The US Court of Appeals for the Eighth Circuit today issued a decision affirming a district court’s grant of summary judgment against a False Claims Act (FCA) relator in United States ex rel. Donegan v. Anesthesia Associates of Kansas City, PC, on which we previously posted.  The case involved a dispute over whether a regulation required an anesthesiologist to be present in the operating room when the patient “emerges” from anesthesia, and the district court had granted summary judgment on the grounds that the defendant had reasonably interpreted the regulation as not requiring presence in the operating room.  The district court’s decision was important because it made clear that the defendant’s interpretation of an ambiguous regulation need not be the “most reasonable” interpretation.

The Eighth Circuit agreed with the district court, holding that the relator could not establish scienter because the regulation was ambiguous, and the defendant’s interpretation was objectively reasonable.  The court held:

Here, the question is whether AAKC’s reasonable interpretation of the ambiguous regulation precludes a finding that it knowingly submitted false or fraudulent claims, even if CMS or a reviewing court would interpret the regulation differently. Relator simply failed to submit evidence refuting AAKC’s strong showing that its interpretation was objectively reasonable. Relator’s experts expressed their opinions that emergence as referred to in Step Three should end before an AAKC patient is transferred to the PACU. But Relator’s contention that the Medicare regulations be interpreted in this fashion is a claim of regulatory noncompliance, not an FCA claim of knowing fraud.  (internal citations and quotations omitted)

This result underscores the fact that an FCA case based on alleged noncompliance with a regulation that is subject to multiple, reasonable interpretations can be a risky endeavor for a relator.

On July 7, 2016, the US Court of Appeals for the Seventh Circuit affirmed the US District Court for the Southern District of Indiana’s grant of summary judgment in favor of a federal subcontractor defendant facing False Claims Act (FCA) allegations. Notably, the Seventh Circuit rejected the district court’s original grounds for summary judgment, an “advice-of-accountant” defense, instead finding that applicable regulations and the trial record created ambiguity making it impossible to demonstrate the defendant’s knowing submission of false claims.

The relator’s FCA claims were premised on alleged violations of the Davis-Bacon Act, which requires that federal construction contractors pay their workers the “prevailing wage.” 40 U.S.C. § 3142(a). US Department of Labor regulations provide further specifics on base wage rates and fringe benefits (i.e., life, dental, vision and health insurance) for varied types of workers. The relator, a union comprised of workers who performed work for the defendant, alleged that its workers had not been paid the prevailing wage under Davis-Bacon due to the defendant’s deduction of $5.00 per hour from each employee to cover fringe benefits. These withholdings were deposited into a trust created by the defendant for its employee insurance benefits, and were withheld from employees whether or not they were eligible for fringe benefits. In the lawsuit, the defendant subcontractor was alleged to have submitted false Certified Payroll Reports to the government including statements attesting compliance with the Davis-Bacon Act, despite the $5.00/per hour withholding which allegedly resulted in payments to workers below the “prevailing wage.”

While upholding the grant of summary judgment for the defendant, the Seventh Circuit based its ruling on different grounds than the district court. The district court had ruled that the defendant’s reliance on the advice of its accountants with respect to withholdings negated any potential showing of knowing submission of false statements. The Seventh Circuit rejected this conclusion, finding that the defendant had failed to demonstrate the facts necessary to provide a basis for an “advice-of-accountant” defense, noting “[w]e do not know precisely what it told its accountants, whether they provided all necessary details, or what exactly the accountants recommended.”

Rather, the Seventh Circuit affirmed the grant of summary judgment for defendant subcontractor on the basis of the “ambiguity” surrounding regulations regarding employer accounting of fringe benefit contributions and absence of evidence as to any withholding requirements contained in the contract. Walking through applicable DoL regulations, the Seventh Circuit found that it was unclear whether the withholdings made by the defendant necessarily violated the Davis-Bacon Act and, further, that the record was unclear as to whether the defendant was contractually obligated to make contributions to the fringe benefit trust for ineligible employees. The Court held, therefore, that it could not be inferred that the defendant “either knew or must have known that it was violating the Davis-Bacon Act.”

