Fresnius Medical Care Holdings, Inc. v. Elisabeth Tucker, M.D. ( 2013 )


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  •              Case: 11-14192   Date Filed: 01/10/2013   Page: 1 of 23
    [PUBLISH]
    IN THE UNITED STATES COURT OF APPEALS
    FOR THE ELEVENTH CIRCUIT
    _____________
    No. 11-14192
    _____________
    D. C. Docket No. 4:03-cv-00411-SPM-GRJ
    FRESENIUS MEDICAL CARE HOLDINGS, INC.,
    a Foreign Corporation
    d.b.a. Fresenius Medical Care North America,
    DAVITA, INC.,
    a Foreign Corporation,
    Plaintiffs-Appellants,
    DVA RENAL HEALTHCARE, INC.,
    a Foreign Corporation
    Plaintiff,
    versus
    ELISABETH TUCKER, M.D.,
    in her official capacity as Chair of the
    Florida Board of Medicine,
    M. RONY FRANCOIS, MD MPHS PhD,
    MAMMEN ZACHARIAH, MD,
    MARK S. AVILA, MD,
    H. FRANK FARMER, JR., MD, et al.,
    Defendants-Appellees.
    Case: 11-14192       Date Filed: 01/10/2013      Page: 2 of 23
    ______________
    Appeal from the United States District Court
    for the Northern District of Florida
    ______________
    (January 10, 2013)
    Before DUBINA, Chief Judge, CARNES and GILMAN, ∗ Circuit Judges.
    DUBINA, Chief Judge:
    This case involves a constitutional challenge to Florida’s “Patient Self-
    Referral Act of 1992” (the “Florida Act”), FLA. STAT. § 456.053, which prohibits
    Florida physicians from referring their patients for services to business entities in
    which the referring physicians have a financial interest. Appellants Fresenius
    Medical Care Holdings, Inc., DVA Renal Healthcare, Inc., and Davita, Inc.
    (collectively “Appellants”) sued the Secretary of the Florida Department of Health,
    the members of the Florida Board of Medicine, and the members of the Florida
    Board of Osteopathic Medicine (collectively “Florida”) seeking declaratory and
    injunctive relief. Appellants allege that the Florida Act is unconstitutional because
    it is (1) preempted by federal law, (2) violative of the dormant Commerce Clause,
    and (3) violative of substantive due process. The district court found no
    constitutional violation and granted summary judgment in favor of Florida. After
    ∗
    Honorable Ronald Lee Gilman, United States Circuit Judge for the Sixth Circuit, sitting
    by designation.
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    considering the parties’ briefs and having the benefit of oral argument, we affirm
    the judgment of the district court.
    I.
    A. Statutory background
    Federal Stark laws
    In an effort to contain health care costs and reduce conflicts of interest,
    Congress passed legislation in 1989 and 1993 that prohibits physicians from
    referring their Medicare and Medicaid patients to business entities in which the
    physicians or their immediate family members have a financial interest. See Pub.
    L. No. 101-239, 103 Stat. 2106 (codified at 42 U.S.C. § 1395nn(a)); Pub. L. No.
    103-66, 107 Stat. 312 (same). The laws are respectively known as “Stark I” and
    “Stark II,” and we collectively refer to them as “Stark.” In promulgating
    regulations to implement Stark, the Secretary of Health and Human Services (the
    “Secretary”) has created various exemptions from the physician self-referral ban,
    including two exemptions relevant to this case. First, Stark exempts physician
    referrals to associated entities for clinical laboratory services related to the
    treatment of end-stage renal disease (“ESRD”). See 42 C.F.R. § 411.351. Second,
    Stark allows physician referrals for designated health services, including laboratory
    services, to entities owned by a publicly traded company in which the referring
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    physician is a shareholder, so long as the company has stockholder equity in excess
    of $75 million. See 
    id. § 411.356(a).
    All Appellants benefit from the former
    exemption, and Davita and Fresenius also benefit from the latter.
