Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
by
The case involves a coalition of states led by Washington suing the FDA over its 2023 REMS, which eliminated in-person dispensing requirements for the abortion drug mifepristone. Washington argues that the FDA should have further reduced restrictions on the drug, claiming that the remaining requirements impose unnecessary hurdles. Idaho, leading another coalition of states, sought to intervene, arguing that the elimination of the in-person dispensing requirement would harm its interests by making the drug easier to obtain and harder to police, potentially increasing Medicaid costs and endangering maternal health and fetal life.The United States District Court for the Eastern District of Washington denied Idaho's motion to intervene. The court found that Idaho did not have a significantly protectable interest that would be impaired by the litigation, as its complaint concerned different aspects of the 2023 REMS. The court also denied permissive intervention, concluding that Idaho's claims did not share common questions of law or fact with Washington's claims.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed the district court's denial of Idaho's motion to intervene as of right. The Ninth Circuit held that Idaho must independently satisfy the requirements of Article III standing because it sought different relief from Washington. The court concluded that Idaho's complaint did not establish a cognizable injury-in-fact that was fairly traceable to the FDA's revised safe-use restrictions. Idaho's alleged economic injuries, law enforcement burdens, and quasi-sovereign interests were deemed too speculative or indirect to confer standing. The court dismissed for lack of jurisdiction the portion of the appeal concerning the denial of permissive intervention. View "STATE OF WASHINGTON V. FDA" on Justia Law

by
A group of hospitals challenged a rule by the Department of Health and Human Services (HHS) that adjusted Medicare reimbursement rates. HHS had increased reimbursements for hospitals in the lowest wage quartile and decreased them for others to maintain budget neutrality. The hospitals argued that this adjustment exceeded HHS's statutory authority under the Medicare Act.The United States District Court for the District of Columbia ruled in favor of the hospitals, finding that HHS lacked the authority to make such adjustments. However, the court did not vacate the rule but remanded it to HHS with instructions to recalculate the reimbursements.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and agreed with the lower court that HHS exceeded its authority. The court held that the Medicare Act's wage-index provision did not allow HHS to deviate from the congressionally prescribed formula. The adjustments provision also did not grant HHS the power to override the specific statutory formula. The court concluded that HHS's action must be vacated, not just remanded. Additionally, the court directed that the hospitals should receive an award of interest on the recalculated reimbursements as required by the Medicare statute.The court affirmed in part, reversed in part, and remanded the case to the district court for further proceedings consistent with its opinion. View "Bridgeport Hospital v. Becerra" on Justia Law

by
The case involves a congressional program that awards grants for family-planning projects, with the Department of Health and Human Services (HHS) setting eligibility requirements. Oklahoma, a grant recipient, expressed concerns about these requirements, citing state laws prohibiting counseling and referrals for abortions. HHS proposed that Oklahoma provide neutral information about family-planning options, including abortion, through a national call-in number. Oklahoma rejected this proposal, leading HHS to terminate the grant. Oklahoma challenged the termination and sought a preliminary injunction.The United States District Court for the Western District of Oklahoma denied Oklahoma's motion for a preliminary injunction, determining that Oklahoma was unlikely to succeed on the merits of its claims. Oklahoma then appealed the decision.The United States Court of Appeals for the Tenth Circuit reviewed the case. Oklahoma argued that it would likely succeed on the merits for three reasons: (1) Congress's spending power did not allow it to delegate eligibility requirements to HHS, (2) HHS's requirements violated the Weldon Amendment, and (3) HHS acted arbitrarily and capriciously. The Tenth Circuit rejected these arguments, holding that:1. The spending power allowed Congress to delegate eligibility requirements to HHS, and Title X was unambiguous in conditioning eligibility on satisfaction of HHS's requirements. 2. The Weldon Amendment, which prohibits discrimination against health-care entities for declining to provide referrals for abortions, was not violated because HHS's proposal to use a national call-in number did not constitute a referral for the purpose of an abortion. 3. HHS did not act arbitrarily and capriciously in terminating Oklahoma's grant, as the eligibility requirements fell within HHS's statutory authority, and Oklahoma did not demonstrate a likely violation of HHS's regulations.The Tenth Circuit affirmed the district court's denial of the preliminary injunction, concluding that Oklahoma had not shown a likelihood of success on the merits of its claims. View "State of Oklahoma v. HHS" on Justia Law

by
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

by
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

by
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

by
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

by
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

by
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

by
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