What is Patient Non-Compliance?
In order to understand how to provide efficient, safe, and law-abiding care while avoiding liability, the first thing that you must do is determine whether or not the patient is non-compliant. A patient who refuses a certain treatment may be non-compliant, and due diligence of knowing whether or not they are so is thus expected. Say, for instance, that a doctor prescribes an antibiotic to a patient who has strep throat. If a patient willfully does not fill his prescription, he could be seen as patient non-compliant . Alternatively, if a medical provider clearly tells the patient the important risks and benefits of the drugs, then the patient is not non-compliant by not taking it; in fact, he may have made a very educated decision. Either way, it is the obligation of the medical provider to try their best to inform the patient of each and every risk to his health. To be certain that the patient understands possible risks, it is important to write things down and document the completed conversation for posterity. Without documentation, it can be a he-said she-said kind of situation. Other ways to determine patient compliance is by giving each patient an informed consent form for all treatment.
Legal Responsibilities of Healthcare Professionals
When faced with a patient who is making decisions regarding his or her care that the doctor believes would be detrimental to health, the doctor must look at the legal and ethical landscape to determine how to proceed appropriately. If patients are entitled to make their own medical decisions, how does the doctor navigate these waters when the decisions made by the patient are not in the patient’s best interest?
The starting point for most legal analyses is with the principle of informed consent. Doctors have a legal obligation to discuss diagnosis and prognosis with patients as well as the benefits and risks of any treatment. When deciding on whether to implement a treatment plan, the physician has to balance the ethical obligation to provide necessary treatment against the legal obligation to explain medical decisions to patients.
This is balanced against the fact that the physician can only provide as much information as he or she knows. Doctors cannot be required to be omniscient. Doctors must ensure that patients understand the information accurately as well.
When there is a failure to obtain informed consent – that is, the patient did not have enough information to truly consent to the procedure performed – the doctor can be held liable for medical malpractice. Patients always have the right to refuse treatment, even life-saving treatment. In such circumstances, the physician must document the patient’s refusal and include the risks associated with refusing treatment in the documentation. It is advisable to have the patient sign off on the treatment options discussed as well as the refusal of treatment if appropriate.
If alternative treatment is available, the physician should discuss that with the patient as well, along with any applicable risks and benefits. The key is to fully document everything discussed with the patient and ensure that the patient signs off on the proposed treatment plan as well as the refusal of treatment by the patient if applicable.
In extreme circumstances, it may become necessary to contact patient guardianship services to assist. Generally, guardianship is limited to very specific circumstances, essentially if the patient truly does not have the capacity to make a decision. Most physicians, however, will find that by simply documenting the discussion and getting the patient’s signature on a treatment plan and refusal of treatment, both the doctor and patient will be able to make informed decisions together.
Possible Legal Ramifications for Patients
Denial of insurance claims for necessary medical care is one of the most obvious consequences of non-compliance. If the care deemed necessary to treat a condition is not followed, the medical provider may make a finding that this failure to comply with the prescribed treatment plan is a breach of policy terms and conditions. Therefore, the policyholder is not entitled to payment for the care and is still liable for those medical expenses. This is a frustrating outcome especially because the insured suffers both the adverse medical consequences of the condition and the improper denial of coverage.
However frustrating and unfair this seems, it is important to understand the insurance company has this right. No insurance policy provides coverage if it is not in "good standing." In these situations, a policy is violated, and a carrier will rightfully take the legal position that the policy has been invalidated.
In addition to denial of coverage for necessary care, increases of the premiums and/or deductibles are a frequent result of non-compliance. Again, there is no recourse for the policyholder. The insurance company is entitled to charge whatever it believes to be reasonable based on its underwriting guidelines and experience. A recurring problem is cases where rates are used to punish non-compliance but are not used to provide incentive for compliance. This is especially troubling in cases where serious consequences can result from the medications not being taken or treatment not being followed.
