Justia U.S. 9th Circuit Court of Appeals Opinion Summaries

Juan Carlos Enriquez, a pharmacy technician, was involved in a scheme to refer Medicare and Medi-Cal beneficiaries to pharmacies owned by his alleged co-conspirator, Irina Sadovsky, in exchange for kickbacks. Enriquez was indicted for conspiracy to receive healthcare kickbacks in violation of 18 U.S.C. § 371 and for receiving prohibited payments in violation of the Anti-Kickback Statute (AKS). He moved to dismiss the indictment, arguing it failed to state an offense and lacked specificity because it did not negate the statutory safe harbor for a bona fide employment relationship under 42 U.S.C. § 1320a-7b(b)(3)(B).The United States District Court for the Central District of California denied Enriquez’s motion to dismiss. Enriquez then entered a conditional guilty plea, reserving the right to appeal the denial of his pretrial motion. The district court sentenced him to one day of imprisonment, followed by two years of supervised release, and ordered him to pay $121,115 in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case. Enriquez argued that the principles from Ruan v. United States, which required the government to prove beyond a reasonable doubt that a defendant knew they were acting in an unauthorized manner under the Controlled Substances Act, should apply to the AKS. He contended that the AKS bona fide employment safe harbor should be treated as a "quasi-element" for pleading purposes. The Ninth Circuit declined to extend Ruan’s reasoning to the AKS or to pleading requirements, affirming that indictments need not allege affirmative defenses. The court held that the indictment provided sufficient detail to inform Enriquez of the charges and enable him to prepare his defense. The district court’s denial of Enriquez’s motion to dismiss was affirmed. View "USA V. ENRIQUEZ" on Justia Law

Elizabeth Holmes and Ramesh "Sunny" Balwani, founders of Theranos, were convicted of defrauding investors about the capabilities of their company's blood-testing technology. Theranos claimed it could run accurate tests with just a drop of blood, attracting significant investments. However, the technology was unreliable, and the company misled investors about its financial health, partnerships, and the validation of its technology by pharmaceutical companies.The United States District Court for the Northern District of California severed their trials due to Holmes's allegations of abuse by Balwani. Holmes was convicted on four counts related to investor fraud, while Balwani was convicted on all counts, including conspiracy to commit wire fraud against investors and patients. Holmes was sentenced to 135 months, and Balwani to 155 months in prison. The district court also ordered them to pay $452 million in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed the convictions, sentences, and restitution order. It held that the district court did not abuse its discretion in admitting testimony from former Theranos employees, even if some of it veered into expert territory. The court found any errors in admitting this testimony to be harmless due to the weight of other evidence against the defendants.The Ninth Circuit also upheld the district court's decision to admit a report from the Center for Medicare and Medicaid Services, finding it relevant to Holmes's knowledge and intent. The court rejected Holmes's argument that the district court violated her Confrontation Clause rights by limiting cross-examination of a former Theranos lab director. Additionally, the court found no merit in Balwani's claims of constructive amendment of the indictment and Napue violations. The court concluded that the district court's factual findings on loss causation and the number of victims were not clearly erroneous and affirmed the restitution order. View "USA V. HOLMES" 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

Julian Omidi and his business, Surgery Center Management, LLC (SCM), were involved in a fraudulent scheme called "Get Thin," which promised weight loss through Lap-Band surgery and other medical procedures. Omidi and SCM defrauded insurance companies by submitting false claims for reimbursement, including fabricated patient data and misrepresented physician involvement. The scheme recruited patients through a call center, pushing them towards expensive medical tests and procedures regardless of medical necessity.A grand jury indicted Omidi and SCM for mail fraud, wire fraud, money laundering, and related charges. After extensive pretrial litigation and a lengthy jury trial, both were convicted on all charges. The district court sentenced Omidi to 84 months in prison and fined SCM over $22 million. The government sought forfeiture of nearly $100 million, arguing that all proceeds from the Get Thin scheme were derived from fraud. The district court agreed, finding that even proceeds from legitimate procedures were indirectly the result of the fraudulent scheme.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed the district court's forfeiture judgment, holding that under 18 U.S.C. § 981(a)(1)(C), all proceeds directly or indirectly derived from a health care fraud scheme must be forfeited. The court rejected the argument that only proceeds from fraudulent transactions should be forfeited, noting that the entire business was permeated with fraud. The court concluded that there is no "100% Fraud Rule" in forfeiture cases seeking proceeds of a fraud scheme, and all proceeds from the Get Thin scheme were subject to forfeiture. View "United States V. Surgery Center Management, LLC" on Justia Law

