Justia Government & Administrative Law Opinion Summaries

A physician licensed in Florida worked at a weight management clinic, where he was responsible for maintaining a federal registration to dispense controlled substances. After a report of missing controlled substances at the clinic, local police and the Drug Enforcement Administration (DEA) began investigating. The investigation revealed that the physician had issued numerous prescriptions for controlled substances without proper documentation of a doctor-patient relationship, failed to maintain required records, did not properly report or store controlled substances, and dispensed medication in violation of labeling requirements. The physician claimed that another clinic employee had forged his signature on some prescriptions and denied personal wrongdoing.The DEA issued an Order to Show Cause, notifying the physician of its intent to revoke his registration and deny pending applications, citing violations of federal and state law. The physician submitted a Corrective Action Plan but did not request a hearing. The DEA Administrator reviewed the evidence, including expert testimony and the physician’s admissions, and found that the physician’s continued registration would be inconsistent with the public interest. The Administrator revoked the registration and denied all pending applications, emphasizing the physician’s failure to accept responsibility and the inadequacy of his proposed corrective measures.The United States Court of Appeals for the Eleventh Circuit reviewed the DEA’s final order under an abuse of discretion standard, deferring to the agency’s factual findings if supported by substantial evidence. The court held that the physician received adequate procedural due process, as he was given notice and an opportunity for a hearing, which he declined. The court also rejected the argument that the DEA was required to find knowing or intentional misconduct under Ruan v. United States, holding that such a mens rea requirement does not apply to administrative revocation proceedings under 21 U.S.C. § 824. The petition for review was denied. View "Ashraf v. Drug Enforcement Administration" on Justia Law

In 2018, the plaintiff was placed on an involuntary 72-hour psychiatric hold, resulting in the creation of a confidential record by the Orange County Sheriff’s Department. In 2021, during a legal dispute over their father’s estate, the plaintiff discovered that his sister’s attorney had obtained this confidential record and used it to threaten him in an attempt to force dismissal of his elder abuse lawsuit against his sister. The record had been released by an office specialist at the Sheriff’s Department, who admitted knowing the sister was not entitled to the record but disclosed it anyway, believing she was concerned for the plaintiff’s well-being.A jury in the Superior Court of Orange County found that the office specialist willfully and knowingly disclosed the confidential record, awarding the plaintiff $29,000 in economic damages and $40,000 in noneconomic damages. The jury also found the plaintiff’s sister and her attorney responsible for 25 percent of the damages. However, the trial court granted a motion for partial judgment notwithstanding the verdict, concluding there was insufficient evidence of willfulness, declined to treble the damages, and apportioned both economic and noneconomic damages, entering judgment for 75 percent of the total damages against the office specialist and the County.The California Court of Appeal, Fourth Appellate District, Division Three, reversed the trial court’s order. The appellate court held that “willfully and knowingly” under Welfare and Institutions Code section 5330 means intentionally releasing confidential records to someone known to be unauthorized, regardless of intent to harm. The court found substantial evidence supported the jury’s finding of willfulness, requiring trebling of damages. The court also held that while noneconomic damages could be apportioned to other tortfeasors, economic damages could not. The case was remanded with instructions to enter judgment for $177,000 against the County and the office specialist, jointly and severally. View "Doe v. County of Orange" on Justia Law

