The Health and Human Services Department issued a guidance document and an open letter to teaching hospitals, medical schools and state regulators Monday reiterating that federal law requires informed consent to conduct tests on unconscious patients.
The guidance from the Centers for Medicare and Medicaid Services' Center for Clinical Standards and Quality and the letter from HHS Secretary Xavier Becerra, CMS Administrator Chiquita Brooks-LaSure and HHS Office for Civil Rights Director Melanie Fontes Rainer cite reports of patients undergoing "sensitive examinations" unrelated to their treatments while under anesthesia without consent.
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"The department is aware of media reports as well as medical and scientific literature highlighting instances where, as part of medical students’ courses of study and training, patients have been subjected to sensitive and intimate examinations — including pelvic, breast, prostate or rectal examinations — while under anesthesia without proper informed consent being obtained prior to the examination," the letter says.
The guidance cites a 2017 incident during which a woman who underwent stomach surgery, then woke up to discover medical residents had performed a Pap smear without her advance knowledge. The patient had a history of sexual abuse and the incident triggered a panic attack, according to a New York Times report.
"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," Becerra, Brooks-LaSure and Fontes Rainer wrote. These consent rules are enforceable under the Health Insurance Portability and Accountability Act of 1996 and civil rights laws, according to the agencies.
CMS wrote that hospitals should have comprehensive informed consent policies in place that comply with legal requirements and that state regulators are obligated to enforce those rules.
“While we recognize that medical training on patients is an important aspect of medical education, this guidance aligns with the standard of care of many major medical organizations, as well as state laws that have enacted explicit protections,” the letter says. “Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy.”
Except as specified for emergency situations, hospitals need written proof that a patient or their representative has been informed about their diagnosis, treatment options and potential risks, the guidance says.
"Informed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia," Becerra, Brooks-LaSure and Fontes Rainer wrote.
