Justia Government & Administrative Law Opinion Summaries

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

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

A skilled nursing facility accepted a new resident who was receiving Medicaid benefits. The resident's husband was designated as her authorized representative. Nearly two years later, the Department of Human Services (DHS) terminated the resident's Medicaid benefits due to excess assets. Both the resident and her husband were incapacitated, and the resident's public guardian submitted a new Medicaid application, which was denied. The nursing facility continued to care for the resident without compensation until her death. The facility later sought an administrative hearing to challenge the eligibility decision, but the request was denied because the facility was not an authorized representative and the appeal was late.The circuit court and the Intermediate Court of Appeals (ICA) affirmed the denial, holding that the nursing home lacked standing to challenge the eligibility determination under Hawai'i Revised Statutes (HRS) § 346-12, which limits appeals to the applicant or recipient. The courts concluded that the nursing home did not have a close relationship with the resident for third-party standing purposes.The Supreme Court of the State of Hawai'i reviewed the case and disagreed with the lower courts regarding standing. The court held that skilled nursing facilities have constitutionally protected property interests in compensation for medical services performed for residents based on DHS eligibility determinations. The court ruled that these facilities have due process rights under the Hawai'i Constitution, including notice and the opportunity to appeal Medicaid eligibility determinations when the beneficiary is incapacitated and no authorized representative is available or willing to appeal. The court vacated the ICA's judgment and the circuit court's order, remanding the case for a new administrative hearing on the merits of the resident's Medicaid eligibility. View "In re FT" on Justia Law

Nikko Cerrone, a sixteen-year-old, received the Gardasil HPV vaccine, Flumist influenza vaccine, and Hepatitis A vaccine on October 7, 2015. He later reported decreased stamina and blood in his stools, leading to a diagnosis of ulcerative colitis (UC) in March 2016. He received a second HPV vaccine dose in February 2016 and a third in June 2016, with no documented reaction to the third dose.Cerrone filed a petition for compensation under the National Vaccine Injury Compensation Program, claiming the vaccines caused his UC. The Chief Special Master of the National Vaccine Injury Compensation Program denied his claim, finding that Cerrone failed to prove causation by a preponderance of the evidence. The Court of Federal Claims upheld this decision.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the lower court's decision, agreeing that Cerrone did not meet the burden of proof required under the Vaccine Act. The court found that the special master correctly applied the legal standards and that the findings were not arbitrary or capricious. The court noted that the special master found the respondent's experts more credible and persuasive than Cerrone's experts. The court also upheld the special master's conclusion that the evidence did not support a proximate temporal relationship between the vaccinations and the onset of UC. The decision of the Court of Federal Claims was affirmed. View "CERRONE v. HHS " on Justia Law

M.R., an inmate serving a prison sentence for racketeering, experienced significant health issues, including balance problems and difficulty writing. In August 2020, he was diagnosed with a malignant brain tumor and underwent surgery in January 2021. By November 2022, M.R. was wheelchair-bound with residual neurological deficits. In February 2023, M.R. applied for compassionate release under the Compassionate Release Act (CRA). The New Jersey Department of Corrections (DOC) designated two physicians to review his medical records, who provided conflicting diagnoses regarding his terminal condition status. The DOC ultimately denied M.R. a Certificate of Eligibility for compassionate release.M.R. appealed the DOC's decision, and in August 2023, the Appellate Division remanded the case for reevaluation due to the conflicting medical opinions. The physicians provided updated reports, now uniformly concluding that M.R. did not suffer from a terminal condition or permanent physical incapacity, again relying solely on M.R.'s electronic medical records. The DOC reaffirmed its denial of the Certificate of Eligibility. The Appellate Division later affirmed the DOC's decision, concluding that the CRA does not require physical examinations and that the denial was not arbitrary, capricious, or unreasonable.The Supreme Court of New Jersey reviewed the case, focusing on whether the CRA and its implementing regulation require physical examinations for compassionate release applications. The Court held that the CRA does not mandate physical examinations for medical diagnoses. However, the Court found the DOC's decision to deny M.R. a Certificate of Eligibility in August 2023 to be arbitrary, capricious, and unreasonable. The Court emphasized the need for contemporaneous and comprehensive medical evaluations to support such decisions and reversed the Appellate Division's judgment. View "M.R. v. New Jersey Department of Corrections" on Justia Law

Keith Huck, an elected member of the Perry County Common Council, was covered under the county's group health insurance plan. In 2023, the Perry County Board of Commissioners voted to exclude part-time employees from health insurance coverage, classifying elected officials, including Huck, as part-time employees. As a result, Huck and his spouse lost their health insurance coverage on January 1, 2024. Huck sought declaratory and injunctive relief, arguing that as an elected official, he should be considered a full-time employee and thus eligible for health insurance coverage.The Perry Circuit Court granted Huck's request for a preliminary injunction, ordering the county to reinstate his insurance coverage. The County appealed, and the Indiana Court of Appeals determined that the county had the authority to classify elected officials as part-time employees and exclude them from health insurance coverage. Huck then sought transfer to the Indiana Supreme Court, which vacated the appellate opinion and reviewed the case.The Indiana Supreme Court held that the county was within its rights to classify Huck as a part-time employee and exclude him from group health insurance coverage. The court found that Indiana law allows local governmental units to exclude part-time employees from group health insurance and that the county's classification of Huck as a part-time employee was permissible. The court reversed the trial court's ruling, vacated the preliminary injunction, and remanded the case for further proceedings consistent with its opinion. View "Perry County v. Huck" on Justia Law

