Legal Insights and Perspectives for the Healthcare Industry

The US Court of Appeals for the Eleventh Circuit has issued its much awaited decision in United States v. Aseracare, and for those who question how mere differences clinical opinion can ever support punitive False Claims Act (FCA) liability, the opinion is especially informative. The decision is significant for hospice providers and all healthcare providers that have battled government enforcers on its theory that evidence of subjective lack of medical necessity is fraud for the last decade. The decisions should be a bellwether for the US Department of Justice (DOJ), as well as an opportunity for DOJ to revisit its enforcement initiatives related to medical necessity, which have gone off the rails in recent years with the pursuit of cases that do not reasonably suggest fraud has actually occurred.

Rejecting DOJ’s signature theory of liability that falsity may be established by mere clinical disagreement divined from a cold retroactive review of the record, the court held that the trial court was right to grant a new trial to Aseracare based on erroneous jury instructions that allowed mere clinical disagreement to be the only evidence of falsity to find punitive FCA liability against the national hospice provider. The district court had granted a new trial on the basis that the instructions were wrong and the Eleventh Circuit agreed. The court further held that the summary judgment subsequently granted to Aseracare should be vacated and reconsidered to give the government an opportunity to present other falsity evidence related to the sample claims, if the government has such actual evidence to be considered. So, procedurally, the case stays alive, but is on thin ice at best.

The court noted that the trial record was devoid of any evidence that physicians had lied regarding their certifications of eligibility or that hospice services were not provided to the patient, and pointed out that much of the evidence showed Aseracare’s compliance with Medicare’s hospice regulatory scheme. The opinion noted that CMS and the Medicare contractor at trial supported the view that the Medicare hospice benefit was structured to consider good-faith, subjective clinical opinions based on the common sense reality that death is an inexact science, and that two physicians could hold different views of a patient’s prognosis and eligibility. Even the government’s expert changed his mind on patient eligibility over time—an incredible situation given that his testimony was the sole evidence to support the jury’s verdict and punitive liability in excess of $200 million.

There are many gems in this well-reasoned and scholarly opinion, the first at the appellate level to consider the government's FCA theory. Some key takeaways for practitioners include the following:

  1. To properly state a claim alleging hospice fraud under the FCA, the government must show facts surrounding a physician’s certification of eligibility that are inconsistent with the proper exercise of a physician’s clinical judgment. Mere differences of reasonable opinion concerning a patient’s likely longevity are not sufficient to allege FCA liability.
  2. Falsity evidence must be linked to the government’s actual samples of false claims. General anecdotal information of business practices untethered to the proffered false claims is not evidence of falsity for FCA purposes.

DOJ’s medical necessity initiatives over the last several years have focused on hospice and therapy providers, virtually all with the same playbook: cold record retrospective review, often by a nurse reviewer, to allege falsity based on alleged inadequate documentation conclusions as to clinical eligibility. There is often no evidence of actual fraud or material noncompliance. Often, the physicians who certify eligibility are not even interviewed regarding their certifications before catastrophic punitive liability is asserted. DOJ’s theory of liability does not require actually developing evidence of falsity, only evidence of clinical disagreement. Many of these investigation matters are founded on clinical disagreement, lightly sprinkled with general anecdotal complaints regarding business practices, or with C-suite emails that look bad but had no influence on the physician’s certification or were even known to the clinicians caring for the patient.

This opinion powerfully reasons why the government’s approach is inconsistent with the FCA statute and the Medicare hospice benefit regulatory scheme. Its reasoning applies with equal vigor to the medical necessity fraud initiative DOJ has developed over the years against other healthcare providers. The opinion also highlights the danger of not developing the right evidence to show fraud and relying on evidentiary shortcuts to assert liability under a highly punitive statute.

Finally, the opinion lays bare the reality that government enforcement practices sometimes ignore the regulations and rationale for the regulatory scheme at issue in order to fashion a more pliable account of how regulations are intended to work—even if that account is contrary to what has been legislated by Congress and implemented by the regulatory agency. In Aseracare, the government enforcers ignored the regulatory scheme as explained by its own Medicare agency witnesses to assert punitive liability under the FCA. This has a chilling and negative effect on all hospice providers, which is the exact opposite of what is right for the patients and their families who need this important benefit.

We hosted a very informative Fast Break session last week on complex FCA issues. If you weren't able to join, the session was led by Katie McDermott and Matt Hogan, who are both authorities in False Claims Act (FCA) litigation. Understanding the complex dynamics for dealing with both the US Department of Justice (DOJ) and qui tam relators, Katie and Matt led us through the minute details of relator litigation, declined qui tams, and partial interventions, just to name a few things.

