Justia Health Law Opinion Summaries

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

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

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

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

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

The Supreme Judicial Court remanded these consolidated cases seeking a judgment declaring the parties' respective rights to each of the remainder proceeds of two annuity contracts, holding that the cases were governed in all material respects by the Court's decision today in Dermody v. Executive office of Health & Human Servs., 491 Mass. __ (2023).In each of these cases, the Executive Office of Health and Human Services (Commonwealth) claimed entitlement to remainder proceeds of the two annuity contracts up to the amount of medical assistance paid on behalf of an institutionalized spouse, whose eligibility for Medicaid long-term care benefits was obtained through the purchase of an annuity during the relevant "look-back" period, as defined under 42 U.S.C. 1396p(c). The Supreme Judicial Court held that the Commonwealth was entitled to remainder proceeds from the annuities to the extent of benefits it paid on behalf of the institutionalized spouses in this case. View "Executive Office of Health & Human Services v. Mondor" on Justia Law

The Supreme Court dismissed this purported appeal brought by K.C. after the district court ordered an evaluation of K.C. and preparation of a plan pursuant to the Development Disabilities Court-Ordered Custody Act (DDCCA), Neb. Rev. Stat. 71-1101 to 71-1134, holding that the order was not final or appealable.The State filed a petition pursuant to the act seeking court-ordered custody and treatment for K.C., alleging that K.C. was a person with a developmental disability who posed a threat of harm to others and was in need of court-ordered custody and treatment. After a hearing, the district court issued an order adjudicating K.C. under the DDCCA. Prior to submission of any plan or dispositional hearing, K.C. filed an appeal. The Supreme Court dismissed the appeal, holding that the Court lacked jurisdiction over the appeal. View "In re Interest of K.C." on Justia Law

This case involved a Washington licensing scheme that disciplines healthcare providers for practicing conversion therapy on minors. The 9th Circuit denied a petition for rehearing en banc.Judge O'Scannlain, joined by Judges Ikuta, Nelson and Vandyke, issued a statement respecting from the court's decision to deny rehearing en banc because the decision correctly applied existing precedent. However, Judge Scannlain noted that the court should have used this case as an opportunity to resolve a circuit split and to "clarify that regulation of the medical profession is not a First-Amendment-free zone."Dissenting from the denial of rehearing en banc, Judge Bumatay wrote that because the speech underpinning conversion therapy is overwhelmingly—if not exclusively— religious, the court should have granted Plaintiff's petition for en banc review to evaluate his Free Speech claim under a more exacting standard. View "BRIAN TINGLEY V. ROBERT FERGUSON, ET AL" on Justia Law

In May 2020, Koballa died of COVID-19. Hudak, the executrix of Koballa’s estate, sued, asserting negligence and related state-law claims against Elmcroft, an assisted-living facility. Elmcroft removed the case to federal court under the general removal statute, 28 U.S.C. 1441(a), and the federal-officer removal statute, 28 U.S.C. 1442(a)(1), based on arguments it made under the Public Readiness and Emergency Preparedness Act (PREP), 42 U.S.C. 247d-6d.The district court found that the PREP Act did not provide grounds for removal under either removal statute and remanded the case to state court for lack of subject-matter jurisdiction. The Sixth Circuit affirmed. Hudak does not allege that Elmcroft engaged in willful misconduct in the administration or use of a covered COVID-19 countermeasure, so the PREP Act does not “provide[] the exclusive cause of action for the claims” and does not completely preempt Hudak’s state-law claims. Hudak’s state-law claims do not arise under federal law and could not be removed. Elmcroft is not a "federal officer"; it operated a facility that came under significant federal regulation as part of the federal government’s COVID-19 response but did not have an agreement with the federal government, did not produce a good or perform a service on behalf of the government, and has not shown that the federal government exercised control over its operations to such a degree that the government acted as Elmcroft’s superior. View "Hudak v. Elmcroft of Sagamore Hills" on Justia Law

Van Dermark served in the Navy from 1963 until his 1976 honorable discharge. The VA found Van Dermark to be totally and permanently disabled due to service-connected injuries. Van Dermark received treatment in Thailand (where he lived) at non-VA facilities, from physicians and others not affiliated with VA, in 2016 and in 2018, both times for cardiac conditions not related to his service-connected disability. For each of the two instances of treatment abroad, Van Dermark filed a claim with VA under 38 U.S.C 1728 and 1725 seeking VA payment—to him or his medical creditors—for the surgical or other heart-related treatment he received abroad.VA Community Care denied both claims. The Board of Veterans’ Appeals maintained the denials. The Veterans Court and Federal Circuit affirmed. Section 1724(a) prohibits the VA from “furnish[ing] hospital . . . care or medical services” abroad, where the care or services are unrelated to the service-connected disability. The “furnishing” phrase encompasses the payment for a veteran’s hospital care or medical expenses abroad at issue here; sections 1728 and 1725 do not override that prohibition. View "Van Dermark v. McDonough" on Justia Law