    The Florida Act
    In 1992, the Florida Legislature enacted the challenged statute for reasons
    similar to Congress’s reasons for enacting Stark, finding specifically that physician
    self-referral practices “may limit or eliminate competitive alternatives in the health
    care services market, may result in overutilization of health care services, may
    increase costs to the health care system, and may adversely affect the quality of
    health care.” FLA. STAT. § 456.053(2). Thus, the Florida Act essentially serves the
    same purpose as Stark by regulating physician self-referrals. The Florida Act
    makes unlawful (1) a physician’s referral of a patient to a clinical laboratory
    service provider in which the physician has an ownership or other financial interest
    or (2) any presentation of a claim for payment for health care services rendered in
    violation of the Act. 
    Id. § 456.053(5)(a),
    (c). The statute provides that violators
    are subject to disciplinary action by the State of Florida and a civil penalty of not
    more than $15,000 for knowing violations. 
    Id. § 456.053(5)(e),
    (g). Originally,
    the Florida Act, like Stark, exempted physicians in the renal dialysis industry from
    the self-referral prohibition. See 
    id. § 455.654(3)(o)3.h.,
    3.l. (2000).
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    Most ESRD patients in Florida are covered by Medicare or Medicaid, 1 and
    most qualify for benefits under Medicare’s ESRD program that reimburses dialysis
    clinics for laboratory services through a bundled rate that includes payment for
    dialysis care and laboratory services. Apparently, the single rate reimbursement
    strongly reduces the risk of fraud or excessive costs to patients or the government.
    For this reason, the Florida House of Representatives Committee on Health
    Regulation in 2001 recommended against removing the physician self-referral
    exemption for Florida doctors serving ESRD patients. Nevertheless, the Florida
    Legislature amended the Florida Act in 2002 to repeal the ESRD exemption.
    B. Facts and district court proceedings
    Appellants are out-of-state corporations providing renal dialysis services in
    Florida, both directly and through subsidiary corporations, to patients suffering
    from ESRD. Appellants wish to use a vertically integrated business model in
    Florida, referring all their ESRD patients’ blood work to associated laboratories
    after providing the patients with dialysis treatment at their clinics. They contend
    that this business model is more efficient and better for ESRD patients than a non-
    integrated system where providers refer patients to independent laboratories for
    blood work. However, keeping laboratory blood work within Appellants’ network
    1
    Medicare covers not only persons aged 65 and older, but also individuals of any age
    “who are medically determined to have [ESRD].” 42 U.S.C. § 1395c.
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    would require its employee-physicians to violate the Florida Act, as they have
    financial interests in Appellants’ laboratories. According to the record and the
    briefs, Appellants’ only competitor providing laboratory services to ESRD patients
    is a Florida business that is not vertically integrated, and thus, it is unaffected by
    the Florida Act. Appellants claim that the Florida Legislature passed the 2002
    Amendments to the Florida Act to benefit their competitor.
    In 2003, after passage of the 2002 Amendments, Appellants sued for
    declaratory and injunctive relief pursuant to 42 U.S.C. § 1983, requesting a
    declaration that the Florida Act is unconstitutional. The complaint alleges that: (1)
    the Florida Act is preempted by federal law; (2) the Florida Act violates the
    dormant Commerce Clause because it is protectionist and discriminatory against
    only out-of-state renal dialysis providers with vertically integrated business
    models; and (3) the Florida Act violates substantive due process because it was not
    enacted with a legitimate purpose and because it is not rationally related to the
    Florida Legislature’s stated purposes for enacting the Florida Act. The district
    court stayed this case until 2006. In 2007, Appellants moved for summary
    judgment, and Florida filed a cross-motion for summary judgment. Four years
    later, the district court entered summary judgment in Florida’s favor. Following
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    the denial of Appellants’ motion for reconsideration, Appellants timely appealed to
    this court.
    II.
    We review the grant of summary judgment de novo, drawing all inferences
    and reviewing all the evidence in the light most favorable to the non-moving party.