In short, the Seventh Circuit embraced the logical premise that contractors cannot reasonably be subjected to multiple damages and penalties under the FCA – which the Supreme Court has characterized as an essentially punitive statute – where the claim is based on alleged violation of an ambiguous statute or regulation.

On May 27, 2016, the US Department of Justice said it will appeal to the Eleventh Circuit its loss in the False Claims Act (FCA) case against hospice chain AseraCare Inc. The government’s decision to appeal comes as no surprise, and it means that the substantial attention this case has received will continue.

As a reminder, this case, U.S. ex rel. Paradies v. AseraCare, Inc., focused on whether AseraCare fraudulently billed Medicare for hospice services for patients who were not terminally ill. AseraCare argued (and the district court ultimately agreed) that physicians could disagree about a patient’s eligibility for end-of-life care and such differences in clinical judgment are not enough to establish FCA falsity.

The government appealed three orders issued by the US District Court for the Northern District of Alabama. We previously posted about each of these three orders.

The first order on appeal is the district court’s May 20, 2015 decision bifurcating the trial, with the element of falsity to be tried first and the element of scienter (and the other FCA elements) to be tried second. The government had unsuccessfully sought reconsideration of this decision.  This is the first instance in which a court ordered an FCA suit to be tried in two parts.

The second order on appeal is the district court’s October 26, 2015 decision ordering a new trial, explaining that the jury instructions contained the wrong legal standard on falsity. This order came after two months of trial on the element of falsity and after a jury verdict largely in favor of the government.

The third order on appeal is the district court’s March 31, 2016 decision, after sua sponte reopening summary judgment, granting summary judgment in favor of AseraCare. In dismissing the case, the court explained that mere differences in clinical judgment are not enough to establish FCA falsity, and the government had not produced evidence other than conflicting medical expert opinions.

The government must file its opening brief 40 days after the record is filed with the Eleventh Circuit. We will be watching this case throughout the appellate process.

After granting a new trial based on error in a jury instruction and sua sponte re-opening summary judgment, on March 31, 2016, the U.S. District Court for the Northern District of Alabama granted summary judgment to AseraCare on all remaining counts in U.S. ex rel. Paradies v. AseraCare, Inc.  The outcome is significant because it confirms that mere difference of clinical judgment—here, regarding conditions for a medical certification of hospice eligibility—is not enough to show that the claims are objectively false under the False Claims Act (FCA).

The turn of events is a significant win for AseraCare, as a jury had determined last October that 104 of 123 hospice claims submitted by AseraCare for Medicare payment were false.  (The trial was bifurcated into falsity and scienter phases.) However, after that jury verdict, on October 29, 2015, the court granted AseraCare’s motion for a new trial on the issue of falsity after expressing concern that it had “committed major reversible error in the jury instructions.”

As the court explained in a subsequent order, the FCA case was based on a false certification theory: specifically, that the underlying medical records did not support the physicians’ certifications of hospice eligibility, rendering the associated claims false. In reviewing its jury instructions, the court held that it should have advised the jury that the FCA requires proof of an “objective” falsehood. It also added that a proper instruction should have stated that a difference of opinion between doctors, without more, is insufficient to show that a Medicare hospice claim is false. The court sua sponte re-opened summary judgment and invited the government to point to evidence, other than its expert’s clinical opinion, that the certifications for the claims in question were false.

In the March 31 summary judgment, the court made clear that it was not satisfied with the government’s proffer, observing that the government only pointed to its own conclusions about the underlying medical records and its expert’s disagreement with AseraCare’s certification. In granting summary judgment, the court again confirmed that mere differences in clinical judgment are not enough to establish FCA falsity: “If the court were to find that all 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 court refuses to go down that road.”

