Justia Government & Administrative Law Opinion Summaries

Dr. Blake Vanderlan, a physician at a hospital operated by Jackson HMA, LLC, alleged that the hospital systematically violated the Emergency Medical Treatment and Labor Act (EMTALA). He reported these violations to the Department of Health and Human Services, prompting an investigation by the Center for Medicare and Medicaid Services (CMS). CMS confirmed the violations and referred the matter to the Office of Inspector General (OIG) for potential civil monetary penalties. Vanderlan then filed a qui tam lawsuit under the False Claims Act (FCA) against Jackson HMA, alleging five FCA violations, including a retaliation claim.The United States District Court for the Southern District of Mississippi handled the case initially. The government investigated Vanderlan’s claims but declined to intervene. The case continued for six and a half years, during which the district court severed Vanderlan’s retaliation claims. The government eventually moved to dismiss the qui tam claims, arguing that the lawsuit interfered with administrative settlement negotiations and lacked merit. The district court granted the dismissal based on written filings and reaffirmed its decision after reconsideration.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court held that the district court did not err in denying Vanderlan an evidentiary hearing, as the FCA only requires a hearing on the briefs. The court also determined that the government’s motion to dismiss fell under Rule 41(a)(1), which allows for dismissal without a court order, and thus, the district court had no discretion to deny the dismissal. The Fifth Circuit affirmed the district court’s judgment, concluding that the government’s decision to dismiss the case was justified and that the district court applied the correct standard. View "Vanderlan v. Jackson HMA" on Justia Law

Jaime Vargas and Francis R. Alvarez, former employees of medical supplier Lincare, Inc., and its subsidiary Optigen, Inc., filed a qui tam complaint under the False Claims Act (FCA). They alleged that Optigen engaged in fraudulent practices, including systematic upcoding of durable medical equipment, improper kickback arrangements, waiver of co-pays, and shipment of unordered supplies. The relators claimed that Optigen billed CPAP batteries and accessories under codes designated for ventilator accessories, waived patient co-pays without assessing financial hardship, shipped CPAP supplies automatically without patient requests, and paid kickbacks to healthcare providers for referrals.The case was initially filed in the Eastern District of Virginia and later transferred to the Middle District of Florida. The United States declined to intervene, and the District Court unsealed the complaint. The relators filed multiple amended complaints, each of which was dismissed by the District Court for failing to meet the heightened pleading standard of Federal Rule of Civil Procedure 9(b). The District Court dismissed the fourth amended complaint, holding that it still failed to plead sufficient facts with the requisite specificity.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court affirmed the District Court's dismissal of the relators' claims regarding improper kickback arrangements, waiver of co-pays, and automatic shipment of supplies, finding that these allegations lacked the necessary specificity and failed to identify any actual false claims submitted to the government. However, the court reversed the dismissal of the upcoding claim, holding that the relators had pleaded sufficient facts with particularity to withstand a motion to dismiss. The court remanded the case for further proceedings limited to the upcoding issue. View "Vargas v. Lincare, Inc." on Justia Law

Two elderly individuals, Ms. Penelope Lamle and Ms. Maxine Houston, applied for Medicaid but faced delays and additional questions from the Oklahoma Department of Human Services, allegedly directed by attorney Susan Eads. They refused to answer these questions and subsequently sued, seeking an expedited decision, payment of Medicaid benefits, and damages. Both applicants died during the litigation, and their estates were substituted as parties in the appeal.The United States District Court for the Western District of Oklahoma dismissed the action with prejudice, citing the plaintiffs' failure to state a valid claim. However, the court was unaware that the applicants had died while the action was pending.The United States Court of Appeals for the Tenth Circuit reviewed the case. The court found that the claims for an injunction became moot when the agency denied benefits and the applicants died. The court noted that the requested relief would no longer benefit the estates, as the Oklahoma Department of Human Services had already denied the applications. The court also held that the Eleventh Amendment barred the requested retrospective relief. Consequently, the court remanded the case to the district court with instructions to vacate the judgment on the claim for a prospective injunction and dismiss it without prejudice.Regarding the claim against Ms. Eads in her individual capacity, the Tenth Circuit held that she was entitled to qualified immunity. The court found that the plaintiffs did not allege facts showing the violation of a clearly established right. As a result, the court affirmed the dismissal with prejudice of the claim for damages against Ms. Eads. View "Lamle v. Eads" on Justia Law

