Justia Government & Administrative Law Opinion Summaries

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

The United States Court of Appeals for the Second Circuit heard a case initiated by Adam Hart, who filed a qui tam action under the False Claims Act (FCA) against pharmaceutical distributor McKesson. Hart alleged that McKesson provided business management tools to its customers for free in exchange for commitments to purchase drugs, which he claimed violated the federal anti-kickback statute (AKS) and several analogous state laws. The district court dismissed Hart's FCA claim, determining he failed to allege McKesson acted "willfully" as required by the AKS.On appeal, the Second Circuit held that to act "willfully" under the AKS, a defendant must knowingly act in a way that is unlawful. The court found that Hart failed to provide sufficient facts to meet this standard. However, the court disagreed with the district court's assertion that Hart's state claims were premised solely on a violation of the federal AKS. Consequently, the Second Circuit affirmed the dismissal of Hart’s federal FCA claim, vacated the dismissal of the remaining state claims, and remanded for further proceedings. View "United States, ex rel. Hart v. McKesson Corp." on Justia Law

The case involves the Mississippi Division of Medicaid and the Women’s Pavilion of South Mississippi, PLLC. Women's Pavilion, a physician-owned OBGYN clinic, challenged Mississippi Division of Medicaid's calculation of the "encounter rate," a set amount of money per visit by a Medicaid patient. Medicaid set the clinic’s encounter rate at $157.94, which was partially based on the compensation of the five physician owners of the clinic.Women’s Pavilion appealed this decision and requested an administrative hearing. The hearing officer evaluated whether Medicaid’s initial decision was supported by substantial evidence, affirming the reimbursement rate. However, Women’s Pavilion appealed again, arguing that the hearing officer applied the wrong standard of review.The Hinds County Chancery Court agreed with Women’s Pavilion, holding that the hearing officer should have made his own findings of fact and determinations of the issues presented, rather than merely evaluating whether Medicaid’s initial decision was supported by substantial evidence. The court vacated Medicaid’s final decision and remanded the matter back to Medicaid.The Mississippi Division of Medicaid appealed to the Supreme Court of Mississippi. The Supreme Court affirmed the decision of the Hinds County Chancery Court, stating that the hearing officer had erred by applying the standard of review for courts reviewing a final administrative decision, rather than following Medicaid’s own administrative rules governing provider appeals. The case was remanded back to Medicaid for further proceedings under the proper standard of review. View "Mississippi Division of Medicaid v. Women's Pavilion of South Mississippi, PLLC" on Justia Law

In this case, the plaintiff, Fallon Community Health Plan, Inc., adopted a policy requiring its employees to be vaccinated against COVID-19. The defendant, Shanika Jefferson, a home health aide employed by Fallon, sought a religious exemption from the vaccination requirement. Her request was denied, and her employment was terminated. Jefferson then applied for and was approved for unemployment benefits from the Department of Unemployment Assistance. However, Fallon contended that Jefferson was ineligible for the benefits and sought review of the decision. The board of review of the department, as well as a District Court judge, affirmed the decision.Fallon argued that Jefferson was disqualified from receiving unemployment benefits as per § 25 (e) (2) of General Laws c. 151A because she refused the COVID-19 vaccine in knowing violation of Fallon's reasonable policy and in wilful disregard of Fallon's interest in keeping its vulnerable patient population healthy. However, the Supreme Judicial Court disagreed with Fallon's contention. The court held that Jefferson did not engage in "deliberate misconduct", but rather made a good faith effort to comply with Fallon's policy by applying for a religious exemption. The court also found that Fallon failed to demonstrate that Jefferson should be disqualified on the basis of a "knowing violation" of that policy. The court considered the unique circumstances of the case, including Jefferson's sincere religious beliefs, which did not present her with a meaningful choice regarding vaccination. Therefore, the Supreme Judicial Court affirmed the decision of the lower courts, allowing Jefferson to receive unemployment benefits. View "Fallon Community Health Plan, Inc. v. Acting Director of the Department of Unemployment Assistance" on Justia Law

The case involved Rhonda Persiani, a defendant charged with multiple counts of driving under the influence (DUI) in California. Due to doubts about Persiani's mental competence, the criminal proceedings were suspended, and she was found mentally incompetent to stand trial. Persiani was evaluated and found suitable for outpatient treatment through mental health diversion. However, the court and parties believed Persiani was ineligible for such treatment due to a California Vehicle Code section that prohibits diversion in cases where a defendant is charged with DUI. Persiani sought dismissal of her cases, asserting that dismissal was required under the Penal Code because she was ineligible for any of the treatment options. The court denied Persiani’s motion to dismiss and imposed mental health treatment provisions as conditions of her release. In an appeal, the Court of Appeal of the State of California Fourth Appellate District held that a trial court has the authority under the Penal Code to order treatment through mental health diversion for a mentally incompetent misdemeanor defendant charged with DUI. The court concluded that the Vehicle Code section that prohibits diversion for DUI does not prevent a court from ordering a mentally incompetent misdemeanor defendant to receive treatment through mental health diversion after criminal proceedings have been suspended. The matter was remanded back to the lower court to determine whether to order Persiani to receive mental health diversion treatment. View "Persiani v. Superior Court" on Justia Law

