Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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This case involves a qui tam action under the False Claims Act (FCA) and the Iowa False Claims Act (IFCA) brought by Stephen Grant, a sleep medicine practitioner, against Steven Zorn, Iowa Sleep Disorders Center, and Iowa CPAP. Grant alleged that the defendants had knowingly overbilled the government for initial and established patient visits and violated the Anti-Kickback Statute and the Stark Law by knowingly soliciting and directing referrals from Iowa Sleep to Iowa CPAP. The district court found the defendants liable for submitting 1,050 false claims to the United States and the State of Iowa and imposed a total award of $7,598,991.50.The district court had rejected the defendants' public disclosure defense and awarded summary judgment to the defendants on the Anti-Kickback Statute and Stark Law claim. After a bench trial, the district court found the defendants liable on several claims, including that Iowa Sleep had violated the anti-retaliation provisions of the FCA and IFCA by firing Grant. The district court also concluded that the defendants had overbilled on initial patient visits but not on established patient visits.On appeal, the United States Court of Appeals for the Eighth Circuit affirmed in part, vacated in part, and remanded for further proceedings. The court held that the public disclosure bar was inapplicable because Grant’s complaint did not allege “substantially the same allegations” contained in the AdvanceMed letters. The court also held that the district court did not abuse its discretion in admitting expert testimony on extrapolation and overbilling. However, the court found that the district court erred in its determination of damages and civil penalties, violating the Eighth Amendment’s Excessive Fines Clause. The court vacated the punitive sanction and remanded the case for further proceedings. View "Grant v. Zorn" on Justia Law

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This case involves two consolidated appeals from Northwestern Medical Center and Rutland Regional Medical Center against the Green Mountain Care Board (GMCB). The GMCB had approved the proposed budgets of both medical centers for the fiscal year 2024, but with certain conditions. The medical centers challenged the GMCB's imposition of budgetary conditions that capped increases to rates charged to commercial payers. However, the medical centers had not properly raised their claims with the GMCB, leaving them unpreserved for review.The GMCB is an independent board that regulates the health care industry in Vermont. It reviews and establishes hospital budgets annually, with the aim of reducing the per-capita rate of growth in expenditures for health services in Vermont across all payers. The GMCB had released its established benchmarks for the 2024 fiscal year budget submissions, which included a benchmark that limited a hospital’s growth of net patient revenue/fixed prospective payment (NPR/FPP) to 8.6%, effectively capping increases to NPR/FPP growth by that amount. It also included a benchmark for commercial rate increases which provided that the GMCB would “also review and may adjust requested hospital commercial rate increases.”The GMCB approved the budgets of Northwestern and Rutland Regional, subject to certain conditions. These conditions included a cap on increases to commercial rates. However, neither Northwestern nor Rutland Regional had raised their claims with the GMCB, leaving them unpreserved for review.On appeal, Northwestern and Rutland Regional argued that the GMCB deprived them of due process by failing to provide adequate notice that it would impose the Commercial Rate Cap Conditions on their proposed budgets. They also claimed that the GMCB had no authority to impose the Commercial Rate Cap Conditions because the conditions lacked a factual basis and contradicted the GMCB’s initial approval of their proposed budgets. However, the Vermont Supreme Court declined to reach the merits of these claims because they were not preserved for review. The court noted that Northwestern and Rutland Regional had several opportunities to raise their claims with the GMCB before the GMCB issued its final budget decisions, but they failed to do so. Therefore, the court affirmed the decisions of the GMCB. View "In re Northwestern Medical Center Fiscal Year 2024" on Justia Law

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The case involves the United States of America, et al. ex rel. Michael Angelo and MSP WB, LLC (Relators-Appellants) against Allstate Insurance Company, et al. (Defendants-Appellees). The relators alleged that Allstate Insurance violated the False Claims Act by avoiding its obligations under the Medicare Secondary Payer Act. They claimed that Allstate failed to report or inaccurately reported to the Centers for Medicare & Medicaid Services (CMS) information regarding its beneficiaries, which led to Allstate failing to reimburse Medicare for auto-accident-related medical costs incurred by beneficiaries insured by Allstate.The United States District Court for the Eastern District of Michigan dismissed the case with prejudice, deeming the relators' second amended complaint deficient in numerous respects. The relators then moved for reconsideration, which the district court denied. They also filed a motion to amend or correct under Rule 59(e), asking the district court to amend its judgment to dismiss the case without prejudice to allow them to file another amended complaint. The district court denied the motion on all grounds.The United States Court of Appeals for the Sixth Circuit affirmed the district court's decision. The court found that the relators failed to state a claim for a violation of the False Claims Act. The court noted that the relators did not provide sufficient facts demonstrating that Allstate had an "established duty" to pay money or property owed to the government. The court also found that the relators did not demonstrate Allstate's understanding that its conduct violated its obligations under federal law. Furthermore, the court found that the relators' claim for conspiracy also failed as they did not provide any specific details regarding the alleged plan or an agreement to execute the plan. The court also affirmed the district court's decision to deny the relators leave to amend their complaint again. View "United States ex rel. Angelo v. Allstate Insurance Co." on Justia Law

