Justia Government & Administrative Law Opinion Summaries

A group of anesthesiology specialty medical practices sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to challenge the Merit-based Incentive Payment System (MIPS). MIPS evaluates eligible clinicians across several performance categories and adjusts their Medicare reimbursement rates accordingly. The plaintiffs received unfavorable MIPS scores and argued that the Total Per Capita Cost (TPCC) measure, one of MIPS’s performance metrics, was arbitrary and capricious as applied to them.The United States District Court for the Northern District of Texas concluded that the plaintiffs' suit was statutorily barred and granted summary judgment for the defendants. The district court determined that 42 U.S.C. §§ 1395w-4(q)(13)(B)(iii) and (p)(10)(C) preclude judicial review of the plaintiffs' claims. Additionally, the court found that even if the claims were justiciable, CMS did not exceed its statutory authority in establishing the TPCC measure and its attribution methodology, and that the TPCC measure, as applied to the plaintiffs, was not arbitrary or capricious.The United States Court of Appeals for the Fifth Circuit reviewed the case and affirmed the district court’s dismissal. The appellate court agreed that 42 U.S.C. § 1395w-4(q)(13)(B)(iii) bars judicial review of the plaintiffs' challenge because CMS’s establishment of an attribution methodology for the TPCC measure falls within the “identification of measures and activities.” The court also concluded that 42 U.S.C. § 1395w-4(p)(10)(C) bars judicial review of the plaintiffs' claims, as it precludes review of the evaluation of costs, including the establishment of appropriate measures of costs. The court found no merit in the plaintiffs' assertion that CMS exceeded its statutory authority. Thus, the appellate court affirmed the district court’s decision to dismiss the plaintiffs' claims for lack of jurisdiction. View "U.S. Anesthesia Partners of Texas v. Health and Human Services" on Justia Law

The Pharmaceutical Coalition for Patient Access (the Coalition), a charitable organization involving drug manufacturers, challenged an unfavorable advisory opinion issued by the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS). The dispute centered on the Coalition’s proposed patient assistance program for Medicare beneficiaries, which aimed to subsidize co-pays for oncology drugs. The OIG determined that the program would violate the Anti-Kickback Statute if the required mens rea were present, as it would offer remuneration to induce the purchase of specific drugs.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the defendants, the United States, HHS, and related officials, and dismissed the Coalition’s claims. The court found that the OIG’s advisory opinion was not arbitrary or capricious and that the Coalition’s program would indeed fall within the Anti-Kickback Statute’s prohibitions.The United States Court of Appeals for the Fourth Circuit reviewed the case de novo. The court affirmed the district court’s decision, agreeing that the word “induce” in the Anti-Kickback Statute should be construed under its ordinary meaning, not its specialized criminal law meaning. The court also concluded that “remuneration” in the statute includes any payment or compensation, not just corrupt payments that distort medical decision-making. The court found that the Coalition’s program involved a quid pro quo, as it offered subsidies for the purchase of specific drugs.The Fourth Circuit also upheld the district court’s dismissal of the Coalition’s disparate treatment claim for lack of subject matter jurisdiction, ruling that the OIG’s enforcement discretion is not subject to judicial review. The court concluded that the OIG had consistently applied the Anti-Kickback Statute to similar proposals and that the Coalition’s challenge was directed against the OIG’s enforcement discretion, which is unreviewable under the Administrative Procedure Act. View "Pharmaceutical Coalition for Patient Access v. United States" on Justia Law

Steven M. Camburn, a former sales specialist for Novartis Pharmaceuticals Corporation, filed a qui tam action under the False Claims Act (FCA) and equivalent state and municipal laws. Camburn alleged that Novartis violated the Anti-Kickback Statute (AKS) by offering remuneration to physicians to induce them to prescribe its drug Gilenya, which treats multiple sclerosis. He claimed that Novartis used its peer-to-peer speaker program and other forms of illicit remuneration to influence physicians' prescribing practices.The United States District Court for the Southern District of New York dismissed Camburn's Third Amended Complaint (TAC) with prejudice, concluding that he had not pleaded his allegations with the particularity required under Rule 9(b) to support a strong inference of an AKS-based FCA violation. The court found that Camburn's allegations did not adequately demonstrate the existence of a kickback scheme.The United States Court of Appeals for the Second Circuit reviewed the case and held that a plaintiff states an AKS violation if they allege with particularity that at least one purpose of the purported scheme was to induce fraudulent conduct. The court found that Camburn had adequately pleaded certain categories of factual allegations that gave rise to a strong inference of an AKS violation. Specifically, Camburn sufficiently alleged that Novartis held sham speaker events with no legitimate attendees, excessively compensated physician speakers for canceled events, and selected and retained speakers to incentivize prescription-writing.The Second Circuit affirmed the district court's dismissal in part but vacated the judgment and remanded the case in part. The court instructed the district court to evaluate whether Camburn had stated all the elements of an FCA claim with respect to the adequately pleaded AKS violations and to assess the adequacy of Camburn's claims under state and municipal law. View "Camburn v. Novartis Pharmaceuticals Corporation" on Justia Law

