Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Agudath Israel of America v. Cuomo
The Second Circuit originally resolved the motions that are the subject of this opinion in an order entered November 9, 2020. Except in unusual circumstances, the court resolves such motions by order, not opinion. The court converted the original order and the dissent into opinions per the dissent's request.These appeals challenge Governor Andrew Cuomo's issuance of an executive order directing the New York State Department of Health to identify yellow, orange, and red "zones" based on the severity of COVID-19 outbreaks and imposing correspondingly severe restrictions on activity within each zone. Appellants, Agudath Israel and the Diocese, each challenged the executive order as a violation of the Free Exercise Clause of the First Amendment. After the district court denied appellants' motion for a preliminary injunction against enforcement of the order, appellants moved for emergency injunctions pending appeal and to expedite their appeals.Preliminarily, the Second Circuit concluded that Agudath Israel did not move first in the district court for an order granting an injunction while an appeal is pending before filing with this court its present motion for an injunction pending appeal. Rather, Agudath Israel moved for a preliminary injunction pending the district court’s final judgment. Furthermore, Agudath Israel has not explained or otherwise justified its failure to comply with the straightforward requirement of Federal Rule of Appellate Procedure 8(a). Agudath Israel has also failed to demonstrate that moving first in the district court would be impracticable, or even futile, particularly in light of the fact that a full eleven days elapsed after the district court's ruling before Agudath Israel sought relief from this court. Therefore, the court denied Agudath Israel's motion for procedural reasons.The court also denied the Diocese's motion, concluding that appellants cannot clear the high bar necessary to obtain an injunction pending appeal. The court stated that, while it is true that the challenged order burdens appellants' religious practices, the order is not substantially underinclusive given its greater or equal impact on schools, restaurants, and comparable secular public gatherings. To the contrary, the executive order extends well beyond isolated groups of religious adherents to encompass both secular and religious conduct. View "Agudath Israel of America v. Cuomo" on Justia Law
Bethesda Health, Inc. v. Azar
Hospitals, in calculating their Medicaid fractions -- the proportion of treatment a hospital provided to Medicaid patients -- sought to include days of care funded by Florida's Low Income Pool, an approved Medicaid demonstration project. The Secretary refused to allow the Hospitals to include these patients in their Medicaid fraction, on the ground that the patients were treated out of charity rather than as designated beneficiaries of a demonstration project.The DC Circuit affirmed the district court's judgment in favor of the Hospitals, and agreed with the district court that the Secretary's own regulation states that, for the purposes of calculating the Medicaid fraction, "hospitals may include all days attributable to populations eligible for [Medicaid] matching payments through a [demonstration project]" so long as the services provided under the demonstration project include "inpatient hospital services." In this case, it was "obvious to the [c]ourt that uninsured and underinsured patients received inpatient hospital services" through the Low Income Pool, because (1) the Secretary authorized federal matching funds to reimburse hospitals for these services, and (2) the hospitals rigorously documented the services provided using funds from the Pool. Furthermore, the Fifth Circuit's opinion in Forrest Gen. Hosp. v. Azar, 926 F.3d 221 (2019), supported this conclusion. View "Bethesda Health, Inc. v. Azar" on Justia Law
Baker v. USD 229 Blue Valley
Plaintiff-appellant Terri Baker appealed the dismissal of this putative class action for lack of standing. She sued on behalf of herself and her son, S.F.B., to challenge Kansas laws and school district policies that: (1) required children to be vaccinated to attend school and participate in child care programs; and (2) provided a religious exemption from these requirements. She claimed these immunization laws and policies violated various federal and state constitutional provisions and statutes. Baker argued she and S.F.B. had standing because the immunization requirements and religious exemptions injured them in two ways: (1) the District misapplied Kansas law when it granted a religious exemption for S.F.B. to attend preschool despite being unvaccinated - her fear that the District would revoke S.F.B.'s religious exemption was an injury in fact that established standing; and (2) Baker "would like the option" of placing S.F.B. in a non-accredited private school (i.e., home school), school programs, or licensed child care - she contended Kansas law inhibited her from exercising these options and caused an injury in fact because she would be unable to secure a religious exemption for S.F.B. if she tried. Finding no reversible error in the district court's dismissal, the Tenth Circuit affirmed. View "Baker v. USD 229 Blue Valley" on Justia Law
