In a long-awaited opinion, on September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit in United States v. Aseracare, Inc., et al, unanimously vacated AseraCare’s False Claims Act (FCA) victory and remanded the case for further proceedings.[1] While this might seem a victory only for the Government at first blush, the opinion contains key takeaways for defendants that will likely reach far beyond just this case.

Importantly, even though the Eleventh Circuit vacated the district court’s grant of summary judgment to AseraCare, it affirmed the district court’s conclusion that a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for purposes of the FCA, when there is only a reasonable disagreement between medical experts as to the accuracy of that conclusion, with no other evidence to prove the falsity of the assessment. The Eleventh Circuit also concluded, however, that the Government should have been allowed to rely on the entire record, not just the trial record, to prove otherwise. The Government was precluded from doing so, the Court found, due to an earlier decision by the district court to bifurcate proceedings into two phases: one on falsity, and the other on the remaining elements of the FCA.

In affirming the district court’s holding regarding clinical judgment, the Eleventh Circuit remarked that it appears to be the “first circuit court to consider the precise question at issue here,”[2] and is an extraordinary move that provides hospice facilities, hospitals, and providers more generally with a degree of assurance that a reasonable disagreement between clinicians in a courtroom, without other evidence of objective falsehood, does not create a jury question and cannot serve as the basis for an action under the FCA: “While there is no question that clinical judgments must be tethered to a patient’s valid medical records, it is equally clear that the law is designed to give physicians meaningful latitude to make informed judgments without fear that those judgments will be second-guessed after the fact by laymen in a liability proceeding.”[3]


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In the latest episode of Payers, Providers, and Patients – Oh My!, Troy Barsky and Alice Hall-Partyka talk with Joe Records and Payal Nanavati about how recent litigation challenging the constitutionality of the Affordable Care Act may impact providers and payers. The discussion focuses on the authority for innovative health care models and

In Gresham v. Azar, United States District Court for the District of Columbia Judge James E. Boasberg “[found] its guiding principle in Yogi Berra’s aphorism, ‘It’s déjà vu all over again.’” No. CV 18-1900 (JEB), 2019 WL 1375241, at *7 (D.D.C. Mar. 27, 2019). In striking down the Department of Health and Human Services (“HHS”) approval of Arkansas’s Medicaid work requirements as “arbitrary and capricious,” Judge Boasberg noted that the agency’s failures were “nearly identical” to those in Stewart v. Azar I, 313 F.Supp.3d 237, 243 (D.D.C. 2018), where he vacated the agency’s approval of Kentucky’s Medicaid Work requirements back in June 2018. The same day the Court issued Gresham, Judge Boasburg declared “[t]he bell now rings for round two” and again vacated Kentucky’s Medicaid work requirements finding the agency’s reaproval “arbitrary and capricious” in Stewart v. Azar II. No. CV 18-152 (JEB), 2019 WL 1375496, at *1 (D.D.C. Mar. 27, 2019).

Under Section 1115 of the Social Security Act, HHS may approve a state’s waiver application and allow a state to waive certain Medicaid program requirements. Such waivers include “experimental, pilot, or demonstration project[s]” that “in the judgment of the Secretary, [are] likely to assist in promoting the [Medicaid Act’s] objectives.” 42 U.S.C. § 1315(a). In March 2017, Seema Verma, the Administrator for the Centers for Medicare & Medicaid Services (“CMS”), along with HHS Secretary at the time, Thomas Price, sent a letter to state governors clarifying the agency’s “intent to use existing Section 1115 demonstration authority to review and approve” Medicaid work requirements. Heeding this call, the governor of Kentucky applied for a Section 1115 waiver to implement an experimental program which includes work requirements as a condition of Medicaid coverage. Under these work requirements, many adults must complete 80 hours of employment or other qualifying activities every month or lose their Medicaid coverage. These requirements primarily target the Medicaid expansion population (individuals who obtained coverage after states expanded eligibility under the Affordable Care Act). Arkansas’ program—which took effect last June as the first work requirements in the history of Medicaid—is substantially similar to the Kentucky program. The Kentucky work requirements had yet to take effect.


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On January 1, 2019, portions of the U.S. Department of Labor’s (DOL) Final Rule expanding the availability of Association Health Plans (AHPs) went into effect. AHPs allow small businesses to band together and negotiate better deals when buying insurance for their members.

The partial government shutdown hasn’t slowed the raging debate over how states are to implement the DOL’s final rule. On December 28, 2018, a federal judge ordered litigation concerning the rule to continue despite the shutdown.

States have reacted to the final rule in dramatically divergent ways. Some states believe that AHPs will make it finally possible for small employers to offer affordable healthcare options for their employees. Other states worry that AHPs will destabilize the individual insurance marketplace. They predict that healthy people will join AHPs because they are less expensive than other insurance options, and this shift will leave sicker people in a smaller pool with higher premiums.  
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Crowell & Moring has issued its Regulatory Forecast 2018: What Corporate Counsel Need to Know for the Coming Year.”

The health care section of the Forecast, “Mergers: Keeping Care Competitive,” outlines how regulators have kept a close eye on the impact of industry consolidation and how the government has been aggressively

Crowell & Moring has issued its Litigation Forecast 2018: What Corporate Counsel Need to Know for the Coming Year.”

 The health care section of the Forecast, “FCA Enforcement: Different, But Still Here,” outlines how health care companies should expect continued enforcement of the False Claims Act, but with perhaps different emphasis

Internet defamation (and intellectual property infringement) cases are on the rise.  And cases involving anonymous defendants are becoming more common.  They of course present tricky First Amendment issues.  Indeed, most such cases result in the anonymous defendants remaining masked and escaping liability.  But in four example health care cases – a scare tactic, accidental disclosure,