Justia Health Law Opinion Summaries

A church in Washington State challenged the validity of two state laws: the Reproductive Parity Act, which requires health insurance carriers to include coverage for all federally approved contraceptives and, if maternity care is covered, for abortions; and a longstanding conscience statute, which allows employers to object to purchasing coverage for specific healthcare services on religious or moral grounds. The church, as an employer providing health insurance to its employees, argued that these laws forced it to provide, pay for, or facilitate access to abortion and certain contraceptives in violation of its religious beliefs and right to religious autonomy.The United States District Court for the Western District of Washington found that the church had standing to sue, but granted summary judgment in favor of the state defendants on the merits, concluding that the challenged laws did not violate the Free Exercise Clause or church autonomy doctrine. Both sides appealed. Previously, the Ninth Circuit vacated the district court’s judgment for lack of standing, but after the Supreme Court’s decision in Diamond Alternative Energy, LLC v. EPA, 606 U.S. 100 (2025), it vacated its own opinion and reheard the case.The United States Court of Appeals for the Ninth Circuit held that the church had Article III standing, as the laws caused it to facilitate abortion indirectly. Assuming, without deciding, that the laws burdened the church’s religious exercise, the court concluded that the laws are neutral and generally applicable. Therefore, rational basis review applied, and the church conceded the laws met that standard. The court affirmed summary judgment for the state defendants, holding that the laws do not violate the Free Exercise Clause or the church autonomy doctrine. View "CEDAR PARK ASSEMBLY OF GOD OF KIRKLAND, WASHINGTON V. KUDERER" on Justia Law

An individual incarcerated at a California state prison suffers from a spinal condition causing severe pain and limited mobility, and also experiences incontinence. For nearly a year, prison staff provided him with adult diapers as a medical accommodation. However, after a transfer to a different housing unit, his access to these supplies was abruptly terminated, and his requests for reinstatement were denied for almost five months. During this period, he was forced to soil himself and his environment, resulting in humiliation and distress, despite repeated written and verbal requests for accommodation.He filed a lawsuit in the United States District Court for the Northern District of California, alleging violations of the Americans with Disabilities Act (ADA) and the Eighth Amendment. The district court granted summary judgment in favor of the California Department of Corrections and Rehabilitation (CDCR) and other defendants, concluding he was not entitled to relief under the ADA because it found no evidence of discrimination due to his disability and determined his claims for injunctive relief were moot once supplies were reinstated.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s summary judgment as to the ADA claim. The appellate court held that a reasonable jury could find the plaintiff is disabled under the ADA due to his spinal condition and incontinence, that he was denied meaningful access to toileting and hygiene services because of his disabilities, and that this denial was because of his disabilities. The court further found there was sufficient evidence to create a triable issue as to whether CDCR acted with deliberate indifference, a necessary element for damages. The panel also clarified that a public entity is not excused from ADA obligations merely because an accommodation is not deemed medically necessary. The case was remanded for further proceedings, including consideration of standing for injunctive relief. View "ADOM V. CALIFORNIA DEPARTMENT OF CORRECTIONS AND REHABILITATION" on Justia Law

A telehealth clinic specializing in gender-affirming care for minors, including the prescription of puberty blockers and cross-sex hormones, was served with an administrative subpoena by the U.S. Department of Justice (DOJ). The subpoena, issued under the Health Insurance Portability and Accountability Act (HIPAA), sought a broad range of documents related to the clinic’s personnel, billing practices, communications with manufacturers and pharmacies, and patient records. The DOJ’s investigation followed executive orders and internal memoranda from the administration, which had publicly articulated opposition to gender-affirming care for minors and directed DOJ to prioritize investigations into potential violations of federal health care laws, particularly the Federal Food, Drug, and Cosmetic Act (FDCA).The United States District Court for the Western District of Washington quashed the subpoena entirely, finding that it was issued for an “improper purpose”—specifically, to advance the administration’s policy goal of eliminating gender-affirming care, rather than to investigate a legitimate violation of federal law. The district court concluded that the DOJ’s actions were pretextual and that its explanations for the subpoena were inadequate. The court did not reach the clinic’s alternate arguments that the subpoena was overbroad or unduly burdensome.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s order. The Ninth Circuit held that the DOJ had statutory authority to issue the subpoena under HIPAA, had complied with procedural requirements, and that the subpoena was relevant to an authorized investigation. The court further held that the clinic had not met the heavy burden to show the subpoena was issued for an improper purpose, stating that the Executive Branch’s public opposition to gender-affirming care was insufficient to establish bad faith. The case was remanded for the district court to consider the unresolved issues of overbreadth and undue burden. View "QUEERDOC, PLLC V. DOJ" on Justia Law

