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  • Washington Highlights

    CMS Clarifies Informed Consent Required for “Sensitive Examinations”

    Gayle Lee, Director, Physician Payment & Quality
    For Media Inquiries

    On April 1, the Centers for Medicare & Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. 

    Along with the change in guidelines, the secretary of Health and Human Services and top officials from the department’s CMS and the Office of Civil Rights  sent a letter to teaching hospitals and medical schools emphasizing that “it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent.”

    The letter emphasized that if hospitals don’t obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws under the Health Insurance Portability and Accountability Act of 1996 and civil rights laws.