Justia Government & Administrative Law Opinion Summaries

A hospital operating in Weston, West Virginia, sought to construct a new facility approximately four miles from its current location, at a cost of about $56 million. The hospital’s current site is about sixteen miles from another hospital in Buckhannon, which holds a critical access hospital (CAH) designation, allowing it to receive higher Medicare and Medicaid reimbursements. The Buckhannon hospital argued that the construction of the new facility within twelve mountainous miles of its own would jeopardize its CAH status and financial stability.Previously, the West Virginia Health Care Authority denied the Weston hospital’s application for a certificate of need, finding that the project would harm the Buckhannon hospital and was not a superior alternative under state law. The Intermediate Court of Appeals of West Virginia affirmed this denial. However, after legislative amendments in 2023 raised the capital expenditure threshold for certificate of need requirements to $100 million, the Weston hospital requested a determination from the Authority as to whether its new project required such a certificate. The Authority, applying an unwritten guideline, concluded that a certificate of need was unnecessary for the relocation of an existing facility within the same service area if the cost was below the new threshold. The Intermediate Court of Appeals affirmed this decision, finding the relevant statute ambiguous and deferring to the Authority’s interpretation.The Supreme Court of Appeals of West Virginia reviewed the case and held that the statutory language requiring a certificate of need for the “construction . . . of a health care facility” is clear and unambiguous. The court determined that the construction of a new hospital building, even as a relocation, falls within this requirement, regardless of the capital expenditure amount. The court reversed the decisions of the lower courts and remanded the case to the Authority for further proceedings consistent with its interpretation. View "St. Joseph's Hospital of Buckhannon v. Stonewall Jackson Memorial Hospital Co." on Justia Law

An inpatient rehabilitation facility employed a sales representative who raised concerns about the facility’s use of nonclinical personnel in the preadmission screening process required for Medicare reimbursement. The sales representative was terminated after five months of employment. Shortly thereafter, she filed a qui tam action under the False Claims Act, alleging that the facility presented false claims to Medicare, used false records to obtain payment, and conspired to submit false claims. She amended her complaint multiple times, and the government declined to intervene in the case.The United States District Court for the Southern District of Texas reviewed the second amended complaint after the defendant moved to dismiss under Rule 12(b)(6). The magistrate judge recommended dismissal of all claims, finding the complaint insufficiently plausible and lacking the particularity required by Rules 8(a) and 9(b). The magistrate judge also recommended denying leave to further amend the complaint as futile under Rule 16. The district court adopted these recommendations, entered final judgment, and dismissed the case with prejudice. The plaintiff timely appealed.The United States Court of Appeals for the Fifth Circuit reviewed the district court’s dismissal de novo and the denial of leave to amend for abuse of discretion. The Fifth Circuit held that the complaint failed to plead sufficient facts to support the elements of a False Claims Act violation, specifically the falsity of the claims and the connection between the alleged conduct and the submission of false claims. The court also found that amendment would be futile, as the plaintiff had already amended her complaint twice without remedying the deficiencies. The Fifth Circuit affirmed the district court’s dismissal of the claims with prejudice. View "Gentry v. Encompass Health Rehabilitation Hospital of Pearland, L.L.C." on Justia Law

An Oregon nonprofit organization, whose board members are guided by sincerely held religious beliefs, challenged a state law requiring most employers to provide insurance coverage for abortion and contraceptive services. The organization’s governing documents and public statements reflect a commitment to traditional Judeo-Christian ethics, including opposition to abortion based on religious grounds. Although the law contains exemptions for certain religious employers, the organization does not qualify for any of these exceptions, a point not disputed by the state. The organization sought relief, arguing that being compelled to provide such coverage violates its rights under the First and Fourteenth Amendments.The United States District Court for the District of Oregon denied the organization’s request for a preliminary injunction and dismissed its complaint. The district court found there was doubt as to whether the organization’s opposition to abortion was genuinely religious in nature. It further concluded that the law was neutral and generally applicable, subject only to rational basis review, which it satisfied.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s dismissal and vacated the denial of a preliminary injunction. The Ninth Circuit held that the organization’s beliefs are religious and sincerely held, and that the district court erred by not accepting these allegations as true at the motion to dismiss stage. The appellate court remanded the case for the district court to reconsider, in light of the Supreme Court’s decision in Catholic Charities Bureau, Inc. v. Wisconsin Labor & Industry Review Commission, whether the selective denial of a religious exemption to the organization violates the First Amendment. The Ninth Circuit expressed no opinion on the ultimate constitutional question, leaving it for the district court to address in the first instance. View "OREGON RIGHT TO LIFE V. STOLFI" on Justia Law