Waskul v. Washtenaw County Community Mental Health
Community Mental Health modified the methodology through which it allocated funding to individuals with disabilities receiving community living support services under a Medicaid waiver received by Michigan. Individuals receiving those services, together Advocacy, challenged that methodology as violating the Medicaid Act, 42 U.S.C. 1396a(a)(8), (a)(10)(A), (a)(10)(B), 1396n(c)(2)(A) and (C); Title II of the Americans with Disabilities Act (ADA), 42 U.S.C. 12132; section 504 of the Rehabilitation Act, 29 U.S.C. 794; the Michigan Mental Health Code; and the terms of Michigan’s Medicaid Habilitation Supports Waiver and the contracts implementing it. The district court dismissed the claims in full.The Sixth Circuit reversed, first holding that the plaintiffs have standing, that the defendants are not entitled to Eleventh Amendment immunity, that the plaintiffs were not required to exhaust their administrative remedies provided by the state under the Medicaid Act, and that the plaintiffs have a private right of action under sections 1396a(a)(8) and (a)(10). The plaintiffs’ allegations suffice to state plausible claims that they are being denied sufficient necessary medical services; that feasible alternatives that provide them a meaningful choice between institutionalized and at-home or community-based care exist and are not being ensured; and that they face a serious risk of institutionalization. View "Waskul v. Washtenaw County Community Mental Health" on Justia Law
Sensory NeuroStimulation, Inc. v. Azar
The Ninth Circuit affirmed the district court's dismissal based on lack of jurisdiction of an action brought by Sensory NueroStimulation, a medical device supplier, seeking Medicare coverage of its product. The panel held that the district court correctly held that 42 U.S.C. 405(h)'s administrative channeling requirement applied and that it therefore had no subject matter jurisdiction to hear Sensory's claims. In this case, the lawsuit is subject to Medicare's administrative channeling requirements; Sensory has not met those requirements; there exists a way to satisfy those requirements; and these conclusions do not completely preclude judicial review so as to trigger a key exception to the channeling requirements. View "Sensory NeuroStimulation, Inc. v. Azar" on Justia Law
Dierlam v. Trump
Plaintiff filed suit challenging the Affordable Care Act (ACA), seeking retrospective and prospective relief for myriad alleged violations of the United States Constitution and the Religious Freedom Restoration Act. The Fifth Circuit declined to reach the merits of plaintiff's claims. The court held that, given the altered legal landscape and the potential effects of plaintiff's request for prospective relief, a mootness analysis must precede the merits. In this case, a year after plaintiff filed his lawsuit, Congress passed and President Trump signed the Tax Cut and Jobs Act, which reduced the shared responsibility payment (imposed on individuals who fail to purchase health insurance) to $0. In the same year, the Department of Health and Human Services created new exemptions to the contraceptive mandate, including an exemption for individuals like plaintiff. These exemptions were enjoined until the Supreme Court's recent decision in Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania. Therefore, the court vacated the district court's dismissal of plaintiff's claims and remanded for the district court to conduct a mootness analysis in the first instance. The court also remanded to allow plaintiff to amend his complaint where the parties agreed that the district court incorrectly dismissed plaintiff's claim for retrospective relief. View "Dierlam v. Trump" on Justia Law
Nasello v. Eagleson
Most people eligible for Medicaid benefits are “categorically needy” because their income falls below a threshold of eligibility. People with higher income but steep medical expenses are “medically needy” once they spend enough of their own assets to qualify, 42 U.S.C. 1396a(a)(10). Plaintiffs contend that medical expenses they incurred before being classified as “medically needy” should be treated as money spent on medical care, whether or not those bills have been paid, which would increase Illinois's payments for their ongoing care.The Seventh Circuit affirmed the dismissal of their suit. Medicaid is a cooperative program through which the federal government reimburses certain expenses of states that abide by the program’s rules. Medicaid does not establish anyone’s entitlement to receive particular payments. The federal-state agreement is not enforceable by potential beneficiaries. Plaintiffs bypassed their administrative remedies and do not have a judicial remedy under 1396a(r)(1)(A). Section 1396a(a)(8) provides that a state’s plan must provide that all individuals wishing to apply for medical assistance under Medicaid shall have the opportunity to do so and that assistance shall be furnished with reasonable promptness to all eligible individuals; some courts have held that this requirement can be enforced in private suits. If such a claim were available, it would fail. Plaintiffs are receiving benefits. The court also rejected claims under the Americans with Disabilities Act, 42 U.S.C. 12131–34, and the Rehabilitation Act, 29 U.S.C. 794. Plaintiffs receive more governmental aid than nondisabled persons. View "Nasello v. Eagleson" on Justia Law
