Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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Med-Cert filed suit against federal officials in charge of administering the Medicare program, alleging that HHS sought to recoup overpaid Medicare funds from Med-Cert before its hearing with an ALJ in violation of Med-Cert's due process rights. The district court enjoined the federal officials from recouping funds until after the hearing. While this case was on appeal, the Fifth Circuit issued Sahara Health Care Inc. v. Azar, 975 F.3d 523 (5th Cir. 2020), which held that a similarly situated health-care provider was not denied due process. Because Sahara is controlling in this case, the court reversed and remanded for the district court to consider Med-Cert's alternative claims. View "Med-Cert Home Care, LLC v. Becerra" on Justia Law

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In November 2021, the Secretary of Health and Human Services issued an interim rule that requires facilities that provide health care to Medicare and Medicaid beneficiaries to ensure that their staff, unless exempt for medical or religious reasons, are fully vaccinated against COVID-19, 86 Fed. Reg. 61,555. Under the rule, covered staff must request an exemption or receive their first dose of a two-dose vaccine or a single-dose vaccine by December 6, 2021. Florida unsuccessfully sought a preliminary injunction to bar the interim rule’s enforcement.The Eleventh Circuit upheld the denial of the motion, first deciding not to apply the mootness doctrine and to exercise jurisdiction despite another district court’s issuance of a nationwide injunction. Florida failed to demonstrate a substantial likelihood that it will prevail on the merits, that it will suffer irreparable injury absent an injunction, or that the balance of the equities favors an injunction. The Secretary has express statutory authority to require facilities voluntarily participating in the Medicare or Medicaid programs to meet health and safety standards to protect patients. The Secretary provided a detailed explanation for why there was good cause for dispensing with the notice-and-comment requirement. Ample evidence supports the Secretary’s determination that facility staff vaccination will provide important protection for patients. View "State of Florida v. Department of Health and Human Services" on Justia Law

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The Eighth Circuit affirmed the district court's dismissal of Regional's declaratory judgment claims alleging that defendants' procedures in suspending Regional's Medicare payments and forcing it out of business without notice, a hearing, or an opportunity to appeal violated its Fifth Amendment rights to procedural and substantive due process. The court concluded that no actual controversy exists between Regional and defendants within the meaning of the Declaratory Judgment Act. The court explained that, having abandoned any claim for damages, Regional seeks nothing more than a judicial pronouncement that its constitutional rights were violated. Therefore, the possibility of Regional re-establishing a business that is certified to receive Medicare reimbursements, again submitting documentation insufficient to meet Medicare requirements for billed services, and again having Medicare payments suspended is too conjectural or hypothetical to pose a real and immediate threat of injury sufficient to confer subject matter jurisdiction in federal court. View "Regional Home Health Care, Inc. v. Becerra" on Justia Law

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The Fifth Circuit granted the Texas Attorney General a stay pending appeal of the permanent injunction that bars him from enforcing Texas Governor Greg Abbott's Executive Order GA-38, which prohibits local governmental entities from imposing mask mandates.After determining that plaintiffs have likely failed to demonstrate standing, the court concluded that the Attorney General has demonstrated a strong likelihood of success on the merits as a matter of law. In this case, the district court lacked jurisdiction over plaintiffs' claims where plaintiffs have not exhausted their administrative remedies under the Individuals with Disabilities Education Act (IDEA). Furthermore, even if a failure to exhaust remedies does not bar plaintiffs' claims, plaintiffs likely failed to make out a prima facie case under the Americans with Disabilities Act (ADA) or the Rehabilitation Act. The court explained that, given the availability of vaccines, voluntary masking, and other possible accommodations, the record before the court likely does not support the conclusion that a mask mandate would be both necessary and obvious under the ADA or the Rehabilitation Act. The court also held that it was likely erroneous for the district court to hold that GA-38 was preempted by either the ADA or the Rehabilitation Act. To the extent that it is even properly before the court, the court did not read the American Rescue Plan Act to preempt GA-38's prohibition of local mask mandates, as the district court did. The court further concluded that, assuming plaintiffs' claims are otherwise viable, at a minimum, the district court's blanket injunction prohibiting the enforcement of GA-38 in all public schools across the State of Texas is overbroad. Finally, the court concluded that the Attorney General has demonstrated the prospect of irreparable injury absent a stay; has shown that maintaining the status quo ante pending appeal will not risk substantial injury to plaintiffs; and that the public interest favors a stay. View "E.T. v. Paxton" on Justia Law

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Teachers and school administrators challenge the denial of motions to preliminarily enjoin the enforcement of an order issued by the New York City Commissioner of Health and Mental Hygiene mandating that individuals who work in New York City schools be vaccinated against the COVID-19 virus.The Second Circuit concluded that the Vaccine Mandate does not violate the First Amendment on its face. However, the court concluded that plaintiffs have established their entitlement to preliminary relief on the narrow ground that the procedures employed to assess their religious accommodation claims were likely constitutionally infirm as applied to them. The court explained that the Accommodation Standards as applied here were neither neutral nor generally applicable to plaintiffs, and thus the court applied a strict scrutiny analysis at this stage of the proceeding. The court concluded that these procedures cannot survive strict scrutiny because denying religious accommodations based on the criteria outlined in the Accommodation Standards, such as whether an applicant can produce a letter from a religious official, is not narrowly tailored to serve the government's interest in preventing the spread of COVID-19. Accordingly, the court vacated the district court's orders denying preliminary relief and concurred with and continued the interim relief granted by the motions panel as to these fifteen individual plaintiffs. The court remanded for further proceedings. View "Kane v. De Blasio" on Justia Law

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Liver-transplant candidates and transplant hospitals challenged HHS's adoption of a new policy for allocating donated livers. In 2019, the Eleventh Circuit held that the plaintiffs had not shown a substantial likelihood of success on the merits of their claim that the Secretary failed to follow procedures under 42 C.F.R. 121.4(b) during the new liver-allocation policy's development. Section 121.4(b) does not require the Secretary to refer the new liver allocation policy to an Advisory Committee on Organ Transplantation or to publish the new policy in the Federal Register for public comment. The court remanded for the district court to consider the remaining Administrative Procedure Act and Fifth Amendment claims.The district court ordered limited discovery on remand. The defendants ultimately produced requested communications between its top-level personnel and outside policymakers that, according to the plaintiffs, exposed “bad faith and improper behavior.” The district court ultimately excluded the documents from the administrative record for the APA claim, while noting that the documents included “colorable evidence of animosity and even some measure of regional bias.” The hospitals moved to unseal the documents. In 2021, the Eleventh Circuit affirmed an order unsealing the documents. The documents here are “plainly judicial records” and the appellants have not shown good cause to keep them sealed. View "Callahan v. United Network for Organ Sharing" on Justia Law

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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

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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

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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

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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