A dispute arose concerning the payment rate for a surgical procedure performed at an out-of-network facility. The patient receiving the surgery was covered by an ERISA-governed health plan provided by the employer and administered by an insurance company. Prior to the surgery, the facility contacted the plan administrator to verify coverage and was told that the plan would reimburse at the usual, customary, and reasonable (“UCR”) rate, not the lower Medicare rate. Relying on this representation, the facility performed the surgery. However, the plan later paid only at the Medicare rate, far less than the full billed amount. The facility’s successor in interest, having obtained the rights to the claim, sought to recover the unpaid balance.The action was first brought in California state court, then removed to the United States District Court for the Central District of California. The plaintiff asserted both ERISA and state law claims. The district court dismissed the ERISA claim for lack of derivative standing, as the plaintiff was not properly assigned the right to sue under ERISA. The court also dismissed the state law claims for negligent misrepresentation and promissory estoppel, holding that these claims were preempted by ERISA because they related to an ERISA-covered plan.The United States Court of Appeals for the Ninth Circuit reviewed the case. It affirmed the district court’s dismissal of the promissory estoppel claim, holding that, under circuit precedent, such claims are preempted by ERISA. However, the Ninth Circuit reversed the dismissal of the negligent misrepresentation claim. The appellate court held that ERISA does not preempt a negligent misrepresentation claim by a provider’s successor in interest when the claim arises from representations made by the plan administrator during a pre-service verification call. The court concluded that such a claim does not sufficiently “relate to” an ERISA plan to trigger preemption, as it is not based on an ERISA-regulated relationship or enforceable under ERISA’s civil enforcement mechanism. The case was remanded for further proceedings on the negligent misrepresentation claim. View "HEALTHCARE ALLY MANAGEMENT OF CALIFORNIA, LLC V. WSP USA, INC." on Justia Law

A company that manufactures flavored e-liquids for use in electronic nicotine delivery systems (ENDS), including fruit and candy flavors, submitted premarket applications to the Food and Drug Administration (FDA) seeking authorization to sell 64 such products. The FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act (TCA) requires that new tobacco products be shown to be “appropriate for the protection of the public health” before they can be marketed. The FDA denied the company’s applications, citing the failure to provide robust comparative evidence demonstrating that its flavored products offer a public health benefit for adult smokers that outweighs the risks to youth, compared to tobacco-flavored ENDS.Following the FDA’s marketing denial order, the company petitioned for review in the United States Court of Appeals for the Ninth Circuit. The company argued that the FDA acted arbitrarily and capriciously by requiring comparative efficacy evidence, failed to adequately consider its marketing and sales restriction plans, and improperly denied authorization for “zero nicotine” products. It also argued that the FDA could only impose a comparative efficacy requirement through notice-and-comment rulemaking under the TCA and the Administrative Procedure Act (APA).The United States Court of Appeals for the Ninth Circuit denied the petition for review. The court held that the FDA’s denial based on the absence of comparative efficacy evidence was neither arbitrary nor capricious, especially since the applicant offered no evidence distinguishing its products’ youth risks from those of other flavored ENDS. The court also found that any error in declining to consider marketing or access restriction plans was harmless. Additionally, the court ruled that the FDA was not required to undertake notice-and-comment rulemaking before applying the comparative efficacy requirement, and the inclusion of “zero nicotine” products in the denial order was proper based on the company’s own representations. View "DRIP MORE LLC V. FDA" on Justia Law