Vapor Technology Association v. United States Food and Drug Administration
The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) allows the FDA to regulate tobacco products. Tobacco products that were not on the market in February 2007 or that were modified after that date must obtain premarket authorization. The 2016 “Deeming Rule” subjected cigars, pipe tobacco, and electronic nicotine delivery systems to the TCA; about 25,000 existing products became subject to 21 U.S.C. 387j(a). The FDA planned to stagger compliance periods for deemed tobacco products.In 2018, public health organizations challenged FDA “guidance” issued under the TCA. The Maryland district court granted them summary judgment. Compliance deadlines had passed but the court concluded that it could impose a deadline because the case presented extraordinary circumstances. The court ordered the FDA to require that premarket applications be filed within 10 months (May 2020) but declined to require enforcement actions. The FDA issued new guidance in January 2020, stating that it intended to prioritize enforcement of the premarket-review requirements for e-cigarettes beginning in May 2020. Before the Fourth Circuit ruled, the district court amended its injunction, in light of the pandemic, to require that applications be submitted by September 2020. The FDA revised its guidance accordingly. The Fourth Circuit dismissed the appeal.An e-cigarette trade organization sought a declaration that FDA’s deadline was unlawful agency action under the APA in the Eastern District of Kentucky, arguing the FDA’s brief and an attached declaration motivated the Maryland court to impose that deadline, which significantly accelerated the original FDA deadline. The Sixth Circuit affirmed that the plaintiffs lacked standing. The Maryland court’s injunction was independent of the FDA’s brief and declaration; the allegedly unauthorized court submissions do not form a plausible legal basis for an injunction against subsequent, independently-caused FDA enforcement proceedings. View "Vapor Technology Association v. United States Food and Drug Administration" on Justia Law
Premier Health Care Investments, LLC v. UHS of Anchor, LP
In 2005, the Georgia Department of Community Health (Department) promulgated a rule, commonly known as the “Psychiatric Rule” (“the Rule”), that required hospitals to obtain a Certificate of Need (“CON”) “prior to the establishment of a new or the expansion of an existing acute care adult psychiatric and/or substance abuse inpatient program,” and defined “expansion” as “the addition of beds to an existing CON-authorized or grandfathered psychiatric and/or substance abuse inpatient program.” The issue this case presented for the Georgia Supreme Court's review centered on whether the Department could, through the Rule, require a licensed hospital with a psychiatric/substance-abuse program authorized by a CON, to obtain an additional CON to redistribute inpatient beds in excess of those identified in its CON to operate a psychiatric/substance-abuse program, but within its total licensed bed capacity. In UHS of Anchor, L.P. v. Department of Community Health, 830 SE2d 413 (2019), the Court of Appeals held that the Department could. The Supreme Court determined the appellate court erred in that conclusion, and reversed. "The General Assembly’s delegation of legislative authority to the Department to promulgate rules as part of its administration of the CON program does not include the authority to define additional new institutional health services requiring a CON, beyond those listed in OCGA 31-6-40 (a)." View "Premier Health Care Investments, LLC v. UHS of Anchor, LP" on Justia Law
In re ACTD LLC, d/b/a The Green Mountain Surgery Center
During the certificate of need (CON) application process, applicant ACTD, LLC (operator of the Green Mountain Surgery Center (GMSC), a for-profit multi-specialty ambulatory surgery center), indicated that it initially planned to offer surgical services in five identified specialties. After the CON was issued, applicant notified the Board that in addition to these five specialties, it planned to offer plastic surgery and ophthalmology procedures. The Board chose to review these changes and, after hearing, issued a decision clarifying that the original CON was limited in scope to the five specialties applicant had identified in its application, and that the proposed addition of plastic surgery and ophthalmology procedures was a nonmaterial change to the project. The Board concluded that applicant had demonstrated a need for greater access to plastic surgery and ophthalmology procedures currently performed in a hospital setting and approved the addition of these services. However, it rejected applicant’s proposal to offer ophthalmology procedures already available at another ambulatory surgery center nearby. The Board also extended applicant’s implementation reporting period for two additional years. Applicant argued on appeal of the Board's decision that the Board improperly restricted the scope of the CON and lacked the power to extend the reporting requirement. Finding that the Board acted within its authority, the Vermont Supreme Court affirmed its decision. View "In re ACTD LLC, d/b/a The Green Mountain Surgery Center" on Justia Law