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Abstract: Since 2000, the opioid epidemic has claimed the lives of more than 500,000 people and policies regarding the prescription of opioids for chronic pain have undergone drastic changes. While neurologists account for a small number of overall opioid prescriptions, they may treat patients on opioids, prescribed by other physicians or obtained illicitly, and need to be aware of the latest practice guidelines and the legal regime regulating opioid prescriptions., (Copyright © 2024 American Academy of Neurology.)

Health care entities doing business with the federal government may run afoul of the False Claims Act and Anti-Kickback Statute not only when they directly submit fraudulent claims for government reimbursement but also when they create schemes that manipulate others into submitting (whether knowingly or unknowingly) illegal claims. In recent years, the Department of Justice is deploying these statutes to ensure that electronic health records are built and maintained with appropriate cybersecurity protections., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Advances in electronic health record technology, the ever-expanding use of social media, and cybersecurity sabotage threaten patient privacy and render physicians and health care organizations liable for violating federal and state laws. Violating a patient's privacy is both an ethical and legal breach with potentially serious legal and reputational consequences. Even an unintentional Health Insurance Portability and Accountability Act of 1996 (HIPAA) violation can result in financial penalties and reputational harm. Staying complaint with HIPAA requires vigilance on the part of both individuals with legitimate access to protected health information (PHI) and the organizations handling that PHI., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Abstract: This article addresses the potential legal ramifications for neurologists caring for patients with Alzheimer disease (AD) who elect neither to prescribe aducanumab nor to refer patients with AD for treatment with aducanumab. To prevail against a neurologist for failing to prescribe aducanumab or refer for aducanumab treatment, the plaintiff would have to establish that the neurologist's failure to prescribe the medication or refer for treatment was a breach of the standard of care. The standard of care is conceptualized as the generally accepted approach to diagnosing or treating a condition. However, the controversy surrounding the US Food and Drug Administration's (FDA's) approval process for aducanumab (which was based on the drug's efficacy at reducing brain amyloidosis rather than on clinically meaningful efficacy) as well as the American Academy of Neurology (AAN) position statement on aducanumab and the recent decision by the Centers for Medicare & Medicaid Services (CMS) to limit Medicare coverage of the drug and its associated costs to patients enrolled in qualifying clinical trials indicate that aducanumab cannot yet be considered the standard of care for the treatment of AD. Although deciding not to prescribe aducanumab does not violate the standard of care, neurologists treating patients with AD and not recommending this treatment should explain to their patients and their patients' surrogate decision makers why they are not recommending the treatment., (Copyright © 2022 American Academy of Neurology.)

Abstract: Using two scenarios based on real-life cases reported in the media, this article examines the ethical and legal controversies that arise when a pregnant woman dies based on neurologic criteria while her fetus remains alive. In the first scenario, all parties agreed to maintain physiologic support until a safe delivery could be achieved, whereas in the second scenario the woman's family sought a legal remedy to stop the hospital from continuing to provide physiologic support for the patient and her neurologically devastated fetus., (Copyright © 2022 American Academy of Neurology.)

Abstract: This article addresses the question of whether neurologists performing interprofessional internet consultations, known as eConsults, face the same malpractice liability as for face-to-face patient care. Because the physician-patient relationship is usually unambiguous, determining the scope of legal liability arising from these relatively new approaches to patient care requires understanding the types of interactions courts have found to establish a patient-physician relationship., (Copyright © 2021 American Academy of Neurology.)

Abstract: The US Department of Health and Human Services Office of the Inspector General identifies the five most important federal fraud and abuse laws that are most applicable to physicians: the False Claims Act, the Anti-Kickback Statute, the Physician Self-Referral Law (Stark Law), the Exclusion Authorities, and the Civil Monetary Penalties LawThe False Claims Act is the US government's primary tool for combating fraud perpetrated through the filing of false claims for federal government reimbursement. Neurologists and companies serving the needs of neurologic patients have not been immune from False Claims Act-related legal action. This article provides an overview of the False Claims Act, uses real-life neurologic cases to illustrate the range of False Claims Act violations and recoveries, and offers some practical compliance suggestions., (Copyright © 2021 American Academy of Neurology.)

