[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.

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______________

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 SelfReferral 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, Pub. L. No. 103-66, 107 Stat. 312 (codified at 42 

U.S.C. § 1395nn(a)). 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 endstage 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 physician is a 

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shareholder, so long as the company has stockholder equity in excess of $75 

million. See 42 C.F.R. § 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 nonintegrated 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, Appellants have managed to operate their 

businesses and their physicians have served ESRD patients in Florida for several 

years. 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 

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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-ofCase: 11-14192 Date Filed: 01/10/2013 Page: 17 of 23 
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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.

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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 selfreferrals 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. 

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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 selfreferrals 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.

Case: 11-14192 Date Filed: 01/10/2013 Page: 22 of 23 
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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.

Case: 11-14192 Date Filed: 01/10/2013 Page: 23 of 23