Justia Government & Administrative Law Opinion Summaries

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

After the Washington Medical Commission adopted a policy to discipline physicians for spreading COVID-19 “misinformation,” several plaintiffs—including physicians who had been charged with unprofessional conduct, physicians who had not been charged, and advocacy organizations—filed suit. The Commission’s actions included investigating and charging doctors for public statements and writings about COVID-19 treatments and vaccines. Some plaintiffs, such as Dr. Eggleston and Dr. Siler, were actively facing disciplinary proceedings, while others, like Dr. Moynihan, had not been charged but claimed their speech was chilled. Additional plaintiffs included a non-profit organization and a public figure who alleged their right to receive information was affected.The United States District Court for the Eastern District of Washington dismissed the plaintiffs’ First Amended Complaint. The court found that the claims were constitutionally and prudentially unripe, and that the doctrine of Younger abstention required federal courts to refrain from interfering with ongoing state disciplinary proceedings. The district court also addressed the merits, concluding that the plaintiffs failed to state a plausible First Amendment or due process claim, but the primary basis for dismissal was abstention and ripeness.On appeal, the United States Court of Appeals for the Ninth Circuit affirmed the district court’s dismissal. The Ninth Circuit held that Younger abstention barred claims challenging ongoing state disciplinary proceedings (including as-applied and facial constitutional challenges, and due process claims) for all plaintiffs subject to such proceedings. The court also held that Younger abstention did not apply to claims for prospective relief by plaintiffs not currently subject to proceedings, but those claims were constitutionally and prudentially unripe because no concrete injury had occurred and further factual development was needed. The Ninth Circuit thus affirmed the dismissal of all claims. View "STOCKTON V. BROWN" on Justia Law

Central Vermont Medical Center (CVMC) submitted its proposed budget for fiscal year 2025, seeking an 11.9% increase in net patient service revenue (NPR) and a 5.5% increase in commercial rates, both of which exceeded the benchmarks set by the Green Mountain Care Board. The Board’s benchmarks, established in its annual guidance, were 3.5% for NPR growth and 3.4% for commercial rate growth. The Board required hospitals exceeding these benchmarks to provide credible justification, such as evidence of improved access or quality of care. CVMC’s submission was reviewed through hearings and public comment, during which the Board found that CVMC’s justifications were insufficient, particularly regarding efficiency, productivity, and cost containment.The Green Mountain Care Board, after considering the evidence and statutory obligations, modified CVMC’s budget, allowing a 6% NPR growth and a 3.4% commercial rate increase. The Board found that CVMC could achieve financial sustainability through cost reductions and improved productivity rather than higher price increases. The Board imposed specific terms and conditions on the budget, emphasizing the need for efficient operations and balancing financial needs with statewide health care affordability and access.On appeal, the Vermont Supreme Court reviewed the Board’s decision under a deferential standard, presuming the Board’s actions valid unless shown otherwise by clear and convincing evidence. The Court rejected CVMC’s arguments that the Board acted with unfettered discretion, violated procedural due process, or was required to regulate on a per-capita basis. The Court found that the Board’s process was guided by statutory standards, rules, and annual guidance, and that CVMC had adequate notice and opportunity to participate. The Supreme Court of Vermont affirmed the Board’s decision. View "In re Central Vermont Medical Center Fiscal Year 2025" on Justia Law

Two pharmaceutical companies challenged a federal program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain high-expenditure prescription drugs lacking generic competition. Under this program, manufacturers of selected drugs must either negotiate a price with CMS or face steep excise taxes on all sales of those drugs, unless they withdraw all their products from specific Medicare and Medicaid programs. Both companies had drugs selected for negotiation and, while litigation was pending, agreed to participate and reached negotiated prices.The United States District Court for the District of New Jersey resolved the cases on cross-motions for summary judgment, as the parties agreed there were no material factual disputes. The District Court ruled in favor of the government, holding that the program did not violate the Takings Clause, the First Amendment, or the unconstitutional conditions doctrine. The companies appealed, and the United States Court of Appeals for the Third Circuit consolidated the appeals.The Third Circuit affirmed the District Court’s orders. It held that participation in Medicare and the negotiation program is voluntary, so there is no physical taking under the Fifth Amendment. The court found that economic incentives to participate do not amount to legal compulsion. It also held that the program’s requirements do not compel speech in violation of the First Amendment, as any speech involved is incidental to the regulation of conduct and participation is voluntary. Finally, the court concluded that the program does not impose unconstitutional conditions, as any compelled speech is limited to the contracts necessary to effectuate the program and does not restrict speech outside those contracts. The court affirmed summary judgment for the government. View "Bristol Myers Squibb Co v. Secretary United States Department of HHS" on Justia Law