Background: Endoscopy under propofol sedation has become a routine procedure. Given the number of Canadians undergoing an endoscopy annually, as well as the pervasive use of cannabis by many patients, understanding the effect of cannabis use on the propofol dose at endoscopy is highly relevant. We aimed to evaluate the association between cannabis exposure and the propofol dose needed to achieve adequate sedation at endoscopy., Methods: A case-control study of individuals undergoing endoscopy was conducted at a single outpatient endoscopy clinic in London, Ontario between 2014 and 2017. Cases included all individuals with any self-reported cannabis exposure, while controls included all individuals without any self-reported history of cannabis use. Dose of propofol administered by a single anesthetist was collected on each subject as well as additional demographic and procedure-related covariates., Results: Three hundred and eighteen participants were included (cases, n = 151; controls, n = 167). Cannabis exposure was associated with an increase in propofol dose (cases 0.33 mg/kg/minute ±0.24; controls, 0.18 mg/kg/minute ±0.11; p<0.0001). Cannabis exposure remained an independent predictor of propofol dose on multivariate linear regression accounting for other important covariates (p<0.0001). Daily cannabis users required a higher propofol dose than weekly or monthly users. Three procedural sedation-related complications occurred in the cannabis-exposed group, while none occurred in the unexposed group., Conclusion: Our data suggest that cannabis use is significantly associated with the quantity of propofol needed for sedation at endoscopy. Further study is needed to better understand the molecular basis for this possible drug-drug interaction., Competing Interests: The authors have declared that no competing interests exist.

Rapid eye movement (REM) sleep behavior disorder (RBD) may result in a patient injuring a bed partner while acting out a dream. This article examines the complexities associated with RBD as a criminal defense strategy as well as the legal implications for physicians and their duty to patients and their families to mitigate risks associated with possible injuries related to RBD.

Stroke is one of the most common conditions neurologists treat in emergency situations. This article examines the issues of surrogate decision makers and the physician's potential legal liability in the context of the administration or nonadministration of recombinant tissue plasminogen activator (rtPA) in a common emergency department scenario.

This medicolegal article examines a physician's liability when he or she has knowledge of adverse effects associated with a prescription medication and suggests ways to mitigate that liability risk. The article also discusses the circumstances under which pharmaceutical companies face liability for side effects such as tardive dyskinesia.

Although the principle of autonomy allows patients to refuse interventions their physicians recommend, patients are not free to ignore legally mandated restrictions on driving, and physicians are ethically justified in constraining their patients' driving rights in compliance with state law. Furthermore, the standard of care for treatment of patients with epilepsy includes counseling about lifestyle modifications that promote patient safety and compliance with the law. Neurologists should not only counsel their patients with epilepsy about legally mandated driving restrictions but also document this counseling in the medical record. Failure to counsel and to document may result in legal liability if patients experience seizures while driving and injure either themselves or third parties. The neurologist's duty of care may be limited to the patient in some jurisdictions but may be extended to injured third parties in others. Furthermore, a patient's own contributory negligence may limit or completely foreclose recovery against the physician to varying degrees, depending on the state in which the injury occurred.

Clinicians caring for patients with dementia are often at a loss when trying to manage dementia-related behavioral disturbances pharmacologically because no drugs have been proven effective for this indication. Antipsychotics are commonly prescribed for these patients despite a US Food and Drug Administration (FDA)-mandated boxed warning about the heightened risk of death in patients with dementia treated with antipsychotic drugs. This boxed warning does not prevent clinicians from prescribing antipsychotics to patients with dementia. However, it serves as a heightened warning to prescribers to include the specific risks mentioned in the boxed warning in their discussion of risks and benefits of the proposed therapy with their patients or their patients' health care proxy and to document this informed consent conversation in the medical record. By documenting that the risks of the treatment, including those the FDA has deemed serious enough to include in a boxed warning, were discussed and accepted by the medical decision maker, the prescriber also reduces the risk of liability should an adverse event ensue.

Purpose: The aromatase inhibitor (AI) letrozole is a first-line drug in the adjuvant treatment of breast cancer in postmenopausal women. Adherence to AI therapy, including letrozole, remains problematic due to the development of debilitating AI-induced arthralgia. Letrozole is metabolized in the liver by CYP2A6. It remains unknown if plasma letrozole levels or CYP2A6 genetic variation is associated with the development of arthralgia., Methods: We enrolled 126 female breast cancer patients initiated on letrozole therapy and prospectively collected blood samples at baseline and two follow-up time points to determine letrozole plasma concentrations and CYP2A6 genotype. At each visit, participants completed two validated questionnaires to assess the severity of arthralgia symptoms., Results: More than half (55%) of patients experienced a significant increase in their arthralgia symptoms after initiation of treatment. The clinical variables of body mass index (P = 0.0003) and age (P = 0.0430) were negatively and positively associated with plasma letrozole concentrations, respectively. CYP2A6 genotype was significantly associated with letrozole levels (P < 0.0001), and increased plasma letrozole levels were observed in patients with CYP2A6 reduced-function genotypes. Plasma levels of letrozole and CYP2A6 genotype were not significantly associated with a change in pain score from baseline., Conclusions: CYP2A6 genotype was a significant predictor of letrozole plasma levels, but was not associated with the development of arthralgia.

