Justia Health Law Opinion Summaries

The plaintiff, an advocacy organization representing nurse anesthetists, filed suit against the Secretary and Department of Health and Human Services (HHS) after several private insurers reduced reimbursement rates for nurse anesthetists practicing independently, compared to physician anesthesiologists. The plaintiff alleged these lower rates violated a nondiscrimination provision in the Affordable Care Act (ACA), which prohibits insurers from discriminating against healthcare providers acting within the scope of their license. The ACA assigns primary enforcement of this provision to the states, but allows HHS to intervene if a state fails to enforce it. The plaintiff sought a writ of mandamus compelling HHS to enforce the provision and also asserted a claim under the Administrative Procedure Act for agency action unlawfully withheld or unreasonably delayed.The United States District Court for the Northern District of Ohio granted HHS’s motion to dismiss, concluding that the plaintiff lacked standing. The court found the plaintiff had not adequately established that its members had suffered a cognizable injury or that any alleged injury was traceable to HHS’s conduct.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed the district court’s dismissal de novo. The Sixth Circuit determined that even if the plaintiff’s members had experienced monetary harm, they failed to show that the harm was caused by HHS’s alleged nonenforcement, as it was the insurers—not HHS—that set the reimbursement rates. The court found the causal link between government inaction and insurers’ decisions too speculative. Additionally, the court held that any relief ordered by the court would not likely redress the alleged injuries, given the discretionary nature of enforcement and uncertainty about how insurers would respond. Therefore, the Sixth Circuit affirmed the district court’s dismissal for lack of standing. View "Am. Ass'n of Nurse Anesthesiology v. Kennedy" on Justia Law

Several third-party payors who covered prescriptions for Avandia, a diabetes medication manufactured by GlaxoSmithKline LLC, brought a putative class action alleging that the company misrepresented Avandia’s cardiovascular risks and benefits. They claimed these misrepresentations led health care providers to prescribe Avandia more frequently than less expensive alternatives, causing the payors to reimburse for prescriptions that otherwise would not have been issued. The plaintiffs sought class certification on behalf of entities that paid for Avandia prescriptions during a specified period.The United States District Court for the Eastern District of Pennsylvania previously reviewed this case. It denied GlaxoSmithKline’s motion to dismiss the plaintiffs’ Racketeer Influenced and Corrupt Organizations Act (RICO) claim, and the Third Circuit affirmed that denial. Later, the District Court granted summary judgment to GlaxoSmithKline on certain claims, but the Third Circuit reversed in part and remanded for further proceedings. Most recently, the District Court granted class certification, finding the class ascertainable and concluding that common issues would predominate regarding causation. It relied on evidence of a common scheme to deceive and statistical analyses showing marketing campaigns increased prescriptions.The United States Court of Appeals for the Third Circuit reviewed the District Court’s class certification. The Third Circuit held that while the class is ascertainable, the record does not yet demonstrate that common questions predominate on causation. The court clarified that plaintiffs in pharmaceutical fraud RICO class actions may use statistical evidence to prove causation, but such evidence must establish causation, not merely correlation. Because the plaintiffs’ statistical evidence failed to satisfy this standard, the Third Circuit vacated the District Court’s class certification and remanded for further fact-finding on predominance under the clarified standard. View "In re Avandia Marketing" on Justia Law

Several pharmaceutical manufacturers participating in the federal 340B program, which requires them to provide discounted drugs to qualifying healthcare providers, proposed changing how they fulfill this obligation. Historically, these manufacturers complied by offering upfront discounts on eligible drug purchases. In 2024, they sought to implement a new rebate model, where providers would purchase drugs at full price and receive a post-purchase rebate to reach the required discounted price. The Secretary of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), responded that such rebate mechanisms had not been approved for these entities, requested further information, and stated that the manufacturers could not move forward with the new models without official approval.The manufacturers sued the Secretary in the United States District Court for the District of Columbia, arguing that the statute allowed them to unilaterally implement rebate models unless expressly disapproved by the Secretary. Advocacy groups and hospitals intervened, contending that rebate models were not permitted at all. The district court granted summary judgment for the Secretary, concluding that manufacturers could not implement such rebate systems without prior approval.Upon review, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that the statutory text of Section 340B permits rebate models but requires the Secretary to affirmatively provide for such mechanisms before manufacturers may implement them. The court found that the statute vests authority in the Secretary to determine acceptable pricing mechanisms and that manufacturers cannot act unilaterally in this regard. Because the Secretary had not approved the proposed rebate models, the court concluded that the manufacturers’ intended implementation was properly blocked. The appellate court therefore affirmed the district court’s decision in favor of the Secretary. View "Novartis Pharmaceuticals Corporation v. Kennedy" on Justia Law

