For long-term care (“LTC”) facilities such as assisted living facilities and nursing homes, the high risk of spread once coronavirus disease 2019 (“COVID-19”) enters a facility means such facilities must take immediate action to protect residents, families, and healthcare personnel from severe infections, hospitalizations, and death. One such action that many States are taking is mandatory testing for the residents and employees of LTC facilities. Specifically, several states, including West Virginia, South Carolina and Florida, are now requiring mandatory testing of residents and employees of skilled nursing and assisted living facilities. Other states have similar proposed legislation in the works, including Pennsylvania, and it is likely that the number of states implementing such measures will continue to grow in the coming weeks and months. The White House has also indicated that the federal government may mandate testing nationwide for all nursing home residents and employees. While widespread testing of residents is an appropriate measure to protect the populations most vulnerable to the disease, mandatory testing raises the issue of whether and how to obtain informed consent from residents, many of whom use a medical powers of attorney (“MPOA”) for decisions regarding their care.
Although updated frequently, the CDC’s guidance regarding mandatory testing of residents and personnel at LTC facilities has not yet addressed the issue of informed consent. Federal regulations grant LTC facility residents the “right to request, refuse, and/or discontinue treatment, to participate in or refuse to participate in experimental research.”[1] In addition, many states have similar codified rights for the residents of assisted living facilities and nursing homes.[2] While some states also include provisions regarding overcoming informed consent requirements in emergency situations,[3] many states are silent regarding this point.[4]
However, federal courts have upheld emergency measures taken by States that curtail constitutional rights.[5] Specifically, the Supreme Court has found that while individual rights secured by the Constitution do not disappear during a public health crisis, such rights may be reasonably restricted during those times.
From a constitutional perspective, the federal courts have stated that “when faced with a society-threatening epidemic, a state may implement emergency measures that curtail constitutional rights so long as the measures have at least some real or substantial relation to the public health crisis and are not beyond all question, a plain, palpable invasion of rights secured by the fundamental law.”[6] For example, State-mandated vaccinations have been held to be a constitutional exercise of a State’s police power.[7]
Informed consent refers to the process of providing the patient with information about the proposed procedure including, but not limited to, benefits of the proposed procedure, risks of the proposed procedure, and alternatives to the proposed procedure. While informed consent to medical treatment is fundamental to the ethical practice of medicine, in the context of State-mandated tests, informed consent appears to become moot. In other words, to the extent States require COVID-19 tests, and such measures have been effected in response to a public health emergency, it is likely that the facilities would not suffer legal repercussions from not obtaining informed consent from residents. However, given the novelty of the COVID-19 circumstances, facilities should still in all possible situations obtain informed consent from residents prior to the implementation of testing measures. In addition, given that many residents of LTC facilities and nursing homes use MPOAs, facilities should begin reaching out to the appropriate contacts to explain the mandated testing measures being put into place and to obtain informed consent to the COVID-19 testing wherever possible.
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If you would like more information on the applicability and implications of mandated COVID-19 testing procedures, please contact your Husch Blackwell healthcare attorney.
[1] 42 C.F.R. § 483.10(c)(6).
[2] See, e.g., 6 Colo. Code Regs. § 1011-1:5-15 (residents of Colorado nursing care facilities have the “right to refuse medication and treatment, unless otherwise indicated by his or her practitioner . . .”); Ariz. Admin. Code R9-10-410(B)(4)(b) (nursing home residents or their representatives may refuse or withdraw consent for treatment before treatment is initiated); Fla. Stat. Ann. § 400.022 (nursing home residents have the right to refuse medication and treatment, unless otherwise indicated by the resident’s physician).
[3] See, e.g., Tex. Health & Safety Code Ann. § 313.003 (the Texas Consent to Medical Treatment Act does not apply to consent for emergency care); Ariz. Admin. Code R9-10-410(B)(4)(a) (residents or their representatives shall have the right to consent or refuse treatment, except in an emergency).
[4] For example, the Virginia nursing home and assisted living facility regulations do not address waiving informed consent requirements in light of emergency circumstances.
[5] See In re Abbott, 954 F.3d 772 (5th Cir. 2020).
[6] Id., at 784 (citations omitted).
[7] Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11, 27 (1905) (“The authority to determine for all what ought to be done in such an emergency must have been lodged somewhere or in some body; and surely it was appropriate for the legislature to refer that question, in the first instance, to a board of health composed of persons residing in the locality affected, and appointed, presumably, because of their fitness to determine such questions.”)