Justia Health Law Opinion Summaries

Scott Breimeister and four codefendants were tried for allegedly defrauding public and private healthcare programs of over $140 million through a scheme involving false claims for prescription drugs. During the trial, the Government made late disclosures of evidence favorable to the defense, affecting a significant portion of the testimony. The district court, concerned about the fairness of the trial, declared a mistrial sua sponte after determining that curative measures would not suffice to ensure a fair verdict.The United States District Court for the Southern District of Texas denied Breimeister's subsequent motion to bar retrial, finding that the Double Jeopardy Clause did not preclude a second trial because the mistrial was a "manifest necessity." Breimeister appealed this decision.The United States Court of Appeals for the Fifth Circuit reviewed the case and affirmed the district court's decision. The appellate court held that Breimeister had impliedly consented to the mistrial by failing to object contemporaneously, and thus, the Double Jeopardy Clause did not bar retrial. Additionally, the court found that the district court did not abuse its discretion in declaring a mistrial due to manifest necessity, given the extensive impact of the Government's late disclosures on the trial's fairness. The appellate court concluded that the district court had carefully considered alternatives and acted within its discretion in declaring a mistrial. View "United States v. Breimeister" on Justia Law

California collects a fee from in-state hospitals and uses the revenue, along with federal Medicaid funds, to provide subsidies to California hospitals serving Medicaid beneficiaries. Out-of-state hospitals near the California border, which sometimes serve California Medicaid beneficiaries but do not pay the fee, sought access to these subsidies. They argued that their exclusion violated the dormant Commerce Clause, the Equal Protection Clause, and federal Medicaid regulations.The United States District Court for the District of Columbia rejected the out-of-state hospitals' arguments and granted summary judgment in favor of the Centers for Medicare and Medicaid Services (CMS). The hospitals appealed the decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo and affirmed the district court's decision. The court held that the QAF program does not discriminate against interstate commerce because it does not tax out-of-state hospitals, and the supplemental payments are based on in-state provision of medical care. The court also found that the program does not violate the Equal Protection Clause, as California could rationally decide to target subsidies to in-state hospitals serving a disproportionate share of Medi-Cal beneficiaries. Lastly, the court concluded that the QAF program does not violate federal Medicaid regulations, as the regulation in question pertains to base payments for specific services rendered to beneficiaries, not supplemental subsidies like the QAF payments. View "Asante v. Kennedy" on Justia Law

Jeffrey Campbell, the owner and lead doctor at Physicians Primary Care (PPC), and Mark Dyer, a nurse practitioner at PPC, were indicted in 2020 on multiple counts related to overprescribing opioids and engaging in a scheme to seek fraudulent reimbursements from health insurance providers. The indictment included charges of unlawfully distributing controlled substances, conspiracy to unlawfully distribute controlled substances, health-care fraud, conspiracy to commit health-care fraud, and money laundering.The case proceeded to trial in the United States District Court for the Western District of Kentucky. The jury found Campbell guilty on several counts, including conspiracy to unlawfully distribute controlled substances, health-care fraud, conspiracy to commit health-care fraud, and money laundering. Dyer was also found guilty on similar counts. The district court sentenced Campbell to 105 months of imprisonment and Dyer to 60 months, followed by three years of supervised release for both. The district court also ordered restitution payments from both defendants.The United States Court of Appeals for the Sixth Circuit reviewed the case. The defendants challenged the jury instructions, sufficiency of the evidence, and the district court’s evidentiary rulings. The appellate court found that the jury instructions, although not fully compliant with the Supreme Court's decision in Ruan v. United States, were adequate under the court's precedents. The court also found sufficient evidence to support the convictions for conspiracy to unlawfully distribute controlled substances, health-care fraud, and money laundering. The court held that the district court did not abuse its discretion in admitting the testimony of government experts and other evidence.The appellate court affirmed the convictions and sentences, concluding that any potential errors in the district court’s intended-loss calculation for sentencing were harmless, as the sentences imposed were well below the applicable Guidelines range. The court also noted that the defendants failed to properly appeal the restitution order, making it outside the scope of the current appeal. View "United States v. Campbell" on Justia Law

The case involves the Food and Drug Administration (FDA) denying authorization for respondents to market certain flavored e-cigarette products. The FDA's decision was based on the lack of sufficient scientific evidence demonstrating that these products would be appropriate for the protection of public health. The FDA emphasized the need for evidence from randomized controlled trials or longitudinal cohort studies, which the respondents did not provide. Instead, respondents submitted literature reviews and cross-sectional surveys, which the FDA found inadequate.The United States Court of Appeals for the Fifth Circuit, sitting en banc, reviewed the FDA's denial orders. The court found that the FDA acted arbitrarily and capriciously by applying different standards than those articulated in its predecisional guidance. The court was particularly concerned with the FDA's failure to review marketing plans, which it had previously deemed critical. The Fifth Circuit rejected the FDA's argument that any errors were harmless and remanded the case to the FDA.The Supreme Court of the United States reviewed the case and vacated the Fifth Circuit's decision. The Court held that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. However, the Court agreed with the FDA that the Fifth Circuit's interpretation of harmless error was overly broad. The Supreme Court remanded the case to the Fifth Circuit to reconsider the harmless-error question without relying on its expansive reading of Calcutt v. FDIC. View "FDA v. Wages and White Lion Investments, LLC" on Justia Law

