PALTmed Connect is a website for Post Acute and Long-Term Care Medical Association (PALTMed) members to post questions related to the care of SNF patients. CMS has released new guidance this month to surveyors in the state operations manual regarding indications for Unnecessary Medications that update expectations for informed consent for psychotropic medications prior to their administration (CMS memo to surveyors QSO-25-07-NH).

Under federal regulations, for admissions, this can be delegated to the admitting nurse, but the nurse or prescriber should document the diagnosis for the medication, the intended benefits, the potential for serious side effects (“black box” warnings), the potential harms of not taking the medication, alternative medications, and disclosure if the use is “off-label.” CMS also expects simultaneous documentation of non-pharmacologic interventions to be implemented. If the patient or family needs further information, the facility nurse should call the admitting physician for their involvement.

To date, the consent forms I have seen and used in SNFs rely on the admitting physician to provide the name of the medication(s), the diagnostic indication and to sign that they have provided informed consent. The patient or surrogate decision-maker then also signs it.

In 2023, our state passed AB 48, the “Nursing Facility Resident Informed Consent Protection Act of 2023”, which updated the informed consent requirements for psychotropic medications (except antidepressants) in SNFs. The law requires written informed consent before administering psychotropic drugs, and the consent must be renewed every 6 months. Besides the CMS process noted above, residents and their representatives have the right to receive the written disclosure in a language they understand and, if this is not possible, in an oral explanation in their language. At the 6-month renewal, similar information should be provided, including information on dosage adjustments and the option to revoke consent.

AB 48 became law on January 1, 2024. CDPH, with input from CALTCM leaders and other stakeholders, has been developing a standardized form that will be required to document informed consent for psychotropic drugs. This form and the instructions for its use should become available soon. However, the requirements are already in effect, so facilities should already be utilizing forms for consent and providing patient information on psychotropic meds.

In the interim, we will be surveyed on the requirements of both federal and state law.

Is your facility in compliance with these expectations?