Justia Government & Administrative Law Opinion Summaries

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

A former employee of a pharmaceutical manufacturer brought a qui tam lawsuit under the False Claims Act, alleging that the company improperly calculated and reported its “Best Price” for certain drugs to the Centers for Medicare and Medicaid Services (CMS), as required under the Medicaid Rebate Statute. The plaintiff claimed that, during a period from 2005 to 2014, the company failed to aggregate multiple rebates and discounts given to different entities on the same drug, resulting in inflated “Best Price” reports and underpayment of rebates owed to Medicaid. The complaint asserted that the company was subjectively aware that CMS interpreted the statute to require aggregation of all such discounts, especially after the company’s communications with CMS during a 2006–2007 rulemaking process and the company’s subsequent internal audit.After the government and several states declined to intervene, the United States District Court for the District of Maryland dismissed the amended complaint, finding that, even under the subjective scienter standard established in United States ex rel. Schutte v. SuperValu Inc., the plaintiff had not plausibly alleged that the company acted with actual knowledge, deliberate ignorance, or reckless disregard as to the truth or falsity of its reports. The district court also suggested that ambiguity in the statute precluded a finding of falsity.On appeal, the United States Court of Appeals for the Fourth Circuit reviewed the dismissal de novo. The Fourth Circuit held that the plaintiff’s allegations—including the company’s awareness of CMS’s interpretation of the rule, its targeted audit and compliance efforts, and its continued use of non-aggregated reporting—plausibly alleged the requisite subjective scienter under the False Claims Act. The court clarified that statutory ambiguity does not, at the pleading stage, negate scienter or falsity, and remanded for the district court to address other elements, including falsity, in the first instance. The Fourth Circuit reversed the dismissal and remanded for further proceedings. View "United States ex rel. Sheldon v. Allergan Sales, LLC" on Justia Law

Three Medicaid beneficiaries in Indiana challenged the federal agency’s approval of a ten-year extension to Indiana’s Medicaid program, known as HIP 2.0, asserting that the program did not comply with the requirements of the federal Medicaid Act. The plaintiffs argued that the agency’s 2020 approval, as well as a 2023 letter maintaining the program despite concerns about coverage reductions, were arbitrary and capricious under the Administrative Procedure Act. Indiana, seeking to defend HIP 2.0, intervened in the case.The United States District Court for the District of Columbia granted summary judgment to the beneficiaries, holding that the agency’s approval was not based on reasoned decision-making and failed to consider all relevant factors, particularly whether the program would help furnish medical assistance. The court vacated the 2020 approval and remanded the matter to the agency for further proceedings but stayed the vacatur order, allowing most of HIP 2.0 to remain in effect except for specific premium requirements. Indiana appealed, seeking review of the district court’s remand order, while the beneficiaries and the federal agency argued that the order was not a final, appealable decision.The United States Court of Appeals for the District of Columbia Circuit reviewed whether it had jurisdiction over Indiana’s appeal. The court held that the district court’s remand order was not a final decision under 28 U.S.C. § 1291 because it did not end the litigation on the merits and substantive proceedings before the agency remained. The appellate court also found that none of the exceptions to the final judgment rule applied, including the collateral-order doctrine or Rule 54(b) certification. Accordingly, the D.C. Circuit dismissed Indiana’s appeal for lack of jurisdiction. View "Rose v. Kennedy" on Justia Law

A Louisiana pharmacy owned by a licensed pharmacist was investigated by the Drug Enforcement Administration after allegations arose that the pharmacy was filling prescriptions for itself and for patients with “red flags” indicating possible misuse or diversion of controlled substances. The DEA’s investigation focused on several prescriptions, including combinations of opioids and benzodiazepines for various patients, out-of-pocket payments for controlled substances, and a prescription filled by the pharmacist herself written by her physician father, which violated state law prohibiting physicians from prescribing controlled substances to immediate family.Following an agency hearing before an administrative law judge, the DEA’s Administrator adopted the ALJ’s recommendation and revoked the pharmacy’s federal registration to dispense controlled substances. The Administrator concluded that the pharmacy had violated federal regulations and Louisiana law by filling prescriptions without adequately resolving red flags and by filling a prescription written in violation of state law. The pharmacy petitioned for review in the United States Court of Appeals for the Fifth Circuit.The Fifth Circuit found that the DEA misinterpreted and misapplied its own regulations and state law. The court held that 21 C.F.R. § 1306.04(a) requires a pharmacist to “knowingly” fill an invalid prescription, which the DEA had not shown, and that a violation of the state-law standard of care is not, by itself, a violation of federal regulations. The court also held that the Louisiana law at issue did not apply to pharmacies. Because the DEA’s order rested on erroneous interpretations of governing regulations and state law, the Fifth Circuit vacated the deregistration order and remanded the matter for further proceedings. View "Neumann's Pharmacy v. Drug Enforcement Administration" on Justia Law

