Informed Consent Clarification

Informed Consent Clarification from CMS

CMS recently published revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent. I have attached this memorandum from CMS for your review.

In summary, effective immediately, when any resident or student participates in a procedure requiring informed consent, the patient must agree to student participation. This includes nursing students, respiratory therapist students, EMT students, nurse practitioner students, nurse anesthetist students, physician assistant students, or medical students. The physician must discuss the student’s involvement with the patient or their representative and document the patient’s consent. Additionally, physicians must obtain consent when a student is performing an intimate examination outside the medically necessary procedure, such as breast, pelvic, prostate, and rectal examinations, particularly on an anesthetized patient.

From the CMS Memo:

“…we are revising our interpretive guidance…to include under the example of a properly executed and well-designed informed consent form, as well as the hospital’s policy and process for informed consent, the following elements…

• Whether practitioners other than the operating practitioner, including, but not limited to, other physicians, residents, advanced practice providers, and medical and other applicable students (such as nurse practitioner and physician assistant), will be performing important tasks related to the surgery, or examinations or invasive procedures for educational and training purposes, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines. Examinations or invasive procedures conducted for educational and training purposes include, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law.

• A written consent form is required for patients undergoing anesthesia procedures, but patients with the ability to verbally affirm consent for procedures that do not require anesthesia should have their medical record reflect that consent was given. In both instances there is written documentation of consent for any examinations.