Justia U.S. 4th Circuit Court of Appeals Opinion Summaries

Articles Posted in Health Law
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Genesis Healthcare was a healthcare provider participating in the federal “340B Program,” which was designed to provide drugs to qualified persons at discounted prices. Under the Program, the Secretary of the Department of Health and Human Services (“HHS”) enters into agreements with drug manufacturers to sell drugs at discounted prices to entities such as Genesis Healthcare, which could, in turn, sell the drugs to their patients at discounted prices. After Genesis Healthcare purchased the covered drugs from the manufacturers, it dispensed them to patients through its wholly owned pharmacies or contract pharmacies. After the Health Resources and Services Administration (“HRSA”) conducted an audit of Genesis Healthcare in June 2017 for Program compliance, HRSA removed Genesis Healthcare from the 340B Program. The audit report found, among other things, that Genesis Healthcare dispensed 340B drugs to individuals who were ineligible because they were not “patients” of Genesis Healthcare. HRSA rejected Genesis Healthcare’s challenges; Genesis Healthcare, in turn, filed suit seeking a declaration it did not violate the requirements of the Program, and injunctive relief requiring HRSA to reinstate it into the Program and to retract any notifications that HRSA had provided to manufacturers stating that Genesis Healthcare was ineligible under the Program. In response to the lawsuit, HRSA ultimately: (1) notified Genesis Healthcare by letter that it “ha[d] voided” all audit findings and that Genesis Healthcare “ha[d] no further obligations or responsibilities in regard to the audit” and (2) filed a motion to dismiss Genesis Healthcare’s action as moot based on the letter. The district court granted HRSA’s motion, finding that the action was moot. The Fourth Circuit reversed the district court's finding the case was moot: Genesis Healthcare continued to be governed by a definition of “patient” that, Genesis maintained, was illegal and harmful to it. Therefore, there remained a live controversy between the parties. View "Genesis HealthCare, Inc. v. Becerra" on Justia Law

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Plaintiff brought a False Claims Act challenge against two doctors, five medical companies, and an accounting firm, collectively referred to hereinafter as Defendants. She alleged that Defendants (1) knowingly submitted false claims to Medicare following the dissolution of one company’s corporate charter and the revocation of its certificate of corporate authorization and (2) engaged in a fraudulent medical upcoding scheme.   The Fourth Circuit affirmed the finding that Plaintiff failed to establish a genuine dispute of material fact regarding the falsity of statements made by one of the defendants. And she failed to adequately allege scienter, materiality, and the presentment of false claims regarding the remaining seven Defendants.   The court explained that the False Claims Act prohibits the knowing presentment of a “false or fraudulent claim” or a “false record or statement material to a false or fraudulent claim.” 31 U.S.C. Section 3729(a)(1)(A), (B). At common law, a false statement encompassed any “words or conduct” that “amount[] to an assertion not in accordance with the truth.” But even under the broad, common-law definition of falsity, Plaintiff has failed to establish a genuine issue of material fact regarding the allegedly false statement made by one of the defendants. Further, the court wrote that it doesn’t help that Plaintiff inconsistently describes what that false statement was. View "United States ex rel. Taylor v. Michael Boyko" on Justia Law

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In March of 2020, West Virginia’s Governor began to adopt public-safety measures in response to the outbreak of the COVID-19 pandemic. Six months later, a group of Plaintiffs sued, challenging those measures as unconstitutional. The district court dismissed their case, holding that the amended complaint failed to state a valid constitutional claim.   On appeal, the Plaintiffs argued for the voluntary cessation exception. The Fourth Circuit vacated the district court’s judgment and remanded with instructions to dismiss the case. The court held that the case is moot because the Governor has long since terminated each of the challenged executive orders, and there is no reasonable chance they will be reimposed.  The court reasoned a defendant claiming mootness based on the voluntary cessation of a challenged practice must show that it is “absolutely clear that the allegedly wrongful behavior could not reasonably be expected to recur. Here, the Governor has not imposed any new COVID-19 restrictions, let alone restrictions similar in scope or subject matter to those Plaintiffs' challenge. Nor have Plaintiffs pointed to any conduct by the Governor suggesting that measures like gathering limits, capacity restrictions, or school closures will be reimposed in the future. View "Eden, LLC v. Jim Justice" on Justia Law

