Informed Consent Required for Pelvic, Breast, and Other Sensitive Exams

The U.S. Department of Health and Human Services announced updated guidelines regarding required written consent from patients for certain exams.

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Hospitals must obtain written consent from patients before performing certain examinations, including pelvic, prostate, breast, and rectal, especially if the patient is under anesthesia, the U.S. Department of Health and Human Services (HHS) announced in a memorandum on Monday.

HHS Secretary Xavier Becerra addressed the updated guidance in a letter to the nation’s teaching hospitals and medical schools. The memorandum was published through the HHS Centers for Medicare & Medicaid Services (CMS).

“The Department is aware of media reports as well as medical and scientific literature highlighting instances where, as part of medical students’ 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 said.

A New York Times investigation in 2020 found that hospitals, doctors, and medical trainees sometimes conducted pelvic exams on women while they were under anesthesia, even though the exams weren’t medically necessary and the patient hadn’t authorized the doctors to do so. The New York Times report also found that some exams were performed to educate medical trainees.

“With this attention, patient advocates, physicians, and the students themselves have expressed concern about whether patients, especially anesthetized patients, have been sufficiently informed about this practice and whether their full consent was obtained before these educational exams were performed,” CMS officials wrote in the memo.

Updated Guidelines

The memo included guidelines clarifying the requirements for informed consent and encouraged hospitals to establish clear guidelines for patients.

“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,” the letter said.

Informed consent was defined as “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.”

CMS said that all informed consent forms must include the name of the hospital, the name of the procedure, the name of the responsible practitioner, a statement that the treatment or procedure, including anticipated benefits, was explained to the patient’s legal representative, and the patient’s signature. These conditions must be met for hospitals to participate in Medicare and Medicaid programs.

“While CMS recognizes that these patient exams are often conducted as part of the vital skills clinical students must obtain during their training and education, we also firmly believe that patients have the right to make informed decisions on the healthcare services they receive so that they can give their full consent for those services including any training- and education-related examinations that may be performed in addition to any treatments or procedure that they expect to receive, especially if those patients will be under anesthesia at the time,” the CMS memo stated.

Hospitals rely heavily on Medicare and Medicaid reimbursements. According to the American Hospital Association (AHA), combined underpayments from Medicare and Medicaid to hospitals totaled $100 billion in 2020, up from $76 billion in 2019. The AHA reported that 94 percent of hospitals have 50 percent of their inpatient days paid by Medicare and Medicaid, and more than 75 percent have 67 percent of Medicare and Medicaid inpatient days.

In other words, they can’t go without payments from these government programs.

The policy’s effective date is immediate, but CMS stated that hospitals have 30 days to implement it.