Ethical and legal issues arise when a patient who is human immunodeficiency virus (HIV) positive lacks decision-making capacity and the HIV status must be disclosed to a surrogate decision maker to allow for informed medical decision making. This article discusses the special exceptions to confidentiality built into the Health Insurance Portability and Accountability Act privacy protections, the limitations on claims of common-law marriage, and public health laws that often require informing individuals who are either sex partners or needle-sharing partners of newly diagnosed HIV-infected individuals that they have been exposed to HIV infection.

Purpose: Tamoxifen is frequently prescribed to prevent breast cancer recurrence. Tamoxifen is a prodrug and requires bioactivation by CYP2D6. Tamoxifen use is often limited by adverse effects including severe hot flashes. There is paucity of prospectively collected data in terms of CYP2D6 genotype and measured tamoxifen, 4-hydroxytamoxifen and endoxifen concentrations in relation to hot flash severity during tamoxifen therapy., Methods: We conducted a longitudinal prospective study of breast cancer patients on tamoxifen (n = 410). At each visit, blood samples were collected, and patients completed a standardized hot flash survey (n = 1144) that reflected hot flash severity during the 7 days prior to the visit. Plasma concentrations of tamoxifen, 4-hydroxytamoxifen, and endoxifen were measured using liquid chromatography-tandem mass spectrometry and genotyping was carried out for CYP2D6. A linear mixed-effects regression analysis assessed the association of covariates in relation to the hot flash severity score (HFSS)., Results: Median age at first assessment was 50 years with 61.9% of patients considered peri-menopausal. Most patients (92.2%) experienced hot flash symptoms with 51.0% having low HFSS (0-4) and 7.32% experiencing HFSS > 25. Age was significantly associated with hot flash severity, with patients aged 45-59 more likely to have higher HFSS. Neither duration of tamoxifen therapy nor observed tamoxifen, endoxifen and 4-hydroxy tamoxifen plasma concentration predicted hot flash severity. Genetic variation in CYP2D6 or CYP3A4 was not predictive of hot flash severity., Conclusions: Hot flash severity during tamoxifen therapy can not be accounted for by CYP2D6 genotype or observed plasma concentration of tamoxifen, 4-hydroxytamoxifen, or endoxifen.

This article presents a hypothetical case of the legal issues a physician must consider when moving to a new medical practice, such as the enforceability of a noncompete clause, malpractice insurance, communicating this change in practice to existing patients, and custody of medical records.

Background: Azathioprine (AZA)-induced pancreatitis is an unpredictable and dose-independent adverse event affecting 2%-7% of patients with inflammatory bowel disease (IBD) patients treated with AZA. There are no tools in clinical practice to identify at-risk individuals; however, a genome wide association study (GWAS) identified a strong association between the Class II HLA gene region polymorphism (rs2647087) and thiopurine-induced pancreatitis., Aim: To independently confirm the findings of the GWAS in an IBD cohort, to evaluate its utility in clinical practice and to offer a novel AZA treatment algorithm for IBD based on pharmacogenomic principles., Methods: A retrospective cohort study evaluated 373 AZA-exposed IBD patients from a tertiary care academic centre in London, Canada. Due to the limited number of patients taking mercaptopurine (MP), such patients were not included this cohort. All subjects underwent screening for the single nucleotide polymorphism (SNP) rs2647087 mapped to the HLA-DQA1*02:01-HLA-DRB1*07:01 haplotype and were sub-divided based on the presence (n = 13) or absence (n = 360) of an AZA-induced pancreatitis diagnosis. The risk of AZA-induced pancreatitis was assessed based on rs2647087 genotype., Results: The risk of pancreatitis during AZA-therapy was highly predictable and genotype dependent: 0.53% for wild type (A/A), 4.25% (OR = 4.19, 95% CI 1.02-36.45, P = 0.044) for heterozygous (A/C), and 14.63% (OR = 15.83, 95% CI 3.80-145.26, P = 0.0001) for homozygous variant (C/C) patients., Conclusions: The class II HLA region (at rs2647087) is an important marker of AZA-induced pancreatitis risk. We propose a simple and clinically implementable algorithm based on rs2647087 and TPMT genotypes for AZA selection and dosing for patients with IBD., (© 2017 John Wiley & Sons Ltd.)

