Justia U.S. 3rd Circuit Court of Appeals Opinion Summaries

Articles Posted in Health Law
by
Dr. Polansky was an official at the Centers for Medicare and Medicaid Services (CMS) before consulting for EHR, a “physician advisor” company that provides review and billing certification services to hospitals and physicians that bill Medicare. Polansky became concerned that EHR was systematically enabling its client hospitals to over-admit patients by certifying inpatient services that should have been provided on an outpatient basis.In 2012, Polansky filed suit under the False Claims Act (FCA), 31 U.S.C. 3729, alleging EHR was causing hospitals to bill the government for inpatient stays that were not “reasonable and necessary” for diagnosis or treatment as required by the Medicare program, 42 U.S.C. 1395y(a)(1)(A). His complaint remained under seal for two years while the government conducted its own investigation and ultimately determined it would not participate in the case.In 2019, the government notified the parties that it intended to dismiss the entire action under 31 U.S.C. 3730(c): “[t]he Government may dismiss the action notwithstanding the objections of the [relator]” so long as the relator receives notice and an opportunity to be heard on the Government’s motion. The district court eventually granted the motion. The Third Circuit affirmed. The government is required to intervene before moving to dismiss and its motion must meet the standard of FRCP 41(a). The district court acted within its discretion in granting the government’s motion. View "Polansky v. Executive Health Resources Inc" on Justia Law

by
The estates of New Jersey nursing home residents, who died from COVID-19, alleged that the nursing homes acted negligently in handling the COVID-19 pandemic. The nursing homes removed the case to federal court. The district court dismissed the cases for lack of subject-matter jurisdiction.The Third Circuit affirmed rejecting three arguments for federal jurisdiction: federal-officer removal, complete preemption of state law, and the presence of a substantial federal issue. The 2005 Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, 247d6e, which protects certain individuals—such as pharmacies and drug manufacturers—from lawsuits during a public-health emergency, was invoked in March 2020 but does not apply because the nursing homes did not assist or help carry out the duties of a federal superior. The PREP Act creates an exclusive cause of action for willful misconduct but the estates allege only negligence, not willful misconduct; those claims do not fall within the scope of the exclusive federal cause of action and are not preempted. The PREP Act’s compensation fund is not an exclusive federal cause of action. The estates would properly plead their state-law negligence claims without mentioning the PREP Act, so the PREP Act is not “an essential element" of the state law claim. View "Estate of Joseph Maglioli v. Alliance HC Holdings, LLC" on Justia Law

by
The hospital, located in Philadelphia, received a reclassification into the New York City area, which would sizably increase the hospital’s Medicare reimbursements due to that area’s higher wage index, 42 U.S.C. 1395ww(d). Although a statute makes such reclassifications effective for three fiscal years, the agency updated the geographical boundaries for the New York City area before the close of that period and reassigned the hospital to an area in New Jersey with an appreciably lower wage index. The hospital successfully sued three agency officials in the Eastern District of Pennsylvania.The Third Circuit vacated and remanded for dismissal. The Medicare Act, 42 U.S.C. 1395oo(f)(1), channels reimbursement disputes through administrative adjudication as a near-absolute prerequisite to judicial review. The hospital did not pursue its claim through administrative adjudication before suing in federal court. By not following the statutory channeling requirement, the hospital has no valid basis for subject-matter jurisdiction. View "Temple University Hospital, Inc. v. Secretary United States Department of Health & Human Services" on Justia Law

by
In 1998, Pennsylvania and 45 other states entered into a settlement agreement with certain cigarette manufacturers, who agreed to disburse funding to the states to cover tobacco-related healthcare costs. Pennsylvania’s 2001 Tobacco Settlement Act established the "EE Program" to reimburse participating hospitals for “extraordinary expenses” incurred for treating uninsured patients according to a formula. The Department of Human Services (DHS) determines the eligibility of each hospital for EE Program payments. The Pennsylvania Auditor General reported that for Fiscal Years 2008-2012, some participating hospitals received disbursements for unqualified claims, and recommended that DHS claw back funds from overpaid hospitals and redistribute the money to hospitals that had been underpaid. DHS followed that recommendation for fiscal years prior to 2010 but discovered methodological discrepancies and discontinued the process for Fiscal Years 2010-2012.Plaintiffs, on behalf of all “underpaid” hospitals, sued an allegedly overpaid hospital, alleging conspiracy to defraud the EE Program in violation of RICO, 18 U.S.C. 1961–1964. The plaintiffs alleged that the defendants submitted fraudulent claims for reimbursement, in violation of the wire fraud statute, 18 U.S.C. 1343 (a RICO predicate offense). The Third Circuit reversed the dismissal of the claims, finding that the theory of liability adequately alleges proximate causation. No independent factors that accounted for the plaintiffs’ injury and no more immediate victim was better situated to sue. View "St. Lukes Health Network, Inc. v. Lancaster General Hospital" on Justia Law

