Justia Health Law Opinion Summaries

Terri R. Winnon, a former executive assistant and controller for a group of skilled nursing facilities (SNFs) in Texas, alleged that her former employers and associated entities engaged in fraudulent schemes to obtain improper reimbursements from Medicare and Texas Medicaid. She claimed that the defendants paid unlawful kickbacks to doctors and hospital discharge planners for patient referrals and inflated therapy service bills to maximize government reimbursements. Winnon’s allegations included specific practices such as employee bonuses tied to Medicare census targets, “sham” medical directorships, and “marketing gifts” to hospital staff, as well as systematic upcoding of therapy services by a contracted provider, RehabCare.After Winnon filed her qui tam action under the False Claims Act (FCA) and related Texas statutes, the United States District Court for the District of Columbia dismissed her claims. The court found that her allegations against RehabCare were barred by the FCA’s public disclosure provision, as similar claims had already been made public in a prior lawsuit, United States ex rel. Halpin & Fahey v. Kindred Healthcare, Inc. The district court also determined that Winnon’s claims against the SNF Defendants did not meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b), as they lacked sufficient particularity regarding the alleged fraudulent conduct.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s dismissals. The appellate court held that Winnon’s claims against RehabCare were precluded by the public disclosure bar because her allegations were substantially similar to those previously disclosed and she did not qualify as an “original source” under the FCA. Regarding the SNF Defendants, the court concluded that Winnon’s allegations failed to satisfy Rule 9(b)’s requirement for particularity, as she did not provide enough specific details to support a strong inference that false claims were actually submitted. The court affirmed the district court’s judgments in full. View "USA v. Lozano" on Justia Law

Arkansas enacted a law in 2021 that prohibits healthcare professionals from providing or referring minors for gender transition procedures, which include certain medical and surgical interventions intended to alter a minor’s physical characteristics to those of a different sex. Four minors, their parents, and two healthcare professionals challenged the law, arguing it violated their constitutional rights. The law was passed over the governor’s veto and defined violations as unprofessional conduct subject to disciplinary action.The United States District Court for the Eastern District of Arkansas initially granted a preliminary injunction, and a panel of the Eighth Circuit affirmed, finding a likelihood of success on the Equal Protection claim. After a bench trial, the district court permanently enjoined enforcement of the law, holding that it violated the Equal Protection Clause, the Due Process Clause, and the First Amendment.The United States Court of Appeals for the Eighth Circuit, sitting en banc, reversed the district court’s decision. The appellate court held that the law does not classify based on sex or transgender status, but rather on age and medical procedure, and is therefore subject to rational basis review. The court found that the state’s interest in protecting the health and safety of minors provided a rational basis for the law. The court also concluded that there is no deeply rooted constitutional right for parents to obtain gender transition procedures for their children over a state prohibition. Regarding the First Amendment, the court determined that the law’s restriction on referrals regulates professional conduct with only incidental effects on speech and survives intermediate scrutiny. The permanent injunction was reversed and the case remanded. View "Brandt v. Griffin" on Justia Law

Two children, E.R. and G.S., have severe, complex medical conditions that require constant, skilled care. Their mothers, who are their primary caregivers and sole financial supporters, have been trained by medical professionals to provide the necessary care at home. For years, Indiana’s Medicaid program reimbursed these mothers for providing “attendant care services” under a waiver program designed to keep individuals out of institutions. In July 2024, the Indiana Family and Social Services Administration (FSSA) implemented a policy change that would make parents ineligible to be paid providers of attendant care for their children, threatening to force E.R. and G.S. into institutional care due to the lack of available in-home nurses.The Indiana Protection and Advocacy Services Commission, along with E.R. and G.S., sued to block the policy change and require FSSA to secure in-home nursing. The United States District Court for the Southern District of Indiana initially granted a preliminary injunction requiring FSSA to take steps to obtain in-home nurses and to pay the mothers for a different, lower-paid service. After further proceedings, the court modified its order, ultimately requiring FSSA to pay the mothers for attendant care at the previous rate until in-home nursing could be secured.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s October 1 injunction. The court held that the plaintiffs are likely to succeed on their claims under the Americans with Disabilities Act’s integration mandate, which requires states to provide services in the most integrated setting appropriate. The court found that prohibiting the mothers from providing paid attendant care placed the children at serious risk of institutionalization and that FSSA had not shown that allowing such care would fundamentally alter the Medicaid program or violate federal law. The case was remanded for further proceedings. View "Indiana Protection and Advocacy Services Comm'n v Indiana Family and Social Services Administration" on Justia Law

