Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Kaul v. Urmanski
In the wake of the U.S. Supreme Court's decision in Dobbs v. Jackson Women’s Health Organization, which held that the U.S. Constitution does not protect the right to abortion, plaintiffs filed a lawsuit seeking a declaration that Wisconsin Statute § 940.04(1), which criminalizes the intentional destruction of an unborn child, does not ban abortion. The plaintiffs included the Attorney General, the Department of Safety and Professional Services, the Medical Examining Board, and three physicians. They argued that the statute either does not apply to abortion or has been impliedly repealed by subsequent legislation.The Dane County Circuit Court denied the defendant's motion to dismiss, concluding that the plaintiffs stated a claim upon which relief could be granted because § 940.04 does not prohibit consensual medical abortions. The court later issued a declaratory judgment that the statute does not prohibit abortions.The Wisconsin Supreme Court reviewed the case de novo. The central question was whether § 940.04(1) bans abortion. The court concluded that comprehensive legislation enacted over the last 50 years, which regulates various aspects of abortion, impliedly repealed the 19th-century near-total ban on abortion. The court held that the legislature's detailed regulation of abortion was meant as a substitute for the earlier statute, and therefore, § 940.04(1) does not ban abortion in Wisconsin.The court affirmed the circuit court's judgment and order, holding that the comprehensive legislative framework governing abortion impliedly repealed the near-total ban on abortion in § 940.04(1). View "Kaul v. Urmanski" on Justia Law
Flanagan v. Fresenius Medical Care Holdings, Inc.
Martin Flanagan, a former employee of Fresenius Medical Care Holdings, Inc., filed a qui tam lawsuit under the False Claims Act (FCA) against his former employer. He alleged that Fresenius engaged in a fraudulent kickback scheme to induce referrals to its dialysis clinics, violating the Anti-Kickback Statute (AKS). Flanagan claimed that Fresenius offered below-cost contracts to hospitals, overcompensated medical directors, and provided other benefits to secure patient referrals, which were then billed to Medicare and Medicaid.The U.S. District Court for the District of Maryland initially handled the case, which was later transferred to the U.S. District Court for the District of Massachusetts. The district court dismissed Flanagan's complaint for failing to meet the heightened pleading standard under Rule 9(b) of the Federal Rules of Civil Procedure. The court found that the amended complaint did not adequately allege specific false claims or provide representative examples. Additionally, the court ruled that some of Flanagan's claims were barred by the FCA's public-disclosure and first-to-file rules. The district court also denied Flanagan's motion to amend his complaint, citing undue delay and potential prejudice to Fresenius.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Flanagan failed to plead the alleged fraud with the required particularity. The appellate court also upheld the denial of the motion to amend, noting that Flanagan had ample time to address the deficiencies in his complaint but failed to do so. The First Circuit concluded that the district court did not abuse its discretion in its rulings. View "Flanagan v. Fresenius Medical Care Holdings, Inc." on Justia Law
Kennedy v. Braidwood Management, Inc.
In 1984, the Department of Health and Human Services (HHS) created the U.S. Preventive Services Task Force to make evidence-based recommendations on preventive healthcare services. The Affordable Care Act of 2010 required most health insurers to cover services rated "A" or "B" by the Task Force without cost sharing. Plaintiffs, including Braidwood Management, objected to these requirements and argued that Task Force members are principal officers who must be appointed by the President with Senate consent, not by the Secretary of HHS.The U.S. District Court for the Northern District of Texas agreed with the plaintiffs, ruling that Task Force members are principal officers because they have no superior who supervises and directs them. The court enjoined the government from enforcing the insurance coverage mandates based on Task Force recommendations issued after 2010. The U.S. Court of Appeals for the Fifth Circuit affirmed, holding that Task Force members are principal officers because they cannot be independent and free from political pressure while being supervised by a political appointee.The Supreme Court of the United States reversed the Fifth Circuit's decision, holding that Task Force members are inferior officers. The Court reasoned that the Secretary of HHS has the authority to remove Task Force members at will and to review and block their recommendations before they take effect. This supervision and direction by the Secretary, a principal officer, means that Task Force members are inferior officers. Therefore, their appointment by the Secretary of HHS is consistent with the Appointments Clause of the Constitution. The case was remanded for further proceedings consistent with this opinion. View "Kennedy v. Braidwood Management, Inc." on Justia Law
Medina v. Planned Parenthood South Atlantic
In 2018, South Carolina excluded Planned Parenthood from its Medicaid program, citing state law prohibiting public funds for abortion. Planned Parenthood and patient Julie Edwards sued, claiming the exclusion violated the Medicaid any-qualified-provider provision, which allows Medicaid beneficiaries to obtain services from any qualified provider. Edwards preferred Planned Parenthood for gynecological care but needed Medicaid coverage. They filed a class action under 42 U.S.C. §1983 to enforce rights under the federal Medicaid statutes.The district court granted summary judgment for the plaintiffs and enjoined the exclusion. The Fourth Circuit affirmed. The Supreme Court granted certiorari, vacated, and remanded the case in light of Health and Hospital Corporation of Marion Cty. v. Talevski, which addressed whether another spending-power statute created §1983-enforceable rights. On remand, the Fourth Circuit reaffirmed its decision.The Supreme Court of the United States held that Section 1396a(a)(23)(A) does not clearly and unambiguously confer individual rights enforceable under §1983. The Court emphasized that spending-power statutes rarely create enforceable rights and that the any-qualified-provider provision lacks the clear rights-creating language necessary to support a §1983 action. The Court reversed the Fourth Circuit's decision and remanded the case for further proceedings consistent with this opinion. View "Medina v. Planned Parenthood South Atlantic" on Justia Law
Cannata v. Town of Mashpee
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
Matter of Bentkowski v City of New York
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
Guardian Flight v. Health Care Service
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 ex rel. Hunt v. CaremarkPCS Health, L.L.C.
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. v. U.S. Food & Drug Administration
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
Stratton v. Health and Human Services
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