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A group of individuals and businesses challenged the Affordable Care Act's requirement for private insurers to cover certain types of preventive care, including contraception, HPV vaccines, and drugs preventing HIV transmission. The plaintiffs argued that the mandates were unlawful because the agencies issuing them violated Article II of the Constitution, as their members were principal officers of the United States who had not been validly appointed under the Appointments Clause. The district court mostly agreed, vacating all agency actions taken to enforce the mandates and issuing both party-specific and universal injunctive relief.The United States Court of Appeals for the Fifth Circuit agreed that the United States Preventive Services Task Force, one of the challenged administrative bodies, was composed of principal officers who had not been validly appointed. However, the court found that the district court erred in vacating all agency actions taken to enforce the preventive-care mandates and in universally enjoining the defendants from enforcing them. The court also held that the Secretary of the Department of Health and Human Services had not validly cured the Task Force’s constitutional problems.The court affirmed in part, reversed in part, and remanded the case for further proceedings. The court did not rule on the plaintiffs' challenges against the other two administrative bodies involved in the case, the Advisory Committee on Immunization Practices and the Health Resources and Services Administration, reserving judgment on whether the Secretary had effectively ratified their recommendations and guidelines. View "Braidwood Mgmt v. Becerra" on Justia Law

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This case involves a dispute over the interpretation of a statute that regulates healthcare providers participating in the federal Medicaid program. The State of Texas, acting through the Attorney General, sought to enforce a statute that imposes penalties on a provider who submits a claim for payment and knowingly fails to indicate the type of professional license and the identification number of the person who actually provided the service. The defendant, a dentist, argued that the statute only applies if a claim fails to indicate both the license type and the identification number of the actual provider.Previously, the trial court granted the State's motion for partial summary judgment and denied the defendant's motion. The court rendered a final judgment awarding the State more than $16,500,000. The defendant appealed, and the court of appeals affirmed the trial court's judgment, except for the amount of attorney’s fees and expenses.The Supreme Court of Texas reversed the lower courts' decisions. The court agreed with the defendant's interpretation of the statute. The court held that the statute applies only if a claim fails to indicate both the license type and the identification number of the actual provider. The court found that the 1,842 claims at issue did indicate the actual providers’ license type, so they did not constitute an unlawful act under the statute. The court rendered judgment in the dentist’s favor. View "MALOUF v. THE STATE OF TEXAS EX RELS. ELLIS AND CASTILLO" on Justia Law

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The case involves Image API, LLC, a company that provided services to the Texas Health and Human Services Commission (HHSC) from 2009 to 2015. Image's job was to manage a processing center for incoming mail related to Medicaid and other benefits programs. The agreement between the parties stated that HHSC would compensate Image using its “retrospective cost settlement model”. In 2016, HHSC notified Image that an independent external firm would conduct an audit of Image’s performance and billing for the years 2010 and 2011. The audit concluded that HHSC had overpaid Image approximately $440,000 in costs relating to bonuses, holiday pay, overtime, and other unauthorized labor expenses. HHSC then sought to recoup the overpayments by deducting from payments on Image’s invoices.The trial court granted HHSC’s motion for summary judgment and signed a final judgment for the commissioner. The court of appeals reversed the trial court’s judgment and dismissed Image’s entire suit for want of jurisdiction. Image sought review.The Supreme Court of Texas held that Image is a Medicaid contractor under Section 32.0705(a), and that the deadline in Section 32.0705(d) for auditing HHSC’s Medicaid contractors is mandatory. However, the court ruled that HHSC’s failure to meet the deadline does not preclude it from using the result of the audit or pursuing recoupment of overcharges found in the audit. The court affirmed the part of the court of appeals’ judgment dismissing Image’s claims arising from the 2016 audit for lack of jurisdiction, reversed the part of the judgment dismissing the remainder of Image’s suit, and remanded to the trial court for further proceedings. View "IMAGE API, LLC v. YOUNG" on Justia Law

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The case involves Roland Black, who was convicted of attempting to possess with intent to distribute a controlled substance, specifically furanyl fentanyl. Law enforcement intercepted a package addressed to Black, believing it contained narcotics. After obtaining a warrant, they found the substance, replaced it with sham narcotics, and delivered the package to Black's residence. Black was arrested after the package was opened and he was found with luminescent powder from the sham narcotics on his hands.Prior to his trial, Black had unsuccessfully moved to dismiss the indictment and suppress all evidence derived from the seizure of the package. He argued that the officers lacked reasonable suspicion to seize the package and requested an evidentiary hearing to resolve related factual disputes. The district court denied these motions, ruling that the totality of the circumstances supported the officers' reasonable suspicion determination.In the United States Court of Appeals for the Seventh Circuit, Black appealed his conviction, raising four arguments. He contended that the officers lacked reasonable suspicion to seize the package, the jury instruction about his requisite mens rea was erroneous, the jury’s verdict was not supported by sufficient evidence, and the court erred in denying his motion to dismiss based on the court’s treatment of furanyl fentanyl as an analogue of fentanyl.The Court of Appeals affirmed the lower court's decision. It found that the officers had reasonable suspicion to seize the package, the jury instruction accurately stated the law, the jury’s verdict was supported by more than sufficient evidence, and Black's motion to dismiss argument was foreclosed by precedent. View "USA v. Black" on Justia Law