An employee of the Department of Veterans Affairs began experiencing respiratory issues at work, which she attributed to the building environment. Over several years, she requested various accommodations, including changes to her work schedule, relocation of her workstation, and the use of air purifiers. The Department provided some accommodations, but the employee found them ineffective. In 2012, she was diagnosed with breast cancer and submitted a Family and Medical Leave Act (FMLA) form to request leave for treatment. Later, she learned that a union steward had been informed of her cancer diagnosis by a human resources manager, which she had not expected. After returning to work, she continued to request further accommodations, eventually being allowed to work from home full-time.The United States District Court for the Middle District of Florida granted summary judgment in favor of the Department on all claims, including disability discrimination, failure to accommodate, unlawful disclosure of medical information, and retaliation or hostile work environment. The court found that the Department had provided reasonable accommodations, that there was no evidence of discrimination or retaliation, and that the employee had not shown a tangible injury from the alleged disclosure of her medical information.On appeal, the United States Court of Appeals for the Eleventh Circuit affirmed the district court’s summary judgment on the claims of disability discrimination, failure to accommodate, retaliation, and hostile work environment. The appellate court agreed that the Department had made reasonable efforts to accommodate the employee and that her dissatisfaction with the accommodations did not amount to a legal violation. However, the Eleventh Circuit reversed the summary judgment on the unlawful disclosure claim, holding that requiring medical information for FMLA leave constituted an employer inquiry under the Rehabilitation Act, and that there were genuine issues of fact as to whether confidential medical information was improperly disclosed and whether the employee suffered a tangible injury as a result. The case was remanded for further proceedings on the unlawful disclosure claim. View "Mullin v. Secretary, Department of Veterans Affairs" on Justia Law

A pharmaceutical company challenged the federal government’s implementation of a new program created by the Inflation Reduction Act of 2022, which authorizes the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain high-expenditure prescription drugs under Medicare. The company’s drug was selected for the program, and it signed an agreement to participate “under protest” while filing suit. The company alleged that the program violated its constitutional rights under the First, Fifth, and Eighth Amendments, and that CMS failed to follow required notice-and-comment procedures under the Administrative Procedure Act (APA) when issuing the standard agreement for participation.The United States District Court for the District of Connecticut granted summary judgment to the government on all claims. The district court found that participation in the program was voluntary, so there was no unlawful deprivation of rights. It also held that the program did not impose unconstitutional conditions on participation in Medicare and Medicaid, and that the Inflation Reduction Act expressly allowed CMS to implement the program for its first three years without notice-and-comment rulemaking.The United States Court of Appeals for the Second Circuit reviewed the case and affirmed the district court’s judgment. The Second Circuit held that, under its precedent in Garelick v. Sullivan, participation in the Medicare Drug Price Negotiation Program is voluntary, and thus the program does not effect a taking, deprive the company of property without due process, or compel speech in violation of the First Amendment. The court further held that the program does not impose unconstitutional conditions because it is designed to control Medicare spending and does not regulate the company’s private market conduct. Finally, the court concluded that the Inflation Reduction Act expressly exempted CMS from the APA’s notice-and-comment requirement for the program’s initial years. View "Boehringer Ingelheim Pharms., Inc. v. Dep't of Health & Hum. Servs." on Justia Law