    Curves, LLC v. Spalding Cnty., Ga., 
    685 F.3d 1284
    , 1289 (11th Cir. 2012) (per
    curiam). We also review de novo the constitutionality of a challenged statute. 
    Id. III. A.
    Preemption
    The Constitution provides that “the Laws of the United States . . . shall be
    the supreme Law of the Land . . . any Thing in the . . . Laws of any State to the
    Contrary notwithstanding.” U.S. CONST. art. VI., cl. 2. Consequently, federal law
    may preempt state law expressly or by implication. Arizona v. United States, ___
    U.S. ___, 
    132 S. Ct. 2492
    , 2500–01 (2012). Although Congress’s “express
    statement on pre-emption is always preferable, the lack of such a statement does
    not end [the] inquiry.” PLIVA, Inc. v. Mensing, ___ U.S. ___, 
    131 S. Ct. 2567
    ,
    2577 n.5 (2011). State law can be impliedly preempted by federal law in cases of
    field preemption and conflict preemption. Field preemption exists where Congress
    determines that a certain field must be regulated exclusively by the federal
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    government. Arizona, ___U.S. at___, 132 S. Ct. at 2501–02.2 Conflict
    preemption, however, arises in instances where (1) “compliance with both federal
    and state regulations is a physical impossibility,” or (2) “the challenged state law
    stands as an obstacle to the accomplishment and execution of the full purposes and
    objectives of Congress.” Id. at ___, 132 S. Ct. at 2501 (internal citations and
    quotation marks omitted). We use our judgment to determine when state law
    creates an unconstitutional obstacle to federal law, and “this judgment is informed
    by examining the federal statute as a whole and identifying its purpose and
    intended effects.” Ga. Latino Alliance for Human Rights v. Governor of Ga., 
    691 F.3d 1250
    , 1263 (11th Cir. 2012) (internal quotation marks omitted) (quoting
    Crosby v. Nat’l Foreign Trade Council, 
    530 U.S. 363
    , 373, 
    120 S. Ct. 2288
    , 2294
    (2000)).
    Moreover, in conducting preemption analysis, we “should assume that the
    historic police powers of the States are not superseded unless that was the clear and
    manifest purpose of Congress.” Arizona, ___U.S. at___, 132 S. Ct. at 2501
    (internal quotation marks omitted); see also Wyeth v. Levine, 
    555 U.S. 555
    , 565,
    
    129 S. Ct. 1187
    , 1194–95 (2009) (reasoning that there are “two cornerstones of
    [Supreme Court] pre-emption jurisprudence”: first, that “the purpose of Congress
    2
    Stark is part of the broader regulatory scheme for Medicare and Medicaid. The
    Medicare and Medicaid programs are built upon the principle of federal and state cooperation;
    thus, Appellants do not argue that field preemption applies in this case.
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    is the ultimate touchstone;” and second, “the assumption that the historic police
    powers of the States were not to be superseded” by federal law unless preemption
    was clearly Congress’s purpose (internal quotation marks omitted)). The Supreme
    Court has stated that these assumptions create a “high threshold” for a party
    alleging conflict preemption. See, e.g., Chamber of Commerce of U.S. v. Whiting,
    ___ U.S. ___, 
    131 S. Ct. 1968
    , 1985 (2011) (quoting Gade v. Nat’l Solid Wastes
    Mgmt. Ass’n, 
    505 U.S. 88
    , 110, 
    112 S. Ct. 2374
    , 2389 (1992) (Kennedy, J.,
    concurring)).
    Appellants argue that conflict preemption exists in this case because the
    Florida Act improperly prohibits and penalizes what federal regulation permits,
    and it contravenes Congress’s intent to benefit Medicare and Medicaid recipients,
    providers, and the government, as payor, by allowing physician self-referral in the
    ESRD-treatment context. The district court rejected these arguments and
    concluded that Congress did not intend for Stark to preempt state laws like the
    Florida Act. In the absence of express language in Stark, the district court looked
    to Congress’s intent, as stated in a conference report discussing amendments to
    Stark, that “[f]ederal law [should] not preempt State laws that are more restrictive.”
