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

CourtCourt of Appeals for the Eleventh Circuit
DecidedJanuary 10, 2013
Docket11-14192
StatusPublished

This text of Fresnius Medical Care Holdings, Inc. v. Elisabeth Tucker, M.D. (Fresnius Medical Care Holdings, Inc. v. Elisabeth Tucker, M.D.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eleventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Fresnius Medical Care Holdings, Inc. v. Elisabeth Tucker, M.D., (11th Cir. 2013).

Opinion

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. 2 Case: 11-14192 Date Filed: 01/10/2013 Page: 3 of 23

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 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 physician is a

3 Case: 11-14192 Date Filed: 01/10/2013 Page: 4 of 23

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).

4 Case: 11-14192 Date Filed: 01/10/2013 Page: 5 of 23

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. 5 Case: 11-14192 Date Filed: 01/10/2013 Page: 6 of 23

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

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