On March 7, the U.S. Court of Appeals for the Fifth Circuit affirmed a grant of summary judgment by the U.S. District Court for the Northern District of Texas in favor of Kaner Medical Group and its owner, David Kaner, in a qui tam suit brought under the False Claims Act (FCA).  United States ex rel. Johnson v. Kaner Med. Grp., 2016 WL 873816 (5th Cir. Mar. 7, 2016).  The suit was filed by a former employee of the group, who alleged that the group submitted false claims for reimbursement to Medicare and TRICARE, and that she was terminated in retaliation for raising concerns regarding the group’s billing practices.

The relator’s FCA claims were based on the group’s practice of entering the National Provider Identifier (NPI) of the provider who referred a patient to the group’s allergy clinic on Medicare claims in a box that, according to instructions from the Centers for Medicare & Medicaid Services (CMS), should have contained the NPI of the provider who supervised the work carried out at the allergy clinic on the day the patient received the service.  The district court found that, although the summary judgement record indicated the possibility that a large number of the group’s claims forms had incorrect provider information, the evidence did not show that the performing medical assistants lacked the requisite supervision or that the services were rendered under circumstances that would cause the group not to be entitled to payment.  U.S. ex rel. Johnson v. Kaner Med. Grp., 2015 WL 631651 (N.D. Tex. Feb. 12, 2015).  Instead, the record “provide[d] evidence that defendants perhaps were negligent in their indications on some of the forms of healthcare provider information.”

In affirming the district court, the appeals court found that the relator presented no evidence that the group acted “knowingly,” i.e., with actual knowledge of information or in deliberate ignorance or reckless disregard with respect to the truth or falsity of the information.  Instead, the appeals court agreed with the district court that the record indicated that “at most, [the group’s] misunderstanding of CMS’s requirements was negligent, which is not sufficient to attach liability under the FCA.”  As the court found in favor of the group on summary judgment, it also found that the relator did not engage in protected activity under the whistleblower protections of the FCA, and affirmed the dismissal of her retaliation claim.

As the outcome in this case demonstrates, the fact that a health care provider has improperly billed Medicare is not enough to support an FCA claim.  Among other things, a plaintiff must raise a genuine dispute of material fact that a defendant knowingly asked Medicare to pay amounts it does not owe.  As the court noted, the FCA “is not a general ‘enforcement device’ for federal statutes, regulations and contracts. . . but the Government’s ‘primary litigation tool’ for recovering losses resulting from fraud.”

On February 25, 2016, the United States District Court for the Eastern District of Virginia dismissed a False Claims Act (FCA) case alleging that PAE Government Services (PAE) intentionally overcharged the Department of State (DOS) for bottled water supplied to various facilities in Iraq.  United States of America ex rel. Anthony Garzione, 2016 WL 775780 (E.D. Va. 2/25/2016).  Even though PAE allegedly chose the highest bidder when it awarded a subcontract for the water and terminated the relator, Anthony Garzione, when Garzione complained, the court dismissed claims that PAE violated the FCA and retaliated against Garzione.  According to the court, the Federal Acquisition Regulations (FAR) required only that PAE award the subcontract at a “reasonable price.”  Id. at *5-6.  Garzione came forward with nothing in his complaint to show that the highest bid was objectively “unreasonable.”  Id.  For the same reason, Garzione did not engage in protected activity when he raised complaints.  Id. *8.

In 2013, DOS awarded PAE a contract to supply “life support and logistical function” at embassies and consulates throughout Iraq.  The contract included “food and supplies,” among other things.  Id. *1.  For the first year of the contract, PAE supplied very small quantities of bottled water to DOS facilities through a subcontract with Taylors International Services, Inc. (Taylors).  In 2014, however, DOS modified the contract to require PAE to supply much greater quantities of bottled water.  PAE immediately issued a request for bid proposals, which ultimately included the following:  a bid from Taylors for $3.65 per case for Pearl brand water; a bid from Pearl itself for $3.50 per case; and a bid from AWI for $1.18 per case.  Id.

