Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Ciraci v. J.M. Smucker Co.
Smucker’s is a federal contractor that supplies food items to the federal government. In 2021, by Executive Order, President Biden directed all federal contractors to “ensure that all [their] employees [were] fully vaccinated for COVID-19,” unless such employees were “legally entitled” to health or religious accommodations. The order made contractors “responsible for considering, and dispositioning, such requests for accommodations.” In September 2021, Smucker’s notified its U.S. employees that it would “ask and expect” them to “be fully vaccinated.” A month later, in the face of “deadlines in the federal order,” Smucker’s announced a formal vaccine mandate with exemptions based on “sincerely held religious beliefs.”The plaintiffs unsuccessfully sought religious exemptions, then sued Smucker's under the First Amendment's free-exercise guarantee. The Sixth Circuit affirmed the dismissal of the suit. When Smucker’s denied the exemption requests, it was not a state actor. Smucker’s does not perform a traditional, exclusive public function; it has not acted jointly with the government or entwined itself with it; and the government did not compel it to deny anyone an exemption. That Smucker’s acted in compliance with federal law and that Smucker’s served as a federal contractor, do not by themselves make the company a government actor. View "Ciraci v. J.M. Smucker Co." on Justia Law
Ascension Borgess Hospital v. Xavier Becerra
Ascension Borgess Hospital and forty-four other hospitals appeal the grant of summary judgment to the Secretary of the U.S. Department of Health and Human Services (“HHS”) dismissing challenges of certain reimbursements for uncompensated care. The Hospitals challenged the “disproportionate share hospital” (“DSH”) payments. The Provider Reimbursement Review Board (“PRRB”) dismissed the complaint for lack of jurisdiction pursuant to the statutory bar on administrative and judicial review of challenges to the methodology for calculating those payments. The Hospitals contend that HHS was required to promulgate its audit instructions by notice and comment rulemaking before using audited data from each hospital’s Worksheet S-10 to estimate the Hospitals’ proportionate shares of the national total of uncompensated care. They maintain that they do not challenge the Secretary’s estimate but seek only an order directing fulfillment of HHS’s notice and comment obligations.
The DC Circuit affirmed the grant of summary judgment to the Secretary. The court held that t the Hospitals’ framing of their challenge as purely procedural under the Medicare Act’s notice and comment requirement does not save their appeal, notwithstanding the “strong presumption in favor of judicial review of final agency action.” Even if, as the Hospitals contend, the alleged procedural violation is reviewable, the Hospitals have failed to identify any standard required to be set by rule that was not. Although neither DCH nor Florida Health addresses whether notice and comment rulemaking is required for protocols or procedures used to modify providers’ raw uncompensated care data before calculating DSH payment estimates, routine audit instructions to Medicare contractors ordinarily fall outside of section 1395hh’s rulemaking requirement. View "Ascension Borgess Hospital v. Xavier Becerra" on Justia Law
Lisa Hill Leonard, et al. v. The Alabama State Board of Pharmacy, et al.
Based in Auburn, Alabama, Plaintiff and her pharmacy were one of the thousands of businesses that answered the call to provide Covid-19 tests to the public. However, the Alabama Board of Pharmacy (the Board) concluded that Plaintiff’s administration of these tests fell short of the medical safety standards required under Alabama law. When the Board instituted an administrative enforcement proceeding against Plaintiff, she sought to avail herself of the legal immunity provided by the Secretary’s PREP Act Declaration. Plaintiff filed a federal suit, seeking to enjoin the Board from even considering the charges against her. The district court exercised its discretion to abstain under Younger v. Harris, 401 U.S. 37 (1971) and declined to intervene in the Board’s proceedings.