At a psychiatric hospital, employees were exposed to violent behavior from disturbed patients. Following a tip, the Occupational Safety and Health Administration (OSHA) investigated and cited the hospital for failing to implement measures that could have protected staff from workplace violence. These measures included reconfiguring nurses’ stations, providing communication devices, fully implementing existing safety programs, maintaining adequate staffing, securing patient belongings, hiring specialized security staff, and investigating each incident of workplace violence. The hospital did not contest the necessity of some measures but challenged the citation overall.An administrative law judge with the Occupational Safety and Health Review Commission conducted a hearing, upheld the citation, and imposed a fine. The judge’s decision became the final decision of the Review Commission when it declined further review. The hospital then petitioned the United States Court of Appeals for the Tenth Circuit for judicial review, arguing that another federal agency, the Centers for Medicare and Medicaid Services, had exclusive authority over hospital safety, that the Secretary of Labor should have deferred to other regulatory bodies, and that the Secretary’s methods and notice were insufficient.The United States Court of Appeals for the Tenth Circuit held that the Secretary of Labor had the authority to enforce the Occupational Safety and Health Act’s general duty clause in this context, as the cited agency did not actually regulate employee safety regarding workplace violence. The court found that the Secretary provided fair notice, acted within statutory authority, and permissibly used adjudication rather than rulemaking. The court also concluded that the abatement measures were feasible, supported by substantial evidence, and that the imposed sanctions for failure to preserve video evidence were appropriate. The Tenth Circuit denied the hospital’s petition for review, upholding the citation and penalty. View "Cedar Springs Hospital v. Occupational Health and Safety" on Justia Law

ARcare, Inc., a nonprofit community health center receiving federal funding, suffered a data breach in early 2022 when an unauthorized third party accessed confidential patient information, including names, social security numbers, and medical treatment details. After ARcare notified affected individuals, several patients filed lawsuits alleging that ARcare failed to adequately safeguard their information as required under federal law. Plaintiffs reported fraudulent invoices and that their information was found for sale on the dark web.The actions were removed to the United States District Court for the Eastern District of Arkansas, where six class actions were consolidated. ARcare sought to invoke absolute immunity under 42 U.S.C. § 233(a) of the Federally Supported Health Centers Assistance Act (FSHCAA), which provides immunity for damages resulting from the performance of “medical, surgical, dental, or related functions.” ARcare moved to substitute the United States as defendant under the Federal Tort Claims Act, arguing the data breach arose from a “related function.” The district court denied the motion, finding that protecting patient information from cyberattacks was not sufficiently linked to the provision of health care to qualify as a “related function” under the statute.On appeal, the United States Court of Appeals for the Eighth Circuit reviewed the statutory immunity issue de novo. The court affirmed the district court’s denial of immunity, holding that the FSHCAA’s language does not extend statutory immunity to claims arising from a health center’s data security practices. The court reasoned that “related functions” must be activities closely connected to the provision of health care, and data security is not such a function. Therefore, ARcare is not entitled to substitute the United States as defendant, and the denial of statutory immunity was affirmed. View "Hale v. ARcare, Inc" on Justia Law

Several pharmaceutical manufacturers and a trade association challenged a Louisiana statute, Act 358, which restricts drug manufacturers from interfering with the delivery of federally discounted drugs through contract pharmacies. The statute was passed in response to manufacturers’ efforts to limit the distribution of discounted drugs under the federal 340B Program, particularly through arrangements with contract pharmacies serving vulnerable populations. The plaintiffs argued that the Louisiana law was preempted by federal law and violated several constitutional provisions, including the Takings Clause, the Contracts Clause, and the Due Process Clause’s prohibition on vagueness.The United States District Court for the Western District of Louisiana considered three related cases together. It denied the manufacturers’ motions for summary judgment and instead granted summary judgment for the State of Louisiana and the Louisiana Primary Care Association (LPCA) on all claims. The district court also allowed LPCA to intervene in each case, over the objection of one plaintiff.On appeal, the United States Court of Appeals for the Fifth Circuit reviewed the case de novo. The court held that Act 358 is not preempted by federal law. It found that the federal 340B statute does not occupy the field of pharmacy regulation and does not conflict with or frustrate federal objectives, as it is silent on the use of contract pharmacies and leaves room for state regulation. The court also concluded that Act 358 does not effect a physical or regulatory taking, does not substantially impair contract rights under the Contracts Clause, and is not unconstitutionally vague. However, the Fifth Circuit reversed the district court’s order permitting LPCA to intervene in AbbVie’s case, finding that LPCA’s interests were adequately represented by the State and it did not show it would present a distinct defense. The court affirmed summary judgment for Louisiana on all claims. View "AstraZeneca v. Murrill" on Justia Law