Lauren Richwine, through her business Death Done Differently, provides services as a “death doula,” assisting clients and their families with end-of-life planning, emotional support, and guidance on funeral arrangements. Richwine is not a licensed funeral director, and her website notes that her services are performed under the supervision of a licensed funeral director. In 2021, a complaint was filed with the Indiana Public Licensing Agency alleging that Richwine was practicing funeral services without a license. Following an investigation, the Indiana Attorney General sought a cease-and-desist order from the State Board of Funeral and Cemetery Service, which was approved. The order prohibited Richwine and her company from advertising or providing certain services related to funeral planning, community death care, and support with funeral homes.After the cease-and-desist order was issued, Richwine and Death Done Differently filed suit in the United States District Court for the Northern District of Indiana, Fort Wayne Division, arguing that enforcement of the Indiana statute against them would violate their First Amendment rights. The district court granted a preliminary injunction, enjoining enforcement of the statute against the plaintiffs. The defendants appealed, arguing that the plaintiffs had waived their rights by signing the cease-and-desist agreement and that federal abstention doctrine barred the suit. The district court rejected these arguments, finding no clear and unmistakable waiver of federal rights and no ongoing state proceeding that would justify abstention.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s decision. The Seventh Circuit held that the Indiana statute, as applied to Richwine and Death Done Differently, burdens substantially more speech than necessary to further the state’s interests in public health, safety, and consumer protection. The court found that the statute’s restrictions on the plaintiffs’ speech and advertising likely violate the First Amendment. The Seventh Circuit affirmed the district court’s preliminary injunction and remanded for further proceedings. View "Richwine v. Matuszak" on Justia Law

A certified nurse midwife in Nebraska sought to provide home birth services but was prevented from doing so by state law. The Nebraska Certified Nurse Midwifery Practice Act requires midwives to work under a supervising physician through a practice agreement and prohibits them from attending home births outside authorized medical facilities. The midwife alleged that these restrictions forced her to turn away women seeking home births and sued state officials, claiming the law violated her constitutional rights and the rights of her prospective patients.The United States District Court for the District of Nebraska dismissed the midwife’s claims. The court found that she failed to state a claim for violation of her own rights under the Due Process Clause and lacked standing to assert claims on behalf of her prospective patients. The district court concluded that the statutory requirements were rationally related to legitimate state interests in health and safety and that the midwife did not have a sufficiently close relationship with prospective patients nor could she show that those patients were hindered from bringing their own suits.On appeal, the United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. The appellate court held that the Nebraska law regulating midwifery is subject to rational basis review and that the legislature could rationally believe the restrictions serve legitimate interests in public health and safety. The court also held that the midwife lacked third-party standing to assert the rights of prospective patients because she did not have a close relationship with them and they were not hindered from bringing their own claims. The Eighth Circuit affirmed the district court’s judgment, upholding the dismissal of all claims. View "Swanson v. Hilgers" on Justia Law

A group of hospitals challenged the calculation of their Medicare fractions for fiscal year 2007, which is a key component in determining eligibility and payment amounts under the Medicare disproportionate share hospital (DSH) adjustment. The DSH adjustment provides increased reimbursement to hospitals serving a high number of low-income patients. The hospitals disputed the inclusion of Medicare Part C beneficiaries in the Medicare fraction, arguing that this reduced their payments. After the Centers for Medicare and Medicaid Services (CMS) published the Medicare fractions, the hospitals appealed to the Provider Reimbursement Review Board, seeking review of the calculation before the final DSH adjustment was determined.The Provider Reimbursement Review Board dismissed the hospitals’ appeal for lack of jurisdiction, reasoning that a challenge could only be brought after the final determination of the DSH adjustment was made and reflected in the Notice of Program Reimbursement (NPR). The Board concluded that publication of the Medicare fraction alone did not constitute a “final determination” as required by statute. The hospitals then sought review in the United States District Court for the District of Columbia, which disagreed with the Board and held that the hospitals’ challenge could proceed, interpreting precedent to allow appeals at the stage of Medicare fraction publication.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and reversed the district court’s judgment. The court held that the Board lacked jurisdiction to hear the hospitals’ challenge prior to the issuance of the NPR, because only the NPR constitutes the Secretary’s “final determination as to the amount of the payment” under the relevant statutory provision. The court clarified that while some prospective payment system components may be appealed before the NPR, retrospective adjustments like the DSH adjustment require final settlement before an appeal is ripe. View "Battle Creek Health System v. Kennedy" on Justia Law