PAE chose Taylors.  Garzione complained and sought to solicit other companies to fill the subcontract. Eventually, the complaint alleges, PAE supervisors began to treat Garzione with hostility, excluded him from meetings and communications, and eventually fired him in February 2015.  Id. *2.  Throughout it all, the subcontract for bottled water remained with Taylors.

Garzione sued, raising three claims. Counts I and II alleged that PAE “falsely certified” that it had complied with the requirements of the FAR to seek the payment of only “reasonable” prices.  As the district court explained, “[t]his claim is based on the legal theory that PAE’s costs for bottled water were necessarily not ‘reasonable’ because it selected Taylors[.]”  Id. *3. Under Count III, Garzione alleged that he engaged in “protected activity” when he questioned PAE’s selection of Taylors and was terminated in retaliation for doing so.  Id.

With little trouble, the district court dismissed all three counts.

First, the court dismissed Counts I and II.  To begin, the court rejected Garzione’s allegations that Taylors’ prices were unreasonable, observing that Garzione did not cite “any authority for the proposition that the highest bid constitutes an ‘unreasonable price’[.]”  Id. at *5.  In addition, the court rejected an argument that PAE had made false statements to the government by impliedly certifying, when it submitted invoices, that the price paid for bottled water was reasonable when, in fact, it was not. Id. at *6.  According to court, there was nothing in the contract requiring PAE to comply with the FAR regulations that the price was “reasonable.”  Id.

Second, the court held that the complaint failed to adequately allege that PAE either had the “specific intent to defraud” the government, or acted with recklessness when it submitted claims for bottled water.  Id. *7.  For these same reasons, the complaint failed to meet Federal Rule of Civil Procedure 9(b)’s heighten pleading standard.  Id.

Finally, the court turned to the retaliation claim and dismissed it. To bring a successful claim for retaliation under the FCA, a plaintiff must allege that he engaged in “protected activity” by acting to prevent a FCA violation at the time of the adverse employment action. Id. at *7.  But “protected activity” requires that the company conduct at issue involve “an objectively reasonable possibility of an FCA action[.]”  Id. *8.  “Here,” the court explained, “plaintiff failed to plead anything more than his subjective belief that PAE” violated the “reasonable” price regulations.  Id. At most, Garzione put PAE on notice that he disagreed with the selection of Taylors, and that he thought the company could get a better price. That was neither enough to state a FCA claim or to act as the foundation for a retaliation claim. Id.

 

Two decisions from the US District Court for the Southern District of Texas limit the extent to which relators can stretch the use of circumstantial evidence to support a False Claims Act case based on an anti-kickback or off-label marketing theory. In two separate decisions on December 10 and December 14 in US ex rel. King v. Solvay Pharmaceuticals, Inc. (SPI)., the court granted SPI’s summary judgment motion finding insufficient evidence for a reasonable juror to support either theory.

For the anti-kickback claim, relators alleged that SPI engaged in a number of activities, such as speaker programs, preceptorships, honorariums, free continuing medical education, and provided gifts such as dinners and event tickets, as part of a national scheme to illegally induce physicians to prescribe SPI’s drugs. In dismissing this claim on December 10, the court first found that the allegations of a nationwide scheme were unsupported because in relator’s response to interrogatories and expert report, only 46 Texas-based physicians were identified as having prescribed SPI’s drugs and as having allegedly received remuneration from SPI. The court observed:

[t]heoretically Relators could survive summary judgment with examples, the examples would have to be linked to remuneration from SPI, some evidence of intent that the remuneration would lead to claims, and claims for prescriptions written by these physicians that a reasonable juror could believe resulted from the unlawful remuneration.  Additionally, to continue a claim on a national-level scheme, Relators would need to demonstrate that kickbacks were provided to physicians in different areas of the country as part of a nationwide scheme to increase prescriptions of the specific Drugs at Issue to patients who are on Medicaid or part of some other government prescription program.

