Justia Health Law Opinion Summaries

When Plaintiff-appellant Linda Smith purchased a prescribed continuous blood glucose monitor (CGM) and its necessary supplies between 2016 and 2018, she sought reimbursement through Medicare Part B. Medicare administrators denied her claims. Relying on a 2017 ruling issued by the Centers for Medicare and Medicaid Services (CMS), Medicare concluded Smith’s CGM was not “primarily and customarily used to serve a medical purpose” and therefore was not covered by Part B. Smith appealed the denial of her reimbursement claims through the multistage Medicare claims review process. At each stage, her claims were denied. Smith then sued the Secretary of the Department of Health and Human Services in federal court, seeking monetary, injunctive, and declaratory relief. Contending that her CGM and supplies satisfied the requirements for Medicare coverage. Instead of asking the court to uphold the denial of Smith’s claims, the Secretary admitted that Smith’s claims should have been covered and that the agency erred by denying her claims. Rather than accept the Secretary’s admission, Smith argued that the Secretary only admitted error to avoid judicial review of the legality of the 2017 ruling. During Smith’s litigation, CMS changed its Medicare coverage policy for CGMs. Prompted by several adverse district court rulings, CMS promulgated a formal rule in December 2021 classifying CGMs as durable medical equipment covered by Part B. But the rule applied only to claims for equipment received after February 28, 2022, so pending claims for equipment received prior to that date were not covered by the new rule. Considering the new rule and the Secretary’s confession of error, the district court in January 2022 remanded the case to the Secretary with instructions to pay Smith’s claims. The district court did not rule on Smith’s pending motions regarding her equitable relief claims; instead, the court denied them as moot. Smith appealed, arguing her equitable claims were justiciable because the 2017 ruling had not been fully rescinded. The Tenth Circuit agreed with the Secretary that Smith’s claims were moot: taken together, the December 2021 final rule and the 2022 CMS ruling that pending and future claims for CGMs would be covered by Medicare deprived the Tenth Circuit jurisdiction for further review. View "Smith v. Becerra" on Justia Law

Plaintiffs worked for MBO and Trustmark, which provide medical billing and debt‐collection services to healthcare providers. After they raised concerns about their employers’ business practices, the plaintiffs were fired. They sued MBO, Trustmark, and MBO's client, the University of Chicago Medical Center (UCMC), under the False Claims Act, 31 U.S.C. 3729. Regulations specify that Medicare providers seeking reimbursement for “bad debts” owed by beneficiaries must first make reasonable efforts to collect those debts. The plaintiffs claim that UCMC knowingly avoided an obligation to repay the government after it effectively learned that it had been reimbursed for non-compliant debts; MBO and Trustmark caused the submission of false claims to the government. Each plaintiff also claimed retaliation.The Seventh Circuit affirmed the dismissal of the complaint, in part. The district court properly dismissed the claim against UCMC, which neither had an established duty to repay the government nor acted knowingly in avoiding any such duty. The direct false claim against MBO was also correctly dismissed. The complaint failed to include specific representative examples of non-compliant patient debts, linked to MBO, for which reimbursement was sought. The court reversed in part; the complaint includes specific examples of patient debts involving Trustmark. Two plaintiffs alleged facts that support the inference that they reasonably believed their employers were causing the submission of false claims. View "Sibley v. University of Chicago Medical Center" on Justia Law

The United States District Court for the District of South Carolina certified a question of law to the South Carolina Supreme Court. Sullivan Management, LLC operated restaurants in South Carolina and filed suit to recover for business interruption losses during COVID-19 under a commercial property insurance policy issued by Fireman's Fund and Allianz Global Risks US Insurance Company (Fireman's). Specifically, the questions was whether the presence of COVID-19 in or near Sullivan's properties, and/or related governmental orders, which allegedly hinder or destroy the fitness, habitability or functionality of property, constituted "direct physical loss or damage" or did "direct physical loss or damage" require some permanent dispossession of the property or physical alteration to the property. The Supreme Court held that the presence of COVID-19 and the corresponding government orders prohibiting indoor dining did not fall within the policy’s trigger language of “direct physical loss or damage.” View "Sullivan Mgmt v. Fireman's Fund" on Justia Law

