Justia Health Law Opinion Summaries

PCMA filed suit claiming that the Employee Retirement Income Security Act of 1974 (ERISA) and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Part D), preempt two sections of the North Dakota Century Code regulating the relationship between pharmacies, pharmacy benefits managers (PBMs), and other third parties that finance personal health services. The district court determined that only one provision in the legislation was preempted by Medicare Part D and entered judgment in favor of North Dakota on the remainder of PCMA's claims.The Eighth Circuit held that it need not address the "connection with" element of the analysis because the legislation is preempted due to its impermissible "reference to" ERISA plans. In this case, the legislation is preempted because its references to "third-party payers" and "plan sponsors" impermissibly relate to ERISA benefit plans. Therefore, the court held that the North Dakota legislation is preempted because it "relates to" ERISA plans "by regulating the conduct of PBMs administering or managing pharmacy benefits." Finally, the court held that North Dakota waived its savings clause argument. Accordingly, the court affirmed in part, reversed in part, and remanded. View "Pharmaceutical Care Management Ass'n v. Tufte" on Justia Law

The Eighth Circuit granted a writ of mandamus in part and directed the district court to dissolve a Temporary Restraining Order (TRO) enjoining the State from enforcing a COVID-19-related health directive against a provider of surgical abortions. The Arkansas Department of Health (ADH) issued a directive requiring that all non-medically necessary surgeries be postponed in response to Executive Order 20-03, directing the ADH to do everything reasonably possible to respond to and recover from the COVID-19 virus.After adopting the Fifth Circuit's reasoning in In re Abbott, No. 20-50264, 2020 WL 1685929 (5th Cir. April 7, 2020), the court held that the State is entitled to mandamus relief because it has satisfied its burden in demonstrating that it has no other means to obtain the relief that it seeks, the State is clearly and indisputably entitled to the writ, and entry of the writ is appropriate under the circumstances.In Jacobson v. Massachusetts, 197 U.S. 11 (1905), the Supreme Court held that, when faced with a public health crisis, a state may implement measures that infringe on constitutional rights, subject to certain limitations. The court found that the district court's failure to apply the Jacobson framework produced a patently erroneous result. In this case, the directive bears a real and substantial relation to the State's interest in protecting public health in the face of the COVID-19 pandemic; the directive is not, beyond all question, a prohibition of pre-viability abortion in violation of the Constitution because it is a delay, not a ban, and contains emergency exceptions; and the district court clearly abused its discretion in finding that the provider is likely to prevail on its argument that the directive will likely operate as a substantial obstacle to a woman's choice to undergo an abortion in a large fraction of the cases in which the directive is relevant. The court declined to exercise its mandamus power to direct the district court to dismiss the supplemental complaint, and denied the emergency motion to stay the ex parte TRO and for a temporary administrative stay as moot. View "In Re: Leslie Rutledge" on Justia Law

Plaintiffs, health care providers and their patients, filed suit against Iowa's Department of Public Health and its Health Facilities Council, alleging that Iowa's Certificate of Need laws violate the Fourteenth Amendment's Due Process, Equal Protection, and Privileges and Immunities Clauses.The Eighth Circuit held that plaintiffs' Privileges and Immunities Clause claim was foreclosed by the Slaughter-Houses cases. Applying rational basis review to the Certificate of Need (CON) regime and capital expenditures exemption, the court held that Iowa's CON requirement is rationally related to a legitimate state interest in full-service hospital viability. Furthermore, Iowa's decision to exempt competitors who are non-hospital CON-holders is rationally related to its interest in protecting the viability of full-service hospitals. Therefore, the court affirmed the district court's orders dismissing plaintiffs' Privileges and Immunities claim and granting summary judgment in favor of the state defendants on the remaining claims. View "Birchansky v. Clabaugh" on Justia Law

Mo. Rev. Stat. Section 191.227.1 permits health care providers to charge patients who request their medical records a "search" fee when there are no responsive medical records to be found. The Eighth Circuit affirmed the district court's dismissal of the action and dismissed movants' appeal of the denial of their motion to intervene as moot. The court rejected plaintiff's claim that CIOX's practice of charging a fee for unsuccessful records searches violated the Missouri statute. View "Graham v. CIOX Health, LLC" on Justia Law

MHA filed suit challenging the part of DSH's 2017 Rule defining "costs incurred" as "costs net of third-party payments, including, but not limited to, payments by Medicare and private insurance." The Eighth Circuit reversed the district court's grant of summary judgment for MHA, holding that the statute did not delegate to the Secretary unfettered discretion to determine "costs incurred;" the terms "costs incurred" and "net of payments" have plain, unambiguous meanings; and MHA's interpretation of "costs" and "payments" was not plainly mandated by the structure of the statute. Therefore, the court held that the Secretary's interpretation was reasonable in light of the statute's purpose and design. Under Missouri's plan, the court explained that the State redistributes overpayments above a particular hospital's DSH annual limit proportionately among other DSH hospitals that are below their hospital-specific limits, redistributions that should benefit the most imperiled DSH members of the MHA. View "Missouri Hospital Assoc. v. Azar" on Justia Law