Since relators provided no physician examples outside of Texas, the court ruled the multi-state claims failed.

The court then examined each of the alleged forms of remuneration and found that the evidence was insufficient to find SPI had the requisite “knowing and willful” intent to induce referrals to support an anti-kickback claim under federal or Texas law. For example, the “physician profile interview program” involved sales representatives interviewing physicians prior to the launch of the drug Aceon to obtain information about the physicians’ practice and treatment of hypertension. Physicians were paid $100 for participating in this 30 minute interview. Sales reps were instructed to not mention Aceon during these interviews. Relators offered no evidence that sales reps failed to follow this instruction. Not surprisingly, the court found that the evidence failed to show that SPI intended the program to induce physicians to write prescriptions for a drug they were not told about. For other forms of remuneration, the court found that relators offered no proof that the physicians who received the remuneration actually prescribed SPI’s drugs.

In a separate ruling on December 14, the court granted SPI’s summary judgment motion dismissing relators’ “fraud-on-DrugDex” theory. To be eligible for government reimbursement for an off-label use of a drug, relators alleged that off-label use has to be listed in one of several drug compendia that evaluate whether sufficient clinical research supports that off-label use (see 42 U.S.C. §§ 1396r-8(d)(1)(B)(I); 1396r-8(k)(6)). DrugDex is one of those compendia. Relators alleged that SPI inappropriately influenced and misled DrugDex to include certain uses for Aceon, AndroGel, and Luvox as medically accepted by allegedly suppressing publication of negative research papers and only publishing “smaller” studies. Relators also alleged that SPI “colluded with” DrugDex “so that the uses listed might be deemed eligible for reimbursement under various government health programs.”

The court, however, found no evidence that SPI had a duty to publish negative studies, much less that the evidence showed SPI suppressed their publication. As far as the “collusion” allegation, relators admitted that they did not have evidence of communications between SPI and DrugDex, but rather that “DrugDex invited undue influence and SPI took advantage” of this invitation. While “relators had substantial time to conduct discovery and obtain proof that SPI and DrugDex communicated and that SPI somehow influenced DrugDex,” the court found no such sufficient evidence in the record to put the question to a jury.

These decisions provide some comfort to defendants, including but not limited to pharmaceutical companies and healthcare providers, that courts will require relators to offer more than innuendo and assumptions to support an FCA claim — a serious allegation with potentially significant consequences. The ability of relators to pursue cases through the costly and lengthy discovery process on flimsy allegations takes some of that comfort away. In this case, the relators filed their original complaint in 2003 — 12 years ago. The Department of Justice decided to decline in 2011.

In what is sure to be a frequently cited ruling, the D.C. Circuit has reversed a jury’s verdict against a False Claims Act (FCA) defendant, finding that there was insufficient evidence for the jury to find that the defendant “knowingly” made a false claim where the defendant relied upon a facially reasonable interpretation of an undefined and ambiguous term upon which the government had offered no pre-litigation guidance.

In the early 1990s, in connection with a financed foreign purchase of irrigation pumps and equipment by Nigeria, appellant-defendant MWI Corporation certified to a U.S. government agency, the Export-Import Bank, that in accord with regulatory requirements it had not paid “any discount, allowance, rebate, commission, fee or other payment in connection with the sale” except for “[r]egular commissions or fees paid or to be paid in the ordinary course of business to [its] regular sales agents.”  In 1998, a relator filed suit alleging that these express certifications were false as MWI had paid a sales agent large commissions that allegedly were payments other than “regular commissions”.  The government subsequently intervened in 2002.  During the litigation, the government asserted that “regular commissions” were those consistent with industry-wide benchmarks, but prior to the litigation, the government had issued no written guidance on the meaning of the term “regular commissions.”  Indeed, during trial Bank officials acknowledged that the Bank preferred to keep this standard flexible in order to improve efficiency in the loan approval process.  MWI argued that the unsettled meaning of the ambiguous term “regular commissions” precluded the government, as a matter of law, from establishing the FCA elements of falsity and knowledge.

