CMS Modifies COVID-19 Education, Testing, and Vaccination Requirements

On May 31, the Biden Administration announced several changes [PDF] to existing policies that required facilities (e.g., hospitals, skilled nursing facilities [SNFs]) to provide COVID-19 testing and vaccination education and administration to patients and staff. With the end of the federally declared public health emergency (PHE) on May 11, this rule demonstrates the Centers for Medicare & Medicaid Services’ (CMS) intent to use quality and value-based care reporting requirements to control the spread of COVID-19 without the use of “mandates”. The policies outlined in this final rule will be effective in late July 2023; however, CMS indicates that it will not conduct audit and enforcement activities. In other words, the policies of the previous rules may technically remain in place for the next 60 days, but CMS will not enforce them. This essentially ends many of the following requirements, effective immediately. 

Facility Staff Vaccine Requirements

In November 2021, CMS issued an interim final rule with comment (IFC) that implemented a vaccine requirement for most Medicare and Medicaid certified providers and suppliers. CMS rescinded this requirement in this final rule [PDF]. 

In the latest final rule, CMS reiterated that this transition away from vaccine requirements was not a result of concerns regarding the safety or efficacy of the COVID-19 vaccine but rather a desire to align vaccine policies across various infectious diseases, such as influenza. In fact, many of the facility-based proposed rules (e.g., SNF) for fiscal year (FY) 2024 included quality measures associated with influenza and COVID-19 vaccination. These quality metrics are publicly reported on CMS maintained websites and could impact payment for these facilities. However, COVID-19 vaccines for staff will no longer be required for a facility to participate in the Medicare program. 

Under the November 2021 final rule, the following facility types were required to vaccinate staff and maintain records of these vaccinations. In addition, they had to establish policies by which staff could request an exemption to the vaccine requirement for health, religious, or other reasons. 

• Ambulatory Surgical Centers (ASCs) – § 416.51(c).
• Hospices – § 418.60(d).
• Psychiatric Residential Treatment Facilities (PRTFs) – § 441.151(c).
• Programs of All-Inclusive Care for the Elderly (PACE) Organizations – § 460.74(d).
• Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) – § 482.42(g).
• Long-Term Care (LTC) Facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs), generally referred to as nursing homes – § 483.80(i).
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) – § 483.430(f).
• Home Health Agencies (HHAs) – § 484.70(d).
• Comprehensive Outpatient Rehabilitation Facilities (CORFs) – § 485.70(n).
• Critical Access Hospitals (CAHs) – § 485.640(f).
• Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (Organizations) – § 485.725(f).
• Community Mental Health Centers (CMHCs) – § 485.904(c).
• Home Infusion Therapy (HIT) Suppliers – § 486.525(c).
• Rural Health Clinics (RHCs) and Medicare Federally Qualified Health Centers (FQHCs) – § 491.8(d).
• End-Stage Renal Disease (ESRD) Facilities – § 494.30(b).

The vaccine requirements did not apply to private practices and physician offices. As a result, audiologists and SLPs employed in most non-facility settings were not subject to federal vaccine requirements. However, ASHA members must consider any vaccination mandates imposed by a state or local jurisdictions or their employers. If these remain, clinicians may still be required to be vaccinated for employment, payment, and/or licensing purposes regardless of practice setting. 

Patient and Staff Testing Requirements

In September 2020, CMS issued an IFC that required long-term care facilities (LTCs) (e.g., SNFs) to test patients and staff for COVID-19 and report these results in an effort to slow transmission and maintain accurate public health data. These requirements have subsequently expired, and CMS is not renewing them. 

Patient and Staff Education Requirements

In May 2021, CMS published an IFC that modified the requirements for LTCs and the Conditions of Participation (CoPs) for ICFs-IID to require the provision of COVID-19 vaccination education and to offer vaccines to residents, clients, and staff. The IFC also revised the infection control requirements for LTC facilities to include COVID-19 data reporting. Through this final rule, CMS made permanent its policy that requires education and offering the COVID-19 vaccine to patients and staff. This documentation must be maintained by the facility.

Under this new policy, before offering a COVID-19 vaccine, all residents, resident representatives, and staff members must be provided with education regarding the benefits, risks, and potential side effects associated with the vaccine. When COVID-19 vaccines are available to the facility, each resident and staff member should be offered a COVID-19 vaccine unless the immunization is medically contraindicated, or the resident or staff member has already been immunized. In situations where COVID-19 vaccination requires multiple doses, the resident, resident representative, or staff member will be provided with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects associated with the COVID-19 vaccine, before requesting consent for administration of any additional doses.

The resident’s medical record must include, at a minimum, a) that the resident or resident representative was provided education regarding the benefits and potential risks associated with the COVID-19 vaccine; b) each dose of COVID-19 vaccine administered to the resident; or c) if the resident did not receive a COVID-19 vaccine due to medical contraindications or refusal. By doing so, LTC facilities must continue to educate residents, resident representatives, and staff about COVID-19 vaccines and offer a COVID-19 vaccine to residents, resident representatives, and staff, as well as complete the appropriate documentation for these activities.

The facility must also maintain documentation related to staff COVID-19 vaccination. The documentation must include, at a minimum, evidence that staff were informed about the risks and benefits of the COVID-19 vaccine. The facility must also document that staff were either offered the COVID-19 vaccine or provided with information on acquiring the COVID-19 vaccine. Lastly, the staff’s COVID-19 vaccine statuses and any associated information must be documented and reported to the National Healthcare Safety Network (NHSN) as indicated by the Centers for Disease Control and Prevention (CDC).

What’s Next?

ASHA members working in LTC facilities such as SNFs, inpatient rehabilitation facilities, and home health agencies, should be aware that while staff vaccination is no longer required by CMS, quality measures that track patient and staff vaccination rates are under consideration. If these measures are finalized, staff working in these settings may still be impacted by vaccination requirements.

Questions?

Email reimbursement@asha.org.