False Claims Act and Anti-Kickback Statute: Avoiding Legal Landmines.

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.

Protecting Privacy: Health Insurance Portability and Accountability Act of 1996, Twenty-First Century Cures Act, and Social Media.

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.

The Medicolegal and Ethical Dimensions of Physician Prescription Reluctance.

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.

Legal and Ethical Challenges in the Care of the Pregnant Patient After Brain Death.

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.

Interprofessional Internet Consultations: The Potential Benefits and Perils of eConsults.

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.

False Claims Act Overview and Implications for Neurologists.

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.

Legal Liability Associated With rtPA Administration and Surrogate Decision Makers.

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.

Criminal Culpability for Acts Committed During a Possible Episode of REM Sleep Behavior Disorder.

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.

Liability and Failure to Warn a Patient.

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.

Driving and Epilepsy: Ethical, Legal, and Health Care Policy Challenges.

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.

Prescribing Antipsychotic Medications to Patients With Dementia: Boxed Warnings and Mitigation of Legal Liability.

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.

Common Legal Considerations When Moving to a New Medical Practice.

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.

Legal and Ethical Considerations of Disclosing Human Immunodeficiency Virus Seropositivity to a Surrogate Decision Maker.

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.

Mitigating Cybersecurity Risks.

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?