Justia Health Law Opinion Summaries

A group of healthcare and air-ambulance providers challenged certain agency rules regarding the No Surprises Act, which aims to protect patients from unexpected medical bills. The key issues involved the calculation of the "qualifying payment amount" (QPA), deadlines for insurers to respond to provider bills, and disclosure requirements for insurers.The United States District Court for the Eastern District of Texas reviewed the case and held several provisions of the rules unlawful, vacating them. The court found that the rules conflicted with the Act's terms and were arbitrary and capricious. The defendant agencies appealed the decision regarding certain provisions, while the plaintiffs cross-appealed the court's upholding of the disclosure requirements.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court reversed the district court's vacatur of the QPA calculation provisions, holding that the rules did not conflict with the Act and were not arbitrary and capricious. The court affirmed the district court's vacatur of the deadline provision, agreeing that it conflicted with the Act's unambiguous terms. The court also affirmed the district court's decision upholding the disclosure requirements, finding them reasonable and adequately explained.In summary, the Fifth Circuit reversed the district court's decision on the QPA calculation provisions, affirmed the vacatur of the deadline provision, and upheld the disclosure requirements. The court concluded that the proper remedy for the unlawful deadline provision was vacatur, not remand, and rejected the idea of party-specific vacatur. View "Texas Medical Association v. Health and Human Services" on Justia Law

The case involves the National Infusion Center Association (NICA) and other plaintiffs challenging the constitutionality of the Drug Price Negotiation Program established by the Inflation Reduction Act. This program requires the Department of Health and Human Services (HHS) to negotiate drug prices with manufacturers, setting a "maximum fair price" between 40% and 75% of the market price. Manufacturers who do not comply face significant fines or must withdraw from Medicare coverage entirely.The United States District Court for the Western District of Texas dismissed NICA's lawsuit for lack of subject-matter jurisdiction. The district court reasoned that NICA's claims had to be "channeled" through HHS as required by 42 U.S.C. § 405, which mandates that claims arising under the Medicare Act be decided by the relevant agency before being brought to federal court. The district court also dismissed the remaining plaintiffs due to improper venue without NICA.The United States Court of Appeals for the Fifth Circuit reviewed the case and found that NICA had standing based on both economic and procedural injuries. The court determined that NICA's claims did not arise under the Medicare Act but rather under the Inflation Reduction Act, and thus did not require channeling through HHS. The court held that the district court had subject-matter jurisdiction over NICA's claims and reversed the lower court's dismissal, remanding the case for further proceedings. View "Natl Infusion Center v. Becerra" on Justia Law

The case involves healthcare providers and air ambulance services challenging regulations established by the Departments of Health and Human Services, Labor, and the Treasury. These regulations were designed to guide independent arbitrators in resolving insurance reimbursement disputes under the No Surprises Act, which aims to protect patients from unexpected medical bills by limiting their out-of-pocket costs for emergency and certain non-emergency services provided by out-of-network providers.The United States District Court for the Eastern District of Texas reviewed the case and vacated the regulations, finding that they improperly favored the qualifying payment amount (QPA) over other statutory factors that arbitrators are required to consider. The court held that the regulations conflicted with the No Surprises Act and violated the Administrative Procedure Act (APA) by imposing additional requirements not found in the statute. The court also found that the plaintiffs had standing to sue based on procedural and financial injuries.The United States Court of Appeals for the Fifth Circuit reviewed the case and affirmed the district court's decision. The Fifth Circuit held that the regulations exceeded the Departments' authority by imposing a sequence in which arbitrators must consider the QPA first, disregarding information deemed not credible or unrelated, and requiring arbitrators to explain why they deviated from the QPA. The court found that these provisions placed undue emphasis on the QPA, contrary to the statute's requirement that all factors be considered equally. The court also upheld the district court's universal vacatur of the challenged provisions, rejecting the Departments' arguments for more limited relief. View "Texas Medical Association v. Health and Human Services" on Justia Law

