New Informed Consent Guidance and Pharmacy Immunity
CMS Releases Guidelines on Informed Consent Requirements for Sensitive Examinations
New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid reimbursement if pelvic and other sensitive exams are performed for training purposes without patients’ explicit consent, including on anesthetized patients. The scope of the examinations covered by the guidance includes breast, pelvic, prostate, and rectal examinations.
The guidelines come after a growing number of states, in the absence of federal guidance, have implemented statutes to regulate the performance of sensitive exams. In the guidance, CMS reiterates the importance of patients having access to their health information and status and the need for informed consent. Recent concerns regarding informed consent when a student or trainee is performing a sensitive procedure and when a patient is under anesthesia have prompted this recent CMS guidance.
CMS revised its interpretive guidance in the State Operations Manual (SOM), Appendix A, for hospitals to include on the example informed consent form, as well as the hospital’s policy and process for informed consent, whether a “medical, advanced practice provider (such as nurse practitioners and physician assistants), and other applicable students” will be performing “examinations or invasive procedures for educational and training purposes.” Explicitly, the revised SOM provides a non-exhaustive list of such sensitive procedures: “[e]xaminations 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.”
In addition to the guidance, the secretary of HHS, along with CMS and the Office for Civil Rights, sent a letter to teaching hospitals and medical schools across the country expressing the agencies’ disapproval of the practice of physicians and students conducting such exams without explicit consent, especially while patients are under anesthesia. The letter stated that “[i]nformed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia.” The revisions to the SOM are effective immediately.
The full text of the April 1, 2024, CMS guidance can be accessed here.
Extension of COVID-19 Flexibilities and Immunities for Pharmacy Workers Through December 2024
As more time passes and COVID-19 is increasingly in the rearview mirror, the federal government continues to end certain rules related to COVID-19. For example, HHS and CMS published a final rule (88 FR 36485), effective August 4, 2023, that ended the vaccination requirement for CMS-certified healthcare facilities official. Even though the federal Public Health Emergency Declaration has ended, the secretary of HHS, Xavier Becerra, executed the 11th amendment to the declaration last year under the Public Readiness and Emergency Preparedness (PREP) Act. The initial PREP Act declaration provided flexibilities and protections for those individuals and entities that have been involved in providing critical COVID-19 countermeasures including vaccines, tests, and treatments.
The 11th amendment allows pharmacies to continue their critical roles in HHS’s response to COVID-19 and continues to extend liability immunities to pharmacy workers who are involved in the COVID-19 response. However, the 11thamendment only extends these flexibilities and immunities through December 2024.
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