[] the release,
    transfer, provision of access to, or divulging in any manner of information
    outside the entity holding the information.” 
    Id.
     § 160.103. The ALJ seized on
    the word “release” and concluded that a covered entity violates the
    Disclosure Rule whenever it loses control of ePHI—regardless of whether
    anyone outside of M.D. Anderson accesses it.
    That interpretation departs from the regulation HHS wrote in at least
    three ways. First, each verb HHS uses to define “disclosure”—release,
    transfer, provide, and divulge—suggests an affirmative act of disclosure, not
    a passive loss of information. One does not ordinarily “transfer” or
    “provide” something as a sideline observer but as an active participant. The
    ALJ recognized as much when he defined “release” as “the act of setting
    something free.” But then he made the arbitrary jump to the conclusion that
    “any loss of ePHI is a ‘release,’” even if the covered entity did not act to set
    free anything. It defies reason to say an entity affirmatively acts to disclose
    information when someone steals it. That is not how HHS defined
    “disclosure” in the regulation. So HHS may not define it that way in an
    adjudication. 4
    4
    That is not to say that a covered entity must knowingly act to disclose ePHI to
    violate HIPAA. To the contrary, Congress specified penalties for unknowing violations. See
    42 U.S.C. § 1320d-5(a)(1)(A) (prescribing penalties where the entity “did not know” it
    committed a violation); cf. infra at 12 (discussing statutory penalties for “reasonable cause”
    and “willful neglect” violations). One can affirmatively disclose something to someone
    outside a covered entity and do so unknowingly—say, by emailing protected information
    to the wrong “John Doe.”
    9
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    Second, each of the regulation’s disclosure-defining verbs is
    transitive. The Disclosure Rule prohibits the release, transfer, provision, and
    divulging of a particular object—namely, “information.” 
    45 C.F.R. § 160.103
    . And the Government nowhere explains how “information” can
    be released, transferred, provided, or divulged without someone to receive it
    and hence be informed by it. To the contrary, the regulation appears to define
    “disclosure” in accordance with its ordinary meaning, which requires
    information to be “made known” to someone. See Webster’s New
    International Dictionary 743 (2d ed. 1934; 1950). HHS never
    explains how someone could “disclose” a secret without actually making it
    known to someone. Nor can we imagine a way.
    Third, the Disclosure Rule does not prohibit disclosure to just any
    someone. The ePHI must be disclosed to someone “outside” of the covered
    entity. 
    45 C.F.R. § 160.103
    . The Government’s loss-of-control standard
    means that a covered entity can be liable under the Disclosure Rule if one
    employee shares or steals another employee’s laptop. But that interpretation
    renders the word “outside” in § 160.103 meaningless surplusage. See Nat’l
    Ass’n of Home Builders v. Defs. of Wildlife, 
    551 U.S. 644
    , 668–69 (2007)
    (rejecting an interpretation that “would render the regulation entirely
    superfluous”). We therefore refuse to interpret § 160.103 to mean that HHS
    can prove that M.D. Anderson “disclosed” ePHI without proving that
    someone “outside” the entity received it. And the Government concedes it
    cannot meet that standard.
    The Government’s principal response is that it will be difficult for
    HHS to enforce the Disclosure Rule if it must show that ePHI was disclosed
    to someone, and harder still if it must show that ePHI was disclosed
    “outside” of the covered entity. Maybe so, maybe not. But that’s precisely
    the sort of policy argument that HHS could vet in a rulemaking proceeding.
    10
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    It’s not an acceptable basis for urging us to transmogrify the regulation HHS
    wrote into a broader one.
    3.
    Third, one of the most remarkable aspects of the ALJ’s order is its
    insistence that the Government can arbitrarily and capriciously enforce the
    CMP rules against some covered entities and not others. The ALJ insisted
    that “I do not evaluate penalties based on a comparative standard. There is
    nothing in the [HHS] regulations that suggests that I do so.” The
    Departmental Appeals Board agreed with the ALJ’s legal reasoning.
