HHS Mandates Written Informed Consent for Sensitive Patient Exams

The U.S. Department of Health and Human Services, through CMS, issued new guidance on April 1 clarifying that hospitals must obtain written informed consent for sensitive exams, such as pelvic, breast or prostate exams, particularly if patients will be unconscious during the exam. 

A letter jointly issued by HHS, CMS and the OCR to the nation’s teaching hospitals and medical schools addressing the informed consent issue reads in relevant part:

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. 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.

Hospitals that fail to obtain appropriate patient informed consent for these sensitive exams could be in violation of the Medicare Conditions of Participation. This may result in a provider being excluded from the Medicare and Medicaid programs. 

Failure to obtain appropriate informed consent for these exams could also lead to a violation of the HIPAA Privacy Rule. The letter noted that the OCR is investigating claims that patients’ protected health information (PHI) was used or disclosed to medical trainees in violation of the rule. According to the OCR, “The HIPAA Privacy Rule safeguards PHI from impermissible use and disclosure and further gives individuals the right to restrict who has access to their PHI, including in scenarios where they may be unconscious during a medical procedure.”

According to the CMS guidance, “Surveyors must ensure that a hospital’s patient informed consent policy and process, as well as its informed consent forms, contain elements and information that allow for a patient, or his or her representative, to make fully informed decisions about their care.” 

It is clear from the CMS guidance that the government expects hospitals to adopt policies that ensure providers and trainees obtain and document written informed consent from patients before performing these sensitive exams. Hospitals would be well served to review their informed consent policies and procedures and make appropriate changes to comply with CMS’ new guidance.

Please contact Jeff Moore or any member of Phelps’ Health Care team if you have questions or need advice or guidance.