California collects a fee from in-state hospitals and uses the revenue, along with federal Medicaid funds, to provide subsidies to California hospitals serving Medicaid beneficiaries. Out-of-state hospitals near the California border, which sometimes serve California Medicaid beneficiaries but do not pay the fee, sought access to these subsidies. They argued that their exclusion violated the dormant Commerce Clause, the Equal Protection Clause, and federal Medicaid regulations.The United States District Court for the District of Columbia rejected the out-of-state hospitals' arguments and granted summary judgment in favor of the Centers for Medicare and Medicaid Services (CMS). The hospitals appealed the decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo and affirmed the district court's decision. The court held that the QAF program does not discriminate against interstate commerce because it does not tax out-of-state hospitals, and the supplemental payments are based on in-state provision of medical care. The court also found that the program does not violate the Equal Protection Clause, as California could rationally decide to target subsidies to in-state hospitals serving a disproportionate share of Medi-Cal beneficiaries. Lastly, the court concluded that the QAF program does not violate federal Medicaid regulations, as the regulation in question pertains to base payments for specific services rendered to beneficiaries, not supplemental subsidies like the QAF payments. View "Asante v. Kennedy" on Justia Law

The case involves the Food and Drug Administration (FDA) denying authorization for respondents to market certain flavored e-cigarette products. The FDA's decision was based on the lack of sufficient scientific evidence demonstrating that these products would be appropriate for the protection of public health. The FDA emphasized the need for evidence from randomized controlled trials or longitudinal cohort studies, which the respondents did not provide. Instead, respondents submitted literature reviews and cross-sectional surveys, which the FDA found inadequate.The United States Court of Appeals for the Fifth Circuit, sitting en banc, reviewed the FDA's denial orders. The court found that the FDA acted arbitrarily and capriciously by applying different standards than those articulated in its predecisional guidance. The court was particularly concerned with the FDA's failure to review marketing plans, which it had previously deemed critical. The Fifth Circuit rejected the FDA's argument that any errors were harmless and remanded the case to the FDA.The Supreme Court of the United States reviewed the case and vacated the Fifth Circuit's decision. The Court held that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. However, the Court agreed with the FDA that the Fifth Circuit's interpretation of harmless error was overly broad. The Supreme Court remanded the case to the Fifth Circuit to reconsider the harmless-error question without relying on its expansive reading of Calcutt v. FDIC. View "FDA v. Wages and White Lion Investments, LLC" on Justia Law

Dr. Jeffery D. Milner, a physician, brought a qui tam action under the False Claims Act (FCA) against Baptist Health Montgomery, Prattville Baptist, and Team Health. Milner alleged that while working at a hospital owned by the defendants, he discovered that they were overprescribing opioids and fraudulently billing the government for them. He claimed that he was terminated in retaliation for whistleblowing after reporting the overprescription practices to his superiors.Previously, Milner filed an FCA retaliation lawsuit against the same defendants in the U.S. District Court for the Northern District of Alabama, which was dismissed with prejudice for failure to state a claim. The court found that Milner did not sufficiently allege that he engaged in protected conduct under the FCA or that his termination was due to such conduct. Following this dismissal, Milner filed the current qui tam action in the U.S. District Court for the Middle District of Alabama. The district court dismissed this action as barred by res judicata, relying on the Eleventh Circuit's decisions in Ragsdale v. Rubbermaid, Inc. and Shurick v. Boeing Co.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's dismissal. The court held that Milner's qui tam action was barred by res judicata because it involved the same parties and the same cause of action as his earlier retaliation lawsuit. The court found that both lawsuits arose from a common nucleus of operative fact: the defendants' alleged illegal conduct and Milner's discovery of that conduct leading to his discharge. The court also noted that the United States, which did not intervene in the qui tam action, was not barred from pursuing its own action in the future. View "Milner v. Baptist Health Montgomery" on Justia Law

Relators Tiffany Montcrief and others filed a False Claims Act suit against Peripheral Vascular Associates, P.A. (PVA), alleging that PVA billed Medicare for vascular ultrasound services that were not completed. The claims were categorized into "Testing Only" and "Double Billing" claims. The district court granted partial summary judgment to Relators, concluding that PVA submitted knowingly false claims. A jury found these claims material and awarded approximately $28.7 million in damages against PVA.The district court granted partial summary judgment to Relators on the issues of falsity and knowledge of falsity. The jury found that the claims were material and caused the Government to pay out money. The district court entered judgment against PVA, including statutory penalties and treble damages. PVA appealed, challenging the district court's grant of partial summary judgment and certain rulings during and after the trial.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court affirmed the district court's grant of partial summary judgment on the Testing Only claims but remanded for a new trial on damages. The court reversed the partial summary judgment ruling on the Double Billing claims, vacated the final judgment, and remanded for a new trial consistent with its opinion. The court concluded that the district court erred in interpreting the CPT–4 Manual and in concluding that the Manual required PVA to create separate, written reports for vascular ultrasounds before billing Medicare. The court also found that the district court abused its discretion in relying on Relators' post-trial expert declaration to calculate damages. View "Montcrief v. Peripheral Vascular" on Justia Law

