DHHS Revises and Clarifies Guidelines for Patients’ Informed Consent When Providing Sensitive Medical Care

April 17, 2024

DHHS Revises and Clarifies Guidelines for Patients’ Informed Consent When Providing Sensitive Medical Care

In recent years, Michigan has been home to two of the largest sexual abuse scandals involving doctors in history: the sexual abuse committed by Larry Nassar while employed by Michigan State University and the sexual abuse committed by Robert Anderson while employed by the University of Michigan. In both circumstances, the former doctors carried out their sexual abuse under the guise of medical procedures and without the informed consent of their targets. Michigan is not alone in being home to these types of sexual abuse scandals as similar acts have been alleged to have been committed by many other health care providers, such as Richard Strauss (Ohio State University), George Tyndall (University of Southern California), Derrick Todd (Bringham and Women’s Faulkner Hospital (Boston, MA)), Major Michael Stockin (United States Army), amongst others.

These cases have not only resulted in massive settlements (e.g. Tyndall ($1,100,000,000.00); Nassar ($900,000,000.00); Anderson ($490,000,000.00); Strauss ($40,900,000.00)), but have also lead to numerous systemic level changes in how medical providers operate when performing sensitive procedures on patients. This trend has recently continued with the United States Department of Health and Human Services’s (the “Department”) most recent guidance and regulations regarding obtaining a patient’s informed consent before performing any sensitive procedure on the patient.

On April 1, 2024, the Department sent a letter[i] and Memorandum QSO-24-10-Hospitals[ii] to the nation’s teaching hospitals and medical schools revising and clarifying healthcare provider guidelines and rules related to obtaining a patient’s informed consent prior to performing sensitive medical procedures on the patient (such as breast, pelvic, prostate, and rectal examinations), and particularly when the procedure is to be performed on an anesthetized patient.

Citing numerous media reports as well as a recent article published in the Annals of Surgery Open,[iii] the Department has recognized “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.” Xavier Becerra, Secretary for the Department, also wrote that “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 as well. Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy. We welcome the opportunity to work with providers to promote compliance with existing federal laws and plan to hold a webinar regarding this requirement soon.”

Informed consent rules for covered entities, such as hospitals, are found in the Patient’s Rights Condition of Participation at 42 CFR 482.13(b)(2); the Medical Record Services Condition of Participation at 482.24(c)(4)(v); and the Surgical Services Condition of Participation at 482.51(b)(2), and as further described in the State Operations Manual (“SOM”), Appendix A.

The Memorandum is from the Department’s Centers for Medicare and Medicaid Services (“CMS”), and provides a summary of the Department’s findings and revisions to its interpretative guidance found in the SOM, Appendix A for hospitals at tag A-0955. Importantly, the Memorandum reiterates that CMS “firmly believe[s] 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.”[iv]

CMS’s revised interpretive guidance of the SOM is contained below in CMS’s new example of the elements of a properly executed and well-designed patient informed consent form (new guidance is in bolded italics):

Whether physicians other than the operating practitioner, including, but not limited to, residents, medical, advanced practice provider (such as nurse practitioners and physician assistants), and other applicable students, will be performing important tasks related to the surgery, or examinations or invasive procedures for educational and training purposes, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines. Examinations or invasive procedures conducted for educational and training purposes include, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law.[v]

Importantly, covered entities must take note that the policy “should be communicated with all survey and certification staff, their managers, and the State/CMS Location training coordinators within 30 days of [April 1, 2024].”

Formed in 2018 by survivors of abuse committed by Larry Nassar, The Army of Survivors is a non-profit that brings awareness, accountability, and transparency to sexual violence against athletes at all levels. Upon learning of the Department’s letter and Memorandum, Executive Director Julie Ann Rivers-Cochran, MSW opined that “a patient's informed consent in healthcare settings is of the utmost importance, especially when considering examinations or procedures of a sensitive and intimate nature like breast or pelvic exams for individuals that have experienced the trauma of sexual abuse. Trauma-informed practices such as the right to refuse consent is essential in taking power back for some abuse survivors.”

Additional information and resources for survivors of abuse committed by medical professionals is maintained by the Rape, Abuse & Incest National Network (“RAINN”) and can be found at https://www.rainn.org/articles/sexual-abuse-medical-professionals.

Foster Swift recommends that health care providers review and update their patient consent forms in light of these new guidelines and rules. For assistance in updating yours or your organization’s patient consent forms, please contact the health care attorneys at Foster Swift Collins & Swift, P.C.

Alexander S. Rusek

Alexander S. Rusek is a Shareholder with Foster, Swift, Collins & Smith, P.C. in Lansing, Michigan. Mr. Rusek’s practice focuses on complex mass action and class action civil litigation, business law & litigation, criminal law, government relations, and appellate law. Mr. Rusek has represented established businesses, new businesses, non-profits, professionals, and individuals involved in multi-party, mass action, and class action litigation, notably representing over 100 survivors of sexual assault in the Michigan State University/Larry Nassar and University of Michigan/Robert Anderson litigations and a defendant in the Flint Water Crisis related civil and criminal litigations.

Mr. Rusek is a graduate of Oakland University and Michigan State University College of Law, cum laude. Mr. Rusek is a founder and board member of The Army of Survivors, Inc., board member of Highfields, Inc., board member and Vice-President of the Ingham County Bar Association, Past-President of the Ingham County Bar Association Young Lawyers Section, Past-Chairperson of the Ingham County Board of Commissioners Equal Opportunity Committee, former Democratic Precinct Delegate for Lansing’s Ward 1, Precinct 6, and a member of multiple local and national bar associations. Mr. Rusek is a 2023 recipient of the Ingham County Bar Association’s President’s Award, 2018 recipient of the Lansing Regional Chamber of Commerce 10 Over the Next 10 Award, a 2018 recipient of Oakland University’s Young Alumni 10 Within 10 Award, and a 2016 recipient of the Ingham County Bar Association Top 5 Under 35 Award. He has authored multiple articles that have appeared in the State Bar of Michigan Journal and other State Bar of Michigan publications, American Bar Association publications, the Detroit Bar Association’s Detroit Lawyer, the Ingham County Bar Association’s BRIEFS, and others. Mr. Rusek was Mental Health First Aid USA certified in 2019 and seeks to incorporate trauma-informed principles into his practice every day.

[i] Available online at https://www.hhs.gov/about/news/2024/04/01/letter-to-the-nations-teaching-hospitals-and-medical-schools.html.
[ii] Available online at https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states/revisions-and-clarifications-hospital-interpretive-guidelines-informed-consent.
[iii] Annals of Surgery Open 3(1):p e120, March 2022.
[iv] Available online at https://www.cms.gov/files/document/qso-24-10-hospitals.pdf
[v] Available online at https://www.cms.gov/files/document/qso-24-10-hospitals.pdf.