Alignment Healthcare, a private health insurer offering Medicare Advantage plans, challenged the accuracy of its star ratings issued by the Centers for Medicare & Medicaid Services (CMS) for two of its contracts. The ratings are partly determined by an annual survey of enrollees, and Alignment claimed that a significant drop in Spanish-language responses resulted from errors in survey administration—specifically, that some Spanish-speaking enrollees received the survey in English despite indicating a preference for Spanish. Alignment argued that this error negatively affected its ratings, as its internal data showed higher satisfaction among Spanish-speaking enrollees.After receiving preliminary survey results in September 2024, Alignment raised these concerns with CMS, requesting a review of the sampling methodology and suppression of the disputed survey data. CMS reviewed the sampling and response data, consulted with the survey vendor, and ultimately found no evidence of a survey administration error. CMS noted that Spanish-speaking enrollees had access to Spanish-language surveys and that the rates of Spanish responses were higher than average. CMS denied Alignment’s requests for data suppression or further validation, stating it had no authority to remove the results absent evidence of protocol violations.Alignment then filed suit under the Administrative Procedure Act in the United States District Court for the District of Columbia, which granted summary judgment for CMS. On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s decision de novo. The appellate court held that Alignment failed to demonstrate that CMS’s actions were arbitrary or capricious or that survey protocols had been violated. The court found CMS’s investigation and explanation adequate, rejected Alignment’s contentions regarding unequal treatment and nondelegation, and affirmed the district court’s grant of summary judgment to CMS. View "Alignment Healthcare Inc. v. HHS" on Justia Law

A laboratory testing company, Boston Heart Diagnostics (BHD), and two rural Texas hospitals, Little River Health Care and Integrity Transitional Hospital, entered into arrangements where affiliated physicians referred blood tests to the hospitals, which then billed payors, including Medicare, at advantageous rates. The hospitals used Management Service Organizations (MSOs) as intermediaries to recruit and pay physicians, and BHD’s sales team—including several defendants—facilitated these relationships. Evidence at trial showed MSOs were used to provide kickbacks to physicians based on referral volume, disguised through sham contracts, resulting in unusually high revenues for BHD. The defendants included BHD’s CEO, vice president of sales, and sales representatives, who were involved in managing and growing these partnerships.A federal grand jury indicted eighteen individuals for conspiracy to commit illegal remunerations in violation of the Anti-Kickback Statute (AKS) and 18 U.S.C. § 371. Five defendants proceeded to a joint jury trial in the United States District Court for the Eastern District of Texas. The government presented testimony from co-conspirators and documentary evidence to show the existence of the scheme and the defendants’ knowledge and participation. The jury found all five guilty of conspiracy. The court denied post-trial motions for acquittal or a new trial, sentenced the defendants, and four of them appealed.The United States Court of Appeals for the Fifth Circuit reviewed the sufficiency of the evidence de novo and other claims under deferential standards. The court affirmed all convictions, holding that a rational jury could find beyond a reasonable doubt that the defendants knowingly and willfully joined a conspiracy to pay illegal kickbacks to induce referrals for federally insured patients. The court also held there was sufficient evidence of a federal nexus and no error in the district court’s handling of jury notes or instructional refusals. The convictions and sentences were affirmed. View "USA v. Theiler" on Justia Law