    H.R. REP. NO. 103-213, at 1507 (1993) (Conf. Rep.). Furthermore, the district
    court considered the Secretary’s regulations implementing Stark, which
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    acknowledge that the regulations “do[] not provide for exceptions or immunity
    from civil or criminal prosecution or other sanctions applicable under any State
    laws.” 42 C.F.R. § 411.350(b). The district court also reasoned that the regulation
    of medical fees was and is a typical exercise of state police power, and that the
    Florida Legislature was not alone in imposing physician self-referral restrictions
    that are more restrictive than federal law.
    According to Appellants, the language in the House conference report
    demonstrates only that Stark does not preempt state laws that are “more restrictive”
    of conduct that Stark prohibits, but Stark does preempt conflicting state laws
    prohibiting conduct that Stark allows. In other words, Appellants posit that Florida
    may impose penalties that are more restrictive than federal law on physicians who
    violate conduct prohibited by federal law, so long as Florida does not attempt to
    penalize conduct that federal law permits. Appellants assert that even if their
    interpretation is wrong, this court should not give much weight to the district
    court’s interpretation because Congress entertained, but ultimately rejected, a draft
    of a proposed anti-preemption subsection “(j)” that would have provided that Stark
    “shall [not] preempt provisions of State law.” [R. 93-2 at 3.] Thus, Appellants
    argue that Congress’s decision not to include this anti-preemption language reflects
    the intent to preempt at least some state laws. Moreover, Appellants assert that 42
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    C.F.R. § 411.350(b) shows only that the Secretary interprets Stark as not
    preempting state laws imposing higher criminal penalties above Stark’s civil
    penalties.
    For several reasons, we are not persuaded by Appellants’ arguments.
    Primarily, we do not see the existence of an actual conflict. See Geier v. Am.
    Honda Motor Co., 
    529 U.S. 861
    , 884, 
    120 S. Ct. 1913
    , 1927 (2000) (“[C]onflict
    pre-emption . . . turns on the identification of ‘actual conflict’ . . . .”). Any
    physician employed by any of the Appellants who provides clinical care for ESRD
    patients in Florida can comply with the Florida Act without neglecting any
    obligations under federal law. Indeed, for several years Appellants have managed
    to operate their businesses, and their physicians have served ESRD patients. Thus,
    we see no “physical impossibility,” see Arizona, ___U.S. at ___, 132 S. Ct. at
    2501, preventing Appellants’ compliance with both federal and state laws.
    Second, we agree with the district court that the Florida Act does not
    frustrate Congress’s legislative intent or the Secretary’s interpretation and
    implementation of Stark. In the absence of impossibility, conflict preemption
    applies in situations where state law acts as an obstacle or frustration to the
    purposes of Congress. Id. at ___, 132 S. Ct. at 2501. While the Florida Act
    frustrates Appellants’ vertically integrated business model, there is no evidence
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    that the Florida Act frustrates the purposes of Stark. In fact, legislative history
    provides evidence to the contrary. See H.R. REP. NO. 103-213, at 1507 (1993)
    (Conf. Rep.) (stating that the conferees “intend that Federal law not preempt State
    laws that are more restrictive”). It makes little difference to us that Congress
    considered but failed to include express language stating that nothing in Stark
    should preempt state law. See Schneidewind v. ANR Pipeline Co., 
    485 U.S. 293
    ,
    306, 
    108 S. Ct. 1145
    , 1154 (1988) (stating that the Supreme Court “generally is
    reluctant to draw inferences from Congress’[s] failure to act”).
