Justia Government & Administrative Law Opinion Summaries

Michael Cannata served as a firefighter for the town of Mashpee for over a decade before leaving in 2004 as a "deferred retiree." During his employment, he was enrolled in the town's group health insurance plan, but his enrollment ended upon his departure. In 2021, after turning fifty-five and beginning to collect retirement benefits, Cannata sought to re-enroll in the town's health insurance plan as a retiree. The town denied his request, citing various reasons, including his lack of "time in-service" and the town's practice of denying coverage to retirees not enrolled in the plan at the time of retirement.Cannata filed an action in the Superior Court, seeking a judgment declaring that the town's denial of benefits violated G. L. c. 32B, § 9. The Superior Court judge granted the town's motion to dismiss for failure to state a claim, concluding that Cannata was required to apply for continued coverage and pay the full premium cost during his deferral period in order to later enroll in the town's group health insurance plan upon retirement. Cannata appealed the decision.The Supreme Judicial Court of Massachusetts reviewed the case. The court held that G. L. c. 32B, § 9, neither requires nor prohibits a municipality from enrolling individuals like Cannata in its group health insurance plan upon retirement. The court concluded that the third paragraph of the statute, which the lower court relied on, did not govern Cannata's case. The court determined that municipalities may, but are not obligated to, allow such individuals to enroll in group health insurance upon retirement. The court affirmed the judgment of dismissal on the alternative ground that Cannata's complaint failed to plausibly allege entitlement to relief beyond a speculative level. The case was remanded with instructions to dismiss the complaint without prejudice, allowing Cannata an opportunity to amend his request for declaratory relief. View "Cannata v. Town of Mashpee" on Justia Law

New York City is legally required to provide health insurance coverage for its retired employees. For over 50 years, the City offered a choice of health insurance plans, including Medicare supplemental plans and Medicare Advantage plans (MAPs). In 2021, to reduce costs, the City decided to discontinue most options, including the popular Senior Care plan, and enroll all retirees in a custom-designed MAP managed by Aetna Life Insurance Company. Petitioners, consisting of nine retirees and one organization, initiated this proceeding to prevent the City from eliminating their existing health insurance plans.The Supreme Court ruled in favor of the petitioners on their promissory estoppel cause of action and their claim under Administrative Code of the City of New York § 12-126 (b) (1). The Appellate Division affirmed the decision, concluding that the City had made a clear and unambiguous promise to provide Medicare supplemental coverage for life and that petitioners reasonably relied on this promise.The Court of Appeals of New York reviewed the case and determined that the petitioners were not entitled to judgment on their promissory estoppel cause of action. The court found that the Summary Program Descriptions (SPDs) provided by the City did not constitute a clear and unambiguous promise of lifetime Medicare supplemental insurance coverage. The court also rejected the petitioners' alternative grounds for relief, including their claim under Administrative Code § 12-126 (b) (1) and the Moratorium Law. Consequently, the Court of Appeals reversed the order of the Appellate Division and remitted the matter to the Supreme Court for further proceedings. View "Matter of Bentkowski v City of New York" on Justia Law

Two air ambulance providers, Guardian Flight, LLC, and Med-Trans Corporation, sued Health Care Service Corporation (HCSC) for failing to timely pay dispute resolution awards under the No Surprises Act (NSA). The providers also claimed that HCSC improperly denied benefits under the Employee Retirement Income Security Act (ERISA) and was unjustly enriched under Texas law.The United States District Court for the Northern District of Texas dismissed the providers' complaint. The court found that the NSA does not provide a private right of action for enforcing dispute resolution awards. It also dismissed the ERISA claim for lack of standing, as the providers did not show that the beneficiaries suffered any injury since the NSA shields them from liability. Lastly, the court dismissed the quantum meruit claim, stating that the providers did not perform their services for HCSC's benefit. The court also denied the providers' request for leave to amend their complaint, deeming it futile.The United States Court of Appeals for the Fifth Circuit affirmed the district court's decision. The appellate court agreed that the NSA does not contain a private right of action and that the statute's text and structure support this conclusion. The court also upheld the dismissal of the ERISA claim, reiterating that the beneficiaries did not suffer any concrete injury. Finally, the court affirmed the dismissal of the quantum meruit claim, as the providers did not render services for HCSC's benefit. The appellate court also found no abuse of discretion in the district court's denial of leave to amend the complaint. View "Guardian Flight v. Health Care Service" on Justia Law