Caris MPI, Inc. (Caris) provided cancer diagnostic services to UnitedHealthcare, Inc. (United) for over ten years without a written contract. United audited Caris’s past claims and determined that Caris had used incorrect billing codes, resulting in overpayments. United began recouping these overpayments by offsetting them against new payment claims from Caris. Caris challenged United’s recoupment through United’s internal process, but after United rejected Caris’s appeals, Caris filed suit in Texas state court alleging various state law claims.United removed the case to the United States District Court for the Northern District of Texas, asserting federal officer jurisdiction under 28 U.S.C. § 1442(a)(1). The district court denied Caris’s motion to remand and dismissed Caris’s claims without prejudice, finding that Caris failed to exhaust administrative remedies under the Medicare Act.The United States Court of Appeals for the Fifth Circuit reviewed the case and agreed that federal officer jurisdiction existed. However, the court found that the district court erred in dismissing Caris’s claims for failure to exhaust administrative remedies. The Fifth Circuit held that the administrative review process under Medicare Part C does not extend to claims where an enrollee has no interest, and there were no administrative remedies for Caris to exhaust. The court distinguished this case from others by noting that no enrollee had requested an organization determination or appeal, and all enrollees had already received the services for which United sought recoupment. Consequently, the court affirmed the denial of the remand motion, reversed the dismissal of Caris’s claims, and remanded the case for further proceedings. View "Caris MPI v. UnitedHealthcare, Incorporated" on Justia Law

A group of individuals and businesses challenged the Affordable Care Act's requirement for private insurers to cover certain types of preventive care, including contraception, HPV vaccines, and drugs preventing HIV transmission. The plaintiffs argued that the mandates were unlawful because the agencies issuing them violated Article II of the Constitution, as their members were principal officers of the United States who had not been validly appointed under the Appointments Clause. The district court mostly agreed, vacating all agency actions taken to enforce the mandates and issuing both party-specific and universal injunctive relief.The United States Court of Appeals for the Fifth Circuit agreed that the United States Preventive Services Task Force, one of the challenged administrative bodies, was composed of principal officers who had not been validly appointed. However, the court found that the district court erred in vacating all agency actions taken to enforce the preventive-care mandates and in universally enjoining the defendants from enforcing them. The court also held that the Secretary of the Department of Health and Human Services had not validly cured the Task Force’s constitutional problems.The court affirmed in part, reversed in part, and remanded the case for further proceedings. The court did not rule on the plaintiffs' challenges against the other two administrative bodies involved in the case, the Advisory Committee on Immunization Practices and the Health Resources and Services Administration, reserving judgment on whether the Secretary had effectively ratified their recommendations and guidelines. View "Braidwood Mgmt v. Becerra" on Justia Law

Barbara Harrison, a severely disabled individual, challenged the Texas Health and Human Services Commission's (HHSC) decision to deny funding for medical services she claimed were necessary for her survival. Harrison lived in a group home and received nursing services funded by HHSC’s program for providing home and community-based care to people with disabilities. However, when her condition deteriorated to the point where she required 24/7 one-on-one nursing care, HHSC determined that the cost of providing Harrison’s necessary level of care exceeded the cost cap set by the program. Harrison was therefore denied program-funded nursing services, meaning her only option for receiving government-funded medical care was to move to an institutional setting.Harrison challenged HHSC’s determination in court, arguing that HHSC discriminated against her because of her disability, in violation of the Americans with Disabilities Act (ADA) and the Rehabilitation Act, by denying her program-funded nursing services. The district court granted a preliminary injunction requiring HHSC to fund 24/7 one-on-one care for Harrison until she received a hearing on her request for general revenue funds. However, the United States Court of Appeals for the Fifth Circuit vacated the preliminary injunction and remanded for further proceedings, holding that Harrison was unlikely to succeed on her due process claim and had not demonstrated a likelihood of success on the ADA/Rehabilitation Act claims.After the case was remanded to the district court, Harrison submitted a new application to HHSC for 24-hour nursing care under the Program, the cost of which again exceeded the Cost Cap. HHSC determined that Harrison did not require 24-hour nursing care and that 5.5 hours of nursing care per day would be sufficient to meet her medical needs. The district court found that Harrison’s change in status— from receiving no Program funding to receiving some Program funding— mooted Harrison’s ADA/Rehabilitation Act claims. The court therefore dismissed them and then granted summary judgment to HHSC on Harrison’s due process claim. Harrison appealed this decision.The Fifth Circuit Court of Appeals affirmed the district court’s grant of summary judgment to HHSC on Harrison’s due process claim but reversed the district court’s dismissal of Harrison’s discrimination claims. The court found that the district court’s mootness determination was erroneous and that the factual record was still not sufficiently developed to support a judgment as to Harrison’s discrimination claims. The case was remanded for further factfinding and proceedings. View "Harrison v. Young" on Justia Law

