Justia Government & Administrative Law Opinion Summaries

The Supreme Court of the State of Delaware considered an appeal from a decision of the Superior Court regarding the adoption of a Medicare Advantage Plan for State retirees by the State Employee Benefits Committee (SEBC). The Superior Court had found that the SEBC's decision was subject to the requirements of Delaware’s Administrative Procedures Act (APA), granted a motion to stay the implementation of the Medicare Advantage Plan, and required the State to maintain its retirees’ Medicare Supplement Plan. The Superior Court also denied the plaintiffs' application for attorneys’ fees.The Supreme Court of the State of Delaware disagreed with the lower court's ruling. It found that the SEBC's decision to adopt a Medicare Advantage Plan was not a "regulation" as defined by the APA. The court reasoned that the decision did not meet the APA's definition of a regulation because it was not a "rule or standard," nor was it a guide for the decision of future cases. Therefore, the Superior Court did not have jurisdiction to stay the implementation of the plan. The Supreme Court reversed the decision of the Superior Court.On cross-appeal, the plaintiffs argued that the Superior Court erred by refusing to grant their application for attorneys’ fees. However, the Supreme Court found this argument moot because fee shifting is available only against a losing party in favor of a prevailing party. Since the Supreme Court reversed the decision below, fee shifting was foreclosed. View "DeMatteis v. RISE Delaware, Inc." on Justia Law

The case involves Vanda Pharmaceuticals, a drug manufacturer, and the Centers for Medicare & Medicaid Services (CMS). Vanda challenged a 2020 regulation by CMS that expanded the definition of a "line extension" drug under the Medicaid Drug Rebate Program. This program requires drug manufacturers to reimburse Medicaid if they increase their prices faster than inflation. A "line extension" drug, which is a new formulation of an existing drug, can also be liable for price increases of the original drug. Vanda argued that the regulation expanded the definition of a line extension beyond what the Medicaid statute permitted.Previously, the district court granted summary judgment to CMS, disagreeing with Vanda's argument. The court held that the agency's regulation was within the bounds of the Medicaid statute.The United States Court of Appeals for the Fourth Circuit affirmed the district court's decision. The court found that the agency's definitions of "line extension" and "new formulation" were within the Medicaid statute's ambit. It also held that the agency's interpretation of the oral-solid-dosage-form requirement was not contrary to law. The court rejected Vanda's argument that the agency's rulemaking process was arbitrary and capricious, finding that the agency had reasonably considered the relevant issues and explained its decision. View "Vanda Pharmaceuticals, Inc. v. Centers for Medicare & Medicaid Services" on Justia Law

In 2019, MO CANN Do, Inc. (MCD) applied for a medical marijuana cultivation license in Missouri. However, the Department of Health and Senior Services (DHSS) rejected MCD's application as it failed to include a certificate of good standing demonstrating its authorization to operate as a business in Missouri. An administrative hearing commission upheld DHSS's decision, and MCD appealed to the circuit court, which also affirmed the decision.The Supreme Court of Missouri found that MCD's application did not meet the minimum standards for licensure, as it failed to provide a certificate of good standing from the Secretary of State, as required by DHSS's regulations. MCD argued that its certificate of incorporation satisfied the standard requiring proof of authorization to operate as a business in Missouri, but the Court disagreed, stating that the regulatory language was unambiguous and the certificate of good standing was a specific requirement.MCD further argued that DHSS waived the certificate of good standing requirement by failing to specify it in the deficiency letter sent to MCD. The Court rejected this argument, stating that DHSS never affirmatively waived the deficiencies in MCD's application.Lastly, MCD claimed that DHSS should be estopped from denying its application based on the missing certificate of good standing due to its failure to notify MCD of this specific deficiency. The Court denied this claim, stating that it is generally inappropriate to estop governmental agencies tasked with administrating licensure in highly regulated industries, which include the marijuana industry. In conclusion, the Supreme Court of Missouri affirmed the circuit court’s judgment. View "MO CANN Do, Inc. vs. Missouri Department of Health and Senior Services" on Justia Law

