Healthcare Law
| Publication year | 2018 |
Healthcare Law
Kathryn S. Dunnam
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This Article serves as a review of significant healthcare developments in the United States Court of Appeals for the Eleventh Circuit over the last two years and builds upon Mercer Law Review's last Healthcare Article1 in Volume 65. Specifically, this Article will cover cases dealing with physician speech, the False Claims Act,2 and the Medicare Secondary Payer Act.3
Wollschlaeger v. Governor4 arose from a challenge of Florida's Firearm Owners' Privacy Act (FOPA)5 enacted in 2011.6 The plaintiffs' claims, grounded in the Free Speech Clause of the First Amendment,7 challenged the constitutionality of FOPA as some portions regulated the content of physician speech.8 Practically, FOPA restricted medical professionals on what they could ask patients regarding firearm ownership.9
Doctors and medical organizations filed suit in the United States District Court of the Southern District of Florida against Florida officials.10 The district court permanently enjoined the law's provisions
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regarding "record-keeping, inquiry, anti-discrimination, and anti-harassment" because those provisions violated the Fourteenth Amendment11 and First Amendment.12 The Florida officials subsequently appealed, and the Eleventh Circuit issued three different opinions upholding FOPA.13 In June 2016, the court voted to rehear the case en banc.14 Applying heightened scrutiny, the Eleventh Circuit ultimately held that FOPA's record-keeping, inquiry, and anti-harassment provisions violated the First Amendment but that the anti-discrimination provision may stand.15
The court first characterized FOPA's record-keeping, inquiry, and anti-harassment provisions as speaker-focused and content-based restrictions on speech because "[t]hey apply only to the speech of doctors and medical professionals, and only on the topic of firearm ownership."16 As such, it rejected rational basis review and applied heightened scrutiny.17 The standard, as established by Sorrell v. IMS Health Inc.,18 requires a showing by state officials that the provisions "directly advance[] a substantial governmental interest and that the measure[s] [are] drawn to achieve that interest. There must be a 'fit between the legislature's ends and the means chosen to accomplish those ends.'"19 The court, therefore, looked to the empirical evidence relied upon by the legislature, which amounted to six anecdotes.20
The court explained that doctors typically ask patients about health and safety risks such as household chemicals, swimming pools, and firearms.21 Per the opinion, the American Medical Association promotes physician inquiry about household firearms so that patients may be educated as to their dangers, especially regarding children.22 The six anecdotes suggested that medical providers began asking Florida patients "unwelcome questions or made purportedly improper comments regarding their ownership of firearms."23 The court noted that a National Rifle Association representative even recounted a scenario where a
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medical provider refused to examine a child if the parent did not answer questions regarding household firearms.24 Thus, FOPA was enacted.25
The purported interests that state officials sought to protect through FOPA included: protecting "the Second Amendment right of Floridians to own and bear firearms" from private encumbrances,26 protection of patient privacy,27 "ensuring access to health care without discrimination or harassment,"28 and "the need to regulate the medical profession in order to protect the public."29 The State further argued that "the First Amendment is not implicated because any effect on speech is merely incidental to the regulation of professional conduct."30 However, the court held that the state's interests did not meet Sorrell's heightened scrutiny test.31 It analogized the facts at hand to Conant v. Walters,32 a United States Court of Appeals for the Ninth Circuit case that "struck down . . . a federal policy which threatened doctors with revocation of their DEA prescription authority if they recommended the medicinal use of marijuana to their patients."33 There, the Ninth Circuit categorized the speech as content and viewpoint based and invalidated it on First Amendment grounds.34 Thus, the Eleventh Circuit struck down all the challenged provisions except for the anti-discrimination section.35
In Wollschlaeger, the court gave deference to physicians and medical providers as an authority. There is value given to what information they believe necessary for treatment. Indeed, the Eleventh Circuit stated that "[i]n 'the fields of medicine and public health . . . information can save
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lives.'"36 The court held that restricting physician speech is an inappropriate methodology to change the way household firearms are discussed in the medical context.37 With that being said, FOPA's anti-discrimination provision still stands, and any discrimination against a patient based solely on the ownership of a firearm will not be tolerated.38
In United States v. AseraCare, Inc.,40 the United States brought an action under the False Claims Act (FCA)41 against AseraCare, Inc. (AseraCare),42 alleging that AseraCare submitted false claims to Medicare on behalf of 123 hospice patients claiming that the patients' medical records did not support the medical prognosis.43 The FCA provides, in relevant part, that if a person:
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(A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim . . . is liable to the United States Government for [civil penalties].44
In 2015, the United States District Court for the Northern District of Alabama bifurcated the trial into phases one and two, with the "falsity element" to be tried in phase one.45 The court subsequently granted AseraCare's motion for new trial because the court did not instruct the jury that a difference of opinion is not enough to prove falsity.46 The court also put the parties on notice that it would consider summary judgment sua sponte in light of its concern over whether or not the United States "[had] sufficient admissible evidence of more than just a difference of opinion to show that the claims at issue are objectively false as a matter of law."47 The court explained that the United States had "to point to objective evidence in the Phase One record that the court may have overlooked that shows a particular claim was false, other than [the expert's] testimony."48
In 2016, the court granted, sua sponte, summary judgment in favor of AseraCare.49 The court noted that the litigation in AseraCare, Inc. "has always been about whether AseraCare knowingly submitted false claims to Medicare by certifying patients as eligible for hospice who did not have a prognosis of 'a life expectancy of 6 months or less if the terminal illness runs its normal course.'"50 It is well established in the Eleventh Circuit that "the submission of a false claim is the sine qua non of a False Claims Act violation."51 The United States must provide "proof of an objective falsehood" in prosecuting a claim.52 When a healthcare entity uses
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improper practices, those practices alone "are insufficient to show falsity without proof that specific claims were, in fact, false when submitted to Medicare."53
In its ruling on the "falsity" requirement, the court disagreed with the United States' argument that the lack of "clinical information" in the patients' medical records supporting their hospice eligibility warranted the claims for those patients as "false."54 The court explained that "[w]hen hospice certifying physicians and medical experts look at the very same medical records and disagree about whether the medical records support hospice eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood."55 The court cautioned that if
[A]ll the Government needed to prove falsity in a hospice provider case was one medical expert who reviewed the medical records and disagreed with the certifying physician, hospice providers would be subject to potential FCA liability any time the Government could find a medical expert who disagreed with the certifying physician's clinical judgment. The [C]ourt refuses to go down that road.56
The court held that the United States failed to prove falsity as a matter of law and granted summary judgment for AseraCare.57
The United States subsequently appealed, and oral arguments took place on March 16, 2017.58 The court has not yet issued an opinion. The ruling on this matter will significantly impact the prosecution of false claims moving forward. As the 2015 Memorandum Opinion stated in the underlying litigation: "One of the undecided areas of law in the Eleventh Circuit is the legal standard for falsity in a case like this one, where the Government alleges that the hospice provider's medical records do not support its hospice eligibility certifications, and, therefore, the certifications are false."59 If the Eleventh Circuit agrees with the Northern District of Alabama, the United States will not be able to merely rely upon expert testimony to provide "proof of an objective
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falsehood" in these hospice cases. According to one healthcare expert, this would constitute "a stunning development in the often clinically murky area of complex medical practice, with major implications for health care fraud enforcement."60
The Eleventh Circuit recently held in Humana Medical Plan, Inc. v. Western Heritage...
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