A group of 53 California hospitals challenged the Secretary of Health and Human Services' (HHS) 2020 low-wage-index policy, which adjusted Medicare payment rates by inflating the rates for the lowest quartile of hospitals and reducing payments to all hospitals by a small percentage. The hospitals argued that the policy violated statutory provisions, was arbitrary and capricious, resulted from a faulty administrative procedure, and was unsupported by evidence.The United States District Court for the Central District of California denied HHS's motion for summary judgment, granted the hospitals' motion for summary judgment, and remanded the matter to the Secretary without vacating the policy. The court held that HHS lacked authority to implement the low-wage-index policy under either the Wage Index Provision or the Exceptions and Adjustments Provision and found procedural defects in the policy's implementation.The United States Court of Appeals for the Ninth Circuit affirmed the district court's holding that the Secretary exceeded his statutory authority in establishing the 2020 wage index. The court held that the low-wage-index policy did not "reflect" area differences in hospital wage levels as required by the statute and that the Exceptions and Adjustments Provision could not independently authorize the policy. The court also vacated the district court's decision to remand the case without vacating the policy, stating that when an agency cannot issue the challenged policy in another way, the only appropriate remedy is vacatur. Judge Nguyen dissented, arguing that the low-wage-index policy was consistent with the statutory text and that the majority's decision would have negative repercussions for vulnerable communities. View "Kaweah Delta Health Care District v. Becerra" on Justia Law

The case involves Planned Parenthood and two physicians challenging the Idaho Attorney General's interpretation of Idaho Code § 18-622(1), which criminalizes performing or attempting to perform an abortion and imposes professional licensing penalties on healthcare providers who assist in performing or attempting to perform an abortion. The Attorney General issued an opinion letter stating that the statute prohibits medical providers from referring patients to out-of-state abortion providers. Plaintiffs argued that this interpretation violates their First Amendment rights by preventing them from providing information about abortion services in other states.The United States District Court for the District of Idaho granted a preliminary injunction, preventing the Attorney General from enforcing his interpretation of the statute. The court found that the plaintiffs had standing, the case was ripe and not moot, and the Attorney General was a proper defendant under Ex parte Young. The court held that the plaintiffs were likely to succeed on the merits of their First Amendment claim and would suffer irreparable harm without an injunction.The United States Court of Appeals for the Ninth Circuit affirmed the district court's decision. The Ninth Circuit held that the plaintiffs had established Article III standing, as they demonstrated a credible threat of prosecution under the Attorney General's interpretation. The case was deemed ripe and not moot despite the Attorney General's withdrawal of the opinion letter, as the withdrawal did not disavow the interpretation. The court also held that the Attorney General was a proper defendant under Ex parte Young due to his authority to assist in the enforcement of the statute. The Ninth Circuit agreed with the district court that the plaintiffs were likely to succeed on the merits of their First Amendment claim and affirmed the preliminary injunction. The request for reassignment to a different district judge was denied. View "PLANNED PARENTHOOD GREAT NORTHWEST, HAWAII, ALASKA V. LABRADOR" on Justia Law

Dr. Fares Jeries Rabadi, a licensed physician in California, had his certificate of registration to dispense controlled substances revoked by the Drug Enforcement Administration (DEA). The DEA initiated an investigation into Rabadi in April 2018 due to his high-risk prescribing practices. In March 2020, the DEA issued an Order to Show Cause and Immediate Suspension of Registration, alleging that Rabadi issued numerous prescriptions for controlled substances outside the usual course of professional practice and not for a legitimate medical purpose to seven individuals. Rabadi requested a hearing before an administrative law judge (ALJ), which took place in September 2020. The ALJ found Rabadi's testimony not credible and recommended revoking his registration. The DEA Administrator adopted the ALJ's recommendations with minor modifications and revoked Rabadi's registration.Rabadi petitioned for review, arguing that the DEA's revocation was invalid because DEA ALJs are unconstitutionally insulated from removal by two layers of "for-cause" protections. The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that Rabadi's argument failed under Decker Coal Co. v. Pehringer, which found similar ALJ removal protections constitutional. The court noted that DEA ALJs perform purely adjudicatory functions, Congress does not mandate the use of ALJs for DEA hearings, and DEA ALJ decisions are reviewed de novo by the DEA Administrator, who is removable at will by the President.Rabadi also argued that the DEA Administrator's order was arbitrary and capricious. The court rejected this argument, finding that the Administrator properly ignored Rabadi's unsupported defense regarding high dosages of prescribed drugs and appropriately analyzed the public interest factors, including Rabadi's lack of a conviction record. The Ninth Circuit denied Rabadi's petition for review, upholding the DEA Administrator's order. View "RABADI V. USDEA" on Justia Law