Two brothers with developmental disabilities, Gaven and Jared, live with their parents, who are certified to provide in-home care. Both brothers qualified for Maine’s “Single Member Services,” which would allow each to receive one-on-one care from a designated provider. The family requested that each parent be reimbursed for providing care to one brother. However, the Maine Department of Health and Human Services determined that, because the brothers lived together, they were only eligible for “Two Member Services,” meaning a single provider would be reimbursed to care for both, at half the total rate. The parents continued to provide one-on-one care to both brothers, but were only reimbursed for one provider, resulting in a significant financial shortfall.The family challenged this determination in Maine Superior Court, which ruled in their favor, finding that the Department’s interpretation of its rules was arbitrary and inconsistent with its policies. Following this decision, the Department began reimbursing both parents for providing one-on-one care. The family then filed a federal lawsuit seeking damages for the period before the state court’s ruling, alleging discrimination under Title II of the Americans with Disabilities Act (ADA). The United States District Court for the District of Maine dismissed the case, holding that the Department was protected by Eleventh Amendment sovereign immunity.On appeal, the United States Court of Appeals for the First Circuit reversed the district court’s dismissal. The First Circuit held that the Department was not entitled to sovereign immunity because Congress validly abrogated such immunity under Title II of the ADA in this context. The court found that the Department’s policy violated the brothers’ equal protection rights, as there was no rational basis for providing reduced services solely because the brothers lived together. The case was remanded for further proceedings. View "McKenna v. Maine Department of Health and Human Services" on Justia Law

A pharmaceutical company sought approval from the Food and Drug Administration (FDA) to market tasimelteon, a drug previously approved for a rare sleep disorder, as a treatment for jet lag. The company submitted results from several clinical trials, focusing on both objective sleep measures and subjective assessments of alertness and next-day functioning. The FDA’s Center for Drug Evaluation and Research issued a complete response letter indicating that the application did not provide substantial evidence of efficacy, particularly criticizing the measurement of next-day impairment and the tools used for subjective endpoints. The company engaged in further discussions and dispute resolution with the FDA, including proposing a narrower indication for approval, but these efforts were unsuccessful.After the FDA issued a formal notice of opportunity for a hearing (NOOH), the company requested a hearing and submitted expert declarations supporting the adequacy of its clinical evidence. The FDA ultimately denied both the application and the hearing request, finding no genuine and substantial issue of fact warranting a hearing. The company then petitioned the United States Court of Appeals for the District of Columbia Circuit for review, arguing that the FDA was required to hold a hearing, that material factual disputes existed, that the FDA’s decision-making was arbitrary and capricious, and that the final decision violated the Appointments Clause.The United States Court of Appeals for the District of Columbia Circuit held that the Food, Drug, and Cosmetic Act does not require the FDA to hold a hearing before denying every new drug application, but the agency must grant a hearing if there are material factual disputes. The court found that, in this case, the FDA’s refusal to hold a hearing was arbitrary and capricious because the company’s expert evidence created genuine disputes over the adequacy of the clinical trials. The court remanded the case to the FDA for further proceedings consistent with its opinion. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

A hospital submitted its proposed budget for the upcoming fiscal year, requesting a 6.1% increase in net patient revenue (NPR) and a 2.8% increase in commercial negotiated rates. The hospital justified its request by citing increased patient volume and efforts to reduce wait times. The Green Mountain Care Board, which regulates hospital budgets in Vermont, had previously issued guidance setting a 3.5% benchmark for NPR growth and a 3.4% benchmark for commercial rate increases, requiring hospitals to justify any requests above these benchmarks.After reviewing the hospital’s proposal, the Green Mountain Care Board approved a 5.0% NPR increase—higher than the benchmark but lower than requested—citing the hospital’s strong financial health and the need to balance access to care with cost containment. The Board also approved the requested 2.8% commercial rate increase but included a footnote reducing this increase to 1.2% due to a prior budget overage, referencing a separate budget-enforcement order. The hospital appealed the Board’s decision to the Vermont Supreme Court, arguing that the Board’s NPR decision was arbitrary and that the reduction in the commercial rate increase violated procedural requirements under the Vermont Administrative Procedure Act (VAPA).The Vermont Supreme Court held that the Board had adequately explained its decision to approve a 5.0% NPR increase and acted within its discretion, given the statutory mandate to balance cost control and access to care. However, the Court struck the footnote reducing the commercial rate increase to 1.2%, because the underlying budget-enforcement order had been reversed by the Vermont Superior Court for failure to follow VAPA procedures and was no longer valid. The Supreme Court otherwise affirmed the Board’s decision. View "In re Rutland Regional Medical Center Fiscal Year 2025" on Justia Law

