1 Analyses of this federal-register by attorneys

  1. New Informed Consent Guidance and Pharmacy Immunity

    McCarter & English, LLPApril 11, 2024

    o 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 2024As 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.[View source.]