    It is a bedrock principle of administrative law that an agency
    must “treat like cases alike.” 32 Charles Alan Wright & Charles
    H. Koch, Federal Practice and Procedure § 8248, at
    431 (2006); see also Nat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs.,
    
    545 U.S. 967
    , 981 (2005) (“Unexplained inconsistency is . . . a reason for
    holding [agency action] to be . . . arbitrary and capricious . . . .”); Burlington
    N. & Santa Fe Ry. Co. v. Surface Transp. Bd., 
    403 F.3d 771
    , 776 (D.C. Cir.
    2005) (“An agency must provide an adequate explanation to justify treating
    similarly situated parties differently.”); Wright & Koch, supra, § 8248,
    at 431 (“General principles of administrative law hold that an agency must
    be consistent . . . .”). This principle is an outgrowth of the old adage from
    State Farm that “an agency changing its course must supply a reasoned
    analysis.” 
    463 U.S. at 57
     (quotation omitted); accord Fox, 
    556 U.S. at 515
    (“[T]he requirement that an agency provide reasoned explanation for its
    action . . . ordinarily demand[s] that it display awareness that it is changing
    position. . . . [T]he agency must show that there are good reasons for the new
    [position].” (emphasis omitted) (citation omitted)); Jupiter Energy Corp. v.
    FERC, 
    407 F.3d 346
    , 349 (5th Cir. 2005) (agency action is arbitrary and
    capricious when it fails to “supply a reasoned analysis for any departure from
    11
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    other agency decisions” (quotation omitted)); Comcast Corp. v. FCC, 
    526 F.3d 763
    , 769 (D.C. Cir. 2008) (“[A]n agency’s unexplained departure from
    precedent must be overturned as arbitrary and capricious.”).
    But in this case, M.D. Anderson proffered examples of other covered
    entities that violated the Government’s understanding of the Encryption
    Rule and faced zero financial penalties. For example, a Cedars-Sinai
    employee lost an unencrypted laptop containing ePHI for more than 33,000
    patients in a burglary. HHS investigated and imposed no penalty at all. The
    Government has offered no reasoned justification for imposing zero penalty
    on one covered entity and a multi-million-dollar penalty on another.
    The Government’s only response is that it evaluates each case on its
    individual facts. As it must. But an administrative agency cannot hide behind
    the fact-intensive nature of penalty adjudications to ignore irrational
    distinctions between like cases. See LeMoyne-Owen Coll. v. NLRB, 
    357 F.3d 55
    , 61 (D.C. Cir. 2004) (“[W]here, as here, a party makes a significant
    showing that analogous cases have been decided differently, the agency must
    do more than simply ignore that argument.”). Were it otherwise, an agency
    could give free passes to its friends and hammer its enemies—while also
    maintaining that its decisions are judicially unreviewable because each case
    is unique. Suffice it to say the APA prohibits that approach.
    4.
    Fourth, the penalty amounts. The ALJ found that M.D. Anderson’s
    violations of the Encryption Rule and the Disclosure Rule were attributable
    to “reasonable cause” and not “willful neglect.” 42 U.S.C. § 1320d-
    5(a)(1)(B). For such “reasonable cause” violations, Congress specified that
    “the total amount imposed on the person for all such violations of an identical
    requirement or prohibition during a calendar year may not exceed
    $100,000.” Id. § 1320d-5(a)(3)(B). The ALJ and the Departmental Appeals
    12
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    Board nevertheless determined that the per-year statutory cap was
    $1,500,000. Then the agency determined that M.D. Anderson owed
    $1,348,000 over the calendar years 2011, 2012, and 2013 for violating the
    Encryption Rule and $3,000,000 for calendar years 2012 and 2013 for
    violating the Disclosure Rule.