Among the overarching issues we discussed, coming on the heels of the US Supreme Court’s Cochise decision, is the Court’s seemingly renewed interest in the FCA and the possibility of statutory amendments to the FCA to balance out many of the, as Katie termed it, “procedural inequities” that now exist when a healthcare organization is an FCA defendant. Katie and Matt also discussed recent DOJ pronouncements about their FCA enforcement procedures and priorities, highlighting that the FCA remains the most significant overarching risk area for healthcare stakeholders.

We had a really fun and insightful edition of our Fast Break webinar series in June. If you didn’t get a chance to join in, the session featured Jonelle Saunders and Jake Harper discussing recent compliance guidance issued by the US Department of Justice (DOJ). Jonelle explained the reasons why the DOJ issued the guidance, how the guidance works, and some practical tips for healthcare providers in assessing their own compliance programs. The guidance can have a major impact on settlement dynamics for defendants in False Claims Act (FCA) cases and other matters, so it is important to understand the DOJ’s thinking on compliance.

We finally got to appear on camera for this Fast Break, which was an interesting experience (although a little more nerve-wracking than usual). It gave us the chance to better interact with our attendees, who asked some great questions on the topic.

The US Supreme Court issued its decision on May 13 in Cochise Consultancy v. United States ex rel Hunt, unanimously holding that the three-year tolling provision in 31 U.S.C. 3731 (b)(2) applies in favor of relators in declined FCA cases. This decision resolves a three-way split in the circuits on whether relators may have up to 10 years to pursue allegations in declined whistleblower cases.

DOJ’s enforcement policy for the False Claims Act (FCA) has largely been static for 30 years or maybe since the forgotten 1998 Holder memo that set out guidelines to assure the FCA was not recklessly deployed for provider billing mistakes. In the last year or so, however, the policy guidance has been astonishing, insightful, and suggests a new attitude is afoot. First, we had the popularly described “Granston Memo” in 2018 on the criteria for seeking dismissal of declined whistleblower suits, which is now part of the Justice Manual and, in fact, there has been an increase in DOJ dismissals as there should be in this practice area.

The Federal Bar Association's Qui Tam Section held a terrific two-day conference in Washington, DC, on February 28 and March 1, attended by over 200 False Claims Act (FCA) practitioners presenting government, defense, and relator perspectives on current FCA practice. Shout-out to our litigation partners Wendy West Feinstein and Rebecca Hillyer who participated on a panel discussing the FCA and opioids and other pharmaceutical products, and our colleagues Katie McDermott and Jonelle Saunders who attended the program.

There is an important pleading standard question being posed to the US Supreme Court in the petition for writ of certiorari by Intermountain Healthcare (IHC) in a False Claims Act (FCA) case filed by a whistleblower in 2012. The issue involves the pleading requirements under Federal Rule of Civil Procedure 9(b), which requires a plaintiff to plead fraud with particularity.

Does a relator have a shorter statute of limitations period than the United States to pursue a False Claims Act (FCA) case when the United States has declined to intervene? A split among the circuit courts has created an opportunity for the US Supreme Court to resolve this vexing question and potentially confirm whether relators are government officials under the statute. In issuing certiorari to the US Court of Appeals for the Eleventh Circuit, in Cochise Consultancy Inc. v. United States, ex rel. Hunt, the Court will address the limitations issue against the backdrop of a growing litigation trend in declined qui tams and lengthy seal durations when sued defendants have no idea they’ve been sued for many years. Partner Kathleen McDermott breaks down the Cochise appeal—characterized in a recent Morgan Lewis LawFlash as “a hot case to watch”—and offers a timely analysis of the case, and the potential legal consequences of a decision by the US Supreme Court to level set the FCA statute of limitations provisions.

Read the Full Law Flash

The HHS OIG recently published a new Fraud Risk Indicator for False Claims Act (FCA) settlements on the risk spectrum for the first quarter of federal fiscal year 2019. Characterized as “an assessment of future risk posed by persons who have allegedly engaged in civil healthcare fraud,” the Fraud Risk Indicator purports to increase transparency by making public where an FCA defendant falls into one of five color-coded categories on a risk spectrum: Highest Risk – Exclusion (red), High Risk – Heighted Scrutiny (orange), Medium Risk – CIAs (yellow), Lower Risk – No Further Action (green); Low Risk – Self-Disclosure (blue).