The United States Court of Appeals for the Fourth Circuit ruled on a case involving a plaintiff, Joann Ford, and a healthcare provider, Sandhills Medical Foundation, Inc. Ford, a former patient of Sandhills, alleged negligence, breach of implied contract, invasion of privacy, and breach of confidentiality against Sandhills for failure to protect her personally identifying information (PII). Her PII was stolen from Sandhills' third-party computer system in a cyberattack after she had ceased being a patient.The district court had previously granted Sandhills immunity from the suit, concluding that the theft of Ford's PII arose out of Sandhills' performance of “medical, surgical, dental, or related functions,” as per 42 U.S.C. § 233(a), thus substituting the United States as the defendant. However, the Fourth Circuit Court disagreed with the lower court's interpretation of § 233(a).The appellate court determined that data security does not fall under a “related function” within the meaning of the statute. The court emphasized that § 233(a) immunity applies when alleged damages arise from the provision of healthcare, which was not the case here. Ford’s injury did not arise from Sandhills’ provision of healthcare, but from a data security breach that occurred at least a year after she ceased being a patient at Sandhills.Therefore, the court concluded that Sandhills was not immune from the suit under § 233(a) and that the United States could not be substituted as the defendant. The case was vacated and remanded for further proceedings. View "Ford v. Sandhills Medical Foundation, Inc." on Justia Law

The Supreme Court of Mississippi was asked to decide whether the Mississippi State Department of Health (MSDH) was required to admit evidence of a concurrent Certificate of Need (CON) application during the CON hearing for another healthcare facility. The MSDH had simultaneously considered two CON applications, one from Encompass Health Rehabilitation Hospital and one from Baptist Memorial Rehabilitation Hospital, for the same category of services. The MSDH did not admit the Baptist application or certificate, and the chancery court reversed the decision solely on this issue.The Supreme Court of Mississippi ruled that the chancery court was in error, and that the MSDH's decision on relevance or its decision not to reopen a closed hearing was not reversible error. The Supreme Court found that the MSDH did not abuse its discretion or violate due process in determining that the Baptist CON application was not relevant to the Encompass' CON application proceedings.The Supreme Court vacated the chancery court’s decision and remanded the case to the chancery court for a decision on the merits of Methodist’s appeal. The chancery court had failed to address the substance of Methodist’s appeal regarding the granting of a CON to Encompass, and the issue was not squarely before the Supreme Court. View "Encompass Health Rehabilitation Hospital of Flowood, LLC v. Mississippi Methodist Hospital and Rehabilitation Center, Inc." on Justia Law

The Supreme Court of North Carolina ruled on a case involving Halikierra Community Services LLC (Halikierra), a provider of home personal care services to Medicaid beneficiaries and the North Carolina Department of Health and Human Services (DHHS). DHHS had placed Halikierra on Medicaid reimbursement prepayment review following several overbilling complaints, leading to several post-payment audits. The audits revealed that Halikierra had erroneously received excess Medicaid reimbursement funds on multiple occasions and found suspicious reimbursement claims.Halikierra filed a lawsuit against DHHS, alleging that the decision to place them on prepayment review violated their substantive due process and equal protection rights under the North Carolina Constitution. The trial court granted summary judgment in favor of DHHS, leading to an appeal from Halikierra.The Supreme Court of North Carolina affirmed the trial court's decision, holding that summary judgment was properly entered against Halikierra. The Court found that Halikierra’s evidentiary forecast failed to disclose any genuine issues of material fact in support of its claims. The Court concluded that DHHS's actions were not arbitrary or capricious, as the prepayment review was rationally related to a legitimate government interest, namely combating Medicaid fraud and ensuring that claims meet the requirements of federal and state laws and regulations. The Court also found no evidence of unequal treatment of Halikierra compared to other Medicaid providers. View "Halikierra Cmty. Servs. LLC v. N.C. Dep't of Health & Hum. Servs" on Justia Law

This case was before the United States Court of Appeals for the Fourth Circuit where the City of Huntington and Cabell County Commission (plaintiffs) brought a suit against AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation (defendants), three distributors of opioids. The plaintiffs alleged that these companies perpetuated the opioid epidemic by repeatedly shipping excessive quantities of opioids to pharmacies, thus creating a public nuisance under West Virginia common law. The district court ruled in favor of the distributors, holding that West Virginia’s common law of public nuisance did not cover the plaintiffs’ claims.After a bench trial in 2021, the district court held that the common law of public nuisance in West Virginia did not extend to the sale, distribution, and manufacture of opioids. The court found that the application of public nuisance law to the sale, marketing, and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product. The court also rejected the plaintiffs’ proposed remedy, a 15-year “Abatement Plan” developed by an expert in opioid abatement intervention. The court held that this relief did not qualify as an abatement as it did not restrict the defendants' conduct or their distribution of opioids but generally proposed programs and services to address the harms caused by opioid abuse and addiction.The plaintiffs appealed the decision to the United States Court of Appeals for the Fourth Circuit, which certified the following question to the Supreme Court of Appeals of West Virginia: Under West Virginia’s common law, can conditions caused by the distribution of a controlled substance constitute a public nuisance and, if so, what are the elements of such a public nuisance claim? View "City of Huntington v. Amerisourcebergen Drug Corporation" on Justia Law