A jury found that MWI had violated the FCA 58 times.  In reversing the jury’s verdict, the court focused in on the ambiguity of the undefined term “regular commissions,” finding that “[a]bsent evidence that the Bank, or other government entity, had officially warned MWI away from its otherwise facially reasonable interpretation of that undefined and ambiguous term, the FCA’s objective knowledge standard . . . did not permit a jury to find that MWI ‘knowingly’ made a false claim.”  The court further noted the “potential due process problems posed by ‘penalizing a private party for violating a rule without first providing adequate notice of the substance of the rule,’” due to the fact that the first actual notice of the meaning of “regular commissions” was not provided by the government until “long after the conduct giving rise to this litigation took place.”  Additionally, the court noted that the government had not pointed to any guidance from the courts of appeals or the relevant agency that might have contradicted MWI’s interpretation of the ambiguous term.

In sum, the court held that MWI could not have knowingly submitted false claims because it relied on a reasonable interpretation of an ambiguous term that the government left undefined.  Of particular note for future and current FCA defendants facing false certification charges on the basis of ambiguous, undefined regulatory terminology is the following admonition from the court to the government:

That MWI’s interpretation may not be the best interpretation does not demonstrate that MWI’s interpretation was necessarily unreasonable. Absent evidence that the negative consequences of an interpretation render it unreasonable, such consequences can play no role in evaluating whether an FCA defendant acted knowingly. . . . Had the government wanted to avoid such consequences, it could have defined its regulatory term to preclude them. Of course, the government may instead determine that its goals are better served by not doing so, much as the Bank officials’ testimony implied. This may be the government’s choice, but then the FCA may cease to be an available remedy if the government concludes after the fact that a particular commission is not “regular” because it is too high.

Other courts have expressed similar sentiments, holding that ambiguous terms cannot form the basis for an FCA claim if the defendant’s interpretation of the regulation was reasonable (see here). The D.C. Circuit’s decision strongly reinforces this point, and is important authority for any defendant facing FCA claims premised on previously undefined regulatory, statutory or contractual language that is subject to more than one interpretation.

On October 30, 2015, the United States District Court for the Northern District of Georgia granted Fresenius Medical Care Holdings, Inc.’s (Fresenius’s) motion for summary judgment in United States ex rel. Saldivar v. Fresenius Medical Care Holdings, Inc., No. 1:10-CV-1614-AT. The district court, in a 108-page decision, found that the undisputed evidence showed that no reasonable jury could find that that Fresenius acted “knowingly.” Thus, the relator could not prevail on his claims.

The relator had alleged that Fresenius violated the False Claims Act (FCA) by billing Medicare for the overfill in medication vials, which is included to facilitate the extraction of the amount labeled on the vial. While the district court did find that billing for the overfill was impermissible, it determined that the relator could not prove that Fresenius either knew it was impermissible, or “acted with deliberate ignorance or reckless disregard as to the impermissibility of billing for administered overfill.”

The district court analyzed whether Fresenius knew that “the overfill was not reimbursable under the Medicare rules and regulations.” The court discussed actual knowledge, finding that the relator presented no evidence that Fresenius actually knew it should not have sought Medicare reimbursement for overfill. The court also held that the evidence presented by the relator would not support a finding that Fresenius recklessly disregarded the statutory or regulatory requirements because Fresenius’s interpretation of the statutory and regulatory scheme was reasonable. In reaching its decision, the court pointed to the following facts:

  • During the relevant time, the law was silent on the issue of billing for overfill;
  • Fresenius relied on counsel in determining that Medicare would reimburse overfill;
  • Fresenius and its counsel made this decision partly based on the belief that many companies had billed overfill for years, and the government knew about it but took no action;
  • Fresenius had disclosed its overfill billing to the government on multiple occasions in previous years, but the government never warned Fresenius that such billing was impermissible;
  • Fresenius was very serious in its efforts to comply with Medicare rules and regulations; and
  • The relator had no evidence to counter any of the above.