A Chinese manufacturer of electronic nicotine delivery systems (ENDS) sought authorization from the Food and Drug Administration (FDA) to market its refillable e-cigarette device in the United States. The device, sold without e-liquid, allows consumers to use a wide range of nicotine concentrations. The manufacturer submitted a premarket tobacco product application (PMTA) in August 2020, asserting that its product was appropriate for the protection of public health. After a preliminary assessment, the FDA identified deficiencies in the application and issued a deficiency letter in March 2023, requesting additional information. The manufacturer responded to some, but not all, of the deficiencies and requested an extension, which the FDA later denied. In January 2024, the FDA issued a final order denying the application, citing insufficient data to evaluate the product’s risks and benefits.The United States Court of Appeals for the Fifth Circuit reviewed the case after the manufacturer and a retailer based in Texas, who was also affected by the denial, petitioned for review. The court determined that venue was proper because the retailer had its principal place of business in the circuit. The petitioners argued that the FDA’s denial was arbitrary and capricious, claiming the agency failed to weigh the public health benefits of the product and improperly limited applicants to a single deficiency letter.The Fifth Circuit held that the FDA’s decision was reasonable and reasonably explained. The court found that the FDA had considered the potential benefits and risks of the product, explained the deficiencies in the application, and did not impose new evidentiary requirements without notice. The court also concluded that the FDA’s policy of issuing only one deficiency letter was adequately justified and not arbitrary. The petition for review was denied. View "Shenzhen Youme v. FDA" on Justia Law

Several minors diagnosed with gender dysphoria, their parents, and a physician challenged an Oklahoma law (SB 613) that prohibits healthcare providers from administering gender transition procedures—including puberty blockers and cross-sex hormones—to individuals under eighteen. The law defines these procedures as medical or surgical interventions intended to affirm a minor’s gender identity when it differs from their biological sex. The statute does not ban mental health counseling or certain other medical treatments. The plaintiffs, all affected by the law’s restrictions, argued that SB 613 violated their constitutional rights.The United States District Court for the Northern District of Oklahoma denied the plaintiffs’ request for a preliminary injunction, finding they had not demonstrated a likelihood of success on the merits of their claims. The plaintiffs appealed this decision to the United States Court of Appeals for the Tenth Circuit. While the appeal was pending, the Tenth Circuit paused proceedings to await the Supreme Court’s decision in United States v. Skrmetti, which addressed a similar Tennessee law.The United States Court of Appeals for the Tenth Circuit affirmed the district court’s denial of a preliminary injunction. The court held that SB 613 does not violate the Equal Protection Clause because it classifies based on age and medical use, not sex or transgender status, and is subject to rational basis review. The court found Oklahoma’s interest in the health and welfare of minors provided a rational basis for the law. The court also rejected the substantive due process claim, concluding that there is no fundamental right for parents to access gender transition procedures for their children, and that the law is rationally related to a legitimate state interest. The court found no evidence of invidious discriminatory intent by the legislature. View "Poe v. Drummond" on Justia Law

Several chambers of commerce, including regional and national organizations, brought a lawsuit on behalf of their pharmaceutical-manufacturer members challenging the constitutionality of the Drug Price Negotiation Program established by the Inflation Reduction Act of 2022. This federal program authorizes the Secretary of Health and Human Services to negotiate prices for certain high-expenditure drugs sold to Medicare and Medicaid. Among the plaintiffs’ members were AbbVie Inc. and its subsidiary Pharmacyclics LLC, manufacturers of a drug selected for the first round of negotiations. Notably, Pharmacyclics joined the Dayton and Ohio Chambers only after the litigation began, while AbbVie had longstanding membership in several chambers.The United States District Court for the Southern District of Ohio reviewed the case after the government moved to dismiss, arguing that the Dayton Chamber lacked associational standing and that venue was therefore improper. The district court allowed limited discovery and permitted the plaintiffs to amend their complaint. Ultimately, the district court dismissed the case, holding that the regional chambers’ purposes were not sufficiently related to the interests at stake in the lawsuit, and thus they lacked associational standing. The court also found that, without standing for the Dayton and Ohio Chambers, venue in the Southern District of Ohio was improper and declined to transfer the case.The United States Court of Appeals for the Sixth Circuit affirmed the district court’s judgment. The Sixth Circuit held that the interests asserted in the lawsuit were not germane to the purposes of the Dayton, Ohio, or Michigan Chambers, as their regional missions were too remote from the national pharmaceutical issues at stake. The court further concluded that, with no plaintiff residing in the district, venue was improper. The judgment of dismissal for improper venue was therefore affirmed. View "Dayton Area Chamber of Commerce v. Kennedy" on Justia Law

