New HHS guidance requires consent for pelvic, breast, and other sensitive examinations

Hospitals performing pelvic and other sensitive exams for training purposes without patients’ explicit consent, including on anesthetized patients, won’t be eligible for Medicare and Medicaid reimbursement, according to new guidance released on Monday by the Department of Health and Human Services’ Centers for Medicare and Medicaid Services.

Examinations of sensitive areas — such breast, pelvic, prostate, and rectal examinations — are an important part of medical training, but they can be incredibly invasive and traumatic. Patients, advocates, and lawmakers have pushed for years to ensure that these exams require specific, informed patient consent. Yet it has been common practice among physicians in training to perform such examinations on anesthetized patients, often despite knowing patients had not given permission to do so.

In the absence of clear federal guidance, these exams have been regulated by individual state statutes. As of 2021, 14 states had rules protecting against non-consensual exams of anesthetized patients, according to a study published in January 2022 in the journal Annals of Surgery Open. These rules varied greatly in scope, often protecting only female patients from exams without consent or extending only to medical students and trainees.

The new HHS guidance harmonizes and expands these protections nationally, and it lists in detail the requirements for patient consent. The guidance says that a well-designed consent form must specify the name of the hospital; the procedure; the practitioner performing the exam; benefits and potential side effects; the name of the practitioner who informed the patient about their consent rights; statements from all other physicians or health professionals who might perform exams clarifying they will limit the scope of the examination to what is expressly consented to; and witness signatures.

“We want our students to have access to these exams so that they can learn and go on to be good physicians. But we can’t forgo patient care just so that they can have education. We also can’t ignore that medical education happens a lot on vulnerable people, Black women,” said Keisha Ray, an associate professor with the McGovern Center for Humanities & Ethics at the University of Texas Health Science Center at Houston. The guidelines, she said, are a welcome step that could help restore trust between the Black community and the medical establishment.

“A lot of the information that we know about gynecology and a woman’s body has come from Black women being used as guinea pigs, as experimentation,” said Ray. “A lot of these examinations that happen while patients are anesthetized are at teaching hospitals, and they tend to be state hospitals or public hospitals where a lot of the clientele are still low-income Black women.”

She added that the Black community has long complained about unwanted examinations and lack of consent, but that these concerns have routinely been ignored. And while she endorsed the new guidelines, Ray said that there are additional safeguards she’d like to see implemented. For instance, hospitals need to set up anonymous channels to report misconduct. “I know a lot of students, they’ll want to say something that they saw that was wrong, but they’re worried about their career,” Ray said. “So there has to be a way to do anonymous reporting that is not going to have some sort of whistleblower blowback on individual people.”