Several pharmaceutical manufacturers and a trade association challenged a Louisiana statute enacted in 2023, which prohibits drug manufacturers and distributors from interfering with the acquisition or delivery of discounted drugs—purchased under the federal Section 340B Drug Pricing Program—to pharmacies contracted by certain healthcare providers. The 340B Program requires drug manufacturers participating in Medicaid and Medicare to provide discounted outpatient drugs to designated healthcare providers serving low-income and rural populations. Many of these providers lack in-house pharmacies and use external contract pharmacies. In response to manufacturer-imposed limits on contract pharmacy use, Louisiana enacted Act 358 to preserve covered entities’ ability to use such pharmacies.The plaintiffs, including AbbVie, AstraZeneca, and the Pharmaceutical Research and Manufacturers of America, filed separate lawsuits in the United States District Court for the Western District of Louisiana against the Louisiana Attorney General, arguing that Act 358 is preempted by federal law, constitutes an unconstitutional taking, impairs contracts in violation of the Contracts Clause, and is unconstitutionally vague. The district court consolidated the cases, granted summary judgment for Louisiana and the Louisiana Primary Care Association (an intervenor), and rejected all of the manufacturers’ claims.On appeal, the United States Court of Appeals for the Fifth Circuit affirmed the district court’s judgment. The Fifth Circuit held that Act 358 is not preempted by federal law, as the federal 340B Program does not regulate drug distribution logistics or the use of contract pharmacies, and thus leaves room for state regulation. The court further concluded that Act 358 does not effect a taking under the Fifth Amendment, does not substantially impair contractual obligations under the Contracts Clause, and is not unconstitutionally vague under the Due Process Clause. The Fifth Circuit thus upheld summary judgment for Louisiana on all claims. View "AbbVie v. Murrill" on Justia Law

Brad Acy Holley, who was serving a 127-month federal sentence after pleading guilty to methamphetamine conspiracy, suffered from significant health issues, including polycystic kidney disease and end-stage renal disease requiring dialysis. Following his declining health and ongoing treatments in a federal medical facility, Holley sought compassionate release, arguing that his condition constituted an extraordinary and compelling reason for a sentence reduction. He also asserted that he was not receiving necessary specialized medical care in prison, particularly a kidney transplant, and requested appointment of counsel and an expert witness to assist with his motion.The United States District Court for the Southern District of West Virginia denied Holley’s requests, finding that his medical condition, while serious, was being adequately managed in prison and did not qualify as a terminal illness or otherwise meet the threshold for extraordinary and compelling reasons for compassionate release. The court also declined to appoint counsel or an expert, determining that neither was warranted under the circumstances. Holley appealed these decisions.The United States Court of Appeals for the Fourth Circuit reviewed the district court’s decisions for abuse of discretion. The appellate court held that the district court did not abuse its discretion in denying compassionate release, finding the court properly relied on Holley’s individualized medical records rather than generalized statistics, and reasonably concluded Holley was not suffering from a terminal illness with an end-of-life trajectory. The Fourth Circuit also held that Holley was not legally entitled to appointed counsel or an expert witness for his compassionate release motion, as there were no exceptional circumstances justifying such appointments. Accordingly, the Fourth Circuit affirmed the district court’s judgment in all respects. View "US v. Holley" on Justia Law