    Moreover, the Secretary’s regulations implementing Stark are consistent
    with the language in the House conference report. It is appropriate to consider “the
    promulgating agency’s contemporaneous explanation of its objectives” as well as
    “the agency’s current views of the regulation’s pre-emptive effect.” See
    Williamson v. Mazda Motor of Am., Inc., ___ U.S. ___, 
    131 S. Ct. 1131
    , 1136
    (2011). Upon enactment of amendments to Stark in 1993,3 as well as today, the
    Secretary’s regulations implementing Stark state that the regulations “do[] not
    provide for exceptions or immunity from civil or criminal prosecution or other
    sanctions applicable under any State laws or under Federal law other than section
    3
    See Medicare Program; Physician Financial Relationships With, and Referrals to,
    Health Care Entities That Furnish Clinical Laboratory Services and Financial Relationship
    Reporting Requirements, 60 Fed. Reg. 41,914, 41,978 (Aug. 14, 1995) (codified at 42 C.F.R.
    § 411.350(b)).
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    1877 of the Act.” 42 C.F.R. § 411.350(b). In other words, a physician who would
    be civilly or criminally liable for self-referral under a state law like the Florida Act
    will find no shelter in the Secretary’s federal exemption for the same conduct. The
    remainder of the regulation makes the Secretary’s interpretation of the law clear.
    “For example, although a particular arrangement involving a physician’s financial
    relationship with an entity may not prohibit the physician from making referrals to
    the entity under this subpart, the arrangement may nevertheless violate another
    provision of . . . other laws administered by . . . any . . . State agency.” 
    Id. (emphasis added).
    The Florida Act is such an “other law” administered by Florida
    that properly prohibits what Stark permits.
    For all these reasons, we conclude that conflict preemption doctrine does not
    apply, and the exemptions in federal law allowing physicians serving ESRD
    patients to engage in self-referral do not preempt Florida’s more restrictive law
    prohibiting such conduct.
    B. Dormant Commerce Clause
    The Commerce Clause empowers Congress to regulate interstate commerce.
    See U.S. CONST. art. I, § 8, cl. 3. “Although the clause speaks literally only to the
    powers of Congress, it is well settled that it has a ‘dormant’ aspect as well . . . .”
    Bainbridge v. Turner, 
    311 F.3d 1104
    , 1108 (11th Cir. 2002). The dormant
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    Commerce Clause “prohibits economic protectionism—that is, regulatory
    measures designed to benefit in-state interests by burdening out-of-state
    competitors.” Wyoming v. Oklahoma, 
    502 U.S. 437
    , 454, 
    112 S. Ct. 789
    , 800
    (1992) (quoting New Energy Co. of Ind. v. Limbach, 
    486 U.S. 269
    , 273–74, 
    108 S. Ct. 1803
    , 1807 (1988)). To determine whether a particular state law violates the
    dormant Commerce Clause, a court first determines whether the challenged law
    discriminates against interstate commerce because a discriminatory law is
    “virtually per se invalid.” See Ore. Waste Sys., Inc. v. Dep’t of Envtl. Quality of
    Ore., 
    511 U.S. 93
    , 99, 
    114 S. Ct. 1345
    , 1350 (1994). Such a law “will survive only
    if it ‘advances a legitimate local purpose that cannot be adequately served by
    reasonable nondiscriminatory alternatives.’” Dep’t of Revenue of Ky. v. Davis, 
    553 U.S. 328
    , 338, 
    128 S. Ct. 1801
    , 1808 (2008) (quoting Ore. 
    Waste, 511 U.S. at 101
    ,
    114 S. Ct. at 1351). But “[w]here [a state law] regulates even-handedly to
    effectuate a legitimate local public interest, and its effects on interstate commerce
    are only incidental, it will be upheld unless the burden imposed on such commerce
    is clearly excessive in relation to the putative local benefits.” Pike v. Bruce
    Church, Inc., 
    397 U.S. 137
    , 142, 
    90 S. Ct. 844
    , 847 (1970).4
    4
    The scheme for scrutinizing alleged dormant Commerce Clause violations has also been
    stated in terms of whether a state law has “direct” or “indirect” effects on commerce.