The Eleventh Circuit affirmed the district court’s decision to abstain under Younger. The court concluded that Plaintiff has not established that she lacks an adequate opportunity to present her federal claims to the Alabama Board of Pharmacy or an adequate opportunity to obtain judicial review of her claims in Alabama’s courts, and so Younger abstention is warranted. The court wrote that it did not decide today whether Plaintiff is immune from the Board’s charges or if they are, in fact, preempted by the PREP Act. All the court concluded is that this is not one of the “extraordinary circumstances” that would justify federal intervention in a state proceeding that is adequate to hear Plaintiff’s claims. View "Lisa Hill Leonard, et al. v. The Alabama State Board of Pharmacy, et al." on Justia Law
Shelley C. v. Commissioner of Social Security Administration
Plaintiff appealed the district court’s order affirming the Social Security Administration’s (“SSA”) denial of her application for Social Security Disability Insurance (“SSDI”). In her application, she alleged major depressive disorder (“MDD”), anxiety disorder, and attention deficit disorder (“ADHD”). Following a formal hearing, the Administrative Law Judge (“ALJ”) determined that Plaintiff suffered from severe depression with suicidal ideations, anxiety features and ADHD, but he nonetheless denied her claim based on his finding that she could perform other simple, routine jobs and was, therefore, not disabled. Plaintiff contends that the ALJ erred by (1) according to only little weight to the opinion of her long-time treating psychiatrist (“Dr. B”) and (2) disregarding her subjective complaints based on their alleged inconsistency with the objective medical evidence in the record.
The Fourth Circuit reversed and remanded with instructions to grant disability benefits. The court agreed with Plaintiff that the ALJ failed to sufficiently consider the requisite factors and record evidence by extending little weight to Dr. B’s opinion. The ALJ also erred by improperly disregarding Plaintiff’s subjective statements. Finally, the court found that the ALJ’s analysis did not account for the unique nature of the relevant mental health impairments, specifically chronic depression. The court explained that because substantial evidence in the record clearly establishes Plaintiff’s disability, remanding for a rehearing would only “delay justice.” View "Shelley C. v. Commissioner of Social Security Administration" on Justia Law
In the Matter of the Necessity for the Hospitalization of: Tonja P.
A woman who suffered from schizophrenia appealed court orders authorizing her involuntary commitment and administration of psychotropic medication. She argued the superior court erred by relying on a cursory report from the court visitor and by failing to make specific findings that involuntary medication was in her best interests. She also contended it was error to commit her to a psychiatric hospital instead of to a less restrictive facility. Finding no reversible error, the Alaska Supreme Court affirmed the superior court’s orders. View "In the Matter of the Necessity for the Hospitalization of: Tonja P." on Justia Law
Wash. Food Indus. Ass’n v. City of Seattle
Six months after United States and global health authorities declared COVID-19 a public health emergency, the city of Seattle (City) passed an ordinance (Seattle Ordinance 126094) authorizing hazard pay for certain workers who delivered food to consumers’ homes. By that time, Governor Inslee had issued stay-at-home orders requiring Washingtonians to leave home only for the most essential of trips. Among some of the conditions in the ordinance were that food delivery network companies could not reduce workers’ compensation or otherwise limit their earning capacity as a result of the ordinance, and they were prohibited from reducing the areas of the City they served or to pass on the cost of the premium pay to customers’ charges for groceries. The Washington Food Industry Association and Maplebear Inc., d/b/a Instacart, challenged the ordinance, seeking a declaration invalidating the ordinance on statutory and state and federal constitutional grounds. The trial court dismissed the statutory claim under chapter 82.84 RCW but permitted all remaining claims to proceed. After review of the limited record, the Washington Supreme Court affirmed in part and reversed in part: (1) affirming dismissal of the 82.84 RCW claim; (2) reversing dismissal of the equal protection claim; and (3) reversing the trial court’s dismissal of the privileges and immunities claim. The Court affirmed in all other respects and remanded for further proceedings. View "Wash. Food Indus. Ass'n v. City of Seattle" on Justia Law
Stone v. Alameda Health System
Under Health and Safety Code 101850, Alameda, a hospital authority was created as “a public agency for purposes of eligibility with respect to grants and other funding and loan guarantee programs.” The plaintiffs worked for Alameda and claim Alamed “automatically deducted ½ hour from each workday” to account for a meal period, although employees “were not allowed or discouraged from clocking out for meal periods.” The trial court dismissed their sis class action Labor Code claims, reasoning that Alameda was a “statutorily created public agency” beyond the reach of the Labor Code and Industrial Welfare Commission (IWC) Wage Order invoked in the complaint. The court held that a Private Attorneys General Act (PAGA) claim would not lie because Alameda is not a “person” within the meaning of section 18, there was no underlying statutory violation from which the PAGA claim could derive, and Alameda’s “public agency” status exempted it from punitive damages.The court of appeal affirmed the dismissal of the fourth claim but otherwise reversed. Alameda lacks many of the hallmarks of sovereignty. Subjecting Alameda to liability would not infringe upon any sovereign governmental powers. Alameda is not a “municipal corporation.” but is not excluded from the category of “governmental entit[ies].” There are at least some Labor Code violations for which a PAGA suit against Alameda may proceed. View "Stone v. Alameda Health System" on Justia Law
CREW v. DOJ
In 2019, the Department of Justice announced that it would resume federal executions using a new lethal agent: the drug pentobarbital. Shortly thereafter, Citizens for Responsibility and Ethics in Washington submitted a Freedom of Information Act (FOIA) request for the Bureau of Prisons’ records related to its procurement of pentobarbital. The Bureau of Prisons supplied some records but withheld any information that could identify companies in the government’s pentobarbital supply chain. The Bureau invoked FOIA Exemption 4, which protects, among other things, trade secrets and confidential commercial information. The district court sustained those withholdings and entered judgment for the Bureau.
