Relevance to Clinical Practice
Under Civil law, cases tend to be assessed under Tort laws that may require intentional acts (which are voluntary acts) or those that do not require intentional acts.
The most common area of litigation in medicine generally and applicable to rehabilitation medicine is negligence1.
Generally, Negligence requires some elements that have to be present and include the following:
- Duty of Care2: is a duty owed to foreseeable plaintiffs in the zone of danger as the amount of care that is expected from a reasonable prudent person under such circumstances. For physicians, this is based on a national standard of care and a specialist care as in rehabilitation medicine will be based on the national standard expected of a board-certified physiatrist. Duties of care are presumed where there is assumption of risk (e.g. as treating physician), statutory obligation (e.g. based on statutory law or regulations), contractual obligation (e.g. concierge medicine), existing relationship (between a patient and a physician even outside the hospital) and creation of a peril (e.g. when a physician tries to help and makes the situation worse). While generally, there is no general duty to come to the aid of another, trying to help and creating more problems leads to duty to care under creation of a peril.
- Breach of Duty: This is when the above duty is not met under the expected circumstance in which for example, the expected standard of care fell short of the national standard.
- Causation: This is based on 2 parts of actual causation and proximate causation. The actual causation is based on the “but for” test if it is a single defendant (i.e. but for the act of that defendant) there will not be harm that ensued. In situations where there are possible multiple defendants, the “substantial factor” test in terms of effects leading to the harm is used. And in situation where this is unascertainable, there is “shift of burden of proof” test, which shifts the burden of proof to the defendant. This shift of burden occurs where multiple physicians are looking after a patient and a mishap occurred with difficulties in finding a substantial factor for the mishap. The burden shifts to each of the defendants to prove that each individually was not culpable. The proximate causation is the direct or indirect cause of the harm that the patient experienced. A direct cause is a foreseeable cause that is expected when such duty is breached, and an indirect cause is a consequence that is an intervening cause. An example of such a case would be if an epidural injection by an interventional physiatrist leads to epidural abscess from negligent non-use of aseptic technique and this leads to the need for surgical decompression, which leads to spinal cord injury. The interventional physiatrist may still be liable for the spinal cord injury because the surgical decompression is an intervening action. The intervening cause test does not apply if such act is due to an intentional tort or a crime.
- Damages: There has to be harm in the process of the breach of the duty of care for a medical negligence to occur.
Res Ipsa Loquitor3
Under breach of duty with the doctrine of Res Ipsa Loquitor, it is presumed that the very nature of a medical mishap causing patient’s injury suggests negligent conduct if there are not enough facts to define a breach because of unknown circumstances of events leading to the injury. This requires 3 elements:
- The harm will not normally occur without negligence.
- Such harm will normally be caused due to Negligence on the part of the defendant, in this case the physician
- The circumstances under which the harm occurred were in the exclusive control of the defendant (physician).
An example of Res Ipsa Loquitor may be in a circumstance where a patient came in for an epidural injection under sedation and he had walked into the procedure room on that day but after the procedure is found to be paraplegic. The above 3 elements will be applicable, and this will avoid the need to try and prove that there is a breach or no breach of duty of care.
There are defenses to medical negligence that include assumption of risk (i.e. when a patient is fully aware of all the risks through an informed consent and opted to proceed with the treatment plan) contributory negligence (that is based on the patient contributing to the harm by her action which may bar recovery in minority jurisdictions) and comparative negligence (in which the jury will assign percentage of faults with pure comparative fault based strictly on that percentage and partial/modified comparative fault only allows the patient to recover her percentage if it is below 50% and none if it is above 50%).
The tort cases requiring intentional acts include Assault, Battery, False imprisonment and intentional infliction of emotional distress.
Assault is the voluntary/intentional act by a defendant, which causes reasonable apprehension of imminent harmful or offensive contact.
The defense to this is consent. A situation of this sort could arise in a situation where a patient feels threatened by a physician action if it is perceived as imminently harmful or offensive contact.
This is a voluntary/intentional act by a defendant that causes harmful or offensive contact.
Also, in this instance, consent is a defense.