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    Appellants do not argue that the Florida Act is facially discriminatory
    because the Florida Act makes no distinction between in-state and out-of-state
    businesses, and it does not exclude out-of-state businesses from operating in
    Florida. Rather, Appellants argue that the Florida Act has the practical effect of
    discriminating against out-of-state commerce. See Hunt v. Wash. Apple Adver.
    Comm’n, 
    432 U.S. 333
    , 350–51, 
    97 S. Ct. 2434
    , 2445 (1977) (recognizing that a
    state law may violate the dormant Commerce Clause by having the “practical
    effect” of discriminating in its operation, even though the law is neutral on its
    face). If Appellants are correct that the Florida Act has the practical effect of
    discriminating against them, the “strictest scrutiny” applicable to a facially
    discriminatory law would apply here as well. See Ore. 
    Waste, 511 U.S. at 101
    , 114
    S. Ct. at 1351. In that instance, we would require Florida to show that (1) the
    statute has a legitimate local purpose; and (2) there are no adequate, reasonable,
    nondiscriminatory alternatives. See 
    Hunt, 432 U.S. at 353
    , 97 S. Ct. at 2446.
    If a regulation directly regulates or discriminates against interstate commerce, or
    has the effect of favoring in-state economic interests, the regulation must be
    shown to advance a legitimate local purpose that cannot be adequately served by
    reasonable nondiscriminatory alternatives. If a regulation has only indirect effects
    on interstate commerce, we examine whether the State’s interest is legitimate and
    whether the burden on interstate commerce clearly exceeds the local benefits.
    Island Silver & Spice, Inc. v. Islamorada, 
    542 F.3d 844
    , 846 (11th Cir. 2008) (internal
    quotations, citations, and alterations omitted).
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    Appellants allege that because the Florida Act impacts only out-of-state
    businesses, the district court erred in finding no discriminatory impact. Appellants
    further argue that the district court failed to find that the prohibition on physician
    self-referral serves no legitimate purpose in an ESRD treatment context and that
    there are nondiscriminatory alternatives to the law. But because the law operates
    to burden in-state and out-of-state ESRD health care providers alike, Appellants
    fail to convince us that the Florida Act has the practical effect of discriminating
    against interstate commerce.
    The Supreme Court’s decision in Exxon Corp. v. Governor of Maryland, 
    437 U.S. 117
    , 
    98 S. Ct. 2207
    (1978), is analogous and instructive here because it offers
    an example of a state law that incidentally, but not unconstitutionally, burdened
    some out-of-state businesses. In Exxon, the Maryland Legislature passed a statute
    prohibiting a producer or refiner of petroleum products from operating any retail
    gasoline station within the state and requiring producers and refiners to extend all
    temporary price reductions to all retail stations they 
    supplied. 437 U.S. at 119
    121, 98 S. Ct. at 2211
    . The Maryland Legislature passed the statute in response to
    complaints about the inequitable distribution of gasoline among retail stations
    during the 1973 oil shortage. Id. at 
    121, 98 S. Ct. at 2211
    . The law “was designed
    to correct the inequities in the distribution and pricing of gasoline” by prohibiting
    16
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    companies from doing business in Maryland as both producers and retailers. Id. at
    
    121, 98 S. Ct. at 2211
    (internal quotation marks omitted).
    Exxon and other refiners argued that the law discriminated against interstate
    commerce at the retail level because the burden of divesting retail service stations
    fell solely on the interstate companies, as there were no Maryland-based refiners at
    that time. See 
    id. at 125,
    98 S. Ct. at 2213–14. The statute, they argued, protected
    Maryland independent retailers from competition because the out-of-state refiners
    and producers who previously operated gasoline stations would no longer have a
    competitive advantage over the independent retailers in terms of pricing and other
    special services. Id. at 
    125, 98 S. Ct. at 2213
    –14. The Supreme Court rejected the
    oil refiners’ argument because the dormant Commerce Clause does not “protect[ ]
    … particular structure[s] or methods of operation in a retail market.” 
