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Obtaining Patient Consent

Client Alert
October 4, 2023

Patients have autonomy to choose what can and cannot be done to their bodies. Therefore, informed consent is required before any treatments or procedures commence. This is a stark contrast to the previously recognized paternalistic approach, which relies solely on the decision-making of the provider.

However, in order for patients to really choose whether or not to submit themselves to a particular healthcare service, they must actually understand what the service is. Therefore, patient consent should help the patient understand the risks and benefits, as well as any alternative treatment options.

Obtaining Consent

Merely having a patient sign an informed consent is not enough for a patient to consent. Rather, providers should have an active dialogue with patients, which starts with explaining a diagnosis, the proposed treatment including its benefits and risks, and any alternative treatment options and their benefits and risks. Providers should allow patients to ask any clarifying questions they may have. Only after this dialogue can a signed consent be obtained.

While some states recognize verbal consents as valid, others require that patients sign an authorization form to show that consent was actually obtained.

Capacity to Consent

Even if a provider engages in a dialogue with a patient clearly laying out the patient’s diagnosis, treatment options, and benefits and risks, some patients still cannot consent due to lack of capacity. If a patient cannot understand or appreciate the benefits, risks, and alternatives, or cannot demonstrate reasoning in their decision-making, the patient likely does not have capacity to give a valid informed consent. One way to determine whether a patient has capacity is to have the patient restate in their own words what they understood about the dialogue with their provider.

Further, while minor patients may seem to have capacity, they are incapable of providing informed consent (although there are some exceptions in states where the minor is emancipated or is being treated for specific illnesses, such as sexually transmitted diseases). Therefore, consent to treat minors will generally require a parent or guardian’s signature. 

Penalties

Failure to adequately obtain informed consent may result in consequences, including but not limited to medical malpractice lawsuits, loss of hospital privileges, or removal from preferred provider lists.

If you have any questions regarding patient consent in general, or whether your current process for obtaining informed consent is compliant with applicable state and/or federal law, please don’t hesitate to contact BMD Health Law Group Member Jeana M. Singleton at jmsingleton@bmdllc.com or 330-253-2001, or BMD Attorney Rachel Stermer at rcstermer@bmdllc.com or 330-253-2019.  

Patient ConsentHealth LawHealthcare Policy
Client Alert

Changes to FFCRA Paid Leave: Congress’ Revisions to Employment COVID-19 Leave Benefits Signals the Light is at the End of the Tunnel

December 28, 2020Late in the evening on December 27th, President Trump signed into law the government’s $900 billion COVID-19 relief package (the “Stimulus Bill”). Among other economic stimulus benefits, the Stimulus Bill contains the $600 stimulus checks that will be issued to eligible individuals as well as, relevantly, changes to the Families First Coronavirus Response Act (“FFCRA”). The FFCRA was implemented in April 2020 and provided benefits to individuals who missed work as a result of an actual or suspected COVID-19 illness or to care for a child when their school or childcare service was closed because of COVID-19. Importantly, the Stimulus Bill extends eligibility for employer payroll tax refunds for leave payments made to employees on or before March 31, 2021 under the FFCRA, signaling to the American people that Congress believes many of the employed public will be vaccinated by this time, the light at the end of the tunnel. However, the Stimulus Bill does contain a caveat that employers are no longer required to provide FFCRA leave benefits after December 31, 2020, but if they do, they will receive the payroll tax credits, up to the maximums provided in the FFCRA, for payments made prior to April 1, 2021. Below we provide a list of questions and answers we received to date following the passage of the Stimulus Bill. We expect the U.S. Department of Labor (“DOL”) to issue additional questions and answers as the Stimulus Bill is implemented, and we will update this Client Alert as these are received.Client Alert

Healthcare Speaker Programs: New OIG Alert

December 11, 2020In a rare Special Fraud Alert issued on November 16, 2020 (the “Alert”), the Office of Inspector General (“OIG”) urged companies who host speaker programs to reassess their programs in light of the “inherent risks” associated with these activities. The Alert reports that, in the last three years, drug and device companies have reported paying nearly $2 billion to health care professionals for speaker-related services.Client Alert

Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes

December 11, 2020The Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued two highly anticipated (and quite extensive) Final Rules to reform the Stark Law and Anti-Kickback Statute (“AKS”) regulations. The Final Rules generally take effect on January 19, 2021. The Final Rules include new safe harbors for the AKS and new exemptions to the Stark Law to allow for greater flexibility. According to the HHS, the goal of updating both laws is to make it easier for providers to engage in care coordination and value-based care programs without running afoul of the statutes. Please note that this client alert could not cover the full extent of the Final Rule changes so please contact your BMD Healthcare attorney with questions.Client Alert

Mandatory Filings Under CFIUS New Rules

December 11, 2020On September 15, 2020, the Committee on Foreign Investment in the United States (“CFIUS”) promulgated a final rule modifying its mandatory declaration requirements for certain foreign investment transactions involving “TID US businesses” (sensitive U.S. businesses dealing in critical technologies, critical infrastructure and sensitive personal data) dealing in “critical technologies” – i.e., U.S. businesses that produce, design, test, manufacture, fabricate, or develop one or more critical technologies. The new rule also makes amendments to the definition of the term “substantial interest” (used to determine whether a foreign government has a substantial interest in an entity). The final rule became effective on October 15, 2020.Client Alert

IRS Guidance on Employee Retention Credit

December 11, 2020The Employee Retention Credit created under Section 2302 of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act is a refundable tax credit against certain employment taxes equal to 50 percent of the qualified wages an eligible employer pays to employees after March 12, 2020, and before January 1, 2021. Since the adoption of the CARES Act, employers have expressed concern that if one employer acquires another employer that previously received a PPP loan, the acquirer’s entire aggregated group may no longer be eligible to claim the Employee Retention Credit.
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