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The case involves a dispute over the eligibility of a married individual, Costa Tingos, for Medicaid long-term care benefits. Costa and his wife, Mary, had been married for over 50 years, but had kept their finances largely separate due to Costa's history of gambling and financial mismanagement. When Costa moved into a nursing home, he applied for Medicaid benefits. However, Mary refused to provide information about her income and assets, which was necessary to determine Costa's eligibility. Costa argued that Mary's refusal to cooperate should not affect his eligibility.The case was initially heard by the Massachusetts Medicaid program, MassHealth, which denied Costa's application. Costa appealed to the MassHealth board of hearings, which also denied his appeal. Costa then sought judicial review in the Superior Court, which vacated the board's decision and remanded the case back to the board. After two more rounds of hearings and appeals, the Superior Court affirmed the board's decision to deny Costa's application.The Supreme Judicial Court of Massachusetts affirmed the decision of the Superior Court. The court held that the board's interpretation of the phrase "refuses to cooperate" in the relevant regulation was reasonable. The court found that Mary's refusal to disclose her financial information did not constitute a refusal to cooperate within the meaning of the regulation, given the couple's long history of cooperation in other aspects of their marriage. The court also rejected Costa's argument that the board's decision was arbitrary and capricious. View "Freiner v. Secretary of the Executive Office of Health and Human Services" on Justia Law

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In 2000, the Food and Drug Administration (FDA) approved the use of mifepristone tablets, marketed under the brand name Mifeprex, for terminating pregnancies up to seven weeks. The FDA imposed additional restrictions on the drug's use and distribution, including requiring doctors to prescribe or supervise the prescription of Mifeprex and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, the FDA relaxed some of these restrictions, and in 2021, it announced that it would no longer enforce the initial in-person visit requirement. Four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require the FDA to either rescind approval of mifepristone or rescind the FDA’s 2016 and 2021 regulatory actions.The District Court agreed with the plaintiffs and effectively enjoined the FDA's approval of mifepristone, ordering it off the market. The FDA and Danco Laboratories, which sponsors Mifeprex, appealed and moved to stay the District Court’s order pending appeal. The Supreme Court ultimately stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit and the Supreme Court. On the merits, the Fifth Circuit held that plaintiffs had standing and concluded that plaintiffs were unlikely to succeed on their challenge to FDA’s 2000 and 2019 drug approvals, but were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful. The Supreme Court granted certiorari with respect to the 2016 and 2021 FDA actions.The Supreme Court of the United States held that the plaintiffs lack Article III standing to challenge the FDA’s actions regarding the regulation of mifepristone. The Court found that the plaintiffs, who are pro-life and oppose elective abortion, have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. However, because the plaintiffs do not prescribe or use mifepristone, they are unregulated parties who seek to challenge the FDA’s regulation of others. The Court concluded that the plaintiffs' theories of causation were insufficient to establish Article III standing. The Court reversed the judgment of the Fifth Circuit and remanded the case for further proceedings consistent with its opinion. View "FDA v. Alliance for Hippocratic Medicine" on Justia Law

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The case involves two petitioners, Daniel Dilly, Superintendent of the Rubenstein Juvenile Center (RJC), and Nancy Oldaker, Health Services Administrator at RJC, who were held in contempt of court by Judge Kurt Hall of the Circuit Court of Lewis County, West Virginia. The contempt charges arose from an incident involving a resident of RJC, identified as D.P., who suffered a broken jaw during a fight with other residents. The court had ordered that D.P. be taken off RJC grounds for an X-ray and that his mother be notified of his medical appointments. The court found that these orders were not adequately followed by the petitioners.The Circuit Court of Lewis County held a hearing to review D.P.'s placement and medical care, resulting in a "Medical Care Order" that directed RJC to schedule an appointment for D.P. with his oral surgeon and to allow D.P.'s mother to attend the appointment. The court also ordered RJC to provide a report concerning the incident that led to D.P.'s injury. When these orders were not fully complied with, the court held a "show cause" hearing and found both Superintendent Dilly and Ms. Oldaker in contempt of court, fining each of them $250.The Supreme Court of Appeals of West Virginia found that procedural errors in the lower court's contempt proceedings deprived the court of jurisdiction to impose such sanctions. The court noted that the lower court failed to provide the petitioners with adequate notice that they were facing indirect criminal contempt proceedings and did not afford them jury trials before imposing the fines. The court concluded that the contempt orders were void and granted the petitioners' requested writs of prohibition, thereby preventing the lower court from enforcing the contempt orders. View "State ex rel. Dilly v. Hall" on Justia Law