Justia Government & Administrative Law Opinion Summaries

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

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

This case arose out of a qui tam action against Prime Healthcare Services—Encino Hospital, LLC (Encino Hospital) and others to impose civil penalties for violation of the Insurance Fraud Prevention Act (IFPA), Insurance Code section 1871 et seq. The State of California and relator (Plaintiffs) appealed from a judgment entered after a bench trial in which the court found insufficient evidence to support their allegations that Defendants engaged in insurance fraud by billing insurers for services performed in a detox center for which they had no appropriate license, and by employing a referral agency to steer patients to the center.   The Second Appellate District affirmed the judgment. The court explained that, CDI alleged that Encino Hospital misrepresented to insurers that it was properly licensed to provide detox services when it was not. The trial court found no evidence suggesting that Defendants presented a false claim to any insurer. The court agreed, reasoning that no authority of which it is aware or to which it has been directed obligates Encino Hospital to hold any license other than its license as a general acute care hospital. Because Encino Hospital needed no separate license or approval, and no evidence showed it concealed any provider, the CDI’s cause of action for false claims failed for lack of a predicate. View "State of Cal. v. Encino Hospital Medical Center" on Justia Law

Plaintiff Lancaster Hospital Corporation (Lancaster) operates an inpatient rehabilitation facility that provides services for Medicare beneficiaries. The Department of Health and Human Services (HHS) denied Plaintiff’s request for reimbursement because the provider failed to submit information in a form that could be audited. The district court granted summary judgment to HHS.   The Fourth Circuit affirmed. The court explained that Lancaster asserts that—even if some reductions were warranted—the Board erred by denying its entire 1997 reimbursement request. There appears no doubt Lancaster provided services to Medicare beneficiaries in 1997, and denying all reimbursement for that year may seem harsh. But the principle that people “must turn square corners when they deal with the Government” “has its greatest force when a private party seeks to spend the Government’s money.” However, the court explained that under Heckler v. Community Health Servs. of Crawford Cnty., Inc., “As a participant in the Medicare program,” Lancaster “had a duty to familiarize itself with the legal requirements for cost reimbursement,” including the need to provide cost data in a form “capable of being audited.” Thus, the Board’s decision to deny reimbursement for the fiscal year 1997 was neither arbitrary nor capricious and was supported by substantial evidence. View "Lancaster Hospital Corporation v. Xavier Becerra" on Justia Law

The 1949 Federal Property and Administrative Services Act concerns the purchase of goods and services on behalf of the federal government, 40 U.S.C. 101. In November 2021, the Safer Federal Workforce Task Force, citing the Act, issued a “Guidance” mandating that employees of federal contractors in covered contracts with the federal government become fully vaccinated against COVID-19. Ohio, Kentucky, and Tennessee and Ohio sheriffs’ offices challenged the mandate. The district court enjoined its enforcement in the three states and denied the government’s request to stay the injunction pending appeal.The Sixth Circuit denied relief in January 2022 and, a year later, affirmed. The Property Act does not authorize the President to issue directives that simply “improve the efficiency of contractors and subcontractors.” The plaintiffs are likely to succeed in showing that the President exceeded his authority in issuing the mandate. The plaintiffs are likely to lose valuable government contracts and incur unrecoverable compliance costs if the mandate is not enjoined. The public interest “lies in a correct application” of the law. Because an injunction limited to the parties can adequately protect the plaintiffs’ interests while the case is pending, the district court abused its discretion in extending the preliminary injunction’s protection to non-party contractors in the plaintiff states. View "Commonwealth of Kentucky v. Biden" on Justia Law

The Washington State Health Care Authority (“HCA”) and the Swinomish Indian Tribal Community petition for review of a Center for Medicare and Medicaid Services (“CMS”) decision denying Washington’s request to amend Apple Health, the Washington State Medicaid plan (the “State Plan”). HCA petitioned CMS to amend the State Plan to include dental health aide therapists (“DHATs”) on the list of licensed providers who can be reimbursed through Medicaid. CMS rejected the Amended State Plan on the basis that it violates the Medicaid free choice of providers statute and regulation guaranteeing all Medicaid beneficiaries equal access to qualified healthcare professionals willing to treat them. Petitioners challenged this denial.   The Ninth Circuit granted the petition of review. The panel rejected CMS’s reasoning on the ground that the underlying Washington statute—Wash. Rev. Code Section 70.350.020—did not violate Section 1396(a)(23) because it merely authorized where and how DHATs can practice and did not in any way restrict Medicaid recipients’ ability to obtain service from DHATs relative to non-Medicaid recipients. CMS’s rejection of the Amended State Plan was “not in accordance with law.” 5 U.S.C. Section 706(2)(A). Accordingly, the panel granted the petition for review and remanded to the agency with instructions to approve the Amended State Plan. View "WASHINGTON STATE HEALTH CARE A, ET AL V. CENTERS FOR MEDICARE & MEDICAI, ET AL" on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

The issue this case presented for the Idaho Supreme Court's review centered on whether the Idaho Constitution protects abortion from the legislature's broad power to enact laws concerning the public’s health, welfare, and safety. Planned Parenthood Great Northwest, Hawaii, Alaska, Indiana, Kentucky, and Caitlin Gustafson, M.D., on behalf of herself and her patients (collectively “Petitioners”), brought three petitions, each seeking a writ of prohibition and declaratory relief blocking implementation and enforcement of recently enacted laws in Idaho. Petitioners also raised various facial challenges, claiming these laws offend important constitutional principles, such as equal protection, due process, the special laws provision, the separation of powers doctrine, and purported “informational privacy” protections under the Idaho Constitution. Petitioners further claimed that the Idaho Human Rights Act limited the legislature’s ability to regulate abortion through the Total Abortion Ban and 6-Week Ban. After careful consideration of the issued raised, the Idaho Supreme Court denied Petitioners’ requests for extraordinary writs of prohibition and declaratory relief. View "Planned Parenthood Great Northwest, et al. v. Idaho" on Justia Law

An elementary school nurse who unsuccessfully attempted to save the life of a choking child sought workers’ compensation benefits for mental health problems she attributed to the incident. She argued that she suffered post-traumatic stress disorder (PTSD) due to exposure to the child’s bodily fluids and resulting risk of disease and to the mental stress of the incident. The Alaska Workers’ Compensation Board denied her claims, concluding that her exposure to bodily fluids was not a sufficient physical injury to trigger a presumption of compensability and that the mental stress of the incident was not sufficiently extraordinary or unusual to merit compensation. The Board was most persuaded by the opinion of the employer’s medical expert that the nurse’s mental health problems were the result of a pre-existing mental health condition and were not caused by the incident. The Alaska Workers’ Compensation Appeals Commission affirmed. After review, the Alaska Supreme Court found: (1) the Board failed to recognize the link between exposure to bodily fluids and mental distress over the risk of serious disease, which under Alaska precedent was enough to establish a presumption that the mental distress is compensable; and (2) the Board failed to consider the particular details of the child’s death and the nurse’s involvement when it concluded as a general matter that the stress of responding to a choking incident at school was not sufficiently extraordinary to merit compensation for mental injury. However, because the Board found in the alternative that the incident was not the cause of the nurse’s mental health problems, and because both the Commission and the Alaska Supreme Court had to respect the Board’s credibility determinations and the weight it gave conflicting evidence, the denial of benefits was affirmed. View "Patterson v. Matanuska-Susitna Borough School District" on Justia Law