    Again, that’s arbitrary, capricious, and contrary to law. Congress
    specified that the per-year cap for all reasonable-cause violations is
    $100,000—not $1,500,000. See 42 U.S.C. § 1320d-5(a)(3)(B); cf. Util. Air
    Regul. Grp. v. EPA, 
    573 U.S. 302
    , 328 (2014) (holding agency has no power
    to rewrite numerical thresholds imposed by Congress). Two months after the
    Departmental Appeals Board’s decision in this case, HHS conceded that it
    had misinterpreted the statutory caps. And it published a “Notice of
    Enforcement Discretion Regarding HIPAA Civil Money Penalties” to
    explain its mea culpa. See 
    84 Fed. Reg. 18,151
    , 18,153 (Apr. 30, 2019). In its
    mea culpa, HHS said that “[u]pon further review of the statute by the HHS
    Office of the General Counsel,” it would exercise “enforcement discretion”
    to follow the statutory caps in 42 U.S.C. § 1320d-5(a)(3)(B). Ibid. (citing
    Heckler v. Chaney, 
    470 U.S. 821
    , 831 (1985)). 5
    5
    Section 1320d-5(a)(1)(B) says that reasonable-cause violations shall incur “a
    penalty for each such violation of an amount that is at least the amount described in
    paragraph (3)(B) but not to exceed the amount described in paragraph (3)(D).” Paragraph
    (3)(B) in turn imposes a per-violation amount of $1,000, and paragraph (3)(D) imposes a
    per-violation amount of $50,000. It is quite obvious from that statutory text that each
    reasonable-cause violation can be penalized from $1,000 to $50,000—but the total of all
    reasonable-cause violations for a calendar year cannot exceed $100,000. In the ALJ’s CMP
    order and the Departmental Appeals Board’s decision, however, HHS said each
    reasonable-cause violation can be penalized from $1,000 to $50,000 up to the calendar-
    year limit of $1,500,000 that applies to uncorrected willful-neglect violations. See 42 U.S.C.
    § 1320d-5(a)(1)(C)(ii). In addition to nonsensically conflating the fault levels specified by
    Congress, HHS’s interpretation rendered meaningless surplusage the statutory cap for
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    We take the opportunity to reiterate what we’ve said before: neither
    “enforcement discretion” nor Heckler v. Chaney empowers an agency to
    disregard Congress’s statutes. See Texas v. United States, 
    809 F.3d 134
    , 152
    n.34 (5th Cir. 2015) (citing Heckler, 
    470 U.S. at 831
    ), aff’d by an equally
    divided Court, 
    136 S. Ct. 2271
     (2016) (per curiam). And the fact that HHS
    later recognized its error in a notice of “enforcement discretion” does
    nothing to change the text of the regulations HHS promulgated through
    notice and comment. Nor does it cure the erroneous premises of the
    decisions by the ALJ and the Departmental Appeals Board.
    Those erroneous premises are particularly problematic because they
    tainted other parts of HHS’s decision. For example, HHS’s own regulations
    require it to consider the following factors (among others) in assessing a
    CMP:
    (1) Whether the violation caused physical harm;
    (2) Whether the violation resulted in financial harm;
    (3) Whether the violation resulted in harm to an individual’s
    reputation; and
    (4) Whether the violation hindered an individual’s ability to
    obtain health care.
    
    45 C.F.R. § 160.408
    (b). It’s undisputed that HHS can prove none of these.
    But the ALJ justified ignoring them because “the penalties that I determine
    to impose are but a small fraction of the maximum penalties that are
    reasonable-cause violations. But see Corley v. United States, 
    556 U.S. 303
    , 314 (2009)
    (emphasizing “one of the most basic interpretive canons, that a statute should be construed
    so that effect is given to all its provisions, so that no part will be inoperative or superfluous,
    void or insignificant” (quotation omitted)). The indefensibility of its prior interpretation
    presumably explains HHS’s notice of “enforcement discretion.”
    14
    Case: 19-60226    Document: 00515706891             Page: 15   Date Filed: 01/14/2021
    No. 19-60226
    permitted by regulation”—a regulation that HHS now concedes in its
    “enforcement discretion” is unlawful.
    *        *         *
    The Government has offered no lawful basis for its civil monetary
    penalties against M.D. Anderson. The petition for review is GRANTED.
    The CMP order is VACATED. And the matter is REMANDED for
    further proceedings consistent with this opinion.
    15