Justia Health Law Opinion Summaries

The United States Court of Appeals for the District of Columbia Circuit ruled in a case involving Regenative Labs ("Regenative"), a manufacturer of medical products containing human cells, tissues, or cellular or tissue-based products ("HCT/Ps"), and the Secretary of Health and Human Services. Following the Centers for Medicare and Medicaid Services ("CMS") issuing two technical direction letters instructing Medicare contractors to deny reimbursement for claims for products manufactured by Regenative, the company filed suit challenging these letters without first exhausting administrative remedies. The District Court dismissed the case due to lack of subject matter jurisdiction as Regenative had failed to exhaust its administrative remedies. On appeal, the Court of Appeals affirmed the District Court’s dismissal, in part for lack of subject matter jurisdiction and in part on grounds of mootness. The Court concluded that the claims raised by Regenative arose under the Medicare Act and had to be pursued through the statutorily-prescribed administrative process. The Court also found that the company’s request for the court to vacate the contested policy was moot because the policy had already been rescinded by CMS. Finally, the court rejected Regenative's argument for mandamus jurisdiction, finding that it did not satisfy the jurisdictional requirements for this relief. View "Row 1 Inc. v. Becerra" on Justia Law

The case in question was heard by the Supreme Court of Texas and revolved around the interpretation of the term "psychiatrist" as it applies to the involuntary civil commitment of individuals exhibiting signs of mental illness. The case involved a 34-year-old man, A.R.C., who had exhibited psychotic symptoms and delusional behavior. Two second-year psychiatry residents completed the required "certificates of medical examination for mental illness," as outlined in Tex. Health & Safety Code § 574.009(a). However, a question arose as to whether these residents could be considered psychiatrists under the statute.The Supreme Court of Texas ruled that these residents were indeed psychiatrists, reversing the lower court's judgment. The court determined that the residents, who were licensed under a physician-in-training program and were engaged in specialized psychiatric training, fell within the definition of a physician specializing in psychiatry. The court rejected the argument that only board-certified psychiatrists qualify under the statute, stating that physicians who specialize in psychiatry qualify as psychiatrists under § 574.009(a).The court emphasized that it is the judge, not the physician, who ultimately decides whether involuntary commitment is necessary or lawful. The court also noted that the legislature has the power to amend the qualifications for psychiatrists and other physicians as it sees fit, provided it adheres to the constitutional requirement of competent medical or psychiatric testimony.The Supreme Court of Texas remanded the case to the court of appeals for consideration of A.R.C.'s remaining challenges. View "IN RE A.R.C." on Justia Law

In November 2013, Ahmad Rashad Davis was indicted for Medicaid fraud and theft by deception for defrauding Medicaid of $14,505.36 by falsifying timesheets over two years. In May 2014, the Commonwealth of Kentucky and Davis entered into a plea agreement in which Davis agreed to plead guilty to Medicaid fraud, and in exchange, the Commonwealth recommended to the trial court that Davis's theft by deception charge be dismissed. The trial court accepted Davis's guilty plea and sentenced him to one year of imprisonment, probated for three years or until restitution was paid in full, and dismissed the theft by deception charge. In December 2021, Davis filed a petition to expunge the theft by deception charge. The Commonwealth objected, arguing that the charge was dismissed in exchange for Davis's guilty plea to Medicaid fraud, making it ineligible for expungement under Kentucky Revised Statute (KRS) 431.076(1)(b). The circuit court granted Davis's petition without holding a hearing, and the Court of Appeals affirmed the decision. The Supreme Court of Kentucky granted discretionary review and reversed the decisions of the lower courts.The Supreme Court of Kentucky held that a circuit court can look beyond the sentencing court's final judgment to determine whether a dismissal was granted in exchange for a guilty plea to another charge. The court ruled that the circuit court erred in failing to do so in Davis's case. As a result, the Supreme Court reversed the Court of Appeals and vacated the circuit court's order granting expungement. View "COMMONWEALTH OF KENTUCKY V. DAVIS" on Justia Law

