Justia Health Law Opinion Summaries

A personal care assistance provider agency in Minnesota was audited by the Department of Human Services (DHS) for recordkeeping deficiencies related to its provision of services under the state’s Medicaid program. The agency, which served both traditional and PCA Choice recipients, was found to have various documentation errors, including missing or incomplete care plans and timesheets, as well as timesheets lacking required elements. DHS did not allege fraud or that services were not provided, but sought to recover over $420,000 in payments, arguing that these deficiencies constituted “abuse” under state law and justified monetary recovery.After an evidentiary hearing, an administrative law judge (ALJ) recommended limited recovery for some missing documentation but rejected most of DHS’s claims, finding that DHS had not shown the deficiencies resulted in improper payments. The DHS Commissioner disagreed, ordering full repayment. The Minnesota Court of Appeals reversed the Commissioner’s decision, holding that DHS must prove not only that the provider engaged in “abuse” but also that the abuse resulted in the provider being paid more than it was entitled to receive. The court also determined that provider agencies must maintain care plans for both traditional and PCA Choice recipients in their files.The Minnesota Supreme Court affirmed in part, reversed in part, and remanded. It held that, to obtain monetary recovery under Minn. Stat. § 256B.064, subd. 1c(a), DHS must prove either: (1) the provider engaged in conduct described in subdivision 1a and, had DHS known of the conduct before payment, it would have been legally prohibited from paying under a statute or regulation independent of subdivision 1a; or (2) the payment resulted from an error such that the provider received more than authorized by law. The Court also held that provider agencies must keep care plans for all PCA services, including PCA Choice, in their files. View "In the Matter of the SIRS Appeal by Best Care, LLC" on Justia Law

An advanced practice registered nurse in Texas, who maintained an active nursing license and a Prescriptive Authority Number, did not have a current prescriptive-authority agreement with a physician, as required by Texas law to prescribe drugs. She was not accused of any misconduct but was attending an educational program to transition careers. Because she lacked a prescriptive-authority agreement, the Drug Enforcement Administration (DEA) initiated proceedings to revoke her federal Certificate of Registration, which allows her to handle controlled substances.An administrative law judge within the DEA recommended revocation, finding that she was “without state authority to handle controlled substances.” The Administrator of the DEA adopted this recommendation and revoked her registration. The nurse then petitioned for review directly to the United States Court of Appeals for the Fifth Circuit, as permitted by statute.The United States Court of Appeals for the Fifth Circuit reviewed the DEA’s action and concluded that the agency exceeded its statutory authority under 21 U.S.C. § 824(a)(3). The court held that the statute requires both the loss of a state license or registration and the lack of state authorization to handle controlled substances before the DEA may revoke a registration. Because the nurse still held all relevant state licenses and registrations, the court determined that the DEA lacked authority to revoke her registration solely due to the absence of a prescriptive-authority agreement. The court granted the petition for review, vacated the DEA’s revocation order, and remanded the case to the agency for further proceedings consistent with its opinion. View "DeWitt v. Drug Enforcement Administration" on Justia Law

A staff member at a university medical school morgue, Cedric Lodge, engaged in a scheme over several years in which he dissected, stole, and sold body parts from cadavers that had been donated for research and education. After Lodge’s federal indictment became public, forty-seven relatives of individuals whose remains were potentially mishandled sued the university, the managing director of the anatomical gift program (Cicchetti), and the program manager (Fay). The plaintiffs alleged that the university and its staff failed to ensure the dignified treatment and disposition of donated remains, pointing to inadequate security and oversight, and referenced a similar prior scandal at another institution.The cases were consolidated in the Massachusetts Superior Court, where the defendants moved to dismiss all claims, arguing they were protected by the “good faith” immunity provision of the Uniform Anatomical Gift Act (UAGA). The Superior Court judge granted the motion, finding that the complaints did not plausibly suggest the defendants failed to act in good faith or were legally responsible for Lodge’s actions.The Supreme Judicial Court of Massachusetts reviewed the case after transferring it from the Appeals Court. The court held that the UAGA’s good faith immunity applies to the entire anatomical donation process, including the final disposition of remains. The court further held that the plaintiffs’ allegations against the university and Cicchetti, if true, could support a finding of “peculiarly pervasive noncompliance” with the act, sufficient to infer a lack of good faith and defeat the motion to dismiss at this stage. However, the court found the allegations against Fay insufficient to overcome the good faith defense. The court reversed the dismissal as to the university and Cicchetti (except for respondeat superior claims), affirmed dismissal as to Fay, and remanded for further proceedings. View "Weiss v. President and Fellows of Harvard College" on Justia Law

