Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
BST Holdings, LLC v. Occupational Safety and Health Administration
This case concerns OSHA's November 5, 2021 Emergency Temporary Standard requiring employees of covered employers to undergo COVID-19 vaccination or take weekly COVID-19 tests and wear a mask.The Fifth Circuit granted petitioners' motion for a stay pending review, holding that the Nken factors favored a stay. The court concluded that petitioners' challenges to the Mandate are likely to succeed on the merits. The court stated that, on the dubious assumption that the Mandate does pass constitutional muster, it is nonetheless fatally flawed on its own terms. The court wrote that the Mandate's strained prescriptions combine to make it the rare government pronouncement that is both overinclusive (applying to employers and employees in virtually all industries and workplaces in America, with little attempt to account for the obvious differences between the risks facing, say, a security guard on a lonely night shift, and a meatpacker working shoulder to shoulder in a cramped warehouse) and underinclusive (purporting to save employees with 99 or more coworkers from a "grave danger" in the workplace, while making no attempt to shield employees with 98 or fewer coworkers from the very same. The court found that promulgation of the Mandate grossly exceeds OSHA's statutory authority and found arguments to the contrary unavailing.The court also concluded that it is clear that denial of petitioners' proposed stay would do them irreparable harm where the Mandate threatens to substantially burden the liberty interests of reluctant individuals, companies, and the States. In contrast, the court stated that a stay will do OSHA no harm whatsoever. Finally, the court concluded that a stay is firmly in the public interest. View "BST Holdings, LLC v. Occupational Safety and Health Administration" on Justia Law
Breeze Smoke, LLC v. United States Food and Drug Administration
The Food and Drug Administration denied Breeze’s Premarket Tobacco Product Applications for its electronic nicotine delivery systems (ENDS). Breeze sought a stay of the FDA’s order. Under the Family Smoking Prevention and Tobacco Control Act “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. 387l(a)(1)(B). Breeze argued that seeking a stay from the FDA would have been impracticable because the order takes effect immediately and the FDA can take months to consider an agency-level request for a stay.The Sixth Circuit denied the requested stay, finding that Breeze had not made a strong showing that it is likely to succeed on the merits.” Breeze has not made a strong showing that it would likely succeed on its claim that the FDA’s review of its application was arbitrary or capricious nor that the FDA’s denial of its application contradicted the FDA’s nonbinding 2019 guidance. That guidance contemplated more rigorous scientific data than contained in Breeze's application that its ENDS product adequately protected public health. The FDA cited well-developed evidence showing that flavored ENDS products’ special appeal to youths harms public health to a degree not outweighed by the (far-less-supported) effects of adult cigarette smokers switching to e-cigarettes. View "Breeze Smoke, LLC v. United States Food and Drug Administration" on Justia Law
Adventist Health System v. U.S. Department of Health and Human Services
The Hospitals filed suit to enjoin the OPTN's new policy, which significantly changes the method for allocating donated kidneys to kidney transplant patients, as unlawful under the Transplant Act and the Administrative Procedure Act (APA).The Eighth Circuit affirmed the district court's denial of the Hospitals' motion for a temporary restraining order and preliminary injunction. Examining the district court's balancing of the Dataphase factors, the court concluded that the district court did not err in concluding that the Hospitals failed to show that their procedural APA claim is likely to succeed on the merits. The court also agreed with the district court that the Hospitals failed to demonstrate that they are likely to succeed on the merits of their claim that adoption of the Fixed Circle Policy was arbitrary and capricious agency action. Furthermore, the district court did not abuse its discretion in concluding that the Hospitals' one-year delay refuted their allegations of irreparable harm, and the balance of the equities and public interest weigh in favor of denying the requested preliminary injunction. View "Adventist Health System v. U.S. Department of Health and Human Services" on Justia Law
Family Rehabilitation, Inc. v. Becerra
Family Rehab brought a procedural due process claim arguing that it is entitled to third step review before recoupment of Medicare overpayments. The district court granted summary judgment in favor of Family Rehab, and entered a permanent injunction barring HHS from recouping the disputed funds until the completion of third step review under 42 C.F.R. 405.1036(c)–(d).However, in reaching its decision, the district court did not have the benefit of the Fifth Circuit's decision in Sahara Health Care Inc. v. Azar, 975 F.3d 523 (5th Cir. 2020), in which the court rejected a similar due process claim under nearly identical facts. In this case, Family Rehab's claims all involve documentation issues that do not require cross-examination and credibility determinations. The court explained that Family Rehab's claims could have been resolved in the first two steps of administrative review by producing the relevant documents. Accordingly, the court reversed the district court's judgment. View "Family Rehabilitation, Inc. v. Becerra" on Justia Law