A health care provider operating imaging centers in Wake County, North Carolina, and a major hospital system both applied for a Certificate of Need (CON) to acquire a new fixed MRI scanner, as required by state law. The state’s 2021 plan determined that only one additional scanner could be approved in the county. The provider sought to place the scanner in Wake Forest, while the hospital system proposed a location in Raleigh. After a competitive review, the North Carolina Department of Health and Human Services awarded the CON to the hospital system, finding its application more effective under certain comparative factors.The provider challenged this decision in the Office of Administrative Hearings, alleging the agency’s review was flawed and prejudicial. The administrative law judge (ALJ) found that the agency’s comparative analysis contained errors, deviated from established practices, and was based on subjective judgment rather than expertise or proper procedure. The ALJ reversed the agency’s decision and awarded the CON to the provider, also finding that the provider suffered substantial prejudice from the denial.On appeal, the North Carolina Court of Appeals affirmed the ALJ’s decision, holding that the appellants failed to challenge specific findings of fact, which made those findings binding on appeal. The court applied the whole record review standard, focusing on whether substantial evidence supported the ALJ’s decision.The Supreme Court of North Carolina reviewed the case and held that, under current law, the ALJ’s final decision—not the agency’s—is the focus of judicial review, and a high degree of deference is owed to the ALJ’s findings. The Court affirmed the lower court’s judgment regarding the comparative analysis but reversed on the issue of substantial prejudice, finding that the provider, as a denied applicant, was inherently prejudiced by the agency’s decision. The award of the CON to the provider was affirmed. View "Pinnacle Health Servs. of N.C. LLC v. N.C. Dep't of Health & Hum. Servs" on Justia Law

A personal care assistance provider agency in Minnesota was audited by the Department of Human Services (DHS) for recordkeeping deficiencies related to its provision of services under the state’s Medicaid program. The agency, which served both traditional and PCA Choice recipients, was found to have various documentation errors, including missing or incomplete care plans and timesheets, as well as timesheets lacking required elements. DHS did not allege fraud or that services were not provided, but sought to recover over $420,000 in payments, arguing that these deficiencies constituted “abuse” under state law and justified monetary recovery.After an evidentiary hearing, an administrative law judge (ALJ) recommended limited recovery for some missing documentation but rejected most of DHS’s claims, finding that DHS had not shown the deficiencies resulted in improper payments. The DHS Commissioner disagreed, ordering full repayment. The Minnesota Court of Appeals reversed the Commissioner’s decision, holding that DHS must prove not only that the provider engaged in “abuse” but also that the abuse resulted in the provider being paid more than it was entitled to receive. The court also determined that provider agencies must maintain care plans for both traditional and PCA Choice recipients in their files.The Minnesota Supreme Court affirmed in part, reversed in part, and remanded. It held that, to obtain monetary recovery under Minn. Stat. § 256B.064, subd. 1c(a), DHS must prove either: (1) the provider engaged in conduct described in subdivision 1a and, had DHS known of the conduct before payment, it would have been legally prohibited from paying under a statute or regulation independent of subdivision 1a; or (2) the payment resulted from an error such that the provider received more than authorized by law. The Court also held that provider agencies must keep care plans for all PCA services, including PCA Choice, in their files. View "In the Matter of the SIRS Appeal by Best Care, LLC" on Justia Law

