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The Meaning of Consent: The Government Provides New Clarification

April 3, 2024

In the opening lines of Pink Floyd’s trippy hit, Comfortably Numb, the doctor instructs the patient to provide a response, saying: “just nod if you can hear me.” While not an exact example of what the medical industry means by “informed consent,” it does help us to think about what that term means. What are the hospital personnel required to convey to the patient? What does the patient need to do to execute a satisfactory response?

According to the Ochsner Journal, informed consent, as a legal concept, began in 1905 with a series of four judicial decisions that dealt with the principles of patient autonomy in the areas of medical treatment and medical research. So, this is not a new notion. It’s been widely adopted and greatly refined over the last century or so; but, now, America’s premier rule-making agency for all things medical has decided that further refinement is required.

On April 1, the Centers for Medicare and Medicaid Services (CMS) issued updated guidance to state survey agency directors, clarifying standards for obtaining informed consent. The guidance came in the form of a memorandum that outlines certain changes in the agency’s “interpretive guidelines” (IGs) that relate to conditions of Medicare participation (CoPs) for hospitals.

The Change

The CMS memorandum specifies that it is revising its IGs in the Medicare State Operations Manual (SOM), Appendix A (for hospitals), at tag A-0955, to include under the example of a properly executed and well-designed informed consent form, as well as the hospital’s policy and process for informed consent, the following elements [new guidance in 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.

The agency goes on to explain that, while it understands the performance of such examinations has been necessary for teaching medical and other students important clinical examination skills, CMS believes patient permission for these exams is an essential part of the informed consent process for hospitals and necessary for compliance with the informed consent requirements in the CMS hospital CoPs.

Reason for the Change

The CMS memorandum provides a rationale for its decision to revisit and revise the guidelines pertaining to informed consent. The agency notes that a growing number of states have statutes regulating the performance of sensitive examinations on anesthetized patients. The scope of the examinations covered includes breast, pelvic, prostate, and rectal examinations, increasing the impact of these laws on surgeons. CMS believes, therefore, that there is a “broadening focus” on obtaining consent for any provider and learner performing these types of examinations. “This focus on the role of patient informed consent to obtain patient permission to perform these examinations has prompted CMS to reinforce the Hospital CoPs to revise our interpretive guidance regarding informed consent, and to clarify our expectations for hospitals regarding this issue.”

The memorandum provides an additional section summarizing its renewed focus on informed consent:

Based on increasing concerns about the absence of informed patient consent prior to allowing practitioners or supervised medical, advanced practice provider, or other applicable students to perform training- and education-related examinations outside the medically necessary procedure (such as breast, pelvic, prostate, and rectal examinations), particularly on anesthetized patients, we are reinforcing hospitals’ informed consent obligations.

Accordingly, surveyors will be required to 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.

Requirements related to informed consent for hospitals are found throughout the Hospital CoP material, such as: the Patient’s Rights CoP at 42 CFR 482.13(b)(2); the Medical Record Services CoP at 482.24(c)(4)(v); and the Surgical Services CoP at 482.51(b)(2). To view the complete five-page memorandum, please click on the following link: QSO-24-10 Hospitals (cms.gov).

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