In a healthcare fraud case involving Medicare kickbacks, defendants Lindell King and Ynedra Diggs appealed their convictions and sentences. They challenged the United States District Court for the Southern District of Texas's decision to admit recordings involving them and other co-conspirators, and disputed the court's calculation of the improper benefit received for the purpose of their sentence, as well as the restitution award. The United States Court of Appeals for the Fifth Circuit examined these arguments and ruled in favor of the lower court.The defendants were accused of receiving bribes from a Medicare provider, Dr. Paulo Bettega, for referring Medicare beneficiaries to him for unnecessary treatment or non-provided treatment. The Court of Appeals rejected the defendants' Confrontation Clause arguments, stating the recordings were not testimonial and did not violate the Confrontation Clause. It further dismissed the defendants' assertion that the recordings were impermissible hearsay.Regarding the calculation of the improper benefit, the court concluded that the government had proved by a preponderance of the evidence that the entire operation was fraudulent. The defendants failed to provide rebuttal evidence of any legitimate medical expenses that should offset the amount paid to Bettega for treatment provided to residents of their group homes.The Court of Appeals also upheld the restitution award. It rejected the defendants' argument that their maximum restitution was limited to the $70,000 they received in kickbacks. The court held the defendants jointly and severally liable for all foreseeable losses within the scope of their conspiracy.In conclusion, the Court of Appeals affirmed the judgment and sentence of the district court, finding no error in its proceedings or decisions. View "USA v. King" on Justia Law

In a class action suit, the plaintiffs, a group of patients, alleged that the Trustees of the University of Pennsylvania (Penn), who operate the Hospital of the University of Pennsylvania Health System (Penn Medicine), were in violation of Pennsylvania privacy law. The plaintiffs claimed that Penn Medicine shared sensitive health information and online activity of its patients with Facebook through its patient portal. Penn removed the case to federal court, asserting that it was "acting under" the federal government, referencing the federal-officer removal statute. However, the District Court rejected this argument and returned the case to state court.This case was primarily focused on whether Penn was "acting under" the federal government in its operation of Penn Medicine's patient portal. The United States Court of Appeals for the Third Circuit affirmed the District Court's decision to remand the case back to state court. The Court of Appeals determined that Penn was not "acting under" the federal government, as it did not demonstrate that it was performing a delegated governmental task. The court declared that Penn was merely complying with federal laws and regulations, which does not qualify as "acting under" the federal government. The court noted that just because a private party has a contractual relationship with the federal government does not mean that it is "acting under" the federal authority. In conclusion, the court determined that the relationship between Penn and the federal government did not meet the requirements for Penn to be considered as "acting under" the federal government, thus the case was correctly returned to state court. View "Mohr v. Trustees of the University of Pennsylvania" on Justia Law

In this case, the parents of W.J., a young man with a chromosomal abnormality and autism, brought a case under the National Childhood Vaccine Injury Act of 1986 against the Secretary of Health and Human Services, claiming that the Measles, Mumps, and Rubella vaccine administered to their son had caused or significantly aggravated his health issues. They filed their petition more than 15 years after the vaccine was administered, well beyond the Act's three-year statute of limitations. The parents argued that the statute of limitations should be equitably tolled due to their son's mental incapacitation, his minority status, and the government's alleged fraudulent concealment of a connection between the vaccine and autism.The United States Court of Appeals for the Federal Circuit affirmed the decision of the United States Court of Federal Claims, which had denied the parents' petition for review and confirmed a special master’s decision to dismiss the case as untimely. The court concluded that the mental incapacitation of the son did not qualify as an "extraordinary circumstance" warranting equitable tolling because the parents, as his legal guardians, had failed to demonstrate that they were unable to file a claim on his behalf. The court also rejected the arguments for minority tolling and fraudulent concealment, finding no basis for these in the Vaccine Act or its legislative history. The court further held that the special master had not erred in raising the issue of the statute of limitations, nor in dismissing the claim for failure to state a claim upon which relief could be granted. View "W. J. v. Health and Human Services" on Justia Law

This case concerns the standard of review that the Commissioner of the Georgia Department of Community Health must apply when reviewing the decision of a hearing officer on an application for a certificate of need to establish a new health service. The Supreme Court of Georgia vacated the Court of Appeals’ judgment, set forth the standard applicable to the Commissioner’s review, and remanded the case to the Court of Appeals. The Supreme Court clarified that "competent substantial evidence" in the context of the Commissioner's review means evidence that is "relevant" such that "a reasonable mind might accept it as adequate to support" a finding of fact, and that is admissible. The court also determined that the Commissioner must provide sufficient detail in his order from which a reviewing court can determine whether the Commissioner has or has not improperly substituted his judgment for the findings of fact of the hearing officer. View "VANTAGE CANCER CENTERS OF GEORGIA, LLC v. GEORGIA DEPARTMENT OF COMMUNITY HEALTH" on Justia Law

The United States Court of Appeals for the District of Columbia Circuit ruled in a case involving Regenative Labs ("Regenative"), a manufacturer of medical products containing human cells, tissues, or cellular or tissue-based products ("HCT/Ps"), and the Secretary of Health and Human Services. Following the Centers for Medicare and Medicaid Services ("CMS") issuing two technical direction letters instructing Medicare contractors to deny reimbursement for claims for products manufactured by Regenative, the company filed suit challenging these letters without first exhausting administrative remedies. The District Court dismissed the case due to lack of subject matter jurisdiction as Regenative had failed to exhaust its administrative remedies. On appeal, the Court of Appeals affirmed the District Court’s dismissal, in part for lack of subject matter jurisdiction and in part on grounds of mootness. The Court concluded that the claims raised by Regenative arose under the Medicare Act and had to be pursued through the statutorily-prescribed administrative process. The Court also found that the company’s request for the court to vacate the contested policy was moot because the policy had already been rescinded by CMS. Finally, the court rejected Regenative's argument for mandamus jurisdiction, finding that it did not satisfy the jurisdictional requirements for this relief. View "Row 1 Inc. v. Becerra" on Justia Law