Ask Mary | April 2024

What are the Medicare requirements for informed consent?  

The patient’s informed consent on items (i)-(viii) under  COP 484.50(c)(4) are not intended to be recorded on a single signed form. Informed consent and patient participation takes 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 manner in which 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.