The Supreme Court affirmed the district court's grant of a preliminary injunction temporarily enjoining the implementation of three laws the Legislature enacted in 2021 that regulate or restrict abortion services, holding that there was no error of law or manifest abuse of discretion.In 2021, the Montana Legislature passed into law and the governor signed into law bills regulating or restricting abortions services and providing for various criminal penalties and civil remedies. The district court granted a preliminary injunction, finding that Plaintiffs made a prima facie showing that the challenged laws violated their rights under the Montana Constitution and determining that Plaintiffs would suffer irreparable injury if the challenged laws took effect. The Supreme Court affirmed, holding that either ground on which the district court granted a preliminary injunction would have been sufficient to justify relief. View "Planned Parenthood of Montana v. State" on Justia Law

Plaintiff alleged that Defendants Kinetic Concepts, Inc., and its indirect subsidiary KCI USA, Inc. (collectively, “KCI”) submitted claims to Medicare in which KCI falsely certified compliance with certain criteria governing Medicare payment for the use of KCI’s medical device for treating wounds. The district court granted summary judgment to KCI, concluding that Plaintiff failed to establish a genuine issue of material fact as to the False Claims Act elements of materiality and scienter.   The Ninth Circuit reversed the district court’s summary judgment. The court agreed that compliance with the specific criterion that there be no stalled cycle would not be material if, upon case-specific review, the Government routinely paid stalled-cycle claims. In other words, if stalled-cycle claims were consistently paid when subject to case-specific scrutiny, then a false statement that avoided that scrutiny and instead resulted in automatic payment would not be material to the payment decision. The court concluded, however, that the record did not show this to be the case. The court considered administrative rulings concerning claims that were initially denied, post-payment and pre-payment audits of particular claims, and a 2007 report by the Office of Inspector General of the U.S. Department of Health and Human Services. The court concluded that none of these forms of evidence supported the district court’s summary judgment ruling.   The court held that the district court further erred in ruling that there was insufficient evidence that KCI acted with the requisite scienter and that the remainder of the district court’s reasoning concerning scienter rested on a clear failure to view the evidence in the light most favorable to Plaintiff. View "STEVEN HARTPENCE V. KINETIC CONCEPTS, INC." on Justia Law

The Seventh Circuit affirmed the judgment of the district court denying Heart of CarDon, LLC's motion for judgment on the pleadings in this interlocutory appeal concerning section 1557 of the Patient Protection and Affordable Care Act, holding that T.S. was a proper plaintiff against CarDon under section 1557, and his suit may continue on that basis.CarDon was a healthcare provider that was reimbursed by Medicare and Medicaid for its serves. CarDon provided health insurance to its employees and their depends through a self-funded employee benefits plan. T.S., a dependent who had autism, brought this action alleging that the plan's exclusion of coverage for autism treatment violated section 1557. CarDon moved for judgment on the pleadings, arguing that only a recipient of CarDon's healthcare services was a permissible plaintiff under section 1557. The district court denied the motion. The Seventh Circuit affirmed, holding that T.S. plausibly alleged an interest that comes within the zone of interests section 1557 seeks to protect. View "T.S. v. Heart of CarDon, LLC" on Justia Law

The First Circuit dismissed this appeal from the dismissal of a 42 U.S.C. 1983 suit filed by Plaintiffs, two college students, against Defendants, their former universities and university officials, asserting constitutional challenges to the universities' COVID-19 vaccination policies, holding that Plaintiffs' claims are moot.The policies at issue required all students either to be vaccinated or to obtain an exemption to be allowed onto campus. Plaintiffs sought declaratory and injunctive relief seeking exemptions from the policies. The district court denied relief and granted Defendants' motion to dismiss. The First Circuit dismissed Plaintiffs' ensuing appeal, holding that where one student had graduated and the other student was no longer enrolled, Plaintiffs' claims were moot. View "Harris v. University of Massachusetts, Lowell" on Justia Law