The case concerns a defendant who, after being excluded from Medicare and Medicaid as part of a civil False Claims Act settlement, purchased a Medicare-participating home healthcare company using an alias and forged documents. The company then submitted hundreds of fraudulent claims to Medicare, resulting in over $2.7 million in payments for services that were never provided. The defendant transferred the proceeds to India, where they remain unrecovered. During the criminal investigation, the defendant also attempted to prevent a former employee from testifying by impersonating another person and making false reports to U.S. authorities, which led to the employee’s visa being denied.A grand jury in the United States District Court for the Eastern District of Michigan indicted the defendant on charges including health care fraud, money laundering, conspiracy, aggravated identity theft, and witness tampering. The trial was delayed, and shortly before it began, the defendant’s counsel experienced internal conflict, leading to motions to withdraw and requests for a mistrial, all of which the district court denied. During trial, the defense sought to call a surprise witness, an unindicted co-conspirator, on the last day. The district court excluded this witness, citing a violation of a discovery order and concerns about delay, prejudice, and the likelihood the witness would invoke the Fifth Amendment.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed whether the district court violated the defendant’s constitutional rights by excluding the witness, denying counsel’s motion to withdraw, and excluding the defendant from an in-chambers conference. The Sixth Circuit held that the exclusion of the witness did not violate the Sixth Amendment, as the district court reasonably balanced the defendant’s right to present a defense against countervailing interests, and the defendant failed to show what exculpatory evidence the witness would have provided. The court also found no abuse of discretion in denying the motion to withdraw and no reversible error in excluding the defendant from the conference. The Sixth Circuit affirmed the district court’s judgment. View "United States v. Pancholi" on Justia Law

A nonprofit substance abuse treatment facility in Kent, Connecticut, challenged the state’s approval of a competitor’s application to establish a similar facility in the same town. The competitor, Birch Hill Recovery Center, LLC, applied for a certificate of need from the Department of Public Health. The plaintiff was granted intervenor status in the administrative proceedings, allowing it to participate in hearings and present evidence. After public hearings, a hearing officer recommended denying Birch Hill’s application, but the Department and Birch Hill later entered into a settlement agreement that approved the application with certain conditions.The plaintiff appealed the Department’s decision to the Superior Court, arguing that the approval was an abuse of discretion, especially given the hearing officer’s earlier recommendation. The defendants moved to dismiss the appeal, contending that the plaintiff was not aggrieved by the decision and thus lacked standing. The Superior Court initially dismissed the appeal on the ground that the settlement agreement was not a final decision. The Appellate Court affirmed this dismissal. However, the Connecticut Supreme Court later held that the settlement agreement was a final decision and remanded the case for further proceedings. On remand, the Superior Court again dismissed the appeal, this time concluding that the plaintiff was not statutorily or classically aggrieved and therefore lacked standing.The Supreme Court of Connecticut affirmed the dismissal, holding that the plaintiff was neither statutorily nor classically aggrieved by the Department’s decision. The Court explained that mere economic competition resulting from governmental action does not confer standing in administrative appeals unless the relevant statute expressly protects competitors’ interests. The Court found that the applicable statute, General Statutes (Rev. to 2017) § 19a-639 (a), did not create such an exception. The plaintiff’s status as an intervenor and its participation in the administrative process did not, by themselves, establish a specific, personal, and legal interest sufficient for standing. View "High Watch Recovery Center, Inc. v. Dept. of Public Health" on Justia Law