The DC Circuit reversed. The court concluded that on de novo review that the Bureau of Prisons has not met its burden to justify the challenged nondisclosures. In particular, the Bureau has not provided the detailed and specific explanation required to justify withholding the information as “commercial” and “confidential” under Exemption 4. The court remanded to the district court to determine in the first instance whether and to what extent any information in the public domain is the basis on which the government seeks to withhold any records or reasonably segregable portions thereof under Exemption 4. View "CREW v. DOJ" on Justia Law
Health Republic Insurance Co. v. United States
The 2010 ACA (Patient Protection and Affordable Care Act; Health Care and Education Reconciliation Act) created a three-year Risk Corridors program with the creation of new health-insurance marketplaces, which presented uncertain risks for participating health-insurance companies. Qualified health-plan issuers (QHP issuers) that offered their products in the new marketplaces were entitled to payments from HHS if they suffered sufficient losses, 42 U.S.C. 18062(b).The government failed to make those payments. QHP issuers sued under the Tucker Act, 28 U.S.C. 1491(a)(1). In two such lawsuits, the Quinn law firm was lead counsel for classes of QHP issuers seeking payments. In the opt-in notices sent to potential class members with court approval, Quinn represented that it would seek attorney’s fees out of any recovery, that it would seek no more than 5% of any judgment or settlement, and that the Claims Court would determine the exact amount by considering how many issuers participated, the amount at issue, and a “lodestar cross-check” (based on hours actually worked). Meanwhile, the Supreme Court, in other cases, held that QHP issuers were entitled to collect ACA-promised payments.The Claims Court entered judgments in favor of the classes, totaling about $3.7 billion, then awarded Quinn 5% of the common funds, rejecting objections. The total fee was about $185 million. The Federal Circuit vacated. The Claims Court’s analysis was inconsistent with the class opt-in notices and did not adequately justify the extraordinarily high award. View "Health Republic Insurance Co. v. United States" on Justia Law
Sanofi Aventis US LLC v. United States Department of Health and Human Services
Drug makers participating in Medicare or Medicaid must offer their drugs at a discount to certain “covered entities,” which typically provide healthcare to low-income and rural individuals, 42 U.S.C. 256b, 1396r-8(a)(1), (5) (Section 340B). Initially, few covered entities had in-house pharmacies. A 1996 HHS guidance stated that covered entities could use one outside contract pharmacy each; a 2010 HHS guidance stated that covered entities could use an unlimited number of contract pharmacies. Drug makers thought that contract pharmacies were driving up duplicate discounting and diversion and adopted policies to limit any covered entity’s use of multiple contract pharmacies. A 2020 HHS Advisory Opinion declared that Section 340B required drug makers to deliver discounted drugs to an unlimited number of contract pharmacies.In 2010, Congress told HHS to establish a process for drug makers and covered entities to resolve Section 340B–related disputes. In 2016, HHS issued a notice of proposed rulemaking and accepted comments on the proposed ADR Rule. HHS subsequently listed the proposed rule as withdrawn. In 2020, HHS stated that it had just “paus[ed] action on the proposed rule,” responded to the four-year-old comments. and issued a final ADR Rule.Drug companies sued. The Third Circuit held that Section 340B does not require drug makers to deliver discounted drugs to an unlimited number of contract pharmacies. HHS did not violate the APA by purporting to withdraw the proposed ADR Rule before later finalizing it. View "Sanofi Aventis US LLC v. United States Department of Health and Human Services" on Justia Law