Justia Health Law 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

In the 1950s, Bert and Donna Miller sought fertility treatment at the University of Iowa Hospitals and Clinics. Dr. John H. Randall, the head of the department, assisted them, resulting in the birth of three children. Decades later, DNA testing revealed that Dr. Randall, not Bert Miller, was the biological father of two of the children. The plaintiffs, Bert Miller and Nancy Duffner, sued the State of Iowa under the Fraud in Assisted Reproduction Act (FARA), alleging that Dr. Randall used his own sperm without their parents' knowledge or consent.The Iowa District Court for Johnson County dismissed the case, ruling that FARA, enacted in 2022, does not apply retroactively to actions taken decades earlier. The court found that FARA lacks any express language indicating legislative intent for retrospective application, and thus, it operates only prospectively. The plaintiffs appealed, arguing that FARA's provision allowing children to sue "at any time" implies retroactive application.The Iowa Supreme Court reviewed the case and affirmed the district court's decision. The court held that FARA does not apply to fertility fraud committed before the statute was enacted. The court emphasized that without an express retroactivity provision, statutes creating new substantive liabilities are presumed to operate only prospectively. The court found no language in FARA that rebuts this presumption and concluded that the statute's provision allowing actions to be brought "at any time" pertains only to future violations. Therefore, the plaintiffs' claims were dismissed with prejudice. View "Miller v. State" on Justia Law

A.J. began experiencing auditory hallucinations around 2010, leading to multiple hospitalizations and incarcerations. Diagnosed with schizophrenia in 2023, he was found mentally incompetent to stand trial on various charges. The criminal court vacated the incompetency order and directed the Public Guardian to investigate an LPS conservatorship. The Public Guardian filed a petition, citing A.J.'s grave disability due to mental health and substance abuse disorders. A.J.'s psychiatrist and social worker testified about his lack of insight into his illness, unwillingness to take medication, and history of aggressive behavior.The trial court appointed a temporary conservator in 2024. During a jury trial, the social worker and psychiatrist testified about A.J.'s inability to maintain housing due to his mental illness and aggressive behavior. The jury found A.J. gravely disabled. The trial court then appointed the Public Guardian as his conservator, granting the power to place him in a psychiatric or other state-licensed facility.The California Court of Appeal, First Appellate District, reviewed the case. A.J. argued that the Public Guardian's closing argument improperly suggested he was unable to provide shelter due to past involuntary detentions and that the trial court improperly delegated the duty to designate the least restrictive placement. The court disagreed with A.J.'s first argument, finding no authority to support his claim and noting that the Public Guardian's argument was based on multiple factors. However, the court agreed that the trial court failed to designate the least restrictive placement, as required by law. The court remanded the case for the trial court to designate the least restrictive placement but otherwise affirmed the judgment. View "In re Conservatorship of the Person of A.J." on Justia Law

Dr. Omar Almusa, a licensed medical physician and surgeon in Pennsylvania, unlawfully distributed hydrocodone between 2014 and 2018. He pleaded guilty to unlawful dispensing and distributing a controlled substance, conspiracy to distribute, and health care fraud. In 2019, he was sentenced to 24 months in prison followed by three years of supervised release. Consequently, the State Board of Medicine automatically suspended his medical license for at least ten years, effective August 15, 2019.Almusa did not appeal the suspension. In 2020, the General Assembly enacted Act 53, redefining how licensing boards consider criminal offenses, specifying that only drug trafficking offenses (involving at least 100 grams of a controlled substance) warrant automatic suspension. Almusa's offense did not meet this threshold. In 2021, Almusa petitioned for reinstatement of his license, arguing that Act 53 should apply to his case, allowing him to seek reinstatement without waiting ten years.The Board denied his petition, stating that Act 53 did not apply retroactively to suspensions imposed before its enactment. The Commonwealth Court affirmed the Board's decision, interpreting the suspension and reinstatement as a single action requiring a ten-year suspension period.The Supreme Court of Pennsylvania reversed the Commonwealth Court's decision. It held that automatic suspension and reinstatement are separate actions under the Medical Practice Act. The Court found that Act 53, effective December 28, 2020, applies to reinstatement proceedings initiated after this date. Since Almusa's offense did not qualify as drug trafficking under Act 53, the ten-year waiting period did not apply to his reinstatement petition. The Court concluded that Almusa was entitled to have his reinstatement petition considered under the new law. View "Almusa v. State Board of Medicine" on Justia Law

