Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the Third Circuit
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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

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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

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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

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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

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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

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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

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The Affordable Care Act (ACA) mandates that women’s health insurance cover preventive health care. Health Resources and Services Administration guidelines indicate that preventative health care includes contraceptive care. Nonprofit religious entity employers could invoke "the Accommodation," which permits employers to send self-certification forms 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 Administrative Procedures Act 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

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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

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Nita and her husband, Kirtish, pled guilty to defrauding Medicare (18 U.S.C. 1347), based on having forged physicians’ signatures on diagnostic reports and having conducted diagnostic testing without the required physician supervision. The government then brought this civil action for the same fraudulent schemes against Nita, Nita’s healthcare company (Heart Solution), Kirtish, and Kirtish’s healthcare company (Biosound). The district court granted the government summary judgment, relying on the convictions and plea colloquies in the criminal case, essentially concluding that Nita had admitted to all elements and issues relevant to her civil liability. Nita and Heart Solution appealed. The Third Circuit affirmed Nita’s liability under the False Claims Act, 31 U.S.C. 3729(a)(1)(A) and for common law fraud but vacated findings that Heart Solution is estopped from contesting liability and damages for all claims and Nita is estopped from contesting liability and damages for the remaining common law claims. The district court failed to dissect the issues that were determined in the criminal case from those that were not, lumping together Nita and Heart Solution, even though Heart Solution was not involved in the criminal case. It also failed to disaggregate claims Medicare paid to Nita and Heart Solution from those paid to Kirtish and Biosound. The plea colloquy did not clarify ownership interests in the companies; who, specifically, made certain misrepresentations; nor whether one company was paid the entire amount or whether the payments were divided between the companies. View "Doe v. Heart Solution PC" on Justia Law

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LifeWatch is one of the two largest sellers of telemetry monitors, a type of outpatient cardiac monitoring devices used to diagnose and treat heart arrhythmias, which may signal or lead to more serious medical complications. An arrhythmia can be without noticeable symptoms. Other outpatient cardiac monitors also record the electrical activity of a patient’s heart to catch any instance of an arrhythmia but they vary in price, method of data capture, and mechanism by which the data are transmitted for diagnosis. LifeWatch sued the Blue Cross Blue Shield Association and five of its member insurance plan administrators under the Sherman Act, 15 U.S.C. 1, claiming they impermissibly conspired to deny coverage of telemetry monitors as “not medically necessary” or “investigational,” although the medical community, other insurers, and independent arbiters viewed it as befitting the standard of care. The Third Circuit reversed the dismissal of the complaint. LifeWatch plausibly stated a claim and has antitrust standing. That so many sophisticated third parties allegedly view telemetry monitors as medically necessary or meeting the standard of care undercuts Blue Cross’s theory that nearly three dozen Plans independently made the opposite determination for 10 consecutive years. Read in the light most favorable to LifeWatch, the complaint alleges competition among all outpatient cardiac monitors such that they are plausibly within the same product market. LifeWatch has alleged actual anticompetitive effects in the relevant market. View "Lifewatch Services Inc. v. Highmark, Inc." on Justia Law