Jackson County Heart ASC, LLC submitted an application to the Mississippi State Department of Health (MSDH) seeking a certificate of need (CON) to establish a joint venture cardiac ambulatory surgical facility (JV-CASF) in Gautier, Mississippi. The proposed facility would provide outpatient cardiac catheterization services and was to be jointly owned by an acute care hospital and licensed cardiologists, as defined by the Mississippi State Health Plan. The application included supporting affidavits from cardiologists and financial projections, indicating that this would be the only freestanding outpatient JV-CASF in the Gulf Coast service area.MSDH staff recommended approval of the application, finding substantial compliance with relevant criteria. Following Singing River Health System’s request for a hearing, a hearing officer considered testimony and evidence from both sides, including expert witnesses and financial analyses. Although one supporting physician withdrew his endorsement at the hearing, the hearing officer ultimately recommended approval based on the entirety of the evidence. MSDH’s state health officer adopted these findings and issued a final order approving the CON. Singing River appealed to the Hinds County Chancery Court, which affirmed the approval after oral argument. Singing River then appealed to the Supreme Court of Mississippi.On appeal, the Supreme Court of Mississippi reviewed arguments regarding the adequacy of the application, economic viability, and potential adverse impacts on Singing River’s services and charitable care. Applying a highly deferential standard, the Court found substantial evidence supporting MSDH’s decision. The Court held that the application met the requirements of the State Health Plan and CON Review Manual, satisfied economic viability, and would not have a significant adverse impact on Singing River or its ability to provide charitable care. The Supreme Court affirmed MSDH’s approval of the CON. View "Singing River Health System v. Mississippi State Department of Health" on Justia Law

Indiana amended its laws in 2022 to prohibit and criminalize the use of telehealth and telemedicine for abortions, requiring that abortion-inducing drugs be dispensed and consumed in person by a physician in a hospital or qualified surgical center. The Satanic Temple, a Massachusetts-based religious nonprofit, operates a telehealth abortion clinic serving only patients in New Mexico but seeks to extend these services to its Indiana members. It does not run, nor intends to operate, an in-person abortion clinic in Indiana or maintain ties to Indiana hospitals or surgical centers. The Temple filed suit against the Indiana Attorney General and Marion County Prosecutor, seeking to enjoin enforcement of the criminal statute (§ 16-34-2-7(a)) and to obtain declaratory relief under Indiana’s Religious Freedom Restoration Act.The United States District Court for the Southern District of Indiana reviewed the case and granted the defendants’ motion to dismiss for lack of standing. The court found that the Satanic Temple failed to identify any specific member who suffered an injury from the challenged law, thus lacking associational standing. It also held that the Temple itself lacked standing, as it could not show an injury in fact and could not demonstrate that favorable relief would redress its alleged harms due to other Indiana laws independently barring its intended conduct.On appeal, the United States Court of Appeals for the Seventh Circuit affirmed the district court’s dismissal. The Seventh Circuit held that the Satanic Temple lacked both associational and individual standing. The Temple failed to identify a specific injured member and relied only on statistical probabilities and generalized claims of stigmatic injury, which were insufficient. Additionally, the Temple did not present concrete plans to violate the law, and even if § 16-34-2-7(a) were enjoined, other statutes would independently prevent its telehealth abortion services in Indiana. Thus, the Seventh Circuit affirmed the dismissal for lack of subject matter jurisdiction. View "Satanic Temple, Inc. v Rokita" on Justia Law

A group of long-term care providers and their associated management company filed cost reports for 2015 with the Mississippi Division of Medicaid (DOM), reporting dividends received from three insurance companies as “other income” rather than offsetting them against insurance costs. This reporting practice had been consistently followed and accepted by DOM for over two decades. When DOM audited the 2015 cost reports around 2018, it changed its approach by offsetting these dividends against current insurance costs, thereby affecting reimbursement rates for services provided by the providers.After DOM made these adjustments, the providers sought reconsideration, but DOM upheld its decision. The providers then pursued an administrative appeal, where a hearing officer found DOM’s adjustments supported by substantial evidence and not arbitrary or capricious, recommending affirmation of DOM’s actions. DOM’s executive director adopted this recommendation. The providers appealed to the Hinds County Chancery Court, which affirmed DOM’s decision, concluding that the State Plan required reference to the Provider Reimbursement Manual (PRM) for guidance, and that DOM acted within its authority and did not violate any statutory or constitutional rights. The chancellor also found no evidence of a written internal policy regarding the treatment of such dividends.On appeal, the Supreme Court of Mississippi reviewed whether DOM’s actions were arbitrary and capricious, whether public notice of the change was required, and other issues. The Court held that DOM’s abrupt reversal of its long-standing unwritten internal policy, without reasonable explanation or public notice, was arbitrary and capricious. The Court further found that public notice was required under federal regulations for significant policy changes affecting payment rates. Accordingly, the Supreme Court of Mississippi reversed the decisions of DOM and the chancery court and rendered judgment in favor of the providers. View "Hattiesburg Medical Park Management Corp. v. Mississippi Division of Medicaid" on Justia Law