Real Time Medical Systems, LLC provides analytics services to skilled nursing facilities by accessing health records from PointClickCare Technologies, Inc., which operates a system hosting patients’ electronic health records. Real Time uses automated bots to access these records. PointClickCare, citing security and performance concerns, blocked users suspected of using bots. Real Time sued to stop PointClickCare from restricting its access, and the district court granted a preliminary injunction in favor of Real Time.The United States District Court for the District of Maryland granted Real Time a preliminary injunction, finding that PointClickCare’s actions likely constituted information blocking under the 21st Century Cures Act. The court concluded that Real Time was likely to succeed on the merits of its claims for unfair competition and tortious interference with contracts. The court also found that Real Time would suffer irreparable harm without the injunction, that the balance of equities favored Real Time, and that the public interest supported granting the injunction.The United States Court of Appeals for the Fourth Circuit reviewed the case and affirmed the district court’s decision. The Fourth Circuit agreed that Real Time was likely to succeed on the merits of its unfair competition claim, as PointClickCare’s actions likely violated the Cures Act’s prohibition on information blocking. The court found that PointClickCare failed to demonstrate that any exceptions to the information-blocking provision applied. The court also agreed that Real Time would suffer irreparable harm without the injunction, that the balance of equities favored Real Time, and that the public interest supported the injunction. The court concluded that the district court did not abuse its discretion in granting the preliminary injunction. View "Real Time Medical Systems, Inc. v. PointClickCare Technologies, Inc." on Justia Law

Joe May was indicted for conspiracy to commit wire fraud, mail fraud, and violations of the Anti-Kickback statute, among other charges, related to defrauding TRICARE. May, a medical doctor, was recruited to sign prescriptions for compounded drugs without evaluating patients. He signed 226 prescriptions, mostly without determining medical necessity. May received cash payments for his participation. When investigated, May created false medical records and lied to the FBI.The United States District Court for the Eastern District of Arkansas convicted May on all counts and sentenced him to 102 months imprisonment, ordering restitution of over $4.6 million. May appealed, challenging the admission of business records, limitations on cross-examination, jury instructions, the government's closing argument, and the sufficiency of evidence for certain charges.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court found no abuse of discretion in admitting business records or limiting cross-examination. The court upheld the jury instructions and found no error in the government's closing argument. The court determined there was sufficient evidence for the conspiracy, mail fraud, and kickback charges. However, the court found plain error in one count of aggravated identity theft related to Perry Patterson, as the jury was not instructed on the correct underlying offense.The Eighth Circuit reversed the conviction on the aggravated identity theft count related to Patterson, remanded to vacate the special assessment for that count, and affirmed all other aspects of the case. View "United States v. May" on Justia Law

Several skilled nursing facilities challenged the State Department of Health Care Services and its director, Michelle Baass, over the formula used to calculate Medi-Cal reimbursement overpayments. The plaintiffs argued that the Department's method, which was based on the amount Medicare paid for ancillary services rather than the amount Medi-Cal overpaid, violated a ministerial duty and constituted an underground regulation.The trial court sustained the Department's demurrer without leave to amend, concluding that the plaintiffs' claim was not cognizable in a traditional writ of mandate proceeding. The court also found that the plaintiffs failed to state a claim that the Department violated a ministerial duty or adopted an underground regulation. Additionally, the trial court denied the plaintiffs' motion to compel discovery of certain documents, deeming them privileged.The California Court of Appeal, Third Appellate District, reviewed the case. The court determined that some of the plaintiffs' claims were indeed cognizable in a traditional writ of mandate proceeding and that the petition stated a claim for relief regarding the Department's use of an underground regulation when calculating Medi-Cal reimbursement overpayments. However, the court found that the plaintiffs did not provide an adequate record to review whether the trial court erred in denying their motion to compel discovery.The appellate court reversed the judgment of dismissal and affirmed the trial court's order denying the plaintiffs' motion to compel. The case was remanded to the trial court with instructions to vacate its order sustaining the Department's demurrer without leave to amend and to enter a new order overruling the demurrer. The plaintiffs were awarded their costs on appeal. View "California Healthcare & Rehabilitation Center v. Baass" on Justia Law