Both Assault and Battery could occur together where touching the patient is termed offensive or causes harm. This could occur where a procedure was performed without consent, performed on the wrong part of the body from that consented to or when the scope of consent is exceeded.
This is an intentional act or omission that confines or restrains a plaintiff by the defendant to a bounded area without alternative option of escape and plaintiff is aware or harmed by such confinement.
This could occur in a rehabilitation setting if a patient wants a discharge against medical advice or is being physically or chemically restrained from moving around.
Intentional Infliction of Emotional Distress (IIED)
This is the intentional or reckless extreme and outrageous conduct that leads to severe emotional distress. This could occur in the way a patient is treated or handled. A bystander could sue for IIED if he or she was present when the injury occurred, is a close relative of the patient and the defendant was aware that that relative was present and closely related to the patient.
All of the above could plead the defense of consent. Consent could be expressed when written or agreed orally (although it is better to always have a consent in writing), but it could also be implied (e.g. when a patient walks in to an office to see a physician but this has to remain within the reasonable scope of expectation). The reasonable standard is an objective standard based on the expectations of a prudent and reasonable member of the public. Consent also requires legal capacity.
Issue of Legal capacity is dependent on age (requires to be 18 years or above in the USA) and mental capacity in which case consent from a Guardian or someone with power of attorney will be required.
There are other tortious acts that could lead to legal actions but in brief include the following:
- Misrepresentation: this could be intentional or negligent in which there is misrepresentation of material fact that the defendant knows or believes is false which induces the plaintiff to justifiably rely on such misrepresentation causing harm.
- Product Liability: this may apply in which a product (e.g., blood products produced by the hospital) leads to harm (e.g., infected with HIV virus or Hepatitis C). Such product liability actions will be analyzed under negligence as stated above.
- Vicarious Liability: Also termed doctrine of Respondeat Superior and makes employers liable for torts committed by employees within the scope of their employment. A frolic is a circumstance where the employee’s actions were not within the scope of employment, and a detour is an action that is not within the scope of employment but is done during the phase of scope of employment. Intentional torts generally are not applicable, except it is within the job description of the employee (e.g., restraining, etc). Also, independent contractors are not employees, and employers are generally not liable except doing a job that is within the control of the employer (e.g., a credentialed medical staff moonlighting) or when there is negligent hiring (e.g., a medical staff with bad records not properly vetted).
Under Criminal laws, there is also Assault and Battery as defined above under torts. Which means that a physician may be liable for assault and battery under civil and criminal actions.
Other criminal liabilities are the following:
Homicide: Is the killing of another human being with malice aforethought and without legal justification (i.e. unlawful killing).
Malice aforethought could be intent to kill, intent to cause serious bodily injury, wanton and reckless indifference to life or felony murder (when death occurs during the commission of a felony of battery, arson, robbery, rape and kidnapping).
Murder under intent to cause serious bodily injury may arise if a treatment action could be seen as having potential to cause severe bodily injury or the action could tantamount to reckless and wanton action.
Under Homicide, there are first-degree murder, second-degree murder, voluntary manslaughter and involuntary manslaughter.
First-degree murder: is the deliberate, willful and premeditated and enumerated murder as stated above. Such a circumstance could arise in rehabilitation medicine in a circumstance of merciful killing of terminally ill persons.
Second-degree murder: is everything other murder as stated above under common law.
Voluntary Manslaughter: arises in a murder with adequate provocation in the heat of passion without time to cool off and there was no cool off period.
Involuntary Manslaughter: death caused by criminal negligence (reckless disregard for others4), battery or misdemeanor. This also could arise with negligent action that leads to death including prescription of opioid analgesics, failing in duty of care as the treating physician
Defenses for homicide applicable in medicine will often be based on lack of the necessary intent to bring a case from first or second-degree manslaughter to a lesser charge of involuntary manslaughter.
There are laws and regulations that a physiatrist could be liable if breached and include:
Civil False Claims Act: Knowingly presenting or causes to be presented a false or fraudulent claim to the US government for payments. This could occur in sending false claims to Medicare for a patient that was never treated, upcoding, falsifying certificates of medical necessity, unbundling, etc. Most physicians have been prosecuted based on reckless disregard for the truth in conduct and that such conduct is out of line with normal business conduct. The penalty for this includes $10,000 fine for each false claim, exclusion from participation in a Federal healthcare program (like Medicare, Medicaid, etc.) and triple damages in any civil suit.