A group of more than 80 former at-will employees of a nonprofit healthcare system in Washington were terminated after refusing to comply with a COVID-19 vaccination mandate issued by their employer, which was in response to an August 2021 proclamation by the state’s governor requiring healthcare workers to be vaccinated. The employees alleged that, at the time, only an “investigational” vaccine authorized for emergency use was available, and they claimed their rights were violated when they were penalized for refusing it. They also argued they were not adequately informed of their right to refuse the vaccine.The United States District Court for the Western District of Washington first dismissed all claims against the governor, then dismissed the federal claims against the healthcare system, and denied the employees’ motions for leave to amend and reconsideration. The district court also declined to exercise supplemental jurisdiction over the remaining state-law claims against the healthcare system.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed the district court’s dismissal. The Ninth Circuit held that none of the employees’ statutory or non-constitutional claims, which were based on various federal statutes, regulations, agreements, and international treaties, alleged specific and definite rights enforceable under 42 U.S.C. § 1983. The court also found that the employees’ constitutional claims failed: the Fourteenth Amendment substantive due process claim was foreclosed by Jacobson v. Massachusetts and Health Freedom Defense Fund, Inc. v. Carvalho; the procedural due process claim failed because at-will employment is not a constitutionally protected property interest; and the equal protection claim failed because the mandate survived rational-basis review. The court further held that amendment of the federal claims would be futile and upheld the district court’s dismissal of the state law claims against the governor and its decision to decline supplemental jurisdiction over the state law claims against the healthcare system. View "Curtis v. Inslee" on Justia Law

Novo Nordisk, a pharmaceutical manufacturer, challenged the implementation of the Drug Price Negotiation Program established by the Inflation Reduction Act of 2022. The Program requires the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate prices for certain high-expenditure drugs covered by Medicare. In the first round of selections, CMS grouped six of Novo Nordisk’s insulin aspart products as a single “negotiation-eligible drug” and selected them for price negotiation. Novo Nordisk signed the required agreements to participate but subsequently filed suit, arguing that CMS’s grouping of its products and the procedures used to implement the Program violated statutory and constitutional provisions.The United States District Court for the District of New Jersey granted summary judgment in favor of the government. The court found it lacked subject matter jurisdiction to review CMS’s decision to treat the six products as one drug due to a statutory bar on judicial review. It also held that Novo Nordisk lacked standing to challenge the identification of more than ten drugs for the initial pricing period. The court rejected Novo Nordisk’s claims under the unconstitutional conditions doctrine, the Due Process Clause, the nondelegation doctrine, and the First Amendment, concluding that the Program did not deprive the company of a protected property interest, that Congress provided an intelligible principle to guide CMS, and that the Program primarily regulated conduct rather than speech.On appeal, the United States Court of Appeals for the Third Circuit affirmed the District Court’s judgment. The Third Circuit held that the statutory bar on judicial review precluded consideration of Novo Nordisk’s challenge to the grouping of its products. The court also held that CMS was authorized to implement the Program through guidance for the initial years without notice and comment rulemaking, that the Act did not violate the nondelegation doctrine or the Due Process Clause, and that Novo Nordisk’s First Amendment claim was foreclosed by precedent. View "Novo Nordisk Inc. v. Secretary US Dept & Health and Human Services" on Justia Law