The United States Court of Appeals for the Ninth Circuit ruled in a case involving a claimant who was denied Social Security benefits. The claimant, who had undergone surgery to treat a brain condition known as Arnold-Chiari malformation, testified to experiencing severe and frequent headaches. However, the Administrative Law Judge (ALJ) rejected his testimony regarding the severity of his headaches, asserting that his headache symptoms were inconsistent with the medical evidence and his daily activities.The court of appeals found that the ALJ failed to provide clear and convincing reasons for rejecting the claimant's symptom testimony regarding his headaches. It noted that the ALJ did not specify which of the claimant's symptoms were inconsistent with the record evidence. The court also rejected the argument that a claimant must provide independent medical evidence to establish the severity of headaches.Furthermore, the court found that the claimant's daily activities were not inconsistent with his testimony about the severity and frequency of his headaches. The district court's affirmation of the ALJ's decision based on the claimant's conservative treatment was also found erroneous since the ALJ did not consider this factor. Consequently, the court reversed the judgment of the district court, remanding it back to the ALJ to reconsider the credibility of the claimant's headache symptom testimony. View "Ferguson v. O'Malley" on Justia Law

The United States Court of Appeals for the Fifth Circuit reviewed a case involving the question of whether the federal Title X program preempts a Texas law that gives parents the right to consent to their teenagers’ obtaining contraceptives. Alexander Deanda, a father raising his children according to Christian beliefs, challenged the Secretary of Health and Human Services' administration of Title X, which funds clinics providing contraceptives to minors without parental notification or consent. Deanda contested this on the grounds that it nullifies his right to consent to his children's medical care, infringing on his state-created right. The court held that Title X does not preempt Texas's law. The statute does not preempt Deanda's parental right to consent to his children's obtaining contraceptives because Title X's goal (encouraging family participation in teens’ receiving family planning services) is not undermined by Texas's goal (empowering parents to consent to their teen’s receiving contraceptives). Instead, the two laws reinforce each other. The court affirmed the district court’s judgment to the extent it declared that Title X does not preempt Texas's parental consent law. However, the court reversed the partial vacatur of a regulation which forbids Title X grantees from notifying parents or obtaining their consent, as the regulation was not challenged by Deanda under the Administrative Procedure Act or otherwise. View "Deanda v. Becerra" on Justia Law

In this case, the United States Court of Appeals for the Eighth Circuit was asked to determine whether Arkansas Code § 23-92-604(c), also known as Act 1103, was preempted by federal law. Act 1103 prohibits pharmaceutical manufacturers from limiting the ability of healthcare providers, who are eligible for drug pricing discounts under the Section 340B Program, to contract with outside pharmacies for drug distribution.The Pharmaceutical Research and Manufacturers of America (PhRMA) sued the Commissioner of the Arkansas Insurance Department, arguing that Act 1103 was unconstitutional because it was preempted by the Section 340B Program and the Federal Food, Drug, and Cosmetic Act, under theories of field, obstacle, and impossibility preemption.The court, however, disagreed with PhRMA's arguments. The court found that Act 1103 did not create an obstacle for pharmaceutical manufacturers to comply with 340B, rather it assisted in fulfilling the purpose of 340B. The court also found that Act 1103 did not make it impossible for drug manufacturers and wholesale distributors to comply with the Risk Evaluation and Mitigation Strategies (REMS) Program under the Federal Food, Drug, and Cosmetic Act.Therefore, the court held that Act 1103 was not preempted by either the Section 340B Program or the Federal Food, Drug, and Cosmetic Act. As such, the court affirmed the district court’s decision in favor of the Intervenors and against PhRMA. View "Pharmaceutical Research and Mfrs of America v. McClain" on Justia Law