Under the Qui Tam Relator doctrine, a whistleblower as a private party can bring an action under this act on behalf of the US government and will be entitled to 15%-30% of the amount recovered by the government along with the legal fees sometimes.
Criminal False Claims Act: is an act making a false claim knowingly with the intention to defraud the government. The penalty for this is a felony punishable by imprisonment for up to 5 years with possible fine of $250,000 for individuals and $500,000 for institutions.
Anti-Kickback Law: was created in 1972 and administered by the office of the Inspector General (OIG) and is knowingly or willfully inducing, soliciting or accepting remuneration, offer, payment, etc. in return for the purchase order of items etc. paid for through a Federal program. Penalties include imprisonment of up to 5 years for each violation, fine of up to $25,000 per violation and exclusion from Federal programs if through criminal prosecution and if through the OIG, it could be civil penalty of up to $50,000 per violation along with assessment up to thrice the amount of the illegal payment.
Stark Law4: Similar to the anti-kickback law and prohibits physician self-referral. Penalties include repayment of all claims made in the self-referral, $15,000 per prohibited service and exclusion from all Federal programs. There is an exception to EMR adoption and cooperation. A recent update to the Stark Law supports the CMS “Patients Over Paperwork” initiatives enabling coordination of care between physicians and other healthcare providers towards providing high quality healthcare across different settings. This allows design and entering into value-based arrangements when such will improve coordination and quality of care while lowering costs but also preventing overutilization and other harms in healthcare delivery. Other arrangements under the updated Stark Law include exceptions like donations of cybersecurity technology, etc.
Obstruction of Criminal Investigation of Healthcare Offenses: is willfully obstructing, misleading, delaying or any action that makes it difficult to have access to records to a criminal investigator in the process of the investigation of a violation of a federal healthcare offense. This tends to occur where requests for records are denied or records are destroyed in the process of avoiding such criminal investigation.
HIPAA/HITECH: the Health Insurance Portability and Accountability Act (HIPAA), passed in 1996 in which a covered entity may not use or disclose protected health information (PHI) except as permitted or required for treatment, payment, healthcare operations, operation of the law, patient authorization or waiver of that patient authorization. It does not cover PHI that has been de-identified.
The Health Information Technology for Economic and clinical Health (HITECH) is part of the American Recovery & Reinvestment Act (ARRA) (also called the “Stimulus Package”) provides expanded and strengthened enforcement for HIPAA with increased penalties, security breach notification expanded, HIPAA extended to Business Associates, etc. Penalties for HIPAA violations includes minimum $100 per violation and maximum of $25,000 per calendar year for cases in which offender was not aware that the act was violated (i.e. not intentional) minimum of $1000 per violation and maximum of $50,000 per calendar year for violations due to reasonable cause but not to willful neglect, minimum $10,000 per violation and maximum $250,000 per calendar year for an infringement corrected by the organization once detected and not due to willful neglect, and minimum $50,000 per violation and maximum $1.5 million per calendar year for violations due to willful neglect not corrected by the organization.
CMS-1135 and Public Health Emergency (PHE) Rules: With the advent of the COVID-19 pandemic, the CMS role is to ensure that Medicare beneficiaries are able to get safe and effective care during the COVID-19 Public Health Emergency (PHE) and also ensure that Medicare payment/coverage policies during this period do not “impede providers to expand capacity to treat patients. This is to ensure that during the pandemic, providers “may be reimbursed for such items and services and exempted from sanctions for such non-compliance, absent any determination of fraud or abuse.”5
The above has enabled CMS to enable significant flexibility in the provision of healthcare services by waivers and regulatory flexibility including waiving some pre-approval requirements, federal licensing requirements, Emergency Medical Treatment and Labor Act (EMTALA), Stark law and “certain deadlines and timetables for performance of required activities” that would have made such activities illegal as discussed earlier.