Dr. Jeffery D. Milner, a physician, brought a qui tam action under the False Claims Act (FCA) against Baptist Health Montgomery, Prattville Baptist, and Team Health. Milner alleged that while working at a hospital owned by the defendants, he discovered that they were overprescribing opioids and fraudulently billing the government for them. He claimed that he was terminated in retaliation for whistleblowing after reporting the overprescription practices to his superiors.Previously, Milner filed an FCA retaliation lawsuit against the same defendants in the U.S. District Court for the Northern District of Alabama, which was dismissed with prejudice for failure to state a claim. The court found that Milner did not sufficiently allege that he engaged in protected conduct under the FCA or that his termination was due to such conduct. Following this dismissal, Milner filed the current qui tam action in the U.S. District Court for the Middle District of Alabama. The district court dismissed this action as barred by res judicata, relying on the Eleventh Circuit's decisions in Ragsdale v. Rubbermaid, Inc. and Shurick v. Boeing Co.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's dismissal. The court held that Milner's qui tam action was barred by res judicata because it involved the same parties and the same cause of action as his earlier retaliation lawsuit. The court found that both lawsuits arose from a common nucleus of operative fact: the defendants' alleged illegal conduct and Milner's discovery of that conduct leading to his discharge. The court also noted that the United States, which did not intervene in the qui tam action, was not barred from pursuing its own action in the future. View "Milner v. Baptist Health Montgomery" on Justia Law

Relators Tiffany Montcrief and others filed a False Claims Act suit against Peripheral Vascular Associates, P.A. (PVA), alleging that PVA billed Medicare for vascular ultrasound services that were not completed. The claims were categorized into "Testing Only" and "Double Billing" claims. The district court granted partial summary judgment to Relators, concluding that PVA submitted knowingly false claims. A jury found these claims material and awarded approximately $28.7 million in damages against PVA.The district court granted partial summary judgment to Relators on the issues of falsity and knowledge of falsity. The jury found that the claims were material and caused the Government to pay out money. The district court entered judgment against PVA, including statutory penalties and treble damages. PVA appealed, challenging the district court's grant of partial summary judgment and certain rulings during and after the trial.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court affirmed the district court's grant of partial summary judgment on the Testing Only claims but remanded for a new trial on damages. The court reversed the partial summary judgment ruling on the Double Billing claims, vacated the final judgment, and remanded for a new trial consistent with its opinion. The court concluded that the district court erred in interpreting the CPT–4 Manual and in concluding that the Manual required PVA to create separate, written reports for vascular ultrasounds before billing Medicare. The court also found that the district court abused its discretion in relying on Relators' post-trial expert declaration to calculate damages. View "Montcrief v. Peripheral Vascular" on Justia Law

In November 2019, Kathleen Welch was admitted to Tulane Medical Center for acute pancreatitis and diabetic ketoacidosis. After her discharge, she was admitted to BridgePoint Healthcare for rehabilitation, where she developed pressure ulcers. She was later transferred to United Medical Physical Rehabilitation Hospital, where her condition persisted. Welch filed a claim for injuries related to her pressure ulcers, naming BridgePoint and United Medical as defendants. United Medical, not being a qualified healthcare provider under the relevant statute, faced a lawsuit alleging negligence.United Medical filed an exception of no cause of action, citing La. R.S. 29:771(B)(2)(c)(i), which limits liability to gross negligence or willful misconduct during a public health emergency. The trial court granted the exception, applying the gross negligence standard but did not rule on the statute's constitutionality. Welch appealed, and the appellate court upheld the trial court's application of the statute but remanded the case for a ruling on its constitutionality. On remand, the trial court found the statute constitutional, and Welch sought supervisory review.The Supreme Court of Louisiana reviewed the case and affirmed the lower court's decision. The court held that La. R.S. 29:771(B)(2)(c)(i) is constitutional, as it is rationally related to a legitimate government interest in ensuring access to healthcare during a public health emergency. The court found that the statute does not violate the Louisiana Constitution's due process or access to courts provisions and is not a prohibited special law. The statute's application to all healthcare providers equally and its rational basis for limiting liability during emergencies were key factors in the court's decision. View "WELCH VS. UNITED MEDICAL HEALTHWEST-NEW ORLEANS L.L.C." on Justia Law

Mark R. Schmidt, a workers' compensation attorney, sustained a work-related injury while loading files into a trial bag. His treatment included pain management with medications like OxyContin and Oxycodone. To avoid increasing his medication dosage, his physician, Dr. Murphy, prescribed CBD oil. Schmidt purchased CBD oil and lotion over the counter and used them as directed. He sought reimbursement from his employer, Schmidt, Kirifides and Rassias, PC, for the CBD oil costs, which the employer refused, arguing that CBD oil is not a pharmaceutical drug.A Workers' Compensation Judge (WCJ) granted Schmidt's penalty petition, ordering the employer to reimburse him for the CBD oil costs. The Workers' Compensation Appeal Board (Board) reversed this decision, stating that Schmidt did not follow the necessary rules for reimbursement and that CBD oil is not a "supply" under the Workers' Compensation Act (WCA) due to the lack of FDA approval. The Commonwealth Court reversed the Board's decision, concluding that CBD oil is a "medicine" or "supply" under the WCA and that Schmidt, not being a provider, was not required to submit standard billing forms for reimbursement.The Supreme Court of Pennsylvania reviewed the case and held that any item prescribed by a health care provider as part of a treatment plan for a work-related injury falls within the meaning of "medicines and supplies" under Section 306(f.1)(1)(i) of the WCA. The court also held that the cost containment provisions of the WCA and related regulations do not apply to claimants who are not providers. Therefore, Schmidt was entitled to reimbursement for the CBD oil costs, and the Commonwealth Court's order was affirmed. View "Schmidt v. Schmidt, Kirifides & Rassias" on Justia Law

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