Dr. Omar Almusa, a licensed medical physician and surgeon in Pennsylvania, unlawfully distributed hydrocodone between 2014 and 2018. He pleaded guilty to unlawful dispensing and distributing a controlled substance, conspiracy to distribute, and health care fraud. In 2019, he was sentenced to 24 months in prison followed by three years of supervised release. Consequently, the State Board of Medicine automatically suspended his medical license for at least ten years, effective August 15, 2019.Almusa did not appeal the suspension. In 2020, the General Assembly enacted Act 53, redefining how licensing boards consider criminal offenses, specifying that only drug trafficking offenses (involving at least 100 grams of a controlled substance) warrant automatic suspension. Almusa's offense did not meet this threshold. In 2021, Almusa petitioned for reinstatement of his license, arguing that Act 53 should apply to his case, allowing him to seek reinstatement without waiting ten years.The Board denied his petition, stating that Act 53 did not apply retroactively to suspensions imposed before its enactment. The Commonwealth Court affirmed the Board's decision, interpreting the suspension and reinstatement as a single action requiring a ten-year suspension period.The Supreme Court of Pennsylvania reversed the Commonwealth Court's decision. It held that automatic suspension and reinstatement are separate actions under the Medical Practice Act. The Court found that Act 53, effective December 28, 2020, applies to reinstatement proceedings initiated after this date. Since Almusa's offense did not qualify as drug trafficking under Act 53, the ten-year waiting period did not apply to his reinstatement petition. The Court concluded that Almusa was entitled to have his reinstatement petition considered under the new law. View "Almusa v. State Board of Medicine" on Justia Law

Several skilled nursing facilities challenged the State Department of Health Care Services and its director, Michelle Baass, over the formula used to calculate Medi-Cal reimbursement overpayments. The plaintiffs argued that the Department's method, which was based on the amount Medicare paid for ancillary services rather than the amount Medi-Cal overpaid, violated a ministerial duty and constituted an underground regulation.The trial court sustained the Department's demurrer without leave to amend, concluding that the plaintiffs' claim was not cognizable in a traditional writ of mandate proceeding. The court also found that the plaintiffs failed to state a claim that the Department violated a ministerial duty or adopted an underground regulation. Additionally, the trial court denied the plaintiffs' motion to compel discovery of certain documents, deeming them privileged.The California Court of Appeal, Third Appellate District, reviewed the case. The court determined that some of the plaintiffs' claims were indeed cognizable in a traditional writ of mandate proceeding and that the petition stated a claim for relief regarding the Department's use of an underground regulation when calculating Medi-Cal reimbursement overpayments. However, the court found that the plaintiffs did not provide an adequate record to review whether the trial court erred in denying their motion to compel discovery.The appellate court reversed the judgment of dismissal and affirmed the trial court's order denying the plaintiffs' motion to compel. The case was remanded to the trial court with instructions to vacate its order sustaining the Department's demurrer without leave to amend and to enter a new order overruling the demurrer. The plaintiffs were awarded their costs on appeal. View "California Healthcare & Rehabilitation Center v. Baass" on Justia Law

The case involves the U.S. Centers for Medicare & Medicaid Services (CMS) approving the New York State Department of Health’s (NYSDOH) application to distribute $361.25 million to certain managed care organizations. These organizations were to direct the funds to the top one-third of revenue-generating licensed home care services agencies (LHCSAs) in New York’s four rate regions, provided they agreed to use the funding in a specified manner. The plaintiffs, who are LHCSAs that did not meet the revenue threshold, argued that the approval was unlawful under federal law and regulations because the class of eligible agencies was improperly defined and the application was not assessed for actuarial soundness before approval.The district court dismissed the amended complaint against the State Appellees for failing to adequately allege a cause of action under Ex parte Young and granted summary judgment to the Federal Appellees. The court concluded that the approval of the State’s application did not violate the Administrative Procedure Act (APA) and denied the plaintiffs’ motion to admit extra-record evidence.The United States Court of Appeals for the Second Circuit reviewed the case and agreed with the district court’s decision. The court held that CMS’s approval of NYSDOH’s application complied with federal law. It found that the provider class was properly defined under 42 C.F.R. § 438.6(c)(2)(ii)(B) and that CMS was not required to assess actuarial soundness during the pre-approval process. The court also concluded that CMS did not act arbitrarily or capriciously in approving the application and that the district court did not abuse its discretion in excluding the extra-record evidence. Consequently, the Second Circuit affirmed the judgment of the district court. View "Safe Haven Home Care, Inc. v. United States Department of Health and Human" on Justia Law