A registered nurse was convicted by a jury of misdemeanor elder or dependent adult abuse for her role in the care of a 62-year-old dependent adult, Michael H., at an unlicensed boarding house in Riverside, California. The facility, Secure Hands, was not authorized to provide medical care and was intended for residents who could manage their own daily activities. However, Michael, who had recently suffered a stroke and had significant physical and mental limitations, was admitted to the facility under the nurse’s assessment and supervision. The nurse determined his care needs, recommended equipment, and was responsible for ensuring that appropriate caregivers were available. Despite knowing the facility was not equipped for dependent adults, she admitted Michael and did not report or address ongoing concerns about his care, including poor hygiene and lack of basic necessities, which were repeatedly brought to her attention.The Superior Court of Riverside County initially charged the nurse with four counts of felony elder or dependent adult abuse, but one count was dismissed before trial. The jury deadlocked on two counts, resulting in a mistrial for those, but found her guilty of the lesser included misdemeanor offense regarding Michael. She was sentenced to four months in county jail and fined $1,000.On appeal, the nurse argued that the definition of “care or custody” from the Elder Abuse and Dependent Adult Civil Protection Act should apply to her criminal prosecution, and that there was insufficient evidence she had such responsibility. The California Court of Appeal, Fourth Appellate District, Division Two, rejected this argument, holding that “care or custody” in Penal Code section 368(c) should be interpreted according to its plain and ordinary meaning, not the more restrictive civil definition. The court found substantial evidence supported the jury’s verdict and affirmed the conviction. View "P. v Molina" on Justia Law

Plaintiffs, which are self-insured health and welfare trust funds, challenged a statutory requirement under the Patient Protection and Affordable Care Act (ACA) that obligated them to pay contributions to the Transitional Reinsurance Program (TRP) for the 2014, 2015, and 2016 benefit years. They argued that these mandatory payments constituted a taking of their property under the Fifth Amendment, claiming a protected property interest in the specific funds held in their trust accounts, which are maintained solely for providing health and welfare benefits to covered individuals.The United States Court of Federal Claims reviewed the case and granted the Government’s motion for partial summary judgment on the Fifth Amendment takings claim. The Claims Court found that the plaintiffs did not possess a cognizable property interest in the TRP payments, as the obligation was merely to pay money, not to surrender specifically identifiable funds. The court rejected the argument that the trust agreements created a property interest in the sums paid, and also dismissed the alternative claim that the trust accounts themselves were the specific funds at issue. The Claims Court further held that a taking would only occur if the government appropriated the entire fund, which did not happen here. Plaintiffs’ motion for reconsideration was denied.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the grant of summary judgment de novo. The Federal Circuit affirmed the Claims Court’s decision, holding that the statutory obligation to pay TRP contributions did not constitute a taking under the Fifth Amendment because it was an obligation to pay money, not an appropriation of a specific, identifiable fund. The court clarified that a mere requirement to pay money, even from a trust account, does not give rise to a takings claim. The Federal Circuit also found harmless error in the Claims Court’s alternative reasoning regarding appropriation of funds in toto. The judgment was affirmed. View "ELECTRICAL WELFARE TRUST FUND v. US " on Justia Law

Jill Esche, who was seven months pregnant, was admitted to Renown Regional Medical Center in Nevada with severe hypertension and erratic behavior. Hospital staff, believing she was mentally ill and a danger to herself and her fetus, petitioned for her involuntary commitment under Nevada law. While the petition was pending, Esche was kept in the hospital, given psychiatric and medical treatment against her will, restricted from visitors and phone use, and not informed that a public defender had been appointed for her. After giving birth by C-section, the hospital decided to withdraw the commitment petition but allowed Esche to leave while she was still in fragile condition. She died outside near the hospital that night. Her estate and survivors sued the hospital and several staff members, alleging violations of her constitutional rights under 42 U.S.C. § 1983 and Nevada law.The United States District Court for the District of Nevada granted summary judgment to the defendants on some claims, including unreasonable seizure and procedural due process claims, but denied summary judgment on others, such as substantive due process, conspiracy, and failure-to-train-or-supervise claims. The court also denied the defendants’ assertion of a good-faith defense to § 1983 liability, finding that the defense did not apply because the hospital was not required by law or directed by a public official to hold Esche involuntarily. Both sides appealed: the defendants challenged the denial of the good-faith defense, and the plaintiffs cross-appealed the dismissal of other constitutional claims.The United States Court of Appeals for the Ninth Circuit reviewed the case and held that the district court’s denial of the good-faith defense was not immediately appealable under the collateral order doctrine, as the defense is a defense to liability, not an immunity from suit. The court dismissed both the defendants’ appeals and the plaintiffs’ cross-appeal for lack of jurisdiction. View "Estate of Esche v. Bunuel-Jordana" on Justia Law