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Plaintiff suffered from back and neck pain for years, and her doctor concluded that surgery would help her relieve her symptoms. After surgery, her insurance provider, Central States, denied her claim. Central States made this determination pursuant to a provision of the plan stating that covered individuals “shall not be entitled to payment of any charges for care, treatment, services, or supplies which are not medically necessary or are not generally accepted by the medical community as Standard Medical Care, Treatment, Services or Supplies.” Central States came to this conclusion based on an independent medical review (IMR) of Plaintiff’s claim, conducted by a physician board-certified in general surgery. Plaintiff filed suit under the Employee Retirement Income Security Act (“ERISA”), and Defendant appealed the district court’s ruling.The Fourth Circuit found that Central States failed to disclose to their IMR physician the medical records that would have been pertinent to his analysis. The court noted that it did not conclude that Central States acted in bad faith or deliberately withheld documentation. But intent aside, Central States owes plan participants a “deliberate, principled reasoning process.” Further, while plan trustees enjoy a good measure of discretion in determining what is “medically necessary” under the terms of the plan, they may not abuse that discretion by employing processes that lead to unreasoned conclusions or by affixing extratextual requirements. The court held that because Central States had ample chance to review Plaintiff’s claim, the district court did not abuse its discretion by awarding benefits outright. View "Dorothy Garner v. Central States, Southeast and Southwest Areas" on Justia Law

Posted in: ERISA, Health Law
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This case arose out of South Carolina's termination of Planned Parenthood's Medicaid provider agreement. The district court granted a preliminary injunction, concluding in relevant part that the individual plaintiff had demonstrated that she was likely to succeed on her Medicaid Act claim since the free-choice-of-provider provision conferred a private right enforceable under 42 U.S.C. 1983 and South Carolina had violated that provision by terminating Planned Parenthood's Medicaid provider agreement. The Fourth Circuit affirmed the district court's decision. The district court then issued a permanent injunction, which South Carolina now challenges in this appeal.The Fourth Circuit first concluded that this case presents a live case or controversy and rejected South Carolina's claim of mootness. Even assuming that the court were free to reexamine its precedents, the court declined to do so in this case. Rather, the court concluded that its previous decision was handed down as a matter of law and resolved the precise legal issue upon which South Carolina now seeks review.The court reaffirmed its prior decision, concluding that the free-choice-of-provider provision confers on Medicaid recipients an individual right enforceable under section 1983. The court stated that the statute plainly reflects Congress's desire that individual Medicaid recipients be free to obtain care from any qualified provider and it implements this policy in direct and unambiguous language. In this case, all three Blessing factors in determining whether a statute creates a private right enforceable under section 1983 are met. Furthermore, the Medicaid Act does not evince Congress's intent to specifically foreclose a remedy under section 1983. Finally, the Supreme Court's decision in O’Bannon v. Town Court Nursing Center, 447 U.S. 773 (1980), does not undermine the court's analysis. The court refused to nullify Congress's undeniable desire to extend a choice of medical providers to the less fortunate among us, individuals who experience the same medical problems as the more fortunate in society but who lack under their own means the same freedom to choose their healthcare provider. View "Planned Parenthood South Atlantic v. Kerr" on Justia Law

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Coffey was employed by the Railway as a locomotive engineer. In 2012, a train that Coffey was operating derailed; a drug test revealed the presence of amphetamines in Coffey’s system. Coffey was permitted to continue working, but he was subject to follow-up drug testing for five years. In 2016, a test showed the presence of amphetamines and codeine. Coffey explained that he had prescriptions for Adderall, which he took for ADHD, and codeine (Tylenol #3), which he took for a back condition. Railway requested that Coffey provide medical records. Six weeks later, Coffey ruptured his Achilles tendon and took medical leave for 10 months. When his physician cleared him to return to work, Railway again requested the records it had previously requested. After two more demands, Railway received some records but was unsatisfied because they failed to include specifically requested information such as medication side effects. In anticipation of a disciplinary hearing, Coffey submitted approximately 400 pages of medical records. Upon determining that those records still did not address much of the required information, Railway terminated Coffey’s employment.The EEOC concluded that there was reasonable cause to believe that Railway’s demands violated the ADA, 42 U.S.C. 12112(a). The district court and Fourth Circuit rejected Coffey’s subsequent suit. Railway made a lawful request under the ADA. Its inquiries were related to Coffey’s job and were required by federal regulation. Complying with federal regulations is, by definition, a business necessity. View "Coffey v. Norfolk Southern Railway Co." on Justia Law