This case involves several dialysis providers, a nonprofit organization, and individual patients challenging a California law (AB 290) aimed at regulating relationships between dialysis providers and nonprofits that assist patients with health insurance premiums. The law was enacted due to concerns that providers were donating to nonprofits to help keep patients on private insurance, which led to higher reimbursements for providers compared to public insurance. Key provisions of the law included capping provider reimbursements if they had a financial relationship with a nonprofit offering patient assistance, requiring disclosure of patients receiving such assistance, restricting nonprofits from conditioning assistance on patient treatment choices, mandating disclosure to patients of all insurance options, and a safe harbor for seeking federal advisory opinions.The United States District Court for the Central District of California granted in part and denied in part motions for summary judgment. It upheld the constitutionality of the reimbursement cap, coverage disclosure requirement, and safe harbor provision, but found the anti-steering, patient disclosure, and financial assistance restriction provisions unconstitutional. The district court also ruled that the unconstitutional parts were severable from the remainder of the statute and rejected claims that federal law preempted the state law.The United States Court of Appeals for the Ninth Circuit reviewed the case. It held that the reimbursement cap, patient disclosure requirement, and financial assistance restriction violated the First Amendment because they burdened the rights of expressive association and were not narrowly tailored to serve the state’s interests. The court found the coverage disclosure requirement constitutional under the standard for compelled commercial speech, as it required only factual, uncontroversial information reasonably related to a state interest. However, it concluded that the unconstitutional provisions were not severable from the coverage disclosure requirement. The court also held challenges to the safe harbor provision moot. The court affirmed in part, reversed in part, and each party was ordered to bear its own costs. View "DOE V. BONTA" on Justia Law

A healthcare provider operating as a covered entity under the federal Section 340B Drug Pricing Program purchased pharmaceuticals from several drug manufacturers. The provider alleged that these manufacturers engaged in a fraudulent scheme by knowingly charging prices for drugs that exceeded the statutory ceiling, resulting in inflated reimbursement claims submitted to Medicaid, Medicare, and other government-funded programs. The provider did not seek compensation for its own overcharges, but instead brought a qui tam action under the False Claims Act (FCA), seeking to recover losses on behalf of the federal and state governments.The United States District Court for the Central District of California dismissed the complaint with prejudice. It reasoned that, under the Supreme Court’s holding in Astra USA, Inc. v. Santa Clara County, Section 340B does not confer a private right of action for covered entities to sue drug manufacturers over pricing disputes; such claims must instead be pursued through the Section 340B Administrative Dispute Resolution process. The district court concluded that the provider’s FCA claims were essentially attempts to enforce Section 340B and should therefore be barred.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s dismissal. The appellate court held that the provider’s FCA claims were not barred by the absence of a private right of action under Section 340B or by the Astra decision, because the action was brought to remediate fraud against the government and not to recover personal losses or enforce Section 340B directly. The court further found that the provider had plausibly pleaded falsity under the FCA. The Ninth Circuit remanded the case for further proceedings. View "ADVENTIST HEALTH SYSTEM OF WEST V. ABBVIE INC." on Justia Law