The case involves the Hawai‘i Disability Rights Center (HDRC), which represents individuals with developmental disabilities, including children with autism. HDRC alleges that the Hawai‘i Departments of Education (DOE) and Human Services (DHS) unlawfully deny students with autism access to Applied Behavioral Analysis (ABA) therapy during school hours, even when medically necessary. DOE provides ABA services only if deemed educationally relevant, and DHS does not provide ABA services during school hours, even if medically necessary and covered by Medicaid or private insurance.The United States District Court for the District of Hawaii granted summary judgment in favor of DOE and DHS, holding that HDRC's failure to exhaust administrative procedures under the Individuals with Disabilities Education Act (IDEA) was fatal to all its claims, including those under the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, and the Medicaid Act. The court concluded that HDRC, as a protection and advocacy organization, must ensure that parents of its constituents exhaust the IDEA’s administrative process.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that HDRC, as Hawai‘i’s designated protection and advocacy system, can pursue administrative remedies under the IDEA and is therefore bound by the IDEA’s administrative exhaustion requirement for its own claim. However, HDRC need not ensure that parents of individual children with autism exhaust their individual IDEA claims. The court found that HDRC did not exhaust its administrative remedies, and no exceptions to IDEA exhaustion applied.The Ninth Circuit also held that HDRC was not required to exhaust the IDEA’s administrative procedures before bringing its claims under the ADA, Section 504, and the Medicaid Act. The court concluded that HDRC’s non-IDEA claims do not allege the denial of a free appropriate public education (FAPE) and therefore do not require exhaustion under the IDEA. The court affirmed in part, reversed in part, and remanded the case. View "HAWAI'I DISABILITY RIGHTS CRT. V. KISHIMOTO" on Justia Law

The case involves a challenge to Montana House Bill 702 (HB 702), which prohibits discrimination based on vaccination status. Plaintiffs, including health care providers and individuals with compromised immune systems, argued that HB 702 is preempted by the Americans with Disabilities Act (ADA) and the Occupational Health and Safety Act (OSH Act) and violates the Equal Protection Clause of the Fourteenth Amendment. They sought to invalidate HB 702 in all health care settings, claiming it prevents employers from knowing employees' vaccination status, thus hindering ADA-required accommodations and OSH Act compliance.The United States District Court for the District of Montana ruled in favor of the plaintiffs, holding that HB 702 is preempted by the ADA and the OSH Act and violates the Equal Protection Clause. The court issued a permanent injunction against the enforcement of HB 702 in health care settings, reasoning that the law conflicts with federal requirements for reasonable accommodations and workplace safety.The United States Court of Appeals for the Ninth Circuit reversed the district court's decision and vacated the injunction. The Ninth Circuit held that neither the ADA nor the OSH Act facially preempts HB 702 in health care settings. The court found that the plaintiffs did not demonstrate a genuine conflict between HB 702 and the ADA or OSH Act in any specific case, much less in all health care settings. The court also held that HB 702 does not violate the Equal Protection Clause, as the classification and differential treatment of facilities could rationally reflect Montana's interest in balancing personal privacy and public health.The Ninth Circuit reserved judgment on whether the ADA and the OSH Act could preempt HB 702 on a narrower, as-applied basis in future cases. The court deemed moot the portion of the district court's order related to interim CMS regulations, as those regulations have been rescinded. The court concluded that HB 702 is not facially invalid under the ADA, OSH Act, or Equal Protection Clause and vacated the district court's injunction in full. View "MONTANA MEDICAL ASSOCIATION V. KNUDSEN" on Justia Law

The case involves Sam Sarkis Solakyan, who owned multiple medical-imaging companies. Solakyan conspired with physicians and medical schedulers to route unsuspecting patients to his companies for unnecessary MRI scans and other medical services, generating $263 million in claims. The scheme involved bribery and kickbacks to physicians who referred patients to Solakyan’s companies, violating California’s anti-kickback statutes.The United States District Court for the Southern District of California presided over the initial trial. Solakyan was charged with conspiracy to commit honest-services mail fraud and health-care fraud, as well as substantive counts of honest-services mail fraud and aiding and abetting. After a seven-day trial, the jury found Solakyan guilty on all counts. The district court sentenced him to 60 months in prison and ordered him to pay $27,937,175 in restitution to the affected insurers.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed Solakyan’s conviction, holding that honest-services mail fraud under 18 U.S.C. §§ 1341 and 1346 includes bribery and kickback schemes that deprive patients of their right to honest services from their physicians. The court also held that actual or intended tangible harm is not an element of honest-services fraud. The indictment was found sufficient in alleging willful misconduct for health-care fraud. The court did not find any abuse of discretion in the jury instructions regarding the mens rea for the conspiracy charges or the use of mails in the fraud scheme. However, the court vacated the restitution order, remanding the case for further proceedings to determine if the restitution amount should be reduced by the cost of medically necessary MRIs that insurers would have paid for absent the fraud. View "USA V. SOLAKYAN" on Justia Law