New and revised survey topics from the Centers for Medicare and Medicaid Services (CMS) took effect in January 2022. You should expect survey teams to include these topics during review of your facility. These include surveyor expectations for COVID-19 Vaccination of Healthcare Personnel, reinforcing EMTALA obligations for maternal patients, revisions to the Emergency Management Appendix of the State Operations Manual, and more focus on how organizations are addressing healthcare disparities. Organizations should ensure they review the hyperlinked references for greater detail.
COVID-19 Health Care Staff Vaccination Compliance
CMS released its mandate for the vaccination of health care staff against COVID-19 in Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination (https://www.cms.gov/files/document/qso-22-09-all-injunction-lifted.pdf). Organizations should pay particular attention to the applicable, respective attachment listed at the end of the document for details on vaccination requirements, including, which staff are required to be fully vaccinated, criteria for meeting fully vaccinated status, requirements for organizational policies and compliance tracking expectations.
Additionally, the organization-specific attachments to the QSO will provide detailed timeline expectations for implementing and completing their vaccination programs. The guidance also addresses the approach to take with vaccination exemptions, including medical and non-medical based exemptions and the provision of accommodations for those qualified.
Organizations will need to review the survey process section as it is specific to how compliance will be assessed through observation, interview, and record review. Scoring criteria for determining the level of deficiency is detailed at the end of the attachment. It is recommended that organizations use this document to run through a mock survey of the COVID-19 vaccination program to determine vulnerabilities and gaps.
Reinforcing EMTALA Rules for Pregnant Patients
There has been greater emphasis placed on maternal safety even prior to the pandemic. CMS has announced a new focus on EMTALA Obligation enforcement for pregnant women who present to a hospital with emergency conditions such as ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe symptoms. Details of this new push for maternal patient safety can be found in QSO-21-22-Hospitals: Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss (https://www.cms.gov/files/document/qso-21-22-hospital.pdf).
The new focus is aligned with the White House’s call for efforts to combat the Maternal Health crisis in the United States. With the nation experiencing the highest maternal mortality rate of any wealthy nation in the world, health care organizations can expect further attention placed on maternal safety standards.
Organizations should review their practice and ensure they are following EMTALA requirements regarding screening, treatment, and transfer of maternal patients in their Emergency Departments. They should ensure their policies and procedures provide clear direction on the delivery of care requirements to the maternal patient with respects to EMTALA obligations.
Revisions to Emergency Preparedness Appendix
CMS has revised Appendix Z (Emergency Preparedness) of the State Operations Manual to reflect the provisions outlined in the Burden Reduction Final Rule 84 FR 51732. This move, outlined in QSO-21-15-ALL, is to support efficiency, transparency, and a reduction of burden for organizations in managing their emergency preparedness programs. These changes are in the Updated Guidance for Emergency Preparedness-Appendix Z of the State Operations Manual (SOM) (https://www.cms.gov/files/document/qso-21-15-all.pdf)
- Facilities – expanding surveyor guidance on addressing potential deficiencies for alternate power sources. Clarification of current guidance on the use of portable generators and maintaining proper temperature controls.
- Exercises – new definitions of acceptable exercises based on the Burden Reduction Final Rule. Clarifications related to testing exercise exemptions when a provider/supplier experiences an actual emergency event.
- Program Management – Clarified expectations surrounding documentation of the emergency program. Additional guidance/considerations for Emerging Infectious Diseases (EID) planning stages. Added additional guidance on risk assessment considerations, to include EIDs. Planning considerations for surge and staffing with additional emphasis on natural disaster surge planning and EID surge planning.
- Operations - Included recommendations for facilities to monitor Centers for Disease Control and Prevention (CDC) and other public health agencies for event-specific guidance and recommendations to healthcare workers during public health emergencies. Expanded guidance and added clarification related to alternate care sites and 1135 Waivers. Established recommendations and best practices for reporting of facility needs, and the ability to provide assistance and occupancy reporting.
- Training – Extensively revised guidance related to the training and testing program, especially for outpatient providers.
Addressing Disparity in Healthcare
Prior to the start of the pandemic, it was known that regulatory agencies were starting to look at disparities in healthcare. The impact of the pandemic on the healthcare system may have even brought out more evidence of inequities in prevention and treatment of patients based on color, creed, gender, socioeconomic status, and the like. Earlier it was mentioned about the renewed focus on EMTALA for maternal patients. Part of the current White House administration’s efforts in addressing maternal safety include a call to leveling the access and quality of new and expectant mothers by confronting healthcare disparities to support improved patient outcomes. We expect there will be increased focus by regulatory and accrediting organizations on healthcare inequities as data is more closely analyzed.
As of now, there are no new regulations or standards addressing the issue of disparity in healthcare. However, organizations should consider reviewing the Department of Health and Human Services (HHS) Action Plan to Reduce Racial and Ethnic Health Disparities https://www.minorityhealth.hhs.gov/assets/pdf/hhs/HHS_Plan_complete.pdf) as the government’s vision for “a nation free of disparities in health and health care”. Even though disparity is not yet well defined, organizations should expect inquiries by survey teams as to how they define, identify, and mitigate it. Surveyors may not expect you to change what you monitor but want to know if you are looking at your data differently to determine if you have evidence of disparity upon which you can act.
As we see the most recent variant surge recede in the pandemic, we expect to see increased emphasis by CMS on the topics we have addressed. Organizations should ensure they have compared the applicable notifications and their programs for alignment. Expect a new focus on healthcare inequities with development in regulations as surveyors identify both gaps and best practices in organizations.