    Id. at 127,
    98
    S. Ct. at 2215. Instead, it “protects the interstate market, not particular interstate
    firms, from prohibitive or burdensome regulations.” 
    Id. at 127–28,
    98 S. Ct. at
    2215 (emphasis added). The Court reasoned: “The fact that the burden of a state
    regulation falls on some interstate companies does not, by itself, establish a claim
    of discrimination against interstate commerce.” 
    Id. at 126,
    98 S. Ct. at 2214. And
    while oil refiners would no longer enjoy the same status in the Maryland retail
    market, in-state independent retailers would not have an advantage over out-of-
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    state retailers; nor were there any barriers impeding out-of-state retailers from
    entering the Maryland retail market. See id. at 
    126, 98 S. Ct. at 2214
    . Thus, there
    was no discriminatory effect.
    Similar to the oil refiners in Exxon, Appellants feel singled out by the
    Florida Act because they are out-of-state entities, and the law adversely affects
    only them—but not the lone, in-state competitor providing ESRD laboratory
    services. Yet the Florida Act prohibits vertical integration of renal dialysis clinics
    and laboratories regardless of whether a business entity is in-state or out-of-state.
    Although the burden at present falls solely on Appellants, and although they may
    no longer enjoy certain competitive advantages over an in-state competitor, the
    Florida Act does not inhibit the competitive, interstate market for the provision of
    renal dialysis clinical and laboratory services. Out-of-state businesses may freely
    enter the market to operate clinics and laboratories in Florida so long as they
    comply with the Florida Act’s prohibition against physician self-referrals.
    In keeping with the analysis of Hunt, Appellants further argue that the
    Florida Act serves no legitimate purpose, and that there are reasonable
    nondiscriminatory alternatives. However, because the Florida Act does not
    discriminate in effect against interstate commerce, it is not Florida’s burden to
    demonstrate the Act’s legitimate purpose or the non-existence of
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    nondiscriminatory alternatives. Rather, we inquire whether the Florida Act’s
    burden on interstate commerce is clearly excessive in relation to the law’s putative
    benefits. See Minnesota v. Clover Leaf Creamery Co., 
    449 U.S. 456
    , 471, 
    101 S. Ct. 715
    , 728 (1981) (citing 
    Pike, 397 U.S. at 142
    , 90 S. Ct. at 847). Appellants
    rest their case on the argument that the Florida Act is discriminatory in effect, and
    they offer no analysis pursuant to the less stringent standard in Pike.
    We hold that the district court correctly found that the Florida Act serves a
    legitimate local interest—the protection of Florida patients—and that the law’s
    burden on out-of-state businesses from providing ESRD care in Florida is not
    excessive. Appellants allege that the Florida Legislature passed the law
    haphazardly, without regard for its consequences on health care for Florida’s
    ESRD patient population. We, however, agree with the district court that “[t]hese
    arguments go to ‘the wisdom of the statute, not to its burden on commerce.’”
    Fresenius Med. Care Holdings, Inc. v. Francois, 
    832 F. Supp. 2d 1364
    , 1369 (N.D.
    Fla. 2011) (quoting 
    Exxon, 437 U.S. at 128
    , 98 S. Ct. at 2215); see also Ferguson
    v. Skrupa, 
    372 U.S. 726
    , 729, 
    83 S. Ct. 1028
    , 1030 (1963) (“[I]t is up to
    legislatures, not courts, to decide on the wisdom and utility of legislation.”).
    In summary, we conclude that the Florida Act does not discriminate against
    interstate commerce, nor does it impose a burden on interstate commerce that is
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    clearly excessive when compared with the law’s putative local benefits. Hence, we
    conclude that the Florida Act does not violate the dormant Commerce Clause.