The case involves Disability Rights Texas (DRTx), an advocacy organization for individuals with mental illness, and Houston Behavioral Healthcare Hospital (Houston Behavioral). DRTx sought to compel Houston Behavioral to disclose video footage related to the involuntary confinement of its client, G.S., who alleged abuse during his detention at the hospital. G.S. had signed a waiver allowing DRTx to access his records. Houston Behavioral initially cooperated with DRTx's requests for information but refused to provide the requested video footage, citing confidentiality regulations related to substance use disorder treatment.The United States District Court for the Southern District of Texas granted summary judgment in favor of DRTx and issued an injunction, compelling Houston Behavioral to disclose the video footage. Houston Behavioral appealed this decision.The United States Court of Appeals for the Fifth Circuit affirmed the lower court's decision. The court found that the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI Act) grants broad investigatory powers to organizations like DRTx, including access to "all records of any individual." The court held that the video footage requested by DRTx falls within the definition of "records" under the PAIMI Act. The court also found that the Health Insurance Portability and Accountability Act (HIPAA) does not bar the disclosure of such records, as the required-by-law exception in HIPAA permits disclosure when another law, such as the PAIMI Act, requires it. The court concluded that Houston Behavioral's refusal to provide the video footage violated the PAIMI Act. View "Disability Rights Texas v. Hollis" on Justia Law

The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims. View "Hickey v. Hospira" on Justia Law

Dr. Randy Lamartiniere, an internal medicine doctor, was convicted of twenty counts of unlawful distribution of controlled substances. Lamartiniere had been practicing medicine for approximately thirty years and had a growing number of chronic pain patients. Concerns arose about his management of opioid and narcotic prescriptions and his inability to maintain timely patient records, leading to his termination from a clinic. He then opened his own practice, where a significant portion of his patients were pain management patients. The Drug Enforcement Administration (DEA) launched an investigation into his prescription practices, which included undercover agents posing as chronic pain patients. Lamartiniere was subsequently charged with twenty-eight counts of unlawful distribution of Schedule II controlled substances.At trial, the Government presented evidence from Lamartiniere’s former patients, undercover agents, and expert witnesses. Lamartiniere testified in his own defense, arguing that he was genuinely trying to treat his patients' legitimate medical conditions. The jury convicted Lamartiniere on twenty counts, and he was sentenced to 180 months per count, to run concurrently. Lamartiniere appealed, challenging the jury instructions and the sufficiency of the evidence supporting his convictions. The United States Court of Appeals for the Fifth Circuit affirmed the convictions, finding no reversible error. View "United States v. Lamartiniere" on Justia Law

In September 2020, George Fluitt was indicted on three counts of fraud and offering kickbacks related to genetic testing services that his company, Specialty Drug Testing LLC, provided to Medicare beneficiaries. As part of a nationwide investigation into genetic testing fraud, the Government executed search warrants at laboratories referred to as the Hurricane Shoals Entities (“HSE”), allegedly operated by Khalid Satary. The Government copied several terabytes of data from HSE, some of which were later determined to be material to Fluitt’s defense.In the lower courts, the Government established a “Filter Team” to review materials seized in its investigation and identify any that might be privileged. The Filter Team’s review was governed in part by a Protocol Order, which established a multi-step process for notifying a third party that it might have a claim of privilege and then adjudicating that claim. HSE and Satary provided privilege logs to the Filter Team, asserting thousands of claims of privilege. Both Fluitt and the Filter Team found these privilege logs to be facially deficient as they made only threadbare assertions of privilege, without any accompanying explanation.In the United States Court of Appeals Fifth Circuit, the court affirmed the lower court's decision. The court found that the appellants failed to establish their claims of privilege. The court also found that the appellants' argument that they are not bound by the Protocol Order was a red herring, as the magistrate judge evaluated the appellants’ privilege logs under the standards established by federal caselaw. The court also rejected the appellants' argument that Fluitt “has not shown a need for the documents” and has not “demonstrated any kind of relevancy.” The court found that the record suggests that Fluitt “has a need” for the potentially privileged documents, as the Government determined that the potentially privileged materials were material to preparing Fluitt’s defense. View "United States v. Fluitt" on Justia Law