Background: Direct-acting oral anticoagulants (DOACs) are widely prescribed for stroke prevention in patients with atrial fibrillation (AF). An important advantage of DOACs is that routine monitoring of an anticoagulation response is not necessary. Nevertheless, because of their mechanism of action, a DOAC anticoagulation effect can be inferred based on the observed plasma concentration. However, there is a paucity of data relating to observed interpatient variation in DOAC plasma concentrations in the postmarket clinical setting., Methods: We determined rivaroxaban and apixaban plasma concentrations in patients with AF during routine clinic visits., Results: Among 243 patients (rivaroxaban, n = 94; apixaban, n = 149) enrolled in this study, a 60- and 50-fold interpatient variation in plasma concentration was observed for rivaroxaban and apixaban, respectively. Approximately 12% of patients receiving rivaroxaban and 13% of patients receiving apixaban exceeded the 95th percentile for predicted maximum plasma concentration observed in clinical trials., Conclusions: In this routine-care setting, rivaroxaban and apixaban plasma concentrations tended to be more variable than those observed in clinical trials. Identification of additional clinical and molecular determinants that more fully predict patients at risk for excessively high or low DOAC concentrations may enable a more precise DOAC dosing regimen for the individual patient., (Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Cybersecurity issues and their impact on compliance with the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act are becoming more of an enforcement focus for a variety of government agencies, including the US Department of Health and Human Services, the Federal Trade Commission, and the Department of Justice. In the case presented in this article, a nurse in a neurology practice opted to speak with a patient about human immunodeficiency virus testing procedures in a manner audible to others in the waiting room. Computer screens with patient information were visible to anyone approaching a desk, the staff had not been trained on cybersecurity issues, and malware infected the computers used in the practice. In light of these circumstances and the launch of Phase 2 of the HIPAA Audit Program by the US Department of Health and Human Services Office for Civil Rights, the neurology practice must consider the following questions. First, could the gaps in the technical, administrative, and physical requirements of HIPAA and the HITECH Act result in an adverse audit and penalties? Second, what course of action does the law mandate in response to a ransomware attack?

This article presents a case in which a neurology group practice is considering investing in an imaging center that is owned by nonphysician investors with the aim of referring patients to this imaging center. The article reviews some important legal pitfalls in federal law that physicians must be aware of when considering such an investment and focuses on the general outlines of and exceptions to the Stark Law and the Federal Anti-Kickback Statute.

Background: As an indicator of physical and cognitive functioning in community-dwelling older adults, there is increasing interest in measuring life space, defined as the geographical area a person covers in daily life. Typically measured through questionnaires, life space can be challenging to assess in amnestic dementia associated with Alzheimer's disease (AD). While global positioning system (GPS) technology has been suggested as a potential solution, there remains a lack of data validating GPS-based methods to measure life space in cognitively impaired populations., Objective: The purpose of the study was to evaluate the construct validity of a GPS system to provide quantitative measurements of global movement for individuals with mild-to-moderate AD., Methods: Nineteen community-dwelling older adults with mild-to-moderate AD (Mini-Mental State Examination score 14-28, age 70.7 ± 2.2 years) and 33 controls (CTL; age 74.0 ± 1.2 years) wore a GPS-enabled mobile phone during the day for 3 days. Measures of geographical territory (area, perimeter, mean distance from home, and time away from home) were calculated from the GPS log. Following a log-transformation to produce symmetrical distributions, group differences were tested using two-sample t tests. Construct validity of the GPS measures was tested by examining the correlation between the GPS measures and indicators of physical function [steps/day, gait velocity, and Disability Assessment for Dementia (DAD)] and affective state (Apathy Evaluation Scale and Geriatric Depression Scale). Multivariate regression was performed to evaluate the relative strength of significantly correlated factors., Results: GPS-derived area (p < 0.01), perimeter (p < 0.01), and mean distance from home (p < 0.05) were smaller in the AD group compared to CTL. The correlation analysis found significant associations of the GPS measures area and perimeter with all measures of physical function (steps/day, DAD, and gait velocity; p < 0.01), symptoms of apathy (p < 0.01), and depression (p < 0.05). Multivariate regression analysis indicated that gait velocity and dependence were the strongest variables associated with GPS measures., Conclusion: This study demonstrated that GPS-derived area and perimeter: (1) distinguished mild-to-moderate AD patients from CTL and (2) were strongly correlated with physical function and affective state. These findings confirm the ability of GPS technology to assess life space behaviour and may be particularly valuable to continuously monitor functional decline associated with neurodegenerative disease, such as AD.