    C. Substantive due process
    We note that Count III of Appellants’ amended complaint alleges only that
    the Florida Act violates “substantive due process,” making no reference to equal
    protection. [R. 67 at 12–13 (alleging that because the Florida Act targets innocent
    business activity, it is arbitrary and capricious and lacks a rational basis).] Florida
    sought summary judgment on Count III and argued in terms of equal protection—
    not substantive due process—to which Appellants responded, also arguing in terms
    of equal protection. The district court then addressed substantive due process and
    equal protection together because the rational basis standard applies to both types
    of claims. See In re Wood, 
    866 F.2d 1367
    , 1371 (11th Cir. 1989). However, a
    substantive due process claim differs from an equal protection claim, and it appears
    that Appellants pled only that the Act violated their rights to due process.
    Presumably, the district court addressed equal protection because the parties
    argued it without pleading it. In any case, it makes no difference in our analysis
    because Appellants’ substantive due process claim fails to survive rational basis
    scrutiny, and an equal protection claim would as well.
    20
    Case: 11-14192     Date Filed: 01/10/2013    Page: 21 of 23
    When a challenged law does not infringe upon a fundamental right, we
    review substantive due process challenges under the rational basis standard. See
    Locke v. Shore, 
    634 F.3d 1185
    , 1195–96 (11th Cir. 2011). Under the rational basis
    standard, the law requires only that the Florida Act’s prohibition on physician self-
    referrals be rationally related to the Florida Legislature’s goal of reducing conflicts
    of interest, lowering health care costs, and improving the quality of health care
    services. See Clover 
    Leaf, 449 U.S. at 462
    –63, 101 S. Ct. at 722–23. The Act will
    be upheld so long as “there is any reasonably conceivable state of facts that could
    provide a rational basis for [the regulation].” FCC v. Beach Commc’ns, Inc., 
    508 U.S. 307
    , 313–15, 
    113 S. Ct. 2096
    , 2101–02 (1993). Appellants bear the burden of
    demonstrating that the law lacks a rational basis. Deen v. Egleston, 
    597 F.3d 1223
    ,
    1230 (11th Cir. 2010). We agree with the district court that the Florida Act passes
    rational basis-scrutiny because, no matter how ineffective the law might actually
    be, it was not irrational for the Florida Legislature to conclude that the
    amendments to the law would accomplish the legislative objectives identified in
    FLA. STAT. § 456.053(2).
    In their brief, Appellants assert that the Florida Legislature’s refusal to
    acknowledge the findings of the 2001 House committee report shows that it was
    irrational to amend the Florida Act in 2002 to remove the ESRD exemption.
    21
    Case: 11-14192     Date Filed: 01/10/2013    Page: 22 of 23
    Further, they argue that “the circumstances surrounding passage of the 2002
    Amendments lead to no conclusion other than that the Florida Legislature was
    motivated to benefit a politically favored in-state provider.” Appellants’ Br. at 42.
    But Appellants’ arguments miss the mark of a rational basis inquiry. Their
    evidence casts doubt on the wisdom of the statute and suggests that perhaps a
    competitor out-lobbied Appellants before the Florida Legislature, but the evidence
    does not demonstrate that the Florida Legislature could not have possibly believed
    that removing the ESRD exemption would reduce conflicts and improve health
    care in the renal-dialysis field. Appellants fail to convince the court that the
    purported reasons given for the enactment of the law “‘could not reasonably be
    conceived to be true by the governmental decisionmaker.’” Clover 
    Leaf, 449 U.S. at 464
    , 101 S. Ct. at 724 (quoting Vance v. Bradley, 
    440 U.S. 93
    , 111, 
    99 S. Ct. 939
    , 949 (1979)). Because it is reasonably conceivable that Florida ESRD patients
    would be better served if their physicians were prohibited from making self-
    referrals to associated laboratories, we conclude that the Florida Act survives
    rational basis scrutiny and that the law does not deprive Appellants of their rights
    to substantive due process.
    IV.
    22
    Case: 11-14192     Date Filed: 01/10/2013   Page: 23 of 23
    In conclusion, because we are persuaded that the district court properly
    granted Florida’s motion for summary judgment on Appellants’ preemption,
    dormant Commerce Clause, and substantive due process claims, we affirm its
    judgment.
    AFFIRMED.
    23