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Updates Required! CMS Releases New Guidelines for Informed Consent

on Wednesday, 24 April 2024 in Health Law Alert: Erin E. Busch, Editor

The Centers for Medicare and Medicaid Services (CMS) recently updated guidelines for obtaining and documenting informed consent.  QSO-24-10[1] outlines CMS’ revisions and clarifications to the hospital interpretive guidelines.  While this guidance specifically summarizes the requirements for acute hospitals, critical access hospitals should also review and update policies and processes for informed consent.

The recent changes are in response to a growing concern about the absence of informed consent prior to sensitive procedures including breast, pelvic, prostate, and rectal exams.  Many of these procedures are performed in the context of training and education-related activities and are done while patients are under anesthesia.

The CMS Conditions of Participation for patient rights, medical record services, and surgical services describe the requirements for obtaining informed consent.  Hospitals are required to use a process that ensures patients are given information to make an informed decision whether to consent to a particular procedure or treatment.  This process must be documented in the patient’s medical record.  CMS also requires specific elements be included in a properly executed informed consent document including, but not limited to, the type of procedure or treatment, the responsible practitioner(s), the risks and benefits, and any alternatives. 

Recently, several articles and media stories have highlighted the practice of allowing supervised providers and students to perform sensitive and invasive exams on patients under anesthesia.  CMS recognizes that these exams are often part of required skills and curricula that clinical students and trainees must complete, but believes that patients must have the right to make informed decisions and give their full consent, for those training and education-related services.  Therefore, CMS is revising the interpretive guidelines (State Operations Manual, Appendix A, Tag A-0955) to include an example of a well-designed informed consent document and process.  The example includes new language that specifically includes advance practice providers and students in the list of practitioners, and a statement that certain tasks will be performed for educational and training purposes.  The guidelines also list examples of exams and invasive procedures including breast, pelvic, prostate, and rectal exams, as well as others specified under state law.

Hospitals should review and update informed consent forms, processes, and policies and procedures to reflect the new CMS guidance.  It is also important to educate and train providers and personnel responsible for obtaining and documenting patient informed consent to ensure compliance with the updated guidance.

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