Dr. Judith Robinson, a former employee of HealthNet, a federally qualified health center in Indiana, brought a qui tam action against HealthNet, alleging fraudulent billing practices, including improper Medicaid billing for ultrasound readings. She claimed that HealthNet billed Medicaid for face-to-face encounters that did not occur. Dr. Robinson initially filed a suit in 2013 (Robinson I), which was settled in 2017, excluding the wrap-around claims. These claims were dismissed without prejudice, allowing for future litigation.In 2019, Dr. Robinson filed a new suit (Robinson II) to address the wrap-around claims. The United States declined to intervene, but Indiana did. Indiana moved to dismiss all claims except for the wrap-around claims from October 18, 2013, to February 28, 2015, as the rest were time-barred. The district court dismissed Count III of Dr. Robinson's complaint, which sought to enforce an alleged oral settlement agreement, due to lack of standing, as Dr. Robinson failed to provide competent proof of the agreement's existence.The United States Court of Appeals for the Seventh Circuit reviewed the case. The court affirmed the district court's dismissal of Count III, agreeing that Dr. Robinson lacked standing because she did not demonstrate any breach of the alleged oral agreement by HealthNet. The court also upheld the district court's approval of the settlement between Indiana and HealthNet, finding it fair, adequate, and reasonable. The court noted that the reduction in the relator’s share was due to Dr. Robinson's own actions, including the failure to obtain a tolling agreement, which led to many claims being time-barred. The court also agreed with the application of the Federal Medical Assistance Percentage (FMAP) in calculating the settlement amount. View "Robinson v. Healthnet, Inc." on Justia Law

Troy Olhausen, a former Senior Vice President of Business Development and Marketing at Arriva Medical, LLC, filed a qui tam action under the False Claims Act against his former employers, Arriva, Alere, Inc., and Abbott Laboratories, Inc. He alleged that the defendants submitted fraudulent claims to the Center for Medicare and Medicaid Services (CMS) for reimbursement. Specifically, Olhausen claimed that Arriva submitted claims without obtaining required assignment-of-benefits signatures and failed to disclose or accredit certain call-center locations that processed claims.The United States District Court for the Southern District of Florida dismissed Olhausen’s third amended complaint, holding that he failed to plead with the particularity required under Federal Rule of Civil Procedure 9(b) that any fraudulent claims were actually submitted to the government. The district court found that Olhausen did not provide sufficient details to establish that false claims had been submitted, as he did not work in the billing department and lacked firsthand knowledge of the claim submissions.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the case. The court concluded that Olhausen adequately pled with particularity that allegedly false claims were submitted under Count II, which involved claims for heating pads that lacked assignment-of-benefits signatures. The court found that the internal audit allegations provided sufficient indicia of reliability to satisfy Rule 9(b). However, the court upheld the dismissal of Count IV, which alleged that Arriva failed to disclose or accredit certain call-center locations, as Olhausen did not adequately allege that any claims involving these locations were actually submitted. Consequently, the court vacated the dismissal of Counts II and VI (conspiracy) and remanded them for further proceedings, while affirming the dismissal of Count IV. View "Olhausen v. Arriva Medical, LLC" on Justia Law

A man named Johnathon Lerke, who was under a Murphy conservatorship, challenged his confinement in a county jail while awaiting transfer to a state hospital. Murphy conservatorships are for individuals found incompetent to stand trial and deemed a danger to others. Despite being ordered to a state hospital, Lerke was held in county jail for months due to a lack of space at the hospital. He argued that his confinement in jail was unauthorized and violated his rights.The Superior Court initially found Lerke incompetent to stand trial and ordered him to a state hospital for competency restoration. After nearly two years, the hospital reported that Lerke had not regained competence. Subsequently, a Murphy conservatorship was established, requiring his placement in a state hospital. However, due to the unavailability of space, he remained in county jail. Lerke's counsel requested his release or transfer to a local psychiatric hospital, but the court denied the request, stating that he would remain in jail until a state hospital bed became available.The California Court of Appeal, Fourth Appellate District, reviewed the case. The court concluded that no legal authority permitted Lerke’s indefinite detention in county jail pending his transfer to the state hospital. The statutory framework requires conservatees to be placed in treatment facilities that promote their treatment and protect the public, and county jails do not meet these requirements. Although the court found Lerke’s confinement in jail unlawful, it denied habeas relief because he had already been transferred to an authorized treatment facility during the proceedings. The petition for writ of habeas corpus was denied as moot. View "In re Lerke" on Justia Law