Family Health Centers of San Diego v. State Dept. of Health Care Service
As part of a request to receive a higher reimbursement rate, plaintiff Family Health Centers of San Diego (Family Health) submitted a cost report detailing the reimbursable costs incurred by its clinics in providing covered services to Medi-Cal patients. Because the costs were not allowable Medi-Cal costs, Family Health eliminated them from its cost report. As part of an audit, however, defendant State Department of Health Care Services (the Department) determined the costs should not have been eliminated from the cost report. Instead, the Department reclassified the costs to a nonreimbursable cost center, which had the effect of disallowing a proportionate share of the clinics’ administrative overhead costs. Family Health filed an administrative appeal to dispute the audit adjustments, but, after a formal hearing, its appeal was denied. Family Health then filed a petition for a writ of mandate challenging the administrative decision, which also was denied. On appeal, Family Health contended the Department did not establish a proper basis for reclassifying the costs to a nonreimbursable cost center, and that the decision to reclassify the costs was not supported by substantial evidence. Family Health separately argued that a significant subset of the costs should not have been included in the nonreimbursable cost center because they were not costs at all. After review, the Court of Appeal found no reversible error and affirmed the judgment denying the petition. View "Family Health Centers of San Diego v. State Dept. of Health Care Service" on Justia Law
Johnson v. Inslee
Petitioners Governor Jay Inslee, the State of Washington, the Washington Department of Corrections, and Cheryl Strange, secretary of the Department of Corrections, sought the Washington Supreme Court's accelerated direct discretionary review of an order of the Franklin County Superior Court denying petitioners’ motion to change venue to Thurston County Superior Court in an action brought by respondent Jeffrey Johnson challenging proclamations the governor issued requiring certain state employees to be vaccinated against COVID-19 by October 18, 2021. The merits of the underlying suit were not before the Court. In an order issued on October 11, 2021, the Court determined that mandatory venue for this action was in Thurston County Superior Court under RCW 4.12.020(2), and therefore granted petitioners’ motion for accelerated discretionary review, reversed the order of the Franklin County Superior Court, and remanded to that court with directions to grant petitioners’ motion to change venue without delay. In this opinion, the Court explained the reasoning underlying its order. View "Johnson v. Inslee" on Justia Law
Fraihat v. United States Immigration and Customs Enforcement
In April 2020, the district court entered a preliminary injunction and provisionally certified nationwide subclasses of ICE detainees with risk factors or disabilities placing them at heightened risk of severe illness and death from COVID-19. The court found that plaintiffs were likely to succeed on claims of deliberate indifference to the medical needs of detainees, punitive conditions of confinement, and violation of the Rehabilitation Act, 29 U.S.C. 794. The preliminary injunction imposed a broad range of obligations on the federal government.The Ninth Circuit reversed, stating that neither the facts nor the law supported a judicial intervention of this magnitude. The plaintiffs did not make a clear showing that ICE acted with deliberate indifference to medical needs or in reckless disregard of health risks. If a particular condition or restriction of pretrial detention is reasonably related to a legitimate governmental objective, it does not, alone, amount to punishment; there was a legitimate governmental objective here, ICE was holding detainees because they were suspected of having violated the immigration laws or were otherwise removable. ICE’s national directives did not create excessive conditions of “punishment.” Rejecting the Rehabilitation Act claim, the court stated that the plaintiffs at most demonstrated that they were subjected to inadequate national policies; they did not show they were treated differently from other detainees “solely by reason” of their disabilities. View "Fraihat v. United States Immigration and Customs Enforcement" on Justia Law
Rock River Health Care, LLC v. Eagleson