by
J.L. and D.W. were covered by employer-sponsored Aetna insurance plans that provided out-of-network benefits only in cases of “Urgent Care or a Medical Emergency” (J.L.) or not at all (D.W.). J.L. needed bilateral breast reconstruction surgery and there were no in-network physicians available to perform the procedure. D.W. required facial reanimation surgery—a niche procedure performed by only a few U.S. surgeons. Both were referred for treatment to the Plastic Surgery Center, an out-of-network New Jersey medical practice. The Center negotiated with Aetna, which agreed to pay a “reasonable amount.” The Center billed $292,742 for J.L.’s services, Aetna paid only $95,534.04. Of the $420,750 the Center billed for D.W.’s services, Aetna paid only $40,230.32.The district court dismissed common law breach of contract, promissory estoppel, and unjust enrichment claims, holding that section 514(a) of the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. 1000, expressly preempted all claims. The Third Circuit reversed as the breach of contract and promissory estoppel claims, which do not require impermissible “reference to” ERISA plans. The claims, as pleaded, plausibly seek to enforce obligations independent of the plan and do not require interpretation or construction of ERISA plans. The claims plausibly arise out of a relationship that ERISA did not intend to govern. View "Plastic Surgery Center, P.A. v. Aetna Life Insurance Co" on Justia Law

by
Care Alternatives provides hospice care to New Jersey patients, employing “interdisciplinary teams” of registered nurses, chaplains, social workers, home health aides, and therapists working alongside independent physicians who serve as hospice medical directors. Former Alternatives employees filed suit under the False Claims Act, 31 U.S.C. 3729–3733 alleging that Alternatives admitted patients who were ineligible for hospice care and directed its employees to improperly alter those patients’ Medicare certifications to reflect eligibility. They retained an expert, who opined in his report that, based on the records of the 47 patients he examined, the patients were inappropriately certified for hospice care 35 percent of the time. Alternatives’ expert testified that a reasonable physician would have found all of those patients hospice-eligible. The district court determined that a mere difference of opinion between experts regarding the accuracy of the prognosis was insufficient to create a triable dispute of fact as to the element of falsity and required that the plaintiffs provide evidence of an objective falsehood. Upon finding they had not adduced such evidence, the court granted Alternatives summary judgment. The Third Circuit vacated, rejecting the objective falsehood requirement for FCA falsity. The plaintiffs’ expert testimony created a genuine dispute of material fact as to falsity. View "Druding v. Care Alternatives" on Justia Law

by
Health benefit plans sued GSK, the manufacturer of the prescription drug Avandia, under state consumer-protection laws and the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. ch. 96 (RICO), based on GSK’s marketing of Avandia as having benefits to justify its price, which was higher than the price of other drugs used to treat type-2 diabetes. The district court granted GSK summary judgment, finding that the state-law consumer-protection claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. ch. 9; the Plans had failed to identify a sufficient “enterprise” for purposes of RICO; and the Plans’ arguments related to GSK’s alleged attempts to market Avandia as providing cardiovascular “benefits” were “belated.” The Third Circuit reversed, applying the Supreme Court’s 2019 "Merck" decision. The state-law consumer-protection claims are not preempted by the FDCA. The Plans should have been given the opportunity to seek discovery before summary judgment on the RICO claims. Further, from the inception of this litigation, the Plans’ claims have centered on GSK’s marketing of Avandia as providing cardiovascular benefits as compared to other forms of treatment, so the district court’s refusal to consider the Plans’ “benefits” arguments was in error because those arguments were timely raised. View "In re: Avandia Marketing, Sales and Products Liability Litigation" on Justia Law

