CMS SOM App. B, Tag G434

The patient has the right to—

(4) Participate in, be informed about, and consent or refuse care in advance of and

during treatment, where appropriate, with respect to –

(i) Completion of all assessments;

(ii) The care to be furnished, based on the comprehensive assessment;

(iii) Establishing and revising the plan of care;

(iv) The disciplines that will furnish the care;

(v) The frequency of visits;

(vi) Expected outcomes of care, including patient-identified goals, and

anticipated risks and benefits;

(vii) Any factors that could impact treatment effectiveness; and

(viii) Any changes in the care to be furnished.

Interpretive Guidelines §484.50(c)(4)

The patient’s informed consent on the items (i)-(viii) is not intended to be recorded on a

single signed form. Informed consent and patient participation take place on an ongoing

basis as the patient’s care changes and evolves during his or her episodes of care. There

must be evidence in the patient’s medical record that, both initially and as changes occur

in the patient’s care, the patient was consulted and consented to planned services and

care.

“Participation” means that the patient is given options regarding care choices and

preferences. For example, patient preferences should be respected in encouraging the

patient to choose between a bath and a shower, unless there are physical restrictions or

medical contraindications that limit patient choice.

“Informed” means that all aspects of the planned care and services, and the way the care

and services will be delivered, are reviewed by HHA staff with the patient and that,

during such review, HHA staff solicits the patient’s agreement or disagreement. When

there is a change to the plan of care, whether initiated by the HHA/physician or at the

request of the patient, documentation in the clinical record should indicate whether the

patient was informed of and agreed to the changes.