In Missouri, Planned Parenthood and other affiliated health organizations sought a declaratory judgment declaring House Bill No. 3014 (HB 3014) unconstitutional and requested injunctive relief to prevent its implementation and enforcement. HB 3014 was a bill passed by the Missouri General Assembly that would cut Medicaid funding for abortion providers and their affiliates, including Planned Parenthood. The plaintiffs alleged that the bill violated the single subject requirement and the equal protection clause of the Missouri Constitution. The Supreme Court of Missouri affirmed the decision of the lower court, which had ruled in favor of Planned Parenthood on both constitutional claims. The state appealed on procedural grounds, alleging that Planned Parenthood failed to exhaust administrative remedies, lacked standing, and waived its right to bring these claims. The state also argued the bill did not violate the single subject or equal protection provisions of the Missouri Constitution. However, the Supreme Court dismissed these arguments, affirming the lower court's ruling. View "Planned Parenthood of the St. Louis Region vs. Knodell" on Justia Law

The United States Court of Appeals for the Fifth Circuit affirmed the district court’s decision to order Marty Johnson, the owner of a mental health rehabilitation clinic, and Keesha Dinkins, an employee of the clinic, to pay $3.5 million in restitution. Johnson and Dinkins had pleaded guilty to charges related to a fraudulent billing scheme targeting Medicaid that lasted from 2014 to 2018. On the day before their jury trial was set to begin, both defendants pled guilty to their respective charges and agreed in their plea deals to recommend $3.5 million in restitution. However, after their pleas were accepted, both defendants objected to the restitution order, arguing that it was erroneous. Johnson challenged the loss and restitution calculation while Dinkins argued that the entire loss should not have been attributed to her. The court held that the defendants were bound by the plea agreements they had made and affirmed the district court’s order for each defendant to pay $3.5 million in restitution. The court found that there was sufficient evidence to support the pleas, the restitution amount did not exceed the actual loss, and the district court appropriately used the total loss amount when calculating Dinkins’s sentence. View "USA v. Dinkins" on Justia Law

In the United States Court of Appeals for the Fifth Circuit, the case involved Marty Johnson, the owner of a mental health rehabilitation clinic, and Keesha Dinkins, an employee of the same clinic. Both defendants fraudulently billed Medicaid for illegitimate services between 2014 and January 2018. On the day their jury trial was scheduled to begin, Johnson pled guilty to conspiracy to commit healthcare and wire fraud, and Dinkins pled guilty to misprision of a felony. Each of their plea agreements stipulated a loss of $3.5 million and recommended that the judge order $3.5 million in restitution to the government. The district court accepted the defendants' recommendations and ordered each to pay $3.5 million in restitution. After receiving the benefit of their plea bargain, both defendants argued that the $3.5 million order was erroneous. Dinkins also contended that under the sentencing guidelines, the entire loss should not have been attributed to her. The court held the defendants to the plea bargain they had made and affirmed the district court's decision. The Court of Appeals determined that the district court's restitution order was valid under the Mandatory Victims Restitution Act (MVRA). View "USA v. Johnson" on Justia Law

The case involves an appellant, M.T.H., who was arrested for criminal endangerment after he pulled the steering wheel in his mother's vehicle while she was driving. M.T.H. was diagnosed with major depressive disorder and paranoid schizophrenia. Following his arrest, the State filed a petition for M.T.H.'s involuntary commitment to the Montana State Hospital (MSH) for up to three months. The District Court of the Twenty-First Judicial District, Ravalli County, ordered his commitment and authorized MSH to involuntarily administer medications to M.T.H. This led to an appeal to the Supreme Court of the State of Montana.The Supreme Court of Montana had two main issues to consider. The first issue was whether the District Court erroneously determined that a signed waiver constituted a sufficient record to commit M.T.H. The Supreme Court found that M.T.H.'s waiver and the District Court’s order committing him were sufficient to constitute an intentional and knowing waiver under the relevant statute. The court emphasized that the record reflected that M.T.H. understood his procedural rights and had a clear presence of mind to consider his position logically.The second issue was whether the District Court erroneously authorized MSH to administer involuntary medications to M.T.H. The Supreme Court held that the District Court erred in this aspect. It emphasized the importance of due process protections and noted that the State must demonstrate a need for involuntary medication before a court may authorize it. In this case, the State did not make this necessary showing. Therefore, the Supreme Court affirmed the District Court’s decision in part but reversed its decision to authorize involuntary medication for M.T.H. View "In re M.T.H." on Justia Law