Petitioner F.E.D., seventy-three years old, was convicted of three counts of first-degree murder and would not be eligible for parole until 2040. In February 2021, the Managing Physician of the New Jersey Department of Corrections submitted to the Commissioner of Corrections a Request for Compassionate Release on behalf of F.E.D. Based on the diagnoses provided by the attesting physicians, the Managing Physician found that F.E.D. “meets the medical conditions established” by N.J.S.A. 30:4-123.51e. Pursuant to N.J.S.A. 30:4-123.51e(d)(1), the Commissioner issued a Certificate of Eligibility for Compassionate Release. A trial court held an evidentiary hearing on the motion. With regard to whether F.E.D. suffered from a “permanent physical incapacity” as defined in N.J.S.A. 30:4-123.51e(1), the trial court relied on the list of “activities of daily living” enumerated in the administration of New Jersey’s Medicaid program, which the court identified to be bathing, dressing, toileting, locomotion, transfers, eating and bed mobility. Applying that standard to the medical diagnoses presented in F.E.D.’s petition for compassionate release, the trial court observed that the attesting physicians had found a diminished ability in instrumental activities of daily living but not an inability to perform activities of basic daily living. The court accordingly found that F.E.D. had not presented clear and convincing evidence that he suffered from a “permanent physical incapacity” within the meaning of N.J.S.A. 30:4-123.51e(d)(1). The Appellate Division found that the Certificate of Eligibility for compassionate release that the Department issued to F.E.D. was invalid based on its view that the Compassionate Release Statute applied only to inmates whose medical conditions rendered them unable to perform any of the activities of basic daily living, and to be inapplicable to any inmate who could conduct one or more of those activities. The New Jersey Supreme Court found that the Compassionate Release Statute did not require that an inmate prove that he is unable to perform any activity of basic daily living in order to establish a “permanent physical incapacity” under N.J.S.A. 30:4-123.51e(l). Rather, the statute required clear and convincing evidence that the inmate’s condition rendered him permanently unable to perform two or more activities of basic daily living, necessitating twenty-four-hour care. Assessing F.E.D.’s proofs in accordance with the statutory standard, the Supreme Court found he did not present clear and convincing evidence that his medical condition gave rise to a permanent physical incapacity under N.J.S.A. 30:4-123.51e(f)(1). View "New Jersey v. F.E.D." on Justia Law

Defendant owned and operated a healthcare clinic. Along with another provider, Defendant engaged in a scheme to fraudulently bill Medicare for home health services that were not properly authorized, not medically necessary, and, in some cases, not provided. Insiders testified to Defendant's role in the conspiracy, indicating she knew the home healthcare agencies were paying marketers to recruit patients. Defendant also told an undercover FBI agent she could show him how to make money by recruiting patients. Defendant was convicted and sentenced to 300 months in federal prison.Defendant appealed, challenging the sufficiency of the evidence against her. However, the Fifth Circuit affirmed her conviction, finding that a rational jury could have concluded that Defendant knew about and willfully joined the conspiracy. Additionally, the court rejected Defendant's challenges to her sentence, finding that the district court did not commit a procedural error and that her sentence was not substantively unreasonable. View "USA v. Rodriguez" on Justia Law

Defendant, a neurosurgeon, chose to use implants distributed by DS Medical, a company wholly owned by his fiancée. Physicians in other practices grew suspicious and filed various claims under the False Claims Act. The jury returned a verdict for the government on two of the three claims. The district court then awarded treble damages and statutory penalties in the amount of $5,495,931.22. Following the verdict, the government moved to dismiss its two remaining claims without prejudice, see Fed. R. Civ. P. 41(a)(2), on the ground that any recovery would be “smaller and duplicative of what the [c]ourt ha[d] already awarded.”   The Eighth Circuit reversed and remanded for a new trial. The court explained that are several ways to prove that a claim is “false or fraudulent” under the False Claims Act. One of them is to show that it “includes items or services resulting from a violation” of the anti-kickback statute. This case required the court to determine what the words “resulting from” mean. The court concluded that it creates a but-for causal requirement between an anti-kickback violation and the “items or services” included in the claim. Thus, the court reversed and remanded because district court did not instruct the jury along these lines. View "United States v. Midwest Neurosurgeons, LLC, et al" on Justia Law