A healthcare provider, Neurological Surgery Practice of Long Island, PLLC, provides out-of-network medical services governed by the No Surprises Act. This Act requires out-of-network providers to seek compensation from the patient’s healthcare plan rather than billing patients directly. If a provider and a healthcare plan cannot agree on a compensation amount, an independent dispute resolution (IDR) process is used. Neurological Surgery alleges that a backlog of disputes has resulted in unpaid or delayed reimbursements due to the Departments of Health and Human Services, Treasury, and Labor failing to implement the Act properly, violating the Administrative Procedure Act (APA) and the Due Process Clause of the Fifth Amendment.The United States District Court for the Eastern District of New York dismissed Neurological Surgery’s claims. The court concluded that the claims were moot due to the reopening of the IDR portal, Neurological Surgery lacked standing to compel the Departments to enforce the Act’s deadlines on third parties, and the claims regarding the Departments’ failure to certify a sufficient number of arbitrators and provide guidance on New York’s surprise billing law were foreclosed by the APA.The United States Court of Appeals for the Second Circuit reviewed the case. The court affirmed the district court’s judgment, agreeing that the challenge to the pause of the IDR portal was moot since the portal was operational. The court also held that Neurological Surgery lacked standing to compel the Departments to enforce deadlines on healthcare plans and IDR entities, as the injury was caused by third parties, not the Departments. Additionally, the court found that the challenge to the Departments’ failure to certify a sufficient number of IDR entities was foreclosed by the APA, as the Act did not specify discrete actions required by the Departments. Lastly, the court held that the challenge to the Departments’ failure to issue guidance on New York’s surprise billing law failed to state a claim under the APA. View "Neurological Surgery v. Department of Health & Human Services" on Justia Law

Plaintiffs, limited liability companies, filed class action lawsuits in the United States District Court for the District of Maryland seeking relief under the Medicare Secondary Payer (MSP) provisions. These provisions make Medicare a secondary payer when a beneficiary has other insurance coverage. Plaintiffs obtained assignments from Medicare Advantage Organizations and other secondary payers to seek reimbursement from primary payers like the defendants, Government Employees Insurance Company and its affiliates (GEICO). Plaintiffs had no preexisting interest in the claims and were compensated on a contingency basis.The United States District Court for the District of Maryland denied GEICO's motion to dismiss the case, which argued that the assignments were void as against Maryland public policy based on the doctrines of maintenance, champerty, and barratry. The court found no clear statement of Maryland law on this issue and certified questions to the Supreme Court of Maryland.The Supreme Court of Maryland held that Plaintiffs did not violate Maryland’s barratry statute, which prohibits soliciting another person to sue for personal gain without an existing relationship or interest. Plaintiffs did not solicit secondary payers to file lawsuits but obtained the right to sue in their own names through assignments. The court also held that the common law doctrines of maintenance, champerty, and barratry, to the extent they still apply, do not invalidate Plaintiffs’ assignments. The court concluded that the assignments are not void as against public policy and did not address the enforceability of choice-of-law provisions in the agreements. View "GEICO v. MAO-MSO Recovery II" on Justia Law

Mississippi Methodist Hospital and Rehabilitation Center Inc. appealed the Hinds County Chancery Court's decision affirming the Mississippi State Department of Health's grant of a certificate of need (CON) to Encompass Health Rehabilitation Hospital of Flowood LLC. The Department identified a need for additional comprehensive medical rehabilitation (CMR) beds, prompting Encompass to apply for a CON to build a new facility in Flowood. Methodist opposed the application, arguing that Encompass's proposed facility would not meet indigent care requirements and would unnecessarily duplicate existing services.The Hinds County Chancery Court initially reversed the Department's decision, finding that the hearing officer failed to consider the relevance of a CON granted to Baptist Memorial Rehabilitation Hospital - Madison LLC. However, the Mississippi Supreme Court vacated this decision, ruling that the hearing officer had considered the relevance of the Baptist CON and found it irrelevant. On remand, the chancery court affirmed the Department's grant of the Encompass CON, finding that the decision was supported by substantial evidence.The Mississippi Supreme Court reviewed the case and affirmed the chancery court's decision. The Court held that the hearing officer's findings were based on substantial evidence, including Encompass's commitment to providing indigent care and the unmet need for CMR services in the Jackson metro area. The Court also rejected Methodist's argument that the state health officer should have considered the impact of the Baptist CON, noting that this issue had already been resolved in the previous appeal. The Court remanded the case to the chancery court to determine the amount of attorneys' fees to which Encompass is entitled under Section 41-7-201(2)(f). View "Mississippi Methodist Hospital and Rehabilitation Center Inc. v. Mississippi State Department of Health and Encompass Health Rehabilitation Hospital of Flowood, LLC" on Justia Law