In a multi-district litigation involving diabetes drug saxagliptin, the plaintiffs claimed that the drug caused their heart failure. They presented a single expert to show the drug could cause heart failure. After a Daubert hearing and expert motions, the United States Court of Appeals for the Sixth Circuit found that the expert's testimony was unreliable due to methodological flaws and therefore excluded it. Subsequently, the district court granted summary judgment for the defendants, rejecting the plaintiffs' claim that other evidence created a genuine issue of material fact. The court also refused the plaintiffs' request for ninety days to find a replacement expert. On appeal, the plaintiffs challenged the district court's exclusion of their expert, its grant of summary judgment, and its refusal to give them more time to find another expert witness. The Court of Appeals affirmed the district court's decisions, stating that the plaintiffs' claims lacked merit. The court found that the expert's reliance on one study to the exclusion of all others was unreliable, that his use of animal data was unreliable due to his admitted lack of qualifications to analyze such studies, and that he did not reliably apply the Bradford Hill criteria - a scientific framework used to analyze whether an association between two variables is causal. The court also found that all jurisdictions require expert testimony to show general causation in complex medical cases such as this one. As the plaintiffs failed to identify a reliable general causation expert, the court granted summary judgment for the defendants. The court also found no good cause to grant the plaintiffs more time to find a replacement expert. View "In re Onglyza (Saxagliptin) and Kombiglyze (Saxagliptin and Metformin) Products Liability Litigation" on Justia Law

In this case, Gardena Hospital in California appealed a decision regarding its reporting of patient days for the purpose of calculating Medi-Cal reimbursement. The controversy centered around whether "bed hold" days — days when a patient is not physically in the hospital's subacute section but is expected to return — should be included in the reported patient days. If these days were included, it would result in a smaller per diem reimbursement to the hospital by the state. The hospital argued that bed hold days should be excluded, pointing to the Accounting and Reporting Manual for California Hospitals (the "Hospital Manual"), which does not specifically mention bed holds. The state, on the other hand, referred to the Accounting and Reporting Manual for California Long-Term Care Facilities (the "Long-Term Manual"), which specifically states that bed hold days should be included in total patient days.The Court of Appeal of the State of California, Second Appellate District, Division Eight ruled in favor of the state, affirming the lower court's decision. The court held that where two state manuals guide health care facility accounting, the one that specifically addresses the issue at hand — in this case, the Long-Term Manual's explicit reference to bed holds — governs. The court reasoned that the specific provision controls the general one and can be regarded as a correction to it. Thus, according to this holding, Gardena Hospital must include bed hold days in its reported patient days for the calculation of Medi-Cal reimbursement. View "Gardena Hospital, L.P. v. Baass" on Justia Law

The United States Court of Appeals for the Tenth Circuit reviewed the dismissal of a case involving Charles Cline, who was terminated by Clinical Perfusion Systems, Inc. after a medical emergency led to an extended hospital stay. Cline brought forward disability discrimination claims under the Rehabilitation Act, the Affordable Care Act (ACA), and the Oklahoma AntiDiscrimination Act (OADA); and age discrimination claims under the OADA. The court concluded that Cline was unable to establish a disability discrimination claim as he failed to plausibly allege that he could perform his job functions with a reasonable accommodation by his employer. The court also disagreed with the district court's dismissal of Cline's age discrimination claim, arguing that Cline had sufficiently alleged that age was a but-for cause of his termination. Therefore, the court affirmed the dismissal of Cline's disability discrimination claims, reversed the dismissal of his age discrimination claim, and remanded the case for further proceedings. View "Cline v. Clinical Perfusion Systems" on Justia Law