A pharmaceutical manufacturer participating in the federal 340B Drug Pricing Program challenged a Missouri law that prohibits manufacturers from restricting the delivery of discounted 340B drugs to contract pharmacies associated with covered entities. The manufacturer argued that its policy of limiting deliveries to only one contract pharmacy conflicted with Missouri’s statute, which requires delivery to all contract pharmacies designated by covered entities. The manufacturer sought declaratory and injunctive relief, claiming the Missouri statute violated the dormant Commerce Clause and was preempted by federal law.The United States District Court for the Western District of Missouri granted a motion to dismiss the manufacturer’s preemption claims, finding Missouri’s statute did not conflict with federal patent or drug exclusivity laws or the 340B Program, and that Eighth Circuit precedent foreclosed the field preemption argument. The court denied the motion to dismiss the dormant Commerce Clause claim, but ultimately denied the manufacturer’s motion for a preliminary injunction, concluding the manufacturer was unlikely to succeed on the merits of its claims, had not shown irreparable harm, and that the balance of equities and public interest weighed against preliminary relief.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s denial of preliminary injunction under the abuse of discretion standard. The appellate court affirmed the district court’s decision, holding that the Missouri statute regulates only in-state delivery of 340B drugs and does not impermissibly control extraterritorial commerce, discriminate against interstate commerce, or impose excessive burdens in relation to local benefits. The court also found the manufacturer’s preemption claims foreclosed by Eighth Circuit precedent and concluded the statute is neither field nor conflict preempted. The district court’s denial of preliminary injunctive relief was affirmed. View "Novartis Pharmaceuticals Corp. v. Hanaway" on Justia Law

Texas Tobacco Barn operated a laboratory and retail shop in Lubbock, Texas, manufacturing and selling e-liquids and vape products. After applying for authorization to sell over 2,200 vape products, including Barn Brewed Beetle Juice e-liquids, the FDA denied approval and warned that these products were considered “adulterated” and “misbranded.” Despite assurances from Texas Tobacco Barn that it would cease sales, a subsequent FDA inspection revealed continued sale of unauthorized products. The FDA initiated proceedings seeking a civil penalty of $19,192 for violations.The enforcement action began with an administrative hearing before an HHS administrative law judge (ALJ), who reviewed evidence including inspection photos and testimony from an FDA inspector. Texas Tobacco Barn admitted that the e-liquids lacked FDA authorization but disputed the inspector’s findings and challenged the FDA’s regulatory authority. The ALJ concluded that the FDA proved its case by a preponderance of the evidence and imposed the civil penalty. On appeal, the HHS Departmental Appeals Board affirmed the ALJ’s ruling, agreeing the ALJ lacked jurisdiction to address constitutional challenges but offering advisory comments on those defenses.Reviewing the agency’s final decision, the United States Court of Appeals for the Fifth Circuit considered Texas Tobacco Barn’s statutory and constitutional arguments. The court rejected the nondelegation challenge, citing its own precedent and Supreme Court guidance clarifying FDA’s explicit authority to regulate vape products. However, the Fifth Circuit held that the administrative process violated Texas Tobacco Barn’s Seventh Amendment right to a jury trial. The court determined that civil penalties for FDCA violations are legal in nature and do not fall under the public-rights exception that would permit agency adjudication without a jury. As a result, the Fifth Circuit granted the petition and vacated the agency’s decision. View "Texas Tobacco Barn v. HHS" on Justia Law

A private health insurer that participates in the Medicare Advantage program consolidated two of its contracts in 2024. One of the pre-existing contracts (“consumed contract”) had provided a Special Needs Plan (SNP) and received a star rating for that measure in 2023, while the other (“surviving contract”) did not. After consolidation, the insurer’s new contract offered an SNP for 2025. The Centers for Medicare and Medicaid Services (CMS) calculates star ratings for consolidated contracts by taking the enrollment-weighted mean of measure scores from the consumed and surviving contracts. Initially, CMS excluded the consumed contract’s SNP data for the 2025 star rating, but after the insurer’s request, CMS included the data, resulting in the same overall rating as before.The insurer challenged this calculation in the United States District Court for the District of Columbia, arguing that including the consumed contract’s SNP data violated the statute, regulations, and agency guidance, and that CMS failed to adequately explain a change in calculation methodology. The district court granted summary judgment in favor of CMS, finding that the agency’s actions complied with applicable law and guidance, and that no further explanation for the calculation was required.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that CMS properly applied its regulations and guidance by including the consumed contract’s SNP measure score in the calculation. The court also found that the methodology provided accurate information to beneficiaries, as required by statute, and that CMS did not make a policy change triggering a requirement for further explanation. The district court’s entry of summary judgment in favor of CMS was affirmed. View "HMO Louisiana, Inc. v. Department of Health and Human Services" on Justia Law