Several individuals who allegedly owed debts to Kentucky public institutions—either for medical services at the University of Kentucky or for educational services at the University of Kentucky, Morehead State University, or the Kentucky Community & Technical College System—challenged the referral of their debts to the Kentucky Department of Revenue for collection. The plaintiffs argued that the statutes used to justify these referrals did not apply to their debts and that the Department unlawfully collected the debts, sometimes without prior court judgments or adequate notice. The Department used its tax collection powers, including garnishments and liens, to recover these debts, and in some cases, added interest and collection fees.In the Franklin Circuit Court, the plaintiffs sought declaratory and monetary relief, including refunds of funds collected. The Circuit Court ruled that the Department was not authorized by statute to collect these debts and held that sovereign immunity did not protect the defendants from the plaintiffs’ claims. The court also certified the medical debt case as a class action. The Court of Appeals reviewed these interlocutory appeals and held that while sovereign immunity did not bar claims for purely declaratory relief, it did bar all claims for monetary relief, including those disguised as declaratory relief.The Supreme Court of Kentucky reviewed the consolidated appeals. It held that sovereign immunity does not bar claims for purely declaratory relief or for a refund of funds that were never due to the state, nor does it bar constitutional takings claims. However, the court held that sovereign immunity does bar claims for a refund of funds that were actually due to the state, even if those funds were unlawfully or improperly collected. The court affirmed in part, reversed in part, and remanded for further proceedings to determine which funds, if any, were never due to the state and thus subject to refund. The court also found that statutory changes rendered prospective declaratory relief in the medical debt case moot, but not retrospective relief. View "LONG V. COMMONWEALTH OF KENTUCKY" on Justia Law

Terri R. Winnon, a former executive assistant and controller for a group of skilled nursing facilities (SNFs) in Texas, alleged that her former employers and associated entities engaged in fraudulent schemes to obtain improper reimbursements from Medicare and Texas Medicaid. She claimed that the defendants paid unlawful kickbacks to doctors and hospital discharge planners for patient referrals and inflated therapy service bills to maximize government reimbursements. Winnon’s allegations included specific practices such as employee bonuses tied to Medicare census targets, “sham” medical directorships, and “marketing gifts” to hospital staff, as well as systematic upcoding of therapy services by a contracted provider, RehabCare.After Winnon filed her qui tam action under the False Claims Act (FCA) and related Texas statutes, the United States District Court for the District of Columbia dismissed her claims. The court found that her allegations against RehabCare were barred by the FCA’s public disclosure provision, as similar claims had already been made public in a prior lawsuit, United States ex rel. Halpin & Fahey v. Kindred Healthcare, Inc. The district court also determined that Winnon’s claims against the SNF Defendants did not meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b), as they lacked sufficient particularity regarding the alleged fraudulent conduct.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s dismissals. The appellate court held that Winnon’s claims against RehabCare were precluded by the public disclosure bar because her allegations were substantially similar to those previously disclosed and she did not qualify as an “original source” under the FCA. Regarding the SNF Defendants, the court concluded that Winnon’s allegations failed to satisfy Rule 9(b)’s requirement for particularity, as she did not provide enough specific details to support a strong inference that false claims were actually submitted. The court affirmed the district court’s judgments in full. View "USA v. Lozano" on Justia Law