Natalya Shvets was convicted by a jury in 2014 for healthcare fraud and conspiracy to commit healthcare fraud, stemming from her role as a nurse at Home Care Hospice, Inc. (HCH). Evidence showed she and other employees created false records for high-priced “continuous care” services, resulting in fraudulent bills submitted to Medicare. Shvets was ordered to pay $253,196 in restitution, jointly and severally with eight other defendants, for her involvement in 52 false bills. The broader scheme allegedly caused $16.2 million in losses to Medicare, with seventeen individuals ordered to pay varying restitution amounts.After sentencing in the United States District Court for the Eastern District of Pennsylvania, Shvets moved for an accounting and to declare her restitution judgment satisfied, arguing that payments by herself and her jointly liable co-defendants had collectively exceeded $253,196. The District Court, relying on United States v. Sheets, held that Shvets’s judgment would not be satisfied until she personally paid the full amount or until all defendants collectively paid $16.2 million. The Clerk of Court, using a complex allocation method, also reported Shvets’s balance as outstanding, but the District Court did not resolve whether the Clerk’s method was correct.On appeal, the United States Court of Appeals for the Third Circuit affirmed in part, vacated in part, and remanded. The Court held that sentencing judges may issue “hybrid” restitution orders under the Mandatory Victim Restitution Act, combining joint and several liability with apportioned liability. The Court found the District Court erred by applying the Sheets rule, which conflicted with the language of Shvets’s judgment. The Third Circuit directed the District Court to determine whether the Clerk’s accounting method is fair and appropriate, and to decide if Shvets’s restitution judgment has been satisfied. View "United States v. Shvets" on Justia Law

A patient with a long history of severe depression and multiple suicide attempts underwent 95 electroconvulsive therapy (ECT) treatments at a Nebraska hospital between 2014 and 2016. The ECT was administered using a device manufactured by Somatics, LLC. After the treatments, the patient experienced significant memory loss and was diagnosed with a neurocognitive disorder. In 2020, he filed suit against Somatics in the United States District Court for the Middle District of Florida, alleging negligence, strict product liability, breach of warranties, violation of Nebraska’s Consumer Protection Act, and fraudulent misrepresentation, primarily claiming that Somatics failed to adequately warn of the risks associated with ECT.The district court dismissed the claims under Nebraska’s Consumer Protection Act and for fraudulent misrepresentation, merged the strict liability and breach of implied warranty claims, and granted summary judgment to Somatics on the design defect, manufacturing defect, and breach of express warranty claims. The remaining claims for negligence and strict liability, both based on failure to warn, were merged for trial. The jury found that while Somatics failed to provide adequate warnings, this failure was not the proximate cause of the plaintiff’s injuries, and awarded no damages. The district court denied the plaintiff’s post-trial motions, including for a new trial.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the district court’s decisions de novo for summary judgment and for abuse of discretion on evidentiary and procedural rulings. The Eleventh Circuit held that the district court properly granted summary judgment on the design defect claim, correctly merged the negligence and strict liability claims, gave an appropriate jury instruction on proximate cause, and did not abuse its discretion in excluding certain evidence and expert testimony. The judgment of the district court was affirmed. View "Thelen v. Somatics, LLC" on Justia Law