Georgia Watch Comments on New CMS Informed Consent Rules

The Centers for Medicare and Medicaid Services (CMS) has proposed new regulations related to the informed consent documents patients receive prior to elective procedures in hospitals. These documents are critical to effectively engaging patients in decisions about their healthcare. However, oftentimes these documents can be unhelpful or difficult to understand and are typically provided to the patient just before treatment when the patient is vulnerable and less likely to ask questions. The proposed CMS quality measure would require informed consent documents to be written in common language, describing the goals of the upcoming procedure and how it will be performed as well as any risks, benefits and alternatives to the treatment. Additionally, the document must be signed by the patient at least one day prior to the procedure. Georgia Watch applauds CMS for developing these new rules and recommends that CMS strengthen the proposed regulations further by requiring the inclusion of a disclosure of any financial incentives for the provider or hospital related to the proposed and alternative treatment(s). Georgia Watch also recommends creating a mechanism to ensure patient satisfaction with the informed consent process and raising the minimum passing score threshold for hospitals’ informed consent documents. You can read the full comments submitted by Georgia Watch here.