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Lighthouse Church filed suit challenging the legality of executive orders the Governor of Virginia issued to combat the spread of COVID-19. The specific executive orders that Lighthouse Church challenged expired in June of 2020, and the state of emergency in Virginia upon which they were predicated ended on July 1, 2021. Furthermore, the end of the state of emergency terminated all outstanding COVID-19-related executive orders.The Fourth Circuit vacated and remanded for dismissal of the action as moot, concluding that the executive orders that Lighthouse Church challenges are no longer in effect and no exception to mootness is applicable. Therefore, there is no live controversy between the parties in these proceedings. Because the action is moot, the court also vacated the district court's judgment without reaching or addressing the issue concerning Governor Northam's entitlement to sovereign immunity. View "Lighthouse Fellowship Church v. Northam" on Justia Law

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Enrollees in the North Carolina State Health Plan for Teachers and State Employees (NCSHP) sued, alleging that NCSHP discriminates against its transgender enrollees by categorically denying coverage for gender dysphoria treatments like counseling, hormone therapy, and surgical care, in violation of section 1557 of the Patient Protection and Affordable Care Act, which prohibits “any health program or activity” that receives federal funds from discriminating against individuals on any ground prohibited by various federal statutes, including Title IX, 42 U.S.C. 18116(a).The Fourth Circuit affirmed the denial of NCSHP’s motion to dismiss, asserting that it was entitled to sovereign immunity under the Eleventh Amendment. NCSHP waived its immunity against this claim by accepting federal financial assistance. Under the Civil Rights Remedies Equalization Act (CRREA), “[a] State shall not be immune under the Eleventh Amendment of the Constitution of the United States from suit in Federal court for a violation of . . . any other Federal Statute prohibiting discrimination by recipients of Federal financial assistance,” 42 U.S.C. 2000d-7. View "Kadel v. North Carolina State Health Plan for Teachers and State Employees" on Justia Law

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Baltimore filed suit against the Government, alleging that HHS's Final Rule, prohibiting physicians and other providers in Title X programs from referring patients for an abortion, even if that is the patient's wish, violates the Administrative Procedure Act (APA). The Final Rule, instead, requires them to refer the patient for prenatal care. Furthermore, the Final Rule requires entities receiving Title X funds, but offering abortion-related services pursuant to another source of funds, to physically separate their abortion-related services from the Title X services. After the district court issued a preliminary injunction enjoining the Government from implementing or enforcing the Final Rule because the Final Rule is likely not in accordance with law, the Government appealed. While the appeal of the preliminary injunction was pending and after discovery, the district court issued a permanent injunction on different grounds.The Fourth Circuit consolidated the appeals and a majority of the full court voted to hear both cases en banc. The court upheld the district court's grant of the permanent injunction on two grounds: first, the Final Rule was promulgated in an arbitrary and capricious manner because it failed to recognize and address the ethical concerns of literally every major medical organization in the country, and it arbitrarily estimated the cost of the physical separation of abortion services; and second, the Final Rule contravenes statutory provisions requiring nondirective counseling in Title X programs and prohibiting interference with physician/patient communications. Accordingly, because the court affirmed the permanent injunction in Case No. 20-1215, the appeal of the preliminary injunction in Case No. 19-1614 is moot and the court dismissed it. View "Mayor and City Council of Baltimore v. Azar" on Justia Law

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Plaintiff filed suit against the hospital, alleging that it violated the Emergency Medical Treatment and Active Labor Act (EMTALA) by failing to properly screen him and stabilize his condition.The Fourth Circuit adopted the requirement of a good faith admission and held that a party claiming an admission was not in good faith must present evidence that the hospital admitted the patient solely to satisfy its EMTALA standards with no intent to treat the patient once admitted and then immediately transferred the patient. The court held that plaintiff failed to point to evidence that creates a genuine issue of material fact as to this high standard. Furthermore, plaintiff failed to point to any evidence in support of his theory that the hospital admitted plaintiff to improperly hoard him in order to garner his premium insurance benefits. View "Williams v. Dimensions Health Corp." on Justia Law