Justia Government & Administrative Law Opinion Summaries

A medical doctor, employed by San Bernardino Medical Group and working for OptumCare Medical Group, faced a summary suspension of his clinical privileges by PrimeCare Medical Network, Inc. after a patient complaint. The patient alleged that the doctor hit her hand during an office visit, which the doctor admitted to in his notes, explaining it was to stop her from arguing. The next day, PrimeCare’s Chief Medical Officer (CMO) summarily suspended the doctor’s privileges, citing imminent danger to patient health.The Corporate Quality Improvement Committee (CQIC) upheld the suspension pending the doctor’s completion of an anger management course. The doctor requested a formal hearing, and PrimeCare’s Judicial Hearing Committee (JHC) found that the summary suspension was not warranted, as the incident was isolated and did not demonstrate imminent danger. The JHC recommended anger management and a chaperone for the doctor but did not find the suspension justified.PrimeCare’s Board of Directors reviewed the JHC’s decision, arguing it was inconsistent with the applicable burden of proof. The Board conducted an independent review, disagreed with the JHC’s findings, and reinstated the suspension, concluding that the doctor’s actions and subsequent comments posed an imminent threat to patients.The doctor filed a petition for writ of administrative mandamus, which the Superior Court of San Bernardino County granted. The court ruled that the Board exceeded its jurisdiction and committed a prejudicial abuse of discretion by independently reviewing and reversing the JHC’s decision. The court ordered the Board to adopt the JHC’s decision, reinstate the doctor’s privileges, and report the reinstatement to relevant entities.The California Court of Appeal, Fourth Appellate District, affirmed the trial court’s judgment, agreeing that the Board’s actions were unauthorized and inconsistent with the statutory requirement that peer review be performed by licentiates. View "Lin v. Board of Directors of PrimeCare Medical Network" on Justia Law

The case involves the United States government alleging that Regeneron Pharmaceuticals violated the Anti-Kickback Statute (AKS) by covering copayments for patients prescribed Eylea, a drug used to treat wet age-related macular degeneration. The government contends that this action induced doctors to prescribe Eylea, leading to Medicare claims that were "false or fraudulent" under the False Claims Act (FCA) because they "resulted from" the AKS violation.The United States District Court for the District of Massachusetts reviewed the case and agreed with Regeneron's interpretation that the phrase "resulting from" in the 2010 amendment to the AKS requires a but-for causation standard. This means that the government must prove that the AKS violation was the actual cause of the Medicare claims. The district court noted the conflict in case law and sought interlocutory review, which was granted.The United States Court of Appeals for the First Circuit affirmed the district court's ruling. The court held that the phrase "resulting from" in the 2010 amendment to the AKS imposes a but-for causation requirement. The court reasoned that the ordinary meaning of "resulting from" requires actual causality, typically in the form of but-for causation, unless there are textual or contextual indications to the contrary. The court found no such indications in the 2010 amendment or its legislative history. Therefore, to establish falsity under the FCA based on an AKS violation, the government must prove that the kickback was a but-for cause of the submitted claim. View "United States v. Regeneron Pharmaceuticals, Inc." on Justia Law

A medical institute and its co-director sought to provide patients with psilocybin, a schedule I controlled substance, for therapeutic use. They requested the Drug Enforcement Administration (DEA) to exempt the co-director from registration under the Controlled Substances Act (CSA) or to waive the registration requirement. The DEA declined both requests, leading the petitioners to seek judicial review.Previously, the petitioners had asked the DEA for guidance on accommodating the Right to Try Act (RTT Act) for psilocybin use. The DEA responded that the RTT Act did not waive CSA requirements, and the petitioners' initial judicial review was dismissed for lack of jurisdiction. The petitioners then made a concrete request to the DEA for exemption or waiver, which the DEA again denied, prompting the current appeal.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that it had jurisdiction under 21 U.S.C. § 877 to review the DEA's final decision. The court found that the DEA's denial was not arbitrary and capricious. The DEA provided a reasonable explanation, stating that the RTT Act did not exempt the CSA's requirements and that the proposed use of psilocybin was inconsistent with public health and safety. The DEA also noted that the petitioners did not provide sufficient details for the proposed regulation. The court denied the petition for review, affirming the DEA's decision. View "ADVANCED INTEGRATIVE MEDICAL SCIENCE INSTITUTE, PLLC V. UNITED STATES DRUG ENFORCEMENT ADMIN" on Justia Law

A personal care assistant (PCA) in a Medicaid program was investigated for submitting inaccurate records of services provided. The investigation substantiated the allegations, and a committee within the overseeing agency decided to terminate her from the program. The PCA was notified and informed of her right to appeal. An administrative law judge (ALJ) recommended adopting the committee’s determination, which the agency did. The PCA appealed to the superior court, which affirmed the agency’s decision. The PCA then appealed, raising several issues.The superior court found the PCA’s Open Meetings Act claim untimely and concluded that the Administrative Procedures Act (APA) did not apply because the sanction procedures were interpretations of existing regulations. It also determined that the PCA had no property interest in future reimbursements from the program and that her liberty interest in her reputation was not implicated. The court found substantial evidence supported the agency’s findings and the termination sanction.The Supreme Court of Alaska reviewed the case. It concluded that the PCA’s Open Meetings Act claim was untimely and that the APA did not require the Department to promulgate new regulations for the sanctions committee. The court also found that the PCA had a protected liberty interest in her reputation but determined that she received due process through the hearing before the ALJ. The court held that substantial evidence supported the Department’s findings and that the sanctions imposed were reasonable. The Supreme Court of Alaska affirmed the superior court’s decision upholding the agency’s termination of the PCA. View "Thomason v. State" on Justia Law

Lisa Wheeler, a physician assistant and former Assistant Medical Director at Acadia Healthcare Company’s Asheville, North Carolina clinic, filed a complaint alleging that Acadia falsified medical records to claim payments from government healthcare programs. Wheeler claimed that Acadia, which provided methadone-assisted treatment for opioid use disorder, failed to provide required therapy and counseling services, instead fabricating therapy notes to submit fraudulent claims to Medicare, Medicaid, and other government programs.The United States District Court for the Western District of North Carolina dismissed Wheeler’s amended complaint, concluding that she failed to adequately plead that Acadia’s false claims were material or submitted to the government. The court found that Wheeler did not sufficiently allege that Acadia’s failure to provide therapy was material to the government’s payment decisions or that false claims were actually submitted to the government.The United States Court of Appeals for the Fourth Circuit reviewed the case and reversed the district court’s decision. The Fourth Circuit held that Wheeler adequately pled her claims of presentment, false statement, false certification, and fraudulent inducement under the False Claims Act. The court found that Wheeler’s allegations of falsified therapy notes and non-compliance with federal opioid treatment standards were material to the government’s payment decisions. The court also concluded that Wheeler sufficiently alleged that Acadia submitted false claims to government healthcare programs and that the fraudulent conduct was central to the government’s decision to pay.Additionally, the Fourth Circuit held that Wheeler adequately pled her reverse false claim, finding that the stipulated penalties in Acadia’s Corporate Integrity Agreement with the government constituted an obligation under the False Claims Act. The court remanded the case for further proceedings consistent with its opinion. View "United States ex rel. Wheeler v. Acadia Healthcare Company, Inc." on Justia Law

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