by
University of Pittsburgh Medical Center includes 20 hospitals. Its more than 2,700 doctors are employed by Medical Center subsidiaries. Each surgeon had a base salary and an annual Work-Unit quota. Every medical service is worth a certain number of Work Units, which are one component of Relative Value Units (RVUs). RVUs are the units that Medicare uses to measure how much a medical procedure is worth. The surgeons were rewarded or punished based on how many Work Units they generated. The number of Work Units billed by the Neurosurgery Department more than doubled in 2006-2009. The relators accuse the surgeons of artificially boosting their Work Units: The surgeons said they acted as assistants on surgeries and as teaching physicians when they did not and billed for procedures that never happened. They did surgeries that were medically unnecessary or needlessly complex. Most of the surgeons reported total Work Units that put them in the top 10% of neurosurgeons nationwide. Whenever a surgeon did a procedure at one of the hospitals, the Medical Center billed for hospital and ancillary services. The United States intervened in a suit as to the physician services claims, settling those claims for $2.5 million. It declined to intervene in the hospital services claims. The Third Circuit reversed the dismissal of those claims. The relators adequately pleaded violations of the Stark Act, 42 U.S.C. 1395nn(b)(4), which forbids hospitals to bill Medicare for certain services when the hospital has a financial relationship with the doctor who requested those services. It is likely that the surgeons' pay is so high that it must take referrals into account. Stark Act exceptions work like affirmative defenses; the burden lies with the defendant, even under the False Claims Act, 31 U.S.C. 3729(a)(1)(A). View "United States v. University of Pittsburgh Medical Center" on Justia Law

by
The Affordable Care Act (ACA) mandated that women’s health insurance include coverage for preventive health care. The Health Resources and Services Administration issued guidelines that indicated that preventative health care includes contraceptive care. Nonprofit religious entity employers could invoke "the Accommodation," which permits employers to send a self-certification form to their insurance issuers to exclude contraceptive coverage from the group health plan while providing payments for contraceptive services for plan participants and beneficiaries, separate from the group health plan, without the imposition of cost sharing, premium, fee, or other charge on plan participants or beneficiaries or on the eligible organization or its plan.Following Supreme Court decisions concerning ACA, the Accommodation was extended to for-profit entities that are not publicly traded, are majority-owned by a relatively small number of individuals, and that object to providing contraceptive coverage based on the owners’ religious beliefs. The district court entered a preliminary injunction, prohibiting the rule’s enforcement nationwide.The Third Circuit affirmed, reasoning that the agencies did not follow the APA and that the regulations are not authorized under the ACA or required by the Religious Freedom Restoration Act. Sates will face unredressable financial consequences from subsidizing contraceptive services, providing funds for medical care associated with unintended pregnancies, and absorbing medical expenses arising from decreased use of contraceptives for other health conditions. The current Accommodation does not substantially burden employers’ religious exercise and its extension is not necessary to protect a legally-cognizable interest. The public interest favors minimizing harm to third-parties by ensuring that women who may lose ACA-guaranteed contraceptive coverage. View "Pennsylvania v. President of the United States" on Justia Law

by
Over seven years, Dr. Greenspan referred more than 100,000 blood tests to Biodiagnostic Laboratory, which made more than $3 million off these tests. In exchange, the Lab gave Greenspan and his associates more than $200,000 in cash, gifts, and other benefits. A jury convicted Greenspan of accepting kickbacks, 42 U.S.C. 1320a-7(b)(1)(A); using interstate facilities with the intent to commit commercial bribery, 18 U.S.C. 1952(a)(1), (3); honest-services wire fraud, 18 U.S.C. 1343, 1346; and conspiracy to do all of those things. The Third Circuit affirmed, characterizing the evidence of his guilt as overwhelming. The district court erred in instructing the jury that Greenspan had to “demonstrate” the prerequisites for an advice-of-counsel defense; in excluding as hearsay some of his testimony about that legal advice; in asking only Greenspan’s counsel, not Greenspan personally, whether he wished to speak at sentencing; and in limiting the scope of the defense to five particular agreements rather than all eight, but all of those errors were harmless. The court properly excluded evidence that the blood tests were medically necessary. That evidence was only marginally relevant and risked misleading the jury. View "United States v. Greenspan" on Justia Law