Providers filed suit under 42 U.S.C. 1983 and the Medicaid Act, alleging that the Department violated constitutional and statutory law in retroactively recalculating their Medicaid reimbursement rates for the three-month period of January through March 2016.The Seventh Circuit reversed the district court's dismissal of the Providers' procedural due process claim, concluding that, at this early stage in the litigation, the allegations are sufficient to allege a violation of procedural due process. First, the court explained that the Providers retain a legitimate entitlement to a rate determined according to that formula, and any action to alter the rate must be conducted with due process. In this case, according to the amended complaint, the auditors failed to provide any notice of the alleged deficiencies prior to the final decision, and the Providers had no opportunity to submit additional documentation or other evidence following that decision. The court stated that the burden on the Department in providing such notice is no impediment, given that the procedures are already in the Code. The court explained that the Department need only follow those procedures rather than routinely bypass them. Therefore, in the absence of that basic and fundamental protection against unfair or mistaken findings, the court concluded that the Providers have sufficiently alleged a violation of due process. Accordingly, the court remanded for further proceedings. View "Rock River Health Care, LLC v. Eagleson" on Justia Law
Northport Health Services of Arkansas, LLC v. U.S. Department of Health and Human Services
The Eighth Circuit affirmed the district court's grant of summary judgment in favor of HHS and CMS in an action brought by Northport, alleging that a regulation promulgated by CMS through notice and comment rulemaking is unlawful and should be set aside for violating the Administrative Procedure Act (APA), the Federal Arbitration Act (FAA), and the Regulatory Flexibility Act (RFA). The revised HHS regulations (Revised Rule) prohibits long-term care facilities from conditioning the admission of Medicare and Medicaid residents on their agreement to pre-dispute, binding arbitration and gives the residents the right to rescind the binding arbitration agreements, as well as certain other rights.The court concluded that the Revised Rule does not, in words or effect, render arbitration agreements entered into in violation thereof invalid or unenforceable, and thus it does not conflict with the FAA. Furthermore, the Revised Rule represents a reasonable accommodation of manifestly competing interests and is entitled to deference, and thus the district court properly concluded that it is not ultra vires. The court also concluded that the Revised Rule reflects CMS's reasoned judgment in light of competing considerations, and is not arbitrary or capricious. Finally, although CMS failed to provide a factual basis in support of its section 605(b) certification in the Revised Rule, the court concluded that failing to do so was harmless error. View "Northport Health Services of Arkansas, LLC v. U.S. Department of Health and Human Services" on Justia Law
Richland County School District 2 v. Lucas
The South Carolina Supreme Court granted petitioners' request for a declaration with respect to Provisos 1.108 and 1.103 of the 2021-2022 Appropriations Act1 were invalid. Proviso 1.108 (enacted June 22, 2021,) was directed to the South Carolina Department of Education for South Carolina's kindergarten through 12th grade (K-12) public schools, and banned face mask mandates at any of its education facilities. Proviso 1.103 permitted school districts to offer a virtual education program for up to five percent of its student population based on the most recent 135 day ADM [(average daily membership)]count without impacting any state funding. For every student participating in the virtual program above the five percent threshold, the school district would not receive 47.22% of the State per pupil funding provided to that district as reported in the latest Revenue and Fiscal Affairs revenue per pupil report pursuant to Proviso 1.3. Although the School District did not require its students to wear masks in its education facilities, it claimed Proviso 1.108 conflicted with local laws regarding mask requirements in schools and placed the School District in an untenable position. In addition, Petitioners claimed the School District reached the five percent cap for virtual enrollment and did not wish to risk losing state funds by exceeding the cap in Proviso 1.103. The School District asked for guidance on its options and obligations regarding face masks and virtual education. Petitioners contended: (1) Provisos 1.108 and 1.103 violate the one-subject rule of article III, section 17 of the South Carolina Constitution; (2) the plain language of Proviso 1.108 permitted the School District to implement and enforce mask mandates in its education facilities if the School District did so with funds not appropriated or authorized in the 2021-2022 Appropriations Act; (3) Provisos 1.108 and 1.103 improperly invade the authority of local school boards; and (4) Provisos 1.108 and 1.103 denied equal protection to students and violated their constitutional right to free public education. The Supreme Court held the provisos were constitutional, and rejected the remaining challenges to the validity of the provisos. View "Richland County School District 2 v. Lucas" on Justia Law