HHS, CMS update informed consent guidance

Hospitals will now need written informed consent from patients before medical professionals and students practice pelvic exams on unconscious female patients, according to updated guidance from the Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS).

The practice of performing pelvic exams on unconscious patients, which is considered a standard part of medical training and legal in about 30 states, involves medical students entering an operating room under supervision and inserting two fingers into a female patient’s vagina to feel for abnormalities in the uterus and ovaries. Often, these patients are under anesthesia for an unrelated procedure and are unaware that medical students are practicing the procedure on their bodies, according to multiple studies and reports.

The guidance also includes “pelvic, breast, prostate, or rectal examinations” and expands the type of provider to include advanced practice providers like nurse practitioners and physician assistants.

The change reflects ongoing state efforts to ban non-consensual pelvic exams and promote the practice of informed consent, which “includes the right to refuse” such examinations, HHS Secretary Xavier Becerra, CMS Administrator Chiquita Brooks-LaSure, and Melanie Fontes Rainer, director for Office for Civil Rights at HHS, wrote in a letter to teaching hospitals and medical schools.

“It is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent from patients before performing sensitive examinations in all circumstances,” according to the letter.

A “properly executed informed consent form” includes details like the name of the hospital, the specific procedure that requires consent, like a pelvic exam, the practitioner's name, a statement “anticipated benefits, material risks, and alternative therapies were explained to the patient,” and a dated signature from the patient, according to the guidance.

Nancy Foster, VP for quality and patient safety policy at the American Hospital Association, said in a statement to Healthcare Brew that the organization “appreciates the additional clarity” on consent form expectations.

“We look forward to sharing additional information with our member hospitals so that all can comply with those requirements,” she said.

Hospitals that don’t comply risk losing their Medicare funding and ability to participate in the program, according to CMS.

This could happen if a hospital is not compliant with Conditions of Participation (CoPs), which are enforced at a facility level—though Gayle Lee, senior director for policy and regulatory at Association of American Medical Colleges, told Healthcare Brew that action “is typically a last resort if the hospital does not follow a plan of correction and continues to be repeatedly out of compliance with the CoPs.”

“There is an implication in the HHS statement that there may be other federal laws, such as civil rights laws or HIPAA that could be implicated if the hospital did not obtain the required informed consent,” Lee said in a statement. “And those other laws may have some types of penalties associated with them (unrelated to Medicare payment).”