West Virginia filed a complaint in state court against CaremarkPCS Health, LLC, a pharmacy benefit manager (PBM), alleging that Caremark unlawfully drove up the cost of insulin, causing financial harm to the state. The complaint included state law claims of civil conspiracy, unjust enrichment, fraud, and breach of contract. Caremark removed the case to federal court under the federal officer removal statute, 28 U.S.C. § 1442(a)(1), arguing that its conduct in negotiating rebates, which is central to the complaint, was performed under the direction of the federal government as part of its work for federal health plans.The United States District Court for the Northern District of West Virginia found that removal was unwarranted and remanded the case to state court. The district court concluded that Caremark failed to meet the requirements for federal officer removal and noted that West Virginia had disclaimed any federal claims in its complaint.The United States Court of Appeals for the Fourth Circuit reviewed the case and reversed the district court's decision. The Fourth Circuit held that Caremark was entitled to remove the case to federal court under § 1442(a)(1). The court found that Caremark acted under a federal officer because it administered health benefits for federal employees under contracts with FEHBA carriers, which are supervised by the Office of Personnel Management (OPM). The court also determined that Caremark had a colorable federal defense, specifically that federal law preempted West Virginia's claims. Finally, the court concluded that the charged conduct was related to Caremark's federal work, as the rebate negotiations for federal and non-federal clients were indivisible. Thus, the Fourth Circuit reversed the district court's remand decision and returned the case to the district court for further proceedings. View "West Virginia ex rel. Hunt v. CaremarkPCS Health, L.L.C." on Justia Law

SWT Global Supply, Inc. (SWT Global), a Missouri-based manufacturer of electronic nicotine delivery system (ENDS) vaping products, sought review of the U.S. Food and Drug Administration's (FDA) denial of market authorization for its menthol-flavored ENDS products. The FDA denied the premarket tobacco product applications (PMTAs) submitted by SWT Global, citing insufficient evidence that the products would benefit adult users enough to outweigh the risks to youth.The FDA's decision was based on the Family Smoking Prevention and Tobacco Control Act of 2009, which requires new tobacco products to receive FDA authorization before being sold. The FDA determined that SWT Global's PMTAs lacked product-specific evidence demonstrating that the menthol-flavored ENDS products would attract adults away from combustible cigarettes and reduce overall harm. The FDA also found SWT Global's marketing plan insufficient to prevent youth access to the products.The United States Court of Appeals for the Eighth Circuit reviewed the case. SWT Global argued that the FDA's denial was arbitrary and capricious, claiming the FDA changed its position on the required scientific evidence and failed to justify its finding that the marketing plan was insufficient. The court referenced the Supreme Court's decision in Food & Drug Administration v. Wages & White Lion Investments, L.L.C., which held that the FDA's denial of PMTAs for flavored ENDS products was consistent with its guidance and did not violate the change-in-position doctrine.The Eighth Circuit found that the FDA did not change its position regarding the scientific evidence required for PMTAs and provided a satisfactory explanation for its decision. The court also determined that the FDA's treatment of menthol-flavored ENDS products was reasonable and consistent with its approach to other non-tobacco-flavored ENDS products. Consequently, the court denied SWT Global's petition for review. View "SWT Global Supply, Inc. v. U.S. Food & Drug Administration" on Justia Law

Abigail Stratton filed a petition with the Office of Special Masters under the National Childhood Vaccine Injury Act, alleging that the Gardasil® vaccine caused her to develop postural orthostatic tachycardia syndrome (POTS) and autonomic dysfunction. These conditions are not listed in the Vaccine Injury Table, requiring her to prove actual causation by a preponderance of the evidence. After filing a Notice of Intent to Withdraw to pursue her claim in federal district court, the Chief Special Master concluded the proceedings on the merits and later awarded her partial attorneys’ fees and costs.The Secretary of Health and Human Services opposed the fee application, arguing that Stratton did not file her petition with the good faith intent of litigating the claim and that there was no reasonable basis for her claim. The Chief Special Master found that Stratton had satisfied both the good faith and reasonable basis requirements and awarded partial fees. The Court of Federal Claims affirmed the Chief Special Master’s decision, concluding that the finding of a reasonable basis was not arbitrary and capricious, and awarded $8,876.86 for attorneys’ fees and costs. The Secretary appealed this decision.The United States Court of Appeals for the Federal Circuit reviewed the case and found that the Chief Special Master failed to adequately explain the determination that Stratton’s petition had a reasonable basis. The court noted that the Chief Special Master acknowledged the Secretary’s concerns about the sufficiency of the medical records but dismissed them without sufficient explanation. The Federal Circuit vacated the decision and remanded the case for further proceedings consistent with its opinion, requiring a more detailed explanation of why the evidence provided a reasonable basis for Stratton’s claim. View "Stratton v. Health and Human Services" on Justia Law

AstraZeneca Pharmaceuticals LP and AstraZeneca AB challenged the Drug Price Negotiation Program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain high-expenditure drugs. CMS issued guidance on selecting qualifying drugs for 2026, including Farxiga, manufactured by AstraZeneca. AstraZeneca sued the Secretary of the Department of Health and Human Services and the CMS Administrator, claiming the Negotiation Program violated procedural due process and that parts of CMS’s guidance violated the Administrative Procedure Act (APA).The United States District Court for the District of Delaware ruled that AstraZeneca failed to state a due process violation and lacked standing to pursue its APA claims. The court entered judgment in favor of the government.The United States Court of Appeals for the Third Circuit reviewed the case. The court found that AstraZeneca lacked Article III standing to challenge the CMS guidance under the APA because the company did not demonstrate a concrete and particularized injury. AstraZeneca's claims about the impact on its business decision-making and difficulty valuing Farxiga in negotiations were deemed hypothetical and conjectural.Regarding the due process claim, the court held that AstraZeneca did not have a protected property interest in selling its drugs at a market rate. The court noted that federal patent laws do not confer a right to sell at a particular price, and the Negotiation Program only sets prices for drugs reimbursed by CMS, not private market transactions. Consequently, the court affirmed the District Court’s judgment, granting summary judgment in favor of the government on both the APA and due process claims. View "AstraZeneca Pharmaceuticals LP v. Secretary United States Department of Health and H" on Justia Law