Daniel R. Smith, who is currently blind, underwent medical examinations upon entering military service in August 1964 and upon leaving in June 1965. Both examinations noted poor night and color vision, with vision correctable in both eyes. After his discharge, Smith filed several claims with the U.S. Department of Veterans Affairs (VA) for benefits based on retinitis pigmentosa, an eye disease causing vision loss. An ophthalmologist opined that Smith's condition preexisted his service and did not worsen during service. The VA denied his claim, and the Board of Veterans’ Appeals agreed, finding clear and unmistakable evidence rebutting the presumption of sound health upon entry into service. The Court of Appeals for Veterans Claims affirmed this decision.The United States Court of Appeals for Veterans Claims reviewed the case and affirmed the Board's decision, finding that Dr. Wilson's opinion constituted clear and unmistakable evidence that Smith's retinitis pigmentosa did not increase in severity during service. Smith appealed, arguing that Dr. Wilson's opinion did not meet the clear and unmistakable evidence standard and that it improperly relied on the absence of evidence.The United States Court of Appeals for the Federal Circuit reviewed the case and dismissed Smith's appeal. The court held that it lacked jurisdiction to review the factual determination that Dr. Wilson's opinion met the clear and unmistakable evidence standard. The court also found that the Veterans Court did not rely on an absence of evidence but rather on affirmative evidence comparing Smith's vision tests at entry and separation from service. Therefore, the Federal Circuit concluded that it could not address Smith's legal contention regarding the sufficiency of the evidence. View "SMITH v. COLLINS " on Justia Law

The case involves the U.S. Centers for Medicare & Medicaid Services (CMS) approving the New York State Department of Health’s (NYSDOH) application to distribute $361.25 million to certain managed care organizations. These organizations were to direct the funds to the top one-third of revenue-generating licensed home care services agencies (LHCSAs) in New York’s four rate regions, provided they agreed to use the funding in a specified manner. The plaintiffs, who are LHCSAs that did not meet the revenue threshold, argued that the approval was unlawful under federal law and regulations because the class of eligible agencies was improperly defined and the application was not assessed for actuarial soundness before approval.The district court dismissed the amended complaint against the State Appellees for failing to adequately allege a cause of action under Ex parte Young and granted summary judgment to the Federal Appellees. The court concluded that the approval of the State’s application did not violate the Administrative Procedure Act (APA) and denied the plaintiffs’ motion to admit extra-record evidence.The United States Court of Appeals for the Second Circuit reviewed the case and agreed with the district court’s decision. The court held that CMS’s approval of NYSDOH’s application complied with federal law. It found that the provider class was properly defined under 42 C.F.R. § 438.6(c)(2)(ii)(B) and that CMS was not required to assess actuarial soundness during the pre-approval process. The court also concluded that CMS did not act arbitrarily or capriciously in approving the application and that the district court did not abuse its discretion in excluding the extra-record evidence. Consequently, the Second Circuit affirmed the judgment of the district court. View "Safe Haven Home Care, Inc. v. United States Department of Health and Human" on Justia Law

A father, Scott Williams, and his son, Taeyan Williams, were convicted by a federal jury of various drug-related offenses, including conspiracy to distribute and possess with intent to distribute marijuana and cocaine. The case stemmed from an investigation into the disappearance of a drug dealer, Noah Smothers, who supplied drugs to Scott and Taeyan. A search of Scott's home revealed large quantities of drugs, firearms, and cash. Both Scott and Taeyan were found guilty of conspiracy and possession with intent to distribute, while Scott was also convicted of additional charges related to methamphetamine and evidence destruction.The United States District Court for the District of Maryland denied Scott's motion to suppress evidence obtained from the search, despite his claim that law enforcement failed to knock and announce before entering. The court held that suppression was not the appropriate remedy. Scott and Taeyan were sentenced to 276 months and 150 months in prison, respectively, followed by five years of supervised release. Both appealed their convictions and sentences.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court affirmed Taeyan's conviction, finding sufficient evidence to support his possession with intent to distribute charges, based on his connection to the drugs found in Scott's home. The court also upheld the district court's denial of Scott's motion to suppress, citing exigent circumstances that justified the no-knock entry. Additionally, the court rejected Scott's request for a sentence reduction under the newly promulgated U.S.S.G. § 4C1.1, advising him to seek relief through a motion under 18 U.S.C. § 3582. Finally, the court found no improper delegation of judicial authority in the conditions of Scott's supervised release, affirming the district court's judgments in their entirety. View "United States v. Williams" on Justia Law