While You Were Sleeping: HHS Releases New Guidance on Sensitive Examinations
"Informed consent" has been described as "a bedrock principle of healthcare in a free society," and if a "patient is denied the ability to exercise or even consider informed consent, the patient's personal liberty suffers."1 The "informed consent doctrine has become firmly entrenched in American tort law" and the "notion of bodily integrity has been embodied in the requirement that informed consent is generally required for medical treatment."2
The U.S. Department of Health and Human Services (HHS) on April 1, 2024, issued a "[l] letter to the nations' teaching hospitals and medical schools"3 (Letter) announcing new interpretive guidelines4 from the Centers for Medicare and Medicaid Services (CMS) regarding informed consent. HHS issued the letter to "provide clarity" to hospitals regarding the performance of pelvic and other "sensitive examinations," especially on anesthetized patients. HHS stated that "[i]t is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent from patients before performing sensitive examinations in all circumstances." The Letter states that patients have the right to refuse consent to sensitive examinations done for teaching purposes, as well as "the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia."
The CMS guidance to which the Letter refers indicates that it was issued as a result of increased concerns about training-related exams being performed on patients without medical necessity – especially for patients under anesthesia. A number of Medicare Conditions of Participation for hospitals reinforce these informed consent obligations. Surveyors are required to make sure that a hospital's informed consent forms, policies and procedures allow patients to make full informed decisions about their care.
The Letter goes on to suggest that the privacy regulations implementing portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) give patients the "right to restrict who has access to" their protected health information (PHI), "including in scenarios where they may be unconscious during a medical procedure." Notably, HIPAA does not specifically give patients this right in all cases. In fact, a covered entity does not have to agree to a request to restrict the use or disclosure of PHI for treatment, payment or healthcare operations purposes, except in certain limited circumstances where a patient can prevent disclosure of PHI to a health plan if the patient has paid out of pocket in full for a procedure.5 The Letter cites a new HHS Office for Civil Rights (OCR) FAQ that correctly indicates that individuals can restrict who has access to their PHI during a procedure "if their health care provider agrees to the restriction."6 Individuals have the right to request these restrictions, but the "covered entity generally is not required to agree" to them.7
Prior to the Letter, a number of states already required special consent for certain procedures performed under anesthesia. For example, Florida law prohibits a healthcare practitioner or student from performing a pelvic exam on an unconscious or anesthetized patient without specific, express consent.8 California law prohibits pelvic exams conducted for training purposes on an anesthetized or unconscious female unless the patient gave informed consent or the exam is within the scope of care or required for diagnostic purposes.9 At least 20 states have similar laws.10
HHS also indicated in the Letter that OCR would be working with covered entities to ensure that their practices regarding sensitive examinations do not discriminate on the basis of a protected class, such as sex or race. HHS recognizes that medical training is important, but "[i]nformed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients' autonomy." HHS stated that it will hold a webinar regarding this requirement soon. CMS also indicated that it would be revising the hospital informed consent interpretive guidance in the State Operations Manual.
Notes
1 Vazzo v. City of Tampa, 415 F.Supp. 3d, 1087, 1100 (M.D. Fla. 2019); see also State v. Presidential Women's Ctr., 937 So. 2d 114, 116 (Fla. 2006) ("The doctrine of informed consent is well recognized, has a long history, and is grounded in the common law and based in the concepts of bodily integrity and patient autonomy."); San Juan-Torregosa v. Garcia, (80 S.W.3d, 539, 541 (Tenn. Ct. App. 2002) ("Most states have recognized that a person has the right to refuse unwanted medical treatment. Many states have found that this right stems from the common law right to be free from any type of medical treatment without giving informed consent.").
2 Cruzan v. Director, Missouri Department of Health, 497 U.S., 261, 269 (1990).
3 HHS: "Letter to the nation's teaching hospitals and medical schools" (visited April 13, 2024).
4 CMS: "Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent," Memo # QSO-24-10-Hospitals (April 1, 2024).
5 See 45 C.F.R. §164.522.
6 OCR FAQ (visited April 13, 2024).
7 Id.
8 See § 456.51, Fla. Stat.
9 See Cal. Bus. & Prof Code § 2281.
10 AP: "More states are requiring patients to give consent for medical students performing pelvic exams," (May 20, 2023) (visited April 13, 2024).