A group of over 200 hospitals claimed that the Department of Health and Human Services (HHS) miscalculated their Disproportionate Share Hospital (DSH) adjustments, which provide additional funding to hospitals treating a high percentage of low-income patients. The dispute centered on the interpretation of the phrase "entitled to supplementary security income (SSI) benefits" under subchapter XVI. The hospitals argued that this phrase should include all patients enrolled in the SSI system at the time of hospitalization, even if they were not entitled to an SSI payment during that month. HHS, however, interpreted it to mean patients who were eligible to receive an SSI payment during the month of hospitalization.The Provider Reimbursement Review Board denied the hospitals' request for additional reimbursement on procedural grounds, and the Centers for Medicare & Medicaid Services denied relief on the merits. The District Court rejected the hospitals' claims and granted summary judgment to HHS. The D.C. Circuit affirmed, concluding that SSI benefits are about cash payments for needy individuals and that it makes little sense to say individuals are entitled to the benefit in months when they are not eligible for a payment.The Supreme Court of the United States held that an individual is "entitled to [SSI] benefits" for purposes of the Medicare fraction when she is eligible to receive an SSI cash payment during the month of her hospitalization. The Court reasoned that SSI benefits are cash benefits determined on a monthly basis, and eligibility for such benefits is also determined monthly. The Court affirmed the judgment of the D.C. Circuit, respecting the specific formula that Congress prescribed for calculating the Medicare fraction. View "Advocate Christ Medical Center v. Kennedy" on Justia Law

Bidi Vapor LLC filed a premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA) in 2020 for its tobacco-flavored electronic nicotine delivery system (ENDS) product, the Bidi Stick – Classic. The FDA identified several deficiencies in the application, and despite Bidi Vapor submitting supplemental information, the FDA found the evidence insufficient. On January 22, 2024, the FDA issued a Marketing Denial Order (MDO) based on three independent grounds: high abuse liability of the product, incomplete study on leachable compounds, and lack of adequate comparison data on harmful constituents. This order prevented Bidi Vapor from marketing the Bidi Classic.Bidi Vapor appealed the FDA’s decision, arguing that the FDA violated the Tobacco Control Act and the Administrative Procedure Act, and acted in an arbitrary and capricious manner. The company contended that the FDA failed to conduct a balanced analysis of the product’s benefits and deficiencies, imposed product standards without proper rulemaking, and did not conduct a second cycle of toxicological review.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that the FDA’s decision was reasonable and not arbitrary or capricious. The court found that the FDA had appropriately considered the relevant data and provided a satisfactory explanation for its actions, particularly regarding the high abuse liability of the Bidi Classic. The court noted that this deficiency alone was sufficient to support the MDO, and therefore did not address the other two grounds. The court denied Bidi Vapor’s petition for review, upholding the FDA’s Marketing Denial Order. View "Bidi Vapor LLC v. Food and Drug Administration" on Justia Law

Robert Saint, an attorney representing a whistleblower in a False Claims Act case, requested a legal memorandum (White Paper) from the Family & Social Services Administration (FSSA) under Indiana’s Access to Public Records Act (APRA). The White Paper was created by HealthNet, a private entity, and given to FSSA for use during Medicaid settlement negotiations. FSSA denied the request, claiming the document was protected by attorney-client privilege and the deliberative material exception.The Marion Superior Court ordered FSSA to disclose the White Paper, finding that FSSA failed to demonstrate an attorney-client relationship or that the document was deliberative material prepared for FSSA’s decision-making. The court also found that any privilege was waived when the document was tendered to FSSA. FSSA appealed, reasserting the deliberative material exception and arguing that the document was used for decision-making within the agency.The Indiana Court of Appeals affirmed the trial court’s decision, rejecting FSSA’s arguments and finding that the White Paper was neither intra-agency nor interagency material. The court also found that FSSA waived its private contractor and confidentiality arguments by not raising them earlier.The Indiana Supreme Court reviewed the case and affirmed the trial court’s order. The court held that the deliberative material exception did not apply because the White Paper was not intra-agency material. The court emphasized that intra-agency material must originate from and be communicated between employees of the same agency. Since the White Paper was created by HealthNet and not generated within FSSA, it did not qualify for the exception. The court concluded that FSSA failed to meet its burden of proof and ordered the disclosure of the White Paper. View "Family & Social Services Administration v. Saint" on Justia Law