The case involves five severely developmentally disabled men who require intensive care in a residential treatment setting and receive services through New Hampshire’s developmental services system. These services were provided by the Judge Rotenberg Educational Center, Inc. (JRC) in Massachusetts, funded by federal Medicaid home and community-based services (HCBS) waiver funding. In 2022, the federal Centers for Medicare and Medicaid Services (CMS) informed the New Hampshire Department of Health and Human Services (DHHS) that JRC was not an approved HCBS provider, and funding for services at JRC would cease. DHHS committed to funding the services with state funds temporarily, but this was not extended beyond September 2, 2022.The petitioners appealed to the DHHS Administrative Appeals Unit (AAU), arguing that the termination of funding without an alternative placement amounted to a termination of their services. The Commissioner initially ordered DHHS to continue funding during the appeals. However, in March 2023, the Commissioner granted summary judgment to DHHS, ruling that the services were not terminated but required to be provided in a qualified facility. The Commissioner also ruled that RSA chapter 171-A prohibits DHHS from using state funds for services that do not comply with the federal Settings Rule.The Supreme Court of New Hampshire reviewed the case and concluded that the petitioners had a right to appeal the termination and non-renewal of their service contracts with JRC. However, the court affirmed the Commissioner’s decision, holding that RSA chapter 171-A prohibits DHHS from using state funds for services provided by a provider that does not comply with the federal Settings Rule. Thus, the court affirmed the summary judgment in favor of DHHS. View "Petition of Mason" on Justia Law

Jerry L. Blankenship applied for living miner benefits under the Black Lung Benefits Act, claiming he suffered from coal dust-induced pneumoconiosis and was totally disabled. An Administrative Law Judge (ALJ) found Blankenship entitled to a rebuttable presumption of total disability due to pneumoconiosis under 30 U.S.C. § 921(c)(4) and determined that his former employer, Island Creek Coal Company, failed to rebut this presumption. Consequently, Blankenship was awarded benefits. The Benefits Review Board affirmed the ALJ’s decision.Island Creek petitioned for review, arguing that the ALJ improperly conflated the presence of pneumoconiosis and disability causation with the separate total disability analysis. Additionally, Island Creek contended that the ALJ failed to adequately explain his decision to credit the opinions of Blankenship’s medical experts over those of Island Creek’s experts.The United States Court of Appeals for the Fourth Circuit reviewed the case and agreed with Island Creek. The court found that the ALJ improperly relied on the presence of pneumoconiosis and the causation of Blankenship’s impairment in concluding that he was totally disabled. The court also determined that the ALJ failed to provide a sufficient explanation for crediting the medical opinions of Drs. Nader and Green over those of Drs. McSharry and Sargent, violating the duty of explanation under the Administrative Procedure Act.The Fourth Circuit granted Island Creek’s petition for review, vacated the decision of the Benefits Review Board, and remanded the case with instructions for the Board to return Blankenship’s case to the ALJ for reconsideration consistent with the court’s opinion. View "Island Creek Coal Co. v. Blankenship" on Justia Law

The case involves the interpretation of Administrative Code of the City of New York § 12-126, which mandates that New York City pay the full cost of health insurance coverage for active employees, retirees, and their dependents, up to a specified cap. The dispute centers on whether the City is required to pay up to the statutory cap for any health insurance plan it offers or just one plan. Petitioners argue that the City must pay for any plan offered, while the City contends it only needs to pay for one plan and any additional plans are subject to collective bargaining agreements.The Supreme Court of New York County granted a preliminary injunction preventing the City from enforcing an opt-out date for a new Medicare Advantage plan and later permanently enjoined the City from passing any costs of the current plan to retirees, except where costs exceed the statutory cap. The court did not determine the exact statutory cap but suggested that the cost of the Senior Care plan did not exceed it. The Appellate Division affirmed the Supreme Court's decision, agreeing that the City must pay the full cost, up to the statutory cap, for any health insurance plan it offers to retirees.The Court of Appeals of New York affirmed the Appellate Division's decision, holding that § 12-126 requires the City to pay up to the statutory cap for each health insurance plan it offers to employees and retirees. The court did not address the issue of how the statutory cap should be determined for Medicare-eligible retirees, as the City had not preserved this question for review. The court concluded that the legislative history supported the interpretation that the City must pay for any plan it offers, aligning with the intent to provide a choice of health insurance plans to employees and retirees. View "Matter of NYC Org. of Pub. Serv. Retirees, Inc. v Campion" on Justia Law

Vanda Pharmaceuticals, Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request, citing a partial clinical hold on the drug due to the lack of long-term animal studies to assess its toxicological effects. Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA, upholding the agency's decision. Vanda then appealed to the United States Court of Appeals for the District of Columbia Circuit.The Court of Appeals affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs. The court also noted that the FDA's definition of the unmet medical need as long-term treatment of gastroparesis symptoms was reasonable, given the chronic nature of the condition and the existing short-term treatment options. The court rejected Vanda's arguments that the FDA's decision was inconsistent with its prior positions and that the agency improperly considered the clinical hold. The court concluded that the FDA's decision was supported by a rational connection between the facts found and the choice made. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law