Legal Risk Mitigation for Physicians and Health Professionals
To mitigate legal risks associated with treating non-compliant patients, healthcare providers should ensure they have appropriate informed consent and disclosure processes in place. During the course of patient care, a provider is under a duty to warn the patient about the material risks inherent in both the proposed treatment and its alternatives. This includes warning the patient of the risk of non-compliance—its potential medical consequences and the legal implications. A provider’s duty to warn will depend on whether a physician-patient relationship existed, whether the risk of non-compliance was foreseeable, and whether the patient was objectively unreasonable in failing to achieve compliance. If a physician-patient relationship does not yet exist with a patient, and thus no duty to warn exists, the issue is likely one of risk management rather than legal consequence. The risks are high when a provider is not the physician directly supervising a patient’s care, or where, for whatever reason, medical records cannot be contemporaneously and appropriately updated . Attention to this potential risk factor is necessary prior to undertaking any provider-supervised care.
Healthcare providers should also educate patients on their responsibilities for self-care. Documentation of patient education is critical. Documentation may be the deciding factor in whether a patient’s non-compliance is deemed reasonable in light of the circumstances or an intervening cause of the adverse health outcome. An effective medical record is the best protection against frivolous litigation, whether it comes in the form of an intrusion into patient privacy through discovery, or an allegation of poor clinical training, inadequate supervision, lack of technical proficiency, or poor judgment. In the event that a provider’s care results in a negative outcome, an appropriately worded informed consent document signed by the patient, and signed by the patient before the treatment discussed, is often viewed as a bar to a malpractice claim. Healthcare providers cannot be expected to render optimal care to all patients at all times, so consent forms are of key importance.
Non-Compliance Case Studies
One of the best ways to understand the serious institutional and legal ramifications of HIPAA non-compliance is through case studies. Below are real-world, non-compliance case studies and the outcomes corresponding with each.
A patient filed a complaint with the Department of Human Resources, Office of Quality Assurance alleging that a hospital admitted a patient with tuberculosis (TB), known as a "TB suspect," to the hospital’s outpatient clinic without taking adequate precautions to ensure the safety of hospital staff and other patients. The complaint further alleged that the patient was permitted to use the hospital’s public restrooms, where, reportedly, staff members and other patients could contract TB germs, and that the hospital did nothing to stop this. The complaint was investigated by agency staff and substantiated following an onsite survey at the hospital. The hospital was served with a corrective action plan and was fined $1,000 for allegedly exposing its staff and other patients to a possible TB infection. The complaint was filed by the family member of a TB patient who later died from the disease.
The HHS recently announced that Atlanta Women’s Specialists, LLC, an Atlanta, Georgia based health center specializing in gynecological care, will pay $35,000 to settle potential violations of HIPAA’s Privacy Rule. An analysis by HHS determined that the company potentially violated the Privacy Rule by impermissibly disclosing PHI to the media and failing to have in place appropriate safeguards to protect PHI during the disclosure. The settlement resolves HHS’ determination that AWCC, doing business as Atlanta Women’s Specialists, violated the Privacy Rule on two occasions: on November 29, 2016, when the organization allegedly failed to adequately respond to a media inquiry about a former employee, and on December 2, 2016, when the organization allegedly sent information about the same media inquiry to 119 former patients via a non-encrypted email. HHS was alerted to the incident through the media and promptly notified AWCC that it was under investigation. The organization voluntarily undertook security measures to prevent further disclosure of unsecured PHI.
Ethics of Patient Non-Compliance
Healthcare practitioners face a serious ethical dilemma when dealing with a non-compliant patient. On the one hand, you have an ethical duty to work collaboratively with the patient and respect their right to make autonomous healthcare decisions. On the other hand, the provider has an ethical duty to act competently and to provide a standard of care that minimizes to the extent possible the risk of future injury to the patient and to third persons. The legal standards (i.e., "community standard" or "reasonable physician," etc.) recently adopted by some states have incorporated these ethical concepts into the laws governing physicians and other healthcare providers. Thus, it is important to understand how your state law frames the issue of the breach of a non-compliant patient.
For example, some states have no law addressing direct physician-patient contact when medical treatment is not accepted by a non-compliant patient . Other states explicitly define the "breaking of the shell" as direct contact with the patient. Some jurisdictions clearly find liability only when the provider is able to satisfy him or herself that the patient will accept the treatment and when continuing the current course of action is reasonably determined to entail a substantial risk of significant harm to the patient or third persons. Some courts have held that the referral to a specialist demonstrates the original provider’s acceptance of responsibility for patient care. Other jurisdictions base the duty to notify a non-compliant patient of the risk of continuing non-compliance on a physician’s ethical duty to "minimize foreseeable harms." Some states recognize a duty to third parties that may be harmed by a non-compliant patient.