An advanced practice registered nurse in Texas, who maintained an active nursing license and a Prescriptive Authority Number, did not have a current prescriptive-authority agreement with a physician, as required by Texas law to prescribe drugs. She was not accused of any misconduct but was attending an educational program to transition careers. Because she lacked a prescriptive-authority agreement, the Drug Enforcement Administration (DEA) initiated proceedings to revoke her federal Certificate of Registration, which allows her to handle controlled substances.An administrative law judge within the DEA recommended revocation, finding that she was “without state authority to handle controlled substances.” The Administrator of the DEA adopted this recommendation and revoked her registration. The nurse then petitioned for review directly to the United States Court of Appeals for the Fifth Circuit, as permitted by statute.The United States Court of Appeals for the Fifth Circuit reviewed the DEA’s action and concluded that the agency exceeded its statutory authority under 21 U.S.C. § 824(a)(3). The court held that the statute requires both the loss of a state license or registration and the lack of state authorization to handle controlled substances before the DEA may revoke a registration. Because the nurse still held all relevant state licenses and registrations, the court determined that the DEA lacked authority to revoke her registration solely due to the absence of a prescriptive-authority agreement. The court granted the petition for review, vacated the DEA’s revocation order, and remanded the case to the agency for further proceedings consistent with its opinion. View "DeWitt v. Drug Enforcement Administration" on Justia Law

Novo Nordisk, a pharmaceutical manufacturer, challenged the implementation of the Drug Price Negotiation Program established by the Inflation Reduction Act of 2022. The Program requires the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate prices for certain high-expenditure drugs covered by Medicare. In the first round of selections, CMS grouped six of Novo Nordisk’s insulin aspart products as a single “negotiation-eligible drug” and selected them for price negotiation. Novo Nordisk signed the required agreements to participate but subsequently filed suit, arguing that CMS’s grouping of its products and the procedures used to implement the Program violated statutory and constitutional provisions.The United States District Court for the District of New Jersey granted summary judgment in favor of the government. The court found it lacked subject matter jurisdiction to review CMS’s decision to treat the six products as one drug due to a statutory bar on judicial review. It also held that Novo Nordisk lacked standing to challenge the identification of more than ten drugs for the initial pricing period. The court rejected Novo Nordisk’s claims under the unconstitutional conditions doctrine, the Due Process Clause, the nondelegation doctrine, and the First Amendment, concluding that the Program did not deprive the company of a protected property interest, that Congress provided an intelligible principle to guide CMS, and that the Program primarily regulated conduct rather than speech.On appeal, the United States Court of Appeals for the Third Circuit affirmed the District Court’s judgment. The Third Circuit held that the statutory bar on judicial review precluded consideration of Novo Nordisk’s challenge to the grouping of its products. The court also held that CMS was authorized to implement the Program through guidance for the initial years without notice and comment rulemaking, that the Act did not violate the nondelegation doctrine or the Due Process Clause, and that Novo Nordisk’s First Amendment claim was foreclosed by precedent. View "Novo Nordisk Inc. v. Secretary US Dept & Health and Human Services" on Justia Law

An attorney based in Oklahoma developed a business model to help out-of-state clients enter the state’s medical marijuana industry, which is governed by strict residency and disclosure requirements. He created a two-entity structure: one company, with nominal Oklahoma-resident owners, obtained the necessary state licenses, while a second company, owned and operated by out-of-state clients, ran the actual marijuana operations. The attorney did not disclose the true ownership structure to state authorities, and in some cases, marijuana was grown before the required state registrations were obtained. State authorities began investigating after noticing irregularities, such as multiple licenses listing the same address and repeated use of the same Oklahoma residents as owners, many of whom had little or no involvement in the businesses.Oklahoma state prosecutors charged the attorney with multiple felonies related to his business practices, including conspiracy and submitting false documents. While those charges were pending, a federal grand jury indicted him for drug conspiracy and maintaining drug-involved premises, based on the same conduct. In the United States District Court for the Western District of Oklahoma, the attorney moved to enjoin his federal prosecution, arguing that a congressional appropriations rider barred the Department of Justice from spending funds to prosecute individuals complying with state medical marijuana laws. The district court held an evidentiary hearing and denied the motion, finding that the attorney had not substantially complied with Oklahoma law, particularly due to nondisclosure of ownership interests and failure to obtain required registrations.On appeal, the United States Court of Appeals for the Tenth Circuit affirmed. The court held that the appropriations rider does bar the Department of Justice from spending funds to prosecute private individuals who comply with state medical marijuana laws. However, the court found that the attorney failed to substantially comply with Oklahoma’s requirements, so the rider did not protect him. The court concluded that the district court did not abuse its discretion in denying the injunction. View "United States v. Stacy" on Justia Law