The defendant operated two companies that provided durable medical equipment, both of which were enrolled as Medicare providers under the names of her mother and nephew. The defendant orchestrated a scheme where patient information was used to submit fraudulent claims for unnecessary medical equipment and repairs, with the assistance of other employees and marketers. Over a ten-year period, the companies submitted more than $24 million in claims, of which Medicare paid approximately $13 million.The United States District Court for the Central District of California presided over the case. The defendant was indicted and, after a second trial, convicted by a jury of conspiracy to launder monetary instruments, healthcare fraud, and aggravated identity theft under 18 U.S.C. § 1028A(a)(1), based on the use of her relatives’ names during the commission of health care fraud. The district court sentenced her to a total of 180 months in custody, including a mandatory consecutive two-year term for aggravated identity theft. The defendant appealed her convictions for aggravated identity theft.The United States Court of Appeals for the Ninth Circuit reviewed the case. The main issue on appeal was whether the use of her relatives’ names constituted aggravated identity theft under the standard clarified in Dubin v. United States, 599 U.S. 110 (2023). The Ninth Circuit held that the government failed to show that the use of the relatives’ names was “at the crux” of the fraud—meaning that the use itself was fraudulent or deceitful and critical to the scheme’s success, as required by Dubin. The court vacated the defendant’s sentence for aggravated identity theft and remanded the case to the district court for resentencing. The healthcare fraud and other convictions were not in dispute. View "USA V. MOTLEY" on Justia Law

Several individuals, representing a class, challenged a health insurance company’s refusal to cover gender-affirming care for transgender individuals diagnosed with gender dysphoria. The company, acting as a third-party administrator for employer-sponsored, self-funded health plans, denied coverage for such treatments based on explicit plan exclusions requested by the employer sponsors. Some plaintiffs also alleged that they were denied coverage for treatments that would have been covered for other diagnoses, such as precocious puberty, but were denied solely because of the concurrent diagnosis of gender dysphoria.The United States District Court for the Western District of Washington certified the class and granted summary judgment in favor of the plaintiffs. The district court rejected the company’s arguments that it was not subject to Section 1557 of the Affordable Care Act because its third-party administrator activities were not federally funded, that it was merely following employer instructions under ERISA, and that it was shielded by the Religious Freedom Restoration Act (RFRA). The district court also found that the exclusions constituted sex-based discrimination under Section 1557.On appeal, the United States Court of Appeals for the Ninth Circuit agreed with the district court that the company is subject to Section 1557, that ERISA does not require administrators to enforce unlawful plan terms, and that RFRA does not provide a defense in this context. However, the Ninth Circuit held that the district court’s analysis of sex-based discrimination was undermined by the Supreme Court’s intervening decision in United States v. Skrmetti, which clarified the application of sex discrimination standards to exclusions for gender dysphoria treatment. The Ninth Circuit vacated the summary judgment and remanded the case for further proceedings to consider whether, under Skrmetti, the exclusions at issue may still constitute unlawful discrimination, particularly in cases involving pretext or proxy discrimination or where plaintiffs had other qualifying diagnoses. View "PRITCHARD V. BLUE CROSS BLUE SHIELD OF ILLINOIS" on Justia Law

An Oregon nonprofit organization, whose board members are guided by sincerely held religious beliefs, challenged a state law requiring most employers to provide insurance coverage for abortion and contraceptive services. The organization’s governing documents and public statements reflect a commitment to traditional Judeo-Christian ethics, including opposition to abortion based on religious grounds. Although the law contains exemptions for certain religious employers, the organization does not qualify for any of these exceptions, a point not disputed by the state. The organization sought relief, arguing that being compelled to provide such coverage violates its rights under the First and Fourteenth Amendments.The United States District Court for the District of Oregon denied the organization’s request for a preliminary injunction and dismissed its complaint. The district court found there was doubt as to whether the organization’s opposition to abortion was genuinely religious in nature. It further concluded that the law was neutral and generally applicable, subject only to rational basis review, which it satisfied.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s dismissal and vacated the denial of a preliminary injunction. The Ninth Circuit held that the organization’s beliefs are religious and sincerely held, and that the district court erred by not accepting these allegations as true at the motion to dismiss stage. The appellate court remanded the case for the district court to reconsider, in light of the Supreme Court’s decision in Catholic Charities Bureau, Inc. v. Wisconsin Labor & Industry Review Commission, whether the selective denial of a religious exemption to the organization violates the First Amendment. The Ninth Circuit expressed no opinion on the ultimate constitutional question, leaving it for the district court to address in the first instance. View "OREGON RIGHT TO LIFE V. STOLFI" on Justia Law