Kearney sought judicial review of the Board's decision denying its application to participate in the Medicare program. Although the facility later received approval, the initial denial prevented Kearney from participating in Medicare and receiving reimbursements for 87 days during 2014.The Eighth Circuit held that the Board failed adequately to explain the legal standard that it applied in resolving Kearney's administrative appeal. In this case, the court was unable to discern what meaning the Board attributed to 42 U.S.C. 1395x(e)(1) and the definition of "hospital." Furthermore, without an adequate explanation for what time period the agency considered in determining whether Kearney was primarily engaged in providing care to inpatients, the court was unable to resolve whether the Board's decision correctly applied the relevant legal standards. Therefore, the court reversed the district court's grant of summary judgment to the Department and remanded with directions. View "Kearney Regional Medical Center, LLC v. US Department of Health and Human Services" on Justia Law

The Eighth Circuit denied Wal-Mart's petition for review of OSHA's citation for two purported violations of the Occupational Safety and Health Act's regulation relating to bloodborne pathogens. OSHA alleged that Wal-Mart failed to comply with regulations pertaining to providing hepatitis B vaccinations to employees who voluntarily served on a Serious Injury Response Team (SIRT) at Wal-Mart's Alachua, Florida, distribution center.The court held that substantial evidence supported the ALJ's finding that the collateral duty exception did not apply in part because SIRT employees did not respond to workplace injuries "generally at the location where the incident occurred" as subparagraph b. of the Occupational Exposure to Bloodborne Pathogens Enforcement Procedures required. The court also held that substantial evidence supported the ALJ's decision to uphold Citation One where Wal-Mart did not provide four SIRT members with the third dose of the vaccine. Furthermore, substantial evidence supported the ALJ's decision to uphold Citation Two, and the ALJ did not err by finding that Citation Two was a repeat violation, where Wal-Mart failed to articulate through record evidence how the failure to offer the hepatitis B vaccine to the SIRT employees resulted in a different hazard than occurred from the failure to offer the vaccine to the retail store employees in 2012. View "Wal-Mart Stores East, LP v. Acosta" on Justia Law

Hospitals challenged the method the Secretary used to calculate the volume-decrease adjustment (VDA) for certain fiscal years during the mid-2000s, as well as the Administrator's classification of certain costs as variable costs when calculating the adjustment.The Eighth Circuit affirmed the district court's decision to uphold the Secretary's actions and held that the Secretary's interpretation of the relevant regulations was a reasonable interpretation of the plain language of the Medicare statute. Given the lack of guidance in the statute and the substantial deference the court affords to the agency, the Secretary's decision reasonably complied with the mandate to provide full compensation. That the Secretary has prospectively adopted a new interpretation was not a sufficient reason to find the Secretary's prior interpretation arbitrary or capricious. The court also held that the Secretary's interpretation of the relevant regulations in these cases was clearly consistent with their text, and the costs at issue were reasonably classified as variable costs. View "Unity HealthCare v. Azar" on Justia Law

The Eighth Circuit affirmed the district court's partial grant of summary judgment for Children's Hospitals and decision to vacate a Medicaid policy, Frequently Asked Question 33, which explained how to calculate a hospital's uncompensated medical care costs. The court held that by imposing new reporting requirements for private insurance payments, Question 33 expanded the footprint of 42 C.F.R. 447.299 and thus constituted a substantive change in the regulation. The court explained that section 447.299 has specific language explicitly stating what payments must be deducted from each hospital's "total cost of care," and the Secretary's own definition of "uncompensated care costs" did not include private insurance payments. The court declined to read substantive changes into the regulation under the guise of interpretation. Furthermore, the court joined the First and Fourth Circuits in concluding that Question 33 was a legislative rule that was not adopted in accordance with the procedure required by law and thus must be set aside, notwithstanding the Secretary's policy arguments to the contrary. View "Children's Health Care v. Centers for Medicare and Medicaid Services" on Justia Law

The 2013 Public Employment Labor Relations Act (PELRA) did not infringe on the First Amendment rights of a group of parents who provide home care services to their disabled children. PELRA applied to persons who provide in-home care to disabled Medicaid recipients, and authorized covered employees to organize and to designate by majority vote an exclusive representative to negotiate employment terms with the state. The parents complained that the Act unconstitutionally compelled them to associate with the exclusive negotiating representative.Determining that the parents had Article III standing, the Eighth Circuit affirmed the district court's judgment and held that, under Minnesota State Board for Community Colleges v. Knight, the current version of PELRA allowed the homecare providers to form their own advocacy groups independent of the exclusive representative, and it did not require any provider to join the union. Therefore, the state did not impinge on the parents' right not to associate by recognizing an exclusive negotiating representative. View "Bierman v. Dayton" on Justia Law