The U.S. Department of Health and Human Services (HHS) through the Centers for Medicare & Medicaid Services (CMS) on April 1 revised and clarified the Hospital Interpretive Guidelines for Informed Consent. The guidance relates to sensitive examinations by medical professionals, particularly on patients under anesthesia. Requirements related to informed consent are part of CMS’ Hospital Conditions of Participation.
CMS reports increasing concerns about the lack of informed patient consent before allowing health care professionals and students to perform examinations outside the medically necessary procedure, such as breast, pelvic, prostate, and rectal examinations, as a form of training or education.
The guidance requires hospitals to set clear guidelines to obtain informed consent before conducting sensitive examinations. Informed consent must be obtained and documented in all circumstances and should include the right to refuse sensitive examinations for teaching purposes or nonconsensual examinations under anesthesia. The patient or the patient representative must receive enough information, provided in a way that they can understand, to ensure that they can effectively make an informed decision.
A properly executed informed consent form should contain:
- Name of hospital where the medical treatment or procedure will take place.
- Name of medical treatment or procedure or which consent is being given.
- Name of administering practitioner.
- Statement that benefits, risks, and alternatives were explained to the patient or their representative.
- Signature of the patient or their representative.
- Date and time.
The informed consent form also may include additional information, such as notification that physicians other than the operating practitioner or other qualified medical practitioners may perform tasks related to the surgery under the supervision of the responsible practitioner.
HHS Secretary Xavier Becerra, CMS Administrator Chiquita Brooks-LaSure, and HHS Office for Civil Rights (OCR) Director Melanie Fontes Rainer wrote an accompanying letter to teaching hospitals and medical schools, emphasizing OCR’s commitment to enforcing HIPAA to protect patients’ protected health information and federal civil rights laws to prevent discrimination for patients undergoing sensitive examinations.
Contact Director of Policy Rob Nelb at rnelb@essentialhospitals.org or 202-585-0127 with questions.