The district court rejected the relator’s argument that Fresenius had the necessary pieces to conclude that overfill billing was impermissible, finding that the relator nonetheless could not establish that Fresenius was reckless.

The court’s decision in this case shows the importance of thoughtful decision-making and appropriate disclosures in the face of a frequently cloudy regulatory scheme. While relators will continue to stretch facts to try to prove knowledge or intent, a number of recent decisions, including this one and others on which we previously reported (Issues of Fact Must Really Be Genuine: Another District Court Ends a Relator’s FCA Suit on Scienter Grounds, Omnicare Decision Demonstrates that Relators Cannot Rely on Ambiguous Evidence of Intent to Survive Summary Judgment, and Should Exercise Caution and Recent Decisions Serve as Reminder that Scienter is a Fertile Ground for Pre-Trial Disposition), demonstrate that a pattern of commitment to compliance, and good faith disclosure of relevant facts to the government, can help preserve the argument that even conduct later determined to be contrary to regulation was conducted in good faith and without any knowledge or reckless disregard of potentially false claims.

As we previously reported, in the FCA case against hospice-provider AseraCare, U.S. ex rel. Paradies v. AseraCare, Inc., the U.S. District Court for the Northern District of Alabama granted AseraCare’s motion for a new trial based on error in instructing the jury during the falsity phase of the trial (The trial was bifurcated into falsity and scienter phases.)  The court released its written order on the motion this week.

This order is an instructive read for any defense of a false certification case. As the court explains, a false certification case does not rest on allegations that, for example, a defendant forged doctor signatures, billed for unperformed services, or submitted claims for fictitious patients. Rather, such a claim, as in this case, rests on a theory that the underlying medical records do not support the physician’s certifications (here, of hospice eligibility), rendering those certifications false. But, as the court ultimately recognized in reviewing its jury instructions, a mere difference of clinical judgment is not enough to show falsity.  The court stated that it should have advised the jury that the FCA requires proof of an “objective” falsehood. It also added that a proper instruction should have stated that a difference of opinion between doctors, without more, is insufficient to show that a Medicare hospice claim is false.

But that was not all, in a case that has proved itself a procedural primer. The court also reopened summary judgment.  The court noted at the outset of its order that the law on many key issues under the FCA is still developing, particularly in the hospice realm. Based on its findings regarding the correct legal standard of falsity and the government’s evidence on falsity, the court notified the parties that it will consider summary judgment under Federal Rule of Civil Procedure 56(f)(3), which provides that a court may “consider summary judgment on its own after identifying for the parties the material facts that may not be genuinely in dispute.”  Thus, before setting a new trial date, the court will reconsider summary judgment, giving the government an opportunity to point to objective evidence of falsity offered during the trial.

The government faces a challenging case on summary judgment under the clarified legal standard.  In replying to contention interrogatories, the government represented that it would use only its expert’s testimony and the underlying medical records to try to prove falsity. Because the government’s evidence showed a difference in only clinical judgment about patients’ terminal prognoses, “the court now questions whether the Government, under the correct legal standard, has 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.”  Government witness testimony at trial further undermines the government’s case. As the court noted, the government expert acknowledged that he had changed his opinion regarding the eligibility of patients between his review in 2010 and 2013: “I was not the same physician in 2013 as I was in 2010.” Likewise, another government witness testified that “two doctors using their clinical judgment could come to different conclusions about a patient’s prognosis and neither be right or wrong.”

As a result of its decision to reconsider summary judgment, it may be that the re-trial of the falsity phase will not happen (and so too the scienter phase), or that the hospice claims for consideration are significantly winnowed. FCA practitioners and the federal jury pool in Birmingham alike eagerly await the court’s decision.