Novartis Pharmaceuticals Corporation manufactures Entresto, a drug used to treat chronic heart failure. MSN Pharmaceuticals, Inc. sought approval from the Food and Drug Administration (FDA) to market a generic version of Entresto by submitting an abbreviated new drug application (ANDA). MSN’s application excluded certain methods of use protected by Novartis’s patents and claimed that the generic drug contained the same active ingredients as Entresto. The FDA approved MSN’s application, prompting Novartis to challenge the approval, arguing that the generic’s labeling and composition were unlawfully different from Entresto.The United States District Court for the District of Columbia reviewed Novartis’s claims under the Administrative Procedure Act. Novartis argued that the FDA’s approval of MSN’s ANDA and denial of Novartis’s citizen petitions were arbitrary and capricious, particularly regarding the omission of patented dosing regimens and indications from the generic’s label, and the determination that the generic contained the same active ingredients as Entresto. The district court granted summary judgment in favor of the FDA, finding that the agency’s actions were reasonable and consistent with statutory and regulatory requirements. Novartis appealed this decision.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that the FDA reasonably concluded the generic drug’s labeling changes were permissible to avoid patent infringement and did not render the generic less safe or effective for non-patented uses. The court also found that the FDA’s determination that the generic and Entresto shared the same active ingredients was supported by scientific evidence and regulatory guidance. The court applied de novo review to legal questions and deferred to the FDA’s scientific expertise, ultimately upholding the agency’s approval of MSN’s ANDA. View "Novartis Pharmaceuticals Corp. v. Kennedy" on Justia Law

An employee at a hospital operated by the University of California, Los Angeles (UCLA Health) photographed confidential patient information and posted it to his personal Instagram account, despite having received training and signing agreements to protect patient privacy. Although the employee redacted some information, personal details of ten patients remained visible. The hospital responded by placing the employee on administrative leave, ultimately terminating him, notifying affected patients, and reiterating privacy policies to staff. No patients reported adverse consequences from the disclosure.The California Department of Public Health investigated and imposed a $75,000 penalty on the hospital, finding a violation of Health and Safety Code section 1280.15, which requires health facilities to prevent unauthorized disclosure of patient medical information. An administrative law judge (ALJ) upheld the Department’s finding and penalty, interpreting section 1280.15 as imposing strict liability for any unauthorized disclosure, regardless of whether the hospital had implemented appropriate safeguards. The ALJ noted that the Department did not find a violation of section 1280.18, which requires reasonable safeguards, but still held the hospital responsible. The Department adopted the ALJ’s decision.The Regents of the University of California challenged the decision in the Superior Court of Sacramento County, seeking a writ of administrative mandate and declaratory relief. The trial court ruled in favor of the hospital, holding that a violation of section 1280.15 cannot occur without a concurrent violation of section 1280.18, thus importing a reasonableness standard into section 1280.15. The court ordered the Department to vacate its decision and remanded the matter.On appeal, the California Court of Appeal, Third Appellate District, affirmed the trial court’s judgment. The court held that section 1280.15 is not a strict liability statute; liability requires a failure to implement reasonable safeguards as mandated by section 1280.18. The hospital was not liable absent proof of such a failure. View "Regents of the Univ. of Cal. v. State Dept. of Public Health" on Justia Law