Don’t Wait – CMS Expects Hospitals to Take Action on Informed Consent for Certain Exams and Procedures

Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent for supervised medical examinations of patients conducted by students for training purposes while the patients are undergoing surgery.[1] The new guidance was prompted by growing concerns of anesthetized patients being subjected to examinations of a sensitive nature for training and educational purposes without their knowledge or consent. Effective immediately, hospitals must now make patients aware that students may perform medical examinations or invasive procedures while patients are sedated or unconscious and first obtain their permission. In effect, patients must be made aware that they have a choice whether to participate. The examinations or invasive procedures affected by these new informed consent standards include, without limitation, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law.

New Standards

A hospital’s informed consent obligations are set forth in the Medicare Conditions of Participation (“CoPs”), including in matters affecting patient’s rights, medical records services, and surgical services. CMS provides interpretive guidance regarding the CoPs and informed consent during surgical procedures in its State Operations Manual (“SOM”). As a result of its recent concerns, however, CMS has expanded the SOM interpretive guidance in Appendix A-Hospitals to specifically account for informed consent to medical examinations and/or invasive procedures for educational and training purposes during surgery.

Surveyors will be responsible for ensuring that a hospital’s informed consent forms and policies allow patients or their representatives to make fully informed health care decisions. To comply with the new guidance, hospitals will need to ensure that their written informed consent forms and policies adhere to existing CMS standards, but also include the following revised disclosure elements for patients:

• Whether medical students, advanced practice provider students (e.g. nurse practitioners and physician assistants), and other applicable students will be performing important tasks related to the surgery; and
• Whether such individuals will be performing examinations or invasive procedures for educational and training purposes.

Note, that obtaining informed consent in these matters also applies to physicians other than the operating practitioner and to residents. However, surveyors will also evaluate whether a hospital’s implemented processes for obtaining informed consent comply with the new guidance in practice. Therefore, it will be important for hospitals to affirmatively adopt these new directives as part of the steps actually taken when obtaining informed consent when interacting with patients during pre-operative care stages.

National and Industry Trend

The new guidance from CMS is parallel with a growing trend across states that have enacted laws that specifically require informed consent for sensitive medical examinations. There are now at least twenty (20) states that have passed such laws, many of which during last five years. CMS has observed this trend and that these informed consent requirements are consistent with the standards of care held by many medical organizations. In essence, the new guidance is a move toward striking a balance between giving medical students opportunities to obtain essential hands-on experience in fundamental patient care settings and the important values of informed decision-making and preserving patient autonomy and trust between patients and providers.

Massachusetts

The new CMS standards for informed consent regarding students should also serve as an important reminder to the Massachusetts hospital community of comprehensive changes to physician informed consent rules promulgated by the Board of Registration in Medicine (the “BORIM”) in 2019. Attending physicians in Massachusetts not only are required to obtain and record a patient's written informed consent prior to any such procedure, intervention or treatment, but must also inform the patient of the names of all of the individuals participating in the procedure, intervention, or treatment prior to the start time. This disclosure must include the names of other physicians (e.g. anesthesiologist or assistant surgeon), as well as all physician extenders, such as a resident, fellow, physician assistant, advanced practice registered nurse, or other person authorized by the health care facility to participate in the procedure. The new CMS guidance and changes to the SOM regarding informed consent are consistent with the BORIM’s rules, though specific to supervised student examinations and procedures of a sensitive nature in a surgical setting. Therefore, the new CMS guidance presents a critical opportunity for Massachusetts hospitals to revisit their informed consent procedures to address both federal and state compliance.

What To Do

Hospitals may consider taking a multi-prong approach toward achieving compliance with the new CMS standards, which may include the following actions:

• Reviewing existing informed consent forms and corresponding written clinical policies to determine areas of compliance or non-compliance.
• Updating hospital forms and policies where necessary to include student examinations and procedures during surgery as needing informed consent; alternatively, develop separate informed consent forms specific to student medical examinations and/or procedures.
• Conducting in-service training for clinical and administrative staff, as appropriate, to ensure that the process actually implemented for obtaining informed consent includes discussion with the patient (or representative) specifically about student examinations and/or procedures.
• Maintaining clear documentation of when and how informed consent for such student involvement was obtained from the patient or denied on a pre-operative basis.
• Ensuring that appropriate personnel are aware of when a surgical patient has chosen to deny consent for student examinations and/or procedures and noting appropriately in the patient’s surgery chart.
• Working closely with health care attorneys to ensure informed consent processes and compliance plans align with relevant laws and regulations, both federal and state.

While each hospital addresses informed consent in its own way, all hospitals benefit from ongoing re-evaluation of their informed consent forms, policies, and implementation to facilitate compliance with the goals articulated by CMS in its guidance, avoid deficiency findings and malpractice claims, and promote transparent and respectful patient-provider relationships. Remember, informed consent is not just about paperwork and signatures—it’s about ensuring that patients fully comprehend their choices and rights in all things involving their care.

Verrill's team of seasoned health care attorneys have decades of experience representing hospitals and other institutional health care providers in regulatory, reimbursement, business, and transactional matters. For more information, please contact Andrew Ferrer or another member of Verrill's team.