Consents During the COVID-19 Pandemic

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The COVID-19 pandemic has many healthcare providers wondering whether they can suspend their consent and admission processes.  Although state and federal regulators have waived some consent requirements to provide greater flexibility and emphasis on patient care and social distancing, these waivers are narrow. 

More importantly, the legal reasons for obtaining patient consent- such as mitigating malpractice risk or creating a contractual agreement to pay for service - continue to exist.

Consent Requirements

Health care providers should continue to obtain a Consent to Treat form authorizing the provider to provide care and memorializing the patient’s agreement to pay for the care received.  This form should be obtained at the time of the patient’s first visit and then periodically thereafter; although it does not have to be obtained at each service.  Providers should also continue to obtain informed consent forms for invasive or experimental procedures.

During the COVID-19 pandemic, providers may want to implement alternative ways to document patient consent, including requesting patients complete electronic forms before admission or use mobile technology where patients can review and electronically sign consents on their mobile device.  The FDA suggests COVID-19 patients in isolation send a photograph of their signed consent form.

CMS approved the use of verbal consents for suspected or confirmed COVID-19 patients when necessary to prevent the likely spread of COVID-19. Providers using verbal consents should ensure they document in the patient’s record:

  • the consent that was read to the patient or his/her legal representative
  • his/her affirmative consent

The record should then be signed by both the provider and a witness. 

CMS has also relaxed requirements for telehealth services.  Providers providing telehealth services are only required to receive the Medicare beneficiary’s consent to telehealth services annually and not necessarily in advance of the service.

COVID-19 Provisions

Providers should consider adding COVID-19 specific language to their current consent forms. Some considerations for addition:

  • Address the risk of COVID-19 transmission
  • Acknowledge the patient is symptom-free
  • Inform the patient of the provider’s COVID-19 related policies
  • Waive claims relating to contracting COVID-19

Providers who provide COVID-19 testing, facilitate convalescent plasma donation, or provide convalescent plasma treatment will need to have specific consent forms for these purposes.

Community-Based Testing Sites

Sites used solely for COVID-19 testing purposes, such as a drive-thru or tent present unique challenges for obtaining consent and other information. Providers will need to consider how they will obtain and record patient consent, as well as contact and billing (if applicable) information.

Providers will also need to confirm the individual is 18 years old or a parent/legal guardian’s consent will be required. Strict HIPAA compliance is not required for such sites as the Office of Civil Rights for Health and Human Services has stated it will suspend HIPAA enforcement actions for providers participating in good faith in community-based testing sites. As a result, a notice of privacy practices will not be required.

Providers partnering with the State of Iowa to participate as Test Iowa sites are covered by the State’s protocols and do not need to obtain their own consent forms.

The Big Picture

A concern about sharing pens and clipboards shouldn’t stop health providers from obtaining consent from their patients. The consent forms are important to mitigate risk, ensure you can obtain payment for your services, comply with requirements from payors, and comply with the state and federal laws and regulations.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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