Such waivers will allow quick hospitals, facilities and providers to expand into other related services, go into partnership with third-parties/entities in providing services and also offer services that are not within clinical care like childcare, free meals or laundry to healthcare workers without the expected sanctions under the Stark law. Sanctions and penalties are also waived arising from noncompliance with HIPAA privacy regulations.6
Under regulatory control with flexibility, services that can be offered without legal consequence were expanded to include those through telehealth, types of physicians that can provide telehealth, lack of sanctions for hospital outpatients temporarily relocating due to PHE and getting exception from lower payments, enabling payments for services provided classified as new hospital level care under FEMA/DOED/State regulation such as in convention center, tents, hotel without incurring any legal liability, etc.
There are also state regulations allowing emergency issuance of state medical licenses by medical boards and also cross-border practice of medicine through telehealth without the need for medical licensing. Some of these waivers are limited to allowing continued care for old patients and not for new patients and also limited to only neighboring states.
Other legal liabilities under COVID-19 pandemic period could be due to negligence as defined above towards patients and towards employees. The Secretary of the Department of Health and Human Services on March 10, 2020 using the authority of the Public Readiness and Emergency preparedness Act of 2005 to provide immunity from legal liability for some providers and entities for claims related to some actions towards treatment and curtailing the COVID-19 pandemic with some states following the Federal in granting the same level of liability immunity to healthcare workers. For employees, such legal liability is not well defined but will be very difficult to prove in a pandemic condition based on recent case laws because of difficulty in proving that source of infection was at work and not elsewhere.7
Cutting Edge/ Unique Concepts/ Emerging Issues
Risk management in a rehabilitation setting involves taking steps to avert an actual or potential calamity through the provision of a safe and effective environment. This entails having a dedicated risk management department staffed with people experienced in taking appropriate steps in preventing or mitigating such risks. State and national regulatory bodies such as Joint Commission for Accreditation of Healthcare Organization (JCAHO) and Commission on Accreditation of Rehabilitation Facilities (CARF) also require this and are recognized by payors and the Center for Medical Services (CMS) as evidence of set standard of care.
This tends to involve the identification, analysis, treatment and evaluation of all possible hazards.
A dedicated risk manager will have the competence and responsibilities in ensuring prevention and reduction of loss, claims management, financial risk, risk regulatory and accreditation compliance5.
There are various protocols and steps that should be in place as part of risk management and these include:
- Adequate documentation of every patient encounter. The EMR helps in this regard.
- Policies, procedures and enforcement of treatment protocols as these form part of the operational steps and standards of care.
- Incidence and Occurrence reporting especially at the time of the incident by those directly involved. This could help in preventing such mishap in future by instituting new policies, training, etc. It could be also be the basis for evidence of events as part of the business record doctrine.
Gaps in Knowledge/ Evidence Base
- Studdert, D et al. Medical Malpractice. New England Journal of Medicine 2004;350:283
- Lesnik, M et al. Legal Aspects of Nursing. Lippincort, Philadelphia, PA. 1947 p. 258.
- Sewick, J et al. the Health care Risk Management Professional: Carroll, R (Ed): Risk Management Handbook for Health Care Organizations, 3rd ed. 2001. p. 3-4 Jossey-Bass. San Francisco
- Modernizing and Clarifying the Physician Self-Referral Regulations Final Rule (CMS-1720-F) https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-final-rule-cms-1720-f accessed January 25. 2021 (accessed on January 25, 2021).
- Medicare 1135 Waivers, May 2020; https://www.cms.gov/files/document/covid-19-regulations-waivers-enable-health-system-expansion.pdf (accessed November 15, 2020).
- Waiver or Modification of Requirements under section 1135 of the Social Security Act , March 13, 2020; https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx (accessed November 15, 2020).
- Immunity from liability in the age of COVID-19: A New reality for Trial Lawyers? https://www.americanbar.org/groups/litigation/committees/trial-practice/articles/2020/immunity-from-liability-covid-19-trial-lawyers/ (accessed on November 16, 2020).
Segun Dawodu, MD. Medico-legal considerations / risk management in rehabilitation. Published 9/11/2015
Segun Dawodu, MD
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